reg 4 Justification of new classes or types of practice
(1) Subject to regulation 20B, a class or type of practice is “new” for the purposes of these Regulations if— (a) no practice in that class or type was carried out in the United Kingdom before 6th February 2018; or (b) a practice in that class or type was carried out in the United Kingdom before 6th February 2018 but in breach of a requirement not to carry out a practice in that class or type until that class or type had been found to be justified, and in either case the class or type of practice has not been found to be justified. (2) In these Regulations, “justified” in relation to a class or type of practice means that the individual or societal benefit resulting from the class or type of practice outweighs the health detriment that it may cause. (3) A “ justification decision ” for the purposes of these Regulations is a decision which— (a) is made by the Justifying Authority in the form specified in regulation 14, and which determines whether a class or type of practice is justified; and (b) in regulation 5(3) , 7 or 21C(4) , or for the purpose of determining whether a class or type of practice has been justified for the purpose of regulation 4(5), applies to the part of the United Kingdom in which it is proposed that the practice in question be carried out. (3A) In making a justification decision in respect of a class or type of practice involving occupational and public exposures, the Justifying Authority must take into account both categories of exposure. (3B) In making a justification decision in respect of a class or type of practice involving medical exposure, the Justifying Authority must take into account medical and, where relevant, occupational and public exposures. (4) A class or type of practice is “ found to be justified ” for the purposes of these Regulations if a justification decision has been made determining that it is justified. (5) No person shall carry out a practice, resulting in exposure to ionising radiation, belonging to a new class or type of practice unless regulation 7 (transitional arrangements) applies.