Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  on the harmonisation of the laws of the Member States relating to making available on the market of simple pressure vessels
Date: 2011-11-21
Institutions: European Commission
Subjects: approximation of laws, free movement of goods, harmonisation of standards, market supervision, marketing, pressure equipment, product safety, single market

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 768 final 

2011/0350 (COD) 

NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of the Goods Package)  

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

 on the harmonisation of the laws of the Member States relating to making available on 
the market of simple pressure vessels 

(Recast) 

(Text with EEA relevance) 

 
 
  
 
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context, reasons for and objectives of this proposal  

This proposal is presented in the framework of the implementation of the “goods package” 
adopted  in  2008.  It  is  part  of  a  package  of  proposals  aligning  ten  product  directives  to 
Decision No 768/2008/EC establishing a common framework for the marketing of products. 

Union (EU) harmonisation legislation ensuring the free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level 
of  protection  and  provides  economic  operators  with  the  means  to  demonstrate  conformity, 
thus ensuring free movement through trust in the products.  

Directive  2009/105/EC  is  an  example  of  that  Union  harmonisation  legislation,  ensuring  the 
free movement of simple pressure vessels. It sets out essential safety requirements that simple 
pressure  vessels  must  comply  with  in  order  to  be  made  available  on  the  EU  market. 
Manufacturers  must  demonstrate  that  a  simple  pressure  vessel  has  been  designed  and 
manufactured in compliance with the essential safety requirements and affix the CE marking.  

Experience  with  the  implementation  of  Union  harmonisation  legislation  has  shown  –  on  a 
cross-sector  scale  -  certain  weaknesses  and  inconsistencies  in  the  implementation  and 
enforcement of this legislation, leading to 

– 

– 

– 

– 

– 

the presence of non-compliant or dangerous products on the market and consequently 
a certain lack of trust in CE marking 

competitive disadvantages for economic operators complying with the legislation as 
opposed to those circumventing the rules 

unequal  treatment  in  the  case  of  non-compliant  products  and  distortion  of 
competition amongst economic operators due to different enforcement practices 

differing  practices  in  the  designation  of  conformity  assessment  bodies  by  national 
authorities 

problems with the quality of certain notified bodies 

Furthermore the regulatory environment has become more and more complex, as frequently 
several  pieces  of 
the  same  product. 
Inconsistencies  in  these  pieces  of  legislation  make  it  increasingly  difficult  for  economic 
operators and authorities to correctly interpret and apply that legislation. 

legislation  apply  simultaneously 

to  one  and 

To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, the “New Legislative Framework” was adopted in 2008 as part of 
the  goods  package.  Its  objective  is  to  strengthen  and  complete  the  existing  rules  and  to 
improve  practical  aspects  of  their  application  and  enforcement.  The  New  Legislative 
Framework  (NLF)  consists  of  two  complementary  instruments,  Regulation  (EC)  No 
765/2008  on  accreditation  and  market  surveillance  and  Decision  No  768/2008/EC 
establishing a common framework for the marketing of products. 

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The  NLF  Regulation  has  introduced  rules  on  accreditation  (a  tool  for  the  evaluation  of 
competence  of  conformity  assessment  bodies)  and  requirements  for  the  organisation  and 
performance  of  market  surveillance  and  controls  of  products  from  third  countries.  Since  1 
January 2010 these rules apply directly in all Member States. 

The NLF Decision sets out a common framework for EU product harmonisation legislation. 
This  framework  consists  of  the  provisions  which  are  commonly  used  in  EU  product 
legislation  (e.g.  definitions,  obligations  of  economic  operators,  notified  bodies,  safeguard 
mechanisms,  etc).  These  common  provisions  have  been  reinforced  to  ensure  that  the 
directives  can  be  applied  and  enforced  more  effectively  in  practice.  New  elements,  such  as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market.  

The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely  interlinked.  The  NLF  Decision  contains  the  corresponding  obligations  for  economic 
operators  and  notified  bodies  allowing  market  surveillance  authorities  and  authorities 
responsible  for  notified  bodies  to  properly  perform  the  tasks  imposed  on  them  by  the  NLF 
Regulation and to ensure an effective and consistent enforcement of EU product legislation.  

However,  unlike  the  NLF  Regulation,  the  provisions  of  the  NLF  Decision  are  not  directly 
applicable.  To  ensure  that  all  economic  sectors  subject  to  Union  harmonisation  legislation 
benefit  from  the  improvements  of  the  NLF,  the  provisions  of  the  NLF  Decision  need  to  be 
integrated into the existing product legislation. 

A  survey  after  the  adoption  of  the  goods  package  in  2008  showed  that  a  majority  of  Union 
harmonisation legislation on products was due to be revised within the following 3 years, not 
only  to  address  the  problems  observed  throughout  all  sectors  but  also  for  sector-specific 
reasons.  Any  such  revision  would  automatically  include  an  alignment  of  the  legislation 
concerned to the NLF Decision since Parliament, Council and Commission have committed 
themselves to use its provisions as much as possible in future legislation on products in order 
to further the utmost coherence of the regulatory framework.  

For  a  number  of  other  Union  harmonisation  directives,  including  simple  pressure  vessels 
Directive  2009/105/EC  no  revision  for  sector-specific  problems  had  been  envisaged  within 
this timeframe. To ensure that the problems in relation to non-compliance and notified bodies 
are  nevertheless  addressed  in  these  sectors,  and  for  the  sake  of  consistency  of  the  overall 
regulatory environment on products, it was decided to align these directives within a package 
to the provisions of the NLF Decision. 

Consistency with other policies and objectives of the Union 

This initiative is in line with the Single Market Act1, which has stressed the need to restore 
consumer  confidence  in  the  quality  of  products  on  the  market  and  the  importance  of 
reinforcing market surveillance. 

Furthermore it supports the Commission’s policy on Better Regulation and simplification of 
the regulatory environment. 

1 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and 
Social Committee and the Committee of the Regions, COM(2011) 206 final. 

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2. 

CONSULTATION  OF 
ASSESSMENT 

Consultation of interested parties 

INTERESTED 

PARTIES  AND 

IMPACT 

The  alignment  of  Directive  2009/105/EC  to  the  NLF  Decision  has  been  discussed  with 
national experts responsible for the implementation of this Directive, the notified body group, 
the  administrative  cooperation  group  as  well  as  in  bilateral  contacts  with  industry 
associations.  

From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted questionnaires for economic operators, 
authorities, notified bodies and users and the Commission services received 300 replies. The 
results are published at:  

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm 

In addition to the general consultation a specific SME consultation was carried out. 603 SMEs 
were  consulted  through  the  Enterprise  Europe  Network  in  May/June  2010.  The  results  are 
available  at  http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-
framework/smes_statistics_en.pdf 

The consultation process revealed widespread support for the initiative. There is unanimity on 
the need to improve market surveillance and the system for assessing and monitoring Notified 
Bodies.  Authorities  fully  support  the  exercise  because  it  will  strengthen  the  existing  system 
and  improve  cooperation  at  EU  level.  Industry  expects  a  more  level  playing  field  resulting 
from more effective actions against products that do not comply with the legislation, as well 
as a simplification effect from the alignment of legislation. Certain concerns were expressed 
on some obligations which are, however, indispensable for increasing the efficiency of market 
surveillance.  These  measures  will  not  entail  significant  costs  for  industry,  and  the  benefits 
resulting from improved market surveillance should by far outweigh the costs.  

Collection and use of expertise 

The  impact  assessment  for  this  implementation  package  has  largely  built  on  the  impact 
assessment  carried  out  for  the  New  Legislative  Framework.  In  addition  to  the  expertise 
collected  and  analysed  in  that  context,  further  consultation  of  sector-specific  experts  and 
interest  groups,  as  well  as  horizontal  experts  active  in  the  area  of  technical  harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 

Impact assessment  

Based on the information collected, the Commission carried out an impact assessment which 
examined and compared three options. 

Option 1 - No changes to the current situation 

This  option  proposes  no  changes  to  the  current  directive  and  relies  exclusively  on  certain 
improvements that can be expected from the NLF Regulation. 

Option 2 – Alignment to the NLF Decision by non-legislative measures 

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Option 2 considers the possibility of encouraging a voluntary alignment to the provisions set 
out in the NLF Decision by, e.g., presenting them as best practices in guidance documents. 

Option 3 – Alignment to NLF Decision by legislative measures 

This  option  consists  in  integrating  the  provisions  of  the  NLF  Decision  into  the  existing 
directives. 

Option 3 was found to be the preferred option because 

– 

– 

– 

– 

– 

it  will  improve  the  competitiveness  of  companies  and  notified  bodies  taking  their 
obligations seriously, as opposed to those cheating on the system; 

it will improve the functioning of the internal market by ensuring equal treatment of 
all economic operators, notably importers and distributors, as well as notified bodies; 

it  does  not  entail  significant  costs  for  economic  operators  and  notified  bodies;  for 
those who are already acting responsibly, no extra costs or only negligible costs are 
expected; 

it  is  considered  more  effective  than  option  2:  due  to  the  lack  of  enforceability  of 
option  2  it  is  questionable  that  the  positive  impacts  would  materialise  under  that 
option; 

options  1  and  2  do  not  provide  answers  to  the  problem  of  inconsistencies  in  the 
regulatory framework and therefore have no positive impact on the simplification of 
the regulatory environment. 

3. 

MAIN ELEMENTS OF THE PROPOSAL 

3.1. 

Horizontal definitions 

The  proposal  introduces  harmonised  definitions  of  terms  which  are  commonly  used 
throughout  Union  harmonisation  legislation  and  should  therefore  be  given  a  consistent 
meaning throughout that legislation.  

3.2. 

Obligations of economic operators and traceability requirements 

The  proposal  clarifies  the  obligations  of  manufacturers  and  authorised  representatives  and 
introduces  obligations  for  importers  and  distributors.  Importers  must  verify  that  the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up  a  technical  documentation.  They  must  also  make  sure  with  the  manufacturer  that  this 
technical  documentation  can  be  made  available  to  authorities  upon  request.  Furthermore 
importers must verify that simple pressure vessels are correctly marked and accompanied by 
the  instructions  and  safety  information.  They  must  keep  a  copy  of  the  Declaration  of 
conformity and indicate their name and address on the product. Distributors must verify that 
the  simple  pressure  vessel  bears  the  CE  marking,  the  name  of  the  manufacturer  and  of  the 
importer,  if  relevant,  and  that  it  is  accompanied  by  the  required  documentation  and 
instructions. 

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Importers  and  distributors  must  cooperate  with  market  surveillance  authorities  and  take 
appropriate actions when they have supplied non-compliant simple pressure vessels. 

Enhanced  traceability  obligations  are  introduced  for  all  economic  operators.  Simple 
pressure vessels have to bear the manufacturer’s name and address and a number allowing to 
identify  and  link  the  simple  pressure  vessel  to  its  technical  documentation.  When  a  simple 
pressure  vessel  is  imported  the  importer’s  name  and  address  must  also  be  on  the  simple 
pressure  vessel.  Furthermore  every  economic  operator  must  be  able  to  identify  towards 
authorities the economic operator who has supplied him  with a  simple pressure vessel or to 
whom he has supplied a simple pressure vessel. 

3.3. 

Harmonised standards 

Compliance  with  harmonised  standards  provides  a  presumption  of  conformity  with  the 
essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation 
on  European  Standardisation2  that  sets  out  a  horizontal  legal  framework  for  European 
standardisation.  The  proposal  for  the  Regulation  contains  inter  alia  provisions  on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure  for  objections to  harmonised standards and on stakeholder participation in 
the standardisation process. Consequently the provisions of Directive 2009/105 which cover 
the same aspects have been deleted in this proposal for reasons of legal certainty.  

The  provision  conferring  presumption  of  conformity  to  harmonised  standards  has  been 
modified to clarify the extent of the presumption of conformity when standards only partially 
cover the essential requirements. 

3.4. 

Conformity assessment and CE marking 

Directive 2009/105/EC has selected the appropriate conformity assessment procedures which 
manufacturers have to apply in order to demonstrate that their simple pressure vessels comply 
with the essential safety requirements. The proposal aligns these procedures to their updated 
versions set out in the NLF Decision. It keeps some specific elements already provided for in 
Directive 2009/105/EC as the welding tests.  

General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while 
the detailed provisions on the affixing of the CE marking to simple pressure vessels have been 
inserted in this proposal. 

3.5. 

Notified Bodies 

The  proposal  reinforces  the  notification  criteria  for  notified  bodies.  It  clarifies  that 
subsidiaries or subcontractors must  also  comply  with  the  notification requirements. Specific 
requirements  for  notifying  authorities  are  introduced,  and  the  procedure  for  notification  of 
notified  bodies  is  revised.  The  competence  of  a  notified  body  must  be  demonstrated  by  an 
accreditation certificate. Where accreditation has not been used to evaluate the competence of 
a  notified  body,  the  notification  must  comprise  the  documentation  demonstrating  how  the 

2 

Proposal for a Regulation of the European Parliament and of the Council on European Standardisation 
and  amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC,  94/25/EC, 
95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/105/EC  and  2009/23/EC  of  the 
European Parliament and of the Council. COM(2011) 315 final 

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competence of that body has been evaluated. Member States will have the possibility to object 
to a notification. 

3.6.  Market surveillance and the safeguard clause procedure 

The  proposal  revises  the  existing  safeguard  clause  procedure.  It  introduces  a  phase  of 
information  exchange  between  Member  States,  and  specifies  the  steps  to  be  taken  by  the 
authorities  concerned,  when  a  non-compliant  simple  pressure  vessel  is  found.  A  real 
safeguard  clause  procedure  –  leading  to  a  Decision  at  Commission  level  on  whether  a 
measure is justified or not - is only launched when another Member State objects to a measure 
taken  against  a  simple  pressure  vessel.  Where  there  is  no  disagreement  on  the  restrictive 
measure taken, all Member States must take the appropriate action on their territory. 

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union. 

Subsidiarity principle 

The internal market is a competence that is shared between the Union and the Member States. 
The  subsidiarity  principle  arises  in  particular  with  regard  to  the  newly  added  provisions 
aiming at the  improvement  of  effective enforcement  of  Directive  2009/105/EC,  namely,  the 
importer  and  distributor  obligations,  the  traceability  provisions,  the  provisions  on  the 
assessment  and  notification  of  notified  bodies,  and  the  enhanced  cooperation  obligations  in 
the context of the revised market surveillance and safeguard procedures.  

Experience with the enforcement of the legislation has shown that measures taken at national 
level  have  led  to  divergent  approaches  and  to  a  different  treatment  of  economic  operators 
inside the EU, which undermines the objective of this directive. If actions are taken at national 
level  to  address  the  problems,  this  risks  creating  obstacles  to  the  free  movement  of  goods. 
Furthermore action at national level is limited to the territorial competence of a Member State. 
In  view  of  the  increasing  internationalisation  of  trade,  the  number  of  cross-border  cases  is 
constantly rising. Coordinated action at EU level can much better achieve the objectives set, 
and will in particular render market surveillance more effective. Hence it is more appropriate 
to take action at EU level. 

As regards the problem of inconsistencies throughout the directives, this is a problem which 
can only be solved by the EU legislator. 

Proportionality 

In  accordance  with  the  principle  of  proportionality,  the  proposed  modifications  do  not  go 
beyond what is necessary to achieve the objectives set.  

The new or modified obligations do not impose unnecessary burdens and costs on industry - 
especially on small and medium sized enterprises - or administrations. Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to  provide  the  most  proportionate  response  to  the  problems  identified.  A  number  of 

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modifications  concern  the  improvement  of  clarity  of  the  existing  Directive  without 
introducing new requirements that entail added cost.  

Legislative technique used 

The  alignment  to  the  NLF  Decision  requires  a  number  of  substantive  amendments  to  the 
provisions  of  Directive  2009/105/EC.  To  ensure  the  readability  of  the  amended  text  the 
technique  of  recasting  has  been  chosen  in  line  with  the  Interinstitutional  Agreement  of  28 
November 2001 on a more structured use of the recasting technique for legal acts3.  

The  changes  made  to  the  provisions  of  Directive  2009/105/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 
standards,  the  declaration  of  conformity,  CE  marking,  notified  bodies,  the  safeguard  clause 
procedure and the conformity assessment procedures. 

The  proposal  does  not  change  the  scope  of  Directive  2009/105/EC  and  the  essential  safety 
requirements.  

5. 

BUDGETARY IMPLICATIONS 

This proposal does not have any implications for the EU budget. 

6. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The adoption of the proposal will lead to repeal of Directive 2009/105/EC. 

European Economic Area 

The proposal concerns the EEA and should therefore be extended to the European Economic 
Area.

3 

OJ C 77, 28.3.2002.  

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(cid:208) 2009/105/EC (adapted) 

2011/0350 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

relating to ⌦ on the harmonisation of the laws of the Member States relating to making 
available on the market of ⌫ simple pressure vessels 

(Recast) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community ⌦ on the Functioning of 
the European Union ⌫ , and in particular Article 95 ⌦ 114 ⌫ thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments,  

Having regard to the opinion of the European Economic and Social Committee4, 

Acting in accordance with the ordinary legislative procedure,  

Whereas: 

(cid:208) 2009/105/EC recital 1 (adapted) 

Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of 
the  Member  States  relating  to  simple  pressure  vessels5  has  been  substantially 
amended  several  times.  In  the  interests  of  clarity  and  rationality  the  said  Directive 
should be codified. 

4 
5 

OJ C 27, 3.2.2009, p. 41. 
OJ L 220, 8.8.1987, p. 48. 

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(cid:216) new 

(1) 

(2) 

(3) 

A  number  of  substantive  changes  are  to  be  made  to  Directive  2009/105/EC  of  the 
European  Parliament  and  of  the  Council  of  16  September  2009  relating  to  simple 
pressure vessels6. In the interests of clarity, that Directive should be recast. 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/937 lays down rules 
on  the  accreditation  of  conformity  assessment  bodies,  provides  a  framework  for  the 
market surveillance of products and for controls on products from third countries, and 
lays down the general principles of the CE marking. 

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  products  and  repealing  Council 
Decision  93/465/EEC8  lays  down  a  common  framework  of  general  principles  and 
reference  provisions  intended  to  apply  across  the  legislation  harmonising  the 
conditions  for  the  marketing  of  products  in  order  to  provide  a  coherent  basis  for 
revision  or  recasts  of  that  legislation.  Directive  2009/105/EC  should  therefore  be 
adapted to that Decision. 

(4)  Member States have the responsibility of ensuring ⌦ should ensure ⌫ the safety on 
their  territory  of  persons,  domestic  animals  and  property  with  regard  to  the  hazards 
resulting from the leakage or bursting of simple pressure vessels. 

