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.

27.6.2014 EN Official Journal of the European Union L 189/183

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
L 189/184 EN Official Journal of the European Union 27.6.2014

The conformity assessment procedures are set out in Annex III.

3. Pressure equipment shall be subject to one of the conformity assessment procedures which may be chosen by the
manufacturer among those laid down for the category in which it is classified. The manufacturer may also choose to
apply one of the procedures which apply to a higher category, if available.

4. In the framework of quality assurance procedures for pressure equipment in categories III and IV referred to in
point (i) of point (a) of Article 4(1), first indent of point (ii) of point (a) of Article 4(1) and point (b) of Article 4(1), the
notified body shall, when performing unexpected visits, take a sample of equipment from the manufacturing or storage
premises in order to perform, or have performed, the final assessment as referred to in Annex I, point 3.2. To this end,
the manufacturer shall inform the notified body of the intended schedule of production. The notified body shall carry out
at least two visits during the first year of manufacturing. The frequency of subsequent visits shall be determined by the
notified body on the basis of the criteria set out in point 4.4 of modules D, E and H and point 5.4 of module H1.

5. In the case of one-off production of vessels and pressure equipment in category III referred to in point (b) of
Article 4(1) under the module H procedure, the notified body shall perform or have performed the final assessment, as
referred to in point 3.2 of Annex I, for each unit. To this end, the manufacturer shall communicate the intended schedule
of production to the notified body.

6. Assemblies referred to in Article 4(2) shall be subject to a global conformity assessment procedure comprising the
following assessments:

(a) the assessment of each item of pressure equipment making up the assembly and referred to in Article 4(1) which has
not been previously subjected to a conformity assessment procedure and to a separate CE marking; the assessment
procedure shall be determined by the category of each item of equipment;

(b) the assessment of the integration of the various components of the assembly as referred to in points 2.3, 2.8 and 2.9
of Annex I which shall be determined by the highest category applicable to the equipment concerned other than that
applicable to any safety accessories;

(c) the assessment of the protection of an assembly against exceeding the permissible operating limits as referred to in
points 2.10 and 3.2.3 of Annex I shall be conducted in the light of the highest category applicable to the items of
equipment to be protected.

7. By way of derogation from paragraphs 1 and 2 of this Article, the competent authorities may, where justified, allow
the making available on the market and putting into service in the territory of the Member State concerned of individual
pressure equipment items and assemblies referred to in Article 2, in respect of which the procedures referred to in
paragraphs 1 and 2 of this Article have not been applied and the use of which is in the interests of experimentation.

8. The records and correspondence relating to conformity assessment procedures shall be drafted in an official
language of the Member State where the body responsible for carrying out these conformity assessment procedures is
established, or in a language accepted by that body.

Article 15
European approval for materials
1. European approval for materials shall be issued at the request of one or more manufacturers of materials or
equipment, by one of the notified bodies referred to in Article 20 specifically designated for that task. The notified
body shall determine and perform, or arrange for the performance of, the appropriate inspections and tests to certify the
conformity of the types of material with the corresponding requirements of this Directive. In the case of materials
recognised as being safe to use before 29 November 1999, the notified body shall take account of the existing data when
certifying such conformity.
27.6.2014 EN Official Journal of the European Union L 189/185

2. Before issuing a European approval for materials, the notified body shall notify the Member States and the
Commission by sending them the appropriate information. Within three months, a Member State or the Commission
may provide comments giving its reasons. The notified body may issue the European approval for materials taking into
account the comments submitted.

3. A copy of the European approval for materials shall be sent to the Member States, the notified bodies and the
Commission.

4. When the European approval for materials satisfies the requirements which it covers and which are set out in
Annex I, the Commission shall publish the references of that approval. The Commission shall keep up to date a list of
such approvals in the Official Journal of the European Union.

5. The notified body which issued the European approval for materials shall withdraw that approval if it finds that it
should not have been issued or if the type of materials is covered by a harmonised standard. It shall immediately inform
the other Member States, the notified bodies and the Commission of any withdrawal of an approval.

6. When a Member State or the Commission considers that a European approval for materials whose references have
been published in the Official Journal of the European Union, does not entirely satisfy the essential safety requirements
which it covers and which are set out in Annex I, the Commission shall decide by means of implementing acts whether
to withdraw the references of that European approval for materials from the Official Journal of the European Union.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the
examination procedure referred to in Article 44(3).

