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Statutory Instrument

The Feeding Stuffs (Establishments and Intermediaries) Regulations 1999

Citation
S.I. 1999/1872
As at
Sections
113
Section 1Title, commencement and revocation

(1) These Regulations may be cited as the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999 and shall come into force on 2nd August 1999.

(2) The Feeding Stuffs (Establishments and Intermediaries) Regulations 1998 (“the 1998 Regulations ”) are hereby revoked.

Section 2Definition of “feeding stuff” and related definitions and general interpretation

(1) In these Regulations—

(a) “complementary feeding stuff” means a compound feeding stuff which has a high content of certain substances and which, by reason of its composition, is sufficient for a daily ration only if it is used in combination with other feeding stuffs;

(b) “complete feeding stuff” means a compound feeding stuff which, by reason of its composition, is sufficient to ensure a daily ration;

(c) “compound feeding stuff” means a mixture of feeding stuffs; and

(d) “feeding stuff” means—

(i) a product of vegetable or animal origin in its natural state (whether fresh or preserved);

(ii) a product derived from the industrial processing of such a product, or

(iii) an organic or inorganic substance, used singly or in a mixture,

whether or not containing additives, for oral feeding to any pet animal or farmed creature, but for the purposes of any definition containing the expression “Article 2.2(d)”, and of regulations 5(1)(d), 33(1)(d), 82, 83 and 94, extends to any such product or substance which is intended for oral feeding to any animal living freely in the wild;

(2) In these Regulations, save where the context otherwise requires,—

“ the Act ” means the Agriculture Act 1970 ;

“additive” has the meaning given by Article 2(a) of Directive 70/524;

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

“animal” includes any bird, insect or fish;

“the Annex” means the Annex to Directive 95/69;

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

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

“the competent body” means—

in Great Britain—

in the case of any establishment, not being a third country establishment, the body referred to in section 67(1), (1A) or (2) of the Act in the area of which the establishment concerned is,

in the case of any third country establishment, the body referred to as aforesaid in the area of which a product of the establishment concerned, covered by the first indent of Article 6.4(b) of Directive 98/51, is located, or an authorised person believes is located, and

in the case of any intermediary, the body referred to as aforesaid in the area of which the intermediary concerned is exercising, or, as the case may be, proposes to exercise, any activity the exercising of which by intermediaries is controlled by these Regulations; and

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

“controlled product” means any additive, premixture, Directive 82/471 product or compound feeding stuff, which is subject to any of the controls contained in these Regulations, and includes any substance or material (other than a machine or implement) appearing to be used, or intended to be used, in the manufacture or production of any such controlled product;

“daily ration” means the average total quantity of feeding stuff, expressed on a 12 per cent moisture basis, required daily by an animal of a given kind, age group and level of production, in order to satisfy all its nutritional needs;

“Directive 70/524” means Council Directive 70/524/ EEC concerning additives in feeding stuffs as amended by amendments up to, but not including, the amendments effected by Council Directive 1999/20/ EC ;

“Directive 82/471” means Council Directive 82/471/EEC concerning certain products used in animal nutrition ;

“Directive 82/471 product” means a product regulated by Directive 82/471;

“Directive 95/53” 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” 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 98/51” 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 ;

“fish” includes shellfish;

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

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

“official checks” means checks of the kinds specified in Article 21.1 of Directive 70/524, 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, Article 13 of Directive 95/69, or which are carried out with a view to enforcement of the provisions of Article 6 of Directive 98/51;

“premises” includes any land, vehicle, vessel, aircraft or hovercraft;

“premixture” means a mixture of additives, or a mixture of one or more additives with substances used as carriers, intended for the manufacture of feeding stuffs;

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

“retained part of the sample” means that part of a sample retained by an authorised person pursuant to regulation 99(d);

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

“zootechnical additive” means an antibiotic, a coccidiostat or other medicinal substance, or a growth promoter;

“zootechnical premixture” means a premixture that contains a zootechnical additive.

(3) Except in so far as the context otherwise requires, in these Regulations—

(a) any reference to a numbered regulation or Schedule is a reference to the regulation or Schedule 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,

(c) the expressions listed in Part I of Schedule 1 have the same meaning as in Directive 70/524,

(d) the expressions listed in Part II of Schedule 1 have the same meaning as in Directive 95/69,

(e) 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, and

(f) any reference to a European Community Directive is a reference to that Directive as amended as at the date these Regulations are made.

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

Section 3Definition of “establishment” and related definitions

In these Regulations, “establishment” has the meaning given by Article 1.3 of Directive 95/69 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;

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

“EC approved Article 2.2(a)(A) 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, as an establishment on which an additive, of any kind referred to in Chapter I.1(a) of the Annex, may be manufactured with a view to putting it into circulation;

“EC approved Article 2.2(a)(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, as an establishment on which a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, may be manufactured with a view to putting it into circulation;

“EC approved Article 2.2(b) 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, as an establishment on which a premixture, which contains additives of any kind referred to in Chapter I.2(a) of the Annex, may be manufactured with a view to putting it into circulation;

“EC approved third country Article 2.2(a)(A) 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 (as read with Directive 98/51), as an establishment as to which an additive, of any kind referred to in Chapter I.1(a) of the Annex, manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC approved third country Article 2.2(a)(P) 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 (as read with Directive 98/51), as an establishment as to which a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC approved third country Article 2.2(b) 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 (as read with Directive 98/51), as an establishment as to which a premixture, which contains additives of any kind referred to in Chapter I.2(a) of the Annex, manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC approved third country Article 2.2(d) 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, as an establishment as to which a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69 (as read with Directive 98/51), manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC permitted Article 2.2(a)(A) establishment” means an establishment located in a member State if—

an additive, of any kind referred to in Chapter I.1(a) of the Annex, 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 a competent authority in the member State, in accordance with any requirements in the member State for the making of such applications, to approve the establishment, pursuant to Directive 95/69, as an establishment on which an additive of any such kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 2.2(a)(P) establishment” means an establishment located in a member State if—

a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, 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 a competent authority in the member State, in accordance with any requirements in the member State for the making of such applications, to approve the establishment, pursuant to Directive 95/69, as an establishment on which a Directive 82/471 product of any such kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 2.2(b) establishment” means an establishment located in a member State if—

a premixture, which contained additives of any kind referred to in Chapter I.2(a) of the Annex, 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 a competent authority in the member State, in accordance with any requirements in the member State for the making of such applications, to approve the establishment, pursuant to Directive 95/69, as an establishment on which a premixture of that kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 7.2(a) establishment” means an establishment located in a member State if—

an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998, a declaration (consideration of which is pending) in respect of the establishment, was submitted to a competent authority in the member State, in accordance with any requirements in the member State for the submission of such declarations, with a view to registration of the establishment, pursuant to Directive 95/69, as an establishment on which an additive of any such kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 7.2(b) establishment” means an establishment located in a member State if—

a premixture, which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II (a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998, a declaration (consideration of which is pending) in respect of the establishment, was submitted to a competent authority in the member State, in accordance with any requirements in the member State for the submission of such declarations, with a view to registration of the establishment, pursuant to Directive 95/69, as an establishment on which a premixture of that kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 7.2(c)(PA) establishment” means an establishment located in a member State if—

a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain 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, a declaration (consideration of which is pending) in respect of the establishment, was submitted to a competent authority in the member State, in accordance with any requirements in the member State for the submission of such declarations, with a view to registration of the establishment, pursuant to Directive 95/69, as an establishment on which a compound feeding stuff of that kind may be manufactured with a view to putting it into circulation;

