The Feedingstuffs (Zootechnical Products) Regulations 1999

• Citation: S.I. 1999/1871
• Sections: 110

Section 1 Title, commencement and revocation

(1) These Regulations may be cited as the Feedingstuffs (Zootechnical Products) Regulations 1999 and shall come into force on the following dates—

(a) all regulations and Schedules, except for regulations 7, 8, 46, 47, 48, 72, 73 and 74, on 2nd August 1999, and

(b) regulations 7, 8, 46, 47, 48, 72, 73 and 74 on 1st October 1999.

(2) The Feedingstuffs (Zootechnical Products) Regulations 1998 (“the 1998 Regulations ”) are hereby revoked.

Section 2 General interpretation and application

(1) In these Regulations—

“the 1968 Act ” means the Medicines Act 1968 .

“the 1970 Act ” means the Agriculture Act 1970 .

“additive” has the meaning given by Article 2(a) of Directive 70/524/EEC until 30th September 1999, but on and after 1st October 1999 has the meaning given by that Article as amended by Directive 96/51/EC ;

“agricultural analyst” means an agricultural analyst appointed under section 67 of the 1970 Act, and includes a deputy agricultural analyst so appointed for the same area, but in Northern Ireland does not include the Chief Agricultural Analyst ;

“analyst” means an agricultural analyst, or, in Great Britain, any other analyst appointed by the Minister for the purposes of these Regulations;

“animal” includes any bird, insect or fish;

“Article 6.4 purpose” means a purpose specified in Article 6.4 of Directive 70/524/EEC;

“authorised person” means a person (whether or not an officer of the enforcement authority) who is authorised by the enforcement authority, either generally or specially, to act in relation to matters arising under these Regulations;

“authorised zootechnical additive” means a BI, BII or BIII zootechnical additive, but excludes any additive deleted, by a Regulation listed in Schedule 1, from Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC;

“a BI zootechnical additive” means a zootechnical additive which is covered by Chapter I of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC and complies with any applicable provisions relating to the additive covered by that Chapter;

“a BII zootechnical additive” means a zootechnical additive which is covered by Chapter II of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC and complies with any applicable provisions relating to the additive covered by that Chapter;

“a BIII zootechnical additive” means a zootechnical additive which is covered by Chapter III of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC, which complies with any applicable provisions relating to the additive covered by that Chapter and for which the period of authorisation covered by that Chapter has not expired;

“the Chief Agricultural Analyst” means the Chief Agricultural Analyst for Northern Ireland;

“a Community authorised zootechnical additive” means a zootechnical additive in respect of which a Community authorisation is in force, and which complies with the requirements relating to the additive contained in that authorisation;

“complete feedingstuff” has the meaning given by Article 2(d) of Directive 70/524/EEC;

“compound feedingstuff” has the meaning given by Article 2(g) of Directive 70/524/EEC;

“ Directive 70/524/EEC concerning additives in feeding-stuffs as amended up to, but not including, the amendments effected by Directive 96/51/EC">Directive 70/524/EEC ” means Council Directive 70/524/ EEC concerning additives in feeding-stuffs as amended up to, but not including, the amendments effected by Directive 96/51/EC ;

“ Directive 87/153/EEC ” means Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition as amended by Commission Directives 94/40/ EC and 95/11/EC ;

“ Directive 95/53/EC ” means Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition (with effect from 1st October 1999 as amended by Council Directive 1999/20/EC );

“ Directive 95/69/EC ” means Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC , 74/63/EEC , 79/373/EEC and 82/471/EEC (with effect from 1st October 1999 as amended by Council Directive 1999/20/EC );

“Directive 96/51/EC” means Council Directive 96/51/EC amending Directive 70/524/ EEC concerning additives in feedingstuffs ;

“ Directive 98/51/EC ” means Commission Directive 98/51/EC laying down certain measures for implementing Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector ;

“dossier” means a dossier compiled in accordance with the relevant provisions of Directive 87/153/EEC and which includes—

a monograph;

an identification note containing the information specified in Article 9o.1 of Directive 70/524/EEC as amended by Directive 96/51/EC; and

in the case of a zootechnical additive to which Article 7a of Directive 70/524/EEC, as amended by Directive 96/51/EC, applies, the documents referred to in the first and second indented paragraphs of the first paragraph of Article 7a of Directive 70/524/EEC as so amended;

“ EEA Agreement ” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1993 as adjusted by the Protocol signed at Brussels on 17th March 1993;

“ EEA State ” means a State which is a contracting party to the EEA Agreement other than the United Kingdom;

“the enforcement authority” means—

in relation to Great Britain, the Royal Pharmaceutical Society of Great Britain, and

in relation to Northern Ireland, the Department of Agriculture for Northern Ireland;

“feedingstuff” has the meaning given by Article 2(b) of Directive 70/524/EEC;

“fish” includes shellfish;

“medicinal tests on animals” has the meaning given by section 32(6) of the 1968 Act and“animal test certificate” shall be construed in accordance with that section;

“Member State” means a member State other than the United Kingdom;

“the MF Regulations ” means the Medicated Feedingstuffs Regulations 1998 ;

“the Minister” means the Minister of Agriculture, Fisheries and Food;

“official checks” means checks of the type specified in Article 21.1 of Directive 70/524/EEC, Articles 3, 4, 7 and 10 to 12, the second paragraph of Article 14, the second and third paragraphs of Article 15.2 and Article 17.1 of Directive 95/53/EC, or Article 13 of Directive 95/69/EC, or which are carried out with a view to enforcement of the provisions of Article 6 of Directive 98/51/EC;

“personal licence” means a licence granted under section 4 of the Animals (Scientific Procedures) Act 1986 ;

“person responsible for putting into circulation” has the meaning given by Article 2(1) of Directive 70/524/EEC as amended by Directive 96/51/EC;

“premixture” has the meaning given by Article 2(h) of Directive 70/524/EEC;

“project licence” means a licence granted under section 5 of the Animals (Scientific Procedures) Act 1986;

“putting into circulation” has the meaning given by Article 1.3(a) of Directive 95/69/EC;

“regulated procedure” has the meaning given by section 2 of the Animals (Scientific Procedures) Act 1986;

“retained part of the sample” means that part of the sample retained by an authorised person pursuant to regulation 77(d);

“the Scientific Committee for Animal Nutrition ” means the committee established by Commission Decision 76/791/EEC establishing a Scientific Committee for Animal Nu trition ;

“supplementary feedingstuff” has the meaning given by Article 2(e) of Directive 70/524/EEC;

“third country” means a country other than a Member State or the United Kingdom;

“unauthorised zootechnical additive” means a zootechnical additive other than an authorised zootechnical additive;

“zootechnical additive” means an additive belonging to one or more of the groups of additives specified in Part I of Annex C to Directive 70/524/EEC, as amended by Directive 96/51/EC;

“zootechnical feedingstuff” means a feedingstuff that contains a zootechnical additive or zootechnical premixture;

“zootechnical premixture” means a premixture that contains a zootechnical additive; and

subject to regulation 76(13), “zootechnical product” means a zootechnical additive, a zootechnical premixture or a zootechnical feedingstuff.

(2) The expressions listed in Part 1 of Schedule 2 have the same meaning as in Directive 70/524/EEC and any other expression which is used in these Regulations and Directive 70/524/EEC, other than an expression which is listed in Part II or III of Schedule 2, shall have, insofar as the context admits, the same meaning as in that Directive.

(3) The expressions listed in Part II of Schedule 2 have the same meaning as in Directive 70/524/EEC as amended by Directive 96/51/EC.

