Legislator Case Law & Legislation
ln_2016_257 MT

Electromagnetic Fields) Regulations, 2016

15 Articles / Provisions · Malta
Open official source Machine-readable Markdown (.md)

Table of Provisions (15)

Statutory Text (15 Articles)

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

L.N. 257 of 2016

OCCUPATIONAL HEALTH AND SAFETY AUTHORITY ACT

(CAP. 424)

Work Place (Minimum Health and Safety Requirements for the

Protection of Workers from Risks resulting from Exposure to

Electromagnetic Fields) Regulations, 2016

IN exercise of the powers conferred by article 12 of the

Occupational Health and Safety Authority Act, the Minister for

Social Dialogue, Consumer Affairs and Civil Liberties, after

consultation with the Occupational Health and Safety Authority, has

made the following regulations

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

The title of these regulations is the Work Place Citation, scope,

(Minimum Health and Safety Requirements for the Protection of applicability

commencement.

Workers from Risks resulting from Exposure to Electromagnetic

Fields) Regulations, 2016.

(2) The scope of these regulations is to lay down minimum

requirements for the protection of workers from risks to their health

and safety arising, or likely to arise, from exposure to electromagnetic

fields during their work. These regulations shall implement Directive

2013/35/EC of the European Parliament and of the Council. These

regulations cover all known direct biophysical effects and indirect

effects caused by electromagnetic fields.

(3) The exposure limit values (ELVs) laid down in these

regulations cover only scientifically well-established links between

short-term direct biophysical effects and exposure to electromagnetic

fields.

(4)

These regulations do not cover suggested long-term

effects.

(5) These regulations do not cover the risks resulting from

contact with live conductors.

(6) These regulations shall apply fully to all workers without

prejudice to more stringent and, or more specific provisions contained

in any other law or regulation on the protection of workers from the

risks related to exposure to electromagnetic fields.

(7) These regulations shall come into force on the 1st July

2016.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

PHYSICAL QUANTITIES REGARDING THE EXPOSURE

TO ELECTROMAGNETIC FIELDS

The following physical quantities are used to describe the exposure to

electromagnetic fields

Electric field strength (E) is a vector quantity that corresponds to the force

exerted on a charged particle regardless of its motion in space. It is expressed in volt

per metre (Vm -1 ). A distinction has to be made between the environmental electric

field and the electric field present in the body (in situ) as a result of exposure

to the environmental electric field.

Limb current (I L ) is the current in the limbs of a person exposed to

electromagnetic fields in the frequency range from 10 MHz to 110 MHz as a result

of contact with an object in an electromagnetic field or the flow of capacitive

currents induced in the exposed body. It is expressed in ampere (A).

Contact current (I C ) is a current that appears when a person comes into

contact with an object in an electromagnetic field. It is expressed in ampere (A). A

steady state contact current occurs when a person is in continuous contact with an

object in an electromagnetic field. In the process of making such contact, a spark

discharge may occur with associated transient currents.

Electric charge (Q) is an appropriate quantity used for spark discharge and is

expressed in coulomb (C).

Magnetic field strength (H) is a vector quantity that, together with the

magnetic flux density, specifies a magnetic field at any point in space. It is

expressed in ampere per metre (Am -1 ).

Magnetic flux density (B) is a vector quantity resulting in a force that acts on

moving charges, expressed in tesla (T). In free space and in biological materials,

magnetic flux density and magnetic field strength can be interchanged using the

magnetic field strength of H = 1 Am -1 equivalence to magnetic flux density of B

= 4π 10 -7 T (approximately 1.25 microtesla).

Power density (S) is an appropriate quantity used for very high frequencies,

where the depth of penetration in the body is low. It is the radiant power incident

perpendicular to a surface, divided by the area of the surface. It is expressed in

watt per square metre (Wm -2 ).

Specific energy absorption (SA) is an energy absorbed per unit mass of

biological tissue, expressed in joule per kilogram (Jkg -1 ). In these regulations, it is

used for establishing limits for effects from pulsed microwave radiation.

Specific energy absorption rate (SAR), averaged over the whole body or over

parts of the body, is the rate at which energy is absorbed per unit mass of body

tissue and is expressed in watt per kilogram (Wkg -1 ). Whole-body SAR is a

widely accepted quantity for relating adverse thermal effects to radio frequency

(RF) exposure. Besides the whole-body average SAR, local SAR values are

necessary to evaluate and limit excessive energy deposition in small parts of the

body resulting from special exposure conditions. Examples of such conditions

include: an individual exposed to RF in the low MHz range (e.g. from dielectric

heaters) and individuals exposed in the near field of an antenna.

Of these quantities, magnetic flux density (B), contact current (I C ), limb

current (I L ), electric field strength (E), magnetic field strength (H), and power

density (S) can be measured directly.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

In these regulations, unless the context otherwise requires -

"Act" means the Occupational Health and Safety Authority Act;

"action levels (ALs)" means operational levels established for

the purpose of simplifying the process of demonstrating the

compliance with relevant ELVs or, where appropriate, to take relevant

protection or prevention measures specified in these regulations.