“EC permitted Article 7.2(d)(PA) establishment” means an establishment located in a member State if—

a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain a zootechnical additive, was being produced on the establishment, for the exclusive requirements of the producer’s holding, on 1st April 1998, and

before 1st September 1998, a declaration (consideration of which is pending) in respect of the establishment, was submitted to a competent authority in the member State, in accordance with any requirements in the member State for the submission of such declarations, with a view to registration of the establishment, pursuant to Directive 95/69, as an establishment on which a compound feeding stuff of that kind may be produced for the exclusive requirements of the producer’s holding;

“EC permitted third country Article 2.2(a)(A) establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Article 2.2(a)(A) establishment) if an additive, of any kind referred to in Chapter I.1(a) of the Annex, 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—

an additive, of any kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which an additive of any such kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 2.2(a)(P) establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Article 2.2(a)(P) establishment) if a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, 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 Directive 82/471 product, of any kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a Directive 82/471 product of any such kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 2.2(b) establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Article 2.2(b) establishment) if a premixture, which contained additives of any kind referred to in Chapter I.2(a) of the Annex, 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 premixture, of the kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a premixture of that kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 2.2(d) establishment” means—

before the applicable day, a third country establishment (other than an EC approved third country Article 2.2(d) establishment) if a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, 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 compound feeding stuff, of any kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a compound feeding stuff of any such kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 7.2(a) establishment” means—

before the applicable day, a third country establishment (other than an EC registered third country Article 7.2(a) establishment) if an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, 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—

an additive, of any kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which an additive of any such kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 7.2(b) establishment” means—

before the applicable day, a third country establishment (other than an EC registered third country Article 7.2(b) establishment) if a premixture, which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter 1.2(a) of the Annex, 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 premixture, of the kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a premixture of that kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 7.2(c)(A) establishment” means—

before the applicable day, a third country establishment (other than an EC registered third country Article 7.2(c)(A) establishment) if a compound feeding stuff, which contained an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, 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 compound feeding stuff, of the kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a compound feeding stuff of that kind, manufactured thereon, may be imported into that member State;

“EC permitted third country Article 7.2(c)(PA) establishment” means—

before the applicable day, a third country establishment (other than an EC registered third country Article 7.2(c)(PA) establishment) if a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain 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 compound feeding stuff, of the kind referred to in sub-paragraph (a) above, 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, with a view to registration of the establishment, pursuant to that Directive, as an establishment as to which a compound feeding stuff of that kind, manufactured thereon, may be imported into that member State;

“EC registered Article 7.2(a) establishment” means an establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an establishment on which an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, may be manufactured with a view to putting it into circulation;

“EC registered Article 7.2(b) establishment” means an establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an establishment on which a premixture, which contains additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, may be manufactured with a view to putting it into circulation;

“EC registered Article 7.2(c)(PA) establishment” means an establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an establishment on which a compound feeding stuff, containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex, but does not contain a zootechnical additive, may be manufactured with a view to putting it into circulation;

“EC registered Article 7.2(d)(PA) establishment” means an establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an establishment on which a compound feeding stuff, containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex, but does not contain a zootechnical additive, may be produced for the exclusive requirements of the producer’s holding;

“EC registered third country Article 7.2(a) establishment” means a third country establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69 (as read with Directive 98/51), as an establishment as to which an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC registered third country Article 7.2(b) establishment” means a third country establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69 (as read with Directive 98/51), as an establishment as to which a premixture (which contains additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex but does not contain an additive of any kind referred to in Chapter 1.2(a) of the Annex) manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC registered third country Article 7.2(c)(A) establishment” means a third country establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69 (as read with Directive 98/51), as an establishment as to which a compound feeding stuff (which contains an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex but does not contain an additive of any kind referred to in Chapter 1.2(a) of the Annex) manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

“EC registered third country Article 7.2(c)(PA) establishment” means a third country establishment included in a list of registered establishments, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69 (as read with Directive 98/51), as an establishment as to which a compound feeding stuff (containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex but does not contain a zootechnical additive) manufactured thereon, may be imported into that member State, and which has a representative established within that member State;

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

“ UK approved Article 2.2(a)(A) establishment” means an establishment approved, pursuant to regulation 6 or, as the case may be, 7, as an establishment on which an additive, of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, may be manufactured with a view to putting it into circulation;

“UK approved Article 2.2(a)(P) establishment” means an establishment approved, pursuant to regulation 6 or, as the case may be, 7, as an establishment on which a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, may be manufactured with a view to putting it into circulation;

“UK approved Article 2.2(b) establishment” means an establishment approved, pursuant to regulation 6, or, as the case may be, 7, as an establishment on which a premixture, which contains additives of any kind referred to in the fourth or fifth indent of Chapter I.2(a) of the Annex, but does not contain a zootechnical additive, may be manufactured with a view to putting it into circulation;

“UK approved Article 2.2(d) establishment” means an establishment approved, pursuant to regulation 6 or, as the case may be, 7, as an establishment on which a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, may be manufactured with a view to putting it into circulation;

“UK approved Article 2.2(f) establishment” means an establishment approved, pursuant to regulation 6 or, as the case may be, 7, as an establishment on which a compound feeding stuff, of any kind the production of which is regulated by Article 2.2(f) of Directive 95/69, may be produced for the exclusive requirements of the producer’s holding;

“UK approved third country Article 2.2(a)(A) establishment” means a third country establishment approved pursuant to regulation 34(1)(a), or, as the case may be, 35(3), as an establishment as to which an additive, of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, manufactured thereon, my be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK approved third country Article 2.2(a)(P) establishment” means a third country establishment approved pursuant to regulation 34(1)(a), or, as the case may be, 35(3), as an establishment as to which a Directive 82/471 product, of any kind referred to in Chapter 1.1(a) of the Annex, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK approved third country Article 2.2(b) establishment” means a third country establishment approved pursuant to regulation 34(1)(a), or, as the case may be, 35(3), as an establishment as to which a premixture (containing additives of any kind referred to in the fourth or fifth indent of Chapter 1.2(a) of the Annex but not containing 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 Article 2.2(d) establishment” means a third country establishment approved pursuant to regulation 34(1)(a), or, as the case may be, 35(3), as an establishment as to which a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK permitted Article 2.2(a)(A) establishment” means an establishment located in the United Kingdom if—

an additive, of any kind referred to in Chapter I.1(a) of the Annex, 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 under regulation 5(1)(a), or a corresponding application under regulation 7(1) (which in either case is pending), made in accordance with regulation 5(2) or, as the case may be, 7(2), was submitted in respect of the establishment;

“UK permitted Article 2.2(a)(P) establishment” means an establishment located in the United Kingdom if—

a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, 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 under regulation 5(1)(b), or a corresponding application under regulation 7(1) (which in either case is pending), made in accordance with regulation 5(2), or, as the case may be, 7(2), was submitted in respect of the establishment;

“UK permitted Article 2.2(b) establishment” means an establishment located in the United Kingdom if—

a premixture, which contained additives of any kind referred to in Chapter 1.2(a) of the Annex, 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 under regulation 5(1)(c), or a corresponding application under regulation 7(1) (which in either case is pending), made in accordance with regulation 5(2), or, as the case may be, 7(2), was submitted in respect of the establishment;

