Regulations, 2007

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,037, 16 ta’ Frar, 2007

L.N. 28 of 2007

PRODUCT SAFETY ACT

(CAP. 427)

The Electromagnetic Compatibility

Regulations, 2007

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

Product Safety Act, 2001, the Minister for Competitiveness and

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

has made the following regulations>-

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

commencement.

Compatibility Regulations, 2007.

(2) These regulations shall come into force on the 20 th July

2007. (3) Notwithstanding the provisions of sub-regulation (2)

hereto, the placing on the market or putting into service of equipment

(a) which is in compliance with the Electromagnetic

L.N. 268 of 2002.

Compatibility Regulations, 2002 and,

(b) which is placed on the market before the 20 th July,

2009,shall not be impeded.

For the purposes of these regulations the following definitions Definitions.

shall apply>

“apparatus” means any finished appliance or combination

thereof made commercially available as a single functional unit,

intended for the end user and liable to generate electromagnetic

disturbance, or the performance of which is liable to be affected

by such disturbance<

“the Community” means the European Community<

“the Director” has the same meaning as it has in the Product

cap 427.

Safety Act<

“the Directorate” means the Consumer and Industrial Goods

Directorate of the Malta Standards Authority as established by the

Malta Standards Authority Establishments of Directorates Order,

2000<

“electromagnetic compatibility” means the ability of

equipment to function satisfactorily in its electromagnetic

environment without introducing intolerable electromagnetic

disturbances to other equipment in that environment<

“electromagnetic disturbance” means any electromagnetic

phenomenon which may degrade the performance of equipment.

An electromagnetic disturbance may be electromagnetic noise, an

unwanted signal or a change in the propagation medium itself<

“electromagnetic environment” means all electromagnetic

phenomena observable in a given location<

“equipment” means any apparatus or fixed installation<

“fixed installation” means a particular combination of several

types of apparatus and, where applicable, other devices, which are

assembled, installed and intended to be used permanently at a

predefined location<

“harmonised standard” means a technical specification

adopted by a recognised European standardisation body under a

mandate from the Commission in conformity with the procedures

laid down in Directive 98#34#EC for the purpose of establishing a

European requirement<

“immunity” means the ability of equipment to perform as

intended without degradation in the presence of an electromagnetic

disturbance<

“Member State” means a member state of the European

Union<

“mobile installations” are defined as a combination of

apparatus and, where applicable, other devices, intended to be

moved and operated in a range of locations<

“safety purposes” means the purposes of safeguarding human

life or property.

Part I

General Provisions

These regulations transpose Directive 2004#108#EC of the General scope.

European Parliament and of the Council of 15 December 2004 on the

approximation of the laws of the Member States relating to

electromagnetic compatibility and repealing Directive 89#336#EEC,

hereinafter referred to as the Directive.

(1) These regulations shall apply to equipment as defined in Applicability.

these regulations.

(2) For the purposes of these regulations the following shall

be deemed to be an apparatus within the meaning of regulation 2 hereof>

- “components” or “sub-assemblies” intended for

incorporation into an apparatus by the end user, which are liable to

generate electromagnetic disturbance, or the performance of which

is liable to be affected by such disturbance<

-

mobile installations.

(3) These regulations shall not apply to>

(a) equipment covered by Directive 1999#5#EC of the

European Parliament and of the Council of 9 March 1999 on radio

equipment and telecommunications terminal equipment and the

mutual recognition of their conformity, which has been

implemented in Malta as the Radio Equipment and

Telecommunications Terminal Equipment and the Mutual

Recognition of their Conformity Regulations, 2002<

L.N. 374 of 2002.

(b) aeronautical products, parts and appliances as referred

to in Regulation (EC) No 1592#2002 of the European Parliament

and of the Council of 15 July 2002 on common rules in the field of

civil aviation and establishing a European Aviation Safety Agency<

(c) radio equipment used by radio amateurs within the

meaning of the Radio Regulations adopted in the framework of

the Constitution and Convention of the ITU1, unless the equipment

is available commercially. Kits of components to be assembled by

radio amateurs and commercial equipment modified by and for

the use of radio amateurs are not regarded as commercially available

equipment.

