B 1249
L.N. 184 of 2020
NUCL EAR SAFE
TY AND RADIATION PROTECTION ACT
(CAP. 585)
Basic Safety Standards for Ionising Radiation 
(Amendment) Regulations, 2020
IN EXERCISE of the powers c onferred by article 62 of the
Nuclear Safety and Radiation Protection Act, the Minister for T ourism
and Consumer Protection has made  the following regulations: 
Citation. 
S.L. 585.01.1. The title of these regulations is the Basic Safety Standards
for Ionising Radiation (Amendmen t) Regulations, 2020, and these
regulations shall be read and co nstrued as one with the Basic S afety
Standards for Ionising Radiation Regulations, hereinafter refer red to as
"the principal regulations".
Amends 
regulation 4 of 
the principal 
regulations.2. Immediately after the definiti on "sievert" in regulation 4 of
the principal regulations there shall be added the following:
" "spacecraft" means a manned vehicle designed to
operate at an altitude of more than 100 km above sea
level;".
Substitutes 
regulation 6 of 
the principal 
regulations.3. Regulation 6 of the princ ipal regulations shall be
substituted by the following:
"6. Dose constraints for the purpose of prospective
optimisation of protection shall be:
(1) (a) for occupational exposure, the dose
constraint shall be establis hed as an operational tool for
optimisation by the undertaking and shall be one third of
any dose limits specified in regulations 9,10 and 11. In
the case of outside workers t he dose constraint shall be
established in cooperation between the employer of theoutside worker and the undertaking;
(b) for public exposure, the dose constraint
shall be 0.25mSv per year for the individual dose
that members of the public receive from the plannedoperation of a specified radiation source;Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 20,400, 5 ta’ Mejju, 2020
Taqsima B
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Verżjoni Elettronika
B 1250
Amends 
regulation 7 of the principal 
regulations.4. Immediately after sub-regulat ion (3)(b) of regulation 7 of
the principal regulations there  shall be added the following:
"(c) in the range up to or equal to 100 mSv per year,
assessment of individual doses and specific information on
radiation risks and on available actions to reduce exposures.".
Substitutes 
regulation 8 of 
the principal 
regulations.5. Regulation 8 of the principal regulations shall be
substituted by the following:
"8. (1) Persons under 18 years of age may not be
assigned to any work which would result in them as being
classed as an exposed worker subject to regulation 11(2).
(2) No person under 16 years of age shall be
allowed to be subject to any form of occupationalexposure.".
Amends 
regulation 10 of 
the principal 
regulations.6. Regulation 10(1) of the principal regulations shall be
substituted by the following:
S.L. 424.11"(1) As soon as a pregnant worker informs the
undertaking or, in the case of an outside worker, the employer of
the outside worker, of the pr egnancy, in accordance with
regulation 3 of Protection of Maternity at Work Places
Regulations, the undertaking, and the employer of the outside
worker, shall ensure that the employment conditions for the
pregnant worker are such that the protection of the unborn chil d
is comparable with that provide d for members of the public and
the equivalent dose to the unbor n child is as low as reasonably
achievable and unlikely to exceed 1mSv during at least theremainder of the pregnancy.".
Adds new 
regulations to 
the principal 
regulations.7. Immediately after regulation 14 of the principal regulations(c) for medical exposure, dose constraints
shall apply only with regard to the protection of
carers and comforters, which shall be 1.5mSv per
five years pursuant to regulation 66(6a) and
volunteers participating in medical or biomedicalresearch pursuant to regulation 66(4c).
(2) In the event that any dose constraint is
exceeded the undertaking is to immediately inform the
Commission and then produce a report detailing the event
and doses received.".
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B 1251
there shall be added the following:
Amends 
regulation 17 of 
the principal regulations.8. Regulation 17(1) of the principal regulations shall be
substituted by the following:
Adds a new 
regulation to the 
principal regulations.9. Immediately after regulation 21 of the principal regulations
there shall be added the following:
Substitutes regulation 32 of the principal 
regulations.10. Regulation 32 of the principal regulations shall be
substituted by the following:
"32. (1) Notified practices which are not exempted from
authorisation shall be subject to regulatory control through
registration or licensing.
(2) Regulatory control through the notification,
registration/ licensing and the inspection process shall use a
graded approach."."Courses in 
medical and 
dental schools.14A. The Commission shall encourage the
introduction of a course on radiation protection in the
basic curriculum of medic al and dental schools.
Exposed workers to provide 
information.14B. Exposed workers shall make available to the
undertaking or the employer of the outside worker
information on their past and present work that is relevant
for ensuring effective and comprehensive protection and
safety for themselves and others.".
