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Mixing of zootechnical additives
     44.  - (1) Subject to paragraph (3), no person shall mix a zootechnical additive with an additive which is not a zootechnical additive in a premixture or feedingstuff unless the mixing of the additives is permitted in accordance with the provisions contained in Article 6.2 of Directive 70/524/EEC.

    (2) Subject to paragraph (3), no person shall mix a zootechnical additive with another zootechnical additive in a premixture or feedingstuff unless the mixing of the additives-

(a) is permitted in accordance with the provisions contained in Article 6.2 of Directive 70/524/EEC, and

(b) does not contravene the provisions contained in Article 6.3 of Directive 70/524/EEC.

    (3) Nothing in paragraphs (1) or (2) shall prohibit a person from mixing a zootechnical additive with another zootechnical additive, or any other additive, where it is intended that-

(a) the resulting mixture of additives, or

(b) a premixture or feedingstuff containing the mixture of additives,

will be fed to an animal for an Article 6.4 purpose, and the use of the mixture of additives, or the premixture or the feedingstuff containing the mixture, as the case may be, will constitute-

(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 that authorises the procedure.

Importation of zootechnical additives
     45. No person shall import into the United Kingdom, from a third country, a zootechnical additive manufactured in a third country, unless it was manufactured on a UK approved or permitted third country Chapter I.1 establishment, or an EC approved or permitted third country Chapter I.1 establishment.

Provision of samples
     46. The person responsible for putting a Community authorised zootechnical additive into circulation shall make a standard sample and a reference sample available to the enforcement authority in accordance with the requirements of Article 9p.1 and 2 of Directive 70/524/EEC as amended by Directive 96/51/EC.

Monitoring of undesirable interactions
     47.  - (1) Where there is found to be an unforeseen undesirable interaction between a Communiuty authorised zootechnical additive and another additive or veterinary medicine the relevant person shall comply with the requirements of Article 21a of Directive 70/524/EEC, as amended by Directive 96/51/EC, relating to the gathering of all the relevant information, and the forwarding on of such information to the enforcement authority.

    (2) For the purposes of paragraph (1) the relevant person is-

(a) the person responsible for putting the zootechnical additive into circulation where the zootechnical additive does not originate in a third country, and

(b) the representative within the European Community of the person responsible for putting the zootechnical additive into circulation where the zootechnical additive originates in a third country.

Provision of information
     48. A person responsible for putting a zootechnical additive into circulation shall comply with the requirements relating to the provision of information contained in Article 9s of Directive 70/524/EEC as amended by Directive 96/51/EC.

(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.

Wrapping, packaging and storage of zootechnical premixtures by intermediaries
     53. No intermediary shall wrap, package or store a zootechnical premixture unless he is a UK approved or permitted Chapter I.2 intermediary.

Duties on intermediaries wrapping, packaging or storing zootechnical premixtures
     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.

Putting zootechnical premixtures into circulation
     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.

Duties on intermediaries putting zootechnical premixtures into circulation
     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.

Supply of zootechnical premixtures
     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.

Use of zootechnical premixtures for the purpose of animal feeding
     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.

Incorporation of zootechnical premixtures
     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.

Importation of zootechnical premixtures
     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.

and, in each case, the compositional characteristics of the feedingstuff comply with the provisions of Article 12.3 of Directive 70/524/EEC.

Labelling of zootechnical feedingstuffs
     67. No person shall put into circulation a zootechnical feedingstuff unless the labelling of the feedingstuff complies with the provisions of paragraphs 1(a), 2, 4, 5, 6 and 8 of Article 16 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.

Labelling of supplementary zootechnical feedingstuffs
     68.  - (1) Subject to paragraph (2), no person shall place a supplementary feedingstuff on the market which contains a zootechnical additive at a level in excess of the maximum additive level fixed for a complete feedingstuff containing the additive unless the directions for use relating to the supplementary feedingstuff are in accordance with the provisions of the first and second paragraphs of Article 17.1, and Article 17.2, of Directive 70/524/EEC.

    (2) The provisions of paragraph (1) shall not apply in the circumstances specified in the third paragraph of Article 17.1 of Directive 70/524/EEC.

Export of zootechnical feedingstuffs to EEA States
     69. No person shall export a zootechnical feedingstuff for marketing in an EEA State unless the details given on the package or container of, or label attached to, the feedingstuff and covered by Article 18 of Directive 70/524/EEC comply with that Article.