Article 16
User inspectorates
1. By way of derogation from the provisions relating to the tasks carried out by the notified bodies, Member States
may authorise on their territory the placing on the market and the putting into service by users, of pressure equipment or
assemblies of which conformity with the essential safety requirements has been assessed by a user inspectorate designated
in accordance with paragraph 7.

2. Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall not bear
the CE marking.

3. The pressure equipment or assemblies referred to in paragraph 1 may be used only in establishments operated by
the group of which the inspectorate is part. The group shall apply a common safety policy as regards the technical
specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies.

4. The user inspectorates shall act exclusively for the group of which they are part.

5. The conformity assessment procedures applicable by user inspectorates shall be modules A2, C2, F and G, set out in
Annex III.

6. Member States shall notify the other Member States and the Commission which user inspectorates they have
authorised, the tasks for which they have been designated and, for each inspectorate, a list of the establishments satisfying
the provisions of paragraph 3.

7. In designating the user inspectorates, the Member States shall apply the requirements set out in Article 25 and
ensure that the group of which the inspectorate is part applies the criteria referred to in the second sentence of paragraph
3 of this Article.
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Article 17
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of 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 IV and shall contain the elements
specified in the relevant conformity assessment procedures set out in Annex III and shall be continuously updated. It shall
be translated into the language or languages required by the Member State in whose market the pressure equipment or
assembly is placed or made available on the market.

3. Where pressure equipment or an assembly 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 Union acts concerned including their publication references.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of
the pressure equipment or assembly with the requirements laid down in this Directive.

Article 18
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 19
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to any of the following:

(a) each item of pressure equipment referred to in Article 4(1) or its dataplate;

(b) each assembly referred to in Article 4(2) or its dataplate.

Where the affixing of the CE marking is not possible or not warranted on account of the nature of the equipment or
assembly, it shall be affixed to the packaging and to the accompanying documents.

The item or assembly referred to in points (a) and (b) of the first subparagraph shall be complete or shall be in a state
permitting final assessment as described in point 3.2 of Annex I.

2. It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an
assembly. Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly
shall continue to bear that marking.

3. The CE marking shall be affixed before the item of pressure equipment or the assembly is placed on the market.

4. The CE marking shall be followed by the identification number of the notified body, where that body is 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.
27.6.2014 EN Official Journal of the European Union L 189/187

5. The CE marking and, where applicable, the identification number referred to in paragraph 4 may be followed by
any other mark indicating a special risk or use.

6. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE
marking and shall take appropriate action in the event of improper use of that marking.

CHAPTER 4

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20
Notification
Member States shall notify the Commission and the other Member States of the notified bodies and the user inspectorates
authorised to carry out conformity assessment tasks in accordance with Article 14, Article 15 or Article 16 and of the
third-party organisations they have recognised, for the purposes of the tasks referred to in points 3.1.2 and 3.1.3 of
Annex I.

Article 21
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, recognised third-party organisations and user inspectorates, including compliance with Article 27.

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 22. 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 22
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.
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Article 23
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, recognised third-party organisations and user inspectorates,
and of any changes thereto.

The Commission shall make that information publicly available.

Article 24
Requirements relating to notified bodies and recognised third-party organisations
1. For the purposes of notification, a notified body or recognised third party organisation shall meet the requirements
laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under national law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party body independent of the organisation or the pressure
equipment or assembly 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 pressure equipment or assemblies 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 pressure equipment or assembly which they assess, nor the representative of any of those parties.
This shall not preclude the use of assessed pressure equipment or assemblies that are necessary for the operations of the
conformity assessment body or the use of such equipment 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 that pressure equipment or assembly, 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 14 or Article 15, or points 3.1.2 and 3.1.3 of Annex I 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.
27.6.2014 EN Official Journal of the European Union L 189/189

At all times and for each conformity assessment procedure and each kind or category of pressure equipment 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 conformity assessment 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.

A conformity assessment body 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 tasks 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 personnel responsible
for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment
tasks 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 14, Article 15, or under points 3.1.2 and 3.1.3 of Annex I or any
provision of national law giving effect to them, except in relation to the competent authorities of the Member State in
which its activities are carried out. Proprietary rights shall be protected.
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11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out
conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body
coordination group established under the relevant Union harmonisation legislation and shall apply as general guidance
the administrative decisions and documents produced as a result of the work of that group.

Article 25
Requirements relating to user inspectorates
1. For the purposes of notification, a user inspectorate shall meet the requirements laid down in paragraphs 2 to 11.