“UK permitted Article 2.2(d) establishment” means an establishment located in the United Kingdom if a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and either—

before 1st September 1998, an application under regulation 5(1)(d), or a corresponding application under regulation 7(1) (which in either case is pending), made in accordance with regulation 5(2), or, as the case may be, 7(2), was submitted in respect of the establishment, or

in any case where, on 1st April 1998, a compound feedingstuff intended for animals living freely in the wild was being manufactured on the establishment, before 1st October 1999, an application under regulation 5(1)(d), or a corresponding application under regulation 7(1) (which in either case is pending) relating to such manufacture, made in accordance with regulation 5(2), or, as the case may be, 7(2), is submitted in respect of the establishment, accompanied by a declaration that, had the 1998 Regulations provided for such an application, there would have been no reason to prevent one being made before 1st September 1998;

“UK permitted Article 2.2(f) establishment” means an establishment located in the United Kingdom if—

a compound feeding stuff, of any kind the production of which is regulated by Article 2.2(f) of Directive 95/69, 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 under regulation 5(1)(e), or a corresponding application under regulation 7(1) (which in either case is pending), made in accordance with regulation 5(2) or, as the case may be, 7(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(a) establishment” means an establishment located in the United Kingdom if—

an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998, a declaration under regulation 19(1)(a), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(b) establishment” means an establishment located in the United Kingdom if—

a premixture, which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998, a declaration under regulation 19(1)(b), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(c)(A) establishment” means an establishment located in the United Kingdom if—

a compound feeding stuff, which contained an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998, and

before 1st September 1998, a declaration under regulation 19(1)(e), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(c)(PA) establishment” means an establishment located in the United Kingdom if—

a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain 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, a declaration under regulation 19(1)(c), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(d)(A) establishment” means an establishment located in the United Kingdom if—

a compound feeding stuff, which contained an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, was being produced on the establishment, for the exclusive requirements of the producer’s holding, on 1st April 1998, and

before 1st September 1998, a declaration under regulation 19(1)(f), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted Article 7.2(d)(PA) establishment” means an establishment located in the United Kingdom if—

a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain a zootechnical additive, was being produced on the establishment, for the exclusive requirements of the producer’s holding, on 1st April 1998, and

before 1st September 1998, a declaration under regulation 19(1)(d), or a corresponding declaration under regulation 21(1) (consideration of which in either case is pending), made in accordance with regulation 19(2), or, as the case may be, 21(2), was submitted in respect of the establishment;

“UK permitted third country Article 2.2(a)(A) establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Article 2.2(a)(A) establishment) if an additive, of any kind referred to in Chapter I.1(a) of the Annex, 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—

an additive, of any kind referred to in sub-paragraph (a) above, 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 33(1)(a), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 2.2(a)(P) establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Article 2.2(a)(P) establishment) if a Directive 82/471 product, of any kind referred to in Chapter I.1(a) of the Annex, 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 Directive 82/471 product, of any kind referred to in sub-paragraph (a) above, 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 33(1)(b), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 2.2(b) establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Article 2.2(b) establishment) if a premixture, which contained additives of any kind referred to in Chapter I.2(a) of the Annex, 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 premixture, of the kind referred to in sub-paragraph (a) above 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 33(1)(c), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 2.2(d) establishment” means—

before 1st October 1999, a third country establishment (other than a UK approved third country Article 2.2(d) establishment) if a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, 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 compound feeding stuff, of any kind referred to in sub-paragraph (a) above, 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 33(1)(d), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 7.2(a) establishment” means—

before 1st October 1999, a third country establishment (other than a UK registered third country Article 7.2(a) establishment) if an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, 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 within the United Kingdom, and

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

an additive, of any kind referred to in sub-paragraph (a) above, 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 33(1)(e), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 7.2(b) establishment” means—

before 1st October 1999, a third country establishment (other than a UK registered third country Article 7.2(b) establishment) if a premixture, which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, 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 premixture, of the kind referred to in sub-paragraph (a) above, 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 33(1)(f), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 7.2(c)(A) establishment” means—

before 1st October 1999, a third country establishment (other than a UK registered third country Article 7.2(c)(A) establishment) if a compound feeding stuff, which contained an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, 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 compound feeding stuff, of the kind referred to in sub-paragraph (a) above, 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 33(1)(h), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK permitted third country Article 7.2(c)(PA) establishment” means—

before 1st October 1999, a third country establishment (other than a UK registered third country Article 7.2(c)(PA) establishment) if a compound feeding stuff, containing a premixture which contained additives of any kind referred to in Chapter II(b) of the Annex, but did not contain a zootechnical additive, was 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 compound feeding stuff, of the kind referred to in sub-paragraph (a) above, 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 33(1)(g), or a corresponding declaration under (or required to be treated as under) regulation 35(1), (consideration of which in either case is pending), made in compliance with (or required to be treated as made in compliance with) regulation 33(2), or, as the case may be, 35(2), and not containing a negative reply to a question specified in regulation 33(2)(g) or, as the case may be, 35(2)(g), has been submitted in respect of the establishment;

“UK registered Article 7.2(a) establishment” means an establishment registered, pursuant to regulation 20, or, as the case may be, 21, as an establishment on which an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, may be manufactured with a view to putting it into circulation;

“UK registered Article 7.2(b) establishment” means an establishment registered, pursuant to regulation 20 or, as the case may be, 21, as an establishment on which a premixture, which contains additives of any kind (other than copper, selenium, viamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, may be manufactured with a view to putting it into circulation;

“UK registered Article 7.2(c)(A) establishment” means an establishment registered, pursuant to regulation 20 or, as the case may be, 21, as an establishment on which a compound feeding stuff, which contains an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, may be manufactured with a view to putting it into circulation;

“UK registered Article 7.2(c)(PA) establishment” means an establishment registered, pursuant to regulation 20 or, as the case may be, 21, as an establishment on which a compound feeding stuff, containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex, but does not contain a zootechnical additive, may be manufactured with a view to putting it into circulation;

“UK registered Article 7.2(d)(A) establishment” means an establishment registered, pursuant to regulation 20 or, as the case may be, 21, as an establishment on which a compound feeding stuff, which contains an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex, may be produced for the exclusive requirements of the producer’s holding;

“UK registered Article 7.2(d)(PA) establishment” means an establishment registered, pursuant to regulation 20 or, as the case may be, 21, as an establishment on which a compound feeding stuff, containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex, but does not contain a zootechnical additive, may be produced for the exclusive requirements of the producer’s holding;

“UK registered third country Article 7.2(a) establishment” means a third country establishment registered pursuant to regulation 34(1)(b), or, as the case may be, 35(3), as an establishment as to which an additive, of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK registered third country Article 7.2(b) establishment” means a third country establishment registered pursuant to regulation 34(1)(b), or, as the case may be, 35(3), as an establishment as to which a premixture (containing additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex but not containing an additive of any kind referred to in Chapter 1.2(a) of the Annex) manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK registered third country Article 7.2(c)(A) establishment” means a third country establishment registered pursuant to regulation 34(1)(b), or, as the case may be, 35(3), as an establishment as to which a compound feeding stuff (which contains an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex but does not contain an additive of any kind referred to in Chapter 1.2(a) of the Annex) manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

“UK registered third country Article 7.2(c)(PA) establishment” means a third country establishment registered pursuant to regulation 34(1)(b), or, as the case may be, 35(3), as an establishment as to which a compound feeding stuff, containing a premixture which contains additives of any kind referred to in Chapter II(b) of the Annex, but does not contain a zootechnical additive, manufactured thereon, may be imported into the United Kingdom, and which has a representative established within the United Kingdom;

