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Environment Protection Act (Cap. 435) Waste Management (Supervision And Control Of Shipments Of Radioactive Waste And Spent Fuel) Regulations, 2009 (Ln 48 Of 2009 )

ENVIRONMENT PROTECTION ACT (CAP. 435)Waste Management (Supervision and Control of Shipments ofRadioactive Waste and Spent Fuel) Regulations, 2009

IN exercise of the powers conferred by articles 9, 10, 11(1)(b) and 28 of the Environment Protection Act, the Prime Minister, after consultation with the Malta Environment and Planning Authority, has made the following regulations:-
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Arrangement of Regulations
Regulations
Part I General Provisions 1 - 6
Part II Types of Shipments 7
Part III Intra-Community Shipments originating
from Malta 8 - 14
Part IV Intra-Community Shipments transiting
through Malta 15 - 21
Part V Intra-Community Shipments destined
to Malta 22 - 28
Part VI Extra-Community Shipments originating
from Malta 29 - 30
Part VII Extra-Community Shipments transiting
through Malta 31 - 32
Part VIII Extra-Community Shipments destined
to Malta 33
Part IX Enforcement 34 - 36

(2) These regulations shall come into force on such date

Title and commencement.

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as the Minister responsible for the environment may by notice in the Gazette appoint and different dates may be so appointed for different provisions and different purposes of these regulations.

Scope.

L.N. 44 of 2003

. Interpretation.

Cap. 435.

March 2008 establishing the standard document for the supervision and control of shipments of radioactive waste and spent fuel referred to in Council Directive 2006/117/EURATOM.
(2) These regulations lay down a system of supervision and control of transboundary shipments of radioactive waste and spent fuel, so as to guarantee an adequate protection of the population.
(3) These regulations provide additional measures, procedures and guidance to those mentioned in the Nuclear Safety and Radiation Protection Regulations, 2003.

definitions shall apply:
“the Act” means the Environment Protection Act;
“the Community” means the European Atomic Energy
Community;
“the Competent Authority” means the Malta Environment and Planning Authority and such other body or person as the Minister may by order in the Gazette, prescribe and different bodies or persons may be designated as the competent authority for different provisions and different purposes of these regulations;
“competent authorities” means any authority which, under the law or regulations of the countries of origin, transit or destination, are empowered to implement the system of supervision and control of shipments of radioactive waste or spent fuel;
“consignee” means any natural or legal person to whom radioactive waste or spent fuel is shipped;

“country or Member State of origin” means any country or Member State from which a shipment is planned to be initiated or is initiated;
“country or Member State of destination” means any country or Member State to which a shipment is planned or takes place;
“country or Member State of transit” means any country or Member State other than the country or the Member State of origin or the country or the Member State of destination, through the territory of which a shipment is planned or takes place;
“disposal” means the emplacement of radioactive waste or spent fuel in an authorised facility without the intention of retrieval;
“disused source” means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted;
“duly completed application” means the standard document that complies with all the requirements, as established in accordance with regulation 5 of these regulations.
“extra-Community shipment” means a shipment carried out where the country of origin and, or the country of destination are third countries;
“holder” means any natural or legal person who, before carrying out a shipment of radioactive waste or spent fuel is responsible under the applicable national law for such materials and plans to carry out a shipment to a consignee;
“intra-Community shipment” means a shipment carried out where the country of origin and the country of destination are Member States;
“Malta” means the Island of Malta, the Island of Gozo and the other islands of the Maltese Archipelago, including the territorial waters thereof;
“the Minister” means the Minister responsible for the environment;
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L.N. 44 of 2003

.

“radioactive waste” means radioactive material in gaseous, liquid or solid form for which no further use is foreseen by the countries of origin and destination, or by a natural or legal person whose decision is accepted by these countries, and which is controlled as radioactive waste by a regulatory body under the legislative and regulatory framework of the countries of origin and destination;
“recognised installation” means a facility located in the territory of a country authorised by the competent authorities of that country in accordance with national law for the long- term storage or disposal of sealed sources or an installation duly authorised under national law for the interim storage of sealed sources;
“reprocessing” means a process or operation, the purpose of which is to extract radioactive isotopes from spent fuel for further use;
“sealed source” has the meaning given to it by the Nuclear Safety and Radiation Protection Regulations, 2003, and includes the capsule, where applicable, enclosing the radioactive material as an integral part of the source;
“shipment” means the whole of operations involved in moving radioactive waste or spent fuel from the country or the Member State of origin to the country or the Member State of destination;
“spent fuel” means nuclear fuel that has been irradiated in and permanently removed from a reactor core; spent fuel may either be considered as usable resource that can be reprocessed or be destined for final disposal with no further use foreseen and shall be treated as radioactive waste;
“storage” means the holding of radioactive waste or spent fuel in a facility that provides for its containment, with the intention of retrieval;
“waste” in addition to what is said in the Act, means any thing, substance, product or object, whether in solid or liquid form, whether hazardous or otherwise, which the holder discards, or intends, or is required to discard, or any other which is deemed to be waste by the competent authority nominated

by the Minister responsible for the environment under article
6 of the Act;
(2) All other terms shall have the same meaning as that assigned to them in regulation 3 of the Nuclear Safety and Radiation Protection Regulations, 2003.

(a) the country of origin or the country of destination or any country of transit is a Member State of the Community; and,
(b) the quantities and concentration of the consignment exceed the levels laid down in paragraphs (a) and (b) of sub- regulation (2) of regulation 18 of the Nuclear Safety and Radiation Protection Regulations, 2003.
(2) These regulations shall not apply to:
(a) shipments of disused sources sent to a supplier or to a manufacturer of radioactive sources or to a recognised installation;
(b) shipments of radioactive materials recovered, through reprocessing, for further use; and
(c) transboundary shipments of waste that contain only naturally occurring radioactive material which does not arise from practices.
(3) These regulations shall not affect the right of a Member State or of an undertaking in that Member State to which radioactive waste is to be shipped for processing, or for other material which is to be shipped with the purpose to recover the radioactive waste, to return the radioactive waste after treatment to its country of origin.
(4) These regulations shall not affect the right of a Member State or of an undertaking in that Member State, to which spent fuel is to be shipped for reprocessing, to return to its
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Applicability.

L.N. 44 of 2003

.

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country of origin radioactive waste recovered from the reprocessing operation.
(5) Without prejudice to the competence of each Member State to define its own spent fuel cycle policy, these regulations shall not affect the right of a Member State to export spent fuel for reprocessing, taking into account the principles of the nuclear common market, in particular the free movement of goods:
Provided that those shipments and exports shall be supervised and controlled in accordance with the procedures laid down in these regulations.
(6) These regulations shall not affect the right of a
Member State to safely return to its country of origin:
(a) shipments of radioactive waste and spent fuel which fall under the scope of these regulations but which were not duly authorised in accordance with these regulations; and
(b) radioactively contaminated waste or material containing a radioactive source where this material has not been declared as radioactive waste by the country of origin.
(7) These regulations shall be without prejudice to rights and obligations under international law and shall apply without prejudice to existing provisions, such as nuclear safety and radiation protection requirements or specific legislation, in particular the Nuclear Safety and Radiation Protection Regulations, 2003.