2. A user inspectorate shall be established under national law of a Member State and have legal personality.

3. A user inspectorate shall be organisationally identifiable and have reporting methods within the group of which it is
part which ensure and demonstrate its impartiality.

4. A user inspectorate, 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 pressure equipment or assembly which they assess, nor the authorised representative of any of those parties. This shall
not preclude the use of assessed pressure equipment or assemblies that are necessary for the operations of the user
inspectorate or the use of such equipment for personal purposes.

A user inspectorate, 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 that pressure equipment or assembly, 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.

5. User inspectorates 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 user inspectorate shall be capable of carrying out all the conformity assessment tasks assigned to it by Article 16
and in relation to which it has been notified, whether those tasks are carried out by the user inspectorate itself or on its
behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of pressure equipment in relation
to which it has been notified, the user inspectorate 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 user inspectorate 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.
27.6.2014 EN Official Journal of the European Union L 189/191

A user inspectorate 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 tasks 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 user inspectorates, their top level management and of the personnel responsible for carrying
out conformity assessment tasks shall be guaranteed. User inspectorates must not engage in any activities that might
conflict with its independence of judgement and integrity in relation to its inspection activities.

The remuneration of the top level management and personnel responsible for carrying out conformity assessment tasks
of a user inspectorate shall not depend on the number of assessments carried out or on the results of those assessments.

9. User inspectorates shall take out liability insurance unless liability is assumed by the group of which they are part.

10. The personnel of user inspectorates shall observe professional secrecy with regard to all information obtained in
carrying out their tasks under Article 16 or any provision of national law giving effect to them, except in relation to the
competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11. User inspectorates shall participate in, or ensure that their personnel responsible for carrying out conformity
assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coord­
ination group established under the relevant Union harmonisation legislation and shall apply as general guidance the
administrative decisions and documents produced as a result of the work of that group.

Article 26
Presumption of conformity of conformity assessment bodies
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 24 or Article 25 in so far as the applicable harmonised
standards cover those requirements.

Article 27
Subsidiaries of and subcontracting by conformity assessment bodies
1. Where a notified body, a user inspectorate or a recognised third-party organisation 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 24 or Article 25 and shall inform the notifying authority accordingly.

2. Notified bodies, user inspectorates and recognised third-party organisations shall take full responsibility for the tasks
performed by subcontractors or subsidiaries wherever these are established.
L 189/192 EN Official Journal of the European Union 27.6.2014

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4. Notified bodies, user inspectorates and recognised third-party organisations 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 14, Article 15, Article 16 or points 3.1.2 and 3.1.3 of
Annex I.

Article 28
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. The application for notification shall be accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the pressure equipment 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 24 or Article 25.

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 24 or Article 25.

Article 29
Notification procedure
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid
down in Article 24 or Article 25.

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 the pressure equipment concerned and the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate as referred to in Article 28(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 24 or Article 25.

5. The body concerned may perform the activities of a notified body, a recognised third-party organisation or a user
inspectorate 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, a recognised third-party organisation or a user inspectorate for the
purposes of this Directive.

6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant
changes to the notification.
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Article 30
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 assigned to them and the activities for which they have been notified.

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

Article 31
Lists of recognised third-party organisations and user inspectorates
The Commission shall make publicly available the list of the recognised third-party organisations and of the user
inspectorates under this Directive and the tasks for which they have been recognised.

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

Article 32
Changes to notifications
1. Where a notifying authority has ascertained or has been informed that a notified body or a recognised third-party
organisation no longer meets the requirements laid down in Article 24 or that it is failing to fulfil its obligations, the
notifying authority shall, as appropriate, restrict, suspend or withdraw the notification, 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.

Where a notifying authority has ascertained or has been informed that a user inspectorate no longer meets the
requirements laid down in Article 25, or that it is failing to fulfil its obligations, the notifying authority shall as
appropriate, restrict, suspend or withdraw the notification, 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, the recognised
third-party organisation or the user inspectorate 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, recognised third-party organ­
isation or user inspectorate, or kept available for the responsible notifying and market surveillance authorities at their
request.

Article 33
Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates
1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the
competence of a notified body, a recognised third-party organisation or a user inspectorate, or the continued fulfilment
by a notified body, a recognised third-party organisation or a user inspectorate 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 conformity assessment body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated
confidentially.
L 189/194 EN Official Journal of the European Union 27.6.2014

4. Where the Commission ascertains that a notified body, a recognised third-party organisation or a user inspectorate
does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the
notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 44(2).

