European Communities (Additives in Feedingstuffs) Regulations, 1999

• Jurisdiction: Ireland

I, JOE WALSH, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purposes of giving effect to Council Directive 96/51/EC of 23 July 19961 , Council Directive 98/92/EC of 14 December 19982 . Council Decision 98/728/EC of 14 December 19983 , Council Directive 99/20/EC of 22 March 19994 and for the purposes of giving effect to Council Directive 70/524/EEC of 23 November 19705 as amended by Council Directive No. 73/103/EEC of 28 April 19736 , Council Directive No. 75/296/EEC of 28 April 19757 , Council Directive No. 84/587/EEC of 29 November 19848 , Commission Directive No. 91/248/EEC of 12 April 19919 , Commission Directive No. 91/249/EEC of 19 April 199110 , Commission Directive No. 91/336/EEC of 10 June 199111 , Commission Directive No. 91/508/EEC of 9 September 199112 , Commission Directive No. 91/620/EEC of 22 November 199113 , Commission Directive No. 92/64/EEC of 13 July 199214 , Commission Directive No. 92/99/EEC of 17 November 199215 , Commission Directive No. 92/113/EEC of 16 December 199216 , Commission Directive No. 93/27/EEC of 4 June 199317 , Commission Directive No. 93/55/EEC of 25 June 199318 , Commission Directive No. 93/107/EEC of 26 November 199319 , Council Directive No. 93/114/EC of 14 December 199320 , Commission Directive No. 94/17/EC of 22 April 199421 , Commission Directive No. 94/40/EC of 22 July 199422 , Commission Directive No. 94/41/EC of 18 July 199423 , Commission Directive No. 94/50/EC of 31 October 199424 , Commission Directive No. 94/77/EC of 20 December 199425 , Commission Directive No. 95/37/EC of 18 July 199526 , Commission Directive No. 95/55/EC of 31 October 199527 , Commission Directive No. 96/7/EC of 21 February 199628 , Commission Directive No. 96/66/EC of 14 October 199629 , Commission Directive No. 97/6/EC of 30 January 199630 , Commission Directive No. 97/72/EC of 15 December 199731 , Commission Directive No. 98/19/EC of 18 March 199832 , hereby make the following Regulations:

PART I Preliminary

1. These Regulations may be cited as the European Communities (Additives in Feedingstuffs) Regulations, 1999.

2. (1) In these Regulations—

“approved establishment” means an establishment granted approval in accordance with Article 2(2) of Council Directive 95/69/EC of 22 December 199533 ,

“approved intermediary” means an intermediary granted approval in accordance with Article 3(1) of Council Directive 95/69/EC of 22 December 199533 ,

“authorised officer” means a person appointed by the Minister under Regulation 25 to be authorised officer for the purposes of these Regulations;

“authorisation” means authorisation in accordance with the Council Directive;

“authorised additive” means an additive which has been granted a Community authorisation;

“community authorisation” shall be construed in accordance with Article 3 of the Council Directive;

“the Council Directive” means Council Directive 70/524/EEC of 23 November, 19705 as amended by Council Directive No. 73/103/EEC of 28 April 19736 , Council Directive No. 75/296/EEC of 28 April 19757 , Council Directive No. 84/587/EEC of 29 November 19848 , Commission Directive No. 91/248/EEC of 12 April 19919 , Commission Directive No. 91/249/EEC of 19 April 199110 , Commission Directive No. 91/336/EEC of 10 June 199111 , Commission Directive No. 91/508/EEC of 9 September 199112 , Commission Directive No. 91/620/EEC of 22 November 199113 , Commission Directive No. 92/64/EEC of 13 July 199214 , Commission Directive No. 92/99/EEC of 17 November 199215 , Commission Directive No. 92/113/EEC of 16 December 199216 , Commission Directive No. 93/27/EEC of 4 June 199317 , Commission Directive No. 93/55/EEC of 25 June 199318 , Commission Directive No. 93/107/EEC of 26 November 199319 , Council Directive No. 93/114/EC of 14 December 199320 , Commission Directive No. 94/17/EC of 22 April 199421 , Commission Directive No. 94/40/EC of 22 July 199422 , Commission Directive No. 94/41/EC of 18 July 199423 , Commission Directive No. 94/50/EC of 31 October 199424 , Commission Directive No. 94/77/EC of 20 December 199425 , Commission Directive No. 95/37/EC of 18 July 199526 , Commission Directive No. 95/55/EC of 31 October 199527 , Commission Directive No. 95/69/EC of 22 December 199533 , Commission Directive No. 96/7/EC of 21 February 199628 , Commission Directive No. 96/25/EC of 23 April 199637 , Commission Directive No. 96/51/EC of 23 July 19961 , Commission Directive No. 96/66/EC of 14 October 199629 , Commission Directive No. 97/6/EC of 30 January 199630 , Commission Directive No. 97/72/EC of 15 December 199731 , Commission Directive No. 98/19/EC of 18 March 199832 ;

