CELEX: 52011PC0768
Language: en
Date: 2011-11-21
Title: 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

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		52011PC0768
		
			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 /* COM/2011/0768 final - 2011/0350 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
General context, reasons for and
objectives of this proposal 
This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing
a common framework for the marketing of products.
Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products. 
Directive 2009/105/EC is an example of that
Union harmonisation legislation, ensuring the free movement of simple pressure
vessels. It sets out essential safety requirements that simple pressure vessels
must comply with in order to be made available on the EU market. Manufacturers
must demonstrate that a simple pressure vessel has been designed and
manufactured in compliance with the essential safety requirements and affix the
CE marking. 
Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain weaknesses
and inconsistencies in the implementation and enforcement of this legislation,
leading to
–                        
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking
–                        
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules
–                        
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices
–                        
differing practices in the designation of
conformity assessment bodies by national authorities
–                        
problems with the quality of certain notified
bodies
Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.
To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
“New Legislative Framework” was adopted in 2008 as part of the goods
package. Its objective is to strengthen and
complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on
accreditation and market surveillance and Decision No 768/2008/EC
establishing a common framework for the marketing of products.
The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.
The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc). These common provisions have been reinforced to ensure that
the directives can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market. 
The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation. 
However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the improvements
of the NLF, the provisions of the NLF Decision need to be integrated into the
existing product legislation.
A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on
products was due to be revised within the following 3 years, not only to
address the problems observed throughout all sectors but also for
sector-specific reasons. Any such revision would automatically include an
alignment of the legislation concerned to the NLF Decision since Parliament,
Council and Commission have committed themselves to use its provisions as much
as possible in future legislation on products in order to further the utmost
coherence of the regulatory framework. 
For a number of other Union harmonisation
directives, including simple pressure vessels Directive 2009/105/EC no revision
for sector-specific problems had been envisaged within this timeframe. To
ensure that the problems in relation to non-compliance and notified bodies are
nevertheless addressed in these sectors, and for the sake of consistency of the
overall regulatory environment on products, it was decided to align these
directives within a package to the provisions of the NLF Decision.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.
Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.
2.           consultation of interested parties and
impact assessment
Consultation of interested parties
The alignment of Directive 2009/105/EC to
the NLF Decision has been discussed with national experts responsible for the
implementation of this Directive, the notified body group, the administrative
cooperation group as well as in bilateral contacts with industry associations. 
From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at: 
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm
In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf
The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation. Certain concerns were
expressed on some obligations which are, however, indispensable for increasing
the efficiency of market surveillance. These measures will not entail significant
costs for industry, and the benefits resulting from improved market
surveillance should by far outweigh the costs. 
Collection and use of expertise
The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of sector-specific experts and
interest groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.
Impact assessment 
Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.
Option 1 - No changes to the current
situation
This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be
expected from the NLF Regulation.
Option 2 – Alignment to the NLF Decision
by non-legislative measures
Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.
Option 3 – Alignment to NLF Decision by
legislative measures
This option consists in integrating the
provisions of the NLF Decision into the existing directives.
Option 3 was
found to be the preferred option because
–                        
it will improve the competitiveness of companies
and notified bodies taking their obligations seriously, as opposed to those
cheating on the system;
–                        
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as notified bodies;
–                        
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected;
–                        
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;
–                        
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.
3.           Main elements of the proposal
3.1.        Horizontal definitions
The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation. 
3.2.        Obligations of economic
operators and traceability requirements
The proposal clarifies the obligations of manufacturers
and authorised representatives and introduces obligations for importers and
distributors. Importers must verify that the manufacturer has carried out the
applicable conformity assessment procedure and has drawn up a technical
documentation. They must also make sure with the manufacturer that this
technical documentation can be made available to authorities upon request.
Furthermore importers must verify that simple pressure vessels are correctly
marked and accompanied by the instructions and safety information. They must
keep a copy of the Declaration of conformity and indicate their name and
address on the product. Distributors must verify that the simple pressure
vessel bears the CE marking, the name of the manufacturer and of the importer,
if relevant, and that it is accompanied by the required documentation and
instructions.
Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant simple pressure vessels.
Enhanced traceability obligations are introduced for all economic operators. Simple pressure vessels
have to bear the manufacturer’s name and address and a number allowing to
identify and link the simple pressure vessel to its technical documentation. When
a simple pressure vessel is imported the importer’s name and address must also
be on the simple pressure vessel. Furthermore every economic operator must be
able to identify towards authorities the economic operator who has supplied him
with a simple pressure vessel or to whom he has supplied a simple pressure
vessel.
3.3.        Harmonised standards
Compliance with harmonised standards
provides a presumption of conformity with the essential requirements. On 1 June
2011 the Commission adopted a proposal for a Regulation on European
Standardisation[2]
that sets out a horizontal legal framework for European standardisation. The
proposal for the Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation Organisations, on
the procedure for objections to harmonised standards and on stakeholder
participation in the standardisation process. Consequently the provisions of
Directive 2009/105 which cover the same aspects have been deleted in this
proposal for reasons of legal certainty. 
The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
requirements.
3.4.        Conformity assessment and
CE marking
Directive 2009/105/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their simple pressure vessels comply with the
essential safety requirements. The proposal aligns these procedures to their
updated versions set out in the NLF Decision. It keeps some specific elements
already provided for in Directive 2009/105/EC as the welding tests. 
General principles of the CE marking are
set out in Article 30 of Regulation 765/2008, while the detailed provisions on
the affixing of the CE marking to simple pressure
vessels have been inserted in this proposal.
3.5.        Notified Bodies
The proposal reinforces the notification
criteria for notified bodies. It clarifies that subsidiaries or subcontractors
must also comply with the notification requirements. Specific requirements for
notifying authorities are introduced, and the procedure for notification of
notified bodies is revised. The competence of a notified body must be demonstrated
by an accreditation certificate. Where accreditation has not been used to
evaluate the competence of a notified body, the notification must comprise the
documentation demonstrating how the competence of that body has been evaluated.
Member States will have the possibility to object to a notification.
3.6.        Market surveillance and
the safeguard clause procedure
The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant simple pressure vessel is found. A real safeguard clause
procedure – leading to a Decision at Commission level on whether a measure is
justified or not - is only launched when another Member State objects to a
measure taken against a simple pressure vessel. Where there is no disagreement
on the restrictive measure taken, all Member States must take the appropriate
action on their territory.
4.           legal elements of the proposal
Legal basis
The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.
Subsidiarity principle
The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 2009/105/EC, namely, the
importer and distributor obligations, the traceability provisions, the
provisions on the assessment and notification of notified bodies, and the
enhanced cooperation obligations in the context of the revised market
surveillance and safeguard procedures. 
Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.
As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.
Proportionality
In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. 
The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been
identified to have negative impacts, the analysis of the impacts of the option
serves to provide the most proportionate response to the problems identified. A
number of modifications concern the improvement of clarity of the existing
Directive without introducing new requirements that entail added cost. 
Legislative technique used
The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Directive 2009/105/EC.
To ensure the readability of the amended text the technique of recasting has
been chosen in line with the Interinstitutional Agreement of 28 November 2001
on a more structured use of the recasting technique for legal acts[3]. 
The changes made to the provisions of
Directive 2009/105/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, notified bodies, the safeguard clause
procedure and the conformity assessment procedures.
The proposal does not change the scope of
Directive 2009/105/EC and the essential safety requirements. 
5.           budgetary implications
This proposal does not have any
implications for the EU budget.
6.           additional information
Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 2009/105/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
ê 2009/105/EC
(adapted)
2011/0350 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
relating to Ö on the
harmonisation of the laws of the Member States relating to making available on
the market of Õ simple
pressure vessels
(Recast)

(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European
Community Ö on the
Functioning of the European Union Õ , and in
particular Article 95
Ö 114 Õ thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments, 
Having regard to the opinion of the
European Economic and Social Committee[4],
Acting in accordance with the ordinary
legislative procedure, 
Whereas:
ê 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
vessels[5] has
been substantially amended several times. In the interests of clarity and
rationality the said Directive should be codified.
ò 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 vessels[6].
In the interests of clarity, that 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 accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93[7] lays down rules on the
accreditation of conformity assessment bodies, provides a framework for the
market surveillance of products and for controls on products from third
countries, and lays down the general principles of the CE marking.
(3)              
Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products and repealing Council Decision
93/465/EEC[8]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. Directive 2009/105/EC should therefore be adapted
to that Decision.
ê 2009/105/EC
recital 2 (adapted)
(4)              
Member States have the responsibility of ensuring
Ö should
ensure Õ the safety on
their territory of persons, domestic animals and property with regard to the
hazards resulting from the leakage or bursting of simple pressure vessels.
ê 2009/105/EC
recital 3
In each Member
State, mandatory provisions define in particular the safety level required of
simple pressure vessels by specifying design and operating characteristics,
conditions of installation and use and inspection procedures before and
after the placing on the market. These mandatory provisions do not necessarily
lead to different safety levels from one Member State to another but do, by
their disparity, hinder trade within the Community.
ê 2009/105/EC
recital 4 
This Directive
should therefore contain only mandatory and essential requirements. To
facilitate proof of conformity with the essential requirements, it is necessary
to have harmonised standards at Community level, in particular as to the
design, operation and installation of simple
pressure vessels, so that products complying with them may be assumed to
conform to the safety requirements. These standards harmonised at Community
level are drawn up by private bodies and should remain non-mandatory texts. For
that purpose, the European Committee for Standardisation (CEN), the European
Committee for Electrotechnical Standardisation (Cenelec) and the European
Telecommunications Standards Institute (ETSI) are recognised as the competent
bodies for the adoption of harmonised
standards in accordance with the general guidelines[9] for cooperation between the Commission, the
European Free Trade Association (EFTA) and those three bodies signed on 28
March 2003.
ò new
(5)              
Economic operators
should be responsible for the compliance of simple pressure vessels, in
relation to their respective roles in the supply chain, so as to ensure a high
level of protection of public interests, such as health and safety and the
protection of users, and to guarantee fair competition on the Union market.
(6)              
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market simple pressure
vessels which are in conformity with this Directive. It is necessary to provide
for a clear and proportionate distribution of obligations which correspond to
the role of each operator in the supply and distribution process.
ê 2009/105/EC
recital 5 (adapted) 
The Council has already adopted a series of Directives
designed to remove technical barriers to trade in accordance with the
principles established in its Resolution of 7 May 1985 on a new approach to
technical harmonisation and standards[10]; each
of those Directives provides for the affixing of the ‘CE’ marking. The
Commission, in its Communication of 15 June 1989 on a global approach to
certification and testing[11],
proposed that common rules be drawn up concerning a ‘CE’ marking with a single
design. The Council, in its Resolution of 21 December 1989 on a global
approach to conformity assessment[12],
approved as a guiding principle the adoption of a consistent approach such as
this with regard to the use of the ‘CE’ marking. The two basic elements of the
new approach which should be applied are the essential requirements and the
conformity assessment procedures.
ò new
(7)              
The manufacturer,
having detailed knowledge of the design and production process, is best placed
to carry out the complete conformity assessment procedure for simple pressure vessels.
Conformity assessment should therefore remain the obligation of the
manufacturer alone.
(8)              
            It is
necessary to ensure that simple pressure vessels from third countries entering
the Union market comply with the requirements of this Directive, and in particular
that the appropriate assessment procedures have been carried out by
manufacturers with regard to those simple pressure vessels. Provision should
therefore be made for importers to make sure that the simple pressure vessels
they place on the market comply with the requirements of this Directive and
that they do not place on the market simple pressure vessels which do not
comply with such requirements or present a risk. Provision should also be made
for importers to make sure that the conformity assessment procedures have been
carried out and that simple pressure vessel marking and documentation drawn up
by manufacturers are available for inspection by the supervisory authorities.
(9)              
            The
distributor makes a simple pressure vessel available on the market after it has
been placed on the market by the manufacturer or the importer and should act
with due care to ensure that its handling of the simple pressure vessel does
not adversely affect the compliance of the simple pressure vessel. 
(10)          
When placing a simple
pressure vessel on the market, every importer should indicate on the simple
pressure vessel his name and the address at which he can be contacted. 
(11)          
            Any
economic operator that either places a simple pressure vessel on the market
under its own name or trademark or modifies a simple pressure vessel in such a
way that compliance with the requirements of this Directive may be affected
should be considered to be the manufacturer and should assume the obligations of the
manufacturer.
(12)          
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and
should be prepared to participate actively, providing those authorities with
all necessary information relating to the simple pressure vessel concerned.
(13)          
Ensuring traceability
of a simple pressure vessel throughout the whole supply chain helps to make
market surveillance simpler and more efficient. An efficient traceability
system facilitates market surveillance authorities' task of tracing economic
operators who made non compliant simple pressure vessels available on the
market.
(14)          
            This
Directive should be limited to the expression of the essential safety
requirements. In order to facilitate conformity assessment with those requirements
it is necessary to provide for presumption of conformity for products which are
in conformity with harmonised standards that are adopted in accordance with
Regulation (EU) No […/…] of the European Parliament and of the Council of …. on
European Standardisation and amending Council Directives 89/686/EEC and
93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament
and of the Council[13]
for the purpose of expressing detailed technical specifications of those
requirements, in particular as to the design, operation and installation of
simple pressure vessels. 
(15)          
Regulation (EU) No […/…]
[on European Standardisation] provides for a procedure for objections to harmonised
standards where those standards do not entirely satisfy the requirements of
this Directive. 
(16)          
In order to enable
economic operators to demonstrate and the competent authorities to ensure that
simple pressure vessels made available on the market comply with the essential
safety requirements it is necessary to provide for conformity assessment
procedures. Decision No 768/2008/EC establishes modules for conformity
assessment procedures, which include procedures from the least to the most
stringent, in proportion to the level of risk involved and the level of safety
required. In order to ensure inter-sectoral coherence and to avoid ad-hoc
variants, conformity assessment procedures should be chosen from among those
modules.