(cid:208) 2009/105/EC recital 2 (adapted) 

(cid:208) 2009/105/EC recital 3 

In  each  Member  State,  mandatory  provisions  define  in  particular  the  safety  level 
required  of  simple  pressure  vessels  by  specifying  design  and  operating 
characteristics,  conditions  of  installation  and  use  and  inspection  procedures  before 
and after the placing on the market. These mandatory provisions do not necessarily 
lead  to  different  safety  levels  from  one  Member  State  to  another  but  do,  by  their 
disparity, hinder trade within the Community. 

This  Directive should therefore contain only mandatory and essential requirements. 
To  facilitate  proof  of  conformity  with  the  essential  requirements,  it  is  necessary  to 

(cid:208) 2009/105/EC recital 4  

6 
7 
8 

OJ L 264, 8.10.2009, p. 12. 
OJ L 218, 13.8.2008, p. 30. 
OJ L 218, 13.8.2008, p. 82. 

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have  harmonised  standards  at  Community  level,  in  particular  as  to  the  design, 
operation and installation of simple pressure vessels, so that products complying with 
them  may  be  assumed  to  conform  to  the  safety  requirements.  These  standards 
harmonised at Community level are drawn up by private bodies and should remain 
non-mandatory texts. For that purpose, the European Committee for Standardisation 
(CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and 
the  European  Telecommunications  Standards  Institute  (ETSI)  are  recognised  as  the 
competent  bodies  for  the  adoption  of  harmonised  standards  in  accordance  with  the 
general  guidelines9  for  cooperation  between  the  Commission,  the  European  Free 
Trade Association (EFTA) and those three bodies signed on 28 March 2003. 

(cid:216) new 

(5) 

(6) 

Economic  operators  should  be  responsible  for  the  compliance  of  simple  pressure 
vessels, in relation to their respective roles in the supply chain, so as to ensure a high 
level of protection of public interests, such as health and safety and the protection of 
users, and to guarantee fair competition on the Union market. 

All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
appropriate  measures  to  ensure  that  they  only  make  available  on  the  market  simple 
pressure vessels which are in conformity with this Directive. It is necessary to provide 
for a clear and proportionate distribution of obligations which correspond to the role of 
each operator in the supply and distribution process. 

(cid:208) 2009/105/EC recital 5 (adapted)  

The Council has already adopted a series of Directives designed to remove technical 
barriers to trade in accordance with the principles established in its Resolution of 7 
May  1985  on  a  new  approach  to  technical  harmonisation  and  standards10;  each  of 
those Directives provides for the affixing of the ‘CE’ marking. The Commission, in 
its  Communication  of  15  June  1989  on  a  global  approach  to  certification  and 
testing11, proposed that common rules be drawn up concerning a ‘CE’ marking with 
a  single  design.  The  Council,  in  its  Resolution  of  21  December  1989  on  a  global 
approach to conformity assessment12, approved as a guiding principle the adoption of 
a consistent  approach such as this with regard to the use of the ‘CE’ marking. The 
two  basic  elements  of  the  new  approach  which  should  be  applied  are  the  essential 
requirements and the conformity assessment procedures. 

9 
10 
11 
12 

OJ C 91, 16.4.2003, p. 7. 
OJ C 136, 4.6.1985, p. 1. 
OJ C 267, 19.10.1989, p. 3. 
OJ C 10, 16.1.1990, p. 1. 

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(cid:216) new 

(7) 

(8) 

The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure  for  simple 
pressure vessels. Conformity assessment should therefore remain the obligation of the 
manufacturer alone. 

 It is necessary to ensure that simple pressure vessels from third countries entering the 
Union market comply with the requirements of this Directive, and in particular that the 
appropriate assessment procedures have been carried out by manufacturers with regard 
to those simple pressure vessels. Provision should therefore be made for importers to 
make sure that the simple pressure vessels they place on the market comply with the 
requirements of this Directive and that they do not place on the market simple pressure 
vessels  which  do  not  comply  with  such  requirements  or  present  a  risk.  Provision 
should  also  be  made  for  importers  to  make  sure  that  the  conformity  assessment 
procedures  have  been  carried  out  and  that  simple  pressure  vessel  marking  and 
documentation  drawn  up  by  manufacturers  are  available  for  inspection  by  the 
supervisory authorities. 

(9) 

 The  distributor  makes  a  simple  pressure  vessel  available  on  the  market  after  it  has 
been placed on the market by the manufacturer or the importer and should act with due 
care to ensure that its handling of the simple pressure vessel does not adversely affect 
the compliance of the simple pressure vessel.  

(10)  When placing a simple pressure vessel on the market, every importer should indicate 

on the simple pressure vessel his name and the address at which he can be contacted.  

(11) 

 Any economic operator that either places a simple pressure vessel on the market under 
its  own  name  or  trademark  or  modifies  a  simple  pressure  vessel  in  such  a  way  that 
compliance  with  the  requirements  of  this  Directive  may  be  affected  should  be 
considered  to  be  the  manufacturer  and  should  assume  the  obligations  of  the 
manufacturer. 

(12)  Distributors  and  importers,  being  close  to  the  market  place,  should  be  involved  in 
market surveillance tasks carried out by the competent national authorities, and should 
be  prepared  to  participate  actively,  providing  those  authorities  with  all  necessary 
information relating to the simple pressure vessel concerned. 

(13)  Ensuring  traceability  of  a  simple  pressure  vessel  throughout  the  whole  supply  chain 
helps to make market surveillance simpler and more efficient. An efficient traceability 
system  facilitates  market  surveillance  authorities'  task  of  tracing  economic  operators 
who made non compliant simple pressure vessels available on the market. 

(14) 

 This Directive should be limited to the expression of the essential safety requirements. 
In order to facilitate conformity assessment with those requirements it is necessary to 
provide  for  presumption  of  conformity  for  products  which  are  in  conformity  with 
harmonised standards that are adopted in accordance with Regulation (EU) No […/…] 
of the European Parliament and of the Council of …. on European Standardisation and 
amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC, 
94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/105/EC 

EN 

12 

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and  2009/23/EC  of  the  European  Parliament  and  of  the  Council13  for  the  purpose  of 
expressing  detailed  technical  specifications  of  those  requirements,  in  particular  as  to 
the design, operation and installation of simple pressure vessels.  

(15)  Regulation  (EU)  No  […/…]  [on  European  Standardisation]  provides  for  a  procedure 
for  objections  to  harmonised  standards  where  those  standards  do  not  entirely  satisfy 
the requirements of this Directive.  

(16) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure  that  simple  pressure  vessels  made  available  on  the  market  comply  with  the 
essential  safety  requirements  it  is  necessary  to  provide  for  conformity  assessment 
procedures. Decision No 768/2008/EC establishes modules for conformity assessment 
procedures,  which  include  procedures  from  the  least  to  the  most  stringent,  in 
proportion  to  the  level  of  risk  involved  and  the  level  of  safety  required.  In  order  to 
ensure  inter-sectoral  coherence  and  to  avoid  ad-hoc  variants,  conformity  assessment 
procedures should be chosen from among those modules. 

(17)  Manufacturers  should  draw  up  an  EU  declaration  of  conformity  to  provide  detailed 
information  on  the  conformity  of  a  simple  pressure  vessel  with  the  requirements  of 
this Directive and of other relevant Union harmonisation legislation. 

(18) 

 The CE marking, indicating the conformity of a simple pressure vessel, is the visible 
consequence of a whole process comprising conformity assessment in a broad sense. 
General  principles  governing  the  CE  marking  and  its  relationship  to  other  markings 
are set out in Regulation (EC) No765/2008/EC. Rules governing the affixing of the CE 
marking should be laid down in this Directive.  

(cid:208) 2009/105/EC recital 6 (adapted) 

(19)  A  check  on  compliance  with  the  relevant  technical  ⌦ essential  safety  ⌫ 
requirements  is  necessary  in  order  to  provide  effective  protection  for  users  and  third 
parties. The existing inspection procedures differ from one Member State to another. 
In  order  to  avoid  multiple  inspections,  which  are  in  effect  barriers  to  the  free 
movement  of  vessels,  arrangements  should  be  made  for  the  mutual  recognition  of 
inspection  procedures  by  the  Member  States.  In  order  to  facilitate  the  mutual 
recognition of inspection procedures, Community procedures should be established as 
well  as  the  criteria  for  appointing  the  bodies  responsible  for  carrying  out  tests, 
surveillance and verification. 

(cid:208) 2009/105/EC recital 7 

The  presence  on  a  simple  pressure  vessel  of  the  ‘CE’  marking  should  raise  a 
presumption  that  it  satisfies  the  provisions  of  this  Directive  and  should  therefore 
make it unnecessary, upon the importation and putting into service of the vessel, to 
repeat the inspections already carried out. Nevertheless simple pressure vessels might 

13 

OJ L […], […], p. […]. 

EN 

13 

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represent  a  safety  hazard.  Provision  should  therefore  be  made  for  a  procedure  to 
reduce this hazard. 

(cid:216) new 

(20)  The conformity assessment procedures set out in this Directive require the intervention 
of  conformity  assessment  bodies,  which  are  notified  by  the  Member  States  to  the 
Commission. 

(21)  Experience  has  shown  that  the  criteria  set  out  in  Directive  2009/105/EC  that 
conformity assessment bodies have to fulfil to be notified to the Commission are not 
sufficient  to  ensure  a  uniformly  high  level  of  performance  of  notified  bodies 
throughout  the  Union.  It  is,  however,  essential  that  all  notified  bodies  perform  their 
functions to the same level and under conditions of fair competition. That requires the 
setting  of  obligatory  requirements  for  conformity  assessment  bodies  wishing  to  be 
notified in order to provide conformity assessment services. 

(22) 

(23) 

(24) 

In  order  to  ensure  a  consistent  level  of  conformity  assessment  quality  it  is  also 
necessary  to  set  requirements  notifying  authorities  and  other  bodies  involved  in  the 
assessment, notification and monitoring of notified bodies. 

 If a conformity assessment body demonstrates conformity with the criteria laid down 
in  harmonised  standards,  it  should  be  presumed  to  comply  with  the  corresponding 
requirements set out in this Directive. 

 The  system  set  out  in  this  Directive  should  be  complemented  by  the  accreditation 
system  provided  for  in  Regulation  (EC)  No  765/2008.  Since  accreditation  is  an 
essential  means  of  verifying  the  competence  of  conformity  assessment  bodies,  it 
should also be used for the purposes of notification. 

(25)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008,  ensuring 
the necessary level of confidence in conformity certificates, should be considered by 
the  national  public  authorities  throughout  the  Union  as  the  preferred  means  of 
demonstrating  the  technical  competence  of  conformity  assessment  bodies.  However, 
national authorities may consider that they possess the appropriate means of carrying 
out this evaluation themselves. In such cases, in order to ensure the appropriate level 
of  credibility  of  evaluations  carried  out  by  other  national  authorities,  they  should 
provide the Commission and the other Member States with the necessary documentary 
evidence demonstrating the compliance of the conformity assessment bodies evaluated 
with the relevant regulatory requirements. 

(26)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 
the  level  of  protection  required  for  the  simple  pressure  vessels  to  be  placed  on  the 
Union  market,  it  is  essential  that  conformity  assessment  subcontractors  and 
subsidiaries  fulfil  the  same  requirements  as  notified  bodies  in  relation  to  the 
performance  of  conformity  assessment  tasks.  Therefore,  it  is  important  that  the 
assessment  of  the  competence  and  the  performance  of  bodies  to  be  notified  and  the 

EN 

14 

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monitoring  of  bodies  already  notified  cover  also  activities  carried  out  by 
subcontractors and subsidiaries. 

(27) 

It is necessary to increase the efficiency and transparency of the notification procedure 
and, in particular, to adapt it to new technologies so as to enable online notification. 

(28)  Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning  a  notified  body.  It  is  therefore  important  to  provide  for  a  period  during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 

(29) 

(30) 

In  the  interests  of  competitiveness,  it  is  crucial  that  notified  bodies  apply  the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to  be  ensured.  That  can  best  be  achieved  through  appropriate  coordination  and 
cooperation between notified bodies. 

In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance  and  control  of  products  entering  the  Union  market  provided  for  in 
Regulation (EC) No 765/2008 apply to simple pressure vessels. This Directive should 
not prevent Member States from choosing the competent authorities to carry out those 
tasks. 

(31)  Directive  2009/105/EC  already  provides  for  a  safeguard  procedure  allowing  the 
Commission  to  examine  the  justification  for  a  measure  taken  by  a  Member  State 
against simple pressure vessels it considers to be non-compliant. In order to increase 
transparency  and  to  reduce  processing  time,  it  is  necessary  to  improve  the  existing 
safeguard  procedure,  with  the  aim  of  making  it  more  efficient  and  of  drawing  on 
expertise available in the Member States. 

(32)  The  existing  system  should  be  supplemented  by  a  procedure  under  which  interested 
parties are informed of measures intended to be taken with regard to simple pressure 
vessels  presenting  a  risk  to  the  health  and  safety  of  persons  or  to  other  aspects  of 
public  interest  protection.  It  should  also  allow  market  surveillance  authorities,  in 
cooperation with the relevant economic operators, to act at an earlier stage in respect 
of such simple pressure vessels. 

(33)  Where Member States and the Commission agree as to the justification for a safeguard 
measure taken by a Member State, no further involvement of the Commission should 
be  required,  except  where  non-compliance  can  be  attributed  to  shortcomings  of  a 
harmonised standard. 

(34) 

It is necessary to provide for transitional arrangements that allow making available on 
the  market  and  putting  into  service  simple  pressure  vessels  that  have  already  been 
placed on the market in accordance with Directive 2009/105/EC. 

(35)  Member States should lay down rules on penalties applicable to infringements of the 
provisions  of  national  law  adopted  pursuant  to  this  Directive  and  ensure  that  these 

EN 

15 

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rules  are  implemented.  The  penalties  provided  for  should  be  effective,  proportionate 
and dissuasive. 

(36)  Since the objective of this Directive, namely to ensure that simple pressure vessels on 
the  market  fulfil  the  requirements  providing  a  high  level  of  protection  of  health  and 
safety  and  other  public  interests  while  guaranteeing  the  functioning  of  the  internal 
market  cannot  be  sufficiently  achieved  by  the  Member  States  and  can  therefore,  by 
reason of its scale and effects, be better achieved at Union level, the Union may adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set 
out  in  that  Article,  this  Directive  does  not  go  beyond  what  is  necessary  in  order  to 
achieve that objective. 

(37)  The obligation to transpose this Directive into national law should be confined to those 
provisions  which  represent  a  substantive  change  as  compared  with  Directive 
2009/105/EC. The obligation to transpose the provisions which are unchanged arises 
under the earlier Directives. 

(38)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating  to  the  time  limits  for  transposition  into  national  law  and  application  of  the 
Directives set out in Annex IV, Part B of Annex IV to Directive 2009/105/EC., 

(cid:208) 2009/105/EC recital 8  

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I1 

(cid:208) 2009/105/EC (adapted) 
(cid:214) new 

SCOPE, DEFINITIONS, PLACING ON THE MARKET AND FREE 
MOVEMENT ⌦ GENERAL PROVISIONS ⌫ 

Article 1 

⌦ Scope ⌫ 

1.  This  Directive  ⌦ shall  apply ⌫  applies  to  simple  pressure  vessels  ⌦ (hereinafter 
vessels) ⌫ manufactured in series ⌦ with the following characteristics ⌫ .: 

(a) 

‘simple pressure vessel’ or ⌦ the vessels are ⌫ ‘vessel’ means any welded, vessel 
subjected  to  an  internal  gauge  pressure  greater  than  0,5  bar,  which  is  intended  to 
contain air or nitrogen and which is ⌦ are ⌫ not intended to be fired.; 

EN 

16 

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(b) 

Tthe  parts  and  assemblies  ⌦ components ⌫  contributing  to  the  strength  of  the 
vessel under pressure shall be ⌦ are ⌫ made either of non-alloy quality steel or of 
non-alloy aluminium or non-age hardening aluminium alloys.; 

(c) 

Tthe vessel shall be ⌦ is ⌫ made of either ⌦ of the following ⌫: 

(i)  a  cylindrical  part  of  circular  cross-section  closed  by 
inwardly 
(cid:214) outwardly  dished and/or flat ends which revolve around the same axis as 
the cylindrical part; or 

(ii) two dished ends revolving around the same axis.; 

(d) 

(e) 

Tthe maximum working pressure of the vessel shall ⌦ does ⌫ not exceed 30 bar 
and  the  product  of  that  pressure  and  the  capacity  of  the  vessel  (PS  x  V)  shall 
⌦ does ⌫ not exceed 10000 bar.lL.; 

Tthe minimum working temperature must be ⌦ is ⌫ no lower than – 50 °C and the 
maximum  working  temperature  must  ⌦ is ⌫  not  be  higher  than  300 °C  for  steel 
and 100 °C for aluminium or aluminium alloy vessels;. 

(cid:208) 2009/105/EC 

(b)  a  ‘harmonised  standard’  means  a  technical  specification  (European  standard  or 
harmonisation document) adopted by the European Committee for Standardisation (CEN), the 
European  Committee  for  Electrotechnical  Standardisation  (Cenelec)  or  the  European 
Telecommunications  Standards  Institute  (ETSI)  or  by  two  or  three  of  those  bodies  upon  a 
remit  from  the  Commission  in  accordance  with  Directive  98/34/EC  of  the  European 
Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of 
information  in  the  field  of  technical  standards  and  regulations  and  of  rules  on  Information 
Society  services14  and  the  general  guidelines  for  cooperation  between  the  Commission,  the 
European Free Trade Association (EFTA) and those three bodies signed on 28 March 2003. 

2.  The  following  vessels  shall  be  excluded  from  the  scope  of  tThis  Directive  ⌦ shall  not 
apply to the following vessels ⌫ : 

(cid:208) 2009/105/EC (adapted) 

(cid:208) 2009/105/EC 

(a)  vessels  specifically  designed  for  nuclear  use,  failure  of  which  may  cause  an 
emission of radioactivity; 

(b)  vessels  specifically  intended  for  installation  in  or  the  propulsion  of  ships  and 
aircraft; 

14 

OJ L 204, 21.7.1998, p. 37. 

EN 

17 

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(c) fire extinguishers. 