The Action Level terminology used in Schedule II is as follows

(a)

for electric fields, "low ALs" and "high ALs"

means levels which relate to the specific protection or

prevention measures specified in these regulations; and

(b)

for magnetic fields, "low ALs" means levels which

relate to the sensory effects ELVs and "high ALs" to the health

effects ELVs;

"Authority" means the Occupational Health and Safety

Authority;

"Commission" means the Commission of the European Union;

"direct biophysical effects" means effects in the human body

directly caused by its presence in an electromagnetic field, including

(a)

thermal effects, such as tissue heating through

energy absorption from electromagnetic fields in the tissue;

(b)

non-thermal effects, such as the stimulation of

muscles, nerves or sensory organs. These effects might have a

detrimental effect on the mental and physical health of exposed

workers. Moreover, the stimulation of sensory organs may lead

to transient symptoms, such as vertigo or phosphenes. These

effects might create temporary annoyance or affect cognition or

other brain or muscle functions, and may thereby affect the

ability of a worker to work safely (i.e. safety risks); and

(c)

limb currents;

"electromagnetic fields" means static electric, static magnetic

and time-varying electric, magnetic and electromagnetic fields with

frequencies up to 300 GHz;

"exposure limit values (ELVs)" means values established on the

basis of biophysical and biological considerations, in particular on the

basis of scientifically well-established short-term and acute direct

effects, i.e. thermal effects and electrical stimulation of tissues;

"health effects ELVs" means those ELVs above which workers

might be subject to adverse health effects, such as thermal heating or

stimulation of nerve and muscle tissue;

"indirect effects" means effects, caused by the presence of an

object in an electromagnetic field, which may become the cause of a

safety or health hazard, such as

(a)

interference with medical electronic equipment and

devices, including cardiac pacemakers and other implants or

medical devices worn on the body;

(b)

the projectile risk from ferromagnetic objects in

static magnetic fields;

(c)

the

initiation

of

electro-explosive

devices

(detonators);

(d)

fires and explosions resulting from the ignition of

flammable materials by sparks caused by induced fields, contact

currents or spark discharges; and

(e)

contact currents;

"sensory effects ELVs" means those ELVs above which workers

might be subject to transient disturbed sensory perceptions and minor

changes in brain functions;

"Union" means the European Union.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

NON-THERMAL EFFECTS

EXPOSURE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY

RANGE FROM 0 Hz TO 10 MHz

PART A.

EXPOSURE LIMIT VALUES (ELVs)

ELVs below 1 Hz (Table A1) are limits for static magnetic field which is

not affected by the tissue of the body.

ELVs for frequencies from 1 Hz to 10 MHz (Table A2) are limits for electric

fields induced in the body from exposure to time-varying electric and magnetic

fields.

ELVs for external magnetic flux density from 0 to 1 Hz

The sensory effects ELV is the ELV for normal working conditions (Table

A1) and is related to vertigo and other physiological effects related to disturbance

of the human balance organ resulting mainly from moving in a static magnetic

field.

The health effects ELV for controlled working conditions (Table A1) is

applicable on a temporary basis during the shift when justified by the practice or

process, provided that preventive measures, such as controlling movements and

providing information to workers, have been adopted.

Table A1

ELVs for external magnetic flux density (B 0 ) from 0 to 1 Hz

Sensory effects ELVs

Normal working conditions

2 T

Localised limbs exposure

8 T

Health effects ELVs

Controlled working conditions

8 T

Health effects ELVs for internal electric field strength from 1 Hz to 10 MHz

Health effects ELVs (Table A2) are related to electric stimulation of all

peripheral and central nervous system tissues in the body, including the head.

Table A2

Health effects ELVs for internal electric field strength

from 1 Hz to 10 MHz

Frequency range

Health effects ELVs

1.1 Vm -1 (peak)

1 Hz ≤ f < 3 kHz

3.8 × 10 -4 f Vm -1 (peak)

3 kHz ≤ f ≤ 10 MHz

Note A2-1: f is the frequency expressed in hertz (Hz).

Note A2-2: The health effects ELVs for internal electric field are spatial peak

values in the entire body of the exposed subject.

Note A2-3: The ELVs are peak values in time which are equal to the Root-

Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of

non-sinusoidal fields, exposure evaluation carried out in accordance with

regulation 4 shall be based on the weighted peak method (filtering in time

domain), explained in the practical guides made available by the Commission but

other scientifically proven and validated exposure evaluation procedures can be

applied, provided that they lead to approximately equivalent and comparable

results.

Sensory effects ELVs for internal electric field strength from 1 Hz to 400 Hz

The sensory effects ELVs (Table A3) are related to electric field effects on the

central nervous system in the head, i.e. retinal phosphenes and minor transient

changes in some brain functions.

Table A3

Sensory effects ELVs for internal electric field strength

from 1 to 400 Hz

Frequency range

Sensory effects ELVs

0.7/f Vm -1 (peak)

1 ≤ f < 10 Hz

0.07 Vm -1 (peak)

10 ≤ f < 25 Hz

0.0028 f Vm -1 (peak)

25 ≤ f ≤ 400 Hz

Note A3-1: f is the frequency expressed in hertz (Hz).

Note A3-2: The sensory effects ELVs for internal electric field are spatial

peak values in the head of the exposed subject.