Use of a standard document.

(a) Section A-1 to A-6 of Schedule 1 to these regulations shall be completed for shipments of radioactive waste;
(b) Section B-1 to B-6 of Schedule 1 to these regulations shall be completed for shipments of spent fuel, including that destined for final disposal and as such categorised as waste;
(c) Section A-1 or B-1 of Schedule 1 to these regulations shall be used for the application for authorisation of shipments

and shall be completed by the applicant, depending on the type of the shipment:
Provided that the applicant shall be:
(i) the holder in case of a shipment between Member States (type MM) or an export from the Community into a third country (type ME);
(ii) the consignee in case of an import into the
Community from a third country (type IM);
(iii) the person responsible for the shipment in the Member State by which the radioactive waste or spent fuel enters the Community in case of a transit through the Community (type TT).
(d) Section A-2 or B-2 of Schedule 1 to these regulations shall be used for the acknowledgement of receipt of application and shall be completed by the relevant competent authorities concerned, depending on the type of the shipment:
Provided that the competent authorities shall be:
(i) of origin in case of a shipment between Member States (type MM) or an export from the Community into a third country (type ME);
(ii) of destination in case of an import into the
Community from a third country (type IM); or
(iii) of transit where the shipment first enters the Community in case of a transit through the Community (type TT).
(e) Section A-3 or B-3 of Schedule 1 to these regulations shall be used for the refusal or consent and shall be completed by all competent authorities concerned.
(f) Section A-4a/A-4b or B-4a/B-4b of Schedule 1 to these regulations shall be used for the authorisation or refusal of shipment and shall be completed by the competent authority responsible for issuing the authorisation, depending on the type of the shipment:
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Provided that the competent authority responsible for issuing the authorisation shall be the competent authority of:
(i) the Member State of origin in case of a shipment between Member States (type MM) or an export from the Community into a third country (type ME);
(ii) the Member State of destination in case of an import into the Community from a third country (type IM); or
(iii) the first Member State of transit, where the shipment enters the Community in case of a transit through the Community (type TT).
(g) Section A-5 or B-5 of Schedule 1 to these regulations shall be used for the description of consignment and list of packages and shall be completed by the applicant:
Provided that the applicant shall be:
(i) the holder in case of a shipment between Member States (type MM) or an export from the Community into a third country (type ME);
(ii) the consignee in case of an import into the
Community from a third country (type IM); or
(iii) the person responsible for the shipment in the Member State by which the radioactive waste or spent fuel enters the Community in case of a transit through the Community (type TT).
(h) Section A-6 or B-6 of Schedule 1 to these regulations shall be used for the acknowledgement of receipt of the shipment and shall be completed by:
(i) the consignee in case of a shipment between Member States (type MM) or an import into the Community from a third country (type IM); or
(ii) the holder in case of an export from the
Community into a third country (type ME); or

(iii) the person responsible for the shipment in the Member State by which the radioactive waste or spent fuel enters the Community in case of a transit through the Community (type TT).
(2) The standard document shall be made available in electronic form, in the format presented in Schedule 1 to these regulations.
(3) The application for authorisation shall be completed and any further documents and information referred to in regulations
12, 19, 26, 29, 31, 32 and 33 hereof shall be supplied in a language that is acceptable to the competent authorities of the Member State to whom the application for authorisation is submitted in accordance with these regulations:
Provided that an authenticated translation shall be supplied by the holder at the request of the competent authorities of the country of destination or transit in a language acceptable to them.
(4) Any additional requirements for authorising a shipment shall be attached to the standard document.
(5) Without prejudice to any other accompanying documents required under other relevant legal provisions, the completed standard document certifying that the authorisation procedure has been duly complied with shall accompany each shipment falling under the scope of these regulations, including cases where the authorisation relates to more than one shipment in a single document.
(6) These documents shall be available to the competent authorities of the country of origin and destination and any country of transit.

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Consultation with the Radiation Protection Board.

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Classification system

for shipments.

Application for authorisation of shipment.

(1) Intra-Community shipment originating from Malta: any shipment of radioactive waste or spent fuel carried out where the country of origin is Malta and the country of destination is another Member State; or
(2) Intra-Community shipment transiting through Malta: any shipment of radioactive waste or spent fuel carried out where the country of origin and the country of destination are Member States and Malta is a country of transit; or
(3) Intra-Community shipment destined to Malta: any shipment of radioactive waste or spent fuel carried out where the country of destination is Malta and the country of origin is another Member State; or
(4) Extra-Community shipment originating from Malta: any shipment of radioactive waste or spent fuel carried out where the country of origin is Malta and the country of destination is a third country; or
(5) Extra-Community shipment transiting through Malta: any shipment of radioactive waste or spent fuel carried out where the country of origin and, or the country of destination are third countries and Malta is a country of transit; or
(6) Extra-Community shipment destined to Malta: any shipment of radioactive waste or spent fuel carried out where the country of origin is a third country and the country of destination is Malta.

shipment of radioactive waste or spent fuel or to arrange for such a shipment to be carried out shall submit a duly completed application for authorisation to the Competent Authority, as competent authority of the Member State of origin.
(2) The application may be sent in respect of more than one shipment, provided that:
(a) the radioactive waste or the spent fuel to which it relates essentially shall have the same physical, chemical and radioactive characteristics; and
(b) the shipments shall be made from the same holder to the same consignee and involve the same competent authorities, and
(c) where shipments involve transit through third countries, such transit shall be via the same frontier post of entry to and, or exit from the Community and via the same frontier post(s) of the third country or countries concerned, unless otherwise agreed between the competent authorities concerned.

(2) The Competent Authority, as competent authority of the Member State of origin, shall take the necessary measures to ensure that all information regarding shipments covered by these regulations shall be handled with due care and protected against any misuse.

(2) In case the application is duly completed, the competent authorities of the Member State of destination shall send an acknowledgement of receipt of application to the Competent Authority, as competent authority of the Member State of origin, and copy it to the other competent authorities concerned, not later
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Transmission of the application to the competent authorities.

Acknowledgement of receipt of application and request for information.

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Consent and refusal.

than ten days after expiry of the twenty day period set out in sub- regulation (1) hereof.
(3) If any of the competent authorities of the Member States concerned considers that the application is not duly completed, it shall request the missing information from the Competent Authority, as competent authority of the Member State of origin, and it shall inform the other competent authorities of such request:
Provided that this request shall be made not later than the expiry of the period set out in sub-regulation (1) hereof.
(4) The Competent Authority, as competent authority of the Member State of origin, shall transmit the requested information to the competent authorities concerned.
(5) Not later than ten days after the date of receipt of the missing information and not earlier than after expiry of the twenty days period set out in sub-regulation (1) of this regulation, the competent authorities of the Member State of destination shall send an acknowledgement of receipt of application to the Competent Authority, as competent authority of the Member State of origin, and they shall copy it to the other competent authorities concerned.
(6) The time periods set out in sub-regulations (1), (2), (3), (4) and (5) hereof for issuing the acknowledgement of receipt of application may be shortened if the competent authorities of destination and transit are satisfied that the application is duly completed.

