TRANSPORTABLE PRESSURE EQUIPMENT REGULATIONS

SUBSIDIARY LEGISLATION 427.30

TRANSPORTABLE PRESSURE EQUIPMENT

REGULATIONS

1st July, 2011 *

LEGAL NOTICE 332 of 2011.

(1) The title of these regulations is the Transportable

Pressure Equipment Regulations.

(2) These regulations transpose Directive 2010/35/EU and lay

down rules concerning transportable pressure equipment to

enhance safety and ensure free movement of such equipment within

the Union.

(3) EEC pattern approval certificates for transportable pressure

equipment issued pursuant to Schedules V, VI or VII to the

Common Provisions for Pressure Vessels and Inspection Methods

Regulations 2002, † and EC design-examination certificates issued

pursuant to the Transportable Pressure Equipment Regulations,

2002, ‡ shall be recognised 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.

(4) Valves and accessories referred to in regulation 5.3 of the

Transportable Pressure Equipment Regulations, 2002 ‡ and marked

with the mark of the Pressure Equipment Regulations, according to

r e g u l a t i o n 5 . 4 o f t h e Tr a n s p o r t a b l e P r e s s u r e E q u i p m e n t

Regulations, 2002 ‡ may still be used.

(1)

These regulations shall apply to

(a) new transportable pressure equipment as defined in

regulation 3, which does not bear the conformity

markings provided for in Schedules V, VI or VII to the

Common Provisions for Pressure Vessels and

Inspection Methods Regulations, 2002, † or in the

Transportable Pressure Equipment Regulations, 2002, ‡

for the purpose of making it available on the market;

(b) transportable pressure equipment as defined in

regulation 3, bearing the conformity markings

provided for in these regulations or in Schedules V, VI

or VII to the Common Provisions for Pressure Vessels

and Inspection Methods Regulations, 2002, † or in the

Transportable Pressure Equipment Regulations, 2002, ‡

for the purposes of its periodic inspections,

intermediate inspections, exceptional checks and use;

*See regulation 1(3) of these regulations, as priginally promulgated.

†Revoked by these Regulations.

‡Revoked by these Regulations.

(c) transportable pressure equipment as defined in

regulation 3, which does not bear the conformity

markings provided for in the Transportable Pressure

Equipment Regulations, 2002, * for the purposes of

reassessment of conformity.

(2) As from the 1st July 2013 at the latest, these regulations

shall also apply to pressure receptacles, their valves and other

accessories used for the carriage of dangerous substances of class

UN No 1745, UN No 1746 or UN No 2495.

(3)

These regulations shall not apply to

(a) transportable pressure equipment which was placed on

the market before the 1st January, 2003, and which has

not been subject to a reassessment of conformity;

(b) transportable pressure equipment used exclusively for

the transport of dangerous goods between Member

States and third countries, carried out in accordance

with Article 4 of Directive 2008/68/EC.

For the purposes of these regulations the following

definitions shall apply

"accreditation" means an attestation by the National

Accreditation Board that a notified body meets the requirements set

out in the second paragraph of paragraph 1.8.6.8 of the Annexes to

Directive 2008/68/EC and the Method for Designating Conformity

Assessment Bodies Regulations;

"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;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from the manufacturer to act on his behalf in relation to specified

tasks;

"conformity assessment" means the assessment and the

procedure for the assessment of conformity set out in the Annexes

to Directive 2008/68/EC;

"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;

"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;

"exceptional check" means the exceptional check and the

procedures governing the exceptional check set out in the Annexes

to Directive 2008/68/EC;

"importer" means any natural or legal person established within

*Revoked by these Regulations.

the Union, who places transportable pressure equipment or parts

thereof from a third country on the Union market;

"intermediate inspection" means the intermediate inspection and

the procedures governing the intermediate inspection as set out in

the Annexes to Directive 2008/68/EC;

"making available on the market" means any supply of

transportable pressure equipment for distribution or use on the

Union market in the course of a commercial or public service

activity, whether in return for payment or free of charge;