(17)          
Manufacturers should
draw up an EU declaration of conformity to provide detailed information on the
conformity of a simple pressure vessel with the requirements of this Directive
and of other relevant Union harmonisation legislation.
(18)          
            The CE marking, indicating the conformity
of a simple pressure vessel, is the visible consequence of a whole process
comprising conformity assessment in a broad sense. General principles governing
the CE marking and its relationship to other markings are set out in
Regulation (EC) No765/2008/EC. Rules governing the affixing of the CE
marking should be laid down in this Directive. 
ê 2009/105/EC
recital 6 (adapted)
(19)          
A check on compliance with the relevant technical
Ö essential
safety Õ requirements
is necessary in order to provide effective protection for users and third
parties. The existing inspection procedures differ from one
Member State to another. In order to avoid multiple inspections, which are in
effect barriers to the free movement of vessels, arrangements should be made
for the mutual recognition of inspection procedures by the Member States. In
order to facilitate the mutual recognition of inspection procedures, Community
procedures should be established as well as the criteria for appointing the
bodies responsible for carrying out tests,
surveillance and verification.
ê 2009/105/EC
recital 7
The presence on a
simple pressure vessel of the ‘CE’ marking should raise a presumption that it
satisfies the provisions of this Directive and should therefore make it
unnecessary, upon the importation and putting into service of the vessel, to
repeat the inspections already carried out. Nevertheless simple pressure
vessels might represent a safety hazard. Provision should therefore be made for
a procedure to reduce this hazard.
ò new
(20)          
The conformity
assessment procedures set out in this Directive require the intervention of
conformity assessment bodies, which are notified by the Member States to the
Commission.
(21)          
Experience has shown
that the criteria set out in Directive 2009/105/EC that conformity assessment
bodies have to fulfil to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of notified bodies throughout the
Union. It is, however, essential that all notified bodies perform their
functions to the same level and under conditions of fair competition. That
requires the setting of obligatory requirements for conformity assessment
bodies wishing to be notified in order to provide conformity assessment
services.
(22)          
In order to ensure a
consistent level of conformity assessment quality it is also necessary to set
requirements notifying authorities and other bodies involved in the assessment,
notification and monitoring of notified bodies.
(23)          
            If a
conformity assessment body demonstrates conformity with the criteria laid down
in harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Directive.
(24)          
            The system
set out in this Directive should be complemented by the accreditation system
provided for in Regulation (EC) No 765/2008. Since accreditation is an
essential means of verifying the competence of conformity assessment bodies, it
should also be used for the purposes of notification.
(25)          
Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate
means of carrying out this evaluation themselves. In such cases, in order to
ensure the appropriate level of credibility of evaluations carried out by other
national authorities, they should provide the Commission and the other Member
States with the necessary documentary evidence demonstrating the compliance of
the conformity assessment bodies evaluated with the relevant regulatory
requirements.
(26)          
Conformity assessment
bodies frequently subcontract parts of their activities linked to the
assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the simple pressure vessels to
be placed on the Union market, it is essential that conformity assessment
subcontractors and subsidiaries fulfil the same requirements as notified bodies
in relation to the performance of conformity assessment tasks. Therefore, it is
important that the assessment of the competence and the performance of bodies
to be notified and the monitoring of bodies already notified cover also
activities carried out by subcontractors and subsidiaries.
(27)          
It is necessary to
increase the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online
notification.
(28)          
Since notified bodies
may offer their services throughout the Union, it is appropriate to give the
other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period
during which any doubts or concerns as to the competence of conformity
assessment bodies can be clarified before they start operating as notified
bodies.
(29)          
In the interests of
competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic
operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between notified bodies.
(30)          
In order to ensure
legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of products entering the Union market provided for in
Regulation (EC) No 765/2008 apply to simple pressure vessels. This Directive
should not prevent Member States from choosing the competent authorities to
carry out those tasks.
(31)          
Directive 2009/105/EC
already provides for a safeguard procedure allowing the Commission to examine
the justification for a measure taken by a Member State against simple pressure
vessels it considers to be non-compliant. In order to increase transparency and
to reduce processing time, it is necessary to improve the existing safeguard
procedure, with the aim of making it more efficient and of drawing on expertise
available in the Member States.
(32)          
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to simple pressure
vessels presenting a risk to the health and safety of persons or to other
aspects of public interest protection. It should also allow market surveillance
authorities, in cooperation with the relevant economic operators, to act at an
earlier stage in respect of such simple pressure vessels.
(33)          
Where Member States
and the Commission agree as to the justification for a safeguard measure taken by
a Member State, no further involvement of the Commission should be required, except where non-compliance can be
attributed to shortcomings of a harmonised standard.
(34)          
It is necessary to
provide for transitional arrangements that allow making available on the market
and putting into service simple pressure vessels that have already been placed
on the market in accordance with Directive 2009/105/EC.
(35)          
Member States should
lay down rules on penalties applicable to infringements of the provisions of
national law adopted pursuant to this Directive and ensure that these rules are
implemented. The penalties provided for should be effective, proportionate and
dissuasive.
(36)          
Since
the objective of this Directive, namely to ensure that simple pressure vessels
on the market fulfil the requirements providing a high level of protection of
health and safety and other public interests while guaranteeing the functioning
of the internal market cannot be sufficiently achieved by the Member States and
can therefore, by reason of its scale and effects, be better achieved at Union
level, the Union may adopt measures, in accordance with the principle of
subsidiarity as set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this Directive does not go beyond what is necessary in order to achieve that
objective.
(37)          
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with
Directive 2009/105/EC. The obligation to transpose the provisions which are
unchanged arises under the earlier Directives.
ê 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.,
ê 2009/105/EC
(adapted)
ð new
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I1
SCOPE, DEFINITIONS, PLACING ON THE MARKET AND FREE
MOVEMENT Ö GENERAL
PROVISIONS Õ
Article 1
Ö Scope Õ
1. This Directive Ö shall
apply Õ applies
to simple pressure vessels Ö (hereinafter
vessels) Õ manufactured
in series Ö with the
following characteristics Õ .:
(a)          ‘simple pressure vessel’ or Ö the
vessels are Õ ‘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 Ö are Õ not intended
to be fired.;
(b)          Tthe parts and assemblies Ö components Õ contributing
to the strength of the vessel under pressure shall be Ö are Õ made either of
non-alloy quality steel or of non-alloy aluminium or non-age hardening
aluminium alloys.;
(c)          Tthe vessel shall be Ö is Õ made of either
Ö of the
following Õ:
         (i) a cylindrical part of circular
cross-section closed by inwardly ð outwardly ï 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)          Tthe maximum working pressure of the
vessel shall
Ö does Õ not exceed 30
bar and the product of that pressure and the capacity of the vessel (PS x V) shall Ö does Õ not exceed
10000 bar.lL.;
(e)          Tthe minimum working temperature must be
Ö is Õ no lower than
– 50 °C and the maximum working temperature must Ö is Õ not be
higher than 300 °C for steel and 100 °C for aluminium or aluminium
alloy vessels;.
ê 2009/105/EC
(b) a ‘harmonised
standard’ means a technical specification (European standard or harmonisation
document) adopted by the European Committee for Standardisation (CEN), the
European Committee for Electrotechnical Standardisation (Cenelec) or the
European Telecommunications Standards Institute (ETSI) or by two or three of
those bodies upon a remit from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the
Council of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations and of rules on
Information Society services[14] and the general guidelines for cooperation
between the Commission, the European Free Trade Association (EFTA) and those
three bodies signed on 28 March 2003.
ê 2009/105/EC
(adapted)
2. The following vessels shall be excluded from the
scope of tThis Directive Ö shall not
apply to the following vessels Õ :
ê 2009/105/EC
              (a) vessels specifically
designed for nuclear use, failure of which may cause an emission of
radioactivity;
              (b) vessels specifically
intended for installation in or the propulsion of ships and aircraft;
              (c) fire extinguishers.
ê 2009/105/EC
(adapted)
Article
2 [Article R1 of Decision No 768/2008/EC]
Ö Definitions Õ
3. For the purposes of this Directive the following definitions shall
apply:
ò new
(1) ‘making
available on the market’ means any supply of a vessel for distribution or use
on the Union market in the course of a commercial activity, whether in return
for payment or free of charge;
(2) ‘placing on the
market’ means the first making available of a vessel on the Union market;
(3)
‘manufacturer’ means any natural or legal person who manufactures a vessel or
has a vessel designed or manufactured, and markets that vessel under his name
or trademark;
(4) ‘authorised
representative’ means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;
(5) ‘importer’
means any natural or legal person established within the Union who places a
vessel from a third country on the Union market;
(6) ‘distributor’
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes a vessel available on the market;
(7) ‘economic
operators’ means the manufacturer, the authorised representative, the importer
and the distributor;
(8) ‘technical
specification’ means a document that prescribes technical requirements to be
fulfilled by a vessel;
(9) ‘harmonised
standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation
(EU) No [../..] [on European Standardisation];
(10)
‘accreditation’ means accreditation as defined in Article 2(10) of Regulation
(EC) No 765/2008;
(11) ‘national
accreditation body’ means national accreditation body as defined in Article
2(11) of Regulation (EC) No 765/2008;
(12) ‘conformity
assessment’ means the process demonstrating whether the requirements of this
Directive relating to a vessel have been fulfilled;
(13) ‘conformity
assessment body’ means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;
(14) ‘recall’
means any measure aimed at achieving the return of a vessel that has already
been made available to the user;
(15) ‘withdrawal’
means any measure aimed at preventing a vessel in the supply chain from being
made available on the market;
(16) ‘CE marking’
means a marking by which the manufacturer indicates that the vessel is in
conformity with the applicable requirements set out in Union harmonisation
legislation providing for its affixing;
(17) ‘Union
harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products.
ê 2009/105/EC
(adapted)
ð new
Article 23
Ö Making
available on the market and putting into service Õ
1. Member States shall take all necessary
steps to ensure that the vessels may be placed
ð made available ï on the market and put into service only if they do not compromise
the safety of persons, domestic animals or property when properly installed and
maintained and used for the purposes for which they are intended.
2. The provisions of this Directive shall
not affect the right of Member States to specify — with due observance of the Treaty —
the requirements they deem necessary in order to ensure that workers are
protected when using vessels, provided it does not mean that those vessels are
modified in a way unspecified in this Directive.
Article 34
Ö Essential
requirements Õ
1. Vessels in respect of which the product
of PS x V exceeds 50 bar.L must Ö shall Õ 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 Ö shall Õ be
manufactured in accordance with sound engineering practice in one of the Member
States and bear
markings as laid down in point 1 of Annex III, with the exception of the
‘CE’ marking referred to in Article 16.
Article 45
Ö Free
movement Õ
Member States shall not impede the placing ð making available ï on the market and the putting into service in Ö on Õ their
territory of vessels which satisfy the requirements of this Directive.
ò new
CHAPTER 2
OBLIGATIONS OF
ECONOMIC OPERATORS
Article 6
[Article R2 of Decision No 768/2008/EC]
Obligations of manufacturers
1.         When
placing on the market the vessels of which the product of PS x V exceeds 50
bar.L, manufacturers shall ensure that they have been designed and manufactured
in accordance with the essential safety requirements set out in Annex I.
When placing on the
market vessels of which the product of PS x V is 50 bar.L or less,
manufacturers shall ensure that they have been designed and manufactured in
accordance with the sound engineering practice in one of the Member States. 
2.         For
vessels of which the product of PS x V exceeds 50 bar.L, manufacturers shall
draw up the technical documentation referred to in points 2 and 3 of Annex III
and carry out the relevant conformity assessment procedure referred to in
Article 13 or have it carried out.
Where compliance
of a vessel of which the product of PS x V exceeds 50 bar.L with the applicable
requirements has been demonstrated by that procedure, manufacturers shall draw
up an EU declaration of conformity and affix the CE marking and the
inscriptions provided for in point 1 of Annex III.
Manufacturers
shall ensure that vessels of which the product of PS x V is 50 bar.L or less,
bear the inscriptions laid down in point 1 of Annex III.
3.         Manufacturers
shall keep the technical documentation and the EU declaration of conformity for
10 years after the vessel has been placed on the market.
4.         Manufacturers
shall ensure that procedures are in place for series production to remain in
conformity. Changes in vessels design or characteristics and changes in the
harmonised standards by reference to which conformity of a vessel is declared
shall be adequately taken into account.
When deemed
appropriate with regard to the risks presented by a vessel, manufacturers shall
to protect the health and safety of users, carry out sample testing of vessels
made available on the market, investigate, and, if necessary, keep a register
of complaints, of non-conforming vessels and vessel recalls, and shall keep
distributors informed of any such monitoring.
5.         Manufacturers
shall ensure that their vessels bear a type and serial or batch identification
allowing their identification.
6.         Manufacturers
shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the vessel. The address must
indicate a single point at which the manufacturer can be contacted.
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 with this Directive shall immediately take the
necessary corrective measures to bring that vessel into conformity, to withdraw
it or recall it, if appropriate. Furthermore, where the vessel presents a risk,
manufacturers shall immediately inform the competent national authorities of
the Member States in which they made the vessel available to that effect,
giving details, in particular, of the non-compliance and of any corrective
measures taken.
9.         Manufacturers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of the vessel, in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by vessels which they have placed
on the market.
Article 7 [Article
R3 of Decision No 768/2008/EC]
Authorised representatives
1.         A
manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid
down in Article 6(1) and the drawing up of technical documentation shall not
form part of the authorised representative's mandate.
