Proposal for a Directive of the European Parliament and of the Council of …. on transportable pressure equipment
Date: 2009-09-18
Institutions: European Commission
Subjects: EC conformity marking, application of EU law, pressure equipment, roadworthiness tests, safety standard, transport of dangerous goods, transport safety

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 18.9.2009 
COM(2009) 482 final 

2009/0131 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

of …. 

on transportable pressure equipment 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The transport of pressure equipment, e. g. tanks, receptacles, drums and cylinders, constitutes 
an important area of the transport of dangerous goods.  

On  29  April  1999  the  Council  adopted  a  Directive  on  transportable  pressure  equipment 
(1999/36/EC, OJ L138 of 1/6/1999). This Directive ensures a high level of transport safety for 
transportable  pressure  equipment  whilst  allowing  their  free  movement  and  use  on  the 
European  transport  market  through  common  norms  for  their  design,  construction  and 
subsequent checks. 

For  the  technical  requirements,  the  existing  Directive  1999/36/EC  refers  to  Directives 
94/55/EC and 96/49/EC, which have been repealed by Directive 2008/68/EC with effect of 1 
July  2009.  Directive  2008/68/EC  incorporates  into  Community  legislation  the  requirements 
contained  in  international  agreements  on  transport  of  dangerous  goods  by  road  (ADR: 
European Agreement concerning the International Carriage of Dangerous Goods by Road), 
rail  (RID:  Regulations  concerning  the  International  Carriage  of  Dangerous  Goods  by  Rail) 
and inland waterways (ADN: European Agreement concerning the International Carriage of 
Dangerous Goods by Inland Waterways). 

As  a  result  of  these  recent  legislative  developments,  which  in  turn  reflect  technical 
developments over the last 10 years, the European Union rules have become complicated and 
highly  difficult  to  understand.  In  addition,  on  a  number  of  technical  issues  the  interplay 
between  European  and  international  rules  will  lead  to  certain  contradictions  which  would 
make  their  application  even  more  difficult.  It  is  therefore  necessary  to  simplify  the  rules 
wherever  possible  by  eliminating  the  contradictions  and  streamlining  the  rules.  As  a  by-
product  this  will  lead  to  a  considerable  reduction  of  the  volume  of  the  legislation  which 
benefits  users  as  well  as  national  authorities  which  are  called  upon  to  ensure  their  full 
application. 

The second key objective of the proposal concerns the use of the equipment itself for transport 
operations in the internal market. Whereas the existing Directive 1999/36/EC already ensures 
the  equipment's  free  movement  and  use,  recent  developments  in  Community  legislation 
relating to the marketing of products on the single European market, i.e. the "New Legislative 
Framework"  Regulation  No  765/2008/EC  and  Decision  No  768/2008/EC,  should  be  taken 
into  account.  The  "New  Legislative  Framework"  sets  a  general  framework  which  should, 
wherever possible, be applied across all industrial sectors. Its principles are appropriate for the 
market  of  transportable  pressure  equipment  and  are  therefore  incorporated  in  this  proposal. 
Such incorporation, whilst not introducing fundamental changes, would contribute towards a 
key  objective  of  the  "New  Legislative  Framework"  of  harmonising  market  rules  in  as  many 
industrial sectors as possible as well as simplify the use of such rules by industry. 

In view of these facts it is necessary to revise Directive 1999/36/EC. 

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2. 

CONSULTATION OF INTERESTED PARTIES 

This  proposal  is  the  result  of  intensive  consultations  with  the  Member  States  and  other 
interested  parties.  There  is  a  general  consensus  that  a  revision  of  Directive  1999/36/EC  is 
warranted. 

The proposal focuses on a highly specified sector using transportable pressure equipment for 
gases and a small number of other substances. Furthermore, issues relating directly to safety, 
namely  technical  design,  construction  and  testing  provisions,  are  not  addressed  by  the 
proposal itself, but by international agreements. Therefore the general public consultation on 
the proposal was not extended to these aspects. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

The  proposed  Directive  is  to  be  adopted  by  codecision  by  the  European  Parliament  and  the 
Council.  It  would  replace  an  existing  Council  Directive.  The  legal  base  of  the  proposal  is 
Article 71of the Treaty. 

Subsidiarity principle 

Besides  guaranteeing  a  high  level  of  safety  in  transport  of  dangerous  goods,  the  proposed 
Directive  also  sets  out  rules  for  maintaining  the  already  existing  internal  market  for  the 
equipment  needed  in  the  transport  operations  by  relying  on  general  European  principles 
specified  in  the  so-called  "New  Legislative  Framework"  rules  Regulation  No  765/2008/EC 
and  Decision  No  768/2008/EC.  Such  an  objective  cannot  be  achieved  by  national  measures 
only. 

Proportionality principle 

As there is an existing Directive, the legislative bodies of the European Union have already 
deemed  such  a  measure  necessary  and  proportional.  This  judgement  appears  well  founded, 
since  transportable  pressure  equipment  is  inherently  dangerous,  but  they  must  be  used  for 
international transport of substances that are not locally available and yet are necessary, inter 
alia,  for  medical,  scientific  and  industrial  uses.  Thus  a  European  legislation  guaranteeing  a 
common  level  of  safety  and  allowing  efficient  use  of  transportable  pressure  equipment  is 
warranted. 

Choice of instrument 

The proposed measure is a Directive. Firstly, it would replace an already existing Directive. 
Secondly, the implementation of the measure allows Member States their own organisational 
choices. 

4. 

BUDGETARY IMPLICATIONS 

Given  that  the  provisions  of  the  existing  Directive  on  transportable  pressure  equipment  are 
already implemented, any further budgetary implications will be minor.  

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5. 

SIMPLIFICATION 

The  need  for  simplification  and  clarification  is  the  main  reason  for  the  Commission  to 
propose  this  revision.  Neither  the  scope,  nor  the  measures  of  the  existing  Directive  will  be 
changed in any substantial way. This also results in minimal budgetary  and  other economic 
impacts on administration and operators. 

As  for  the  technical  provisions,  a  central  simplification  objective  is  to  remove  conflicting 
issues between the existing Directive on Transportable Pressure Equipment and international 
rules  on  the  transport  of  dangerous  goods,  in  particular  since  these  rules  have  already  been 
extended to Community legislation through Directive 2008/68/EC. 

The  proposal  simplifies  existing  provisions,  in  particular  those  relating  to  the  modules  on 
conformity  assessment  procedures.  This  dimension  will  be  substantially  streamlined  and 
simplified  in  the  proposal,  which  makes  reference  to  the  relevant  international  agreements. 
The  technical  rules  and  administrative  procedures  are  more  consistently  presented  in  one 
source,  i.e.  in  the  international  agreements.  The  proposed  Directive  focuses  on  those  issues 
that can be treated satisfactorily only through European legislation. 

As  for  making  the  equipment  required  for  transport  operations  available  on  the  market,  the 
Community has recently adopted rules relating to the marketing of products on the EU single 
market  ("New  Legislative  Framework")  which  should,  wherever  possible,  be  applied  across 
all industrial sectors. By incorporating these rules into the proposal for the specific sector of 
transportable  pressure  equipment  the  Commission  will  help  to  simplify  the  rules  by  not 
creating different, sector-specific rules where the general rules would serve the purpose.  

6. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The proposal will repeal Council Directive 1999/36/EC and a number of obsolete Directives 
on pressure cylinders. 

Correlation table 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of  national 
provisions  transposing  the  directive  as  well  as  a  correlation  table  between  those  provisions 
and this directive. 

European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the  European 
Economic Area. 