"manufacturer" means any natural or legal person who

manufactures transportable pressure equipment, or parts thereof, or

who has such equipment designed or manufactured and markets it

under his name or trademark;

"market surveillance" means the activities carried out and

measures taken by public authorities to ensure that transportable

pr essu re equ ip men t dur in g its li fe cycl e co mp lie s wi th th e

requirements set out in Directive 2008/68/EC and these regulations

and does not endanger health, safety or any other aspect of public

interest protection;

"Member States" means the Member States of the Union;

"National Accreditation Board (Malta)" means the National

Accreditation Board (Malta) established in terms of regulation 3 of

t h e N a t i o n a l A c c r e d i t a t i o n B o a r d ( M a l t a ) ( E st a b l i s h m e n t )

Regulations;

"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;

"notified body" means an inspection body meeting the

requirements set out in the Annexes to Directive 2008/68/EC and

th e con di t io ns set o ut in r eg ul at io n 1 5 and th e Met ho d f or

Designating Conformity Assessment Bodies Regulations, and has

been notified in accordance with regulation 16;

"operator" means any natural or legal person established in the

Union using transportable pressure equipment;

"owner" means any natural or legal person established within the

Union who owns transportable pressure equipment;

"periodic inspection" means the periodic inspection and the

procedures governing the periodic inspection as set out in the

Annexes to Directive 2008/68/EC;

"Pi marking" means a marking which indicates that the

transportable pressure equipment is in conformity with the

applicable conformity assessment requirements set out in the

Annexes to Directive 2008/68/EC and in these regulations;

"placing on the market" means the first making available of

transportable pressure equipment on the Union market;

"reassessment of conformity" means the procedure undertaken,

at the r eq uest of th e owner o r oper at or, f or th e sub sequent

assessment of the conformity of transportable pressure equipment

manufactured and placed on the market before the 1st January,

2003;

"recall" means any measure aimed at achieving the return of

transportable pressure equipment that has already been made

available to the end user;

"transportable pressure equipment" means

(a) all pressure receptacles, their valves and other

accessories when appropriate, as covered in Chapter

2 of the Annexes to Directive 2008/68/EC,

(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,

w hen th e equ ipm ent u nder p arag rap hs (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 classification

code, and for the transport of the dangerous substances of other

classes specified in Schedule I.

Transportable pressure equipment shall be understood as

including gas cartridges (UN No 2037) and excluding aerosols (UN

No 1950), open cryogenic receptacles, gas cylinders for breathing

apparatus, fire extinguishers (UN No 1044), transportable pressure

equipment exempted according to paragraph 1.1.3.2 of the Annexes

to Directive 2008/68/EC and transportable pressure equipment

exempted from the rules for construction and testing of packaging

according to special provisions in paragraph 3.3 of the Annexes to

Directive 2008/68/EC;

" Te c h n i c a l R e g u l a t i o n s D i v i s i o n " m e a n s t h e Te c h n i c a l

Regulations Division of the Malta Competition and Consumer

Affairs Authority as established by the Malta Competition and

Consumer Affairs Authority Act;

"the Union" means the European Union;

"use" means filling, temporary storage linked to carriage,

emptying and refilling of transportable pressure equipment;

"withdrawal" means any measure aimed at preventing

transportable pressure equipment from being made available on the

market or from being used.

4. (1) Only transportable pressure equipment complying with

these regulations shall be placed on the market.

(2) Without prejudice to the safeguard procedures in regulation

17 and to the market surveillance framework set out in Regulation

(EC) No 765/2008, the making available on the market and the use

of transportable pressure equipment, which complies with these

regulations shall not be prohibited, restricted or impeded.

5. (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 these regulations.

(2) Where the compliance of the transportable pressure

equipment with the applicable requirements has been demonstrated

through the conformity assessment process set out in the Annexes

to Directive 2008/68/EC and in these regulations, manufacturers

shall affix the Pi marking in accordance with regulation 14.

(3) Manufacturers shall keep the technical documentation

specified in the Annexes to Directive 2008/68/EC. This

documentation 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 these regulations shall immediately take the corrective

measures necessary to bring the transportable pressure equipment

into conformity, to withdraw it or to recall it, if appropriate.