" (1)  Emergency workers who are identified in an
emergency response plan of an undertaking or the
employer of an outside worker and persons involved in thenational radiological emergency plan as established by
article 31 of the Act, shall be  given adequate information:
(a) that is regularly updated on the health
risks their intervention might involve and on the
precautionary measures to be taken in such an event;
(b) on appropriate radiation protection
training;
(c) on national radiological emergency plan
as set out in regulation 122: 
Provided that this information shall take
into account the range of potential emergencies andthe type of intervention.".
"
Resources. 21A.  The Commission shall allocate the necessary
resources in order that staff of its Secretariat to obtain,maintain and further develop e xpertise and skills required
in discharging the Commissi on’s responsibilities.".
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B 1252
Adds new 
regulations to 
the principal regulations.11. Immediately after regulation 32 of the principal regulations
there shall be added the following:
Amends regulation 48 of the principal regulations. 12. Regulation 48(4) of the principal regulations shall be
substituted by the following:
"(4) Monitoring equipment used for radiological
surveillance of the workplace shall be annually recalibrated and
the calibration shall be traceable to an accredited standardslaboratory.".
Amends 
regulation 62 of 
the principal regulations.13 Immediately regulation 62(2) of the principal regulations
there shall be added the following:
"(3) The Secretariat shall be informed if the exposure of
spacecraft crew is likely to exc eed dose limits and shall ensur e
that it is managed as a specially authorised exposure.".
Amends 
regulation 64 of 
the principal regulations.14. Regulation 64(3) of the principal regulations shall be
substituted the following:
"(3) In areas within workplaces, where the radon
concentration (as an annual aver age), continues to exceed the
national reference level, despite the action taken in accordanc e
with the principle of  optimisation as set out in Part III and t aking
into account parameters containe d in the national action plan as
under point 2 of the Sixteenth Schedule notification in
accordance with regulations 34( 4) and 44(2) shall apply.".
Amends 
regulation 65 of 
the principal regulations.15. Regulation 65 of the principal r egulations shall be amended
as follows:"Registers. 32A.  The Secretariat shall be responsible for
maintaining a registers of:
(1) undertakings and empl oyers of outside workers;
(2) equipment that require s notification under these
regulations;
(3) radioactive material that requires notification
under these regulations, and in  particular the following
information:
(a) radionuclide involved;
(b) the activity at the time of manufacture or,
if this activity is  not known, the activ ity at the time of
the first placing on the market; and
(c) the type of source.
(4) Transfers of equipment and radioactive material
that requires notification un der these regulations.".
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B 1253
(a) sub-regulation (2)(g) there of shall be substituted the
following:
"(g) Undertakings shall obtain clearance from the
Commission before any type  of health screening is
performed. The Comm ission shall seek advice from any
appropriate medical scientific societies and health
regulatory bodies and shall make reference to any available
internationally accepted justification norms for screening."
and 
(b) immediately after sub-regulation (2) thereof, there
shall be added the following:
"(3) Referrers shall as part of the justification
process:
(a) ensure and document that the medical
exposure of the patient is warranted based on the
medical indications;
(b) make reference to referral criteria;
(c) refer the patient to a practitioner,
providing adequate clinical details;
(d) state on each individual referral the
clinical question t o be answered; 
(e) where practical, seek, to obtain previous
diagnostic information or medical records relevant to
the planned exposure and consider this data to avoid
unnecessary exposure; and 
(f) seek the outcome of the exposure and act
on the result.".
Amends 
regulation 65 of 
the principal 
regulations.16. Sub-regulation (2)(f) of regulation 65 of the principal
regulations shall be substituted the following:
"(f) For the justification of any medical exposure for
medical or biomedical research undertakings shall obtain
clearance from the Commission. Pr ior to the Commission issuing
clearance for any medical exposur e for medical or biomedical
research the undertakings shall  provide confirmation that they
have obtained clearance from the ethics committee.".
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B 1254
Amends 
regulation 66 of 
the principal regulations.17. Regulation 66(3) of the principal regulations shall be
substituted the following:
"(3) The Commission shall establish and regular review
their use of diagnostic reference levels for radio-diagnostic
examinations, having regard to the current European diagnosticreference levels where available, and where appropriate, for
interventional radiology procedures, and the availability of
guidance for this purpose.".
Amends 
regulation 71 of the principal 
regulations.18. Regulation 71(1) of the principal regulations shall be
substituted the following:
"(1) The Commission shall set the training and recognition
requirements, as laid down in re gulations 102 and 14, for the
practitioner, the medical physi cs expert and the individuals
referred to in regulation 69.".
