L 189/168 EN Official Journal of the European Union 27.6.

2014

there should be an adequate procedure or a choice between different procedures of equivalent stringency. 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. The details added to those procedures are justified by the nature of the verification
required for pressure equipment.

(32) Member States should be in a position to authorise user inspectorates to carry out certain tasks for conformity
assessment in the framework of this Directive. For that purpose this Directive should set out criteria for the
authorisation of user inspectorates by Member States.

(33) Under certain procedures for conformity assessment it should be possible for each item to be inspected and tested
by a notified body or a user inspectorate as part of the final assessment of the pressure equipment or assembly. In
other cases provision should be made to ensure that the final assessment may be monitored by a notified body by
means of unexpected visits.

(34) Manufacturers should draw up an EU declaration of conformity to provide information required under this
Directive on the conformity of the pressure equipment or assembly with the requirements of this Directive and
of other relevant Union harmonisation legislation.

(35) To ensure effective access to information for market surveillance purposes, in cases where pressure equipment or
an assembly is covered by several pieces of Union harmonisation legislation, the information required to identify
all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the
administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up
of relevant individual declarations of conformity.

(36) A check on compliance with the essential safety requirements is necessary in order to provide effective protection
for consumers, other users and third parties.

(37) Pressure equipment and assemblies should, as a general rule, bear the CE marking. The CE marking, indicating the
conformity of pressure equipment or assemblies, 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) No 765/2008. Rules governing the affixing of the CE marking
should be laid down in this Directive.

(38) For pressure equipment defined in this Directive which presents only a minor pressure risk and for which
certification procedures are therefore not justified, the CE marking should not be affixed.

(39) Certain 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.

(40) Experience has shown that the criteria set out in Directive 97/23/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 those
bodies throughout the Union. It is, however, essential that all conformity assessment 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.

(41) 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.
27.6.2014 EN Official Journal of the European Union L 189/169

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

(43) 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.

(44) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of
confidence in certificates of conformity, 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 that 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.

(45) 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
pressure equipment or assembly 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.

(46) 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.

(47) Since conformity assessment 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.

(48) In the interests of competitiveness, it is crucial that conformity assessment 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 conformity assessment bodies.

(49) Member States should take all appropriate measures to ensure that pressure equipment and assemblies may be
placed on the market only if, when properly stored and used for their intended purpose, or under conditions of
use which can be reasonably foreseen, they do not endanger the health and safety of persons. Pressure equipment
or assemblies should be considered as non-compliant with the essential safety requirements laid down in this
Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from
lawful and readily predictable human behaviour.

(50) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be
conferred to the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011
of the European Parliament and of the Council (1).

(1) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general
principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55,
28.2.2011, p. 13).
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(51) The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member
State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet
the requirements for their notification.

(52) The examination procedure should be used for the adoption of implementing acts with respect to European
approvals for materials presenting shortcomings and whose references were already published in the Official
Journal of the European Union, given that such decisions could have consequences on the presumption of conformity
with the applicable essential requirements.

(53) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to
compliant pressure equipment or assemblies which present a risk to the health or safety of persons, to domestic
animals or to property, imperative grounds of urgency so require.

(54) In line with established practice, the committee set up by this Directive can play a useful role in examining matters
concerning the application of this Directive raised either by its chair or by a representative of a Member State in
accordance with its rules of procedure.

(55) When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in
a Commission expert group, the European Parliament should in line with existing practice receive full information
and documentation and, where appropriate, an invitation to attend such meetings.

(56) The Commission should, by means of implementing acts and, given their special nature, acting without the
application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect
of non-compliant pressure equipment or assemblies are justified or not.

(57) In order to take into account emerging very serious safety reasons, the power to adopt acts in accordance with
Article 290 TFEU should be delegated to the Commission in respect of amendments to classification of pressure
equipment or assemblies. The reclassification should be based on appropriate evidence and justification in each
case. It is of particular importance that the Commission carry out appropriate consultations during its preparatory
work, including at expert level.