2.         An
authorised representative shall perform the tasks specified in the mandate
received from the manufacturer. The mandate shall allow the authorised
representative to do at least the following:
(a)          keep
the EU declaration of conformity and the technical documentation at the
disposal of national surveillance authorities for 10 years after the vessel has
been placed on the market;
(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;
(c)          cooperate
with the competent national authorities, at their request, on any action taken
to eliminate the risks posed by vessels covered by the authorised
representative’s mandate.
Article 8
[Article R4 of Decision No 768/2008/EC]
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 appropriate conformity assessment procedure
referred to in Article 6 has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
vessel bears the CE marking and the inscriptions provided for in point 1 of
Annex III and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article 6(5) and
(6).
Where an importer
considers or has reason to believe that a vessel of which the product of PS x V
exceeds 50 bar.L is not in conformity with the essential safety requirements
set out in Annex I, he shall not place the vessel on the market until it has
been brought into conformity. Furthermore, where the vessel presents a risk,
the importer shall inform the manufacturer and the market surveillance
authorities to that effect.
Before placing on
the market a vessel of which the product of PS x V is 50 bar.L or less,
importers shall ensure that it bears the inscriptions provided for in point 1
of Annex III and that the manufacturer has complied with the requirements set
out in Article 6(5) and (6).
3.         Importers
shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the vessel or, where that is not
possible, on its packaging or in a document accompanying the vessel.
4.         Importers
shall ensure that the vessel of which the product of PS x V exceeds 50 bar.L,
is accompanied by the instructions and safety information referred to in point
2 of Annex III, in the official language or languages of the Member State of
destination.
5.         Importers
shall ensure that, while a vessel in respect 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.
6.         When
deemed appropriate with regard to the risks presented by a vessel, importers
shall, to protect the health and safety of users, carry out sample testing of
vessels made available on the market, investigate, and, if necessary, keep a
register of complaints, of non-conforming vessels and vessel recalls, and shall
keep distributors informed of such monitoring.
7.         Importers
who consider or have reason to believe that a vessel which they have placed on
the market is not in conformity with this Directive shall immediately take the
corrective measures necessary to bring that vessel into conformity, to withdraw
it or recall it, if appropriate. Furthermore, where the vessel presents a risk,
importers shall immediately 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 product of PS x V exceeds 50 bar.L, importers shall, for
10 years after the vessel has been placed on the market, keep a copy of the EU
declaration of conformity at the disposal of the market surveillance
authorities and ensure that the technical documentation can be made available
to those authorities, upon request.
9.         Importers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of a vessel in a language which can be easily understood by that
authority. They shall cooperate with that authority, at its request, on any
action taken to eliminate the risks posed by vessels which they have placed on
the market.
Article 9 [Article R5 of Decision No 768/2008/EC]
Obligations of distributors
1.         When
making a vessel available on the market 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 vessel bears the CE marking and
the inscriptions provided for in point 1 of Annex III, that it is accompanied
by the required documents and by instructions and safety information in a
language which can be easily understood by users in the Member State in which
the vessel is to be made available on the market, and that the manufacturer and
the importer have complied with the requirements set out in Article 6(5) and
(6) and Article 8(3).
Where a
distributor considers or has reason to believe that a vessel of which the
product of PS x V exceeds 50 bar.L is not in conformity with the essential
safety requirements set out in Annex I, he shall not make the vessel available
on the market until it has been brought into conformity. Furthermore, where the
vessel presents a risk, the distributor shall inform the manufacturer or the
importer to that effect as well as the market surveillance authorities.
Before making a
vessel of which the product of PS x V is 50 bar.L or less available on the
market, distributors shall verify that the vessel bears the inscriptions provided
for in point 1 of Annex III and that the manufacturer and the importer have
complied with the requirements set out in Article 6(5) and (6) and Article
8(3).
3.         Distributors
shall ensure that, while a vessel of which the product of PS x V exceeds 50 bar.L
is under their responsibility, storage or transport conditions do not
jeopardise its compliance with the essential safety requirements set out in
Annex I.
4.         Distributors
who consider or have reason to believe that a vessel which they have made
available on the market is not in conformity with this Directive shall make
sure that the corrective measures necessary to bring that vessel into
conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the vessel presents a risk, distributors shall immediately
inform the competent national authorities of the Member States in which they
made the vessel available to that effect, giving details, in particular, of the
non-compliance and of any corrective measures taken.
5.         Distributors
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of a vessel. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by vessels which they
have made available on the market.
Article 10 [Article
R6 of Decision No 768/2008/EC]
Cases in which obligations of manufacturers apply to importers and
distributors
An importer or
distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places a vessel on the market under his name or trademark
or modifies a vessel already placed on the market in such a way that compliance
with the requirements of this Directive may be affected.
Article 11 [Article
R7 of Decision No 768/2008/EC]
Identification of economic operators
Economic
operators shall, on request, identify the following to the market surveillance
authorities:
(a)          any
economic operator who has supplied them with a vessel;
(b)          any
economic operator to whom they have supplied a vessel.
Economic
operators shall be able to present the information referred to in the first
subparagraph for a period of 10 years after they have been supplied with the
vessel and for a period of 10 years after they have supplied the vessel.
CHAPTER 3
CONFORMITY OF
VESSELS OF WHICH THE PRODUCT OF PS x V EXCEEDS 50 bar.L
ê 2009/105/EC
(adapted)
Article 512 [Article R8 of Decision No 768/2008/EC]
Ö Presumption of conformity Õ
ò new
Vessels of which
the product of PS x V exceeds 50 bar.L and which are in conformity with
harmonised standards or parts thereof the references of which have been
published in the Official Journal of the European Union shall be
presumed to be in conformity with the essential safety requirements covered by
those standards or parts thereof, set out in Annex I.
[Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex I or Article 21, the Commission shall publish the references
of those standards in the Official Journal of the European Union.] 
ê 2009/105/EC
Member States
shall presume that vessels bearing the CE marking comply with all the
provisions of this Directive.
Conformity of
vessels with the national standards which transpose the harmonised standards,
the reference numbers of which have been published in the Official Journal of the European Union, shall result in a presumption of conformity to
the essential safety requirements set out in Annex I.
Member States
shall publish the reference numbers of such national standards.
2. Member States
shall presume that vessels for which the standards referred to in the second
subparagraph of paragraph 1 do not exist or in respect of which the
manufacturer has not applied or has only partially applied such standards,
comply with the essential safety requirements set out in Annex I, where, after receipt of an EC type-examination certificate,
their conformity with the approved model has been certified by the affixation
of the ‘CE’ marking.
3. Where vessels
are subject to other Directives covering other aspects and which also provide
for the affixing of the ‘CE’ marking, the latter shall indicate that the
vessels in question are also presumed to conform to the provisions of those
other Directives.
However, where one
or more of those Directives allow the manufacturer, during a transitional
period, to choose which arrangements to apply, the ‘CE’ marking shall
indicate conformity only to the Directives applied by the manufacturer. In this
case, particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given in the documents, notices or
instructions required by the Directives and accompanying such vessels.
ê 2009/105/EC
(adapted)
ð new
CHAPTER II
Certification
Section 1 Article13
Certification Ö Conformity assessment Õ procedures
Article 8
1. Prior to production of Ö their
manufacture Õ pressure
vessels of which the product of PS x V exceeds 50 bar.L, manufactured in accordance with the harmonised
standards ð shall be subject to the EU-type
examination (Module B) ï 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, Ö as
follows Õ :
ò new
(a)          for
vessels manufactured in accordance with the harmonised standards referred to in
Article 12, at the choice of the manufacturer, in either of the following two
manners:
ê 2009/105/EC
(a) inform an approved inspection body as referred to in
Article 9, which, after examining the design and manufacturing schedule
referred to in point 3 of Annex II, shall draw up a certificate of adequacy
attesting that the schedule is satisfactory 
ò new
i)       assessment
of the adequacy of the technical design of the vessel through examination of
the technical documentation and supporting evidence without examination of a
specimen (Module B - design type);
ê 2009/105/EC
ð new
(bii)-  ð examination of ï submit a prototype vessel
ð representative of the production
envisaged of the complete vessel ï for the EC type-examination referred to in Article
10 ð Module B – production type) ï .
ê 2009/105/EC
(adapted)
2.(b)       Prior
to production of pressure Ö for Õ vessels of which the product of
PS x V exceeds 50 bar.lL not manufactured, or
manufactured only partly, in accordance with the harmonised standards referred
to in Article 5(1)12,
the manufacturer, or his authorised representative established
within the Community, shall submit Ö for
examination Õ a prototype
vessel for the EC
type-examination referred to in Article 10 Ö representative
of the production envisaged of the complete vessel (Module B – production
type) Õ .
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 Ö placing Õ on the market,
Ö vessels
shall Õ be subject Ö to the
following procedures Õ :
ê 2009/105/EC
ð new
(a)          to the EC
verification referred to in Article 11 where the
product of PS x V exceeds 3000 bar.lL ð , to Module C1 (conformity to type
based on internal production control plus supervised product testing) set out
in point 2 of Annex II ï;
ê 2009/105/EC
(adapted)
ð new
(b)          at the choice of the manufacturer,
where the product of PS x V does not exceed 3000 bar.lL but exceeds 50 ð 200 ï bar.lL,
Ö at the
choice of the manufacturer, to Õ either Ö of the
following modules Õ :
ê 2009/105/EC
ð new
         (i) to the EC
declaration ð Module C1 ï of
(conformity ð to type based on internal production
control plus supervised product testing) ï referred to in Article 12 point 2 of Annex II; or
         (ii) to the EC
verification ð Module C2 (conformity to type based
on internal production control plus supervised product checks at random
intervals ï referred to in Article 11 point 3 Annex II.
ò new
(c)          where
the product of PS x V does not exceed 200 bar.L but exceeds 50 bar.L,
at the choice of the manufacturer, to either of the following modules:
(i) Module C1
(conformity to type based on internal production control plus supervised
product testing) referred to in point 2 of Annex II;
(ii) Module C
(conformity to type based on internal production control) referred to in point
4 of Annex II.
ê 2009/105/EC
(adapted)
43. The records and correspondence relating to the certification
procedures referred to in paragraphs 1 and 2
and
3 shall be drafted in an official language of the Member
State in which the approved
inspection Ö notified Õ body is
established or in a language accepted by that body.
ò 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 Annex I has been demonstrated.
2.         The EU
declaration of conformity shall have 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.
3.         Where
the vessel is subject to more than one Union act requiring an EU declaration of
conformity, a single EU declaration of conformity shall be drawn up in respect
of all such Union acts. That declaration shall contain the identification of
the acts concerned including the publication references. 
4.         By
drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for the compliance of the vessel.
Article 15
[Article R11 of Decision No 768/2008/EC]
General principles of the CE marking
The CE marking
shall be subject to the general principles set out in Article 30 of Regulation
(EC) No 765/2008.
Article 16
[Article R12 of Decision No 768/2008/EC]
Rules and conditions for affixing the CE marking and other markings
1.         The CE
marking and the inscriptions
referred 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 identification 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
number referred to in paragraph 3 may be followed by a pictogram or any other
mark indicating a special risk or use.
ê 2009/105/EC
Article 6
Where a Member
State or the Commission considers that the harmonised standards referred to
in Article 5(1) do not entirely meet the essential safety requirements set out
in Annex I, the Commission or the Member State concerned shall bring the matter
before the standing committee set up under
Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the committee’,
giving the reasons therefor.
The committee
shall deliver an opinion without delay.
In the light of
the committee’s opinion, the Commission shall inform the Member States
whether or not it is necessary to withdraw those standards from the
publications referred to in Article 5(1).
Article 7
1. Where a Member
State finds that vessels bearing the ‘CE’ marking and used in accordance with
their intended purpose might compromise the safety of persons, domestic
animals or property, it shall take all appropriate measures to withdraw those
products from the market or to prohibit or restrict their being placed on the
market.
The Member State
concerned shall immediately inform the Commission of any such measure,
indicating the reasons for its decision, and in particular whether
non-conformity is due to:
          (a)
failure to meet the essential safety requirements set out in Annex I, where the
vessel does not meet the harmonised standards referred to in Article 5(1);
          (b)
incorrect application of the harmonised standards referred to in Article 5(1);
          (c)
shortcomings in the harmonised standards referred to in Article 5(1).
2. The Commission
shall enter into consultation with the parties concerned as soon as
possible. Where, after such consultation, the Commission finds that any measure
as referred to in paragraph 1 is justified, it shall immediately so inform the
Member State that took the action and the other Member States.
Where the decision
referred to in paragraph 1 is attributed to shortcomings in the standards, the
Commission, after consulting the parties concerned, shall bring the matter
before the committee within two months if the Member State which has taken the
measures intends to maintain them and shall
set in motion the procedure referred to in Article 6.
3. Where a vessel
which does not comply bears the ‘CE’ marking, the competent Member State shall
take appropriate action against whomsoever has affixed the marking and shall inform
the Commission and the other Member States thereof.
4. The Commission
shall ensure that the Member States are kept informed of the progress and
outcome of the procedure referred to in paragraphs 1, 2 and 3.
CHAPTER II
CERTIFICATION 
SECTION 1
Certification procedures
Article 9
1. Member States
shall notify the Commission and the other Member States of the approved
inspection bodies which they have appointed to carry out the procedures
referred to in Article 8(1), (2) and (3) together with the specific tasks
which those bodies have been appointed to carry out and the identification
numbers assigned to them beforehand by the Commission.
The Commission
shall publish in the Official
Journal of the European Union a list of the notified bodies with their identification
numbers and the tasks for which they have been notified. The Commission shall
ensure that this list is kept up to date.
2. For the
purposes of approval of the bodies referred to in paragraph 1, Member States
shall meet the minimum criteria set out in Annex III.
3. A Member State
which has approved an inspection body shall withdraw approval if it finds that
the body no longer meets the minimum criteria set out in Annex III.
