SUPPLEMENTARY PROVISIONS AS TO INCORPORATION OB SUBSTANCES AND ARTICLES IN ANIMAL FEEDING STUFFS. (Hansard, 18 October 1968)

§ Mr. Speaker
I suggest that we take, at the same time, the consequential Government Amendment to the Bill, in page 94, line 24, after 'incorporated', insert: 'or in which any substance or article has been incorporated for a medicinal purpose' and also Lords Amendments Nos. 63, 64, 75, 101, 141, 143 and 144. They are all linked.

§ The Joint Parliamentary Secretary to the Ministry of Agriculture, Fisheries and Food (Mr. John Mackie)
I beg to move, That the House doth agree with the Lords in the said Amendment.
The new Clause "F" set out in Lords Amendment No. 55 has been introduced in the light of the constructive comment made in Committee and as a result of further Departmental consideration. It is generally accepted that any substance or article added to an animal feeding stuff for a medicinal purpose should be the 792 subject of appropriate control. The object of this Clause is to treat any substance or article as a medicinal product for the purposes of Clauses 36(3) and 37 if, although it is not a medicinal product, it is incorporated in an animal feeding stuff for a medicinal purpose.
Subsection (1) achieves this end. The important point to note is that, whereas, for instance, a mineral or vitamin added to an animal feeding stuff for such a purpose would be subject to the provisions of the Clause, a vitamin or mineral added to the feed solely to balance the dietary mixture would not be subject to such control because it would not be "for a medicinal purpose". I am sure that the hon. Member for Derbyshire, West (Mr. Scott-Hopkins) will have instances in mind, for example, the use of a mineral such as copper to balance the diet but which can also be used in larger quantities to help growth, and so on.
793 Subsection (2) enables a person selling, supplying or manufacturing a substance which may be added to feeding stuffs for a medicinal purpose to apply for a product licence for that substance as though it were a medicinal product.
Similarly, subsection (3) provides that a person who proposes to obtain such a substance in order to add it to an animal feeding stuff for a medicinal purpose may also apply for a product licence for that substance. This is to enable the substance to be so used as a medicinal feed additive even though its importer or the person responsible for its composition does not choose to get a product licence for this purpose.
Subsection (4) makes clear that a product licence, in so far as it relates to any substance to be incorporated in animal feeding stuffs, may include provisions about such incorporation whether by the licence holder or anyone who may have been told of those provisions.
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Subsection (5) provides that a feeding-stuff shall not itself be taken to be a medicinal product simply because the provisions of the Clause apply to a substance included in it.
Finally, subsections (6) and (7) provide for Ministers by Order to terminate or modify the provisions of Clause 36 or subsections (1) to (5) of this Clause. The Order would be subject to the Affirmative Resolution procedure. This provision has been introduced in the interests of maintaining an appropriate degree of flexibility, a word much used in Committee for a complex field.
The other Amendments are consequential to the new Clause as is that to Clause 102(4). This allows arrangements to be made by the Northern Ireland Ministers relating to enforcement in Northern Ireland in respect of

§ Mr. Scott-Hopkins
I congratulate the Parliamentary Secretary on bringing this subject before the House again. These Amendments get over one of the most difficult problems which we met when we discussed the matter in Committee. As the hon. Gentleman said, one does not want to penalise those manufacturers who want only to bring a compound to a balanced diet level. This has been a very thorny problem and I congratulate the hon. Gentleman on the ingenuity with which it has been solved.
This, too, has met with the approval of those in the industry who will have to deal with it, because not only does it get over the problem, but it gives the manufacturer a choice, because he will be able to apply for a product licence if he wishes. The final safeguard, for which I thank the Parliamentary Secretary, is the fact that regulations will be subject to the affirmative procedure, which is a very satisfactory way in which to deal with them.

25	and he were proposing to sell or supply it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.
30	(3) Where a person proposes to sell, supply or manufacture a substance or article, other than a medicinal product, in the circumstances specified in paragraph (a) or paragraph (b) of subsection (2) of this section, any person who proposes, by purchase or otherwise, to obtain from him a supply of the substance or article with a view to incorporating it for a medicinal purpose in any animal feeding stuff may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to procure the sale or supply, or the manufacture for sale or supply, of that product in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.
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45	(4) On the grant, renewal or variation (whether by virtue of subsection (2) or subsection (3) of this section or otherwise) of a product licence, in so far as it relates to any substance or article which is to be incorporated in animal feeding stuffs, the licence may (without prejudice to the generality of section 20(1) of this Act) include provisions as to the manner in which the substance or article in question may be so incorporated, whether by the holder of the licence or by any other person to whom those provisions of the licence have been communicated.
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55	(5) Without prejudice to the operation of section 117(6) of this Act, a substance manufactured, sold, supplied or exported as an animal feeding stuff shall not be taken to be a medicinal product for the purposes of this Act by reason only that any of the preceding provisions of this section has effect in relation to a substance or article incorporated in it.
60	(6) The appropriate Ministers may by order provide that any of the provisions of section 36 of this Act or of subsections (1) to (5) of this section shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.
65	(7) No order shall be made under subsection (6) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament."

	"G.—(1) Where in the course of a business carried on by him a person sells or exports a substance or article for use wholly or mainly in either or both of the ways specified in section 117(1) of this Act, and the substance or article, not having been—
5	(a) manufactured or imported for such use, or
10	(b) previously sold or supplied for such use, does not constitute a medicinal product before that person so sells or exports it, then (subject to subsection (2) of this section) subsection (2) of section 7 of this Act, if apart from this subsection it would not so have effect, shall have effect in relation to the sale or exportation of the substance or article as if he were selling or exporting it in circumstances to which that subsection applies.