Notice of the making of this Statutory Instrument was published in

"Iris Oifigiúil" of 27th July, 2012.

I, SIMON COVENEY, Minister for Agriculture, Food and the Marine, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), for the purpose of giving effect to Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009¹ and Commission Regulation (EU) No. 37/2010 of 22 December 2009² as amended by Commission Regulation (EU) No. 758/2010 of 24 August 2010³ , Commission Regulation (EU) No. 759/2010 of 24 August 2010⁴ , Commission Regulation (EU) No. 761/2010 of 25 August 2010⁵ , Commission Regulation (EU) No. 890/2010 of 8 October 2010⁶ , Commission Regulation (EU) No. 914/2010 of 12 October 2010⁷ , Commission Regulation (EU) No. 362/2011 of 13 April 2011⁸ , Commission Regulation (EU) No. 363/2011 of 13 April 2011⁹ , Commission Implementing Regulation (EU) No. 84/2012 of 1 February 2012¹⁰ , Commission Implementing Regulation (EU) No. 85/2012 of 1 February 2012¹¹ , Commission Implementing Regulation (EU) No. 86/2012 of 1 February 2012¹² , Commission Implementing Regulation (EU) No. 107/2012 of 8 February 2012¹³ , Commission Implementing Regulation (EU) No. 122/2012 of 13 February 2012¹⁴ , Commission Implementing Regulation (EU) No. 123/2012 of 13 February 2012¹⁵ , Commission Implementing Regulation (EU) No. 201/2012 of 8 March 2012¹⁶ , Commission Implementing Regulation (EU) No. 202/2012 of 8 March 2012¹⁷ , Commission Implementing Regulation (EU) No. 221/2012 of 14 March 2012¹⁸ and Commission Implementing Regulation (EU) No. 222/2012 of 14 March 2012¹⁹ , hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Control of Animal Remedies and their Residues) (Amendment) Regulations 2012.

2. The European Communities (Control of Animal Remedies and their Residues) Regulations 2009 ( S.I. No. 183 of 2009 ) are amended-

(a) in Regulation 2(1)-

(i) by the insertion after the definition of "Council Directives" of-

" "Commission Regulation (EU) No. 37/2010" means Commission Regulation (EU) No. 37/2010 of 22 December 2009 as amended by Commission Regulation (EU) No. 758/2010 of 24 August 2010, Commission Regulation (EU) No. 759/2010 of 24 August 2010, Commission Regulation (EU) No. 890/2010 of 8 October 2010, Commission Regulation (EU) No. 914/2010 of 12 October 2010, Commission Regulation (EU) No. 363/2011 of 13 April 2011, Commission Implementing Regulation (EU) No. 84/2012 of 1 February 2012, Commission Implementing Regulation (EU) No. 85/2012 of 1 February 2012, Commission Implementing Regulation (EU) No. 86/2012 of 1 February 2012, Commission Implementing Regulation (EU) No. 107/2012 of 8 February 2012, Commission Implementing Regulation (EU) No. 122/2012 of 13 February 2012, Commission Implementing Regulation (EU) No. 123/2012 of 13 February 2012, Commission Implementing Regulation (EU) No. 201/2012 of 8 March 2012, Commission Implementing Regulation (EU) No. 202/2012 of 8 March 2012, Commission Implementing Regulation (EU) No. 221/2012 of 14 March 2012 and Commission Implementing Regulation (EU) No. 222/2012 of 14 March 2012;",

(ii) by the substitution for the definition of "establishment" of-

"establishment" means an establishment registered or approved or requiring to be registered or approved in accordance with Regulation 3 or 4 of the European Communities (Food and Feed Hygiene) Regulations 2009 ( S.I. No. 432 of 2009 );",

(iii) by the substitution for the definition of "identity card" of-

"identity card" means-

(a) a cattle identity card or a passport within the meaning of the European Communities (Identification of Bovines) Regulations 2009 (S.I. No. 77/2009), or

(b) an identification document within the meaning of the European Communities (Equine) Regulations 2011 ( S.I. No. 357 of 2011 );",

(iv) by the substitution for the definition of "maximum residue limit" of-

" "maximum residue limit" has the same meaning as it has in Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009;", and

(v) by the insertion after the definition of "registered veterinary practitioner" of-

" "Regulation (EC) No. 470/2009" means Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No. 2377/90 and amending Directive 2001/82 of the European Parliament and of the Council and Regulation (EC) No. 726/2004 of the European Parliament and of the Council;",

(b) by the substitution for Regulation 6 of-

"6.(1) Subject to Articles 23 and 24 of Regulation (EC) No. 470/2009 and Article 23(2) of Council Directive 96/23/EC²⁰ , a person shall not sell or slaughter a farm or aquaculture animal to which a prohibited animal remedy has been administered.

(2) A person shall not sell or slaughter a farm or aquaculture animal where there is present in the animal a quantity of a substance in excess of the maximum residue limit specified in Table 1 of the Annex to Commission Regulation (EU) 37/2010.

(3) A person shall not sell meat, meat product or other food of animal origin that contains a substance in excess of the maximum residue limit specified in Table 1 of the Annex to Commission Regulation (EU) No. 37/2010.

