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Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,214, 18 ta’
 Ġunju, 2019
Taqsima  B
____________________________________________________________________B 879
L.N. 123 of 2019
NUCLEAR SAFETY AND RADIATION PROTECTION  ACT
(CAP. 585)
Management of Radioactive Waste Regulations, 2019
IN EXERCISE of the powers conferred by article 62 of the
Nuclear Safety and Radiation Protection Act, the Minister for
European Affairs and Equality has made the following regulations:-
Title. 1. The title of these regulations is the Management of
Radioactive Waste Regulations, 2019.
Scope. 2. (1) The objective of these regulations is to ensure that
radioactive waste is managed in a manner that protects human he alth
and the environment now and in the future, without imposing und ue
burdens on future generations. 
 (2)  These regulations:
(a) provide the arrangements for safety in radioactive
waste management to protect workers and the general public
against the dangers arising from ionising radiation;
(b) apply to all stages of: radioactive waste management,
from generation to disposal, when the radioactive waste resultsfrom civilian activities;
(c) provide for the necessary public information and
participation in relation to radioactive waste management whilehaving due regard to security and proprietary information;
(d) bring into effect the provisions of Council Directive
2011/70/Euratom of 19 July 2011 establishing a Communityframework for the responsible and safe management of spent
fuel and radioactive waste and the International Atomic Energy
Agency’s Joint Convention on the Safety of Spent Fuel
Management and on the Safety of Radioactive Waste
Management; and
S.L.585.01.(e) provide additional measures, procedures and
guidance to those mentioned in Basic Safety Standards forIonising Radiation Regulations. 
Application. 3. (1) These regulations shall apply to all radioactive waste
with the exception of: 
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S.L.585.01.(a) releases authorised by virtue of regulation 87 of the
Basic Safety Standards for Ionising Radiation Regulations; and  
S.L.549.50. (b) waste that may be radioactive which falls within the
scope of the Waste Management (Management of Waste from
Extractive Industries and Backfilling) Regulations. 
(2) Regulation 15 shall not apply to repatriation of disused
sealed sources to a supplier or manufacturer.
(3) These regulations allow for the return of radioactive waste
after processing in Malta to its country of origin where: 
(a) the radioactive waste is to be shipped to that Member
State or undertaking for processing; or 
(b) other material is to be shipped to that Member State
or undertaking with the purpose of recovering the radioactivewaste:
S.L. 549.51.Provided that relevant provisions of the Waste
Management (Supervision and Control of Shipments ofRadioactive Waste and Spent Fuel) Regulations are complied
with. 
Interpretation. 4. For the purpose of these regulations, unless the context
otherwise:
Cap. 585. "Act" means the Nuclear Safety and Radiation Protection
Act;
"closure" means the completion of all operations at some
time after the emplacement of radioactive waste in a disposal
facility, including the final e ngineering or othe r work require d to
bring the facility to a condition that will be safe in the long term; 
"Commission" means the Com mission for the Protection
from Ionising and Non-Ionising Radiation, as established by
article 10 of the Act which acts as the regulatory authority in the
field of nuclear safety and radiation protection and has the le gal
authority for the purpose of these regulations; 
"disposal" means the emplacement of radioactive waste in a
facility without the intention of retrieval;
"disposal facility" means any facility or installation the
primary purpose of which is radioactive waste disposal;
"licence" means a legal document issued by the
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Commission related to the management of radioactive waste, or
to confer responsibility for siting, design, construction,
commissioning, operation, decommissioning or closure of aradioactive waste management facility;
 "licence holder" means a legal or natural person having
overall responsibility for any activity or facility related to the
management of radioactive waste as specified in a licence;  
"Minister" means the minister responsible for the Act; 
 "radioactive waste" means radioactive material in gaseous,
liquid or solid form for which no further use is foreseen or
considered by the Commission;  
 "radioactive waste management" means all activities that
relate to handling, pre-treatment, treatment, conditioning,storage, or disposal of radioactive waste, excluding off-sitetransportation;
 "radioactive waste management facility" means any
facility or installation the primary purpose of which isradioactive waste management;
Cap. 585. "Secretariat" means the Secr etariat to the Commission, as
established by article 12 of the Nuclear Safety and RadiationProtection Act. 
 "storage" means the holding of radioactive waste in a
facility with the intention of retrieval.
Radioactive 
Waste 
Management 
Programme.5. (1) There shall be a national programme for the
management of radioactive waste in Malta entitled the ‘Radioactive
Waste Management Programme’.
