I
(Legislative acts)
DIRECTIVES
DIRECTIVE 2010/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 June 2010
on transportable pressure equipment and repealing Council Directives 76 /767/EEC, 84/525/EEC,
84/526/EEC, 84/527/EEC and 1999/36/EC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 91 thereof,
Having regard to the proposal from the European Commission,Having regard to the opinion of the European Economic and
Social Committee (
1),
After consulting the Committee of the Regions,Acting in accordance with the ordinary legislative procedure (
2),
Whereas:
(1)Council Directive 1999/36/EC of 29 April 1999 on trans-
portablepressureequipment (3)wasadoptedasafirststep
towardsenhancingtransportsafetyfortransportablepres-sure equipment, whilst ensuring the free movement oftransportable pressure equipment in a single transportmarket.
(2)In the light of developments in transport safety, it is nec-
essary to update certain technical provisions of Directive1999/36/EC.
(3)Directive 2008/68/EC of the European Parliament and of
theCouncilof24September2008ontheinlandtransportof dangerous goods (
4) extended the application of theprovisions of certain international agreements to cover
nationaltrafficinordertoharmonisetheconditionsunder
which dangerous goods are transported by road, rail andinland waterways across the Union.
(4)It is therefore necessary to update the provisions of Direc-
tive 1999/36/EC accordingly to avoid conflicting rules, inparticularasregardsconformityrequirements,conformityassessmentandconformityassessmentproceduresinrela-tion to transportable pressure equipment.
(5)In order to enhance safety with regard to transportable
pressure equipment approved for the inland transport ofdangerous goods and to ensure free movement, includingplacingonthemarket,makingavailableonthemarketanduse of such transportable pressure equipment within theUnion, it is necessary to lay down detailed rules concern-ingtheobligationsofthevariousoperatorsandtherequire-ments to be fulfilled by the equipment concerned.
(6)DecisionNo768/2008/ECoftheEuropeanParliamentand
oftheCouncilof9July2008onacommonframeworkforthe marketing of products (
5) constitutes a general frame-
work of a horizontal nature for future legislation harmo-nising the conditions for the marketing of products. Thisframework should apply where appropriate for the trans-portable pressure equipment sector in line with the objec-tive of harmonising rules on the free movement ofproducts.
(7)InordernottohindertransportoperationsbetweenMem-
ber States and third countries, this Directive should notapplytotransportablepressureequipmentexclusivelyusedforthetransportofdangerousgoodsbetweentheterritoryof the Union and that of third countries.(1) Opinion of 17 February 2010 (not yet published in the Official Jour-
nal).
(2) PositionoftheEuropeanParliamentof5May2010(notyetpublished
in the Official Journal) and Decision of the Council of 31 May 2010.
(3) OJ L 138, 1.6.1999, p. 20.
(4) OJ L 260, 30.9.2008, p. 13. (5) OJ L 218, 13.8.2008, p. 82.30.6.2010 EN Official Journal of the European Union L 165/1(8)The obligations of the different economic operators,
including owners and operators of transportable pressureequipment, should be clearly defined in the interests oftransport safety and the free movement of transportablepressure equipment.
(9)Economic operators should in relation to their respective
rolesinthesupplychainberesponsibleforthecomplianceof transportable pressure equipment with the safety andmarket access rules.
(10)Complianceofnewtransportablepressureequipmentwith
the technical requirements of the Annexes to Directive2008/68/ECandthisDirectiveshouldbedemonstratedbymeansofaconformityassessmenttoprovideevidencethatthe transportable pressure equipment is safe.
(11)Periodic inspections, intermediate inspections and excep-
tional checks of transportable pressure equipment shouldbecarriedoutinaccordancewiththeAnnexestoDirective2008/68/EC and with this Directive to ensure continuedcompliance with their safety requirements.
(12)Transportable pressure equipment should bear a mark
indicating its compliance with Directive 2008/68/EC andthis Directive to ensure its free movement and free use.
(13)This Directive should not apply to transportable pressure
equipmentwhichwasplacedonthemarketbeforetherel-evantdateofimplementationofDirective1999/36/ECandwhichhasnotbeensubjecttoreassessmentofconformity.
(14)Where existing transportable pressure equipment not pre-
viouslyassessedforconformitywithDirective1999/36/ECistobenefitfromfreemovementandfreeuse,itshouldbesubject to reassessment of conformity.
(15)It is necessary to set requirements for authorities respon-
sible for the assessment, notification and monitoring ofnotifiedbodiesinordertoensureaconsistentlevelofqual-ity in the performance of notified bodies.
(16)Theconformityassessmentproceduresprovidedforinthe
Annexes to Directive 2008/68/EC and in this Directiverequire the intervention of inspection bodies setting outdetailedoperationalrequirementstoensureauniformlevelof performance throughout the Union. These inspectionbodiesshouldthenbenotifiedbytheMemberStatestotheCommission.
(17)The notifying authority should retain responsibility for
monitoringthenotifiedbodyregardlessofwherethenoti-fied body performs its activities in order to ensure clearresponsibility for ongoing monitoring.(18)It is necessary to lay down common rules for the mutual
recognition of notified bodies which ensure compliancewithDirective2008/68/ECandthisDirective.Thosecom-mon rules will have the effect of eliminating unnecessarycostsandadministrativeproceduresrelatedtotheapprovalof the equipment and of eliminating technical barriers totrade.
(19)Member States should be able to take measures to limit or
prohibit the placing on the market and use of equipmentin cases where such equipment presents a risk to safety incertain specified circumstances, including when suchequipment is in compliance with Directive 2008/68/ECand with this Directive.
(20)The Commission should draw up specific guidelines to
facilitatethepracticalimplementationofthetechnicalpro-visions of this Directive, taking into account the results ofthe exchange of experiences as foreseen in Articles 28and 29.
(21)TheCommissionshouldbeempoweredtoadoptdelegated
acts in accordance with Article 290 of the Treaty on theFunctioning of the European Union (TFEU) in respect ofcertain adaptations of the Annexes. It is of particularimportance that the Commission carry out appropriateconsultations during its preparatory work, including atexpert level.
(22)Council Directive 76/767/EEC of 27 July 1976 on the
approximationofthelawsoftheMemberStatesrelatingtocommon provisions for pressure vessels and methods forinspecting them (
1), Council Directive 84/525/EEC of
17 September 1984 on the approximation of the laws ofthe Member States relating to seamless, steel gas cylin-ders (
2), Council Directive 84/526/EEC of 17 September
1984 on the approximation of the laws of the MemberStates relating to seamless, unalloyed aluminium and alu-minium alloy gas cylinders (
3), Council Directive
84/527/EECof17September1984ontheapproximationof the laws of the Member States relating to welded unal-loyedsteelgascylinders(
4)andDirective1999/36/EChave
become obsolete and should therefore be repealed.
(23)In accordance with paragraph 34 of the Interinstitutional
Agreement on better law-making (5), Member States are
encouraged to draw up, for themselves and in the interestof the Union, their own tables, which will, as far as pos-sible, illustrate the correlation between this Directive andtheir transposition measures, and to make those tablespublic,
(1) OJ L 262, 27.9.1976, p. 153.
(2) OJ L 300, 19.11.1984, p. 1.
