Simple Pressure Vessels Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,549, 22 ta’ Marzu, 2016

L.N. 99 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Simple Pressure Vessels Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following regulations:-

(1) The title of these regulations is Simple Pressure Title and scope.

Vessels Regulations, 2016.

(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)

These regulations shall apply as from the 20th April Commencement.

2016. (2) The putting into service of vessels or the making available

on the market of safety components for vessels covered by the Simple

Pressure Vessels Order which are in conformity with those S.L. 427.01

regulations and which were placed on the market before 20th April

2016 shall not be impeded.

(3) Certificates and decisions by notified bodies issued under

Simple Pressure Vessels Order shall be valid under these regulations. S.L. 427.01

(1) These regulations shall apply to simple pressure Applicability.

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 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 Making

into service only if they satisfy the requirements of these regulations available

market and

when they are properly installed and maintained and used for the putting into

service.

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

ScheduleI.

(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

service of vessels which satisfy the requirements of these 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 inscriptions provided for in point

1 of Schedule III and is 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 the

technical documentation can be made available to that 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

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) 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

conformity with these regulations shall make sure that the 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 Cases in which

manufacturer for the purposes of these regulations and he shall be obligations

manufacturers

subject to the obligations of the manufacturer under regulation 8, apply

importers and

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

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 Identification of

economic

following to the market surveillance authorities

operators.

(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 Presumption of

and which are in conformity with harmonised standards or parts conformity

vessels of which

thereof the references of which have been published in the Official the

PS × V exceeds

Journal of the European Union shall be presumed to be in conformity 50 bar.L

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 Conformity

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

procedures.

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 EU Declaration

fulfilment of the essential safety requirements set out in Schedule I of Conformity.

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 CE marking.

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 its 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 body only where no objections are raised by the European

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 Commission and the other Member States 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 Operational

assessment obligations

assessments in accordance with the conformity

notified bodies.

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 risk to the health or safety of persons or, where 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 operators shall cooperate as

necessary with the Technical 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

taken by Technical Regulations Division; the European 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

European Commission and the other Member States. That

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 Penalties.

provisions of these regulations shall be those provided for in Part IV Cap. 427

of the Product Safety Act.

The Making Available on the Market of Simple Pressure

Vessels Regulations are hereby being revoked.

(1) Any references to the revoked regulations shall be

construed as 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.

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.

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 1.1.2.

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.

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 R m ,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.

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.

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 ,

—

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.

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.

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.

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 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.

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.

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.

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)

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.

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).

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 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 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 or a description

of the proposed checks.

The notified body shall

For the vessel

examine the technical documentation and supporting evidence to assess

the adequacy of the technical design of the vessel.

For the prototype vessel(s)

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;

carry out appropriate examinations and tests, or have them carried out,

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

solutions in the relevant harmonised standards, these have been applied

correctly;

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;

agree with the manufacturer on a location where the examinations and

tests will be carried out.

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.

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.

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.

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 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.

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.

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)

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.

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.

Vessel checks

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).

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.

CE marking and EU declaration of conformity

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.

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.

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

the relevant authorities upon request.

Authorised representative

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)

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.

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 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.

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.

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.

CE marking and EU declaration of conformity

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.

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.

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)

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.

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 requirements of these regulations

that apply to them.

Before commencing manufacture, the manufacturer shall provide the

notified body which issued the EU-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.

CE marking and EU declaration of conformity

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.

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.

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

the relevant authorities upon request.

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

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.

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.

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

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

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.

Symbols

elongation after fracture (L o = %

5,65√S o )

elongation after fracture (L o = %

80 mm)

bending rupture energy

J/cm 2

design pressure

Bar

maximum working pressure

Bar

hydrostatic or pneumatic test Bar

pressure

0.2% proof strength

N/mm 2

yield strength at maximum N/mm 2

working temperature

upper yield point

N/mm 2

tensile strength

N/mm 2

R m, max

maximum tensile strength

N/mm 2

1.0% proof strength

N/mm 2

maximum

working °C

temperature

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.

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

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)

B

€1.98