(4) These regulations shall not apply to equipment the

inherent nature of the physical characteristics of which is such that>-

• it is incapable of generating or contributing to

electromagnetic emissions which exceed a level allowing radio

and telecommunication equipment and other equipment to operate

as intended< and-

• it will operate without unacceptable degradation in the

presence of the electromagnetic disturbance normally consequent

upon its intended use.

(5) Where, for the equipment referred to in sub-regulation

(1) hereto, the essential requirements referred to in Schedule I are wholly

or partly laid down more specifically by any other law that transposes

Community directives, the present regulations shall not apply, or shall

cease to apply, to that equipment insofar as such requirements which

are dealt with by the other legislation as from the date of implementation

of that law.

(6) These regulations shall not affect the application of

Community or local laws regulating the safety of equipment.

(1) Equipment shall be placed on the market or put into

service only if it complies with the requirements of these regulations

when properly installed, maintained and used for its intended purpose.

(2) The placing on the market or the putting into service of

equipment which complies with these regulations shall not be impeded,

for reasons relating to electromagnetic compatibility.

(3) The display or demonstration at trade fairs, exhibitions

or similar events of equipment which does not comply with these

regulations shall not be impeded, provided that a visible sign clearly

indicates that such equipment shall not be placed on the market or put

into service until it has been brought into conformity with these

regulations. Demonstration shall only take place provided that adequate

measures are taken to avoid electromagnetic disturbances.

(1) These regulations shall not prevent the application of

the following special measures by any Authority or regulator in Malta

concerning the putting into service or use of equipment>

- measures to overcome an existing or predicted

electromagnetic compatibility problem at a specific site<

- measures taken for safety reasons to protect public

telecommunications networks or receiving or transmitting stations

when used for safety purposes in well-defined spectrum situations.

(2) (a) The measures taken in sub-regulation (1) hereto

shall be notified immediately to the Directorate giving details of the

measures, including whether the measures are to be applied for an

indefinite or definite period, and the reasons justifying their

implementation.

(b) The Directorate shall deliver its opinion on the

measures taken and shall notify these measures to the Commission

and the other Member States.

(3) Sub-regulation (2) hereof shall be without prejudice to

the provisions of the Notification Procedure Regulations, 2003.

L.N. 373 of 2003.

(1) Equipment shall meet the essential requirements set out Essential

requirements.

in Schedule I to these regulations.

(2) (a) The compliance of equipment with the relevant

harmonized standards whose references have been published in the

Official Journal of the European Union shall raise a presumption of

conformity with the essential requirements referred to in Schedule I of

these regulations to which such standards relate.

(b) Such presumption of conformity is limited to the

scope of the harmonized standards applied and the relevant essential

requirements covered by such harmonized standards.

(3)

Compliance with a “harmonised standard” is not

compulsory.

Part II

Apparatus

Compliance of apparatus with the essential requirements Conformity

assessment

referred to in Schedule I shall be demonstrated by means of the procedure procedure for

described in Schedule II (internal production control). However, at the apparatus.

discretion of the manufacturer or of his authorised representative in the

Community, the procedure described in Schedule III may also be

followed.

(1) Apparatus whose compliance with these regulations has ‘CE’ marking.

been established by means of the procedure laid down in regulation 8

hereof shall bear the ‘CE’ marking which attests to that fact. The affixing

of the CE marking shall be the responsibility of the manufacturer or his

authorised representative in the Community and it shall be affixed in

accordance with Schedule V hereof.

(2) The affixing to the apparatus, or to its packaging, or to

the instructions for its use, of marks which are likely to mislead third

parties in relation to the meaning and#or graphic form of the CE marking

is prohibited.

(3) Any other mark may be affixed to the apparatus, its

packaging, or the instructions for its use, provided that neither the

visibility nor the legibility of the ‘CE’ marking is thereby impaired.