Note A3-3: The ELVs are peak values in time which are equal to the Root-

Mean-Square (RMS) values multiplied by √2 for sinusoidal fields. In the case of

non-sinusoidal fields, the exposure evaluation carried out in accordance with

regulation 4 shall be based on the weighted peak method (filtering in time

domain), explained in the practical guides made available by the Commission, but

other scientifically proven and validated exposure evaluation procedures can be

applied, provided that they lead to approximately equivalent and comparable

results.

PART B. ACTION LEVELS (ALs)

The following physical quantities and values are used to specify the action

levels (ALs), the magnitude of which are established to ensure by simplified

assessment the compliance with relevant ELVs or at which relevant protection or

prevention measures specified in regulation 5 must be taken

-

Low ALs(E) and high ALs(E) for electric field strength E of

time varying electric fields as specified in Table B1;

-

Low ALs(B) and high ALs(B) for magnetic flux density B of

time varying magnetic fields as specified in Table B2;

-

ALs(I C ) for contact current as specified in Table B3;

-

ALs(B 0 ) for magnetic flux density of static magnetic fields as

specified in Table B4.

ALs correspond to calculated or measured electric and magnetic field values

at the workplace in the absence of the worker.

Action levels (ALs) for exposure to electric fields

Low ALs (Table B1) for external electric field are based on limiting the internal

electric field below the ELVs (Tables A2 and A3) and limiting spark discharges in

the working environment.

Below high ALs, the internal electric field does not exceed the ELVs (Tables

A2 and A3) and annoying spark discharges are prevented, provided that the

protection measures referred to in regulation 5(6) are taken.

Table B1

ALs for exposure to electric fields from 1 Hz to 10 MHz

Electric field strength

Electric field strength

Low ALs (E)[Vm -1 ]

High ALs (E) [Vm -1 ]

Frequency range

(RMS)

(RMS)

2.0 × 10 4

2.0 × 10 4

1 ≤ f < 25 Hz

5.0 × 10 5 /f

2.0 × 10 4

25 ≤ f < 50 Hz

5.0 × 10 5 /f

1.0 × 10 6 /f

50 Hz ≤ f < 1.64 kHz

5.0 × 10 5 /f

6.1 × 10 2

1.64 ≤ f < 3 kHz

1.7 × 10 2

6.1 × 10 2

3 kHz ≤ f ≤ 10 MHz

Note B1-1: f is the frequency expressed in hertz (Hz).

Note B1-2: The low ALs (E) and high ALs (E) are the Root-Mean-Square

(RMS) values of the electric field strength which are equal to the peak values

divided by √2 for sinusoidal fields. In the case of non-sinusoidal fields, the exposure

evaluation carried out in accordance with regulation 4 shall be based on the

weighted peak method (filtering in time domain), explained in the practical guides

made available by the Commission, but other scientifically proven and validated

exposure evaluation procedures can be applied, provided that they lead to

approximately equivalent and comparable results.

Note B1-3: ALs represent maximum calculated or measured values at the

workers’ body position. This results in a conservative exposure assessment and

automatic compliance with ELVs in all non-uniform exposure conditions. In

order to simplify the assessment of compliance with ELVs, carried out in

accordance with regulation 4, in specific non-uniform conditions, criteria for the

spatial averaging of measured fields based on established dosimetry laid down in

the practical guides made available by the Commission. In the case of a very

localised source within a distance of a few centimetres from the body, the induced

electric field shall be determined dosimetrically, case by case.

Action levels (ALs) for exposure to magnetic fields

Low ALs (Table B2) are, for frequencies below 400 Hz, derived from the

sensory effects ELVs (Table A3) and, for frequencies above 400 Hz, from the

health effects ELVs for internal electric field (Table A2).

High ALs (Table B2) are derived from the health effects ELVs for internal

electric field related to electric stimulation of peripheral and autonomous nerve

tissues in head and trunk (Table A2). Compliance with the high ALs ensures that

health effects ELVs are not exceeded, but the effects related to retinal phosphenes

and minor transient changes in brain activity are possible, if the exposure of the

head exceeds the low ALs for exposures up to 400 Hz. In such a case, regulation

5(6) applies.

ALs for exposure of limbs are derived from the health effects ELVs for

internal electric field related to electric stimulation of the tissues in limbs by

taking into account that the magnetic field is coupled more weakly to the limbs

than to the whole body.

Table B2

ALs for exposure to magnetic fields from 1 Hz to 10 MHz

Magnetic flux

density ALs for

Magnetic flux

Magnetic flux

exposure of

density Low

density High

Frequency range

limbs to a

ALs(B)[μT]

ALs(B) [μT]

localised

(RMS)

(RMS)

magnetic field

[μT] (RMS)

2.0 × 10 5 /f 2

3.0 × 10 5 /f

9.0 × 10 5 /f

1 ≤ f < 8 Hz

2.5 × 10 4 /f

3.0 × 10 5 /f

9.0 × 10 5 /f

8 ≤ f < 25 Hz

1.0 × 10 3

3.0 × 10 5 /f

9.0 × 10 5 /f

25 ≤ f < 300 Hz

3.0 × 10 5 /f

3.0 × 10 5 /f

9.0 × 10 5 /f

300 Hz ≤ f < 3 kHz

1.0 × 10 2

1.0 × 10 2

3.0 × 10 2

3 kHz ≤ f ≤ 10 MHz

Note B2-1: f is the frequency expressed in hertz (Hz).

