The Feedingstuffs (Zootechnical Products) Regulations 1999

Explanatory Note

(This note is not part of the Regulations)

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

(a) insofar as they relate to zootechnical products, the following European Community Directives—

• Council Directive 70/524/EEC concerning additives in feeding stuffs (OJ No. L270, 14.12.70, p. 1, OJ/SE Vol. 18, p. 4), including the amendments thereto in Council Directive 96/51/EC (OJ No. L235, 17.9.96, p. 39);

• Third Commission Directive 72/199/EC (OJ No. L123, 29.5.72, p. 6) (OJ/SE 1966—72 p. 74) establishing Community methods of analysis for the official control of feeding stuffs;

• Fifth Commission Directive 74/203/EEC (OJ No. L108, 22.4.74, p. 7) establishing Community methods of analysis for the official control of feeding stuffs;

• First Commission Directive 76/371/EEC (OJ No. L102, 15.4.76, p. 1) establishing Community methods of sampling for the official control of feeding stuffs;

• Eighth Commission Directive 78/633/EEC (OJ No. L206, 29.7.78, p. 43) establishing Community methods of analysis for the official control of feeding stuffs;

• Commission Directive 81/680/EEC (OJ No. L246, 29.8.81, p. 32) amending Directives 71/250/EEC, 71/393/EEC, 72/199/EEC, 73/46/EEC, 74/203/EEC, 75/84/EEC, 76/372/EEC and 78/633/EEC establishing Community methods of analysis for the official control of feeding stuffs;

• Commission Directive 84/4/EEC (OJ No. L15, 18.1.84, p. 28) amending Directives 71/393/EEC, 72/199/EEC and 78/633/EEC establishing Community methods of analysis for the official control of feeding stuffs;

• 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);

• 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);

• Council Directive 96/51/EC amending Directive 70/524/EEC concerning additives in feedingstuffs (OJ No. L235, 17.9.96, p. 39);

• 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);

• Commission Directive 98/54/EC (OJ No. L208, 24.7.98, p. 49) amending Directives 71/250/EEC, 72/199/EEC, 73/46/EEC and repealing Directive 75/84/EEC;

• Commission Directive 98/64/EC (OJ No. L257, 19.9.98, p. 14) establishing Community methods of analysis for the determination of amino acids, crude oils and fats, and olaquindox in feedingstuffs and amending Directive 71/393/EEC;

• 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; and

• Commission Directive 1999/27/EC (OJ No. L118, 6.5.99, p. 36) establishing Community methods of analysis for the determination of amprolium, diclazuril and carbadox in feedingstuffs and amending Directives 71/250/EEC, 73/46/EEC and repealing Directive 74/203/EEC; and

(b) in full, the following Community Directives—

• Ninth Commission Directive 81/715/EEC (OJ No. L257, 10.9.81, p. 38) establishing Community methods of analysis for the official control of feedingstuffs;

• Tenth Commission Directive 84/425/EEC (OJ No. L238, 6.9.84, p. 34) establishing Community methods of analysis for the official control of feedingstuffs;

• Eleventh Commission Directive 93/70/EEC (OJ No. L234, 17.9.93, p. 17) establishing Community methods of analysis for the official control of feedingstuffs; and

• Twelfth Commission Directive 93/117/EEC (OJ No. L329, 30.12.93, p. 54) establishing Community methods of analysis for the official control of feedingstuffs.

2.  The Regulations also provide for the enforcement of the following European Community Regulations—

• Commission Regulation (EC) No. 2788/98 (OJ No. L347, 23.12.98, p. 31) amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards the withdrawal of authorisation for certain growth promoters;

• Council Regulation (EC) No. 2821/98 (OJ No. L351, 29.12.98, p. 4) amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs; and

• Commission Regulation (EC) No. 45/1999 (OJ No. L6, 12.1.1999, p. 3) amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation for certain additives belonging to the group of coccidiostats and other medicinal substances.

3.  In implementation of Directive 70/524/EEC as amended (other than Article 13), the Regulations prescribe the requirements for Community authorisation of zootechnical additives (regulations 5 to 9), control the marketing, as regards certain compositional and related matters and labelling, of zootechnical additives, zootechnical premixtures and zootechnical compound feeding stuffs and make provision relating to tests and use of information (regulations 35, 36, 41(1) and (3), 42, 43(1) to (4), 44, 46 to 8, 51, 52, 57(2), 58(2), 59(2), 65 to 70(1) and 72 to 4). In both cases the Regulations re-enact (or re-enact with modifications) provisions previously contained in Regulations revoked by these Regulations—the Feedingstuffs (Zootechnical Products) Regulations 1998 (“the 1998 Regulations”—S.I. 1998/1047).

4.  There exists a category of additive producers who are not “eligible persons” within the meaning of regulation 5 but who are putting an additive into circulation and require Community authorisation under Directive 70/524/EEC as amended to continue marketing the additive on or after 1st October 1999. To enable such producers to apply before 1st October 1999 for Community authorisation of the additive they are currently putting into circulation, regulation 6 has been introduced. A fee is payable by an applicant when the Minister forwards the dossier, in support of the application for Community authorisation, to the Commission and other member States (regulation 6(4) and Schedule 3).