(4) Insofar as the context admits the expressions listed in Part III of Schedule 2 have the same meaning as in Directive 95/69/EC.

(5) In the expressions “representative established within the United Kingdom” and“representative established within a member State”, “representative” and “established within”shall have the same meanings as in the expression “representative established within the European Community” in Directive 98/51/EC.

(6) In these Regulations, unless the context otherwise requires—

(a) any reference to a numbered regulation or to a numbered Schedule is a reference to the regulation of or the Schedule to these Regulations so numbered in these Regulations,

(b) any reference in a regulation to a numbered paragraph is a reference to the paragraph so numbered in the regulation in which the reference occurs, and

(c) any reference to any things done under provisions of these Regulations shall be taken to include things done under the corresponding provisions of the 1998 Regulations.

(7) These Regulations shall apply in the field of animal feeding—

(a) until 30th September 1999, to zootechnical products to which Directive 70/524/EEC applies, and

(b) on and after 1st October 1999, to zootechnical products to which that Directive, as amended by Directive 96/51/EC, applies.

Section 2 Applications for the approval of establishments

An application made under paragraph (1) shall be in writing, in the English langauge, (or, where the establishment in respect of which the application is made is situated wholly or partly in Wales, in either that language or the Welsh language) signed by or on behalf of the applicant, and shall contain the name (or business name) and address of the applicant, shall specify each activity in relation to which the application is made, and shall be accompanied by particulars which seek to demonstrate that the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

Section 2 Amendment of approvals

Where an application complying with regulation 10(2) is made under paragraph (1), the enforcement authority shall (subject to regulation 15) amend the approval relating to the establishment, and approve the establishment as an establishment on which the new establishment activity may be exercised, if, following the procedure in regulation 11(1), it is satisfied that, in respect of the new establishment activity, the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

(3) Where, pursuant to paragraph (2), the enforcement authority amends an approval relating to an approved establishment, it shall update the register of approved establishments to show all the establishment activities that may be exercised on the approved establishment.

Section 3 Definition of “establishment” and other related definitions

In these Regulations “establishment” has the meaning given by Article 1.3(b) of Directive 95/69/EC and—

“the applicable day” means, in relation to any Member State, the date treated by that Member State as the first date after the closure of the period allowed by it for submission of declarations to it pursuant to Article 6.3 of Directive 98/51/EC;

“Article 12 establishment” means an establishment to which Article 12 of Directive 95/69/EC applies;

“EC approved Chapter I.1 establishment” means an establishment listed on a register of approved establishments maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an establishment on which a zootechnical additive may be manufactured with a view to putting it into circulation;

“EC approved Chapter I.2 establishment” means an establishment listed on a register of approved establishments maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an establishment on which a zootechnical premixture may be manufactured with a view to putting it into circulation;

“EC approved Chapter I.3(M) establishment” means an establishment listed on a register of approved establishments maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an establishment on which a zootechnical compound feedingstuff may be manufactured with a view to putting it into circulation;

“EC approved Chapter I.3(P) establishment” means an establishment listed on a register of approved establishments maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an establishment on which a zootechnical compound feedingstuff may be produced for the exclusive requirements of the producer’s holding;

“EC approved third country Chapter I.1 establishment” means a third country establishment listed on a register of approved establishments, maintained by a competent authority in a Member State, in implementation of Article 5 of Directive 95/69/EC (as read with Directive 98/51/EC), as being an establishment as to which a zootechnical additive, manufactured thereon, may be imported into that Member State, and which has a representative established within that Member State;

“EC approved third country Chapter I.2 establishment” means a third country establishment listed on a register of approved establishments, maintained by a competent authority in a Member State, in implementation of Article 5 of Directive 95/69/EC (as read with Directive 98/51/EC), as being an establishment as to which a zootechnical premixture, manufactured thereon, may be imported into that Member State, and which has a representative established within that Member State;

“EC approved third country Chapter I.3(M) establishment” means a third country establishment listed on a register of approved establishments, maintained by a competent authority in a Member State, in implementation of Article 5 of Directive 95/69/EC (as read with Directive 98/51/EC), as being an establishment as to which a zootechnical compound feedingstuff, manufactured thereon, may be imported into that Member State, and which has a representative established within that Member State;

“EC permitted Chapter I.1 establishment” means an establishment located in a Member State if—

a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending) in respect of the establishment was made to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to approve the establishment, pursuant to Directive 95/69/EC, as an establishment on which such an additive may be manufactured with a view to putting it into circulation;

“EC permitted Chapter I.2 establishment” means an establishment located in a Member State if—

a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending) in respect of the establishment was made to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to approve the establishment, pursuant to Directive 95/69/EC, as an establishment on which such a premixture may be manufactured with a view to putting it into circulation;

“EC permitted Chapter I.3(M) establishment” means an establishment located in a Member State if—

a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending) in respect of the establishment was made to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to approve the establishment, pursuant to Directive 95/69/EC, as an establishment on which such a feedingstuff may be manufactured with a view to putting it into circulation;

“EC permitted Chapter I.3(P) establishment” means an establishment located in a Member State if—

a zootechnical compound feedingstuff was being produced on the establishment for the exclusive requirements of the producer’s holding on 1st April 1998, and

before 1st September 1998 an application (which is pending) in respect of the establishment was made to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to approve the establishment, pursuant to Directive 95/69/EC, as an establishment on which such a feedingstuff may be produced for the exclusive requirements of the producer’s holding;

“EC permitted third country Chapter I.1 establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Chapter I.1 establishment) if a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within a Member State, and

on and after the applicable day, a third country establishment if—

a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before the applicable day, a declaration (consideration of which is pending) in respect of the establishment, has been submitted to a competent authority in the Member State, in accordance with any requirements in the Member State for the submission of such declarations pursuant to Article 6.3 of Directive 98/51/EC, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which such an additive, manufactured thereon, may be imported into that Member State;

“EC permitted third country Chapter I.2 establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Chapter I.2 establishment) if a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within a Member State, and

on and after the applicable day, a third country establishment if—

a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before the applicable day, a declaration (consideration of which is pending) in respect of the establishment, has been submitted to a competent authority in the Member State, in accordance with any requirements in the Member State for the submission of such declarations pursuant to Article 6.3 of Directive 98/51/EC, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which such a premixture, manufactured thereon, may be imported into that Member State;

“EC permitted third country Chapter I.3(M) establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Chapter I.3(M) establishment) if a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within a Member State, and

on and after the applicable day, a third country establishment if—

a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before the applicable day, a declaration (consideration of which is pending) in respect of the establishment, has been submitted to a competent authority in the Member State, in accordance with any requirements in the Member State for a submission of such declarations pursuant to Article 6.3 of Directive 98/51/EC, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which such a feedingstuff, manufactured thereon, may be imported into that Member State;

“specially approved manufacturing establishment” means an establishment approved pursuant to regulation 10(1)(e) as an establishment on which a zootechnical compound feedingstuff may be manufactured using a minimum proportion of 0.05% by weight of a premixture;

“third country establishment” means an establishment located in a third country;

“ UK approved Chapter I.1 establishment” means an establishment approved pursuant to regulation 11 or, as the case may be, 12, as an establishment on which a zootechnical additive may be manufactured with a view to putting it into circulation;

“UK approved Chapter I.2 establishment” means an establishment approved pursuant to regulation 11 or, as the case may be, 12, as an establishment on which a zootechnical premixture may be manufactured with a view to putting it into circulation;

“UK approved Chapter I.3(M) establishment” means an establishment approved pursuant to regulation 11 or, as the case may be, 12, as an establishment on which a zootechnical compound feedingstuff may be manufactured with a view to putting it into circulation, and includes a specially approved manufacturing establishment;