“Directive 95/69/EC” means Council Directive No. 95/69/EC of 22 December 199533 ;

“the Minister” means the Minister for Agriculture, Food and Rural Development;

“official methods of analysis” means a method of analysis specified in the European Communities (Feedingstuffs) (Methods of Sampling and Analysis) Regulations, 1999 (S.I. 289 of 1999);

“registered establishment” means an establishment registered in accordance with Article 7(2) of Directive 95/69/EC;

“State Chemist” means the head of the State laboratory or a person authorised in writing by him or her to perform the functions assigned to the State Chemist under these Regulations.

(2) A word or expression that is used in these Regulations and is also used in the Council Directive shall, unless the contrary intention appears, have in these Regulations the same meaning that it has in the Council Directive.

(3) In these Regulations, unless otherwise indicated—

(a) a reference to a Regulation is a reference to a Regulation of these Regulations, and

(b) a reference to a paragraph or subparagraph is a reference to a paragraph or subparagraph of the provision in which the reference occurs.

3. (1) Subject to this Regulation, these Regulations shall apply to additives in feedingstuffs.

(2) These Regulations shall not apply to processing aids used deliberately as substances in the processing of feed materials or of feedingstuffs in order to achieve a certain technological objective during treatment or processing which may result in the unintentional but technically unavoidable presence of residues of the substances or their derivatives in the final product, provided that these residues do not present any health risk and do not have any technological effect on the finished product.

(3) Provided they are not derived from products specially enriched with substances corresponding to additives, substances present in their natural state in feed materials which are part of the normal composition of feedingstuffs and which correspond to a substance authorized under these Regulations shall not be regarded as additives.

(4) The Minister may authorise, but only for practical tests conducted for scientific purposes and for non-commercial ends, the use as additives of products which are not authorised at Community level or the use of additives under conditions other than those laid down in the authorisation regulation, provided that:

(a) the tests are carried out in accordance with the principles and conditions laid down in Directive 87/153/EEC34 , and

(b) an adequate official inspection has been performed.

(5) These Regulation shall not apply to additives, premixtures and feedingstuffs which are shown by appropriate indications to be exclusively for export to countries which are not Member States of the European Union.

4. (1) Where the Minister acts as rapporteur for the examination of dossiers arising from the obligations laid down in Articles 4(2), 9b(1), 9c(3) and 9g(4) of the Council Directive, a fee to be determined by the Minister may be charged on application according to the additive group and the nature of the Community authorisation requested. The fee shall be payable to the Minister at the time of submission of the dossiers for such examination.

PART II Additives, Premixtures and Feedingstuffs

5. (1) A person shall not put into circulation an additive, or a premixture or feedingstuff containing an additive, unless—

(a) a Community authorisation has been granted for the additive;

(b) the additive complies with the conditions, if any, specified in the said authorisation.

(2) A person shall not incorporate an additive in a premixture or feedingstuff unless—

(a) a Community authorisation has been granted for the additive

(b) the additive is incorporated in the premixture or feedingstuff in accordance with the conditions, if any, specified in the said authorisation.

(3) Subject to paragraph (4), a person shall not use an additive for the purposes of animal feeding unless:—

(a) a Community authorisation has been granted for the additive;

(b) the additive has been incorporated in a feedingstuff in accordance with the conditions, if any, specified in the said authorisation.

(4) Additives belonging to groups other than antibiotics, coccidiostats and other medicinal substances, and growth promoters may be used if administered by a method other than incorporation in feedingstuffs, on condition that the method is provided for in the Community authorisation.

(5) A person shall not have on any premises an additive, or a premixture or feedingstuff in which an additive has been incorporated, unless a Community authorisation has been granted for the additive and the specifications and use of the additive, premixture or feedingstuff complies with the requirements laid down in the Community authorisation.

6. The person responsible for putting the additives referred to in Annex A, Part A to the Council Directive into circulation shall, upon request, make available to the Minister a standard sample having the characteristics and properties described in the monograph referred to in Article 9...