(3) OJ L 300, 19.11.1984, p. 20.
(4) OJ L 300, 19.11.1984, p. 48.
(5) OJ C 321, 31.12.2003, p. 1.L 165/2 EN Official Journal of the European Union 30.6.2010HAVE ADOPTED THIS DIRECTIVE:
CHAPTER 1
SCOPE AND DEFINITIONS
Article 1
Scope
1. This Directive sets out detailed rules concerning transport-
ablepressureequipmenttoenhancesafetyandensurefreemove-ment of such equipment within the Union.
2. This Directive shall apply to:(a) new transportable pressure equipment as defined in
Article 2(1), which does not bear the conformity markingsprovided for in Directives 84/525/EEC, 84/526/EEC,84/527/EEC or 1999/36/EC, for the purpose of making itavailable on the market;
(b) transportable pressure equipment as defined in Article 2(1),
bearing the conformity markings provided for in this Direc-tive or in Directives 84/525/EEC, 84/526/EEC, 84/527/EECor 1999/36/EC, for the purposes of its periodic inspections,intermediate inspections, exceptional checks and use;
(c) transportable pressure equipment as defined in Article 2(1),
which does not bear the conformity markings provided forinDirective1999/36/EC,forthepurposesofreassessmentofconformity.
3. This Directive shall not apply to transportable pressure
equipment which was placed on the market before the date ofimplementationofDirective1999/36/ECandwhichhasnotbeensubject to a reassessment of conformity.
4. This Directive shall not apply to transportable pressure
equipmentusedexclusivelyforthetransportofdangerousgoodsbetween Member States and third countries, carried out in accor-dance with Article 4 of Directive 2008/68/EC.
Article 2
Definitions
For the purposes of this Directive the following definitions shall
apply:
(1) ‘transportable pressure equipment’ means:
(a) all pressure receptacles, their valves and other accesso-
ries when appropriate, as covered in Chapter 6.2 of theAnnexes to Directive 2008/68/EC;
(b) tanks, battery vehicles/wagons, multiple-element gas
containers (MEGCs), their valves and other accessorieswhen appropriate, as covered in Chapter 6.8 of theAnnexes to Directive 2008/68/EC;when the equipment under (a) or (b) is used in accordance
with those Annexes for the transport of Class 2 gases,excluding gases or articles with figures 6 and 7 in the clas-sification code, and for the transport of the dangerous sub-stancesofotherclassesspecifiedinAnnexItothisDirective.
Transportable pressure equipment shall be understood as
including gas cartridges (UN No 2037) and excluding aero-sols (UN No 1950), open cryogenic receptacles, gas cylin-ders for breathing apparatus, fire extinguishers (UNNo 1044), transportable pressure equipment exemptedaccording to 1.1.3.2 of the Annexes to Directive2008/68/EC and transportable pressure equipmentexempted from the rules for construction and testing ofpackaging according to special provisions in 3.3 of theAnnexes to Directive 2008/68/EC;
(2) ‘Annexes to Directive 2008/68/EC’ means Section I.1 of
Annex I, Section II.1 of Annex II, and Section III.1 ofAnnex III to Directive 2008/68/EC;
(3) ‘placing on the market’ means the first making available of
transportable pressure equipment on the Union market;
(4) ‘makingavailableonthemarket’meansanysupplyoftrans-
portable pressure equipment for distribution or use on theUnion market in the course of a commercial or public ser-viceactivity,whetherinreturnforpaymentorfreeofcharge;
(5) ‘use’ means filling, temporary storage linked to carriage,
emptying and refilling of transportable pressure equipment;
(6) ‘withdrawal’ means any measure aimed at preventing trans-
portable pressure equipment from being made available onthe market or from being used;
(7) ‘recall’ means any measure aimed at achieving the return of
transportable pressure equipment that has already beenmade available to the end user;
(8) ‘manufacturer’meansanynaturalorlegalpersonwhomanu-
factures transportable pressure equipment, or parts thereof,or who has such equipment designed or manufactured andmarkets it under his name or trademark;
(9) ‘authorised representative’ means any natural or legal per-
sonestablishedwithintheUnionwhohasreceivedawrittenmandate from the manufacturer to act on his behalf in rela-tion to specified tasks;
(10) ‘importer’ means any natural or legal person established
within the Union, who places transportable pressure equip-ment or parts thereof from a third country on the Unionmarket;
(11) ‘distributor’ means any natural or legal person established
within the Union, other than the manufacturer or theimporter, who makes transportable pressure equipment orparts thereof available on the market;30.6.2010
EN Official Journal of the European Union L 165/3(12) ‘owner’meansanynaturalorlegalpersonestablishedwithin
the Union who owns transportable pressure equipment;
(13) ‘operator’ means any natural or legal person established in
the Union using transportable pressure equipment;
(14) ‘economicoperator’meansthemanufacturer,theauthorised
representative, the importer, the distributor, the owner orthe operator acting in the course of a commercial or publicservice activity, whether in return for payment or free ofcharge;
(15) ‘conformity assessment’ means the assessment and the pro-
cedure for the assessment of conformity set out in theAnnexes to Directive 2008/68/EC;
(16) ‘Pimarking’meansamarkingwhichindicatesthatthetrans-
portablepressureequipmentisinconformitywiththeappli-cable conformity assessment requirements set out in theAnnexes to Directive 2008/68/EC and in this Directive;
(17) ‘reassessment of conformity’ means the procedure under-
taken, at the request of the owner or operator, for the sub-sequent assessment of the conformity of transportablepressure equipment manufactured and placed on the mar-ket before the date of implementation of Directive1999/36/EC;
(18) ‘periodic inspection’ means the periodic inspection and the
procedures governing the periodic inspection as set out inthe Annexes to Directive 2008/68/EC;
(19) ‘intermediate inspection’ means the intermediate inspection
andtheproceduresgoverningtheintermediateinspectionasset out in the Annexes to Directive 2008/68/EC;
(20) ‘exceptionalcheck’meanstheexceptionalcheckandthepro-
cedures governing the exceptional check set out in theAnnexes to Directive 2008/68/EC;
(21) ‘nationalaccreditationbody’meansthesolebodyinaMem-
ber State that performs accreditation with authority derivedfrom the State;
(22) ‘accreditation’ means an attestation by a national accredita-
tion body that a notified body meets the requirements setout in the second paragraph of 1.8.6.8 of the Annexes toDirective 2008/68/EC;
(23) ‘notifying authority’ means the authority designated by a
Member State pursuant to Article 17;
(24) ‘notified body’ means an inspection body meeting the
requirements set out in the Annexes to Directive2008/68/ECandtheconditionssetoutinArticles20and26of this Directive and notified in accordance with Article 22of this Directive;
(25) ‘notification’ is the process of awarding notified body status
to an inspection body and includes communication of thisinformation to the Commission and to the Member States;(26) ‘market surveillance’ means the activities carried out and
measures taken by public authorities to ensure that trans-portable pressure equipment during its life cycle complieswith the requirements set out in Directive 2008/68/EC andthis Directive and does not endanger health, safety or anyother aspect of public interest protection.
Article 3
On-site requirements
Member States may on their territory establish on-site require-
ments for the mid- or long-term storage or the on-site use oftransportablepressureequipment.However,MemberStatesshallnot establish additional requirements for the transportable pres-sure equipment itself.
