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Version Superseded: 11/07/2013
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3.—(1) Subject to paragraphs (2) to (6), these Regulations shall apply to any dangerous substance or dangerous preparation.
(2) These Regulations shall not apply to a substance or preparation which is—
(a)intended for use as a medicinal product within the meaning of section 130 of the Medicines Act 1968(1);
(b)intended for use as a veterinary medical product within the meaning of regulation 2(1) of the Veterinary Medicines Regulations 2008(2);
(c)intended for use as an investigational medical product within the meaning of the Medicines for Human Use (Clinical Trials) Regulations 2004(3);
(d)specified in an order made under section 104 or 105 of the Medicines Act 1968(4) which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to medicinal products within the meaning of that Act;
(e)a controlled drug within the meaning of the Misuse of Drugs Act 1971(5) except that these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act (which makes it unlawful to supply a controlled drug) by Regulations made under section 7(1)(a) of that Act;
(f)a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations 2008(6);
(g)in the form of waste to which the Waste Management Licensing Regulations (Northern Ireland) 2003(7) or the Hazardous Waste Regulations (Northern Ireland) 2005(8) apply;
(h)intended for use as food within the meaning of Article 2(2) of the Food Safety (Northern Ireland) Order 1991(9);
(i)intended for use as feeding stuff within the meaning of section 66(1) of the Agriculture Act 1970(10);
(j)a radioactive substance or a preparation containing radioactive substances; or
(k)a medical device within the meaning of the Medical Devices Regulations 2002(11) which is invasive or used in direct contact with the human body,
in the finished state, intended for the final user.
(3) These Regulations shall not apply to—
(a)a substance or preparation which is a sample taken by an authority responsible for the enforcement of any requirement imposed by or under any enactment;
(b)a substance or preparation which is under customs control; or
(c)subject to Regulation (EC) No. 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals(12), of which Annexes I and V are as amended from time to time, a substance or a preparation which is intended for export to a country which is not an EEA State.
(4) Regulations 6 to 11 shall only apply to substances and preparations which are supplied in packages.
(5) These Regulations shall not apply to a substance to which the Explosives Acts (Northern Ireland) 1875 to 1970(13), the Explosives (Northern Ireland) Order 1972(14), [F1the Explosives (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 2009] or the Manufacture and Storage of Explosives Regulations (Northern Ireland) 2006(15).
(6) These Regulations shall not apply to the carriage of substances or preparations by rail, road, inland waterway, sea or air.
Textual Amendments
F1Words in reg. 3(5) substituted (24.8.2009) by The Explosives (Hazard Information and Packaging for Supply) Regulations (Northern Ireland) 2009 (S.R. 2009/273), regs. 1, 17(2), Sch. 7
Commencement Information
1968 c. 67, as amended by S.I. 2004/1031, S.I. 2008/2297 and S.I. 2006/2407
S.R. 2003 No. 493, as amended by S.R. 2006 No. 280, S.R. 2006 No. 489 and S.R. 2008 No. 18
1970 c. 40, as amended by regulation 3(1)(a) of S.R. 2005 No. 545
O.J. No. L204, 31.7.08, p.1
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