“UK approved Chapter I.3(P) establishment” means an establishment approved pursuant to regulation 11 or, as the case may be, 12, as an establishment on which a zootechnical compound feedingstuff may be produced for the exclusive requirements of the producer’s holding;

“UK approved third country Chapter I.1 establishment” means a third country establishment approved pursuant to regulation 27(1)(a) or, as the case may be, 28(3), as an establishment as to which a zootechnical additive, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK approved third country Chapter I.2 establishment” means a third country establishment approved pursuant to regulation 27(1)(a) or, as the case may be, 28(3), as an establishment as to which a zootechnical premixture, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK approved third country Chapter I.3(M) establishment” means a third country establishment approved pursuant to regulation 27(1)(a) or, as the case may be, 28(3), as an establishment as to which a zootechnical compound feedingstuff, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK permitted Chapter I.1 establishment” means an establishment located in the United Kingdom if—

a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending and complies with regulation 10(2)) was submitted in respect of the establishment under regulation 10(1)(a) (or under regulation 12(1) in relation to zootechnical additive manufacture);

“UK permitted Chapter I.2 establishment” means an establishment located in the United Kingdom if—

a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending and complies with regulation 10(2)) was submitted in respect of the establishment under regulation 10(1)(b) (or under regulation 12(1) in relation to zootechnical premixture manufacture);

“UK permitted Chapter I.3(M) establishment” means an establishment located in the United Kingdom if—

a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998 an application (which is pending and complies with regulation 10(2)) was submitted in respect of the establishment under regulation 10(1)(c) (or under regulation 12(1) in relation to zootechnical compound feedingstuff manufacture); and

“UK permitted Chapter I.3(P) establishment” means an establishment located in the United Kingdom if—

a zootechnical compound feedingstuff was being produced on the establishment for the exclusive requirements of the producer’s holding on 1st April 1998, and

before 1st September 1998 an application (which is pending and complies with regulation 10(2)) was submitted in respect of the establishment under regulation 10(1)(d) (or under regulation 12(1) in relation to zootechnical compound feedingstuff production for the exclusive requirements of the producer’s holding).

“UK permitted third country Chapter I.1 establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Chapter I.1 establishment) if a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within the United Kingdom, and

on and after 1st October 1999, a third country establishment if—

a zootechnical additive was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before 1st October 1999, a declaration under (or required to be treated as under) regulation 26(1)(a), or a corresponding declaration under (or required to be treated as under) regulation 28(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 26(2), or, as the case may be, 28(2), and not containing a negative reply to a question specified in regulation 26(2)(g) or, as the case may be, 28(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Chapter I.2 establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Chapter I.2 establishment) if a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within the United Kingdom, and

on and after 1st October 1999, a third country establishment if—

a zootechnical premixture was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before 1st October 1999, a declaration under (or required to be treated as under) regulation 26(1)(b), or a corresponding declaration under (or required to be treated as under) regulation 28(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 26(2), or, as the case may be, 28(2), and not containing a negative reply to a question specified in regulation 26(2)(g) or, as the case may be, 28(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Chapter I.3(M) establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Chapter I.3(M) establishment) if a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and the establishment has, at all times since that date, had a representative established within the United Kingdom, and

on and after 1st October 1999, a third country establishment if—

a zootechnical compound feedingstuff was being manufactured on the establishment, with a view to putting it into circulation, on 31st December 1998, and, at all times since that date, the establishment has had a representative as aforesaid, and

before 1st October 1999, a declaration under (or required to be treated as under) regulation 26(1)(c), or a corresponding declaration under (or required to be treated as under) regulation 28(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 26(2), or, as the case may be, 28(2), and not containing a negative reply to a question specified in regulation 26(2)(g) or, as the case may be, 28(2)(g), has been submitted in respect of the establishment.

Section 4 Definition of “intermediary” and other related definitions

In these Regulations “intermediary” has the meaning given by Article I.3(c) of Directive 95/69/EC and—

“EC approved Chapter I.1 intermediary” means an intermediary listed on a register of approved intermediaries maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an intermediary who may wrap, package, store and put into circulation a zootechnical additive;

“EC approved Chapter I.2 intermediary” means an intermediary listed on a register of approved intermediaries maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an intermediary who may wrap, package, store and put into circulation a zootechnical premixture;

“EC permitted Chapter I.1 intermediary” means an intermediary whose facilities are located in a Member State and who—

was wrapping, packaging, storing or putting into circulation a zootechnical additive on 1st April 1998, and

has made an application (which is pending) to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to be approved pursuant to Directive 95/69/EC as an intermediary who may wrap, package, store and put into circulation such an additive;

“EC permitted Chapter I.2 intermediary” means an intermediary whose facilities are located in a Member State and who—

was wrapping, packaging, storing or putting into circulation a zootechnical premixture on 1st April 1998, and

has made an application (which is pending) to the competent authority in that State, in accordance with any requirements in that State for the making of such applications, to be approved pursuant to Directive 95/69/EC as an intermediary who may wrap, package, store and put into circulation such a premixture;

“UK approved Chapter I.1 intermediary” means an intermediary approved pursuant to regulation 19 or, as the case may be, 20, as an intermediary who may wrap, package, store and put into circulation a zootechnical additive;

“UK approved Chapter I.2 intermediary” means an intermediary approved pursuant to regulation 19 or, as the case may be, 20, as an intermediary who may wrap, package, store and put into circulation a zootechnical premixture;

“UK permitted Chapter I.1 intermediary” means an intermediary whose facilities are located in the United Kingdom and who—

was wrapping, packaging, storing or putting into circulation such an additive on 1st April 1998, and

has submitted an application (which is pending and complies with regulation 18(2)) under regulation 18(1)(a) (or under regulation 20(1) in relation to zootechnical additive intermediary activity); and

“UK permitted Chapter I.2 intermediary” means an intermediary whose facilities are located in the United Kingdom and who—

was wrapping, packaging, storing or putting into circulation a zootechnical premixture on 1st April 1998, and

has submitted an application (which is pending and complies with regulation 18(2)) under regulation 18(1)(b) (or under regulation 20(1) in relation to zootechnical premixture intermediary activity).

Section 5 Transitional applications

(1) An eligible person who wishes the United Kingdom to act as the rapporteur in connection with an application for the Community authorisation of a BI, BII or BIII zootechnical additive may submit an application for such authorisation, accompanied by a monograph and identification note relating to the additive, to the Minister.

(2) Where documentation is submitted to the Minister pursuant to paragraph (1), he shall process this in accordance with the requirements of—

(a) Article 9g.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of an application relating to a BI zootechnical additive;

(b) Article 9h.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of an application relating to a BII zootechnical additive; and

(c) Article 9i.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of an application relating to a BIII zootechnical additive.

(3) A person who applies for the Community authorisation of a BI zootechnical additive for which the United Kingdom is acting as rapporteur may submit a dossier relating to the additive to the Minister in accordance with the requirements of Article 9g.4 of Directive 70/524/EEC, as amended by Directive 96/51/EC.

(4) Where a dossier relating to a BI zootechnical additive is submitted to the Minister pursuant to paragraph (3), he shall (subject to regulation 9)—

(a) forward it to the Commission, and

(b) forward a copy of it to each Member State,

if he is satisfied as specified in paragraph (5).

(5) The Minister is satisfied in accordance with this paragraph if he is satisfied that—

(a) the dossier submitted pursuant to paragraph (3) has been compiled in accordance with the applicable provisions of Directive 87/153/EEC, and

(b) the zootechnical additive to which the dossier relates meets the conditions laid down in Article 3a of Directive 70/524/EEC as amended by Directive 96/51/EC.