Section 4Definition of “intermediary” and related definitions

In these Regulations, “intermediary” has the meaning given by Article 1.3 of Directive 95/69 and—

“EC approved Article 3.1(A) 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, as an intermediary who may wrap, package, store and put into circulation an additive of any kind referred to in Chapter I.1(a) of the Annex;

“EC approved Article 3.1(P) 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, as an intermediary who may wrap, package, store and put into circulation a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex;

“EC approved Article 3.1(PA) 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, as an intermediary who may wrap, package, store and put into circulation a premixture which contains additives of any kind referred to in Chapter I.2(a) of the Annex;

“EC permitted Article 3.1(A) intermediary” means an intermediary whose facilities are located in a member State, who—

on 1st April 1998 was wrapping, packaging, storing or putting into circulation an additive of any kind referred to in Chapter I.1(a) of the Annex, and

before 1st September 1998 submitted to a competent authority in the member State an application (which is pending), made in accordance with any requirements in the member State for the making of such applications, to be approved pursuant to Directive 95/69 as an intermediary who may wrap, package, store and put into circulation an additive of any such kind;

“EC permitted Article 3.1(P) intermediary” means an intermediary whose facilities are located in a member State, who—

on 1st April 1998 was wrappng, packaging, storing or putting into circulation a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex, and

before 1st September 1998 submitted to a competent authority in the member State an application (which is pending), made in accordance with any requirements in the member State for the making of such applications, to be approved pursuant to Directive 95/69 as an intermediary who may wrap, package, store and put into circulation a product of any such kind;

“EC permitted Article 3.1(PA) intermediary” means an intermediary whose facilities are located in a member State, who—

on 1st April 1998 was wrapping, packaging, storing or putting into circulation a premixture, which contained additives of any kind referred to in Chapter I.2(a) of the Annex, and

before 1st September 1998 submitted to a competent authority in the member State an application (which is pending), made in accordance with any requirements in the member State for the making of such applications, to be approved pursuant to Directive 95/69 as an intermediary who may wrap, package, store and put into circulation a premixture of that kind;

“EC permitted Article 8.1(A) intermediary” means an intermediary whose facilities are located in a member State, who—

on 1st April 1998 was wrapping, packaging, storing or putting into circulation an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69; and

before 1st September 1998 submitted to a competent authority in the member State a declaration (consideration of which is pending), made in accordance with any requirements in the member State for the submission of such declarations, with a view to his being registered pursuant to Directive 95/69 as an intermediary who may wrap, package, store and put into circulation an additive of any such kind;

“EC permitted Article 8.1(PA) intermediary” means an intermediary whose facilities are located in a member State, who—

on 1st April 1998 was wrapping, packaging, storing or putting into circulation a premixture which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex; and

before 1st September 1998 submitted to a competent authority in the member State a declaration (consideration of which is pending), made in accordance with any requirements in the member State for the submission of such declarations, with a view to his being registered pursuant to Directive 95/69 as an intermediary who may wrap, package, store and put into circulation a premixture of that kind;

“EC registered Article 8.1(A) intermediary” means an intermediary included in a list of registered intermediaries, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an intermediary who may wrap, package, store and put into circulation an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69;

“EC registered Article 8.1(PA) intermediary” means an intermediary included in a list of registered intermediaries, maintained by a competent authority in a member State, in implementation of Article 10 of Directive 95/69, as an intermediary who may wrap, package, store and put into circulation a premixture which contains additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex;

“UK approved Article 3.1(A) intermediary” means an intermediary approved, pursuant to regulation 13 or, as the case may be, 14, as an intermediary who may wrap, package, store and put into circulation an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex;

“UK approved Article 3.1(P) intermediary” means an intermediary approved, pursuant to regulation 13 or, as the case may be, 14, as an intermediary who may wrap, package, store and put into circulation a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex;

“UK approved Article 3.1(PA) intermediary” means an intermediary approved, pursuant to regulation 13 or, as the case may be, 14, as an intermediary who may wrap, package, store and put into circulation a premixture which contains additives of any kind referred to in the fourth or fifth indent of Chapter I.2(a) of the Annex, but does not contain a zootechnical additive;

“UK permitted Article 3.1(A) intermediary” means an intermediary whose facilities are located in the United Kingdom, who—

on 1st April 1998, was wrapping, packaging, storing or putting into circulation an additive of any kind referred to in chapter I.1(a) of the Annex, and

before 1st September 1998, submitted an application under regulation 12(1)(a), or a corresponding application under regulation 14(1) (which in either case is pending), made in accordance with regulation 12(2), or, as the case may be, 14(2);

“UK permitted Article 3.1(P) intermediary” means an intermediary whose facilities are located in the United Kingdom, who—

on 1st April 1998, was wrapping, packaging, storing or putting into circulation a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex, and

before 1st September 1998, submitted an application under regulation 12(1)(b), or a corresponding application under regulation 14(1) (which in either case is pending), made in accordance with regulation 12(2), or, as the case may be, 14(2);

“UK permitted Article 3.1(PA) intermediary” means an intermediary whose facilities are located in the United Kingdom, who—

on 1st April 1998, was wrapping, packaging, storing or putting into circulation a premixture which contained additives of any kind referred to in Chapter I.2(a) of the Annex; and

before 1st September 1998, submitted an application under regulation 12(1)(c), or a corresponding application under regulation 14(1) (which in either case is pending), made in accordance with regulation 12(2), or, as the case may be, 14(2);

“UK permitted Article 8.1(A) intermediary” means an intermediary whose facilities are located in the United Kingdom, who—

on 1st April 1998, was wrapping, packaging, storing or putting into circulation an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69; and

before 1st September 1998, submitted a declaration under regulation 26(1)(a), or a corresponding declaration under regulation 28(1) (consideration of which in either case is pending), made in accordance with regulation 26(2), or, as the case may be, 28(2);

“UK permitted Article 8.1(PA) intermediary” means an intermediary whose facilities are located in the United Kingdom, who—

on 1st April 1998, was wrapping, packaging, storing or putting into circulation a premixture, which contained additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but did not contain an additive of any kind referred to in Chapter I.2(a) of the Annex; and

before 1st September 1998, submitted a declaration under regulation 26(1)(b), or a corresponding declaration under regulation 28(1) (consideration of which in either case is pending), made in accordance with regulation 26(2), or, as the case may be, 28(2);

“UK registered Article 8.1(A) intermediary” means an intermediary registered, pursuant to regulation 27, or, as the case may be, 28, as an intermediary who may wrap, package, store and put into circulation an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69;

“UK registered Article 8.1(PA) intermediary” means an intermediary registered, pursuant to regulation 27 or, as the case may be, 28, as an intermediary who may wrap, package, store and put into circulation a premixture which contains additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but does not contain an additive of any kind referred to in Chapter I.2(a) of the Annex.

Section 5Applications for the approval of establishments

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

(a) the manufacture of an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, with a view to putting it into circulation;

(b) the manufacture of a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex, with a view to putting it into circulation;

(c) the manufacture of a premixture, containing additives of any kind referred to in the fourth or fifth indent of Chapter I.2(a) of the Annex, but not containing a zootechnical additive, with a view to putting it into circulation;

(d) the manufacture of a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, with a view to putting it into circulation; or

(e) the production of a compound feeding stuff, of any kind the production of which is regulated by Article 2.2(f) of Directive 95/69, for the exclusive requirements of the applicant’s holding.