Note B2-2: The low ALs and the high ALs are the Root-Mean-Square (RMS)

values which are equal to the peak values divided by √2 for sinusoidal fields. In the

case of non-sinusoidal fields the exposure evaluation carried out in accordance with

regulation 4 shall be based on the weighted peak method (filtering in time

domain), explained in the practical guides made available by the Commission, but

other scientifically proven and validated exposure evaluation procedures can be

applied, provided that they lead to approximately equivalent and comparable

results.

Note B2-3: ALs for exposure to magnetic fields represent maximum values at

the workers’ body position. This results in a conservative exposure assessment and

automatic compliance with ELVs in all non-uniform exposure conditions. In order

to simplify the assessment of compliance with ELVs, carried out in accordance

with regulation 4, in specific non-uniform conditions, criteria for the spatial

averaging of measured fields based on established dosimetry laid down in the

practical guides made available by the Commission. In the case of a very localised

source within a distance of a few centimetres from the body, the induced electric

field shall be determined dosimetrically, case by case.

Table B3

ALs for contact current I C

ALs (I C ) steady state contact current

Frequency

[mA] (RMS)

up to 2.5 kHz

1.0

2.5 ≤ f < 100 kHz

0.4 f

100 ≤ f ≤ 10 000 kHz

Note B3-1: f is the frequency expressed in kilohertz (kHz).

Action levels (ALs) for magnetic flux density of static magnetic fields

Table B4

ALs for magnetic flux density of static magnetic fields

Hazards

ALs(B 0 )

Interference with active implanted

devices, e.g. cardiac pacemakers

0.5 mT

Attraction and projectile risk in the

fringe field of high field strength

sources (> 100 mT)

3 mT

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

Physical quantities regarding exposure to Exposure limit

electromagnetic fields are indicated in Schedule I. Health effects values

action levels.

ELVs, sensory effects ELVs and ALs are set out in Schedules II and

III.

(2) Employers shall ensure that the exposure of workers to

electromagnetic fields is limited to the health effects ELVs and

sensory effects ELVs set out in Schedule II, for non-thermal effects,

and in Schedule III, for thermal effects. Compliance with health

effects ELVs and sensory effects ELVs must be established by the use

of relevant exposure assessment procedures referred to in regulation

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

THERMAL EFFECTS

EXPOSURE LIMIT VALUES AND ACTION LEVELS IN THE FREQUENCY

RANGE FROM 100 kHz TO 300 GHz

PART A.

EXPOSURE LIMIT VALUES (ELVs)

Health effects ELVs for frequencies from 100 kHz to 6 GHz (Table A1) are

limits for energy and power absorbed per unit mass of body tissue generated from

exposure to electric and magnetic fields.

Sensory effects ELVs for frequencies from 0.3 to 6 GHz (Table A2) are limits

on absorbed energy in a small mass of tissue in the head from exposure to

electromagnetic fields.

Health effects ELVs for frequencies above 6 GHz (Table A3) are limits for

power density of an electromagnetic wave incident on the body surface.

Table A1

Health effects ELVs for exposure to electromagnetic fields

from 100 kHz to 6 GHz

SAR values averaged over any six-

Health effects ELVs

minute period

ELVs related to whole body heat stress

0.4 Wkg -1

expressed as averaged SAR in the body

ELVs related to localised heat stress

in head and trunk expressed as

10 Wkg -1

localised SAR in the body

ELVs related to localised heat stress in

the limbs expressed as localised SAR in

20 Wkg -1

the limbs

Note A1-1: Localised SAR averaging mass is any 10 g of contiguous tissue;

the maximum SAR so obtained should be the value used for estimating exposure.

This 10 g of tissue is intended to be a mass of contiguous tissue with roughly

homogeneous electrical properties. In specifying a contiguous mass of tissue, it is

recognised that this concept may be used in computational dosimetry but may

present difficulties for direct physical measurements. A simple geometry, such as

cubic or spheric tissue mass, can be used.

Sensory effects ELVs from 0.3 GHz to 6 GHz

This sensory effects ELVs (Table A2) is related to avoiding auditory effects

caused by exposures of the head to pulsed microwave radiation.

Table A2

Sensory effects ELVs for exposure to electromagnetic fields

from 0.3 to 6 GHz

Localised specific energy absorption

Frequency range

(SA)

10 mJkg -1

0.3 ≤ f ≤ 6 GHz

Note A2-1: Localised SA averaging mass is 10 g of tissue.

Table A3

Health effects ELVs for exposure to electromagnetic fields

from 6 to 300 GHz

Health effects ELVs related to power

Frequency range

density

50 Wm -2

6 ≤ f ≤ 300 GHz

Note A3-1: The power density shall be averaged over any 20 cm 2 of exposed

area. Spatial maximum power densities averaged over 1 cm 2 should not exceed

20 times the value of 50Wm -2 . Power densities from 6 to 10 GHz are to be

averaged over any six-minute period. Above 10 GHz, the power density shall

be averaged over any 68/f 1.05 -minute period (where f is the frequency in GHz) to

compensate for progressively shorter penetration depth, as the frequency

increases.