(6) If, in relation to a dossier submitted pursuant to paragraph (3), the Minister is not satisfied about both of the matters specified in paragraph (5), he shall reject the dossier, or postpone taking the action specified in paragraph (4) in relation to it, until such time as he is satisfied about both of those matters.

(7) Where the Minister rejects a dossier submitted to him pursuant to paragraph (3), or postpones taking the action specified in paragraph (4) in relation to it, he shall inform the Commission and each Member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

(8) If requested to do so by the Commission, the Minister shall forward a copy of all or part of a dossier relating to a BI zootechnical additive submitted to him pursuant to paragraph (3) to each member of the Scientific Committee for Animal Nutrition.

(9) In paragraph (1) “eligible person” means a person who is entitled to apply for the Community authorisation of a BI, BII or BIII zootechnical additive, as the case may be, in accordance with the provisions of—

(a) Article 9g.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of a BI zootechnical additive;

(b) Article 9h.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of a BII zootechnical additive; and

(c) Article 9i.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC, in the case of a BIII zootechnical additive.

Section 6 Preliminary ordinary applications

(1) A person who, in the specified circumstances, wishes the Minister to act in accordance with the following provisions of this regulation in connection with an application for the Community authorisation of a zootechnical additive may submit an application for the Community authorisation of the additive and a dossier relating to the additive to the Minister.

(2) Where documentation is submitted to the Minister pursuant to paragraph (1), he shall—

(a) forward it to the Commission, and

(b) forward a copy of it to each Member State,

if he is satisfied as specified in paragraph (3) and has received the appropriate fee in accordance with paragraph (4).

(3) The Minister is satisfied in accordance with this paragraph if he is satisfied that—

(a) the dossier submitted pursuant to paragraph (1) has been compiled in accordance with the applicable provisions of Directive 87/153/EEC, and

(b) the zootechnical additive to which the dossier relates meets the conditions laid down in Article 3a of Directive 70/524/EEC as amended by Directive 96/51/EC.

(4) If the Minister is satisfied in accordance with paragraph (3), the Minister shall notify the person who has submitted the documentation pursuant to paragraph (1) of the Minister’s intention, subject to receipt of the appropriate fee, to forward the dossier to the Commission and the other Member States in accordance with paragraph (2), and upon receipt of such notice such person shall pay the appropriate fee to the Minister and any unpaid sum shall be recoverable as a debt.

(5) If, in relation to a dossier submitted pursuant to paragraph (1), the Minister is not satisfied about both of the matters specified in paragraph (3), he shall reject the documentation or postpone taking the action specified in paragraph (2) in relation to the documentation, until such time as he is satisfied about both of those matters.

(6) Where the Minister rejects the documentation submitted to him pursuant to paragraph (1), or postpones taking the action specified in paragraph (2) in relation to it, he shall inform the person who has submitted the application pursuant to paragraph (1), the Commission and each Member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

(7) If requested to do so by the Commission, the Minister shall forward a copy of all or part of a dossier relating to a zootechnical additive for which an application has been submitted to him pursuant to paragraph (1) to each member of the Scientific Committee for Animal Nutrition.

(8) For the purposes of this regulation—

(a) the “specified circumstances” apply where—

(i) the person in question is, at the time these Regulations come into force, putting the additive in question into circulation,

(ii) he is not an eligible person under regulation 5 in relation to that additive,

(iii) he wishes to be able to continue putting the additive into circulation lawfully on or after 1st October 1999, and

(iv) he submits the documentation required pursuant to paragraph (1) to the Minister and this is received by the Minister before 1st October 1999; and

(b) “the appropriate fee” means the fee specified in relation to an application under regulation 6(1) in Part I of Schedule 3.

(9) The Minister shall, subject to paragraph (10), treat any documentation submitted to him in anticipation of paragraph (1) as submitted pursuant thereto, and accordingly references in this regulation to anything submitted pursuant to that paragraph shall be taken to include anything required by this paragraph to be so treated.

(10) Paragraph (9) shall only apply where the person who has submitted the documentation in question has, following the coming into force of that paragraph, notified the Minister that he wishes the documentation to be treated as specified in that paragraph.

Section 7 Ordinary applications

(1) A person who wishes the United Kingdom to act as the rapporteur in connection with—

(a) an application for the Community authorisation of a zootechnical additive, or

(b) an application for the Community authorisation of a new use of an already authorised zootechnical additive,

may submit an application for the Community authorisation of the additive or the new use of the additive, as the case may be, and a dossier relating to the additive, or the new use, as the case may be, to the Minister.

(2) Where documentation is submitted to the Minister pursuant to paragraph (1), he shall (subject to regulation 9)—

(a) forward it to the Commission, and

(b) forward a copy of it to each Member State,

in accordance with Article 4.3 of Directive 70/524/EEC, as amended by Directive 96/51/EC, if he is satisfied as specified in paragraph (3) below.

(3) The Minister is satisfied in accordance with this paragraph if he is satisfied that—

(a) the dossier submitted pursuant to paragraph (1) has been compiled in accordance with the applicable provisions of Directive 87/153/EEC, and

(b) the zootechnical additive to which the dossier relates, or the new use to which the dossier relates, as the case may be, meets the conditions laid down in Article 3a of Directive 70/524/EEC as amended by Directive 96/51/EC.

(4) If, in relation to a dossier submitted pursuant to paragraph (1), the Minister is not satisfied about both of the matters specified in paragraph (3), he shall reject the documentation, or postpone taking the action specified in paragraph (2) in relation to the documentation, until such time as he is satisfied about both of those matters.

(5) Where the Minister rejects documentation submitted to him pursuant to paragraph (1), or postpones taking the action specified in paragraph (2) in relation to it, he shall inform the Commission and each Member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

(6) If requested to do so by the Commission, the Minister shall forward a copy of all or part of a dossier relating to a zootechnical additive for which an application has been submitted to him pursuant to paragraph (1) to each member of the Scientific Committee for Animal Nutrition.

Section 8 Renewal applications

(1) A person who wishes the United Kingdom to act as the rapporteur in connection with an application to renew a Community authorisation relating to a zootechnical additive may submit an application to renew the Community authorisation relating to the additive and a dossier relating to the additive to the Minister.

(2) Where documentation is submitted to the Minister pursuant to paragraph (1), he shall (subject to regulation 9)—

(a) forward it to the Commission, and

(b) forward a copy of it to each Member State,

if he is satisfied in paragraph (3).

(3) The Minister is satisfied in accordance with this paragraph if he is satisfied that—

(a) the dossier submitted pursuant to paragraph (1) has been compiled in accordance with the applicable provisions of Directive 87/153/EEC, and

(b) the zootechnical additive to which the dossier relates continues to meet the conditions laid down in Article 3a of Directive 70/524/EEC as amended by Directive 96/51/EC.

(4) If, in relation to a dossier submitted pursuant to paragraph (1), the Minister is not satisfied about both of the matters specified in paragraph (3), he shall reject the documentation, or postpone taking the action specified in paragraph (2) in relation to the documentation, until such time as he is satisfied about both of those matters.

(5) Where the Minister rejects documentation submitted to him pursuant to paragraph (1), or postpones taking the action specified in paragraph (2) in relation to it, he shall inform the Commission and each Member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

(6) If requested to do so by the Commission, the Minister shall forward a copy of all or part of a dossier relating to a zootechnical additive for which an application has been submitted to him pursuant to paragraph (1) to each member of the Scientific Committee for Animal Nutrition.

