Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC  (Text with EEA relevance)
Date: 2010-06-16
Institutions: Council of the European Union, European Parliament
Subjects: EC conformity marking, marketing standard, pressure equipment, roadworthiness tests, safety standard, transport of dangerous goods, transport safety

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I

(Legislative acts)

DIRECTIVES

DIRECTIVE 2010/35/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 June 2010

on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC,
84/526/EEC, 84/527/EEC and 1999/36/EC

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 91 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1)

(2)

(3)

Council Directive 1999/36/EC of 29 April 1999 on trans-
portable pressure equipment (3) was adopted as a first step
towards enhancing transport safety for transportable pres-
sure equipment, whilst ensuring the free movement of
transportable pressure equipment in a single transport
market.

In the light of developments in transport safety, it is nec-
essary to update certain technical provisions of Directive
1999/36/EC.

Directive 2008/68/EC of the European Parliament and of
the Council of 24 September 2008 on the inland transport
of dangerous goods (4) extended the application of the

(1) Opinion of 17 February 2010 (not yet published in the Official Jour-

nal).

(2) Position of the European Parliament of 5 May 2010 (not yet published
in the Official Journal) and Decision of the Council of 31 May 2010.

(3) OJ L 138, 1.6.1999, p. 20.
(4) OJ L 260, 30.9.2008, p. 13.

provisions of certain international agreements to cover
national traffic in order to harmonise the conditions under
which dangerous goods are transported by road, rail and
inland waterways across the Union.

It is therefore necessary to update the provisions of Direc-
tive 1999/36/EC accordingly to avoid conflicting rules, in
particular as regards conformity requirements, conformity
assessment and conformity assessment procedures in rela-
tion to transportable pressure equipment.

In order to enhance safety with regard to transportable
pressure equipment approved for the inland transport of
dangerous goods and to ensure free movement, including
placing on the market, making available on the market and
use of such transportable pressure equipment within the
Union, it is necessary to lay down detailed rules concern-
ing the obligations of the various operators and the require-
ments to be fulfilled by the equipment concerned.

Decision No 768/2008/EC of the European Parliament and
of the Council of 9 July 2008 on a common framework for
the marketing of products (5) constitutes a general frame-
work of a horizontal nature for future legislation harmo-
nising the conditions for the marketing of products. This
framework should apply where appropriate for the trans-
portable pressure equipment sector in line with the objec-
tive of harmonising rules on the free movement of
products.

In order not to hinder transport operations between Mem-
ber States and third countries, this Directive should not
apply to transportable pressure equipment exclusively used
for the transport of dangerous goods between the territory
of the Union and that of third countries.

(4)

(5)

(6)

(7)

(5) OJ L 218, 13.8.2008, p. 82.

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(8)

(9)

(10)

(11)

the different economic operators,
The obligations of
including owners and operators of transportable pressure
equipment, should be clearly defined in the interests of
transport safety and the free movement of transportable
pressure equipment.

Economic operators should in relation to their respective
roles in the supply chain be responsible for the compliance
of transportable pressure equipment with the safety and
market access rules.

Compliance of new transportable pressure equipment with
the technical requirements of the Annexes to Directive
2008/68/EC and this Directive should be demonstrated by
means of a conformity assessment to provide evidence that
the transportable pressure equipment is safe.

Periodic inspections, intermediate inspections and excep-
tional checks of transportable pressure equipment should
be carried out in accordance with the Annexes to Directive
2008/68/EC and with this Directive to ensure continued
compliance with their safety requirements.

(12)

Transportable pressure equipment should bear a mark
indicating its compliance with Directive 2008/68/EC and
this Directive to ensure its free movement and free use.

(13)

This Directive should not apply to transportable pressure
equipment which was placed on the market before the rel-
evant date of implementation of Directive 1999/36/EC and
which has not been subject to reassessment of conformity.

(14) Where existing transportable pressure equipment not pre-
viously assessed for conformity with Directive 1999/36/EC
is to benefit from free movement and free use, it should be
subject to reassessment of conformity.

It is necessary to set requirements for authorities respon-
sible for the assessment, notification and monitoring of
notified bodies in order to ensure a consistent level of qual-
ity in the performance of notified bodies.

(15)

(16)

(18)

It is necessary to lay down common rules for the mutual
recognition of notified bodies which ensure compliance
with Directive 2008/68/EC and this Directive. Those com-
mon rules will have the effect of eliminating unnecessary
costs and administrative procedures related to the approval
of the equipment and of eliminating technical barriers to
trade.

(19) Member States should be able to take measures to limit or
prohibit the placing on the market and use of equipment
in cases where such equipment presents a risk to safety in
certain specified circumstances,
including when such
equipment is in compliance with Directive 2008/68/EC
and with this Directive.

(20)

(21)

(22)

The Commission should draw up specific guidelines to
facilitate the practical implementation of the technical pro-
visions of this Directive, taking into account the results of
the exchange of experiences as foreseen in Articles 28
and 29.

The Commission should be empowered to adopt delegated
acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union (TFEU) in respect of
certain adaptations of the Annexes. It is of particular
importance that the Commission carry out appropriate
consultations during its preparatory work, including at
expert level.

Council Directive 76/767/EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to
common provisions for pressure vessels and methods for
inspecting them (1), Council Directive 84/525/EEC of
17 September 1984 on the approximation of the laws of
the Member States relating to seamless, steel gas cylin-
ders (2), Council Directive 84/526/EEC of 17 September
1984 on the approximation of the laws of the Member
States relating to seamless, unalloyed aluminium and alu-
minium alloy
cylinders (3), Council Directive
84/527/EEC of 17 September 1984 on the approximation
of the laws of the Member States relating to welded unal-
loyed steel gas cylinders (4) and Directive 1999/36/EC have
become obsolete and should therefore be repealed.

gas

The conformity assessment procedures provided for in the
Annexes to Directive 2008/68/EC and in this Directive
require the intervention of inspection bodies setting out
detailed operational requirements to ensure a uniform level
of performance throughout the Union. These inspection
bodies should then be notified by the Member States to the
Commission.

(23)

In accordance with paragraph 34 of the Interinstitutional
Agreement on better law-making (5), Member States are
encouraged to draw up, for themselves and in the interest
of the Union, their own tables, which will, as far as pos-
sible, illustrate the correlation between this Directive and
their transposition measures, and to make those tables
public,

(17)

The notifying authority should retain responsibility for
monitoring the notified body regardless of where the noti-
fied body performs its activities in order to ensure clear
responsibility for ongoing monitoring.

