The Feeding Stuffs (Establishments and Intermediaries) Regulations 1999

Explanatory Note

(This note is not part of the Regulations)

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

(a) the requirements of Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition (OJ No. L265, 8.11.95, p. 17);

(b) 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);

(c) 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);

(d) Articles 6, 8 and 9 of 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 (OJ No. L208, 24.7.98, p. 43); and Article 3 of Council Directive 1999/20/EC (OJ No. L80, 25.3.1999, p. 20) amending Directives 70/524/EEC concerning additives in feedingstuffs, 82/471/EEC concerning certain products used in animal nutrition, 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector;

in relation to feeding stuffs, and related products, which do not contain zootechnical additives (i.e. antibiotics, coccidiostats and other medical substances or growth promoters).

2.  In implementation of Directive 95/69/EC, the Regulations re-enact requirements previously contained in Regulations revoked by these Regulations—the Feeding Stuffs (Establishments and Intermediaries) Regulations 1998 (“the 1998 Regulations”—S.I. 1998/1049) under which—

(a) “establishments” (as defined in Article 1.3 of Directive 95/69/EC) in the United Kingdom must be approved/registered by the relevant competent body (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/EC) must be approved/registered by the same competent bodies for the wrapping, packaging, storing and “putting into circulation” (see definition in Article 1.3 of Directive 95/69/EC) of certain feed additives, premixtures and products regulatd 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 sub-paragraph (b), must be approved/registered by the competent authorities in the member State concerned,

(regulations 40 to 51, 57 to 68, 74 to 79 and 82 to 93).

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/EC, and that is a precondition before approval (which can only be given following an inspection by the competent body) can be given. The obligation to comply with those requirements continues once approval/registration has been obtained.

4.  Application for approval/registration (which may now be made in the Welsh language in certain circumstances) must be made to the competent body, and the application must contain specified information. The competent body 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 body 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 until their application is processed, provided they applied before 1st September 1998—(see the definitions in regulations 3 and 4 commencing with “EC permitted Article” or “UK permitted Article”).

6.  By way of rectification of omissions in the 1998 Regulations, the Regulations—

(a) extend, to manufacturers of compound feeding stuffs for animals living freely in the wild, the rules relating to approval of establishments manufacturing compound feeding stuffs containing contaminants above prescribed levels; (see the definitions in regulation 2(1) of “complementary feeding stuff”, “complete feeding stuff”, “compound feeding stuff” and “feeding stuff”, and the provisions referred to in the last mentioned definition); and

(b) include provisions in regulation 71(2)(c) (re-enacting with amendments regulation 62(2)(c) in the 1998 Regulations) the effect of which provisions is that the premixture governed by regulation 71(2)(c) now extend to those which include zootechnical additives.

7.  In implementation of Article 13 of Directive 70/524/EEC, as substituted by Directive 96/51/EC, the Regulations also re-enact provisions in the 1998 Regulations regulating, in relation to establishments and intermediaries requiring approval/registration—

(a) the putting into circulation of certain additives, premixtures containing those additives and products regulated by Directive 82/471 (regulations 52, 69 and 80);

(b) the supply of certain additives, alone or in premixtures (regulations 53 and 70), and

(c) the incorporation of certain additives, and premixtures containing such additives, in compound feeding stuffs (regulations 54 and 71).

8.  The Regulations provide for their enforcement by the competent body 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 97 to 113).

9.  The principal changes effected by the Regulations are as follows—

(a) among the provisions referred to in paragraph 8 there are added a number which, for the purposes of these Regulations, and in relation to products covered by the instruments referred to in paragraph 1, give effect to certain of the requirements of Directive 95/53/EC, including those relating to sampling and analysis and the manner of carrying out, and the frequency of, enforcement checks to be carried out by competent authorities;

(b) in accordance with Article 6 of Directive 98/51/EC (transitional provisions), the Regulations introduce, in relation to establishments located in third countries and their UK based representatives, as regards the products referred to in sub-paragraph (a), requirements similar to those described in paragraphs 2(a) and 3 to 5, the main differences being that—

(i) approval/registration is granted by the Minister of Agriculture, Fisheries and Food and is for the importation into the United Kingdom of the products concerned. (It is made an offence to import those products into the United Kingdom, unless such approval/registration has been obtained or the transitional arrangements described in sub-paragraph (iv) apply, or importation is permitted by virtue of parallel arrangements operating in another member State—regulations 55, 56, 72, 73, 81, 94, 95 and 96);

(ii) application for approval/registration, including amendment applications, is made by the UK based representative to the Minister, who will maintain the register/list of approved/registered third country establishments, and have the power to withdraw approvals/registrations where there is non-compliance by an establishment or its representative with quality control requirements (regulations 33 to 39);

(iii) no prior inspection by the competent body (local authorities in Great Britain and the Department of Agriculture for Northern Ireland in Northern Ireland) is necessary before approval (or registration) is granted;

(iv) the applicable transitional provisions operate in the case of third country establishments manufacturing the product concerned on 1st December 1998, and which at all times since have had a representative established in the European Community. Importation from such establishments may lawfully continue after the Regulations come into force, (provided the necessary application is made by 30th September 1999), until the application is processed. (See the definitions in regulations 3 and 4 commencing with “EC permitted third country” and “UK permitted third country”);

(c) certain provisions in the 1998 Regulations applied to establishments “located in a third country”. In the corresponding provisions in these Regulations there is substituted for that expression reference to the relevant type of approved, permitted or registered third country establishment provided for in these Regulations (regulations 52(1) and (2), 53(1)(a)(iii) and (iv), 54(a), 54(b)(iv) and (v), 69(1) and (2), 70(1)(c) and (d) and 80(c) and (d));

(d) in implementation of Articles 8 and 9 of Directive 98/51/EC, the Regulations prescribe the formats of the register and approval numbers provided for in Article 5 of Directive 95/69/EC and of the list and registration numbers provided for in Article 10 of that Directive (regulations 6(2)(b), 13(3)(B), 20(b), 27(b), 34(1)(a)(ii) and 34(1)(b)(ii));

(e) the Regulations create a new offence of making a false statement in connection with the Regulations (regulation 107(b)); and

(f) the Regulations omit from those definitions in regulations 3 and 4 which also appear in the 1998 Regulations all wording which is now spent.

10.  The provisions referred to in paragraph 1 implemented by these Regulations are implemented, so far as relevant to feeding stuffs containing zootechnical additives, by the Feedingstuffs (Zootechnical Products) Regulations 1999, but the requirements in Directive 95/69/EC and 98/51/EC relating to registration do not apply to those products.