(cid:208) 2009/105/EC (adapted) 

Article 2 [Article R1 of Decision No 768/2008/EC] 

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

⌦ Definitions ⌫ 

(cid:216) new 

(1) ‘making available on the market’ means any supply of a vessel for distribution or use on 
the Union market in the course of a commercial activity, whether in return for payment or free 
of charge; 

(2) ‘placing on the market’ means the first making available of a vessel on the Union market; 

(3)  ‘manufacturer’  means  any  natural  or  legal  person  who  manufactures  a  vessel  or  has  a 
vessel designed or manufactured, and markets that vessel under his name or trademark; 

(4) ‘authorised representative’ means any natural or legal person established within the Union 
who  has  received  a  written  mandate  from  a  manufacturer  to  act  on  his  behalf  in  relation  to 
specified tasks; 

(5) ‘importer’  means any natural or legal person established  within the  Union who places a 
vessel from a third country on the Union market; 

(6)  ‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes a vessel available on the market; 

(7) ‘economic operators’ means the manufacturer, the authorised representative, the importer 
and the distributor; 

(8)  ‘technical  specification’  means  a  document  that  prescribes  technical  requirements  to  be 
fulfilled by a vessel; 

(9)  ‘harmonised  standard’  means  harmonised  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No [../..] [on European Standardisation]; 

(10)  ‘accreditation’  means  accreditation  as  defined  in  Article  2(10)  of  Regulation  (EC)  No 
765/2008; 

(11)  ‘national  accreditation  body’  means  national  accreditation  body  as  defined  in  Article 
2(11) of Regulation (EC) No 765/2008; 

EN 

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(12)  ‘conformity  assessment’  means  the  process  demonstrating  whether  the  requirements  of 
this Directive relating to a vessel have been fulfilled; 

(13)  ‘conformity  assessment  body’  means  a  body  that  performs  conformity  assessment 
activities including calibration, testing, certification and inspection; 

(14)  ‘recall’  means  any  measure  aimed  at  achieving  the  return  of  a  vessel  that  has  already 
been made available to the user; 

(15) ‘withdrawal’ means any measure aimed at preventing a vessel in the supply chain from 
being made available on the market; 

(16) ‘CE marking’ means a marking by which the manufacturer indicates that the vessel is in 
conformity  with  the  applicable  requirements  set  out  in  Union  harmonisation  legislation 
providing for its affixing; 

(17)  ‘Union  harmonisation  legislation’  means  any  Union  legislation  harmonising  the 
conditions for the marketing of products. 

(cid:208) 2009/105/EC (adapted) 
(cid:214) new 

Article 23 

⌦ Making available on the market and putting into service ⌫ 

1.  Member  States  shall  take  all  necessary  steps  to  ensure  that  the  vessels  may  be  placed 
(cid:214) made available  on the market and put into service only if they do not compromise the 
safety of persons, domestic animals or property when properly installed and maintained and 
used for the purposes for which they are intended. 

2. The provisions of this Directive shall not affect the right of Member States to specify — 
with due observance of the Treaty — the requirements they deem necessary in order to ensure 
that workers are protected when using  vessels, provided it does not mean that those vessels 
are modified in a way unspecified in this Directive. 

Article 34 

⌦ Essential requirements ⌫ 

1.  Vessels  in  respect  of  which  the  product  of  PS  x  V  exceeds  50  bar.L  must  ⌦ shall ⌫ 
satisfy the essential safety requirements set out in Annex I. 

2. Vessels in respect of which the product of PS x V is 50 bar.L or less must ⌦ shall ⌫ be 
manufactured in accordance with sound engineering practice in one of the Member States and 
bear markings as laid down in point 1 of Annex III, with the exception of the ‘CE’ marking 
referred to in Article 16. 

EN 

19 

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Article 45 

⌦ Free movement ⌫ 

Member  States  shall  not  impede  the  placing  (cid:214) making  available   on  the  market  and  the 
putting  into  service  in ⌦ on ⌫  their  territory  of  vessels  which  satisfy  the  requirements  of 
this Directive. 

(cid:216) new 

CHAPTER 2 

OBLIGATIONS OF ECONOMIC OPERATORS 

Article 6 [Article R2 of Decision No 768/2008/EC] 

Obligations of manufacturers 

1. 
When placing on the market the vessels of which the product of PS x V exceeds 50 
bar.L,  manufacturers  shall  ensure  that  they  have  been  designed  and  manufactured  in 
accordance with the essential safety requirements set out in Annex I. 

When  placing  on  the  market  vessels  of  which  the  product  of  PS  x  V  is  50  bar.L  or  less, 
manufacturers shall ensure that they have been designed and manufactured in accordance with 
the sound engineering practice in one of the Member States.  

2. 
For  vessels  of  which  the  product  of  PS  x  V  exceeds  50  bar.L,  manufacturers  shall 
draw up the technical documentation referred to in points 2 and 3 of Annex III and carry out 
the relevant conformity assessment procedure referred to in Article 13 or have it carried out. 

Where  compliance  of  a  vessel  of  which  the  product  of  PS  x  V  exceeds  50  bar.L  with  the 
applicable requirements  has been demonstrated by that procedure, manufacturers  shall draw 
up an EU declaration of conformity and affix the CE marking and the inscriptions provided 
for in point 1 of Annex III. 

Manufacturers  shall  ensure  that  vessels  of  which  the  product  of  PS  x  V  is  50  bar.L  or  less, 
bear the inscriptions laid down in point 1 of Annex III. 

Manufacturers  shall  keep  the  technical  documentation  and  the  EU  declaration  of 

3. 
conformity for 10 years after the vessel has been placed on the market. 

4. 
Manufacturers shall ensure that procedures are in place for series production to remain 
in  conformity.  Changes  in  vessels  design  or  characteristics  and  changes  in  the  harmonised 
standards by reference to which conformity of a vessel is declared shall be adequately taken 
into account. 

EN 

20 

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When deemed appropriate with regard to the risks presented by a vessel, manufacturers shall 
to protect the health and safety of users, carry out sample testing of vessels made available on 
the  market,  investigate,  and,  if  necessary,  keep  a  register  of  complaints,  of  non-conforming 
vessels and vessel recalls, and shall keep distributors informed of any such monitoring. 

Manufacturers  shall  ensure  that  their  vessels  bear  a  type  and  serial  or  batch 

5. 
identification allowing their identification. 

Manufacturers  shall  indicate  their  name,  registered  trade  name  or  registered  trade 
6. 
mark and the address at which they can be contacted on the vessel. The address must indicate 
a single point at which the manufacturer can be contacted. 

Manufacturers shall ensure that the vessel of which the product of PS x V exceeds 50 
7. 
bar.L,  is  accompanied  by  the  instructions  and  safety  information  referred  to  in  point  2  of 
Annex III, in the official language or languages of the country Member State of destination. 

Manufacturers who consider or have reason to believe that a vessel which they have 
8. 
placed  on  the  market  is  not  in  conformity  with  this  Directive  shall  immediately  take  the 
necessary corrective measures to bring that vessel into conformity, to withdraw it or recall it, 
if appropriate. Furthermore, where the vessel presents a risk, manufacturers shall immediately 
inform the competent national authorities of the Member States in which they made the vessel 
available  to  that  effect,  giving  details,  in  particular,  of  the  non-compliance  and  of  any 
corrective measures taken. 

9. 
Manufacturers shall, further to a reasoned request from a competent national authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the vessel, in a language which can be easily understood by that authority. They 
shall  cooperate  with  that  authority,  at  its  request,  on  any  action  taken  to  eliminate  the  risks 
posed by vessels which they have placed on the market. 

Article 7 [Article R3 of Decision No 768/2008/EC] 

Authorised representatives 

1. 

A manufacturer may, by a written mandate, appoint an authorised representative. 

The obligations laid down in Article 6(1) and the drawing up of technical documentation shall 
not form part of the authorised representative's mandate. 

2. 
An authorised representative shall perform the tasks specified in the mandate received 
from  the  manufacturer.  The  mandate  shall  allow  the  authorised  representative  to  do  at  least 
the following: 

(a) 

(b) 

keep  the  EU  declaration  of  conformity  and  the  technical  documentation  at  the 
disposal  of  national  surveillance  authorities  for  10  years  after  the  vessel  has  been 
placed on the market; 

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 a vessel; 

EN 

21 

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(c) 

cooperate  with  the  competent  national  authorities,  at  their  request,  on  any  action 
taken  to  eliminate  the  risks  posed  by  vessels  covered  by  the  authorised 
representative’s mandate. 

Article 8 [Article R4 of Decision No 768/2008/EC] 

1. 

Importers shall place only compliant vessels on the market. 

Obligations of importers 

Before  placing  on  the  market  a  vessel  of  which  the  product  of  PS  x  V  exceeds  50 
2. 
bar.L, importers shall ensure that the appropriate conformity assessment procedure referred to 
in Article 6 has been carried out by the manufacturer. They shall ensure that the manufacturer 
has  drawn  up  the  technical  documentation,  that  the  vessel  bears  the  CE  marking  and  the 
inscriptions  provided  for  in  point  1  of  Annex  III  and  is  accompanied  by  the  required 
documents, and that the manufacturer has complied with the requirements set out in Article 
6(5) and (6). 

Where an importer considers or has reason to believe that a vessel of which the product of PS 
x  V  exceeds  50  bar.L  is  not  in  conformity  with  the  essential  safety  requirements  set  out  in 
Annex I, he shall not place the vessel on the market until it has been brought into conformity. 
Furthermore, where the vessel presents a risk, the importer shall inform the manufacturer and 
the market surveillance authorities to that effect. 

Before  placing  on  the  market  a  vessel  of  which  the  product  of  PS  x  V  is  50  bar.L  or  less, 
importers shall ensure that it bears the inscriptions provided for in point 1 of Annex III and 
that the manufacturer has complied with the requirements set out in Article 6(5) and (6). 

3. 
Importers shall indicate their name, registered trade name or registered trade mark and 
the address at which they can be contacted on the vessel or, where that is not possible, on its 
packaging or in a document accompanying the vessel. 

4. 
Importers  shall  ensure  that  the  vessel  of  which  the  product  of  PS  x  V  exceeds  50 
bar.L,  is  accompanied  by  the  instructions  and  safety  information  referred  to  in  point  2  of 
Annex III, in the official language or languages of the Member State of destination. 

Importers shall ensure that, while a vessel in respect of which the product of PS x V 
5. 
exceeds  50  bar.L  is  under  their  responsibility,  storage  or  transport  conditions  do  not 
jeopardise its compliance with the essential safety requirements set out in Annex I. 

When  deemed  appropriate  with  regard  to  the  risks  presented  by  a  vessel,  importers 
6. 
shall,  to  protect  the  health  and  safety  of  users,  carry  out  sample  testing  of  vessels  made 
available on the market, investigate, and, if necessary, keep a register of complaints, of non-
conforming  vessels  and  vessel  recalls,  and  shall  keep  distributors  informed  of  such 
monitoring. 

7. 
Importers who consider or have reason to believe that a vessel which they have placed 
on the market  is  not in  conformity with this Directive shall immediately take the  corrective 
measures  necessary  to  bring  that  vessel  into  conformity,  to  withdraw  it  or  recall  it,  if 
appropriate.  Furthermore,  where  the  vessel  presents  a  risk,  importers  shall  immediately 

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inform the competent national authorities of the Member States in which they made the vessel 
available  to  that  effect,  giving  details,  in  particular,  of  the  noncompliance  and  of  any 
corrective measures taken. 

For vessels of which the product of PS x V exceeds 50 bar.L, importers shall, for 10 
8. 
years  after  the  vessel  has  been  placed  on  the  market,  keep  a  copy  of  the  EU  declaration  of 
conformity at the disposal of the market surveillance authorities and ensure that the technical 
documentation can be made available to those authorities, upon request. 

9. 
Importers  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of a vessel in a language which can be easily understood by that authority. They 
shall  cooperate  with  that  authority,  at  its  request,  on  any  action  taken  to  eliminate  the  risks 
posed by vessels which they have placed on the market. 

Article 9 [Article R5 of Decision No 768/2008/EC] 

Obligations of distributors 

When making a vessel available on the market distributors shall act with due care in 

1. 
relation to the requirements of this Directive. 

Before making a vessel of which the product of PS x V exceeds 50 bar.L available on 
2. 
the market, distributors shall verify that the vessel bears the CE marking and the inscriptions 
provided for in point 1 of Annex III, that it is accompanied by the required documents and by 
instructions and safety information in a language which can be easily understood by users in 
the  Member  State  in  which  the  vessel  is  to  be  made  available  on  the  market,  and  that  the 
manufacturer  and  the  importer  have  complied  with  the  requirements  set  out  in  Article  6(5) 
and (6) and Article 8(3). 

Where a distributor considers or has reason to believe that a vessel of which the product of PS 
x  V  exceeds  50  bar.L  is  not  in  conformity  with  the  essential  safety  requirements  set  out  in 
Annex I, he shall not make the vessel available on the market until it has been brought into 
conformity.  Furthermore,  where  the  vessel  presents  a  risk,  the  distributor  shall  inform  the 
manufacturer or the importer to that effect as well as the market surveillance authorities. 

Before making a vessel of which the product of PS x V is 50 bar.L or less available on the 
market, distributors shall verify that the vessel bears the inscriptions provided for in point 1 of 
Annex III and that the manufacturer and the importer have complied with the requirements set 
out in Article 6(5) and (6) and Article 8(3). 

3. 
Distributors shall ensure that, while a vessel of which the product of PS x V exceeds 
50  bar.L  is  under  their  responsibility,  storage  or  transport  conditions  do  not  jeopardise  its 
compliance with the essential safety requirements set out in Annex I. 

4. 
Distributors  who  consider  or  have  reason  to  believe  that  a  vessel  which  they  have 
made available on the market is not in conformity with this Directive shall make sure that the 
corrective measures necessary to bring that vessel into conformity, to withdraw it or recall it, 
if  appropriate,  are  taken.  Furthermore,  where  the  vessel  presents  a  risk,  distributors  shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 

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made  the  vessel  available  to  that  effect,  giving  details,  in  particular,  of  the  non-compliance 
and of any corrective measures taken. 

5. 
Distributors shall, further to a reasoned  request from  a competent  national authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of a vessel. They shall cooperate with that authority, at its request, on any action 
taken to eliminate the risks posed by vessels which they have made available on the market. 

Article 10 [Article R6 of Decision No 768/2008/EC] 

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 he shall be subject to the obligations of the manufacturer under Article 6, where 
he  places  a  vessel  on  the  market  under  his  name  or  trademark  or  modifies  a  vessel  already 
placed on the market in such a way that compliance with the requirements of this Directive 
may be affected. 

Article 11 [Article R7 of Decision No 768/2008/EC] 

Identification of economic operators 

Economic  operators  shall,  on  request,  identify  the  following  to  the  market  surveillance 
authorities: 

(a) 

(b) 

any economic operator who has supplied them with a vessel; 

any economic operator to whom they have supplied a vessel. 

Economic  operators  shall  be  able  to  present  the  information  referred  to  in  the  first 
subparagraph for a period of 10 years after they have been supplied with the vessel and for a 
period of 10 years after they have supplied the vessel. 

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CHAPTER 3 

CONFORMITY OF VESSELS OF WHICH THE PRODUCT OF 
PS x V EXCEEDS 50 bar.L 

(cid:208) 2009/105/EC (adapted) 

Article 512 [Article R8 of Decision No 768/2008/EC] 

⌦ Presumption of conformity ⌫ 

(cid:216) new 

Vessels of which the product of PS x V exceeds 50 bar.L and which are in conformity with 
harmonised  standards  or  parts  thereof  the  references  of  which  have  been  published  in  the 
Official  Journal  of  the  European  Union  shall  be  presumed  to  be  in  conformity  with  the 
essential safety requirements covered by those standards or parts thereof, set out in Annex I. 

[Where a harmonised standard satisfies the requirements which it covers and which are set out 
in Annex I or Article 21, the Commission shall publish the references of those standards in the 
Official Journal of the European Union.]  

(cid:208) 2009/105/EC 

Member  States  shall  presume  that  vessels  bearing  the  CE  marking  comply  with  all  the 
provisions of this Directive. 

Conformity of vessels with the national standards which transpose the harmonised standards, 
the reference numbers of which have been published in the Official Journal of the European 
Union, shall result in a presumption of conformity to the essential safety requirements set out 
in Annex I. 

Member States shall publish the reference numbers of such national standards. 

2. Member States shall presume that vessels for which the standards referred to in the second 
subparagraph  of  paragraph  1  do  not  exist  or  in  respect  of  which  the  manufacturer  has  not 
applied  or  has  only  partially  applied  such  standards,  comply  with  the  essential  safety 
requirements  set  out  in  Annex  I,  where,  after  receipt  of  an  EC  type-examination  certificate, 
their  conformity  with  the  approved  model  has  been  certified  by  the  affixation  of  the  ‘CE’ 
marking. 

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3. Where vessels are subject to other Directives covering other aspects and which also provide 
for the affixing of the ‘CE’ marking, the latter shall indicate that the vessels in question are 
also presumed to conform to the provisions of those other Directives. 

However, where one or more of those Directives allow the manufacturer, during a transitional 
period,  to  choose  which  arrangements  to  apply,  the  ‘CE’  marking  shall  indicate  conformity 
only to the Directives applied by the manufacturer. In this case, particulars of the Directives 
applied,  as  published  in  the  Official  Journal  of  the  European  Union,  shall  be  given  in  the 
documents, notices or instructions required by the Directives and accompanying such vessels. 

(cid:208) 2009/105/EC (adapted) 
(cid:214) new 

CHAPTER II 

Certification 

Section 1 Article13 

Certification ⌦ Conformity assessment ⌫ procedures 

Article 8 

1. Prior to production of ⌦ their manufacture ⌫ pressure vessels of which the product of PS 
x V exceeds 50 bar.L, manufactured in accordance with the harmonised standards (cid:214) shall be 
subject  to  the  EU-type  examination  (Module  B)   referred  to  in  Article  5(1),  the 
manufacturer, or his authorised representative established within the Community, shall at his 
own choice either point 1 of Annex II, ⌦ as follows ⌫ : 

(a) 

for vessels manufactured in accordance with the harmonised standards referred to in 
Article 12, at the choice of the manufacturer, in either of the following two manners: 

(cid:216) new 

(a) inform an approved inspection body as referred to in Article 9, which, after examining the 
design  and  manufacturing  schedule  referred  to  in  point  3  of  Annex  II,  shall  draw  up  a 
certificate of adequacy attesting that the schedule is satisfactory  

(cid:208) 2009/105/EC 

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i) 

assessment  of  the  adequacy  of  the  technical  design  of  the  vessel  through 
examination  of  the  technical  documentation  and  supporting  evidence  without 
examination of a specimen (Module B - design type); 

(cid:216) new 

(cid:208) 2009/105/EC 
(cid:214) new 

(bii)- (cid:214) examination of    submit  a  prototype  vessel  (cid:214) representative  of  the 
production  envisaged  of  the  complete  vessel   for  the  EC  type-examination 
referred to in Article 10 (cid:214) Module B – production type)  . 