(1) OJ L 262, 27.9.1976, p. 153.
(2) OJ L 300, 19.11.1984, p. 1.
(3) OJ L 300, 19.11.1984, p. 20.
(4) OJ L 300, 19.11.1984, p. 48.
(5) OJ C 321, 31.12.2003, p. 1.

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HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

SCOPE AND DEFINITIONS

Article 1

Scope

1.
This Directive sets out detailed rules concerning transport-
able pressure equipment to enhance safety and ensure free move-
ment of such equipment within the Union.

2.

This Directive shall apply to:

(a) new transportable pressure equipment as defined in
Article 2(1), which does not bear the conformity markings
provided for
in Directives 84/525/EEC, 84/526/EEC,
84/527/EEC or 1999/36/EC, for the purpose of making it
available on the market;

(b)

(c)

transportable pressure equipment as defined in Article 2(1),
bearing the conformity markings provided for in this Direc-
tive or in Directives 84/525/EEC, 84/526/EEC, 84/527/EEC
or 1999/36/EC, for the purposes of its periodic inspections,
intermediate inspections, exceptional checks and use;

transportable pressure equipment as defined in Article 2(1),
which does not bear the conformity markings provided for
in Directive 1999/36/EC, for the purposes of reassessment of
conformity.

This Directive shall not apply to transportable pressure
3.
equipment which was placed on the market before the date of
implementation of Directive 1999/36/EC and which has not been
subject to a reassessment of conformity.

4.
This Directive shall not apply to transportable pressure
equipment used exclusively for the transport of dangerous goods
between Member States and third countries, carried out in accor-
dance with Article 4 of Directive 2008/68/EC.

Article 2

Definitions

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

(1)

‘transportable pressure equipment’ means:

(a) all pressure receptacles, their valves and other accesso-
ries when appropriate, as covered in Chapter 6.2 of the
Annexes to Directive 2008/68/EC;

when the equipment under (a) or (b) is used in accordance
with those Annexes for the transport of Class 2 gases,
excluding gases or articles with figures 6 and 7 in the clas-
sification code, and for the transport of the dangerous sub-
stances of other classes specified in Annex I to this Directive.

for breathing apparatus,

Transportable pressure equipment shall be understood as
including gas cartridges (UN No 2037) and excluding aero-
sols (UN No 1950), open cryogenic receptacles, gas cylin-
(UN
ders
No 1044), transportable pressure equipment exempted
to Directive
according to 1.1.3.2 of
2008/68/EC and
equipment
exempted from the rules for construction and testing of
packaging according to special provisions in 3.3 of the
Annexes to Directive 2008/68/EC;

fire extinguishers

the Annexes

transportable

pressure

(2)

‘Annexes to Directive 2008/68/EC’ means Section I.1 of
Annex I, Section II.1 of Annex II, and Section III.1 of
Annex III to Directive 2008/68/EC;

(3)

‘placing on the market’ means the first making available of
transportable pressure equipment on the Union market;

(4)

‘making available on the market’ means any supply of trans-
portable pressure equipment for distribution or use on the
Union market in the course of a commercial or public ser-
vice activity, whether in return for payment or free of charge;

(5)

‘use’ means filling, temporary storage linked to carriage,
emptying and refilling of transportable pressure equipment;

(6)

(7)

(8)

(9)

‘withdrawal’ means any measure aimed at preventing trans-
portable pressure equipment from being made available on
the market or from being used;

‘recall’ means any measure aimed at achieving the return of
transportable pressure equipment that has already been
made available to the end user;

‘manufacturer’ means any natural or legal person who manu-
factures transportable pressure equipment, or parts thereof,
or who has such equipment designed or manufactured and
markets it under his name or trademark;

‘authorised representative’ means any natural or legal per-
son established within the Union who has received a written
mandate from the manufacturer to act on his behalf in rela-
tion to specified tasks;

(10) ‘importer’ means any natural or legal person established
within the Union, who places transportable pressure equip-
ment or parts thereof from a third country on the Union
market;

(b)

tanks, battery vehicles/wagons, multiple-element gas
containers (MEGCs), their valves and other accessories
when appropriate, as covered in Chapter 6.8 of the
Annexes to Directive 2008/68/EC;

(11) ‘distributor’ means any natural or legal person established
within the Union, other than the manufacturer or the
importer, who makes transportable pressure equipment or
parts thereof available on the market;

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(12) ‘owner’ means any natural or legal person established within
the Union who owns transportable pressure equipment;

(13) ‘operator’ means any natural or legal person established in

the Union using transportable pressure equipment;

(26) ‘market surveillance’ means the activities carried out and
measures taken by public authorities to ensure that trans-
portable pressure equipment during its life cycle complies
with the requirements set out in Directive 2008/68/EC and
this Directive and does not endanger health, safety or any
other aspect of public interest protection.

(14) ‘economic operator’ means the manufacturer, the authorised
representative, the importer, the distributor, the owner or
the operator acting in the course of a commercial or public
service activity, whether in return for payment or free of
charge;

(15) ‘conformity assessment’ means the assessment and the pro-
cedure for the assessment of conformity set out in the
Annexes to Directive 2008/68/EC;

(16) ‘Pi marking’ means a marking which indicates that the trans-
portable pressure equipment is in conformity with the appli-
cable conformity assessment requirements set out in the
Annexes to Directive 2008/68/EC and in this Directive;

(17) ‘reassessment of conformity’ means the procedure under-
taken, at the request of the owner or operator, for the sub-
sequent assessment of the conformity of transportable
pressure equipment manufactured and placed on the mar-
ket before the date of
implementation of Directive
1999/36/EC;

(18) ‘periodic inspection’ means the periodic inspection and the
procedures governing the periodic inspection as set out in
the Annexes to Directive 2008/68/EC;

(19) ‘intermediate inspection’ means the intermediate inspection
and the procedures governing the intermediate inspection as
set out in the Annexes to Directive 2008/68/EC;

(20) ‘exceptional check’ means the exceptional check and the pro-
cedures governing the exceptional check set out in the
Annexes to Directive 2008/68/EC;

(21) ‘national accreditation body’ means the sole body in a Mem-
ber State that performs accreditation with authority derived
from the State;

(22) ‘accreditation’ means an attestation by a national accredita-
tion body that a notified body meets the requirements set
out in the second paragraph of 1.8.6.8 of the Annexes to
Directive 2008/68/EC;

(23) ‘notifying authority’ means the authority designated by a

Member State pursuant to Article 17;

(24) ‘notified body’ means an inspection body meeting the
requirements
to Directive
2008/68/EC and the conditions set out in Articles 20 and 26
of this Directive and notified in accordance with Article 22
of this Directive;

in the Annexes

set out

Article 3

On-site requirements

Member States may on their territory establish on-site require-
ments for the mid- or long-term storage or the on-site use of
transportable pressure equipment. However, Member States shall
not establish additional requirements for the transportable pres-
sure equipment itself.

