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) 
  
EN 2   EN 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 aligni ng ten product directives to 
Decision No 768/2008/EC  establishing a common framework for the marketing of products. 
Union (EU) harmonisation legislation ensuring th e 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 econom ic 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 orde r 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 requiremen ts and affix the CE marking.  
Experience with the implementation of Uni on 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 operato rs complying with the legislation as 
opposed to those circumventing the rules 
– unequal treatment in the case of non-co mpliant 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 beco me more and more complex, as frequently 
several pieces of legisla tion apply simultaneously to one and the same product. 
Inconsistencies in these piece s of legislation make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
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 applica tion and enforcement. The New Legislative 
Framework (NLF) consists of tw o 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 .  
EN 3   EN 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 contro ls of products from th ird countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc). These common provisions ha ve been reinforced to ensure that the 
directives can be applied and enforced more ef fectively 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 authoriti es and authorities 
responsible for notified bodies to properly pe rform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation.  
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that all economic sect ors subject to Union ha rmonisation legislation 
benefit from the improvements of the NLF, th e provisions of the NLF Decision need to be 
integrated into the ex isting product legislation. 
A survey after the adoption of the goods packag e 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 Parlia ment, Council and Comm ission have committed 
themselves to use its provisions as much as po ssible in future legislation on products in order 
to further the utmost coheren ce of the regulatory framework.  
For a number of other Union harmonisation dir ectives, 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 no n-compliance and notified bodies 
are nevertheless addressed in these sectors, an d 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 polic y 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.  
EN 4   EN 2. CONSULTATION OF INTERE STED PARTIES AND IMPACT 
ASSESSMENT 
Consultation of interested parties 
The alignment of Directive 2009/105/EC to th e NLF Decision has been discussed with 
national experts responsible for the implementa tion of this Directive,  the notified body group, 
the administrative cooperation group as well as in bilateral co ntacts 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 quest ionnaires for economic operators, 
authorities, notified bodies and users and the Commission servic es received 300 replies. The 
results are published at:  
http://ec.europa.eu/enterpri se/policies/single-market-goods /regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm  
In addition to the general cons ultation a specific SME consulta tion was carried out. 603 SMEs 
were consulted through the En terprise Europe Network in May/June 2010. The results are 
available at http://ec.europa.eu/ enterprise/policies/ single-market-goods/f iles/new-legislative-
framework/smes_statistics_en.pdf  
The consultation process revealed widespread su pport for the initiative. There is unanimity on 
the need to improve market surveillance and th e system for assessing and monitoring Notified 
Bodies. Authorities fully support the exercise b ecause it will strengthen the existing system 
and improve cooperation at EU level. Industry expects a more level playing field resulting 
from more effective actions agai nst products that do not comply with the legislation, as well 
as a simplification effect from the alignment of  legislation. Certain co ncerns were expressed 
on some obligations which are, however, indispen sable for increasing the efficiency of market 
surveillance. These measures wi ll not entail significant costs for industry, and the benefits 
resulting from improved market surveill ance should by far outweigh the costs.  
Collection and use of expertise 
The impact assessment for this implementati on package has largely built on the impact 
assessment carried out for the New Legislativ e Framework. In addition to the expertise 
collected and analysed in that context, furt her consultation of sector-specific experts and 
interest groups, as well as horizontal expert s active in the area of technical harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 
Impact assessment  
Based on the information collected, the Commissi on 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 Deci sion by non-legislative measures  
EN 5   EN Option 2 considers the possibility  of encouraging a voluntary ali gnment 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 Deci sion by legislative measures 
This option consists in integrating the provis ions of the NLF Decisi on 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 th at the positive impacts w ould materialise under that 
option; 
– options 1 and 2 do not provide answers to the problem of inc onsistencies in the 
regulatory framework and therefore have no positive impact on the simplification of 
the regulatory environment. 
3. M
AIN ELEMENTS OF THE PROPOSAL  
3.1. Horizontal definitions 
The proposal introduces harmonised definitions of terms which are commonly used 
throughout Union harmonisation le gislation and should therefor e be given a consistent 
meaning throughout that legislation.  
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obligat ions of manufacturers and au thorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble 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 mark ing, the name of the manufacturer and of the 
importer, if relevant, and that it is accompanied by the required documentation and instructions.  
EN 6   EN Importers and distributors must cooperate w ith market surveillance authorities and take 
appropriate actions when they have supplie d non-compliant simple pressure vessels. 
Enhanced traceabi lity 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 documen tation. When a simple 
pressure vessel is imported the importer’s name  and address must also be on the simple 
pressure vessel. Furthermore every economic ope rator must be able to identify towards 
authorities the economic operator who has supplied him with a si mple 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 pro posal for a Regulation 
on European Standardisation2 that sets out a horizontal legal framework for European 
standardisation. The proposal for the Regu lation 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 stakehol der 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 conf ormity 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 select ed the appropriate conformity assessment procedures which 
manufacturers have to a pply in order to demonstrate that th eir simple pressure vessels comply 
with the essential safety requirements. The prop osal aligns these proc edures 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 crite ria for notified bodies.  It clarifies that 
subsidiaries or subcontractors mu st also comply with the notif ication requirements. Specific 
requirements for notifying authorities are intro duced, and the procedure for notification of 
notified bodies is revised. The competence of a notified body must be demonstrated by an 
accreditation certificate. Where accr editation has not been used to evaluate the competence of 
a notified body, the notification must compri se 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  
EN 7   EN 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 cl ause 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 si mple pressure vessel is found. A real 
safeguard clause procedure – leading to a Decision at Commissi on level on whether a 
measure is justified or not - is only launched wh en another Member State objects to a measure 
taken against a simple pressure vessel. Wher e 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 Tr eaty on the Functioning of the European Union. 
Subsidiarity principle 
The internal market is a competence that is sh ared between the Union and the Member States. 
The subsidiarity principle aris es in particular with regard  to the newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 2009/105/EC, namely, the 
importer and distributor obligations, the tr aceability provisions, the provisions on the 
assessment and notification of notified bodies, and the enhanced cooperation obligations in 
the context of the revised market su rveillance and safeguard procedures.  
Experience with the enforcement of the legislat ion has shown that measures taken at national 
level have led to divergent ap proaches and to a different tr eatment of economic operators 
inside the EU, which undermines the objective of th is directive. If actions are taken at national 
level to address the problems, this risks cr eating 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 ac tion at EU level can much be tter 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 thro ughout the directives, th is is a problem which 
can only be solved by the EU legislator. 
Proportionality  
In accordance with the principle of proportiona lity, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - 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 respons e to the problems identified. A number of  
EN 8   EN modifications concern the improvement of cl arity of the existing Directive without 
introducing new requirements th at 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 Dir ective 2009/105/EC concern: the definitions, the 
obligations of economic operators, the presum ption 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 th e 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.   
EN 9   EN  
Ð 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 CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing 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 Eu ropean Economic and Social Committee
4, 
Acting in accordance with the ordi nary legislative procedure,  
Whereas: 
 
Ð 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 OJ C 27, 3.2.2009, p. 41. 
5 OJ L 220, 8.8.1987, p. 48.   
EN 10   EN  
Ø new 
(1) 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, th at Directive should be recast. 
(2) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accredit ation and market surveillance relating to 
the marketing of products and re pealing Regulation (EEC) No 339/937 lays down rules 
on the accreditation of conf ormity assessment bodies, provides a framework for the 
market surveillance of products and for cont rols on products from third countries, and 
lays down the general princi ples of the CE marking. 
(3) Decision No 768/2008/EC of the European Par liament and of the Council of 9 July 
2008 on a common framework for the marketi ng of products and repealing Council 
Decision 93/465/EEC8 lays down a common framework of general principles and 
reference provisions intende d to apply across the le gislation harmonising the 
conditions for the marketing of products in order to provide a coherent basis for 
revision or recasts of that legislati on. Directive 2009/105/EC should therefore be 
adapted to that Decision. 
 
Ð 2009/105/EC recital 2 (adapted) 
(4) Member States have the respo nsibility of ensuring  ⌦ should ensure ⌫ the safety on 
their territory of persons, domestic animal s and property with regard to the hazards 
resulting from the leakage or burs ting of simple pressure vessels. 
 
Ð 2009/105/EC recital 3 
In each Member State, mandatory provisions define in particular the safety level 
required of simple pressure vess els 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.  
 
Ð 2009/105/EC recital 4  
This Di rective should therefore c ontain only mandatory and essential requirements. 
To facilitate proof of conformity with th e essential requirements, it is necessary to 
                                                 
6 OJ L 264, 8.10.2009, p. 12. 
7 OJ L 218, 13.8.2008, p. 30. 
8 OJ L 218, 13.8.2008, p. 82.  
EN 11   EN have harmonised standards at Community le vel, in particular as to the design, 
operation and in stallation of simple pressure vessel s, so that products complying with 
them may be assumed to conform to th e safety requirements. These standards 
harmonised at Community level are drawn up by private bodies and should remain 
non-mandatory texts. For that p urpose, the European Committee for Standardisation 
(CEN), the European Committee for Electr otechnical Standardisation (Cenelec) and 
the European Telecommunications Standards Institute (ETSI) are recognised as the 
competent bodies for th e adoption of harmon ised 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.  
 
Ø new 
(5) Economic operators should be responsible for the complia nce of simple pressure 
vessels, in relation to their re spective roles in the supply chai n, so as to ensure a high 
level of protection of public interests, such as health a nd safety and the protection of 
users, and to guarantee fair competition on the Union market. 
(6) All economic operators interv ening in the supply and dist ribution 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. 
 
Ð 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 prin ciples established in its Resolution of 7 
May 1985 on a new approach to tec hnical 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 gl obal approach to certification and 
testing11, proposed that common rules be draw n 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 essent ial 
requirements and the conformity assessment procedures.  
                                                 
9 OJ C 91, 16.4.2003, p. 7.  
10 OJ C 136, 4.6.1985, p. 1.  
11 OJ C 267, 19.10.1 989, p. 3.  
12 OJ C 10, 16.1.1990, p. 1.   
EN 12   EN  
Ø new 
(7) The manufacturer, having detailed knowledge  of the design and pr oduction process, is 
best placed to carry out the complete c onformity assessment procedure for simple 
pressure vessels. Conformity assessment s hould therefore remain the obligation of the 
manufacturer alone. 
(8)  It is necessary to ensure that simple pre ssure 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 manufa cturers with regard 
to those simple pressure vessels. Provision sh ould 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 re quirements or present a risk. Provision 
should also be made for importers to ma ke sure that the conformity assessment 
procedures have been carri ed 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 ve ssel 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 th e 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 si mple 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 carri ed out by the competent national authorities, and should 
be prepared to participate actively, providing those auth orities with all necessary 
information relating to the simp le pressure vessel concerned. 
(13) Ensuring traceability of a simple pressure vessel throughout the whole supply chain 
helps to make market surveillance simpler a nd more efficient. An efficient traceability 
system facilitates market su rveillance authorities' task of tracing economic operators 
who made non compliant simple pressu re vessels available on the market. 
(14)  This Directive should be limited to the expres sion of the essential safety requirements. 
In order to facilitate conformity assessment with those requirements it is necessary to 
provide for presumption of conformity fo r products which are in conformity with 
harmonised standards that are adopted in accordance with Regulation (EU) No […/…] 
of the European Parliament and of the C ouncil of …. on European Standardisation and 
amending Council Directives 89/686/EEC and 93/15/EEC and Di rectives 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 13   EN and 2009/23/EC of the European Parliament and of the Council13 for the purpose of 
expressing detailed technical sp ecifications of those requirem ents, in particular as to 
the design, operation and installati on of simple pressure vessels.  
(15) Regulation (EU) No […/…] [on European St andardisation] provi des for a procedure 
for objections to harmonised standards wh ere those standards do not entirely satisfy 
the requirements of this Directive.  
(16) In order to enable economic operators to de monstrate and the competent authorities to 
ensure that simple pressure  vessels made available on the market comply with the 
essential safety requirements it is necessa ry to provide for conformity assessment 
procedures. Decision No 768/2008/EC establis hes 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 avoi d ad-hoc variants, c onformity assessment 
procedures should be chosen from among those modules. 
(17) Manufacturers should draw up an EU declara tion of conformity to provide detailed 
information on the conformity of a simple pressure vessel with the requirements of 
this Directive and of other releva nt Union harmonisa tion legislation. 
(18)  The CE marking, indicating the conformity of  a simple pressure ve ssel, is the visible 
consequence of a whole proces s comprising conformity asse ssment in a broad sense. 
General principles governing the CE marki ng 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 .  
 
Ð 2009/105/EC recital 6 (adapted) 
(19) A check on compliance with the relevant technical  ⌦ essential safety ⌫ 
requirements is necessary in order to provi de 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 sh ould be made for the mutual recognition of 
inspection procedures by the Member States . In order to facilitate the mutual 
recognition of inspection procedures, Commun ity procedures should be established as 
well as the criteria for appointing the bodies resp onsible for carrying out tests, 
surveillance and verification.  
 
Ð 2009/105/EC recital 7 
The presence on a simple pressure vessel  of the ‘CE’ marking should raise a 
presumption that it satisfies the provisi ons of this Directive and should ther efore 
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 14   EN represent a safety hazard. Provision shoul d therefore be made for a procedure to 
reduce this hazard.  
 
Ø 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 Directiv e 2009/105/EC that 
conformity assessment bodies have to fulfil to be notified to the Commission are not 
sufficient to ensure a uniformly high le vel of performance of notified bodies 
throughout the Union. It is, however, essentia l that all notified bodies perform their 
functions to the same level and under conditi ons of fair competition. That requires the 
setting of obligatory requirements for conf ormity assessment bodies wishing to be 
notified in order to provide conformity assessment services. 
(22) In order to ensure a consistent level of  conformity assessment quality it is also 
necessary to set requirements notifying aut horities and other bodies involved in the 
assessment, notification and monitoring of notified bodies. 
(23)  If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be pres umed to comply w ith the corresponding 
requirements set out in this Directive. 
(24)  The system set out in this Directive s hould be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since accreditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(25) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confid ence in conformity certificates , should be considered by 
the national public authorit ies 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 th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(26) Conformity assessment bodies frequently subc ontract parts of their activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard 
the level of protection required for the simp le pressure vessels to be placed on the 
Union market, it is essential that conf ormity assessment subcontractors and 
subsidiaries fulfil the same requirement s 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 15   EN monitoring of bodies alr eady notified cover also activities carried out by 
subcontractors and subsidiaries. 
(27) It is necessary to increase the efficiency a nd transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies 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 Co mmission 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 co mpetence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 
(29) 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 ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achie ved through appropriate  coordination and 
cooperation between notified bodies. 
(30) In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance and control of products ente ring 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 th e competent authoritie s to carry out those 
tasks. 
(31) Directive 2009/105/EC already provides fo r a safeguard procedure allowing the 
Commission to examine the justification for a measure taken by a Member State 
against simple pressure vessels it consider s 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 maki ng it more efficient and of drawing on 
expertise available in the Member States. 
(32) The existing system should be supplemen ted 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 th e health and safety of pers ons or to other aspects of 
public interest protection. It should also allow market surveilla nce authorities, in 
cooperation with the relevant economic operato rs, 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 furt her 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 penalt ies applicable to infringements of the 
provisions of national law adopt ed pursuant to this Direct ive and ensure that these  
EN 16   EN rules are implemented. The penalties provide d 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 protec tion of health and 
safety and other public interests while gua ranteeing the functioning of the internal 
market cannot be sufficiently achieved by th e Member States a nd 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 in to 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. 
 
Ð 2009/105/EC recital 8  
(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. , 
 
Ð 2009/105/EC (adapted) 
Ö new 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER  I1 
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 17   EN (b) T the 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) T the vessel shall be  ⌦ is ⌫ made of either ⌦ of the following ⌫: 
 (i) a cylindrical part of circul ar cross-section closed by inwardly  
Ö 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) T the maximum working pressure of the vessel shall  ⌦ does ⌫ not exceed 30 bar 
and the product of that pressure and th e capacity of the vessel (PS x V) shall  
⌦ does ⌫ not exceed 10000 bar.l L.; 
(e) T the 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; . 
 
Ð 2009/105/EC 
(b) a ‘harmonised standard’ means a techni cal specification (European standard or 
harmonisation document) adopted by the European Committee for Standardisation (CEN), the 
European Committee for Electro technical Standardisation (Cenelec) or the European 
Telecommunications Standards Institute (ETS I) or by two or thr ee 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 standard s and regulations and of  rules on Information 
Society services14 and the general guidelines for  cooperation between  the Commission, the 
European Free Trade Association (EFTA) a nd those three bodies signed on 28 March 2003.  
 
Ð 2009/105/EC (adapted) 
2. The following vessels shall be excluded from the scope of  tThis Directive ⌦ shall not 
apply to the following vessels ⌫ : 
 
Ð 2009/105/EC 
 (a) vessels specifically de signed for nuclear use, failu re of which may cause an 
emission of ra dioactivity; 
 (b) vessels specifically intended for insta llation in or the propulsion of ships and 
aircraft; 
                                                 
14 OJ L 204, 21.7.1998, p. 37.   
EN 18   EN  (c) fire extinguishers. 
 
Ð 2009/105/EC (adapted) 
Article 2  [Article R1 of Decision No 768/2008/EC] 
⌦ Definitions  ⌫ 
3. For the purposes of this Directive the following definitions shall  apply: 
 
Ø new 
(1) ‘making available on the market’ means a ny supply of a vessel for distribution or use on 
the Union market in the course of a commercial  activity, whether in retu rn for payment or free 
of charge; 
(2) ‘placing on the market’ means the first maki ng available of a vessel on the Union market; 
(3) ‘manufacturer’ means any natural or lega l 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 natura l or legal person established within the Union 
who has received a written mandate from a manuf acturer to act on his be half in relation to 
specified tasks; 
(5) ‘importer’ means any natural or legal pers on established within the Union who places a 
vessel from a third country on the Union market; 
(6) ‘distributor’ means any natural or lega l person in the supply chain, other than the 
manufacturer or the importer, who ma kes a vessel available on the market; 
(7) ‘economic operators’ means the manufacturer , the authorised repres entative, the importer 
and the distributor; 
(8) ‘technical specification’ means a document th at prescribes technical  requirements to be 
fulfilled by a vessel; 
(9) ‘harmonised standard’ means harmonised st andard as defined in  Article 2(1)(c) of 
Regulation (EU) No [../..] [on European Standardisation];  
(10) ‘accreditation’ m eans accreditation as defi ned in Article 2(10) of  Regulation (EC) No 
765/2008; 
(11) ‘national accred itation body’ means natio nal accreditation body as  defined in Article 
2(11) of Regulation (EC) No 765/2008;  
EN 19   EN (12) ‘conformity assessment’ means the proces s 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 calib ration, testing, certification and inspection; 
(14) ‘recall’ means any measure aimed at achie ving the return of a ve ssel 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 ha rmonisation legislation 
providing for its affixing; 
(17) ‘Union harmonisation legislation’ m eans any Union legislation harmonising the 
conditions for the marketing of products. 
 
Ð 2009/105/EC (adapted) 
Ö new 
Article 2 3 
⌦ Making available on the market and putting into service  ⌫ 
1. Member States shall take all necessary step s to ensure that the vessels may be placed  
Ö made available  on the market and put in to 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 aff ect 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 3 4 
⌦ 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, wi th the exception of the ‘CE’ marking 
referred to in Article 16.   
EN 20   EN Article 4 5 
⌦ Free movement  ⌫ 
Member States shall not impede the placing  Ö making available  on the market and the 
putting into service in  ⌦ on ⌫ their territory of vessels which satisfy the requirements of 
this Directive. 
 