(cid:208) 2009/105/EC (adapted) 

2.(b) 

Prior  to  production  of  pressure ⌦ for ⌫  vessels  of  which  the  product  of  PS  x  V 
exceeds 50 bar.lL not manufactured, or manufactured only partly, in accordance with 
the  harmonised  standards  referred  to  in  Article  5(1)12,  the  manufacturer,  or  his 
authorised  representative  established  within  the  Community,  shall  submit  ⌦ for 
examination ⌫ a prototype vessel for the EC type-examination referred to in Article 
10 ⌦ representative of the production envisaged of the complete vessel (Module B 
– production type) ⌫ . 

32. Vessels manufactured in accordance with the harmonised standards referred to in Article 
5(1) or with the approved prototype shall, pPrior to their being placed ⌦ placing ⌫ on the 
market, ⌦ vessels shall ⌫ be subject ⌦ to the following procedures ⌫ : 

(a) 

to the EC verification referred to in Article 11 where the product of PS x V exceeds 
3000  bar.lL  (cid:214) ,  to  Module  C1  (conformity  to  type  based  on  internal  production 
control plus supervised product testing) set out in point 2 of Annex II ; 

(cid:208) 2009/105/EC 
(cid:214) new 

(b) 

at the choice of the manufacturer, where the product of PS x V does not exceed 3000 
bar.lL but exceeds 50 (cid:214) 200  bar.lL, ⌦ at the choice of the manufacturer, to ⌫ 
either ⌦ of the following modules ⌫ : 

(cid:208) 2009/105/EC (adapted) 
(cid:214) new 

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(cid:208) 2009/105/EC 
(cid:214) new 

(i) to the EC declaration (cid:214) Module C1  of (conformity (cid:214) to type based on 
internal  production  control  plus  supervised  product  testing)   referred  to  in 
Article 12 point 2 of Annex II; or 

(ii) to the EC verification (cid:214) Module C2 (conformity to type based on internal 
production  control  plus  supervised  product  checks  at  random  intervals  
referred to in Article 11 point 3 Annex II. 

(cid:216) new 

(c) 

where the product of PS x V does not exceed 200 bar.L but exceeds 50 bar.L, at the 
choice of the manufacturer, to either of the following modules: 

(i)  Module  C1  (conformity  to  type  based  on  internal  production  control  plus 

supervised product testing) referred to in point 2 of Annex II; 

(ii) Module C (conformity to type based on internal production control) referred to in 

point 4 of Annex II. 

43.  The  records  and  correspondence  relating  to  the  certification  procedures  referred  to  in 
paragraphs  1  and 2  and  3  shall  be  drafted  in  an  official  language  of  the  Member  State  in 
which the approved inspection ⌦ notified ⌫ body is established or in a language accepted 
by that body. 

(cid:208) 2009/105/EC (adapted) 

(cid:216) new 

Article 14 [Article R10 of Decision No 768/2008/EC] 

EU declaration of conformity 

The EU declaration of conformity shall state that the fulfilment of the essential safety 

1. 
requirements set out in Annex I has been demonstrated. 

The EU declaration of conformity shall have the model structure set out in Annex III 
2. 
of Decision No 768/2008/EC, shall contain the elements specified in the relevant modules set 
out in Annex II of this Directive and shall be continuously updated. It shall be translated into 
the language or languages required by the Member State in which market the vessel is placed 
or made available. 

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3. 
Where the vessel is subject to more than one Union act requiring an EU declaration of 
conformity,  a  single  EU  declaration  of  conformity  shall  be  drawn  up  in  respect  of  all  such 
Union  acts.  That  declaration  shall  contain  the  identification  of  the  acts  concerned  including 
the publication references.  

By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 

4. 
responsibility for the compliance of the vessel. 

Article 15 [Article R11 of Decision No 768/2008/EC] 

General principles of the CE marking 

The CE marking shall be subject to the general principles set out in Article 30 of Regulation 
(EC) No 765/2008. 

Article 16 [Article R12 of Decision No 768/2008/EC] 

Rules and conditions for affixing the CE marking and other markings 

The  CE  marking  and  the  inscriptions  referred  to  in  point  1  of  Annex  III  shall  be 

1. 
affixed visibly, legibly and indelibly to the vessel or to its data plate.  

2. 

The CE marking shall be affixed before the vessel is placed on the market.  

The CE marking shall be followed by the identification number of the notified body 

3. 
involved in the production control phase. 

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

The  CE  marking  and  the  identification  number  referred  to  in  paragraph  3  may  be 

4. 
followed by a pictogram or any other mark indicating a special risk or use. 

(cid:208) 2009/105/EC 

Article 6 

Where a Member State or the Commission considers that the harmonised standards referred to 
in Article 5(1) do not entirely meet the essential safety requirements set out in Annex I, the 
Commission  or  the  Member  State  concerned  shall  bring  the  matter  before  the  standing 
committee  set  up  under  Article  5  of  Directive  98/34/EC,  hereinafter  referred  to  as  ‘the 
committee’, giving the reasons therefor. 

The committee shall deliver an opinion without delay. 

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In  the  light  of  the  committee’s  opinion,  the  Commission  shall  inform  the  Member  States 
whether or not it is necessary to withdraw those standards from the publications referred to in 
Article 5(1). 

Article 7 

1. Where a Member State finds that vessels bearing the ‘CE’ marking and used in accordance 
with  their  intended  purpose  might  compromise  the  safety  of  persons,  domestic  animals  or 
property, it shall take all appropriate measures to withdraw those products from the market or 
to prohibit or restrict their being placed on the market. 

The Member State concerned shall immediately inform the Commission of any such measure, 
indicating the reasons for its decision, and in particular whether non-conformity is due to: 

(a) failure to meet the essential safety requirements set out in Annex I, where 

the vessel does not meet the harmonised standards referred to in Article 5(1); 

(b)  incorrect  application  of  the  harmonised  standards  referred  to  in  Article 

5(1); 

(c) shortcomings in the harmonised standards referred to in Article 5(1). 

2.  The  Commission  shall  enter  into  consultation  with  the  parties  concerned  as  soon  as 
possible. Where, after such consultation, the Commission finds that any measure as referred 
to in paragraph 1 is justified, it shall immediately so inform the Member State that took the 
action and the other Member States. 

Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, 
the  Commission,  after  consulting  the  parties  concerned,  shall  bring  the  matter  before  the 
committee within two months if the Member State which has taken the measures intends to 
maintain them and shall set in motion the procedure referred to in Article 6. 

3.  Where  a  vessel  which  does  not  comply  bears  the  ‘CE’  marking,  the  competent  Member 
State  shall  take  appropriate  action  against  whomsoever  has  affixed  the  marking  and  shall 
inform the Commission and the other Member States thereof. 

4. The Commission shall ensure that the Member States are kept informed of the progress and 
outcome of the procedure referred to in paragraphs 1, 2 and 3. 

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CHAPTER II 

CERTIFICATION  

SECTION 1 

CERTIFICATION PROCEDURES 

Article 9 

1. Member States shall notify the Commission and the other Member States of the approved 
inspection bodies which they have appointed to carry out the procedures referred to in Article 
8(1), (2) and (3) together with the specific tasks which those bodies have been appointed to 
carry out and the identification numbers assigned to them beforehand by the Commission. 

The  Commission  shall  publish  in  the  Official  Journal  of  the  European  Union  a  list  of  the 
notified  bodies  with  their  identification  numbers  and  the  tasks  for  which  they  have  been 
notified. The Commission shall ensure that this list is kept up to date. 

2. For the purposes of approval of the bodies referred to in paragraph 1, Member States shall 
meet the minimum criteria set out in Annex III. 

3. A Member State which has approved an inspection body shall withdraw approval if it finds 
that the body no longer meets the minimum criteria set out in Annex III. 

It shall immediately inform the Commission and the other Member States accordingly. 

SECTION 2 

EC TYPE-EXAMINATION 

Article 10 

(cid:208) 2009/105/EC (adapted) 

1. EC type-examination is the procedure whereby an approved inspection body ascertains and 
certifies that a prototype vessel satisfies the provisions of this Directive which apply to it. 

2.  The  application  for  EC  type-examination  shall  be  lodged  by  the  manufacturer  or  by  his 
authorised  representative  with  a  single  approved  inspection  body  in  respect  of  a  prototype 
vessel or of a prototype representing a family of vessels. That authorised representative must 
be established in the Community. 

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The application shall include: 

(a)  the  name  and  address  of  the  manufacturer  or  of  his  authorised 

representative and the place of manufacture of the vessels; 

(b) the design and manufacturing schedule referred to in point 3 of Annex II. 

(cid:208) 2009/105/EC 

It shall be accompanied by a vessel which is representative of the production envisaged. 

3.  The  approved  inspection  body  shall  carry  out  the  EC  type-examination  in  the  manner 
referred to in the second and third subparagraphs. 

It  shall  examine  not  only  the  design  and  manufacturing  schedule  in  order  to  check  its 
conformity, but also the vessel submitted. 

When examining the vessel, the body shall: 

(a) verify that the vessel has been manufactured in conformity with the design 
and  manufacturing  schedule  and  may  safely  be  used  under  its  intended  working 
conditions; 

(b)  perform  appropriate  examinations  and  tests  to  check  that  the  vessel 

complies with the essential requirements applicable to it. 

4. If the prototype complies with the provisions applicable to it the approved inspection body 
shall draw up an EC type-examination certificate which shall be forwarded to the applicant. 
That  certificate  shall  state  the  conclusions  of  the  examination,  indicate  any  conditions  to 
which  its  issue  may  be  subject  and  be  accompanied  by  the  descriptions  and  drawings 
necessary for identification of the approved prototype. 

The  Commission,  the  other  approved  inspection  bodies  and  the  other  Member  States  may 
obtain  a  copy  of  the  certificate  and,  on  a  reasoned  request,  a  copy  of  the  design  and 
manufacturing schedule and the reports on the examinations and tests carried out. 

5.  An  approved  inspection  body  which  refuses  to  issue  an  EC  type-examination  certificate 
shall so inform the other approved inspection bodies. 

An  approved  inspection  body  which  withdraws  an  EC  type-examination  certificate  shall  so 
inform the Member State which approved it. The latter shall inform the other Member States 
and the Commission thereof, giving the reasons for the decision. 

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SECTION 3 

EC VERIFICATION 

Article 11 

1.  EC  verification  is  the  procedure  whereby  a  manufacturer  or  his  authorised  representative 
established  within  the  Community  ensures  and  declares  that  the  vessels  which  have  been 
checked in accordance with paragraph 3 are in conformity with the type described in the EC 
type-examination  certificate  or  with  the  design  and  manufacturing  schedule  referred  to  in 
point 3 of Annex II having received a certificate of adequacy. 

2. The manufacturer shall take all necessary measures for the manufacturing process to ensure 
that the vessels conform to the type described in the EC type-examination certificate or to the 
design and manufacturing schedule referred to in point 3 of Annex II. The manufacturer or his 
authorised  representative  established  within  the  Community  shall  affix  the  ‘CE’  marking  to 
each vessel and draw up a declaration of conformity. 

(cid:208) 2009/105/EC (adapted) 

3.  The  approved  inspection  body  shall  carry  out  the  appropriate  examinations  and  tests  in 
order  to  check  the  conformity  of  the  vessels  with  the  requirements  of  this  Directive  by 
examination and testing of vessels in accordance with the second to tenth subparagraphs. 

The manufacturer shall present his vessels in the form of uniform batches and shall take all 
necessary  measures  in  order  that  the  manufacturing  process  ensures  the  uniformity  of  each 
batch produced. 

Those  batches  shall  be  accompanied  by  the  EC  type-examination  certificate  referred  to  in 
Article  10  or,  where  the  vessels  are  not  manufactured  in  accordance  with  an  approved 
prototype, by the design and manufacturing schedule referred to in point 3 of Annex II. In the 
latter case the approved inspection body shall, prior to EC verification, examine the schedule 
in order to certify its conformity. 

When  a  batch  is  examined,  the  approved  inspection  body  shall  ensure  that  the  vessels  have 
been manufactured and checked in accordance with the design and manufacturing schedule, 
and shall perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in 
the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to check its 
soundness. The pneumatic test shall be subject to acceptance of the test safety procedures by 
the Member State in which the test is performed. 

Moreover,  the  approved  inspection  body  shall  carry  out  tests  on  test-pieces  taken  from  a 
representative production test-piece or from a vessel, as the manufacturer chooses, in order to 
examine  the  weld  quality.  The  tests  shall  be  carried  out  on  longitudinal  welds.  However, 
where differing weld techniques are used for longitudinal and circular welds, the tests shall be 
repeated on the circular welds. 

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For  the  vessels  referred  to  in  point  2.1.2  of  Annex  I,  these  tests  on  test-pieces  shall  be 
replaced  by  a  hydrostatic  test  on  five  vessels  taken  at  random  from  each  batch  in  order  to 
check that they conform to the essential safety requirements set out in point 2.1.2 of Annex I. 

In  the  case  of  accepted  batches,  the  approved  inspection  body  shall  affix  its  identification 
number,  or  cause  that  number  to  be  affixed,  to  each  vessel  and  shall  draw  up  a  written 
certificate  of  conformity  relating  to  the  tests  carried  out.  All  vessels  in  the  batch  may  be 
placed  on  the  market  except  for  those  which  have  not  successfully  undergone  a  hydrostatic 
test or a pneumatic test. 

If a batch is rejected, the approved inspection body shall take appropriate measures to prevent 
the  placing  on  the  market  of  that  batch.  In  the  event  of  frequent  rejection  of  batches,  the 
approved inspection body may suspend the statistical verification. 

The  manufacturer  may,  under  the  responsibility  of  the  approved  inspection  body,  affix  the 
latter’s identification number during the manufacturing process. 

(cid:208) 2009/105/EC 

The  manufacturer  or  his  authorised  representative  must  be  able  to  supply  on  request  the 
approved inspection body’s certificates of conformity referred to in the seventh subparagraph. 

(cid:208) 2009/105/EC (adapted) 

(cid:208) 2009/105/EC 

SECTION 4 

EC DECLARATION OF CONFORMITY 

Article 12 

1.  A  manufacturer  fulfilling  the  obligations  arising  under  Article  13  shall  affix  the  ‘CE’ 
marking provided for in Article 16 to vessels which he declares to be in conformity with: 

(a) the design and manufacturing schedule referred to in point 3 of Annex II in 

respect of which a certificate of adequacy has been drawn up; or 

(b) an approved prototype. 

2.  By  the  EC  declaration  of  conformity  procedure  the  manufacturer  becomes  subject  to  EC 
surveillance, in cases where the product of PS x V exceeds 200 bar.L. 

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The purpose of EC surveillance is to ensure, as required by the second paragraph of Article 
14, that the manufacturer duly fulfils the obligations arising under Article 13(2). Surveillance 
shall  be  performed  by  the  approved  inspection  body  which  issued  the  EC  type-examination 
certificate referred to in the first subparagraph of Article 10(4) where the vessels have been 
manufactured  in  accordance  with  an  approved  prototype  or,  if  this  is  not  the  case,  by  the 
approved body to which the design and manufacturing schedule was sent in accordance with 
Article 8(1)(a). 

Article 13 

(cid:208) 2009/105/EC (adapted) 

1. Where a manufacturer makes use of the procedure referred to in Article 12, he shall, before 
commencing  manufacture,  send  the  approved  inspection  body  which  issued  the  EC  type-
examination  certificate  or 
the 
manufacturing  processes  and  all  of  the  predetermined  systematic  measures  taken  to  ensure 
conformity of the pressure vessels to the standards referred to in Article 5(1) or the approved 
prototype. 

the  certificate  of  adequacy  a  document  describing 

2. The document referred to in paragraph 1 shall include: 

(a) a description of the means of manufacture and checking appropriate to the 

construction of the vessels; 

(b) an inspection document describing the  appropriate examinations and tests 
to be carried out during manufacture, together with the procedures in respect thereof 
and the frequency with which they are to be performed; 

(c) an undertaking to carry out the examinations and tests in accordance with 
the  inspection  document  referred  to  in  point  (b)  and  to  have  a  hydrostatic  test  or, 
subject to the agreement of the Member State, a pneumatic test carried out on each 
vessel manufactured at a test pressure equal to 1,5 times the design pressure; 

those  examinations  and  tests  shall  be  carried  out  under  the  responsibility  of 
qualified staff who are sufficiently independent from production personnel, and shall 
be the subject of a report; 

(d)  the  addresses  of  the  places  of  manufacture  and  storage  and  the  date  on 

which manufacture is to commence. 

3. When the product of PS x V exceeds 200 bar.L, manufacturers shall authorise access to the 
said  places  of  manufacture  and  storage  by  the  body  responsible  for  EC  surveillance,  for 
inspection  purposes,  and  shall  allow  that  body  to  select  sample  vessels  and  shall  provide  it 
with all necessary information, and in particular: 

(a) the design and manufacturing schedule; 

(b) the inspection report; 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
 
(c)  the  EC  type-examination  certificate  or  certificate  of  adequacy,  where 

appropriate; 

(d) a report on the examinations and tests carried out. 

Article 14 

The approved inspection body which issued the EC type-examination certificate or certificate 
of  adequacy  shall,  before  the  date  on  which  any  manufacture  begins,  examine  both  the 
document referred to in Article 13(1) and the design and manufacturing schedule referred to 
in point 3 of Annex II, in order to certify its conformity, where vessels are not manufactured 
in accordance with an approved prototype. 

In  addition,  where  the  product  of  PS  x  V  exceeds  200  bar.L,  that  body  shall  during 
manufacture: 

(cid:208) 2009/105/EC 

(cid:208) 2009/105/EC (adapted) 

(a)  ensure  that  the  manufacturer  actually  checks  series-produced  vessels  in 

accordance with Article 13(2)(c); 

(b) take random samples at the places of manufacture or at the place of storage 

of vessels for inspection purposes. 

The  approved  inspection  body  shall  supply  the  Member  State  which  approved  it  and,  on 
request, the other approved inspection bodies, the other Member States and the Commission, 
with a copy of the inspection report. 

(cid:216) new  

CHAPTER 4 

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  

Article 17 [Article R13 of Decision No 768/2008/EC] 

Notification 

Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 

EN 

36 

   EN 

 
 
 
 
 
 
 
 
Article 18 [Article R14 of Decision No 768/2008/EC] 

Notifying authorities 

Member  States  shall  designate  a  notifying  authority  that  shall  be  responsible  for 
1. 
setting  up  and  carrying  out  the  necessary  procedures  for  the  assessment  and  notification  of 
conformity  assessment  bodies  and  the  monitoring  of  notified  bodies,  including  compliance 
with the provisions of Article 23. 

2. 
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. 