Section 9 Fees

(1) In this regulation, “the relevant fee”, in relation to any application under regulation 5(3), 7(1)(a) or (b) or 8(1), means the fee specified opposite the application in question in Part I of Schedule 3, and it shall be payable by the person who submits a dossier to the Minister in connection with that application pursuant to the regulation concerned.

(2) Any relevant fee shall be paid at the time that the dossier is submitted to the Minister.

(3) Any unpaid sum due by way of a relevant fee, or any part of such fee, shall be recoverable as a debt.

(4) The Minister need not process any application made under regulation 5(3), 7(1) or 8(1), unless the application is accompanied by the relevant fee.

Section 10 Applications for the approval of establishments

(1) An eligible person may apply to the enforcement authority to approve an establishment as an establishment on which one or more of the following activities may be exercised—

(a) the manufacture of a zootechnical additive with a view to putting it into circulation;

(b) the manufacture of a zootechnical premixture with a view to putting it into circulation;

(c) the manufacture of a zootechnical compound feedingstuff with a view to putting it into circulation;

(d) the production of a zootechnical compound feedingstuff for the exclusive requirements of the applicant’s holding; and

(e) the manufacture of a zootechnical compound feedingstuff using a minimum proportion of 0.05% by weight of a premixture.

Section 11 Approval of establishments

(1) Where an application is made under regulation 10 or 12, the enforcement authority shall (subject to regulation 15)—

(a) check by means of an on the spot verification whether the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, and

(b) process the application in accordance with the requirements of the second paragraph of Article 4.1 or the second paragraph of Article 4.2 of Directive 95/69/EC as applicable.

(2) Where the enforcement authority is satisfied that, in respect of the relevant establishment activity, the establishment meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, it shall approve the establishment as an establishment on which the relevant establishment activity may be exercised, and register the establishment on the register of approved establishments in accordance with Article 5.1 of Directive 95/69/EC, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51/EC, as being an approved establishment on which the relevant establishment activity may be exercised.

Section 12 Amendment of approvals

(1) An eligible person may apply to the enforcement authority to approve an approved establishment as an establishment on which a further establishment activity (“the new establishment activity”) may be exercised—

(a) in addition to an establishment activity in respect of which the establishment is already approved, or

(b) instead of that activity.

Section 13 Withdrawal of approvals

(1) The enforcement authority shall withdraw an approval relating to the exercise of an establishment activity on an approved establishment if it is satisfied that the exercise of that activity on the establishment has ceased.

(2) The enforcement authority shall withdraw an approval relating to the exercise of an establishment activity on an approved establishment if, following the procedure in regulation 14, it is not satisfied that the person exercising the relevant activity on the establishment is complying with the duties imposed on him by regulations 34, 50, 62 or 64 as the case may be.

(3) Where, pursuant to paragraph (1) or (2), the enforcement authority withdraws an approval relating to the exercise of an establishment activity on an approved establishment, it shall update the register of approved establishments—

(a) to show any remaining establishment activity that may continue to be exercised on the approved establishment, or

(b) by removing the establishment from the register where, as a result of withdrawing the approval relating to the exercise of the relevant establishment activity, the establishment is no longer approved as an establishment on which an establishment activity of any sort may be exercised.

Section 14 Procedure relating to the withdrawal of approvals

(1) Where the enforcement authority proposes to withdraw an approval relating to the exercise of an establishment activity on an approved establishment because it is not satisfied that the person exercising the activity on the establishment is complying with the duties imposed on him by regulation 34, 50, 62 or 64, as the case may be, the enforcement authority shall not withdraw the approval unless—

(a) it serves a notice complying with the requirements of paragraph (2) on that person (“the recipient of the notice”), and

(b) it is not satisfied, after the time for compliance with the notice has expired, that the recipient of the notice has complied with the requirements specified in the notice.

(2) A notice served by the enforcement authority under paragraph (1) shall—

(a) state that it proposes to withdraw the approval of the establishment relating to the relevant establishment activity because it is not satisfied that the recipient of the notice is complying with the duties imposed on him by regulation 34, 50, 62 or 64 as the case may be;

(b) specify—

(i) the essential conditions that the enforcement authority is not satisfied that the recipient of the notice is complying with; and

(ii) the requirements that the recipient of the notice must comply with in order to satisfy the enforcement authority as to compliance with those essential conditions; and

(c) specify that, unless it is satisfied that the recipient of the notice has complied with the requirements specified in the notice within such reasonable time as is specified in the notice, the approval of the establishment insofar as it relates to the relevant establishment activity will be withdrawn.

Section 15 Fees

(1) In this regulation, “the relevant fee”, in relation to any application, means the fee specified opposite the application in question in Part II of Schedule 3, and (subject to paragraphs (5) to (11)) it shall be payable by a person who applies to the enforcement authority under regulation 10 or 12 to approve an establishment as an establishment on which an establishment activity may be exercised.

(2) Any fee payable under paragraph (1) shall be paid at the time the application is submitted to the enforcement authority.

(3) Any unpaid sum due by way of a fee payable under paragraph (1), or any part of such fee, shall be recoverable as a debt.

(4) Where any fee is payable under paragraph (1) in relation to any application, the enforcement authority need not process any application under regulation 10 or 12, unless the application is accompanied by that fee.

(5) Where an eligible person applies to the enforcement authority under regulation 10 for an establishment to be approved and in his application seeks approval to exercise more than one establishment activity, such person shall be liable to pay only one fee and, where the amount of the relevant fee differs according to establishment activity, the fee payable shall be the highest.

(6) Where an eligible person applies to the enforcement authority under regulation 10 for an establishment to be approved as an establishment on which an establishment activity may be exercised and, in relation to the same establishment, applies on the same date (evidenced by the date on the application forms) under regulation 3 of the MF Regulations to the relevant authority for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, he shall be liable to pay only one fee under both these Regulations and the MF Regulations and, where the relevant fee differs in amount from the fee payable under the MF Regulations, the fee payable shall be the higher amount.

(7) An eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 10 for an establishment to be approved as an establishment on which an establishment activity may be exercised and, in relation to the same establishment, has applied under regulation 3 of the MF Regulations for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, if he applies under regulation 10 within twelve months of his application under regulation 3 of the MF Regulations and at the date of his application under regulation 10—

(a) an inspection by the relevant authority is pending in relation to his application under regulation 3 of the MF Regulations, or

(b) the relevant authority has conducted such inspection and has granted approval pursuant to regulation 4 of the MF Regulations which remains valid.

(8) Where an eligible person applies to the enforcement authority under regulation 12 for an establishment to be approved and in his application seeks approval to exercise more than one new establishment activity, such person shall be liable to pay only one fee and, where the amount of the relevant fee differs according to establishment activity, the fee payable shall be the highest.

(9) Subject to paragraph (10), an eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment, has applied under regulation 10(1)(a), (b) or (e), if he applies under regulation 12 within twelve months of his application under regulation 10 and at the date of his application under regulation 12—

(a) an on the spot verification by the enforcement authority is pending in relation to his application under regulation 10 at the date of his application under regulation 12, or

(b) the relevant authority has conducted an on the spot verification in relation to his application under regulation 10, and has granted approval pursuant to regulation 11 which has not been withdrawn.

(10) Where an eligible person applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment, applies on the same date (evidenced by the date on the application forms) under regulation 3 of the MF Regulations to the relevant authority for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, he shall be liable to pay only one fee under both these Regulations and the MF Regulations and, where the relevant fee differs in amount from the fee payable under the MF Regulations, the fee payable shall be the higher amount.

