The Feedingstuffs (Zootechnical Products) Regulations 1998

• (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.

Provision of samples

38

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 the Additives Directive as amended by Directive 96/51/EC.

Monitoring of undesirable interactions

39

• (1) Where there is found to be an unforeseen undesirable interaction between a Community authorised zootechnical additive and another additive or veterinary medicine the relevant person shall comply with the requirements of Article 21a of the Additives Directive, 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 Community of the person responsible for putting the zootechnical additive into circulation where the zootechnical additive originates in a third country.

Provision of information

40

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 the Additives Directive as amended by Directive 96/51/EC.

PART VI — CONTROL OF ZOOTECHNICAL PREMIXTURES

Manufacture of zootechnical premixtures

41

No person shall manufacture a zootechnical premixture with a view to putting it into circulation except on a U.K. approved or permitted Chapter I.2 establishment.

Duties on persons manufacturing zootechnical premixtures

42

A person manufacturing a zootechnical premixture on a U.K. 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 the Establishments Directive.

Packaging of zootechnical premixtures

43

No person shall market a zootechnical premixture unless the premixture is packaged in accordance with the requirements of Article 10 of the Additives Directive.

Labelling of zootechnical premixtures

44

• (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 the Additives Directive as amended by Directive 96/51/EC.

• (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 the Additives Directive, as amended by Directive 96/51/EC, or

• (b) authorised by virtue of Article 15.2 of the Additives Directives, 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 the Additives Directive as amended by Directive 96/51/EC.

Wrapping, packaging and storage of zootechnical premixtures by intermediaries

45

No intermediary shall wrap, package or store a zootechnical premixture unless he is a U.K. approved or permitted Chapter I.2 intermediary.

Duties on intermediaries wrapping, packaging or storing zootechnical premixtures

46

A U.K. 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 the Establishments Directive.

Putting zootechnical premixtures into circulation

47

• (1) No person shall put a zootechnical premixture into circulation unless it has been manufactured—

• (a) on a U.K. or E.C. approved or permitted Chapter I.2 establishment, or

• (b) on an establishment located in a third country:

• (i) if it is listed in relation to zootechnical premixtures under arrangements to implement the second indent of the second paragraph of Article 15(a) of the Establishments Directive,

• (ii) pending the making of those arrangements, if it is reasonable to conclude that it would have been so listed if those arrangements had been made.

• (2) No intermediary shall put a zootechnical premixture into circulation unless he is a U.K. or E.C. approved or permitted Chapter I.2 intermediary.

Duties on intermediaries putting zootechnical premixtures into circulation

48

A U.K. 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 the Establishments Directive.

Supply of zootechnical premixtures

49

• (1) Subject to paragraph (2), no person shall supply a zootechnical premixture otherwise than to—

• (a) a U.K. or E.C. approved or permitted Chapter I.2 intermediary;

• (b) a person manufacturing, or intending to manufacture, a compound feedingstuff on a U.K. or E.C. approved or permitted Chapter I.3(M) establishment;

• (c) a person producing, or intending to produce, a compound feedingstuff on a U.K. or E.C. 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

50

• (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 51.

• (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 51

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

51

• (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 the Additives Directive, 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 U.K. approved or permitted Chapter I.3(M) establishment or a U.K. 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.

PART VII — CONTROL OF ZOOTECHNICAL FEEDINGSTUFFS

Manufacture of zootechnical compound feedingstuffs

52

No person shall manufacture a zootechnical compound feedingstuff with a view to putting it into circulation except on a U.K. approved or permitted Chapter I.3(M) establishment.

Duties on persons manufacturing zootechnical compound feedingstuffs

53

A person manufacturing a zootechnical compound feedingstuff on a U.K. approved Chapter I.3(M) establishment, with a view to putting it into circulation, shall fulfil the essential conditions contained in Chapter I.3(b) of the Annex to the Establishments Directive.

Production of zootechnical compound feedingstuffs

54

No person shall produce a zootechnical compound feedingstuff for the exclusive requirements of his holding except on a U.K. approved or permitted Chapter I.3(P) establishment.

