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3.—(1) Subject to paragraphs (3) to (8), these Regulations shall apply to any dangerous substance or dangerous preparation.
(2) Subject to paragraphs (3) to (8)—
(a)regulation 5, except paragraph (1), shall apply to the preparations specified in paragraph (3) of that regulation;
(b)regulation 7 and paragraphs (2) and (4) to (6) of regulation 11 shall apply to the preparations specified in paragraph (3) of regulation 11;
(c)paragraphs (1) and (2) of regulation 9 shall apply to a preparation to which section B or C of Part II of Schedule 5 applies; and
(d)paragraphs (4) and (5) of regulation 8 shall apply to a substance or preparation specified in those paragraphs.
(3) 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)specified in an order made under section 104 or 105 of the Medicines Act 1968 which is for the time being in force and which directs that specified provisions of that Act shall have effect in relation to that dangerous substance or dangerous preparation as such provisions have effect in relation to medicinal products within the meaning of that Act;
(c)a controlled drug within the meaning of the Misuse of Drugs Act 1971(2) 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;
(d)a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations 1996(3);
(f)intended for use as food within the meaning of section 1 of the Food Safety Act 1990(6);
(g)intended for use as an animal feeding stuff within the meaning of section 66(1) of the Agriculture Act 1970(7);
(h)radioactive substances or preparations containing radioactive substances; or
(i)a medical device within the meaning of the Medical Devices Regulations 2002(8) which is invasive or used in direct contact with the human body,
in the finished state, intended for the final user.
(4) 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;
(c)subject to Council Regulation EC 2455/92(9) on the export notification and information exchange of dangerous substances, a substance or preparation which is intended for export to a country which is not an EEA State; or
(d)a substance to which paragraph (7) of regulation 6 of the NONS Regulations applies (including new substances not yet fully tested) which is labelled in accordance with the provisions of that paragraph;
(5) Regulations 7 to 11 shall only apply to dangerous substances, dangerous preparations or preparations specified in regulation 5(3) which are supplied in packages.
(6) Regulations 7 to 11 shall not apply to munitions and explosives which are placed on the market with a view to obtaining an explosive or pyrotechnic effect.
(7) Regulation 6 shall not apply to a plant protection product approved under the Plant Protection Products Regulations or to a product approved under the Control of Pesticides Regulations 1986(10).
(8) These Regulations shall not apply to the carriage of substances or preparations by rail, road, inland waterway, sea or air.
S.I. 1996/2925, to which there are amendments not relevant to these Regulations.
S.I. 1994/1056, to which there are amendments not relevant to these Regulations.
S.I. 1996/972, to which there are amendments not relevant to these Regulations.
O.J. No. L251, 29.8.92, p.13.
S.I. 1986/1510, to which there are amendments not relevant to these Regulations.
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