1999L0036 — EN — 17.01.2001 — 001.002 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE1999/36/EC
of29April1999
ontransportablepressureequipment
(OJ L 138, 1.6.1999, p. 20)
Amended by:
Official Journal
No page date
►M1Commission Directive 2001/2/EC of 4 January 2001 L 5 4 10.1.2001
Corrected by:
►C1Corrigendum, OJ L 168, 27.6.2002, p. 58 (1999/36/EC)
▼B
COUNCILDIRECTIVE1999/36/EC
of29April1999
ontransportablepressureequipment
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 75(1)(c) 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 withth e 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 transport safety;
(2)Whereas each Member State currently requires all transportableequipment to be used on its territory to undergo certification andinspection, including periodic inspections, by its designatedbodies; whereas this practice, requiring multiple approvals ifequipment is to be used in more than one State in the course of
a transport operation, constitutes an obstacle to the provision of
transport services within the Community; whereas action by theCommunity to harmonise approval procedures is justified inorder to facilitate the use of transportable pressure equipmenton the territory of another Member State in the context of atransport operation;
(3)Whereas measures should be adopted for the progressive estab-
lishment of a single market in transport and, in particular, for
free movement of transportable pressure equipment;
(4)Whereas action at Community level is the only possible way ofachieving such harmonisation, since Member States acting inde-pendently or through international agreements cannot establishthe same degree of harmonisation in the approvals for suchequipment; whereas, currently, recognition of approvals givenin different Member States is not satisfactory because of the
element of discretion;
(5)Whereas a Council Directive is the appropriate legal instrumentto enhance the safety of this equipment, as it provides a frame-
work for uniform and compulsory application of the approvalprocedures by Member States;
(6)Whereas Council Directives 94/55/EC(4) and 96/49/EC(5) have
extended the application of the provisions of the ADR(6) and
RID(7) to cover national traffic in order to harmonise across the
Community the conditions under which dangerous goods are
transported by road and by rail;1999L0036 — EN — 17.01.2001 — 001.002 — 2
(1) OJ C 95, 24.3.1997, p. 2, and OJ C 186, 16.6.1998, p. 11.
(2) OJ C 296, 29.9.1997, p. 6.
(3) Opinion of the European Parliament of 19 February 1998 (OJ C 80,
16.3.1998, p. 217), Council Common Position of 30 November 1998 (OJ C
18, 22.1.1999, p. 1) and Decision of the European Parliament of 10 March
1999 (not yet published in the Official Journal).
(4) Council Directive 94/55/EC of 21 November 1994 on the approximation of
the laws of the Member States with regard to the transport of dangerous
goods by road (OJ L 319, 12.12.1994, p. 7).
(5) Council Directive 94/49/EC of 23 July 1996 on the approximation of the
laws of the Member States with regard to the transport of dangerous goods
by rail (OJ L 235, 17.9.1996, p. 25).
(6) ADR: European Agreement concerning the International Carriage of
Dangerous Goods by Road.
(7) RID: Regulations concerning the International Carriage of Dangerous Goods
by Rail as set out in Annex I to Appendix B of the amended version of the
Convention concerning the international carriage of goods by rail (COTIF).
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(7)Whereas Directives 94/55/EC and 96/49/EC provide for the
option of applying conformity assessment procedures based on
modules in accordance withDecision 93/465/EEC(1) to certain
new transportable pressure equipment; whereas this optionshould be replaced by an obligation extended to cover all newtransportable pressure equipment used for the transport ofdangerous goods and falling within the scope of Directives 94/
55/EC and 96/49/EC;
(8)Whereas Directive 97/23/EC(2) lays down the general require-
ments for the free movement and safety of pressure equipment;
(9)Whereas aerosol dispensers and gas cylinders for breathingappliances should be excluded from the scope of this Directiveas their free movement and safety are already covered by Direc-tive 75/324/EEC(
3) and Directive 97/23/EC;
(10)Whereas recognition of the approval certificates issued by theinspection bodies designated by the Member States' competent
authorities, of the conformity assessment or reassessment proce-
dures and of the periodic inspection procedures contributestowards removing obstacles to freedom to provide transportservices; whereas such an objective cannot be achieved satisfac-torily at another level by the Member States; whereas, toeliminate the element of discretion, it is necessary to establish
clearly which procedures should be followed;
(11)Whereas it is necessary to lay down common rules for estab-
lishing recognition of designation inspection bodies whichensure compliance withDirectives 94/55/EC and 96/49/EC;whereas these common rules will have the effect of eliminatingunnecessary costs and administrative procedures related to theapproval of the equipment and of eliminating technical barriers
to trade;
(12)Whereas, in order not to hinder transport operations between a
Member State and a third country, this Directive should not beapplied to transportable pressure equipment exclusively used fortransport operations of dangerous goods between the territory ofthe Community and that of third countries;
(13)Whereas Member States have to designate inspection bodiesentitled to perform the conformity assessment or reassessment
procedures and periodic inspections; whereas they must also
ensure that such bodies are sufficiently independent, efficientand professionally able to carry out their appointed tasks;
(14)Whereas specific procedures should be introduced for evaluatingthe conformity of new valves and other accessories used fortransport;
(15)Whereas provisions should be introduced regarding the reassess-ment of existing equipment, as defined in Annex IV, Part II; so
as to enable this Directive to be applied to such equipment;
(16)Whereas compliance with the technical provisions of the
Annexes to Directives 94/55/EC and 96/49/EC for new equip-ment must be shown by means of the conformity assessmentprocedures set out in Annex IV, Part I; whereas periodic inspec-tions of existing equipment will be carried out according to the
procedures set out in Annex IV, Part III;1999L0036 — EN — 17.01.2001 — 001.002 — 3
(1) Council 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 harmonisation directive (OJ L 220, 30.8.1993, p. 23).
(2) Directive 97/23/EC of the European Parliament and of the Council of 29
May 1997 on the approximation of the laws of the Member Statesconcerning pressure equipment (OJ L 181, 9.7.1997, p. 1).
(
3) Council Directive 75/324/EEC of 20 May 1975 on the approximation of the
laws of the Member States relating to aerosol dispensers (OJ L 147,
9.6.1975, p. 40). Directive as amended by Directive 94/1/EC (OJ L 23,
28.1.1994, p. 28).
▼B
(17)Whereas equipment referred to in this Directive should bear a
mark to indicate its compliance withth e requirements of Direc-
tive 94/55/EC or 96/49/EC and this Directive in order to beplaced on the market, filled, used and refilled in accordancewithits intended purpose;
(18)Whereas Member States must allow transportable pressureequipment bearing the mark referred to in Annex VII to movefreely on their territory, to be placed on the market, to be usedin the course of any transport operation or to be used in accor-
dance with its intended purpose, without undergoing further
assessment or having to comply with further technical require-ments;
(19)Whereas it is appropriate that a Member State, provided itinforms the Commission, should be able to take measures tolimit or prohibit the placing on the market and use of equipmentin cases where it presents a particular risk to safety;
(20)Whereas a committee procedure should be followed for amend-ment of the Annexes to this Directive and for postponing thedate the Directive is brought into effect for certain transportablepressure equipment;
(21)Whereas provision should be made for transitional arrangementsto enable pressure equipment, manufactured in accordance withthe national rules in force before this Directive is brought into
effect, to be placed on the market and put into service;
(22)Whereas Directives 84/525/EEC(1) 84/526/EEC(2) and 84/527/
EEC(3) on gas cylinders provide for a conformity procedure
different from that provided for by this Directive; whereas asingle procedure should be established for all transportable pres-sure equipment;
(23)Whereas a periodic inspection procedure should be establishedfor existing gas cylinders which are in accordance with Direc-tives 84/525/EEC, 84/526/EEC and 84/527/EEC,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Scope
1. The purpose of this Directive shall be to enhance safety with
regard to transportable pressure equipment approved for the inlandtransport of dangerous goods by road and by rail and to ensure thefree movement of such equipment within the Community, including
the placing on the market and repeated putting into service and
repeated use aspects.
2. This Directive shall apply:
(a) for the purpose of placing on the market: to new transportable pres-
sure equipment as defined in Article 2;
(b) for the purpose of reassessment of conformity: to existing transpor-
table pressure equipment as defined in Article 2 which meets thetechnical requirements laid down in Directives 94/55/EC and 96/49/EC;1999L0036 — EN — 17.01.2001 — 001.002 — 4
(1) Council Directive 84/525/EEC of 17 September 1984 on the approximation
of the laws of the Member States relating to seamless, steel gas cylinders
(OJ L 300, 19.11.1984, p. 1).
(2) Council Directive 84/526/EEC of 17 September 1984 on the approximation
of the laws of the Member States relating to seamless, unalloyed aluminium
and aluminium alloy gas cylinders (OJ L 300, 19.11.1984, p. 20).
(3) Council Directive 84/527/EEC of 17 September 1984 on the approximation
of the laws of the Member States relating to welded unalloyed steel gas
cylinders (OJ L 300, 19.11.1984, p. 48).
▼B
(c) for repeated use and periodic inspections:
— to the transportable pressure equipment referred to in (a) and
(b),
— to existing gas cylinders bearing the conformity marking laid
down in Directives 84/525/EEC, 84/526/EEC and 84/527/EEC.
3. Transportable pressure equipment which was placed on the
market before 1 July 2001 or, in the case of Article 18, within two
years of that date and which has not been reassessed as to its confor-mity with the requirements of Directives 94/55/EC and 96/49/EC, shallbe outside the scope of this Directive.
4. Transportable pressure equipment used exclusively for the trans-
port of dangerous goods between Community territory and third-
country territory, carried out in accordance withArticle 6(1) andArticle 7 of Directive 94/55/EC or Article 6(1) and Article 7(1) and(2) of Directive 96/49/EC, shall be outside the scope of this Directive.