Provided that the competent authorities of the Member State of destination or of any Member State of transit may request a further period of not more than one month in addition to the period referred to in sub-regulation (1) hereof to make their position known.

(2) If upon expiry of the periods set out in sub-regulation (1) hereof, no reply has been received from the competent authorities of the Member State of destination and, or the intended Member State of transit, those countries shall be deemed to have given their consent for the shipment requested.
(3) Reasons shall be given by competent authorities for any refusal to grant consent, or for conditions attached to their consent, which shall be based:
(a) for the competent authorities of the Member States of transit, on the relevant national, Community or international legislation applicable to the transport of radioactive material;
(b) for the competent authorities of the Member State of destination, on relevant legislation applicable to the management of radioactive waste or spent fuel or on relevant national, Community or international legislation applicable to the transport of radioactive material:
Provided that any conditions imposed by the competent authorities of the Member States of transit or of destination, may not be more stringent than those laid down for similar shipments within those Member States.
(4) The competent authorities of the Member States of transit which gave consent to transit for a given shipment may not refuse to give consent to reshipment in the following cases:
(a) when the initial consent concerned material being shipped for treatment or reprocessing purposes, if the reshipment concerns radioactive waste or other products equivalent to the original material after treatment or reprocessing, and all relevant legislation is respected;
(b) under the circumstances described in regulation 14 hereof, if the reshipment is undertaken on the same conditions and with the same specifications.

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Authorisation of shipments.

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Acknowledgement of receipt of the shipment.

Shipment failure.

(2) The authorisation referred to in sub-regulation (1) hereof shall not in any way affect the responsibility of the holder, the transporters, the owner, the consignee or any other natural or legal person involved in the shipment.
(3) A single authorisation may cover more than one shipment, where the conditions set out in sub-regulation (2) of regulation 8 hereof are met.
(4) Any authorisation shall be valid for a period of not more than three years:
Provided that, when establishing this period of validity, the Competent Authority as competent authority of the Member State of origin, shall take into account any conditions set out in the consent given by the Member States of destination or of transit.

(2) The competent authorities of the Member State of destination shall send copies of the acknowledgement of receipt of the shipment to the Competent Authority as competent authority of the Member State of origin, and the competent authorities of any Member State or third country of transit.
(3) The Competent Authority, as competent authority of the Member State of origin, shall send a copy of the acknowledgement of receipt of the shipment to the original holder.

Provided that such Member State shall forthwith inform the competent authorities of the other Member States involved in the shipment of this decision.
(2) Where a shipment cannot be completed or if the

conditions for shipment are not complied with in accordance with these regulations, the Competent Authority as competent authority of the Member State of origin, shall ensure that the radioactive waste or the spent fuel in question is taken back by the holder, unless an alternative safe arrangement can be made:
Provided that these competent authorities shall ensure that the person responsible for the shipment takes corrective safety measures where necessary.
(3) The holder shall be liable for costs arising in cases where the shipment cannot or may not be completed.

(2) The application may be sent in respect of more than one shipment, provided that:
(a) the radioactive waste or the spent fuel to which it relates essentially shall have the same physical, chemical and radioactive characteristics;
(b) the shipments shall be made from the same holder to the same consignee and involve the same competent authorities, and
(c) where shipments involve transit through third countries, such transit shall be via the same frontier post of entry to and, or exit from the Community and via the same frontier post(s) of the third country or countries concerned, unless otherwise agreed between the competent authorities concerned.

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Application for authorisation of shipment.

Transmission of the application to the competent authorities.

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Acknowledgement of receipt of application and request for information.

Member State of destination, the Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any.
(2) The Competent Authority, as competent authority of the Member State of transit, shall take the necessary measures to ensure that all information regarding shipments covered by these regulations shall be handled with due care and protected against any misuse.

(2) In case the application is duly completed, the competent authorities of the Member State of destination shall send an acknowledgement of receipt of application to the competent authorities of the Member State of origin and they shall copy it to the Competent Authority, as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, not later than ten days after expiry of the twenty days period set out in sub-regulation (1) of this regulation.
(3) If any of the competent authorities of the Member States concerned consider that the application is not duly completed, they shall request the missing information from the competent authorities of the Member State of origin and inform the Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, of such request:
Provided that this request shall be made not later than the expiry of the period set out in sub-regulation (1) of this regulation.
(4) The competent authorities of the Member State of origin shall transmit the requested information to the competent authorities concerned.
(5) Not later than ten days after the date of receipt of the missing information and not earlier than after expiry of the twenty day period set out in sub-regulation (1) hereof , the competent authorities of the Member State of destination shall send

an acknowledgement of receipt of application to the competent authorities of the Member State of origin and shall copy it to the Competent Authority, as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any.
(6) The time periods set out in sub-regulations (1), (2), (3), (4) and (5) hereof for issuing the acknowledgement of receipt of application may be shortened if the competent authorities of destination, Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, are satisfied that the application is duly completed.

Provided that the competent authorities of destination, the Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, may request a further period of not more than one month in addition to the period referred to in sub-regulation (1) hereof to make their position known.
(2) If upon expiry of the periods set out in sub-regulation (1) hereof, no reply has been received from the competent authorities of destination, the Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, those countries shall be deemed to have given their consent for the shipment requested.
(3) Reasons shall be given by the competent authorities for any refusal to grant consent, or for conditions attached to its consent, which shall be based:
(a) for the Competent Authority, as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, on the relevant
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Consent and refusal.

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Authorisation of shipments.

national, Community or international legislation applicable to the transport of radioactive material;
(b) for the competent authorities of destination, on relevant legislation applicable to the management of radioactive waste or spent fuel or on relevant national, Community or international legislation applicable to the transport of radioactive material:
Provided that any conditions imposed by the competent authorities of destination, the Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, may not be more stringent than those laid down for similar shipments within those Member States.
(4) The Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, which gave consent to transit for a given shipment may not refuse to give consent to reshipment in the following cases:
(a) when the initial consent concerned material being shipped for treatment or reprocessing purposes, if the reshipment concerns radioactive waste or other products equivalent to the original material after treatment or reprocessing, and all relevant legislation is respected; and
(b) under the circumstances described in regulation 21 hereof, if the reshipment is undertaken on the same conditions and with the same specifications.

(2) The authorisation referred to in sub-regulation (1) hereof shall not in any way affect the responsibility of the holder, the transporters, the owner, the consignee or any other natural or legal person involved in the shipment.

(3) A single authorisation may cover more than one shipment, where the conditions set out in sub-regulation (2) of regulation 15 hereof are met.
(4) Any authorisation shall be valid for a period of not more than three years:
Provided that, when establishing this period of validity, the Competent Authority, as competent authority of the Member State of transit, shall take into account any conditions set out in the consent given by the competent authorities of the Member State of destination, and the competent authorities of the other Member States of transit, if any.

