SIMPLE PRESSURE VESSELS REGULATIONS

SUBSIDIARY LEGISLATION 427.01

SIMPLE PRESSURE VESSELS REGULATIONS

20th April, 2016 *

LEGAL NOTICE 99 of 2016.

(1) The title of these regulations is the Simple Pressure

Vessels Regulations.

(2) These regulations transpose Directive 2014/29/EU of the

European Parliament and of the Council of 26 February 2014 on the

harmonisation of the laws of the Member States relating to the

making available on the market of simple pressure vessels (recast).

(1) The putting into service of vessels or the making

available on the market of safety components for vessels covered

b y t h e S i m p l e P r e s s u r e Ve s s e l s O r d e r, 1 9 9 8 w h i c h a r e i n

conformity with those regulations and which were placed on the

market before 20th April 2016 shall not be impeded.

(2) Certificates and decisions by notified bodies issued under

Simple Pressure Vessels Order, 1998 shall be valid under these

regulations.

(1) These regulations shall apply to simple pressure

vessels (‘vessels’) manufactured in series with the following

characteristics

(a) the vessels are welded, intended to be subjected to an

internal gauge pressure greater than 0.5 bar and to

contain air or nitrogen, and are not intended to be

fired;

(b) the parts and assemblies contributing to the strength of

the vessel under pressure are made either of non-alloy

quality steel or of non-alloy aluminium or non-age

hardening aluminium alloys;

(c) the vessel is made of either of the following elements

(i)

a cylindrical part of circular cross-section closed

by outwardly dished and/or flat ends which

revolve around the same axis as the cylindrical

part;

(ii) two dished ends revolving around the same axis;

(d) the maximum working pressure of the vessel does not

exceed 30 bar and the product of that pressure and the

capacity of the vessel (PS × V) does not exceed 10 000

bar.L;

(e) the minimum working temperature is no lower than -

50°C and the maximum working temperature is not

higher than 300°C for steel and 100°C for aluminium

* See regulation 2(1) of these Regulations as originally promulgated.

or aluminium alloy vessels.

(2)

These regulations shall not apply to

(a) vessels specifically designed for nuclear use, failure of

which may cause an emission of radioactivity;

(b) vessels specifically intended for installation in or the

propulsion of ships and aircraft;

(c) fire extinguishers.

For the purposes of these regulations, the following

definitions shall apply

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

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

tasks;

"CE marking" means a marking by which the manufacturer

indicates that the vessel is in conformity with the applicable

requirements set out in Union harmonisation legislation providing

for its affixing;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

"conformity assessment" means the process demonstrating

whether the essential safety requirements of these regulations

relating to a vessel have been fulfilled;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes a

vessel available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"harmonised standard" means harmonised standard as defined in

point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

"importer" means any natural or legal person established within

the Union who places a vessel from a third country on the Union

market;

"making available on the market" means any supply of a vessel

for distribution or use on the Union market in the course of a

commercial activity, whether in return for payment or free of

charge;

"manufacturer" means any natural or legal person who

manufactures a vessel or has a vessel designed or manufactured,

and markets that vessel under his name or trade mark;

"national accreditation body" means national accreditation body

as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

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

vessel on the Union market;

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

vessel that has already been made available to the end- user;

"technical specification" means a document that prescribes

technical requirements to be fulfilled by a vessel;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of vessels;

"withdrawal" means any measure aimed at preventing a vessel in

the supply chain from being made available on the market.

(1) Vessels may be made available on the market or put into

service only if they satisfy the requirements of these regulations

when they are properly installed and maintained and used for the

purposes for which they are intended.

(2) The provisions of these regulations shall not affect the right

from laying down any the requirements deemed necessary to ensure

that workers are protected when using vessels, provided that this

does not mean that those vessels are modified in a way unspecified

in these regulations.

(1)

Vessels of which the product of PS × V exceeds 50

bar.L shall satisfy the essential safety requirements set out in

Schedule I.

(2) Vessels of which the product of PS × V is 50 bar.L or less

shall be designed and manufactured in accordance with the sound

engineering practice in one of the Member States.

The making available on the market and the putting into

s e r v i c e o f v e s s e l s w h i c h sa t i sf y t h e r e q u i r e m en t s o f t h e s e

regulations shall not be impeded.

(1) When placing on the market their vessels of which the

product of PS × V exceeds 50 bar.L, manufacturers shall ensure

that they have been designed and manufactured in accordance with

the essential safety requirements set out in Schedule I.

(2) When placing on the market their vessels of which the

product of PS × V is 50 bar.L or less, manufacturers shall ensure

that they have been designed and manufactured in accordance with

the sound engineering practice in one of the Member States.

(3) For vessels of which the product of PS × V exceeds 50

bar.L, manufacturers shall draw up the technical documentation

referred to in Schedule II and carry out the relevant conformity

assessment procedure referred to in regulation 15 or have it carried

out.

(4) Where compliance of a vessel of which the product of PS ×

V exceeds 50 bar.L with the applicable requirements has been

demonstrated by that procedure, manufacturers shall draw up an

EU declaration of conformity and affix the CE marking and the

inscriptions provided for in point 1 of Schedule III.

(5) Manufacturers shall ensure that vessels of which the

product of PS × V is 50 bar.L or less, bear the inscriptions laid

down in point 1 of Schedule III.

(6) Manufacturers shall keep the technical documentation and

the EU declaration of conformity for 10 years after the vessel has

been placed on the market.

(7) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in vessels design or characteristics and changes in the

harmonised standards or in other technical specifications by

reference to which conformity of a vessel is declared shall be

adequately taken into account.

(8) When deemed appropriate with regard to the risks presented

by a vessel, manufacturers shall, to protect the health and safety of

end-users, carry out sample testing of vessels made available on the

market, investigate, and, if necessary, keep a register of complaints,

of non-conforming vessels and vessel recalls, and shall keep

distributors informed of any such monitoring.

(9) Manufacturers shall ensure that vessels which they have

placed on the market bear a type and serial or batch identification

allowing their identification.

(10) Manufacturers shall indicate on the vessel their name,

registered trade name or registered trade mark and the postal

address at which they can be contacted. The address shall indicate a

single point at which the manufacturer can be contacted. The

contact details shall be in at least the Maltese or English language.

(11) Manufacturers shall ensure that the vessel is accompanied

by the instructions and safety information referred to in point 2 of

Schedule III, in at least the Maltese and English. Such instructions

and safety information, as well as any labelling, shall be clear,

understandable and intelligible.

(12) Manufacturers who consider or have reason to believe that

a vessel which they have placed on the market is not in conformity

with these regulations shall immediately take the corrective

measures necessary to bring that vessel into conformity, to

withdraw it or recall it, if appropriate. Furthermore, where the

vessel 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.

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

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of the vessel with these regulations, in

at least the Maltese or English language. They shall cooperate with

the Technical Regulations Divisions, at its request, on any action

taken to eliminate the risks posed by vessels which they have

placed on the market.

(1) A manufacturer may, by a written mandate, appoint an

authorised representative.

The obligations laid down in regulation 8(1) and the

obligation to draw up technical documentation referred to sub-

regulation (3) shall not form part of the authorised representative’s

mandate.

