The Feedingstuffs (Zootechnical Products) Regulations 1998

• (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

[^f00001]: S.I. 1972/1811.

[^f00002]: 1972 c. 68.

[^f00003]: OJ No. L270, 14.12.70, p.1 OJ/SE Vol. 18, p.4.

[^f00004]: the next most recent amending instrument was Council Directive 96/25/EC (OJ No. L125, 23.5.96, p.35).

[^f00005]: OJ No. L64, 7.3.87, p.19.

[^f00006]: OJ No. L208, 11.8.94, p.15.

[^f00007]: OJ No. L106, 11.5.95, p.23.

[^f00008]: OJ No. L235, 17.9.96, p.39.

[^f00009]: OJ No. L1, 3.1.94, p.3.

[^f00010]: OJ No. L1, 3.1.94, p.572.

[^f00011]: OJ No. L332, 30.12.95, p.15.

[^f00012]: 1968 c. 67.

[^f00013]: 1986 c. 14.

[^f00014]: OJ No. L279, 9.10.76, p.35.

[^f00015]: S.I. 1998/1046.

[^f00016]: 1995 c. 46.

[^f00017]: 1968 c. 67.

Editorial notes

[^c16636291]: S.I. 1972/1811.

[^c16636301]: 1972 c.68.

[^c16636311]: OJ No. L270, 14.12.70, p.1 OJ/SE Vol. 18, p.4.

[^c16636321]: the next most recent amending instrument was Council Directive 96/25/EC (OJ No. L125, 23.5.96, p.35).

[^c16636331]: OJ No. L64, 7.3.87, p.19.

[^c16636341]: OJ No. L208, 11.8.94, p.15.

[^c16636351]: OJ No. L106, 11.5.95, p.23.

[^c16636361]: OJ No. L235, 17.9.96, p.39.

[^c16636371]: OJ No. L1, 3.1.94, p.3.

[^c16636381]: OJ No. L1, 3.1.94, p.572.

[^c16636391]: OJ No. L332, 30.12.95, p.15.

[^c16636401]: 1968 c.67.

[^c16636411]: 1986 c.14.

[^c16636421]: OJ No. L279, 9.10.76, p.35.

[^c16636431]: S.I. 1998/1046.

[^c16636441]: 1995 c.46.

[^c16636451]: 1968 c.67.

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

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