Ø 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 en sure 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 ma nufactured 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 re ferred to in Article 13 or have it carried out. 
Where compliance of a vessel of which the pr oduct 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 whic h the product of PS x V is 50 bar.L or less, 
bear the inscriptions laid down in point 1 of Annex III. 
3. Manufacturers shall keep the technical do cumentation and the EU declaration of 
conformity for 10 years after the ve ssel has been placed on the market. 
4. Manufacturers shall ensure that procedures are in place for series  production to remain 
in conformity. Changes in vess els design or characteristics and changes in the harmonised 
standards by reference to which conformity of a vessel is declared sha ll be adequately taken 
into account.  
EN 21   EN When deemed appropriate with regard to the risks presented by a vesse l, 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. 
5. Manufacturers shall ensure that their ve ssels bear a type and serial or batch 
identification allowing their identification. 
6. Manufacturers shall indicate their name, regi stered trade name or  registered trade 
mark and the address at which th ey can be contacted on the vesse l. The address must indicate 
a single point at which the ma nufacturer can be contacted. 
7. Manufacturers 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 country Member State of destination. 
8. Manufacturers who consider or have reason to believe that a vessel which they have 
placed on the market is not in conformity w ith this Directive shall immediately take the 
necessary corrective measures to bring that vessel  into conformity, to withdraw it or recall it, 
if appropriate. Furthermore, wh ere 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, gi ving 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 info rmation and documentation necessary to demonstrate the 
conformity of the vessel, in a language which can be easily unde rstood by that authority. They 
shall cooperate with that authority, at its re quest, 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 author ised representative's mandate. 
2. An authorised representative shall perform the tasks specified in the mandate received 
from the manufacturer. The mandate shall allow th e authorised representative to do at least 
the following: 
(a) keep the EU declaration of conform ity and the technical documentation at the 
disposal of national surveillance authori ties for 10 years after the vessel has been 
placed on the market; 
(b) 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 22   EN (c) cooperate with the competent national authorities, at thei r 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] 
Obligations of importers 
1. Importers shall place only compliant vessels on the market. 
2. Before placing on the market a vessel of which the product of PS x V exceeds 50 
bar.L, importers shall ensure that the appropria te conformity assessmen t procedure referred to 
in Article 6 has been carried out by the manufact urer. 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 complie d with the requirements set out in Article 
6(5) and (6). 
Where an importer considers or has reason to be lieve that a vessel of wh ich 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 ma rket until it has been brought into conformity. 
Furthermore, where the vessel presents a risk, the importer shall inform the manufacturer and 
the market surveillance aut horities 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 inscri ptions provided for in point 1 of Annex III and 
that the manufacturer has comp lied with the requirements set out in Article 6(5) and (6). 
3. Importers shall indicate their name, register ed 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. 
5. Importers shall ensure that, while a vesse l in respect of which the product of PS x V 
exceeds 50 bar.L is under their responsibilit y, storage or transport conditions do not 
jeopardise its compliance with the essential safety requirements set out in Annex I. 
6. When deemed appropriate with regard to  the risks presented by a vessel, importers 
shall, to protect the health and safety of us ers, carry out sample te sting of vessels made 
available on the market, investigate, and, if ne cessary, keep a register of complaints, of non-
conforming vessels and vessel recalls, and sha ll keep distributors informed of such 
monitoring. 
7. Importers who consider or have reason to be lieve 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 pr esents a risk, importers shall immediately  
EN 23   EN 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. 
8. For vessels of which the pr oduct of PS x V exceeds 50 bar.L,  importers shall, for 10 
years after the vessel ha s been placed on the market, keep a copy of the EU declaration of 
conformity at the disposal of the market survei llance authorities and ensu re that the technical 
documentation can be made available to those authori ties, upon request. 
9. Importers shall, further to a reasoned request from a competent national authority, 
provide it with all the info rmation and documentation necessary to demonstrate the 
conformity of a vessel in a langua ge which can be easily unders tood by that authority. They 
shall cooperate with that authority, at its re quest, 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 
1. When making a vessel available on the mark et distributors shall act with due care in 
relation to the requirements of this Directive. 
2. Before making a vessel of which the product of PS x V exceeds 50 bar.L available on 
the market, distributors shall verify that the ve ssel bears the CE marki ng 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 langua ge 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 be lieve 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 availa ble on the market until it has been brought into 
conformity. Furthermore, where the vessel presen ts a risk, the distributor shall inform the 
manufacturer or the importer to that effect as well as the ma rket 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 be ars the inscriptions provided for in point 1 of 
Annex III and that the manufacturer and the im porter 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 sh all make sure that the 
corrective measures necessary to bring that vessel into conformit y, 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  
EN 24   EN made the vessel available to that  effect, giving details, in pa rticular, 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 info rmation and documentation necessary to demonstrate the 
conformity of a vessel. They shall cooperate wi th 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 manufactu rers apply to importers and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subject to the obliga tions 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 comp liance 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 re quest, identify the following to  the market surveillance 
authorities: 
(a) any economic operator who ha s supplied them with a vessel; 
(b) any economic operator to whom they have supplied a vessel. 
Economic operators shall be able to presen t the information referred to in the first 
subparagraph for a period of 10 y ears after they have been supp lied with the vessel and for a 
period of 10 years after they  have supplied the vessel.  
EN 25   EN CHAPTER 3 
CONFORMITY OF VESSELS OF WHICH THE PRODUCT OF 
PS x V EXCEEDS 50 bar.L 
 
Ð 2009/105/EC (adapted) 
Article 5 12 [Article R8 of Decision No 768/2008/EC] 
⌦ Presumption of conformity ⌫ 
 
Ø 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 st andards or parts thereof,  set out in Annex I. 
[Where a harmonised standard sa tisfies the requirements which it  covers and which are set out 
in Annex I or Article 21, the Comm ission shall publish the referenc es of those standards in the 
Official Journal of the European Union .]  
 
Ð 2009/105/EC 
Member States shall presume t hat vessels bearing the CE marking comply with all the 
provisions of this Directive.  
Conformity of vessels with th e national standards which trans pose the harmonised standards, 
the reference numbers of which have been published in the  Official Journal of t he European 
Union , shall result in a presumption of conformity to the essential safety requirements set out 
in Annex I.  
Member States shall publish the referen ce 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 wh ich the manufacturer has not 
applied or has only partially applied such st andards, comply with the essential safety 
requirements set out in Annex I, where, afte r receipt of an EC type -examination certificate, 
their conformity with the approved model has been certified by the a ffixation of the ‘CE’ 
marking.   
EN 26   EN 3. Where vessels are subject to other Directives  covering other aspects and which also provide 
for the affix ing of the ‘CE’ marking, the latter shall in dicate that the vessels in question are 
also presumed to conform to the pr ovisions of those other Directives.  
However, where one or more of those Directiv es allow the manufacturer, during a transitional 
period, t o choose which arrangements to apply, the ‘CE’ marking shall in dicate 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 g iven in the 
documents, notices or instructions required by the Directives and accompanying such vessels.  
 
Ð 2009/105/EC (adapted) 
Ö 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 acco rdance with the harmonised standards  Ö 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 ⌫ : 
 
Ø new 
(a) for vessels manufactured in accordance w ith the harmonised standards referred to in 
Article 12, at the choice of the manufacturer , in either of the following two manners: 
 
Ð 2009/105/EC 
(a) inform an approved inspection body as referred to in Article 9, which, after examining the 
design and manufacturing schedul e referred to in point 3 of  Annex II, shall draw up a 
certificate of adequacy attesting that the schedule is satisfactory   
EN 27   EN  
Ø new 
i) assessment of the adequacy of th e technical design of the vessel through 
examination of the technical documen tation and supporting evidence without 
examination of a specimen (Module B - design type); 
 
Ð 2009/105/EC 
Ö new 
(bii)- Ö examination of  submit  a prototype vessel Ö representative of the 
production envisaged of the complete vessel  for the EC type -examination 
referred to in Article 10  Ö Module B – production type)  . 
 
Ð 2009/105/EC (adapted) 
2.(b) Prior to production of pressure  ⌦ for ⌫ vessels of which the product of PS x V 
exceeds 50 bar.l L 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 envisa ged 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 ⌫ : 
 
Ð 2009/105/EC 
Ö new 
(a) to the EC verification referred to in Article 11  where the product of PS x V exceeds 
3000 bar.l L Ö , to Module C1 (conformity to type based on internal production 
control plus supervised product testin g) set out in point 2 of Annex II ; 
 
Ð 2009/105/EC (adapted) 
Ö new 
(b) at the choice of the manufacturer,  where the product of PS x V does not exceed 3000 
bar.lL but exceeds 50  Ö 200  bar.l L, ⌦ at the choice of the manufacturer, to ⌫ 
either ⌦ of the following modules ⌫ :  
EN 28   EN  
Ð 2009/105/EC 
Ö new 
 (i) to the  EC declaration  Ö Module C1  of (conformity Ö to type based on 
internal production control plus  supervised pr oduct testing)  referred to in 
Article 12  point 2 of Annex II ; or 
 (ii) to t he EC verification  Ö 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 . 
 
Ø 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 ba sed on internal production control plus 
supervised product testing) referr ed to in point 2 of Annex II; 
(ii) Module C (conformity to type based on internal production cont rol) referred to in 
point 4 of Annex II. 
 
Ð 2009/105/EC (adapted) 
43. The records and correspondence relating to th e 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. 
 
Ø new 
Article 14 [Article R10 of Decision No 768/2008/EC] 
EU declaration of conformity 
1. The EU declaration of conformity shall state that the fulfilment of the essential safety 
requirements set out in Anne x I has been demonstrated. 
2. The EU declaration of conformity shall ha ve the model structure set out in Annex III 
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.  
EN 29   EN 3. Where the vessel is subject to more than one  Union act requiring an  EU declaration of 
conformity, a single EU declaration of conform ity shall be drawn up in respect of all such 
Union acts. That declaration shall contain the identification of the act s concerned including 
the publication references.  
4. By drawing up the EU declaration of c onformity, the manufacturer shall assume 
responsibility for the co mpliance 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 Ar ticle 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 
1. The CE marking and the inscriptions refe rred to in point 1 of Annex III shall be 
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.  
3. The CE marking shall be followed by the id entification number of the notified body 
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. 
4. The CE marking and the identification num ber referred to in paragraph 3 may be 
followed by a pictogram or any other mark  indicating a special risk or use. 
 