(2) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a) keep the EU declaration of conformity and the

technical documentation at the disposal of national

market surveillance authorities for 10 years after the

vessel has been placed on the market;

(b) further to a reasoned request from the Technical

Regulations Divisions, provide that authority with all

the information and documentation necessary to

demonstrate the conformity of a vessel;

(c) cooperate with the Technical Regulations Divisions, at

their request, on any action taken to eliminate the risks

posed by vessels covered by the authorised

representative’s mandate.

(1) Importers shall place only compliant vessels on the

market.

(2) Before placing on the market a vessel of which the product

of PS × V exceeds 50 bar.L, importers shall ensure that the

appropriate conformity assessment procedure referred to in

regulation 15 has been carried out by the manufacturer. They shall

ensure that the manufacturer has drawn up the technical

documentation, that the vessel bears the CE marking and the

i ns c r ip t i o n s p r o v i d e d f o r i n p o i n t 1 o f S c he d u l e I I I a n d i s

accompanied by the required documents, and that the manufacturer

has complied with the requirements set out in regulation 8(9) and

regulation 8(10).

(3) Where an importer considers or has reason to believe that a

vessel of which the product of PS × V exceeds 50 bar.L is not in

conformity with the essential safety requirements set out in

Schedule I, he shall not place the vessel on the market until it has

been brought into conformity. Furthermore, where the vessel

presents a risk, the importer shall inform the manufacturer and the

Technical Regulations Division to that effect.

(4) Before placing on the market a vessel of which the product

of PS × V is 50 bar.L or less, importers shall ensure that it has been

designed and manufactured in accordance with the sound

engineering practice in one of the Member States, bears the

inscriptions provided for in point 1.2 of Schedule III and that the

manufacturer has complied with the requirements set out in

regulation 8(9) and regulation 8(10).

(5) Importers shall indicate on the vessel their name, registered

trade name or registered trade mark and the postal address at which

they can be contacted or, where that is not possible, in a document

accompanying the vessel. The contact details shall be in at least the

Maltese or English language.

(6)

Importers shall ensure that the vessel is accompanied by the

instructions and safety information referred to in point 2 of

Schedule III, in at least the Maltese or English language.

(7) Importers shall ensure that, while a vessel in respect of

which the product of PS × V exceeds 50 bar.L is under their

responsibility, its storage or transport conditions do not jeopardise

its compliance with the essential safety requirements set out in

Schedule I.

(8) When deemed appropriate with regard to the risks presented

by a vessel, importers shall, to protect the health and safety of end-

users, carry out sample testing of vessels made available on the

market, investigate, and, if necessary, keep a register of complaints,

of non-conforming vessels and vessel recalls, and shall keep

distributors informed of any such monitoring.

(9) Importers who consider or have reason to believe that a

vessel which they have placed on the market is not in conformity

with these regulations shall immediately take the corrective

measures necessary to bring that vessel into conformity, to

withdraw it or recall it, if appropriate. Furthermore, where the

vessel presents a risk, importers shall immediately inform the

Technical Regulations Division to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(10) For vessels of which the product of PS × V exceeds 50

bar.L, importers shall, for 10 years after the vessel has been placed

on the market, keep a copy of the EU declaration of conformity at

the disposal of the Technical Regulations Division and ensure that

t h e te c h n ic a l d o c u m e n t a t io n c a n be m a de a v a i la bl e t o t h a t

authority, upon request.

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

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a vessel in at least the Maltese or

Engli sh language. They shall cooperate wit h the Technical

Regulations Divisions, at its request, on any action taken to

eliminate the risks posed by vessels which they have placed on the

market.

(1) When making a vessel available on the market

distributors shall act with due care in relation to the requirements

of these regulations.

(2) Before making available on the market a vessel of which

the product of PS × V exceeds 50 bar.L, distributors shall verify

that the vessel bears the CE marking and the inscriptions provided

for in point 1 of Schedule III, that it is accompanied by the required

documents and by instructions and safety information referred to in

point 2 of Schedule III in at least the Maltese or English language,

and that the manufacturer and the importer have complied with the

requirements set out in regulations 8(9) and 8(10) and regulation

10(5) respectively.

(3) Where a distributor considers or has reason to believe that a

vessel of which the product of PS × V exceeds 50 bar.L is not in

conformity with the essential safety requirements set out in

Schedule I, he shall not make the vessel available on the market

until it has been brought into conformity. Furthermore, where the

vessel presents a risk, the distributor shall inform the manufacturer

or the importer to that effect as well as the market surveillance

authorities.

(4) Before making available on the market a vessel of which

the product of PS × V is 50 bar.L or less, distributors shall verify

that the vessel bears the inscriptions provided for in point 1.2 of

Schedule III and is accompanied by the instructions and safety

information referred to in point 2 of Schedule III in at least the

Maltese or English language, and that the manufacturer and the

importer have complied with the requirements set out in regulation

8(9) and regulation 8(10) and regulation 10(5) respectively.

(5) Distributors shall ensure that, while a vessel of which the

product of PS × V exceeds 50 bar.L is under their responsibility, its

storage or transport conditions do not jeopardise its compliance

with the essential safety requirements set out in Schedule I.

(6) Distributors who consider or have reason to believe that a

vessel which they have made available on the market is not in

conform it y w it h t hese reg ul atio ns sh all m ake sure t hat th e

corrective measures necessary to bring that vessel into conformity,

to withdraw it or recall it, if appropriate, are taken. Furthermore,

where the vessel presents a risk, distributors shall immediately

inform the Technical Regulations Division to that effect, giving

details, in particular, of the non-compliance and of any corrective

measures taken.

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

Technical Regulations Division, provide it with all the information

and documentation in paper or electronic form necessary to

demonstrate the conformity of a vessel. They shall cooperate with

the Technical Regulations Divisions, at its request, on any action

taken to eliminate the risks posed by vessels which they have made

available on the market.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 8,

where he places a vessel on the market under his name or trade

mark or modifies a vessel already placed on the market in such a

way that compliance with these regulations may be affected.

(1) Economic operators shall, on request, identify the

following to the market surveillance authorities

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

vessel;

(b) any economic operator to whom they have supplied a

vessel.

(2) Economic operators shall be able to present the information

referred to in sub-regulation (1) for 10 years after they have been

supplied with the vessel and for 10 years after they have supplied

the vessel.

Vessels of which the product of PS × V exceeds 50 bar.L

and which are in conformity with harmonised standards or parts

thereof the references of which have been published in the Official

J ou r na l o f t he E u rop e a n Un i on s h a l l b e pr e s u m e d t o b e i n

conformity with the essential safety requirements set out in

Schedule I covered by those standards or parts thereof.

(1) Prior to their manufacture, vessels of which the product

of PS × V exceeds 50 bar.L shall be subject to the EU-type

examination (Module B) set out to in point 1 of Schedule II, as

follows

(a) for vessels manufactured in accordance with the

harmonised standards referred to in regulation 14, at

the choice of the manufacturer, in either of the

following two manners

(i)

assessment of the adequacy of the technical

design of the vessel through examination of the

technical

documentation

and

supporting

evidence without examination of a specimen

(Module B - design type);

(ii) assessment of the adequacy of the technical

design of the vessel through examination of the

technical

documentation

and

supporting

evidence, plus examination of a prototype,

representative of the production envisaged, of

the complete vessel (Module B – production

type).

(b) for vessels not manufactured, or manufactured only

partly, in accordance with the harmonised standards

referred to in regulation 14, the manufacturer shall

submit for examination a prototype, representative of

the production envisaged, of the complete vessel and

the technical documentation and supporting evidence

for examination and assessment of the adequacy of the

technical design of the vessel (Module B - production

type).