Article 34
Operational obligations of notified bodies, user inspectorates and recognised third party organisations
1. Notified bodies, user inspectorates and recognised third-party organisations shall carry out conformity assessments
in accordance with the conformity assessment tasks provided for in Article 14, Article 15, Article 16, or in points 3.1.2
and 3.1.3 of Annex I.

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 pressure equipment or assembly 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 pressure equipment with the requirements of this Directive.

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

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a conformity assessment
body finds that pressure equipment 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 conformity assessment body shall
restrict, suspend or withdraw any certificates, as appropriate.

Article 35
Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates
Member States shall ensure that appeal procedures against decisions of notified bodies, recognised third-party organ­
isations and user inspectorates are available.

Article 36
Information obligation on notified bodies, recognised third party organisations and user inspectorates
1. Notified bodies, recognised third-party organisations and user inspectorates 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 or conditions for notification;

27.6.2014 EN Official Journal of the European Union L 189/195

(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, recognised third-party organisations and user inspectorates shall provide the other bodies notified
under this Directive carrying out similar conformity assessment activities covering the same pressure equipment with
relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 37
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 38
Coordination of notified bodies, recognised third-party organisations and user inspectorates
The Commission shall ensure that appropriate coordination and cooperation between the conformity assessment bodies
notified under this Directive are put in place and properly operated in the form of a sectoral group or groups of
conformity assessment bodies.

Member States shall ensure that the conformity assessment 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 PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION
MARKET, AND UNION SAFEGUARD PROCEDURE

Article 39
Union market surveillance and control of pressure equipment and assemblies entering the Union market
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to pressure equipment and assemblies
covered by Article 1 of this Directive.

Article 40
Procedure for dealing with pressure equipment or assemblies presenting a risk at national level
1. Where the market surveillance authorities of one Member State have sufficient reasons to believe that pressure
equipment or assemblies covered by this Directive present a risk to the health or safety of persons or to domestic animals
or property, they shall carry out an evaluation in relation to the pressure equipment or assembly concerned covering all
relevant requirements laid down in this Directive. The relevant economic operators shall cooperate as necessary with the
market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that
the equipment or assembly 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 actions to bring the pressure equipment or
assembly into compliance with those requirements, to withdraw the equipment or assembly 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.
L 189/196 EN Official Journal of the European Union 27.6.2014

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

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

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the pressure
equipment and assemblies 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 equipment’s or assembly’s being made available on their national market, to withdraw the
equipment or assembly 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 the second subparagraph of paragraph 4 shall include all available details, in
particular the data necessary for the identification of the non-compliant equipment or assembly, the origin of the
equipment or assembly, the nature of the non-compliance alleged and the risk involved, the nature and duration of
the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market
surveillance authorities shall indicate whether the non-compliance is due to either of the following:

(a) failure of the equipment or assembly to meet requirements relating to the health or safety of persons or to the
protection of domestic animals or property; or

(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 under this Article 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 equipment or assembly concerned, and, in the event of disagreement with
the adopted national measure, of their objections.

7. Where, within three months of receipt of the information referred to in the second subparagraph of 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, such as withdrawal of the equipment or assembly
from the market, are taken in respect of the equipment or assembly concerned without delay.

Article 41
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 40(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
adopt an implementing act determining whether the national measure is justified or not.
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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 necessary measures to ensure that the
non-compliant equipment or assembly is withdrawn from their market, and shall inform the Commission accordingly. If
the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

3. Where the national measure is considered justified and the non-compliance of the equipment or assembly is
attributed to shortcomings in the harmonised standards referred to in point (b) of Article 40(5) of this Directive, the
Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 42
Compliant pressure equipment or assemblies which present a risk
1. Where, having carried out an evaluation under Article 40(1), a Member State finds that although pressure
equipment or an assembly is in compliance with this Directive, it presents a risk to the health or safety of persons,
to domestic animals or property, it shall require the relevant economic operator to take all appropriate measures to
ensure that the equipment or assembly concerned, when placed on the market, no longer presents that risk, to withdraw
the equipment or assembly 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 equipment or assemblies
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 equipment or assembly concerned,
the origin and the supply chain of the equipment or assembly, 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 by means of implementing acts whether the national measure is justified or not and, where
necessary, propose appropriate measures.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the
examination procedure referred to in Article 44(3).

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, or of domestic
animals or of property, the Commission shall adopt immediately applicable implementing acts in accordance with the
procedure referred to in Article 44(4).