Importation of zootechnical feedingstuffs
     70.  - (1) No person shall import from an EEA State a zootechnical feedingstuff for marketing in the United Kingdom unless the details given on the package or container of, or label attached to, the feedingstuff and covered by Article 18 of Directive 70/524/EEC comply with that Article.

    (2) No person shall import into the United Kingdom, from a third country, a zootechnical compound feedingstuff manufactured in a third country, unless it was manufactured on a UK approved or permitted third country Chapter I.3(M) establishment, or an EC approved or permitted third country Chapter I.3(M) establishment.

Putting zootechnical compound feedingstuffs into circulation
     71. No person shall put a zootechnical compound feedingstuff into circulation unless it has been manufactured on-

(a) a UK or EC approved or permitted Chapter I.3(M) establishment, or

(b) a UK or EC approved or permitted third country Chapter I.3(M) establishment.

Confidential information relating to zootechnical additives
     73.  - (1) Subject to paragraphs (2) and (3), no person shall publish or disclose any confidential information relating to a zootechnical additive obtained by him in the performance of functions under these Regulations and to which this regulation applies without the previous consent in writing of the person responsible for putting the additive into circulation.

    (2) Nothing in paragraph (1) shall restrict the publication or disclosure of such information for the purpose of the exercise of functions under Part II of these Regulations or the disclosure of such information for the purpose of the exercise of any function, or of assisting any authority in the exercise of any function bestowed on it, in implementation of any Directive referred to in regulation 2.

    (3) Nothing in paragraph (1) shall prevent the publication or disclosure of confidential information of a type specified in Article 7.2 of Directive 70/524/EEC as amended by Directive 96/51/EC.

    (4) In this regulation, "confidential information" means information of the type specified in Article 7.1 of Directive 70/524/EEC as amended by Directive 96/51/EC.

Use of Article 9c data
     74. No person shall use scientific data and other information of the type specified in Article 9c of Directive 70/524/EEC, as amended by Directive 96/51/EC, unless the use of the data is in accordance with Article 9c of Directive 70/524/EEC as so amended.

Official checks and enforcement
     75. It shall be the duty of the enforcement authority to carry out official checks and enforce these Regulations.

Powers of authorised persons
     76.  - (1) An authorised person may exercise the powers specified in this regulation for the purposes of-

(a) carrying out any official checks, and

(b) ascertaining whether an offence under regulation 85(a), (b) or (c) has been or is being committed.

    (2) An authorised person shall have the right at all reasonable times, and on producing, if so required, some duly authenticated document showing his authority, to enter-

(a) any premises on which he has reasonable cause to believe that a zootechnical product has been, or is being, manufactured or produced, or is being kept for the purpose of being put into circulation, placed on the market, marketed, supplied, incorporated or used, and

(b) any premises (not being premises appearing to be used only as a dwelling) on which he has reasonable cause to believe that there is any such product which the occupier of the premises has in his possession or under his control.

    (3) If a justice of the peace, on sworn information in writing, is satisfied that there is reasonable ground for entry into any such premises as are mentioned in paragraph (2), for any such purpose as is mentioned in paragraph (1), and either-

(a) that admission to the premises has been refused, or a refusal is apprehended, and that notice of the intention to apply for a warrant has been given to the occupier; or

(b) that an application for admission, or the giving of such a notice, would defeat the object of the entry, or that the case is one of urgency, or that the premises are unoccupied or the occupier temporarily absent,

the justice may by warrant signed by him authorise the authorised officer to enter the premises, if need be by reasonable force.

    (4) Every warrant granted under this regulation shall continue in force for a period of one month.

    (5) In the application of paragraph (3)-

(a) to Scotland, any reference to a justice of the peace includes a reference to the sheriff and to a magistrate, and

(b) to Northern Ireland, the reference to a sworn information in writing includes a reference to a sworn complaint in writing.

    (6) An authorised person entering any premises by virtue of this regulation, or of a warrant issued under it, may take with him such other persons and such equipment as may appear to him to be necessary for the purposes mentioned in sub-paragraphs (a) and (b) of paragraph (1), and on leaving any unoccupied premises which he has entered by virtue of such a warrant, shall leave them as effectively secured against unauthorised entry as he found them.