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 4

Obligations of manufacturers

1. When placing their transportable pressure equipment on
the market, manufacturers shall ensure that the equipment has
been designed, manufactured and documented in accordance
with the requirements set out in the Annexes to Directive
2008/68/EC and in this Directive.

2. Where the compliance of the transportable pressure equip-
ment with the applicable requirements has been demonstrated
through the conformity assessment process set out in the Annexes
to Directive 2008/68/EC and in this Directive, manufacturers
shall affix the Pi marking in accordance with Article 15 of this
Directive.

3. Manufacturers shall keep the technical documentation
specified in the Annexes to Directive 2008/68/EC. This documen-
tation shall be kept for the period specified therein.

4. Manufacturers who consider or have reason to believe that
transportable pressure equipment which they have placed on the
market is not in conformity with the Annexes to Directive
2008/68/EC or with this Directive shall immediately take the cor-
rective measures necessary to bring the transportable pressure
equipment into conformity, to withdraw it or to recall it, if appro-
priate. Furthermore, where the transportable pressure equipment
presents a risk, manufacturers shall immediately inform the com-
petent national authorities of the Member States in which they
made the transportable pressure equipment available to that
effect, giving details, in particular, of the non-compliance and of
any corrective measures taken.

(25) ‘notification’ is the process of awarding notified body status
to an inspection body and includes communication of this
information to the Commission and to the Member States;

5. Manufacturers shall document all such instances of non-
compliance and corrective measures.

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6. Manufacturers shall, further to a reasoned request from the
competent national authority, provide it with all the information
and documentation necessary to demonstrate the conformity of
the transportable pressure equipment, in a language easily under-
stood by that authority. They shall cooperate with that authority,
at its request, as regards any action taken to eliminate the risks
posed by transportable pressure equipment which they have
placed on the market.

7. Manufacturers shall only provide information to operators
which complies with the requirements set out in the Annexes to
Directive 2008/68/EC and in this Directive.

Article 5

Authorised representatives

1. Manufacturers may, by a written mandate, appoint an
authorised representative.

The obligations set out in Article 4(1) and (2) and the drawing up
of technical documentation shall not form part of the authorised
representative’s mandate.

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

(a) keep the technical documentation at the disposal of national
surveillance authorities for at least the period as specified in
the Annexes to Directive 2008/68/EC for manufacturers;

(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 transportable pressure equipment in a language easily
understood by that authority;

(c)

cooperate with the competent national authorities, at their
request, on any action taken to eliminate the risks posed by
transportable pressure equipment covered by the mandate.

3.
The identity and address of the authorised representative
shall be indicated on the certificate of conformity specified in the
Annexes to Directive 2008/68/EC.

4.
Authorised representatives shall only provide information
to operators which complies with the requirements set out in the
Annexes to Directive 2008/68/EC and in this Directive.

Article 6

Obligations of importers

1.
Importers shall only place on the Union market transport-
able pressure equipment which is in conformity with the Annexes
to Directive 2008/68/EC and with this Directive.

Before placing transportable pressure equipment on the
2.
market, importers shall ensure that the appropriate conformity
assessment procedure has been carried out by the manufacturer.
They shall ensure that the manufacturer has drawn up the tech-
nical documentation and that the transportable pressure equip-
ment bears the Pi marking and is accompanied by the certificate
of conformity specified in the Annexes to Directive 2008/68/EC.

Where an importer considers or has reason to believe that the
transportable pressure equipment is not in conformity with the
Annexes to Directive 2008/68/EC or with this Directive, he shall
not place the transportable pressure equipment on the market
until it has been brought into conformity. Furthermore, where the
transportable pressure equipment presents a risk, the importer
shall
inform the manufacturer and the market surveillance
authorities to that effect.

3.
Importers shall indicate their name and the address at which
they can be contacted either in, or attached to, the certificate of
conformity specified in the Annexes to Directive 2008/68/EC.

4.
Importers shall ensure that, while transportable pressure
equipment is under their responsibility, storage or transport con-
ditions do not jeopardise its compliance with the requirements set
out in the Annexes to Directive 2008/68/EC.

is not

Importers who consider or have reason to believe that trans-
5.
portable pressure equipment which they have placed on the mar-
ket
in conformity with the Annexes to Directive
2008/68/EC or with this Directive shall immediately take the cor-
rective measures necessary to bring the transportable pressure
equipment into conformity, to withdraw it or to recall it, if appro-
priate. Furthermore, where the transportable pressure equipment
presents a risk, importers shall immediately inform the manufac-
turer and the competent national authorities of the Member States
in which they made the transportable pressure equipment avail-
in particular, of the non-
able to that effect, giving details,
compliance and of any corrective measures taken.

Importers shall document all such instances of non-compliance
and corrective measures.

Importers shall, for at least the period specified in the
6.
Annexes to Directive 2008/68/EC for manufacturers, keep a copy
of the technical documentation at the disposal of the market sur-
veillance authorities and ensure that the technical documentation
can be made available to those authorities upon request.

7.
Importers shall, further to a reasoned request from the com-
petent national authority, provide it with all the information and
documentation necessary to demonstrate the conformity of the
transportable pressure equipment, in a language easily understood
by that authority. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by trans-
portable pressure equipment which they have placed on the
market.

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Importers shall only provide information to operators
8.
which complies with the requirements set out in the Annexes to
Directive 2008/68/EC and in this Directive.

Distributors shall only provide information to operators
5.
which complies with the requirements set out in the Annexes to
Directive 2008/68/EC and in this Directive.

Article 7

Obligations of distributors

Article 8

Obligations of owners

1.
Distributors shall only make available on the Union market
transportable pressure equipment which is in conformity with the
Annexes to Directive 2008/68/EC and with this Directive. Before
making transportable pressure equipment available on the mar-
ket distributors shall verify that the transportable pressure equip-
ment bears the Pi marking, and that it is accompanied by the
certificate of conformity and the contact address referred to in
Article 6(3) of this Directive.