Ð 2009/105/EC 
Article 6  
Where a Member State o r the Commission considers that th e harmonised standards referred to 
in Article 5(1) do not entirely meet the essentia l safety requirements set out in Annex I, the 
Commission or the Member Stat e concerned shall bring the matter before the standing 
committe e 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.   
EN 30   EN In the light of the committee’s opinion, th e Commission shall inform the Member S tates 
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 bear ing the ‘CE’ marking a nd used in accordance 
with their intended purpose might compr omise the safety of persons, domestic animals or 
property, it shall take all appr opriate measures to withdraw th ose products from the market or 
to prohibit or restrict thei r being placed on the market.  
The Member State concerned shall immediately inform th e Commission of any such measure, 
indicating the reasons for its decisi on, 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 standard s referred to in Article 5(1);  
 (b) incorrect application of the harmonised standard s referred to in Article 
5(1);  
 (c) shortcomings in the harmonised st andards referred to in Article 5(1).  
2. The Commission shall enter into consultation with the parties c oncerned as soon as 
possible. Where, after such consultation, the Commission finds that any measure as referred 
to in paragraph 1 is justified, it shall immediat ely so inform the Member State that took the 
action and the other Member States.  
Where the deci sion referred to in paragra ph 1 is attributed to shortc omings in the standards, 
the Commission, after consulting the parties co ncerned, shall bring the matter before the 
committee within two months if the Member St ate which has taken the measures intends t o 
maintain them and shall set in motion th e procedure referred to in Article 6.  
3. Where a vessel which does not comply bear s 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.   
EN 31   EN CHAPTER II  
CERTIFICATION  
SECTION  1 
CERTIFIC ATION PROCEDURES  
Article 9  
1. Member States shall notify the Commission and the other Me mber States of the approved 
inspection bodies which they have appointed to carry out the procedures referred to in Article 
8(1), (2) and (3) togeth er with the specific tasks which those bodies ha ve been appointed to 
carry out and the identifica tion 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 iden tification 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 re ferred to in paragraph 1, Member States shall 
meet the minimum criteria set o ut 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 mi nimum criteria set out in Annex III.  
It shall immediately inform the Comm ission and the other Member States acc ordingly.  
SECTION  2 
EC TYPE -EXAMINATION  
Article 10  
 
Ð 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 prov isions of this Directiv e 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 a pproved inspection body in respect of a prototype 
vessel or of a prototype repr esenting a family of vesse ls. That authorised representative must 
be established in the Community.   
EN 32   EN The application shall include:  
 (a) the name and address of the ma nufacturer or of his authorised 
representative and the place of  manufacture of the vessels;  
 
Ð 2009/105/EC 
 (b) the design and manufacturing schedul e referred to in point 3 of Annex II.  
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 manne r 
referred to in the second  and third subparagraphs.  
It shall examine not only the design and ma nufacturing 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 appl icable to it.  
4. If the prototype complies with the provision s 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 exa mination, indicate any conditions to 
which its issue may be subject and be acco mpanied 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 certifi cate 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 whic h refuses to issue an EC type -examination certif icate 
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 Commissio n thereof, giving the reasons for the decision.   
EN 33   EN SECTION  3 
EC VERIFICATION  
Article 11  
1. EC verification is the proced ure whereby a manufact urer or his author ised representative 
established within the Community ensures and declares that the vessels which ha ve been 
checked in accordance with paragraph 3 are in c onformity 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 receiv ed a certificate of adequacy.  
2. The manufacturer shall take all necessary meas ures 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 refe rred 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.  
 
Ð 2009/105/EC (adapted) 
3. The approved inspection body shall carry out t he 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 accord ance with the second to tenth subparagraphs.  
The manufacturer shall present his ves sels in the form of uniform batches and shall take all 
necessary measures in order that the manuf acturing process ensures the uniformity of each 
batch produced.  
Those batches shall be accompanied by the EC type -examination certificate referred to in 
Articl e 10  or, where the vessels are not manufactur ed in accordance with an approved 
prototype, by the design and manufacturing schedul e referred to in point 3 of Annex II. In the 
latter case the approved inspection body shal l, prior to EC ve rification, examine the schedule 
in order to certify its conformity.  
When a batch is examined, the approved inspec tion body shall ensure that the vessels have 
been manufactured and checked in accordance with the design and manufacturing schedule, 
and shall perform a hydrostat ic test or a pneumatic test of equivalent effect on each vessel in 
the batch at a pressure Ph equa l 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 b y 
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 ma nufacturer chooses, in order to 
examine the weld qua lity. The tests shall be carried out on longitudinal welds. However, 
where differing weld techni ques are used for longitudinal and ci rcular welds, the tests shall be 
repeated on the circular welds.   
EN 34   EN For the vessels referred to in point 2.1.2 of Annex I, the se tests on test -pieces shall be 
replaced by a hydrostatic  test on five vessels taken at rand om 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 sha ll 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 marke t except for those which have not successfully undergone a hydrostatic 
test or a pneumatic test.  
If a batch is rejected, the a pproved inspection body shall take a ppropriate measures to prevent 
the placing on the market of that batch. In the event of freque nt rejection of batches, the 
approved inspection body may suspe nd the statistical verification.  
 
Ð 2009/105/EC 
The manufacturer may, under the responsibilit y of the approved inspection body, affix the 
latter’s identification number during the  manufacturing process.  
 
Ð 2009/105/EC (adapted) 
The manufacturer or his authorised representative  must be able to supply on request the 
approved inspection body’s certificates of conform ity referred to in the seventh subparagraph.  
 
Ð 2009/105/EC 
SECTION  4 
EC DECLARATION OF CONF ORMITY  
Article 12  
1. A manufacturer fulfilling the obligations ar ising under Article 13 shall affix the ‘CE’ 
marking provided for in Article 16 to vessels wh ich he declares to be in conformity with:  
 (a) the design and manufacturing schedule refe rred 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 proce dure the manufacturer becomes subject to EC 
surveillance, in cases where the product of PS x V exceeds 200 bar.L.   
EN 35   EN The purpose of EC surveillance is to ensure, as  required by the second  paragraph of Article 
14, that the manufacturer duly fulfils the obligations arisi ng under Article 13(2). Surveillan ce 
shall be performed by the approved in spection 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 n ot the case, by the 
approved body to which the design and manufact uring schedule was sent in accordance with 
Article 8(1)(a).  
Article 13  
 
Ð 2009/105/EC (adapted) 
1. Where a manufacturer makes use of th e 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 certificate of adequacy  a document describing the 
manufacturing processes and all of the predetermined systematic measures take n to ensure 
conformity of the pressure vessels to the standards referred to in Ar ticle 5(1) or the approved 
prototype . 
2. The document referred to in paragraph 1 shall include:  
 (a) a description of the means of manufacture and ch ecking appropriate to the 
construction of the vessels;  
 (b) an inspection document describing th e appropriate examinations and tests 
to be carried out during manuf acture, together with the pr ocedures 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 poin t (b) and to have a hydrostatic test or, 
subject to the agreement of the Member St ate, a pneumatic test carried out on each 
vessel manufacture d 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 indepe ndent from production personnel, and shall 
be the subject of a report;  
 (d) the addresses of the places of manu facture 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 manufactur e and storage by the body resp onsible for EC surveillance, for 
inspection purposes, and shall allow th at body to select sample vessels and shall provide it 
with all necessary inform ation, and in particular:  
 (a) the design and manufacturing schedule;  
 (b) the inspection report;   
EN 36   EN  (c) th e EC type -examination certificate or cer tificate of adequacy, where 
appropriate;  
 (d) a report on the examinati ons and tests carried out.  
Article 14  
The approved inspection body which issued the EC type -examination certificate or certificate 
of adequacy sh all, before the date on which any manufacture begins, examine both the 
document referred to in Article 13(1) and th e design and manufacturi ng schedule referred to 
in point 3 of Annex II, in or der to certify its conformity,  where vessels are not manufacture d 
in accordance with an approved prototype.  
 
Ð 2009/105/EC 
In addition, where the product of PS x V exceeds 200 bar.L, that body shall during 
manufacture:  
 
Ð 2009/105/EC (adapted) 
 (a) ensure that the manufacturer actually check s 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 suppl y the Member State which approved it  and, on 
request, the other approved inspection bodies, the other Member Stat es and the Commission, 
with a copy of the inspection report.  
 
