B 763
Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,857, 13 ta’ Mejju , 2022
Taqsima  B
____________________________________________________________________B 763
L.N. 139 of 2022
NUCLEAR SAFETY AND RADI ATION PROTECTION ACT
(CAP. 585)
Basic Safety Standards for Ionising 
Radiation (Amendment) Regulations, 2022
IN EXERCISE of the powers conferred by article 62 of the
Nuclear Safety and Radiation Protection Act, the Minister for
Inclusion, V oluntary Organisations and Consumer Rights has made  the
following regulations:-
Citation.
S.L. 585.01.1. The title of these regulations is the Basic Safety Standards
for Ionising Radiation (Amendment) Regulations, 2022 and these
regulations shall be read and construed as one with the Basic S afety
Standards for Ionising Radiation Regulations, hereinafter refer red to as
"the principal regulations".
Amends 
regulation 9 of 
the principal regulations.2. Sub-regulation (2) of regulation 9 of the principal
regulations shall be substituted by the following new sub-regulation:
"(2) The limit on effective dose for occupational exposure
shall be 20mSv in any single year. In special circumstances or
for certain exposure situations where the Secretariat is satisf ied
that a dose in excess of the annual limit is appropriate, theSecretariat may authorise a higher effective dose of up to 50mS v
in a single year, provided that the average annual dose over an y
five (5) consecutive years, inclu ding the years for which the limit
has been exceeded, does not exceed 20mSv.".
Amends 
regulation 12 of the principal 
regulations.3. Sub-regulation (2) of regul ation 12 of the principal
regulations shall be s ubstituted by the following new sub-regul ation:
"(2) The limit of the effective dose for public exposure is
1mSv per annum.".
Amends 
regulation 31 of 
the principal 
regulations.4. Regulation 31 of the principal regulations shall be amended
as follows:
(a) paragraph (a) of sub-regul ation (1) thereof shall be
substituted by the following new paragraph:
"(a) the practice is subject to licensing by the
Commission and shall impose specific requirements,
including criteria for individual implementation, that havebeen established by the Comm ission, making reference to
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guidance available from international bodies, in
cooperation with Maltese professional bodies of
practitioners, other governmental regulatory bodies and anyother such persons or bodies that the Commission sees fit
as appropriate;"; and
(b) sub-regulation (2) thereof shall be substituted by the
following new sub-regulation:
"(2) For procedures not using medical radiological
equipment, shall have dose constraints that shall be
established by the Commission and its value shall not
exceed an effective dose of 0.005mSv per procedure with alimit of 0.1mSv per year for the individual exposed to that
procedure and;".
Amends 
regulation 34 of 
the principal 
regulations. 5. Sub-regulation (1) of regulation 34 of the principal
regulations shall be substituted by the following new sub-regulation:
"(1) Notification is required for all justified practices,
including those identified according to regulation 33. The
notification shall be made at least thirty (30) days prior to a
practice commencing. Existing practices shall notify within
thirty (30) days of the publication of this regulation. TheSecretariat shall specify the information to be provided in
conjunction with the notification. Where an application for an
authorisation is submitted, no separate notification is needed.  An
authorisation may lead to the Secretariat issuing the undertaking
with either a registration or license.".
Substitutes 
regulation 36 of the principal 
regulations. 6. Regulation 36 of the principal regulations shall be
substituted by the following new regulation:
"36. (1) The Commission shall require either
registration or licensing of the following practices: 
(a) the operation of radiation generators or
accelerators or radioactive sources for medical
exposures or for non-medical imaging exposure
purposes; and 
(b) the operation of radiation generators or
accelerators, except electron microscopes, orradioactive sources for purposes not covered by
sub-paragraph (a). 