Detailed explanation of the proposal 

Article 1: Scope 

The Article identifies safety and the integrity of the internal market as key objectives and sets 
out the equipment to which the Directive applies. 

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Article 2: Definitions 

The Article defines a number of terms regarding transportable pressure equipment, actors and 
measures  guaranteeing  the  safety  of  the  equipment  and  its  use  on  the  internal  market. 
Furthermore, the relevant terminology from the "New Legislative Framework" is defined. 

Article 3: On-site requirements 

The Article details when additional requirements for transportable pressure equipment may be 
established. 

Article 4: Obligations of manufacturers  

The Article establishes the obligations of manufacturers of transportable pressure equipment 
in normal operation and in cases where there is a reason to believe that the equipment is not in 
conformity with the rules. 

Article 5: Authorised representatives 

The Article specifies the steps to appoint an authorised representative and the tasks for such a 
body. 

Article 6: Obligations of importers  

The  Article  establishes  the  obligations  of  importers  of  transportable  pressure  equipment  in 
normal operations and in cases where there is reason to believe that the equipment is not in 
conformity with the rules. 

Article 7: Obligations of distributors  

The Article establishes the obligations of distributors of transportable pressure equipment in 
normal operations and in cases where there is reason to believe that the equipment is not in 
conformity with the rules. 

Article 8: Obligations of owners  

The Article establishes the obligations of owners of transportable pressure equipment. Given 
the inherent danger of such equipment there needs to be formal obligations for guaranteeing 
continuing safety as long as the transportable pressure equipment is being used. 

Article 9: Obligations of operators  

The  Articles  ensures  that  operators  use  only  equipment  that  is  in  conformity  with  the  rules. 
Where  the  transportable  pressure  equipment  presents  a  risk  the  operator  shall  inform  the 
owner and market surveillance authorities.  

Article 10: Cases in which obligations of manufacturers apply to importers and distributors 

The Article specifies the cases when the importers or distributors shall have the obligations of 
the manufacturer, namely when they place transportable pressure equipment on the market. 

Article 11: Identification of economic operators 

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The Article lays down the obligations relating to identification of actors in the supply chain of 
transportable pressure equipment. 

Article 12: Conformity of the transportable pressure equipment and its assessment 

The Article defines the necessary conformity assessment requirements for new transportable 
pressure equipment and for transportable pressure equipment previously assessed and marked 
under  Directive  1999/36/EC  and  old  cylinder  directives.  The  Article  also  ensures  that 
conformity assessments, reassessments, periodic inspections and exceptional checks shall be 
valid in all Member States. 

Article 13: Reassessment of conformity  

The  Article  provides  for  the  reassessment  of  conformity  of  old  transportable  pressure 
equipment not previously assessed under Directive 1999/36/EC to bring it under the scope of 
this Directive.  

Article 14: General principles of the Pi marking 

The Article specifies the relevance of the Pi marking, when a Pi marking can be affixed, the 
responsibilities relating to the affixing of the marking and provisions to prohibit the misuse of 
the marking. 

Article 15: Rules and conditions for the affixing of the Pi marking 

The Article lays down the rules regarding the Pi marking itself, including its shape, size and 
the auxiliary markings of the inspection body. 

Article 16: Free movement of the transportable pressure equipment 

The  Article  provides  for  the  free  movement  of  transportable  pressure  equipment  in  the 
European Union.  

Article 17: Notifying authorities 

The Article lays down the procedures and responsibilities regarding notifying authorities. 

Article 18: Requirements relating to notifying authorities 

The  Article  defines  the  conditions  for  guaranteeing  the  proper  functioning  of  notifying 
authorities. 

Article 19: Information obligation for the notifying authorities 

The  Article  ensures  the  transparency  of  assessment,  notification  and  monitoring  of  notified 
bodies. 

Article 20: General requirements relating to notified bodies 

The Article sets out requirements relating to the capabilities of the body to carry out the tasks.  

Articles 21, 22, 23, 24 and 25: Procedures relating to notified bodies and notification 

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These  Articles  define  the  application  and  procedures  for  notifications,  identification  of 
notified bodies, subsequent changes to notifications and course of action in cases where there 
is doubt over the capacity of a notified body. 

Article 26: Operational obligations for notified bodies 

The  Article  sets  out  operational  obligations  for  the  notified  bodies  including  mutual 
recognition of those bodies. 

Article 27: Information obligations for notified bodies 

The Article sets out information obligations for the notified bodies including where there has 
been a refusal or withdrawal of certificates.  

Article 28 and 29: Cooperation between notified bodies 

These  Articles  provide  for  an  exchange  of  experience  and  coordination  among  authorities 
responsible for notification policy, market surveillance and notified bodies. 

Article 30, 31, 32 and 33: Safeguard procedures 

These  Articles  lay  down  the  procedures  for  dealing  with  safety  and  other  risks,  including 
formal issues, at national and Community levels.  

Article 34: Transitional provisions 

The Article provides for transitional measures through Annex II of the proposal.  

Article 35: Adaptations 

Any adaptations of the annexes for technical and scientific progress will take place through 
the regulatory procedure with scrutiny. 

Article 36: Committee 

The  Committee  set  up  under  the  Directive  on  the  inland  transport  of  dangerous  goods 
(2008/68/EC) will be used for the purposes of this Directive. 

Article 37: Repeal 

The  existing  Directive  1999/36/EC  as  well  as  a  number  of  obsolete  directives  on  pressure 
cylinders will be repealed 

Article 38: Recognition of equivalence 

The  Article  provides  for  recognition  of  EEC  pattern  approvals  issued  under  obsolete 
directives  on  pressure  cylinders  and  for  valves  and  accessories  marked  according  to  the 
Pressure equipment directive.  

Article 39: Transposition 

The standard approach on transposition is followed. The Member States shall implement the 
Directive  by  30  June  2011,  when  the  transitory  period  contained  in  the  international 

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agreements on transport of dangerous goods ends, to avoid conflict with the existing Directive 
1999/36/EC. 

A delay in the application of the Directive for equipment used by some dangerous goods is 
provided for in order to give a reasonable period for compliance as they were not previously 
under the scope of Directive 1999/36/EC.  

Article 40: Entry into force 

The  Directive  will  enter  into  force  on  the  twentieth  day  following  its  publication  in  the 
Official Journal.  

Article 41: Addressees 

The Directive is addressed to the Member States. 

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2009/0131 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

of …. 

on transportable pressure equipment 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
71 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

(3) 

Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment5 
was  adopted  as  a  first  step  towards  enhancing  transport  safety  for  transportable 
pressure  equipment,  whilst  ensuring  the  free  movement  of  transportable  pressure 
equipment in a single transport market. 

In  the  light  of  developments  in  transport  safety,  it  is  necessary  to  update  certain 
technical provisions of Directive 1999/36/EC. 

Directive 2008/68/EC of the European Parliament and of the Council of 24 September 
2008  on  the  inland  transport  of  dangerous  goods6  extended  the  application  of  the 
provisions  of  certain  international  agreements  to  cover  national  traffic  in  order  to 
harmonise  the  conditions  under  which  dangerous  goods  are  transported  by  road,  rail 
and inland waterways across the Community. 

(4) 

It is therefore necessary to update the provisions of Directive 1999/36/EC accordingly 
to avoid conflicting rules, in particular as regards conformity requirements, conformity 

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OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ L 138, 1.6.1999, p. 20. 
OJ L 260, 30.9.2008, p. 13. 

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assessment and conformity assessment procedures in relation to transportable pressure 
equipment.  