3. 
Where  the  notifying  authority  delegates  or  otherwise  entrusts  the  assessment, 
notification or 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 laid down in Article 19(1) to (6). In addition it shall have arrangements to cover 
liabilities arising out of its activities. 

The  notifying  authority  shall  take  full  responsibility  for  the  tasks  performed  by  the 

4. 
body referred to in paragraph 3. 

Article 19 [Article R15 of Decision No 768/2008/EC] 

Requirements relating to notifying authorities 

A  notifying  authority  shall  be  established  in  such  a  way  that  no  conflict  of  interest 

1. 
with conformity assessment bodies occurs. 

A notifying authority shall be organised and operated so as to safeguard the objectivity 

2. 
and impartiality of its activities. 

A notifying authority shall be organised in  such a way that each decision relating to 
3. 
notification  of  a  conformity  assessment  body  is  taken  by  competent  persons  different  from 
those who carried out the assessment. 

A  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 

4. 
assessment bodies perform or consultancy services on a commercial or competitive basis. 

5. 

A notifying authority shall safeguard the confidentiality of the information it obtains. 

A  notifying  authority  shall  have  a  sufficient  number  of  competent  personnel  at  its 

6. 
disposal for the proper performance of its tasks. 

EN 

37 

   EN 

 
Article 20 [Article R16 of Decision No 768/2008/EC] 

Information obligation on notifying authorities 

Member  States  shall  inform  the  Commission  of  their  procedures  for  the  assessment  and 
notification  of  conformity  assessment  bodies  and  the  monitoring  of  notified  bodies,  and  of 
any changes thereto. 

The Commission shall make that information publicly available. 

Article 21 [Article R17 of Decision No 768/2008/EC] 

Requirements relating to notified bodies 

For  the  purposes  of  notification,  a  conformity  assessment  body  shall  meet  the 

1. 
requirements laid down in paragraphs 2 to 11. 

A conformity assessment body shall be established under national law and have legal 

2. 
personality. 

A  conformity  assessment  body  shall  be  a  third-party  body  independent  of  the 

3. 
organisation or the vessel it assesses. 

A  body  belonging  to  a  business  association  or  professional  federation  representing 
undertakings involved in the design, manufacturing, provision, assembly, use or maintenance 
of vessels which it assesses, may, on condition that its independence and the absence of any 
conflict of interest are demonstrated, be considered such a body. 

A  conformity  assessment  body,  its  top  level  management  and  the  personnel 
4. 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the  designer, 
manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of  the  vessels  which 
they assess, nor the authorised representative of any of those parties. This shall not preclude 
the use of assessed vessels that are necessary for the operations of the conformity assessment 
body or the use of such vessels for personal purposes. 

A  conformity  assessment  body,  its  top  level  management  and  the  personnel  responsible  for 
carrying  out  the  conformity  assessment  tasks  shall  not  be  directly  involved  in  the  design, 
manufacture  or  construction,  the  marketing,  installation,  use  or  maintenance  of  those 
products,  or  represent  the  parties  engaged  in  those  activities.  They  shall  not  engage  in  any 
activity  that  may  conflict  with  their  independence  of  judgement  or  integrity  in  relation  to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 

Conformity  assessment  bodies  shall  ensure  that  the  activities  of  their  subsidiaries  or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities. 

Conformity  assessment  bodies  and  their  personnel  shall  carry  out  the  conformity 
5. 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  the  requisite 

EN 

38 

   EN 

 
technical  competence  in  the  specific  field  and  shall  be  free  from  all  pressures  and 
inducements,  particularly  financial,  which  might  influence  their  judgement  or  the  results  of 
their conformity assessment activities, especially as regards persons or groups of persons with 
an interest in the results of those activities. 

6. 
A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  by  Article  13(1),  (2)  and  (3)  and  in  relation  to  which  it  has 
been notified, whether those tasks are carried out by the conformity assessment body itself or 
on its behalf and under its responsibility. 

At  all  times  and  for  each  conformity  assessment  procedure  and  each  kind  or  category  of 
vessels in relation to which it has been notified, a conformity assessment body shall have at its 
disposal the necessary: 

(a) 

(b) 

(c) 

personnel  with  technical  knowledge  and  sufficient  and  appropriate  experience  to 
perform the conformity assessment tasks; 

descriptions  of  procedures  in  accordance  with  which  conformity  assessment  is 
carried  out,  ensuring  the  transparency  and  the  ability  of  reproduction  of  those 
procedures. It shall have appropriate policies and procedures in place that distinguish 
between tasks it carries out as a notified body and other activities; 

procedures for the performance of activities which take due account of the size of an 
undertaking, the sector in which it operates, its structure, the degree of complexity of 
the  product  technology  in  question  and  the  mass  or  serial  nature  of  the  production 
process. 

It shall have the means necessary to perform the technical and administrative tasks connected 
with the conformity assessment activities in an appropriate manner and shall have access to 
all necessary equipment or facilities. 

The personnel responsible for carrying out conformity assessment activities shall have 

7. 
the following: 

(a) 

(b) 

(c) 

(d) 

sound  technical  and  vocational  training  covering  all  the  conformity  assessment 
activities in relation to which the conformity assessment body has been notified; 

satisfactory  knowledge  of  the  requirements  of  the  assessments  they  carry  out  and 
adequate authority to carry out those assessments; 

appropriate knowledge and understanding of the essential safety requirements set out 
in Annex I, of the applicable harmonised standards and of the relevant provisions of 
Union harmonisation legislation and of national legislation; 

the ability to draw up certificates, records and reports demonstrating that assessments 
have been carried out. 

The impartiality of the conformity assessment bodies, their top level management and 

8. 
of the assessment personnel shall be guaranteed. 

EN 

39 

   EN 

 
The  remuneration  of  the  top  level  management  and  assessment  personnel  of  a  conformity 
assessment body shall not depend on the number of assessments carried out or on the results 
of those assessments. 

Conformity  assessment  bodies  shall  take  out  liability  insurance  unless  liability  is 
9. 
assumed by the State in accordance with national law, or the Member State itself is directly 
responsible for the conformity assessment. 

The  personnel  of  a  conformity  assessment  body  shall  observe  professional  secrecy 
10. 
with regard to all information obtained in carrying out their tasks under Article 13(1), (2) and 
(3) of this Directive or any provision of national law giving effect to it, except in relation to 
the  competent  authorities  of  the  Member  State  in  which  its  activities  are  carried  out. 
Proprietary rights shall be protected. 

11. 
Conformity  assessment  bodies  shall  participate  in,  or  ensure  that  their  assessment 
personnel  are  informed  of,  the  relevant  standardisation  activities  and  the  activities  of  the 
notified  body  coordination  group  established  under  the  relevant  Union  harmonisation 
legislation  and  apply  as  general  guidance  the  administrative  decisions  and  documents 
produced as a result of the work of that group. 

Article 22 [Article R18 of Decision No 768/2008/EC] 

Presumption of conformity 

Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in  the  relevant  harmonised  standards  or  parts  thereof  the  references  of  which  have  been 
published in the Official Journal of the European Union it shall be presumed to comply with 
the requirements set out in Article 21 in so far as the applicable harmonised standards cover 
those requirements. 

Article 23 [Article R20 of Decision No 768/2008/EC] 

Subsidiaries of and subcontracting by notified bodies 

1. 
Where  a  notified  body  subcontracts  specific  tasks  connected  with  conformity 
assessment  or  has  recourse  to  a  subsidiary,  it  shall  ensure  that  the  subcontractor  or  the 
subsidiary  meets  the  requirements  set  out  in  Article  21  and  shall  inform  the  notifying 
authority accordingly. 

Notified bodies shall take full responsibility for the tasks performed by subcontractors 

2. 
or subsidiaries wherever these are established. 

Activities may be subcontracted or carried out by a subsidiary only with the agreement 

3. 
of the client. 

4. 
Notified  bodies  shall  keep  at  the  disposal  of  the  notifying  authority  the  relevant 
documents  concerning  the  assessment  of  the  qualifications  of  the  subcontractor  or  the 
subsidiary and the work carried out by them under Article 13(1), (2) and (3). 

EN 

40 

   EN 

 
Article 24 [Article R22 of Decision No 768/2008/EC] 

Application for notification 

1. A conformity assessment body shall submit an application for notification to the notifying 
authority of the Member State in which it is established. 

2.  That  application  shall  be  accompanied  by  a  description  of  the  conformity  assessment 
activities, the conformity assessment module or modules and the vessel or vessels for which 
that body claims to be competent, as well as by an accreditation certificate, where one exists, 
issued by a national accreditation body attesting that the conformity assessment body fulfils 
the requirements laid down in Article 21. 

3.  Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  the  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance with the 
requirements laid down in Article 21. 

Article 25 [Article R23 of Decision No 768/2008/EC] 

Notification procedure 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 

1. 
satisfied the requirements laid down in Article 21. 

They  shall  notify  the  Commission  and  the  other  Member  States  using  the  electronic 

2. 
notification tool developed and managed by the Commission. 

The notification shall include full details of the conformity assessment activities, the 
3. 
conformity assessment module or modules and vessel or vessels concerned and the relevant 
attestation of competence. 

Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in 
4. 
Article  24(2),  the  notifying  authority  shall  provide  the  Commission  and  the  other  Member 
States  with  documentary  evidence  which  attests  to  the  conformity  assessment  body's 
competence  and  the  arrangements  in  place  to  ensure  that  that  body  will  be  monitored 
regularly and will continue to satisfy the requirements laid down in Article 21. 

5. 
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 where an accreditation certificate is used or within two months of a notification 
where accreditation is not used. 

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 

6. 
relevant changes to the notification. 

EN 

41 

   EN 

 
Article 26 [Article R13 of Decision No 768/2008/EC] 

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 Union acts. 

The Commission shall make publicly available the list of the bodies notified under this 
2. 
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 27 [Article R25 of Decision No 768/2008/EC] 

Changes to notifications 

1. 
Where a notifying authority has ascertained or has been informed that a notified body 
no  longer  meets  the  requirements  laid  down  in  Article  21,  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  restriction,  suspension  or  withdrawal  of  notification,  or  where  the 
2. 
notified body has ceased its activity, the notifying Member State shall take 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 at their request. 

Article 28 [Article R26 of Decision No 768/2008/EC] 

Challenge of the competence of notified bodies 

The Commission shall investigate all cases where it doubts, or doubt is brought to its 
1. 
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 
2. 
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 

3. 
its investigations is treated confidentially. 

Where  the  Commission  ascertains  that  a  notified  body  does  not  meet  or  no  longer 
4. 
meets  the  requirements  for  its  notification,  it  shall  inform  the  notifying  Member  State 

EN 

42 

   EN 

 
accordingly and request it to take the necessary corrective measures, including de-notification 
if necessary. 

Article 29 [Article R27 of Decision No 768/2008/EC] 

Operational obligations of notified bodies 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 

1. 
conformity assessment procedures provided for in Article 13(1), (2) and (3). 

Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 

2. 
unnecessary burdens for economic operators. 

Conformity assessment bodies shall perform their activities taking due account of the size of 
an undertaking, the sector in which it operates, its structure, the degree of complexity of the 
vessel technology in question and the mass or serial nature of the production process. 

In  so  doing  they  shall  nevertheless  respect  the  degree  of  rigour  and  the  level  of  protection 
required for the compliance of the vessel with the provisions of this Directive. 

3. 
Where a notified body finds that the essential safety requirements set out in Annex I or 
corresponding harmonised standards have not been met by a manufacturer, it shall require that 
manufacturer  to  take  appropriate  corrective  measures  and  shall  not  issue  a  conformity 
certificate. 

Where,  in  the  course  of  the  monitoring  of  conformity  following  the  issue  of  a 
4. 
certificate,  a  notified  body  finds  that  a  vessel  no  longer  complies,  it  shall  require  the 
manufacturer  to  take  appropriate  corrective  measures  and  shall  suspend  or  withdraw  the 
certificate if necessary. 

Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the 

5. 
notified body shall restrict, suspend or withdraw any certificates, as appropriate. 

Article 30  

Appeal against decisions of notified bodies 

Member  States  shall  ensure  that  an  appeal  procedure  against  decisions  of  notified  bodies  is 
available. 

Article 31 [Article R28 of Decision No 768/2008/EC] 

Information obligation on notified bodies 

Notified bodies shall inform the notifying authority of the following: 

any refusal, restriction, suspension or withdrawal of a certificate; 

43 

   EN 

1. 

(a) 

EN 

 
(b) 

(c) 

(d) 

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; 

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

2. 
Notified  bodies  shall  provide  the  other  bodies  notified  under  this  Directive  carrying 
out  similar  conformity  assessment  activities  covering  the  same  products  with  relevant 
information  on  issues  relating  to  negative  and,  on  request,  positive  conformity  assessment 
results. 

Article 32 [Article R13 of Decision No 768/2008/EC] 

Exchange of experience 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  between  the 
Member States' national authorities responsible for notification policy. 

Article 33 [Article R30 of Decision No 768/2008/EC] 

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 or groups of notified bodies. 

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

CHAPTER 5 

UNION MARKET SURVEILLANCE, CONTROL OF VESSELS 
ENTERING THE UNION MARKET AND SAFEGUARD 
PROCEDURES 

Article 34 

Union market surveillance, control of vessels entering the Union market 

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to vessels. 

EN 

44 

   EN 

 
Article 35 [Article R31 of Decision No 768/2008/EC] 

Procedure for dealing with vessels presenting a risk at national level 

Where  the  market  surveillance  authorities  of  one  Member  State  have  taken  action 
1. 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason 
to  believe  that  a  vessel  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 
carry out an evaluation in relation to the vessel concerned covering all the requirements laid 
down in this Directive. The relevant economic operators shall cooperate as necessary with the 
market surveillance authorities. 

Where, in the course of that evaluation, the market surveillance authorities find that the vessel 
does not comply with the requirements laid down in this Directive, they shall without delay 
require  the  relevant  economic  operator  to  take  all  appropriate  corrective  action  to  bring  the 
vessel into compliance with those requirements, to withdraw the vessel from the market, or to 
recall  it  within  a  reasonable  period,  commensurate  with  the  nature  of  the  risk,  as  they  may 
prescribe. 

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

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

2. 
Where  the  market  surveillance  authorities  consider  that  noncompliance  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. 

3. 
The  economic  operator  shall  ensure  that  all  appropriate  corrective  action  is  taken  in 
respect of all the vessels concerned that it has made available on the market throughout the 
Union. 

4. 
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  vessel’s 
being made available on their national market, to withdraw the vessel from that market or to 
recall it. 

The  market  surveillance  authorities  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 identification of the noncompliant vessel, the origin of the 
vessel, the nature of the noncompliance 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 of the following: 

(a) 

failure of the vessel to meet requirements relating to the health or safety of persons or 
to other aspects of public interest protection laid down in this Directive; 

EN 

45 

   EN 

 
(b) 

shortcomings  in  the  harmonised  standards  referred  to  in  Article  12  conferring  a 
presumption of conformity. 

6. 
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  vessel 
concerned,  and,  in  the  event  of  disagreement  with  the  notified  national  measure,  of  their 
objections. 

7. 
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 

8. 
of the vessel concerned, without delay. 

Article 36 [Article R32 of Decision No 768/2008/EC] 

Union safeguard procedure 

1. 
Where, on completion of the procedure set out in Article 35(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  Union  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 the relevant economic 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 vessel is withdrawn from their market, 
and  shall  inform  the  Commission  accordingly.  If  the  national  measure  is  considered 
unjustified, the Member State concerned shall withdraw the measure. 

3. 
Where  the  national  measure  is  considered  justified  and  the  noncompliance  of  the 
vessel is attributed to shortcomings in the harmonised standards referred to in Article 35(5)(b) 
of  this  Directive,  the  Commission  shall  apply  the  procedure  provided  for  in  Article  8  of 
Regulation (EU) No […/…] [on European Standardisation]. 

Article 37 [Article R33 of Decision No 768/2008/EC] 

Compliant vessels which present a risk to health and safety 

1. 
Where, having performed an evaluation under Article 35(1), a Member State finds that 
although a vessel is in compliance with 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 vessel concerned, when 

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placed on the market, no longer presents that risk, to withdraw the vessel 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 

2. 
vessels concerned that he has made available on the market throughout the Union. 

3. 
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  vessel  concerned,  the  origin  and  the  supply  chain  of  the  vessel,  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 
4. 
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 

5. 
communicate it to them and the relevant economic operator or operators. 

Article 38 [Article R34 of Decision No 768/2008/EC] 

Formal non-compliance 

1. 
Without  prejudice  to  Article  35,  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: 

(a) 

(b) 

(c) 

(d) 

(e) 

the CE marking and/or the inscriptions referred to in point 1 of Annex III have been 
affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of 
this Directive; 

the CE marking and/or the inscriptions provided for in point 1 of Annex III have not 
been affixed; 

the EU declaration of conformity has not been drawn up; 

the EU declaration of conformity has not been drawn up correctly; 

the technical documentation is either not available or not complete. 

Where  the  non-compliance  referred  to  in  paragraph  1  persists,  the  Member  State 
2. 
concerned  shall  take  all  appropriate  measures  to  restrict  or  prohibit  the  vessel  being  made 
available on the market or ensure that it is recalled or withdrawn from the market. 

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(cid:208) 2009/105/EC 

CHAPTER III 

‘CE’ MARKING AND INSCRIPTIONS 

Without prejudice to Article 7: 

Article 15 

(a) where a Member State establishes that the ‘CE’ marking has been affixed 
unduly,  the  manufacturer  or  his  authorised  representative  established  within  the 
Community  shall  be  obliged  to  make  the  product  conform  with  the  provisions 
concerning  the  ‘CE’  marking  and  to  end  the  infringement  under  the  conditions 
imposed by that Member State; 

(b)  where  the  non-conformity  continues,  the  Member  State  must  take  all 
appropriate measures to restrict or prohibit the placing on the market of the product 
in question or to ensure that it is withdrawn from the market in accordance with the 
procedure laid down in Article 7. 

Article 16 

1. The ‘CE’ marking and the inscriptions provided for in point 1 of Annex II, shall be affixed 
in a visible, legible and indelible form to the vessel or to a data plate attached to the vessel in 
such a way that it cannot be removed. 

The ‘CE’ marking shall consist of the initials ‘CE’ in the form shown in the specimen in point 
1.1 of Annex II. The ‘CE’ marking shall be followed by the identification number referred to 
in  Article  9(1)  of  the  approved  inspection  body  responsible  for  ‘CE’  verifications  or  ‘CE’ 
surveillance. 

2. The affixing on the vessels of markings which are likely to deceive third parties as to the 
meaning and form of the ‘CE’ marking shall be prohibited. Any other marking may be affixed 
to the vessels or the data plate provided that the visibility and legibility of the ‘CE’ marking 
are not thereby reduced. 