Ø new  
CHAPTER 4 
NOTIFICATION OF CONFORMI TY ASSESSMENT BODIES  
Article 17 [Article R13 of Decision No 768/2008/EC] 
Notification 
Member States shall notify the Commission and th e other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive.  
EN 37   EN Article 18 [Article R14 of Decision No 768/2008/EC] 
Notifying authorities 
1. Member States shall designate a notifying authority that shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and notification of 
conformity assessment bodies and the monito ring 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 referr ed to in paragraph 1 to a b ody 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 sh all have arrangements to cover 
liabilities arising out of its activities. 
4. The notifying authority shall take full re sponsibility for the tasks performed by the 
body referred to in paragraph 3. 
Article 19 [Article R15 of Decision No 768/2008/EC] 
Requirements relating to notifying authorities 
1. A notifying authority shall be established in  such a way that no conflict of interest 
with conformity assessment bodies occurs. 
2. A notifying authority shall be organised and operated so as to safeguard the objectivity 
and impartiality of its activities. 
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity a ssessment body is taken by competent persons different from 
those who carried out the assessment. 
4. A notifying authority shall not offer or provide any activities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent number of compet ent personnel at its 
disposal for the proper performance of its tasks.  
EN 38   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 a ssessment bodies and the monitori ng 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 
1. For the purposes of notification, a c onformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be esta blished under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body i ndependent of the 
organisation or the vessel it assesses. 
A body belonging to a business association or professional federation representing 
undertakings involved in the de sign, 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. 
4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out th e conformity assessm ent tasks shall not be the designer, 
manufacturer, supplier, installer,  purchaser, owner, user or ma intainer of the vessels which 
they assess, nor the authorised representative of any of those pa rties. 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 asse ssment tasks shall not be dir ectly involved in the design, 
manufacture or construction, th e marketing, installation, us e or maintenance of those 
products, or represent the partie s engaged in those activities. They shall not engage in any 
activity that may c onflict with their independence of judge ment or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 
Conformity assessment bodies sh all ensure that th e activities of their subsidiaries or 
subcontractors do not affect the c onfidentiality, objectivity or impartiality of their conformity 
assessment activities. 
5. Conformity assessment bodies and their pe rsonnel shall carry out the conformity 
assessment activities with the highest degree of professional integr ity and the requisite  
EN 39   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 capab le 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 assessm ent procedure and each kind or category of 
vessels in relation to which it has been notifie d, a conformity assessment body shall have at its 
disposal the necessary: 
(a) personnel with technical knowledge and sufficient and appropr iate experience to 
perform the conformity assessment tasks; 
(b) 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 a ppropriate policies and procedur es in place that distinguish 
between tasks it carries out as a notified body and other activities; 
(c) procedures for the performance of activitie s 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 ma ss or serial nature of the production 
process. 
It shall have the means necessary to perform the technical and admini strative tasks connected 
with the conformity assessment activities in an  appropriate manner and shall have access to 
all necessary equipment or facilities. 
7. The personnel responsible for carrying out conformity assessment activities shall have 
the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to wh ich the conformity assessmen t body has been notified; 
(b) satisfactory knowledge of the requirements  of the assessments they carry out and 
adequate authority to ca rry out those assessments; 
(c) appropriate knowledge and understanding of the essential safety requirements set out 
in Annex I, of the applicable harmonised st andards and of the relevant provisions of 
Union harmonisation legislation and of national legislation; 
(d) the ability to draw up certificates, record s and reports demonstrating that assessments 
have been carried out. 
8. The impartiality of the conformity asse ssment bodies, their top level management and 
of the assessment pers onnel shall be guaranteed.  
EN 40   EN The remuneration of the top level management  and assessment pers onnel of a conformity 
assessment body shall not depend on the number of  assessments carried out or on the results 
of those assessments. 
9. Conformity assessment bodies  shall take out lia bility insurance unless liability is 
assumed by the State in accordance with national law, or the Memb er State itself is directly 
responsible for the conformity assessment. 
10. The personnel of a conformity assessm ent body shall observe professional secrecy 
with regard to all information obtained in ca rrying out their tasks under Article 13(1), (2) and 
(3) of this Directive or any pr ovision of national law giving eff ect to it, except in relation to 
the competent authorities of the Member St ate in which its activities are carried out. 
Proprietary rights shall be protected. 
11. Conformity assessment bodies shall partic ipate in, or ensure that their assessment 
personnel are informed of, the relevant standa rdisation activities and the activities of the 
notified body coordination gr oup established under the re levant 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 subcontrac ting by notified bodies 
1. Where a notified body subcontracts specif ic 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. 
2. Notified bodies shall take full responsibil ity for the tasks performed by subcontractors 
or subsidiaries wherever these are established. 
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement 
of the client. 
4. Notified bodies shall keep at the disposal  of the notifying authority the relevant 
documents concerning the assessment of the qua lifications of the subcontractor or the 
subsidiary and the work carried out by them under Article 13(1), (2) and (3).  
EN 41   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 accreditati on body attesting that the conf ormity assessment body fulfils 
the requirements laid down in Article 21. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and re gular monitoring of its compliance with the 
requirements laid down in Article 21. 
Article 25 [Article R23 of Decision No 768/2008/EC] 
Notification procedure 
1. Notifying authorities may notify only conf ormity assessment bodies which have 
satisfied the requirements laid down in Article 21. 
2. They shall notify the Commission and the ot her Member States using the electronic 
notification tool developed and managed by the Commission. 
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules and ve ssel or vessels concerned and the relevant 
attestation of competence. 
4. Where a notification is not based on an accreditation certificate as referred to in 
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 th e requirements laid down in Article 21. 
5. The body concerned may perform the activ ities 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 accreditati on certificate is used or within  two months of a notification 
where accreditation is not used. 
Only such a body shall be considered a notifie d body for the purposes of this Directive. 
6. The Commission and the othe r Member States shall be notified of any subsequent 
relevant changes to the notification.  
EN 42   EN Article 26 [Article R13 of Decision No 768/2008/EC] 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single such number even wh ere the body is notified under several Union acts. 
2. The Commission shall make publicly available the list of the bodies  notified under this 
Directive, including the identif ication 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 Artic le 21, or that it is failing to fulfil its 
obligations, the notifying authority shall rest rict, suspend or withdraw notification as 
appropriate, depending on the seriousness of the fa ilure to meet those requirements or fulfil 
those obligations. It sh all immediately inform the Commi ssion and the other Member States 
accordingly. 
2. In the event of restriction, suspension or  withdrawal of notification, or where the 
notified body has ceased its activity, the notifyi ng 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 
1. The Commission shall investigate all cases  where it doubts, or doubt  is brought to its 
attention regarding the competence of a notifie d body or the continued fulfilment by a notified 
body of the requirements and responsi bilities to which it is subject. 
2. The notifying Member State shall provide  the Commission, on request, with all 
information relating to the basis for the notifi cation or the maintenance of the competence of 
the body concerned. 
3. The Commission shall ensure that all sensi tive information obtained in the course of 
its investigations is treated confidentially. 
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it  shall inform the notifying Member State  
EN 43   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 
1. Notified bodies shall carry out conformity assessments in accordance with the 
conformity assessment procedures provide d for in Article 13(1), (2) and (3). 
2. Conformity assessments shall be carried  out in a proportionate  manner, avoiding 
unnecessary burdens for economic operators. 
Conformity assessment bodies shall perform their activities taking due acc ount of the size of 
an undertaking, the sector in which it operates, it s 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 nevert heless respect the degree of rigour  and the level of protection 
required for the compliance of the vessel wi th the provisions of this Directive. 
3. Where a notified body finds that the essential safety requirem ents set out in Annex I or 
corresponding harmonised standards have not been met by a manufacturer, it  shall require that 
manufacturer to take appropr iate corrective measures and shall not issue a conformity 
certificate. 
4. Where, in the course of the monitori ng of conformity follo wing the issue of a 
certificate, a notified body finds that a vess el no longer complies, it shall require the 
manufacturer to take appropria te corrective measures and sh all suspend or withdraw the 
certificate if necessary. 
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any cer tificates, as appropriate. 
Article 30  
Appeal against decisions of notified bodies 
Member States shall ensure that an appeal pr ocedure against decisions of notified bodies is 
available. 
Article 31 [Article R28 of Decision No 768/2008/EC] 
Information obligation on notified bodies 
1. Notified bodies shall inform the no tifying authority of the following: 
(a) any refusal, restriction, suspensi on or withdrawal of a certificate;  
EN 44   EN (b) any circumstances affecting the scop e of and conditions for notification; 
(c) any request for information which they have received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activit ies performed within the scope of their 
notification and any other activity perfor med, including cross-border activities and 
subcontracting. 
2. Notified bodies shall provide the other bodi es 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 coope ration between bodies 
notified under this Directive are put in place an d properly operated in the form of a sectoral 
group or groups of notified bodies. 
Member States shall ensure that the bodies notifie d by them participate in the work of that or 
those group or groups, directly or by m eans 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 Regula tion (EC) No 765/2008 shall apply to vessels.  
EN 45   EN Article 35 [Article R31 of Decision No 768/2008/EC] 
Procedure for dealing with vessels p resenting a risk at  national level 
1. Where the market surveillance authoritie s of one Member State have taken action 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason 
to believe that a vessel covered by this Directiv e 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 vess el concerned covering a ll the requirements laid 
down in this Directive. The relevant economic ope rators shall cooperate as necessary with the 
market surveillance authorities. 
Where, in the course of that evaluation, the ma rket surveillance authorit ies find that the vessel 
does not comply with the requirem ents 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 reasonab le period, commensurate with the nature of the risk, as they may 
prescribe. 
The market surveillance author ities 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 authori ties consider that noncompliance is not 
restricted to their national territory, they sh all 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 en sure that all appropriate co rrective action is taken in 
respect of all the vessels concerned that it ha s 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 subparagr aph of paragraph 1, the market surveillance 
authorities shall take all appropr iate provisional measures to pr ohibit or restri ct 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 fo r the identification of the noncomp liant vessel, the origin of the 
vessel, the nature of the noncompliance alleged and the risk involved, th e nature and duration 
of the national measures taken and the argum ents put forward by the relevant economic 
operator. In particular, the market surveillance authoritie s shall indicate whether the non-
compliance is due to either of the following: 
(a) failure of the vessel to meet requirements re lating to the health or safety of persons or 
to other aspects of public interest prot ection laid down in this Directive;  
EN 46   EN (b) shortcomings in the harmonised standa rds referred to in Ar ticle 12 conferring a 
presumption of conformity. 
6. Member States other than the Member St ate initiating the procedure shall without 
delay inform the Commission and the other Memb er 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 w ith the notified national measure, of their 
objections. 
7. Where, within two months of receipt of th e 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. 
8. Member States shall ensure that appropriate  restrictive measures are taken in respect 
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 ou t 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 le gislation, 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 releva nt 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-comp liant vessel is withdrawn from their market, 
and shall inform the Commission accordingly. If the national measure is considered 
unjustified, the Member State concer ned shall withdraw the measure. 
3. Where the national measure is considered  justified and the noncompliance of the 
vessel is attributed to shortcomings in the harm onised 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 inte rest protection, it shall require the relevant 
economic operator to take all appropriate measur es to ensure that th e vessel concerned, when  
EN 47   EN 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 na ture of the risk, as it may 
prescribe. 
2. The economic operator shall ensu re that corrective action is taken in respect of all the 
vessels concerned that he has made av ailable on the market throughout the Union. 
3. The Member State shall immediately info rm the Commission and the other Member 
States. That information shall include all availabl e details, in particular  the data necessary for 
the identification of th e vessel concerned, the origin and th e supply chain of the vessel, the 
nature of the risk involved and the nature and duration of the national measures taken. 
4. The Commission shall without delay enter in to consultation with the Member States 
and the relevant economic opera tor or operators and shall ev aluate the national measures 
taken. On the basis of the results of that ev aluation, the Commission shall decide whether the 
measure is justified or not, and where necessary, propose appropriate measures. 
5. The Commission shall address its decision to  all Member States and shall immediately 
communicate it to them and the releva nt 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 re levant economic operator to put an end to the non-compliance 
concerned: 
(a) the CE marking and/or the inscriptions re ferred to in point 1 of Annex III have been 
affixed in violation of Article 30 of Regul ation (EC) No 765/2008 or of Article 16 of 
this Directive; 
(b) the CE marking and/or the inscriptions provided for in point 1 of Annex III have not 
been affixed; 
(c) the EU declaration of conformity has not been drawn up; 
(d) the EU declaration of conform ity has not been drawn up correctly; 
(e) the technical documentation is eith er not available or not complete. 
2. Where the non-compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appropriate measures to restrict or prohibi t the vessel being made 
available on the market or ensure that it is  recalled or withdrawn from the market.  
EN 48   EN  
Ð 2009/105/EC 
CHAPTER III  
‘CE’ MARKING AND INSCRIPTIONS  
Article 15  
Without prejudice to Article 7:  
 (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 e nd the infringement under the conditions 
imposed by tha t Member State;  
 (b) where the non -conformity continues, the Member State must take all 
appropriate measures to restrict or prohi bit the placing on the ma rket of the product 
in question or to ensure that it is wit hdrawn from the market in accordance with t he 
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 ve ssel or to a data plate attached to the vessel in 
such a way th at it cannot be removed.  
The ‘CE’ marking shall consist of the initials ‘C E’ in the form shown in the specimen in point 
1.1 of Annex II. The ‘CE’ marking shall be foll owed by the identificati on 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 ma rking may be affixed 
to the v essels or the data plate provided that the vi sibility and legibility of the ‘CE’ marking 
are not thereby reduced.   
EN 49   EN  
Ð 2009/105/EC (adapted) 
CHAPTER IV 6 
⌦ TRANSITIONAL AND ⌫ FINAL  PROVISIONS 
 
Ð 2009/105/EC 
Article 17  
Any decision taken pursuant to this Directive which results in restri ctions 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 sh all be notified without de lay to the party concer ned, 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.  
 