Furthermore, where the transportable pressure equipment presents

a risk, manufacturers shall immediately inform the Technical

Regulations Division to that effect, giving details, in particular, of

the non-compliance and of any corrective measures taken.

(5) Manufacturers shall document all such instances of

noncompliance and corrective measures.

(6) Manufacturers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of the

transportable pressure equipment, in at least the English or Maltese

language. They shall cooperate with that Division, 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 these regulations.

6. (1) Manufacturers may, by a written mandate, appoint an

authorised representative.

The obligations set out in regulation 5(1) and (2) and the drawing

up of technical documentation shall not form part of the authorised

representative’s mandate.

(2) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a) keep the technical documentation at the disposal of the

Technical Regulations Division for at least the period

as specified in the Annexes to Directive 2008/68/EC

for manufacturers;

(b) further to a reasoned request from the Technical

Regulations Division, provide that Division with all

the information and documentation necessary to

demonstrate the conformity of the transportable

pressure equipment in at least the English or Maltese

language;

(c) cooperate with the Technical Regulations Division, 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 these regulations.

(1) Importers shall only place on the market transportable

pressure equipment which is in conformity with the Annexes to

Directive 2008/68/EC and with these regulations.

(2) Before placing transportable pressure equipment on the

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 technical

documentation and that the transportable pressure equipment 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 these regulations, 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 Technical Regulations Division 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

conditions do not jeopardize its compliance with the requirements

set out in the Annexes to Directive 2008/68/EC.

(5) Importers 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 these regulations shall immediately take the corrective

measures necessary to bring the transportable pressure equipment

into conformity, to withdraw it or to recall it, if appropriate.

Furthermore, where the transportable pressure equipment presents

a risk, importers shall immediately inform the manufacturer and the

Technical Regulations Division to that effect, giving details, in

particular, of the noncompliance and of any corrective measures

taken.

Importers shall document all such instances of non-compliance

and corrective measures.

(6) Importers shall, for at least the period specified in the

Annexes to Directive 2008/68/EC for manufacturers, keep a copy

of the technical documentation at the disposal of the Technical

Regulations Division and ensure that the technical documentation

can be made available to that Division upon request.

(7) Importers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of the

transportable pressure equipment, in at least the English or Maltese

language. They shall cooperate with the Technical Regulations

Division, at its request, on any action taken to eliminate the risks

posed by transportable pressure equipment which they have placed

on the market.

(8) Importers shall only provide information to operators which

complies with the requirements set out in the Annexes to Directive

2008/68/EC and in these regulations.

(9) An importer shall be considered a manufacturer for the

purposes of these regulations and subject to the obligations of the

manufacturer pursuant to regulation 5, where he places

transportable pressure equipment on the market under his name or

trademark or modifies transportable pressure equipment already

placed on the market in such a way that compliance with the

applicable requirements may be affected.

(1) Distributors shall only make available on the market

transportable pressure equipment which is in conformity with the

Annexes to Directive 2008/68/EC and with these regulations.

Before making transportable pressure equipment available on the

market distributors shall verify that the transportable pressure

equipment bears the Pi marking, and that it is accompanied by the

certificate of conformity and the contact address referred to in

regulation 7(3).

Where a distributor considers or has reason to believe that

transportable pressure equipment is not in conformity with the

Annexes to Directive 2008/68/EC or with these regulations, 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 Technical Regulations Division.

(2) Distributors shall ensure that, while transportable pressure

equipment is under their responsibility, storage or transport

conditions do not jeopardize 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 these regulations shall make sure that the

corrective measures necessary to bring that transportable pressure

equipment into conformity, to withdraw it or to recall it, if

appropriate, are taken. Furthermore, where the transportable

pressure equipment presents a risk, distributors shall immediately

inform the manufacturer, the importer, where relevant, and the

Technical Regulations Division, giving details, in particular, of the

non-compliance and of any corrective measures taken.

Distributors shall document all such instances of non-compliance

and corrective measures.