(2) Prior to their placing on the market, vessels shall be subject

to the following procedures

(a) where the product of PS × V exceeds 3 000 bar.L, to

conformity to type based on internal production

control plus supervised vessel testing (Module C1) set

out in point 2 of Schedule II;

(b) where the product of PS × V does not exceed 3 000

bar.L but exceeds 200 bar.L, at the choice of the

manufacturer, to either of the following

(i)

conformity to type based on internal production

control plus supervised vessel testing (Module

C1) set out in point 2 of Schedule II;

(ii) conformity to type based on internal production

control plus supervised vessel checks at random

intervals (Module C2) set out in point 3

Schedule II;

(c) where the product of PS × V does not exceed 200 bar.L

but exceeds 50 bar.L, at the choice of the

manufacturer, to either of the following

(i) conformity to type based on internal production

control plus supervised vessel testing (Module

C1) set out in point 2 of Schedule II;

(ii) conformity to type based on internal production

control (Module C) set out in point 4 of

Schedule II.

(3) The records and correspondence relating to the conformity

assessment procedures referred to in sub-regulations (1) and (2)

shall be drawn up in at least the Maltese and English language.

(1) The EU declaration of conformity shall state that the

fulfilment of the essential safety requirements set out in Schedule I

has been demonstrated.

(2) The EU declaration of conformity shall have the model

structure set out in Schedule IV, shall contain the elements

specified in the relevant modules set out in Schedule II and shall be

continuously updated. It shall be translated into either the Maltese

or English language.

(3) Where a vessel is subject to more than one Union act

requiring an EU declaration of conformity, a single EU declaration

of conformity shall be drawn up in respect of all such Union acts.

That declaration shall contain the identification of the Union acts

concerned including their publication references.

(4) By drawing up the EU declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

vessel with the requirements laid down in these regulations.

(1) The CE marking shall be subject to the general

principles set out in Article 30 of Regulation (EC) No 765/2008.

(2) The CE marking and the inscriptions referred to in point 1

of Schedule III shall be affixed visibly, legibly and indelibly to the

vessel or to its data plate.

(3) The CE marking shall be affixed before the vessel is placed

on the market.

(4) The CE marking shall be followed by the identification

number of the notified body involved in the production control

phase. The identification number of the notified body shall be

affixed by the body itself or, under i ts instructions, by the

manufacturer or his authorised representative.

(5) The CE marking and the identification number of the

notified body may be followed by any other mark indicating a

special risk or use.

(6) The Technical Regulations Division shall build upon

existing mechanisms to ensure correct application of the regime

governing the CE marking and shall take appropriate action in the

event of improper use of that marking.

(1) The Technical Regulations Division shall notify the

European Commission and the other Member States of bodies

authorised to carry out third-party conformity assessment under

these regulations.

(2) The Technical Regulations Division shall be responsible for

setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies and

the monitoring of notified bodies, including compliance with

regulations 19(13) to 19(16).

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

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall take full

responsibility for the tasks performed by National Accreditation

Board (Malta) referred to in sub-regulation (3).

(5) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (11) and in the

Method for Designating Conformity Assessment Bodies

Regulations.

(2) A conformity assessment body shall be established under

Maltese law and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or vessel it assesses. A body

belonging to a business association or professional federation

representing undertakings involved in the design, manufacturing,

provision, assembly, use or maintenance of vessels which it

assesses, may, on condition that its independence and the absence

of any conflict of interest are demonstrated, be considered such a

body.

(4)

(a) A conformity assessment body, its top level

management and the personnel responsible for carrying

out the conformity assessment tasks shall not be the

designer, manufacturer, supplier, installer, purchaser,

owner, user or maintainer of vessels which they assess,

nor representative of any of those parties. This shall

not preclude the use of assessed vessels that are

necessary for the operations of the conformity

assessment body or the use of such vessels personal

purposes. This does not preclude the possibility of

exchange of technical information between the

manufacturer or the installer and the body.

(b) A conformity assessment body, its top level

management and the personnel responsible for

carrying out the conformity assessment tasks shall not

be directly involved in the design, manufacture or

construction, the marketing, installation, use or

maintenance of those vessels or safety components for

vessels, or represent the parties engaged in those

activities. They shall not engage in any activity that

may conflict with their independence of judgement or

integrity in relation to conformity assessment

activities for which they are notified. This shall in

particular apply to consultancy services.

(c) Conformity assessment bodies shall ensure that the

activities of their subsidiaries or subcontractors do not

affect the confidentiality, objectivity or impartiality of

their conformity assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest

degree of professional integrity and the requisite technical

competence in the specific field and shall be free from all pressures

and inducements, particularly financial, which might influence

their judgement or the results of their conformity assessment

activities, especially as regards persons or groups of persons with

an interest in the results of those activities.

(6)

(a) A conformity assessment body shall be capable of

carrying out all the conformity assessment tasks

assigned to it by Schedule IV to XII and in relation to

which it has been notified, whether those tasks are

carried out by the conformity assessment body itself or

on its behalf and under its responsibility.

(b) At all times and for each conformity assessment

procedure and each kind of vessel in relation to which

it has been notified, a conformity assessment body

shall have at its disposal the necessary

(i)

personnel with technical knowledge and

sufficient and appropriate experience to perform

the conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out,

ensuring the transparency and the ability of

reproduction of those procedures. It shall have

appropriate policies and procedures in place that

distinguish between tasks it carries out as a

notified body and other activities;

(iii) procedures for the performance of activities

which take due account of the size of an

undertaking, the sector in which it operates, its

structure, the degree of complexity of the

product technology in question and the mass or

serial nature of the production process.

(c) A conformity assessment body shall have the means

necessary to perform the technical and administrative

tasks connected with the conformity assessment

activities in an appropriate manner and shall have

access to all necessary equipment or facilities.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a) sound technical and vocational training covering all

the conformity assessment activities in relation to

which the conformity assessment body has been

notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to

carry out those assessments;

(c) appropriate knowledge and understanding of the

essential safety requirements set out in Schedule I, of

the applicable harmonised standards and of the

relevant provisions of Union harmonisation legislation

and of national legislation;

(d) the ability to draw up certificates, records and reports

demonstrating that assessments have been carried out.

(8) The impartiality of the conformity assessment bodies, their

top level management and of the personnel responsible for carrying

out the conformity assessment tasks shall be guaranteed. The

remuneration of the top level management and personnel

responsible for carrying out the conformity assessment tasks of a

conformity assessment body shall not depend on the number of

assessments carried out or on the results of those assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance

with national law, or the Member State itself is directly responsible

for the conformity assessment.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information

obtained in carrying out their tasks under point 3.2 of Schedule I

and under Schedule II or any provision of national law giving effect

to it, except in relation to the competent authorities of the Member

State in which its activities are carried out. Proprietary rights shall

be protected.

(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

conformity assessment tasks are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under the relevant Union

harmonisation legislation and shall apply as general guidance the

administrative decisions and documents produced as a result of the

work of that group.

(12) Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof the references of which have been

published in the Official Journal of the European Union it shall be

presumed to comply with the requirements set out in sub-

regulations (1) to (11) insofar as the applicable harmonised

standards cover those requirements.

(13) Where

a

notified

body

subcontracts

specific

tasks

connected with conformity assessment or has recourse to a

subsidiary, it shall ensure that the subcontractor or the subsidiary

meets the requirements set out in sub-regulations (1) to (11) and

shall inform the Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries wherever these are

established.

