- a BI zootechnical additive
means a zootechnical additive which is covered by Chapter I of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC and complies with any applicable provisions relating to the additive covered by that Chapter;
- a BII zootechnical additive
means a zootechnical additive which is covered by Chapter II of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC and complies with any applicable provisions relating to the additive covered by that Chapter;
- a BIII zootechnical additive
means a zootechnical additive which is covered by Chapter III of Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC, which complies with any applicable provisions relating to the additive covered by that Chapter and for which the period of authorisation covered by that Chapter has not expired;
- a Community authorised zootechnical additive
means a zootechnical additive in respect of which a Community authorisation is in force, and which complies with the requirements relating to the additive contained in that authorisation;
- additive
has the meaning given by Article 2(a) of Directive 70/524/EEC until 30th September 1999, but on and after 1st October 1999 has the meaning given by that Article as amended by Directive 96/51/EC;
- agricultural analyst
means an agricultural analyst appointed under section 67 of the 1970 Act, and includes a deputy agricultural analyst so appointed for the same area, but in Northern Ireland does not include the Chief Agricultural Analyst;
- analyst
means an agricultural analyst, or, in Great Britain, any other analyst appointed by the Minister for the purposes of these Regulations;
- animal
includes any bird, insect or fish;
- approved establishment
means an establishment approved by the enforcement authority as an establishment on which an establishment activity may be exercised;
- approved intermediary
means a person approved by the enforcement authority as an intermediary who may exercise an intermediary activity;
- approved third country establishment
means an establishment approved by the Minister pursuant to regulation 27(1)(a) or, as the case may be, 28(3);
- Article 12 establishment
means an establishment to which Article 12 of Directive 95/69/EC applies;
- Article 6.4 purpose
means a purpose specified in Article 6.4 of Directive 70/524/EEC;
- authorised person
means a person (whether or not an officer of the enforcement authority) who is authorised by the enforcement authority, either generally or specially, to act in relation to matters arising under these Regulations;
- authorised zootechnical additive
means a BI, BII or BIII zootechnical additive, but excludes any additive deleted, by a Regulation listed in Schedule 1, from Annex B to Directive 70/524/EEC as amended by Directive 96/51/EC;
- complete feedingstuff
has the meaning given by Article 2(d) of Directive 70/524/EEC;
- compound feedingstuff
has the meaning given by Article 2(g) of Directive 70/524/EEC;
- confidential information
means information of the type specified in Article 7.1 of Directive 70/524/EEC as amended by Directive 96/51/EC.
- defendant
includes a prospective defendant.
- Directive 87/153/EEC
means Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition as amended by Commission Directives 94/40/EC and 95/11/EC;
- Directive 95/53/EC
means Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition (with effect from 1st October 1999 as amended by Council Directive 1999/20/EC);
- Directive 95/69/EC
means Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC (with effect from 1st October 1999 as amended by Council Directive 1999/20/EC);
- Directive 96/51/EC
means Council Directive 96/51/EC amending Directive 70/524/ EEC concerning additives in feedingstuffs;
- Directive 98/51/EC
means Commission Directive 98/51/EC laying down certain measures for implementing Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector;
- dossier
means a dossier compiled in accordance with the relevant provisions of Directive 87/153/EEC and which includes— (a) a monograph;
- eligible person
means a person who is entitled to apply to the enforcement authority in accordance with the first paragraph of Article 4.1 of Directive 95/69/EC or the first paragraph of Article 4.2 of that Directive for an establishment to be approved as an establishment on which an establishment activity may be exercised;
- essential conditions
means the essential conditions in— (a) Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of the exercise of the establishment activity specified in regulation 10(1)(a);
- establishment
has the meaning given by Article 1.3(b) of Directive 95/69/EC and— • “the applicable day” means, in relation to any Member State, the date treated by that Member State as the first date after the closure of the period allowed by it for submission of declarations to it pursuant to Article 6.3 of Directive 98/51/EC;
- establishment activity
means an activity specified in sub-paragraph (a), (b), (c), (d) or (e) of regulation 10(1).
- feedingstuff
has the meaning given by Article 2(b) of Directive 70/524/EEC;
- fish
includes shellfish;
- intermediary
has the meaning given by Article I.3(c) of Directive 95/69/EC and— • “EC approved Chapter I.1 intermediary” means an intermediary listed on a register of approved intermediaries maintained by a competent authority in a Member State in implementation of Article 5 of Directive 95/69/EC as being an intermediary who may wrap, package, store and put into circulation a zootechnical additive;
- intermediary activity
means an activity specified in sub-paragraph (a) or (b) of regulation 18(1).