(4) Without prejudice to regulation 11 hereof, if it is

established that the CE marking has been unduly affixed, the

manufacturer or his authorised representative in the Community shall

bring the apparatus into conformity with the provisions concerning the

CE marking under conditions imposed by the Director.

(1) Each apparatus shall be identified in terms of type, batch,

serial number or any other information allowing for the identification

of the apparatus.

(2) Each apparatus shall be accompanied by the name and

address of the manufacturer and, if he is not established within the

Community, the name and address of his authorised representative or

of the person in the Community responsible for placing the apparatus

on the Community market.

(3) The manufacturer shall provide information on any

specific precautions that must be taken when the apparatus is assembled,

installed, maintained or used, in order to ensure that, when put into

service, the apparatus is in conformity with the protection requirements

set out in Schedule I, point 1, hereto.

(4) Apparatus for which compliance with the protection

requirements is not ensured in residential areas shall be accompanied

by a clear indication of this restriction of use, where appropriate also on

the packaging.

(5) The information required to enable apparatus to be used

in accordance with the intended purpose of the apparatus shall be

contained in the instructions accompanying the apparatus.

(1) Where it is ascertained that apparatus bearing the CE Withdrawal from

the market.

marking does not comply with the requirements of these regulations,

all appropriate measures to withdraw the apparatus from the market, to

prohibit its placing on the market or its putting into service, or to restrict

the free movement thereof shall be taken.

(2) The Director shall immediately inform the head of the

Directorate of any such measure, indicating the reason for its decision

and in particular, whether non-conformity is due to>-

(a) failure to satisfy the essential requirements referred to

in Schedule I hereto, where the apparatus does not comply with

harmonised standards referred to in regulation 7 hereof<

(b) incorrect application of the standards referred to in

regulation 7 hereof<

(c) shortcomings in the standards themselves referred to in

regulation 7 hereof<

(3) Any decision taken pursuant to these regulations, hereto,

to withdraw apparatus from the market, prohibit or restrict its placing

on the market or its putting into service, or restrict the free movement

thereof, shall state the exact grounds on which it is based. Such decisions

shall be notified without delay to the party concerned, who shall at the

same time be informed of the remedies available to him under the laws

of Malta and of the time limits to which such remedies are subject.

(4) In the event of a decision as referred to in sub-regulation

(3) hereof the manufacturer, his authorised representative, or any other

interested party shall have the opportunity to put forward his point of

view in advance, unless such consultation is not possible because of the

urgency of the measure to be taken as justified in particular with respect

to public interest requirements.

(1) Bodies which have been designated to carry out the tasks Notified bodies.

referred to in Schedule III to this regulation shall be notified to the

Commission.

(2) Such bodies are subject to the Method for Designating

Conformity Assessment Bodies Regulations, 2003 and to the criteria L.N. 136 of 2003.

set out in Schedule VI hereto.

(3) Such notification shall state whether the bodies are

designated to carry out the tasks referred to in Schedule III to these

regulations for all apparatus covered by these regulations, or the essential

requirements referred to in Schedule I or whether the scope of

designation is limited to certain specific aspects or categories of

apparatus.

(4) Bodies which comply with the assessment criteria

established by the relevant harmonised standards shall be presumed to

comply with the criteria set out in Schedule VI to these regulations

covered by such harmonised standards The references of these

harmonized standards shall be found published in the Official Journal

of the European Union.

(5) Where a non-compliant apparatus has been subject to

the conformity assessment procedure referred to in Schedule III to these

regulations and the body concerned has been designated by Malta, then

the body shall be subject to extraordinary surveillance referred to in

regulation 8 of the Method for Designating Conformity Assessment

Bodies Regulations 2003.

(6) The Consumer and Industrial Goods Directorate of the

Malta Standards Authority shall inform the Commission and the other

Member States accordingly.

Part III

Fixed Installations

(1) Apparatus which has been placed on the market and

which may be incorporated into a fixed installation is subject to all

relevant provisions for apparatus set out in these regulations.