In order to enhance safety with regard  to transportable pressure equipment approved 
for  the  inland  transport  of  dangerous  goods  and  to  ensure  the  free  movement, 
including  placing  on  the  market,  making  available  on  the  market  and  use  of  such 
transportable  pressure  equipment  within  the  Community,  it  is  necessary  to  lay  down 
detailed rules concerning the obligations of the various operators and the requirements 
to be fulfilled by the equipment concerned. 

Decision  No.  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008  on  a  common  framework  for  the  marketing  of  products7  constitutes  a  general 
framework of a horizontal nature for future legislation harmonising the conditions for 
the  marketing  of  products.  This  framework  should  apply  where  appropriate  for  the 
transportable pressure equipment sector in line with the objective of harmonising rules 
on the free movement of products.  

In order not to hinder transport operations between Member States and third countries, 
this  Directive  should  not  apply  to  transportable  pressure  equipment  exclusively  used 
for the transport of dangerous goods between the territory of the Community and that 
of third countries. 

The obligations of the different economic operators, including owners and operators of 
transportable pressure equipment, should be clearly defined in the interests of transport 
safety and the free movement of transportable pressure equipment. 

Economic operators should be responsible for the compliance of transportable pressure 
equipment with the safety and market access rules in relation to their respective roles 
in the supply chain. 

(5) 

(6) 

(7) 

(8) 

(9) 

(10)  Compliance of new transportable pressure equipment with the technical requirements 
of the Annexes to Directive 2008/68/EC and this Directive should be shown by means 
of  a  conformity  assessment  to  provide  evidence  that  the  transportable  pressure 
equipment is safe.  

(11)  Periodic  inspections  and  exceptional  checks  of  transportable  pressure  equipment 
should  be  carried  out  in  accordance  with  the  Annexes  to  Directive  2008/68/EC  and 
with this Directive to ensure continued compliance with their safety requirements.  

(12)  Transportable  pressure  equipment  should bear  a  mark  indicating  its  compliance  with 
Directive 2008/68/EC and this Directive to ensure its free movement and use.  

(13)  Existing transportable pressure equipment not previously assessed for conformity with 
Directive 1999/36/EC should be reassessed and marked according to the provisions of 
this  Directive  in  order  to  demonstrate  its  compliance  with  safety  requirements  and 
ensure free movement and use.  

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OJ L 218, 13.8.2008, p. 82. 

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(14) 

It  is  necessary  to  set  requirements  for  authorities  responsible  for  the  assessment, 
notification and monitoring of notified bodies in order to ensure a consistent level of 
quality in the performance of notified bodies.  

(15)  The  conformity  assessment  procedures  provided  for  in  the  Annexes  to  Directive 
2008/68 and in this Directive require the intervention of inspection bodies setting out 
detailed operational requirements to ensure a uniform level of performance throughout 
the Community. These inspection bodies should then be notified by the Member States 
to the Commission.  

(16)  The  notifying  authority  should  retain  responsibility  for  monitoring  the  notified  body 
regardless  of  where  the  notified  body  performs  its  activities  in  order  to  ensure  clear 
responsibility for ongoing monitoring.  

(17) 

It is necessary to lay down common rules for the mutual recognition of notified bodies 
which  ensure  compliance  with  Directive  2008/68/EC  and  this  Directive.  Those 
common rules will have the effect of eliminating unnecessary costs and administrative 
procedures  related  to  the  approval  of  the  equipment  and  of  eliminating  technical 
barriers to trade; 

(18)  Member States should be able to take measures to limit or prohibit the placing on the 
market  and  use  of  equipment  in  cases  where  it  presents  a  risk  to  safety  in  certain 
specified circumstances. 

(19)  The measures necessary for the implementation of this Directive should be adopted in 
accordance  with  Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the 
procedures for the exercise of implementing powers conferred on the Commission8. 

(20) 

In particular the Commission should be empowered to adapt the Annexes to scientific 
and technical progress. Since those measures are of general scope and are designed to 
amend  non-essential  elements  of  this  Directive,  inter  alia,  by  supplementing  it  with 
new  non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

(21)  Council Directive 76/767/EEC of 27 July 1976 on the approximation of the laws of the 
Member  States  relating  to  common  provisions  for  pressure  vessels  and  methods  for 
inspecting  them9,  Council  Directive  84/525/EEC  of  17  September  1984  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  seamless,  steel  gas 
cylinders10,  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 cylinders11, 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  cylinders12  and  Directive  1999/36/EC  have  become 
obsolete and should therefore be repealed, 

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12 

OJ L184, 17.7.1999, p. 23. 
OJ L 262, 27.9.1976, p. 153. 
OJ L 300, 19.11.1984, p. 1. 
OJ L 300, 19.11.1984, p. 20. 
OJ L 300, 19.11.1984, p. 48 

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HAVE ADOPTED THIS DIRECTIVE: 

Chapter 1 
Scope and definitions 

Article 1 

Scope 

1. 

2. 

(a) 

(b) 

(c) 

3. 

4. 

This Directive sets out detailed rules concerning transportable pressure equipment to 
enhance safety and ensure free movement of such equipment within the Community.  

This Directive shall apply to: 

new transportable pressure equipment as defined in Article 2(1), which does not bear 
the  conformity  markings  provided  for  in  Directives  84/525/EEC,  84/526/EEC, 
84/527/EEC or 99/36/EC, for the purpose of making them available on the market; 

transportable pressure  equipment as defined  in  Article  2(1),  bearing  the  conformity 
markings  provided  for  in  this  Directive  or  in  Directives  84/525/EEC,  84/526/EEC, 
84/527/EEC or 99/36/EC, for the purposes of their periodic inspections, exceptional 
checks and use; 

transportable pressure equipment as defined in Article 2(1), which does not bear the 
conformity  markings  provided  for  in  Directive  99/36/EC,  for  the  purposes  of 
reassessment of conformity. 

This Directive shall not apply to transportable pressure equipment which was placed 
on the market before the date of implementation of Directive 1999/36/EC and which 
has not been subject to a reassessment of conformity. 

This Directive shall not apply to transportable pressure equipment used exclusively 
for  the  transport  of  dangerous  goods  between  Member  States  and  third  countries, 
carried out in accordance with Article 4 of Directive 2008/68/EC. 

Article 2 

Definitions 

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

1. 

(a) 

(b) 

"transportable pressure equipment" means 

all  pressure  receptacles,  their  valves  and  other  accessories  when  appropriate,  as 
defined in chapter 6.2 of the Annexes to Directive 2008/68/EC, 

tanks,  battery  vehicles/wagons,  multiple-element  gas  containers  (MEGCs),  their 
valves  and  other  accessories  when  appropriate,  as  defined  in  chapter  6.8  of  the 
Annexes to Directive 2008/68/EC, 

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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 
classification code, and for the transport of the dangerous substances of other classes 
specified in Annex I to this Directive; 

"Annexes to Directive 2008/68" means Annex I, Section I.1, Annex II, Section II.1, 
and Annex III, Section III.1 to Directive 2008/68/EC; 

“placing  on  the  market”  means  the  first  making  available  of  transportable  pressure 
equipment on the Community market; 

“making  available  on  the  market”  means  any  supply  of  transportable  pressure 
equipment  for  distribution  or  use  on  the  Community  market  in  the  course  of  a 
commercial  or  public  service  activity,  whether  in  return  for  payment  or  free  of 
charge; 

"use" means filling, temporary storage linked to carriage, emptying and refilling of 
transportable pressure equipment; 

“withdrawal”  means  any  measure  aimed  at  preventing  transportable  pressure 
equipment from being made available on the market or from being used; 

“recall” means any measure aimed at achieving the return of transportable pressure 
equipment that has already been made available to the end user; 