Where a distributor considers or has reason to believe that trans-
portable pressure equipment is not in conformity with the
Annexes to Directive 2008/68/EC or with this Directive, he shall
not make the transportable pressure equipment available on the
market until it has been brought into conformity. Furthermore,
where the transportable pressure equipment presents a risk, the
distributor shall inform the manufacturer or the importer to that
effect as well as the market surveillance authorities.

Distributors shall ensure that, while transportable pressure
2.
equipment is under their responsibility, storage or transport con-
ditions do not jeopardise its compliance with the requirements set
out in the Annexes to Directive 2008/68/EC.

3.
Distributors who consider or have reason to believe that
transportable pressure equipment which they have made available
on the market is not in conformity with the Annexes to Directive
2008/68/EC or with this Directive shall make sure that the cor-
rective measures necessary to bring that transportable pressure
equipment into conformity, to withdraw it or to recall it, if appro-
priate, are taken. Furthermore, where the transportable pressure
equipment presents a risk, distributors shall immediately inform
the manufacturer, the importer, where relevant, and the compe-
tent national authorities of the Member States in which they made
the transportable pressure equipment available to that effect, giv-
ing details, in particular, of the non-compliance and of any cor-
rective measures taken.

1. Where an owner considers or has reason to believe that
transportable pressure equipment is not in conformity with the
Annexes to Directive 2008/68/EC, including the requirements for
periodic inspection, and with this Directive, he shall not make it
available or use it until it has been brought into conformity. Fur-
thermore, where the transportable pressure equipment presents a
risk, the owner shall inform the manufacturer or the importer or
the distributor to that effect as well as the market surveillance
authorities.

Owners shall document all such instances of non-compliance and
corrective measures.

2.
Owners shall ensure that, while transportable pressure
equipment is under their responsibility, storage or transport con-
ditions do not jeopardise its compliance with the requirements set
out in the Annexes to Directive 2008/68/EC.

3.
Owners shall only provide information to operators which
complies with the requirements set out in the Annexes to Direc-
tive 2008/68/EC and in this Directive.

4.
This Article shall not apply to private individuals intending
to use or using transportable pressure equipment for their per-
sonal or domestic use or for their leisure or sporting activities.

Article 9

Obligations of operators

1.
Operators shall only use transportable pressure equipment
which is in conformity with the requirements set out in the
Annexes to Directive 2008/68/EC and in this Directive.

2. Where the transportable pressure equipment presents a risk,
the operator shall inform the owner to that effect as well as the
market surveillance authorities.

Distributors shall document all such instances of non-compliance
and corrective measures.

Article 10

Cases in which obligations of manufacturers apply to
importers and distributors

4.
Distributors shall, further to a reasoned request from the
competent national authority, provide it with all the information
and documentation necessary to demonstrate the conformity of
the transportable pressure equipment in a language easily under-
stood by that authority. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by
transportable pressure equipment which they have made available
on the market.

An importer or distributor shall be considered a manufacturer for
the purposes of this Directive and subject to the obligations of the
manufacturer pursuant to Article 4, where he places transport-
able pressure equipment on the market under his name or trade-
mark or modifies transportable pressure equipment already
placed on the market in such a way that compliance with the
applicable requirements may be affected.

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Article 11

Identification of economic operators

The Pi marking shall be affixed in accordance with Annex III to
this Directive.

Economic operators shall, on request from the market surveil-
lance authority, identify the following to it for a period of at least
10 years:

Article 14

General principles of the Pi marking

(a) any economic operator who has supplied them with trans-

portable pressure equipment;

(b) any economic operator to whom they have supplied trans-

portable pressure equipment.

The Pi marking shall only be affixed by the manufacturer or,
1.
in cases of reassessment of conformity, as set out in Annex III. For
gas
cylinders previously in compliance with Directives
84/525/EEC, 84/526/EEC or 84/527/EEC the Pi mark shall be
affixed by or under the surveillance of the notified body.

CHAPTER 3

CONFORMITY OF TRANSPORTABLE PRESSURE EQUIPMENT

The Pi marking shall be affixed only to transportable pres-

2.
sure equipment which:

(a) meets the conformity assessment requirements in the

Annexes to Directive 2008/68/EC and in this Directive; or

Article 12

Conformity of transportable pressure equipment and its
assessment

(b) meets the reassessment of conformity requirements referred

to in Article 13.

The transportable pressure equipment

1.
referred to in
Article 1(2)(a) shall meet the relevant conformity assessment, peri-
odic inspection, intermediate inspection and exceptional checks
requirements set out in the Annexes to Directive 2008/68/EC and
in Chapters 3 and 4 of this Directive.

The transportable pressure equipment

referred to in
2.
Article 1(2)(b) shall meet the specifications of the documentation
according to which the equipment was manufactured. The equip-
ment shall be subject to periodic inspections, intermediate inspec-
tions and exceptional checks in accordance with the Annexes to
Directive 2008/68/EC and with the requirements of Chapters 3
and 4 of this Directive.

Certificates of conformity assessment and certificates of
3.
reassessment of conformity and reports of periodic inspections,
intermediate inspections and exceptional checks issued by a noti-
fied body shall be valid in all Member States.

For demountable parts of refillable transportable pressure equip-
ment a separate conformity assessment may be carried out.

Article 13

Reassessment of conformity

The reassessment of conformity of transportable pressure equip-
ment referred to in Article 1(2)(c) manufactured and put into ser-
vice before the date of implementation of Directive 1999/36/EC
shall be established in accordance with the conformity reassess-
ment procedure set out in Annex III to this Directive.

It shall not be affixed to any other transportable pressure
equipment.

3.
By affixing or having affixed the Pi marking, the manufac-
turer indicates that he takes responsibility for the conformity of
the transportable pressure equipment with all applicable require-
ments set out in the Annexes to Directive 2008/68/EC and in this
Directive.

4.
For the purposes of this Directive, the Pi marking shall be
the only marking which attests conformity of the transportable
pressure equipment with the applicable requirements set out in
the Annexes to Directive 2008/68/EC and in this Directive.