(15) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(16) Notified bodies shall keep at the disposal of the notifying

authority the relevant documents concerning the assessment of the

qualifications of the subcontractor or the subsidiary and the work

carried out by them under point 3.2 of Schedule I and under

Schedule II.

(1) A conformity assessment body established in Malta

shall submit an application for notification under these regulations

to the Technical Regulations Division.

(2) The application referred to in the preceding sub-regulation

shall be accompanied by a description of the conformity assessment

activities, the conformity assessment module or modules and the

vessel or vessels for which that body claims to be competent, as

well as by an accreditation certificate, issued by the National

Accreditation Board (Malta) attesting that the conformity

assessment body fulfils the requirements laid down in regulations

19(1) to 19(11) and the Method for Designating Conformity

Assessment Bodies Regulations.

(3) The Technical Regulations Division may only notify

conformity assessment bodies which have satisfied the

requirements laid down in regulation 21 and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify conformity

assessment bodies to the European Commission and the other

Member States using the electronic notification tool developed and

managed by the European Commission.

(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment procedure or

procedures and the vessels or the safety component for vessels

concerned and the relevant attestation of competence.

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

bo d y o nl y w he r e no ob j e c t i on s ar e r a i s e d by t h e E u ro p e a n

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.

(7) The Technical Regulations Division shall notify the

European Co mmission and the ot her Mem ber Stat es of any

subsequent relevant changes to the notification.

(8) Where the Technical Regulations Division has ascertained

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

requirements laid down in regulations 19(1) to 19(11) or the

Method for Designating Conformity Assessment Bodies

Regulations, 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 European Commission and the other

Member States accordingly.

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

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

Technical Regulations Division shall take appropriate steps to

ensure that the files of that body are either processed by another

notified body or kept available to the responsible notifying and

Technical Regulations Division, at their request.

(10) 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.

(1) Notified bodies shall carry out conformity assessments

in accordance with the conformity assessment procedures provided

for in Schedule II.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Conformity assessment bodies shall perform their

activities taking due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of complexity

of the technology of the vessel in question and the mass or serial

nature of the production process. In so doing, they shall

nevertheless respect the degree of rigour and the level of protection

required for the compliance of the vessel with these regulations.

(3) Where a notified body finds that the essential safety

requirements set out in Schedule I or corresponding harmonised

standards or other technical specifications have not been met by a

manufacturer, it shall require that manufacturer to take appropriate

corrective measures and shall not issue a certificate of conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that a

vessel no longer complies; it shall require the manufacturer to take

appropriate corrective measures and shall suspend or withdraw the

certificate if necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or

withdraw any certificates, as appropriate.

(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 or conditions

for notification;

(c) any request for information which they have received

from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and

any other activity performed, including cross-border

activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified these

regulations carrying out similar conformity assessment activities

covering the same vessels 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 European

Commission.

(1) The Technical Regulations Division shall take

appropriate measures to ensure that vessels may only be placed on

the market if they satisfy the essential safety requirements set out

in Schedule I.

(2) Article 15(3) and Articles 16 to 29 of regulation (EC) No

765/2008 shall apply to vessels covered by regulation 3 of these

regulations.

(3) Where the Technical Regulations Division have sufficient

reasons to believe that a vessel covered by these regulations

presents a r isk to the h ealth or safety of persons or, wher e

appropriate to the safety of property, they shall carry out an

evaluation in relation to the vessel concerned covering all relevant

requirements laid down in these regulations. The relevant economic

o p e r a t o r s s h a l l c o o p e r a t e a s n e c e s s a r y w i t h t h e Te c h n i c a l

Regulations Division for that purpose.

(4) Where, in the course of the evaluation referred to in the

sub-regulation (3), the Technical Regulations Division find that a

vessel does not comply with the requirements laid down in these

regulations, they shall without delay require the installer to take all

appropriate corrective actions to bring the vessels into compliance

with those requirements, to withdraw the vessels from the market,

or to recall it within a reasonable period, commensurate with the

nature of the risk, as they may prescribe. They shall also inform the

notified body accordingly.

(5) Article 21 of Regulation (EC) No 765/2008 shall apply to

the measures referred to in sub-regulation (4).

(6) Where the Technical Regulations Division consider that

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

inform the European 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.

(7) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the vessels concerned

that it has made available on the market throughout the European

Union.

(8) Where the relevant economic operator does not take

adequate corrective action within the period referred to in sub-

regulation (4), the Technical Regulations Division shall take all

appropriate provisional measures to prohibit or restrict the vessel’s

being made available on the Maltese market, to withdraw the vessel

from the Maltese market or to recall it.

(9) The Technical Regulations Division shall inform the

European Commission and the other Member States, without delay,

of those measures.

(10) The information referred to in sub-regulation (9) shall

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

identification of the non-compliant vessel, the origin of the vessel,

the nature of the non-compliance alleged and the risk involved, the

nature and duration of the national measures taken and the

arguments put forward by the relevant economic operator. In

particular, Technical Regulations Division shall indicate whether

the non-compliance is due to either of the following

(a) failure of the vessel to meet requirements relating to

the health or safety of persons, to the protection of

domestic animals or property; or

(b) shortcomings in the harmonised standards referred to

in regulation 14 conferring a presumption of

conformity.

(11) When the procedure under this Regulation is initiated by

another Member State, the Technical Regulations Division, shall

without delay inform the European Commission and the other

Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of the

vessel concerned, and, in the event of disagreement with the

adopted national measure, of their objections.

(12) Where, within three months of receipt of the information

referred to in sub-regulation (9), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall be

deemed justified.

(13) In such cases, the Technical Regulations Division shall

ensure that appropriate restrictive measures, such as withdrawal of

the vessel from the market, are taken in respect of the vessel

concerned without delay.

(14) Where on completion of the procedure set out in sub-

regulations (7) and (8), objections are raised against the measures

t a k e n b y 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 E u r o p e a n

Commission shall conduct an evaluation including appropriate

consultations with these entities and the relevant economic operator

or operators.

(15) If, on the basis of this evaluation, the national measure is

considered justified, the Technical Regulations Division shall take

the measures necessary to ensure that the placing on the market or

use of the non-compliant vessel is withdrawn from the Maltese

market and shall inform the European Commission accordingly. If,

on the basis of this evaluation, the national measure is considered

unjustified, the national measure shall be withdrawn.

(16) Where, having carried out an evaluation under sub-

regulation (3), the Technical Regulations Division, finds that

although a vessel is in compliance with 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 vessel

concerned, when placed on the market, no longer presents that risk,

to withdraw the vessel from the market or to recall it within a

reasonable period, commensurate with the nature of the risk, as it

may prescribe.

(17) The economic operator shall ensure that corrective action is

taken in respect of all the vessels concerned that he has made

available on the market throughout the European Union.

(18) The Technical Regulations Division, upon consultation

with the Commissioner of Police, shall immediately inform the

E u r o p e a n C o m m i s s i o n a n d t h e o t h e r M e m b e r St a t e s . T h a t

information shall include all available details, in particular the data

necessary for the identification of the vessel concerned, the origin

and the supply chain of the vessel, the nature of the risk involved

and the nature and duration of the national measures taken.