(2) An application made under paragraph (1) shall—

(a) be in writing,

(b) be in the English language 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,

(c) be signed by or on behalf of the applicant,

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

(e) identify the establishment in respect of which the application is made, and

(f) identify the establishment activity which the applicant is exercising or, as the case may be, intends to exercise, on that establishment.

Section 6Approval of establishments

(1) Where an application complying with regulation 5(2) is made under paragraph (1) of that regulation, the competent body shall—

(a) check by means of an on the spot verification whether the establishment meets the applicable conditions, 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, as the case may be.

(2) Where the competent body is satisfied that the establishment meets the applicable conditions, the competent body shall—

(a) approve the establishment as an establishment on which the establishment activity concerned may be exercised, and

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

Section 7Amendment of approvals

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

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

(b) instead of that activity.

(2) An application made under paragraph (1) shall—

(a) be in writing,

(b) be in the English language 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,

(c) be signed by or on behalf of the applicant,

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

(e) identify the establishment in respect of which the application is made,

(f) identify the new establishment activity which the applicant is exercising or, as the case may be, intends to exercise on that establishment, and

(g) state under which sub-paragraph of paragraph (1) the application is made.

(3) Where an application complying with paragraph (2) is made under paragraph (1)—

(a) regulation 6(1) shall apply, as if the application was made under regulation 5(1), and

(b) if the competent body is satisfied that the establishment meets the applicable conditions, it shall approve the establishment as an establishment on which the new establishment activity may be exercised.

(4) Where, pursuant to paragraph (3), the competent body approves an establishment, the competent body shall amend the register maintained by it under regulation 6(2)(b), to show all the establishment activities the exercise of which on that establishment is approved under regulation 6(2)(a) or under paragraph (3).

Section 8Withdrawal of approvals

(1) The competent body shall withdraw an approval for the exercise of an establishment activity on an approved establishment if the competent body is satisfied that the exercise of that activity on the establishment has ceased.

(2) The competent body shall withdraw an approval for the exercise of an establishment activity on an approved establishment if, following the procedure in regulation 9, the competent body is not satisfied that the person exercising on the establishment the activity concerned is complying, in relation to that activity, with regulation 41, 58, 75, 83 or 85, as the case may be.

(3) Where, pursuant to paragraph (1) or (2), the competent body withdraws an approval, it shall amend the register maintained by it under regulation 6(2)(b), by deleting from it the entry recording approval in respect of the establishment activity for which approval has been withdrawn.

Section 9Procedure relating to the withdrawal of approvals

(1) Where, in the circumstances described in regulation 8(2), the competent body proposes to withdraw an approval relating to the exercise of an establishment activity on an approved establishment, the competent body shall not withdraw the approval unless—

(a) it serves a written notice complying with the requirements of paragraph (2) on the person exercising the activity concerned on the establishment (“the recipient”), and

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

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

(a) state that it proposes to withdraw the approval relating to the establishment activity concerned, because it is not satisfied that the recipient is complying, in relation to that activity, with regulation 41, 58, 75, 83 or 85, as the case may be,

(b) specify—

(i) the essential conditions it is not satisfied that the recipient is complying with; and

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

(c) state that, unless it is satisfied that the recipient has complied with those requirements, within such reasonable time as is specified in the notice, the approval for the exercise of the establishment activity concerned will be withdrawn.

Section 10National lists of approved establishments

Every competent body shall provide to 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 of Directive 95/69 in relation to lists of approved establishments.

Section 11Interpretation of Part II

In this Part—

“the applicable conditions” means the conditions laid down or referred to in—

Chapter I.1(b) of the Annex, 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 5(1)(a) may be exercised;

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

Chapter I.1(b) of the Annex, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 5(1)(b) may be exercised;

Chapter I.2(b) of the Annex, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 5(1)(c) may be exercised;

Chapter I.4 of the Annex, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 5(1)(d) may be exercised; and

with the exception of the requirements set out in point 7 thereof, Chapter I.4 of the Annex, in the case of an application to approve an establishment as an establishment on which the activity specified in regulation 5(1)(e) may be exercised;

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

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

“essential conditions” means the essential conditions laid down or referred to in—

Chapter I.1(b) of the Annex, in the case of the exercise of the establishment activities specified in regulation 5(1)(a) and (b);

Chapter I.2(b) of the Annex, in the case of the exercise of the establishment activity specified in regulation 5(1)(c);

Chapter I.4 of the Annex, in the case of the exercise of the establishment activity specified in regulation 5(1)(d); and

with the exception of the requirements set out in point 7, Chapter I.4 of the Annex, in the case of the exercise of the establishment activity specified in regulation 5(1)(e); and

“establishment activity” means an activity specified in paragraph (a), (b), (c), (d) or (e) of regulation 5(1).

Section 12Applications for the approval of intermediaries

(1) An eligible person may apply to the competent body to be approved as an intermediary who may exercise one or more of the following activities—

(a) wrapping, packaging, storing and putting into circulation an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex,

(b) wrapping, packaging, storing and putting into circulation a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex, or

(c) wrapping, packaging, storing and putting into circulation a premixture, containing additives of any kind referred to in the fourth or fifth indent of Chapter I.2(a) of the Annex, but not containing a zootechnical additive.

(2) An application made under paragraph (1) shall—

(a) be in writing,

(b) be 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,

(c) be signed by or on behalf of the applicant,

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

(e) identify the intermediary activity which the applicant is exercising or, as the case may be, intends to exercise, and

(f) identify the facilities in respect of which the application is made.

(3) A person making an application under paragraph (1) may lodge with the competent body a declaration of the type specified in the second paragraph of Article 5.1 of Directive 95/69.

Section 13Approval of intermediaries

(1) Where an application complying with regulation 12(2) is made under paragraph (1) of that regulation, the competent body shall—

(a) subject to paragraph (2), check by means of an on the spot verification whether the applicant meets the applicable conditions, 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, as the case may be.

(2) Paragraph (1)(a) shall not apply in the case of a person who makes an application under regulation 12(1) if—

(a) he is a person of the kind referred to in the second paragraph of Article 5.1 of Directive 95/69, and

(b) at the time he makes his application, he lodges with the competent body a declaration of the kind specified in that paragraph.

(3) Where the competent body is satisfied that the applicant—

(a) meets the applicable conditions, or

(b) is a person of the kind referred to in paragraph (2)(a) who satisfies paragraph (2)(b),

it shall—

(A) approve the applicant as an intermediary who may exercise the intermediary activity concerned, and

(B) in accordance with Article 5.1 of Directive 95/69, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51, enter the applicant on a register, which the competent body shall maintain, under an individual approval number which identifies the applicant, as an intermediary approved for the exercise of that activity.

Section 14Amendment of approvals

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

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

(b) instead of that activity.

(2) An application made under paragraph (1) shall—

(a) be in writing,

(b) be 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,

(c) be signed by or on behalf of the applicant,

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

(e) identify the new intermediary activity which the applicant is exercising or, as the case may be, intends to exercise,

(f) identify the facilities in respect of which the application is made, and

(g) state under which sub-paragraph of paragraph (1) the application is made.