(11) An eligible person shall not be liable to pay the relevant fee where he applies to the enforcement authority under regulation 12 for an establishment to be approved as an establishment on which a new establishment activity may be exercised and, in relation to the same establishment and establishment activity, has applied under regulation 3 of the MF Regulations for approval of the establishment as premises on which medicated feedingstuffs may be manufactured, if he applies under regulation 12 within twelve months of his application under regulation 3 of the MF Regulations and at the date of his application under regulation 12—

(a) an inspection by the relevant authority is pending in relation to his application under regulation 3 of the MF Regulations, or

(b) the relevant authority has conducted such inspection and has granted approval pursuant to regulation 4 of the MF Regulations which remains valid.

(12) A fee payable under combined regulations as described in paragraphs (6) and (10) shall, as well as a fee payable by reference to paragraph (5) or (8), be treated for the purposes of paragraphs (2) to (4) as included among fees payable under paragraph (1).

Section 16 Publication of the national list of approved establishments

The enforcement authority shall provide the Minister in writing, on demand being made by him, such information as is available to it and which will assist the Minister to comply with the requirements of Article 6.1 of Directive 95/69/EC relating to the publication of the national list of approved establishments, as read with Article 13.3 and 13.4 of Directive 70/524/EEC as amended by Directive 96/51/EC.

Section 17 Interpretation of Part III

In this Part—

“the applicable minimum conditions laid down in the Annex to Directive 95/69/EC” means the minimum conditions laid down in—

Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment, other than an Article 12 establishment, as an establishment on which the activity specified in regulation 10(1)(a) may be exercised;

points 4, 5, 6.2 and 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve an Article 12 establishment as an establishment on which the activity specified in regulation 10(1)(a) may be exercised;

Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(b) or (e) may be exercised;

Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(c) may be exercised; and

with the exception of the requirements set out in point 7, Chapter I.3(b) of the Annex to Directive 95/69/EC, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 10(1)(d) may be exercised;

“approved establishment” means an establishment approved by the enforcement authority as an establishment on which an establishment activity may be exercised;

“eligible person” means a person who is entitled to apply to the enforcement authority in accordance with the first paragraph of Article 4.1 of Directive 95/69/EC or the first paragraph of Article 4.2 of that Directive for an establishment to be approved as an establishment on which an establishment activity may be exercised;

“essential conditions” means the essential conditions in—

Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(a);

Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(b) or (e);

Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(c);

with the exception of the requirements set out in point 7, Chapter I.3(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(d); and

“establishment activity” means an activity specified in sub-paragraph (a), (b), (c), (d) or (e) of regulation 10(1).

Section 18 Applications for the approval of intermediaries

(1) An eligible person may apply to the enforcement authority to be approved as an intermediary who may—

(a) wrap, package, store or put into circulation any zootechnical additive; or

(b) wrap, package, store or put into circulation any zootechnical premixture.

(2) An application made under paragraph (1) shall be in writing, in the English language, (or, where the facilities in respect of which the application is made are situated wholly or partly in Wales, in either that language or the Welsh language) signed by or on behalf of the applicant, and shall contain name (or business name) and address of the applicant, shall specify each activity in relation to which the application is made, and shall be accompanied by particulars which demonstrate that the applicant meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

Section 19 Approval of intermediaries

(1) Where an application is made under regulation 18 and is accompanied by the relevant fee, the enforcement authority shall (subject to paragraph (2) and regulation 23)—

(a) check by means of an on the spot verification whether the applicant meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, and

(b) process the application in accordance with the requirements of the second paragraph of Article 4.1 or the second paragraph of Article 4.2 of Directive 95/69/EC as applicable.

(2) The obligation imposed on the enforcement authority by paragraph (1)(a) shall not apply if the person who has applied to be approved as an intermediary has lodged a declaration of the type specified in the second paragraph of Article 5.1 of Directive 95/69/EC with the enforcement authority.

(3) Where the enforcement authority is satisfied that the applicant meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC, it shall—

(a) approve the applicant as an intermediary who may exercise the relevant intermediary activity, and

(b) register the applicant on the register of approved intermediaries in accordance with Article 5.1 of Directive 95/69/EC, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51/EC, as being an approved intermediary who may exercise that activity.

Section 20 Amendments of approvals

(1) An eligible person may apply to the enforcement authority to be approved as an approved intermediary who may exercise a further intermediary activity (“the new intermediary activity”)—

(a) in addition to an intermediary activity which he is already approved to exercise, or

(b) instead of that activity.

(2) Where an application, complying with regulation 18(2), is made under paragraph (1), the enforcement authority shall (subject to regulation 23) amend the approval relating to the intermediary, and approve him as an intermediary who may exercise the new intermediary activity, if the enforcement authority is satisfied that, in respect of the new intermediary activity, the applicant meets the applicable minimum conditions laid down in the Annex to Directive 95/69/EC.

(3) Where, pursuant to paragraph (2), the enforcement authority amends an approval relating to an approved intermediary, it shall update the register of approved intermediaries to show all the intermediary activities that may be exercised by the intermediary.

Section 21 Withdrawal of approvals

(1) The enforcement authority shall withdraw an approval relating to the exercise of an intermediary activity by an approved intermediary if the enforcement authority is satisfied that the intermediary has ceased exercising that activity.

(2) The enforcement authority shall withdraw an approval relating to the exercise of an intermediary activity by an approved intermediary if, following the procedure in regulation 22, it is not satisfied that the intermediary is complying with the duties imposed on him by regulation 38, 40, 54 or 56 as the case may be.

(3) Where, pursuant to paragraphs (1) or (2), the enforcement authority withdraws an approval relating to the exercise of an intermediary activity by an approved intermediary, it shall update the register of approved intermediaries—

(a) to show any remaining intermediary activity that the intermediary may continue to exercise, or

(b) by removing the intermediary from the register where, as a result of withdrawing the approval relating to the exercise of the relevant intermediary activity, the intermediary is no longer approved to exercise an intermediary activity of any sort.

Section 22 Procedure relating to the withdrawal of approvals

(1) Where the enforcement authority proposes to withdraw an approval relating to the exercise of an intermediary activity by an approved intermediary, because it is not satisfied that the intermediary is complying with the duties imposed on him by regulation 38, 40, 54 or 56, as the case may be, the enforcement authority shall not withdraw the approval unless—

(a) it serves a notice complying with the requirements of paragraph (2) on the intermediary, and

(b) it is not satisfied, after the time for compliance with that notice has expired, that the intermediary has complied with the requirements specified in the notice.

(2) A notice served by the enforcement authority under paragraph (1) shall—

(a) state that it proposes to withdraw the approval relating to the intermediary’s exercise of the relevant intermediary activity because it is not satisfied that the intermediary is complying with the duties imposed on him by regulation 38, 40, 54 or 56, as the case may be;

(b) specify—

(i) the essential conditions that the enforcement authority is not satisfied that the intermediary is complying with; and

(ii) the requirements that the intermediary must comply with in order to satisfy the enforcement authority as to compliance with those essential conditions; and

(c) specify that, unless it is satisfied that the intermediary has complied with the requirements specified in the notice within such reasonable time as is specified in the notice, the intermediary’s approval, insofar as it relates to the relevant intermediary activity, will be withdrawn.

Section 23 Fees

(1) In this regulation, “the relevant fee” in relation to any application means the fee specified opposite the application in question in Part III of Schedule 3, and it shall be payable by a person who applies to the enforcement authority under regulation 18 or 20 to be approved as an intermediary who may exercise an intermediary activity.

(2) Any relevant fee shall be paid at the time the application is submitted to the enforcement authority.

(3) Any unpaid sum due by way of a relevant fee, or any part of such fee, shall be recoverable as a debt.