(19) Without prejudice to sub-regulations (3) to (13), where the

Technical Regulations Division and/or the Commissioner of Police

make one of the following findings, it shall require the relevant

economic operator to put an end to the non-compliance concerned

(a) the CE marking has been affixed in violation of article

30 of regulation (EC) No 765/2008 or of regulation 19;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved

in the production control phase has been affixed in

violation of regulation 17 or has not been affixed;

(d) the inscriptions referred to in point 1 of Schedule III

have not been affixed or have been affixed in violation

of regulation 17 or point 1 of Schedule III;

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

up;

(f)

the EU declaration of conformity has not been drawn

up correctly;

(g) technical documentation is either not available or not

complete;

(h) the information referred to in regulation 8(10) or

regulation 10(5) is absent, false or incomplete;

(i)

any other administrative requirement provided for in

regulation 6 or regulation 8 is not fulfilled.

(20) Where the non-compliance referred to in sub-regulation

(19) persists, the Technical Regulations Division shall take all

appropriate measures to restrict or prohibit the vessel being made

available on the Maltese market or ensure that it is recalled or

withdrawn from the Maltese market.

(21) The powers of the Commissioner of Police under this

regulation may be exercised by any officer or other entity as he

may direct.

The penalties applicable for the infringement of any of the

provisions of these regulations shall be those provided for in Part

IV of the Product Safety Act.

(1) Any references to the Simple Pressure Vessels Order,

1 9 9 8 , r e v o k e d b y t he s e R e g u la t i ons , s h a ll b e c o n s t r u e d a s

references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 2007/23/EC shall be

construed as references to Directive 2013/29/EU.

SIMPLE PRESSURE VESSELS

Schedule I

ESSENTIAL SAFETY REQUIREMENTS

1. Materials

Materials shall be selected according to the intended use of the vessels and in

accordance with points 1.1 to 1.4.

1.1. Pressurised parts

The materials used for manufacturing the pressurised parts of the vessels shall be

(a) capable of being welded;

(b) ductile and tough, so that a rupture at minimum working temperature

does not give rise to either fragmentation or brittle-type fracture;

(c) not adversely affected by ageing.

For steel vessels, the materials shall in addition meet the requirements set out in

point 1.1.1 and, for aluminium or aluminium alloy vessels, those set out in point

They shall be accompanied by an inspection slip as defined in point (i) of point 3.1

of Schedule III, drawn up by the producer of the materials.

1.1.1. Steel vessels

Non-alloy quality steels shall meet the following requirements

(a) they shall be non-effervescent and supplied after normalisation

treatment, or in an equivalent state;

(b) the content per product of carbon shall be less than 0.25% and that of

sulphur and phosphorus shall each be less than 0.05%;

(c) they shall have the following mechanical properties per product

(i)

the maximum tensile strength Rm,max shall be less than 580 N/

mm 2 ;

(ii) the elongation after fracture shall be

if test pieces are taken parallel to the direction of rolling

thickness ≥ 3 mm

A

≥ 22%,

thickness < 3 mm

A 80 mm

≥ 17%,

if test pieces are taken perpendicular to the direction of rolling

thickness ≥ 3 mm

A

≥ 20%,

thickness < 3 mm

A 80 mm

≥ 15%;

(iii) the average bending rupture energy KCV for three longitudinal

test pieces at minimum working temperature shall not be less than

35 J/cm 2 . Not more than one of the three figures may be less than

35 J/cm 2 , with a minimum of 25 J/cm 2 . In the case of steels

intended to be used in the manufacture of vessels the minimum

working temperature of which is lower than -10°C and the wall

thickness of which exceeds 5 mm, this property shall be checked.

1.1.2. Aluminium vessels

Non-alloy aluminium shall have an aluminium content of at least 99,5% and the

alloys referred to in point (b) of point 1(1) shall display adequate resistance to

intercrystalline corrosion at maximum working temperature.

SIMPLE PRESSURE VESSELS

Moreover, these materials shall satisfy the following requirements

(a) they shall be supplied in an annealed state;

(b) they shall have the following mechanical characteristics per product

-

the maximum tensile strength R m,max shall be no more than 350

N/mm 2 ,

-

the elongation after fracture shall be

- A ≥ 16% if the test piece is taken parallel to the direction of

rolling,

- A ≥ 14% if the test piece is taken perpendicular to the

direction of rolling.

1.2. Welding materials

The welding materials used to manufacture the welds on or of the vessel shall be

appropriate to and compatible with the materials to be welded.

1.3. Accessories contributing to the strength of the vessel

These accessories (for example bolts and nuts) shall be made of a material

specified in point 1.1 or of other kinds of steel, aluminium or an appropriate

aluminium alloy compatible with materials used for the manufacture of pressurised

parts.

The latter materials shall at minimum working temperature have an appropriate

elongation after fracture and bending rupture energy.

1.4. Non-pressurised parts

All unpressurised parts of welded vessels shall be of materials which are

compatible with that of the components to which they are welded.

2. Vessel design

(a) The manufacturer shall, when designing the vessel, define the use to

which it will be put, and select

(i) the minimum working temperature T min ;

(ii) the maximum working temperature T max ;

(iii) the maximum working pressure PS.

However, should a minimum working temperature exceeding -10°C be selected,

the qualities required of the materials shall be satisfied at -10°C.

(b) The manufacturer shall also take account of the following provisions

(i) it shall be possible to inspect the inside of vessels;

(ii) it shall be possible to drain the vessels;

(iii) the mechanical qualities shall be maintained throughout the

period of use of the vessel for the intended purpose;

(iv) the vessels shall, bearing in mind their prescribed use, be

adequately protected against corrosion.

(c) The manufacturer shall take account of the fact that under the

conditions of use envisaged

(i)

the vessels shall not be subjected to stresses likely to impair their

safety in use;

(ii) internal pressure shall not permanently exceed the maximum

working pressure PS. However, it may momentarily do so by up to

SIMPLE PRESSURE VESSELS

10%.

(d) Circumferential and longitudinal seams shall be made using full

penetration welds or welds of equivalent effectiveness. Convex ends

other than hemispherical ones shall have a cylindrical edge.

2.1. Wall thickness

If the product of PS × V is not more than 3 000 bar.L, the manufacturer shall select

one of the methods described in points 2.1.1 and 2.1.2 for determining vessel wall

thickness; if the product of PS × V is more than 3 000 bar.L, or if the maximum

working temperature exceeds 100°C, such thickness shall be determined by the

method described in point 2.1.1.

The actual wall thickness of the cylindrical section and ends shall, however, be not

less than 2 mm in the case of steel vessels and not less than 3 mm in the case of

aluminium or aluminium alloy vessels.

2.1.1. Calculation method

The minimum thickness of pressurised parts shall be calculated having regard to

the intensity of the stresses and to the following provisions

(a) the calculation pressure to be taken into account shall not be less than

the maximum working pressure PS selected;

(b) the permissible general membrane stress shall not exceed the lower of

the values 0.6 R eT or 0.3 R m . The manufacturer shall use the R eT and

R m minimum values guaranteed by the producer of the material in order

to determine the permissible stress.

However, where the cylindrical portion of the vessel has one or more longitudinal

welds made using a non-automatic welding process, the thickness calculated as

referred to in the first paragraph shall be multiplied by the coefficient 1.15.

2.1.2. Experimental method

Wall thickness shall be so determined as to enable the vessels to resist at ambient

temperature a pressure equal to at least five times the maximum working pressure,

with a permanent circumferential deformation factor of no more than 1%.