5.
The affixing on transportable pressure equipment of mark-
ings, signs and inscriptions which are likely to mislead third par-
ties as to the meaning or form of the Pi marking, shall be
prohibited. Any other marking shall be affixed to the transport-
able pressure equipment in such a way that the visibility, legibil-
ity and meaning of the Pi marking are not thereby impaired.

Demountable parts of refillable transportable pressure

6.
equipment with a direct safety function shall be Pi-marked.

7. Member States shall ensure correct implementation of the
rules governing the Pi marking and shall take appropriate action
in the event of improper use of the marking. Member States shall
also provide for penalties for infringements, which may include
criminal sanctions for serious infringements. Those penalties shall
be proportionate to the seriousness of the offence and constitute
an effective deterrent against improper use.

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Article 15

Article 16

Rules and conditions for the affixing of the Pi marking

Free movement of transportable pressure equipment

The Pi marking shall consist of the following symbol in the

1.
following form:

2.
The minimum height of the Pi marking shall be 5 mm. For
transportable pressure equipment with a diameter less than or
equal to 140 mm the minimum height shall be 2,5 mm.

3.
The proportions given in the graduated drawing in para-
graph 1 shall be respected. The grid does not form part of the
marking.

4.
The Pi marking shall be affixed visibly, legibly and perma-
nently to the transportable pressure equipment or to its data plate
as well as to demountable parts of refillable transportable pres-
sure equipment having a direct safety function.

The Pi marking shall be affixed before the new transport-
5.
able pressure equipment or demountable parts of refillable trans-
portable pressure equipment having a direct safety function are
placed on the market.

6.
The Pi marking shall be followed by the identification num-
ber of the notified body involved in the initial inspections and
tests.

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

The marking of the date of the periodic inspection or, where
7.
appropriate, the intermediate inspection shall be accompanied by
the identification number of the notified body responsible for the
periodic inspection.

8. With regard to gas cylinders previously in compliance with
Directives 84/525/EEC, 84/526/EEC or 84/527/EEC not bearing
the Pi marking, when the first periodic inspection is carried out
in accordance with this Directive, the identification number of the
notified body responsible shall be preceded by the Pi marking.

Without prejudice to the safeguard procedures in Articles 30
and 31 of this Directive and to the market surveillance framework
set out in Regulation (EC) No 765/2008 (1), no Member State
shall prohibit, restrict or impede on its territory the free move-
ment, the making available on the market and the use of trans-
portable pressure equipment, which complies with this Directive.

CHAPTER 4

NOTIFYING AUTHORITIES AND NOTIFIED BODIES

Article 17

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, notification and subsequent moni-
toring of notified bodies.

2. Member States may decide that the assessment and moni-
toring 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 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 set
out in Article 18(1) to (6). In addition the entrusted body shall
have arrangements to cover liabilities arising out of its activities.

The notifying authority shall take full responsibility for the

4.
tasks performed by the body referred to in paragraph 3.

Article 18

Requirements relating to notifying authorities

The notifying authority shall be established in such a way

1.
that no conflicts of interest with notified bodies occur.

The notifying authority shall be organised and operated so

2.
as to safeguard the objectivity and impartiality of its activities.

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

(1) Regulation (EC) No 765/2008 of the European Parliament and of the
Council of 9 July 2008 setting out the requirements for accreditation
and market surveillance relating to the marketing of products
(OJ L 218, 13.8.2008, p. 30).

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The notifying authority shall not offer or provide any activi-
4.
ties or consultancy services on a commercial or competitive basis
that notified bodies perform.

The notifying authority shall safeguard the confidentiality of

5.
the information obtained.

6.
The notifying authority shall have a sufficient number of
competent personnel at its disposal for the proper performance
of its tasks.

Article 19

Information obligation of notifying authorities

Member States shall inform the Commission of their national pro-
cedures for the assessment, notification and monitoring of noti-
fied bodies, and of any changes to that information.

The Commission shall make that information publicly available.

Article 20

Requirements relating to notified bodies

1.
For the purposes of notification, a notified body shall meet
the requirements set out in the Annexes to Directive 2008/68/EC
and in this Directive.

2.
A competent authority, within the meaning of the Annexes
to Directive 2008/68/EC may be a notified body provided it meets
the requirements set out in the Annexes to Directive 2008/68/EC
and in this Directive and that it does not also act as the notifying
authority.

(d) an accreditation certificate issued by a national accreditation
body within the meaning of Regulation (EC) No 765/2008,
attesting that the inspection body fulfils the requirements set
out in Article 20 of this Directive.

Article 22

Notification procedure

Notifying authorities shall notify only those bodies which

1.
have satisfied the requirements set out in Article 20.

2.
They shall notify the Commission and the other Member
States using the electronic tool developed and managed by the
Commission.

The notification shall include the information required in

3.
Article 21(2).

4.
The body concerned may perform the activities of a noti-
fied body only where no objections are raised by the Commission
or the other Member States within two weeks of a notification.

Only such a body shall be considered a notified body for the pur-
poses of this Directive.

The Commission and the other Member States shall be noti-

5.
fied of any subsequent relevant changes to the notification.

In–house inspection services of the applicant as defined in

6.
the Annexes to Directive 2008/68/EC shall not be notified.

The notified body shall be established under national law

3.
and shall have legal personality.

Identification numbers and lists of notified bodies

Article 23

4.
The notified body shall participate in, or ensure that its
assessment personnel is informed of, the relevant standardisation
activities and the activities of the notified body coordination
group established pursuant to Article 29 and apply as general
guidance the administrative decisions and documents produced as
a result of the work of that group.

Article 21

Application for notification

1.
An inspection body shall submit an application for notifi-
cation to the notifying authority of the Member State in which it
is established.

2.

The application shall be accompanied by a description of:

(a)

the activities relating to conformity assessment, periodic
inspection, intermediate inspection, exceptional checks and
reassessment of conformity;

(b)

the procedures relating to point (a);

(c)

the transportable pressure equipment for which the body
claims to be competent;

The Commission shall assign an identification number to a

1.
notified body.

It shall assign a single such number even where the body is noti-
fied under several Union acts.

The Commission shall make publicly available the list of the
2.
bodies notified under this Directive, including the identification
numbers that have been allocated to them and the activities for
which they have been notified.

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

Article 24

Changes to notifications

1. Where a notifying authority has ascertained or has been
informed that a notified body no longer meets the requirements
set out in Article 20, or that it is failing to fulfil its obligations, the
notifying authority shall restrict, suspend or withdraw notifica-
tion, as appropriate, depending on the seriousness of the failure
to meet those requirements or fulfil those obligations. It shall
immediately inform the Commission and the other Member
States accordingly.

