EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations are part of a package of measures to transpose Council Directive 2013/59/Euratom (OJ No. L13, 17.1.2014) laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. The Regulations extend to the whole of the United Kingdom.
Regulations 3 to 24 contain amendments to the Justification of Practices Involving Ionising Radiation Regulations 2004 (the “2004 Regulations”). In summary:
a
regulation 5 of these Regulations amends regulation 4 of the 2004 Regulations. It sets out a new definition of when a class or type of practice will be “new”, as well as what “justified” means in relation to a class or type of practice. It also sets out new requirements for the making of justification decisions in respect of classes or types of practice involving both occupational and public exposures and in respect of classes or types of practice involving medical exposure;
b
regulation 7 amends regulation 6 to add a requirement for the Justifying Authority to be functionally separate from all other persons concerned with the promotion or utilisation of practices in relation to which the Justifying Authority is exercising functions;
c
regulation 9 amends regulation 10 to require the Justifying Authority to consider carrying out a review of an existing class or type of practice where new and important evidence about it is acquired;
d
regulation 14 amends regulation 20 to prohibit practices involving the activation of materials used in toys or personal ornaments where that may increase their radioactivity. It also prohibits the import and export of such products and materials;
e
regulation 15 inserts new regulations 20A and 20B, which set out requirements relating to consumer products whose intended use would constitute a practice. They also describe when a class or type of practice involving activation of material in a consumer product is considered to be “new”;
f
regulation 16 amends regulation 21 to preserve an exemption from the requirement for justification at the class- or type-level for medical exposures that are permitted by the Ionising Radiation (Medical Exposure) Regulations 2017, but to exclude from the exemption imaging exposures carried out for non-medical purposes;
g
regulation 17 inserts new regulations 21A to 21G, which introduce specific requirements for persons carrying out non-medical imaging exposures not using medical radiological equipment (an “imaging practice”). Regulation 21C sets out a procedure for seeking a justification determination in respect of an imaging practice. New imaging practices must be subjected to this procedure before they can be carried out. Regulation 21D requires persons carrying out imaging practices either to ensure that each individual exposure is justified or to carry out regular reviews. Regulation 21E sets out the process for the granting of approvals to persons carrying out imaging practices and the establishing of specific requirements that are contained in those approvals. Regulation 21F sets out requirements for dose constraints for imaging practices. Regulation 21G imposes information and consent requirements on the carrying out of imaging practices;
h
regulation 19 inserts new regulation 23A, which obliges the Justifying Authority to establish an inspection programme and to ensure that the findings of inspections carried out under the programme are communicated to the persons concerned;
i
regulation 20 inserts new regulation 25A, which provides that the Crown cannot be criminally liable for a breach of any of the requirements of the 2004 Regulations;
j
regulation 22 inserts new regulation 28, which requires the Secretary of State to carry out a review of the 2004 Regulations at intervals not exceeding 5 years;
k
regulation 23 inserts new Schedule A1, which sets out further relevant information that is referenced in regulation 20A of the 2004 Regulations.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.