Regulations, 2007

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,146, 9 ta’ Novembru, 2007

L.N. 348 of 2007

PRODUCT SAFETY ACT

(CAP. 427)

Efficiency Requirements for New Hot-Water Boilers Fired with

Liquid or Gaseous Fuels (Implementing Measures)

Regulations, 2007

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, the Minister for Competitiveness and

Communications, on the advice of the Malta Standards Authority, has

made the following regulations>-

(1) The title of these regulations is the Efficiency Citation and

Requirements for New Hot-Water Boilers Fired with Liquid or Gaseous commencement.

Fuels (Implementing Measures) Regulations, 2007.

(2) These regulations shall be interpreted in terms of the

Framework for the Setting of Ecodesign Requirements for Energy-Using

Products Regulations, 2007, herein after referred to as “the Ecodesign

Regulations”.

(3) (a) These regulations implement the requirements of

Council Directive 92#42#EEC (1) of 21 May 1992 on efficiency

requirements for new hot-water boilers fired with liquid or gaseous fuels

as amended by

i.) Directive 2004#8#EC on the promotion of cogeneration

based on a useful heat demand in the internal energy market and

amending Directive 92#42#EEC and,

ii.) Directive 2005#32#EC of the European Parliament and

of the Council of 6 th July 2005 Establishing a Framework for the

Setting of Ecodesign Requirements for Energy-Using Products and

Amending Council Directive 92#42#EEC and Directives 96#57#EC (2)

and 2000#55#EC (3) of the European Parliament and of the Council.

OJ No. L167, 22-06-1992, p. 17-28

OJ No. L236, 18-09-1996, p. 36-43

OJ No. L279, 01-11-2000, p. 33-39

(b) Council Directive 92#42#EEC falls under the SAVE

programme concerning the promotion of energy efficiency in the

Community.

(4) These regulations constitute an implementing measure

with in the meaning of the principal regulations with regard to energy

efficiency during use of boilers.

(5) These regulations shall come into force on the 11 th

August, 2007.

(1) These regulations determine the efficiency requirements

applicable to new hot-water boilers fired by liquid or gaseous fuels

with a rated output of no less than 4 kW and no more than 400 kW,

hereinafter called “boilers”.

(2)

The following shall be excluded from the scope of these

regulations>

a) hot-water boilers capable of being fired by different fuels

including solid fuels,

b) equipment for the instantaneous preparation of hot water,

c) boilers designed to be fired by fuels the properties of

which differ appreciably from the properties of the liquid and

gaseous fuels commonly marketed (industrial waste gas, biogas,

etc),

d) cookers and appliances designed mainly to heat the

premises in which they are installed and, as a subsidiary function,

to supply hot water for central heating and sanitary hot water,

e) appliances with rated outputs of less than 6 kW using

gravity circulation and designed solely for the production of stored

sanitary hot water,

f) appliances with rated outputs of less than 6 kW using

gravity circulation and designed solely for the production of stored

sanitary hot water,

g)

boilers manufactured on a one-off basis,

h) cogeneration units as defined in Directive 2004#8#EC of

the European Parliament and of the Council of 11 February 2004

on the promotion of cogeneration based on useful heat demand in

the internal energy market (4).

For the purposes of these regulations, the definitions of the Definitions.

Ecodesign Regulations as well as the following definitions shall apply>

“Appliance” means the boiler body designed to have a burner

fitted, or the burner designed to be fitted to a boiler body<

“Average temperature of the boiler water” means the average

of the water temperatures at the entry and exit of the boiler<

“Back-boiler” means a boiler designed to supply a central-

heating system and to be installed in a fireplace recess as part of a

back boiler#gas fire combination,

“Boiler” means the combined boiler body-burner unit,

designed to transmit to water the heat released from burning<

“Boiler to be installed in the living space” means a boiler

with an effective rated output of less than 37 kW, designed to

provide heat to the part of the living space in which it is installed

by means of the emission of heat from the casing having an open

expansion chamber, supplying hot water using gravity circulation<

such boilers shall bear on their casings the explicit indication that

they must be installed in living space<

“Effective rated output (expressed in kW)” means the

maximum calorific output laid down and guaranteed by the

manufacturer as being deliverable during continuous operation

while complying with the useful efficiency indicated by the

manufacturer<

“Gas condensing boiler” means a boiler designed to condense

permanently a large part of the water vapour contained in the

combustion gases<

“Low-temperature boiler” means a boiler which can work

continuously with a water supply temperature of 35 to 40°C,

possibly producing condensation in certain circumstances,

including condensing boilers using liquid fuel<

“Part load (expressed in %)” means the ratio between the

effective output of a boiler operating intermittently or at an output

lower than the effective rated output and the same effective rated

output<

“Standard boiler” means a boiler for which the average water

temperature can be restricted by design<

“Useful efficiency (expressed in %)” means the ratio between

the heat output transmitted to the boiler water and the product of

the net calorific value at constant fuel pressure and the consumption

expressed as a quantity of fuel per unit time.