Article 2
Definitions
For the purposes of this Directive:1. ‘transportable pressure equipment’ means:
— all receptacles (cylinders, tubes, pressure drums, cryogenic
receptacles, bundles of cylinders as defined in Annex A toDirective 94/55/EC),
— all tanks, including demountable tanks, tank containers (mobile
tanks), tanks of tank wagons, tanks or receptacles of batteryvehicles or battery wagons, tanks of tank vehicles,
used for the transport of Class 2 gases in accordance with the
Annexes to Directives 94/55/EC and 96/49/EC and for the transportof certain dangerous substances of other classes indicated in AnnexVI to this Directive, including their valves and other accessoriesused for transport.
This definition excludes equipment subject to the general exemption
principles applicable to small quantities and to the special casesprovided for in the Annex to Directive 94/55/EC and the Annex to
Directive 96/49/EC as well as aerosol dispensers (UN number 1950)
and gas cylinders for breathing appliances;
2. ‘mark’ means the symbol referred to in Article 10;
3. ‘conformity assessment procedures’ means those procedures set out
in Annex IV, Part I;
4. ‘reassessment of conformity’ means the procedure for subsequent
assessment, at the request of the owner or his authorised representa-tive established in the Community or of the holder, of the
conformity of transportable pressure equipment already manufac-
tured and put into service before 1 July 2001 or, in the case ofArticle 18, within two years of that date;
5. ‘notified body’ means an inspection body designated by the national
competent authority of a Member State in accordance with Article 8and meeting the criteria of Annexes I and II;
6. ‘approved body’ means an inspection body designated by the
national competent authority of a Member State in accordance withArticle 9 and meeting the criteria of Annexes I and III.
Article 3
ConformityassessmentortheplacingontheCommunitymarketof
newtransportablepressureequipment
1. New receptacles and new tanks shall meet the relevant provisions
of Directive 94/55/EC and 96/49/EC. The compliance of such transpor-table pressure equipment with these provisions shall be established by anotified body exclusively in accordance withth e conformity assessmentprocedures set out in Annex IV, Part I, and specified in Annex V.1999L0036 — EN — 17.01.2001 — 001.002 — 5
▼B
2. New valves and other accessories used for transport shall meet
the relevant provisions of the Annexes to Directives 94/55/EC and 96/49/EC.
3. Valves and other accessories having a direct safety function in
transportable pressure equipment, in particular safety valves, valvesfor filling and emptying and cylinder valves, shall be subject to aconformity assessment procedure at least a stringent as that undergoneby the receptacle or tank to which they are fitted.
Suchvalves and oth er accessories used for transport may be subject to
a different conformity assessment procedure separate from that used for
the receptacle or tank.
4. Should Directive 94/55/EC and 96/49/EC not contain any detailed
technical provisions for the valves and accessories referred to in para-graph3, suchvalves and accessories must meet th e requirements ofDirective 97/23/EC and, pursuant to that Directive, be subject to a cate-
gory II, III or IV conformity assessment procedure as laid down in
Article 10 of Directive 97/23/EC according to whether the receptacleor tank belongs to category 1, 2 or 3 as laid down in Annex V to thisDirective.
5. No Member State shall prohibit, restrict or impede the placing on
the market or putting into service on its territory of transportable pres-
sure equipment referred to in Article 1(2)(a) which complies with thisDirective and bears the relevant mark provided for in Article 10(1) and(2).
Article 4
Conformity assessment for the placing on the national market of
newtransportablepressureequipment
1. By way of derogation from Article 3, Member States may
authorise on their territory the placing on the market, transport and
putting into service by users, of the receptacles — including theirvalves and other accessories used for transport — covered by Article1(2)(a), the conformity of which has been assessed by an approvedbody.
2. Transportable pressure equipment the conformity of which has
been assessed by an approved body may not bear the marking
described in Article 10(1).
3. The approved body shall work exclusively for the group of which
it is a member.
4. The procedures applicable to conformity assessment by approved
bodies shall be modules A1, C1, F and G, as described in Annex IV,
Part I.
5. The effects of this Article shall be monitored by the Commission
and evaluated as from 1 July 2004. To this end, Member States shallforward to the Commission any useful information on the implementa-tion of this Article. If necessary the evaluation shall be accompanied bya proposal for amendment of this Directive.
Article 5
Reassessment of conformity for existing transportable pressure
equipment
1. The conformity of the transportable pressure equipment referred
to in Article 1(2)(b) with the relevant provisions of the Annexes toDirectives 94/55/EC and 96/49/EC shall be established by a notifiedbody in accordance withth e conformity reassessment procedure set
out in Annex IV, Part II, to this Directive.
Where such equipment was manufactured in series, Member States
may authorise the reassessment of conformity with regard to recepta-cles, including their valves and other accessories used for transport, tobe carried out by an approved body provided that conformity of thetype is reassessed by a notified body.1999L0036 — EN — 17.01.2001 — 001.002 — 6
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2. No Member States shall prohibit, restrict or impede the placing
on the market or putting into service on its territory of transportablepressure equipment referred to in Article 1(2)(b) which complies with
this Directive and bears the relevant mark provided for in Article 10(1).
Article 6
Periodic inspectionandrepeateduse
1. Periodic inspections of the receptacles, including their valves and
accessories used for transport, referred to in Article 1(2)(c) shall be
arranged by a notified or approved body in accordance withth e proce-dure set out in Annex IV, Part III. Periodic inspections of tanks,including their valves and other accessories used for transport, shallbe arranged by a notified body in accordance withth e procedure laid
down in Annex IV, Part III, module 1.
However, Member States may permit periodic inspections of tanks
carried out on their territory also to be performed by the approvedbodies which have been recognised for carrying out periodic inspec-tions of tanks and which act under the supervision of a body notifiedunder the procedure provided for in Annex IV, Part III, Module 2concerning periodic inspection through quality assurance.
2. The transportable pressure equipment referred to in Article 1(2)
may be subjected to periodic inspection in any Member State.
3. No Member State may, on grounds concerning transportable pres-
sure equipment as such, prohibit, restrict or impede the use (includingfilling, storing, emptying and refilling) on its territory of the followingtransportable pressure equipment:
— the equipment referred to in Article 1(2)(a) and (b) and the first
indent of Article 1(2)(c), which satisfies the provisions of thisDirective and bears the corresponding mark,
— existing gas cylinders bearing the conformity mark provided for in
Directives 84/525/EEC, 84/526/EEC and 84/527/EEC and the markand identification number referred to in Article 10(3) of this Direc-tive indicating that it has undergone periodic inspection.
4. Member States may establishnational requirements for th e
storage or use of transportable pressure equipment, but not for transpor-
table pressure equipment itself or for the accessories needed during
transport. Member States may, however, pursuant to Article 7, retainnational requirements for connecting devices, colour codes and refer-ence temperatures.
Article 7
Nationalprovisions
1. A Member State may retain its national provisions concerning
devices intended for connection withoth er equipment and colour codesapplicable to transportable pressure equipment until suchtime asEuropean standards for use are added to the Annexes to Directives 94/
55/EC and 96/49/EC.
However, where safety problems arise with the transport or use of
certain types of gas, a short transitional period may be allowed, inaccordance withth e procedure laid down in Article 15, in order toenable Member States to retain their national provisions even after theEuropean standards have been added to the Annexes to Directives 94/
55/EC and 96/49/EC.
2. A Member State in which the ambient temperature is regularly
lower than − 20 ºC may impose more stringent standards as regardsthe operating temperature of material intended for use in the nationaltransport of dangerous goods within its territory until provisions onthe appropriate reference temperatures for given climatic zones areincorporated in the Annexes to Directives 94/55/EC and 96/49/EC.1999L0036 — EN — 17.01.2001 — 001.002 — 7
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Article 8
Notifiedbodies
1. Member States shall communicate to the Commission and the
other Member States the list of notified bodies established within theCommunity which they have designated to carry out the new transpor-
table pressure equipment conformity assessment procedures pursuant to
Annex IV, Part I, to reassess the conformity of existing types or equip-ment with the requirements of the Annexes to Directives 94/55/EC and96/49/EC pursuant to Annex IV, Part II, and/or to perform the task ofperiodic inspections pursuant to Annex IV, Part III, module 1 and/or to
perform the task of surveillance pursuant to Annex IV, Part III, module
2. They shall also communicate the identification numbers assigned tothem beforehand by the Commission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies, with their identification
numbers and the tasks for which they have been notified. The Commis-sion shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annexes I and II
for the designation of notified bodies. Each body shall submit to the
Member State which intends to designate it complete informationconcerning, and evidence of, compliance withth e criteria in AnnexesI and II.
3. A Member State which has notified a body shall withdraw such
notification if it finds that the body no longer meets the criteria referredto in paragraph2.
It shall forthwith inform the Commission and the other Member States
of any suchwith drawal of notification.
Article 9
Approvedbodies
1. Member States shall communicate to the Commission and the
other Member States the list of approved bodies established in theCommunity, which they have recognised in accordance with the criteria
of paragraph2, for th e purpose of carrying out periodic inspections of
receptacles — including their valves and other accessories used fortransport — referred to in Article 2(1), first indent, or conformity reas-sessment of existing receptacles — including their valves and otheraccessories used for transport — which conform to a type reassessedby a notified body, to ensure continued compliance withth e relevant
provisions of Directives 94/55/EC and 96/49/EC in accordance with
the procedures laid down in Annex IV, Part III, module 1. They shallalso communicate the identification numbers assigned to them before-hand by the Commission.
Member States using the option provided for in Article 6(1), second
subparagraph, shall also communicate to the Commission and the otherMember States the list of approved bodies established in the Commu-nity, which they have recognised for the purpose of carrying outperiodic inspections of tanks.
The Commission shall publish in the Official Journal of the European
Communities a list of the approved bodies recognised, with their iden-
tification numbers and the tasks for which they have been recognised.The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annexes I and III
for the recognition of approved bodies. Each body shall submit to theMember State which intends to recognise it complete informationconcerning, and evidence of, compliance with the criteria in those
Annexes.