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In the event of withdrawal, restriction or suspension of noti-
2.
fication or where the notified body has ceased its activity, the
notifying Member State shall take the appropriate steps to ensure
that the files of that body are either processed by another notified
body or kept available for the responsible notifying and market
surveillance authorities on request.

(c) any request for information on activities performed which
they have received from market surveillance authorities;

(d) on request, activities performed within the scope of their
including

notification and any other activity performed,
cross-border activities and subcontracting.

Article 25

Challenge to the competence of notified bodies

1.
The Commission shall investigate all cases where it doubts
or doubt is brought to its attention regarding the competence of
a notified body or the continued fulfilment by a notified body of
the requirements and responsibilities to which it is subject.

2.
The notifying Member State shall provide the Commission,
on request, with all information relating to the basis for the noti-
fication or the maintenance of the competence of the body
concerned.

The Commission shall ensure that all sensitive information
3.
obtained in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does
not meet, or no longer meets, the requirements for its notifica-
tion, it shall inform the notifying Member State accordingly and
request it to take the necessary corrective measures, including
de-notification, if necessary.

Article 26

Operational obligations of notified bodies

1.
Notified bodies shall carry out conformity assessments, peri-
odic inspections, intermediate inspections and exceptional checks
in accordance with the terms of their notification and the proce-
dures set out in the Annexes to Directive 2008/68/EC.

Notified bodies shall carry out reassessments of conformity

2.
in accordance with Annex III.

Notified bodies notified by one Member State shall be
3.
authorised to work in all Member States. The notifying authority
which carried out the initial assessment and notification retains
the responsibility for monitoring the ongoing activities of the
notified body.

Article 27

Information obligation of notified bodies

Notified bodies shall inform the notifying authority of the

1.
following:

(a) any refusal, restriction, suspension or withdrawal of a

certificate;

(b) any circumstances affecting the scope of and conditions for

notification;

2.
Notified bodies shall provide the other bodies notified under
this Directive carrying out similar conformity assessment, peri-
odic inspection, intermediate inspections and exceptional checks
activities covering the same transportable pressure equipment
with relevant information on issues relating to negative and, on
request, positive conformity assessment results.

Article 28

Exchange of experience

The Commission shall provide for the organisation of exchange
of experience between the Member States’ national authorities
responsible under this Directive for:

(a) notification policy;

(b) market surveillance.

Article 29

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and
cooperation between bodies notified under this Directive are put
in place and properly operated in the form of a sectoral group of
notified bodies.

Member States shall ensure that the bodies notified by them par-
ticipate in the work of that group, directly or by designated
representatives.

CHAPTER 5

SAFEGUARD PROCEDURES

Article 30

Procedure for dealing with transportable pressure
equipment presenting a risk at national level

1. Where the market surveillance authorities of one Member
State have taken action pursuant to Article 20 of Regulation (EC)
No 765/2008 or where they have sufficient reason to believe that
transportable pressure equipment covered by this Directive pre-
sents a risk to the health or safety of persons or to other aspects
of public interest protection covered by this Directive, they shall
carry out an evaluation in relation to the transportable pressure
equipment concerned covering all the requirements laid down in
this Directive. The relevant economic operators shall cooperate as
necessary with the market surveillance authorities,
including
granting access to their premises and providing samples as
appropriate.

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Where, in the course of that evaluation, the market surveillance
authorities find that the transportable pressure equipment does
not comply with the requirements set out in the Annexes to
Directive 2008/68/EC and in this Directive, they shall without
delay require the relevant economic operator to take all appropri-
ate corrective action to bring the transportable pressure equip-
ment into compliance with those requirements, to withdraw the
transportable pressure equipment 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 noti-
fied body accordingly.

6. Member States other than the Member State initiating the
procedure shall without delay inform the Commission and the
other Member States of any measures adopted and of any addi-
tional
relating to the non-
their disposal
compliance of the transportable pressure equipment concerned,
and, in the event of disagreement with the notified national mea-
sure, of their objections.

information at

7. Where, within two months of receipt of the information
referred to in paragraph 4, no objection has been raised by either
a Member State or the Commission in respect of a provisional
measure taken by a Member State, that measure shall be deemed
justified.

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

8. Member States shall ensure that appropriate restrictive mea-
sures are taken in respect of the transportable pressure equipment
concerned, such as withdrawal of the transportable pressure
equipment from their market, without delay.

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.

The economic operator shall ensure that all appropriate cor-
3.
rective action is taken in respect of transportable pressure equip-
ment that it has made available on the Union market.

4. Where the relevant economic operator does not take
adequate corrective action within the period referred to in the sec-
ond subparagraph of paragraph 1,
the market surveillance
authorities shall take all appropriate provisional measures to pro-
hibit or restrict the transportable pressure equipment being made
available on their national market, to withdraw the equipment
from that market or to recall it.

They shall inform the Commission and the other Member States,
without delay, of those measures.

The information referred to in paragraph 4 shall include all
5.
available details, in particular the data necessary for the identifi-
cation of the non-compliant transportable pressure equipment,
the origin of the equipment, the nature of the alleged non-
compliance 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:

(a)

failure of the transportable pressure equipment to meet
requirements relating to the health or safety of persons or to
other aspects of public interest protection set out in the
Annexes to Directive 2008/68/EC and in this Directive, or

Article 31

Union safeguard procedure

the procedure set out

in
1. Where, on completion of
Article 30(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 a legally binding Union act, the Com-
mission shall without delay enter into consultation with the Mem-
ber States and the relevant economic operator or operators and
shall evaluate the national measure. On the basis of the results of
that evaluation, the Commission shall decide whether the national
measure is justified or not.

The Commission shall address its decision to all Member States
and shall immediately communicate it to them and to the relevant
economic operator or operators.

2.
If the national measure is considered justified, all Member
States shall take the measures necessary to ensure that the non-
compliant transportable pressure equipment is withdrawn from
their markets, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member
State concerned shall withdraw it.

3. Where the national measure is considered justified and the
non-compliance of the transportable pressure equipment is attrib-
uted to shortcomings in the standards as referred to in
Article 30(5)(b), the Commission shall inform the relevant Euro-
pean standardisation body or bodies and may bring the matter
before the Committee set up by Article 5 of Directive
98/34/EC (1). That Committee may consult the relevant European
standardisation body or bodies before delivering its opinion.