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(cid:208) 2009/105/EC (adapted) 

CHAPTER IV6 

⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 

(cid:208) 2009/105/EC 

Article 17 

Any decision taken pursuant to this Directive which results in restrictions on the placing on 
the market or the putting into service of a vessel shall state the exact grounds on which it is 
based. Such a decision shall be notified without delay to the party concerned, who shall at the 
same time be informed of the judicial remedies available to him under the laws in force in the 
Member State in question and of the time limits to which such remedies are subject. 

(cid:216) new 

Article 39 

Penalties 

Member States shall lay down rules on penalties  applicable to infringements of the national 
provisions adopted pursuant to this Directive and shall take all measures necessary to ensure 
that they are enforced. 

The penalties provided for shall be effective, proportionate and dissuasive. 

Member  States  shall  notify  those  provisions  to  the  Commission  by  [the  date  set  out  in  the 
second  subparagraph  of  Article  41(1)]  at  the  latest  and  shall  notify  it  without  delay  of  any 
subsequent amendment affecting them. 

Article 40 

Transitional provisions  

Member  States  shall  not  impede  the  making  available  on  the  market  and/or  the  putting  into 
service  of  vessels  covered  by  Directive  2009/105/EC  which  are  in  conformity  with  that 
Directive  and  which  were  placed  on  the  market  before  [the  date  set  out  in  the  second 
subparagraph of Article 41(1)]. 

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Certificates  of  conformity  issued  under  Directive  2009/105/EC  shall  be  valid  under  this 
Directive  until  [the  date  set  out  in  the  second  subparagraph  of  Article  41(1)]  unless  they 
expire before that date. 

(cid:208)  

Article 1841 

Transposition 

1. 
Member States shall adopt and publish by [insert date – 2 years after adoption] at the 
latest, the laws, regulations and administrative provisions necessary to comply with Articles 2, 
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 
32,  33,  34,  35,  36,  37,  38,  39,  40  and  Annex  II.  They  shall  forthwith  communicate  to  the 
Commission the text of those provisions and a correlation table between those provisions and 
this Directive. 

They shall apply those provisions from [day after date set out in first subparagraph]. 

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. They shall 
also  include  a  statement  that  references  in  existing  laws,  regulations  and  administrative 
provisions to the directive repealed by this Directive shall be construed as references to this 
directive.  Member  States  shall  determine  how  such  reference  is  to  be  made  and  how  that 
statement is to be formulated. 

Member States shall communicate to the Commission the text of the main provisions 

2. 
of national law which they adopt in the field covered by this Directive. 

(cid:208) 2009/105/EC 

(cid:208) 2009/105/EC (adapted) 

Article 1942 

⌦ Repeal ⌫ 

Directive 87/404/EEC 2009/105/EC , as amended by the Directives listed in Annex IV, Part 
A, is repealed ⌦ with effect from [day after the date set out in the second subparagraph of 
Article 41(1)] ⌫ , without prejudice to the obligations of the Member States relating to the 
time  limits  for  transposition  into  national  law  and  application  of  the  Directives  set  out  in 
Annex IV, Part B of Annex IV to Directive 2009/105/EC.  

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References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex IV. 

(cid:208) 2009/105/EC 

(cid:208) 2009/105/EC (adapted) 

Article 2043 

⌦ Entry into force ⌫ 

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

(cid:208) 2009/105/EC 

Articles  1,  3,  4,  5  and  Annexes  I  and  III  shall  apply  from  [the  date  set  out  in  the  second 
subparagraph of Article 41(1)].  

(cid:208)  

(cid:208) 2009/105/EC (adapted) 

Article 244 

⌦ Addressees ⌫ 

This Directive is addressed to the Member States. 

Done at […], 

(cid:208) 2009/105/EC 

For the European Parliament 
The President 

For the Council 
The President

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(cid:208) 2009/105/EC  

ANNEX I 

ESSENTIAL SAFETY REQUIREMENTS 

(referred to in Article 3(1)) 

1. MATERIALS 

(cid:208) 2009/105/EC (adapted) 

Materials  must ⌦ shall ⌫  be  selected  according  to  the  intended  use  of  the  vessels  and  in 
accordance with points 1.1 to 1.4. 

1.1. Pressurised parts 

(cid:208) 2009/105/EC 

The  materials  referred  to  in  Article  1  used  for  manufacturing  the  pressurised  parts  of  the 
vessels must ⌦ shall ⌫ be: 

(cid:208) 2009/105/EC (adapted) 

(a) 

capable of being welded; 

(cid:208) 2009/105/EC 

ductile and tough, so that a rupture at minimum working temperature does not 

(b) 
give rise to either fragmentation or brittle-type fracture; 

(c) 

not adversely affected by ageing. 

(cid:208) 2009/105/EC (adapted) 

For steel vessels, the materials must ⌦ shall ⌫ in addition meet the requirements set out in 
point 1.1.1 and, for aluminium or aluminium alloy vessels, those set out in point 1.1.2. 

They  must  ⌦ shall ⌫  be  accompanied  by  an  inspection  slip  as  described  in  point  1.3. 
of Annex II, drawn up by the producer ⌦ manufacturer ⌫ of the materials. 

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1.1.1. Steel vessels 

Non-alloy quality steels shall meet the following requirements: 

(cid:208) 2009/105/EC 

(cid:208) 2009/105/EC (adapted) 

(a) 

(b) 

they  must  ⌦ shall ⌫  be  non-effervescent  and  supplied  after  normalisation 
treatment, or in an equivalent state; 

the content per product of carbon must ⌦ shall ⌫ be less than 0,25 % and that of 
sulphur and phosphorus must ⌦ shall ⌫ each be less than 0,05 %; 

(c) they must ⌦ shall ⌫ have the following mechanical properties per product: 

(i) the maximum tensile strength Rm,max must ⌦ shall ⌫ be less than 580 N/mm2,; 

(ii) the elongation after rupture must ⌦ fracture shall ⌫ be: 

if test pieces are taken parallel to the direction of rolling: 

(cid:208) 2009/105/EC 

thickness ≥ 3 mm:  A 

≥ 22 %, 

thickness < 3 mm:  A80 mm 

≥ 17 %, 

if test pieces are taken perpendicular to the direction of rolling: 

thickness ≥ 3 mm:  A 

≥ 20 %, 

thickness < 3 mm:  A80 mm 

≥ 15 %, 

(cid:208) 2009/105/EC (adapted) 

(iii)  the  average  failure  ⌦ bending  rupture ⌫  energy  KCV  for  three  longitudinal 
test pieces at minimum working temperature must ⌦ shall ⌫ not be less than 
35 J/cm2.  Not  more  than  one  of  the  three  figures  may  be  less  than  35 J/cm2, 
with a minimum of 25 J/cm2. 

In the case of steels used in the manufacture of vessels the minimum working temperature of 
which is lower than -10 °C and the wall thickness of which exceeds 5 mm, this property must 
⌦ shall ⌫ be checked. 

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1.1.2. Aluminium vessels 

Non-alloy aluminium must ⌦ shall ⌫ have an aluminium content of at least 99,5 % and the 
alloys  referred  to  in  Article  1(3)(a)  1(1)(b)  must ⌦ shall ⌫  display  adequate  resistance  to 
intercrystalline corrosion at maximum working temperature. 

Moreover, these materials must ⌦ shall ⌫ satisfy the following requirements: 

(a) they must ⌦ shall ⌫ be supplied in an annealed state; and 

(b) they must ⌦ shall ⌫ have the following mechanical characteristics per product: 

– 

the  maximum  tensile  strength  Rm,max  must  ⌦ shall ⌫  be  no  more  than 
350 N/mm2,; 

– 

the elongation after rupture must ⌦ fracture shall ⌫ be: 

(cid:208) 2009/105/EC 

– 

– 

A ≥ 16 % if the test piece is taken parallel to the direction of rolling,; 

A ≥ 14 %  if  the  test  piece  is  taken  perpendicular  to  the  direction  of 
rolling. 

1.2. Welding materials 

The welding materials used to manufacture the welds on or of the simple pressure vessel must 
⌦ shall ⌫ be appropriate to and compatible with the materials to be welded. 

(cid:208) 2009/105/EC (adapted) 

1.3. Accessories contributing to the strength of the vessel 

These  accessories  (for  example  bolts  and  nuts)  must  ⌦ shall ⌫  be  made  of  a  material 
specified in point 1.1 or of other kinds of steel, aluminium or an appropriate aluminium alloy 
compatible with materials used for the manufacture of pressurised parts. 

The latter materials must ⌦ shall ⌫ at minimum working temperature have an appropriate 
elongation after rupture ⌦ fracture ⌫ and toughness ⌦ bending rupture energy ⌫ . 

1.4. Non-pressurised parts 

All  unpressurised  parts  of  welded  vessels  must  ⌦ shall ⌫  be  of  materials  which  are 
compatible with that of the components to which they are welded. 

2. VESSEL DESIGN 

(a) 

The  manufacturer  must  ⌦ shall ⌫,  when  designing  the  vessel,  define  the  use  to 
which it will be put, and select: 

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(cid:208) 2009/105/EC 

(a)(i) the minimum working temperature Tmin; 

(b)(ii) the maximum working temperature Tmax; 

(c)(iii) the maximum working pressure PS. 

However, should a minimum working temperature exceeding -10 °C be selected, the qualities 
required of the materials must ⌦ shall ⌫ be satisfied at -10 °C. 

(b) 

The manufacturer must ⌦ shall ⌫ also take account of the following provisions: 

(cid:208) 2009/105/EC (adapted) 

(i) 

it must ⌦ shall ⌫ be possible to inspect the inside of vessels; 

(ii) 

it must ⌦ shall ⌫ be possible to drain the vessels; 

(iii) 

the mechanical qualities must ⌦ shall ⌫ be maintained throughout the period 
of use of the vessel for the intended purpose; 

(iv) 

the  vessels  must  ⌦ shall ⌫,  bearing  in  mind  their  prescribed  use,  be 
adequately protected against corrosion,; 

and ⌦ (c) 

The manufacturer shall take account of ⌫ the fact that under the conditions of 

use envisaged: 

(i) 

the vessels must ⌦ shall ⌫ not be subjected to stresses likely to impair their 
safety in use; 

(ii) 

internal  pressure  must  ⌦ shall ⌫  not  permanently  exceed  the  maximum 
working pressure PS. However, it may momentarily do so by up to 10 %. 

Circular ⌦ (d) Circumferential ⌫ and longitudinal seams must ⌦ shall ⌫ be made using 
full  penetration  welds  or  welds  of  equivalent  effectiveness.  Convex  ends  other  than 
hemispherical ones must ⌦ shall ⌫ have a cylindrical edge. 

2.1. Wall thickness 

If  the  product  of  PS × V  is  not  more  than  3000  bar.L,  the  manufacturer  must  ⌦ shall ⌫ 
select  one  of  the  methods  described  in  points  2.1.1  and  2.1.2  for  determining  vessel  wall 
thickness;  if  the  product  of  PS × V  is  more  than  3000  bar.L,  or  if  the  maximum  working 
temperature exceeds 100 °C, such thickness must ⌦ shall ⌫ be determined by the method 
described in point 2.1.1. 

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The actual wall thickness of the cylindrical section and ends shall, however, be not less than 
2 mm  in  the  case  of  steel  vessels  and  not  less  than  3  mm  in  the  case  of  aluminium  or 
aluminium alloy vessels. 

(cid:208) 2009/105/EC 

2.1.1. Calculation method 

(cid:208) 2009/105/EC (adapted) 
(cid:214) new 

The minimum thickness of pressurised parts must ⌦ shall ⌫ be calculated having regard to 
the intensity of the stresses and to the following provisions: 

(a) 

(b) 

the calculation pressure to be taken into account must ⌦ shall ⌫ not be less than 
the maximum working pressure PS selected; 

the permissible general membrane stress must ⌦ shall ⌫ not exceed the lower of 
the values 0,6 ReT or 0,3 Rm. The manufacturer must ⌦ shall ⌫ use the ReT and Rm 
minimum values guaranteed by the material manufacturer in order to determine the 
permissible stress. 

However, where the cylindrical portion of the vessel has one or more longitudinal welds made 
using  a  non-automatic  welding  process,  the  thickness  calculated  as  referred  to  in  the  first 
paragraph must ⌦ shall ⌫ be multiplied by the coefficient 1,15. 

2.1.2. Experimental method 

Wall thickness must ⌦ shall ⌫ be so determined as to enable the vessels to resist at ambient 
temperature  a  pressure  equal  to  at  least  five  times  the  maximum  working  pressure,  with  a 
permanent circumferential deformation factor of no more than 1 %. 

3. MANUFACTURING PROCESSES 

Vessels shall be constructed and subjected to production checks in accordance with the design 
and manufacturing record referred to in points (cid:214) 2,  3 (cid:214) or 4  of Annex II. 

3.1. Preparation of the component parts 

Preparation of the component parts (for example forming and chamfering) must ⌦ shall ⌫ 
not give rise to surface defects or cracks or changes in the mechanical characteristics likely to 
be detrimental to the safety of the vessels. 

3.2. Welds on pressurised parts 

The characteristics of welds and adjacent zones must ⌦ shall ⌫ be similar to those of the 
welded materials and must ⌦ shall ⌫ be free of any surface or internal defects detrimental 
to the safety of the vessels. 

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Welds  must  ⌦ shall ⌫  be  performed  by  qualified  welders  or  operators  possessing  the 
appropriate  level  of  competence,  in  accordance  with  approved  welding  processes.  Such 
approval  and  qualification  tests  must  ⌦ shall ⌫  be  carried  out  by  approved  inspection 
⌦ notified ⌫ bodies. 

The manufacturer must ⌦ shall ⌫ also, during manufacture, ensure consistent weld quality 
by conducting appropriate tests using adequate procedures. These tests must ⌦ shall ⌫ be 
the subject of a report. 

4. PUTTING INTO SERVICE OF THE VESSELS 

Vessels must ⌦ shall ⌫ be accompanied by the instructions drawn up by the manufacturer, 
as referred to in point 2 of Annex III. 

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ANNEX II 

⌦ CONFORMITY ASSESSMENT PROCEDURES ⌫ 

⌦ 1.  EU-TYPE EXAMINATION MODULE B ⌫  

⌦ 1.1. 
EU-type  examination  is  the  part  of  a  conformity  assessment  procedure  in 
which notified body examines the technical design of a vessel and verifies and attests that the 
technical design of the vessel meets the requirements of this Directive that apply to it. ⌫ 

(cid:216) new 

1.2. 

EU-type examination may be carried out in either of the following manners: 

– 

– 

examination of a prototype vessel, representative of the production envisaged, of the 
complete vessel (production type); 

assessment of the adequacy of the technical design of the vessel through examination 
of  the  technical  documentation  and  supporting  evidence  referred  to  in  point  3, 
without examination of a prototype vessel (design type). 

(cid:208) 2009/105/EC (adapted) 

⌦ 1.3. 
The application for EU-type examination shall be lodged by the manufacturer 
or by his authorised representative with a single notified body in respect of a prototype vessel 
or of a prototype representing a family of vessels. ⌫ 

⌦ The  manufacturer  shall  lodge  an  application  for  EU-type  examination  with  a  single 
notified body of his choice. ⌫ 

⌦ The application shall include: ⌫ 

⌦ (a) 

the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by 
the authorised representative, his name and address as well; ⌫ 

(cid:216) new 

(b) 

(c) 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other 
notified body; 

the technical documentation. The technical documentation shall make it possible to 
assess the vessel's conformity with the applicable requirements of this Directive and 
shall include an adequate analysis and assessment of the risk(s).  

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The technical documentation shall specify the applicable requirements and cover, as 
far  as  relevant  for  the  assessment,  the  design,  manufacture  and  operation  of  the 
vessel.  The  technical  documentation  shall  contain,  wherever  applicable,  at  least  the 
following elements: 

(i) 

a general description of the vessel; 

(ii) 

conceptual  design  and  manufacturing  drawings  of  the  type  and  schemes  of 
components, etc.; 

(iii)  descriptions  and  explanations  necessary  for  the  understanding  of  those 

drawings and schemes and the operation of the product; 

(iv)  a list of the harmonised standards the references of which have been published 
in  the  Official  Journal  of  the  European  Union,  applied  in  full  or  in  part,  and 
descriptions of the solutions adopted to meet the essential safety requirements 
of this Directive where those harmonised standards have not been applied. In 
the event of partly applied harmonised standards, the technical documentation 
shall specify the parts which have been applied; 

(v) 

results of design calculations made, examinations carried out, etc.; 

(vi) 

test reports; 

(vii)  the prototype vessels representative of the production envisaged. The notified 
body may request further prototype vessels if needed for carrying out the test 
programme; 

(viii)  the supporting evidence for the adequacy of the technical design solution. This 
supporting  evidence  shall  mention  any  documents  that  have  been  used,  in 
particular  where  the  relevant  harmonised  standards  have  not  been  applied  in 
full. The supporting evidence shall include, where necessary, the results of tests 
carried  out  by  the  appropriate  laboratory  of  the  manufacturer,  or  by  another 
testing laboratory on his behalf and under his responsibility. 

(cid:208) 2009/105/EC (adapted) 

⌦ (ix) 

the instructions; ⌫ 

⌦ (x) 

a document describing: ⌫ 

–  ⌦ the materials selected; ⌫ 

–  ⌦ the welding processes selected; ⌫ 

–  ⌦ the checks selected; ⌫ 

–  ⌦ any pertinent details as to the vessel design. ⌫ 

⌦ When a prototype vessel is examined, the technical documentation shall also include: ⌫ 

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– 

– 

– 

⌦ the certificates relating to the suitable qualification of the welding operations and 
of the welders or welding operators; ⌫ 

⌦ the  inspection  slip  for  the  materials  used  in  the  manufacture  of  parts  and 
components contributing to the strength of the vessel; ⌫ 

⌦ a report on the examinations and tests performed or a description of the proposed 
checks. ⌫ 

1.4. The notified body shall:  

For the vessel: 

(cid:216) new 

1.4.1. examine the technical documentation and supporting evidence to assess the adequacy of 
the technical design of the vessel. 

For the prototype vessel(s):  

1.4.2.  verify  that  the  prototype  vessels  have  been  manufactured  in  conformity  with  the 
technical documentation that it may safely be used under its intended working conditions and 
identify the elements which have been designed in accordance with the applicable provisions 
of  the  relevant  harmonised  standards,  as  well  as  the  elements  which  have  been  designed 
without applying the relevant provisions of those standards; 

1.4.3.  carry  out  appropriate  examinations  and  tests,  or  have  them  carried  out,  to  check 
whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised 
standards, these have been applied correctly; 

1.4.4.  carry  out  appropriate  examinations  and  tests,  or  have  them  carried  out,  to  check 
whether, where the solutions in the relevant harmonised standards have not been applied, the 
solutions  adopted  by  the  manufacturer  meet  the  corresponding  essential  safety  requirements 
of this Directive; 

1.4.5.  agree  with  the  manufacturer  on  a  location  where  the  examinations  and  tests  will  be 
carried out. 