It shall
immediately inform the Commission and the other Member States accordingly.
SECTION 2
EC type-examination
Article 10
ê 2009/105/EC
(adapted)
1. EC type-examination is the procedure whereby an
approved inspection body ascertains and certifies that a prototype vessel
satisfies the provisions of this Directive which apply to it.
2. The application for EC type-examination shall
be lodged by the manufacturer or by his authorised representative with a single
approved inspection body in respect of a prototype vessel or of a prototype
representing a family of vessels. That authorised representative must be
established in the Community.
The application shall include:
          (a) the name and address of the manufacturer or of
his authorised representative and the place of manufacture of the vessels;
ê 2009/105/EC
          (b) the
design and manufacturing schedule 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 manner
referred to in the second and third subparagraphs.
It shall examine
not only the design and manufacturing schedule in order to check its
conformity, but also the vessel submitted.
When examining the
vessel, the body shall:
          (a)
verify that the vessel has been manufactured in conformity with the design
and manufacturing schedule and may safely be used under its intended working
conditions;
          (b)
perform appropriate examinations and tests to check that the vessel complies
with the essential requirements applicable to it.
4. If the
prototype complies with the provisions applicable to it the approved inspection
body shall draw up an EC type-examination certificate which shall be forwarded
to the applicant. That certificate shall state the conclusions of the examination,
indicate any conditions to which its issue may be subject and be accompanied by
the descriptions and drawings necessary for identification of the approved
prototype.
The Commission,
the other approved inspection bodies and the other Member States may obtain
a copy of the certificate and, on a reasoned request, a copy of the design and
manufacturing schedule and the reports on the examinations and tests carried
out.
5. An approved
inspection body which refuses to issue an EC type-examination certificate
shall so inform the other approved inspection bodies.
An approved
inspection body which withdraws an EC type-examination certificate shall so
inform the Member State which approved it. The latter shall inform the other
Member States and the Commission thereof, giving the reasons for the
decision.
SECTION 3
EC verification
Article 11
1. EC verification
is the procedure whereby a manufacturer or his authorised representative
established within the Community ensures and declares that the vessels which have
been checked in accordance with paragraph 3 are in conformity with the type
described in the EC type-examination certificate or with the design and
manufacturing schedule referred to in point 3 of Annex II having received a
certificate of adequacy.
2. The
manufacturer shall take all necessary measures for the manufacturing process to
ensure that the vessels conform to the type described in the EC
type-examination certificate or to the design and manufacturing schedule
referred to in point 3 of Annex II. The
manufacturer or his authorised representative established within the Community
shall affix the ‘CE’ marking to each vessel and draw up a declaration of
conformity.
ê 2009/105/EC
(adapted)
3. The approved inspection body shall carry out the
appropriate examinations and tests in order to check the conformity of the
vessels with the requirements of this Directive by examination and testing of
vessels in accordance with the second to tenth subparagraphs.
The manufacturer shall present his vessels in
the form of uniform batches and shall take all necessary measures in order that
the manufacturing process ensures the uniformity of each batch produced.
Those batches shall be accompanied by the EC
type-examination certificate referred to in Article 10 or, where the vessels are not manufactured in
accordance with an approved prototype, by the design and manufacturing schedule
referred to in point 3 of Annex II. In the latter case the approved inspection
body shall, prior to EC verification, examine the schedule in order to
certify its conformity.
When a batch is examined, the approved inspection
body shall ensure that the vessels have been manufactured and checked in
accordance with the design and manufacturing schedule, and shall perform a
hydrostatic test or a pneumatic test of equivalent effect on each vessel in
the batch at a pressure Ph equal to 1,5 times the vessel’s design pressure in
order to check its soundness. The pneumatic test shall be subject to acceptance
of the test safety procedures by the Member
State in which the test is performed.
Moreover, the approved inspection body shall carry
out tests on test-pieces taken from a representative production test-piece or
from a vessel, as the manufacturer chooses, in order to examine the weld quality.
The tests shall be carried out on longitudinal welds. However, where differing
weld techniques are used for longitudinal and circular welds, the tests shall
be repeated on the circular welds.
For the vessels referred to in point 2.1.2 of
Annex I, these tests on test-pieces shall be replaced by a hydrostatic test
on five vessels taken at random from each batch in order to check that they
conform to the essential safety requirements set out in point 2.1.2 of Annex I.
In the case of accepted batches, the approved
inspection body shall affix its identification number, or cause that number to
be affixed, to each vessel and shall draw up a written certificate of
conformity relating to the tests carried out. All vessels in the batch may be
placed on the market except for those which
have not successfully undergone a hydrostatic test or a pneumatic test.
If a batch is rejected, the approved inspection
body shall take appropriate measures to prevent the placing on the market of
that batch. In the event of frequent rejection of batches, the approved
inspection body may suspend the statistical verification.
ê 2009/105/EC
The manufacturer
may, under the responsibility of the approved inspection body, affix the
latter’s identification number during the manufacturing process.
ê 2009/105/EC
(adapted)
The manufacturer or his authorised representative must be
able to supply on request the approved inspection body’s certificates of
conformity referred to in the seventh subparagraph.
ê 2009/105/EC
SECTION 4
EC declaration of conformity
Article 12
1. A manufacturer
fulfilling the obligations arising under Article 13 shall affix the ‘CE’
marking provided for in Article 16 to vessels which he declares to be in
conformity with:
          (a) the
design and manufacturing schedule referred to in point 3 of Annex II in respect
of which a certificate of adequacy has been drawn up; or
          (b) an
approved prototype.
2. By the EC
declaration of conformity procedure the manufacturer becomes subject to EC surveillance,
in cases where the product of PS x V exceeds 200 bar.L.
The purpose of EC
surveillance is to ensure, as required by the second paragraph of Article 14,
that the manufacturer duly fulfils the obligations arising under Article 13(2).
Surveillance shall be performed by the approved inspection body which issued
the EC type-examination certificate referred to in the first subparagraph of
Article 10(4) where the vessels have been manufactured in accordance with an
approved prototype or, if this is not the
case, by the approved body to which the design and manufacturing schedule was
sent in accordance with Article 8(1)(a).
Article 13
ê 2009/105/EC
(adapted)
1. Where a manufacturer makes use of the procedure
referred to in Article 12, he shall, before commencing
manufacture, send the approved inspection body which issued the EC type-examination certificate
or the certificate of adequacy a document describing the
manufacturing processes and all of the predetermined systematic measures taken
to ensure conformity of the pressure vessels to the standards referred to in Article 5(1) or the
approved prototype.
2. The document referred to in paragraph 1 shall
include:
          (a) a description of the means of manufacture and
checking appropriate to the construction of the vessels;
          (b) an inspection document describing the
appropriate examinations and tests to be carried out during manufacture,
together with the procedures in respect thereof and the frequency with which
they are to be performed;
          (c) an undertaking to carry out the
examinations and tests in accordance with the inspection document referred to
in point (b) and to have a hydrostatic test or, subject to the agreement of the
Member State, a pneumatic test carried out on each vessel manufactured at a test pressure equal to 1,5 times the design
pressure;
          those examinations and tests shall be carried out
under the responsibility of qualified staff who are sufficiently independent
from production personnel, and shall be the subject of a report;
          (d) the addresses of the places of manufacture
and storage and the date on which manufacture is to commence.
3. When the
product of PS x V exceeds 200 bar.L, manufacturers shall authorise access to the said places of
manufacture and storage by the body responsible for EC surveillance, for
inspection purposes, and shall allow that body to select sample vessels and
shall provide it with all necessary information, and in particular:
          (a) the design and manufacturing schedule;
          (b) the inspection report;
          (c) the EC type-examination certificate or
certificate of adequacy, where appropriate;
          (d) a report on the examinations and tests carried
out.
Article 14
The approved inspection body which issued the EC
type-examination certificate or certificate of adequacy shall, before the
date on which any manufacture begins, examine both the document referred to in
Article 13(1) and the design and manufacturing schedule referred to in point 3
of Annex II, in order to certify its conformity, where vessels are not manufactured in
accordance with an approved prototype.
ê 2009/105/EC
In addition, where
the product of PS x V exceeds 200 bar.L, that body shall during manufacture:
ê 2009/105/EC
(adapted)
          (a) ensure that the manufacturer actually checks
series-produced vessels in accordance with Article 13(2)(c);
          (b) take random samples at the places of
manufacture or at the place of storage of vessels for inspection purposes.
The approved inspection body shall supply the
Member State which approved it and, on request, the other approved
inspection bodies, the other Member States and the Commission, with a copy of
the inspection report.
ò new 
CHAPTER 4
NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES 
Article 17 [Article
R13 of Decision No 768/2008/EC]
Notification
Member States
shall notify the Commission and the other Member States of bodies authorised to
carry out third-party conformity assessment tasks under this Directive.
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 monitoring of notified
bodies, including compliance with the provisions of Article 23.
2.         Member
States may decide that the assessment and monitoring referred to in paragraph 1
shall be carried out by a national accreditation body within the meaning of and
in accordance with Regulation (EC) No 765/2008.
3.         Where
the notifying authority delegates or otherwise entrusts the assessment,
notification or monitoring referred to in paragraph 1 to a body which is not a
governmental entity, that body shall be a legal entity and shall comply mutatis
mutandis with the requirements laid down in Article 19(1) to (6). In
addition it shall have arrangements to cover liabilities arising out of its
activities.
4.         The
notifying authority shall take full responsibility 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 assessment 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 confidentiality of the information it
obtains.
6.         A
notifying authority shall have a sufficient number of competent personnel at
its disposal for the proper performance of its tasks.
Article 20
[Article R16 of Decision No 768/2008/EC]
Information obligation on notifying authorities
Member States
shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, and of any changes thereto.
The Commission
shall make that information publicly available.
Article 21 [Article
R17 of Decision No 768/2008/EC]
Requirements relating to notified bodies
1.         For
the purposes of notification, a conformity assessment body shall meet the requirements
laid down in paragraphs 2 to 11.
2.         A
conformity assessment body shall be established under national law and have
legal personality.
3.         A
conformity assessment body shall be a third-party body independent of the
organisation or the vessel it assesses.
A body belonging
to a business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of vessels which it assesses, may, on condition that its independence and the
absence of any conflict of interest are demonstrated, be considered such a
body.
4.         A
conformity assessment body, its top level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be the
designer, manufacturer, supplier, installer, purchaser, owner, user or
maintainer of the vessels which they assess, nor the authorised representative
of any of those parties. This shall not preclude the use of assessed vessels
that are necessary for the operations of the conformity assessment body or the
use of such vessels for personal purposes.
A conformity
assessment body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in
the design, manufacture or construction, the marketing, installation, use or
maintenance of those products, or represent the parties engaged in those
activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.
Conformity
assessment bodies shall ensure that the activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality
of their conformity assessment activities.
5.         Conformity
assessment bodies and their personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures
and inducements, particularly financial, which might influence their judgement
or the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.
6.         A
conformity assessment body shall be capable of carrying out all the conformity
assessment tasks assigned to it by Article 13(1), (2) and (3) and in relation
to which it has been notified, whether those tasks are carried out by the
conformity assessment body itself or on its behalf and under its
responsibility.
At all times and
for each conformity assessment procedure and each kind or category of vessels
in relation to which it has been notified, a conformity assessment body shall
have at its disposal the necessary:
(a)          personnel
with technical knowledge and sufficient and appropriate 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 appropriate policies and procedures in place that distinguish
between tasks it carries out as a notified body and other activities;
(c)          procedures
for the performance of activities which take due account of the size of an
undertaking, the sector in which it operates, its structure, the degree of
complexity of the product technology in question and the mass or serial nature
of the production process.
It shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.
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 which the conformity assessment body has been notified;
(b)          satisfactory
knowledge of the requirements of the assessments they carry out and adequate
authority to carry out those assessments;
(c)          appropriate
knowledge and understanding of the essential safety requirements set out in
Annex I, of the applicable harmonised standards and of the relevant provisions
of Union harmonisation legislation and of national legislation;
(d)          the
ability to draw up certificates, records and reports demonstrating that
assessments have been carried out.
8.         The
impartiality of the conformity assessment bodies, their top level management
and of the assessment personnel shall be guaranteed.
The remuneration
of the top level management and assessment personnel of a conformity assessment
body shall not depend on the number of assessments carried out or on the
results of those assessments.
9.         Conformity
assessment bodies shall take out liability insurance unless liability is
assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the conformity assessment.
10.       The
personnel of a conformity assessment body shall observe professional secrecy
with regard to all information obtained in carrying out their tasks under
Article 13(1), (2) and (3) of this Directive or any provision of national law
giving effect to it, except in relation to the competent authorities of the
Member State in which its activities are carried out. Proprietary rights shall
be protected.
11.       Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation legislation and apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.
Article 22 [Article
R18 of Decision No 768/2008/EC]
Presumption of conformity
Where a
conformity assessment body demonstrates its conformity with the criteria laid
down in the relevant harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union it
shall be presumed to comply with the requirements set out in Article 21 in so
far as the applicable harmonised standards cover those requirements.
Article 23
[Article R20 of Decision No 768/2008/EC]
Subsidiaries of and subcontracting by notified bodies
1.         Where
a notified body subcontracts specific tasks connected with conformity
assessment or has recourse to a subsidiary, it shall ensure that the
subcontractor or the subsidiary meets the requirements set out in Article 21
and shall inform the notifying authority accordingly.
2.         Notified
bodies shall take full responsibility 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 qualifications of the subcontractor
or the subsidiary and the work carried out by them under Article 13(1), (2) and
(3).
Article 24 [Article
R22 of Decision No 768/2008/EC]
Application for notification
1. A conformity
assessment body shall submit an application for notification to the notifying
authority of the Member State in which it is established.