    (7) An authorised person entering premises by virtue of this regulation, or of a warrant issued under it, shall have the right to inspect-

(a) any material appearing to him to be a zootechnical product;

(b) any article appearing to him to be a container or package used or intended to be used to wrap, package or store any such product, or to be a label used or intended to be used in connection with any such product; or

(c) any plant or equipment appearing to him to be used, or intended to be used, in connection with the manufacture or production of any zootechnical product, and any process of manufacture or production of such a product, and the means employed, at any stage in the process of manufacture or production, for testing the product after it has been subject to those processes.

    (8) Subject to paragraph (9), an authorised person entering premises by virtue of this regulation, or of a warrant issued under it, shall have the right to take on those premises, and prepare, a sample of-

(a) any material appearing to him to be a zootechnical product manufactured, produced, wrapped, packaged, stored, circulated, marketed or supplied, or intended to be circulated, marketed or supplied; or

(b) any material appearing to him to be a zootechnical product, used, or intended to be used, for the purpose of animal feeding,

in the like manner as that prescribed-

(i) in the case of Great Britain, in Part II of Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations 1999[23], or

(ii) in the case of Northern Ireland, in Part II of Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations (Northern Ireland) 1999[24],



and paragraph 10 of Part II of Schedule 1 to the Regulations concerned shall have effect for the purposes of the certificate referred to in regulations 80 and 82(2)(b).

    (9) For the purposes of this Part of these Regulations, the provisions of regulation 3 and Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations 1999 or, as the case may be, of regulation 3 and Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations (Northern Ireland) 1999 shall have effect as if-

(a) for all references to "feeding stuff" or to "feeding stuffs" there were substituted references to "zootechnical product" or to "zootechnical products" respectively, and

(b) in paragraph 1 of Part II of Schedule 1 to the Regulations concerned, the expression ", except where section 68(2)(b) of the Act applies" were omitted.

    (10) An authorised person entering premises by virtue of this regulation, or of a warrant issued under it, shall have the right-

(a) to require any person carrying on, or appearing to be carrying on, a business which consists of or includes the activities of manufacture, production, wrapping, packaging, storage, circulation, marketing, supply or use of a zootechnical product, and any person employed in connection with such a business, to produce any record (in whatever form it is held) relating to or arising out of the exercise in the course of that business of any such activity, and which is in his possession or under his control, and

(b) to inspect and take copies of any record, or of any entry in any record, produced in pursuance of the preceding sub-paragraph.

    (11) An authorised person exercising the power conferred by paragraph (10) in respect of a record held by means of a computer-

(a) shall be entitled at any reasonable time to have access to, and inspect and check the operation of, any computer and associated apparatus or material which is or has been, or which it appears is or has been, in use in connection with the record in question;

(b) may require-


(i) the person by whom or on whose behalf the computer is or has been so used, or

(ii) any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material,



to afford the authorised person such reasonable assistance as he may require for that purpose; and

(c) may require the record, or an extract from the record, to be produced in a form in which it may be taken away.

    (12) An authorised person entering premises by virtue of this regulation, or of a warrant issued under it, shall have the right to seize and detain any product which he has reason to believe to be a zootechnical product in relation to which, or by means of which, an offence under these Regulations is being or has been committed, and any record which he has reasonable cause to believe to be a record which may be required as evidence in proceedings under these Regulations.

    (13) In this regulation-

(a) "premises" includes any land, vehicle, vessel, aircraft or hovercraft; and

(b) "zootechnical product" has the same meaning as that given to it in regulation 2(1), but also includes any substance or material (other than a machine or implement) appearing to be used, or intended to be used, in the manufacture or production of any zootechnical product.

Division of samples
     77. Where, in accordance with these Regulations, an authorised person obtains a sample, and decides to have it analysed for the purpose of ascertaining whether there is or has been any contravention of any provision of these Regulations in connection with a zootechnical product, he shall divide the sample into three parts, of as near as may be equal size and shall-

(a) cause each part to be marked, sealed and fastened in the like manner as that prescribed-


(i) in the case of Great Britain, in Part III of Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations 1999, or

(ii) in the case of Northern Ireland, in Part III of Schedule 1 to the Feeding Stuffs (Sampling and Analysis) Regulations (Northern Ireland) 1999;



(b) send one part for analysis to-



(i) in Great Britain, an analyst, and

(ii) in Northern Ireland, an agricultural analyst in Northern Ireland;



(c) send another part to the person subject to the official check; and

(d) retain and preserve the remaining part as an officially sealed reference sample.

[23] S.I. 1999/1663.back

[24] S.R. 1999/No.back