(2) The radioactive waste management programme shall: 
(a) enable radioactive waste to be treated in a sustainable
manner that protects human health and the environment now and
in the future without imposing undue burdens on futuregenerations;  
(b) include policies and strategies for the management of
radioactive waste. The policies shall reflect priorities,circumstances, structures, and available human and financial
resources whilst the strategies s hall implement the policies an d
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shall consider:
 (i) all stages of radio active waste management,
from generation to disposal;
(ii) the concepts or plans for the post-closure period
of a disposal facility’s lifetim e, including the period during
which appropriate controls are retained and the means to be
employed to preserve knowledge of that facility in the
longer term; and
(iii) research, development and demonstration
activities that are needed in order to implement solutions
for the management of spent fuel and radioactive waste.
 (3) In the event that radioactive waste is sent overseas for
processing, the ultimate responsibility for the safe and responsibledisposal of those materials, will remain in Malta or the other country
from which the radioactive material was shipped. 
General 
principles.6. (1) Radioactive policies referred to in regulation 5(2)(b)
shall take into due account:
(a) the requirement for the minimisation of activity and
volume of radioactive waste and shall include the options to
recycle and reuse of materials; 
(b) the use of passive safety features for the long term
management of radioactive waste;
(c) the need:
(i) to consider the interdependencies between all
steps in radioactive waste generation and management,including the need for the appropriate conditioning of
waste;
(ii) for the implementation of measures to follow a
graded approach; 
(iii) that the radioactive waste management can be
financed in the long term; and
(d) the need for evidence-based and documented
decision-making process to be applied with regard to all stages
of the management of radioactive waste.
(2) Radioactive waste shall be:
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S.L. 549.51.(a) disposed of in the Member State in which it was
generated, unless at the time of shipment an agreement, taking
into account the Waste Management (Supervision and Control of
Shipments of Radioactive Waste and Spent Fuel) Regulations,
has entered into force between Malta and another country to usea disposal facility in one of them; and
(b) managed in the long term by an entity independent
from the Commission and licensed by the Commission.
(3) The public and workers shall be involved in the decision
making process and shall be given, in particular:
(a) necessary information on the management of
radioactive waste; and
(b)  the necessary opportunities to participate effectively
in the decision- making process regarding radioactive waste.
(4) The Commission shall set up procedures for:
(a) gaining control over sources that are out of regulatory
control; and 
(b) setting discharge limits from nuclear medicine
departments.
Financing the 
radioactive waste 
management 
programme. 7. (1) The Commission shall provide the Minister with
estimates of the costing of the  radioactive waste management
programme. 
(2) The estimates shall include an assessment of the national
programme costs and the underlying basis and hypotheses for that
assessment, which must include a profile over time.
8. All licence holders:
(a) shall be responsible for financing of the management
of their radioactive waste; and
(b) may be charged for the storage and disposal of
radioactive waste.
Responsibility 
for waste in the 
case there is no 
license holder.9. If there is no licence holder for a source or other
responsible party, the responsibility for the source rests with the
government of Malta. 
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Radioactive 
waste 
management facilities.10.  In order to license a waste management facility, the
Commission shall consider the following with regard to waste
facilities: 
(a) siting, design and construction;
(b) safety and environmental assessments; (c) operational aspects; 
(d) post closure aspects; and
(e) any other relevant factors.
Licensing of 
radioactive waste 
management 
activities and facilities.11. (1) Radioactive Waste management activities and
facilities shall require a license to be issued by the Commission.