CHAPTER 2
OBLIGATIONS OF ECONOMIC OPERATORS
Article 4
Obligations of manufacturers
1. When placing their transportable pressure equipment on
the market, manufacturers shall ensure that the equipment hasbeen designed, manufactured and documented in accordancewith the requirements set out in the Annexes to Directive2008/68/EC and in this Directive.
2. Where the compliance of the transportable pressure equip-
ment with the applicable requirements has been demonstratedthroughtheconformityassessmentprocesssetoutintheAnnexesto Directive 2008/68/EC and in this Directive, manufacturersshall affix the Pi marking in accordance with Article 15 of thisDirective.
3. Manufacturers shall keep the technical documentation
specifiedintheAnnexestoDirective2008/68/EC.Thisdocumen-tation shall be kept for the period specified therein.
4. Manufacturers who consider or have reason to believe that
transportable pressure equipment which they have placed on themarket is not in conformity with the Annexes to Directive2008/68/ECorwiththisDirectiveshallimmediatelytakethecor-rective measures necessary to bring the transportable pressureequipmentintoconformity,towithdrawitortorecallit,ifappro-priate. Furthermore, where the transportable pressure equipmentpresentsarisk,manufacturersshallimmediatelyinformthecom-petent national authorities of the Member States in which theymade the transportable pressure equipment available to thateffect, giving details, in particular, of the non-compliance and ofany corrective measures taken.
5. Manufacturers shall document all such instances of non-
compliance and corrective measures.L 165/4
EN Official Journal of the European Union 30.6.20106. Manufacturers shall, further to a reasoned request from the
competent national authority, provide it with all the informationand documentation necessary to demonstrate the conformity ofthetransportablepressureequipment,inalanguageeasilyunder-stoodbythatauthority.Theyshallcooperatewiththatauthority,at its request, as regards any action taken to eliminate the risksposed by transportable pressure equipment which they haveplaced on the market.
7. Manufacturers shall only provide information to operators
which complies with the requirements set out in the Annexes toDirective 2008/68/EC and in this Directive.
Article 5
Authorised representatives
1. Manufacturers may, by a written mandate, appoint an
authorised representative.
TheobligationssetoutinArticle4(1)and(2)andthedrawingup
of technical documentation shall not form part of the authorisedrepresentative’s mandate.
2. An authorised representative shall perform the tasks speci-
fiedinthemandatereceivedfromthemanufacturer.Themandateshall allow the authorised representative to do at least thefollowing:
(a) keepthetechnicaldocumentationatthedisposalofnational
surveillance authorities for at least the period as specified inthe Annexes to Directive 2008/68/EC for manufacturers;
(b) further to a reasoned request from a competent national
authority,providethatauthoritywithalltheinformationanddocumentation necessary to demonstrate the conformity ofthe transportable pressure equipment in a language easilyunderstood by that authority;
(c) cooperate with the competent national authorities, at their
request, on any action taken to eliminate the risks posed bytransportable pressure equipment covered by the mandate.
3. The identity and address of the authorised representative
shallbeindicatedonthecertificateofconformityspecifiedintheAnnexes to Directive 2008/68/EC.
4. Authorised representatives shall only provide information
tooperatorswhichcomplieswiththerequirementssetoutintheAnnexes to Directive 2008/68/EC and in this Directive.
Article 6
Obligations of importers
1. Importers shall only place on the Union market transport-
ablepressureequipmentwhichisinconformitywiththeAnnexesto Directive 2008/68/EC and with this Directive.2. Before placing transportable pressure equipment on the
market, importers shall ensure that the appropriate conformityassessment procedure has been carried out by the manufacturer.They shall ensure that the manufacturer has drawn up the tech-nical documentation and that the transportable pressure equip-ment bears the Pi marking and is accompanied by the certificateof conformity specified in the Annexes to Directive 2008/68/EC.
Where an importer considers or has reason to believe that the
transportable pressure equipment is not in conformity with theAnnexes to Directive 2008/68/EC or with this Directive, he shallnot place the transportable pressure equipment on the marketuntilithasbeenbroughtintoconformity.Furthermore,wherethetransportable pressure equipment presents a risk, the importershall inform the manufacturer and the market surveillanceauthorities to that effect.
3. Importersshallindicatetheirnameandtheaddressatwhich
they can be contacted either in, or attached to, the certificate ofconformity specified in the Annexes to Directive 2008/68/EC.
4. Importers shall ensure that, while transportable pressure
equipmentisundertheirresponsibility,storageortransportcon-ditionsdonotjeopardiseitscompliancewiththerequirementssetout in the Annexes to Directive 2008/68/EC.
5. Importerswhoconsiderorhavereasontobelievethattrans-
portablepressureequipmentwhichtheyhaveplacedonthemar-ket is not in conformity with the Annexes to Directive2008/68/ECorwiththisDirectiveshallimmediatelytakethecor-rective measures necessary to bring the transportable pressureequipmentintoconformity,towithdrawitortorecallit,ifappro-priate. Furthermore, where the transportable pressure equipmentpresents a risk, importers shall immediately inform the manufac-turerandthecompetentnationalauthoritiesoftheMemberStatesin which they made the transportable pressure equipment avail-able to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
Importers shall document all such instances of non-compliance
and corrective measures.
6. Importers shall, for at least the period specified in the
AnnexestoDirective2008/68/ECformanufacturers,keepacopyofthetechnicaldocumentationatthedisposalofthemarketsur-veillanceauthoritiesandensurethatthetechnicaldocumentationcan be made available to those authorities upon request.
7. Importersshall,furthertoareasonedrequestfromthecom-
petent national authority, provide it with all the information anddocumentation necessary to demonstrate the conformity of thetransportablepressureequipment,inalanguageeasilyunderstoodby that authority. They shall cooperate with that authority, at itsrequest,onanyactiontakentoeliminatetherisksposedbytrans-portable pressure equipment which they have placed on themarket.30.6.2010
EN Official Journal of the European Union L 165/58. Importers shall only provide information to operators
which complies with the requirements set out in the Annexes toDirective 2008/68/EC and in this Directive.
Article 7
Obligations of distributors
1. DistributorsshallonlymakeavailableontheUnionmarket
transportablepressureequipmentwhichisinconformitywiththeAnnexestoDirective2008/68/ECandwiththisDirective.Beforemaking transportable pressure equipment available on the mar-ket distributors shall verify that the transportable pressure equip-ment bears the Pi marking, and that it is accompanied by thecertificate of conformity and the contact address referred to inArticle 6(3) of this Directive.
Where a distributor considers or has reason to believe that trans-
portable pressure equipment is not in conformity with theAnnexes to Directive 2008/68/EC or with this Directive, he shallnot make the transportable pressure equipment available on themarket until it has been brought into conformity. Furthermore,where the transportable pressure equipment presents a risk, thedistributor shall inform the manufacturer or the importer to thateffect as well as the market surveillance authorities.
2. Distributors shall ensure that, while transportable pressure
equipmentisundertheirresponsibility,storageortransportcon-ditionsdonotjeopardiseitscompliancewiththerequirementssetout in the Annexes to Directive 2008/68/EC.