(58) The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and
appropriate transmission of relevant documents to the European Parliament and to the Council.

(59) Directive 97/23/EC provides for a transitional arrangement enabling pressure equipment and assemblies which
comply with the national regulations in force on the date of application of Directive 97/23/EC to be put into
service. For reasons of legal certainty, it is necessary to include that transitional arrangement also in this Directive.

(60) It is necessary to provide for reasonable transitional arrangements that allow the making available on the market
and the putting into service, without the need to comply with further product requirements, of pressure equipment
and assemblies that have already been placed on the market in accordance with Directive 97/23/EC before the date
of application of national measures transposing this Directive. Distributors should therefore be able to supply
pressure equipment and assemblies that have been placed on the market, namely stock that is already in the
distribution chain, before the date of application of national measures transposing this Directive.

(61) 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 those rules are enforced. The penalties provided for should be
effective, proportionate and dissuasive.
27.6.2014 EN Official Journal of the European Union L 189/171

(62) Since the objective of this Directive, namely to ensure that pressure equipment or assemblies on the market fulfil
the requirements providing a high level of protection of health and safety of persons and protection of domestic
animals or property while guaranteeing the functioning of the internal market cannot be sufficiently achieved by
the Member States but can rather, 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.

(63) The obligation to transpose this Directive into national law should be confined to those provisions which represent
a substantive amendment as compared to the earlier Directive. The obligation to transpose the provisions which
are unchanged arises under the earlier Directive.

(64) This Directive should be without prejudice to the obligations of the Member States relating to the time-limit for
transposition into national law and the date of application of the Directive set out in Annex V, Part B,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

GENERAL PROVISIONS

Article 1
Scope
1. This Directive shall apply to the design, manufacture and conformity assessment of pressure equipment and
assemblies with a maximum allowable pressure PS greater than 0,5 bar.

2. This Directive shall not apply to:

(a) pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from
an installation (onshore or offshore) starting from and including the last isolation device located within the confines
of the installation, including all the annexed equipment designed specifically for pipelines; this exclusion shall not
apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;

(b) networks for the supply, distribution and discharge of water and associated equipment and headraces such as
penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;

(c) simple pressure vessels covered by Directive 2014/29/EU of the European Parliament and of the Council (1);

(d) aerosol dispensers covered by Council Directive 75/324/EEC (2);

(e) equipment intended for the functioning of vehicles defined by the following legal acts:

(i) Directive 2007/46/EC of the European Parliament and of the Council (3);

(1) Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).
(2) Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers
(OJ L 147, 9.6.1975, p. 40).
(3) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval
of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework
Directive) (OJ L 263, 9.10.2007, p. 1).
L 189/172 EN Official Journal of the European Union 27.6.2014

(ii) Regulation (EU) No 167/2013 of the European Parliament and of the Council (1);

(iii) Regulation (EU) No 168/2013 of the European Parliament and of the Council (2);

(f) equipment classified as no higher than category I under Article 13 of this Directive and covered by one of the
following Directives:

(i) Directive 2006/42/EC of the European Parliament and of the Council (3);

(ii) Directive 2014/33/EU of the European Parliament and of the Council (4);

(iii) Directive 2014/35/EU of the European Parliament and of the Council (5);

(iv) Council Directive 93/42/EEC (6);

(v) Directive 2009/142/EC of the European Parliament and of the Council (7);

(vi) Directive 2014/34/EU of the European Parliament and of the Council (8);

(g) equipment covered by point (b) of Article 346(1) TFEU;

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

(i) well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in under­
ground storage which is intended to contain and/or control well pressure; this shall comprise the wellhead (Christmas
tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;

(j) equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are
based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic oper­
ational effects or other operational characteristics and for which pressure is not a significant design factor; such
equipment may include:

(i) engines including turbines and internal combustion engines;

(ii) steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;