(4) The enforcement authority need not process any application under regulation 18 or 20, unless the application is accompanied by the relevant fee.

Section 24 Publication of the national list of approved intermediaries

The enforcement authority shall provide the Minister in writing, on demand being made by him, such information as is available to it and which will assist the Minister to comply with the requirements of Article 6.1 of Directive 95/69/EC relating to the publication of the national list of approved intermediaries.

Section 25 Interpretation of Part IV

In this Part—

“the applicable minimum conditions laid down in the Annex to Directive 95/69/EC” means the minimum conditions laid down or referred to in—

point 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve a person as an intermediary who may exercise the intermediary activity specified in regulation 18(1)(a); and

point 7 of Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of an application to approve a person as an intermediary who may exercise the intermediary activity specified in regulation 18(1)(b);

“approved intermediary” means a person approved by the enforcement authority as an intermediary who may exercise an intermediary activity;

“eligible person” means a person who is entitled to apply to the enforcement authority in accordance with the provisions of the first paragraph of Article 4.1 of Directive 95/69/EC or the first paragraph of Article 4.2 of that Directive to be approved as an intermediary who may exercise an intermediary activity;

“essential conditions” means the essential conditions contained or referred to in—

point 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of the exercise of the intermediary activity specified in regulation 18(1)(a); and

point 7 of Chapter I.2(b) of the Annex to Directive 95/69/EC in the case of the exercise of the intermediary activity specified in regulation 18(1)(b); and

“intermediary activity” means an activity specified in sub-paragraph (a) or (b) of regulation 18(1).

Section 26 Declarations leading to the approval of establishments located in third countries

(1) An eligible person may submit to the Minister a declaration relating to a third country establishment on which there is being exercised, or on which it is intended to exercise, one or more of the following activities—

(a) the manufacture of a zootechnical additive, with a view to putting it into circulation;

(b) the manufacture of a zootechnical premixture, with a view to putting it into circulation;

(c) the manufacture of a zootechnical compound feedingstuff, with a view to putting it into circulation.

(2) A declaration submitted under paragraph (1) shall—

(a) be in writing,

(b) be in the English language,

(c) be signed by or on behalf of the person submitting the declaration,

(d) contain the name (or business name) and address of that person,

(e) identify the establishment to which the declaration relates,

(f) identify the establishment activity which is being exercised or, as the case may be, it is intended to exercise, on that establishment,

(g) (if made by 30th September 1999) state—

(i) whether the establishment activity was being exercised on the establishment on 31st December 1998, and

(ii) if so, whether an eligible person would have been in a position to submit a declaration equivalent to one under paragraph (1) in relation to the establishment activity at a date after 30th December 1998 but before 1st May 1999, had paragraph (1) been in force at that date;

(h) contain a statement that the establishment complies, and an undertaking that when the establishment activity is exercised on it it will comply, with the applicable conditions, and

(i) contain an undertaking of the kind described in the second indent of Article 6.2 of Directive 98/51/EC.

Section 27 Approval of establishments located in third countries

(1) Where a declaration complying with regulation 26(2) is submitted under paragraph (1) of that regulation, the Minister shall—

(a) approve the establishment as an establishment as to which any product manufactured thereon, in the course of carrying out the establishment activity to which the declaration relates, may be imported into the United Kingdom, and

(b) in accordance with Article 5.1 of Directive 95/69/EC, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51/EC, enter the establishment on a register, which the Minister shall maintain, under an individual approval number which identifies the establishment, as an establishment approved in relation to the establishment activity concerned.

(2) The Minister shall, for the purposes of paragraph (1), treat a declaration as submitted in anticipation of regulation 26(1) as submitted thereunder and complying with regulation 26(2) if the declaration either—

(a) complies with all the requirements set out in regulation 26(2), or

(b) if made after 30th December 1998 but before 1st May 1999, complies with all those requirements other than the requirement set out in regulation 26(2)(g)(ii).

Section 28 Amendment of approvals

(1) An eligible person may submit to the Minister a declaration relating to an approved third country establishment on which it is intended to exercise an establishment activity (“the new establishment activity”)—

(a) in addition to an establishment activity for the exercise of which the establishment is already approved, or

(b) instead of that activity.

(2) A declaration submitted under paragraph (1) shall—

(a) be in writing,

(b) be in the English language,

(c) be signed by or on behalf of the person submitting the declaration,

(d) contain the name (or business name) and address of that person,

(e) identify the establishment to which the declaration relates,

(f) identify the new establishment activity which is being exercised or, as the case may be, it is intended to exercise, on that establishment,

(g) (if made by 30th September 1999) state—

(i) whether the new establishment activity was being exercised on the establishment on 31st December 1998, and

(ii) if so, whether an eligible person would have been in a position to submit a declaration equivalent to one under paragraph (1) in relation to the new establishment activity at a date after 30th December 1998 but before 1st May 1999, had paragraph (1) been in force at that date;

(h) state under which sub-paragraph of paragraph (1) the declaration is submitted,

(i) contain a statement that the establishment complies, and an undertaking that when the new establishment activity is exercised on it it will comply, with the applicable conditions, and

(j) contain an undertaking of the kind prescribed in the second indent of Article 6.2 of Directive 98/51/EC.

(3) Where a declaration complying with paragraph (2) is submitted under paragraph (1), the Minister shall approve the establishment as an establishment as to which any product manufactured thereon, in the course of carrying out the new establishment activity, may be imported into the United Kingdom.

(4) Where, pursuant to paragraph (3), the Minister approves an establishment, he shall amend the register maintained by him under regulation 27(1)(b), to show all the establishment activities in relation to which the establishment is approved under regulation 27(1)(a), or under paragraph (3).

(5) The Minister shall, for the purposes of paragraphs (3) and (4), treat a declaration submitted in anticipation of paragraph (1) as submitted thereunder and complying with paragraph (2) if the declaration either—

(a) complies with all the requirements set out in paragraph (2), or

(b) if made after 30th December 1998 but before 1st May 1999, complies with all those requirements other than the requirement set out in paragraph (2)(g)(ii).

Section 29 Cancellation of approvals

(1) The Minister shall cancel an approval relating to the exercise of an establishment activity on an approved third country establishment if, as a result of official checks, or an on-the spot inspection carried out pursuant to Article 5.1 of Directive 98/51/EC, and after following the procedure in regulation 30, he is not satisfied that the person exercising on the establishment the activity concerned (“the manufacturer”), is fulfilling, in relation to that activity, the essential conditions, or that the representative of that establishment established within the United Kingdom is fulfilling the essential representative conditions.

(2) Where, pursuant to paragraph (1), the Minister cancels an approval, he shall amend the register maintained by him under regulation 27(1)(b) by deleting from it the entry in respect of the establishment activity in relation to which approval has been cancelled.

Section 30 Procedure relating to the cancellation of approvals

(1) Where, in the circumstances described in regulation 29(1), the Minister proposes to cancel an approval relating to the exercise of an establishment activity on an approved third country establishment, he shall not cancel it unless—

(a) he serves a written notice complying with the requirements of paragraph (2) on the representative established within the United Kingdom of the establishment (“the recipient”), and

(b) after the time for compliance with the notice has expired, he is not satisfied that the manufacturer or, as the case may be, the recipient, has complied with the requirements specified in the notice.