Role of the 
Commission.12. The Commission shall:
(a) have overall responsibility for the implementation of
these regulations;
(b) develop and maintain national Radioactive Waste
Management Programme;
 (c) in particular have the following functions with
respect to these regulations:
(i) advise the Minister on financial issues relating
to the radioactive waste management programme;
(ii) advise the Minister on assignment of
responsibilities to various stakeholders;
(d) have the responsibility for the monitoring of the
radioactive waste management programme key performance
indicators. The key performance indicators shall include the
significant milestones to achieve the permanent solution
(including central storage and disposal) and time-frames for th e
achievement of those milestones;
(e) maintain an inventory of all radioactive waste and
estimates for future quantities, indicating the location andamount of the radioactive waste in accordance with appropriate
classification of the radioactive waste as required;
(f) provide licensing of rad ioactive waste management
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activities, including appropriate measures for the post-closure
periods of disposal facilities; 
(g) perform enforcement actions, including the
suspension of activities and the modification, expiration orrevocation of a licence together with requirements, if
appropriate, for alternative solutions that lead to improvedsafety; 
(h) seek to improve the national framework, taking into
account operating experience, insights gained from the decision -
making process referred to in regulation 6(2), and thedevelopment of relevant technology and research;
(i) review and update as required the national
programme, taking into account t echnical and scientific progres s
as appropriate as well as recommendations, lessons learned andgood practices from peer reviews;
(j) notify to the European Commission of the national
programmes and any subsequent significant changes;
(k) report to the European Commission on the
implementation of these regulations for the first time by 23August 2015, and every 3 years thereafter, taking advantage ofthe review and reporting under the Joint Convention;
(l) respond to any request from the European
Commission for any clarification made in connection with thenational programme;
(m) at least every 10 years, arrange for self-assessments
of their national framework, competent regulatory authority,national programme and its implementation, and invite
international peer review of their national framework, competen t
regulatory authority and, or national programme with the aim of
ensuring that high safety standards are achieved in the safe
management of radioactive waste. The outcomes of any peer
review shall be reported to the European Commission and theother Member States, and may be made available to the public
where there is no conflict with security and proprietary
information; and 
(n) comply with the local reporting requirements and full
attendance of meetings under the Joint Convention on the Safetyof Spent Fuel Management and on the Safety of Radioactive
Waste Management.
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Training. 13. (1) The Commission shall ensure that the members of its
Secretariat have sufficient understanding of the safety and sec urity
aspects related to management of radioactive waste. In particul ar the
Commission shall ensure that members of the Secretariat participate in
on-going training.
(2) During the licensing process by the Commission, the
Secretariat shall require that arrangements for education and traininghave been undertaken by potential license holders.  
Duties of 
licence holders.14. (1) The prime responsibility for the safety of radioactive
waste management facilities and, or activities rests with the licence
holder. 
(2) Licence holders shall:
(a) regularly assess, verify and continuously improve, as
far as is reasonably achievable, the safety of the radioactivewaste management facility or activity in a systematic and
verifiable manner. This shall be achieved through an appropriat e
safety assessment, other arguments and evidence; 
(b) as part of the licensing of a facility or activity the
safety demonstration shall cover the development and operation
of an activity and the development, operation and
decommissioning of a facility or closure of a disposal facility  as
well as the post-closure phase of a disposal facility. The exte nt of
the safety demonstration shall be commensurate with thecomplexity of the operation and the magnitude of the hazards
associated with the radioactive waste, and the facility or acti vity.
The licensing process shall contribute to safety in the facility or
activity during normal operating conditions, anticipated
operational occurrences and design basis accidents. It shallprovide the required assurance of safety in the facility or act ivity.
Measures shall be in place to prevent accidents and mitigate th e
consequences of accidents, including verification of physicalbarriers and the licence holder’s administrative protection
procedures that would have to fail before workers and the
general public would be significantly affected by ionising
radiation. That approach shall identify and reduce uncertaintie s;
(c) establish and implement integrated management
systems, including quality assur ance, which give due priority for
overall management of radioactive waste to safety and are
regularly verified by the Commission; and
(d) provide for and mainta in adequate financial and
human resources to fulfil their obligations with respect to the
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safety of radioactive waste management.  
Waste 
shipments to 
third countries.15. Prior to a shipment to a third country, the Commission shall
inform the European Commission of the content of any such
agreement and take reasonable measures to be assured that: 
(a) the country of destination has concluded an
agreement with the Community covering radioactive wastemanagement or is a party to the Joint Convention on the Safety
of Spent Fuel Management and on the Safety of RadioactiveWaste Management; 
(b) the country of destinat ion has radioactive waste
management and disposal programmes with objectivesrepresenting a high level of safety equivalent to those establi shed
by these regulations; and
(c) the disposal facility in the country of destination is
authorised for the radioactive waste to be shipped, is operatin g
prior to the shipment, and is managed in accordance with therequirements set down in the rad ioactive waste management and
disposal programme of that country of destination. 
Enforcement. 16. (1) The Commission shall enforce these regulations. 
(2) Any breach of any of these regulations shall be deemed an
offence.
(3) In any proceedings for an offence under these regulations
consisting of a failure to comply with a duty or requirement to do
something, it shall be for the accused to prove, as the case may be, that
it was not practicable to do more than was in fact done to sati sfy the
requirement or duty, or that there was no better practicable me ans than
was in fact used to satisfy the duty or requirement.
Repeal.
S.L. 365.45.17.  The Convention on Nuclear Safety Regulations are hereby
repealed. 
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