(1) Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market
surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).
(2) Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market
surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).
(3) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive
95/16/EC (OJ L 157, 9.6.2006, p. 24).
(4) Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251).
(5) Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
(OJ L 96, 29.3.2014, p. 357).
(6) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(7) Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to appliances burning gaseous
fuels (OJ L 330, 16.12.2009, p. 10).
(8) Directive 2014/34/EU of the European Parliament and the Council of 26 February 2014 on the harmonisation of the laws of the
Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96,
29.3.2014, p. 309).
27.6.2014 EN Official Journal of the European Union L 189/173

(k) blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-
gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-
melting, de-gassing and casting of steel, iron and non-ferrous metals;

(l) enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating
machines;

(m) pressurised pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;

(n) ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board
or the propulsion thereof;

(o) pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and
other similar pressure equipment;

(p) exhaust and inlet silencers;

(q) bottles or cans for carbonated drinks for final consumption;

(r) vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a
maximum allowable pressure not exceeding 7 bar;

(s) equipment covered by Directive 2008/68/EC and Directive 2010/35/EU and equipment covered by the International
Maritime Dangerous Goods Code and the Convention on International Civil Aviation;

(t) radiators and pipes in warm water heating systems;

(u) vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

Article 2
Definitions
For the purposes of this Directive, the following definitions shall apply:

(1) ‘pressure equipment’ means vessels, piping, safety accessories and pressure accessories, including, where applicable,
elements attached to pressurised parts, such as flanges, nozzles, couplings, supports, lifting lugs;

(2) ‘vessel’ means a housing designed and built to contain fluids under pressure including its direct attachments up to
the coupling point connecting it to other equipment; a vessel may be composed of more than one chamber;

(3) ‘piping’ means piping components intended for the transport of fluids, when connected together for integration into
a pressure system; piping includes in particular a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or
other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or
heating air shall be considered as piping;

(4) ‘safety accessories’ means devices designed to protect pressure equipment against the allowable limits being
exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices,
buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the
means for correction or provide for shutdown or shutdown and lockout, such as pressure switches or temperature
switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices;
L 189/174 EN Official Journal of the European Union 27.6.2014

(5) ‘pressure accessories’ means devices with an operational function and having pressure-bearing housings;

(6) ‘assemblies’ means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and
functional whole;

(7) ‘pressure’ means pressure relative to atmospheric pressure, i.e. gauge pressure. As a consequence, vacuum is
designated by a negative value;

(8) ‘maximum allowable pressure PS’ means the maximum pressure for which the equipment is designed, as specified by
the manufacturer, and defined at a location specified by him, being either the connection of protective and/or
limiting devices, or the top of equipment or, if not appropriate, any point specified;

(9) ‘maximum/minimum allowable temperature TS’ means the maximum/minimum temperatures for which the
equipment is designed, as specified by the manufacturer;

(10) ‘volume (V)’ means the internal volume of a chamber, including the volume of nozzles to the first connection or
weld and excluding the volume of permanent internal parts;

(11) ‘nominal size (DN)’ means a numerical designation of size which is common to all components in a piping system
other than components indicated by outside diameters or by thread size; it is a convenient round number for
reference purposes and is only loosely related to manufacturing dimensions; the nominal size is designated by DN
followed by a number;

(12) ‘fluids’ means gases, liquids and vapours in pure phase as well as mixtures thereof; fluids may contain a suspension
of solids;

(13) ‘permanent joints’ means joints which cannot be disconnected except by destructive methods;

(14) ‘European approval for materials’ means a technical document defining the characteristics of materials intended for
repeated use in the manufacture of pressure equipment which are not covered by any harmonised standard;

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

(16) ‘placing on the market’ means the first making available of pressure equipment or assemblies on the Union market;

(17) ‘putting into service’ means the first use of pressure equipment or an assembly by its user;

(18) ‘manufacturer’ means any natural or legal person who manufactures pressure equipment or an assembly or has such
equipment or assembly designed or manufactured, and markets that pressure equipment or assembly under his
name or trademark or uses it for his own purposes;