(2) The competent authorities of the Member State of destination shall send copies of the acknowledgement of receipt of the shipment to the competent authorities of the Member State of origin, the Competent Authority as competent authority of the Member State of transit, and the competent authorities of any other Member State or third country of transit, if any.
(3) The competent authorities of the Member State of origin shall send a copy of the acknowledgement of receipt of the shipment to the original holder.

Provided that such Member State shall forthwith inform the competent authorities of the other Member States involved in the shipment of this decision.
(2) Where a shipment cannot be completed or if the conditions for shipment are not complied with in accordance with
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Acknowledgement of receipt of the shipment.

Shipment failure.

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Application for authorisation of shipment.

Transmission of the application to the competent authorities.

these regulations, the competent authorities of the Member State of origin shall ensure that the radioactive waste or the spent fuel in question is taken back by the holder, unless an alternative safe arrangement can be made:
Provided that these competent authorities shall ensure that the person responsible for the shipment takes corrective safety measures where necessary.
(3) The holder shall be liable for costs arising in cases where the shipment cannot or may not be completed.

(2) The application may be sent in respect of more than one shipment, provided that:
(a) the radioactive waste or the spent fuel to which it relates essentially shall have the same physical, chemical and radioactive characteristics; and
(b) the shipments shall be made from the same holder to the same consignee and involve the same competent authorities, and
(c) where shipments involve transit through third countries, such transit shall be via the same frontier post of entry to and, or exit from the Community and via the same frontier post(s) of the third country or countries concerned, unless otherwise agreed between the competent authorities concerned.

competent authority of the Member State of destination, and the competent authorities of the Member States of transit, if any.
(2) The Competent Authority, as competent authority of the Member State of destination, shall take the necessary measures to ensure that all information regarding shipments covered by these regulations shall be handled with due care and protected against any misuse.

(2) In case the application is duly completed, the Competent Authority, as competent authority of the Member State of destination, shall send an acknowledgement of receipt of application to the competent authorities of the Member State of origin and copy it to the other competent authorities concerned, not later than ten days after expiry of the twenty day period set out in sub-regulation (1) hereof.
(3) If any of the competent authorities of the Member States concerned consider that the application is not duly completed, they shall request the missing information from the competent authorities of the Member State of origin and inform the other competent authorities of such request:
Provided that this request shall be made not later than the expiry of the period set out in sub-regulation (1) of this regulation.
(4) The competent authorities of the Member State of origin shall transmit the requested information to the competent authorities concerned.
(5) Not later than ten days after the date of receipt of the missing information and not earlier than after expiry of the twenty day period set out in sub-regulation (1) hereof, the Competent Authority as competent authority of the Member State of destination, shall send an acknowledgement of receipt of application to the competent authorities of the Member State of origin and copy it to the other competent authorities concerned.
(6) The time periods set out in sub-regulations (1), (2),
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Acknowledgement of receipt of application and request for information.

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Consent and refusal.

(3), (4) and (5) hereof for issuing the acknowledgement of receipt of application may be shortened if the Competent Authority as competent authority of the Member State of destination, and the competent authorities of transit are satisfied that the application is duly completed.

Provided that the Competent Authority as competent authority of the Member State of destination, and the competent authorities of any Member State of transit may request a further period of not more than one month in addition to the period referred to in the sub-regulation (1) hereof to make their position known.
(2) If upon expiry of the periods set out in sub-regulation (1) hereof, no reply has been received from the Competent Authority as competent authority of the Member State of destination, and/or the competent authorities of the intended Member State of transit, those countries shall be deemed to have given their consent for the shipment requested.
(3) Reasons shall be given by the competent authorities for any refusal to grant consent, or for conditions attached to its consent, which shall be based:
(a) for the competent authorities of the Member States of transit, on the relevant national, Community or international legislation applicable to the transport of radioactive material;
(b) for the Competent Authority, as competent authority of the Member State of destination, on relevant legislation applicable to the management of radioactive waste or spent fuel or on relevant national, Community or international legislation applicable to the transport of radioactive material:
Provided that any conditions imposed by the competent authorities of the Member States of transit or the Competent Authority as competent authority of the Member State of destination, may not be more stringent than those laid down for similar shipments within those Member States.

(4) The competent authorities of the Member State or States of transit which gave consent to transit for a given shipment may not refuse to give consent to reshipment in the following cases:
(a) when the initial consent concerned material being shipped for treatment or reprocessing purposes, if the reshipment concerns radioactive waste or other products equivalent to the original material after treatment or reprocessing, and all relevant legislation is respected;
(b) under the circumstances described in regulation 28 hereof, if the reshipment is undertaken on the same conditions and with the same specifications.

(2) The authorisation referred to in sub-regulation (1) hereof shall not in any way affect the responsibility of the holder, the transporters, the owner, the consignee or any other natural or legal person involved in the shipment.
(3) A single authorisation may cover more than one shipment, where the conditions set out in sub-regulation (2) of regulation 22 hereof are met.
(4) Any authorisation shall be valid for a period of not more than three years:
Provided that, when establishing this period of validity, the Competent Authority shall take into account any conditions set out in the consent given by the Competent Authority as competent authority of the Member State of destination, or the competent authorities of the Member States of transit.

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Authorisation of shipments.

Acknowledgement of receipt of the shipment.

B 598

Shipment failure.

Exports out of Malta.

(2) The Competent Authority as competent authority of the Member State of destination, shall send copies of the acknowledgement of receipt of the shipment to the competent authorities of the Member State of origin and any Member State or third country of transit.
(3) The competent authorities of the Member State of origin shall send a copy of the acknowledgement of receipt of the shipment to the original holder.

Provided that such Member State shall forthwith inform the competent authorities of the other Member States involved in the shipment of this decision.
(2) Where a shipment cannot be completed or if the conditions for shipment are not complied with in accordance with these regulations, the competent authorities of the Member State of origin shall ensure that the radioactive waste or the spent fuel in question is taken back by the holder, unless an alternative safe arrangement can be made:
Provided that these competent authorities shall ensure that the person responsible for the shipment takes corrective safety measures where necessary.
(3) The holder shall be liable for costs arising in cases where the shipment cannot or may not be completed.

Provided that the application may be sent in respect of more than one shipment, under the conditions set out in sub- regulation (2) of regulation 8 hereof.
(2) The Competent Authority as competent authority of the Member State of origin, shall:
(a) notify the competent authorities of the country of destination of the planned shipment and ask their consent; and
(b) send the application referred to in sub-regulation (1) hereof for consent to the competent authorities of the Member States of transit, if any:
Provided that regulation 10 of these regulations shall apply.
(3) If all the consents necessary for shipment have been given, the Competent Authority as competent authority of the Member State of origin, shall be entitled to authorise the holder to carry out the shipment and shall inform the competent authorities of the third country of destination and of any Member State or third country of transit accordingly:
Provided that sub-regulations (2), (3) and (4) of regulation
12 hereof shall apply.
(4) The holder shall notify the Competent Authority as competent authority of the Member State of origin, that the radioactive waste or spent fuel has reached its destination in the third country within fifteen days of the date of arrival and shall indicate the last customs post in the Community through which the shipment passed:
Provided that the notification shall be substantiated by a declaration or certification by the consignee stating that the radioactive waste or spent fuel has reached its proper destination and indicating the customs post of entry in the third country.
(5) The Competent Authority, as competent authority of the Member State of origin, or the competent authorities of any Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with these regulations, or are not in accordance with the authorisations or consents issued pursuant to these regulations:
B 599

B 600

Prohibited exports.