(4) Distributors shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of the

transportable pressure equipment in at least the English or Maltese

language. They shall cooperate with the Technical Regulations

Division, at its request, on any action taken to eliminate the risks

posed by transportable pressure equipment which they have made

available on the market.

(5) Distributors shall only provide information to operators

which complies with the requirements set out in the Annexes to

Directive 2008/68/EC and in these regulations.

(6) A distributor shall be considered a manufacturer for the

purposes of these regulations and subject to the obligations of the

manufacturer pursuant to regulation 5, where he places

transportable pressure equipment on the market under his name or

trademark or modifies transportable pressure equipment already

placed on the market in such a way that compliance with the

applicable requirements may be affected.

(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 these regulations, he shall not make it

available or use it until it has been brought into conformity.

Furthermore, 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 Technical Regulations

Division.

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

conditions do not jeopardize 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 Directive

2008/68/EC and in these regulations.

(4) The preceding sub-regulations shall not apply to private

individuals intending to use or using transportable pressure

equipment for their personal or domestic use or for their leisure or

sporting activities.

(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 these regulations.

(2) Where the transportable pressure equipment presents a risk,

the operator shall inform the owner to that effect as well as the

Technical Regulations Division.

In addition to the preceding regulations, any economic

operator shall, on request from the Technical Regulations Division,

identify the following to it for a period of at least ten years after the

transportable pressure equipment has been placed on the market

(a) any economic operator who has supplied them with

transportable pressure equipment;

(b) any economic operator to whom they have supplied

transportable pressure equipment.

(1) The transportable pressure equipment referred to in

regulation 2(1)(a) shall meet the relevant conformity assessment,

periodic inspection, intermediate inspection and exceptional checks

requirements set out in the Annexes to Directive 2008/68/EC and in

regulations 4 and 12 to 16.

(2) The transportable pressure equipment referred to in

regulation 2(1)( b ) shall meet the specifications of the

documentation according to which the equipment was

manufactured. The equipment shall be subject to periodic

inspections, intermediate inspections and exceptional checks in

accordance with the Annexes to Directive 2008/68/EC and with the

requirements of regulations 4 and 12 to 16 .

(3) Certificates of conformity assessment and certificates of

reassessment of conformity and reports of periodic inspections,

intermediate inspections and exceptional checks issued by a

notified body shall be valid in all Member States.

(4) For demountable parts of refillable transportable pressure

equipment a separate conformity assessment may be carried out.

(1) The reassessment of conformity of transportable

pressure equipment referred to in regulation 2(1)(c) manufactured

an d pu t i n to ser vi ce b ef o re t h e 1st Jan ua r y, 2 00 3, sh al l b e

established in accordance with the conformity reassessment

procedure set out in Schedule II to these regulations.

(2) The Pi marking shall be affixed in accordance with

Schedule II.

(1) The Pi marking shall be affixed only to transportable

pressure equipment which

(a) meets the conformity assessment requirements in the

Annexes to Directive 2008/68/EC and in these

regulations; or

(b) meets the reassessment of conformity requirements

referred to in regulation 13.

It shall not be affixed to any other transportable pressure

equipment.

(2) The Pi marking shall consist of the following symbol in the

following form

(3) The minimum height of the Pi marking shall be 5mm. For

transportable pressure equipment with a diameter less than or equal

to 140mm the minimum height shall be 2.5mm.

(4) The proportions given in the graduated drawing in sub-

regulation (2) shall be respected. The grid does not form part of the

marking.

(5) The Pi marking shall be affixed visibly, legibly and

permanently to the transportable pressure equipment or to its data

plate as well as to demountable parts of refillable transportable

pressure equipment having a direct safety function.

(6) The Pi marking shall be affixed before the new

transportable pressure equipment or demountable parts of refillable

transportable pressure equipment having a direct safety function

are placed on the market.

(7) The Pi marking shall be followed by the identification

number 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.

(8) The Pi marking shall only be affixed by the manufacturer

or, in cases of reassessment of conformity, as set out in Schedule II.

For gas cylinders previously in compliance with Schedules V, VI or

VII to the Common Provisions for Pressure Vessels and Inspection

Methods Regulations, 2002, * the Pi mark shall be affixed by or

under the surveillance of the notified body.