3. Distributors who consider or have reason to believe that
transportablepressureequipmentwhichtheyhavemadeavailableonthemarketisnotinconformitywiththeAnnexestoDirective2008/68/EC or with this Directive shall make sure that the cor-rective measures necessary to bring that transportable pressureequipmentintoconformity,towithdrawitortorecallit,ifappro-priate, are taken. Furthermore, where the transportable pressureequipment presents a risk, distributors shall immediately informthe manufacturer, the importer, where relevant, and the compe-tentnationalauthoritiesoftheMemberStatesinwhichtheymadethetransportablepressureequipmentavailabletothateffect,giv-ing details, in particular, of the non-compliance and of any cor-rective measures taken.
Distributorsshalldocumentallsuchinstancesofnon-compliance
and corrective measures.
4. Distributors shall, further to a reasoned request from the
competent national authority, provide it with all the informationand documentation necessary to demonstrate the conformity ofthe transportable pressure equipment in a language easily under-stoodbythatauthority.Theyshallcooperatewiththatauthority,at its request, on any action taken to eliminate the risks posed bytransportablepressureequipmentwhichtheyhavemadeavailableon the market.5. Distributors shall only provide information to operators
which complies with the requirements set out in the Annexes toDirective 2008/68/EC and in this Directive.
Article 8
Obligations of owners
1. Where an owner considers or has reason to believe that
transportable pressure equipment is not in conformity with theAnnexestoDirective2008/68/EC,includingtherequirementsforperiodic inspection, and with this Directive, he shall not make itavailable or use it until it has been brought into conformity. Fur-thermore,wherethetransportablepressureequipmentpresentsarisk, the owner shall inform the manufacturer or the importer orthe distributor to that effect as well as the market surveillanceauthorities.
Ownersshalldocumentallsuchinstancesofnon-complianceand
corrective measures.
2. Owners shall ensure that, while transportable pressure
equipmentisundertheirresponsibility,storageortransportcon-ditionsdonotjeopardiseitscompliancewiththerequirementssetout in the Annexes to Directive 2008/68/EC.
3. Owners shall only provide information to operators which
complies with the requirements set out in the Annexes to Direc-tive 2008/68/EC and in this Directive.
4. This Article shall not apply to private individuals intending
to use or using transportable pressure equipment for their per-sonal or domestic use or for their leisure or sporting activities.
Article 9
Obligations of operators
1. Operators shall only use transportable pressure equipment
which is in conformity with the requirements set out in theAnnexes to Directive 2008/68/EC and in this Directive.
2. Wherethetransportablepressureequipmentpresentsarisk,
the operator shall inform the owner to that effect as well as themarket surveillance authorities.
Article 10
Cases in which obligations of manufacturers apply to
importers and distributors
Animporterordistributorshallbeconsideredamanufacturerfor
thepurposesofthisDirectiveandsubjecttotheobligationsofthemanufacturer pursuant to Article 4, where he places transport-able pressure equipment on the market under his name or trade-
mark or modifies transportable pressure equipment alreadyplaced on the market in such a way that compliance with theapplicable requirements may be affected.L 165/6
EN Official Journal of the European Union 30.6.2010Article 11
Identification of economic operators
Economic operators shall, on request from the market surveil-
lanceauthority,identifythefollowingtoitforaperiodofatleast10 years:
(a) any economic operator who has supplied them with trans-
portable pressure equipment;
(b) any economic operator to whom they have supplied trans-
portable pressure equipment.
CHAPTER 3
CONFORMITY OF TRANSPORTABLE PRESSURE EQUIPMENT
Article 12
Conformity of transportable pressure equipment and its
assessment
1. The transportable pressure equipment referred to in
Article1(2)(a)shallmeettherelevantconformityassessment,peri-odic inspection, intermediate inspection and exceptional checksrequirementssetoutintheAnnexestoDirective2008/68/ECandin Chapters 3 and 4 of this Directive.
2. The transportable pressure equipment referred to in
Article1(2)(b)shallmeetthespecificationsofthedocumentationaccordingtowhichtheequipmentwasmanufactured.Theequip-mentshallbesubjecttoperiodicinspections,intermediateinspec-tions and exceptional checks in accordance with the Annexes toDirective 2008/68/EC and with the requirements of Chapters 3and 4 of this Directive.
3. Certificates of conformity assessment and certificates of
reassessment of conformity and reports of periodic inspections,intermediateinspectionsandexceptionalchecksissuedbyanoti-fied body shall be valid in all Member States.
For demountable parts of refillable transportable pressure equip-
ment a separate conformity assessment may be carried out.
Article 13
Reassessment of conformity
The reassessment of conformity of transportable pressure equip-
mentreferredtoinArticle1(2)(c)manufacturedandputintoser-vice before the date of implementation of Directive 1999/36/ECshall be established in accordance with the conformity reassess-ment procedure set out in Annex III to this Directive.The Pi marking shall be affixed in accordance with Annex III to
this Directive.
Article 14
General principles of the Pi marking
1. ThePimarkingshallonlybeaffixedbythemanufactureror,
incasesofreassessmentofconformity,assetoutinAnnexIII.Forgas cylinders previously in compliance with Directives84/525/EEC, 84/526/EEC or 84/527/EEC the Pi mark shall beaffixed by or under the surveillance of the notified body.
2. The Pi marking shall be affixed only to transportable pres-
sure equipment which:
(a) meets the conformity assessment requirements in the
Annexes to Directive 2008/68/EC and in this Directive; or
(b) meets the reassessment of conformity requirements referred
to in Article 13.
It shall not be affixed to any other transportable pressure
equipment.
3. By affixing or having affixed the Pi marking, the manufac-
turer indicates that he takes responsibility for the conformity ofthe transportable pressure equipment with all applicable require-mentssetoutintheAnnexestoDirective2008/68/ECandinthisDirective.
4. For the purposes of this Directive, the Pi marking shall be
the only marking which attests conformity of the transportablepressure equipment with the applicable requirements set out inthe Annexes to Directive 2008/68/EC and in this Directive.
5. The affixing on transportable pressure equipment of mark-
ings, signs and inscriptions which are likely to mislead third par-ties as to the meaning or form of the Pi marking, shall beprohibited. Any other marking shall be affixed to the transport-able pressure equipment in such a way that the visibility, legibil-ity and meaning of the Pi marking are not thereby impaired.
6. Demountable parts of refillable transportable pressure
equipment with a direct safety function shall be Pi-marked.
7. Member States shall ensure correct implementation of the
rules governing the Pi marking and shall take appropriate actionintheeventofimproperuseofthemarking.MemberStatesshallalso provide for penalties for infringements, which may includecriminalsanctionsforseriousinfringements.Thosepenaltiesshallbe proportionate to the seriousness of the offence and constitutean effective deterrent against improper use.30.6.2010
EN Official Journal of the European Union L 165/7Article 15
Rules and conditions for the affixing of the Pi marking
1. The Pi marking shall consist of the following symbol in the
following form:
2. The minimum height of the Pi marking shall be 5 mm. Fortransportable pressure equipment with a diameter less than orequal to 140 mm the minimum height shall be 2,5 mm.
3. The proportions given in the graduated drawing in para-
graph 1 shall be respected. The grid does not form part of themarking.