PART B.

ACTION LEVELS (ALs)

The following physical quantities and values are used to specify the action

levels (ALs), the magnitude of which are established to ensure by simplified

assessment the compliance with the relevant ELVs or at which relevant protection

or prevention measures specified in regulation 5 must be taken

-

ALs(E) for electric field strength E of time varying electric

field, as specified in Table B1;

-

ALs(B) for magnetic flux density B of time varying magnetic

field, as specified in Table B1;

-

ALs(S) for power density of electromagnetic waves, as

specified in Table B1;

-

ALs(I C ) for contact current, as specified in Table B2;

-

ALs(I L ) for limb current, as specified in Table B2.

ALs correspond to calculated or measured field values at the workplace in

the absence of the worker, as maximum value at the position of the body or

specified part of the body.

Action levels (ALs) for exposure to electric and magnetic fields

ALs(E) and ALs(B) are derived from the SAR or power density ELVs

(Tables A1 and A3) based on the thresholds related to internal thermal effects

caused by exposure to (external) electric and magnetic fields.

Table B1

ALs for exposure to electric and magnetic fields

from 100 kHz to 300 GHz

Electric field

Magnetic flux

Power density

Frequency range

strength ALs(E)

density ALs(B)

ALs(S)

[Vm -1 ] (RMS)

[Wm -2 ]

[μT] (RMS)

6.1 × 10 2

2.0 × 10 6 /f

100 kHz ≤ f < 1 MHz

-

6.1 × 10 8 /f

2.0 × 10 6 /f

1≤ f < 10 MHz

-

10 ≤ f < 400 MHz

0.2

-

3 × 10 -3 f ½

1. 0 × 10 -5 f ½

400 MHz ≤ f < 2 GHz

-

1.4 × 10 2

4.5 × 10 -1

2 ≤ f < 6 GHz

-

1.4 × 10 2

4.5 × 10 -1

6 ≤ f ≤ 300 GHz

Note B1-1: f is the frequency expressed in hertz (Hz).

Note B1-2: [ALs(E)] 2 and [ALs(B)] 2 are to be averaged over a six-minute

period. For RF pulses, the peak power density averaged over the pulse width shall

not exceed 1000 times the respective ALs(S) value. For multi-frequency fields,

the analysis shall be based on summation, as explained in the practical guides

made available by the Commission.

Note B1-3: ALs(E) and ALs(B) represent maximum calculated or measured

values at the workers’ body position. This results in a conservative exposure

assessment and automatic compliance with ELVs in all non-uniform exposure

conditions. In order to simplify the assessment of compliance with ELVs,

carried out in accordance with regulation 4, in specific non-uniform conditions,

criteria for the spatial averaging of measured fields based on established

dosimetry laid down in the practical guides made available by the Commission. In

the case of a very localised source within a distance of a few centimetres from the

body, compliance with ELVs shall be determined dosimetrically, case by case.

Note B1-4: The power density shall be averaged over any 20 cm 2 of exposed

area. Spatial maximum power densities averaged over 1 cm 2 should not exceed

20 times the value of 50Wm -2 . Power densities from 6 to 10 GHz are to be

averaged over any six-minute period. Above 10 GHz, the power density shall

be averaged over any 68/f 1.05 -minute period (where f is the frequency in GHz) to

compensate for progressively shorter penetration depth as the frequency increases.

Table B2

ALs for steady state contact currents and induced limb currents

Steady state contact

Induced limb current in

Frequency range

current, ALs(I C ) [mA]

any limb, ALs(I L ) [mA]

(RMS)

(RMS)

100 kHz ≤ f < 10 MHz

-

10 ≤ f ≤ 110 MHz

Note B2-1: [ALs(I L )] 2 is to be averaged over a six-minute period.

€2.25

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

Where the exposure of workers to electromagnetic fields exceeds

the ELVs, the employer shall take immediate action in accordance

with regulation 5(8).

(3) For the purpose of these regulations, where it is

demonstrated that the relevant ALs set out in Schedules II and III are

not exceeded, the employer shall be deemed to be in compliance with

the health effects ELVs and sensory effects ELVs. Where the

exposure exceeds the ALs, the employer shall act in accordance with

regulation 5(2), unless the assessment carried out in accordance with

regulations 4(1), (2) and (3) demonstrates that the relevant ELVs are

not exceeded and that safety risks can be excluded.

Notwithstanding the provisions of sub-regulation (1), exposure

(a)

low ALs for electric fields (Schedule II, Table B1),

where justified by the practice or process, provided that either

the sensory effects ELVs (Schedule II, Table A3) are not

exceeded; or

(i) the health effects ELVs (Schedule II, Table

A2) are not exceeded;

(ii) the excessive spark discharges and contact

currents (Schedule II, Table B3) are prevented by specific

protection measures as set out in regulation 5(6); and

(iii) information on the situations referred to in

regulation 6(f) has been given to workers;

(b)

low ALs for magnetic fields (Schedule II, Table

B2) where justified by the practice or process, including in the

head and torso, during the shift, provided that either the sensory

effects ELVs (Schedule II, Table A3) are not exceeded; or

(i) the sensory effects ELVs are exceeded only

temporarily;

(ii) the health effects ELVs (Schedule II, Table

A2) are not exceeded;

(iii) action is taken, in accordance with regulation

5(9), where there are transient symptoms under paragraph

(a) of that regulation; and

(iv) information on the situations referred to in

regulation 6(f) has been given to workers.