3. Manufacturing processes

Vessels shall be constructed and subjected to production checks in accordance

with points 2, 3 or 4 of Schedule II.

3.1. Preparation of the component parts

Preparation of the component parts (for example forming and chamfering) shall

not give rise to surface defects or cracks or changes in the mechanical characteristics

likely to be detrimental to the safety of the vessels.

3.2. Welds on pressurised parts

The characteristics of welds and adjacent zones shall be similar to those of the

welded materials and shall be free of any surface or internal defects detrimental to

the safety of the vessels.

Welds shall be performed by qualified welders or operators possessing the

appropriate level of competence, in accordance with approved welding processes.

Such approval and qualification tests shall be carried out by notified bodies.

The manufacturer shall also, during manufacture, ensure consistent weld quality

by conducting appropriate tests using adequate procedures. These tests shall be the

subject of a report.

4. Putting into service of the vessels

Vessels shall be accompanied by the instructions drawn up by the manufacturer, as

referred to in point 2 of Schedule III.

Schedule II

CONFORMITY ASSESSMENT PROCEDURES

1. EU-Type examination (Module B)

1.1. EU-type examination is the part of a conformity assessment procedure in

which a notified body examines the technical design of a vessel and verifies and

attests that the technical design of the vessel meets the requirements of these

regulations that apply to it.

1.2. EU-type examination shall be carried out in either of the following manners

in accordance with regulation 15

assessment of the adequacy of the technical design of the vessel through

examination of the technical documentation and supporting evidence

referred to in point 1.3, plus examination of a prototype, representative

of the production envisaged, of the complete vessel (production type),

assessment of the adequacy of the technical design of the vessel through

examination of the technical documentation and supporting evidence

referred to in point 1.3, without examination of a prototype vessel

(design type).

1.3. The manufacturer shall lodge an application for EU-type examination with a

single notified body of his choice.

The application shall include

(a) the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well;

(b) a written declaration that the same application has not been lodged with

any other notified body;

(c) the technical documentation. The technical documentation shall make it

possible to assess the vessel’s conformity with the applicable

requirements of these regulations and shall include an adequate analysis

and assessment of the risk(s).

The technical documentation shall specify the applicable requirements and cover,

as far as relevant for the assessment, the design, manufacture and operation of the

vessel. The technical documentation shall contain, wherever applicable, at least the

following elements

(i) a general description of the vessel;

(ii) conceptual design and manufacturing drawings and schemes of

components, etc.;

(iii) descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the vessel;

(iv) a list of the harmonised standards applied in full or in part, the

references of which have been published in the Official Journal of

SIMPLE PRESSURE VESSELS

the European Union, and, where those harmonised standards have

not been applied, descriptions of the solutions adopted to meet the

essential safety requirements of these regulations, including a list

of other relevant technical specifications applied. In the event of

partly applied harmonised standards, the technical documentation

shall specify the parts which have been applied;

(v)

results of design calculations made, examinations carried out,

etc.;

(vi)

test reports;

(vii)

the instructions and safety information referred to in point 2 of

Schedule III;

(viii) a document describing

- the materials selected,

- the welding processes selected,

- the checks selected,

- any pertinent details as to the vessel design;

(d) where applicable, the prototype vessels representative of the production

envisaged. The notified body may request further prototype vessels if

needed for carrying out the test programme;

(e) the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents that

have been used, in particular where the relevant harmonised standards

have not been applied in full. The supporting evidence shall include,

where necessary, the results of tests carried out in accordance with other

relevant technical specifications by the appropriate laboratory of the

manufacturer, or by another testing laboratory on his behalf and under

his responsibility.

When a prototype vessel is examined, the technical documentation shall also

the certificates relating to the suitable qualification of the welding

operations and of the welders or welding operators,

the inspection slip for the materials used in the manufacture of parts and

components contributing to the strength of the vessel,

a report on the examinations and tests performed or a description of the

proposed checks.

1.4. The notified body shall

For the vessel

1.4.1. examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the vessel.

For the prototype vessel(s)

1.4.2. verify that the prototype vessel(s) has/have been manufactured in

conformity with the technical documentation, that it may safely be used under its

intended working conditions and identify the elements which have been designed in

accordance with the applicable provisions of the relevant harmonised standards, as

well as the elements which have been designed in accordance with other relevant

technical specifications;

1.4.3. carry out appropriate examinations and tests, or have them carried out, to

SIMPLE PRESSURE VESSELS

check whether, where the manufacturer has chosen to apply the solutions in the

relevant harmonised standards, these have been applied correctly;

1.4.4. carry out appropriate examinations and tests, or have them carried out, to

check whether, where the solutions in the relevant harmonised standards have not

been applied, the solutions adopted by the manufacturer applying other relevant

technical specifications meet the corresponding essential safety requirements of

these regulations;

1.4.5. agree with the manufacturer on a location where the examinations and tests

will be carried out.

1.5. The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 1.4 and their outcomes. Without

prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall

release the content of that report, in full or in part, only with the agreement of the

manufacturer.

1.6. Where the type meets the requirements of these regulations, the notified

body shall issue an EU-type examination certificate to the manufacturer. That

certificate shall contain the name and address of the manufacturer, the conclusions of

the examination, the conditions (if any) for its validity and the necessary data for

identification of the approved type. The EU-type examination certificate may have

one or more Schedules attached.

The EU-type examination certificate and its Schedules shall contain all relevant

information to allow the conformity of manufactured vessels with the examined type

to be evaluated and to allow for in-service control. It shall also indicate any

conditions to which its issue may be subject and be accompanied by the descriptions

and drawings necessary for identification of the approved type.

Where the type does not satisfy the applicable requirements of these regulations,

the notified body shall refuse to issue an EU-type examination certificate and shall

inform the applicant accordingly, giving detailed reasons for its refusal.

1.7. The notified body shall keep itself apprised of any changes in the generally

acknowledged state of the art which indicate that the approved type may no longer

comply with the applicable requirements of these regulations, and shall determine

whether such changes require further investigation. If so, the notified body shall

inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical

documentation relating to the EU-type examination certificate of all modifications to

the approved type that may affect the conformity of the vessel with the essential

safety requirements of these regulations or the conditions for validity of that

certificate. Such modifications shall require additional approval in the form of an

addition to the original EU-type examination certificate.

1.8. Each notified body shall inform its notifying authority concerning the EU-

type examination certificates and/or any additions thereto which it has issued or

withdrawn, and shall, periodically or upon request, make available to its notifying

authority the list of such certificates and/or any additions thereto refused, suspended

or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU-type

examination certificates and/or any additions thereto which it has refused,

withdrawn, suspended or otherwise restricted, and, upon request, concerning such

certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on

SIMPLE PRESSURE VESSELS

request, obtain a copy of the EU-type examination certificates and/or additions

thereto. On request, the Commission and the Member States may obtain a copy of

the technical documentation and the results of the examinations carried out by the

notified body. The notified body shall keep a copy of the EU-type examination

certificate, its Schedules and additions, as well as the technical file including the

documentation submitted by the manufacturer, until the expiry of the validity of that

certificate.

1.9. The manufacturer shall keep a copy of the EU-type examination certificate,

its Schedules and additions together with the technical documentation at the disposal

of the national authorities for 10 years after the vessel has been placed on the

market.

1.10. The manufacturer’s authorised representative may lodge the application

referred to in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9,

provided that they are specified in the mandate.

