reg 5 Amendment of regulation 4 (justification of new classes and types of practice)
(1) Regulation 4 is amended as follows. (2) For paragraph (1) substitute— (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. (3) For paragraph (2) substitute— (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. (4) In paragraph (3)(b) for “or 7” substitute “, 7 or 21C(4)”. (5) After paragraph (3) insert— (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.