Substitutes regulation 72 of 
the principal regulations.19. Regulation 72 of the principal regulations shall be
substituted the following:
"72. (1) The responsibility to ensure that the equipment
is fit for clinical use re sides with the undertaking.
(2) Prior to acquiring medical  radiological equipment the
undertaking shall ensure that there is adequate information on
the radiological risks for patients, and on the clinical evalua tion
of the its use.".
Substitutes 
regulation 76 of the principal 
regulations.20. Regulation 76 of the principal regulations shall be
substituted by the following:
"76. The calibration of equipment used for dosimetry of
patients and acceptance or constancy testing shall be traceable  to
an accredited standards dosime try laboratory and shall be
routinely re-calibrated according to its instructions for use. In the
absence of any specified dosimet er re-calibration period, the
equipment calibration period must not exceed a period of two
years.".
Amends 
regulation 79 of 
the principal regulations.21. Sub-regulation (1)(d) of re gulation 79 of the principal
regulations shall be substituted the following:
"(d) When radiological equipment is not being used it
must be left in a safe and secure condition and when it is in u se it
must be kept under strict surveillance regarding radiation
protection.".
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B 1255
Amends 
regulation 89 of 
the principal regulations.22. Regulation 89(2) of the principal regulations shall be
substituted the following:
"(2) The national radiological protection plan shall be
developed following a national radiological hazard assessment
that shall be performed by the Commission.".
Substitutes regulation 91 of the principal 
regulations.23. Regulation 91 of the principal regulations shall be
substituted by the following:
Amends 
regulation 100 of the principal 
regulations.24. Immediately after regulatio n 100(3) of the principal
regulations there shall be added the following:
"(4) Undertakings shall record any report received from a
worker that identifies any radiological safety concerns or and
shall take appropriate action"
Amends 
regulation 101 of the principal 
regulations.25. Regulation 101(1) of the prin cipal regulations shall be
substituted the following:
"(1) It is the responsibility of the undertaking to ensure
that appropriate safety assessment/s are performed. The safety
assessment shall:"Emergencies 
on or outside 
Maltese territory."91.(1) In the event of an emergency on or
outside Maltese territory , the Commission shall:
(a) work with the civil protection authorities
to organise the appropriate protective measures,
taking account of the real characteristics of the
emergency and in accordance with the optimisedprotection strategy as part of the national
radiological emergency plan referred to in regulation
89, whereby the elements to be included in anemergency response plan a re indicated in Section B
of the Tenth Schedule;
(b) coordinate the recovery of any
radioactive material;
(c) advice on the termination of 
nuclear or
radiological emergency  and the transition to normal
activities;
(d) assess and record the consequences of the
emergency and of the effec tiveness of the protective
measures.
(2) Undertakings shall have appropriate
emergency preparedness and response procedures in placeas indicated in the Tenth Schedule." .
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B 1256
(a) identify ways in whic h potential exposures or
accidental and unintended med ical exposures could occur; 
(b) estimate, to the extent practicable, the
probabilities and magnit ude of potential exposures; 
(c) assess the quality and extent of protection and
safety provisions, including engi neering features, as well as
administrative procedures; 
(d) define the operational limits and conditions of
operation.".
Amends 
regulation 105 
of the principal regulations.26. Immediately after regulation 105(4) of the principal
regulations there shall  be added the following:
"(5) Where a radiation protection expert is consulted
pursuant to the requirements of t hese regulations the undertaking
shall appoint that radi ation protection expe rt in writing and s hall
include in that appointment the scope of the advice which the
radiation protection expe rt is required to give.".
Substitutes 
regulation 114 of the principal 
regulations.27. Regulation 114 of the principal regulations shall be
substituted by the following:
"114.  (1) Undertakings sha ll obtain a prior license
from the Secretariat for a ny practice involving a high
activity source, including taking possession of a source. 