1.5. 
The  notified  body  shall  draw  up  an  evaluation  report  that  records  the  activities 
undertaken  in  accordance  with  point  1.4  and  their  outcomes.  Without  prejudice  to  its 
obligations vis-à-vis the notifying authorities, the notified body shall release the content of the 
report, in full or in part, only with the agreement of the manufacturer. 

1.6.  Where the type meets the requirements of this Directive, the notified body shall issue 
an EU-type examination certificate to the manufacturer. The certificate shall contain the name 
and address of the manufacturer, the conclusions of the examination, the conditions (if any) 
for its validity and the necessary data for identification of the approved type. The certificate 
may have one or more annexes attached. 

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The certificate and its annexes shall contain all relevant information to allow the conformity 
of  manufactured  vessels  with  the  examined  type to be  evaluated and to  allow for  in-service 
control.  It  shall  also  indicate  any  conditions  to  which  its  issue  may  be  subject  and  be 
accompanied  by  the  descriptions  and  drawings  necessary  for  identification  of  the  approved 
type. 

Where  the  type  does  not  satisfy  the  applicable  requirements  of  this  Directive,  the  notified 
body shall refuse to issue an EU-type examination certificate and shall inform the applicant 
accordingly, giving detailed reasons for its refusal. 

1.7.  The  notified  body  shall  keep  itself  apprised  of  any  changes  in  the  generally 
acknowledged  state  of  the  art  which  indicate that  the  approved  type  may  no  longer  comply 
with the applicable requirements of this Directive, and shall determine whether such changes 
require  further  investigation.  If  so,  the  notified  body  shall  inform  the  manufacturer 
accordingly. 

The  manufacturer  shall  inform  the  notified  body  that  holds  the  technical  documentation 
relating to the EU-type examination certificate of all modifications to the approved type that 
may affect the conformity of the vessel with the essential safety requirements of this Directive 
or  the  conditions  for  validity  of  the  certificate.  Such  modifications  shall  require  additional 
approval in the form of an addition to the original EU-type examination certificate. 

1.8. Each notified body shall immediately inform its notifying authorities concerning the EU-
type examination certificates and/or any additions thereto which it has issued or withdrawn, 
and shall, periodically or upon request, make available to its notifying authorities the list of 
certificates and/or any additions thereto refused, suspended or otherwise restricted. 

The Commission, the Member States and the other notified bodies may, on request, obtain a 
copy  of  the  EU-type  examination  certificates  and/or  additions  thereto.  On  request,  the 
Commission  and  the  Member  States  may  obtain  a  copy  of  the  technical  documentation  and 
the results of the examinations carried out by the notified body. The notified body shall keep a 
copy  of  the  EU-type  examination  certificate,  its  annexes  and  additions,  as  well  as  the 
technical file including the documentation submitted by the manufacturer, until the expiry of 
the validity of the certificate. 

1.9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes 
and  additions  together  with  the  technical  documentation  at  the  disposal  of  the  national 
authorities for 10 years after the vessel has been placed on the market. 

1.10.  The  manufacturer's  authorised  representative  may  lodge  the  application  referred  to  in 
point  1.3  and  fulfil  the  obligations  set  out  in  points  1.7  and  1.9,  provided  that  they  are 
specified in the mandate. 

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⌦ 2.  CONFORMITY  TO  TYPE  BASED  ON  INTERNAL  PRODUCTION  CONTROL  PLUS 

SUPERVISED PRODUCT TESTING (MODULE C1) ⌫ 

(cid:208) 2009/105/EC (adapted) 

(cid:216) new 

2.1.  Conformity  to  type  based  on  internal  production  control  is  the  part  of  a  conformity 
assessment  procedure  whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  points 
2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the vessels concerned 
are in conformity with the type described in the EU-type examination certificate and satisfy 
the requirements of this Directive that apply to them. 

2.2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring  to  ensure  conformity  of  the  manufactured  vessels  with  the  approved  type 
described in the EU-type examination certificate and with the requirements of this Directive 
that apply to them.  

2.3. 

Product checks  

2.3.1.  For  each  individual  vessel  manufactured  one  or  more  tests  on  one  or  more  specific 
aspects  of  the  vessel  shall  be  carried  out  by  the  manufacturer  or  on  his  behalf,  in  order  to 
verify conformity with the type described in the EU-type examination certificate and with the 
corresponding  requirements  of  this  Directive.  The  tests  shall  be  carried  out  under  the 
responsibility of a notified body, chosen by the manufacturer. 

The manufacturer shall, under the responsibility of the notified body, affix the notified body’s 
identification number during the manufacturing process. 

(cid:208) 2009/105/EC (adapted) 

⌦ 2.3.2. The notified body shall carry out the appropriate examinations and tests in order to 
check  the  conformity  of  the  vessels  with  the  requirements  of  this  Directive  by  examination 
and testing of vessels in accordance with the following paragraphs: ⌫ 

⌦ (a)  The manufacturer shall present his vessels in the form of uniform batches and shall 
take  all  necessary  measures  in  order  that  the  manufacturing  process  ensures  the 
uniformity of each batch produced. ⌫ 

⌦ (b)  Those batches shall be accompanied by the EU-type examination certificate. ⌫ 

⌦ (c)  When a batch is examined, the notified body shall ensure that the vessels have been 
manufactured and checked in accordance with the technical documentation, and shall 
perform a hydrostatic test or a pneumatic test of equivalent effect on each vessel in 

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the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in order to 
check its strength. The pneumatic test shall be subject to acceptance of the test safety 
procedures by the Member State in which the test is performed. ⌫ 

⌦ (d)  Moreover,  the  notified body  shall  carry  out  tests  on  test-pieces  taken  from  a 
representative production test-piece or from a vessel, as the manufacturer chooses, in 
order  to  examine  the  weld  quality.  The  tests  shall  be  carried  out  on  longitudinal 
welds.  However,  where  differing  weld  techniques  are  used  for  longitudinal  and 
circumferential welds, the tests shall be repeated on the circumferential welds. ⌫ 

⌦ (e)  For the vessels referred to in point 2.1.2 of Annex I, these tests on test-pieces shall be 
replaced  by  a  hydrostatic  test  on  five  vessels  taken  at  random  from  each  batch  in 
order to check that they conform to the essential safety requirements set out in point 
2.1.2 of Annex I. ⌫ 

⌦ (f) 

In  the  case  of  accepted  batches,  the  notified body  shall  affix  its  identification 
number,  or  cause  that  number  to  be  affixed,  to  each  vessel  and  shall  draw  up  a 
written  certificate  of  conformity  relating  to  the  tests  carried  out.  All  vessels  in  the 
batch  may  be  placed  on  the  market  except  for  those  which  have  not  successfully 
undergone a hydrostatic test or a pneumatic test. ⌫ 

⌦ (g)  If a batch is rejected, the notified body shall take appropriate measures to prevent the 
placing on the market of that batch. In the event of frequent rejection of batches, the 
notified body may suspend the statistical verification. ⌫ 

⌦ (h)  The manufacturer shall be able to supply on request the notified body’s certificates of 

conformity referred to in the seventh subparagraph (f). ⌫ 

⌦ 2.4. CE marking and declaration of conformity ⌫ 

(cid:216) new 

2.4.1. The manufacturer shall affix the CE marking set out in this Directive to each individual 
vessel that is in conformity with the type described in the EU-type examination certificate and 
satisfies the applicable requirements of this Directive. 

2.4.2. The manufacturer shall draw up a written declaration of conformity for a vessel model 
and  keep  it  at  the  disposal  of  the  national  authorities  for  10  years  after  the  vessel  has  been 
placed on the market. The declaration of conformity shall identify the vessel model for which 
it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

2.5. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  2.4  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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3. 

CONFORMITY  TO  TYPE  BASED  ON  INTERNAL  PRODUCTION  CONTROL  PLUS 
SUPERVISED VESSEL CHECKS AT RANDOM INTERVALS (MODULE C2) 

3.1. Conformity to type based on internal production control plus supervised vessel checks at 
random intervals is the part of a conformity assessment procedure whereby the manufacturer 
fulfils  the  obligations  laid  down  in  points  3.2,  3.3  and  3.4,  and  ensures  and  declares  on  his 
sole responsibility that the vessels concerned are in conformity with the type described in the 
EU-type  examination  certificate  and  satisfy  the  requirements  of  this  Directive  that  apply  to 
them. 

3.2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure conformity of the manufactured vessels with the type described in the EU-
type examination certificate and with the requirements of this Directive. 

⌦ 3.2.1.  Before  commencing  manufacture,  the  manufacturer  shall  send  the  notified body  a 
document  describing  the  manufacturing  processes  and  all  of  the  predetermined  systematic 
measures taken to ensure conformity of the vessels to the EU-type examination certificate. ⌫ 

(cid:208) 2009/105/EC (adapted)  

⌦ 3.2.2. The document shall include: ⌫ 

⌦ (a)  a  description  of  the  means  of  manufacture  and  checking  appropriate  to  the 

construction of the vessels; ⌫ 

⌦ (b)  an  inspection  document  describing  the  appropriate  examinations  and  tests  to  be 
carried out during manufacture, together with the procedures in respect thereof and 
the frequency with which they are to be performed; ⌫ 

⌦ (c)  an  undertaking  to  carry  out  the  examinations  and  tests  in  accordance  with  the 
inspection document and to have a hydrostatic test or, subject to the agreement of the 
Member  State,  a  pneumatic  test  carried  out  on  each  vessel  manufactured  at  a  test 
pressure equal to 1,5 times the design pressure; ⌫ 

⌦ those  examinations  and  tests  shall  be  carried  out  under  the  responsibility  of 
qualified staff who are sufficiently independent from production personnel, and shall 
be the subject of a report; ⌫ 

⌦ (d) 

the  addresses  of  the  places  of  manufacture  and  storage  and  the  date  on  which 
manufacture is to commence. ⌫ 

3.3. Vessel checks 

(cid:216) new 

A  notified  body,  chosen  by  the  manufacturer,  shall  carry  out  vessel  checks  or  have  them 
carried out at appropriate intervals determined by the body, in order to verify the quality of 

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the internal checks on the vessel, taking into account, inter alia, the technological complexity 
of the vessels and the quantity of production. An adequate sample of the final vessels, taken 
on  site  by  the  notified  body  before  the  placing  on  the  market,  shall  be  examined  and 
appropriate tests as identified by the relevant parts of the harmonised standards or equivalent 
tests, shall be carried out to check the conformity of the vessel with the type described in the 
EU-type examination certificate and with the relevant requirements of this Directive.  

(cid:208) 2009/105/EC (adapted) 

⌦ The notified body shall also ensure that the manufacturer actually checks series-produced 
vessels in accordance with point 3.2 c); ⌫ 

⌦ The manufacturer  shall  provide  the  notified  body with  all  necessary  information,  and  in 
particular: ⌫ 

⌦ (a) 

the technical documentation; ⌫ 

⌦ (b) 

the inspection report; ⌫ 

⌦ (c) 

the EU-type examination certificate; ⌫  

⌦ (d)  a report on the examinations and tests carried out. ⌫ 

⌦ The  notified body  shall  supply  the  Member  State  which  notified it  and,  on  request,  the 
other  notified  bodies,  the  other  Member  States  and  the  Commission,  with  a  copy  of  the 
inspection report. ⌫ 

(cid:216) new 

Where  a  sample  does  not  comply  with  the  acceptable  quality  level,  the  body  shall  take 
appropriate measures. 

The  acceptance  sampling  procedure  to  be  applied  is  intended  to  determine  whether  the 
manufacturing  process  of  the  vessel  performs  within  acceptable  limits,  with  a  view  to 
ensuring conformity of the vessel. 

Where  the  tests  are  carried  out  by  notified  body,  the  manufacturer  shall,  under  the 
responsibility of the notified body, affix the notified body's identification number during the 
manufacturing process. 

3.4. CE marking and declaration of conformity 

3.4.1. The manufacturer shall affix the CE marking set out in this Directive to each individual 
vessel that is in conformity with the type described in the EU-type examination certificate and 
satisfies the applicable requirements of this Directive. 

3.4.2. The manufacturer shall draw up a written declaration of conformity for a vessel model 
and  keep  it  at  the  disposal  of  the  national  authorities  for  10  years  after  the  vessel  has  been 

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placed on the market. The declaration of conformity shall identify the vessel model for which 
it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

A  copy  of  the  declaration  shall  be  supplied  with  each  vessel  that  is  placed  on  the  market. 
However,  this  requirement  may  be  interpreted as  applying  to  a  batch  or  consignment  rather 
than individual vessels in those cases where a large number of vessels is delivered to a single 
user. 

3.5. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  3.4  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

4. 

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C) 

4.1.  Conformity  to  type  based  on  internal  production  control  is  the  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2 
and 4.3, and ensures and declares that the vessels concerned are in conformity with the type 
described in the EU-type examination certificate and satisfy the requirements of this Directive 
that apply to them. 

4.2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure conformity of the manufactured vessels with the approved type described 
in the EU-type examination certificate and with the requirements of this Directive that apply 
to them. 

Before commencing manufacture, the manufacturer shall send the notified body which issued 
the EU-type examination certificate a document describing the manufacturing processes and 
all of the predetermined systematic measures taken to ensure conformity of the vessels to the 
EU-type examination certificate. 

(cid:208) 2009/105/EC (adapted) 

⌦ The document shall include: ⌫ 

⌦ (a)  a  description  of  the  means  of  manufacture  and  checking  appropriate  to  the 

construction of the vessels; ⌫ 

⌦ (b)  an  inspection  document  describing  the  appropriate  examinations  and  tests  to  be 
carried out during manufacture, together with the procedures in respect thereof and 
the frequency with which they are to be performed; ⌫ 

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⌦ (c)  an  undertaking  to  carry  out  the  examinations  and  tests  in  accordance  with  the 
inspection document and to have a hydrostatic test or, subject to the agreement of the 
Member  State,  a  pneumatic  test  carried  out  on  each  vessel  manufactured  at  a  test 
pressure equal to 1,5 times the design pressure; ⌫ 

⌦ those  examinations  and  tests  shall  be  carried  out  under  the  responsibility  of 
qualified  staff  who  are  independent  from  production  personnel,  and  shall  be  the 
subject of a report; ⌫ 

⌦ (d) 

the  addresses  of  the  places  of  manufacture  and  storage  and  the  date  on  which 
manufacture is to commence. ⌫ 

⌦ The notified body which issued the EU-type examination certificate shall, before the date 
on which any manufacture begins, examine the document referred to in point 4.2 in order to 
certify its conformity with the EU-type examination certificate. ⌫ 

4.3. CE marking and declaration of conformity 

(cid:216) new 

4.3.1.  The  manufacturer  shall  affix  the  CE  marking  to  each  individual  vessel  that  is  in 
conformity  with  the  type  described  in  the  EU-type  examination  certificate  and  satisfies  the 
applicable requirements of this Directive. 

4.3.2. The manufacturer shall draw up a written declaration of conformity for a vessel model 
and  keep  it  at  the  disposal  of  the  national  authorities  for  10  years  after  the  vessel  has  been 
placed on the market. The declaration of conformity shall identify the vessel model for which 
it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

A  copy  of  the  declaration  shall  be  supplied  with  each  vessel  that  is  placed  on  the  market. 
However,  this  requirement  may  be  interpreted as  applying  to  a  batch  or  consignment  rather 
than individual vessels in those cases where a large number of vessels is delivered to a single 
user. 

4.4. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  4.3  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

(cid:208) 2009/105/EC (adapted) 

ANNEX III 

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‘CE’  MARKING, 

INSCRIPTIONS, 

INSTRUCTIONS, 

DESIGN 

AND 

MANUFACTURE SCHEDULES, DEFINITIONS AND SYMBOLS 

1. ‘CE’ ⌦ CE ⌫ MARKING AND INSCRIPTIONS  

1.1.‘CE’ marking 

The ‘CE’ marking shall consist of the initials ‘CE’ in the following form:  

(cid:208) 2009/105/EC 

If the ‘CE’ marking is reduced or enlarged the proportions given in the graduated drawing set 
out in this point must be respected. 

The  various  components  of  the  ‘CE’  marking  must  have  substantially  the  same  vertical 
dimension, which may not be less than 5 mm. 

Vessels of which the product of PS x V exceeds 50 bar.L must bear the CE marking referred 
to in Articles 15 and 16.  

(cid:216) new 

(cid:208) 2009/105/EC (adapted) 

1.2.Inscriptions 

⌦ In addition to the CE marking and to the labelling requirements referred to in Article 6, 
paragraphs 5 and 6, ⌫ Tthe vessel or ⌦ its ⌫ data plate must ⌦ shall ⌫ bear at least the 
following information: 

(a) 

the maximum working pressure (PS in bar); 

(b) 

the maximum working temperature (Tmax in °C); 

(cid:208) 2009/105/EC  

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(c) 

the minimum working temperature (Tmin in °C); 

(d) 

the capacity of the vessel (V in lL); 

(e) the name or mark of the manufacturer; 

(f) the type and serial or batch identification of the vessel; 

the  last  two  digits  of  the  year  in  which  the  ‘CE’  ⌦ CE ⌫  marking  was 

(ge) 
affixed. 

(cid:208) 2009/105/EC (adapted) 

Where the data plate is used, it must ⌦ shall ⌫ be so designed that it cannot be reused and 
must ⌦ shall ⌫ include a vacant space to enable other information to be provided. 

(cid:208) 2009/105/EC (adapted) 

2. INSTRUCTIONS ⌦ AND SAFETY INFORMATION ⌫ 

The instructions must ⌦ shall ⌫ contain the following information: 

(cid:208) 2009/105/EC 

(a) 

the particulars given in point 1 except for the vessel’s serial identification; 

(b) 

the intended use of the vessel; 

(c) 

the maintenance and installation requirements for vessel safety. 

They  must  be  in  the  official  language  or  languages  of  the  country ⌦ Member  State ⌫  of 
destination. 

(cid:208) 2009/105/EC (adapted) 

3. DESIGN AND MANUFACTURING SCHEDULES 

(cid:208) 2009/105/EC 

The  design  and  manufacturing  schedules  must  contain  a  description  of  the  techniques  and 
operations employed in order to meet the essential safety requirements set out in Annex I or 
the harmonised standards referred to in Article 5(1), and in particular: 

(a) a detailed manufacturing drawing of the vessel type; 

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(b) the instructions; 

(c) a document describing: 

the materials selected, 

the welding processes selected, 

the checks selected, 

any pertinent details as to the vessel design. 