Transit through the Community where Malta is the first Member State of transit.

Provided that such competent authorities of Member State of transit shall forthwith inform the Competent Authority, as competent authority of the Member State of origin, of this decision:
Provided also that sub-regulations (2) and (3) of regulation
14 hereof, shall apply.

(a) to a destination south of latitude 60° south; or
(b) to a State which is party to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States of the one part, and the European Community and its Member States, of the other part, (Cotonou ACP-EC Agreement) which is not a Member State, without prejudice to sub-regulations (3) and (4) of regulation 4 hereof, or
(c) to a third country which does not, in the opinion of the Competent Authority as competent authority of the Member State of origin, in accordance with the criteria referred to in sub-regulation (1) (b) of this regulation, have the administrative and technical capacity and regulatory structure to manage the radioactive waste or spent fuel safely, as stated in the Joint Convention:
Provided that in coming to an opinion on this issue, the Competent Authority as competent authority of the Member State of origin, shall take duly into account any relevant information from the competent authorities of other Member States.

Competent Authority, as competent authority of the first Member
State of transit:
Provided that the application may be sent in respect of more than one shipment, under the conditions set out in sub- regulation (2) of regulation 15 hereof.
Provided also that the application shall include evidence that the consignee established in the third country has made an arrangement with the holder established in the third country, and accepted by the competent authorities of that third country, obliging that holder to take back radioactive waste or the spent fuel where a shipment cannot be completed in accordance with these regulations, as provided for in sub-regulation (5) of this regulation.
(2) The Competent Authority as competent authority of the first Member State of transit, shall send the application referred to in sub-regulation (1) hereof for consent to the competent authorities of other Member States of transit, if any.
Provided that regulations 17 and 18 hereof shall apply. (3) If all the consents necessary for shipment have been
granted, the Competent Authority as competent authority of the first
Member State of transit, shall be entitled to authorise the person responsible referred to in sub-regulation (1) hereof to carry out the shipment and shall inform the competent authorities of any other Member State or third country of transit or of origin accordingly:
Provided that sub-regulations (2), (3) and (4) of regulation
19 hereof shall apply.
(4) The person responsible referred to in sub-regulation (1) hereof shall notify the Competent Authority as competent authority of the first Member State of transit, that the radioactive waste or spent fuel has reached its destination in the third country within fifteen days of the date of arrival and shall indicate the last customs post in the Community through which the shipment passed:
Provided that the notification shall be substantiated by a declaration or certification by the consignee stating that the radioactive waste or spent fuel has reached its proper destination and indicating the customs post of entry in the third country.
B 601

B 602

Transit through the Community where Malta is not the first Member State of transit.

(5) The competent authorities of a Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with these regulations, or are not in accordance with the authorisations or consents issued pursuant to these regulations:
Provided that such Member State shall forthwith inform the competent authorities of the country of origin of this decision:
Provided also that the person responsible referred to in sub-regulation (1) of this regulation shall be liable for costs arising in cases where the shipment cannot or may not be completed.

Provided that the application may be sent in respect of more than one shipment, under the conditions set out in sub- regulation (2) of regulation 15 hereof:
Provided also that the application shall include evidence that the consignee established in the third country has made an arrangement with the holder established in the third country, and accepted by the competent authorities of that third country, obliging that holder to take back radioactive waste or the spent fuel where a shipment cannot be completed in accordance with these regulations, as provided for in sub-regulation (5) hereof.
(2) The competent authorities of the first Member State of transit shall send the application referred to in sub-regulation (1) hereof for consent to the Competent Authority, as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any:
Provided that regulations 17 and 18 hereof shall apply. (3) If all the consents necessary for shipment have been
granted, the competent authorities of the first Member State of transit

shall be entitled to authorise the person responsible referred to in sub-regulation (1) hereof to carry out the shipment and shall inform the Competent Authority as competent authority of the Member State of transit, the competent authorities of any other Member State or third country of transit or of origin accordingly:
Provided that sub-regulations (2), (3) and (4) of regulation
19 hereof shall apply.
(4) The person responsible referred to in sub-regulation (1) hereof shall notify the competent authorities of the first Member State of transit that the radioactive waste or spent fuel has reached its destination in the third country within fifteen days of the date of arrival and shall indicate the last customs post in the Community through which the shipment passed:
Provided that the notification shall be substantiated by a declaration or certification by the consignee stating that the radioactive waste or spent fuel has reached its proper destination and indicating the customs post of entry in the third country.
(5) The Competent Authority as competent authority of the Member State of transit, and the competent authorities of the other Member States of transit, if any, may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with these regulations, or are not in accordance with the authorisations or consents issued pursuant to these regulations:
Provided that such Member State shall forthwith inform the competent authorities of the country of origin of this decision:
Provided also that the person responsible referred to in sub-regulation (1) hereof shall be liable for costs arising in cases where the shipment cannot or may not be completed.

B 603

Imports into Malta.

B 604
submit an application for authorisation to the Competent Authority as competent authority of the Member State of destination:
Provided that the application may be sent in respect of more than one shipment, under the conditions set out in sub- regulation (2) of regulation 22 hereof.
Provided also that the application shall include evidence that the consignee has made an arrangement with the holder established in the third country, and which has been accepted by the competent authorities of that third country, obliging that holder to take back the radioactive waste or the spent fuel where a shipment cannot be completed in accordance with these regulations, as provided for in sub-regulation (5) of this regulation.
(2) The Competent Authority as competent authority of the Member State of destination, shall send the application referred to in sub-regulation (1) hereof for consent to the competent authorities of the Member States of transit, if any:
Provided that regulations 24 and 25 hereof shall apply. (3) If all the consents necessary for the shipment have
been granted, the Competent Authority as competent authority of
the Member State of destination, shall be entitled to authorise the consignee to carry out the shipment and shall inform the competent authorities of any Member State or third country of origin or of transit accordingly:
Provided that sub-regulations (2), (3) and (4) of regulation
26 hereof shall apply.
(4) Within fifteen days of receipt of the shipment, the consignee shall send the Competent Authority, as competent authority of the Member State of destination, an acknowledgement of receipt of each shipment:
Provided that the Competent Authority as competent authority of the Member State of destination, shall send copies of the acknowledgement to the country of origin and to any Member State or third country of transit.
(5) The Competent Authority as competent authority of the Member State of destination, or the competent authorities of any

Member State of transit may decide that the shipment may not be completed if the conditions for shipment are no longer complied with in accordance with these regulations, or are not in accordance with the authorisations or consents issued pursuant to these regulations:
Provided that such Member State shall forthwith inform the competent authorities of the country of origin of this decision.
(6) The consignee shall be liable for costs arising in cases where the shipment cannot or may not be completed.