(2) The Commission may require registration or
licensing of other types of practices. B 765
Amends 
regulation 44 of the principal 
regulations. 7. Sub-regulation (2) of regulation 44 of the principal
regulations shall be substituted by the following new sub-regulation: 
"(2) For workplaces specified in regulation 64(3) and
where the exposure of workers is liable to exceed an effective
dose of 6mSv per year or a corresponding time-integrated radon
exposure value to be determined by the Commission based oninternational guidan ce, these shall be managed as a planned
exposure situation and the Co mmission shall determine which
requirements set out in this Part VI are appropriate. Forworkplaces specified in regulation 64(3), and where the effecti ve
dose to workers is less than or equal to 6mSv per year, or theexposure less than the corresponding time integrated radonexposure value for the workers, the Commission shall require
that exposures are kept under review.".
Substitutes 
regulation 45 of the principal 
regulations. 8. Regulation 45 of the principal regulations shall be
substituted by the following new regulation:(3) Subject to regulation 37, the Commission
shall, in accordance with sub-regulations (1) and (2),
determine which practices are subject to registration or
licensing. The Commission shall base its decision to
submit a type of practice to registration or licensing,using a graded approach and based on regulatory
experience taking into account:
(a) the magnitude of expected or potential
doses resulting from the practice; 
(b) the impact that regulatory control may
have in reducing such doses or improving
radiological safety; 
(c) the complexity of the practice; and 
(d) safety and security having regard to the
circumstances in which the relevant practice is
proposed to be carried out.".
"45. (1) Undertakings shall ensure that
workplaces are designated as either controlled or
supervised, where appropriate, on the basis of the safety
assessment, made pursuant to regulation 101, of the
expected annual doses and the probability and magnitude
of potential exposures.
(2) Undertakings shall refer to the Commission
guidance on the classifi cation of controlled and
supervised areas with regard to particular circumstances.
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Amends 
regulation 44 of the principal 
regulations. 7. Sub-regulation (2) of regulation 44 of the principal
regulations shall be substituted by the following new sub-regulation: 
"(2) For workplaces specified in regulation 64(3) and
where the exposure of workers is liable to exceed an effective
dose of 6mSv per year or a corresponding time-integrated radon
exposure value to be determined by the Commission based oninternational guidan ce, these shall be managed as a planned
exposure situation and the Co mmission shall determine which
requirements set out in this Part VI are appropriate. Forworkplaces specified in regulation 64(3), and where the effecti ve
dose to workers is less than or equal to 6mSv per year, or theexposure less than the corresponding time integrated radonexposure value for the workers, the Commission shall require
that exposures are kept under review.".
Substitutes 
regulation 45 of the principal 
regulations. 8. Regulation 45 of the principal regulations shall be
substituted by the following new regulation:(3) Subject to regulation 37, the Commission
shall, in accordance with sub-regulations (1) and (2),
determine which practices are subject to registration or
licensing. The Commission shall base its decision to
submit a type of practice to registration or licensing,using a graded approach and based on regulatory
experience taking into account:
(a) the magnitude of expected or potential
doses resulting from the practice; 
(b) the impact that regulatory control may
have in reducing such doses or improving
radiological safety; 
(c) the complexity of the practice; and 
(d) safety and security having regard to the
circumstances in which the relevant practice is
proposed to be carried out.".
"45. (1) Undertakings shall ensure that
workplaces are designated as either controlled or
supervised, where appropriate, on the basis of the safety
assessment, made pursuant to regulation 101, of the
expected annual doses and the probability and magnitude
of potential exposures.
(2) Undertakings shall refer to the Commission
guidance on the classifi cation of controlled and
supervised areas with regard to particular circumstances.
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Amends 
regulation 66 of 
the principal 
regulations. 9. Sub-regulation (3) of regulation 66 of the principal
regulations shall be substituted by the following new sub-regulation:(3) Undertakings shall designate as a controlled
area any area under their control which:
(a) it is necessary for any person who enters
or works in the area to follow special procedures
designed to restrict signifi cant exposure to ionising
radiation in that area or prevent or limit theprobability and magnitude of radiation accidents ortheir effects; or
(b) any person working in the area is likely
to receive an effective do se greater than 6mSv a
year or an equivalent dose greater than three-tenthsof any relevant dose limit referred to in these
regulations.
(4) Undertakings shall designate as a supervised
area any area under their control, not being an area
designated as a controlled area:
(a) where it is necessary to keep the
conditions of the area u nder review to determine
whether the area shoul d be designated as a
controlled area; or
(b) in which any person is likely to receive
an effective dose greater than 1mSv a year or anequivalent dose greater than one-tenth of any
relevant dose limit referred to in these regulations.
(5) On the basis of the documentation supplied,
including the Safety Asses sment, by the undertaking to
the Commission, the Secretariat shall confirm that theappropriate area classi fication has been made.".
"(3)(a) The Commission shall establish and
regularly review national diagnostic reference levels for
radio-diagnostic examinations, having regard to the
current European diagnostic reference levels whereavailable, and where appropriate, for interventional
radiology procedures, and the availability of guidance for
this purpose.
(b) An undertaking shall ensure that diagnostic
reference levels for their radio-diagnostic examinations,
and where appropriate for interventional radiology
procedures, are established, regularly reviewed and used,
having regard to the national diagnostic reference levelswhere available.".
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Substitutes 
regulation 85 of 
the principal regulations. 10. Regulation 85 of the principal regulations shall be
substituted by the following new regulation:
"Planning for 
the protection of members of the public.85. (1) Undertakings shall take such measures
as are necessary to ensure the operational protection of
members of the public in normal circumstances havingregard to the relevant provisions of these regulations. 
(2) For the purposes of these regulations,
"operational protec tion of members of the public" means,
in normal circumstances, all arrangements and surveysfor detecting and eliminating the factors which, in thecourse of any operation, may result in actual or potential
exposure to members of the public exceeding the relevant
dose constraint such that the exposure from any onepractice is not liable to exceed 0.25mSv in a year. 
(3) For relevant activities, the Commission shall
before granting a registration or a licence in respect of a
practice or amending any condition attached to a
registration or specified in a licence, or acceptance intoservice of a facility, require the undertaking to submit to
it for examination and approval:
(a) the proposed siting of the workplaces
from a radiation protection point of view, taking
into account relevant demographic, meteorological,geological, hydrological and ecological conditions; 
(b) a statement of pl anned arrangements to
ensure adequate protection against any exposure or
radioactive contamination liable to extend beyond
the perimeter of the workplaces or radioactivecontamination liable to extend to the ground
beneath the facility; 
(c) pursuant to regulation 87, plans for the
discharge of radioactive effluents; 
(d) the results of a screening assessment of
the doses liable to be received by the population as
a result of any practice carried out by it; and 
(e) a statement of planned measures to
control the access of members of the public to the
facility. 
(4) The Commission shall, pursuant to regulation
87, where appropriate, establish limits and conditions on
the quantities of radionuclides discharged to air or waterduring a specified period, which shall take into account:
(a) the results of the optimisation of
radiation protection; 
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Amends 
regulation 96 of 
the principal 
regulations. 11. Sub-regulation (2) of regulation 96 of the principal
regulations shall be substituted by the following new sub-regulation: 
Amends regulation 98 of 
the principal 
regulations. 12. Sub-regulations (2) and (3) of regulation 98 of the principal
regulations shall be substituted by the following new sub-regul ations:(b) good practice in the operation of similar
facilities; and
(c) where appropriate, results of generic
screening assessment bas ed on internationally
recognised scientific guidance, where such an
assessment has been required by the Commission.".