5.  In implementation of Article 13 of Directive 70/524/EEC as amended, the Regulations also re-enact provisions in the 1998 Regulations regulating, in relation to establishments and intermediaries requiring approval—

(a) the putting into circulation of zootechnical additives, zootechnical premixtures and zootechnical compound feeding stuffs (regulations 39(1), 55(1) and 71);

(b) the supply of zootechnical additives, or of zootechnical premixtures (regulations 41(2) and 57(1)); and

(c) the incorporation of zootechnical additives, and of zootechnical premixtures, in compound feeding stuffs (regulations 43(5), 58(1) and 59(1)).

6.  In implementation of Directive 95/69/EC, the Regulations re-enact requirements previously contained in the 1998 Regulations under which—

(a) “establishments” (as defined in Article 1.3 of Directive 95/69/EC) in the United Kingdom must be approved by the relevant competent authority (the Royal Pharmaceutical Society of Great Britain 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 zootechnical additives, zootechnical premixtures and zootechnical compound feeding stuffs,

(b) “intermediaries” based in the United Kingdom (also defined in Article 1.3 of Directive 95/69/EC) must be approved by the same competent authorities for the wrapping, packaging, storing and “putting into circulation” (see definition in Article 1.3 of Directive 95/69/EC) of zootechnical additives and zootechnical premixtures, 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 by the competent authorities in the member State concerned,

and each category must comply with approval conditions in relation to the activities in question (regulations 33, 34, 37, 38, 39(2), 40, 49, 50, 53, 54, 55(2), 56 and 61 to 64).

7.  Both 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 authority) can be given.

8.  Application for approval (which may now be made in the Welsh language in certain circumstances) must be made to the competent authority, and the application must contain specified information. The competent authority must keep registers of approved establishments and intermediaries and must update them as necessary. Applicants may apply for approval in respect of activities additional to, or replacing, any for which they are already approved, and the competent authority can cancel approval in cases where an activity is no longer being exercised, or where the quality control requirements are not being met (regulations 10 to 25).

9.  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 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 Chapter” or “UK permitted Chapter”).

10.  The Regulations provide for examination of dossiers (regulations 5 to 8) and set fees for the examination (regulation 9), for the approval of establishments (regulation 15) and for the approval of intermediaries (regulation 23), all as read with Schedule 3. The fees replicate those in the 1998 Regulations, with the exception that the fee for applications under regulation 6 (a new type of application) and the fee for acting under regulation 7 in relation to new Community authorisation of an additive (£10,000 under the 1998 Regulations) are both aligned with that for acting under regulation 5 (£25,000).

11.  The Regulations exclude the application of the Medicines Act 1968 to zootechnical additives, except in relation to—

(a) any advisory function of a committee relating to veterinary medicinal products, and

(b) animal test certificates for unauthorised zootechnical additives (regulation 92).

12.  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 75 to 91 and Schedules 4 and 5).

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

(a) among the provisions referred to in paragraph 12 there are included a number which, for the purposes of control of zootechnical products, and in relation to substances 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, 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 5(a) and 6 to 8, the main differences being that—

(i) approval 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 from a third country into the United Kingdom, unless such approval 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 45, 60 and 70(2));

(ii) application for approval, including amendment applications, is made by the UK based representative to the Minister, who will maintain the register of approved third country establishments, and have the power to withdraw approvals where there is non-compliance by an establishment or its representative with quality control requirements (regulations 26 to 32);

(iii) no prior inspection by the competent authority (the Royal Pharmaceutical Society for Great Britain in Great Britain and the Department of Agriculture for Northern Ireland in Northern Ireland) is necessary before approval 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 regulation 3 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 or permitted third country establishment provided for in these Regulations (regulations 39(1), 43(5), 55(1) and 71);

(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 (regulations 11(2), 19(3)(b) and 27(1)(b));

(e) for enforcement purposes, the Regulations include reference to European Community Regulations withdrawing Community authorisations previously accorded to the (growth promoter) additives carbadox and olaquindox, to the (antibiotic) additives bacitracin zinc, spiramycin, virginiamycin and tylosin phosphate and, with effect from 30th September 1999, to the (coccidiostats and other medicinal substances) additives arprinocide, dinitolmide and ipronidazole (regulation 2(1) and Schedule 1);

(f) the Regulations create a new offence of making a false statement in connection with the Regulations (regulation 85(c));

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

(h) the Regulations amend regulation 3 of the Feeding Stuffs (Sampling and Analysis) Regulations 1999 (S.I. 1999/1663) in order to rectify drafting errors (regulation 93).

14.  The provisions referred to in paragraph 1 implemented by these Regulations are implemented, so far as relevant to certain feeding stuffs and products not containing zootechnical additives, by the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999.

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