4. The Pi marking shall be affixed visibly, legibly and perma-
nentlytothetransportablepressureequipmentortoitsdataplateas well as to demountable parts of refillable transportable pres-sure equipment having a direct safety function.
5. The Pi marking shall be affixed before the new transport-
able pressure equipment or demountable parts of refillable trans-portable pressure equipment having a direct safety function areplaced on the market.
6. ThePimarkingshallbefollowedbytheidentificationnum-
ber of the notified body involved in the initial inspections andtests.
Theidentificationnumberofthenotifiedbodyshallbeaffixedby
the body itself, or under its instructions, by the manufacturer.
7. Themarkingofthedateoftheperiodicinspectionor,where
appropriate,theintermediateinspectionshallbeaccompaniedbytheidentificationnumberofthenotifiedbodyresponsiblefortheperiodic inspection.
8. With regard to gas cylinders previously in compliance with
Directives 84/525/EEC, 84/526/EEC or 84/527/EEC not bearingthe Pi marking, when the first periodic inspection is carried outinaccordancewiththisDirective,theidentificationnumberofthenotified body responsible shall be preceded by the Pi marking.Article 16
Free movement of transportable pressure equipment
Without prejudice to the safeguard procedures in Articles 30
and31ofthisDirectiveandtothemarketsurveillanceframeworkset out in Regulation (EC) No 765/2008 (
1), no Member State
shall prohibit, restrict or impede on its territory the free move-ment, the making available on the market and the use of trans-portablepressureequipment,whichcomplieswiththisDirective.
CHAPTER 4
NOTIFYING AUTHORITIES AND NOTIFIED BODIES
Article 17
Notifying authorities
1. Member States shall designate a notifying authority that
shall be responsible for setting up and carrying out the necessaryproceduresfortheassessment,notificationandsubsequentmoni-toring of notified bodies.
2. Member States may decide that the assessment and moni-
toringreferredtoinparagraph1shallbecarriedoutbyanationalaccreditationbodywithinthemeaningofandinaccordancewithRegulation (EC) No 765/2008.
3. Where the notifying authority delegates or otherwise
entrusts the monitoring referred to in paragraph 1 to a bodywhich is not a governmental entity, that body shall be a legalentityandshallcomply mutatismutandis withtherequirementsset
out in Article 18(1) to (6). In addition the entrusted body shallhave arrangements to cover liabilities arising out of its activities.
4. The notifying authority shall take full responsibility for the
tasks performed by the body referred to in paragraph 3.
Article 18
Requirements relating to notifying authorities
1. The notifying authority shall be established in such a way
that no conflicts of interest with notified bodies occur.
2. The notifying authority shall be organised and operated so
as to safeguard the objectivity and impartiality of its activities.
3. The notifying authority shall be organised in such a way
thateachdecisionrelatingtonotificationofthenotifiedbodiesistakenbycompetentpersonsdifferentfromthosewhocarriedoutthe assessment.
(1) Regulation (EC) No 765/2008 of the European Parliament and of the
Council of 9 July 2008 setting out the requirements for accreditationand market surveillance relating to the marketing of products(OJ L 218, 13.8.2008, p. 30).L 165/8 EN Official Journal of the European Union 30.6.20104. Thenotifyingauthorityshallnotofferorprovideanyactivi-
tiesorconsultancyservicesonacommercialorcompetitivebasisthat notified bodies perform.
5. Thenotifyingauthorityshallsafeguardtheconfidentialityof
the information obtained.
6. The notifying authority shall have a sufficient number of
competent personnel at its disposal for the proper performanceof its tasks.
Article 19
Information obligation of notifying authorities
MemberStatesshallinformtheCommissionoftheirnationalpro-
cedures for the assessment, notification and monitoring of noti-fied bodies, and of any changes to that information.
The Commission shall make that information publicly available.
Article 20
Requirements relating to notified bodies
1. For the purposes of notification, a notified body shall meet
therequirementssetoutintheAnnexestoDirective2008/68/ECand in this Directive.
2. Acompetentauthority,withinthemeaningoftheAnnexes
toDirective2008/68/ECmaybeanotifiedbodyprovideditmeetstherequirementssetoutintheAnnexestoDirective2008/68/ECand in this Directive and that it does not also act as the notifyingauthority.
3. The notified body shall be established under national law
and shall have legal personality.
4. The notified body shall participate in, or ensure that its
assessmentpersonnelisinformedof,therelevantstandardisationactivities and the activities of the notified body coordinationgroup established pursuant to Article 29 and apply as generalguidancetheadministrativedecisionsanddocumentsproducedasa result of the work of that group.
Article 21
Application for notification
1. An inspection body shall submit an application for notifi-
cation to the notifying authority of the Member State in which itis established.
2. The application shall be accompanied by a description of:(a) the activities relating to conformity assessment, periodic
inspection, intermediate inspection, exceptional checks andreassessment of conformity;
(b) the procedures relating to point (a);(c) the transportable pressure equipment for which the body
claims to be competent;(d) an accreditation certificate issued by a national accreditation
body within the meaning of Regulation (EC) No 765/2008,attestingthattheinspectionbodyfulfilstherequirementssetout in Article 20 of this Directive.
Article 22
Notification procedure
1. Notifying authorities shall notify only those bodies which
have satisfied the requirements set out in Article 20.
2. They shall notify the Commission and the other Member
States using the electronic tool developed and managed by theCommission.
3. The notification shall include the information required in
Article 21(2).
4. The body concerned may perform the activities of a noti-
fiedbodyonlywherenoobjectionsareraisedbytheCommissionor the other Member States within two weeks of a notification.
Onlysuchabodyshallbeconsideredanotifiedbodyforthepur-
poses of this Directive.
5. TheCommissionandtheotherMemberStatesshallbenoti-
fied of any subsequent relevant changes to the notification.
6. In–house inspection services of the applicant as defined in
the Annexes to Directive 2008/68/EC shall not be notified.
Article 23
Identification numbers and lists of notified bodies
1. The Commission shall assign an identification number to a
notified body.
It shall assign a single such number even where the body is noti-
fied under several Union acts.
2. TheCommissionshallmakepubliclyavailablethelistofthe
bodies notified under this Directive, including the identificationnumbers that have been allocated to them and the activities forwhich they have been notified.
The Commission shall ensure that that list is kept up to date.
Article 24
Changes to notifications
1. Where a notifying authority has ascertained or has been
informed that a notified body no longer meets the requirementssetoutinArticle20,orthatitisfailingtofulfilitsobligations,thenotifying authority shall restrict, suspend or withdraw notifica-tion, as appropriate, depending on the seriousness of the failureto meet those requirements or fulfil those obligations. It shallimmediately inform the Commission and the other MemberStates accordingly.30.6.2010
EN Official Journal of the European Union L 165/92. Intheeventofwithdrawal,restrictionorsuspensionofnoti-
fication or where the notified body has ceased its activity, thenotifyingMemberStateshalltaketheappropriatestepstoensurethatthefilesofthatbodyareeitherprocessedbyanothernotifiedbody or kept available for the responsible notifying and marketsurveillance authorities on request.
