The Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotlandand Wales) Regulations 2005

Statutory Instruments

2005 No. 1033

AGRICULTURE

The Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotlandand Wales) Regulations 2005

Made

24th March 2005

Laid before Parliament

1st April 2005

Coming into force

22nd April 2005

The Secretary of State for Environment, Food and Rural Affairs, being designated for the purposes of section 2(2) of the European Communities Act 1972(1) in relation to the common agricultural policy of the European Community(2), in exercise of the powers conferred upon her by the said section 2(2), and having carried out the consultation required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(3), hereby makes the following Regulations:

Title, commencement and extent

1.  These Regulations may be cited as the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2005, shall extend to England, Scotland and Wales and shall come into force on 22nd April 2005.

Amendment of the Feedingstuffs (Zootechnical Products) Regulations 1999

2.—(1) The Feedingstuffs (Zootechnical Products) Regulations 1999(4) shall be amended in accordance with this regulation.

(2) In regulation 2(1), for the definition of “the MF Regulations”, substitute—

““the MF Regulations” means the Medicated Feedingstuffs Regulations 1998(5) as last amended by the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2005;”.

(3) In Schedule 3—

(a) for the table and notes in Part II, substitute those in Part 1 of the Schedule to these Regulations; and

(b) for the table in Part III, substitute that in Part 2 of the Schedule to these Regulations.

Amendment of the Medicated Feedingstuffs Regulations 1998

3.—(1) The Medicated Feedingstuffs Regulations 1998 shall be amended in accordance with this regulation.

(2) In regulation 35, for paragraph (12), substitute—

“(12) In this regulation “the ZT Regulations” means the Feedingstuffs (Zootechnical Products) Regulations 1999 as last amended by the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2005.”.

(3) In Schedule 1—

(a) for the table and notes in Part I, substitute those in Part 3 of the Schedule to these Regulations; and

(b) for the table in Part II, substitute that in Part 4 of the Schedule to these Regulations.

Ben Bradshaw

Parliamentary Under Secretary of State

Department for Environment, Food and Rural Affairs

24th March 2005

Regulations 2 and 3

SCHEDULE

PART 1 Substitution of the table in Part II of Schedule 3 to the Feedingstuffs (Zootechnical Products) Regulations 1999

Fees payable in relation to the approval and official checks of establishments

Application for the approval of an establishment to manufacture a zootechnical—	Fee (£)
Notes 1. If an application for an approval under regulation 10(1)(a) is made at the same time as an application relating to those premises for a manufacturer’s licence to manufacture a medicated premix under the Medicines Act 1968, no fee is payable under these Regulations. 2. If premises used for manufacturing zootechnical compound feedingstuffs are inspected for an official check at the same time as they are inspected for the renewal of an approval under the MF Regulations, no fee is payable in relation to the zootechnical compound feedingstuffs. 3. Where more than one of the manufacturing activities tabulated above is carried on at a premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).
additive with a view to putting it into circulation under regulation 10(1)(a) or 12, or the annual fee covering official checks payable in respect of that establishment under regulation 75	866
premixture with a view to putting it into circulation under regulation 10(1)(b) or 12, or the annual fee covering official checks payable in respect of that establishment under regulation 75	866
compound feedingstuff with a view to putting it into circulation under regulation 10(1)(c) or 12, or the annual fee covering official checks payable in respect of that establishment under regulation 75	188
compound feedingstuff for the exclusive use of the applicant’s holding under regulation 10(1)(d) or 12, or the annual fee covering official checks payable in respect of that establishment under regulation 75	115
compound feedingstuff, using a minimum proportion of 0.05% by weight of a premixture, under regulation 10(1)(e) or 12, or the annual fee covering official checks payable in respect of that establishment under regulation 75	546

PART 2 Substitution of the table in Part III of Schedule 3 to the Feedingstuffs (Zootechnical Products) Regulations 1999

Fees payable in relation to the approval and official checks of intermediaries

Application/annual fee—	Fee (£)
for the approval to exercise an intermediary activity under regulation 18 or 20, or the annual fee covering official checks in respect of that intermediary under regulation 75	128

PART 3 Substitution of the table in Part I of Schedule 1 to the Medicated Feedingstuffs Regulations 1998

Fees payable in relation to the grant or renewal of approvals of premises

Application for the grant or renewal of an approval of premises to manufacture—	Fee (£)
Note Where more than one of the manufacturing activities tabulated above is carried on at a premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).
authorised intermediate products	546
medicated feedingstuffs incorporating medicated pre-mixes at any concentration	546
medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more only	365
medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more for the manufacturer’s own use	135

PART 4 Substitution of the table in Part II of Schedule 1 to the Medicated Feedingstuffs Regulations 1998

Fees payable in relation to the grant or renewal of approvals of distributors

Application—	Fee (£)
for the grant or renewal of a distributor’s approval	128

Explanatory Note

(This note is not part of the Order)

These Regulations amend the Feedingstuffs (Zootechnical Products) Regulations 1999 (S.I. 1999/1871) and the Medicated Feedingstuffs Regulations 1998 (S.I. 1998/1046) in relation to England, Scotland and Wales.

The Feedingstuffs (Zootechnical Products) Regulations 1999 implement in relation to zootechnical feedingstuffs a number of Community instruments including Council Directive 95/69/EC (OJ No. L 332, 30.12.95, p. 15) laying down the conditions and arrangements for the approval and registration of establishments and intermediaries operating in the animal feed sector.

The first effect of the amendments made by these Regulations (regulation 2(2) and Parts 1 and 2 of the Schedule) is to raise the level of fees charged under the Feedingstuffs (Zootechnical Products) Regulations 1999 for applications and subsequent official checks in respect of establishments for which approvals are sought and held for the various activities that the manufacture and production of zootechnical feedingstuffs involves.

The Medicated Feedingstuffs Regulations 1998 implement Council Directive 90/167/EEC (OJ No. L 92, 7.4.90, p. 42) laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community.

The second effect of the amendments made by these Regulations (regulation 3(2) and Parts 3 and 4 of the Schedule) is to raise the level of fees charged under the Medicated Feedingstuffs Regulations for applications and subsequent official checks in respect of establishments for which approvals are sought and held for the various activities that the manufacture, production and distribution of medicated feedingstuffs involves.

The changes are itemised in the table below.

A Regulatory Impact Assessment has been prepared and a copy has been placed in the library of each House of Parliament. Copies may be obtained from the Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS.

(1)

1972 c. 68.

(2)

S.I. 1972/1811.

(3)

OJ No. L.31, 1.2.2002, p. 1.

(4)

S.I. 1999/1871; relevant amending instruments are S.I. 2000/1686, 2002/696, 2003/545 and 2004/1036.

(5)

S.I. 1998/1046; relevant amending instruments are S.I. 2000/1686, 2002/697, 2003/752 and 2004/1036.