Ø 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 eff ective, 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 late st and shall notify it without delay of any 
subsequent amendment affecting them. 
Article 40 
Transitional provisions  
Member States shall not impede the making av ailable 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 pla ced on the market before [the  date set out in the second 
subparagraph of Article 41(1)].  
EN 50   EN Certificates of conformity is sued 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. 
 
Ð  
Article 18 41 
Transposition 
1. Member States shall adopt and publish by [ins ert 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 refere nce to this Directive 
or be accompanied by such a reference on the occas ion 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 Direc tive 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. 
 
Ð 2009/105/EC 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
 
Ð 2009/105/EC (adapted) 
Article 19 42 
⌦ 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 th e 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 .   
EN 51   EN  
Ð 2009/105/EC 
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 I V. 
 
Ð 2009/105/EC (adapted) 
Article 20 43 
⌦ Entry into force  ⌫ 
 
Ð 2009/105/EC 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
 
Ð  
Articles 1, 3, 4, 5 and Annexes I and III shall a pply from [the date set out in the second 
subparagraph of Article 41(1)].  
 
Ð 2009/105/EC (adapted) 
Article 2 44 
⌦ Addressees  ⌫ 
 
Ð 2009/105/EC 
This Directive is addressed to the Member States. 
Done at […], 
For the European Parliament For the Council 
The President The President 
EN 52   EN  
 
Ð 2009/105/EC  
ANNEX I  
ESSENTIAL SAFETY REQUIREMENTS 
 
Ð 2009/105/EC (adapted) 
(referred to in Article 3(1))  
1. MATERIALS 
Materials must  ⌦ shall ⌫ be selected according to the intended use of the vessels and in 
accordance with points 1.1 to 1.4. 
 
Ð 2009/105/EC 
1.1. Pressurised parts 
 
Ð 2009/105/EC (adapted) 
The materials referred to in Article 1  used for manufacturing the pressurised parts of the 
vessels must  ⌦ shall ⌫ be: 
 
Ð 2009/105/EC 
 (a) capable of being welded; 
 (b) ductile and tough, so that a rupture at minimum working temperature does not 
give rise to either fragment ation or brittle-type fracture; 
 (c) not adversely affected by ageing. 
 
Ð 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 a lloy vessels, those se t 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.  
EN 53   EN  
Ð 2009/105/EC 
1.1.1. Steel vessels  
Non-alloy quality steels shall meet the following requirements: 
 
Ð 2009/105/EC (adapted) 
(a) they must  ⌦ shall ⌫ be non-effervescent and supplied after normalisation 
treatment, or in an equivalent state; 
(b) 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 mechanic al 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: 
 
Ð 2009/105/EC 
if test pieces are taken parallel  to the direction of rolling: 
thickness ≥ 3 mm: A ≥ 22 %, 
thickness < 3 mm: A80 mm ≥ 17 %, 
 
if test pieces are taken perpendicu lar to the direction of rolling: 
thickness ≥ 3 mm: A ≥ 20 %, 
thickness < 3 mm: A80 mm ≥ 15 %, 
 
Ð 2009/105/EC (adapted) 
(iii) the average failur e ⌦ 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 thic kness of which exceeds 5 mm, this property must  
⌦ shall ⌫ be checked.  
EN 54   EN 1.1.2. Aluminium vessels 
Non-alloy aluminium must  ⌦ shall ⌫ have an aluminium conten t 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  characteristic s 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: 
 
Ð 2009/105/EC 
– A ≥ 16 % if the test piece is taken pa rallel to the direction of rolling, ; 
– A ≥ 14 % if the test piece is taken pe rpendicular to the direction of 
rolling. 
1.2. Welding materials 
 
Ð 2009/105/EC (adapted) 
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. 
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 th e manufacture of pressurised parts. 
The latter materials must  ⌦ shall ⌫ at minimum working temper ature 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 vesse l, define the use to 
which it will be put, and select:  
EN 55   EN  
Ð 2009/105/EC 
 (a) (i) the minimum working temperature T min; 
 (b) (ii) the maximum working temperature T max; 
 (c) (iii) the maximum working pressure PS. 
 
Ð 2009/105/EC (adapted) 
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: 
(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 stress es 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 equivale nt 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.  
EN 56   EN  
Ð 2009/105/EC 
The actual wall thickness of the cylindrical secti on and ends shall, however, be not less than 
2 mm in the case of steel vessels and not le ss than 3 mm in the case of aluminium or 
aluminium alloy vessels. 
2.1.1.  Calculation method  
 
Ð 2009/105/EC (adapted) 
Ö new 
The minimum thickness of pressurised parts must  ⌦ shall ⌫ be calculated having regard to 
the intensity of the stresses a nd to the following provisions: 
(a) the calculation pressure to  be taken into account must  ⌦ shall ⌫ not be less than 
the maximum working pressure PS selected; 
(b) the permissible general membrane stress must  ⌦ shall ⌫ not exceed the lower of 
the values 0,6 ReT or 0,3 Rm. The manufacturer m ust ⌦ 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 ve ssel has one or more longitudinal welds made 
using a non-automatic welding pr ocess, 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 pr oduction checks in acco rdance with the design 
and manufacturing record referred to in  points  Ö 2,  3 Ö 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 mechan ical characteristics likely to 
be detrimental to the safety of the vessels. 
3.2. Welds on pressurised parts 
The characteristics of we lds and adjacent zones must  ⌦ shall ⌫ be similar to those of the 
welded materials and must  ⌦ shall ⌫ be free of any surface or in ternal defects detrimental 
to the safety of the vessels.  
EN 57   EN Welds must  ⌦ shall ⌫ be performed by qualified weld ers or operators possessing the 
appropriate level of competence, in accordan ce 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, ensu re consistent weld quality 
by conducting appropriate tests using ad equate 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 .  
EN 58   EN  
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 require ments of this Directive that apply to it. ⌫ 
 
Ø new 
1.2. EU-type examination may be carried out  in either of the following manners: 
– examination of a prototype vessel, represen tative of the produc tion envisaged, of the 
complete vessel (production type); 
– assessment of the adequacy of  the technical design of th e vessel through  examination 
of the technical documentation and supporti ng evidence referred to in point 3, 
without examination of a prot otype vessel (design type). 
 
Ð 2009/105/EC (adapted) 
⌦ 1.3. The application for EU-type examina tion shall be lodged by the manufacturer 
or by his authorised representative with a single  notified body in respec t of a prototype vessel 
or of a prototype representing a family of vessels. ⌫ 
⌦ The manufacturer shall lodge an applicati on for EU-type examination with a single 
notified body of his choice. ⌫ 
⌦ The application shall include: ⌫ 
⌦ (a) the name and address of the manufact urer and, if the app lication is lodged by 
the authorised representative, his name and address as well; ⌫ 
 
Ø new 
(b) a written declaration that the same app lication has not been lodged with any other 
notified body; 
(c) the technical documentation. The technica l 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).   
EN 59   EN The technical documentation shall specify th e applicable requireme nts and cover, as 
far as relevant for the assessment, th e design, manufacture and operation of the 
vessel. The technical documentation shall co ntain, 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 th e 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 sa fety 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 ma de, 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 adequ acy of the technical design solution. This 
supporting evidence shall mention any doc uments that have been used, in 
particular where the relevant harmonise d standards have not been applied in 
full. The supporting evidence shall include, where necessary, the results of tests 
carried out by the appropria te laboratory of the ma nufacturer, or by another 
testing laboratory on his behalf  and under his responsibility. 
 
Ð 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 t echnical documentation shall also include: ⌫  
EN 60   EN – ⌦ 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 manufac ture of parts and 
components contributing to the strength of the vessel; ⌫ 
– ⌦ a report on the examinations and tests pe rformed or a description of the proposed 
checks. ⌫ 
 
Ø new 
1.4. The notified body shall:  
For the vessel: 
1.4.1. examine the technical documentation and suppor ting evidence to asse ss 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 wo rking conditions and 
identify the elements which have been designe d in accordance with the applicable provisions 
of the relevant harmonised standards, as well  as the elements which have been designed 
without applying the relevant pr ovisions 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 manufact urer meet the corresponding esse ntial 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 eval uation report that records the activities 
undertaken in accordance with point 1.4 and th eir outcomes. Without prejudice to its 
obligations vis-à-vis the notifyi ng authorities, the notified body sh all 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 no tified body shall issue 
an EU-type examination certificate to the manuf acturer. The certificate shall contain the name 
and address of the manufacturer, the conclusion s of the examination, the conditions (if any) 
for its validity and the necessary data for iden tification of the approve d type. The certificate 
may have one or more annexes attached.  
EN 61   EN 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 indicat e 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 examina tion 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 Dire ctive, and shall determine whether such changes 
require further investigation. If so, the notified body shall info rm the manufacturer 
accordingly. 
The manufacturer shall inform the notified body that holds the technical documentation 
relating to the EU-type examinati on certificate of all modificati ons 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 th e original EU-type examination certificate. 
1.8. Each notified body shall immediately  inform its notifying aut horities concerning the EU-
type examination certificates and/or any additions  thereto which it has issued or withdrawn, 
and shall, periodically or upon request, make avai lable to its notifying au thorities the list of 
certificates and/or any additi ons thereto refused, suspende d or otherwise restricted. 
The Commission, the Member Stat es and the other notified bodi es may, on request, obtain a 
copy of the EU-type examination certificates and/or additions thereto. On request, the 
Commission and the Member St ates may obtain a copy of the technical documentation and 
the results of the examinations carried out by the notified body. The no tified body shall keep a 
copy of the EU-type examination certificate, it s 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 do cumentation at the disposal of the national 
authorities for 10 years after the ve ssel 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 obligatio ns set out in points 1.7 a nd 1.9, provided that they are 
specified in the mandate.  
EN 62   EN  
Ð 2009/105/EC (adapted) 
⌦ 2. C ONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS 
SUPERVISED PRODUCT TESTING (MODULE C1) ⌫ 
 
Ø new 
2.1. Conformity to type based on internal pro duction 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 necessa ry so that the manufacturing process and its 
monitoring to  ensure conformity of the manufactur ed 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 test s 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 th is 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. 
 