(2) The Commission shall require that adequate
provision, by way of a finan cial security or any other
equivalent means appropriate  to the source in question,
having been made for the safe management of sources
when they become disused sources, including the case
where the holder becomes insolvent or goes out ofbusiness
(3) Undertakings are required, that in addition to
the general licensing requirements set out in Part V , shall
have provided for, within its radiation protection
programme for: 
(a) the safe and secure management of
sources;
(b) disused sources, including agreements
regarding the transfer, if appropriate, of disusedsources to a supplie r, another licensee;
(c) assignment of responsibilities within the
undertaking;
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(d) provision of minimum staff
competencies, including information and training;
(e) obtaining the minimum source, source
container and additional equipment performance
criteria;
(f) emergency procedures and
communication links;
(g) work procedures to be followed;
(h) maintenance of equipment, sources and
containers;
(i) adequate management of disused
sources, including agreements regarding the
transfer, if appropriate, of disused sources to a
supplier, another authoris ed holder or a recognised
installation;
(j) developed a security plan or assessment
including measures to detect and delay the
unauthorised access to, or the theft, loss or
unauthorised use or removal of radioactive sourcesduring all stages of management. The degree of
security required, shall be dependent on the security
level as laid out in the three columns of Table 1 ofthe Second Schedule. Security measures for the
different security levels are given in Table 1 in the
Fourteenth Schedule. The security plan orassessment shall be periodically reviewed and
records of such reviews kept; 
(k) minimum performance criteria and
maintenance requirements for equipment and
systems used to ensure the safety and security ofradioactive sources;
(l) measures to determine, as appropriate,
the trustworthiness of individuals involved in the
management of radioactive sources; and
(m) the confidentiality of information
relating to the security of sources.
(4) Each undertaking in possession of high activity
sealed sources shall:
(a) ensure that suitable tests, such as leak
tests based on international standards, are
undertaken every 14 months in order to check andmaintain the integrity of each source;
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B 1258
Amends 
regulation 122 of the principal 
regulations.28. Regulation 122(2) of the principal regulations shall be
substituted by the following:
"(2) The national radiological emergency plan shall take(b) carry out verification that each source
and, where relevant, the equipment containing the
source, is still present and in apparently good
condition at its place of use or of storage.
Verification frequency shall be as listed in Table 1 in
the Fourteenth Schedule;
(c) ensure that each fixed and mobile source
is subject to adequate documented measures, such as
written protocols and procedures, aimed at
preventing unauthorised access to or loss or theft ofthe source or its damage by fire;
(d) promptly notify the Secretariat of any
loss, leakage, theft or unauthorised use of a source,
arrange for a check on the integrity of each sourceafter any event, includi ng fire, that may have
damaged the source and, if appropriate, inform theBoard thereof and of the measures taken;
(e) return each disused source to the supplier
or place it in a facility for long term storage ordisposal or transfer it to another authorised
undertaking unless otherwise agreed by the
Commission, without undue d elay after termination
of the use; 
(f) ascertain that, before a transfer is made,
the recipient holds appropriate license;
(g) promptly notify the Secretariat of any
incident or accident res ulting in unintentional
exposure of a worker or a member of the public.
(5) Each undertaking in possession of high activity
sealed sources shall in connection for training andinformation ensure:
(a) includes specific requirements for the
safety and security of th e management of sources;
(b) contain specific information on possible
consequences of the loss of adequate control ofsources;
(c) repeated at regular intervals and
documented, with a view to preparing the relevant
workers adequately for such events, be addressed to
exposed workers.".
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B 1259
into account the risks identifie d in the national radiological
hazard assessment performed by the Commission.".
Amends the 
Fourth Schedule to the principal 
regulations.29. Immediately after point (b) o f 2ii of the Fourth Schedule
the principal regulations there  shall be added the following:
"(c) Use of ionising radiati on for detection of concealed
objects on or attached to the human body.".
Amends the Tenth Schedule 
to the principal regulations.30. Immediately after point (6) o f Part A of the Tenth Schedule
the principal regulations there  shall be added the following:
"(7) Arrangements for individual monitoring or
assessment of individual doses o f emergency workers and the
recording of doses; 
(8) Public information arrangements; 
(9) Involvement of stakeholders; 
(10) Transition from an emergency exposure situation to
an existing exposure situation including recovery and
remediation.".
Amends the 
Eleventh Schedule to the 
principal 
regulations.31. Immediately after point (3) of Part A of the Eleventh
Schedule of the principal regul ations there shall be added the
following
"(4)  Appropriate information on action to be taken by the
public in the event of an emergency.".
Amends the Seventeenth 
Schedule to the 
principal regulations.32. The table in Part 2 of the Seventeenth Schedule of the
principal regulations shall be substituted the following:
"
Qualification Medical doctors who are on the Specialist Register s held by the
Medical Council for:
Radiology; 
Radiotherapy; 
Nuclear Medicine,
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B 1260
".or
Medical doctors who are on the Specialist Register held by the
Medical Council for: 
Cardiology; Gastroenterology; Respiratory Medicine; Rheumatology; Orthopedic Surgery; and General Surgery 
Oral and maxillo-facial surgery  while carrying out interventions, 
or
Dental surgeons, 
or
Medical radiographers registere d with Council for Professions 
complimentary to medicine
Experience At least one month on the job experience under the supervision of 
an approved practitioner, excluding dental surgeons. No initial experience for dental work performed by dental surgeons.
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