3. A Member State which has recognised a body shall withdraw the
approval if it finds that the body no longer meets the criteria referred toin paragraph2.1999L0036 — EN — 17.01.2001 — 001.002 — 8
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It shall forthwith inform the Commission and the other Member States
of any suchwith drawal of approval.
Article 10
Marking
1. Without prejudice to the requirements for the marking of recepta-
cles and tanks laid down in Directives 94/55/EC and 96/49/EC,receptacles and tanks satisfying the provisions of Article 3(1) andArticle 5(1) shall have a mark affixed to them in accordance withAnnex IV, Part I. The form of the mark to be used is set out in AnnexVII. This mark shall be visibly and immovably affixed and shall be
accompanied by the identification number of the notified body which
has performed the conformity assessment procedure on the receptaclesand tanks. In the event of reassessment, this mark shall be accompaniedby the identification number of the notified or approved body.
For transportable pressure equipment complying withArticle 7(2), th e
identification number of the notified or approved body shall befollowed by ‘− 40 ºC’.
2. New valves and other accessories having a direct safety function
shall bear either the mark provided for in Annex VII hereto or that
provided for in Annex VI to Directive 97/23/EC. Suchmarks need not
be accompanied by the identification number of the notified bodywhich carried out the conformity assessment on the valves and otheraccessories used for transport.
The other valves and accessories shall not be subject to any special
marking requirements.
3. Without prejudice to the requirements for the marking of recepta-
cles and tanks laid down in Directives 94/55/EC and 96/49/EC, for thepurposes of periodic inspections, all transportable pressure equipmentreferred to in Article 6(1) shall bear the identification number of the
body which performed the periodic inspection of the equipment to indi-
cate that it may continue to be used.
Withregard to gas cylinders covered by Directives 84/525/EEC, 84/
526/EEC and 84/527/EEC, when the first periodic inspection is carriedout in accordance with this Directive, the aforementioned identificationnumber shall be preceded by the mark described in Annex VII.
4. For bothconformity assessment and reassessment and for periodic
inspections, the identification number of the notified or approved bodyshall be visibly and immovably affixed under its responsibility eitherby the body itself or by the manufacturer, or his authorised representa-
tive established within the Community, or by the owner or his
authorised representative established in the Community, or by theholder.
5. The affixing of markings on transportable pressure equipment
which are likely to mislead third parties with regard to the meaning orthe graphics of the mark referred to in this Directive shall be prohib-ited. Any other marking may be affixed to equipment provided that
the visibility and legibility of the marking in Annex VII is not thereby
reduced.
Article 11
Safeguardclause
1. Where a Member State finds that transportable pressure equip-
ment, when correctly maintained and used for its intended purpose, isliable to endanger the health and/or safety of persons and, where appro-
priate, domestic animals or property, during transport and/or use,
notwithstanding the fact that it bears a mark, it may restrict or prohibitthe placing on the market, transport or use of the equipment in questionor have it withdrawn from the market or from circulation. It shall forth-with inform the Commission of any such measure, indicating thereasons for its decision.1999L0036 — EN — 17.01.2001 — 001.002 — 9
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2. The Commission shall enter into consultation with the parties
concerned without delay. Where the Commission considers, after thisconsultation, that the measure is justified, it shall immediately so
inform the Member State which took the initiative and the other
Member States.
Where the Commission considers, after this consultation, that the
measure is unjustified, it shall immediately so inform the Member Statewhich took the initiative and the owner or his authorised representative
established in the Community or the holder, or the manufacturer or his
authorised representative established within the Community.
3. Where transportable pressure equipment which does not comply
bears the marking provided for in Article 10, the competent MemberState shall take appropriate action against the person(s) who affixedthe marking and shall so inform the Commission and the other Member
States.
4. The Commission shall ensure that the Member States are kept
informed of the progress and outcome of this procedure.
Article 12
Unduemarking
Without prejudice to Article 11, where a Member State establishes that
the marking described in Annex VII has been affixed unduly, theowner or his authorised representative established in the Community
or the holder, or the manufacturer or his authorised representative
established within the Community, shall be obliged to make the trans-portable pressure equipment conform as regards the provisionsconcerning the marking and to end the infringement under the condi-tions imposed by the Member State.
Should non-conformity persist, the Member State shall immediately
inform the Commission othereof and take all appropriate measures to
restrict or prohibit the placing on the market, transport or use of theequipment in question or to ensure that it is withdrawn from the marketor from circulation in accordance withth e procedure laid down inArticle 11.
Article 13
Decisionsleadingtorefusalorrestriction
Any decision taken pursuant to this Directive which has the effect of
restricting the placing on the market, transport or use or requires the
withdrawal from the market or from circulation of transportable pres-sure equipment shall state the exact grounds on which it is based.Such Decision shall be notified forthwith to the party concerned, whoshall at the same time be informed of the legal remedies available tohim under the laws in the Member State concerned and of the time
limits to which such remedies are subject.
Article 14
Committee
The amendments necessary for adapting the Annexes to this Directive
shall be adopted in accordance with the procedure laid down in Article15.
Article 15
1. Where reference is made to the procedure provided for in this
Article, the Commission shall be assisted by the Committee on the
transport of dangerous goods set up under Article 9 of Directive 94/
55/EC, hereinafter referred to as ‘the Committee’, composed of repre-sentatives of the Member States and chaired by a representative of theCommission.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee shall1999L0036 — EN — 17.01.2001 — 001.002 — 10
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deliver its opinion on the draft within a time limit which the chairman
may lay down according to the urgency of the matter. The opinionshall be delivered by the majority laid down in Article 148(2) of the
Treaty in the case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives ofthe Member States within the Committee shall be weighted in themanner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in
accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the
Committee, or if no opinion is delivered, the Commission shall,
without delay, submit to the Council a proposal relating to themeasures to be taken. The Council shall act by a qualified majority.
If within three months of the date of referral to the Council the Council
has not acted, the proposed measures shall be adopted by the Commis-sion.
Article 16
Adoptionandpublication
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply withth is Directive no
later than 1 December 2000. They shall forthwith inform the Commis-sion thereof.
When Member States adopt those measures they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on theoccasion of their official publication. The methods of making such
reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of
the main provisions of national law which they adopt in the fieldgoverned by this Directive.
Article 17
Implementation
1. Member States shall adopt no later than 1 July 2001 the provi-
sions which they have adopted to comply with this Directive totransportable pressure equipment.
2. The date referred to in paragraph 1 shall be deferred for certain
transportable pressure equipment for which there are no detailed tech-
nical specifications or for which adequate reference to the relevant
European standards has not been added to the Annexes to Directives94/55/EC and 96/49/EC.
The equipment concerned by any such deferral and the date on which
this Directive becomes applicable to it shall be determined in accor-dance withth e procedure laid down in Article 15.
Article 18
Transitionalarrangements
Member States shall authorise the placing on the market and putting
into service of transportable pressure equipment which complies with
the regulations in force within their territory before 1 July 2001 until24 months from that date and shall authorise the subsequent puttinginto service of such equipment placed on the market prior to that date.
Article 19
Penalties
Member States shall lay down a system of penalties for breaches of the
national provisions adopted pursuant to this Directive and shall take allthe measures necessary to ensure that those penalties are applied. The1999L0036 — EN — 17.01.2001 — 001.002 — 11
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penalties thus provided for shall be effective, proportionate and dissua-
sive.
Member States shall notify the relevant provisions to the Commission
not later than 1 December 2000 and shall inform it of any subsequent
changes as soon as possible.
Article 20
ApplicabilityofprovisionsofotherDirectives
As from 1 July 2001 or, in the case of Article 18, within two years of
the date, the only provisions of Directives 84/525/EEC, 84/526/EECand 84/527/EEC to remain applicable shall be those of Article 1 andthose of Annex I, Parts 1 to 3, of each of those Directives.
The provisions of Directive 76/767/EEC(
1) shall no longer apply from
1 July 2001 or, in the case of Article 18, within two years of that date,for transportable pressure equipment falling within the scope of this
Directive.
However, EEC pattern approval certificates for cylinders, issued
pursuant to Directives 84/525/EEC, 84/526/EEC and 84/527/EEC shallbe recognised as equivalent to the EC type-examination certificatesprovided for in this Directive.
Article 21
This Directive shall enter into fore on the day of its publication on the
Official Journal of the European Communities .
Article 22
This Directive is addressed to the Member States.1999L0036 — EN — 17.01.2001 — 001.002 — 12
(1) Council Framework Directive 76/767/EEC of 27 July 1976 on the approxi-
mation of the laws of the Member States relating to common provisions for
pressure vessels and methods of inspecting them (OJ L 262, 27.9.1976, p.
153). Directive as last amended by the 1994 Act of Accession.
▼B
ANNEX I
MINIMUM CRITERIA TO BE MET BY NOTIFIEDOR APPROVED
BODIES,ASREFERREDTOINARTICLES8AND9
1. A notified inspection body or an approved inspection body that is part of an
organisation involved in functions other than inspection must be identifiable
within that organisation.
2. The inspection body and its staff must not engage in any activities that may
conflict with their independence of judgment and integrity in relation to their
inspection activities. In particular the staff of the inspection body must be
free from any commercial, financial and other pressures which might affect
their judgment, particularly from persons or organisations external to the
inspection body with an interest in the results of inspections carried out. the
impartiality of the inspection staff of the body must be guaranteed.
3. The inspection body must have at its disposal the necessary staff and possess
the necessary facilities to enable it to perform the technical and administra-
tive tasks connected withth e inspection and verification operations properly.
It must also have access to the equipment required to perform special verifi-
cations.
4. The staff of the inspection body who are responsible for inspection must
have appropriate qualifications, sound technical and vocational training and
a satisfactory knowledge of the requirements of the inspections to be carried
out and adequate experience of suchoperations. In order to guarantee a h igh
level of safety the inspection body must be in a position to provide expertise
in the field of safety of transportable pressure equipment. The staff must
have the ability to make professional judgments as to conformity with
general requirements using examination results and to report thereon. They
must also have the ability required to draw up the certificates, records and
reports to demonstrate that the inspections have been carried out.
