49. No person shall manufacture a zootechnical premixture with a view to putting it into circulation except on a UK approved or permitted Chapter I.2 establishment.
50. A person manufacturing a zootechnical premixture on a UK approved Chapter I.2 establishment, with a view to putting it into circulation, shall fulfil the essential conditions contained in Chapter I.2(b) of the Annex to Directive 95/69/EC.
51. No person shall market a zootechnical premixture unless the premixture is packaged in accordance with the requirements of Article 10 of Directive 70/524/EEC.
52.—(1) No person shall market a zootechnical premixture unless the labelling of the premixture complies with the provisions of Article 15.1.A and 15.1.B(a) (as read with Article 15.3) of Directive 70/524/EEC as amended by Directive 96/51/EC or, with effect from 1st October 1999, complies with those provisions as amended as aforesaid, and as further amended by Council Directive 1999/20/EC(1).
(2) No person shall market a zootechnical premixture if the premixture is labelled with information other than that—
(a)required by virtue of Articles 15.1.A and 15.1.B(a) (as read with Article 15.3) of Directive 70/524/EEC, as amended by Directive 96/51/EC or, with effect from 1st October 1999, as so amended and as amended further by Council Directive 1999/20/EC, or
(b)authorised by virtue of Article 15.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC,
unless that information is clearly separated from the required and authorised information in accordance with Article 15.4 of Directive 70/524/EEC as amended by Directive 96/51/EC.
53. No intermediary shall wrap, package or store a zootechnical premixture unless he is a UK approved or permitted Chapter I.2 intermediary.
54. A UK approved Chapter I.2 intermediary wrapping, packaging or storing a zootechnical premixture shall fulfil the applicable essential conditions referred to in point 7 of Chapter I.2(b) of the Annex to Directive 95/69/EC.
55.—(1) No person shall put a zootechnical premixture into circulation unless it has been manufactured—
(a)on a UK or EC approved or permitted Chapter I.2 establishment, or
(b)a UK or EC approved or permitted third country Chapter I.2 establishment.
(2) No intermediary shall put a zootechnical premixture into circulation unless he is a UK or EC approved or permitted Chapter I.2 intermediary.
56. A UK approved Chapter I.2 intermediary putting a zootechnical premixture into circulation shall fulfil the applicable essential conditions referred to in point 7 of Chapter I.2(b) of the Annex to Directive 95/69/EC.
57.—(1) Subject to paragraph (2), no person shall supply a zootechnical premixture otherwise than to—
(a)a UK or EC approved or permitted Chapter I.2 intermediary;
(b)a person manufacturing, or intending to manufacture, a compound feedingstuff on a UK or EC approved or permitted Chapter I.3(M) establishment;
(c)a person producing, or intending to produce, a compound feedingstuff on a U.K. or EC approved or permitted Chapter I.3(P) establishment; or
(d)a person who intends to export it to a third country.
(2) Nothing in paragraph (1) shall prohibit a person from supplying a zootechnical premixture to a person (in this paragraph called “the recipient”) who intends—
(a)to use the premixture, or
(b)to incorporate the premixture in a feedingstuff and then use that feedingstuff,
for an Article 6.4 purpose if the use of the premixture or the feedingstuff, as the case may be, will constitute—
(i)a medicinal test on animals for which the recipient has been issued with an animal test certificate, or
(ii)a regulated procedure for which the recipient holds a personal licence and which is specified in a project licence which authorises the procedure.
58.—(1) Subject to paragraph (2), no person shall use a zootechnical premixture for the purpose of animal feeding unless the premixture is incorporated in a compound feedingstuff and was incorporated in the feedingstuff in accordance with regulation 59.
(2) Nothing in paragraph (1) shall prohibit a person from feeding an animal—
(a)a zootechnical premixture that has not been incorporated in a compound feedingstuff, or
(b)a feedingstuff containing a zootechnical premixture that was not incorporated in the feedingstuff in accordance with regulation 59,
for an Article 6.4 purpose if the use of the premixture or the feedingstuff, as the case may be, constitutes—
(i)a medicinal test on animals for which he has been issued with an animal test certificate, or
(ii)a regulated procedure for which he holds a personal licence, and which is specified in a project licence which authorises the procedure.
59.—(1) Subject to paragraph (2), no person shall incorporate a zootechnical premixture into a compound feedingstuff unless—
(a)the incorporation of the premixture is in accordance with any applicable provisions of Annex B to Directive 70/524/EEC, as amended by Directive 96/51/EC, covering the incorporation, and
(b)the establishment on which the premixture is incorporated in the compound feedingstuff is—
(i)a UK approved or permitted Chapter I.3(M) establishment or a UK approved or permitted Chapter I.3(P) establishment and the premixture is incorporated in the compound feedingstuff in a proportion of at least 0.2 per cent by weight, or
(ii)a specially approved manufacturing establishment and the premixture is incorporated in the compound feedingstuff in a proportion of at least 0.05 per cent by weight.
(2) Nothing in paragraph (1) shall prohibit a person from incorporating a zootechnical premixture in a feedingstuff otherwise than in accordance with the provisions of paragraph (1) where it is intended that the resulting feedingstuff will be fed to an animal for an Article 6.4 purpose and the use of the feedingstuff will constitute—
(a)a medicinal test on animals for which he has been issued with an animal test certificate, or
(b)a regulated procedure for which he holds a personal licence and which is specified in a project licence that authorises the procedure.
60. No person shall import into the United Kingdom, from a third country, a zootechnical premixture manufactured in a third country, unless it was manufactured on a UK approved or permitted third country Chapter I.2 establishment, or an EC approved or permitted third country Chapter I.2 establishment.
OJ No. L80, 25.3.99, p. 20.