(19) ‘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;

(20) ‘importer’ means any natural or legal person established within the Union who places pressure equipment or
assemblies from a third country on the Union market;
27.6.2014 EN Official Journal of the European Union L 189/175

(21) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer,
who makes pressure equipment or assemblies available on the market;

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

(23) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by pressure
equipment or assemblies;

(24) ‘harmonised standard’ means harmonised standard as defined in point (c) of Article 2(1) of Regulation (EU)
No 1025/2012;

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

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

(27) ‘conformity assessment’ means the process demonstrating whether the essential safety requirements of this Directive
relating to pressure equipment or assemblies have been fulfilled;

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

(29) ‘recall’ means any measure aimed at achieving the return of pressure equipment or assemblies that have already been
made available to consumers or other users;

(30) ‘withdrawal’ means any measure aimed at preventing pressure equipment or assemblies in the supply chain from
being made available on the market;

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

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

Article 3
Making available on the market and putting into service
1. Member States shall take all appropriate measures to ensure that pressure equipment and assemblies may be made
available on the market and put into service only if they satisfy the requirements of this Directive when properly installed
and maintained and used for the purposes for which they are intended.

2. This Directive shall not affect Member States’ entitlement to lay down such requirements as they may deem
necessary to ensure that persons and, in particular, workers are protected during use of the pressure equipment or
assembly in question provided that this does not mean modifications to such equipment or assembly in a way not
specified in this Directive.

3. At trade fairs, exhibitions, demonstrations and other similar events, Member States shall not prevent the showing of
pressure equipment or assemblies which do not comply with this Directive, provided that a visible sign clearly indicates
that such pressure equipment or assemblies may not be made available on the market and/or put into service until they
are brought into conformity. During demonstrations, appropriate safety measures shall be taken in accordance with any
requirements laid down by the competent authority of the Member State concerned in order to ensure the safety of
persons.
L 189/176 EN Official Journal of the European Union 27.6.2014

Article 4
Technical requirements
1. The following pressure equipment shall satisfy the essential safety requirements set out in Annex I:

(a) vessels, except those referred to in point (b), for:

(i) gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure at the
maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within
the following limits:

— for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 25 bar·L, or with
a pressure PS greater than 200 bar (Annex II, table 1),

— for fluids in Group 2, with a volume greater than 1 L and a product of PS and V is greater than 50 bar·L, or
with a pressure PS greater than 1 000 bar, and all portable extinguishers and bottles for breathing apparatus
(Annex II, table 2);

(ii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal
atmospheric pressure (1 013 mbar) within the following limits:

— for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar·L, or
with a pressure PS greater than 500 bar (Annex II, table 3),

— for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10 000
bar·L, or with a pressure PS greater than 1 000 bar (Annex II, table 4);

(b) fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or super-
heated water at temperatures higher than 110 °C having a volume greater than 2 L, and all pressure cookers (Annex
II, table 5);

(c) piping intended for:

(i) gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the
maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1 013 mbar) within
the following limits:

— for fluids in Group 1 with a DN greater than 25 (Annex II, table 6),

— for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1 000 bar (Annex
II, table 7);

(ii) liquids having a vapour pressure at the maximum allowable temperature of not more than 0,5 bar above normal
atmospheric pressure (1 013 mbar) within the following limits:

— for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2 000 bar (Annex
II, table 8),

— for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN
greater than 5 000 bar (Annex II, table 9).

(d) safety and pressure accessories intended for equipment covered by points (a), (b), and (c) including where such
equipment is incorporated into an assembly.
27.6.2014 EN Official Journal of the European Union L 189/177

2. The following assemblies which include at least one item of pressure equipment covered by paragraph 1 shall satisfy
the essential safety requirements set out in Annex I:

(a) assemblies intended for generating steam or superheated water at a temperature higher than 110 °C comprising at
least one item of fired or otherwise heated pressure equipment presenting a risk of overheating;

(b) assemblies other than those referred to in point (a), if the manufacturer intends them to be made available on the
market and put into service as assemblies.