5. They must also have relevant knowledge of the technology used for the
manufacturing of the transportable pressure equipment, including accessories,
which they inspect, of the way in which the equipment submitted to their
inspections is used or is intended to be used, and of the defects which may
occur during use or in service.
6. The inspection body and its staff must carry out the assessments and verifica-
tions with the highest degree of professional integrity and technical
competence. The inspection body must ensure the confidentiality of informa-
tion obtained in the course of its inspection activities. Proprietary rights must
be protected.
7. The remuneration of persons engaged in inspection activities must not
directly depend on the number of inspections carried out and in no case on
the results of such inspections.
8. The inspection body must have adequate liability insurance unless its liability
is assumed by the State in accordance with national laws or by the organisa-
tion of which it forms a part.
9. The inspection body must itself normally perform the inspections which it
contracts to undertake. When a inspection body sub-contracts any part of
the inspection, it must ensure and be able to demonstrate that its sub-
contractor is competent to perform the service in question and must take
full responsibility for that sub-contracting.1999L0036 — EN — 17.01.2001 — 001.002 — 13
▼B
ANNEX II
SUPPLEMENTARY CRITERIA TO BE MET BY THE NOTIFIED
BODIESREFERREDTOINARTICLE8
1. A notified body must be independent of the parties involved and therefore
provide ‘third party’ inspection services.
The notified body and its staff responsible for carrying out the inspection
must not be the designer, manufacturer, supplier, purchaser, owner, holder,
user or maintainer of the transportable pressure equipment, including acces-
sories, which that body inspects, nor the authorised representative of any of
these parties. They must not be directly involved in the design, manufacture,
marketing or maintenance of the transportable pressure equipment, including
accessories, nor represent the parties engaged in these activities. This does
not preclude the possibility of exchanges of technical information between
the manufacturer of transportable pressure equipment and the inspection
body.
2. All interested parties must have access to the services of the inspection body.
There must be no undue financial or other conditions. The procedures under
which the body operates must be administered in a non-discriminatory
manner.1999L0036 — EN — 17.01.2001 — 001.002 — 14
▼B
ANNEX III
SUPPLEMENTARY CRITERIA TO BE MET BY THE APPROVED
BODIESREFERREDTOINARTICLE9
1. The approved body must form a separate and identifiable part of an organisa-
tion involved in the design, manufacture, supply, use or maintenance of the
items it inspects.
2. The approved body must not become directly involved in the design, manu-
facture, supply or use of the transportable pressure equipment, including
accessories inspected, or similar competitive items.
3. There must be a clear separation of the responsibilities of the inspection staff
from those of the staff employed in the other functions, which must be estab-
lished by organisational identification and the reporting methods of the
inspection body within the parent organisation.1999L0036 — EN — 17.01.2001 — 001.002 — 15
▼B
ANNEX IV
PART I
CONFORMITYASSESSMENTPROCEDURES
ModuleA (internal production control)
1. This module describes the procedure whereby the manufacturer, or his
authorised representative established within the Community who carries out
the obligations laid down in point 2, ensures and declares that transportable
pressure equipment satisfies the requirements of the Directive which apply to
it. The manufacturer, or his authorised representative established within the
Community, must affix the Πmarking to all transportable pressure equip-
ment and draw up a written declaration of conformity.
2. The manufacturer must draw up the technical documentation described in
point 3 and either the manufacturer or his authorised representative estab-
lished within the Community must keep it at the disposal of the relevant
national authorities for inspection purposes for a period of 10 years after the
last of the transportable pressure equipment has been manufactured. Where
neither the manufacturer nor his authorised representative is established
within the Community, the obligation to keep the technical documentation
available is the responsibility of the person who places the transportable pres-
sure equipment on the Community market.
3. The technical documentation must enable an assessment to be made of the
conformity of the transportable pressure equipment with the requirements
of the Directive which apply to it. It must, as far as is relevant for such
assessment, cover the design, manufacture and operation of the transpor-
table pressure equipment and contain:
— a general description of the transportable pressure equipment,
— conceptual design and manufacturing drawings and diagrams of
components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the
said drawings and diagrams and the operation of the transportable
pressure equipment,
— a description of the solutions adopted to meet the requirements of the
Directive,
— results of the design calculations, examinations carried out, etc.,
— test reports.
4. The manufacturer, or his authorised representative established within the
Community, must keep a copy of the declaration of conformity with the
technical documentation.
5. The manufacturer must take all measures necessary to ensure that the
manufacturing process requires the manufactured transportable pressure
equipment to comply with the technical documentation referred to in point
2 and with the requirements of the Directive which apply to it.
Module A1 (internal manufacturing checks with monitoring of the final assess-
ment)
In addition to the requirements of module A, the following applies.
Final assessment must be performed by the manufacturer and monitored by
means of unexpected visits by a notified body chosen by the manufacturer.
During suchvisits, th e notified body must:— ensure that the manufacturer actually performs final assessment,
— take samples of transportable pressure equipment at the manufacturing or
storage premises in order to conduct checks. The notified body assesses the
number of items of equipment to sample and whether it is necessary to
perform, or have performed, all or part of the final assessment of the equip-
ment samples.
Should one or more of the items of transportable pressure equipment not
conform, the notified body must take appropriate measures.
On the responsibility of the notified body, the manufacturer must affix that
body's identification number to eachitem of transportable pressure equipment.
ModuleB (EC type-examination)
1. This module describes the part of the procedure by which a notified body
ascertains and attests that a representative example of the production envi-
saged meets the provisions of the Directive which apply to it.1999L0036 — EN — 17.01.2001 — 001.002 — 16
▼B
2. The application for EC type-examination must be lodged by the manufacturer
or by his authorised representative established within the Community with a
single notified body of his choice.
The application must include:
— the name and address of the manufacturer and, if the application is
lodged by the authorised representative established within the Commu-
nity, his name and address as well,
— a written declaration that the same application has not been lodged with
any other notified body,
— the technical documentation described in point 3.
The applicant must place at the disposal of the notified body a representative
example of the production envisaged, hereinafter called ‘type’. The notified
body may request further examples should the test programme so require.
A type may cover several versions of transportable pressure equipment
provided that the differences between the versions do not affect the level of
safety.
3. The technical documentation must enable an assessment to be made of the
conformity of the transportable pressure equipment with the requirements of
the Directive which apply to it. It must, as far as is relevant for such assess-
ment, cover the design, manufacture and operation of the transportable
pressure equipment and contain:
— a general description of the type,
— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the said
drawings and diagrams and the operation of the transportable pressure
equipment,
— a description of the solutions adopted to meet the essential requirements
of the Directive,
— results of the design calculations made, examinations carried out, etc.,— test reports,— information concerning the tests provided for in manufacture,— information concerning the qualifications or approvals.
4. The notified body must:
4.1. examine the technical documentation, verify that the type has been
manufactured in conformity withit and identify th e components
designed in accordance with the relevant provisions of the Directive.
In particular, the notified body must:
— examine the technical documentation with respect to the design and
the manufacturing procedures,
— assess the materials used where these are not in conformity with the
relevant provisions of the Directive and check the certificate issued
by the materials manufacturer,
— approve the procedures for the permanent joining of pressure equip-
ment parts or check that they have been previously approved,
— verify that the staff undertaking the permanent joining of pressure
equipment parts and the non-destructive tests are qualified or
approved,
4.2. perform or have performed the appropriate examinations and necessary
tests to establish whether the solutions adopted by the manufacturer
meet the requirements of the Directive;
4.3. perform or have performed the appropriate examinations and necessary
tests to establish whether the relevant provisions of the Directive have
been applied;
4.4. agree with the applicant the location where the examinations and neces-
sary tests are to be carried out.
5. Where the type satisfies the provisions of the Directive which apply to it, the
notified body must issue an EC type-examination certificate to the applicant.
The certificate, which should be valid for 10 years and be renewable, must
contain the name and address of the manufacturer, the conclusions of the
examination and the necessary data for identification of the approved 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 the notified body refuses to issue an EC type-examination certificate to the
manufacturer or to his authorised representative established within the1999L0036 — EN — 17.01.2001 — 001.002 — 17
▼B
Community, that body must provide detailed reasons for such refusal. Provi-
sion must be made for an appeals procedure.
6. The applicant must inform the notified body that holds the technical docu-
mentation concerning the EC type-examination certificate of all
modifications to the approved transportable pressure equipment; these are
subject to additional approval where they may affect conformity with the
requirements of the Directive or the prescribed conditions for use of the
equipment. This additional approval must be given in the form of an addition
to the original EC type-examination certificate.
7. Each notified body must communicate to the Member States the relevant
information concerning EC type-examination certificates which it has with-
drawn, and, on request, those it has issued.
Each notified body must also communicate to the other notified bodies the
relevant information concerning the EC type-examination certificates it has
withdrawn or refused.
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The annexes to the certificates must be
held at the disposal of the other notified bodies.
9. The manufacturer, or his authorised representative established within the
Community, must keep with the technical documentation copies of EC type-
examination certificates and their additions for a period of 10 years after the
last of the transportable pressure equipment has been manufactured.
Where neither the manufacturer nor his authorised representative is estab-
lished within the Community, the obligation to keep the technical
documentation available is the responsibility of the person who places theproduct on the Community market.
ModuleB1 (EC design examination)
1. This module describes the part of the procedure whereby a notified body
ascertains and attests that the design of an item of transportable pressure
equipment meets the provisions of the Directive which apply to it.
2. The manufacturer, or his authorised representative established within the
Community, must lodge an application for EC design examination witha
single notified body.
The application must include:
— the name and address of the manufacturer and, if the application is
lodged by the authorised representative established within the Commu-
nity, his name and address as well,
— a written declaration that the same application has not been lodged with
any other notified body,
— the technical documentation described in point 3.
The application may cover several versions of the transportable pressure
equipment provided that the differences between the versions do not affect
the level of safety.