(3) Where an application complying with paragraph (2) is made under paragraph (1)—

(a) regulations 12(3) and 13(1) and (2) shall apply, as if the application were made under regulation 12(1), and

(b) if the competent body is satisfied that the applicant—

(i) meets the applicable conditions, or

(ii) is a person who—

(A) is of the kind referred to in the second paragraph of Article 5.1 of Directive 95/96, and

(B) at the time he made his application, lodged with the competent body a declaration of the kind specified in that paragraph,

it shall approve the applicant as an intermediary who may exercise the new intermediary activity.

(4) Where, pursuant to paragraph (3), the competent body approves an intermediary, it shall amend the register maintained by it under regulation 13(3)(B), to show all the intermediary activities for the exercise of which that intermediary is approved under regulation 13(3)(A) or under paragraph (3).

Section 15Withdrawal of approvals

(1) The competent body shall withdraw an approval for the exercise of an intermediary activity by an approved intermediary if the competent body is satisfied that the intermediary has ceased exercising that activity.

(2) The competent body shall withdraw an approval for the exercise of an intermediary activity by an approved intermediary if, following the procedure in regulation 16, the competent body is not satisfied that, in relation to that activity, the intermediary is complying with regulation 45, 49, 62, 66, 77 or 79, as the case may be.

(3) Where, pursuant to paragraphs (1) or (2), the competent body withdraws an approval, it shall amend the register maintained by it under regulation 13(3)(B), by deleting from it the entry recording approval in respect of the intermediary activity for which approval has been withdrawn.

Section 16Procedure relating to the withdrawal of approvals

(1) Where, in the circumstances described in regulation 15(2), the competent body proposes to withdraw an approval relating to the exercise of an intermediary activity by an approved intermediary, the competent body shall not withdraw the approval unless—

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

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

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

(a) state that it proposes to withdraw the approval relating to the intermediary activity concerned, because it is not satisfied that the intermediary is complying, in relation to that activity, with regulation 45, 49, 62, 66, 77 or 79, as the case may be;

(b) specify—

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

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

(c) state that, unless it is satisfied that the intermediary has complied with those requirements, within such reasonable time as is specified in the notice, the approval for the exercise of the intermediary activity concerned will be withdrawn.

Section 17National lists of approved intermediaries

Every competent body shall provide to 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 of Directive 95/69 in relation to lists of approved intermediaries.

Section 18Interpretation of Part III

In this Part—

“the applicable conditions” means the conditions laid down or referred to in—

point 7 of Chapter I.1(b) of the Annex, in the case of an application to approve a person as an intermediary who may exercise the intermediary activity specified in regulation 12(1)(a) or who may exercise that specified in regulation 12(1)(b); and

point 7 of Chapter I.2(b) of the Annex, in the case of an application to approve a person as an intermediary who may exercise the intermediary activity specified in regulation 12(1)(c).

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

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

“essential conditions” means the essential conditions laid down or referred to in—

point 7 of Chapter I.1(b) of the Annex, in the case of the exercise of the intermediary activities specified in regulation 12(1)(a) and (b), and

point 7 of Chapter I.2(b) of the Annex, in the case of the exercise of the intermediary activity specified in regulation 12(1)(c);

“intermediary activity” means an activity specified in paragraph (a), (b) or (c) of regulation 12(1).

Section 19Declarations leading to the registration of establishments

(1) An eligible person may submit to the competent body a declaration relating to an establishment on which he intends to exercise one or more of the following activities—

(a) the manufacture of an additive of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, with a view to putting it into circulation;

(b) the manufacture of a premixture, containing additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but not containing an additive of any kind referred to in Chapter I.2(a) of the Annex, with a view to putting it into circulation;

(c) the manufacture of a compound feeding stuff containing a premixture containing additives of any kind referred to in Chapter II(b) of the Annex, but not containing a zootechnical additive, with a view to putting it into circulation;

(d) the production of any such compound feeding stuff, for the exclusive requirements of the applicant’s holding;

(e) the manufacture of a compound feeding stuff, containing an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but not containing an additive of any kind referred to in Chapter I.2(a) of the Annex, with a view to putting it into circulation; or

(f) the production of any such compound feeding stuff, for the exclusive requirements of the applicant’s holding.

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

(a) be in writing,

(b) be in the English language or, where the establishment to which the declaration relates is situated wholly or partly in Wales, in either that language or the Welsh 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 the person submitting the declaration is exercising or, as the case may be, intends to exercise, on that establishment, and

(g) 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.

(3) For the purposes of the statement referred to in paragraph (2)(g), and pursuant to Article 7.3 of Directive 95/69, an establishment shall be deemed to comply with the applicable conditions if it is an establishment which, pursuant to these Regulations, the Feedingstuffs (Zootechnical Products) Regulations 1999 or both, is approved for the exercise on that establishment of a corresponding activity referred to in Article 2.2(a), (b), (c) or (e) of that Directive.

Section 20Registration of establishments

Where a declaration complying with regulation 19(2) is submitted under paragraph (1) of that regulation, the competent body shall—

(a) register the establishment as an establishment on which the establishment activity concerned may be exercised, and

(b) in accordance with Article 10.1 of Directive 95/69, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51, enter the establishment on a list, which the competent body shall maintain, under an individual registration number which identifies the establishment, as an establishment registered for the exercise of that activity.

Section 21Amendment of registrations

(1) An eligible person may submit to the competent body a declaration relating to a registered establishment on which he intends 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 registered, or

(b) instead of that activity.

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

(a) be in writing,

(b) be in the English language or, where the establishment to which the declaration relates is situated wholly or partly in Wales, in either that language or the Welsh 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 the person submitting the declaration is exercising or, as the case may be, intends to exercise, on that establishment,

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

(h) 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.

(3) For the purposes of the statement referred to in paragraph (2)(h), and pursuant to Article 7.3 of Directive 95/69, an establishment shall be deemed to comply with the applicable conditions if it is an establishment which, pursuant to these Regulations, the Feedingstuffs (Zootechnical Products) Regulations 1999 or both, is approved for the exercise on that establishment of a corresponding activity referred to in Article 2.2(a), (b), (c) or (e) of that Directive.

(4) Where a declaration complying with paragraph (2) is submitted under paragraph (1), the competent body shall register the establishment as an establishment on which the new establishment activity may be exercised.

(5) Where, pursuant to paragraph (4), the competent body registers an establishment, the competent body shall amend the list maintained by it under regulation 20(b), to show all the establishment activities for the exercise of which on that establishment the establishment is registered under regulation 20(a) or under paragraph (4).

Section 22Cancellation of registrations

(1) The competent body shall cancel a registration for the exercise of an establishment activity on a registered establishment if the competent body is satisfied that the exercise of that activity on the establishment has ceased.

(2) The competent body shall cancel a registration for the exercise of an establishment activity on a registered establishment if, following the procedure in regulation 23, the competent body is not satisfied that the person exercising on the establishment the activity concerned is complying, in relation to that activity, with regulation 43, 60, 87, 89, 91 or 93, as the case may be.

(3) Where, pursuant to paragraphs (1) or (2), the competent body cancels a registration, it shall amend the list maintained by it under regulation 20(b), by deleting from it the entry effecting registration in respect of the establishment activity for which registration has been cancelled.