By way of derogation from the first subparagraph, assemblies intended for generating warm water at temperatures not
greater than 110 °C which are manually fed with solid fuels and have a PS·V greater than 50 bar·L shall comply with the
essential safety requirements referred to in points 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I.

3. Pressure equipment and assemblies below or equal to the limits set out in points (a), (b) and (c) of paragraph 1 and
in paragraph 2 respectively shall be designed and manufactured in accordance with the sound engineering practice of a
Member State in order to ensure safe use. Pressure equipment and assemblies shall be accompanied by adequate
instructions for use.

Without prejudice to other applicable Union harmonisation legislation providing for its affixing, such equipment or
assemblies shall not bear the CE marking referred to in Article 18.

Article 5
Free movement
1. Member States shall not, on grounds of the risks due to pressure, prohibit, restrict or impede the making available
on the market or the putting into service under the conditions specified by the manufacturer of pressure equipment or
assemblies which comply with this Directive.

Member States shall not, on grounds of the risks due to pressure, prohibit, restrict or impede the making available on the
market or the putting into service of pressure equipment or assemblies which comply with Article 4(3).

2. When a Member State has designated a user inspectorate in accordance with the requirements set out in Article 25,
it may not, on grounds of the risks due to pressure, prohibit, restrict or impede the placing on the market or putting into
service under the conditions provided for in Article 16, of pressure equipment or assemblies the conformity of which has
been assessed by a user inspectorate designated by another Member State in accordance with the requirements set out in
Article 25.

3. Member States may require, to the extent that it is needed for safe and correct use of pressure equipment and
assemblies, the information referred to in points 3.3 and 3.4 of Annex I to be provided in the official language(s) of the
Union which may be determined by the Member State in which the equipment or assembly is made available on the
market.

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6
Obligations of manufacturers
1. When placing their pressure equipment or assemblies referred to in Article 4(1) and (2) on the market or using
them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance
with the essential safety requirements set out in Annex I.
L 189/178 EN Official Journal of the European Union 27.6.2014

When placing their pressure equipment or assemblies referred to in Article 4(3) on the market or using them for their
own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the sound
engineering practice of a Member State.

2. For the pressure equipment or assemblies referred to in Article 4(1) and (2), manufacturers shall draw up the
technical documentation referred to in Annex III and carry out the relevant conformity assessment procedure referred to
in Article 14 or have it carried out.

Where compliance of the pressure equipment or assemblies referred to in Article 4(1) and (2) with the applicable
requirements has been demonstrated by the procedure referred to in the first subparagraph of this paragraph, manu­
facturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after
pressure equipment or assemblies have been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this
Directive. Changes in design or characteristics of pressure equipment or assemblies and changes in the harmonised
standards or in other technical specifications by reference to which conformity of pressure equipment or assemblies is
declared shall be adequately taken into account.

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

5. Manufacturers shall ensure that their pressure equipment or assemblies bear a type, batch or serial number or other
element allowing their identification, or, where the size or nature of the equipment or assembly does not allow it, that the
required information is provided on the packaging or in a document accompanying the equipment.

6. Manufacturers shall indicate on the pressure equipment or assembly their name, registered trade name or registered
trade mark and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a
document accompanying the equipment or assembly. The address shall indicate a single point at which the manufacturer
can be contacted. The contact details shall be in a language easily understood by consumers, other users and market
surveillance authorities.

7. Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4(1) and (2) is accom­
panied by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can
be easily understood by consumers and other users, as determined by the Member State concerned. Such instructions and
safety information shall be clear, understandable and intelligible.

Manufacturers shall ensure that the pressure equipment or assemblies referred to in Article 4(3) are accompanied by
instructions and safety information in accordance with Article 4(3), in a language which can be easily understood by
consumers and other users, as determined by the Member State concerned. Such instructions and safety information shall
be clear, understandable and intelligible.