Duties on persons producing zootechnical compound feedingstuffs

55

A person producing a zootechnical compound feedingstuff for the exclusive requirements of his holding on a U.K. approved Chapter I.3(P) establishment shall fulfil the essential conditions contained in Chapter I.3(b) of the Annex to the Establishments Directive with the exception of point 7.

Level of zootechnical additives in complete feedingstuffs

56

• (1) No person shall put a complete feedingstuff containing a zootechnical additive into circulation unless the level of the additive in the feedingstuff is not less than any relevant minimum level, and not more than any relevant maximum level for the additive covered by Annex B to the Additives Directive as amended by Directive 96/51/EC.

• (2) Where applicable, the zootechnical additive level in a complete feedingstuff shall be determined taking into account the provisions contained in Article 6.1 of the Additives Directive.

Level of zootechnical additives in supplementary feedingstuffs

57

• (1) Subject to paragraph (2), no person shall market a supplementary feedingstuff containing a zootechnical additive unless the level of the additive in the feedingstuff is in accordance with the provisions of Article 12.1 of the Additives Directive.

• (2) Nothing in paragraph (1) shall prohibit a person from marketing a supplementary feedingstuff containing a zootechnical additive at a level that is higher than that provided for in Article 12.1 of the Additives Directive if (in circumstances in which marketing is permissible under Article 12.2 thereof)—

• (a) the zootechnical additive contained in the feedingstuff belongs to the antibiotics or growth promoters group of additives and the level of the additive in the feedingstuff is in accordance with the provisions of Article 12.2(a) of the Additives Directive;

• (b) the zootechnical additive contained in the feedingstuff belongs to the antibiotics or growth promoters group of additives and the level of the additive in the feedingstuff is in accordance with the provisions of the first indent of Article 12.2(b) of the Additives Directive; or

• (c) the zootechnical additive contained in the feedingstuff belongs to the coccidiostats and other medicinal substances group of additives and the level of the additive in the feedingstuff is in accordance with the provisions of the second indent of Article 12.2(b) of the Additives Directive;

and, in each case, the compositional characteristics of the feedingstuff comply with the provisions of Article 12.3 of the Additives Directive.

Labelling of zootechnical feedingstuffs

58

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 the Additives Directive as amended by Directive 96/51/EC.

Labelling of supplementary zootechnical feedingstuffs

59

• (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 the Additives Directive.

• (2) The provisions of paragraph (1) shall not apply in the circumstances specified in the third paragraph of Article 17.1 of the Additives Directive.

Export of zootechnical feedingstuffs to E.E.A. States

60

No person shall export a zootechnical feedingstuff for marketing in an E.E.A. State unless the details given on the package or container of, or label attached to, the feedingstuff and covered by Article 18 of the Additives Directive comply with that Article.

Import of zootechnical feedingstuffs

61

No person shall import from an E.E.A. 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 the Additives Directive comply with that Article.

Putting zootechnical compound feedingstuffs into circulation

62

No person shall put a zootechnical compound feedingstuff into circulation unless it has been manufactured on—

• (a) a U.K. or E.C. approved or permitted Chapter I.3(M) establishment, or

• (b) on an establishment located in a third country:

• (i) if it is listed in relation to zootechnical compound feedingstuffs under arrangements to implement the second indent of the second paragraph of Article 15(a) of the Establishments Directive, or

• (ii) pending the making of those arrangements, if it is reasonable to conclude that it would have been so listed if those arrangements had been made.

PART VIII — MISCELLANEOUS AND SUPPLEMENTAL PROVISIONS

Restrictions on toxicological tests on vertebrates

63

No person applying, or intending to apply, for the Community authorisation of a zootechnical additive shall begin toxicological tests on vertebrates unless, before beginning the tests, he has—

• (a) carried out a check of the type specified in the first paragraph of Article 9c.6 of the Additives Directive, as amended by Directive 96/51/EC, and

• (b) otherwise complied with the requirements of the first and second paragraphs of Article 9c.6 of the Additives Directive as amended by Directive 96/51/EC.

Confidential information relating to zootechnical additives

64

• (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 the Additives Directive, the Additives Directive as amended by Directive 96/51/EC or the Establishments Directive.