Section 23Procedure relating to the cancellation of registrations

(1) Where, in the circumstances described in regulation 22(2), the competent body proposes to cancel a registration relating to the exercise of an establishment activity on a registered establishment, the competent body shall not cancel the registration unless—

(a) it serves a written notice complying with the requirements of paragraph (2) on the person exercising the activity concerned on the establishment (“the recipient”), and

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

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

(a) state that it proposes to cancel the registration relating to the establishment activity concerned, because it is not satisfied that the recipient is complying, in relation to that activity, with regulation 43, 60, 87, 89, 91 or 93, as the case may be;

(b) specify—

(i) the essential conditions it is not satisfied that the recipient is complying with; and

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

(c) state that, unless it is satisfied that the recipient has complied with those requirements, within such reasonable time as is specified in the notice, the registration for the exercise of the establishment activity concerned will be cancelled.

Section 24National lists of registered establishments

Every competent body shall provide to 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 11 of Directive 95/69, as read with Article 13.3 and 4 of Directive 70/524, in relation to lists of registered establishments.

Section 25Interpretation of Part IV

In this Part—

“the applicable conditions” means the conditions laid down or referred to in Chapter II(c) of the Annex;

“eligible person” means a person who is entitled to apply to the competent body, in accordance with Article 9.1 or 9.2 of Directive 95/69, for an establishment to be registered as an establishment on which an establishment activity may be exercised;

“essential conditions” means the essential conditions laid down or referred to in Chapter II(c) of the Annex;

“establishment activity” means an activity specified in paragraph (a), (b), (c), (d), (e) or (f) of regulation 19(1);

“registered establishment” means an establishment registered by the competent body as an establishment on which an establishment activity may be exercised.

Section 26Declarations leading to the registration of intermediaries

(1) An eligible person may submit to the competent body a declaration, with a view to being registered by it as an intermediary who may carry out either or both of the following activities—

(a) wrapping, packaging, storing and putting into circulation an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69; or

(b) wrapping, packaging, storing and putting into circulation a premixture containing additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but not containing an additive of any kind referred to in Chapter I.2(a) of the Annex.

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

(a) be in writing,

(b) be in the English language or, where the facilities in respect of which the declaration is submitted are situated wholly or partly in Wales, in either that language or the Welsh 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 intermediary activity which that person is exercising or, as the case may be, intends to exercise,

(f) identify the facilities in respect of which the declaration is submitted, and

(g) contain a statement that that person complies, and an undertaking that when he exercises the intermediary activity he will comply, with the applicable conditions.

(3) For the purposes of the statement referred to in paragraph (2)(g), and pursuant to Article 8.2 of Directive 95/69, an intermediary shall be deemed to comply with the applicable conditions if he is an intermediary the exercise by whom of a corresponding activity, referred to in Article 3.1 of that Directive, is approved pursuant to these Regulations, the Feedingstuffs (Zootechnical Products) Regulations 1999 or both.

Section 27Registration of intermediaries

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

(a) register the person submitting the declaration as an intermediary who may exercise the intermediary activity concerned, and

(b) in accordance with Article 10.1 of Directive 95/69, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51, enter the intermediary on a list, which the competent body shall maintain, under an individual registration number which identifies the intermediary, as an intermediary registered for the exercise of that activity.

Section 28Amendment of registrations

(1) An eligible person may submit to the competent body a declaration, with a view to being registered by it as a registered intermediary who may exercise an intermediary activity (“the new intermediary activity”)—

(a) in addition to an intermediary activity for the exercise of which he is already registered, or

(b) instead of that activity.

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

(a) be in writing,

(b) be in the English language or, where the facilities in respect of which the declaration is made are situated wholly or partly in Wales, in either that language or the Welsh 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 new intermediary activity which that person is exercising or, as the case may be, intends to exercise,

(f) identify the facilities in respect of which the declaration is submitted,

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

(h) contain a statement that the person submitting the declaration complies, and an undertaking that when he exercises the new intermediary activity he will comply, with the applicable conditions.

(3) For the purposes of the statement referred to in paragraph (2)(h), and pursuant to Article 8.2 of Directive 95/69, an intermediary shall be deemed to comply with the applicable conditions if he is an intermediary the exercise by whom of a corresponding activity referred to in Article 3.1 of that Directive, is approved pursuant to these Regulations, the Feedingstuffs (Zootechnical Products) Regulations 1999 or both.

(4) Where a declaration complying with paragraph (2) is submitted under paragraph (1), the competent body shall register the intermediary as an intermediary who may exercise the new intermediary activity.

(5) Where, pursuant to paragraph (4), the competent body registers an intermediary, the competent body shall amend the list maintained by it under regulation 27(b), to show all the intermediary activities for the exercise of which the intermediary is registered under regulation 27(a) or under paragraph (4).

Section 29Cancellation of registrations

(1) The competent body shall cancel a registration for the exercise by a registered intermediary of an intermediary activity if the competent body is satisfied that the intermediary has ceased exercising that activity.

(2) The competent body shall cancel a registration for the exercise of an intermediary activity by a registered intermediary if, following the procedure in regulation 30, the competent body is not satisfied that, in relation to that activity, the intermediary is complying with regulation 47, 51, 64 or 68, as the case may be.

(3) Where, pursuant to paragraphs (1) or (2), the competent body cancels a registration, it shall amend the list maintained by it under regulation 27(b), by deleting from it the entry effecting registration in respect of the intermediary activity for which registration has been cancelled.

Section 30Procedure relating to the cancellation of registrations

(1) Where, in the circumstances described in regulation 29(2), the competent body proposes to cancel a registration relating to the exercise of an intermediary activity by a registered intermediary, the competent body shall not cancel the registration unless—

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

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

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

(a) state that it proposes to cancel the registration relating to the intermediary activity concerned, because it is not satisfied that the intermediary is complying, in relation to that activity, with regulation 47, 51, 64 or 68, as the case may be;

(b) specify—

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

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

(c) state that, unless it is satisfied that the intermediary has complied with those requirements, within such reasonable time as is specified in the notice, the registration for the exercise of the intermediary activity concerned will be cancelled.

Section 31National lists of registered intermediaries

Every competent body shall provide to 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 11 of Directive 95/69 in relation to lists of registered intermediaries.

Section 32Interpretation of Part V

In this Part—

“the applicable conditions” means the conditions laid down or referred to in point 7 of Chapter II(c) of the Annex;

“eligible person” means a person who is entitled to apply to the competent body, in accordance with Article 9.1 or 9.2 of Directive 95/69, to be registered as an intermediary who may exercise an intermediary activity;

“essential conditions” means the essential conditions laid down or referred to in point 7 of Chapter II(c) of the Annex;

“intermediary activity” means an activity specified in sub-paragraph (a) or (b) of regulation 26(1);

“registered intermediary” means a person registered by the competent body as an intermediary who may exercise an intermediary activity.

Section 33Declarations leading to the approval or registration 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 an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, with a view to putting it into circulation;

(b) the manufacture of a Directive 82/471 product of any kind referred to in Chapter I.1(a) of the Annex, with a view to putting it into circulation;

(c) the manufacture of a premixture, containing additives of any kind referred to in the fourth or fifth indent of Chapter I.2(a) of the Annex, but not containing a zootechnical additive, with a view to putting it into circulation;

(d) the manufacture of a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of Directive 95/69, with a view to putting it into circulation;

(e) the manufacture of an additive of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, with a view to putting it into circulation;

(f) the manufacture of a premixture, containing additives of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but not containing an additive of any kind referred to in Chapter I.2(a) of the Annex, with a view to putting it into circulation;

(g) the manufacture of a compound feeding stuff containing a premixture containing additives of any kind referred to in Chapter II(b) of the Annex, but not containing a zootechnical additive, with a view to putting it into circulation; or

(h) the manufacture of a compound feeding stuff, containing an additive of any kind (other than copper, selenium, vitamin A and vitamin D) referred to in Chapter II(a) of the Annex, but not containing an additive of any kind referred to in Chapter I.2(a) of the Annex, 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.