8. Manufacturers who consider or have reason to believe that pressure equipment or assemblies which they have
placed on the market are not in conformity with this Directive shall immediately take the corrective measures necessary
to bring that pressure equipment or those assemblies into conformity, to withdraw it or recall it, if appropriate.
Furthermore, where pressure equipment or assemblies present a risk, manufacturers shall immediately inform the
competent national authorities of the Member States in which they made that pressure equipment or those assemblies
available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures
taken.
27.6.2014 EN Official Journal of the European Union L 189/179

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 pressure equipment or assembly with
this Directive, in a language which can be easily understood by that authority. That information and documentation may
be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by the pressure equipment or assembly which they have placed on the market.

Article 7
Authorised representatives
1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in
Article 6(2) 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 market
surveillance authorities for 10 years after the pressure equipment or assembly 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 the pressure equipment or assembly;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed
by the pressure equipment or assembly covered by the authorised representative’s mandate.

Article 8
Obligations of importers
1. Importers shall place only compliant pressure equipment or assemblies on the market.

2. Before placing on the market the pressure equipment or assemblies referred to in Article 4(1) and (2), importers
shall ensure that the appropriate conformity assessment procedure in accordance with Article 14 has been carried out by
the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that pressure
equipment or assemblies bear the CE marking and are accompanied by instructions and safety information in accordance
with points 3.3 and 3.4 of Annex I, and that the manufacturer has complied with the requirements set out in Article 6(5)
and (6).

Before placing on the market the pressure equipment or assemblies referred to in Article 4(3), importers shall ensure that
the manufacturer has drawn up the technical documentation and that pressure equipment or assemblies are accompanied
by adequate instructions for use 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 the pressure equipment or assembly is not in conformity with
the essential safety requirements set out in Annex I, he shall not place the pressure equipment or assembly on the market
until it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a risk, the
importer shall inform the manufacturer and the market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which
they can be contacted on the pressure equipment or assembly, or, where that is not possible, on its packaging or in a
document accompanying the equipment or assembly. The contact details shall be in a language easily understood by
consumers, other users and market surveillance authorities.
L 189/180 EN Official Journal of the European Union 27.6.2014

4. Importers shall ensure that pressure equipment or assemblies referred to in Article 4(1) and (2) are accompanied by
instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a language which can be easily
understood by consumers and other users, as determined by the Member State concerned.

Importers shall ensure that the pressure equipment or assembly referred to in Article 4(3) is accompanied by instructions
and safety information in a language which can be easily understood by consumers and other users, as determined by the
Member State concerned.

5. Importers shall ensure that, while pressure equipment or assemblies referred to in Article 4(1) and (2) are under
their responsibility, storage or transport conditions do not jeopardise their compliance with the essential safety
requirements set out in Annex I.

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

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

8. Importers shall, for 10 years after the pressure equipment or assembly 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 pressure equipment or an assembly in a
language which can be easily understood by that authority. That information and documentation may be provided in
paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the
risks posed by pressure equipment or an assembly which they have placed on the market.

Article 9
Obligations of distributors
1. When making pressure equipment or assemblies available on the market distributors shall act with due care in
relation to the requirements of this Directive.

2. Before making the pressure equipment or assemblies referred to in Article 4(1) and (2) available on the market
distributors shall verify that the pressure equipment or assembly bears the CE marking, that it is accompanied by the
required documents and by instructions and safety information in accordance with points 3.3 and 3.4 of Annex I, in a
language which can be easily understood by consumers and other users in the Member State in which the pressure
equipment or assembly 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) respectively.

Where a distributor considers or has reason to believe that pressure equipment or assemblies are not in conformity with
the essential safety requirements set out in Annex I, he shall not make the pressure equipment or assembly available on
the market until it has been brought into conformity. Furthermore, where the pressure equipment or assembly presents a
risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance
authorities.
27.6.2014 EN Official Journal of the European Union L 189/181

Before making the pressure equipment or assembly referred to in Article 4(3) available on the market, distributors shall
verify that that pressure equipment or assembly is accompanied by adequate instructions for use, in a language which can
be easily understood by consumers and other users in the Member State in which that pressure equipment or assembly 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) respectively.