(4) Subject to Articles 23 and 24 of Regulation (EC) No. 470/2009 and Article 23(2) of Council Directive 96/23/EC, a person shall not sell meat, meat product or other food of animal origin that contains a prohibited animal remedy.",

(c) in Regulation 21 by the substitution for paragraphs (1) and (2) of-

"21.(1) Without prejudice to any obligations deriving from Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002²¹ , the owner or person in charge of an establishment shall, if so directed by the Minister, prepare and submit a plan, in respect of the following calendar year, for the detection of substances, veterinary drugs and contaminants specified in Annex 1 to Council Directive 96/23 of 29 April 1996 in-

(a) animals presented for slaughter,

(b) meat, meat products or other food derived from such animals, and

(c) milk, honey or eggs

at the establishment, and the owner or person in charge shall implement the plan in accordance with paragraph (4), (6) or (7), as appropriate.

(2) Without prejudice to the generality of paragraph (1), the Minister may direct that a plan prepared and submitted under this Regulation shall contain such provisions and comply with such requirements as are specified in the direction, including provisions and requirements relating to-

(a) the form of the plan,

(b) taking of specimens at an establishment as may be appropriate,

(c) the manner in which analysis of specimens is to be carried out,

(d) the frequency with which testing is to be conducted,

(e) the number, species and age of animals to be tested,

(f) the foods of animal origin to be tested, and

(g) measures to be taken by the owner or person in charge of the establishment concerned if a positive result is detected.",

(d) by the substitution for Regulation 34 of-

"34.(1) A person commits an offence if he or she-

(a) contravenes Regulation 3(1), (2)(b) or (3), 4(1) or (2), 5(1) or (2), 6(1), (2), (3) or (4), 8(3), 9(3), 10(3), 11(1), (2), (3), (4) or (5), 12, 16(1), (2), (3) or (4), 17(3), (4), (5) or (6), 19(1) or (2)(b), 20(1), (2) or (3), 21(1), (3), (6), (8), (9) or (11), 23(1), (2) or (3), 32, 33(1) or (2),

(b) fails to comply with a direction, permit or requirement under Regulation 7(1), (2) or (3), 14(1), (2), (3) or (5), 21(1), (3) or (10), 28 or 30(2),

(c) contravenes Article 14(6), 16 or 23 of Regulation (EC) No. 470/2009, or

(d) counsels, aids or abets a contravention of subparagraph (a), (b) or (c).

(2) A person who commits an offence to which paragraph 1 refers is liable-

(a) on summary conviction, to a Class A fine or to a term of imprisonment not exceeding 6 months, or to both, or

(b) on conviction on indictment, to a fine not exceeding €500,000 or to a term of imprisonment not exceeding 3 years, or to both.

(3) The Minister may prosecute an offence under these Regulations in a summary manner.

(4) Notwithstanding section 10(4) of the Petty Sessions (Ireland) Act 1851 (14 & 15 Vict.), summary proceedings for an offence under these Regulations may be instituted within 2 years from the date of the offence.

(5) If an offence under these Regulations has been committed by a body corporate and it is proved to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person who, when the offence was committed, was a director, manager, secretary or other officer of the body corporate, or a person purporting to act in any such capacity, that person, as well as the body corporate, commits an offence and is liable to be proceeded against and punished as if guilty of the first-mentioned offence.

(6) If the affairs of a body corporate are managed by its members, paragraph (5) applies in relation to the acts and defaults of a member in connection with the functions of management as if the member is a director or manager of the body corporate.".

Given under my Official Seal,

19 July 2012.

SIMON COVENEY,

Minister for Agriculture, Food and the Marine.

EXPLANATORY MEMORANDUM

(This Note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations update the control regime relating to compliance with Maximum Residue Limits in food of animal origin, in particular by giving effect to Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 2009 and Commission Regulation (EU) No. 37/2010 of 22 December 2009 and by updating related control and enforcement provisions.

1 O.J. L152, 16.6.2009, p.11

2 O.J. L15, 20.01.2010, p.1

3 O.J. L 223, 25.8.2010, p.37

4 O.J. L 223, 25.8.2010, p.39

5 O.J. L 224, 26.8.2010, p.1

6 O.J. L 266, 9.10.2010, p.1

7 O.J. L 269, 13.10.2010, p.5

8 O.J. L 100, 14.4.2011, p.26

9 O.J. L 100, 14.4.2011, p.28

10 O.J. L 30, 2.2.2012, p.1

11 O.J. L 30, 2.2.2012, p.4

12 O.J. L 30, 2.2.2012, p.6

13 O.J. L 36, 9.2.2012, p.25

14 O.J. L 40, 14.2.2012, p.2

15 O.J. L 40, 14.2.2012, p.4

16 O.J. L 71, 9.3.2012, p.37

17 O.J. L 71, 9.3.2012, p.40

18 O.J. L 75, 15.3.2012, p.7

19 O.J. L 75, 15.3.2012, p.10

20 O.J. L 125, 23.5.1996, p.10

21 O.J. L 31, 01.02.2002, p.1