The Shipments of Radioactive Substances (EU Exit) Regulations 2019
Commencement: Exit day
Revokes: Council Regulation (Euratom) 1493/93
These Regulations replace and revoke the directly acting Council Regulation (Euratom) 1493/93 on shipments of radioactive substances between Member States (the Euratom Regulation) in the UK. The entry to this Regulation on LUS can be found here.
They come into force the day the UK leaves the European Union (EU) and are only applicable in the event of a no-deal Brexit scenario.
The Euratom Regulation requires that shipments of radioactive sources between Member States are controlled and documented. Due to the UK leaving the EU, the Euratom Regulation needs to be replaced with domestic legislation.
The requirements held within the Euratom Regulation are retained within these Regulations. However, as a result of the UK no longer being a Member State within the EU, updates are required to ensure the system in place continues to function.
The Regulations apply to shipments from EU Member States into the UK of sealed sources* whenever the quantities and concentrations exceed the levels stated in Table B of Annex VII of Council Directive 2013/59/Euratom (The Basic Safety Standards Directive 2013).
*Sealed sources has the meaning stated in the Basic Safety Standards Directive 2013 which is:
a radioactive source in which the radioactive material is permanently sealed in a capsule or incorporated in a solid form with the objective of preventing, under normal conditions of use, any dispersion of radioactive substances.
Note that the Regulations only apply to sealed sources and not to unsealed sources as the Euratom Regulation does. This is because the duty that applied to unsealed sources has been removed (see below information in the duties section). Unsealed sources are often test vials and powders, which tend to be lower activity and are safe to be unsealed.
These Regulations do not place any additional requirements or obligations on industry or regulators than those that were required under Council Regulation (Euratom) 1493/93 and ensure the UKs robust safety standards are maintained.
For shipments into the UK from EU Member States after Brexit:
Prior written declarations (declaration of compliance)
Before any shipment of sealed sources can take place, source holders are required to obtain a prior written declaration from the consignee of the source (the source receiver).
Prior written declarations are still to be made by consignees, however these now only apply to imports from the EU into the UK only. Previously, under the Euratom Regulation, prior written declarations had to be made on imports to the UK from the EU and exports from the UK to the EU. Therefore, prior written declarations are no longer required when shipping sealed radioactive sources to the EU.
The consignee (which means any person to who the material is going to be shipped) must complete a prior written declaration on a standard form that confirms the consignee has complied in full with all relevant national requirements in the UK for the safe storage, use or disposal of those sources. This is known as a declaration of compliance. The standard form is available here.
The consignee must send the completed declaration of compliance to the competent authority, who are the following:
- in England, the Environment Agency;
- in Scotland, the Scottish Environment Protection Agency;
- in Wales, the Natural Resources Body for Wales; and
- in Northern Ireland, the Chief Inspector.
Upon receipt of a declaration of compliance, the competent authority must send a written acknowledgement of receipt to the consignee. The declaration of compliance and acknowledgement of receipt must then be sent by the consignee to the source holder before the shipment can take place.
Note the holder means any person who has the legal responsibility under the applicable national law for the sealed sources to be contained in the shipment.
The declaration is valid for 3 years from the date the acknowledgement of receipt is sent by the competent authority. Any existing written declarations for shipments from the EU to the UK stamped prior to exit day under the provisions of the Euratom Regulation, and which have not reached the end of their 3 year lifespan, will continue to be recognised as valid after the UK leaves the EU.
The declaration issued can refer to multiple shipments if:
- the sealed sources have the same physical and chemical characteristics;
- the sealed sources do not exceed the levels of activity set out in the declaration; and
- the shipments are made from the same holder to the same consignee and involve the same competent authorities.
Note that the position in relation to UK exports into the EU sits within the EUs competence after the UK leaves the EU.
The requirement on holders to submit a quarterly return to the competent authorities in the Member State of destination detailing all of the shipments made during the preceding quarter has been removed within these Regulations. This requirement is set out in Article 6 of the Euratom Regulation. This is due to the fact that the UK cannot place an obligation on EU source holders to submit a quarterly return to a UK based competent authority.
Note that the requirement to submit quarterly returns applied to sealed and unsealed sources under the Euratom Regulation. This was the only duty specified for unsealed sources. As this requirement has been removed this means these Regulations therefore only apply to sealed sources.
Exporting from the UK to the EU
The UK no longer requires UK exporters to make a prior written declaration when shipping sealed radioactive sources to the EU.
UK exporters to the EU should seek guidance from the European Commission and EU countries on any requirements they must comply with before shipping.
Note there is no change to the processes for shipments of radioactive sources between the UK and the rest of the world.
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