3. Distributors shall ensure that, while the pressure equipment or assemblies referred to in Article 4(1) and (2) are
under their responsibility, storage or transport conditions do not jeopardise their compliance with the essential safety
requirements set out in Annex I.

4. Distributors who consider or have reason to believe that pressure equipment or assemblies which they have made
available on the market are not in conformity with this Directive shall make sure that the corrective measures necessary
to bring that equipment or assembly into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore,
where the pressure equipment or assembly presents a risk, distributors shall immediately inform the competent national
authorities of the Member States in which they made the equipment or assembly available on the market 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 pressure equipment or assemblies. That
information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at
its request, on any action taken to eliminate the risks posed by the pressure equipment or assemblies which they have
made available on the market.

Article 10
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to
the obligations of the manufacturer under Article 6, where he places pressure equipment or an assembly on the market
under his name or trademark or modifies pressure equipment or an assembly already placed on the market in such a way
that compliance with the requirements of this Directive may be affected.

Article 11
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 pressure equipment or an assembly;

(b) any economic operator to whom they have supplied pressure equipment or an assembly.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have
been supplied with the pressure equipment or assembly and for 10 years after they have supplied the pressure equipment
or assembly.

CHAPTER 3

CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES

Article 12
Presumption of conformity
1. Pressure equipment or assemblies referred to in Article 4(1) and (2) 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, referred
to in Annex I.
L 189/182 EN Official Journal of the European Union 27.6.2014

2. The materials used for the manufacture of pressure equipment or assemblies which are in conformity with European
approvals for materials, the references of which have been published in the Official Journal of the European Union in
accordance with Article 15(4), shall be presumed to be in conformity with the applicable essential safety requirements set
out in Annex I.

Article 13
Classification of pressure equipment
1. Pressure equipment referred to in Article 4(1) shall be classified by category in accordance with Annex II, according
to an ascending level of hazard.

For the purposes of such classification fluids shall be divided into the following two groups:

(a) group 1 consisting of substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC)
No 1272/2008, that are classified as hazardous in accordance with the following physical or health hazard classes laid
down in Parts 2 and 3 of Annex I to that Regulation:

(i) unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;

(ii) flammable gases, category 1 and 2;

(iii) oxidising gases, category 1;

(iv) flammable liquids, category 1 and 2;

(v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;

(vi) flammable solids, category 1 and 2;

(vii) self-reactive substances and mixtures, type A to F;

(viii) pyrophoric liquids, category 1;

(ix) pyrophoric solids, category 1;

(x) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;

(xi) oxidising liquids, category 1, 2 and 3;

(xii) oxidising solids, category 1, 2 and 3;

(xiii) organic peroxides types A to F;

(xiv) acute oral toxicity, category 1 and 2;

(xv) acute dermal toxicity, category 1 and 2;

(xvi) acute inhalation toxicity, category 1, 2 and 3;

(xvii) specific target organ toxicity – single exposure, category 1.

Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable
temperature TS which exceeds the flashpoint of the fluid;

(b) group 2 consisting of substances and mixtures not referred to in point (a).

2. Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the
individual chambers. Where a chamber contains several fluids, classification shall be on the basis of the fluid which
requires the highest category.

Article 14
Conformity assessment procedures
1. The conformity assessment procedures to be applied to an item of pressure equipment shall be determined by the
category, as set out in Article 13, in which the equipment is classified.

2. The conformity assessment procedures to be applied for the various categories are the following:

(a) category I:

— Module A

(b) category II:

— Module A2

— Module D1

— Module E1

(c) category III:

— Modules B (design type) + D

— Modules B (design type) + F

— Modules B (production type) + E

— Modules B (production type) + C2

— Module H

(d) category IV:

— Modules B (production type) + D

— Modules B (production type) + F

— Module G

— Module H1