“manufacturer”  means  any  natural  or  legal  person  who  manufactures  transportable 
pressure  equipment,  or  parts  thereof,  or  who  has  such  equipment  designed  or 
manufactured and markets it under his name or trademark; 

“authorised representative” means any natural or legal person established within the 
Community who has received a written mandate from the manufacturer to act on his 
behalf in relation to specified tasks; 

“importer”  means  any  natural  or  legal  person  established  within  the  Community, 
who places transportable pressure equipment or parts thereof from a third country on 
the Community market; 

“distributor”  means  any  natural  or  legal  person  established  within  the  Community, 
other  than  the  manufacturer  or  the  importer,  who  makes  transportable  pressure 
equipment or parts thereof available on the market; 

"owner" means any natural or legal person established within the Community which 
owns transportable pressure equipment; 

"operator"  means  any  natural  or  legal  person  established  in  the  Community  using 
transportable pressure equipment; 

“economic  operators”  means  the  manufacturer,  the  authorised  representative,  the 
importer,  the  distributor,  the  owner  or  the  operator  acting  in  the  course  of  a 
commercial activity, whether in return for payment or free of charge; 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

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13 

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15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

“conformity assessment” means the assessment and the procedure for the assessment 
of conformity set out in the Annexes to Directive 2008/68/EC; 

“Pi  marking”  means  a  marking  which  indicates  that  the  transportable  pressure 
equipment is in conformity with the applicable conformity assessment requirements 
set out in the Annexes to Directive 2008/68/EC and in this Directive; 

"reassessment of conformity" means the procedure undertaken, at the request of the 
owner,  for  the  subsequent  assessment  of  the  conformity  of  transportable  pressure 
equipment manufactured and placed on the market before the date of implementation 
of Directive 1999/36/EC; 

"periodic inspection" means the periodic inspection and the procedures governing the 
periodic inspection as set out in the Annexes to Directive 2008/68/EC; 

"exceptional check" means the exceptional check and the procedures governing the 
exceptional check set out in the Annexes to Directive 2008/68/EC;  

“national accreditation body” means the sole body in a Member State that performs 
accreditation with authority derived from the State; 

“accreditation” means an attestation by a national accreditation body that a notified 
body  meets  the  requirements  set  out  in  the  second  paragraph  of  1.8.6.4  of  the 
Annexes to Directive 2008/68/EC;  

"notifying authority" means the authority designated by a Member State pursuant to 
Article 17; 

"notified  body"  means  an  inspection  body  meeting  the  requirements  set  out  in 
Annexes  to  Directive  2008/68/EC  and  the  conditions  set  out  in  Articles  20  and  26 
and notified in accordance with Article 22 of this Directive;  

"notification"  is the process  of awarding  notified body status to an inspection body 
and  includes  communication  of  this  information  to  the  Commission  and  to  the 
Member States; 

"market surveillance" means the activities carried out and measures taken by public 
authorities  to  ensure  that  transportable  pressure  equipment  during  its  life  cycle 
complies  with  the  requirements  set  out  in  Directive  2008/68/EC  and  this  Directive 
and does not endanger health, safety or any other aspect of public interest protection; 

Transportable  pressure  equipment  shall  be  understood  as  including  gas  cartridges  (UN  No. 
2037)  and  excluding  aerosols  (UN  No.  1950),  open  cryogenic  receptacles,  gas  cylinders  for 
breathing  apparatus,  fire  extinguishers  (UN  No.  1044),  transportable  pressure  equipment 
exempted  according  to  1.1.3.2  of  the  Annexes  to  Directive  2008/68/EC  and  transportable 
pressure  equipment  exempted  from  the  rules  for  construction  and  testing  of  packaging 
according to special provisions in 3.3 of the Annexes to Directive 2008/68/EC. 

EN 

14 

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Article 3 

On-site requirements 

Member States may on their territory establish on-site requirements for the mid- or long-term 
storage or the on-site use of transportable pressure equipment. However, Member States shall 
not establish additional requirements for the transportable pressure equipment itself.  

Chapter 2 
Obligations of Economic Operators 

Article 4 

Obligations of manufacturers 

1. 

2. 

3. 

4. 

5. 

6. 

When  placing  their  transportable  pressure  equipment  on  the  market,  manufacturers 
shall ensure that the equipment has been designed, manufactured and documented in 
accordance  with  the  requirements  set  out  in  the  Annexes  to  Directive  2008/68/EC 
and in this Directive. 

Where  the  compliance  of  the  transportable  pressure  equipment  with  the  applicable 
requirements has been demonstrated through the conformity assessment process set 
out  in  the  Annexes  to  Directive  2008/68/EC  and  in  this  Directive,  manufacturers 
shall affix the Pi marking in accordance with Article 15. 

Manufacturers  shall  keep  the  technical  documentation  specified  in  the  Annexes  to 
Directive  2008/68/EC.  This  documentation  shall  be  kept  for  the  period  specified 
therein.  

Manufacturers  who  consider  or  have  reason  to  believe  that  transportable  pressure 
equipment  which  they  have  placed  on  the  market  is  not  in  conformity  with  the 
Annexes to Directive 2008/68/EC and with this Directive shall immediately take the 
necessary  corrective  measures  to  bring  the  transportable  pressure  equipment  into 
conformity,  to  withdraw  it  or  to  recall  it,  if  appropriate.  Furthermore,  where  the 
transportable  pressure  equipment  presents  a  risk,  manufacturers  shall  immediately 
inform the competent national authorities of the Member States in which they made 
the  transportable  pressure  equipment  available  to  that  effect,  giving  details,  in 
particular, of the non-compliance and of any corrective measures taken. 

Manufacturers shall document all such instances of non-compliances and corrective 
measures. 

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

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7. 

Manufacturers shall only provide information to operators which complies with the 
Annexes to Directive 2008/68/EC and with this Directive. 

Article 5 

Authorised representatives 

1. 

Manufacturers may, by a written mandate, appoint an authorised representative. 

2. 

(a) 

(b) 

(c) 

3. 

4. 

1. 

2. 

The obligations set out in Article 4(1) and the drawing up of technical documentation 
shall not form part of the authorised representative's mandate. 

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

keep the technical documentation at the disposal of national surveillance authorities 
for  at  least  20  years  from  the  date  of  manufacture  of  the  transportable  pressure 
equipment; 

further  to  a  reasoned  request  from  a  competent  national  authority,  provide  that 
authority  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the transportable pressure equipment in a language easily understood 
by that authority; 

cooperate  with  the  competent  national  authorities,  at  their  request,  on  any  action 
taken  to  eliminate  the  risks  posed  by  transportable  pressure  equipment  covered  by 
their mandate. 

The  identity  and  address  of  the  authorised  representative  shall  be  indicated  on  the 
certificate of conformity specified in the Annexes to Directive 2008/68/EC. 

Authorised  representatives  shall  only  provide  information  to  operators  which 
complies with the Annexes to Directive 2008/68/EC and with this Directive. 

Article 6 

Obligations of importers 

Importers  shall  only  place  on  the  Community  market  transportable  pressure 
equipment  which  is  in  conformity  with  the  Annexes  to  Directive  2008/68/EC  and 
with this Directive.  

Before  placing  transportable  pressure  equipment  on  the  market,  importers  shall 
ensure that the appropriate conformity assessment procedure has been carried out by 
the manufacturer. They shall ensure that the manufacturer has drawn up the technical 
documentation  and  that  the  transportable  pressure  equipment  bears  the  Pi  marking 
and  is  accompanied  by  the  certificate  of  conformity  specified  in  the  Annexes  to 
Directive 2008/68/EC.  

