Transportable Pressure Equipment Regulations, 2011

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,795, 23 ta’ Awwissu, 2011

L.N. 332 of 2011

PRODUCT SAFETY ACT

(CAP. 427)

Transportable Pressure Equipment Regulations, 2011

IN exercise of the powers conferred by article 38 of the

Product Safety Act, the Prime Minister on the advice of the Malta

Competition and Consumer Affairs Authority, has made the

following regulations:-

(1) The title of these regulations is the Transportable

Pressure Equipment Regulations, 2011.

(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)

These regulations shall come into force on 1st July

2011. (4) 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 L.N. 146 of 2002.

pursuant to the Transportable Pressure Equipment Regulations, L.N. 331 of 2002.

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.

(5) Valves and accessories referred to in regulation

3 of the Transportable Pressure Equipment Regulations, 2002

and marked with the mark of the Pressure Equipment Regulations,

2002 according to regulation 5.4 of the Transportable Pressure

Equipment Regulations, 2002 may still be used.

2. (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;

(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.

3. 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 1.8.6.8 of

the Annexes to Directive 2008/68/EC and the Method for

Designating Conformity Assessment Bodies Regulations,

2003;

“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 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 pressure equipment during its life cycle

complies with the 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 the National Accreditation Board (Malta)

(Establishment) Regulations, 2007;

“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 the conditions set out in regulation 15 and the Method

for Designating Conformity Assessment Bodies Regulations,

2003, 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 request of the owner or operator, for the

subsequent 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 6.2

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,

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 classification code, and for the transport

of the dangerous substances of other classes specified in

Schedule I to these regulations.

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 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 3.3 of the Annexes to Directive 2008/68/EC;

“Technical Regulations Division” means the Technical

Regulations Division of the Malta Competition and Consumer

Affairs Authority as established by the Malta Competition and

Consumer Affairs Authority Act of 2011;

“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.

(1) Manufacturers may, by a written mandate, appoint

an authorised representative.

The obligations set out in regulations 5(1) and 5(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 Obligations of owners.

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 10 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 of these regulations.

(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 of these regulations.

(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

and put into service before the 1st January, 2003, shall be

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 to these regulations.

(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 manufacturer 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.

(10) For the purposes of these regulations, 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 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, 2003.

(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, 2003,

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, 2003.

(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 checks activities covering the same transportable

pressure 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 Technical Regulations Division. 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 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, 2003.

(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 requirements laid down in regulation 15 or the 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 Regulations Division finds that the transportable pressure

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.

Technical Regulations Division shall inform the

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 identification of the non-compliant transportable pressure

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 relevant economic operator. In particular, the Technical

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 either a Member State or the Commission in respect of 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 sub-regulation (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 following findings, it shall require the relevant 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 Penalties.

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

Product Safety Act.

The Transportable Pressure Equipment Regulations,

2002, and the Common Provisions for Pressure Vessels and

2002. Inspection Methods Regulations, 2002, are hereby being revoked.

References to the revoked regulations shall be construed

as references to these regulations.

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

Exlucing 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 1 st 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 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 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,

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.

€1.08