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 43
Formal non-compliance
1. Without prejudice to Article 40, 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 has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 19 of this
Directive;
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(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved in the production control phase, has been affixed in violation
of Article 19 or has not been affixed;

(d) the marking and labelling referred to in point 3.3. of Annex I have not been affixed or have been affixed in violation
of Article 19 or point 3.3 of Annex I;

(e) the EU declaration of conformity has not been drawn up;

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

(g) the technical documentation is either not available or not complete;

(h) the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;

(i) any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.

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

CHAPTER 6

COMMITTEE PROCEDURE AND DELEGATED ACTS

Article 44
Committee procedure
1. The Commission shall be assisted by the Committee on Pressure Equipment. That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with
Article 5 thereof, shall apply.

5. The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is
required by Regulation (EU) No 1025/2012 or by any other Union legislation.

The committee may furthermore examine any other matter 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.

Article 45
Delegated power
1. In order to take into account emerging very serious safety reasons, the Commission shall be empowered to adopt
delegated acts in accordance with Article 46 reclassifying pressure equipment or assemblies so as to:

(a) make an item or family of pressure equipment referred to in Article 4(3) subject to the requirements of Article 4(1);
27.6.2014 EN Official Journal of the European Union L 189/199

(b) make an assembly or family of assemblies referred to in Article 4(3) subject to the requirements of Article 4(2);

(c) classify an item or family of pressure equipment, by way of derogation from the requirements of Annex II, in another
category.

2. A Member State having concerns about the safety of pressure equipment or assemblies shall immediately inform the
Commission of its concerns and provide reasons in support.

3. Prior to adopting a delegated act the Commission shall carry out a thorough assessment of the risks that require
reclassification.

Article 46
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this
Article.

2. The power to adopt delegated acts referred to in Article 45 shall be conferred on the Commission for a period of
five years from 1 June 2015. The Commission shall draw up a report in respect of the delegation of power not later than
nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an
identical duration, unless the European Parliament or the Council opposes such extension not later than three months
before the end of each period.

3. The delegation of power referred to in Article 45 may be revoked at any time by the European Parliament or by the
Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect
the day following the publication of the decision in the Official Journal of the European Union or at a later date specified
therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and
to the Council.

5. A delegated act adopted pursuant to Article 45 shall enter into force only if no objection has been expressed either
by the European Parliament or the Council within a period of two months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both
informed the Commission that they will not object. That period shall be extended by two months at the initiative of the
European Parliament or of the Council.

CHAPTER 7

TRANSITIONAL AND FINAL PROVISIONS

Article 47
Penalties
Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of
national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented.
Such rules may include criminal penalties for serious infringements.

The penalties referred to in the first paragraph shall be effective, proportionate and dissuasive.

Article 48
Transitional provisions
1. Member States shall not impede the putting into service of pressure equipment and assemblies which comply with
the regulations in force in their territory at the date of application of Directive 97/23/EC and were placed on the market
until 29 May 2002.
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2. Member States shall not impede the making available on the market and/or the putting into service of pressure
equipment or assemblies covered by Directive 97/23/EC which are in conformity with that Directive and which were
placed on the market before 1 June 2015.

3. Certificates and decisions issued by conformity assessment bodies under Directive 97/23/EC shall be valid under this
Directive.

Article 49
Transposition
1. Member States shall adopt and publish, by 28 February 2015, the laws, regulations and administrative provisions
necessary to comply with Article 13. They shall forthwith communicate the text of those measures to the Commission.

They shall apply those measures from 1 June 2015.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such
reference on the occasion of their official publication. They shall also include a statement that references in existing laws,
regulations and administrative provisions to Article 9 of Directive 97/23/EC shall be construed as references to Article 13
of this Directive. Member States shall determine how such reference is to be made and how that statement is to be
formulated.

2. Member States shall adopt and publish, by 18 July 2016, the laws, regulations and administrative provisions
necessary to comply with Article 2(15) to (32), Articles 6 to 12, 14, 17 and 18, Article 19(3) to (5), Articles 20 to
43, 47 and 48 and Annexes I, II, III and IV. They shall forthwith communicate the text of those measures to the
Commission.

They shall apply those measures from 19 July 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such
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.

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

Article 50
Repeal
Article 9 of Directive 97/23/EC is deleted with effect from 1 June 2015, 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 that Article, set
out in Annex V, Part B.

Directive 97/23/EC, as amended by the acts listed in Annex V, Part A, is repealed with effect from 19 July 2016, 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.