(4) Notwithstanding the provisions of sub-regulations (2) and

(3), exposure may exceed

(a)

the sensory effects ELVs (Schedule II, Table A1)

during the shift, where justified by the practice or process,

provided that

(i)

they are exceeded only temporarily;

(ii) the health effects ELVs (Schedule II, Table

A1) are not exceeded;

(iii) specific protection measures have been taken

in accordance with regulation 5(7);

(iv) action is taken in accordance with regulation

5(9), where there are transient symptoms under paragraph

(b) of that regulation; and

(v) information on the situations referred to in

regulation 6(f) has been given to workers;

(b)

the sensory effects ELVs (Schedule II, Table A3

and Schedule III, Table A2) during the shift, where justified by

the practice or process, provided that

(i)

they are exceeded only temporarily;

(ii) the health effects ELVs (Schedule II, Table

A2 and Schedule III, Table A1 and Table A3) are not

exceeded;

(iii) action is taken in accordance with regulation

5(9), where there are transient symptoms under paragraph

(a) of that regulation; and

(iv) information on the situations referred to in

regulation 6(f) has been given to workers.

The employer shall assess all risks for workers Assessment of

arising from electromagnetic fields at the workplace and, if necessary, risks

determination of

measure or calculate the levels of electromagnetic fields to which exposure.

workers are exposed.

Without prejudice to regulation 12 of the General S.L. 424.18

Provisions for Health and Safety at Work Places Regulations and

regulation 6 of these regulations, that assessment can be made public

on request in accordance with relevant Union and national laws and

practice. In particular, in the case of processing the personal data of

employees in the course of such an assessment, any publication shall

comply with the Data Protection Act on the protection of individuals Cap. 440.

with regard to the processing of personal data and on the free

movement of such data. Unless there is an overriding public interest

in disclosure, public authorities that are in possession of a copy of the

assessment may refuse a request for access to it or a request to make it

public, where disclosure would undermine the protection of

commercial interests of the employer, including those relating to

intellectual property. Employers may refuse to disclose or make

public the assessment under the same conditions in accordance with

the relevant Union and national laws and practice.

(2) For the purpose of the assessment provided for in sub-

regulation (1) the employer shall identify and assess electromagnetic

fields at the workplace, taking into account the relevant practical

guides made available by the Commission and other relevant

standards

or

guidelines,

including

exposure

databases.

Notwithstanding the employer’s obligations under this regulation, the

employer shall also be entitled, where relevant, to take into account

the emission levels and other appropriate safety-related data

provided, by the manufacturer or distributor, for the equipment, in

accordance with relevant Union law, including an assessment of risks,

if applicable to the exposure conditions at the workplace or place of

installation.

(3) If compliance with the ELVs cannot be reliably determined

on the basis of readily accessible information, the assessment of the

exposure shall be carried out on the basis of measurements or

calculations. In such a case, the assessment shall take into account

uncertainties concerning the measurements or calculations, such as

numerical errors, source modelling, phantom geometry and the

electrical properties of tissues and materials, determined in

accordance with relevant good practice.

(4) The assessment, measurement and calculations referred to

in sub-regulations (1), ( 2) and ( 3) shall be planned and carried out

by competent services or persons at suitable intervals, taking into

account the guidance given under these regulations and taking

particular account of regulations 9 and 13 of the General Provisions

for Health and Safety at Work Places Regulations. The data obtained

from the assessment, measurement or calculation of the level of

exposure shall be preserved in a suitable traceable form so as to

permit consultation at a later stage, in accordance with national law

and practice.

(5) When carrying out the risk assessment, the employer shall

give particular attention to the following

(a)

the health effects ELVs, the sensory effects ELVs

and the ALs referred to in regulation 3 and Schedules II and

III;

(b)

the frequency, the level, duration and type of

exposure, including the distribution over the worker’s body and

over the volume of the workplace;

(c)

any direct biophysical effects;

(d)

any effects on the health and safety of workers at

particular risk, in particular workers who wear active or passive

implanted medical devices, such as cardiac pacemakers,

workers with medical devices worn on the body, such as insulin

pumps, and pregnant workers;

(e)

any indirect effects;

(f)

the existence of replacement equipment designed

to reduce the level of exposure to electromagnetic fields;

(g)

appropriate information obtained from the health

surveillance referred to in regulation 8;

(h)

information provided by the manufacturer of

equipment;

(i)

other

relevant

health

and

safety

related

information;

(j)

multiple sources of exposure;

(k)

simultaneous exposure to multiple frequency

fields.