Article 25
Challenge to the competence of notified bodies
1. The Commission shall investigate all cases where it doubts
or doubt is brought to its attention regarding the competence ofa notified body or the continued fulfilment by a notified body ofthe requirements and responsibilities to which it is subject.
2. The notifying Member State shall provide the Commission,
on request, with all information relating to the basis for the noti-fication or the maintenance of the competence of the bodyconcerned.
3. The Commission shall ensure that all sensitive information
obtainedinthecourseofitsinvestigationsistreatedconfidentially.
4. WheretheCommissionascertainsthatanotifiedbodydoes
not meet, or no longer meets, the requirements for its notifica-tion, it shall inform the notifying Member State accordingly andrequest it to take the necessary corrective measures, includingde-notification, if necessary.
Article 26
Operational obligations of notified bodies
1. Notifiedbodiesshallcarryoutconformityassessments,peri-
odicinspections,intermediateinspectionsandexceptionalchecksin accordance with the terms of their notification and the proce-
dures set out in the Annexes to Directive 2008/68/EC.
2. Notifiedbodiesshallcarryoutreassessmentsofconformity
in accordance with Annex III.
3. Notified bodies notified by one Member State shall be
authorised to work in all Member States. The notifying authoritywhich carried out the initial assessment and notification retainsthe responsibility for monitoring the ongoing activities of thenotified body.
Article 27
Information obligation of notified bodies
1. Notified bodies shall inform the notifying authority of the
following:
(a) any refusal, restriction, suspension or withdrawal of a
certificate;
(b) any circumstances affecting the scope of and conditions for
notification;(c) any request for information on activities performed which
they have received from market surveillance authorities;
(d) on request, activities performed within the scope of their
notification and any other activity performed, includingcross-border activities and subcontracting.
2. Notifiedbodiesshallprovidetheotherbodiesnotifiedunder
this Directive carrying out similar conformity assessment, peri-odic inspection, intermediate inspections and exceptional checksactivities covering the same transportable pressure equipmentwith relevant information on issues relating to negative and, onrequest, positive conformity assessment results.
Article 28
Exchange of experience
The Commission shall provide for the organisation of exchange
of experience between the Member States’ national authoritiesresponsible under this Directive for:
(a) notification policy;(b) market surveillance.
Article 29
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and
cooperation between bodies notified under this Directive are putin place and properly operated in the form of a sectoral group ofnotified bodies.
Member States shall ensure that the bodies notified by them par-
ticipate in the work of that group, directly or by designatedrepresentatives.
CHAPTER 5
SAFEGUARD PROCEDURES
Article 30
Procedure for dealing with transportable pressure
equipment presenting a risk at national level
1. Where the market surveillance authorities of one Member
State have taken action pursuant to Article 20 of Regulation (EC)No765/2008orwheretheyhavesufficientreasontobelievethattransportable pressure equipment covered by this Directive pre-sents a risk to the health or safety of persons or to other aspectsof public interest protection covered by this Directive, they shallcarry out an evaluation in relation to the transportable pressureequipment concerned covering all the requirements laid down inthisDirective.Therelevanteconomicoperatorsshallcooperateasnecessary with the market surveillance authorities, including
granting access to their premises and providing samples asappropriate.L 165/10
EN Official Journal of the European Union 30.6.2010Where, in the course of that evaluation, the market surveillance
authorities find that the transportable pressure equipment doesnot comply with the requirements set out in the Annexes toDirective 2008/68/EC and in this Directive, they shall withoutdelayrequiretherelevanteconomicoperatortotakeallappropri-ate corrective action to bring the transportable pressure equip-ment into compliance with those requirements, to withdraw thetransportable pressure equipment from the market or to recall itwithinareasonableperiod,commensuratewiththenatureoftherisk, as they may prescribe.
Themarketsurveillanceauthoritiesshallinformtherelevantnoti-
fied body accordingly.
Article21ofRegulation(EC)No765/2008shallapplytothecor-
rective action referred to in the second subparagraph of thisparagraph.
2. Where the market surveillance authorities consider that
non-compliance is not restricted to their national territory, theyshallinformtheCommissionandtheotherMemberStatesoftheresults of the evaluation and of the actions which they haverequired the economic operator to take.
3. Theeconomicoperatorshallensurethatallappropriatecor-
rective action is taken in respect of transportable pressure equip-ment that it has made available on the Union market.
4. Where the relevant economic operator does not take
adequatecorrectiveactionwithintheperiodreferredtointhesec-ond subparagraph of paragraph 1, the market surveillanceauthoritiesshalltakeallappropriateprovisionalmeasurestopro-hibitorrestrictthetransportablepressureequipmentbeingmadeavailable on their national market, to withdraw the equipmentfrom that market or to recall it.
They shall inform the Commission and the other Member States,
without delay, of those measures.
5. The information referred to in paragraph 4 shall include all
available details, in particular the data necessary for the identifi-cation of the non-compliant transportable pressure equipment,the origin of the equipment, the nature of the alleged non-compliance and the risk involved, the nature and duration of thenational measures taken and the arguments put forward by therelevanteconomicoperator.Inparticular,themarketsurveillanceauthorities shall indicate whether the non-compliance is due toeither:
(a) failure of the transportable pressure equipment to meet
requirementsrelatingtothehealthorsafetyofpersonsortoother aspects of public interest protection set out in theAnnexes to Directive 2008/68/EC and in this Directive, or
(b) shortcomings in the standards or technical codes referred to
in the Annexes to Directive 2008/68/EC or in other provi-sions of that Directive.6. Member States other than the Member State initiating the
procedure shall without delay inform the Commission and theother Member States of any measures adopted and of any addi-tional information at their disposal relating to the non-compliance of the transportable pressure equipment concerned,and,intheeventofdisagreementwiththenotifiednationalmea-sure, of their objections.
7. Where, within two months of receipt of the information
referredtoinparagraph4,noobjectionhasbeenraisedbyeithera Member State or the Commission in respect of a provisionalmeasure taken by a Member State, that measure shall be deemedjustified.
8. MemberStatesshallensurethatappropriaterestrictivemea-
suresaretakeninrespectofthetransportablepressureequipmentconcerned, such as withdrawal of the transportable pressureequipment from their market, without delay.
Article 31
Union safeguard procedure
1. Where, on completion of the procedure set out in
Article30(3)and(4),objectionsareraisedagainstameasuretakenbyaMemberStateorwheretheCommissionconsidersanationalmeasure to be contrary to a legally binding Union act, the Com-missionshallwithoutdelayenterintoconsultationwiththeMem-ber States and the relevant economic operator or operators andshall evaluate the national measure. On the basis of the results ofthatevaluation,theCommissionshalldecidewhetherthenationalmeasure is justified or not.
The Commission shall address its decision to all Member States
andshallimmediatelycommunicateittothemandtotherelevanteconomic operator or operators.
2. If the national measure is considered justified, all Member
States shall take the measures necessary to ensure that the non-compliant transportable pressure equipment is withdrawn fromtheir markets, and shall inform the Commission accordingly.
If the national measure is considered unjustified, the Member
State concerned shall withdraw it.
3. Where the national measure is considered justified and the
non-complianceofthetransportablepressureequipmentisattrib-uted to shortcomings in the standards as referred to inArticle 30(5)(b), the Commission shall inform the relevant Euro-pean standardisation body or bodies and may bring the matterbefore the Committee set up by Article 5 of Directive98/34/EC(
1).ThatCommitteemayconsulttherelevantEuropean
standardisation body or bodies before delivering its opinion.