(9) By affixing or having affixed the Pi marking, the

m a n uf a ct u r er i nd i ca t es t h at he ta k es r es po n si b i li t y f o r t he

conformity of the transportable pressure equipment with all

applicable requirements set out in the Annexes to Directive 2008/

68/EC and in these regulations.

(10) For the purposes of these regulations, the Pi marking shall

be the only marking which attests conformity of the transportable

*Revoked by these Regulations.

pressure equipment with the applicable requirements set out in the

Annexes to Directive 2008/68/EC and in these regulations.

(11) The affixing on transportable pressure equipment of

markings, signs and inscriptions which are likely to mislead third

parties as to the meaning or form of the Pi marking, is prohibited.

Any other marking may be affixed to the transportable pressure

equipment in such a way that the visibility, legibility and meaning

of the Pi marking are not thereby impaired.

(12) Demountable parts of refillable transportable pressure

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

(13) The marking of the date of the periodic inspection or, where

appropriate, the intermediate inspection shall be accompanied by

the identification number of the notified body responsible for the

periodic inspection.

(14) With regard to gas cylinders previously in compliance with

Schedules V, VI or VII to the Common Provisions for Pressure

Vessels and Inspection Methods Regulations, 2002, not bearing the

Pi marking, when the first periodic inspection is carried out in

accordance with these regulations, the identification number of the

notified body responsible shall be preceded by the Pi marking.

(1) For the purposes of notification under these

regulations, a notified body shall meet the requirements set out in

the Annexes to Directive 2008/68/EC, in these regulations and in

the Method for Designating Conformity Assessment Bodies

Regulations.

(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, in

these regulations, and in the Method for Designating Conformity

Assessment Bodies Regulations, and that it does not also act as the

notifying authority.

(3) 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 regulation 15(8) and apply as general

guidance the administrative decisions and documents produced as a

result of the work of that group.

(4) Notified bodies shall carry out conformity assessments,

periodic inspections, intermediate inspections and exceptional

checks in accordance with the terms of their notification and the

procedures set out in the Annexes to Directive 2008/68/EC and the

Method for Designating Conformity Assessment Bodies

Regulations.

(5) Notified bodies shall carry out reassessments of conformity

in accordance with Schedule II.

(6) Notified bodies shall inform the Technical Regulations

Division of the following

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

certificate;

(b) any circumstances affecting

the

scope

of

and

conditions for notification;

(c) any request for information on activities performed

which they have received from market surveillance

authorities;

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

their notification and any other activity performed,

including cross-border activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified

under these regulations carrying out similar conformity assessment,

periodic inspection, intermediate inspections and exceptional

c hec ks act iv i ti es co ver i ng t h e sa m e t r an spo r tab l e p r essu re

equipment with relevant information on issues relating to negative

and, on request, positive conformity assessment results.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the

Commission.

(1) The Technical Regulations Division shall be

responsible for setting up and carrying out the necessary

procedures for the assessment, notification and subsequent

monitoring of notified bodies.

(2) The assessment and monitoring referred to in sub-

regulation (1) shall be carried out by the National Accreditation

Board (Malta).

(3) The Technical Regulations Division shall inform the

Commission of its procedures for the assessment, notification and

monitoring of notified bodies, and of any changes to that

information.

(4) For the purposes of notification under these regulations, an

inspection body shall submit an application for notification to the

Te c h n i c a l R e g u l a t i o n s D i v i s i o n . T h e a p p l i c a t i o n s h a l l b e

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 such activities;

(c) the transportable pressure equipment for which the

body claims to be competent;

(d) an accreditation certificate issued by the National

Accreditation Board (Malta) attesting that the

inspection body fulfils the requirements laid down in

regulation 15 and the Method for Designating

Conformity Assessment Bodies Regulations, 2003.

(5) The Technical Regulations Division shall notify only those

bodies which have satisfied the requirements set out in regulation

15 and the Method for Designating Conformity Assessment Bodies

Regulations.