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Where an importer considers or has reason to believe that the transportable pressure 
equipment  is  not  in  conformity  with  the  Annexes  to  Directive  2008/68/EC  or  with 
this Directive, he shall not place the transportable pressure equipment on the market 
until  it  has  been  brought  into  conformity.  Furthermore,  where  the  transportable 
pressure  equipment  presents  a  risk,  the  importer  shall  inform  the  manufacturer  and 
the market surveillance authorities to that effect. 

Importers  shall  indicate  their  name  and  the  address  at  which  they  can  be  contacted 
either  in,  or  attached  to,  the  certificate  of  conformity  specified  in  the  Annexes  to 
Directive 2008/68/EC. 

Importers  shall  ensure  that,  while  transportable  pressure  equipment  is  under  their 
responsibility, storage or transport conditions do not jeopardise its compliance with 
the requirements set out in the Annexes to Directive 2008/68/EC.  

Importers  who  consider  or  have  reason  to  believe  that  transportable  pressure 
equipment  which  they  have  placed  on  the  market  is  not  in  conformity  with  the 
Annexes  to  Directive  2008/68/EC  or  with  this  Directive  shall  immediately  take  the 
corrective  measures  necessary  to  bring  the  transportable  pressure  equipment  into 
conformity,  to  withdraw  it  or  to  recall  it,  if  appropriate.  Furthermore,  where  the 
transportable pressure equipment presents a risk, importers shall immediately inform 
the  manufacturer  and  the  competent  national  authorities  of  the  Member  States  in 
which they made the transportable pressure equipment available 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-compliances  and  corrective 
measures. 

Importers  shall,  for  at  least  20  years  from  the  date  of  the  manufacture  of  the 
transportable pressure equipment, keep a copy of the technical documentation at the 
disposal  of  the  market  surveillance  authorities  and  ensure  that  the  technical 
documentation can be made available to those authorities upon request. 

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

3. 

4. 

5. 

6. 

7. 

8. 

Importers  shall  only  provide  information  to  operators  which  complies  with  the 
Annexes to Directive 2008/68/EC and with this Directive. 

Article 7 

Obligations of distributors 

1. 

Distributors  shall  only  make  available  on  the  Community  market  transportable 
pressure  equipment  which  is  in  conformity  with  the  Annexes  to  Directive 
2008/68/EC and with this Directive. Before making transportable pressure equipment 
available  on  the  market  distributors  shall  verify  that  the  transportable  pressure 

EN 

17 

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equipment  bears  the  Pi  marking,  that  it  is  accompanied  by  the  certificate  of 
conformity and the contact address referred to in Article 6(3). 

Where  a  distributor  considers  or  has  reason  to  believe  that  transportable  pressure 
equipment  is  not  in  conformity  with  the  Annexes  to  Directive  2008/68/EC  or  this 
Directive,  he  shall  not  make  the  transportable  pressure  equipment  available  on  the 
market  until  it  has  been  brought  into  conformity.  Furthermore,  where  the 
transportable  pressure  equipment  presents  a  risk,  the  distributor  shall  inform  the 
manufacturer  or  the  importer  to  that  effect  as  well  as  the  market  surveillance 
authorities. 

Distributors shall ensure that, while transportable pressure equipment is under their 
responsibility, storage or transport conditions do not jeopardise its compliance with 
the requirements set out in the Annexes to Directive 2008/68/EC. 

Distributors  who  consider  or  have  reason  to  believe  that  transportable  pressure 
equipment which they have made available on the market is not in conformity with 
the Annexes to Directive 2008/68/EC or with this Directive shall make sure that the 
corrective  measures  necessary  to  bring  that  transportable  pressure  equipment  into 
conformity,  to  withdraw  it  or  to  recall  it,  if  appropriate,  are  taken.  Furthermore, 
where  the  transportable  pressure  equipment  presents  a  risk,  distributors  shall 
immediately  inform  the  manufacturer,  the  importer,  where  relevant,  and  the 
competent  national  authorities  of  the  Member  States  in  which  they  made  the 
transportable pressure equipment available to that effect, giving details, in particular, 
of the non-compliance and of any corrective measures taken. 

Distributors  shall  document  all  such  instances  of  non-compliances  and  corrective 
measures. 

Distributors  shall,  further  to  a  reasoned  request  from  the  competent  national 
authority,  provide  it  with  all  the  information  and  documentation  necessary  to 
demonstrate  the  conformity  of  the  transportable  pressure  equipment  in  a  language 
easily  understood  by  that  authority.  They  shall  cooperate  with  that  authority,  at  its 
request,  on  any  action  taken  to  eliminate  the  risks  posed  by  transportable  pressure 
equipment which they have made available on the market. 

2. 

3. 

4. 

5. 

Distributors  shall  only  provide  information  to  operators  which  complies  with  the 
Annexes to Directive 2008/68/EC and with 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 the Annexes to Directive 2008/68/EC, including 
the requirements for periodic inspection, and with this Directive, he shall not make 
available or use it until it has been brought into conformity. Furthermore, where the 
transportable  pressure  equipment  presents  a  risk,  the  owner  shall  inform  the 
manufacturer  or  the  importer  or  the  distributor  to  that  effect  as  well  as  the  market 
surveillance authorities. 

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Owners  shall  document  all  such  instances  of  non-compliances  and  corrective 
measures. 

Owners  shall  ensure  that,  while  transportable  pressure  equipment  is  under  their 
responsibility, storage or transport conditions do not jeopardise its compliance with 
the requirements set out in the Annexes to Directive 2008/68/EC. 

Owners  shall  only  provide  information  to  operators  which  complies  with  the 
Annexes to Directive 2008/68/EC and with this Directive. 

Article 9  

Obligations of operators 

Operators  shall  only  use  transportable  pressure  equipment  which  is  in  conformity 
with  the  requirements  set  out  in  the  Annexes  to  Directive  2008/68/EC  and  in  this 
Directive. 

Where the transportable pressure equipment presents a risk, the operator shall inform 
the owner to that effect as well as the market surveillance authorities.  

2. 

3. 

1. 

2. 

Article 10 

Cases in which obligations of manufacturers apply to importers and distributors 

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Directive and subject to the obligations of the manufacturer under Article 4, where he places 
transportable  pressure  equipment  on  the  market  under  his  name  or  trademark  or  modifies 
transportable pressure equipment already placed on the market in such a way that compliance 
with the applicable requirements may be affected. 

Article 11 

Identification of economic operators 

Economic  operators  shall,  on  request  from  the  market  surveillance  authority,  identify  the 
following to it for the period specified in the Annexes to Directive 2008/68/EC  

(a) 

(b) 

any  economic  operator  who  has  supplied  them  with  transportable  pressure 
equipment; 

any  economic  operator  to  whom  they  have  supplied  transportable  pressure 
equipment. 

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Chapter 3 
Conformity of transportable pressure equipment 

Article 12 

1. 

2. 

3. 

Conformity of the transportable pressure equipment and its assessment 

The  transportable  pressure  equipment  referred  to  in  Article  1(2)  (a)  shall  meet  the 
relevant  conformity  assessment,  periodic 
inspection  and  exceptional  checks 
requirements set out in the Annexes to Directive 2008/68/EC and Chapters 3 and 4 of 
this Directive. 

The  transportable  pressure  equipment  referred  to  in  Article  1(2)  (b)  shall  meet  the 
specifications  of  the  documentation  according  to  which  the  equipment  was 
manufactured.  The  equipment  shall  be  subject  to  periodic  inspections  and 
exceptional checks and the requirements of Chapters 3 and 4 of this Directive. 