(1) With regard to placing on the market and putting into

service mentioned in the principal regulations the following shall apply>

(a) Boilers shall satisfy the efficiency requirements set out

in Schedule I section 1 hereto, and the conditions for entry into

service laid down on the basis of local climatic conditions and the

energy and the occupancy characteristics of the buildings<

(b) However, where back-boilers and#or boilers that are to

be installed in the living space are widely installed at the date of

the adoption of the Efficiency Requirements for New Hot-Water

Boilers Fired with Liquid or Gaseous Fuels Regulations,2002, the

Malta Standards Authority shall authorise their entry into service,

provided that their efficiency both at rated output and at 30% part

load is not more than 4% below the requirements laid down in

Schedule I section 1 hereto, for standard boilers<

(c) In the case of boilers with a dual function, that of heating

premises and also providing sanitary hot water, the efficiency

requirements referred to in Schedule I section 1 hereto, concern

the heating function only<

(d) Where boilers are subject to other regulations concerning

other aspects which also provide for the affixing of the ‘CE’

marking, the latter shall indicate that the boilers in question are

also presumed to conform to the provisions of those regulations.

(2) Where one or more of these regulations allow the

manufacturer, during a transitional period, to choose which arrangements

to apply, the CE marking shall indicate conformity to the provisions

only of those regulations applied by the manufacturer. In this case,

particulars of the regulations applied, as published in the OJ, must be

given in the documents, notices or instructions required by the

regulations and accompanying the boilers.

(1) With regard to the conformity assessment procedures

mentioned in the Ecodesign regulations the conformity of series-

produced boilers shall be certified by>

a) the examination of the efficiency of a boiler type in

accordance with module B as described in Schedule II hereto, and

b) a declaration of conformity to the approved type in

accordance with module C, D or E as described in Schedule III

hereto.

For boilers burning gaseous fuels, the procedures for assessing the

conformity of their efficiency shall be those used to assess conformity

to the safety requirements laid down in Directive 90#396#EEC 4 on the

approximation of the laws of the Member States relating to appliances

burning gaseous fuels.

(2) Where appliances marketed separately are placed on the

market, they must bear the CE marking and be accompanied by the

declaration of conformity, which defines the parameters enabling them

after assembly to achieve the useful efficiency levels laid down in

Schedule I hereto.

With regard to notified bodies mentioned in the principal Notified Bodies.

regulations a notified body shall also fulfil the criteria listed in Schedule

IV hereto.

The Efficiency Requirements for New Hot-Water Boilers Fired Repeals L.N. 62 of

2002. with Liquid or Gaseous Fuels Regulations, 2002 are hereby being

repealed.

L.N. 52 of 1996> Appliances Burning Gaseous Fuels, implementing Directive

90#396#EEC (OJ No. L 196, 26.07.90, p. 15-29).

Schedule I

Based on Article 5 of directive 92/42/EC

THE EFFICIENCY REQUIREMENTS

1. Boilers must comply with the following useful efficiency requirements

- at rated output, i.e. operating at rated output Pn expressed in kW, at an

average boiler-water temperature of 70 °C , and

- a part load, i.e. operating at 30 % part load, at an average boiler-water

temperature which varies according to the type of the boiler.

The useful efficiency requirements to be complied with are set out in the following table

2. The harmonized standards relating to the requirements of these regulations drawn

up under mandate from the Commission in accordance with directive

83/189/EEC 5 and 88/182/EEC 6 shall determine, inter alia, the verification

methods valid for production and measurements.

5 OJ No. L 109, 26.04.83, P. 08-12.

6 OJ No. L 81, 26.03.88, P. 75.

Appropriate tolerances must be incorporated in the efficiency levels.

Schedule II

Based on Annex III of directive 92/42/EC

EC-TYPE EXAMINATION

Module B: EC type-examination

1. This module describes that part of the procedure by which a notified body

ascertains and attests that an example, representative of the production envisaged,

meets the relevant provisions of these regulations.

2. The application for EC type-examination is lodged by the manufacturer or his

authorized representative with a notified body of his choice.

The application must include

- the name and address of the manufacturer and, if the application is lodged

by the authorized representative, the name and address in addition,

- a written declaration that the same application has not been lodged with any

other notified body,

- the technical documents, as described in section 3 of this Module.