(a) he fails to comply with any provisions of these regulations or fails to comply with permit conditions or with any order lawfully given in terms of any provision of these regulations; or
(b) he contravenes any restriction, prohibition or requirement imposed by or under these regulations; or
(c) he acts in contravention of any of the provisions of these regulations; or
(d) he conspires, attempts, aids, or abets, any other person by whatever means, including advertising, counselling or procurement to contravene the provisions of these regulations or to fail to comply with any such provisions (including any order lawfully given in terms of any of the provisions of these regulations) or to contravene any restriction, prohibition or requirement imposed by or under the said regulations.

(a) on a first conviction, to a fine (multa) of not less than one thousand and one hundred and sixty-four euro and sixty-nine cents (€1,164.69), but not exceeding two thousand and three hundred and twenty-nine euro and thirty-seven cents (€2,329.37);
B 605

Offences under these regulations.

Penalties.

B 606

Applicability of the Criminal Code. Cap. 9.

Revokes L.N. 338 of

2001.

(b) on a second conviction or subsequent convictions, to a fine (multa) of not less than two thousand and three hundred and twenty-nine euro and thirty-seven cents (€2,329.37), but not exceeding four thousand and six hundred and fifty-eight euro and seventy-five cents (€4,658.75), or to imprisonment for a term not exceeding two years, or to both such fine and imprisonment:
Provided that whenever any person is found guilty of committing an offence under these regulations by means of a vehicle, the owner of the said vehicle, where applicable, is held liable in the same manner and degree:
Provided also that the court may order any person who has been found guilty of committing an offence against these regulations to pay for the expenses incurred by the Competent Authority mentioned in these regulations as a result of the said offence, the revocation of the permit issued by the Competent Authority and the confiscation of the corpus delicti, including the vehicle, if applicable.
36. (1) The provisions of articles 23 and 30 of the Criminal Code shall, mutatis mutandis, apply to proceedings in respect of offences against these regulations, so however that the disqualification from holding or obtaining a licence, permit or authority shall in no case be for less than one year.
(2) Notwithstanding the provisions of article 370 of the Criminal Code, proceedings for an offence against these regulations shall be held before the Court of Magistrates (Malta) or the Court of Magistrates (Gozo), as the case may be, and shall be in accordance with the provisions of the Criminal Code regulating the procedure before the said courts as courts of criminal judicature.
(3) Notwithstanding the provisions of the Criminal Code, the Attorney General shall always have a right of appeal to the Court of Criminal Appeal from any judgement given by the Court of Magistrates (Malta) or the Court of Magistrates (Gozo) in respect of proceedings for any offence against these regulations.

Waste Regulations, 2001 are hereby being revoked.

B 607

Registration No:

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 608

B 609

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

SECTION A-2

2 In case of a Type MM or type ME shipment

3 In case of a Type IM shipment

4 In case of a Type TT shipment

5 Not required by the Directive, Country of origin may be consulted on a voluntary basis in case of Type

TT and IM shipments.

B 610

Registration No:

SECTION A-3

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

6 Not required by the Directive, country of origin may be consulted on a voluntary basis in case of Type

TT and IM shipments.

7 In case of a Type MM or ME shipment

8 In case of Type MM, IM, ME or TT shipments, if one or more Member States of transit are concerned.

B 611

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

9 This authorisation in no way diminishes the responsibility of the holder, carrier, owner, consignee or any other physical or legal person concerned in the shipment.

B 612

Registration No:

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 613

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

SECTION A-5

10 According to Regulations for the Safe Transport of Radioactive Material 2005 Edition, Safety

Requirements TS-R-1 , IAEA, Vienna, 2005

B 614

Registration No:

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 615

B 616

Registration No:

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 617

11 According to Regulations for the Safe Transport of Radioactive Material 2005 Edition, Safety

Requirements TS-R-1, IAEA, Vienna, 2005

B 618

Registration No:

SECTION B-2

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

12 In case of a Type MM or type ME shipment

13 In case of a Type IM shipment

14 In case of a Type IM or TT shipment

15 Not required by the Directive, Country of origin may be consulted on a voluntary basis in case of Type

TT and IM shipments

B 619

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

SECTION B-3

16 Not required by the Directive, Country of origin may be consulted on a voluntary basis in case of Type

TT and IM shipments.

17 In case of a Type MM or ME shipments

18 In case of Type MM, IM, ME or TT shipment, if one or more Member States of transit are concerned.

B 620

Registration No:

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

19 This authorisation in no way diminishes the responsibility of the holder, carrier, owner, consignee or any other physical or legal person concerned in the shipment.

B 621

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 622

Registration No:

SECTION B-5

(To be completed by the competent authority responsible for issuing the shipments authorisation.)

20 According to Regulations for the Safe Transport of Radioactive Material 2005 Edition, Safety

Requirements TS-R-1, IAEA, Vienna, 2005

B 623

Registration No: (To be completed by the competent authority responsible for issuing the shipments authorisation.)

B 624

B 625

Definition of a duly completed application: An application for the authorisation of a shipment of radioactive waste or spent fuel is duly completed in accordance with Directive 2006/117/Euratom, if – in case of shipments of radioactive waste – each item of section A-1, or – in case of shipments of spent fuel – each item of section B-1, contains the required information, either by ticking the relevant box, deleting (=crossing out) the non-applicable option or filling in the relevant data and values. In case of an application for several shipments, items 8 and 9 may contain estimates.
(1) The applicant must duly complete all items 1 to 14. In item 1 tick one of the boxes as applicable to define the type of shipment and fill in the relevant frontier posts in case third countries are concerned in the shipment,
(a) Tick Type MM for shipments between Member States, eventually passing through one or more other Member States or third countries.
(b) Tick Type IM for shipments from a third country to a Member State (= import into the Community), bearing in mind, that the application must include evidence that the consignee has made an arrangement with the holder established in the third country, and which has been accepted by the competent authority of that third country, obliging that holder to take back the radioactive waste or spent fuel where a shipment cannot or may not be completed.
(c) Tick Type ME for shipments from a Member State to a third Country
(= export from the Community), or
(d) Tick Type TT for shipments from one third country to another third country passing one or more Member States, bearing in mind that the application must include evidence that the consignee established in the third country has made an arrangement with the holder established in the third country, and accepted by the competent authority of that third country, obliging that holder to take back radioactive waste or spent fuel where a shipment cannot or may not be completed.
(2) By ticking the relevant box, the applicant must state clearly whether the application covers only one shipment within a period of time (e.g. 05/2010, 2009 or
2010-2011) or whether the application covers more than one shipment within a period of time, but not more than a period of three years from the date of authorisation. A

B 626
single application may be sent in respect of more than one shipment, provided the following conditions are met as set out in Article 6(2) of the Directive 2006/117/ Euratom:
(a) the radioactive waste or spent fuel to which it relates essentially has the same physical, chemical and radioactive characteristics; and
(b) the shipments are to be made from the same holder to the same consignee and involve the same competent authorities, and
(c) where the shipments involve transit through third countries, such transit is made via the same frontier post of entry to and/or exit from the Community and via the same frontier post(s) of the third country or countries concerned, unless otherwise agreed between the competent authorities concerned.
(3) The applicant must fill in the relevant frontier posts in case one or more third countries are concerned in the shipment. These frontier posts must be identical for all shipments covered by the application unless otherwise agreed by the competent authorities.
(4) The applicant must fill in his/her trade name, address and contact details. The trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another. The applicant must tick the appropriate box to define his/her function, which is the following, depending on the type of shipment:
(a) the holder in case of a shipment between Member States (Type MM)
or an export from the Community into a third country (Type ME);
(b) the consignee in case of an import into the Community from a third country (Type IM);
(c) the person responsible for the shipment in the Member State by which the radioactive waste or spent fuel enters the Community in case of a transit through the Community (Type TT).
(5) The applicant must fill in the trade name, address and contact details of the location, where the radioactive waste or spent fuel is held before the shipment, which can be different from the address of the applicant.
(6) The applicant must fill in the trade name, address and contact details of the
consignee. In case of shipment type IM, this information is identical with item 4.