(6) In workplaces open to the public it is not necessary for the

exposure assessment to be carried out if an evaluation has already

been undertaken in accordance with the provisions on the limitation

of exposure of the general public to electromagnetic fields, if the

restrictions specified in those provisions are respected for workers

and if the health and safety risks are excluded. Where equipment

intended for the public use is used as intended and complies with

Union law on products that establish stricter safety levels than those

provided for by these regulations, and no other equipment is used,

these conditions are deemed to be met.

(7) The employer shall be in possession of an assessment of

the risks in accordance with regulation 10 of the General Provisions S.L. 424.18

for Health and Safety at Work Places Regulations, and shall identify

which measures must be taken in accordance with regulation 5 of

these regulations. The risk assessment may include the reasons why

the employer considers that the nature and the extent of the risks

related to electromagnetic fields make a further detailed risk

assessment unnecessary. The risk assessment shall be updated on a

regular basis, particularly if there have been significant changes

which could render it out of date, or if the results of the health

surveillance referred to in regulation 8 show this to be necessary.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

Taking account of technical progress and the

availability of measures to control the production of electromagnetic

fields at the source, the employer shall take the necessary actions to

ensure that risks arising from electromagnetic fields at the workplace

are eliminated or reduced to a minimum.

(2) On the basis of the risk assessment referred to in regulation

4, once the relevant ALs, referred to in regulation 3 and in Schedules

II and III, are exceeded and unless the assessment carried out in

accordance with regulation 4(1), (2) and (3) demonstrates that the

relevant ELVs are not exceeded and that safety risks can be excluded,

the employer shall devise and implement an action plan that shall

include technical and, or organisational measures to prevent exposure

exceeding the health effects ELVs and sensory effects ELVs, taking

into account, in particular

(a)

other working methods that entail less exposure to

electromagnetic fields;

(b)

the choice of equipment emitting less intense

electromagnetic fields, taking account of the work to be done;

(c)

technical measures to reduce the emission of

electromagnetic fields, including, where necessary, the use of

inter- locks, shielding or similar health protection mechanisms;

(d)

appropriate delimitation and access measures, such

as signals, labels, floor markings, barriers, in order to limit or

control access;

(e)

in the case of exposure to electric fields, measures

and procedures to manage spark discharges and contact currents

through technical means and through the training of workers;

(f)

appropriate maintenance programmes for work

equipment, workplaces and workstation systems;

(g)

the

design

and

layout

of

workplaces

and

workstations;

(h)

limitations of the duration and intensity of the

exposure;

(i)

the availability of adequate personal protection

equipment.

(3) On the basis of the risk assessment referred to in regulation

4, the employer shall devise and implement an action plan that

shall include technical and, or organisational measures to prevent any

risks to workers at particular risk, and any risks due to indirect

effects, referred to in regulation 4.

(4) In addition to providing the information set out in

regulation 6, the employer shall adapt the measures referred to in this

regulation to the requirements of workers at particular risk and, where

applicable, to individual risks assessments, in particular in respect of

workers who have declared the use of active or passive implanted

medical devices, such as cardiac pacemakers, or the use of medical

devices worn on the body, such as insulin pumps, or in respect of

pregnant workers who have informed their employer of their

condition.

(5) On the basis of the risk assessment referred to in regulation

4, workplaces where workers are likely to be exposed to

electromagnetic fields that exceed the ALs shall be indicated by

appropriate signs in accordance with Schedules II and III and with the

Work Place (Provision of Health and, or Safety Signs) Regulations. S.L. 424.16

The areas in question shall be identified and access to them limited,

as appropriate. Where access to these areas is suitably restricted for

other reasons and workers are informed of the risks arising from

electromagnetic fields, signs and access restrictions specific to

electromagnetic fields shall not be required.

(6) Where regulation 3(3)(a) applies, specific protection

measures shall be taken, such as the training of workers in accordance

with regulation 6 and the use of technical means and personal

protection, for example the grounding of work objects, the bonding of

workers with work objects (equipotential bonding) and, where

appropriate and in accordance with Article 4(1)(a) of Council

Directive 89/656/EEC of 30 November 1989 on the minimum health

and safety requirements for the use by workers of personal protective

equipment at the workplace, the use of insulating shoes, gloves and

protective clothing.

(7) Where regulation 3(4)(a) applies, specific protection

measures, such as controlling movements, shall be taken.

(8) Workers shall not be exposed above the health effects

ELVs and sensory effects ELVs, unless the conditions under either

regulation 9(1)(a) or (c) or regulation 3(3) or (4) are fulfilled. If,

despite the measures taken by the employer, the health effects ELVs

and sensory effects ELVs are exceeded, the employer shall take

immediate action to reduce exposure below these ELVs. The

employer shall identify and record the reasons why the health effects

ELVs and sensory effects ELVs have been exceeded, and shall amend

the protection and prevention measures accordingly in order to

prevent them being exceeded again. The amended protection and

prevention measures shall be preserved in a suitable traceable form so

as to permit consultation at a later stage, in accordance with national

law and practice.

(9) Where the provisions of regulation 3(3) and (4) apply and

where the worker reports transient symptoms, the employer shall, if

necessary, update the risk assessment and the prevention measures.