The applicant must place at the disposal of the notified body an example

representative of the production envisaged, hereinafter called ‘type’. The notified

body may request further examples if needed for carrying out the test programme.

3. The technical documents must enable the conformity of the appliance with the

requirements of these regulations to be assessed. They must, as far as is relevant

for such assessment, cover the design, manufacture and operation of the appliance

and contain as far as is relevant for assessment

- a general type-description,

- conceptual design and manufacturing drawings and diagrams of

components, sub-assemblies, circuits, etc.,

- descriptions and explanations necessary for the understanding of the

drawings and diagrams and the operation of the product,

- a list of the standards referred to in Schedule I paragraph 2 hereto, applied

in full or in part, and descriptions of the solutions adopted to meet the

essential requirements of these regulations where the standards referred to

in Schedule I hereto, have not been applied,

- results of design calculations made, examinations carried out, etc.,

- test reports.

4. The notified body must

examine the technical documents, verify that the type has been manufactured in

conformity with those documents and identify the elements which have been

designed in accordance with the relevant provisions of the standards referred to in

paragraph 2 of Schedule I hereto, as well as the components which have been

designed without applying the relevant provisions of those standards;

perform or have performed the appropriate examinations and necessary tests to

check whether, where the standards referred to in paragraph 2 of Schedule I

hereto have not been applied, the solutions adopted by the manufacturer meet the

essential requirements of these regulations;

perform or have performed the appropriate examinations and necessary tests to

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

standards, these have actually been applied;

agree with the applicant the location where the examinations and necessary tests

are to be carried out.

5. Where the type meets the relevant provisions of these regulations, the notified

body issues an EC type-examination certificate to the applicant. The certificate

contains the name and address of the manufacturer, the conclusion of the

examination and necessary data for identification of the approved type.

A list of the relevant parts of the technical documents is annexed to the certificate

and a copy kept by the notified body.

If the manufacturer or his authorized representative is refused a type certificate,

the notified body must provide detailed reasons for such refusal.

Provision must be made for an appeals procedure.

6. The applicant informs the notified body that holds the technical documents

concerning the EC type-examination certificate of all modifications to the

approved appliance which must receive additional approval where such changes

may affect the conformity with the essential requirements or the prescribed

conditions for use of the product. This additional approval is given in the form of

an addition to the original EC type-examination certificate.

7. Each notified body must communicate to the other notified bodies the relevant

information concerning the EC type-examination certificates and additions issued

and withdrawn.

The other notified bodies may receive copies of the EC type-examination

certificates and/or their additions. The Annexes to the certificates must be kept at

the disposal of the other notified bodies.

The manufacturer or his authorized representative must keep with the technical

documents copies of EC type-examination certificates and their additions for a

period of at least 10 years after the last date of manufacture of the product

concerned.

Where neither the manufacturer nor his authorized representative is established in

Malta, the obligation to keep the technical documents available is the

responsibility of the person who places the product on the market.

Schedule III

Based on Annex IV of directive 92/42/EC

CONFORMITY TO TYPE AND QUALITY ASSURANCE

Module C: Conformity to type

1. This module describes that part of the procedure whereby the manufacturer or his

authorized representative ensures and declares that the appliances concerned are

in conformity with the type as described in the EC type-examination certificate

and satisfy the requirements of these regulations that apply to them. The

manufacturer or his authorized representative shall affix the CE marking to each

appliance and draw up a written declaration of conformity.

2. The manufacturer must take all measures necessary to ensure that the

manufacturing process assures the conformity of the manufactured appliances

with the type as described in the EC type-examination certificate and with the

efficiency requirements of the regulations.

3. The manufacturer or his authorized representative must keep a copy of the

declaration of conformity for a period of at least 10 years after the last date of

manufacture of the product concerned.

Where neither the manufacturer nor his authorized representative is established in

Malta, the obligation to keep the technical documents available is the

responsibility of the person who places the product on the market.

4. A notified body chosen by the manufacturer must perform or have performed

examinations of the product at random intervals. A suitable sample of the finished

products, taken on the spot by the notified body, is examined and appropriate

tests, defined in the applicable standard or standards referred to in Schedule I

paragraph 2 hereto, or equivalent tests are carried out to check the conformity of

the product with the requirements of the corresponding directive. In the event of

one or more samples of the products examined not conforming, the notified body

must take the appropriate measures.