3. The technical documentation must enable an assessment to be made of the
conformity of the transportable pressure equipment with the requirements of
the Directive which apply to it. It must, as far as is relevant for such assess-
ment, cover the design, manufacture and operation of the transportable
pressure equipment and contain:
— a general description of the equipment in question,
— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the said
drawings and diagrams and the operation of the equipment,
— a description of the solutions adopted to meet the requirements of the
Directive,
— the necessary supporting evidence for the adequacy of the design solu-
tion; this supporting evidence must include the results of tests carried
out by the appropriate laboratory of the manufacturer or on his behalf,
— results of the design calculations made, examinations carried out, etc.,— information regarding qualifications or approvals.
4. The notified body must:
4.1. examine the technical documentation and identify the components which
have been designed in accordance with the relevant provisions of the
Directive.1999L0036 — EN — 17.01.2001 — 001.002 — 18
▼B
In particular, the notified body must:
— assess the materials used where these are not in conformity with the
relevant provisions of the Directive,
— approve the procedures for the permanent joining of pressure equip-
ment parts or check that they have been previously approved,
— verify that the staff undertaking the permanent joining of pressure
equipment parts and the non-destructive tests are qualified or
approved;
4.2. perform the necessary examinations to establish whether the solutions
adopted by the manufacturer meet the requirements of the Directive;
4.3. perform the necessary examinations to establish whether the relevant
provisions of the Directive have actually been applied.
5. Where the design meets the provisions of the Directive which apply to it, the
notified body must issue an ►C1EC design-examination ◄certificate to
the applicant. The certificate must contain the name and address of the appli-
cant, the conclusions of the examination, conditions for its validity and the
necessary data for identification of the approved design.
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 the notified body refuses to issue an ►C1EC design-examination ◄
certificate to the manufacturer or to his authorised representative established
within the Community, that body must provide detailed reasons for such
refusal. Provision must be made for an appeals procedure.
6. The applicant must inform the notified body that holds the technical docu-
mentation concerning the ►C1EC design-examination ◄certificate of all
modifications to the approved design; these are subject to additional approval
where they may affect conformity with the requirements of the Directive or
the prescribed conditions for use of the equipment. This additional approval
must be given in the form of an addition to the original ►C1EC design-
examination ◄certificate.
7. Each notified body must communicate to the Member States the relevant
information concerning EC design-examination certificates which it has with-
drawn, and, on request, those it has issued.
Each notified body must also communicate to the other notified bodies the
relevant information concerning the ►C1EC design-examination ◄certifi-
cates it has withdrawn or refused.
8. The other notified bodies may on request obtain the relevant information
concerning:
— the EC design-examination certificates and additions granted,
— the EC design-examination certificates and additions withdrawn.
9. The manufacturer, or his authorised representative established within the
Community, must keep with the technical documentation referred to in point3 copies of EC design-examination certificates and their additions for a
period of 10 years after the last of the transportable pressure equipment has
been manufactured.
Where neither the manufacturer nor his authorised representative is estab-
lished within the Community, the obligation to keep the technical
documentation available is the responsibility of the person who places the
product on the community market.
ModuleC1 (conformity to type)
1. This module describes that part of the procedure whereby the manufacturer,
or his authorised representative established within the Community, ensures
and declares that transportable pressure equipment is in conformity with the
type as described in the EC type-examination certificate and satisfies the
requirements of the Directive which apply to it. The manufacturer, or his
authorised representative established within the Community, must affix the
Πmarking to all transportable pressure equipment and draw up a written
declaration of conformity.
2. The manufacturer must take all measures necessary to ensure that the manu-
facturing process requires the manufactured transportable pressure equipment
to comply with the type as described in the EC type-examination certificate
and with the requirements of the Directive which apply to it.
3. The manufacturer, or his authorised representative established within the
Community, must keep a copy of the declaration of conformity for a period1999L0036 — EN — 17.01.2001 — 001.002 — 19
▼B
of 10 years after the last of the transportable pressure equipment has been
manufactured.
Where neither the manufacturer nor his authorised representative is estab-
lished within the Community, the obligation to keep the technical
documentation available is the responsibility of the person who places the
transportable pressure equipment on the Community market.
4. Final assessment must be subject to monitoring in the form of unexpected
visits by a notified body chosen by the manufacturer.
During suchvisits, th e notified body must:
— ensure that the manufacturer actually performs final assessment,
— take samples of transportable pressure equipment at the manufacturing or
storage premises in order to conduct checks. The notified body assesses
the number of items of equipment to sample and whether it is necessary
to perform, or have performed, all or part of the final assessment of the
equipment samples.
Should one or more of the items of transportable pressure equipment not
conform, the notified body must take appropriate measures.
On the responsibility of the notified body, the manufacturer must affix that
body's identification number to eachitem of transportable pressure equip-
ment.
ModuleD (production quality assurance)
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 2 ensures and declares that the transportable pressure
equipment concerned is in conformity with the type described in the EC
type-examination certificate and satisfies the requirements of the Directive
which apply to it. The manufacturer, or his authorised representative estab-
lished within the Community, must affix the Πmarking to all transportable
pressure equipment and draw up a written declaration of conformity. The Π
marking must be accompanied by the identification number of the notified
body responsible for Community surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for production,
final inspection and testing as specified in point 3 and be subject to surveil-
lance 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.
The application must include:
— all relevant information on the transportable pressure equipment
concerned,
— the documentation concerning the quality system,
— the technical documentation for the approved type and a copy of the
EC type-examination certificate.
3.2. The quality system must ensure compliance of the transportable pressure
equipment with the type described in the EC type-examination certifi-
cate and with the requirements of the Directive which apply to it.
All the elements, requirements and provisions adopted by the manufac-
turer must 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, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the transportable pressure equipment,
— the manufacturing, quality control and quality assurance techniques,
processes and systematic measures that will be used, particularly the
procedures 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, calibra-
tion data, reports concerning the qualifications or approvals of the
personnel concerned,1999L0036 — EN — 17.01.2001 — 001.002 — 20
▼B
— the means of monitoring the achievement of the required 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 referred to in 3.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-
ment procedure must include an inspection 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. Provision must be made for an appeals procedure.
3.4. The manufacturer must undertake to fulfil the obligations arising out of
the quality system as approved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorised representative established within the
Community, must inform the notified body that has approved the quality
system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether
the amended quality system will still satisfy the requirements referred to
in 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
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, testing and storage
and provide it withall necessary information, in particular:
— the quality system documentation,
— the quality records, such as inspection reports and test data, calibra-
tion data, reports concerning the qualifications of the personnel
concerned, etc.
4.3. The notified body must carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and provide the
manufacturer withan audit report. Th e frequency of periodic audits
must be such that a full reassessment is carried out every three years.
4.4. In addition, the notified body may pay unexpected visits to the manufac-
turer. The need for such additional visits, and the frequency thereof, will
be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must be considered in
the visit control system:
— the category of the equipment,
— the results of previous surveillance visits,
— the need to follow up corrective action,— where applicable, special conditions linked to the approval of the
system,
— significant changes in manufacturing organisation, policy or techni-
ques.
During suchvisits th e notified body may, if necessary, carry out tests, or
have them carried out, to verify that the quality system is functioning
correctly. The notified body must provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
5. The manufacturer must, for a period of 10 years after the last of the transpor-
table pressure equipment has been manufactured, hold at the disposal of the
national authorities:
— the documentation referred to in the second indent of 3.1,
— the adjustments referred to in the second paragraph of 3.4,— the decisions and reports from the notified body which are referred to in
the last paragraph of 3.3, in the last paragraph of 3.4, and in 4.3 and 4.4.
6. Each notified body must communicate to the Member States the relevant
information concerning the quality system approvals which it has withdrawn,
and, on request, those it has issued.1999L0036 — EN — 17.01.2001 — 001.002 — 21
▼B
Each notified body must also communicate to the other notified bodies the
relevant information concerning the quality system approvals it has with-
drawn or refused.
ModuleD1 (production quality assurance)
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 3 ensures and declares that the items of transportable
pressure equipment concerned satisfy the requirements of the Directive which
apply to them. The manufacturer, or his authorised representative established
within the Community, must affix the Πmarking to all transportable pressure
equipment and draw up a written declaration of conformity. The Πmarking
must be accompanied by the identification number of the notified body
responsible for Community surveillance as specified in point 5.
2. The manufacturer must draw up the technical documentation described
below.
The technical documentation must enable an assessment to be made of the
conformity of the transportable pressure equipment with the requirements of
the Directive which apply to it. It must, as far as is relevant for such assess-
ment, cover the design, manufacture and operation of the transportablepressure equipment and contain:
— a general description of the equipment in question,
— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the said
drawings and diagrams and the operation of the equipment,
— a description of the solutions adopted to meet the requirements of the
Directive,
— results of the design calculations made, examinations carried out, etc.;
— test reports.
3. The manufacturer must operate an approved quality system for production,
final inspection and testing as specified in point 4 and be subject to surveil-
lance as specified in point 5.
4.Quality system
4.1. The manufacturer must lodge an application for assessment of his
quality system with a notified body of his choice.
The application must include:
— all relevant information on the transportable pressure equipment
concerned,
— the documentation concerning the quality system.
4.2. The quality system must ensure compliance of the transportable pressure
equipment with requirements of the Directive which apply to it.
All the elements, requirements and provisions adopted by the manufac-
turer must 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, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the transportable pressure equipment,
— the manufacturing, quality control and quality assurance techniques,
processes and systematic measures 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, calibra-
tion data, reports concerning the qualifications or approvals of the
personnel concerned,
— the means of monitoring the achievement of the required quality and
the effective operation of the quality system.
4.3. The notified body must assess the quality system to determine whether
it satisfies the requirements referred to in 4.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-1999L0036 — EN — 17.01.2001 — 001.002 — 22
▼B
ment procedure must include an inspection 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. Provision must be made for an appeals procedure.
