Deregulation Act 2015

Establishment of common regulatory system

3 For section 2 substitute—

“2 Regulated substances and reportable substances

(1) This section defines some key terms used in this Act.

(2) “Regulated substance” means a regulated explosives precursor or regulated poison.

(3) Subject to subsection (4), a “regulated explosives precursor”—

(a) is a substance listed in Part 1 of Schedule 1A in a concentration higher than the limit set out for that substance in that Part, and

(b) includes a mixture or another substance in which a substance listed in that Part is present in a concentration higher than the relevant limit,

but, in each case, only if the substance or mixture is not excluded.

(4) For the purposes of section 3C however, and the meaning of “regulated substance” in or in relation to that section, a “regulated explosives precursor”—

(c) is a substance listed in Part 1 of Schedule 1A, and

(d) includes a mixture or another substance in which a substance listed in that Part is present,

but, in each case, only if the substance or mixture is not excluded.

(5) A “regulated poison”—

(a) is a substance listed in Part 2 of Schedule 1A in a concentration higher than the limit (if any) set out for that substance in that Part, and

(b) includes a mixture or another substance in which a substance listed in that Part is present in a concentration higher than the relevant limit,

but, in each case, only if the substance or mixture is not excluded.

(6) “Reportable substance” means a reportable explosives precursor or a reportable poison.

(7) A “reportable explosives precursor”—

(a) is a substance listed in Part 3 of Schedule 1A, and

(b) includes a mixture or another substance in which a substance listed in that Part is present,

but, in each case, only if the substance or mixture is not excluded.

(8) A “reportable poison”—

(a) is a substance listed in Part 4 of Schedule 1A in a concentration higher than the limit (if any) set out for that substance in that Part, and

(b) includes a mixture or another substance in which a substance listed in that Part is present in a concentration higher than the relevant limit,

but, in each case, only if the substance or mixture is not excluded.

(9) For the purposes of this section, a substance or mixture is “excluded” if—

(a) it is medicinal, or

(b) it is contained in a specific object.

(10) A substance or mixture is “medicinal” if it is—

(a) a medicinal product as defined by regulation 2 of the Human Medicines Regulations 2012 (S.I. 2012/1916),

(b) an investigational medicinal product as defined by regulation 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031),

(c) a substance to which Part 12 of the Human Medicines Regulations 2012 or Part 6 of the Medicines for Human Use (Clinical Trials) Regulations 2004 applies by virtue of an order under section 104 or 105 of the Medicines Act 1968 (whether applying subject to exceptions and modifications or not and, in the case of an order under section 104, whether the substance is referred to in the order as a substance or an article), or

(d) a veterinary medicinal product as defined by regulation 2 of the Veterinary Medicines Regulations 2013 (S.I. 2013/2033).

(11) A “specific object” is—

(a) an object that, during production, is given a special shape, surface or design that determines its function to a greater degree than does its chemical composition, or

(b) an article that contains explosive substances or an explosive mixture of substances designed to produce heat, light, sound, gas or smoke or a combination of such effects through self-sustained exothermic chemical reactions, including—

(i) pyrotechnic equipment falling within the scope of Council Directive 96/98/EC on marine equipment, and

(ii) percussion caps intended specifically for toys falling within the scope of Council Directive 88/378/EEC concerning the safety of toys.

(12) See also section 9B (which contains power to disapply requirements of this Act in specified circumstances).

2A Power to amend Schedule 1A

(1) The Secretary of State may by regulations—

(a) amend Schedule 1A (whether to add, vary or remove a substance or concentration limit or make any other change), and

(b) amend section 2 in consequence of any amendment made under paragraph (a).

(2) The power in subsection (1) to add a concentration limit includes power to add a concentration limit in any Part of Schedule 1A (whether for an explosives precursor or a poison).

(3) In determining the distribution of substances as between the various Parts of Schedule 1A, regard must be had to the desirability of restricting Parts 3 and 4 to substances that meet each of the following criteria—

(a) they are in common use, or are likely to come into common use, for purposes other than the treatment of human ailments, and

(b) it is reasonably necessary to include them in one of those Parts if members of the general public are to have adequate facilities for obtaining them.”