(2) A notice served by the Minister under paragraph (1) shall—

(a) state that he proposes to cancel the approval relating to the establishment activity concerned, because he is not satisfied that—

(i) the manufacturer is complying, in relation to that activity, with the essential conditions, or, as the case may be,

(ii) the recipient is complying with the essential representative conditions;

(b) specify—

(i) the essential conditions or, as the case may be, the essential representative conditions, he is not satisfied that the manufacturer or, as the case may be, the recipient, is complying with; and

(ii) the requirements that the manufacturer or, as the case may be, the recipient, must comply with in order to satisfy the Minister as to compliance with those essential conditions or, as the case may be, those essential representative conditions; and

(c) state that, unless he is satisfied that the manufacturer or, as the case may be, the recipient, has complied with those requirements, within such reasonable time as is specified in the notice, the approval relating to the establishment activity concerned will be cancelled.

Section 31 Obligation of the enforcement authorities to supply certain information to the Minister of Agriculture, Fisheries and Food

Where any enforcement authority comes into possession of information which it considers will assist the Minister to exercise his functions under regulations 29 and 30, it shall as soon as practicable provide that information to him in writing.

Section 32 Interpretation of Part V

In this Part—

“the applicable Chapter” means—

in the case of a declaration made pursuant to regulation 26(1)(a), Chapter I.1(b) of the Annex to Directive 95/69/EC;

in the case of a declaration made pursuant to regulation 26(1)(b), Chapter I.2(b) of the Annex to Directive 95/69/EC; and

in the case of a declaration made pursuant to regulation 26(1)(c), Chapter I.3(b) of the Annex to Directive 95/69/EC;

“the applicable conditions” means conditions at least as stringent as the conditions laid down or referred to in the applicable Chapter;

“approved third country establishment” means an establishment approved by the Minister pursuant to regulation 27(1)(a) or, as the case may be, 28(3);

“eligible person” means a person who is entitled to submit a declaration to the Minister in accordance with Article 6.2 or 6.3 of Directive 98/51/EC;

“essential conditions” means the essential conditions contained or referred to in the applicable Chapter; and

“essential representative condition”, in relation to a representative established within the United Kingdom of a third country establishment, has the same meaning as the expression“essential condition applicable to their activities” in Article 6.4(b) of Directive 98/51/EC has in relation to him;

“establishment activity” means an activity specified in sub-paragraph (a), (b) or (c) of regulation 26(1).

Section 33 Manufacture of zootechnical additives

No person shall manufacture a zootechnical additive with a view to putting it into circulation except on a UK approved or permitted Chapter I.1 establishment.

Section 34 Duties on persons manufacturing zootechnical additives

A person manufacturing a zootechnical additive on a UK approved Chapter I.1 establishment, with a view to putting it into circulation, shall fulfil the essential conditions contained in Chapter I.1(b) of the Annex to Directive 95/69/EC.

Section 35 Packaging of zootechnical additives

No person shall market a zootechnical additive unless the additive is packaged in accordance with the requirements of Article 10 of Directive 70/524/EEC.

Section 36 Labelling of zootechnical additives

(1) No person shall put a zootechnical additive into circulation unless the labelling of the additive complies with the requirements of Article 14.1.A and B(a) 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 amended further by Council Directive 1999/20/ EC .

(2) No person shall put a zootechnical additive into circulation if information other than that—

(a) required by virtue of Articles 14.1.A and B(a) 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 14.2 of Directive 70/524/EEC, as amended by Directive 96/51/EC,

appears on the package, container or label of the additive, unless that information is clearly separated from the required and authorised information in accordance with Article 14.3 of Directive 70/524/EEC as amended by Directive 96/51/EC.

Section 37 Wrapping, packaging and storage of zootechnical additives by intermediaries

No intermediary shall wrap, package or store a zootechnical additive unless he is a UK approved or permitted Chapter I.1 intermediary.

Section 38 Duties on intermediaries wrapping, packaging or storing zootechnical additives

A UK approved Chapter I.1 intermediary wrapping, packaging or storing a zootechnical additive shall fulfil the applicable essential conditions referred to in point 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC.

Section 39 Putting zootechnical additives into circulation

(1) Subject to paragraph (2) and regulation 41(3), no person shall put a zootechnical additive into circulation other than an authorised zootechnical additive manufactured on—

(a) a UK approved or permitted Chapter I.1 establishment;

(b) an EC approved or permitted Chapter I.1 establishment;

(c) a UK approved or permitted third country Chapter I.1 establishment; or

(d) an EC approved or permitted third country Chapter I.1 establishment.

(2) Subject to regulation 41(3), no intermediary shall put an authorised zootechnical additive into circulation unless he is a UK or EC approved or permitted Chapter I.1 intermediary.

Section 40 Duties on intermediaries putting zootechnical additives into circulation

A UK approved Chapter I.1 intermediary putting a zootechnical additive into circulation shall fulfil the applicable essential conditions referred to in point 7 of Chapter I.1(b) of the Annex to Directive 95/69/EC.

Section 41 Supply of zootechnical additives

(1) Subject to paragraph (3), no person shall supply an unauthorised zootechnical additive.

(2) Subject to paragraph (3), no person shall supply an authorised zootechnical additive other than to—

(a) a UK or EC approved or permitted Chapter I.1 intermediary;

(b) a person manufacturing, or intending to manufacture, a zootechnical premixture on a UK or EC approved or permitted Chapter I.2 establishment;

(c) where the zootechnical additive is delivered at the last stage of circulation, a person manufacturing, or intending to manufacture, a compound feedingstuff on a UK or EC approved or permitted Chapter I.3(M) establishment, if 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; or

(d) a person who intends to export it to a third country.

(3) Nothing in regulation 39(1) or paragraphs (1) or (2) shall prohibit a person from supplying an unauthorised or authorised zootechnical additive to a person (in this paragraph called “the recipient”) who intends—

(a) to use the additive, or

(b) to incorporate the additive in a feedingstuff and then use that feedingstuff,

for an Article 6.4 purpose if the use of the additive or the resulting 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.

Section 42 Use of zootechnical additives for the purpose of animal feeding

(1) Subject to paragraph (2), no person shall use a zootechnical additive for the purpose of animal feeding except an authorised zootechnical additive which—

(a) has been incorporated in a feedingstuff, and

(b) was incorporated in the feedingstuff in accordance with regulation 43.

(2) Nothing in paragraph (1) shall prohibit a person from feeding an animal—

(a) an unauthorised zootechnical additive, or

(b) a feedingstuff containing an unauthorised zootechnical additive,

for an Article 6.4 purpose if the use of the additive or the feedingstuff, 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 which authorises the procedure.

Section 43 Incorporation of zootechnical additives

(1) Subject to paragraph (3), no person shall incorporate an unauthorised zootechnical additive into a feedingstuff.

(2) Subject to paragraph (3), no person shall incorporate an authorised zootechnical additive into a feedingstuff other than a compound feedingstuff.

(3) Nothing in paragraphs (1) or (2) shall prohibit a person (“the relevant person”) from incorporating—

(a) an unauthorised zootechnical additive in a feedingstuff, or

(b) 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).

(4) For the purpose of the previous paragraph the following uses are specified—

(a) a medicinal test on animals for which the relevant person has been issued with an animal test certificate, or

(b) a regulated procedure for which the relevant person holds a personal licence and which is specified in a project licence that authorises the procedure.

(5) No person shall incorporate an authorised zootechnical additive into a compound feedingstuff unless—

(a) the additive has been prepared beforehand in the form of a premixture—

(i) on a UK or EC approved or permitted Chapter I.2 establishment, or

(ii) 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

(b) 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.

Section 44 Mixing of zootechnical additives

(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.

Section 45 Importation of zootechnical additives

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.

Section 46 Provision of samples

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.

Section 47 Monitoring of undesirable interactions

(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.

Section 48 Provision of information

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.