2. That
application shall be accompanied by a description of the conformity assessment
activities, the conformity assessment module or modules and the vessel or
vessels for which that body claims to be competent, as well as by an
accreditation certificate, where one exists, issued by a national accreditation
body attesting that the conformity assessment body fulfils the requirements
laid down in Article 21.
3. Where the
conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with all the documentary
evidence necessary for the verification, recognition and regular monitoring of
its compliance with the requirements laid down in Article 21.
Article 25 [Article
R23 of Decision No 768/2008/EC]
Notification procedure
1.         Notifying
authorities may notify only conformity assessment bodies which have satisfied
the requirements laid down in Article 21.
2.         They
shall notify the Commission and the other 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 vessel 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 the requirements
laid down in Article 21.
5.         The
body concerned may perform the activities of a notified body only where no
objections are raised by the Commission or the other Member States within two
weeks of a notification where an accreditation certificate is used or within
two months of a notification where accreditation is not used.
Only such a body
shall be considered a notified body for the purposes of this Directive.
6.         The
Commission and the other Member States shall be notified of any subsequent
relevant changes to the notification.
Article 26
[Article R13 of Decision No 768/2008/EC]
Identification numbers and lists of notified bodies
1.         The
Commission shall assign an identification number to a notified body.
It shall assign a
single such number even where the body is notified under several Union acts.
2.         The
Commission shall make publicly available the list of the bodies notified under
this Directive, including the identification numbers that have been allocated
to them and the activities for which they have been notified.
The Commission
shall ensure that that list is kept up to date.
Article 27 [Article
R25 of Decision No 768/2008/EC]
Changes to notifications
1.         Where
a notifying authority has ascertained or has been informed that a notified body
no longer meets the requirements laid down in Article 21, or that it is failing
to fulfil its obligations, the notifying authority shall restrict, suspend or
withdraw notification as appropriate, depending on the seriousness of the
failure to meet those requirements or fulfil those obligations. It shall
immediately inform the Commission and the other Member States accordingly.
2.         In the
event of restriction, suspension or withdrawal of notification, or where the
notified body has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body or kept available for the responsible notifying and market
surveillance authorities at their request.
Article 28 [Article
R26 of Decision No 768/2008/EC]
Challenge of the competence of notified bodies
1.         The
Commission shall investigate all cases where it doubts, or doubt is brought to
its attention regarding the competence of a notified body or the continued
fulfilment by a notified body of the requirements and responsibilities to which
it is subject.
2.         The
notifying Member State shall provide the Commission, on request, with all
information relating to the basis for the notification or the maintenance of
the competence of the body concerned.
3.         The
Commission shall ensure that all sensitive 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 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
provided 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 account of the size
of an undertaking, the sector in which it operates, its structure, the degree
of complexity of the vessel technology in question and the mass or serial
nature of the production process.
In so doing they
shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the vessel with the provisions of this
Directive.
3.         Where
a notified body finds that the essential safety requirements set out in Annex I
or corresponding harmonised standards have not been met by a manufacturer, it
shall require that manufacturer to take appropriate corrective measures and
shall not issue a conformity certificate.
4.         Where,
in the course of the monitoring of conformity following the issue of a
certificate, a notified body finds that a vessel no longer complies, it shall
require the manufacturer to take appropriate corrective measures and shall
suspend or withdraw the certificate if necessary.
5.         Where
corrective measures are not taken or do not have the required effect, the
notified body shall restrict, suspend or withdraw any certificates, as
appropriate.
Article 30 
Appeal against decisions of notified bodies
Member States
shall ensure that an appeal procedure against decisions of notified bodies is
available.
Article 31 [Article
R28 of Decision No 768/2008/EC]
Information obligation on notified bodies
1.         Notified
bodies shall inform the notifying authority of the following:
(a)          any refusal,
restriction, suspension or withdrawal of a certificate;
(b)          any
circumstances affecting the scope of and conditions for notification;
(c)          any
request for information which they have received from market surveillance
authorities regarding conformity assessment activities;
(d)          on
request, conformity assessment activities performed within the scope of their
notification and any other activity performed, including cross-border
activities and subcontracting.
2.         Notified
bodies shall provide the other bodies notified under this Directive carrying
out similar conformity assessment activities covering the same products with
relevant information on issues relating to negative and, on request, positive
conformity assessment results.
Article 32 [Article
R13 of Decision No 768/2008/EC]
Exchange of experience
The Commission
shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.
Article 33
[Article R30 of Decision No 768/2008/EC]
Coordination of notified bodies
The Commission
shall ensure that appropriate coordination and cooperation between bodies
notified under this Directive are put in place and properly operated in the
form of a sectoral group or groups of notified bodies.
Member States
shall ensure that the bodies notified by them participate in the work of that
or those group or groups, directly or by means of designated representatives.
CHAPTER 5
UNION MARKET
SURVEILLANCE, CONTROL OF VESSELS ENTERING THE UNION MARKET AND SAFEGUARD
PROCEDURES
Article 34
Union market surveillance, control of vessels entering the Union market
Article 15(3) and
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to vessels.
Article 35
[Article R31 of Decision No 768/2008/EC]
Procedure for dealing with vessels presenting a risk at national level
1.         Where
the market surveillance authorities of one Member State have taken action
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have
sufficient reason to believe that a vessel covered by this Directive presents a
risk to the health or safety of persons or to other aspects of public interest
protection covered by this Directive, they shall carry out an evaluation in
relation to the vessel concerned covering all the requirements laid down in
this Directive. The relevant economic operators shall cooperate as necessary
with the market surveillance authorities.
Where, in the
course of that evaluation, the market surveillance authorities find that the
vessel does not comply with the requirements laid down in this Directive, they
shall without delay require the relevant economic operator to take all
appropriate corrective action to bring the vessel into compliance with those
requirements, to withdraw the vessel from the market, or to recall it within a
reasonable period, commensurate with the nature of the risk, as they may
prescribe.
The market
surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of
Regulation (EC) No 765/2008 shall apply to the measures referred to in the
second subparagraph.
2.         Where
the market surveillance authorities consider that noncompliance is not
restricted to their national territory, they shall inform the Commission and
the other Member States of the results of the evaluation and of the actions
which they have required the economic operator to take.
3.         The
economic operator shall ensure that all appropriate corrective action is taken
in respect of all the vessels concerned that it has made available on the
market throughout the Union.
4.         Where
the relevant economic operator does not take adequate corrective action within
the period referred to in the second subparagraph of paragraph 1, the market
surveillance authorities shall take all appropriate provisional measures to
prohibit or restrict the vessel’s being made available on their national
market, to withdraw the vessel from that market or to recall it.
The market
surveillance authorities shall inform the Commission and the other Member
States, without delay, of those measures.
5.         The
information referred to in paragraph 4 shall include all available details, in
particular the data necessary for the identification of the noncompliant
vessel, the origin of the vessel, the nature of the noncompliance alleged and
the risk involved, the nature and duration of the national measures taken and
the arguments put forward by the relevant economic operator. In particular, the
market surveillance authorities shall indicate whether the non-compliance is
due to either of the following:
(a)          failure
of the vessel to meet requirements relating to the health or safety of persons
or to other aspects of public interest protection laid down in this Directive;
(b)          shortcomings
in the harmonised standards referred to in Article 12 conferring a presumption
of conformity.
6.         Member
States other than the Member State initiating the procedure shall without delay
inform the Commission and the other Member States of any measures adopted and
of any additional information at their disposal relating to the non-compliance
of the vessel concerned, and, in the event of disagreement with the notified
national measure, of their objections.
7.         Where,
within two months of receipt of the information referred to in paragraph 4, no
objection has been raised by either a Member State or the Commission in respect
of a provisional measure taken by a Member State, that measure shall be deemed
justified.
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 out in Article 35(3) and (4), objections are
raised against a measure taken by a Member State, or where the Commission considers
a national measure to be contrary to Union legislation, the Commission shall
without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measure. On the
basis of the results of that evaluation, the Commission shall decide whether
the national measure is justified or not.
The Commission
shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.
2.         If the
national measure is considered justified, all Member States shall take the
measures necessary to ensure that the non-compliant vessel is withdrawn from
their market, and shall inform the Commission accordingly. If the national
measure is considered unjustified, the Member State concerned shall withdraw
the measure.
3.         Where
the national measure is considered justified and the noncompliance of the
vessel is attributed to shortcomings in the harmonised standards referred to in
Article 35(5)(b) of this Directive, the Commission shall apply the procedure
provided for in Article 8 of Regulation (EU) No […/…] [on European
Standardisation].
Article 37 [Article
R33 of Decision No 768/2008/EC]
Compliant vessels which present a risk to health and safety
1.         Where,
having performed an evaluation under Article 35(1), a Member State finds that
although a vessel is in compliance with this Directive, it presents a risk to
the health or safety of persons or to other aspects of public interest
protection, it shall require the relevant economic operator to take all
appropriate measures to ensure that the vessel concerned, when placed on the
market, no longer presents that risk, to withdraw the vessel from the market or
to recall it within a reasonable period, commensurate with the nature of the
risk, as it may prescribe.
2.         The
economic operator shall ensure that corrective action is taken in respect of
all the vessels concerned that he has made available on the market throughout
the Union.
3.         The
Member State shall immediately inform the Commission and the other Member
States. That information shall include all available details, in particular the
data necessary for the identification of the vessel concerned, the origin and
the supply chain of the vessel, the nature of the risk involved and the nature
and duration of the national measures taken.
4.         The
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measures taken. On the basis of the results of that evaluation, the Commission
shall decide whether the measure is justified or not, and where necessary,
propose appropriate measures.
5.         The
Commission shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.
Article 38 [Article
R34 of Decision No 768/2008/EC]
Formal non-compliance
1.         Without
prejudice to Article 35, where a Member State makes one of the following
findings, it shall require the relevant economic operator to put an end to the
non-compliance concerned:
(a)          the CE
marking and/or the inscriptions referred to in point 1 of Annex III have been
affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article
16 of this Directive;
(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 conformity has not been drawn up correctly;
(e)          the
technical documentation is either 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 prohibit the
vessel being made available on the market or ensure that it is recalled or
withdrawn from the market.
ê 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 end the infringement under the conditions
imposed by that Member State;
          (b)
where the non-conformity continues, the Member State must take all appropriate
measures to restrict or prohibit the placing on the market of the product in
question or to ensure that it is withdrawn from the market in accordance with the
procedure laid down in Article 7.
Article 16
1. The ‘CE’
marking and the inscriptions provided for in point 1 of Annex II, shall be
affixed in a visible, legible and indelible form to the vessel or to a data
plate attached to the vessel in such a way that it cannot be removed.
The ‘CE’ marking
shall consist of the initials ‘CE’ in the form shown in the specimen in point
1.1 of Annex II. The ‘CE’ marking shall be followed by the identification
number referred to in Article 9(1) of the approved inspection body
responsible for ‘CE’ verifications or ‘CE’ surveillance.
2. The affixing on
the vessels of markings which are likely to deceive third parties as to the
meaning and form of the ‘CE’ marking shall be prohibited. Any other marking may
be affixed to the vessels or the data plate provided that the visibility and
legibility of the ‘CE’ marking are not thereby reduced.
ê 2009/105/EC
(adapted)
CHAPTER IV6
Ö TRANSITIONAL
AND Õ FINAL PROVISIONS
ê 2009/105/EC
Article 17
Any decision taken
pursuant to this Directive which results in restrictions on the placing on the
market or the putting into service of a vessel shall state the exact grounds on
which it is based. Such a decision shall be notified without delay to the
party concerned, who shall at the same time be informed of the judicial
remedies available to him under the laws in force in the Member State in
question and of the time limits to which such remedies are subject.
ò new
Article 39
Penalties
Member States
shall lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and shall take all measures
necessary to ensure that they are enforced.
The penalties
provided for shall be effective, proportionate and dissuasive.
Member States
shall notify those provisions to the Commission by [the date set out in the
second subparagraph of Article 41(1)] at the latest and shall notify it without
delay of any subsequent amendment affecting them.
Article 40
Transitional provisions 
Member States
shall not impede the making available on the market and/or the putting into
service of vessels covered by Directive 2009/105/EC which are in conformity
with that Directive and which were placed on the market before [the date set
out in the second subparagraph of Article 41(1)].
Certificates of
conformity issued under Directive 2009/105/EC shall be valid under this
Directive until [the date set out in the second subparagraph of Article 41(1)]
unless they expire before that date.
ê 
Article 1841
Transposition
1.         Member States shall adopt and
publish by [insert date – 2 years after adoption] at the latest, the laws,
regulations and administrative provisions necessary to comply with Articles 2,
6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26,
27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 and Annex II. They
shall forthwith communicate to the Commission the text of those provisions and
a correlation table between those provisions and this Directive.
They shall apply those provisions from [day
after date set out in first subparagraph].
When Member States adopt those provisions,
they shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. They shall also
include a statement that references in existing laws, regulations and
administrative provisions to the directive repealed by this Directive shall be
construed as references to this directive. Member States shall determine how
such reference is to be made and how that statement is to be formulated.
ê 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.
ê 2009/105/EC
(adapted)
Article 1942
Ö Repeal Õ
Directive 87/404/EEC 2009/105/EC , as amended by the Directives listed in Annex IV,
Part A, is repealed Ö with
effect from [day after the date set out in the second subparagraph of Article
41(1)] Õ , 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.

ê 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 IV.
ê 2009/105/EC
(adapted)
Article 2043
Ö Entry into force Õ
ê 2009/105/EC
This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
ê 
Articles 1,
3, 4, 5 and Annexes I and III shall apply from [the date set out in the second
subparagraph of Article 41(1)]. 
ê 2009/105/EC
(adapted)
Article 244
Ö Addressees Õ
ê 2009/105/EC
This
Directive is addressed to the Member States.
Done at […],
For the European Parliament                       For
the Council
The
President                                                 The President
ê 2009/105/EC

ANNEX I
ESSENTIAL
SAFETY REQUIREMENTS
ê 2009/105/EC
(adapted)
(referred
to in Article 3(1))
1. MATERIALS
Materials must Ö shall Õ be selected
according to the intended use of the vessels and in accordance with points 1.1
to 1.4.
ê 2009/105/EC
1.1. Pressurised parts
ê 2009/105/EC
(adapted)
The materials referred to in Article 1 used
for manufacturing the pressurised parts of the vessels must Ö shall Õ be:
ê 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
fragmentation or brittle-type fracture;
              (c)      not adversely affected
by ageing.
ê 2009/105/EC
(adapted)
For steel vessels, the materials must Ö shall Õ in addition
meet the requirements set out in point 1.1.1 and, for aluminium or aluminium
alloy vessels, those set out in point 1.1.2.
They must Ö shall Õ be accompanied
by an inspection slip as described in point
1.3. of Annex II, drawn up by the producer Ö manufacturer Õ of the
materials.
ê 2009/105/EC
1.1.1. Steel vessels
Non-alloy quality steels shall meet the
following requirements:
ê 2009/105/EC
(adapted)
(a)          they must Ö shall Õ be
non-effervescent and supplied after normalisation treatment, or in an
equivalent state;
(b)          the content per product of carbon
must
Ö shall Õ be less than
0,25 % and that of sulphur and phosphorus must Ö shall Õ each be less
than 0,05 %;
(c) they must Ö shall Õ have the
following mechanical properties per product:
(i) the maximum tensile strength Rm,max must Ö shall Õ be less than
580 N/mm2,;
(ii) the elongation after rupture must Ö fracture
shall Õ be:
ê 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 perpendicular to the
direction of rolling:
 thickness ≥ 3 mm: || A || ≥ 20 %, 
 thickness < 3 mm: || A80 mm || ≥ 15 %, 
ê 2009/105/EC
(adapted)
(iii) the average failure Ö bending
rupture Õ energy KCV
for three longitudinal test pieces at minimum working temperature must Ö shall Õ not be less
than 35 J/cm2. Not more than one of the three figures may be
less than 35 J/cm2, with a minimum of 25 J/cm2.
In the case of steels used in the
manufacture of vessels the minimum working temperature of which is lower
than -10 °C and the wall thickness of which exceeds 5 mm, this
property must
Ö shall Õ be checked.
1.1.2. Aluminium vessels
Non-alloy aluminium must Ö shall Õ have an
aluminium content of at least 99,5 % and the alloys referred to in Article
1(3)(a)
1(1)(b) must Ö shall Õ display adequate
resistance to intercrystalline corrosion at maximum working temperature.
Moreover, these materials must Ö shall Õ satisfy the
following requirements:
              (a) they must Ö shall Õ be supplied in
an annealed state; and
              (b) they must Ö shall Õ have the
following mechanical characteristics per product:
–              
the maximum tensile strength Rm,max
must
Ö shall Õ be no more
than 350 N/mm2,;
–              
the elongation after rupture must Ö fracture
shall Õ be:
ê 2009/105/EC
–              
A ≥ 16 %
if the test piece is taken parallel to the direction of rolling,;
–              
A ≥ 14 %
if the test piece is taken perpendicular to the direction of rolling.
1.2. Welding materials
ê 2009/105/EC
(adapted)
The welding materials used to manufacture the
welds on or of the simple
pressure vessel must Ö shall Õ 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
Ö shall Õ be made of a
material specified in point 1.1 or of other kinds of steel, aluminium or an
appropriate aluminium alloy compatible with materials used for the manufacture
of pressurised parts.
The latter materials must Ö shall Õ at minimum
working temperature have an appropriate elongation after rupture Ö fracture Õ and toughness
Ö bending
rupture energy Õ .
1.4. Non-pressurised parts
All unpressurised parts of welded vessels must Ö shall Õ be of
materials which are compatible with that of the components to which they are
welded.
2. VESSEL DESIGN
(a)          The manufacturer must Ö shall Õ, when
designing the vessel, define the use to which it will be put, and select:
ê 2009/105/EC
         (a)(i) the minimum working temperature Tmin;
         (b)(ii) the maximum working temperature Tmax;
         (c)(iii) the maximum working pressure PS.
ê 2009/105/EC
(adapted)
However, should a minimum working
temperature exceeding -10 °C be selected, the qualities required of
the materials must
Ö shall Õ be satisfied
at -10 °C.
(b)          The manufacturer must Ö shall Õ also take
account of the following provisions:
(i)      it must
Ö shall Õ be possible to
inspect the inside of vessels;
(ii)     it must
Ö shall Õ be possible to
drain the vessels;
(iii)     the mechanical qualities must Ö shall Õ be maintained
throughout the period of use of the vessel for the intended purpose;
(iv)    the vessels must Ö shall Õ, bearing in
mind their prescribed use, be adequately protected against corrosion,;
and Ö (c)       The
manufacturer shall take account of Õ the fact that
under the conditions of use envisaged:
(i)      the vessels must Ö shall Õ not be
subjected to stresses likely to impair their safety in use;
(ii)     internal pressure must Ö shall Õ not
permanently exceed the maximum working pressure PS. However, it may momentarily
do so by up to 10 %.
Circular
Ö (d) Circumferential Õ and
longitudinal seams must
Ö shall Õ be made using
full penetration welds or welds of equivalent effectiveness. Convex ends other
than hemispherical ones must Ö shall Õ have a cylindrical
edge.
2.1. Wall thickness
If the product of PS × V is not
more than 3000 bar.L, the manufacturer must Ö shall Õ 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 Ö shall Õ be determined
by the method described in point 2.1.1.
ê 2009/105/EC
The actual wall thickness of the
cylindrical section and ends shall, however, be not less than 2 mm in the
case of steel vessels and not less than 3 mm in the case of aluminium or
aluminium alloy vessels.
2.1.1. Calculation method
ê 2009/105/EC
(adapted)
ð new
The minimum thickness of pressurised parts must Ö shall Õ be calculated
having regard to the intensity of the stresses and to the following provisions:
(a)          the calculation pressure to be
taken into account must
Ö shall Õ not be less
than the maximum working pressure PS selected;
(b)          the permissible general membrane
stress must
Ö shall Õ not exceed the
lower of the values 0,6 ReT or 0,3 Rm.
The manufacturer must
Ö shall Õ use the ReT
and Rm minimum values guaranteed by the material manufacturer
in order to determine the permissible stress.
However, where the cylindrical portion of
the vessel has one or more longitudinal welds made using a non-automatic
welding process, the thickness calculated as referred to in the first paragraph
must
Ö shall Õ be multiplied
by the coefficient 1,15.
2.1.2. Experimental method
Wall thickness must Ö shall Õ be so
determined as to enable the vessels to resist at ambient temperature a pressure
equal to at least five times the maximum working pressure, with a permanent
circumferential deformation factor of no more than 1 %.
3. MANUFACTURING PROCESSES
Vessels shall be constructed and subjected
to production checks in accordance with the design and manufacturing record referred to in points ð 2, ï 3 ð or 4 ï of Annex II.
3.1. Preparation of the component
parts
Preparation of the component parts (for
example forming and chamfering) must Ö shall Õ not give rise
to surface defects or cracks or changes in the mechanical characteristics
likely to be detrimental to the safety of the vessels.
3.2. Welds on pressurised parts
The characteristics of welds and adjacent
zones must
Ö shall Õ be similar to
those of the welded materials and must Ö shall Õ be free of any
surface or internal defects detrimental to the safety of the vessels.
Welds must Ö shall Õ be performed
by qualified welders or operators possessing the appropriate level of
competence, in accordance with approved welding processes. Such approval and
qualification tests must
Ö shall Õ be carried out
by approved
inspection Ö notified Õ bodies.
The manufacturer must Ö shall Õ also, during
manufacture, ensure consistent weld quality by conducting appropriate tests
using adequate procedures. These tests must Ö shall Õ be the subject
of a report.
4. PUTTING INTO SERVICE OF THE VESSELS
Vessels must Ö shall Õ be accompanied
by the instructions drawn up by the manufacturer, as referred to in point 2 of
Annex III.
ANNEX
II
Ö CONFORMITY
ASSESSMENT PROCEDURES Õ
Ö 1.     EU-type
examination module B Õ 
Ö 1.1.            EU-type
examination is the part of a conformity assessment procedure in which notified
body examines the technical design of a vessel and verifies and attests that
the technical design of the vessel meets the requirements of this Directive
that apply to it. Õ
ò new
1.2.      EU-type
examination may be carried out in either of the following manners:
–                        
examination of a
prototype vessel, representative of the production envisaged, of the complete
vessel (production type);
–                        
assessment of the
adequacy of the technical design of the vessel through examination of the
technical documentation and supporting evidence referred to in point 3, without
examination of a prototype vessel (design type).
ê 2009/105/EC
(adapted)
Ö 1.3.            The
application for EU-type examination shall be lodged by the manufacturer or by
his authorised representative with a single notified body in respect of a
prototype vessel or of a prototype representing a family of vessels. Õ
Ö The
manufacturer shall lodge an application for EU-type examination with a single
notified body of his choice. Õ
Ö The
application shall include: Õ
Ö (a)    the
name and address of the manufacturer and, if the application is lodged by
the authorised representative, his name and address as well; Õ
ò new
(b)          a
written declaration that the same application has not been lodged with any
other notified body;
(c)          the
technical documentation. The technical documentation shall make it possible to
assess the vessel's conformity with the applicable requirements of this
Directive and shall include an adequate analysis and assessment of the risk(s).

The technical documentation
shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the vessel. The technical
documentation shall contain, wherever applicable, at least the following
elements:
(i)      a general description
of the vessel;
(ii)     conceptual
design and manufacturing drawings of the type and schemes of components, etc.;
(iii)     descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the product;
(iv)    a list of
the harmonised standards the references of which have been published in the Official
Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential safety requirements of this Directive
where those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;
(v)     results of
design calculations made, examinations carried out, etc.;
(vi)    test
reports;
(vii)    the
prototype vessels representative of the production envisaged. The notified body
may request further prototype vessels if needed for carrying out the test
programme;
(viii)   the
supporting evidence for the adequacy of the technical design solution. This
supporting evidence shall mention any documents that have been used, in
particular where the relevant harmonised standards have not been applied in
full. The supporting evidence shall include, where necessary, the results of
tests carried out by the appropriate laboratory of the manufacturer, or by
another testing laboratory on his behalf and under his responsibility.
ê 2009/105/EC
(adapted)
Ö (ix)           the
instructions; Õ
Ö (x)            a
document describing: Õ
–              
Ö the
materials selected; Õ
–              
Ö the
welding processes selected; Õ
–              
Ö the
checks selected; Õ
–              
Ö any
pertinent details as to the vessel design. Õ
Ö When a
prototype vessel is examined, the technical documentation shall also
include: Õ
–                        
Ö the
certificates relating to the suitable qualification of the welding operations
and of the welders or welding operators; Õ
–                        
Ö the
inspection slip for the materials used in the manufacture of parts and
components contributing to the strength of the vessel; Õ
–                        
Ö a report
on the examinations and tests performed or a description of the proposed checks. Õ
ò new
1.4. The notified
body shall: 
For the vessel:
1.4.1. examine
the technical documentation and supporting evidence to assess the adequacy of
the technical design of the vessel.
For the prototype
vessel(s): 
1.4.2. verify
that the prototype vessels have been manufactured in conformity with the
technical documentation that it may safely be used under its intended working
conditions and identify the elements which have been designed in accordance
with the applicable provisions of the relevant harmonised standards, as well as
the elements which have been designed without applying the relevant provisions
of those standards;
1.4.3. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the manufacturer has chosen to apply the solutions in the relevant
harmonised standards, these have been applied correctly;
1.4.4. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the solutions in the relevant harmonised standards have not been applied,
the solutions adopted by the manufacturer meet the corresponding essential
safety requirements of this Directive;
1.4.5. agree with
the manufacturer on a location where the examinations and tests will be carried
out.
1.5.      The
notified body shall draw up an evaluation report that records the activities
undertaken in accordance with point 1.4 and their outcomes. Without prejudice
to its obligations vis-à-vis the notifying authorities, the notified body shall
release the content of the report, in full or in part, only with the agreement
of the manufacturer.
1.6.      Where
the type meets the requirements of this Directive, the notified body shall issue
an EU-type examination certificate to the manufacturer. The certificate shall
contain the name and address of the manufacturer, the conclusions of the
examination, the conditions (if any) for its validity and the necessary data
for identification of the approved type. The certificate may have one or more
annexes attached.
The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured vessels with the examined type to be evaluated and to allow for
in-service control. It shall also indicate any conditions to which its issue
may be subject and be accompanied by the descriptions and drawings necessary
for identification of the approved type.
Where the type
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue an EU-type examination certificate and shall inform
the applicant accordingly, giving detailed reasons for its refusal.
1.7. The notified
body shall keep itself apprised of any changes in the generally acknowledged
state of the art which indicate that the approved type may no longer comply
with the applicable requirements of this Directive, and shall determine whether
such changes require further investigation. If so, the notified body shall
inform the manufacturer accordingly.
The manufacturer
shall inform the notified body that holds the technical documentation relating
to the EU-type examination certificate of all modifications to the approved
type that may affect the conformity of the vessel with the essential safety
requirements of this Directive or the conditions for validity of the
certificate. Such modifications shall require additional approval in the form
of an addition to the original EU-type examination certificate.
1.8. Each
notified body shall immediately inform its
notifying authorities concerning the EU-type examination certificates and/or
any additions thereto which it has issued or withdrawn, and shall, periodically
or upon request, make available to its notifying authorities the list of
certificates and/or any additions thereto refused, suspended or otherwise
restricted.