4.4. The manufacturer must undertake to fulfil the obligations arising out of
the quality system as approved and to ensure that it remains satisfactoryand efficient.
The manufacturer, or his authorised representative established within the
Community, must inform the notified body that has approved the quality
system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether
the amended quality system will still satisfy the requirements referred to
in 4.2 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.
5.Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
5.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of manufacture, inspection, testing and storage
and provide it withall necessary information, in particular:
— the quality system documentation,
— the quality records, such as inspection reports and test data, calibra-
tion data, reports concerning the qualifications of the personnel
concerned, etc.
5.3. The notified body must carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and provide the
manufacturer withan audit report. Th e frequency of periodic audits
must be such that a full reassessment is carried out every three years.
5.4. In addition, the notified body may pay unexpected visits to the manufac-
turer. The need for such additional visits, and the frequency thereof, will
be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must be considered in
the visit control system:
— the category of the equipment,
— the results of previous surveillance visits,— the need to follow up corrective action,— where applicable, special conditions linked to the approval of the
system,
— significant changes in manufacturing organisation, policy or techni-
ques.
During suchvisits th e notified body may, if necessary, carry out tests, or
have them carried out, to verify that the quality system is functioning
correctly. The notified body must provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
6. The manufacturer must, for a period of 10 years after the last of the transpor-
table pressure equipment has been manufactured, hold at the disposal of the
national authorities:
— the documentation referred to in point 2,
— the documentation referred to in the second indent of 4.1,— the adjustments referred to in the second paragraph of 4.4,— the decisions and reports from the notified body which are referred to in
the last paragraph of 4.3, in the last paragraph of 4.4, and in 5.3 and 5.4.
7. Each notified body must communicate to the Member States the relevant
information concerning the quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must communicate to the other notified bodies the rele-
vant information concerning the quality system approvals it has withdrawn or
refused.1999L0036 — EN — 17.01.2001 — 001.002 — 23
▼B
ModuleE (product quality assurance)
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 2 ensures and declares that the item of transportable
pressure equipment is in conformity with the type as described in the EC
type-examination certificate and satisfies the requirements of the Directive
which apply to it. The manufacturer, or his authorised representative estab-
lished within the Community, must affix the Πmarking to eachproduct
and draw up a written declaration of conformity. The Πmarking must be
accompanied by the identification number of the notified body responsible
for Community surveillance as specified in point 4.
2. The manufacturer must operate an approved quality system for production,
final inspection and testing as specified in point 3 and be subject to surveil-
lance 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.
The application must include:
— all relevant information on the transportable pressure equipment
concerned,
— the documentation concerning the quality system,
— the technical documentation for the approved type and a copy of the
EC type-examination certificate.
3.2. Under the quality system, each item of transportable pressure equipment
must be examined and appropriate tests must be carried out in order to
ensure its conformity with the requirements of the Directive which apply
to it. 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. The quality
system documentation must permit a consistent interpretation of the
quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the transportable pressure equipment,
— the examinations and tests to 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, calibra-
tion data, reports concerning the qualifications or approvals of the
personnel concerned.
3.3. The notified body must assess the quality system to determine whether
it satisfies the requirements referred to in 3.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-
ment procedure must include an inspection 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. Provision must be made for an appeals procedure.
3.4. The manufacturer must undertake to fulfil the obligations arising out of
the quality system as approved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorised representative established within the
Community, must inform the notified body that has approved the quality
system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether
the amended quality system will still satisfy the requirements referred to
in 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
4.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.1999L0036 — EN — 17.01.2001 — 001.002 — 24
▼B
4.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of manufacture, inspection, testing and storage
and provide it withall necessary information, in particular:
— the quality system documentation,
— the technical documentation,— the quality records, such as inspection reports and test data, calibra-
tion data, reports concerning the qualifications of the personnel
concerned, etc.
4.3. The notified body must carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and provide the
manufacturer withan audit report. Th e frequency of periodic audits
must be such that a full reassessment is carried out every three years.
4.4. In addition, the notified body may pay unexpected visits to the manufac-
turer. The need for such additional visits, and the frequency thereof, will
be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must be considered in
the visit control system:
— the category of the equipment,
— the results of previous surveillance visits,
— the need to follow up corrective action,
— where applicable, special conditions linked to the approval of the
system,
— significant changes in manufacturing organisation, policy or techni-
ques.
During suchvisits th e notified body may, if necessary, carry out tests, or
have them carried out, to verify that the quality system is functioning
correctly. The notified body must provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
5. The manufacturer must, for a period of 10 years after the last of the transpor-
table pressure equipment has been manufactured, hold at the disposal of the
national authorities:
— the documentation referred to in the second indent of 3.1,
— the adjustments referred to in the second paragraph of 3.4,— the decisions and reports from the notified body which are referred to in
the last paragraph of 3.3, in the last paragraph of 3.4, and in 4.3 and 4.4.
6. Each notified body must communicate to the Member States the relevant
information concerning the quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must also communicate to the other notified bodies the
relevant information concerning the quality system approvals it has with-
drawn or refused.
ModuleE1 (production quality assurance)
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 3 ensures and declares that the transportable pressure
equipment satisfies the requirements of the Directive which apply to it. The
manufacturer, or his authorised representative established within the Commu-
nity, must affix the II marking to each item of transportable pressure
equipment and draw up a written declaration of conformity. The II marking
must be accompanied by the identification number of the notified body
responsible for surveillance as specified in point 5.
2. The manufacturer must draw up the technical documentation described
below.
The technical documentation must enable an assessment to be made of the
conformity of the transportable pressure equipment with the requirements of
the Directive which apply to it. It must, as far as is relevant for such assess-
ment, cover the design, manufacture and operation of the transportable
pressure equipment and contain:
— a general description of the equipment in question,
— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the said
drawings and diagrams and the operation of the equipment,
— a description of the solutions adopted to meet the requirements of the
Directive,
— results of the design calculations made, examinations carried out, etc.;1999L0036 — EN — 17.01.2001 — 001.002 — 25
▼B
— test reports.
3. The manufacturer must operate an approved quality system for the final
transportable pressure equipment inspection and testing as specified in point
4 and be subject to surveillance as specified in point 5.
4.Quality system
4.1. The manufacturer must lodge an application for assessment of his
quality system with a notified body of his choice.
The application must include:
— all relevant information on the transportable pressure equipment
concerned,
— the documentation concerning the quality system.
4.2. Under the quality system, each item of transportable pressure equipment
must be examined and appropriate tests must be carried out in order to
ensure its conformity with the requirements of the Directive which apply
to it. 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. The quality
system documentation must permit a consistent interpretation of the
quality programmes, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the transportable pressure equipment,
— the procedures used for the joining of parts,
— the examinations and tests to 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, calibra-
tion data, reports concerning the qualifications or approvals of the
staff concerned.
4.3. The notified body must assess the quality system to determine whether
it satisfies the requirements referred to in 4.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-
ment procedure must include an inspection 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. Provision must be made for an appeals procedure.
4.4. The manufacturer must undertake to discharge the obligations arising
from the quality system as approved and to ensure that it remains satis-
factory and efficient.
The manufacturer, or his authorised representative established within the
Community, must inform the notified body which has approved the
quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether
the modified quality system will still satisfy the requirements referred to
in 4.2 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.
5.Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
5.2. The manufacturer must allow the notified body access for inspection
purposes to the locations of manufacture, inspection, testing and storage
and provide it withall necessary information, in particular:
— the quality system documentation,
— the technical documentation,— the quality records, such as inspection reports and test data, calibra-
tion data, reports concerning the qualifications of the personnel
concerned, etc.1999L0036 — EN — 17.01.2001 — 001.002 — 26
▼B
5.3. The notified body must carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and provide the
manufacturer withan audit report. Th e frequency of periodic audits
must be such that a full reassessment is carried out every three years.
5.4. In addition, the notified body may pay unexpected visits to the manufac-
turer. The need for such additional visits, and the frequency thereof, will
be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must be considered in
the visit control system:
— the category of the equipment,
— the results of previous surveillance visits,— the need to follow up corrective action,— where applicable, special conditions linked to the approval of the
system,
— significant changes in manufacturing organisation, policy or techni-
ques.
During suchvisits th e notified body may, if necessary, carry out tests, or
have them carried out, to verify that the quality system is functioningcorrectly. The notified body must provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
6. The manufacturer must, for a period of 10 years after the last of the transpor-
table pressure equipment has been manufactured, hold at the disposal of the
national authorities:
— the documentation referred to in section 2,
— the documentation referred to in the third indent of 4.1,— the adjustments referred to in the second paragraph of 4.4,— the decisions and reports from the notified body which are referred to in
the last paragraph of 4.3, in the last paragraph of 4.4, and in 5.3 and 5.4.
7. Each notified body must communicate to the Member States the relevant
information concerning the quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must communicate to the other notified bodies the rele-
vant information concerning the quality system approvals it has withdrawn or
refused.
ModuleF (product verification)
1. This module describes the procedure whereby a manufacturer, or his
authorised representative established within the Community, ensures and
declares that the transportable pressure equipment subject to the provisions
of point 3 is in conformity withth e type described:
— in the EC type-examination certificate, or
— in the EC design-examination certificate,
and satisfies the requirements of the Directive which apply to it.
2. The manufacturer must take all measures necessary to ensure that the manu-
facturing process requires the transportable pressure equipment to comply
withth e type described:
— in the EC type-examination certificate, or
— in the EC design-examination certificate,
and with the requirements of the Directive which apply to it.The manufacturer, or his authorised representative established within the
Community, must affix the II marking to all transportable pressure equipment
and draw up a declaration of conformity.
3. The notified body must perform the appropriate examinations and tests in
order to check the conformity of the transportable pressure equipment with
the relevant requirements of the Directive by examining and testing every
product in accordance withpoint 4.
The manufacturer, or his authorised representative established within the
Community, must keep a copy of the declaration of conformity for a period
of 10 years after the last of the transportable pressure equipment has been
manufactured.