Ð 2009/105/EC (adapted) 
⌦ 2.3.2. The notified body shall carry out the appropr iate 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 accordan ce with the following paragraphs: ⌫ 
⌦ (a) The manufacturer shall pr esent his vessels in the form of uniform batches and shall 
take all necessary measures in order th at 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 th e vessels have been 
manufactured and checked in accordance w ith the technical documentation, and shall 
perform a hydrostatic test or a pneumatic test of equivale nt effect on each vessel in  
EN 63   EN the batch at a pressure Ph equal to 1,5 tim es 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-p ieces taken from a 
representative production test-piece or from a vessel, as the manu facturer chooses, in 
order to examine the weld quality. The te sts shall be carried out on longitudinal 
welds. However, where differing weld t echniques 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 e ssential safety requirements set out in point 
2.1.2 of Annex I. ⌫ 
⌦ (f) In the case of accepted batches, th e notified body shall affix its identification 
number, or cause that number to be affi xed, 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 excep t for those which have not successfully 
undergone a hydrostatic test or a pneumatic test. ⌫ 
⌦ (g) If a batch is rejected, th e notified body shall take appropr iate measures to prevent the 
placing on the market of that batch. In the ev ent of frequent rejection of batches, the 
notified body may suspend th e statistical verification. ⌫ 
⌦ (h) The manufacturer shall be able to supply on request the notified body’s cer tificates of 
conformity referred to in th e seventh subparagraph (f). ⌫ 
⌦ 2.4. CE marking and declaration of conformity ⌫ 
 
Ø new 
2.4.1. The manufacturer shall affix the CE marking se t out in this Directive to each individual 
vessel that is in conformity with the type desc ribed in the EU-type examination certificate and 
satisfies the applicable requirements of this Directive. 
2.4.2. The manufacturer shall draw up a written d eclaration of conformity for a vessel model 
and keep it at the disposal of the national auth orities for 10 years after the vessel has been 
placed on the market. The declaration of confor mity shall identify the vessel model for which 
it has been drawn up. 
A copy of the declaration of conformity shall be  made available to th e 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 a nd under his responsibility, provided that they are specified in 
the mandate.  
EN 64   EN 3. C ONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS 
SUPERVISED VESSEL CHECKS AT RANDOM INTERVALS (MODULE C2) 
3.1. Conformity to type based on internal produ ction control plus supe rvised vessel checks at 
random intervals is the part of  a conformity assessment pro cedure 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 Di rective that apply to 
them. 
3.2. Manufacturing 
The manufacturer shall take all measures necessa ry 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. 
 
Ð 2009/105/EC (adapted)  
⌦ 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. ⌫ 
⌦ 3.2.2. The document shall include: ⌫ 
⌦ (a) a description of the means of manufacture and ch ecking appropriate to the 
construction of the vessels; ⌫ 
⌦ (b) an inspection document describing the appropriate examinations and tests to be 
carried out during manufacture, together wi th the procedures in respect thereof and 
the frequency with which th ey 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 ou t on each vessel manuf actured at a test 
pressure equal to 1,5 times the design pressure; ⌫ 
⌦ those examinations and tests shall be carried out under th e responsibility of 
qualified staff who are sufficiently indepe ndent from production personnel, and shall 
be the subject of a report; ⌫ 
⌦ (d) the addresses of the places of manuf acture and storage and the date on which 
manufacture is to commence. ⌫ 
 
Ø new 
3.3. Vessel checks 
A notified body, chosen by the manufacturer, sha ll carry out vessel checks or have them 
carried out at appropriate  intervals determined by the body, in  order to verify the quality of  
EN 65   EN the internal checks on the vessel, ta king 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 placi ng on the market, shall be examined and 
appropriate tests as identified by the relevant pa rts of the harmonised standards or equivalent 
tests, shall be carried out to ch eck the conformity of the vessel with the type described in the 
EU-type examination certificate and with the re levant requirements of this Directive.  
 
Ð 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 notifie d 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 Stat es and the Commission, with a copy of the 
inspection report. ⌫ 
 
Ø new 
Where a sample does not comply with the a cceptable quality level, the body shall take 
appropriate measures. 
The acceptance sampling procedure to be applie d 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 notifie d 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 w ith 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 d eclaration of conformity for a vessel model 
and keep it at the disposal of the national auth orities for 10 years after the vessel has been  
EN 66   EN placed on the market. The declaration of confor mity shall identify the vessel model for which 
it has been drawn up. 
A copy of the declaration of conformity shall be  made available to th e 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 a nd under his responsibility, provided that they are specified in 
the mandate. 
4. C ONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C) 
4.1. Conformity to type based on internal pro duction 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 examinat ion certificate and satisfy the requirements of this Directive 
that apply to them. 
4.2. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactur ed vessels with the approved type described 
in the EU-type examination certificate and with th e requirements of this Directive that apply 
to them. 
Before commencing manufacture, the manufacturer  shall send the notif ied body which issued 
the EU-type examination certific ate a document describing the manufacturing processes and 
all of the predetermined systematic measures take n to ensure conformity of the vessels to the 
EU-type examination certificate. 
 
Ð 2009/105/EC (adapted) 
⌦ The document shall include: ⌫ 
⌦ (a) a description of the means of manufacture and ch ecking appropriate to the 
construction of the vessels; ⌫ 
⌦ (b) an inspection document describing the appropriate examinations and tests to be 
carried out during manufacture, together wi th the procedures in respect thereof and 
the frequency with which th ey are to be performed; ⌫  
EN 67   EN ⌦ (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 ou t on each vessel manuf actured at a test 
pressure equal to 1,5 times the design pressure; ⌫ 
⌦ those examinations and tests shall be carried out under th e 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 manuf acture and storage and the date on which 
manufacture is to commence. ⌫ 
⌦ The notified body which issued the EU-type exam ination certificate shall, before the date 
on which any manufacture begins, examine the doc ument referred to in point 4.2 in order to 
certify its conformity with the EU-type examination certificate. ⌫ 
 
Ø new 
4.3. CE marking and declaration of conformity 
4.3.1. The manufacturer shall affix the CE marki ng 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 d eclaration of conformity for a vessel model 
and keep it at the disposal of the national auth orities for 10 years after the vessel has been 
placed on the market. The declaration of confor mity shall identify the vessel model for which 
it has been drawn up. 
A copy of the declaration of conformity shall be  made available to th e 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 a nd under his responsibility, provided that they are specified in 
the mandate. 
 
Ð 2009/105/EC (adapted) 
ANNEX II I  
EN 68   EN ‘CE’  MARKING,  INSCRIPTIONS,  INSTRUCTIONS,  DESIGN  AND  
MANUFACTURE  SCHEDULES,  DEFINITIONS  AND  SYMBOLS 
1. ‘CE’  ⌦ CE ⌫ MARKING AND INSCRIPTIONS  
 
Ð 2009/105/EC 
1.1.‘CE’ marking  
The ‘CE’ marking shall consist of the initials ‘CE’ in the following form:  
 
If the ‘CE’ marking is reduced or enlarged th e proportions given in th e graduated drawing set 
out in this point must be respected.  
The various components of the ‘CE’ marking mu st have substantiall y the same vertical 
dimension, which may not be less than 5  mm. 
 
Ø new 
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.  
 
Ð 2009/105/EC (adapted) 
1.2.Inscriptions  
⌦ In addition to the CE marking and to the labe lling requirements referred to in Article 6, 
paragraphs 5 and 6, ⌫ Tthe vessel or ⌦ its ⌫ data plate must  ⌦ shall ⌫ bear at least the 
following information: 
 
Ð 2009/105/EC  
 (a) the maximum working pressure (PS in bar); 
 (b) the maximum working temperature (T max in °C);  
EN 69   EN  (c) the minimum working temperature (T min in °C); 
 (d) the capacity of the vessel (V in l L); 
 (e) the name or mark of the manufacturer;  
 (f) the type and serial or ba tch identification of the vessel;  
 
Ð 2009/105/EC (adapted) 
 (g e) the last two digits of the year in which the ‘CE’  ⌦ CE ⌫ marking was 
affixed. 
 
Ð 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. 
2. INSTRUCTIONS ⌦ AND SAFETY INFORMATION ⌫ 
The instructions must  ⌦ shall ⌫ contain the following information: 
 
Ð 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. 
 
Ð 2009/105/EC (adapted) 
They must be in the official language or languages of the country  ⌦ Member State ⌫ of 
destination. 
 
Ð 2009/105/EC 
3. DESIGN AND MANUFACTURING SCHEDULES  
The design and manufacturing schedul es must contain a description o f the techniques and 
operations employed in order to meet the essent ial safety requirements set out in Annex I or 
the harmonised standards referred to in  Article 5(1), and in particular:  
 (a) a detailed manufacturing dr awing of the vessel type;   
EN 70   EN  (b) the in structions;  
 (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, th e schedule must also 
inclu de: 
 (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 press ure 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) The design pressure ‘P’ is the gauge pre ssure chosen by the manuf acturer and used to 
determine the thickness of th e vessel’s pressurised parts. 
(b) The maximum working pressure ‘PS’ is the maximum gauge pressure which may be 
exerted under normal conditions of use of the vessel. 
(c) The minimum working temperature T min is the lowest stabilised temperature which 
the wall of the vessel may attain under normal conditions of use. 
(d) The maximum working temperature T max is the highest stabilised temperature which 
the wall of the vessel may attain under normal conditions of use. 
 
Ð 2009/105/EC (adapted) 
(e) The yield strength ‘ ReT’ is the value at the maximum working temperature T max of 
⌦ any of the following ⌫ : 
 
Ð 2009/105/EC 
(i) the upper yield point ReH, for a material with both a lower and an upper yield 
point, ;  
EN 71   EN  
Ð 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. 
 