(2) The provisions of sub-regulation 7(1) and of regulations

8, 9, 10, hereof shall not be compulsory in the case of apparatus which

is intended for incorporation into a given fixed installation and is

otherwise not commercially available. In such cases, the accompanying

documentation shall identify the fixed installation and its electromagnetic

compatibility characteristics and shall indicate the precautions to be

taken for the incorporation of the apparatus into the fixed installation in

order not to compromise the conformity of that installation. It shall

furthermore include the information referred to in sub-regulations 10(1)

and 10(2) of these regulations.

(3) Where there are indications of non-compliance of the

fixed installation, and in particular, where there are complaints about

disturbances being generated by the installation, evidence of compliance

of the fixed installation shall be requested by the Director>

Provided that -

(a) an assessment, when appropriate, shall be initiated,

and

(b) the parties involved are identified.

(4) Where non-compliance is established, appropriate

measures to bring the fixed installation into compliance with the

protection requirements set out in Schedule I, point 1, hereto, shall be

imposed by the Director after consulting the parties involved.

The Directorate shall be informed of any such measures if

the non-compliance was due to a shortcoming in good engineering

practice, a short coming in a standard or the failure of apparatus to

satisfy the essential requirements.

(5) The person who by virtue of ownership or operation has

control of the relevant fixed installation shall be responsible to establish

the compliance of a fixed installation with the relevant essential

requirements.

Part IV

Final Provisions

The Electromagnetic Compatibility Regulations, 2002 are L.N. 368 of 2002.

hereby repealed.

Schedule I

(Regulation 7)

1. Protection requirements

Equipment shall be so designed and manufactured, having regard to the state

of the art, as to ensure that>

(a) the electromagnetic disturbance generated does not exceed the level

above which radio and telecommunications equipment or other equipment cannot

operate as intended<

(b) it has a level of immunity to the electromagnetic disturbance to be

expected in its intended use which allows it to operate without unacceptable

degradation of its intended use.

2. Specific requirements for fixed installations

Installation and intended use of components>

A fixed installation shall be installed applying good engineering practices

and respecting the information on the intended use of its components, with a

view to meeting the protection requirements set out in Point 1 above. Those good

engineering practices shall be documented and the documentation shall be held

by the person(s) responsible at the disposal of the bodies mentioned in regulation

13 hereto for inspection purposes for as long as the fixed installation is in operation.

Schedule II

(Regulation 8)

Conformity assessment procedure

1. The manufacturer shall perform an electromagnetic compatibility assessment

of the apparatus, on the basis of the relevant phenomena, with a view to meeting the

protection requirements set out in Schedule I, point 1, hereto. The correct application

of all the relevant harmonised standards whose references have been published in the

Official Journal of the European Union shall be equivalent to the carrying out of the

electromagnetic compatibility assessment.

2. The electromagnetic compatibility assessment shall take into account all normal

intended operating conditions. Where the apparatus is capable of taking different

configurations, the electromagnetic compatibility assessment shall confirm whether

the apparatus meets the protection requirements set out in Schedule I, point 1 hereto,

in all the possibleconfigurations identified by the manufacturer as representative of its

intended use.

3. In accordance with the provisions set out in Schedule IV , hereto, the

manufacturer shall draw up technical documentation providing evidence of the

conformity of the apparatus with the essential requirements of these regulations.

4. The manufacturer or his authorised representative in the Community shall hold

the technical documentation at the disposal of the competent authorities for at least ten

years after the date on which such apparatus was last manufactured.

5. The compliance of apparatus with all relevant essential requirements shall be

attested by an EC declaration of conformity issued by the manufacturer or his authorised

representative in the Community.

6. The manufacturer or his authorised representative in the Community shall hold

the EC declaration of conformity at the disposal of the competent authorities for a

period of at least ten years after the date on which such apparatus was last manufactured.

7. If neither the manufacturer nor his authorised representative is established within

the Community, the obligation to hold the EC declaration of conformity and the

technical documentation at the disposal of the competent authorities shall lie with the

person who places the apparatus on the Community market.