The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU-type examination certificates and/or additions thereto. On request,
the Commission and the Member States may obtain a copy of the technical
documentation and the results of the examinations carried out by the notified
body. The notified body shall keep a copy of the EU-type examination
certificate, its annexes and additions, as well as the technical file including
the documentation submitted by the manufacturer, until the expiry of the
validity of the certificate.
1.9. The
manufacturer shall keep a copy of the EU-type examination certificate, its
annexes and additions together with the technical documentation at the disposal
of the national authorities for 10 years after the vessel has been placed on
the market.
1.10. The
manufacturer's authorised representative may lodge the application referred to
in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided
that they are specified in the mandate.
ê 2009/105/EC
(adapted)
Ö 2.     Conformity
to type based on internal production control plus supervised product testing
(Module C1) Õ
ò new
2.1. Conformity
to type based on internal production control is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility
that the vessels concerned are in conformity with the type described in the EU-type
examination certificate and satisfy the requirements of this Directive that
apply to them.
2.2.
Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring to ensure conformity of the manufactured vessels with the
approved type described in the EU-type examination certificate and with the
requirements of this Directive that apply to them. 
2.3.      Product
checks 
2.3.1. For each
individual vessel manufactured one or more tests on one or more specific
aspects of the vessel shall be carried out by the manufacturer or on his
behalf, in order to verify conformity with the type described in the EU-type examination
certificate and with the corresponding requirements of this Directive. The
tests shall be carried out under the responsibility of a notified body, chosen
by the manufacturer.
The manufacturer
shall, under the responsibility of the notified body, affix the notified body’s
identification number during the manufacturing process.
ê 2009/105/EC
(adapted)
Ö 2.3.2.
The notified body shall carry out the appropriate examinations and tests
in order to check the conformity of the vessels with the requirements of this
Directive by examination and testing of vessels in accordance with the
following paragraphs: Õ
Ö (a)    The
manufacturer shall present his vessels in the form of uniform batches and shall
take all necessary measures in order that the manufacturing process ensures the
uniformity of each batch produced. Õ
Ö (b)    Those
batches shall be accompanied by the EU-type examination certificate. Õ
Ö (c)    When
a batch is examined, the notified body shall ensure that the vessels have
been manufactured and checked in accordance with the technical documentation,
and shall perform a hydrostatic test or a pneumatic test of equivalent effect
on each vessel in the batch at a pressure Ph equal to 1,5 times the vessel’s
design pressure in order to check its strength. The pneumatic test shall be
subject to acceptance of the test safety procedures by the Member State in
which the test is performed. Õ
Ö (d)    Moreover,
the notified body shall carry out tests on test-pieces taken from a
representative production test-piece or from a vessel, as the manufacturer
chooses, in order to examine the weld quality. The tests shall be carried out
on longitudinal welds. However, where differing weld techniques are used for
longitudinal and circumferential welds, the tests shall be repeated on the
circumferential welds. Õ
Ö (e)    For
the vessels referred to in point 2.1.2 of Annex I, these tests on test-pieces
shall be replaced by a hydrostatic test on five vessels taken at random from
each batch in order to check that they conform to the essential safety
requirements set out in point 2.1.2 of Annex I. Õ
Ö (f)     In
the case of accepted batches, the notified body shall affix its
identification number, or cause that number to be affixed, to each vessel and
shall draw up a written certificate of conformity relating to the tests carried
out. All vessels in the batch may be placed on the market except for those
which have not successfully undergone a hydrostatic test or a pneumatic
test. Õ
Ö (g)    If
a batch is rejected, the notified body shall take appropriate measures to
prevent the placing on the market of that batch. In the event of frequent
rejection of batches, the notified body may suspend the statistical
verification. Õ
Ö (h)    The
manufacturer shall be able to supply on request the notified body’s
certificates of conformity referred to in the seventh subparagraph (f). Õ
Ö 2.4. CE
marking and declaration of conformity Õ
ò new
2.4.1.
The manufacturer shall affix the CE marking set out in this Directive to each
individual vessel that is in conformity with the type described in the EU-type
examination certificate and satisfies the applicable requirements of this
Directive.
2.4.2. The
manufacturer shall draw up a written declaration of conformity for a vessel
model and keep it at the disposal of the national authorities for 10 years
after the vessel has been placed on the market. The declaration of conformity
shall identify the vessel model for which it has been drawn up.
A copy of the declaration of conformity shall be made
available to the relevant authorities upon request.
2.5. Authorised
representative
The
manufacturer's obligations set out in point 2.4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
3.           Conformity to type based on internal production
control plus supervised vessel checks at random intervals (Module C2)
3.1. Conformity
to type based on internal production control plus supervised vessel checks at
random intervals is the part of a conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 3.2, 3.3 and 3.4, and
ensures and declares on his sole responsibility that the vessels concerned are
in conformity with the type described in the EU-type examination certificate
and satisfy the requirements of this Directive that apply to them.
3.2.
Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured vessels with the type
described in the EU-type examination certificate and with the requirements of
this Directive.
ê 2009/105/EC
(adapted) 
Ö 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. Õ
Ö 3.2.2.
The document shall include: Õ
Ö (a)    a
description of the means of manufacture and checking appropriate to the
construction of the vessels; Õ
Ö (b)    an
inspection document describing the appropriate examinations and tests to be
carried out during manufacture, together with the procedures in respect thereof
and the frequency with which they are to be performed; Õ
Ö (c)    an
undertaking to carry out the examinations and tests in accordance with the
inspection document and to have a hydrostatic test or, subject to the agreement
of the Member State, a pneumatic test carried out on each vessel manufactured
at a test pressure equal to 1,5 times the design pressure; Õ
Ö those
examinations and tests shall be carried out under the responsibility of
qualified staff who are sufficiently independent from production personnel, and
shall be the subject of a report; Õ
Ö (d)    the
addresses of the places of manufacture and storage and the date on which
manufacture is to commence. Õ
ò new
3.3. Vessel
checks
A notified body,
chosen by the manufacturer, shall carry out vessel checks or have them carried
out at appropriate intervals determined by
the body, in order to verify the quality of the internal checks on the vessel,
taking into account, inter alia, the technological complexity of the
vessels and the quantity of production. An adequate sample of the final
vessels, taken on site by the notified body before the placing on the market,
shall be examined and appropriate tests as identified by the relevant parts of
the harmonised standards or equivalent tests, shall be carried out to check the
conformity of the vessel with the type described in the EU-type examination
certificate and with the relevant requirements of this Directive. 
ê 2009/105/EC
(adapted)
Ö The
notified body shall also ensure that the manufacturer actually checks
series-produced vessels in accordance with point 3.2 c); Õ
Ö The manufacturer
shall provide the notified body with all necessary information, and in
particular: Õ
Ö (a)    the
technical documentation; Õ
Ö (b)    the
inspection report; Õ
Ö (c)    the
EU-type examination certificate; Õ 
Ö (d)    a
report on the examinations and tests carried out. Õ
Ö The
notified body shall supply the Member State which notified it and, on
request, the other notified bodies, the other Member States and the Commission,
with a copy of the inspection report. Õ
ò new
Where a sample
does not comply with the acceptable quality level, the body shall take
appropriate measures.
The acceptance
sampling procedure to be applied is intended to determine whether the
manufacturing process of the vessel performs within acceptable limits, with a
view to ensuring conformity of the vessel.
Where the tests
are carried out by notified body, the manufacturer shall, under the
responsibility of the notified body, affix the notified body's identification
number during the manufacturing process.
3.4. CE marking
and declaration of conformity
3.4.1. The
manufacturer shall affix the CE marking set out in this Directive to each
individual vessel that is in conformity with the type described in the EU-type
examination certificate and satisfies the applicable requirements of this
Directive.
3.4.2. The
manufacturer shall draw up a written declaration of conformity for a vessel
model and keep it at the disposal of the national authorities for 10 years
after the vessel has been placed on the market. The declaration of conformity
shall identify the vessel model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
A copy of the
declaration shall be supplied with each vessel that is placed on the market.
However, this requirement may be interpreted as applying to a batch or
consignment rather than individual vessels in those cases where a large number
of vessels is delivered to a single user.
3.5. Authorised
representative
The
manufacturer's obligations set out in point 3.4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
4.           Conformity to type
based on internal production control (Module C)
4.1. Conformity
to type based on internal production control is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 4.2 and 4.3, and ensures and declares that the vessels concerned are
in conformity with the type described in the EU-type examination certificate
and satisfy the requirements of this Directive that apply to them.
4.2.
Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured vessels with the approved type
described in the EU-type examination certificate and with the requirements of
this Directive that apply to them.
Before commencing
manufacture, the manufacturer shall send the notified body which issued
the EU-type examination certificate a document describing the
manufacturing processes and all of the predetermined systematic measures taken
to ensure conformity of the vessels to the EU-type examination certificate.
ê 2009/105/EC
(adapted)
Ö The document
shall include: Õ
Ö (a)    a
description of the means of manufacture and checking appropriate to the
construction of the vessels; Õ
Ö (b)    an
inspection document describing the appropriate examinations and tests to be
carried out during manufacture, together with the procedures in respect thereof
and the frequency with which they are to be performed; Õ
Ö (c)    an
undertaking to carry out the examinations and tests in accordance with the
inspection document and to have a hydrostatic test or, subject to the agreement
of the Member State, a pneumatic test carried out on each vessel manufactured
at a test pressure equal to 1,5 times the design pressure; Õ
Ö those
examinations and tests shall be carried out under the responsibility of
qualified staff who are independent from production personnel, and shall be the
subject of a report; Õ
Ö (d)    the
addresses of the places of manufacture and storage and the date on which
manufacture is to commence. Õ
Ö The
notified body which issued the EU-type examination certificate shall,
before the date on which any manufacture begins, examine the document referred
to in point 4.2 in order to certify its conformity with the EU-type examination
certificate. Õ
ò new
4.3. CE marking
and declaration of conformity
4.3.1. The
manufacturer shall affix the CE marking to each individual vessel that is in
conformity with the type described in the EU-type examination certificate and
satisfies the applicable requirements of this Directive.
4.3.2. The
manufacturer shall draw up a written declaration of conformity for a vessel
model and keep it at the disposal of the national authorities for 10 years
after the vessel has been placed on the market. The declaration of conformity
shall identify the vessel model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
A
copy of the declaration shall be supplied with each vessel that is placed on
the market. However, this requirement may be interpreted as applying to a batch
or consignment rather than individual vessels in those cases where a large
number of vessels is delivered to a single user.
4.4. Authorised
representative
The
manufacturer's obligations set out in point 4.3 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ê 2009/105/EC
(adapted)
ANNEX III
‘CE’ MARKING,
INSCRIPTIONS, INSTRUCTIONS, DESIGN AND MANUFACTURE SCHEDULES,
DEFINITIONS AND SYMBOLS
1. ‘CE’ Ö CE Õ MARKING
AND INSCRIPTIONS 
ê 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 the proportions given in the graduated drawing
set out in this point must be respected.
The various
components of the ‘CE’ marking must have substantially the same vertical
dimension, which may not be less than 5 mm.
ò 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. 
ê 2009/105/EC
(adapted)
1.2.Inscriptions
Ö In
addition to the CE marking and to the labelling requirements referred to in
Article 6, paragraphs 5 and 6, Õ Tthe vessel or Ö its Õ data plate must Ö shall Õ bear at least
the following information:
ê 2009/105/EC

              (a)      the maximum working
pressure (PS in bar);
              (b)     the maximum working
temperature (Tmax in °C);
              (c)      the minimum working temperature
(Tmin in °C);
              (d)     the capacity of the
vessel (V in lL);
              (e) the name or
mark of the manufacturer;
              (f) the type and
serial or batch identification of the vessel;
ê 2009/105/EC
(adapted)
              (ge)    the last two digits of the year in
which the ‘CE’
Ö CE Õ marking was
affixed.
ê 2009/105/EC
(adapted)
Where the data plate is used, it must Ö shall Õ be so designed
that it cannot be reused and must Ö shall Õ include a
vacant space to enable other information to be provided.
2. INSTRUCTIONS Ö AND
SAFETY INFORMATION Õ
The instructions must Ö shall Õ contain the
following information:
ê 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.
ê 2009/105/EC
(adapted)
They must be in the official language or
languages of the country
Ö Member
State Õ of
destination.
ê 2009/105/EC
3. DESIGN AND MANUFACTURING SCHEDULES
The design and
manufacturing schedules must contain a description of the techniques and
operations employed in order to meet the essential safety requirements set out
in Annex I or the harmonised standards referred to in Article 5(1), and in
particular:
          (a) a
detailed manufacturing drawing of the vessel type;
          (b) the
instructions;
          (c) a
document describing:
the materials
selected,
the welding
processes selected,
the checks
selected,
any pertinent
details as to the vessel design.
When the
procedures laid down in Articles 11 to 14 are applied, the schedule must also
include:
          (a) the
certificates relating to the suitable qualification of the welding operations
and of the welders or operators;
          (b) the
inspection slip for the materials used in the manufacture of parts and
assemblies contributing to the strength of the pressure vessel;
          (c) a
report on the examinations and tests performed or a description of the proposed
checks.
43. DEFINITIONS AND SYMBOLS
43.1.Definitions
(a)          The design pressure ‘P’ is the
gauge pressure chosen by the manufacturer and used to determine the thickness
of the 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 Tmin
is the lowest stabilised temperature which the wall of the vessel may attain
under normal conditions of use.
(d)          The maximum working temperature Tmax
is the highest stabilised temperature which the wall of the vessel may attain
under normal conditions of use.