2. Conformity to type based on internal production control plus supervised

vessel testing (Module C1)

2.1. Conformity to type based on internal production control plus supervised

vessel testing is the part of a conformity assessment procedure whereby the

manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures

and declares on his sole responsibility that the vessels concerned are in conformity

with the type described in the EU-type examination certificate and satisfy the

requirements of these regulations that apply to them.

2.2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured vessels with the

type described in the EU-type examination certificate and with the requirements of

these regulations that apply to them.

Before commencing manufacture, the manufacturer shall provide a notified body

of his choice with all necessary information, and in particular

(a) the technical documentation, which shall also include

-

the certificates relating to the suitable qualification of the welding

operations and of the welders or welding operators,

-

the inspection slip for the materials used in the manufacture of

parts and components contributing to the strength of the vessel,

-

a report on the examinations and tests performed;

(b) the inspection document, describing the appropriate examinations and

tests to be carried out during manufacture, together with the procedures

in respect thereof and the frequency with which they are to be

performed;

(c) the EU-type examination certificate.

2.3. Vessel checks

2.3.1. For each individual vessel manufactured, the notified body shall carry out

the appropriate examinations and tests in order to verify the conformity of the vessel

with the type described in the EU-type examination certificate and with the

corresponding requirements of these regulations in accordance with the following

points

(a) The manufacturer shall present his vessels in the form of uniform

batches and shall take all necessary measures in order that the

manufacturing process ensures the uniformity of each batch produced.

(b) When a batch is examined, the notified body shall ensure that the

vessels have been manufactured and checked in accordance with the

technical documentation, and shall perform a hydrostatic test or a

pneumatic test of equivalent effect on each vessel in the batch at a

pressure Ph equal to 1.5 times the vessel’s design pressure in order to

check its strength. The pneumatic test shall be subject to acceptance of

the test safety procedures by the Member State in which the test is

performed.

(c) Moreover, the notified body shall carry out tests on test-pieces taken

from a representative production test- piece or from a vessel, as the

manufacturer chooses, in order to examine the weld quality. The tests

shall be carried out on longitudinal welds. However, where differing

weld techniques are used for longitudinal and circumferential welds, the

tests shall be repeated on the circumferential welds.

(d) For the vessels subject to the experimental method referred to in point

2.1.2 of Schedule I, these tests on test- pieces shall be replaced by a

hydrostatic test on five vessels taken at random from each batch in order

to check that they conform to the essential safety requirements set out in

point 2.1.2 of Schedule I.

(e) In the case of accepted batches, the notified body shall affix its

identification number, or cause that number to be affixed, to each vessel

and shall draw up a written certificate of conformity relating to the tests

carried out. All vessels in the batch may be placed on the market except

for those which have not successfully undergone a hydrostatic test or a

pneumatic test.

(f)

If a batch is rejected, the notified body shall take appropriate measures

to prevent the placing on the market of that batch. In the event of

frequent rejection of batches, the notified body may suspend the

statistical verification.

(g) The manufacturer shall be able to supply on request by the relevant

authorities the notified body’s certificates of conformity referred to in

point (e).

2.3.2. The notified body shall supply the Member State which notified it and, on

request, the other notified bodies, the other Member States and the Commission,

with a copy of the inspection report issued by it.

2.3.3. The manufacturer shall, under the responsibility of the notified body, affix

the notified body’s identification number during the manufacturing process.

2.4. CE marking and EU declaration of conformity

2.4.1. The manufacturer shall affix the CE marking to each individual vessel that

is in conformity with the type described in the EU-type examination certificate and

satisfies the applicable requirements of these regulations.

2.4.2. The manufacturer shall draw up a written EU declaration of conformity for

each vessel model and keep it at the disposal of the national authorities for 10 years

after the vessel has been placed on the market. The EU declaration of conformity

shall identify the vessel model for which it has been drawn up.

2.4.3. A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

2.5. Authorised representative

SIMPLE PRESSURE VESSELS

The manufacturer ’s obligations set out in point 2.4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

3. Conformity to type based on internal production control plus supervised

vessel checks at random intervals (Module C2)

3.1. Conformity to type based on internal production control plus supervised

vessel checks at random intervals is the part of a conformity assessment procedure

whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.3 and 3.4,

and ensures and declares on his sole responsibility that the vessels concerned are in

conformity with the type described in the EU-type examination certificate and

satisfy the requirements of these regulations that apply to them.

3.2. Manufacturing

3.2.1. The manufacturer shall take all measures necessary so that the

manufacturing process and its monitoring ensure conformity of the manufactured

vessels with the type described in the EU-type examination certificate and with the

requirements of these regulations that apply to them.

3.2.2. Before commencing manufacture, the manufacturer shall provide a notified

body of his choice with all necessary information, and in particular

(a) the technical documentation, which shall also include

-

the certificates relating to the suitable qualification of the welding

operations and of the welders or welding operators,

-

the inspection slip for the materials used in the manufacture of

parts and components contributing to the strength of the vessel,

-

a report on the examinations and tests performed;

(b) the EU-type examination certificate;

(c) a document describing the manufacturing processes and all of the

predetermined systematic measures taken to ensure conformity of the

vessels with the type described in the EU-type examination certificate.

The notified body shall, before the date on which any manufacture begins,

examine those documents in order to certify their conformity with the EU-type

examination certificate.

3.2.3. The document referred to in point (c) of point 3.2.2 shall include

(a) a description of the means of manufacture and checking appropriate to

the construction of the vessels;

(b) an inspection document describing the appropriate examinations and

tests to be carried out during manufacture, together with the procedures

in respect thereof and the frequency with which they are to be

performed;

(c) an undertaking to carry out the examinations and tests in accordance

with the inspection document and to have a hydrostatic test or, subject

to the agreement of the Member State, a pneumatic test carried out on

each vessel manufactured at a test pressure equal to 1.5 times the design

pressure; those examinations and tests shall be carried out under the

responsibility of qualified staff who are independent from production

personnel, and shall be the subject of a report;

(d) the addresses of the places of manufacture and storage and the date on

which manufacture is to commence.

SIMPLE PRESSURE VESSELS

3.3. Vessel checks

The notified body shall carry out vessel checks or have them carried out on

random samples at random intervals determined by the body, in order to verify the

quality of the internal checks on the vessel, taking into account, inter alia, the

technological complexity of the vessels and the quantity of production. An adequate

sample of the final vessels, taken on site by the notified body before the placing on

the market, shall be examined and appropriate tests as identified by the relevant parts

of the harmonised standards and/or equivalent tests set out in other relevant

technical specifications, shall be carried out to check the conformity of the vessel

with the type described in the EU-type examination certificate and with the relevant

requirements of these regulations.

The notified body shall also ensure that the manufacturer actually checks series-

produced vessels in accordance with point (c) of point 3.2.3.

Where a sample does not conform to the acceptable quality level, the notified

body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether

the manufacturing process of the vessel performs within acceptable limits, with a

view to ensuring conformity of the vessel.

The notified body shall supply the Member State which notified it and, on request,

the other notified bodies, the other Member States and the Commission, with a copy

of the inspection report issued by it.

The manufacturer shall, under the responsibility of the notified body, affix the

notified body’s identification number during the manufacturing process.

3.4. CE marking and EU declaration of conformity

3.4.1. The manufacturer shall affix the CE marking to each individual vessel that

is in conformity with the type described in the EU-type examination certificate and

satisfies the applicable requirements of these regulations.