Ð 2009/105/EC 
(f) Families of vessels: 
Vessels form part of the same family if th ey differ from the prot otype only in diameter, 
provided that the permissible requirements re ferred to in points 2.1.1 and 2.1.2 of Annex I are 
complied with, and/or in the length of thei r cylindrical portion within the following limits: 
 
Ð 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 tw o dished ends, variants must  ⌦ shall ⌫ have no 
shell rings. 
Variations in length causing the apertures a nd/or penetrations to be modified must  ⌦ shall 
⌫ be shown in the drawing for each variant. 
 
Ð 2009/105/EC 
(g) A batch of vessels consists at the most of 3000 vessels of the model of the same type. 
(h) 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 w ith a common design and using the same 
manufacturing processes. 
(i) Inspection slip: document by which the produ cer certifies that the products delivered 
meet the requirements of the order and in wh ich he sets out the re sults 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.  
EN 72   EN 43.2.Symbols 
 
Ð 2009/105/EC (adapted) 
A elongation after rupture  ⌦ fracture ⌫ (Lo = 
5,65√So) % 
A80 mm elongation after rupture  ⌦ fracture ⌫ (Lo = 
80 mm) % 
KCV ⌦ bending ⌫ rupture energy J/cm2 
P design pressure Bar 
PS maximum working pressure Bar 
Ph hydrostatic or pneumatic test pressure Bar 
Rp0,2 ⌦ 0,2% ⌫ proof stress  ⌦ strength ⌫ at 0,2  % N/mm2 
ReT yield strength at maximum working temperature N/mm2 
ReH upper yield point N/mm2 
Rm tensile strength N/mm2 
Rm, max  maximum tensile strength N/mm2 
Rp1,0 ⌦ 1,0% ⌫ proof stress  ⌦ strength ⌫ at 1,0  % N/mm2 
Tmax maximum working temperature °C 
Tmin minimum working temperature °C 
V capacity of the vessel l L 
 
Ð 2009/105/EC 
ANNEX III  
MINI MUM  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 respons ible for carrying out the 
verification tests shall not be the designer, manufactu rer, supplier or installer of vessels which 
they inspect, nor the authorised representative of  any of those parties. They shall not become  
EN 73   EN directly involved in the desi gn, construction, marketing or main tenance of the vessels, nor 
represent the parties eng aged 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 verifi cation tests with the 
highest degree of professional in tegrity and technical competence and must be free from all 
pressures and inducements, particularly financia l, which might influence their judgment or the 
results of the inspection, especially  from persons or groups of person s 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 verificatio n; 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 require ments of the tests they carry out a nd 
adequate experience of such tests;  
 (c) the ability to draw up the certificat es, 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 li ability insurance unle ss its liability is 
assumed by the State in accordance with national law, or the Memb er State itself is directly 
respons ible 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 a ctivities are carried out) under this 
Directive or any provision of national law giving effect to it.  
 
Ð 2009/105/EC (adapted) 
ANNEX IV  
PART  A 
Repealed Directive with list of its successive amendments  
(referred to in Article 19)  
Council Dir ective 87/404/EEC    
EN 74   EN (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) Article 1, point 1, and Article 2 
only 
 
PART  B 
List of time limits for transposition into n ational 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 
 
Ð 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), fi rst 
subparagraph  
Article 1(2), second subparagraph, first indent  Article 1(3), point (a), second 
                                                 
15 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 se rvice of vessels conforming to the rules in force 
in their territories before 1 July 1990.  
16 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 w ith the marking arrangements in force 
before 1 January 1995.   
EN 75   EN subparagraph  
Article 1(2), second subp aragraph, 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(3), point (a), fourth 
subparagraph  
Article 1(2), second subparagraph, fourth indent  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(1)  
Article 5(2)  Article 5(2)  
Article 5(3), points (a) and (b)  Article 5(3), first and second 
subparagraphs  
Article 6  Article 6  
Article 7(1)  Article 7(1)  
Article 7(2), fi rst and second sentences  Article 7(2), first subparagraph  
Article 7(2), third sentence  Article 7(2), second subparagraph  
Article 7(3)  Article 7(3)  
Article 7(4)  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)  
Article 8(2), point (a)  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 8(4)  
Article 9  Article 9  
Article 10(1)  Article 10(1)  
Article 10(2), first subparagraph  Article 10(2), first subparagraph   
EN 76   EN Article 10(2), second subparagraph, first and 
second indents  Article 10(2), sec ond 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 1 0(3), third subparagraph, points (a) and (b)  Article 10(3), third subparagraph, 
points (a) and (b)  
Article 10(4)  Article 10(4)  
Article 10(5), first sentence  Article 10(5), first subparagraph  
Article 10(5), second and third sentences  Article 10(5), secon d 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), second subparagraph  
Article 11(3), point 3.2  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), po int 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  Arti cle 11(3), tenth subparagraph  
Article 12(1), first subpar agraph, 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)  
Article 13(1), second subparagraph  Article 13(2)  
Article 13(2), indents 1 to 4  Article 13(3), points (a) to (d)   
EN 77   EN Article 14(1)  Article 14, first paragraph  
Article 14(2), first subpar agraph, 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 18  
— Article 19  
— Article 20  
Article 19  Article 21  
Annex I, point 1  Annex I, point 1.  
Annex I, point 1.1, first pa ragraph, 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 pa ragraph, 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 1.1, first, second and 
third paragraphs  
Annex II, point 1.b, first pa ragraph, indents 1 to 7  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 pa ragraph, first, second and 
third indents  Annex II, point 2, first paragraph, 
points (a), (b) and (c)   
EN 78   EN 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 pa ragraph, 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, poin t 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  
— Annex IV  
— Annex V  
⌦ Article 1(1) ⌫ ⌦ Article 1(1), introductory 
wording ⌫ 
⌦ Article 1(2) ⌫ ⌦ Article 1(2) ⌫ 
⌦ Article 1(3) (a) ⌫ ⌦ Article 1(1), points (a) to (e) ⌫ 
⌦ Article 1(3) (b) ⌫ ⌦ — ⌫ 
⌦ Article 2 ⌫ ⌦ Article 3 ⌫ 
⌦ ___ ⌫ ⌦ Article 2 ⌫ 
⌦ Article 3 ⌫ ⌦ Article 4 ⌫ 
⌦ Article 4 ⌫ ⌦ Article 5 ⌫ 
⌦ ___ ⌫ ⌦ Article 6 ⌫ 
⌦ — ⌫ ⌦ Article 7 ⌫ 
⌦ — ⌫ ⌦ Article 8 ⌫ 
⌦ — ⌫ ⌦ Article 9 ⌫ 
⌦ — ⌫ ⌦ Article 10 ⌫ 
⌦ — ⌫ ⌦ Article 11 ⌫ 
⌦ — ⌫ ⌦ Article 12 ⌫ 
⌦ Article 5 ⌫  ⌦ — ⌫  
EN 79   EN ⌦ Article 6 ⌫ ⌦ — ⌫ 
⌦ Article 7 ⌫ ⌦ — ⌫ 
⌦ Article 8 ⌫ ⌦ ___ ⌫ 
⌦ — ⌫ ⌦ Article 13 ⌫ 
⌦ Article 9 ⌫ ⌦ — ⌫ 
⌦ Article 10 ⌫ ⌦ — ⌫ 
⌦ Article 11 (1) and (2) ⌫ ⌦ — ⌫ 
⌦ Article 11 (3) ⌫ ⌦ Point 2.3.2. of Annex II ⌫ 
⌦ Article 12 ⌫ ⌦ — ⌫ 
⌦ Article 13 (1) ⌫ ⌦ Point 3.2.1. of Annex II ⌫ 
⌦ Article 13 (2) ⌫ ⌦ Point 3.2.2. of Annex II ⌫ 
⌦ Article 13 (3) ⌫ ⌦ — ⌫ 
⌦ Article 14, first paragraph ⌫ ⌦ — ⌫ 
⌦ Article 14, second paragraph, introductory 
wording ⌫ ⌦ — ⌫ 
⌦ Article 14, second paragraph (a) ⌫ ⌦ Second paragraph of point 3.3. of 
Annex II ⌫ 
⌦ Article 14, second paragraph (b) ⌫ ⌦ — ⌫ 
⌦ Article 14, third paragraph ⌫ ⌦ — ⌫ 
⌦ — ⌫ ⌦ Article 14 ⌫ 
⌦ — ⌫ ⌦ Article 15 ⌫ 
⌦ — ⌫ ⌦ Article 16 ⌫ 
⌦ — ⌫ ⌦ Article 17 ⌫ 
⌦ — ⌫ ⌦ Article 18 ⌫ 
⌦ — ⌫ ⌦ Article 19 ⌫ 
⌦ — ⌫ ⌦ Article 20 ⌫ 
⌦ — ⌫ ⌦ Article 21 ⌫  
EN 80   EN ⌦ — ⌫ ⌦ 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 15 ⌫ ⌦ — ⌫ 
⌦ Article 16 ⌫ ⌦ — ⌫ 
⌦ Article 17 ⌫ ⌦ — ⌫ 
⌦ — ⌫ ⌦ Article 34 ⌫ 
⌦ — ⌫ ⌦ Article 35 ⌫ 
⌦ — ⌫ ⌦ Article 36 ⌫ 
⌦ — ⌫ ⌦ Article 37 ⌫ 
⌦ — ⌫ ⌦ Article 38 ⌫ 
⌦ — ⌫ ⌦ Article 39 ⌫ 
⌦ — ⌫ ⌦ Article 40 ⌫ 
⌦ Article 18 ⌫ ⌦ Article 41(2) ⌫ 
⌦ — ⌫ ⌦ Article 41(1) ⌫ 
⌦ Article 19 ⌫ ⌦ Article 42 ⌫ 
⌦ Article 20 ⌫ ⌦ Article 43 ⌫  
EN 81   EN ⌦ Article 21 ⌫ ⌦ Article 44 ⌫ 
⌦ Annex I ⌫ ⌦ Annex I ⌫ 
⌦ — ⌫ ⌦ Annex II ⌫ 
⌦ Annex II ⌫ ⌦ Annex III ⌫ 
⌦ Annex III ⌫ ⌦ — ⌫ 
⌦ Annex IV ⌫ ⌦ — ⌫ 
⌦ Annex V ⌫ ⌦ Annex IV ⌫