- medicinal tests on animals
has the meaning given by section 32(6) of the 1968 Act and“animal test certificate” shall be construed in accordance with that section;
- Member State
means a member State other than the United Kingdom;
- official checks
means checks of the type specified in Article 21.1 of Directive 70/524/EEC, Articles 3, 4, 7 and 10 to 12, the second paragraph of Article 14, the second and third paragraphs of Article 15.2 and Article 17.1 of Directive 95/53/EC, or Article 13 of Directive 95/69/EC, or which are carried out with a view to enforcement of the provisions of Article 6 of Directive 98/51/EC;
- person responsible for putting into circulation
has the meaning given by Article 2(1) of Directive 70/524/EEC as amended by Directive 96/51/EC;
- personal licence
means a licence granted under section 4 of the Animals (Scientific Procedures) Act 1986;
- premises
includes any land, vehicle, vessel, aircraft or hovercraft;
- premixture
has the meaning given by Article 2(h) of Directive 70/524/EEC;
- project licence
means a licence granted under section 5 of the Animals (Scientific Procedures) Act 1986;
- putting into circulation
has the meaning given by Article 1.3(a) of Directive 95/69/EC;
- regulated procedure
has the meaning given by section 2 of the Animals (Scientific Procedures) Act 1986;
- retained part of the sample
means that part of the sample retained by an authorised person pursuant to regulation 77(d);
- specially approved manufacturing establishment
means an establishment approved pursuant to regulation 10(1)(e) as an establishment on which a zootechnical compound feedingstuff may be manufactured using a minimum proportion of 0.05% by weight of a premixture;
- supplementary feedingstuff
has the meaning given by Article 2(e) of Directive 70/524/EEC;
- the 1968 Act
means the Medicines Act 1968. • “the 1970 Act” means the Agriculture Act 1970. • “additive” has the meaning given by Article 2(a) of Directive 70/524/EEC until 30th September 1999, but on and after 1st October 1999 has the meaning given by that Article as amended by Directive 96/51/EC;
- the 1970 Act
means the Agriculture Act 1970. • “additive” has the meaning given by Article 2(a) of Directive 70/524/EEC until 30th September 1999, but on and after 1st October 1999 has the meaning given by that Article as amended by Directive 96/51/EC;
- the applicable Chapter
means— (a) in the case of a declaration made pursuant to regulation 26(1)(a), Chapter I.1(b) of the Annex to Directive 95/69/EC;
- the applicable conditions
means conditions at least as stringent as the conditions laid down or referred to in the applicable Chapter;
- the applicable day
means, in relation to any Member State, the date treated by that Member State as the first date after the closure of the period allowed by it for submission of declarations to it pursuant to Article 6.3 of Directive 98/51/EC;
- the applicable minimum conditions laid down in the Annex to Directive 95/69/EC
means the minimum conditions laid down in— (a) Chapter I.1(b) of the Annex to Directive 95/69/EC in the case of an application to approve an establishment, other than an Article 12 establishment, as an establishment on which the activity specified in regulation 10(1)(a) may be exercised;
- the appropriate fee
means the fee specified in relation to an application under regulation 6(1) in Part I of Schedule 3.
- the Chief Agricultural Analyst
means the Chief Agricultural Analyst for Northern Ireland;
- the enforcement authority
means— (a) in relation to Great Britain, the Royal Pharmaceutical Society of Great Britain, and (b) in relation to Northern Ireland, the Department of Agriculture for Northern Ireland;
- the MF Regulations
means the Medicated Feedingstuffs Regulations 1998;
- the Minister
means the Minister of Agriculture, Fisheries and Food;
- the Scientific Committee for Animal Nutrition
means the committee established by Commission Decision 76/791/EEC establishing a Scientific Committee for Animal Nu trition;
- third country
means a country other than a Member State or the United Kingdom;
- third country establishment
means an establishment located in a third country;
- unauthorised zootechnical additive
means a zootechnical additive other than an authorised zootechnical additive;
- zootechnical additive
means an additive belonging to one or more of the groups of additives specified in Part I of Annex C to Directive 70/524/EEC, as amended by Directive 96/51/EC;
- zootechnical feedingstuff
means a feedingstuff that contains a zootechnical additive or zootechnical premixture;
- zootechnical premixture
means a premixture that contains a zootechnical additive;
- zootechnical product
means a zootechnical additive, a zootechnical premixture or a zootechnical feedingstuff.