The Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2004

Made31st March 2004

Laid before Parliament1st April 2004

Coming into force22nd April 2004

The Secretary of State for Environment, Food and Rural Affairs, being designated for the purposes of section 2(2) of the European Communities Act 19721 in relation to the Common Agricultural Policy of the European Community2, in exercise of the powers conferred upon her by the said section 2(2), and having carried out any 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 safety3, hereby makes the following Regulations:

Title, commencement and extent1.

These Regulations may be cited as the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2004, shall extend to England, Scotland and Wales and shall come into force on 22nd April 2004.

Amendment of the Feedingstuffs (Zootechnical Products) Regulations 19992.

(1)

The Feedingstuffs (Zootechnical Products) Regulations 19994 shall be amended in accordance with this regulation.

(2)

In regulation 2(1), in the definition of “the MF Regulations”, for “and the Medicated Feedingstuffs (Amendment) (Scotland, England and Wales) Regulations 20035” substitute “, the Medicated Feedingstuffs (Amendment) (Scotland, England and Wales) Regulations 2003 and the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2004”.

(3)

In Schedule 3, for Parts II and III, substitute Parts II and III as set out in Schedule 1 to these Regulations.

Amendment of the Medicated Feedingstuffs Regulations 19983.

(1)

The Medicated Feedingstuffs Regulations 19986 shall be amended in accordance with this regulation.

(2)

In regulation 35(12), delete the final “and” and insert at the end “and the Feedingstuffs (Zootechnical Products) and Medicated Feedingstuffs (Amendment) (England, Scotland and Wales) Regulations 2004”.

(3)

For Schedule 1, substitute that Schedule as set out in Schedule 2 to these Regulations.

Ben Bradshaw

Parliamentary Under Secretary of State,

Department for Environment, Food and Rural Affairs

31st March 2004

SCHEDULE 1Substitution of Parts II and III of Schedule 3 to the Feedingstuffs (Zootechnical Products) Regulations 1999

Regulation 2

“PART II
Fees payable in relation to the approval and official checks of establishments
Application
Fee (£)
Previous fee (£)
Application under regulation 10(1)(a) or 12 for the approval of an establishment to manufacture a zootechnical additive with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75
840
720
Application under regulation 10(1)(b) or 12 for the approval of an establishment to manufacture a zootechnical premixture with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75
840
720
Application under regulation 10(1)(c) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75
182
157
Application under regulation 10(1)(d) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff for the exclusive use of the applicant’s holding, or the annual fee covering official checks payable in respect of that establishment under regulation 75
112
100
Application under regulation 10(1)(e) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff, using a minimum proportion of 0.05% by weight of a premixture, or the annual fee covering official checks payable in respect of that establishment under regulation 75
530
484
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 one premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).
PART III
Fees payable in relation to the approval and official checks of intermediaries
Application
Fee (£)
Previous fee (£)
Application for approval under regulation 18 or 20 to exercise an intermediary activity, or the annual fee covering official checks payable in respect of that establishment under regulation 75
124
112”

Application	Fee (£)	Previous fee (£)
Application under regulation 10(1)(a) or 12 for the approval of an establishment to manufacture a zootechnical additive with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75	840	720
Application under regulation 10(1)(b) or 12 for the approval of an establishment to manufacture a zootechnical premixture with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75	840	720
Application under regulation 10(1)(c) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff with a view to putting it into circulation, or the annual fee covering official checks payable in respect of that establishment under regulation 75	182	157
Application under regulation 10(1)(d) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff for the exclusive use of the applicant’s holding, or the annual fee covering official checks payable in respect of that establishment under regulation 75	112	100
Application under regulation 10(1)(e) or 12 for the approval of an establishment to manufacture a zootechnical compound feedingstuff, using a minimum proportion of 0.05% by weight of a premixture, or the annual fee covering official checks payable in respect of that establishment under regulation 75	530	484
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 one premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).

Application	Fee (£)	Previous fee (£)
Application for approval under regulation 18 or 20 to exercise an intermediary activity, or the annual fee covering official checks payable in respect of that establishment under regulation 75	124	112”

SCHEDULE 2Substitution of Schedule 1 to the Medicated Feedingstuffs Regulations 1998

Regulation 3

“SCHEDULE 1
Regulation 35
PART I
Fees payable in relation to the grant or renewal of approvals of premises
Application
Fee (£)
Previous fee (£)
Grant or renewal of an approval of premises to manufacture an authorised intermediate product
530
484
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at any concentration
530
484
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more only
354
296
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more for the manufacturer’s own use
131
115
Notes
Where more than one of the manufacturing activities tabulated above is carried on at one premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).
PART II
Fees payable in relation to the grant or renewal of approvals of distributors
Application
Fee (£)
Previous fee (£)
Grant or renewal of an approval of distributors
124
112”

Application	Fee (£)	Previous fee (£)
Grant or renewal of an approval of premises to manufacture an authorised intermediate product	530	484
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at any concentration	530	484
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more only	354	296
Grant or renewal of an approval of premises to manufacture medicated feedingstuffs incorporating medicated pre-mixes at a concentration of 2kg per tonne or more for the manufacturer’s own use	131	115
Notes Where more than one of the manufacturing activities tabulated above is carried on at one premises, only one fee is payable, which shall be the higher (or, as the case may be, the highest).

Application	Fee (£)	Previous fee (£)
Grant or renewal of an approval of distributors	124	112”

(This note is not part of the Regulations)

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 and their contents a number of Community instruments including, in particular, 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 effect of the amendments made by these Regulations (regulation 2 and Schedule 1) 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 various activities involving the manufacture and production of types of zootechnical feedingstuffs and their constituents and for intermediary activities.

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 effect of the amendments made by these Regulations (regulation 3 and Schedule 2) is to raise the level of fees charged under the Medicated Feedingstuffs Regulations 1998 for applications for approvals and renewals of approvals in respect of premises where activities involving the manufacture of types of medicated feedingstuffs and constituents of medicated feedingstuffs are carried out or proposed to be carried out and for applications for approvals and renewals of approvals of persons as distributors of medicated feedingstuffs.

A Regulatory Impact Assessment has been carried out in respect of the measures effected by these Regulations and copies have 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.