Section 34Approval or registration of establishments located in third countries

(1) Where a declaration complying with regulation 33(2) is submitted under paragraph (1) of that regulation, the Minister shall—

(a) where the declaration is submitted under sub-paragraph (a), (b), (c) or (d) of that paragraph—

(i) 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 sub-paragraph concerned relates, may be imported into the United Kingdom, and

(ii) in accordance with Article 5.1 of Directive 95/69, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51, 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, and

(b) where the declaration is submitted under sub-paragraph (e), (f), (g) or (h) of that paragraph—

(i) register the establishment as an establishment as to which any product manufactured thereon, in the course of carrying out the establishment activity to which the sub-paragraph concerned relates, may be imported into the United Kingdom, and

(ii) in accordance with Article 10.1 of Directive 95/69, as read with Articles 8 and 9 of, and the Annex to, Directive 98/51, enter the establishment on a list, which the Minister shall maintain, under an individual registration 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 submitted in anticipation of regulation 33(1) as submitted thereunder and complying with regulation 33(2) if the declaration either—

(a) complies with all the requirements set out in regulation 33(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 33(2)(g)(ii).

Section 35Amendment of approvals or registrations

(1) An eligible person may submit to the Minister a declaration relating to an approved or, as the case may be, registered, 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, as the case may be, registered, 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.

(3) Where a declaration complying with paragraph (2) is submitted under paragraph (1), the Minister shall approve or, as the case may be, register, 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 or, as the case may be, registers an establishment, he shall amend the register or, as the case may be, list, maintained by him under regulation 34(1)(a) or, as the case may be, (b), to show all the establishment activities in relation to which the establishment is approved or, as the case may be, registered, under regulation 34(1)(a) or, as the case may be, (b), 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 36Cancellation of approvals or registrations

(1) The Minister shall cancel an approval or, as the case may be, registration, relating to the exercise of an establishment activity on an approved or, as the case may be, registered, 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, and after following the procedure in regulation 37, 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 or, as the case may be, a registration, he shall amend the register or, as the case may be, list, maintained by him under regulation 34(1)(a) or, as the case may be, (b), by deleting from it the entry in respect of the establishment activity in relation to which approval or, as the case may be, registration, has been cancelled.

Section 37Procedure relating to the cancellation of approvals or registrations

(1) Where, in the circumstances described in regulation 36(1), the Minister proposes to cancel an approval or, as the case may be, registration, relating to the exercise of an establishment activity on an approved or, as the case may be, registered, 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 or, as the case may be, registration, 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 or, as the case may be, registration, relating to the establishment activity concerned will be cancelled.

Section 38Obligation of competent bodies to supply certain information to the Minister of Agriculture, Fisheries and Food

Where any competent body comes into possession of information which it considers will assist the Minister to exercise his functions under regulations 36 and 37, it shall as soon as practicable provide that information to him in writing.

Section 39Interpretation of Part VI

In this Part—

“the applicable Chapter” means—

in the case of a declaration made pursuant to regulation 33(1)(a) or 33(1)(b), Chapter I.1(b) of the Annex;

in the case of a declaration made pursuant to regulation 33(1)(c), Chapter I.2(b) of the Annex;

in the case of a declaration made pursuant to regulation 33(1)(d), Chapter I.4 of the Annex; and

in the case of a declaration made pursuant to regulation 33(1)(e), (f), (g) or (h), Chapter II(c) of the Annex;

“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 a third country establishment approved by the Minister pursuant to regulation 34(1)(a) or, as the case may be, 35(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;

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

“essential representative conditions”, 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 has in relation to him;

“establishment activity” means an activity specified in sub-paragraph (a), (b), (c), (d), (e), (f), (g) or (h) of regulation 33(1); and

“registered third country establishment” means a third country establishment registered by the Minister pursuant to regulation 34(1)(b) or, as the case may be, 35(3).

Section 40Manufacture of certain additives referred to in Article 2.2(a) of Directive 95/69

No person shall manufacture an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, with a view to putting it into circulation, except on a UK approved or permitted Article 2.2(a)(A) establishment.

Section 41Further control of manufacture of additives to which regulation 40 applies

No person shall manufacture an additive of any kind to which regulation 40 applies on a UK approved Article 2.2(a)(A) establishment, with a view to putting it into circulation, unless he fulfils the essential conditions contained or referred to in Chapter I.1(b) of the Annex.

Section 42Manufacture of additives referred to in Article 7.2(a) of Directive 95/69

No person shall manufacture an additive of any kind the manufacture of which is regulated by Article 7.2(a) of Directive 95/69, with a view to putting it into circulation, except on a UK registered or permitted Article 7.2(a) establishment.

Section 43Further control of manufacture of additives to which regulation 42 applies

No person shall manufacture an additive of any kind to which regulation 42 applies on a UK registered Article 7.2(a) establishment, with a view to putting it into circulation, unless he fulfils the essential conditions contained or referred to in Chapter II(c) of the Annex.

Section 44Wrapping, packaging and storage by intermediaries of certain additives referred to in Article 3.1 of Directive 95/69

No intermediary shall wrap, package or store an additive of any kind referred to in the fourth to the ninth indents of Chapter I.1(a) of the Annex, other than a UK approved or permitted Article 3.1(A) intermediary.

Section 45Further control of wrapping, packaging or storing by intermediaries of additives to which regulation 44 applies

No UK approved Article 3.1(A) intermediary shall wrap, package or store an additive of any kind to which regulation 44 applies, unless he fulfils the essential conditions contained or referred to in point 7 of Chapter I.1(b) of the Annex.

Section 46Wrapping, packaging and storage by intermediaries of additives referred to in Article 8.1 of Directive 95/69

No intermediary shall wrap, package or store an additive of any kind the wrapping, packaging, storing and putting into circulation of which is regulated by Article 8.1 of Directive 95/69, other than a UK registered or permitted Article 8.1(A) intermediary.

Section 47Further control of wrapping, packaging or storing by intermediaries of additives to which regulation 46 applies

No UK registered Article 8.1(A) intermediary shall wrap, package or store an additive of any kind to which regulation 46 applies, unless he fulfils the essential conditions contained or referred to in point 7 of Chapter II(c) of the Annex.

Section 48Putting into circulation by intermediaries of additives to which regulation 44 applies

No intermediary shall put into circulation an additive of any kind to which regulation 44 applies, other than an EC or UK approved or permitted Article 3.1(A) intermediary.

Section 49Further control of putting into circulation by intermediaries of additives to which regulation 44 applies

No EC or UK approved Article 3.1(A) intermediary shall put into circulation an additive of any kind to which regulation 44 applies, unless he fulfils the essential conditions contained or referred to in point 7 of Chapter I.1(b) of the Annex.

Section 50Putting into circulation by intermediaries of additives to which regulation 46 applies

No intermediary shall put into circulation an additive of any kind to which regulation 46 applies, other than an EC or UK registered or permitted Article 8.1(A) intermediary.

113 sections

Cite this legislation

The Feeding Stuffs (Establishments and Intermediaries) Regulations 1999 (legislation.gov.uk, OGL v3.0). Retrieved via LawPlayer, https://lawplayer.com/uk/act/uksi-1999-1872

Contains public sector information licensed under the Open Government Licence v3.0.

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