Transient symptoms may include

(a)

sensory perceptions and effects in the functioning

of the central nervous system in the head evoked by time

varying magnetic fields; and

(b)

static magnetic field effects, such as vertigo and

nausea.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

Without prejudice to the provisions of regulations 12 and

14 of the General Provisions for Health and Safety at Work Places

Regulations, the employer shall ensure that workers who are likely to

be exposed to risks from electromagnetic fields at work and, or their

representatives receive any necessary information and training

relating to the outcome of the risk assessment provided for in

regulation 4 of these regulations, concerning in particular

(a)

measures taken in application of these regulations;

(b)

the values and concepts of the ELVs and ALs, the

associated possible risks and the preventive measures taken;

(c)

the possible indirect effects of exposure;

(d)

the results of the assessment, measurement or

calculations of the levels of exposure to electromagnetic fields,

carried out in accordance with regulation 4;

(e)

how to detect adverse health effects of exposure

and how to report them;

(f)

the possibility of transient symptoms and

sensations related to effects in the central or peripheral nervous

system;

(g)

the circumstances in which workers are entitled to

health surveillance;

(h)

safe working practices to minimise risks resulting

from exposure;

(i)

workers at particular risk, as referred to in

regulation 4(5)(d) and regulation 5(3) and (4).

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

Consultation and participation of workers and, or their Consultation

representatives on the matters covered by these regulations and the and

participation of

Schedules hereto, including the assessment, measurement and, or workers.

calculations of the levels of exposure to electromagnetic fields

experienced at work, shall take place in accordance with the General S.L. 424.18

Provisions for Health and Safety at Work places Regulations.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

With the objective of the prevention and the early Health

diagnosis of any adverse health effects due to exposure to surveillance.

electromagnetic fields, an employer shall make arrangements for

carrying out appropriate health surveillance of workers exposed to

electromagnetic fields. Health records shall be made available to the

Authority.

(2) An employer shall ensure that the results of health

surveillance are preserved in a suitable form that allows them to be

consulted at a later date, subject to compliance with confidentiality

requirements. Individual workers shall, at their request, have access

to their own personal health records.

If any undesired or unexpected health effect is reported by

a worker, or in any event where exposure above the ELVs is detected,

the employer shall ensure that appropriate medical examinations or

individual health surveillance is provided to the worker(s).

Such examinations or surveillance shall be made available

during hours chosen by the worker, and any costs arising shall be

borne by the employer.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

By way of derogation from regulation 3 but Derogations.

without prejudice to the provisions of regulation 5(1), the following

shall apply

(a)

exposure may exceed the ELVs if the exposure is

related to the installation, testing, use, development,

maintenance of or research related to magnetic resonance

imaging (MRI) equipment for patients in the health sector,

provided that all the following conditions are met

(i) the risk assessment carried out in accordance

with regulation 4 has demonstrated that the ELVs are

exceeded;

(ii) given the state of the art, all technical and, or

organisational measures have been applied;

(iii) the circumstances duly justify exceeding the

ELVs;

(iv) the characteristics of the workplace, work

equipment, or work practices have been taken into

account; and

(v) the employer demonstrates that workers are

still protected against adverse health effects and against

safety risks, including by ensuring that the instructions for

safe use provided by the manufacturer in accordance with

Council Directive 93/42/EEC of 14 June 1993 concerning

medical devices are followed;

(b)

the Minister responsible for defence may allow

equivalent or more specific protection systems to be

implemented for personnel working in operational military

installations or involved in military activities, including in joint

international military exercises, provided that adverse health

effects and safety risks are prevented;

(c)

the Authority may allow, in duly justified

circumstances and only for as long as they remain duly justified,

for the ELVs to be temporarily exceeded in specific sectors or

for specific activities outside the scope of sub-regulation (1)(a)

and (b). For the purposes of this sub-regulation, "duly justified

circumstances" shall mean circumstances in which the

following conditions are met

(i) the risk assessment carried out in accordance

with regulation 4 has shown that the ELVs are exceeded;

(ii) given the state of the art, all technical and, or

organisational measures have been applied;

(iii) the specific characteristics of the workplace,

work equipment, or work practices have been taken into

account; and

(iv) the employer demonstrates that workers are

still protected against adverse health effects and safety

risks, including using comparable, more specific and

internationally recognised standards and guidelines.

In such cases the employer shall inform the Authority in

writing before the start of these activities.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

In any proceedings for an offence under these regulations Onus of proof.

consisting of failure to comply with a duty or requirement to do

something, or to do something so far as is reasonably practicable, it

shall be for the accused to prove, as the case may be, that it was not

practicable or not reasonably practicable to do more than was in fact

done to satisfy the duty or requirement, or there was no better

practicable means than was in fact used to satisfy the duty or

requirement.

Malta Government Gazette — Legal Notice 2016 257 · Gazzetta tal-Gvern ta’ Malta Nru. 19,609 – 15.07.2016 — Electromagnetic Fields) Regulations, 2016

(1)

Any breach by any person of any provision of these Offences.

regulations shall be deemed an offence.

(2) Any person who knowingly or recklessly interferes with

the performance of a duty or obligation by a person under these

regulations shall be guilty of an offence.

Need to analyze how this provision applies to your matter?

Cross-reference this statute against case law, commentaries, and related legislative provisions inside Legislator AI.

Open in Legislator →