When  the  procedures  laid  down  in  Articles  11  to  14  are  applied,  the  schedule  must  also 
include: 

(a)  the  certificates  relating  to  the  suitable  qualification  of  the  welding 

operations and of the welders or operators; 

(b)  the  inspection  slip  for  the  materials  used  in  the  manufacture  of  parts  and 

assemblies contributing to the strength of the pressure vessel; 

(c)  a  report  on  the  examinations  and  tests  performed  or  a  description  of  the 

proposed checks. 

43. DEFINITIONS AND SYMBOLS 

43.1.Definitions 

(a) 

(b) 

(c) 

(d) 

The design pressure ‘P’ is the gauge pressure chosen by the manufacturer and used to 
determine the thickness of the vessel’s pressurised parts. 

The maximum working pressure ‘PS’ is the maximum gauge pressure which may be 
exerted under normal conditions of use of the vessel. 

The  minimum  working  temperature  Tmin  is  the  lowest  stabilised  temperature  which 
the wall of the vessel may attain under normal conditions of use. 

The maximum working temperature Tmax is the highest stabilised temperature which 
the wall of the vessel may attain under normal conditions of use. 

(e) 

The  yield  strength  ‘ReT’  is  the  value  at  the  maximum  working  temperature  Tmax  of 
⌦ any of the following ⌫ : 

(cid:208) 2009/105/EC (adapted) 

(i) 

the upper yield point ReH, for a material with both a lower and an upper yield 
point,; 

(cid:208) 2009/105/EC 

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(cid:208) 2009/105/EC (adapted) 

(ii) 

the ⌦ 0,2% ⌫ proof stress ⌦ strength ⌫ Rp0,2 ,; or 

(iii) 

the  ⌦ 1,0% ⌫  proof  stress  ⌦ strength ⌫  Rp1,0  in  the  case  of  non-alloy 
aluminium. 

(f) 

Families of vessels: 

(cid:208) 2009/105/EC 

Vessels  form  part  of  the  same  family  if  they  differ  from  the  prototype  only  in  diameter, 
provided that the permissible requirements referred to in points 2.1.1 and 2.1.2 of Annex I are 
complied with, and/or in the length of their cylindrical portion within the following limits: 

(cid:208) 2009/105/EC (adapted) 

(i)  where a prototype has one or more shell rings in addition to the ends, variants 

must ⌦ shall ⌫ have at least one shell ring,; 

(ii)  where a prototype has just two dished ends, variants must ⌦ shall ⌫ have no 

shell rings. 

Variations  in  length  causing  the  apertures  and/or  penetrations  to  be  modified  must ⌦ shall 
⌫ be shown in the drawing for each variant. 

(cid:208) 2009/105/EC 

(g) 

(h) 

(i) 

A batch of vessels consists at the most of 3000 vessels of the model of the same type. 

There  is  series  manufacture  within  the  meaning  of  this  Directive  if  more  than  one 
vessel  of  the  same  type  is  manufactured  during  a  given  period  by  a  continuous 
manufacturing  process,  in  accordance  with  a  common  design  and  using  the  same 
manufacturing processes. 

Inspection slip: document by which the producer certifies that the products delivered 
meet the requirements of the order and in which he sets out the results of the routine 
in-plant  inspection  test,  in  particular  chemical  composition  and  mechanical 
characteristics  performed  on  products  made  by  the  same  production  process  as  the 
supply, but not necessarily on the products delivered. 

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43.2.Symbols 

(cid:208) 2009/105/EC (adapted) 

A 

A80 mm 

elongation after rupture ⌦ fracture ⌫ (Lo = 
5,65√So) 

elongation after rupture ⌦ fracture ⌫ (Lo = 
80 mm) 

KCV 

⌦ bending ⌫ rupture energy 

design pressure 

maximum working pressure 

hydrostatic or pneumatic test pressure 

⌦ 0,2% ⌫ proof stress ⌦ strength ⌫ at 0,2 %  N/mm2 

yield strength at maximum working temperature  N/mm2 

P 

PS 

Ph 

Rp0,2 

ReT 

ReH 

Rm 

upper yield point 

tensile strength 

Rm, max 

maximum tensile strength 

% 

% 

J/cm2 

Bar 

Bar 

Bar 

N/mm2 

N/mm2 

N/mm2 

Rp1,0 

Tmax 

Tmin 

V 

⌦ 1,0% ⌫ proof stress ⌦ strength ⌫ at 1,0 %  N/mm2 

maximum working temperature 

minimum working temperature 

capacity of the vessel 

°C 

°C 

lL 

(cid:208) 2009/105/EC 

ANNEX III 

MINIMUM CRITERIA TO BE MET BY MEMBER STATES FOR THE APPROVAL OF 

INSPECTION BODIES 

(referred to in Article 9(2)) 

1.  The  approved  inspection  body,  its  director  and  the  staff  responsible  for  carrying  out  the 
verification tests shall not be the designer, manufacturer, supplier or installer of vessels which 
they inspect, nor the authorised representative of any of those parties. They shall not become 

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directly  involved  in  the  design,  construction,  marketing  or  maintenance  of  the  vessels,  nor 
represent  the  parties  engaged  in  those  activities.  This  does  not  preclude  the  possibility  of 
exchanges  of  technical  information  between  the  manufacturer  and  the  approved  inspection 
body. 

2.  The  approved  inspection  body  and  its  staff  must  carry  out  the  verification  tests  with  the 
highest degree of professional integrity and technical competence and must be free from all 
pressures and inducements, particularly financial, which might influence their judgment or the 
results of the inspection, especially from persons or groups of persons with an interest in the 
result of verifications. 

3.  The  approved  inspection  body  must  have  at  its  disposal  the  necessary  staff  and  the 
necessary  facilities  to  enable  it  to  perform  properly  the  administrative  and  technical  tasks 
connected  with  verification;  it  must  also  have  access  to  the  equipment  required  for  special 
verification. 

4. The staff responsible for inspection must have: 

(a) sound technical and professional training; 

(b) satisfactory knowledge of the requirements of the tests they carry out and 

adequate experience of such tests; 

(c)  the  ability  to  draw  up  the  certificates,  records  and  reports  required  to 

authenticate the performance of the tests. 

5.  The  impartiality  of  inspection  staff  must  be  guaranteed.  Their  remuneration  must  not 
depend on the number of tests carried out or on the results of such tests. 

6.  The  approved  inspection  body  must  take  out  liability  insurance  unless  its  liability  is 
assumed by the State in accordance with national law, or the Member State itself is directly 
responsible for the tests. 

7.  The  staff  of  the  approved  inspection  body  is  bound  to  observe  professional  secrecy  with 
regard  to  all  information  gained  in  carrying  out  its  tasks  (except  vis-à-vis  the  competent 
administrative  authorities  of  the  State  in  which  its  activities  are  carried  out)  under  this 
Directive or any provision of national law giving effect to it. 

(cid:208) 2009/105/EC (adapted) 

ANNEX IV 

PART A 

Repealed Directive with list of its successive amendments 

(referred to in Article 19) 

Council Directive 87/404/EEC 

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(OJ L 220, 8.8.1987, p. 48) 

Council Directive 90/488/EEC 

(OJ L 270, 2.10.1990, p. 25) 

Council Directive 93/68/EEC 

(OJ L 220, 30.8.1993, p. 1) 

PART B 

Article 1, point 1, and Article 2 
only 

List of time limits for transposition into national law and application 

(referred to in Article 19) 

Directive 

Time limit for transposition  Date of application 

87/404/EEC 

31 December 1989 

1 July 199015 

90/488/EEC 

1 July 1991 

— 

93/68/EEC 

30 June 1994 

1 January 199516 

(cid:208) 2009/105/EC (adapted) 

ANNEX IV 

CORRELATION TABLE 

Directive 87/404/EEC ⌦ 2009/105/EC ⌫ 

This Directive 

Recital 5, fifth sentence 

Article 1(3), point (b) 

Article 1(1) 

Article 1(1) 

Article 1(2), first subparagraph 

Article 1(3), point (a), first 
subparagraph 

Article 1(2), second subparagraph, first indent 

Article 1(3), point (a), second 

15 

16 

In accordance with the third subparagraph of Article 18(2), Member States shall, for the period up to 1 
July 1992, permit the placing on the market and/or in service of vessels conforming to the rules in force 
in their territories before 1 July 1990. 
In  accordance  with  Article  14(2),  until  1  January  1997  Member  States  shall  allow  the  placing  on  the 
market and the bringing into service of products which comply with the marking arrangements in force 
before 1 January 1995. 

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subparagraph 

Article 1(2), second subparagraph, second indent, 
first and second sub-indents 

Article 1(3), point (a), third 
subparagraph, points (i) and (ii) 

Article 1(2), second subparagraph, third indent 

Article 1(2), second subparagraph, fourth indent 

Article 1(3), point (a), fourth 
subparagraph 

Article 1(3), point (a), fifth 
subparagraph 

Article 1(3), first, second and third indents 

Article 1(2), points (a), (b) and (c) 

Articles 2, 3 and 4 

Articles 2, 3 and 4 

Article 5(1) 

Article 5(2) 

Article 5(1) 

Article 5(2) 

Article 5(3), points (a) and (b) 

Article 5(3), first and second 
subparagraphs 

Article 6 

Article 7(1) 

Article 6 

Article 7(1) 

Article 7(2), first and second sentences 

Article 7(2), first subparagraph 

Article 7(2), third sentence 

Article 7(2), second subparagraph 

Article 7(3) 

Article 7(4) 

Article 7(3) 

Article 7(4) 

Article 8(1), introductory wording and point (a), 
introductory wording 

Article 8(1), introductory wording 

Article 8(1), point (a), first and second indents 

Article 8(1), points (a) and (b) 

Article 8(1), point (b) 

Article 8(2), point (a) 

Article 8(2) 

Article 8(3), point (a) 

Article 8(2), point (b), first and second indents 

Article 8(3), points (b)(i) and (ii) 

Article 8(3) 

Article 9 

Article 10(1) 

Article 8(4) 

Article 9 

Article 10(1) 

Article 10(2), first subparagraph 

Article 10(2), first subparagraph 

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Article 10(2), second subparagraph, first and 
second indents 

Article 10(2), second subparagraph, 
points (a) and (b) 

Article 10(2), third subparagraph 

Article 10(2), third subparagraph 

Article 10(3), first subparagraph 

Article 10(3), first subparagraph 

Article 10(3), second subparagraph 

Article 10(3), second subparagraph 

Article 10(3), third subparagraph, points (a) and (b)  Article 10(3), third subparagraph, 

Article 10(4) 

points (a) and (b) 

Article 10(4) 

Article 10(5), first sentence 

Article 10(5), first subparagraph 

Article 10(5), second and third sentences 

Article 10(5), second subparagraph 

Article 11(1) and (2) 

Article 11(1) and (2) 

Article 11(3), introductory wording 

Article 11(3), first subparagraph 

Article 11(3), point 3.1 

Article 11(3), point 3.2 

Article 11(3), second subparagraph 

Article 11(3), third subparagraph 

Article 11(3), point 3.3, first subparagraph 

Article 11(3), fourth subparagraph 

Article 11(3), point 3.3, second subparagraph 

Article 11(3), fifth subparagraph 

Article 11(3), point 3.3, third subparagraph 

Article 11(3), sixth subparagraph 

Article 11(3), point 3.4, first subparagraph 

Article 11(3), seventh subparagraph 

Article 11(3), point 3.4, second subparagraph 

Article 11(3), eighth subparagraph 

Article 11(3), point 3.4, third subparagraph 

Article 11(3), ninth subparagraph 

Article 11(3), point 3.5 

Article 11(3), tenth subparagraph 

Article 12(1), first subparagraph, first and second 
indents 

Article 12(1), points (a) and (b) 

Article 12(1), second subparagraph 

Article 12(2), first subparagraph 

Article 12(2) 

Article 12(2), second subparagraph 

Article 13(1), first subparagraph 

Article 13(1), second subparagraph 

Article 13(1) 

Article 13(2) 

Article 13(2), indents 1 to 4 

Article 13(3), points (a) to (d) 

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Article 14(1) 

Article 14, first paragraph 

Article 14(2), first subparagraph, first and second 
indents 

Article 14, second paragraph, points (a) 
and (b) 

Article 14(2), second subparagraph 

Article 14, third paragraph 

Articles 15, 16 and 17 

Articles 15, 16 and 17 

Article 18(1) 

Article 18(2) 

— 

— 

Article 19 

Annex I, point 1 

— 

Article 18 

Article 19 

Article 20 

Article 21 

Annex I, point 1. 

Annex I, point 1.1, first paragraph, first, second and 
third indents 

Annex I, point 1.1., first paragraph, 
points (a), (b) and (c) 

Annex I, point 1.1, second and third paragraphs 

Annex I, point 1.1., second and third 
paragraphs 

Annex I, points 1.1.1 and 1.1.2 

Annex I, points 1.1.1 and 1.1.2 

Annex I, points 1.2, 1.3 and 1.4 

Annex I, points 1.2, 1.3 and 1.4 

Annex I, point 2, first paragraph, first, second and 
third indents 

Annex I, point 2, first paragraph, points 
(a), (b) and (c) 

Annex I, point 2, second, third and fourth 
paragraphs 

Annex I, point 2, second, third and 
fourth paragraphs 

Annex I, points 2.1, 3 and 4 

Annex I, points 2.1, 3 and 4 

Annex II, point 1 

Annex II, point 1 

Annex II, point 1.a, first, second and third indents 

Annex II, point 1.b, first paragraph, indents 1 to 7 

Annex II, point 1.1, first, second and 
third paragraphs 

Annex II, point 1.2, first paragraph, 
points (a) to (g) 

Annex II, point 1.b, second paragraph 

Annex II, point 1.2, second paragraph 

Annex II, point 2, first paragraph, first, second and 
third indents 

Annex II, point 2, first paragraph, 
points (a), (b) and (c) 

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Annex II, point 2, second paragraph 

Annex II, point 2, second paragraph 

Annex II, point 3, first paragraph 

Annex II, point 3, first paragraph 

Annex II, point 3, second paragraph, points (i), (ii) 
and (iii) 

Annex II, point 3, second paragraph, 
points (a), (b) and (c) 

Annex II, point 4 

Annex II, point 4 

Annex III, points 1, 2 and 3 

Annex III, points 1, 2 and 3 

Annex III, point 4, first, second and third indents 

Annex III, point 4, points (a), (b) and 
(c) 

Annex III, points 5, 6 and 7 

Annex III, points 5, 6 and 7 

— 

— 

⌦ Article 1(1) ⌫ 

⌦ Article 1(2) ⌫ 

⌦ Article 1(3) (a) ⌫ 

⌦ Article 1(3) (b) ⌫ 

⌦ Article 2 ⌫ 

⌦ ___ ⌫ 

⌦ Article 3 ⌫ 

⌦ Article 4 ⌫ 

⌦ ___ ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Article 5 ⌫  

Annex IV 

Annex V 

⌦ Article 1(1), introductory 
wording ⌫ 

⌦ Article 1(2) ⌫ 

⌦ Article 1(1), points (a) to (e) ⌫ 

⌦ — ⌫ 

⌦ Article 3 ⌫ 

⌦ Article 2 ⌫ 

⌦ Article 4 ⌫ 

⌦ Article 5 ⌫ 

⌦ Article 6 ⌫ 

⌦ Article 7 ⌫ 

⌦ Article 8 ⌫ 

⌦ Article 9 ⌫ 

⌦ Article 10 ⌫ 

⌦ Article 11 ⌫ 

⌦ Article 12 ⌫ 

⌦ — ⌫ 

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⌦ Article 6 ⌫ 

⌦ Article 7 ⌫ 

⌦ Article 8 ⌫ 

⌦ — ⌫ 

⌦ Article 9 ⌫ 

⌦ Article 10 ⌫ 

⌦ Article 11 (1) and (2) ⌫ 

⌦ Article 11 (3) ⌫ 

⌦ Article 12 ⌫ 

⌦ Article 13 (1) ⌫ 

⌦ Article 13 (2) ⌫ 

⌦ Article 13 (3) ⌫ 

⌦ Article 14, first paragraph ⌫ 

⌦ Article 14, second paragraph, introductory 
wording ⌫ 

⌦ Article 14, second paragraph (a) ⌫ 

⌦ Article 14, second paragraph (b) ⌫ 

⌦ Article 14, third paragraph ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ ___ ⌫ 

⌦ Article 13 ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Point 2.3.2. of Annex II ⌫ 

⌦ — ⌫ 

⌦ Point 3.2.1. of Annex II ⌫ 

⌦ Point 3.2.2. of Annex II ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Second paragraph of point 3.3. of 
Annex II ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Article 14 ⌫ 

⌦ Article 15 ⌫ 

⌦ Article 16 ⌫ 

⌦ Article 17 ⌫ 

⌦ Article 18 ⌫ 

⌦ Article 19 ⌫ 

⌦ Article 20 ⌫ 

⌦ Article 21 ⌫ 

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⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Article 15 ⌫ 

⌦ Article 16 ⌫ 

⌦ Article 17 ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Article 18 ⌫ 

⌦ — ⌫ 

⌦ Article 19 ⌫ 

⌦ Article 20 ⌫ 

⌦ Article 22 ⌫ 

⌦ Article 23 ⌫ 

⌦ Article 24 ⌫ 

⌦ Article 25 ⌫ 

⌦ Article 26 ⌫ 

⌦ Article 27 ⌫ 

⌦ Article 28 ⌫ 

⌦ Article 29 ⌫ 

⌦ Article 30 ⌫ 

⌦ Article 31 ⌫ 

⌦ Article 32 ⌫ 

⌦ Article 33 ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Article 34 ⌫ 

⌦ Article 35 ⌫ 

⌦ Article 36 ⌫ 

⌦ Article 37 ⌫ 

⌦ Article 38 ⌫ 

⌦ Article 39 ⌫ 

⌦ Article 40 ⌫ 

⌦ Article 41(2) ⌫ 

⌦ Article 41(1) ⌫ 

⌦ Article 42 ⌫ 

⌦ Article 43 ⌫ 

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⌦ Article 21 ⌫ 

⌦ Annex I ⌫ 

⌦ — ⌫ 

⌦ Annex II ⌫ 

⌦ Annex III ⌫ 

⌦ Annex IV ⌫ 

⌦ Annex V ⌫ 

⌦ Article 44 ⌫ 

⌦ Annex I ⌫ 

⌦ Annex II ⌫ 

⌦ Annex III ⌫ 

⌦ — ⌫ 

⌦ — ⌫ 

⌦ Annex IV ⌫ 

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