(6) The Technical Regulations Division shall notify to the

Commission and the other Member States using the electronic

notification tool developed and managed by the Commission.

The notification shall include the information required in sub-

regulation (4).

(7) The body concerned may perform the activities of a notified

body only where no objections are raised by the Commission or the

other Member States within two weeks of a notification.

Only such a body shall be considered a notified body for the

purposes of these regulations.

(8) The Technical Regulations Division shall notify the

Commission and the other Member States of any subsequent

relevant changes to the notification.

(9) In-house inspection services of the applicant as defined in

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

(10) Where the Technical Regulations Division has ascertained

or has been informed that a notified body no longer meets the

requirem ents laid down in regulation 15 or t he Method for

Designating Conformity Assessment Bodies Regulations, 2003, or

that it is failing to fulfil its obligations, the Technical Regulations

Division shall restrict, suspend or withdraw notification as

appropriate, depending on the seriousness of the failure to meet

those requirements or fulfil those obligations. It shall immediately

inform the Commission and the other Member States accordingly.

(11) In the event of withdrawal, restriction or suspension of

notification or where the notified body has ceased its activity, the

Technical Regulations Division 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.

(12) The Technical Regulations Division shall provide the

Commission, on request, with all information relating to the basis

for the notification or the maintenance of the competence of the

body concerned.

(13) Notified bodies notified by the Technical Regulations

Division shall be authorised to work in all Member States. The

Technical Regulations Division, having carried out the initial

assessment and notification, retains the responsibility for

monitoring the ongoing activities of the notified body.

(1) Where the Technical Regulations Division takes any

action pursuant to these regulations or Article 20 of Regulation

(EC) No 765/2008 or where it has sufficient reason to believe that

transportable pressure equipment covered by these regulations

presents a risk to the health or safety of persons or to other aspects

of public interest protection covered by these regulations, it shall

carry out an evaluation in relation to the transportable pressure

equipment concerned covering all the requirements laid down in

these regulations.

(2)

The relevant economic operators shall cooperate as

necessary with the Technical Regulations Division, including

granting access to their premises and providing samples as

appropriate.

(3) Where, in the course of that evaluation, the Technical

R e g u l a t i o n s D i v i si o n f i n d s t h at t h e t r an s p o r t a b l e p r e s su r e

equipment does not comply with the requirements set out in the

Annexes to Directive 2008/68/EC and in these regulations, it shall

without delay require the relevant economic operator to take all

appropriate corrective action to bring the transportable pressure

equipment 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. In such cases, Article 21 of Regulation

(EC) No 765/2008 shall apply to such corrective actions and the

Technical Regulations Division shall inform the relevant notified

body accordingly.

(4) Where the Technical Regulations Division considers that

non-compliance is not restricted to the Maltese national territory, it

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.

(5) The economic operator shall ensure that all appropriate

corrective action is taken in respect of transportable pressure

equipment that it has made available on the market.

(6) Where the relevant economic operator does not take

adequate corrective action within the period referred to in the sub-

regulation (3), the Technical Regulations Division shall take all

appropriate provisional measures to prohibit or restrict the

transportable pressure equipment being made available on the

market, to withdraw the equipment from that market or to recall it.

T h e Te c h n i c a l R e g u l a t i o n s D i v i s i o n s h a l l i n f o r m t h e

Commission and the other Member States, without delay, of those

measures.

(7) The information referred to in sub-regulation (6) shall

include all available details, in particular the data necessary for the

i d e n t i f i ca t i o n o f t h e n o n - c o m p l i a n t t r an s p o r t a b l e p r e s su r e

equipment, the origin of the equipment, the nature of the alleged

noncompliance and the risk involved, the nature and duration of the

national measures taken and the arguments put forward by the

r e l e v a n t e c o n o m i c o p e r a t o r. I n p a r t i c u l a r, t h e Te c h n i c a l

Regulations Division 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 these

regulations, or

(b) shortcomings in the standards or technical codes

referred to in the Annexes to Directive 2008/68/EC or

in other provisions of that Directive.