B 627
(7) The applicant must fill in the trade name, address and contact details of the location, where the radioactive waste or spent fuel will be held after the shipment, which can be different from the address of the consignee.
(8) The applicant must complete all fields either by ticking the appropriate box (more than one answer is possible) or filling in the specific characteristics and values of the radioactive waste or spent fuel. These values may be estimates in case of several shipments.
(9) The applicant must complete item 9, the values may be estimates.
(10) The applicant must tick and define the type of activity giving rise to the radioactive waste or spent fuel and tick the appropriate box(es) or specify any other activity. More than one answer is possible.
(11) The applicant must define the purpose of the shipment and tick the
appropriate box (only one answer is possible) or specify any other purpose.
(12) The applicant must list up, as planned, the different modes of transport foreseen for the shipment (road, rail, sea, air, inland waterway) and add accordingly the relevant point of departure, point of arrival and the planned carrier (if already known). Changes of this schedule at a later point during the application procedure are possible and should be notified to the competent authorities but do not require a new application for approval.
(13) The applicant must list up all countries concerned in the shipment, starting with the first Member State or third country where the radioactive waste or spent fuel is held and ending with the last Member State or third country, where it will be held after the completion of the shipment. Should the applicant whish to change the sequential list of countries, a new application is required.
(14) The applicant must declare who takes back the radioactive waste or spent fuel in case the shipment(s) cannot take place or if the conditions for shipment cannot be fulfilled. Where the shipment is of type IM or TT, the applicant must attach to the application evidence of an arrangement between the consignee in the Member State or third country of destination and the holder of the radioactive waste or spent fuel in the third country which has been approved by the competent authorities of the third country.
Having completed items 1 to 14 the applicant must send the section 1 of the standard document to the competent authority, which is responsible for issuing the authorisation for the shipment.
The competent authority responsible for issuing the shipment authorisation or refusal is the following, depending on the type of the shipment is:

B 628
• the competent authority of the Member State of origin in case of
shipments between Member States (Type MM) and exports out of the Community
(Type ME);
• the competent authority of the Member State of destination in case of
an import into the Community (Type IM);
• the competent authority of the first Member State of transit, where the shipment enters the Community in case of a transit through the Community (Type TT).
The relevant contact data can be retrieved from the electronic communication platform established and maintained by the Commission or from the published list of competent authorities.
(15) Immediately upon receipt of the application, the competent authority responsible for issuing the authorisation for the shipment must
(a) enter the registration number at the top of each section of the standard document, starting with section 1.
(b) verify that all items of section 1 have been duly completed by the applicant,
(c) complete item 15 of section 2 and make sufficient copies of sections
1, 2 and 3 for each Member State or Country concerned. Third countries of transit are consulted for information only.
(16) The competent authority responsible for the authorisation must
(a) complete, as appropriate, item 16 of section 2 (and 18 of section 3) for each competent authority of the Member States or Countries concerned as listed in item 13, whose consent is required for the shipment(s) to be authorised, and
(b) send the duly completed application (section 1) together with section
2 – without delay – for consent to each competent authority concerned named in item 16.
(17) Item 17 to be completed by the competent authority of the Member State(s) concerned. The date of the application and of receipt must be entered immediately upon receipt of the application. Within 20 days after the date of receipt the competent authority of the Member States concerned must verify, if the application is duly completed (all items 1 to 14 must be completed and no information may be

B 629
missing; some values may be estimates). Only 17(a) or 17(b) can apply, please delete as applicable.
(a) If the competent authority of the Member State(s) of transit, if any, or of destination consider the application not duly completed, they must complete item 17(a), delete item 17(b) and notify their request for missing information to the competent authority responsible for issuing the authorisation (referred to as in item 15). They have to clearly state, which information is missing (fill in or attach document). The competent authority requesting the missing information must send copies of section 2 to all other competent authorities of the Member States concerned referred to as in item 13 within a period of 20 days from the date of receipt of the application. The relevant contact data can be retrieved from the electronic communication platform established and maintained by the Commission or from the published list of competent authorities. If one Member State concerned considers the application not duly completed, the procedure is stopped. In this case, even if the competent authority of Member State of destination considers the application duly completed, they may not send an acknowledgement of receipt until the requested information has been received and no further request has been sent within 10 days after the receipt of the missing information. This procedure may be repeated until all missing information has been received and no further requests for missing information have been sent.
Not later than 10 days after expiry of the 20 days from the receipt of application, if no request for missing information has been received within the
20-days period and if the competent authority of the Member State concerned deems the application duly completed, it must send section 2 to the competent authority responsible for the authorisation as referred to as in item 15 and copies thereof to all other competent authorities of the Member States concerned as referred to as in item 13. The relevant contact data can be retrieved from the electronic communication platform established and maintained by the Commission or from the published list of competent authorities.
Shorter periods of time can be agreed between all competent authorities of the Member States concerned.
(b) In order to allow the competent authorities to request missing information within a period of 20 days after the receipt of the application, the competent authority of the Member State of destination must not issue their acknowledgement of receipt before the expiry of the 20 days deadline. Upon expiry of the 20-days deadline, if the competent authority of the Member States of destination consider the application duly completed and if either no other Member States are concerned or no other competent authority concerned requested missing information, it (the competent authority of the Member States of destination) must complete item 17(b).

