Regulation 43 Incorporation of zootechnical additives
Subject to paragraph (3), no person shall incorporate an unauthorised zootechnical additive into a feedingstuff.
Subject to paragraph (3), no person shall incorporate an authorised zootechnical additive into a feedingstuff other than a compound feedingstuff.
Nothing in paragraphs (1) or (2) shall prohibit a person (“the relevant person”) from incorporating—
an unauthorised zootechnical additive in a feedingstuff, or
an authorised zootechnical additive in a feedingstuff other than a compound feedingstuff,
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 use specified in paragraph (4).
For the purpose of the previous paragraph the following uses are specified—
a medicinal test on animals for which the relevant person has been issued with an animal test certificate, or
a regulated procedure for which the relevant person holds a personal licence and which is specified in a project licence that authorises the procedure.
No person shall incorporate an authorised zootechnical additive into a compound feedingstuff unless—
the additive has been prepared beforehand in the form of a premixture—
on a UK or EC approved or permitted Chapter I.2 establishment, or
a UK or EC approved or permitted third country Chapter I.2 establishment,
and in accordance with the requirements specified, or in the case of a third country establishment, requirements equivalent to those specified, in the first paragraph of Article 13.3 of Directive 70/524/EEC, as amended by Directive 96/51/EC, and he incorporates the premixture in the feedingstuff in accordance with regulation 59; or
the incorporation is carried out on a UK approved or permitted Chapter I.3(M) establishment and the conditions specified in the first and third indented paragraphs of Article 13.4(b) of Directive 70/524/EEC, as amended by Directive 96/51/EC, are complied with;
and, in either case, the additive is incorporated in accordance with the applicable provisions of the relevant Chapter entry covering the additive in Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC.