The Feeding Stuffs (Establishments and Intermediaries) Regulations 1998

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations, which extend to the United Kingdom, implement—

(a) 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 (OJ No. L332, 30.12.95, p.15), and

(b) Article 1:10 of Council Directive 96/51/EC amending Directive 70/524/EEC concerning additives in feeding stuffs (OJ No. L235, 17.9.96, p.39),

in relation to feeding stuffs which do not contain antibiotics, coccidiostats and other medicinal substances or growth promoters.

2.  The Regulations introduce new requirements, in accordance with Directive 95/69/EC, under which—

(a) “establishments” in the United Kingdom (as defined in Article 1.3 of Directive 95/69) must be approved/registered by the competent authorities (local authorities in Great Britain and the Department of Agriculture for Northern Ireland in Northern Ireland) for the manufacture with a view to putting them into circulation of certain feed additives, premixtures, products regulated by Council Directive 82/471/EEC and compound feeding stuffs,

(b) “intermediaries” based in the United Kingdom (also defined in Article 1.3 of Directive 95/69) must be approved/registered by the same competent authorities for the wrapping, packaging, storing and “putting into circulation” (see definition in Article 1.3 of Directive 95/69) of certain feed additives, premixtures and products regulated by Directive 82/471/EEC, and

(c) intermediaries based in a member state other than the United Kingdom, and putting into circulation in the United Kingdom products of the kinds referred to in (b) above, must be approved/registered by the competent authorities in the member state concerned,

(regulations 33 to 44, 48 to 59, 63 to 68 and 70 to 81).

3.  In general terms, the approval requirement applies to the exercise of activities which, under Directive 95/69/EC, are considered potentially hazardous to animals, humans or the environment, whereas the registration provisions govern products considered less sensitive. In both cases, however, establishments and intermediaries must comply with detailed “quality control” requirements specified in the Annex to Directive 95/69, and that is a precondition before approval (which can only be given following an inspection by the competent authority) can be given. The obligation to comply with those requirements continues once approval/registration has been obtained.

4.  Application for approval/registration must be made to the competent authority, and the application must contain specified information. The competent authority must keep a register/list of approved/registered establishments and intermediaries and must update them as necessary. Applicants may apply for approval/registration in respect of activities additional to or replacing any for which they are already approved/registered, and the competent authority can cancel approval/registration in cases where an activity is no longer being exercised, or where the quality control requirements are not being met (regulations 5 to 32).

5.  Transitional arrangements apply in the case of establishments and intermediaries which were already exercising, on 1st April 1998, activities of a kind for which approval/registration is necessary. In particular, they may continue to exercise the activities concerned after that date, and until their application is processed, provided they apply before 1st September 1998—see the definitions in regulations 3 and 4 commencing with “EC permitted” or “UK permitted”.

6.  In implementation of Article 13 of Directive 70/524/EEC, as substituted by Directive 96/51, the Regulations also contain provisions regulating, in relation to establishments and intermediaries requiring approval/registration—

(a) the putting into circulation of certain additives, premixtures containing those additives and compound feeding stuffs containing such premixtures (regulations 45 and 60);

(b) the supply of certain additives, alone or in premixtures (regulations 45 and 61), and

(c) the incorporation of certain additives, and premixtures containing such additives, in compound feeding stuffs (regulations 47 and 62).

7.  The Regulations provide for their enforcement by the competent authority and contain detailed provisions for that purpose, including provision for the taking of samples of products controlled by the Regulations, analysis of such samples, offences and penalties (regulations 82 to 97).

8.  The provisions of Directive 95/69 and Article 1:10 of Directive 96/51 implemented by these Regulations are implemented, so far as relevant to feeding stuffs containing antibiotics, coccidiostats and other medicinal substances or growth promoters, by the Feedingstuffs (Zootechnical Products) Regulations 1998, save that the requirements in Directive 95/69 relating to registration do not apply to these products.

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