(b)

shortcomings in the standards or technical codes referred to
in the Annexes to Directive 2008/68/EC or in other provi-
sions of that Directive.

(1) Directive 98/34/EC of the European Parliament and of the Council of
22 June 1998 laying down a procedure for the provision of informa-
tion in the field of technical standards and regulations and of rules on
Information Society services (OJ L 204, 21.7.1998, p. 37).

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Article 32

Compliant transportable pressure equipment which
presents a risk to health and safety

to
1. Where having performed an evaluation pursuant
Article 30(1) a Member State finds that although transportable
pressure equipment is in compliance with Directive 2008/68/EC
and this Directive, it presents a risk to the health or safety of per-
sons or to other aspects of public interest protection, it shall
require the relevant economic operator to take all appropriate
measures to ensure that the transportable pressure equipment
concerned, when placed on the market, no longer presents that
risk, to withdraw the equipment 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 transportable pressure equipment con-
cerned that he has made available on the market or is using
throughout the Union.

3.
The Member State shall immediately inform the Commis-
sion and the other Member States. That information shall include
all available details, in particular the data necessary for the iden-
tification of the transportable pressure equipment concerned, the
origin and the supply chain of the equipment, the nature of the
risk involved and the nature and duration of the national mea-
sures taken.

4.
The Commission shall without delay enter into consultation
with the Member States and the relevant economic operator or
operators and shall evaluate the national measures taken. On the
basis of the results of that evaluation, the Commission shall decide
whether the measure is justified or not, and where necessary, pro-
pose appropriate measures.

5.
The Commission shall address its decision to all Member
States and shall immediately communicate it to them and to the
relevant economic operator or operators.

Article 33

Formal non-compliance

1. Without prejudice to Article 30, 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)

that the Pi marking has been affixed in violation of Article 12,
13, 14 or 15;

(b)

that the Pi marking has not been affixed;

(c)

(d)

that the technical documentation is either not available or
not complete;

the

requirements of

that
to Directive
2008/68/EC and of this Directive have not been complied
with.

the Annexes

CHAPTER 6

FINAL PROVISIONS

Article 34

Transitional provisions

Within their territory, Member States may maintain the provi-
sions listed in Annex II.

Member States which maintain such provisions shall inform the
Commission thereof. The Commission shall inform the other
Member States.

Article 35

Adaptation to scientific and technical progress

The Commission may adopt delegated acts in accordance with
Article 290 TFEU as regards adaptations of the Annexes to this
Directive to scientific and technical progress, in particular taking
to Directive
into account amendments
2008/68/EC.

to the Annexes

For the delegated acts referred to in this Article, the procedures set
out in Articles 36, 37 and 38 shall apply.

Article 36

Exercise of delegation

1.
The powers to adopt the delegated acts referred to in
Article 35 shall be conferred on the Commission for an indeter-
minate period of time.

2.
As soon as it adopts a delegated act, the Commission shall
notify it simultaneously to the European Parliament and the
Council.

3.
The powers to adopt delegated acts are conferred on the
Commission subject to the conditions laid down in Articles 37
and 38.

Article 37

Revocation of the delegation

The delegation of power referred to in Article 35 may be

1.
revoked by the European Parliament or by the Council.

2.
The institution which has commenced an internal proce-
dure for deciding whether to revoke the delegation of powers
shall endeavour to inform the other institution and the Commis-
sion within a reasonable time before the final decision is taken,
indicating the delegated powers which could be subject to revo-
cation and possible reasons for a revocation.

2. Where the non-compliance referred to in paragraph 1 per-
sists, the Member State concerned shall take all appropriate mea-
sures to restrict or prohibit the transportable pressure equipment
being made available on the market or shall ensure that it is
recalled or withdrawn from the market.

3.
The decision of revocation shall put an end to the delega-
tion of the powers specified in that decision and shall take effect
immediately or at a later date specified therein. It shall not affect
the validity of the delegated acts already in force. It shall be pub-
lished in the Official Journal of the European Union.

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Article 38

Article 41

Objections to delegated acts

Obligations on Member States

1.
The European Parliament or the Council may object to a
delegated act within a period of two months from the date of
notification.

At the initiative of the European Parliament or the Council this
period shall be extended by two months.

2.
If, on expiry of that period, neither the European Parliament
nor the Council has objected to the delegated act it shall be pub-
lished in the Official Journal of the European Union and shall enter
into force at the date stated therein.

The delegated act may be published in the Official Journal of the
European Union and enter into force before the expiry of that
period if the European Parliament and the Council have both
informed the Commission of
to raise
objections.

their intention not

If the European Parliament or the Council objects to a del-
3.
egated act, it shall not enter into force. The institution which
objects shall state the reasons for objecting to the delegated act.

Article 39

Repeal

Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC
and 1999/36/EC are repealed with effect from 1 July 2011.

References to the repealed Directive 1999/36/EC shall be con-
strued as references to this Directive.

Member States shall take the necessary measures to ensure that
the economic operators concerned comply with the provisions
set out in Chapters 2 and 5. Member States shall also ensure that
the necessary implementing measures are taken in respect of
Articles 12 to 15.

Article 42

Transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 30 June 2011 at the latest. They shall forthwith
inform the Commission thereof.

When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such refer-
ence on the occasion of their official publication. The methods of
making such reference shall be laid down by Member States.

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

3.
Notwithstanding paragraph 1, Member States shall ensure
that Article 21(2)(d) applies with effect from 1 January 2012 at
the latest.

4. Member States shall ensure the laws, regulations and admin-
istrative provisions referred to in paragraph 1 apply to pressure
receptacles, their valves and other accessories used for the carriage
of UN No 1745, UN No 1746 and UN No 2495 from 1 July 2013
at the latest.

Article 43

Entry into force

Article 40

Recognition of equivalence

This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Union.

issued

pursuant

to Directives

EEC pattern approval certificates for transportable pressure
1.
equipment
84/525/EEC,
84/526/EEC and 84/527/EEC and EC design-examination certifi-
cates issued pursuant to Directive 1999/36/EC shall be recogn-
ised as equivalent to the type approval certificates referred to in
the Annexes to Directive 2008/68/EC and shall be subject to the
provisions on time-limited recognition of type approvals set out
in those Annexes.

Article 44

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 16 June 2010.