(8) Where procedures against the placing on the market of

products are initiated in another Member State, the Technical

Regulations Division shall without delay take the measures

necessary to ensure that the non-compliant transportable pressure

equipment is withdrawn from the local market and shall inform the

Commission and the other Member States of any such measures

adopted locally and of any additional information at its disposal

relating to the non-compliance of the transportable pressure

equipment concerned, or, in the event of disagreement with the

notified measure, of its objections.

(9) Where, within two months of receipt of the information

referred to in sub-regulation (6), no objection has been raised by

e i t h e r a M e m b e r St a t e o r t h e C o m m i s s i o n i n r e s p e c t o f a

provisional measure taken by the Technical Regulations Division,

that measure shall be deemed justified.

(10) The Technical Regulations Division shall ensure that

appropriate restrictive measures are taken in respect of the

transportable pressure equipment concerned, such as withdrawal of

the transportable pressure equipment from their market, without

delay.

(11) (a) Where, having performed an evaluation pursuant to

sub-regulations (1) to (3), the Technical Regulations

Division finds that although transportable pressure

equipment is in compliance with Directive 2008/68/EC

and these regulations, it presents a risk to the health or

safety of persons or to other aspects of public interest

protection, it shall require the relevant economic

operator to take all appropriate measures to ensure that

the 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.

(b) The economic operator shall ensure that corrective

action is taken in respect of all the transportable

pressure equipment concerned that he has made

available on the market or is using throughout the

Union.

(c) Where paragraph (a) applies, the Technical

Regulations Division 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 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 measures taken.

(12) (a) Without prejudice to the preceding regulations, where

the Technical Regulations Division makes any of the

f o l l o w i n g f i n d i n g s, i t sh a l l r e q u i r e t h e r e l e v an t

economic operator to put an end to the non-compliance

concerned

(i)

that the Pi marking has been affixed in violation

of these regulations;

(ii) that the Pi marking has not been affixed;

(iii) that the technical documentation is either not

available or not complete;

(iv) that the requirements of the Annexes to

Directive 2008/68/EC and of these regulations

have not been complied with.

(b) Where such non-compliance persists, the Technical

Regulations Division concerned shall take all

appropriate measures 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.

The penalties applicable for the infringement of any of the

provisions above shall be those provided for in Part IV of the

Product Safety Act.

TRANSPORTABLE PRESSURE EQUIPMENT

Schedule I

LIST OF DANGEROUS GOODS OTHER THAN THOSE IN CLASS 2

UN Number

Class

Dangerous substance

6.1

HYDROGEN CYANIDE, STABILISED

Containing less than 3% water

HYDROGEN FLUORIDE, ANHYDROUS

5.1

BROMINE PENTAFLUORIDE

Exluding carriage in tanks

5.1

BROMINE TRIFLUORIDE

Excluding carriage in tanks

HYDROFLUORIC ACID

With more than 85% hydrogen fluoride

5.1

IODINE PENTAFLUORIDE

Excluding carriage in tanks

Schedule II

PROCEDURE FOR REASSESSMENT OF CONFORMITY

(1) The method for ensuring that the transportable pressure equipment referred

to in regulation 2(1)(c) manufactured and put into service before the 1st January

2003 complies with the relevant provisions of the Annexes to Directive 2008/68/EC

and of these regulations as applicable at the time of reassessment shall be as set out

in this Schedule.

(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 inform ation 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 equipment 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

inspection are met the Pi marking shall be applied by or under the surveillance of the

notified body responsible for the periodic inspection in accordance with regulations

14 and 15. 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, the manufacturer

may carry out the reassessment of conformity of individual pressure receptacles,

TRANSPORTABLE PRESSURE EQUIPMENT

including their valves and other accessories used for transport. Such reassessment is

to be carried out by a notified body notified for periodic inspection of the relevant

transportable pressure receptacles provided that conformity of the type has been

assessed in accordance with paragraph 3 by a type A notified body, responsible for

the reassessment 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 pressure equipment being reassessed

when the holder is not the manufacturer;

(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 conformity of the transportable pressure

equipment with all applicable requirements set out in the Annexes to Directive 2008/

68/EC and in these regulations as applicable at the time of reassessment.