Certificates of conformity assessment and certificates of reassessment of conformity 
and reports of periodic inspections and exceptional checks issued by a notified body 
shall be valid in all Member States. 

For  demountable  parts  of  transportable  pressure  equipment  a  separate  conformity 
assessment may be carried out. 

Article 13 

Reassessment of conformity 

The reassessment of conformity of transportable pressure equipment referred to in Article 1 
(2)  (c)  manufactured  and  put  into  service  before  the  date  of  implementation  of  Directive 
1999/36/EC  shall  be  established  in  accordance  with  the  conformity  reassessment  procedure 
set out in Annex III. 

The Pi marking shall be affixed in accordance with Annex III. 

Article 14 

General principles of the Pi marking 

1. 

2. 

(a) 

The Pi marking shall only be affixed by the manufacturer or, in cases of reassessment 
of  conformity,  as  set  out  in  Annex  III.  For  gas  cylinders  previously  in  compliance 
with  Directives  84/525/EEC,  84/526/EEC  and  84/527/EEC  the  Pi  mark  shall  be 
affixed by or under the surveillance of the notified body. 

The Pi marking shall be affixed only to transportable pressure equipment: 

which  meets  the  conformity  assessment  requirements  in  the  Annexes  to  Directive 
2008/68/EC and in this Directive, or 

EN 

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(b) 

which meets the reassessment of conformity requirements referred to in Article 13,  

3. 

4. 

5. 

6. 

7. 

It shall not be affixed to any other transportable pressure equipment. 

By affixing or having affixed the Pi marking, the manufacturer indicates that he takes 
responsibility  for  the  conformity  of  the  transportable  pressure  equipment  with  all 
applicable requirements set out in the Annexes to Directive 2008/68/EC and in this 
Directive.  

For the purposes of this Directive, the Pi marking shall be the only marking which 
attests  conformity  of  the  transportable  pressure  equipment  with  the  applicable 
requirements set out in the Annexes to Directive 2008/68/EC and in this Directive. 

The affixing on transportable pressure equipment of markings, signs and inscriptions 
which are likely to mislead third parties as to the meaning or form of the Pi marking, 
shall be prohibited. Any other marking shall be affixed to the transportable pressure 
equipment in such a way that the visibility, legibility and meaning of the Pi marking 
is not thereby impaired. 

Demountable parts with a direct safety function shall be Pi-marked.  

Member  States  shall  ensure  correct  implementation  of  the  rules  governing  the  Pi 
marking  and  shall  take  appropriate  action  in  the  event  of  improper  use  of  the 
marking.  Member  States  shall  also  provide  for  penalties  for  infringements,  which 
may  include  criminal  sanctions  for  serious  infringements.  Those  penalties  shall  be 
proportionate  to  the  seriousness  of  the  offence  and  constitute  an  effective  deterrent 
against improper use. 

Article 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: 

EN 

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2. 

3. 

4. 

5. 

6. 

7. 

8. 

The  minimum  height  of  the  Pi  marking  shall  be  5  mm.  For  transportable  pressure 
equipment with a diameter less than or equal to 140 mm the minimum height shall be 
2.5 mm. 

The  proportions  given  in  the  graduated  drawing  in  paragraph  1  shall  be  respected. 
The grid does not form part of the marking. 

The Pi marking shall be affixed visibly, legibly and permanently to the transportable 
pressure  equipment  or  to  its  data  plate  as  well  as  to  demountable  parts  of 
transportable pressure equipment having a direct safety function.  

The Pi marking shall be affixed before the new transportable pressure equipment or 
demountable  parts  of  transportable  pressure  equipment  having  a  direct  safety 
function are placed on the market.  

The Pi marking shall be followed by the identification number of the notified body 
involved in the initial inspections and tests. 

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

The  marking  of  the  date  of  the  periodic  inspection  shall  be  followed  by  the 
identification number of the notified body responsible for the periodic inspection.  

With regard to gas cylinders previously in compliance with Directives 84/525/EEC, 
84/526/EEC  and  84/527/EEC  not  bearing  the  Pi  marking,  when  the  first  periodic 
inspection is carried out in accordance with this Directive, the identification number 
of the notified 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 and 31 of this Directive and to 
the market surveillance framework set out in Regulation (EC) No 765/2008, no Member State 
shall prohibit, restrict or impede on its territory the free movement, making available on the 
market and use of transportable pressure equipment, which complies with this Directive.  

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 necessary procedures for the assessment, notification 
and subsequent monitoring of notified bodies. 

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2. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

6. 

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008. 

Where the notifying authority delegates or otherwise entrusts the monitoring referred 
to in paragraph 1 to a body which is not a governmental entity, that body shall be a 
legal  entity  and  shall  comply  mutatis  mutandis  with  the  requirements  set  out  in 
Article 18(1) to (6). In addition the entrusted body shall have arrangements to cover 
liabilities arising out of its activities. 

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 

The notifying authority shall be established in such a way that no conflicts of interest 
with notified bodies occur. 

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

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

The  notifying  authority  shall  not  offer  or  provide  any  activities  or  consultancy 
services on a commercial or competitive basis that notified bodies perform. 

The  notifying  authority  shall  safeguard  the  confidentiality  of  the  information 
obtained. 

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

Article 19 

Information obligation for the notifying authorities 

Member States shall inform the Commission of their national procedures for the assessment, 
notification and monitoring of notified bodies, and of any changes to that information.  

The Commission shall make that information publicly available. 

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Article 20 

General requirements relating to notified bodies 

For the purposes of notification, a notified body shall meet the requirements set out 
in the Annexes to Directive 2008/68/EC and in this Directive. 

A competent authority, within the meaning of the Annexes to Directive 2008/68/EC 
may be a notified body provided it meets the requirements set out in the Annexes to 
Directive  2008/68/EC  and  in  this  Directive  and  that  it  does  not  also  act  as  the 
notifying authority. 

The notified body shall be established under national law and have legal personality. 

The  notified  body  shall  participate  in,  or  ensure  that  its  assessment  personnel  is 
informed  of,  the  relevant  standardisation  activities  and  the  activities  of  the  notified 
body  co-ordination  group  established  pursuant  to  Article  29  and  apply  as  general 
guidance  the  administrative  decisions  and  documents  produced  as  a  result  of  the 
work of that group. 

Article 21 

Application for notified body status 

An  inspection  body  shall  submit  an  application  for  notification  to  the  notifying 
authority of the Member State in which it is established. 

The application shall be accompanied by a description of  

the activities relating to conformity assessment and reassessment of conformity; 

the procedures relating to a) above including periodic inspection, exceptional checks 
and reassessment of conformity; 

the transportable pressure equipment for which the body claims to be competent; 

an  accreditation  certificate  issued  by  a  national  accreditation  body  within  the 
meaning of Regulation (EC) No 765/2008, attesting that the inspection body fulfils 
the requirements set out in Article 20 of this Directive. 

Article 22 

Notification procedure 

Notifying  authorities  shall  notify  only  those  bodies  which  have  satisfied  the 
requirements set out in Article 20. 

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

1. 

2. 

3. 

4. 

1. 

2. 

(a) 

(b) 

(c) 

(d) 

1. 

2. 

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3. 

4. 

5. 

6. 

The  notification  shall  include  full  details  of  the  conformity  assessment,  periodic 
inspection  and  exceptional  check  activities,  the  procedures  used,  the  transportable 
pressure equipment concerned and the relevant attestation of competence. 

The  body  concerned  may  perform  the  activities  of  a  notified  body  only  where  no 
objections  are  raised  by  the  Commission  or  the  other  Member  States  within  two 
weeks of a notification.  