"(2) For areas with long-lasting residual
contamination the Commission shall consult entities that
have responsibilities for land use planning, land
ownership, environmental protection and public health
and shall advise the government on allowing habitationand the resumption of social and economic activities, to
ensure that arrangements are in place, as necessary, for
the ongoing control of exposure with the aim ofestablishing living conditions that can be considered as
normal, including:
(a) establishment of appropriate reference
levels;
(b) establishment of an infrastructure to
support continuing self-help protective measures in
the affected areas, such as information provision,advice and monitoring;
(c) if appropriate, remedial measures;
(d) if appropriate, delineated areas.".
"(2) For building materials which are identified by
the Commission as being of concern from a radiation
protection point of view, taking into account the
indicative list of materials set out in the Twelfth Schedule
with regard to their emitted gamma radiation, theCommission shall consult with the entity responsible for
placing materials on the market in order that, before such
materials are placed on the market:
(a) the activity concentrations of the
radionuclides specified in t he Seventh Schedule are
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Amends 
regulation 106 
of the principal 
regulations. 13. Paragraph (a) of sub-regulation (1) of regulation 106 of the
principal regulations shall be substituted by the following new
paragraph: 
"(a) have a degree in radiation protection, physics,
engineering, mathematic s, radiography or a s uitable combination
of other qualifications and experience; and".
Amends 
regulation 109 of the principal 
regulations.14. Sub-regulation (1) of regulation 109 of the principal
regulations shall be substituted by the following new sub-regul ation:
Amends 
regulation 114 of the principal 
regulations. 15. Regulation 114 of the principal regulations shall be
amended as follows: 
(a) sub-regulation (3) thereof shall be amended as
follows:
(i) the words "Undertakings are required, that in
addition to the general licensi ng requirement set out in Part
V , shall have provided for, within its radiation protection
progamme for:" shall be substituted by the words "The
radiation protection progamme shall address the following(b) information to the Commission on the
results of measurements and the correspondingactivity concentration index, as well as other
relevant factors, as define d in the Seventh Schedule
are provided if requested.
(3) For types of building materials identified in
accordance with sub-regulation (2) which are liable to
give doses exceeding the reference level, the
Commission consults the entity responsible for building
and construction on appropriate measures, which may
include specific requirements in relevant building codes
or restrictions on the envisaged use of such materials.". 
"(1) Medical physics experts shall meet the
following criteria for initial certification by the
Commission:
(a) be registered by the Council for the
Professions complimentary to Medicine in Malta as
a medical physicist; and
(b) two (2) years do cumented full time
work experience, within the preceding twenty-eight(28) months, in specialty (radiotherapy, nuclear
medicine, diagnostic and interventional radiology)
with documented Continuous ProfessionalDevelopment.".
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Amends 
regulation 106 
of the principal 
regulations. 13. Paragraph (a) of sub-regulation (1) of regulation 106 of the
principal regulations shall be substituted by the following new
paragraph: 
"(a) have a degree in radiation protection, physics,
engineering, mathematic s, radiography or a s uitable combination
of other qualifications and experience; and".
Amends 
regulation 109 of the principal 
regulations.14. Sub-regulation (1) of regulation 109 of the principal
regulations shall be substituted by the following new sub-regul ation:
Amends 
regulation 114 of the principal 
regulations. 15. Regulation 114 of the principal regulations shall be
amended as follows: 
(a) sub-regulation (3) thereof shall be amended as
follows:
(i) the words "Undertakings are required, that in
addition to the general licensi ng requirement set out in Part
V , shall have provided for, within its radiation protection
progamme for:" shall be substituted by the words "The
radiation protection progamme shall address the following(b) information to the Commission on the
results of measurements and the correspondingactivity concentration index, as well as other
relevant factors, as define d in the Seventh Schedule
are provided if requested.
(3) For types of building materials identified in
accordance with sub-regulation (2) which are liable to
give doses exceeding the reference level, the
Commission consults the entity responsible for building
and construction on appropriate measures, which may
include specific requirements in relevant building codes
or restrictions on the envisaged use of such materials.". 