Module D: Production quality assurance

1. This module describes the procedure whereby the manufacturer who satisfies the

obligations of section 2 of this Module, ensures and declares that the appliances

concerned are in conformity with the type as described in the EC type

examination certificate and satisfy the requirements of these regulations. The

manufacturer or his authorized representative shall affix the CE marking to each

appliance and draw up a written declaration of conformity. The CE marking is

accompanied by the identification number of the notified body responsible for the

checks referred to in section 4 of this Module.

2. The manufacturer must operate an approved quality system for production, final

appliance inspection and testing as specified in section 3 of this Module. He is

subject to the checks referred to in section 4 of this Module.

3. Quality system

The manufacturer lodges an application for assessment of his quality system with

a notified body of his choice, for the appliances concerned.

The application must include

- all relevant information for the appliance category envisaged,

- the documents concerning the quality system,

- the technical documents pertaining to the approved type and a copy of the

EC type-examination certificate.

The quality system must ensure conformity of appliances with the type as

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

these regulations that apply to them.

All the elements, requirements and provisions adopted by the manufacturer must

be documented in a systematic and orderly manner in the form of written policies,

procedures and instructions. The quality system documents must permit a

consistent interpretation of the quality programmes, plans, manuals and quality

records.

It must contain in particular an adequate description of

- the quality objectives and the organizational structure, responsibilities and

powers of the management with regard to appliance quality,

- the manufacturing, quality control and quality assurance techniques,

processes and systematic actions that will be used,

- the examinations and tests that will be carried out before, during and after

manufacture, and the frequency with which they will be carried out,

- the quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.,

- the means of monitoring the achievement of the required appliance quality

and the effective operation of the quality system.

The notified body must assess the quality system to determine whether it satisfies

the requirements referred to in point 3.2 of this Module. It must presume

conformity with those requirements in respect of quality systems that implement

the relevant harmonized standard. The auditing team must have at least one

member with experience of assessing the relevant product technology.

The assessment procedure includes an inspection visit to the manufacturer’s

premises.

The decision is notified to the manufacturer. The notification must contain the

conclusions of the examination and the duly substantiated assessment decision.

The manufacturer must undertake to fulfil the obligations arising out of the

quality system as approved and maintain it at an adequate and efficient level.

The manufacturer or his authorized representative must keep the notified body

that has approved the quality system informed of any proposed change in the

quality system.

The notified body must assess the changes proposed and decide whether the

altered quality system will still satisfy the requirements referred to in point 3.2 of

this Module or whether reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the

conclusions of the examination and the substantiated assessment decision.

4. Monitoring under the responsibility of the notified body

The purpose of monitoring is to make sure that the manufacturer duly fulfils the

obligations arising out of the approved quality system.

The manufacturer must allow the notified body access for inspection purposes to

the manufacturing, inspection, testing and storage premises and provide it with all

necessary information, in particular

- the quality system documents,

- the quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc..

The notified body must periodically carry out audits to make sure that the

manufacturer maintains and applies the quality system and provides an audit

report to the manufacturer.

Additionally the notified body may pay unannounced visits to the manufacturer.

During such visits the notified body may carry out tests or have them carried out

to verify that the quality system is functioning correctly; if necessary, the notified

body must provide the manufacturer with a visit report and, if a test has taken

place, with a test report.

5. The manufacturer must, for a period of at least 10 years after the last date of

manufacture of the product, keep at the disposal of the national authorities

- the document referred to in the second indent of point 3.1 of this Module,

- the updating referred to in the second paragraph of point 3.4 of this Module,

- the decisions and reports from the notified body which are referred to in the

final paragraph of point 3.4, and in point 4.3 and point 4.4 of this Module.

6. Each notified body must give the other notified bodies the relevant information

concerning the quality system approvals issued and withdrawn.

Module E: Product quality assurance

1. This module describes the procedure whereby the manufacturer who satisfies the

obligations of section 2 of this Module ensures and declares that the boilers and

appliances are in conformity with the type as described in the EC type

examination certificate.

The manufacturer or his authorized representative shall affix the CE marking to

each boiler and appliance and draw up a written declaration of conformity.

The CE marking must be accompanied by the identification number of the

notified body responsible for the checks referred to in section 4 of this Module.

2. The manufacturer must operate an approved quality system for final boiler and

appliance inspection and testing as specified in section 3 of this Module. He must

be subject to the checks referred to in section 4 of this Module.

3. Quality system

The manufacturer lodges an application with a notified body of this choice for the

assessment of the quality system for his boilers and appliances.

The application must include

- all relevant information for the boiler or appliance category envisaged,

- the quality system’s documentation,

- the technical documents pertaining to the approved type and a copy of the

EC type-examination certificate.