2.
Valves and accessories referred to in Article 3(3) of Direc-
tive 1999/36/EC and marked with the mark of Directive
97/23/EC (1) according to Article 3(4) of Directive 1999/36/EC
may still be used.

For the European Parliament
The President
J. BUZEK

For the Council
The President
D. LÓPEZ GARRIDO

(1) Directive 97/23/EC of the European Parliament and of the Council of
29 May 1997 on the approximation of the laws of the Member States
concerning pressure equipment (OJ L 181, 9.7.1997, p. 1).

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ANNEX I

List of dangerous goods other than those in class 2

UN Number

1051

1052

1745

1746

1790

2495

Class

6.1

8

5.1

5.1

8

5.1

Dangerous substance

HYDROGEN CYANIDE, STABILISED
containing less than 3 % water

HYDROGEN FLUORIDE, ANHY-
DROUS

BROMINE PENTAFLUORIDE
Excluding carriage in tanks

BROMINE TRIFLUORIDE
Excluding carriage in tanks

HYDROFLUORIC ACID
with more than 85 % hydrogen fluoride

IODINE PENTAFLUORIDE
Excluding carriage in tanks

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ANNEX II

TRANSITIONAL PROVISIONS

1. Member States may retain their national provisions concerning devices intended for connection with other equipment
and colour codes applicable to transportable pressure equipment until such time as relevant standards for use are added
to the Annexes to Directive 2008/68/EC.

2. Member States in which the ambient temperature is regularly lower than – 20 °C may impose more stringent standards
as regards the operating temperature of material intended for transportable pressure equipment for use in the national
transport of dangerous goods within their territory until provisions on the appropriate reference temperatures for given
climatic zones are incorporated into the Annexes to Directive 2008/68/EC.

In that case, in the Pi marking of the transportable pressure equipment, including the demountable parts having a direct
safety function, the identification number of the notified body shall be followed by ‘– 40 °C’ or other relevant marking
approved by the competent authority.

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ANNEX III

PROCEDURE FOR THE REASSESSMENT OF CONFORMITY

1. The method for ensuring that the transportable pressure equipment referred to in Article 1(2)(c) manufactured and put
into service before the dates of implementation of Directive 1999/36/EC complies with the relevant provisions of the
Annexes to Directive 2008/68/EC and of this Directive as applicable at the time of reassessment shall be as set out in
this Annex.

2. The owner or operator must make available to a notified body conforming to EN ISO/IEC 17020:2004 type A, notified
for reassessment of conformity, the information regarding the transportable pressure equipment which enables that body
to identify the equipment precisely (origin, design rules, and for acetylene cylinders also details of the porous material).
The information shall include, where appropriate, any prescribed restrictions on use, and any notes on possible damage
or repairs which have been carried out.

3. The type A notified body, notified for reassessment of conformity, shall assess whether the transportable pressure equip-
ment affords at least the same degree of safety as the transportable pressure equipment referred to in the Annexes to
Directive 2008/68/EC. The assessment shall be carried out on the basis of the information produced in accordance with
paragraph 2 and, where appropriate, of further inspections.

4.

If the results of the assessment in paragraph 3 are satisfactory, the transportable pressure equipment shall be subject to
the periodic inspection provided for in the Annexes to Directive 2008/68/EC. If the requirements of that periodic inspec-
tion are met the Pi marking shall be applied by or under the surveillance of the notified body responsible for the peri-
odic inspection in accordance with Article 14(1) to (5). The Pi marking shall be followed by the identification number of
the notified body responsible for the periodic inspection. The notified body responsible for the periodic inspection shall
issue a certificate of reassessment in accordance with paragraph 6.

5. Where pressure receptacles were manufactured in series, Member States may authorise the reassessment of conformity
of individual pressure receptacles, including their valves and other accessories used for transport, to be carried out by a
notified body notified for periodic inspection of the relevant transportable pressure receptacles provided that confor-
mity of the type has been assessed in accordance with paragraph 3 by a type A notified body, responsible for the reas-
sessment of conformity, and a certificate of type reassessment issued. The Pi marking shall be followed by the
identification number of the notified body responsible for the periodic inspection.

6.

In all cases the notified body responsible for the periodic inspection shall issue the certificate of reassessment containing
as a minimum:

(a)

the identification of the notified body issuing the certificate, and, if different, the identification number of the type
A notified body responsible for the reassessment of conformity in accordance with paragraph 3;

(b)

the name and address of owner or operator specified in paragraph 2;

(c)

in the case of the application of the procedure in paragraph 5, the data identifying the certificate of type
reassessment;

(d)

the data for identification of the transportable pressure equipment to which Pi marking has been applied including
at least the serial number or numbers; and

(e)

the date of issue.

7. A certificate of type reassessment shall be issued.

Where the procedure in paragraph 5 is applied the type A body, responsible for the reassessment of conformity, shall
issue the certificate of type reassessment containing as a minimum:

(a)

the identification of the notified body issuing the certificate;

(b)

the name and address of the manufacturer and the holder of the original type approval for the transportable pres-
sure equipment being reassessed when the holder is not the manufacturer;

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Official Journal of the European Union

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(c)

the data identifying the transportable pressure equipment belonging to the series;

(d)

the date of issue; and

(e)

the words: ‘this certificate does not authorise manufacture of transportable pressure equipment or parts thereof’.

8. By affixing or having affixed the Pi marking, the owner or operator indicates that he takes responsibility for the con-
formity of the transportable pressure equipment with all applicable requirements set out in the Annexes to Directive
2008/68/EC and in this Directive as applicable at the time of reassessment.

9. Where appropriate, the provisions of Annex II (2) shall be taken into account and the cold marking provided for in that

Annex shall also be affixed.

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Official Journal of the European Union

30.6.2010

Statement by the European Parliament, the Council and the Commission on Article 290 TFEU

‘The European Parliament, Council and Commission declare that the provisions of this Directive shall be with-
out prejudice to any future position of the institutions as regards the implementation of Article 290 TFEU or
individual legislative acts containing such provisions.’

Statement by the Commission concerning the notification of delegated acts

‘The European Commission takes note that except in cases where the legislative act provides for an urgency
procedure, the European Parliament and the Council consider that the notification of delegated acts, shall take
into account the periods of recess of the institutions (winter, summer and European elections), in order to
ensure that the European Parliament and the Council are able to exercise their prerogatives within the time
limits laid down in the relevant legislative acts, and is ready to act accordingly.’