"(1) Medical physics experts shall meet the
following criteria for initial certification by the
Commission:
(a) be registered by the Council for the
Professions complimentary to Medicine in Malta as
a medical physicist; and
(b) two (2) years do cumented full time
work experience, within the preceding twenty-eight(28) months, in specialty (radiotherapy, nuclear
medicine, diagnostic and interventional radiology)
with documented Continuous ProfessionalDevelopment.".
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issues, which are in addition to the general licensing
requirements set out in Part V , shall be provided to the
Commission when applying for a license:";
(ii)  paragraph (m) thereof shall be substituted by
the following new paragraph:
"(m) the confidentiality of information relating
to the security of sources;"; and 
(iii) immediately after par agraph (m) thereof there
shall be added the following new paragraph:
"(n) any other specific requirement that the
Commission may require."; and
(b) immediately after sub-re gulation (5) thereof there
shall be added the following new sub-regulation:
"(6) The Commission shall review the radiation
protection programme at the authorisation stage and may
impose specific conditions involving the use of high
activity sources in any licence that may be issued.". 
Substitutes 
regulation 125 of the principal 
regulations. 16. Regulation 125 of the principal regulations shall be
substituted by the following new regulation:
"125.  (1) The Commission strategy to ensure the
appropriate management of existing exposure situations
commensurate with the risks and with the effectiveness
of protective measures shall consider:
(a) delineation of the affected areas and
identification of the affected members of thepublic; 
(b) consideration of the need for and extent
of protective measures to be applied to the affectedareas and members of the public; 
(c) consideration of the need to prevent or
control access to the affected areas, or to imposerestrictions on living conditions in these areas; 
(d) assessment of the exposure of different
groups in the population and assessment of the
means available to individuals for controlling their
own exposure; 
(e) controls on commodities incorporating
radionuclides from the contaminated area; 
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Amends 
regulation 126 of the principal 
regulations. 17. Sub-regulation (1) of regulation 126 of the principal
regulations shall be substituted by the following new sub-regulation: 
"(1) Following consultations with entities responsible for
land use planning, land ownership, environmental protection and
public health, the Commission sh all advise these entities and the
government on the implementation of strategies for the
management of existing exposure situations, and ensure
appropriate coordination between the entities involved in the
implementation of remedial and protective measures.Stakeholders shall be involved as appropriate in decisions
regarding the development and implementation of strategies for
managing exposure situations.".
Amends 
regulation 127 
of the principal regulations. 18. Sub-regulation (2) of regulation 127 of the principal
regulations shall be substituted by the following new sub-regulation: 
"(2) The Commission shall ma ke recommendations to the
entity responsible for building and construction on any
appropriate measures that may need to be included in thenational building codes to reduce radon ingress into new
buildings.".
Amends the 
Eleventh 
Schedule to the 
principal regulations. 19. Section B(1) of the Eleventh Schedule to the principal
regulations shall be substituted by the following new section: (f) consideration of the need to ensure that
the form, scale and duration of all protective
measures in the strategy are optimised; and 
(g) provision for cooperation, where
appropriate, with entities responsibilities for land
use planning, land ownership, environmental
protection and public health.".
"(1) On the basis of the emergency response plan
previously drawn up in the  Commission, the members of
the public actually affected in the event of an emergency
shall rapidly and regularly receive:
(a) information on the type of emergency
which has occurred and, where possible, its
characteristics (e.g. its origin, extent and probabledevelopment);
(b) advice on protection, which, depending
on the type of emergency, may:
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(i) cover the following: restrictions on
the consumption of certain foodstuffs and
water likely to be contaminated, simple rules
on hygiene and decontamination,
recommendations to stay indoors, distributionand use of protective substances, evacuation
arrangements;
(ii) be accompanied, where necessary,
by special warnings for certain groups of the
members of the public;
(c) announcements recommending
cooperation with instructions or requests.".
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