(1) Directive 98/34/EC of the European Parliament and of the Council of
22 June 1998 laying down a procedure for the provision of informa-tioninthefieldoftechnicalstandardsandregulationsandofrulesonInformation Society services (OJ L 204, 21.7.1998, p. 37).30.6.2010 EN Official Journal of the European Union L 165/11Article 32
Compliant transportable pressure equipment which
presents a risk to health and safety
1. Where having performed an evaluation pursuant to
Article 30(1) a Member State finds that although transportablepressure equipment is in compliance with Directive 2008/68/ECand this Directive, it presents a risk to the health or safety of per-sons or to other aspects of public interest protection, it shallrequire the relevant economic operator to take all appropriatemeasures to ensure that the transportable pressure equipmentconcerned, when placed on the market, no longer presents thatrisk, to withdraw the equipment from the market or to recall itwithinareasonableperiod,commensuratewiththenatureoftherisk, as it may prescribe.
2. Theeconomicoperatorshallensurethatcorrectiveactionis
taken in respect of all the transportable pressure equipment con-cerned that he has made available on the market or is usingthroughout the Union.
3. The Member State shall immediately inform the Commis-
sionandtheotherMemberStates.Thatinformationshallincludeall available details, in particular the data necessary for the iden-tificationofthetransportablepressureequipmentconcerned,theorigin and the supply chain of the equipment, the nature of therisk involved and the nature and duration of the national mea-sures taken.
4. TheCommissionshallwithoutdelayenterintoconsultation
with the Member States and the relevant economic operator oroperators and shall evaluate the national measures taken. On thebasisoftheresultsofthatevaluation,theCommissionshalldecidewhetherthemeasureisjustifiedornot,andwherenecessary,pro-pose appropriate measures.
5. The Commission shall address its decision to all Member
States and shall immediately communicate it to them and to therelevant economic operator or operators.
Article 33
Formal non-compliance
1. Without prejudice to Article 30, where a Member State
makes one of the following findings, it shall require the relevanteconomic operator to put an end to the non-complianceconcerned:
(a) thatthePimarkinghasbeenaffixedinviolationofArticle12,
13, 14 or 15;
(b) that the Pi marking has not been affixed;(c) that the technical documentation is either not available or
not complete;
(d) that the requirements of the Annexes to Directive
2008/68/EC and of this Directive have not been compliedwith.
2. Where the non-compliance referred to in paragraph 1 per-
sists, the Member State concerned shall take all appropriate mea-surestorestrictorprohibitthetransportablepressureequipmentbeing made available on the market or shall ensure that it isrecalled or withdrawn from the market.CHAPTER 6
FINAL PROVISIONS
Article 34
Transitional provisions
Within their territory, Member States may maintain the provi-
sions listed in Annex II.
Member States which maintain such provisions shall inform the
Commission thereof. The Commission shall inform the otherMember States.
Article 35
Adaptation to scientific and technical progress
The Commission may adopt delegated acts in accordance with
Article 290 TFEU as regards adaptations of the Annexes to thisDirective to scientific and technical progress, in particular takinginto account amendments to the Annexes to Directive2008/68/EC.
ForthedelegatedactsreferredtointhisArticle,theproceduresset
out in Articles 36, 37 and 38 shall apply.
Article 36
Exercise of delegation
1. The powers to adopt the delegated acts referred to in
Article 35 shall be conferred on the Commission for an indeter-minate period of time.
2. As soon as it adopts a delegated act, the Commission shall
notify it simultaneously to the European Parliament and theCouncil.
3. The powers to adopt delegated acts are conferred on the
Commission subject to the conditions laid down in Articles 37and 38.
Article 37
Revocation of the delegation
1. The delegation of power referred to in Article 35 may be
revoked by the European Parliament or by the Council.
2. The institution which has commenced an internal proce-
dure for deciding whether to revoke the delegation of powersshall endeavour to inform the other institution and the Commis-sion within a reasonable time before the final decision is taken,indicating the delegated powers which could be subject to revo-cation and possible reasons for a revocation.
3. The decision of revocation shall put an end to the delega-
tion of the powers specified in that decision and shall take effectimmediately or at a later date specified therein. It shall not affectthe validity of the delegated acts already in force. It shall be pub-lished in the Official Journal of the European Union .L 165/12
EN Official Journal of the European Union 30.6.2010Article 38
Objections to delegated acts
1. The European Parliament or the Council may object to a
delegated act within a period of two months from the date ofnotification.
At the initiative of the European Parliament or the Council this
period shall be extended by two months.
2. If,onexpiryofthatperiod,neithertheEuropeanParliament
nor the Council has objected to the delegated act it shall be pub-lished in the Official Journal of the European Union and shall enter
into force at the date stated therein.
The delegated act may be published in the Official Journal of the
European Union and enter into force before the expiry of that
period if the European Parliament and the Council have bothinformed the Commission of their intention not to raiseobjections.
3. If the European Parliament or the Council objects to a del-
egated act, it shall not enter into force. The institution whichobjects shall state the reasons for objecting to the delegated act.
Article 39
Repeal
Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC
and 1999/36/EC are repealed with effect from 1 July 2011.
References to the repealed Directive 1999/36/EC shall be con-
strued as references to this Directive.
Article 40
Recognition of equivalence
1. EEC pattern approval certificates for transportable pressure
equipment issued pursuant to Directives 84/525/EEC,84/526/EEC and 84/527/EEC and EC design-examination certifi-cates issued pursuant to Directive 1999/36/EC shall be recogn-ised as equivalent to the type approval certificates referred to inthe Annexes to Directive 2008/68/EC and shall be subject to theprovisions on time-limited recognition of type approvals set outin those Annexes.
2. Valves and accessories referred to in Article 3(3) of Direc-
tive 1999/36/EC and marked with the mark of Directive97/23/EC (
1) according to Article 3(4) of Directive 1999/36/EC
may still be used.Article 41
Obligations on Member States
Member States shall take the necessary measures to ensure that
the economic operators concerned comply with the provisionsset out in Chapters 2 and 5. Member States shall also ensure thatthe necessary implementing measures are taken in respect ofArticles 12 to 15.
Article 42
Transposition
1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with thisDirective by 30 June 2011 at the latest. They shall forthwithinform the Commission thereof.
When Member States adopt these measures, they shall contain a
referencetothisDirectiveorshallbeaccompaniedbysuchrefer-enceontheoccasionoftheirofficialpublication.Themethodsofmaking such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt inthe field covered by this Directive.
3. Notwithstanding paragraph 1, Member States shall ensure
that Article 21(2)(d) applies with effect from 1 January 2012 atthe latest.
4. MemberStatesshallensurethelaws,regulationsandadmin-
istrative provisions referred to in paragraph 1 apply to pressurereceptacles,theirvalvesandotheraccessoriesusedforthecarriageofUNNo1745,UNNo1746andUNNo2495from1July2013at the latest.
Article 43
Entry into force
ThisDirectiveshallenterintoforceonthe20thdayfollowingits
publication in the Official Journal of the European Union .