4.Verification by examination and testing of each item of transportable pres-
sure equipment
4.1. Eachitem of transportable pressure equipment must be individually
examined and must undergo appropriate examinations and tests in order1999L0036 — EN — 17.01.2001 — 001.002 — 27
▼B
to verify that it conforms to the type and the requirements of the Direc-
tive which apply to it.
In particular, the notified body must:
— verify that the personnel undertaking the permanent joining of parts
and the non-destructive tests are qualified or approved,
— check the certificate issued by the materials manufacturer,
— carry out the final inspection and proof test or have them carried out
and, where appropriate, examine the safety devices.
4.2. The notified body must affix its identification number or have it affixed
to eachitem of transportable pressure equipment and draw up a written
certificate of conformity relating to the tests carried out.
4.3. The manufacturer, or his authorised representative established within the
Community, must ensure that the certificates of conformity issued by
the notified body can be made available on request.
ModuleG (EC unit verification)
1. This module describes the procedure whereby the manufacturer ensures and
declares that transportable pressure equipment which has been issued with
the certificate referred to in point 4.1 satisfies the requirements of the Direc-
tive which apply to it. The manufacturer, or his authorised representative
established within the Community, must affix the Πmarking to the equip-
ment and draw up a declaration of conformity.
2. The manufacturer must apply to a notified body of his choice for unit verifi-
cation. The application must contain:
— the name and address of the manufacturer and the location of the trans-
portable pressure equipment,
— a written declaration to the effect that a similar application has not been
lodged withanoth er notified body,
— technical documentation.
3. The technical documentation must enable the conformity of the transportable
pressure equipment with the requirements of the Directive which apply to it
to be assessed and the design, manufacture and operation of the transportable
pressure equipment to be understood.
The technical documentation must contain:
— a general description of the equipment in question,
— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for an understanding of the said
drawings and diagrams and the operation of the equipment,
— results of design calculations made, examinations carried out, etc.,— test reports,— appropriate details relating to the approval of the manufacturing and test
procedures and of the qualifications or approvals of the staff concerned.
4. The notified body must examine the design and construction of each item of
transportable pressure equipment and during manufacture perform appro-
priate tests to ensure its conformity with the requirements of the Directive
which apply to it.
4.1. The notified body must affix its identification number or have it affixed
to the transportable pressure equipment and draw up a certificate of
conformity for the tests carried out. This certificate must be kept for a
period of 10 years.
4.2. The manufacturer, or his authorised representative established within the
Community, must ensure that the declaration of conformity and certifi-
cate of conformity issued by the notified body can be made available on
request.
In particular, the notified body must:
— examine the technical documentation with respect to the design and
the manufacturing procedures,
— assess the materials used where these are not in conformity with the
relevant provisions of the Directive and check the certificate issued
by the materials manufacturer,
— approve the procedures for the permanent joining of pressure equip-
ment parts,
— verify the qualifications or approvals required,1999L0036 — EN — 17.01.2001 — 001.002 — 28
▼B
— perform the final inspection, perform the proof test or have it
performed and examine the safety devices if applicable.
ModuleH (full quality assurance)
1. This module describes the procedure whereby the manufacturer who satisfies
the obligations of point 2 ensures and declares that the transportable pressure
equipment in question satisfies the requirements of the Directive which apply
to it. The manufacturer, or his authorised representative established within
the Community, must affix the II marking to each item of transportable pres-
sure equipment and draw up a written declaration of conformity. The II
marking must be accompanied by the identification number of the notified
body responsible for the surveillance referred to in point 4.
2. The manufacturer must implement an approved quality system for design,
manufacture, final inspection and testing as specified in point 3 and 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 of his choice.
The application must include:
— all relevant information concerning the transportable pressure equip-
ment in question,
— the documentation concerning the quality system.
3.2. The quality system must ensure compliance of the transportable pressure
equipment with the requirements of the Directive which apply to it.
All the elements, requirements and provisions adopted by the manufac-
turer must 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 procedural
and quality measures suchas programmes, plans, manuals and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the design and to product quality,
— the technical design specifications, including standards, that will be
applied,
— the design control and design verification techniques, processes and
systematic measures that will be used when designing the transpor-
table pressure equipment,
— the corresponding manufacturing, quality control and quality assur-
ance techniques, processes and systematic measures that will be
used,
— the examinations and tests to 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, calibra-
tion data, reports concerning the qualifications or approvals of the
personnel concerned,
— the means of monitoring the achievement of the required transpor-
table pressure equipment design and 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 referred to in 3.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-
ment procedure must include an inspection 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. Provision must be made for an appeals procedure.
3.4. The manufacturer must undertake to fulfil the obligations arising out of
the quality system as approved and to ensure that it remains satisfactory
and efficient.
The manufacturer, or his authorised representative established within the
Community, must inform the notified body that has approved the quality
system of any intended adjustment to the quality system.1999L0036 — EN — 17.01.2001 — 001.002 — 29
▼B
The notified body must assess the proposed changes and decide whether
the modified quality system will still satisfy the requirements referred to
in 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
4.1. The purpose of this 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, testing
and storage and provide it withall necessary information, in particular:
— the quality system documentation,
— the quality records provided for in the design part of the quality
system, suchas results of analyses, calculations, tests, etc.,
— the quality records provided for in the manufacturing part of the
quality system, suchas inspection reports and test data, calibrationdata, reports concerning the qualifications of the staff concerned, etc.
4.3. The notified body must carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and provide the
manufacturer withan audit report. Th e frequency of periodic audits
must be such that a full reassessment is carried out every three years.
4.4. In addition, the notified body may pay unexpected visits to the manufac-
turer. The need for such additional visits, and the frequency thereof, will
be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must be considered in
the visit control system:
— the category of the equipment,
— the results of previous surveillance visits,
— the need to follow up corrective action,
— where applicable, special conditions linked to the approval of the
system,
— significant changes in manufacturing organisation, policy or techni-
ques.
During suchvisits th e notified body may, if necessary, carry out tests, or
have them carried out, to verify that the quality system is functioning
correctly. The notified body must provide the manufacturer with a visit
report and, if a test has taken place, with a test report.
5. The manufacturer must, for a period of 10 years after the last of the transpor-
table pressure equipment has been manufactured, keep at the disposal of the
national authorities:
— the documentation referred to in the second indent of the second para-
graphof 3.1,
— the adjustments referred to in the second paragraph of 3.4,
— the decisions and reports from the notified body which are referred to in
the last paragraph of 3.3, in the last paragraph of 3.4, and in 4.3 and 4.4.
6. Each notified body must communicate to the Member States the relevant
information concerning the quality system approvals which it has withdrawn,
and, on request, those it has issued.
Each notified body must also communicate to the other notified bodies the
relevant information concerning the quality system approvals it has with-
drawn or refused.
ModuleH1 (full quality assurance withdesign examination and special surveil-
lance of the final test)
1. In addition to the requirements of module H, the following apply:
(a) the manufacturer must lodge an application for examination of the design
withth e notified body;
(b) the application must enable the design, manufacture and operation of the
transportable pressure equipment to be understood, and enable confor-
mity with the relevant requirements of the Directive to be assessed.
It must include:
— the technical design specifications, including standards, which have
been applied,1999L0036 — EN — 17.01.2001 — 001.002 — 30
▼B
— the necessary supporting evidence for their adequacy. This supporting
evidence must include the results of tests carried out by the appro-
priate laboratory of the manufacturer or on his behalf;
(c) the notified body must examine the application and where the design
meets the provisions of the Directive which apply to it issue an EC
design-examination certificate to the applicant. The certificate must
contain the conclusions of the examination, the conditions for its validity,
the necessary data for identification of the approved design and, if rele-
vant, a description of the functioning of the transportable pressure
equipment;
(d) the applicant must inform the notified body that has issued the EC
design-examination certificate of all modifications to the approved
design. Modifications to the approved design must receive additional
approval from the notified body that issued the EC design-examination
certificate where they may affect conformity with the requirements of
the Directive or the prescribed conditions for use of the transportable
pressure equipment. This additional approval must be given in the form
of an addition to the original EC design-examination certificate;
(e) each notified body must also communicate to the other notified bodies
the relevant information concerning the EC design-examination certifi-
cates it has withdrawn or refused.
2. Final assessment is subject to increased surveillance in the form of unex-
pected visits by the notified body. In the course of such visits, the notified
body must conduct examinations on the transportable pressure equipment.
PART II
CONFORMITYREASSESSMENTPROCEDURE
1. This procedure describes the method for ensuring that transportable pressure
equipment placed on the market as defined in Article 1(2)(b) complies with
the relevant requirements of Directive 94/55/EC and 96/49/EC.
2. The user must make available to a notified body information regarding trans-
portable pressure equipment placed on the market which enables that body to
identify the equipment precisely (origin, design rules and, for acetylene
cylinders, also details of the porous mass). The user must, where appropriate,
notify any prescribed restrictions on use, and forward any notes on possible
damage or repairs which have been carried out.
The notified body must also check that valves and other accessories having a
direct safety function ensure a level of safety in line withth at defined
pursuant to Article 3 of this Directive.
3. The notified body must check whether transportable pressure equipment
which has been placed on the market affords at least the same degree of
safety as the transportable pressure equipment referred to in Directive 94/
55/EC and 96/49/EC. The check must be carried out on the basis of docu-
ments produced in accordance withpoint 2 and, wh ere appropriate, of
further inspections.
4. If the results of the above checks are satisfactory, the transportable pressure
equipment must be subject to the periodic inspection provided for in Annex
IV, Part III.
5. For receptacles manufactured in series, including their valves and other
accessories used for transport, the relevant conformity reassessment opera-
tions relating to individual inspections of equipment, as indicated in points
3 and 4 above, may be carried out by an approved body provided that a noti-
fied body has previously carried out the relevant conformity reassessment
operations indicated in point 3.