3.4.2. The manufacturer shall draw up a written EU declaration of conformity for

each vessel model and keep it at the disposal of the national authorities for 10 years

after the vessel has been placed on the market. The EU declaration of conformity

shall identify the vessel model for which it has been drawn up.

3.4.3. A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

3.5. Authorised representative

The manufacturer ’s obligations set out in point 3.4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

4. Conformity to type based on internal production control (Module C)

4.1. Conformity to type based on internal production control is the part of a

conformity assessment procedure whereby the manufacturer fulfils the obligations

laid down in points 4.2 and 4.3, and ensures and declares that the vessels concerned

are in conformity with the type described in the EU-type examination certificate and

satisfy the requirements of these regulations that apply to them.

4.2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured vessels with the

approved type described in the EU-type examination certificate and with the

SIMPLE PRESSURE VESSELS

requirements of these regulations that apply to them.

Before commencing manufacture, the manufacturer shall provide the notified

body which issued the E U-type examination certificate with all necessary

information, and in particular

(a) the certificates relating to the suitable qualification of the welding

operations and of the welders or welding operators;

(b) the inspection slip for the materials used in the manufacture of parts and

components contributing to the strength of the vessel;

(c) a report on the examinations and tests performed;

(d) a document describing the manufacturing processes and all of the

predetermined systematic measures taken to ensure conformity of the

vessels with the type described in the EU-type examination certificate.

That document shall include

(i)

a description of the means of manufacture and checking

appropriate to the construction of the vessels;

(ii) an inspection document describing the appropriate examinations

and tests to be carried out during manufacture, together with the

procedures in respect thereof and the frequency with which they

are to be performed;

(iii) an undertaking to carry out the examinations and tests in

accordance with the inspection document and to have a

hydrostatic test or, subject to the agreement of the Member State,

a pneumatic test carried out on each vessel manufactured at a test

pressure equal to 1.5 times the design pressure; those

examinations and tests shall be carried out under the

responsibility of qualified staff who are independent from

production personnel, and shall be the subject of a report;

(iv) the addresses of the places of manufacture and storage and the

date on which manufacture is to commence.

The notified body shall, before the date on which any manufacture begins,

examine those documents in order to certify their conformity with the EU-type

examination certificate.

4.3. CE marking and EU declaration of conformity

4.3.1. The manufacturer shall affix the CE marking to each individual vessel that

is in conformity with the type described in the EU-type examination certificate and

satisfies the applicable requirements of these regulations.

4.3.2. The manufacturer shall draw up a written EU declaration of conformity for

each vessel model and keep it at the disposal of the national authorities for 10 years

after the vessel has been placed on the market. The EU declaration of conformity

shall identify the vessel model for which it has been drawn up.

4.3.3. A copy of the EU declaration of conformity shall be made available to the

relevant authorities upon request.

4.4. Authorised representative

The manufacturer ’s obligations set out in point 4.3 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

Schedule III

INSCRIPTIONS, INSTRUCTIONS, DEFINITIONS AND SYMBOLS

1. CE marking and inscriptions

1.1. Vessels of which the product of PS × V exceeds 50 bar.L must bear the CE

marking provided for in Schedule II of Regulation (EC) No 765/2008 and the last

two digits of the year in which the CE marking was affixed.

1.2. Vessels or their data plates shall bear at least the following information

(a) the maximum working pressure (PS in bar);

(b) the maximum working temperature (T max in °C);

(c) the minimum working temperature (T min in °C);

(d) the capacity of the vessel (V in L);

(e) the name, registered trade name or registered trade mark and the address

of the manufacturer;

(f)

the type and serial or batch identification of the vessel.

1.3. Where the data plate is used, it shall be so designed that it cannot be reused

and shall include a vacant space to enable other information to be provided.

2. Instructions and safety information

The instructions shall contain the following information

(a) the particulars given in point 1.2 except for the vessel’s serial or batch

identification

(b) the intended use of the vessel;

(c) the maintenance and installation requirements for vessel safety.

3. Definitions and symbols

3.1. Definitions

(a) The design pressure ‘P’ is the gauge pressure chosen by the

manufacturer and used to determine the thickness of the vessel’s

pressurised parts.

(b) The maximum working pressure ‘PS’ is the maximum gauge pressure

which may be exerted under normal conditions of use of the vessel.

(c) The minimum working temperature T min is the lowest stabilised

temperature which the wall of the vessel may attain under normal

conditions of use.

(d) The maximum working temperature T max is the highest stabilised

temperature which the wall of the vessel may attain under normal

conditions of use.

(e) The yield strength ‘R eT ’ is the value at the maximum working

temperature T max of any of the following

(i)

the upper yield point R eH , for a material with both a lower and an

upper yield point;

(ii) the 0.2% proof strength R p0.2 ;

(iii) the 1.0% proof strength R p1,0 in the case of non-alloy aluminium.

(f)

Families of vessels

SIMPLE PRESSURE VESSELS

Vessels form part of the same family if they differ from the prototype

only in diameter, provided that the permissible requirements referred to

in points 2.1.1 and 2.1.2 of Schedule I are complied with, and/or in the

length of their cylindrical portion within the following limits

(i)

where a prototype has one or more shell rings in addition to the

ends, variants shall have at least one shell ring;

(ii) where a prototype has just two dished ends, variants shall have no

shell rings.

Variations in length causing the apertures and/or penetrations to be

modified shall be shown in the drawing for each variant.

(g) A batch of vessels consists at the most of 3 000 vessels of the model of

the same type.

(h) There is series manufacture within the meaning of these regulations if

more than one vessel of the same type is manufactured during a given

period by a continuous manufacturing process, in accordance with a

common design and using the same manufacturing processes.

(i)

Inspection slip: document by which the producer of the materials

certifies that the products delivered meet the requirements of the order

and in which he sets out the results of the routine in-plant inspection

test, in particular chemical composition and mechanical characteristics,

performed on products made by the same production process as the

supply, but not necessarily on the products delivered.

3.2. Symbols

elongation after fracture (L o = 5,65√S o )

%

A 80 mm

elongation after fracture (L o = 80 mm)

%

J/cm 2

KCV

bending rupture energy

design pressure

Bar

PS

maximum working pressure

Bar

Ph

hydrostatic or pneumatic test pressure

Bar

N/mm 2

R p0.2

0.2% proof strength

N/mm 2

R eT

yield strength at maximum working temperature

N/mm 2

R eH

upper yield point

N/mm 2

R m

tensile strength

N/mm 2

R m, max

maximum tensile strength

N/mm 2

R p1,0

1.0% proof strength

T max

maximum working temperature

°C

T min

minimum working temperature

°C

capacity of the vessel

L

Schedule IV

EU DECLARATION OF CONFORMITY (No XXXX) ( * )

1. Vessel/vessel model (product, type, batch or serial number)

2. Name and address of the manufacturer and, where applicable, his authorised

representative

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer.

4. Object of the declaration (identification of the vessel allowing traceability;

it may, where necessary for the identification of the vessel, include an image)

5. The object of the declaration described above is in conformity with the

relevant Union harmonisation legislation

6. References to the relevant harmonised standards used or references to the

other technical specifications in relation to which conformity is declared

7. The notified body … (name, number) performed … (description of

intervention) and issued the certificate

8. Additional information

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

* It is optional for the manufacturer to assign a number to the declaration of conformity.