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

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

In–house  inspection  services  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  notified  under  several 
Community acts. 

2. 

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

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

Article 24 

Changes to the notification 

1. 

2. 

Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements set out in Article 20, or that it is failing to fulfil its 
obligations, the notifying authority shall restrict, suspend or withdraw notification, as 
appropriate, depending on the seriousness of the failure to meet those requirements 
or fulfil those obligations. It shall immediately inform the Commission and the other 
Member States accordingly. 

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

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Article 25 

Challenge of the competence of notified bodies 

The Commission shall investigate all cases where it doubts or doubt is brought to its 
attention regarding the competence of a notified body or the continued fulfilment by 
a notified body of the requirements and responsibilities to which it is subject. 

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

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

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

Article 26 

Operational obligations for notified bodies 

Notified  bodies  shall  carry  out  conformity  assessments,  periodic  inspections  and 
exceptional  checks  in  accordance  with  the  terms  of  their  notification  and  with  the 
conformity assessment procedures set out in the Annexes to Directive 2008/68/EC. 

Notified  bodies  shall  carry  out  reassessments  of  conformity  in  accordance  with 
Annex III. 

Notified  bodies  notified  by  one  Member  State  shall  be  authorised  to  work  in  all 
Member States. The notifying authority which carried out the initial assessment and 
notification  retains  the  responsibility  for  monitoring  the  ongoing  activities  of  the 
notified body.  

Article 27 

Information obligation on notified bodies 

Notified bodies shall inform the notifying authority of the following: 

any refusal, restriction, suspension or withdrawal of certificates; 

any circumstances affecting the scope of and conditions for notification; 

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

1. 

2. 

3. 

4. 

1. 

2. 

3. 

1. 

(a) 

(b) 

(c) 

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(d) 

2. 

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

Notified bodies shall provide the other bodies notified under this Directive carrying 
out  similar  conformity  assessment,  periodic  inspection  and  exceptional  checks 
activities  covering  the  same  transportable  pressure  equipment  with  relevant 
information  on  issues  relating  to  negative  and,  on  request,  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 authorities responsible for  

(a) 

(b) 

notification policy; 

market surveillance.  

Article 29 

Coordination of notified bodies 

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

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

Chapter 5 
Safeguard procedures 

Article 30 

Procedure to deal 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) No 765/2008 or where they have sufficient 
reason  to  believe  that  transportable  pressure  equipment  covered  by  this  Directive 
presents a risk to the health or safety of persons or to other aspects of public interest 
protection covered by this Directive, they shall perform an evaluation in relation to 
the transportable pressure equipment concerned covering all the requirements set out 
in this Directive. The relevant economic operators shall cooperate as necessary with 

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27 

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the  market  surveillance  authorities,  including  granting  access  to  their  premises  and 
providing samples as appropriate. 

Where, in the course of that evaluation, the market surveillance authorities find that 
the transportable pressure equipment does not comply with the requirements set out 
in  the  Annexes  to  Directive  2008/68/EC  and  in  this  Directive,  they  shall  without 
delay require the relevant economic operator to take all appropriate corrective action 
to  bring 
those 
requirements, to withdraw the transportable pressure equipment from the market or 
to recall it within a reasonable period, commensurate with the nature of the risk, as 
they may prescribe. 

transportable  pressure  equipment 

into  compliance  with 

the 

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

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

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

The economic operator shall ensure that all appropriate corrective action is taken in 
respect  of  all  the  transportable  pressure  equipment  concerned  that  it  has  made 
available on the market throughout the Community. 

Where  the  relevant  economic  operator  does  not  take  adequate  corrective  action 
within the period referred to in the second subparagraph of paragraph 1, the market 
surveillance authorities shall take all appropriate provisional measures to prohibit or 
restrict the transportable pressure equipment being made available on their national 
market, to withdraw the equipment from that market or to recall it. 

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

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

failure of the transportable pressure equipment to meet requirements relating to the 
health or safety of persons or to other aspects of public interest protection set out in 
the Annexes to Directive 2008/68/EC and in this Directive, or 

shortcomings  in  the  standards  or  technical  codes  referred  to  in  the  Annexes  to 
Directive 2008/68/EC or in other provisions of that Directive. 

2. 

3. 

4. 

5. 

(a) 

(b) 

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28 

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6. 

7. 

8. 

1. 

2. 

3. 

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

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

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

Article 31 

Community safeguard procedure 

Where,  on  completion  of  the  procedure  set  out  in  Article  30(3)  and  (4),  objections 
are  raised  against  a  measure  taken  by  a  Member  State  or  where  the  Commission 
considers  a  national  measure  to  be  contrary  to  Community  legislation,  the 
Commission shall without delay enter into consultation with the Member States and 
the relevant economic operator or operators and shall evaluate the national measure. 
On the basis of the results of that evaluation, the Commission shall decide whether 
the national measure is justified or not. 

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

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  from  their  markets,  and  shall  inform  the  Commission 
accordingly.  If  the  national  measure  is  considered  unjustified,  the  Member  State 
concerned shall withdraw the measure. 

Where  the  national  measure  is  considered  justified  and  the  non-compliance  of  the 
transportable  pressure  equipment  is  attributed  to  shortcomings  in  the  standards  as 
referred to in Article 30(5) (b), the Commission shall inform the relevant European 
standardisation body or bodies and may bring the matter before the Committee set up 
by  Article  5  of  Directive  98/34/EC13.  That  Committee  may  consult  the  relevant 
European standardisation body or bodies before delivering its opinion.  

13 

OJ L 204, 21.7.1998, p.37. 

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29 

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Compliant transportable pressure equipment which presents a risk to health and safety 

Article 32 

Where having performed an evaluation under Article 30(1) a Member State finds that 
although  transportable  pressure  equipment  is  in  compliance  with  Directive 
2008/68/EC and this Directive, it presents a risk to the health or safety of persons or 
to  other  aspects  of  public  interest  protection,  it  shall  require  the  relevant  economic 
operator  to  take  all  appropriate  measures  to  ensure  that  the  transportable  pressure 
equipment  concerned,  when  placed  on  the  market,  no  longer  presents  that  risk,  to 
withdraw  the  equipment  from  the  market  or  to  recall  it  within a  reasonable  period, 
commensurate with the nature of the risk, as it may prescribe. 

The economic operator shall ensure that corrective action is taken in respect of all the 
transportable pressure equipment concerned that he has made available on the market 
or is using throughout the Community. 

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

The Commission shall without delay enter into consultation with the Member States 
and  the  relevant  economic  operator  or  operators  and  shall  evaluate  the  national 
measures taken. On the basis of the results of that evaluation, the Commission shall 
decide  whether  the  measure  is  justified  or  not,  and  where  necessary,  propose 
appropriate measures. 

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

Article 33  

Formal non-compliance 

Without prejudice to Article 30, where a Member State makes one of the following 
findings,  it  shall  require  the  relevant  economic  operator  to  put  an  end  to  the  non-
compliance concerned: 

the Pi marking has been affixed in violation of Article 12, Article 13 or Article 14; 

the Pi marking has not been affixed; 

the technical documentation is either not available or not complete; 

the  requirements  of  the  Annexes  to  Directive  2008/68/EC  have  not  been  complied 
with. 

1. 

2. 

3. 

4. 

5. 

1. 

(a) 

(b) 

(c) 

(d) 

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2. 

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

Chapter 6 
Final provisions 

Article 34 

Transitional provisions 

Within their territory, Member States may maintain the provisions listed in Annex II. 