ê 2009/105/EC
(adapted)
(e)          The yield strength ‘ReT’
is the value at the maximum working temperature Tmax of Ö any of
the following Õ :
ê 2009/105/EC
(i)      the upper yield point ReH, for a material
with both a lower and an upper yield point,;
ê 2009/105/EC
(adapted)
(ii)     the Ö 0,2% Õ proof stress Ö strength Õ Rp0,2
,; or
(iii)     the Ö 1,0% Õ proof stress Ö strength Õ Rp1,0
in the case of non-alloy aluminium.
ê 2009/105/EC
(f)           Families of vessels:
Vessels form part of the same family if
they differ from the prototype only in diameter, provided that the permissible
requirements referred to in points 2.1.1 and 2.1.2 of Annex I are complied
with, and/or in the length of their cylindrical portion within the following
limits:
ê 2009/105/EC
(adapted)
(i)      where a prototype has one or more shell rings in addition to
the ends, variants must
Ö shall Õ have at least
one shell ring,;
(ii)     where a prototype has just two dished ends, variants must Ö shall Õ have no shell
rings.
Variations in length causing the apertures
and/or penetrations to be modified must Ö shall Õ be shown in
the drawing for each variant.
ê 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 with a common design and using the same manufacturing processes.
(i)           Inspection slip: document by
which the producer certifies that the products delivered meet the requirements
of the order and in which he sets out the results of the routine in-plant
inspection test, in particular chemical composition and mechanical
characteristics performed on products made by the same production process as
the supply, but not necessarily on the products delivered.
43.2.Symbols
ê 2009/105/EC
(adapted)
 A || elongation after rupture Ö fracture Õ (Lo = 5,65√So) || % 
 A80 mm || elongation after rupture Ö fracture Õ (Lo = 80 mm) || % 
 KCV || Ö bending Õ rupture energy || J/cm2 
 P || design pressure || Bar 
 PS || maximum working pressure || Bar 
 Ph || hydrostatic or pneumatic test pressure || Bar 
 Rp0,2 || Ö 0,2% Õ proof stress Ö strength Õ 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 || Ö 1,0% Õ proof stress Ö strength Õ at 1,0 % || N/mm2 
 Tmax || maximum working temperature || °C 
 Tmin || minimum working temperature || °C 
 V || capacity of the vessel || lL 
ê 2009/105/EC
ANNEX
III
MINIMUM
CRITERIA TO BE MET BY MEMBER STATES FOR THE APPROVAL OF INSPECTION BODIES
(referred to in Article 9(2))
1. The approved
inspection body, its director and the staff responsible for carrying out the
verification tests shall not be the designer, manufacturer, supplier or
installer of vessels which they inspect, nor the authorised representative of
any of those parties. They shall not become directly involved in the design,
construction, marketing or maintenance of the vessels, nor represent the
parties engaged in those activities. This
does not preclude the possibility of exchanges of technical information between
the manufacturer and the approved inspection body.
2. The approved
inspection body and its staff must carry out the verification tests with the highest
degree of professional integrity and technical competence and must be free from
all pressures and inducements, particularly financial, which might influence
their judgment or the results of the inspection, especially from persons or
groups of persons with an interest in the
result of verifications.
3. The approved
inspection body must have at its disposal the necessary staff and the necessary
facilities to enable it to perform properly the administrative and technical
tasks connected with verification; it must also have access to the equipment
required for special verification.
4. The staff
responsible for inspection must have:
          (a)
sound technical and professional training;
          (b)
satisfactory knowledge of the requirements of the tests they carry out and
adequate experience of such tests;
          (c) the
ability to draw up the certificates, records and reports required to
authenticate the performance of the tests.
5. The
impartiality of inspection staff must be guaranteed. Their remuneration must
not depend on the number of tests carried out or on the results of such
tests.
6. The approved
inspection body must take out liability insurance unless its liability is
assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the tests.
7. The staff of
the approved inspection body is bound to observe professional secrecy with
regard to all information gained in carrying out its tasks (except vis-à-vis
the competent administrative authorities of the State in which its activities
are carried out) under this Directive or any provision of national law giving
effect to it.
ê 2009/105/EC
(adapted)
ANNEX IV
PART A
 Repealed Directive with list of its successive amendments 
 (referred to in Article 19) 
 Council Directive 87/404/EEC (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 national law and application 
 (referred to in Article 19) 
 Directive || Time limit for transposition || Date of application 
 87/404/EEC || 31 December 1989 || 1 July 1990[15] 
 90/488/EEC || 1 July 1991 || — 
 93/68/EEC || 30 June 1994 || 1 January 1995[16] 
ê 2009/105/EC
(adapted)
ANNEX IV
 CORRELATION TABLE 
 Directive 87/404/EEC Ö 2009/105/EC Õ || This Directive 
 Recital 5, fifth sentence || Article 1(3), point (b) 
 Article 1(1) || Article 1(1) 
 Article 1(2), first subparagraph || Article 1(3), point (a), first subparagraph 
 Article 1(2), second subparagraph, first indent || Article 1(3), point (a), second subparagraph 
 Article 1(2), second subparagraph, second indent, first and second sub-indents || Article 1(3), point (a), third subparagraph, points (i) and (ii) 
 Article 1(2), second subparagraph, third indent || Article 1(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), first 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 
 Article 10(2), second subparagraph, first and second indents || Article 10(2), second subparagraph, points (a) and (b) 
 Article 10(2), third subparagraph || Article 10(2), third subparagraph 
 Article 10(3), first subparagraph || Article 10(3), first subparagraph 
 Article 10(3), second subparagraph || Article 10(3), second subparagraph 
 Article 10(3), third subparagraph, points (a) and (b) || Article 10(3), third subparagraph, 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), second subparagraph 
 Article 11(1) and (2) || Article 11(1) and (2) 
 Article 11(3), introductory wording || Article 11(3), first subparagraph 
 Article 11(3), point 3.1 || Article 11(3), 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), point 3.4, first subparagraph || Article 11(3), seventh subparagraph 
 Article 11(3), point 3.4, second subparagraph || Article 11(3), eighth subparagraph 
 Article 11(3), point 3.4, third subparagraph || Article 11(3), ninth subparagraph 
 Article 11(3), point 3.5 || Article 11(3), tenth subparagraph 
 Article 12(1), first subparagraph, first and second indents || Article 12(1), points (a) and (b) 
 Article 12(1), second subparagraph || Article 12(2), first subparagraph 
 Article 12(2) || Article 12(2), second subparagraph 
 Article 13(1), first subparagraph || Article 13(1) 
 Article 13(1), second subparagraph || Article 13(2) 
 Article 13(2), indents 1 to 4 || Article 13(3), points (a) to (d) 
 Article 14(1) || Article 14, first paragraph 
 Article 14(2), first subparagraph, first and second indents || Article 14, second paragraph, points (a) and (b) 
 Article 14(2), second subparagraph || Article 14, third paragraph 
 Articles 15, 16 and 17 || Articles 15, 16 and 17 
 Article 18(1) || — 
 Article 18(2) || Article 18 
 — || Article 19 
 — || Article 20 
 Article 19 || Article 21 
 Annex I, point 1 || Annex I, point 1. 
 Annex I, point 1.1, first paragraph, first, second and third indents || Annex I, point 1.1., first paragraph, points (a), (b) and (c) 
 Annex I, point 1.1, second and third paragraphs || Annex I, point 1.1., second and third paragraphs 
 Annex I, points 1.1.1 and 1.1.2 || Annex I, points 1.1.1 and 1.1.2 
 Annex I, points 1.2, 1.3 and 1.4 || Annex I, points 1.2, 1.3 and 1.4 
 Annex I, point 2, first paragraph, first, second and third indents || Annex I, point 2, first paragraph, points (a), (b) and (c) 
 Annex I, point 2, second, third and fourth paragraphs || Annex I, point 2, second, third and fourth paragraphs 
 Annex I, points 2.1, 3 and 4 || Annex I, points 2.1, 3 and 4 
 Annex II, point 1 || Annex II, point 1 
 Annex II, point 1.a, first, second and third indents || Annex II, point 1.1, first, second and third paragraphs 
 Annex II, point 1.b, first paragraph, 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 paragraph, first, second and third indents || Annex II, point 2, first paragraph, points (a), (b) and (c) 
 Annex II, point 2, second paragraph || Annex II, point 2, second paragraph 
 Annex II, point 3, first paragraph || Annex II, point 3, first paragraph 
 Annex II, point 3, second paragraph, points (i), (ii) and (iii) || Annex II, point 3, second paragraph, points (a), (b) and (c) 
 Annex II, point 4 || Annex II, point 4 
 Annex III, points 1, 2 and 3 || Annex III, points 1, 2 and 3 
 Annex III, point 4, first, second and third indents || Annex III, point 4, points (a), (b) and (c) 
 Annex III, points 5, 6 and 7 || Annex III, points 5, 6 and 7 
 — || Annex IV 
 — || Annex V 
 Ö Article 1(1) Õ || Ö Article 1(1), introductory wording Õ 
 Ö Article 1(2) Õ || Ö Article 1(2) Õ 
 Ö Article 1(3) (a) Õ || Ö Article 1(1), points (a) to (e) Õ 
 Ö Article 1(3) (b) Õ || Ö — Õ 
 Ö Article 2 Õ || Ö Article 3 Õ 
 Ö ___ Õ || Ö Article 2 Õ 
 Ö Article 3 Õ || Ö Article 4 Õ 
 Ö Article 4 Õ || Ö Article 5 Õ 
 Ö ___ Õ || Ö Article 6 Õ 
 Ö — Õ || Ö Article 7 Õ 
 Ö — Õ || Ö Article 8 Õ 
 Ö — Õ || Ö Article 9 Õ 
 Ö — Õ || Ö Article 10 Õ 
 Ö — Õ || Ö Article 11 Õ 
 Ö — Õ || Ö Article 12 Õ 
 Ö Article 5 Õ  || Ö — Õ 
 Ö Article 6 Õ || Ö — Õ 
 Ö Article 7 Õ || Ö — Õ 
 Ö Article 8 Õ || Ö ___ Õ 
 Ö — Õ || Ö Article 13 Õ 
 Ö Article 9 Õ || Ö — Õ 
 Ö Article 10 Õ || Ö — Õ 
 Ö Article 11 (1) and (2) Õ || Ö — Õ 
 Ö Article 11 (3) Õ || Ö Point 2.3.2. of Annex II Õ 
 Ö Article 12 Õ || Ö — Õ 
 Ö Article 13 (1) Õ || Ö Point 3.2.1. of Annex II Õ 
 Ö Article 13 (2) Õ || Ö Point 3.2.2. of Annex II Õ 
 Ö Article 13 (3) Õ || Ö — Õ 
 Ö Article 14, first paragraph Õ || Ö — Õ 
 Ö Article 14, second paragraph, introductory wording Õ || Ö — Õ 
 Ö Article 14, second paragraph (a) Õ || Ö Second paragraph of point 3.3. of Annex II Õ 
 Ö Article 14, second paragraph (b) Õ || Ö — Õ 
 Ö Article 14, third paragraph Õ || Ö — Õ 
 Ö — Õ || Ö Article 14 Õ 
 Ö — Õ || Ö Article 15 Õ 
 Ö — Õ || Ö Article 16 Õ 
 Ö — Õ || Ö Article 17 Õ 
 Ö — Õ || Ö Article 18 Õ 
 Ö — Õ || Ö Article 19 Õ 
 Ö — Õ || Ö Article 20 Õ 
 Ö — Õ || Ö Article 21 Õ 
 Ö — Õ || Ö Article 22 Õ 
 Ö — Õ || Ö Article 23 Õ 
 Ö — Õ || Ö Article 24 Õ 
 Ö — Õ || Ö Article 25 Õ 
 Ö — Õ || Ö Article 26 Õ 
 Ö — Õ || Ö Article 27 Õ 
 Ö — Õ || Ö Article 28 Õ 
 Ö — Õ || Ö Article 29 Õ 
 Ö — Õ || Ö Article 30 Õ 
 Ö — Õ || Ö Article 31 Õ 
 Ö — Õ || Ö Article 32 Õ 
 Ö — Õ || Ö Article 33 Õ 
 Ö Article 15 Õ || Ö — Õ 
 Ö Article 16 Õ || Ö — Õ 
 Ö Article 17 Õ || Ö — Õ 
 Ö — Õ || Ö Article 34 Õ 
 Ö — Õ || Ö Article 35 Õ 
 Ö — Õ || Ö Article 36 Õ 
 Ö — Õ || Ö Article 37 Õ 
 Ö — Õ || Ö Article 38 Õ 
 Ö — Õ || Ö Article 39 Õ 
 Ö — Õ || Ö Article 40 Õ 
 Ö Article 18 Õ || Ö Article 41(2) Õ 
 Ö — Õ || Ö Article 41(1) Õ 
 Ö Article 19 Õ || Ö Article 42 Õ 
 Ö Article 20 Õ || Ö Article 43 Õ 
 Ö Article 21 Õ || Ö Article 44 Õ 
 Ö Annex I Õ || Ö Annex I Õ 
 Ö — Õ || Ö Annex II Õ 
 Ö Annex II Õ || Ö Annex III Õ 
 Ö Annex III Õ || Ö — Õ 
 Ö Annex IV Õ || Ö — Õ 
 Ö Annex V Õ || Ö Annex IV Õ 
[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.
[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
[3]               OJ C 77, 28.3.2002. 
[4]               OJ C 27, 3.2.2009, p. 41.
[5]               OJ L 220, 8.8.1987, p. 48.
[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.
[9]               OJ C 91, 16.4.2003, p. 7.
[10]             OJ C 136, 4.6.1985, p. 1.
[11]             OJ C 267, 19.10.1989, p. 3.
[12]             OJ C 10, 16.1.1990, p. 1.
[13]             OJ L […], […], p. […].
[14]             OJ L 204, 21.7.1998, p. 37.
[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 service 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 with the marking arrangements in force
before 1 January 1995.