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

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

Use of Article 9c data

65

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

Official checks and enforcement

66

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

Powers of authorised persons

67

• (1) An authorised person may at all reasonable times and on producing, if so required, some duly authenticated document showing his authority, 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 68 has been or is being committed.

• (2) An authorised person shall have the right to enter—

• (a) any premises on which he has reasonable cause to believe that a zootechnical product has been manufactured 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 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.

• (3) An authorised person entering any premises by virtue of this regulation 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).

• (4) An authorised person shall have the right to inspect—

• (a) any substance or article 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 of any zootechnical product and any process of manufacture of such a product, and the means employed, at any stage in the process of manufacture, for testing the product after it has been subject to those processes.

• (5) An authorised person shall have the right to take a sample of—

• (a) a substance or article used, or intended to be used, in the manufacture of a zootechnical product;

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

• (c) a product appearing to him to be a zootechnical product, used, or intended to be used, for the purpose of animal feeding.

• (6) An authorised person shall have the right—

• (a) to require any person carrying on a business which consists of or includes the activities of manufacture, wrapping, packaging, storage, circulation, marketing, supply or use of zootechnical products, and any person employed in connection with such a business, to produce any record (in whatever form it is held) relating to those activities which is in his possession or under his control, and

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

• (7) An authorised person exercising the power conferred by paragraph (6) 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 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 the 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.

• (8) An authorised person shall have the right to seize and detain a 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.

• (9) In this regulation, “premises" includes any land, vehicle, vessel, aircraft or hovercraft.

Offences

68

It shall be an offence for a person—

• (a) without reasonable excuse, to contravene any provision of regulation 26, 28, 29, 30, 32, 34(1) or (2), 35(1), 36(1), (2) or (5), 37(1) or (2), 41, 43, 44, 45, 47, 49(1), 50(1), 51(1), 52, 54, 56, 57(1), 58, 59(1), 60 to 63 inclusive, 64(1) or 65;

• (b) without reasonable excuse, to fail to comply with any provision of regulation 27, 31, 33, 38, 39(1), 40, 42, 46, 48, 53 or 55;

• (c) intentionally to obstruct an authorised person in the exercise of a power conferred by regulation 67; or

• (d) without reasonable excuse, to fail to comply with any requirement made of him, pursuant to regulation 67, by an authorised person.

Punishment of offences

69

• (1) Any person who commits any of the offences set out in regulation 68(a) shall be liable—

• (a) on summary conviction, to a fine not exceeding the statutory maximum; and

• (b) on conviction on indictment, to a fine.

• (2) Any person who commits any of the offences set out in regulation 68(b) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

• (3) Any person who commits any of the offences set out in regulation 68(c) or 68(d) shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale.

Time limit for prosecutions

70

• (1) Proceedings for an offence under regulation 68(b) may, subject to paragraph (2) below, be commenced within the period of six months from the date on which evidence sufficient in the opinion of the prosecutor to warrant proceedings comes to his knowledge.

• (2) No such proceedings shall be commenced by virtue of this regulation more than two years after the commission of the offence.

• (3) For the purpose of this regulation, a certificate signed by or on behalf of the prosecutor and stating the date on which evidence sufficient in his opinion to warrant the proceedings came to his knowledge shall be conclusive evidence of that fact.

• (4) A certificate stating that matter and purporting to be so signed shall be deemed to be so signed unless the contrary is proved.

• (5) In relation to proceedings in Scotland, subsection (3) of section 136 of the Criminal Procedure (Scotland) Act 1995 (date of commencement of proceedings) shall apply for the purposes of this regulation as it applies for the purposes of that section.

Offences by bodies corporate and Scottish partnerships

71

• (1) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to be attributable to, any neglect on the part of—

• (a) any director, manager, secretary or other similar officer of the body corporate, or

• (b) any person who was purporting to act in any such capacity,

he, as well as the body corporate, shall be guilty of the offence and be liable to be proceeded against and punished accordingly.

• (2) For the purposes of paragraph (1), “director" in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

• (3) Where a Scottish partnership is guilty of an offence under these Regulations in respect of an act or default which is shown to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner in the partnership, he, as well as the partnership, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

Defence

72

Where a person responsible for putting a zootechnical product into circulation is charged with an offence under these Regulations in respect of a product that has been manufactured or assembled to his order by another person and which has been so manufactured or assembled so as not to comply with his order, it shall be a defence for him to prove—

• (a) that, in placing his order, a copy of the documents relating to the manufacture and assembly of the product were available, or had been provided, to that other person and the person responsible for putting the product into circulation had instructed that other person to manufacture or assemble the product in accordance with those documents,

• (b) that if that other person had complied with that instruction, no offence would have been committed, and

• (c) that the person responsible for putting the product into circulation did not know, and could not by the exercise of reasonable care have known, that those instructions had not been complied with.

Service of notices

73

Any notice required to be served on a person under any provision of these Regulations may be served—

• (a) by delivering it to him;

• (b) by leaving it at the usual or last known place of abode or business of that person, or, in a case where an address for service has been given by that person, at that address;

• (c) by sending it in a prepaid registered letter, or by the recorded delivery service, addressed to that person at his usual or last-known place of abode or business or, in a case where an address for service has been given by that person, at that address; or

• (d) in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or by sending it in a prepaid registered letter, or by the recorded delivery service, addressed to the secretary or clerk of that body corporate at that office.

Exclusion of application of the Medicines Act 1968

74

• (1) Except as specified in paragraph (2), the Medicines Act 1968 , and instruments made wholly or partly under that Act, shall not apply to zootechnical products.

• (2) The provisions of sections 32 to 36 (other than section 35(8)(a)), 38 and 39 of the Medicines Act 1968, and instruments made under any of those provisions, shall continue to apply to unauthorised zootechnical additives as if paragraph (1) had not come into force.

Revocation of product licences

75

Any product licence granted in respect of a zootechnical product under the Medicines Act 1968 which is extant immediately before this regulation comes into force shall automatically be revoked on the coming into force of this regulation.

SCHEDULE 1 — INTERPRETATION

PART I — Expressions having the same meaning as in the Additives Directive

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART II — Expressions having the same meaning as in the Additives Directive as amended by Directive 96/51/EC

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART III — Expressions having the same meaning as in the Establishments Directive

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 2 — FEES

PART I — Fees payable in relation to the submission of dossiers

Application	Fee (£) per dossier
Application under regulation 6(3)	25,000
Application under regulation 7(1)	10,000
Application under regulation 8(1)	2,500

PART II — Fees payable in relation to the approval of establishments

Application	Fee (£)
Application under regulation 10(1)(a) or 12 for approval of an establishment for the manufacture of a zootechnical additive	405
Application under regulation 10(1)(b) or 12 for approval of an establishment to manufacture a zootechnical premixture	405
Application under regulation 10(1)(c) or 12 for approval of an establishment to manufacture a zootechnical compound feedingstuff	113
Application under regulation 10(1)(d) or 12 for approval of an establishment to produce a zootechnical compound feedingstuff for the exclusive requirements of the applicant’s holding	113
Application under regulation 10(1)(e) or 12 for approval of an establishment to manufacture a zootechnical compound feedingstuff using a minimum proportion of 0.05% by weight of a premixture	405

PART III — Fees payable in relation to the approval of intermediaries

Application	Fee (£)
Application for approval under regulation 18 or 20 to exercise an intermediary activity	151

Signed

Jeff Rooker — Minister of State, Ministry of Agriculture, Fisheries and Food — 9th April 1998

Sewel — Parliamentary Under-Secretary of State, Scottish Office — 1st April 1998

Explanatory note

(This note is not part of the Regulations)

Footnotes

Editorial notes

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

animal feeding

antibiotics

coccidiostats and other medicinal substances

compositional characteristics

country of destination

growth promoters

market

use

Community authorisation

delivered

identification note

incorporate

last stage of circulation

monograph

originate

period of authorisation

reference sample

representative within the Community

standard sample

supply

toxicological tests on vertebrates

unforeseen undesirable interaction

veterinary medicine

cease

demonstrate

essential condition

exclusive requirements

facilities

holding

located

manufacture

on the spot verification

package

produce

reasonable time

register

store

update

wrap