Under the quality system, each boiler or appliance is examined and appropriate

tests as defined in the relevant standard(s) referred to in out in Schedule I hereto,

or equivalent tests are carried out in order to verify its conformity with the

relevant requirements of these regulations. All the elements, requirements and

provisions adopted by the manufacturer must be documented in a systematic and

orderly manner in the form of written policies, procedures and instructions.

This quality system documentation must enable the quality programmes, plans,

manuals and records to be interpreted in a uniform manner.

It must in particular contain an adequate description of

- the quality objectives and the organizational structure, responsibilities and

powers of the management with regard to product quality,

- the examination and tests that will be carried out after manufacture,

- the means of monitoring the effective operation of the quality system,

- quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

The notified body must assess the quality system to determine whether it satisfies

the requirements referred to in point 3.2 of this Module. It must presume

conformity with these requirements in respect of quality systems that implement

the relevant harmonized standard.

The auditing team must have at least one member with experience of assessing

the relevant product technology. The assessment procedure must include an

inspection visit to the manufacturer’s premises.

The manufacturer must be notified of the decision. The notification must contain

the conclusions of the examination and the substantiated assessment decision.

The manufacturer must undertake to fulfil the obligations arising out of the

quality system as approved and maintain it at an adequate and efficient level.

The manufacturer or his authorized representative must keep the notified body

which has approved the quality system informed of any proposed change in the

quality system.

The notified body must assess the changes proposed and decide whether the

altered quality system will still satisfy the requirements referred to in section 3.2

of this Schedule or whether a reassessment is required.

It must notify the manufacturer of its decision. The notification must contain the

conclusions of the examination and the substantiated assessment decision.

4. Monitoring under the responsibility of the notified body

The purpose of monitoring is to make sure that the manufacturer duly fulfils the

obligations arising out of the approved quality system.

The manufacturer must allow the notified body access for inspection purposes to

the inspection, testing and storage premises and provide it with all necessary

information, in particular

- the quality system documentation,

- the technical documents,

- the quality records, such as inspection reports and test data, calibration data,

qualification reports of the personnel concerned, etc.

The notified body must periodically carry out audits to ensure that the

manufacturer maintains and applies the quality system and must provide an audit

report to the manufacturer.

Additionally, the notified body may pay unannounced visits to the manufacturer.

During such visits the notified body may carry out tests or have them carried out

to verify that the quality system is functioning correctly; if necessary, the notified

body must provide the manufacturer with a visit report and, if a test has been

carried out, with a test report.

5. The manufacturer must, for a period of at least 10 years after the last date of

manufacture of the boiler or appliance, keep at the disposal of the national

authorities

- the documents referred to in the third indent of point 3.1 of this Module,

- the changes referred to in the second paragraph of point 3.4 of this Module,

- the decisions and reports from the notified body which are referred to in the

final paragraph of point 3.4, and in point 4.3 and point 4.4 of this Module.

6. Each notified body must forward to the other notified bodies the relevant

information concerning the quality system approvals issued and withdrawn.

Schedule IV

Based on Annex V of directive 92/42/EC

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT FOR THE

NOTIFICATION OF BODIES

1. The body, its director and the staff responsible for carrying out the verification

tests may not be the designer, manufacturer, supplier or installer of appliances

which they inspect, nor the authorized representative of any of those parties. They

may not become either involved directly or as authorized representatives in the

design, construction, marketing or maintenance of such boilers and appliances.

This does not preclude the possibility of exchanges of technical information

between the manufacturer and the body.

2. The body and its staff must carry out the verification tests with the highest degree

of professional integrity and technical competence and must be free from all

pressures and inducements, particularly financial, which might influence their

judgment of the results of the inspection, especially from persons or groups of

persons with an interest in the result of verifications.

3. The body must have at its disposal the necessary staff and possess the necessary

facilities to enable it to perform properly the administrative and technical tasks

connected with verification; it must also have access to the equipment required

for special verification.

4. The staff responsible for inspection must have

- sound technical and professional training,

- satisfactory knowledge of the requirements of the tests they carry out and

adequate experience of such tests,

- the ability to draw up the certificates, records and reports required to

authenticate the performance of the tests.

5. The impartiality of inspection staff must be guaranteed. Their remuneration must

not depend on the number of tests carried out or on the results of such tests.

6. The body must take out liability insurance unless its liability is assumed by the

State in accordance with national law, or the Member State itself is directly

responsible for the tests.

7. The staff of the body must be bound to observe professional secrecy (except vis-

à-vis the competent administrative authorities of the State in which its activities

are carried out) under these regulations or any provision of national law giving

effect to it.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

Lm0.36 (€0.84)