The Medicated Feedingstuffs Regulations 1998

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Council Directive 90/167/EEC (OJ No. L92, 7.4.90, p.42) laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community. These Regulations control the manufacture and distribution of medicated feedingstuffs.

These Regulations provide for the approval (regulations 3 and 4), renewal of approval (regulation 5), late renewal (regulation 6) and withdrawal of approval (regulations 8 and 9) of premises for manufacturing medicated feedingstuffs. Regulations 10 to 16 also provide for a system of approval, renewal of approval and withdrawal of approval of distributors of medicated feedingstuffs. Regulation 17 covers the controls on agricultural merchants.

Applications for approval, renewal of approval or late renewal of approval of premises or as distributor, subject to exceptions, must be accompanied by payment of such fee as specified in Schedule 1 (regulations 2(1) and 35).

Regulations 19, 22 and 28(3) place record keeping requirements on persons engaged in the supply of medicated feedingstuffs and in the retail supply of products used to manufacture them.

There are provisions controlling the manufacture, retail supply, packaging and labelling of particular products used to make medicated feedingstuffs (regulations 20, 21 and 23) and manufacture, packaging, labelling and supply of medicated feedingstuffs (regulations 24 to 28). Further controls are contained in regulations 29 to 34.

Breach of the regulations is an offence under regulation 38, with penalties set out in regulation 39 and a defence in regulation 41.

The Regulations exclude the application of the Medicines Act 1968 save for matters in relation to animal test certificates (regulation 43).

A Regulatory Appraisal has been prepared and a copy has been placed in the library of each House of Parliament.