B 630
(18) Immediately upon receipt of the acknowledgement of receipt of a duly completed application of the competent authority of the Member State of destination the competent authority responsible for the authorisation must verify if the deadlines have been respected, and complete item 18 of section 3 for each Member State concerned, as listed in item 13, whose consent is required for the shipment(s) to be authorised.
The competent authority concerned must make necessary additional entries in item 18.
(19) The competent authority responsible for the authorisation must fill in the general deadline for automatic approval, which applies to all Member States concerned. This expiry date is in general two months after the date of acknowledgement of receipt of the Member State of destination as referred to as in item 17(b). Then the competent authority responsible for the authorisation has to send section 3 on the consent or refusal to all Member States or Countries concerned.
Immediately upon receipt of section 3, any competent authority concerned must decide if a further period of time is needed to decide upon refusal or consent to the shipment. An additional period of up to one month may be requested by deleting the general deadline in item 19, filling in the new deadline and notifying the extended deadline to all competent authorities concerned.
(20) The competent authority concerned must give the application due consideration. Not later than the expiry of the deadline for the automatic approval, the competent authority concerned must complete item 20 and return the original copy of section 3 (scanned original if sent by e-mail) to the competent authority responsible for issuing the authorisation (as referred to as in item 15). In case consent is refused, reasons must be given and must be based (for Member States of Transit) on the relevant national, Community or international legislation applicable to the transport of radioactive material or - for Member States of destination - on relevant legislation applicable to the management of radioactive waste or spent fuel or on relevant national, Community or international legislation applicable to the transport of radioactive material. Any conditions imposed must not be more stringent than those laid down for similar shipments within Member States. Failure to complete and return the standard document by the due time shall be taken as deemed consent to the shipment application, subject to Article 9 (2) of Directive 2006/117/Euratom.
(21) The competent authority responsible for issuing the shipment authorisation must complete items 21 to 23, when all consents necessary for the shipment have been given by the competent authorities concerned, bearing in mind, that tacit consent is deemed to be given only provided that
(a) the acknowledgement of receipt has been received (at least) from the

B 631
competent authority of the Member State of destination (as referred to as in item
17(b), and
(b) no request for missing information have been left unanswered, and
(c) no reply (neither consent nor refusal) has been received within the applicable deadlines as referred to as in item 19 from the competent authorities concerned.
(22) The competent authority referred to as in item 21 must list up or attach, if space provided is not sufficient, all consents (incl. conditions) and refusals (incl. reasons) received, if any, from all competent authorities concerned.
(23) The competent authority referred to as in item 21 must
(a) complete item 23 bearing in mind that the maximum period of validity for the authorisation is three years and that a single authorisation may cover more than one shipment, where the conditions set out in Article 6(2) of the Directive 2006/117/Euratom are met,
(b) send the original of section 4a to the applicant together with the sections 1, 4a, 5 and 6 and
(c) send copies of section 4a to all other competent authorities concerned.
(24) The competent authority responsible for issuing the shipment authorisation must complete items 24 to 25, if at least one of the competent authorities concerned did not give their consent to the shipment.
(25) The competent authority as referred to in item 24 must list up or attach all consents and refusals received, including all conditions and reasons for refusal and send the original copy of section 4b to the applicant and copies of this section to all other competent authorities concerned.
(26) If the shipment(s) has(ve) been authorised and the applicant has received sections 4a, 5 and 6, he/she must duly complete item 26. In case the application covers several shipments, he/she must make sufficient copies of section 5 for each shipment.
(27) The applicant must tick the appropriate box, indicating whether the authorisation covers a single shipment or several shipments. In case of several shipments, the appropriate serial number must be filled in.
(28) Before each shipment the applicant must duly complete item 28 to 30

B 632
(even if the authorisation relates to several shipments). In this section, the values must not be estimates!
(29) The applicant must duly complete item 29 (list of packages) and indicate at the bottom the total number of packages, the total number of each type of package, the total net mass, the total gross mass and the total activity (GBq) of all packages. If the place provided in the document is not sufficient, please attach a separate list with the information requested.
(30) The applicant must complete item 30 (date of origin and declaration) before each shipment of radioactive waste of spent fuel (even if the authorisation relates to several shipments). Together with sections 1 and 4a, section 5 accompanies the radioactive waste or spent fuel while it is being shipped. The description of consignment and list of packages (section 5) is then attached to the section 6 (acknowledgement of receipt).
(31) The consignee (in case of MM and IM shipments), the holder (in case of ME shipments) or the person responsible for the shipment (in case of TT shipments) must duly complete items 31 to 35 (36, if applicable); any necessary additions being made by the applicant. However, a consignee located outside the European Community may acknowledge receipt of the radioactive waste or spent fuel by means of a declaration separate from the standard document.
(32) The consignee must duly complete the name, address and contact details of the place where the radioactive waste or spent fuel is held after the shipment.
(33) The consignee must complete item 33 (as referred to as in item 23) and indicate if the shipment received is the last shipment covered by the authorisation.
(a) In cases where the authorisation covers a single shipment of the types MM or IM, the consignee must complete section 6 within 15 days of receiving the radioactive waste or spent fuel and submit sections 5 and 6 to the competent authority of the Member State of destination. The competent authority of the Member State of destination then forward copies of sections 5 and 6 to the other competent authorities concerned (and, where appropriate, the original of these two sections to the competent authority who issued the authorisation). For shipments of the type MM, the competent authority of the Member State of origin must send a copy of the acknowledgement of receipt to the holder.
(b) In cases where the authorisation covers a single shipment of type ME or TT the applicant must ensure that the consignee located outside the European Community sends him section 5 and section 6 duly completed immediately on receipt of the radioactive waste or spent fuel. Section 6 may be replaced by a declaration on the part of the consignee providing at least the information contained in items 31to 36. Within 15 days after receipt of the radioactive waste

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or spent fuel, the applicant must forward section 5, section 6 (if the consignee did not use section 6, the applicant must complete it) and, where applicable, the consignee’s declaration, to the competent authority which issued the authorisation. This authority must then send copies of sections 5 and 6, and, where applicable, the consignee’s declaration, to the other competent authorities concerned.
(c) In cases where the authorisation covers several shipments of the types MM or IM, the consignee must complete section 6 after each shipment (having made several copies of a blank section 6 for this purpose) and submit this section directly to the competent authority which issued the authorisation. The consignee attaches section 5 relating to the same shipment.
(d) In cases where the authorisation covers several shipments of the types ME or TT the applicant must ensure that after each shipment the consignee located outside the European Communities completes for each shipment a (blank) copy of section 6 and returns it together with the appropriate section 5.
(34) The consignee must tick “not applicable” or complete item 34 for shipments of type ME or TT or attach a separate declaration and give the reference to the attachment
(35) The consignee must complete item 35 when the single shipment or all the shipments covered by the authorisation have been carried out. In cases where the authorisation covers several shipments the final acknowledgement of receipt is completed and submitted as if the authorisation were valid for a single shipment only except that:
(a) It is stated in item 30 of section 6 that the shipment in question is the last shipment covered by the authorisation.
(b) Any declaration made by a consignee located outside the European Communities must state that all the radioactive waste or spent fuel covered by the shipment authorisation has indeed arrived.
The consignee must send the section 6 (acknowledgement of receipt) together with section 5 depending on the type of shipment to the competent authority of the Member State of destination in case of Type MM or IM shipments, or to the applicant as referred to as in item 5 (section 1) in case of a Type ME or TT shipment. To provide an overview, the section 6 for each of the shipments covered by the authorisation must be attached to the final acknowledgement of receipt.
(36) The consignee must tick “not applicable” or complete item 36 in case of shipments of type ME or TT, or replace it by a separate declaration, referring to the attachment. The applicant must forward sections 5 and 6 to the authority which issued

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the authorisation. To provide an overview, the section 6 for each of the shipments covered by the authorisation must be attached to the final acknowledgement of receipt.

Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press <.. image removed ..>

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