PART III
PROCEDURESFORPERIODICINSPECTION
Module1 (periodic inspection of products)
1. This module describes the procedure whereby an owner or his authorised
representative established within the Community or the holder ensures that
the transportable pressure equipment subject to point 3 continues to meet
the requirements of this Directive.
2. To meet the requirements referred to in point 1 the owner or his authorised
representative established in the Community or the holder must take all
measures necessary to ensure that the conditions of use and of maintenance1999L0036 — EN — 17.01.2001 — 001.002 — 31
▼B
ensure the continued conformity of the transportable pressure equipment to
the requirements of this Directive, in particular so that:
— the transportable pressure equipment is used as intended,
— it is filled in appropriate filling centres,— any maintenance work or repairs are carried out,
— the periodic inspections necessary are carried out.
The measures carried out must be recorded in documents and held at the
disposal of the national authorities by the owner or his authorised representa-
tive established in the Community or the holder.
3. The inspection body must perform the appropriate examinations and tests in
order to check the conformity of the transportable pressure equipment with
the relevant requirements of the Directive by examining and testing every
product.
3.1. All transportable pressure equipment must be examined individually and
appropriate tests, as set out in the Annexes to Directives 94/55/EC and
96/49/EC, must be carried out in order to check that it meets the
requirements of those Directives.
3.2. The inspection body must affix its identification number or have it
affixed to eachproduct being periodically inspected immediately after
the date of periodic inspection and draw up a written periodic-inspection
certificate. That certificate may cover a number of items of equipment
(group certificate).
3.3. The owner or his authorised representative established in the Commu-
nity or the holder must keep the periodic-inspection certificate required
under section 3.2, and the documents required under point 2 at least
until the next periodic inspection.
Module2 (periodic inspection through quality assurance)
1. This module describes the following procedures:
— the procedure whereby the owner or his authorised representative estab-
lished in the Community or the holder, who satisfies the obligations of
point 2, ensures and declares that the transportable pressure equipment
continues to meet the requirements of the Directive. The owner or his
authorised representative established in the Community or the holder
must affix the date of periodic inspection to all transportable pressure
equipment and draw up a written declaration of conformity. The date of
periodic inspection must be accompanied by the identification number of
the notified body responsible for surveillance as specified in point 4,
— the procedure whereby, in the case of periodic inspection of tanks
performed by the approved body in accordance with the second paragraph
of Article 6(1), the approved body which satisfies the obligations of the
last paragraph of point 2, certifies that the transportable pressure equip-
ment continues to meet the requirements of this Directive. The approved
body must affix the date of periodic inspection to all transportable pres-
sure equipment and draw up a periodic inspection certificate.
The date of periodic inspection must be accompanied by the identification
number of the approved body.
2. The owner or his authorised representative established in the Community or
the holder must take all steps necessary to ensure that the conditions of use
and of maintenance are suchas to enable th e transportable pressure equip-
ment to comply permanently with the requirements of this Directive and in
particular that:
— the transportable pressure equipment is used as intended,
— it is filled in appropriate filling centres,
— any maintenance work or repairs are carried out,
— the periodic inspections necessary are carried out.
The measures carried out must be recorded in documents and held by the
owner or his authorised representative established in the Community or the
holder at the disposal of the national authorities.
The owner or his authorised representative established within the Community
or the holder must ensure that the qualified staff and necessary facilities
within the meaning of Annex I, points 3 to 6, are available for the purpose
of the periodic inspections.
The owner or his authorised representative established in the Community or
the holder or the approved body must operate an approved quality system for
the periodic inspection and tests of the equipment as specified in point 3, and
be subject to surveillance as specified in point 4.1999L0036 — EN — 17.01.2001 — 001.002 — 32
▼B
3.Quality system
3.1. The owner or his authorised representative established in the Commu-
nity or the holder or the approved body must lodge an application for
assessment of his quality system for the transportable pressure equip-
ment with a notified body of his choice.
The application must include:
— all relevant information on the transportable pressure equipment
being submitted for periodic inspection,
— the documentation regarding the quality system.
3.2. Under the quality system, each item of transportable pressure equipment
must be examined and appropriate tests must be carried out in order to
ensure its conformity with the requirements set out in the Annexes to
Directives 94/55/EC and 96/49/EC. 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, proce-dures and instructions. This quality system documentation must permit
a consistent interpretation of the quality programmes, plans, manuals
and records.
It must contain in particular an adequate description of:
— the quality objectives and the organisational structure, responsibil-
ities and powers of the management with regard to the quality of
the transportable pressure equipment,
— the examinations and tests to be carried out for the periodic inspec-
tion,
— the means of monitoring the effective operation of the quality
system,
— the quality records, such as inspection reports and test data, calibra-
tion data, reports concerning the qualifications or approvals of the
staff concerned.
3.3. The notified body must assess the quality system to determine whether
it satisfies the requirements referred to in 3.2.
The auditing team must have at least one member with experience of
assessing the transportable pressure equipment concerned. The assess-
ment procedure must include an inspection visit to the premises of the
owner or of his authorised representative established in the Community
or of the holder or of the approved body.
The decision must be notified to the owner or this authorised represen-
tative established in the Community or to the holder or the approved
body. The notification must contain the conclusions of the examination
and the reasoned assessment decision.
3.4. The owner or his authorised representative established in the Commu-
nity or the holder or the approved body must undertake to discharge
the obligations arising from the quality system as approved and to
ensure that it remains satisfactory and efficient.
The owner or his authorised representative established in the Commu-
nity or the holder or the approved body must inform the notified body
which has approved the quality system of any intended adjustment to
the quality system.
The notified body must assess the proposed changes and decide whether
the modified quality system will still satisfy the requirements referred to
in 3.2 or whether a reassessment is required.
It must notify its decision to the owner or his authorised representative
established in the Community or to the holder or the approved body.
The notification must 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 owner or his
authorised representative established in the Community or the holder or
the approved body duly fulfils the obligations arising out of the
approved quality system.
4.2. The owner or his authorised representative established in the Commu-
nity or the holder or the approved body must allow the notified body
access for inspection purposes to the locations of inspection, testing
and storage and provide it withall necessary information, in particular:
— the quality system documentation,
— the technical documentation,1999L0036 — EN — 17.01.2001 — 001.002 — 33
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— the quality records, such as inspection reports and test data, reports
concerning the qualifications of the personnel concerned, etc.
4.3. The notified body must carry out periodic audits to make sure that the
owner or his authorised representative established in the Community or
the holder or the approved body maintains and applies the quality
system and provide the owner or his authorised representative estab-
lished in the Community or the holder or the approved body with an
audit report.
4.4. In addition, the notified body may pay unannounced visits to the owner
or his authorised representative established in the Community or the
holder or the approved body. During such visits, the notified body may
if necessary perform tests or have tests performed to verify if necessary
that the quality system is functioning correctly. The notified body must
provide the owner or his authorised representative established in the
Community or the holder or the approved body with a visit report and,
if a test has taken place, with a test report.
5. The owner or his authorised representative established in the Community or
the holder or the approved body must, for a period of 10 years from the date
of the last periodic inspection of the transportable pressure equipment, hold
at the disposal of the national authorities:
— the documentation referred to in the second indent of the second para-
graphof 3.1,
— the adjustments referred to in the second paragraph of 3.4,
— the decisions and reports from the notified body which are referred to in
the last paragraph of 3.3, in the last paragraph of 3.4 and in 4.3 and 4.4.1999L0036 — EN — 17.01.2001 — 001.002 — 34
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ANNEX V
MODULESTOBEFOLLOWEDFORCONFORMITYASSESSMENT
The following table indicates which conformity assessment modules as
described in Annex IV, Part I, are to be followed for the transportable pressure
equipment defined in Article 2(1).
Categories of transportable pressure equipment Modules
1. Receptacles in respect of which the
product of the test pressure and the capa-
city is not more than 30 MPa × litre (300
bar × litre),A1, or D1 or E1
2. Receptacles in respect of which the
product of the test product of the test pres-
sure and the capacity is more than 30 and
not more than 150 MPa × litre (300 and
1 500 bar × litre respectively),H, or B in combination with
E, or B in combination with
C1 or B1 in combination
withF, or B1 in combination
withD
3. Receptacles in respect of which the
product of the test pressure and the
capactiy is more than 150 MPa × litre
(1 500 bar × litre), and likewise for the
tanks.G, or H1, or B in combination
withD, or B in combination
withF
Notice1. Transportable pressure equipment must be subject, at the choice of the
manufacturer, to one of the conformity assessment procedures laid
down for the category in which it is classified. In the case of recepta-
cles, or their valves or other accessories used for transport, the
manufacturer may also choose to apply one of the set procedures for
the higher categories.
Notice 2. As part of the quality assurance procedures, the notified body must,
when making unannounced visits, take a sample of the equipment at
the manufacturing or storage premises for the purpose of carrying out
a check, or having a check carried out, to verify compliance with the
requirements of this Directive. For this purpose the manufacturer
must inform the notified body of the production programme planned.
The notified body shall carry out at least two visits during the first
year of manufacturing. The frequency of subsequent visits will be
determined by the notified body on the basis of the criteria set out
in point 4.4 of the relevant modules in Annex IV, Part I.1999L0036 — EN — 17.01.2001 — 001.002 — 35
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ANNEX VI
LIST OF DANGEROUS SUBSTANCES OTHER THAN THOSE IN
CLASS2REFERREDTOINARTICLE2
UN number ClassADR/RID
figuresDangerous substances
1 051 6.1 1 Stabilised hydrogen cyanide
1 052 8 6 Anhydrous hydrogen fluoride1 790 8 6 Hydrofluoric acid1999L0036 — EN — 17.01.2001 — 001.002 — 36
▼B
ANNEX VII
MARKOFCONFORMITY
The conformity mark shall take the following form:
If the mark is reduced or enlarged, the proportions of the above drawing must
be respected.
The various components of the mark must have substantially the same vertical
dimensions, which may not be less than 5 mm.
This minimum dimension may be waived for small devices.1999L0036 — EN — 17.01.2001 — 001.002 — 37