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

are manufactured in accordance with the technical documentation referred to in point

3 and with the provisions of these regulations that apply to them.

9. The technical documentation and the EC declaration of conformity shall be

drawn up in accordance with the provisions set out in Schedule IV.

B

Schedule III

(Regulation 8)

Alternative conformity assessment procedure

1. This procedure consists of applying Schedule II, hereto, completed as follows>

2. The manufacturer or his authorised representative in the Community shall

present the technical documentation to a notified body referred to in Article 12 of the

Directive and request the notified body for an assessment thereof. The manufacturer

or his authorised representative in the Community shall specify to the notified body

which aspects of the essential requirements must be assessed by the notified body.

3. The notified body shall review the technical documentation and assess whether

the technical documentation properly demonstrates that the requirements of these

regulations that it is to assess have been met. If the compliance of the apparatus is

confirmed, the notified body shall issue a statement to the manufacturer or his authorised

representative in the Community confirming the compliance of the apparatus. That

statement shall be limited to those aspects of the essential requirements which have

been assessed by the notified body.

4. The manufacturer shall add the statement of the notified body to the technical

documentation.

Schedule IV

Technical documentation and EC declaration of conformity

1. Technical documentation

The technical documentation must enable the conformity of the apparatus with

the essential requirements to be assessed. It must cover the design and manufacture of

the apparatus, in particular>

- a general description of the apparatus<

- evidence of compliance with the harmonised standards, if any, applied in

full or in part<

- where the manufacturer has not applied harmonised standards, or has applied

them only in part, a description and explanation of the steps taken to meet the

essential requirements of these regulations, including a description of the

electromagnetic compatibility assessment set out in Schedule II, point 1, hereto,

results of design calculations made, examinations carried out, test reports, etc.<

- a statement from the notified body, when the procedure referred to in

Schedule III, hereto, has been followed.

2. EC declaration of conformity

The EC declaration of conformity must contain, at least, the following>

- a reference to these regulations,

- an identification of the apparatus to which it refers, as set out in sub-

regulation 10(1) hereto,

- the name and address of the manufacturer and, where applicable, the name

and address of his authorised representative in the Community,

- a dated reference to the specifications under which conformity is declared

to ensure the conformity of the apparatus with the provisions of these regulations,

- the date of that declaration,

- the identity and signature of the person empowered to bind the manufacturer

or his authorised representative.

B

Schedule V

(Regulation 9)

CE marking

The ‘CE’ marking shall consist in the initials ‘CE’ taking the following form>

The CE marking must have a height of at least 5 mm. If the CE marking is

reduced or enlarged the proportions given in the above graduated drawing must be

respected.The CE marking must be affixed to the apparatus or to its data plate. Where

this is not possible or not warranted on account of the nature of the apparatus, it must

be affixed to the packaging, if any, and to the accompanying documents.Where the

apparatus is the subject of other regulations covering other aspects and which also

provide for the CE marking, the latter shall indicate that the apparatus also conforms

with those other regulations. However, where one or more of those regulations allow

the manufacturer, during a transitional period, to choose which arrangements to apply,

the CE marking shall indicate conformity only with the regulations applied by the

manufacturer. In that case, particulars of the regulations applied or Directives which

they transpose (as published in the Official Journal of the European Union), must be

given in the documents, notices or instructions required by the regulations and

accompanying such apparatus.

Schedule VI

(Regulation 12)

Criteria for the assessment of the bodies to be notified

1. The bodies notified by the Member States shall fulfill the following minimum

conditions>

(a)

availability of personnel and of the necessary means and equipment<

(b) technical competence and professional integrity of personnel<

(c) independence in preparing the reports and performing the verification

function provided for in these regulations<

(d) independence of staff and technical personnel in relation to all interested

parties, groups or persons directly or indirectly concerned with the equipment in

question<

(e) maintenance of professional secrecy by personnel<

(f) possession of civil liability insurance unless such liability is covered

by the Member State under national law.

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