Article 44
Addressees
This Directive is addressed to the Member States.
Done at Strasbourg, 16 June 2010.
For the European Parliament
The President
J. BUZEKFor the Council
The President
D. LÓPEZ GARRIDO
(1) Directive 97/23/EC of the European Parliament and of the Council of
29May1997ontheapproximationofthelawsoftheMemberStatesconcerning pressure equipment (OJ L 181, 9.7.1997, p. 1).30.6.2010 EN Official Journal of the European Union L 165/13ANNEX I
List of dangerous goods other than those in class 2
UN Number Class Dangerous substance
1051 6.1 HYDROGEN CYANIDE, STABILISED
containing less than 3 % water
1052 8 HYDROGEN FLUORIDE, ANHY-
DROUS
1745 5.1 BROMINE PENTAFLUORIDE
Excluding carriage in tanks
1746 5.1 BROMINE TRIFLUORIDE
Excluding carriage in tanks
1790 8 HYDROFLUORIC ACID
with more than 85 % hydrogen fluoride
2495 5.1 IODINE PENTAFLUORIDE
Excluding carriage in tanksL 165/14 EN Official Journal of the European Union 30.6.2010ANNEX II
TRANSITIONAL PROVISIONS
1. Member States may retain their national provisions concerning devices intended for connection with other equipment
andcolourcodesapplicabletotransportablepressureequipmentuntilsu chtimeasrelevantstandardsforuseareadded
to the Annexes to Directive 2008/68/EC.
2. MemberStatesinwhichtheambienttemperatureisregularlylowerthan– 20 °Cmayimposemorestringentstandards
as regards the operating temperature of material intended for transporta ble pressure equipment for use in the national
transportofdangerousgoodswithintheirterritoryuntilprovisionsont heappropriatereferencetemperaturesforgiven
climatic zones are incorporated into the Annexes to Directive 2008/68/EC .
Inthatcase,inthePimarkingofthetransportablepressureequipment,in cludingthedemountablepartshavingadirect
safety function, the identification number of the notified body shall be f ollowed by ‘– 40 °C’ or other relevant marking
approved by the competent authority.30.6.2010 EN Official Journal of the European Union L 165/15ANNEX III
PROCEDURE FOR THE REASSESSMENT OF CONFORMITY
1. The method for ensuring that the transportable pressure equipment refe rred to in Article 1(2)(c) manufactured and put
into service before the dates of implementation of Directive 1999/36/EC c omplies with the relevant provisions of the
Annexes to Directive 2008/68/EC and of this Directive as applicable at the time of reassessment shall be as set out in
this Annex.
2. Theowneroroperatormustmakeavailabletoanotifiedbodyconformingt oENISO/IEC17020:2004typeA,notified
forreassessmentofconformity,theinformationregardingthetransport ablepressureequipmentwhichenablesthatbody
to identify the equipment precisely (origin, design rules, and for acetyl ene cylinders also details of the porous material).
Theinformationshallinclude,whereappropriate,anyprescribedrestri ctionsonuse,andanynotesonpossibledamage
or repairs which have been carried out.
3. ThetypeAnotifiedbody,notifiedforreassessmentofconformity,shal lassesswhetherthetransportablepressureequip-
ment affords at least the same degree of safety as the transportable pressu re equipment referred to in the Annexes to
Directive2008/68/EC.Theassessmentshallbecarriedoutonthebasisoft heinformationproducedinaccordancewith
paragraph 2 and, where appropriate, of further inspections.
4. If the results of the assessment in paragraph 3 are satisfactory, the tra nsportable pressure equipment shall be subject to
theperiodicinspectionprovidedforintheAnnexestoDirective2008/68/ EC.Iftherequirementsofthatperiodicinspec-
tion are met the Pi marking shall be applied by or under the surveillance of t he notified body responsible for the peri-
odicinspectioninaccordancewithArticle14(1)to(5).ThePimarkingsha llbefollowedbytheidentificationnumberof
thenotifiedbodyresponsiblefortheperiodicinspection.Thenotifiedb odyresponsiblefortheperiodicinspectionshall
issue a certificate of reassessment in accordance with paragraph 6.
5. Where pressure receptacles were manufactured in series, Member States may authorise the reassessment of conformity
of individual pressure receptacles, including their valves and other acc essories used for transport, to be carried out by a
notified body notified for periodic inspection of the relevant transport able pressure receptacles provided that confor-
mity of the type has been assessed in accordance with paragraph 3 by a type A n otified body, responsible for the reas-
sessment of conformity, and a certificate of type reassessment issued. Th e Pi marking shall be followed by the
identification number of the notified body responsible for the periodic i nspection.
6. Inallcasesthenotifiedbodyresponsiblefortheperiodicinspections hallissuethecertificateofreassessmentcontaining
as a minimum:
(a) the identification of the notified body issuing the certificate, and, if different, the identification number of the type
A notified body responsible for the reassessment of conformity in accorda nce with paragraph 3;
(b) the name and address of owner or operator specified in paragraph 2;(c) in the case of the application of the procedure in paragraph 5, the data i dentifying the certificate of type
reassessment;
(d) thedataforidentificationofthetransportablepressureequipmentt owhichPimarkinghasbeenappliedincluding
at least the serial number or numbers; and
(e) the date of issue.
7. A certificate of type reassessment shall be issued.
Where the procedure in paragraph 5 is applied the type A body, responsible f or the reassessment of conformity, shall
issue the certificate of type reassessment containing as a minimum:
(a) the identification of the notified body issuing the certificate;(b) the name and address of the manufacturer and the holder of the original t ype approval for the transportable pres-
sure equipment being reassessed when the holder is not the manufacturer;L 165/16 EN Official Journal of the European Union 30.6.2010(c) the data identifying the transportable pressure equipment belonging to the series;
(d) the date of issue; and(e) the words: ‘this certificate does not authorise manufacture of transp ortable pressure equipment or parts thereof’.
8. By affixing or having affixed the Pi marking, the owner or operator indic ates that he takes responsibility for the con-
formity of the transportable pressure equipment with all applicable requ irements set out in the Annexes to Directive
2008/68/EC and in this Directive as applicable at the time of reassessment .
9. Whereappropriate,theprovisionsofAnnexII(2)shallbetakenintoacc ountandthecoldmarkingprovidedforinthat
Annex shall also be affixed.30.6.2010 EN Official Journal of the European Union L 165/17Statement by the European Parliament, the Council and the Commission on Ar ticle 290 TFEU
‘TheEuropeanParliament,CouncilandCommissiondeclarethattheprovis ionsofthisDirectiveshallbewith-
out prejudice to any future position of the institutions as regards the imp lementation of Article 290 TFEU or
individual legislative acts containing such provisions.’
Statement by the Commission concerning the notification of delegated act s
‘The European Commission takes note that except in cases where the legisla tive act provides for an urgency
procedure,theEuropeanParliamentandtheCouncilconsiderthatthenoti ficationofdelegatedacts,shalltake
into account the periods of recess of the institutions (winter, summer and European elections), in order to
ensure that the European Parliament and the Council are able to exercise th eir prerogatives within the time
limits laid down in the relevant legislative acts, and is ready to act accor dingly.’L 165/18 EN Official Journal of the European Union 30.6.2010