Member  States  which  maintain  such  provisions  shall  inform  the  Commission  thereof.  The 
Commission shall inform the other Member States. 

Article 35 

Adaptation to scientific and technical progress 

The Commission may adapt the Annexes to this Directive to scientific and technical progress, 
in particular taking into account amendments to the Annexes to Directive 2008/68/EC. Those 
measures,  designed  to  amend  non-essential  elements  of  this  Directive,  inter  alia  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 36(2). 

Article 36 

Committee 

1. 

2. 

The  Commission  shall  be  assisted  by  the  Committee  on  the  transport  of  dangerous 
goods set up under Article 9 of Directive 2008/68/EC. 

Where  reference  is  made  to  this  paragraph,  Article  5a(1)  to  (4)  and  Article  7  of 
Decision  1999/468/EC  shall  apply  having  regard  to  the  provisions  of  Article  8 
thereof. 

The  time-limits  provided  for  in  Article  5a(3)(c),  and  (4)(b)  and  (e)  of  Decision 
1999/468/EC shall be one month, one month and two months respectively. 

Article 37 

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.  

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31 

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References  to  the  repealed  Directive  1999/36/EC  shall  be  construed  as  references  to  this 
Directive. 

Article 38 

Recognition of equivalence 

1. 

2. 

1. 

2. 

3. 

4. 

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 certificates issued pursuant to Directive 1999/36/EC shall be recognised 
as equivalent to the type approval certificates referred to in the Annexes to Directive 
2008/68/EC.  

Valves  and  accessories  referred  to  in  Article  3(3)  of  Directive  1999/36/EC  and 
marked with the mark of Directive 97/23/EC14 according to Article 3(4) of Directive 
1999/36/EC may still be used. 

Article 39 

Transposition 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  30  June  2011  at  the  latest. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions 
and a correlation table between those provisions and this Directive. 

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

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

Member States shall ensure that Article 21(2) (d) applies from 1 January 2012 at the 
latest. 

Member  States  shall  ensure  the  laws,  regulations  and  administrative  provisions 
referred  to  in  paragraph  1  apply  to  pressure  receptacles,  their  valves  and  other 
accessories  used  for  the  carriage  of UN  1745,  UN  1746  and  UN  2495  from  1  July 
2013 at the latest. 

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

Article 40 

14 

OJ L 181, 9.7.1997, p.1 

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32 

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Article 41 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I 

LIST OF DANGEROUS GOODS OTHER THAN THOSE IN CLASS 2 

UN number 

Class 

Dangerous substance 

1051 

1052 

1745 

1746 

1790 

2495 

6.1 

8 

5.1 

HYDROGEN CYANIDE, STABILIZED 
containing less than 3% water 

HYDROGEN FLUORIDE, ANHYDROUS 

BROMINE PENTAFLUORIDE 

Excluding carriage in tanks 

5.1 

BROMINE TRIFLUORIDE 

Excluding carriage in tanks 

8 

HYDROFLUORIC ACID, SOLUTION, 
WITH MORE THAN 85% HYDRFLUORIC 
ACID 

5.1 

IODINE PENTAFLUORIDE 

Excluding carriage in tanks 

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TRANSITIONAL PROVISIONS 

ANNEX II 

1. 

2. 

Member States may retain their national provisions concerning devices intended for 
connection  with  other  equipment  and  colour  codes  applicable  to  transportable 
pressure  equipment  until  such  time  as  relevant  standards  for  use  are  added  to  the 
Annexes to Directive 2008/68/EC. 

Member States in which the ambient temperature is regularly lower than -20 °C may 
impose  more  stringent  standards  as  regards  the  operating  temperature  of  material 
intended  for  transportable  pressure  equipment  for  use  in  the  national  transport  of 
dangerous  goods  within  their  territory  until  provisions  on  the  appropriate  reference 
temperatures for given climatic zones are incorporated into the Annexes to Directive 
2008/68/EC. 

In this case, in the Pi marking of the transportable pressure equipment, including the 
demountable  parts  having  a  direct  safety  function,  the  identification  number  of  the 
notified body shall be followed by "-40 °C" or other relevant marking approved by 
the competent authority.  

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PROCEDURE FOR THE REASSESSMENT OF CONFORMITY 

ANNEX III 

1. 

2. 

3. 

4. 

5. 

The  method  for  ensuring  that  the  transportable  pressure  equipment  referred  to  in 
Article  1  (2)  (c)  manufactured  and  put  into  service  before  the  dates  of 
implementation of Directive 1999/36/EC complies with the relevant provisions of the 
Annexes to Directive 2008/68/EC as applicable at the time of reassessment shall be 
as set out in this Annex. 

The owner or his authorised representative established within the Community or the 
holder  must  make  available  to  a  notified  body  conforming  to  EN  ISO/IEC 
17020:2004  type  A  the  information  regarding  the  transportable  pressure  equipment 
which enables that body to identify the equipment precisely (origin, design rules, and 
for  acetylene  cylinders  also  details  of  the  porous  material).  The  information  shall 
include,  where  appropriate,  any  prescribed  restrictions  on  use,  and  any  notes  on 
possible damage or repairs which have been carried out. 

The type A notified body shall assess whether the transportable pressure equipment 
affords  at  least  the  same  degree  of  safety  as  the  transportable  pressure  equipment 
referred to in the Annexes to Directive 2008/68/EC. The assessment shall be carried 
out on the basis of the information produced in accordance with point 2 and, where 
appropriate, of further inspections. 

Where  pressure  receptacles  were  manufactured  in  series,  Member  States  may 
authorise the assessment of conformity of individual pressure receptacles, including 
their valves and other accessories used for transport, to be carried out by a notified 
body  conforming  to  EN  ISO/IEC  17020:2004  Type  B  provided  that  conformity  of 
the type has been assessed in accordance with paragraph 3 by a type A notified body. 

If  the  results  of  the  assessments  in  paragraphs  3  and  4  are  satisfactory,  the 
transportable pressure equipment shall be subject to the periodic inspection provided 
for in the Annexes to Directive 2008/68/EC and the Pi marking shall be applied by 
the notified body responsible for the periodic inspection in accordance with Article 
14  (1)  –  (5).  The  Pi  marking  shall  be  followed  by  the  identification  number  of  the 
type A notified body responsible for the reassessment of conformity and, if different, 
the identification number of the notified body responsible for periodic inspection. 

6. 

A certificate of reassessment shall be issued. 

(a) 

(b) 

Where  the  procedure  in  paragraph  4  is  applied  the  type  A  body  shall  issue  the 
certificate of reassessment containing as a minimum: 

the identification of the notified body; 

the  name  and  address  of  the  manufacturer  and  the  holder  of  the  original  type 
approval for the transportable pressure equipment being reassessed when the holder 
is not the manufacturer; 

(c) 

the data identifying the transportable pressure equipment belonging to the series; and 

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36 

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(d) 

7. 

(a) 

(b) 

(c) 

the date of issue. 

In all other cases the notified body responsible for the periodic inspection shall issue 
the certificate of reassessment containing as a minimum: 

the identification of the notified body; 

the name and address of the owner or his authorised representative established within 
the Community or the holder specified in paragraph 2; 

the  data  for  identification  of  the  transportable  pressure  equipment  to  which  Pi 
marking has been applied including at least the serial number or numbers; and 

(d) 

the date of issue. 

By affixing or having affixed the Pi marking, the owner or operator indicates that he 
takes responsibility for the conformity of the transportable pressure equipment with 
all  applicable  requirements  set  out  in  the  Annexes  to  Directive  2008/68/EC  and  in 
this Directive as applicable at the time of reassessment. 

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