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 VI.
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Article 51
Entry into force and application
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.

Article 1, points 1 to 14 of Article 2, Articles 3, 4, 5, 14, 15 and 16, Article 19(1) and (2), and Articles 44, 45 and 46
shall apply from 19 July 2016.

Article 52
Addressees
This Directive is addressed to the Member States.

Done at Brussels, 15 May 2014.

For the European Parliament For the Council

The President The President
M. SCHULZ D. KOURKOULAS
L 189/202 EN Official Journal of the European Union 27.6.2014

ANNEX I

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS

1. The obligations arising from the essential safety requirements listed in this Annex for pressure equipment also
apply to assemblies where the corresponding hazard exists.

2. The essential safety requirements laid down in this Directive are compulsory. The obligations following from
those essential safety requirements apply only if the corresponding hazard exists for the pressure equipment in
question when it is used under conditions which are reasonably foreseeable by the manufacturer.

3. The manufacturer is under an obligation to analyse the hazards and risks in order to identify those which apply
to his equipment on account of pressure; he shall then design and construct it taking account of his analysis.

4. The essential safety requirements are to be interpreted and applied in such a way as to take account of the state
of the art and current practice at the time of design and manufacture as well as of technical and economic
considerations which are consistent with a high degree of health and safety protection.

1. GENERAL

1.1. Pressure equipment shall be designed, manufactured and checked, and if applicable equipped and installed, in
such a way as to ensure its safety when put into service in accordance with the manufacturer’s instructions, or in
reasonably foreseeable conditions.

1.2. In choosing the most appropriate solutions, the manufacturer shall apply the principles set out below in the
following order:

— eliminate or reduce hazards as far as is reasonably practicable;

— apply appropriate protection measures against hazards which cannot be eliminated;

— where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate
special measures to reduce the risks at the time of installation and/or use.

1.3. Where the potential for misuse is known or can be clearly foreseen, the pressure equipment shall be designed to
prevent risks from such misuse or, if that is not possible, adequate warning given that the pressure equipment
shall not be used in that way.

2. DESIGN

2.1. General

The pressure equipment shall be properly designed taking all relevant factors into account in order to ensure that
the equipment will be safe throughout its intended life.

The design shall incorporate appropriate safety coefficients using comprehensive methods which are known to
incorporate adequate safety margins against all relevant failure modes in a consistent manner.

2.2. Design for adequate strength

2.2.1. The pressure equipment shall be designed for loadings appropriate to its intended use and other reasonably
foreseeable operating conditions. In particular, the following factors shall be taken into account:

— internal/external pressure,
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— ambient and operational temperatures,

— static pressure and mass of contents in operating and test conditions,

— traffic, wind, earthquake loading,

— reaction forces and moments which result from the supports, attachments, piping, etc.,

— corrosion and erosion, fatigue, etc.,

— decomposition of unstable fluids.

Various loadings which can occur at the same time shall be considered, taking into account the probability of
their simultaneous occurrence.

2.2.2. Design for adequate strength shall be based on either of the following:

— as a general rule, a calculation method, as described in point 2.2.3, and supplemented if necessary by an
experimental design method as described in point 2.2.4,

— an experimental design method without calculation, as described in point 2.2.4, when the product of the
maximum allowable pressure PS and the volume V is less than 6 000 bar·L or the product PS·DN less than
3 000 bar.

2.2.3. Calculation method

(a) P r e s s u r e c o n t a i n m e n t a n d o t h e r l o a d i n g a s p e c t s
The allowable stresses for pressure equipment shall be limited having regard to reasonably foreseeable failure
modes under operating conditions. To this end, safety factors shall be applied to eliminate fully any uncer­
tainty arising out of manufacture, actual operational conditions, stresses, calculation models and the prop­
erties and behaviour of the material.

These calculation methods shall provide sufficient safety margins consistent, where applicable, with the
requirements of point 7.

The requirements set out above may be met by applying one of the following methods, as appropriate, if
necessary as a supplement to or in combination with another method:

— design by formula,

— design by analysis,

— design by fracture mechanics.

(b) R e s i s t a n c e
Appropriate design calculations shall be used to establish the resistance of the pressure equipment concerned.

In particular:

— the calculation pressures shall not be less than the maximum allowable pressures and take into account
static head and dynamic fluid pressures and the decomposition of unstable fluids. Where a vessel is
separated into individual pressure-containing chambers, the partition wall shall be designed on the basis of
the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber,