Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 3rd January, 2020.

Contents

I, Michael Creed, Minister for Agriculture, Food and the Marine, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 , for the purpose of giving effect to Directive 2002/32 of the European Parliament and of the Council of 7 May 2002¹ (as amended by Commission Directive 2003/57/EC of 17 June 2003² , Commission Directive 2003/100/EC of 31 October 2003³ , Commission Directive 2005/8/EC of 27 January 2005⁴ , Commission Directive 2005/86/EC of 5 December 2005⁵ , Commission Directive 2005/87/EC of 5 December 2005⁶ , Commission Directive 2006/13/EC of 3 February 2006⁷ , Commission Directive 2006/77/EC of 29 September 2006⁸ , Commission Directive 2008/76/EC of 25 July 2008⁹ , Commission Directive 2009/8/EC of 10 February 2009¹⁰ , Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009¹¹ , Commission Directive 2009/141/EC of 23 November 2009¹² , Commission Directive 2010/6/EU of 9 February 2010¹³ , Commission Regulation (EU) No 574/2011 of 16 June 2011¹⁴ , Commission Regulation (EU) No 277/2012 of 28 March 2012¹⁵ , Commission Regulation (EU) No 744/2012 of 16 August 2012¹⁶ , Commission Regulation (EU) No 107/2013 of 5 February 2013¹⁷ , Commission Regulation (EU) No 1275/2013 of 6 December 2013¹⁸ , Commission Regulation (EU) 2015/186 of 6 February 2015¹⁹ and Commission Regulation (EU) 2017/2229 of 4 December 2017²⁰ ); Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002²¹ (as amended by Regulation (EC) No 1642/2003 of the European Parliament and of the Council of 22 July 2003²² , Commission Regulation (EC) No 575/2006 of 7 April 2006²³ , Commission Regulation (EC) No 202/2008 of 4 March 2008²⁴ , Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014²⁵ , Commission Regulation (EU) 2017/228 of 9 February 2017²⁶ , Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019²⁷ and Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019²⁸ ); Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004²⁹ (as amended by Commission Regulation (EC) No 1019/2008 of 17 October 2008³⁰ and Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009³¹ ); Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004³² (as amended by Commission Regulation (EC) No 2074/2005 of 5 December 2005³³ , Commission Regulation (EC) No 1662/2006 of 6 November 2006³⁴ , Commission Regulation (EC) No 1243/2007 of 24 October 2007³⁵ , Commission Regulation (EC) No 1020/2008 of 17 October 2008³⁶ , Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009³⁷ , Commission Regulation (EC) No 1161/2009 of 30 November 2009³⁸ , Commission Regulation (EU) No 558/2010 of 24 June 2010³⁹ , Commission Regulation (EU) No 150/2011 of 18 February 2011⁴⁰ , Commission Regulation (EU) No 1276/2011 of 8 December 2011⁴¹ , Commission Regulation (EU) No 16/2012 of 11 January 2012⁴² , Council Regulation (EU) No 517/2013 of 13 May 2013⁴³ , Commission Regulation (EU) No 786/2013 of 16 August 2013⁴⁴ , Commission Regulation (EU) No 218/2014 of 7 March 2014⁴⁵ , Commission Regulation (EU) No 633/2014 of 13 June 2014⁴⁶ , Commission Regulation (EU) No 1137/2014 of 27 October 2014⁴⁷ , Commission Regulation (EU) 2016/355 of 11 March 2016⁴⁸ , Commission Regulation (EU) 2017/1978 of 31 October 2017⁴⁹ and Commission Regulation (EU) 2017/1981 of 31 October 2017⁵⁰ ); Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005⁵¹ (as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009⁵² , Commission Regulation (EU) No 225/2012 of 15 March 2012⁵³ and Commission Regulation (EU) 2015/1905 of 22 October 2015⁵⁴ ); Commission Regulation (EC) No 2073/2005 of 15 November 2005⁵⁵ (as amended by Commission Regulation (EC) No 1441/2007 of 5 December 2007⁵⁶ , Commission Regulation (EU) No 365/2010 of 28 April 2010⁵⁷ , Commission Regulation (EU) No 1086/2011 of 27 October 2011⁵⁸ , Commission Regulation (EU) No 209/2013 of 11 March 2013⁵⁹ , Commission Regulation (EU) No 1019/2013 of 23 October 2013⁶⁰ , Commission Regulation (EU) No 217/2014 of 7 March 2014⁶¹ , Commission Regulation (EU) 2015/2285 of 8 December 2015⁶² , Commission Regulation (EU) 2017/1495 of 23 August 2017⁶³ and Commission Regulation (EU) 2019/229 of 7 February 2019⁶⁴ ); Commission Regulation (EC) No 2074/2005 of 5 December 2005⁶⁵ (as amended by Commission Regulation (EC) No 1664/2006 of 6 November 2006⁶⁶ , Commission Regulation (EC) No 1244/2007 of 24 October 2007⁶⁷ , Commission Regulation (EC) No 1022/2008 of 17 October 2008⁶⁸ , Commission Regulation (EC) No 1250/2008 of 12 December 2008⁶⁹ , Commission Regulation (EU) No 15/2011 of 10 January 2011⁷⁰ , Commission Implementing Regulation (EU) No 809/2011 of 11 August 2011⁷¹ , Commission Implementing Regulation (EU) No 1012/2012 of 5 November 2012⁷² , Commission Regulation (EU) No 218/2014 of 7 March 2014⁷³ ,Commission Implementing Regulation (EU) No 2015/2295 of 9 December 2015⁷⁴ , Commission Implementing Regulation (EU) 2016/759 of 28 April 2016⁷⁵ , Commission Regulation (EU) 2017/1973 of 30 October 2017⁷⁶ , Commission Regulation (EU) 2017/1980 of 31 October 2017⁷⁷ , Commission Implementing Regulation (EU) 2019/627 of 15 March 2019⁷⁸ , Commission Implementing Regulation (EU) 2019/628 of 8 April 2019⁷⁹ and Commission Implementing Regulation (EU) 2019/1139 of 3 July 2019⁸⁰ ); Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009⁸¹ (as amended by Commission Regulation (EU) No 454/2010 of 26 May 2010⁸² , Commission Regulation (EU) No 568/2010 of 29 June 2010⁸³ , Commission Regulation (EU) No 939/2010 of 20 October 2010⁸⁴ , Commission Regulation (EU) 2017/2279 of 11 December 2017⁸⁵ and Commission Regulation (EU) 2018/1903 of 5 December 2018⁸⁶ ); Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011⁸⁷ ; Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013⁸⁸ ; Commission Regulation (EU) No 210/2013 of 11 March 2013⁸⁹ ; Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015⁹⁰ ; Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017⁹¹ (as amended, supplemented or implemented by Commission Delegated Regulation (EU) 2018/631 of 7 February 2018⁹² , Commission Implementing Regulation (EU) 2018/329 of 5 March 2018⁹³ , Commission Implementing Regulation (EU) 2018/1587 of 22 October 2018⁹⁴ , Commission Delegated Regulation (EU) 2019/478 of 14 January 2019⁹⁵ , Commission Implementing Regulation (EU) 2019/66 of 16 January 2019⁹⁶ , Commission Delegated Regulation (EU) 2019/624 of 8 February 2019⁹⁷ , Commission Delegated Regulation (EU) 2019/625 of 4 March 2019⁹⁸ , Commission Delegated Regulation (EU) 2019/1081 of 8 March 2019⁹⁹ , Commission Delegated Regulation (EU) 2019/1012 of 12 March 2019¹⁰⁰ , Commission Implementing Regulation (EU) 2019/530 of 27 March 2019¹⁰¹ , Commission Implementing Regulation (EU) 2019/723 of 2 May 2019¹⁰² , Commission Implementing Regulation (EU) 2019/626 of 5 March 2019¹⁰³ (as amended by Commission Implementing Regulation (EU) 2019/1981 of 28 November 2019¹⁰⁴ ), Commission Implementing Regulation (EU) 2019/627 of 15 March 2019¹⁰⁵ , Commission Implementing Regulation (EU) 2019/628 of 8 April 2019¹⁰⁶ , Commission Implementing Regulation (EU) 2019/1013 of 16 April 2019¹⁰⁷ , Commission Delegated Regulation (EU) 2019/1602 of 23 April 2019¹⁰⁸ , Commission Implementing Regulation (EU) 2019/1014 of 12 June 2019¹⁰⁹ , Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019¹¹⁰ , Commission Delegated Regulation (EU) 2019/1666 of 24 June 2019¹¹¹ , Commission Implementing Regulation (EU) 2019/1139 of 3 July 2019¹¹² , Commission Delegated Regulation (EU) 2019/2074 of 23 September 2019¹¹³ , Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019¹¹⁴ , Commission Implementing Regulation (EU) 2019/1685 of 4 October 2019¹¹⁵ , Commission Implementing Regulation (EU) 2019/1793 of 22 October 2019¹¹⁶ , Commission Implementing Regulation (EU) 2019/1873 of 7 November 2019¹¹⁷ , Commission Implementing Regulation (EU) 2019/2007 of 18 November 2019¹¹⁸ and Commission Implementing Regulation (EU) 2019/2093 of 29 November 2019¹¹⁹ ), hereby make the following regulations:

Citation

1. These Regulations may be cited as the European Union (Food and Feed Hygiene) Regulations 2019.

Application

2. (1) Subject to paragraphs (2), (3) and (4), these Regulations shall apply to all stages of production, processing and distribution of food and feed.

(2) These Regulations do not apply to a primary producer or other food or feed business engaged in–

(a) retail sale or supply directly to a final consumer except-

(i) if the sale or supply is from an establishment registered or approved under these Regulations, or

(ii) subject to subparagraph (c) retail of fish or a fishery product (by, or on behalf of a primary producer),

(b) primary production, domestic preparation, handling or storage for private domestic production,

(c) the supply of fish feed for, and feeding of fish feed to, fish –

(i) kept for domestic production, or

(ii) not kept for food production, or

(d) marginal, localised and restricted supply of a food of animal origin from a retail establishment to another retail establishment, to the extent that the food or feed business engages in any of these activities.

(3) Regulation No 852/2004 and Regulation No 853/2004 do not apply to a primary producer engaged in –

(a) direct supply of a primary product of fishing or aquaculture, not exceeding 30 kilogrammes per week, to the final consumer or to a local retail establishment supplying directly to the final consumer, (with respect to live bivalve molluscs this exemption applies only to live bivalve molluscs harvested from class A areas (classified by the Sea Fisheries Protection Authority in accordance with Article 53 of Commission Implementing Regulation (EU) 2019/626 of 5 March 2019) and where the area has not been closed due to excessive levels of toxin (in accordance with Article 62 of Commission Implementing Regulation (EU) 2019/626 of 5 March 2019)),

(b) direct supply of eggs from a flock of hens (gallus gallus domesticus) or quail not exceeding 50 birds, or a flock of ducks or geese not exceeding 20 birds, to the final consumer or to retail establishments supplying directly to the final consumer, located no more than 100 kilometres from the production site,

(c) direct supply of raw milk, not exceeding 30 litres per week, to the final consumer or to retail establishments supplying directly to the final consumer, located no more than 20 kilometres from the holding,

(d) hunting, where the primary producer is engaged solely in the supply of wild game that he or she has hunted if –

(i) no more than one large wild game or no more than three small wild game are supplied in a week, with a maximum of three large wild game or thirty small wild game supplied in a year, and

(ii) the wild game is supplied only to final consumers, or to retail establishments that supply the final consumer, located no more than 100 kilometres from where the wild game was hunted, to the extent that the food or feed business engages in any of these activities.

(4) Regulation No 853/2004 does not apply to-

(a) a primary producer engaged in direct supply of poultry and lagomorphs, slaughtered on the holding, to the final consumer or to retail establishments supplying the meat directly to the final consumer, located no more than 100 kilometres from the holding, if

(i) no more than 1,000 birds are slaughtered in a week, with a maximum of 10,000 birds being slaughtered in a calendar year, or

(ii) no more than 1,000 animals are slaughtered in a week, with a maximum of 10,000 animals being slaughtered in a calendar year, or

(b) the supply, by a hunter, of wild game or wild game meat to the final consumer, or to retail establishments that supply the final consumer, located no more than 100 kilometres from where the wild game was hunted, if –

(i) the meat of no more than one large wild game or no more than three small wild game is supplied in a week, and

(ii) the meat of no more than three large wild game or thirty small wild game is supplied in a year, to the extent that the food or feed business engages in any of these activities.

(5) These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998.

Interpretation

3. (1) In these Regulations-

“Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);

“authorised officer” means –

(a) an authorised officer within the meaning of the Animal Health and Welfare Act 2013 (No. 15 of 2013),

(b) an authorised officer within the meaning of the Act of 1998,

(c) a sea-fisheries protection officer (within the meaning of section 16 of the Sea-Fisheries and Maritime Jurisdiction Act 2006 (No. 8 of 2006)),

(d) an authorised officer within the meaning of the European Communities (Marketing Standards for eggs) Regulations 2009 ( S.I. No. 140 of 2009 ),

(e) a person who, immediately before the making of these Regulations, was an authorised officer under the Regulations of 2009,

(f) a member of the Garda Síochána,

(g) an officer of the Revenue Commissioners, or

(h) a person appointed under Regulation 13;

“European legislation on food and feed” means Regulation No 178/2002, Regulation No 852/2004, Regulation No 853/2004, Regulation No 183/2005, Regulation No 2073/2005, Regulation No 2074/2005, Regulation No 767/2009, Commission Regulation (EU) No. 1162/2009 of 1 December 2009, Regulation No 931/2011, Regulation No 208/2013, Regulation No 210/2013, Regulation No 2015/1375 or Regulation No 2017/625;

“local authority” has the meaning assigned to it by the Local Government Act 2001 (No. 37 of 2001) (as amended by section 5 of the Local Government Reform Act 2014 (No. 1 of 2014)), and the functional area of the local authority has the meaning, subject to an agreement under sections 85, 86 and 149A of the Local Government Act 2001 , assigned to “administrative area” as defined in that Act;

“Minister” means the Minister for Agriculture, Food and the Marine;

“premises” includes land (including land under water) with or without buildings, an establishment, a vehicle (including a boat, ship, hovercraft, aircraft or off-shore installation (being an offshore installation within the meaning of the Safety, Health and Welfare (Offshore Installations) Act 1987 (No. 18 of 1987))), railway wagon, container or other thing used in connection with, or ancillary to, such a thing;

“registering authority” means the person to whom an application in accordance with Regulation 4 or 5 is made or should be made;

“Regulation No 178/2002” means Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 as amended by Regulation (EC) No 1642/2003 of the European Parliament and of the Council of 22 July 2003, Commission Regulation (EC) No 575/2006 of 7 April 2006, Commission Regulation (EC) No 202/2008 of 4 March 2008, Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014, Commission Regulation (EU) 2017/228 of 9 February 2017, Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 and Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019;

“Regulation No 852/2004” means Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 as amended by Commission Regulation (EC) No 1019/2008 of 17 October 2008 and Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009;

“Regulation No 853/2004” means Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 (and, in so far as is required by Article 2 thereof, Articles 2 and 3 of Regulation No 178/2002 and Regulation No 852/2004) as amended by Commission Regulation (EC) No 2074/2005 of 5 December 2005, Commission Regulation (EC) No 1662/2006 of 6 November 2006, Commission Regulation (EC) No 1243/2007 of 24 October 2007, Commission Regulation (EC) No 1020/2008 of 17 October 2008, Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009, Commission Regulation (EC) No 1161/2009 of 30 November 2009, Commission Regulation (EU) No 558/2010 of 24 June 2010, Commission Regulation (EU) No 150/2011 of 18 February 2011, Commission Regulation (EU) No 1276/2011 of 8 December 2011, Commission Regulation (EU) No 16/2012 of 11 January 2012, Council Regulation (EU) No 517/2013 of 13 May 2013, Commission Regulation (EU) No 786/2013 of 16 August 2013, Commission Regulation (EU) No 218/2014 of 7 March 2014, Commission Regulation (EU) No 633/2014 of 13 June 2014, Commission Regulation (EU) No 1137/2014 of 27 October 2014, Commission Regulation (EU) 2016/355 of 11 March 2016, Commission Regulation (EU) 2017/1978 of 31 October 2017, Commission Regulation (EU) 2017/1981 of 31 October 2017 and Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019;

“Regulation No 183/2005” means Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009, Commission Regulation (EU) No 225/2012 of 15 March 2012 and Commission Regulation (EU) 2015/1905 of 22 October 2015;

“Regulation No 2073/2005” means Commission Regulation (EC) No 2073/2005 of 15 November 2005 as amended by Commission Regulation (EC) No 1441/2007 of 5 December 2007, Commission Regulation (EU) No 365/2010 of 28 April 2010, Commission Regulation (EU) No 1086/2011 of 27 October 2011, Commission Regulation (EU) No 209/2013 of 11 March 2013, Commission Regulation (EU) No 1019/2013 of 23 October 2013, Commission Regulation (EU) No 217/2014 of 7 March 2014, COMMISSION REGULATION (EU) 2015/2285 of 8 December 2015, COMMISSION REGULATION (EU) 2017/1495 of 23 August 2017 and COMMISSION REGULATION (EU) 2019/229 of 7 February 2019;

“Regulation No 2074/2005” means Commission Regulation (EC) No 2074/2005 of 5 December 2005 as amended by Commission Regulation (EC) No 1664/2006 of 6 November 2006, Commission Regulation (EC) No 1244/2007 of 24 October 2007, Commission Regulation (EC) No 1022/2008 of 17 October 2008, Commission Regulation (EC) No 1250/2008 of 12 December 2008, Commission Regulation (EU) No 15/2011 of 10 January 2011, Commission Implementing Regulation (EU) No 809/2011 of 11 August 2011, Commission Implementing Regulation (EU) No 1012/2012 of 5 November 2012, Commission Regulation (EU) No 218/2014 of 7 March 2014, Commission Implementing Regulation (EU) No 2015/2295 of 9 December 2015, Commission Implementing Regulation (EU) 2016/759 of 28 April 2016, Commission Regulation (EU) 2017/1973 of 30 October 2017, Commission Regulation (EU) 2017/1980 of 31 October 2017, Commission Implementing Regulation (EU) 2019/627 of 15 March 2019, Commission Implementing Regulation (EU) 2019/628 of 8 April 2019 and Commission Implementing Regulation (EU) 2019/1139 of 3 July 2019;

“Regulation No 767/2009” means Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 as amended by Commission Regulation (EU) No 454/2010 of 26 May 2010, Commission Regulation (EU) No 568/2010 of 29 June 2010, Commission Regulation (EU) No 939/2010 of 20 October 2010, Commission Regulation (EU) 2017/2279 of 11 December 2017 and Commission Regulation (EU) 2018/1903 of 5 December 2018;

“Regulation No 931/2011” means Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011;

“Regulation No 208/2013” means Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013;

“Regulation No 210/2013” means Commission Regulation (EU) No 210/2013 of 11 March 2013;

“Regulation No 2015/1375” means Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015;

“Regulation No 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 as amended, supplemented or implemented by Commission Delegated Regulation (EU) 2018/631 of 7 February 2018, Commission Implementing Regulation (EU) 2018/329 of 5 March 2018, Commission Implementing Regulation (EU) 2018/1587 of 22 October 2018, Commission Delegated Regulation (EU) 2019/478 of 14 January 2019, Commission Implementing Regulation (EU) 2019/66 of 16 January 2019, Commission Delegated Regulation (EU) 2019/624 of 8 February 2019, Commission Delegated Regulation (EU) 2019/625 of 4 March 2019, Commission Delegated Regulation (EU) 2019/1081 of 8 March 2019, Commission Delegated Regulation (EU) 2019/1012 of 12 March 2019, Commission Implementing Regulation (EU) 2019/530 of 27 March 2019, Commission Implementing Regulation (EU) 2019/723 of 2 May 2019, Commission Implementing Regulation (EU) 2019/626 of 5 March 2019 (as amended by Commission Implementing Regulation (EU) 2019/1981 of 28 November 2019), Commission Implementing Regulation (EU) 2019/627 of 15 March 2019, Commission Implementing Regulation (EU) 2019/628 of 8 April 2019, Commission Implementing Regulation (EU) 2019/1013 of 16 April 2019, Commission Delegated Regulation (EU) 2019/1602 of 23 April 2019, Commission Implementing Regulation (EU) 2019/1014 of 12 June 2019, Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019, Commission Delegated Regulation (EU) 2019/1666 of 24 June 2019, Commission Implementing Regulation (EU) 2019/1139 of 3 July 2019, Commission Delegated Regulation (EU) 2019/2074 of 23 September 2019, Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019, Commission Implementing Regulation (EU) 2019/1685 of 4 October 2019, Commission Implementing Regulation (EU) 2019/1793 of 22 October 2019, Commission Implementing Regulation (EU) 2019/1873 of 7 November 2019, Commission Implementing Regulation (EU) 2019/2007 of 18 November 2019 and Commission Implementing Regulation (EU) 2019/2093 of 29 November 2019;

“Regulations of 2009” means the European Communities (Food and Feed Hygiene) Regulations 2009 ( S.I. No. 432 of 2009 ).

(2) A word or expression that is used in these Regulations and is also used in the European legislation on food and feed has, unless the contrary intention appears, the same meaning in these Regulations (other than Regulation 9) as it has in the European legislation on food and feed.

(3) In these Regulations, if the context so requires or admits, a reference to a fishery product includes a reference to live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods.

Registration of food business and feed business

4. (1) Without prejudice to Regulation 5, a person shall not operate-

(a) a food business unless his or her name, the name and address of the establishment and the nature of the food business operated in the establishment, or

(b) a feed business unless his or her name, the name and address of the establishment and the nature of the feed business operated in the establishment is entered in a register maintained for the purposes of –

(i) Article 6 of Regulation No 852/2004 (“Register of food businesses”),

(ii) Article 9 of Regulation No 183/2005 (“Register of feed businesses”), or

(iii) Article 10 of Regulation No 2017/625 (“Official Control Register”).

(2) An application for registration in respect of –

(a) (i) a primary producer (other than a primary producer whose production relates to fishery products or to wild game),

(ii) an importer or distributor of foods of animal origin who engages in the distribution of 20 tonnes or more of animal products at any one time, or

(iii) a feed business shall be in a form and contain any information that the Minister may require,

(b) a primary producer or an establishment engaged in the production, processing, distribution, export, import, or otherwise placing on the market, of fishery products not subject to Regulation 5, shall be in a form and contain information that the Sea Fisheries Protection Authority may require,

(c) a primary producer engaged in hunting and supply of wild game shall be in a form and contain any information that the Minister for Culture, Heritage and the Gaeltacht may require,

(d) (i) a food business engaged in the production of poultry and lagomorphs referred to in Regulation 2(4)(a), or

(ii) an importer or distributor of foods of animal origin who engages in the distribution of animal products and is not referred to in subparagraph (a)(ii), shall be in a form and contain any information that the local authority in whose functional area the business is situated may require.

(3) An application for registration in respect of a food business to which this Regulation relates that is not referred to in paragraph (2), and

(a) in respect of which the Health Service Executive exercised statutory functions prior to the making of these Regulations, or

(b) is of a class or type of food business assigned to the Health Service Executive by the Food Safety Authority of Ireland’s inter-agency agreement on supervisory arrangements, shall be in a form and contain any information that the Executive may require.

(4) An application for registration in respect of a food business to which these Regulations applies that is not otherwise specified in this Regulation shall be made to the registering authority to which the Food Safety Authority of Ireland directs the notification.

(5) A registering authority may enter the name and address of a person, the name and address of an establishment and the nature of the food or feed business operated in the establishment in a register of food businesses or a register of feed businesses, suspend or revoke registration or refuse an application.

(6) Notwithstanding paragraph (1), a primary producer who is of a class or type who may be eligible to receive a payment under Regulation (EC) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 is considered to be entered in the register of food businesses and, where appropriate, the register of feed businesses.

(7) Notwithstanding paragraph (1), a hunter who supplies wild game and is licensed by the Minister for Culture, Heritage and the Gaeltacht in accordance with Sections 28 and 29 of the Wildlife Acts 1976 to 2018 shall be considered to be entered in the register of food businesses.

(8) If an establishment is –

(a) engaged in more than one activity to which this Regulation relates, and

(b) those activities would, but for this paragraph, be subject to an application to different registering authorities, the application shall be accepted by one registering authority agreed between the registering authorities concerned.

(9) Notwithstanding paragraphs (2), (3), (4), (6), (7) and (8) a registering authority may transfer an application to another registering authority by agreement between the registering authorities.

(10) A registering authority shall not consider an application unless it contains all the material and particulars sought by the authority and is accompanied by the fee (if any) set in accordance with Regulation 20.

(11) A person whose name is entered in a register of food businesses or a register of feed businesses shall make such returns to the Minister or registering authority as the Minister or registering authority may require.

Approval of food business & feed business

5. (1) A person shall not operate –

(a) a food business to which-

(i) Article 4(3) of Regulation No 853/2004, or

(ii) Article 2 of Regulation No 210/2013 applies other than under and in accordance with an approval granted for the purposes of those provisions (“food business approval”), or

(b) a feed business to which Article 10 of Regulation No 183/2005 applies other than under and in accordance with an approval granted for the purposes of that provision (“feed business approval”).

(2) An application for a food business approval in respect of—

(a) a food business engaged in the slaughter of animals where no more than 100 livestock units are slaughtered in any week with a maximum of 1,000 livestock units slaughtered in a calendar year,

(b) a food business engaged in the slaughter of poultry where no more than 3,000 birds are slaughtered in any week with a maximum of 150,000 birds slaughtered in a calendar year,

(c) a food business engaged in the slaughter of lagomorphs where no more than 3,000 lagomorphs are slaughtered in any week with a maximum of 150,000 lagomorphs slaughtered in a calendar year,

(d) a food business engaged in the preparation of minced meat or mechanically separated meat where no more than 5 tonnes of minced meat and mechanically separated meat in total is produced in any week,

(e) a food business engaged in the production of meat preparations or meat products, where no more than 20 tonnes of finished products or preparations in total are produced in any week,

(f) a food business operating as a cutting plant where no more than 20 tonnes of fresh meat is produced in any week, or

(g) a food business engaged in the handling of wild game where no more than 8 livestock units are handled in any week with a maximum of 200 livestock units being handled in a calendar year,

shall be in a form and contain any information that the local authority in whose functional area the business is situated may require.

(3) An application for a food business approval or feed business approval in respect of—

(a) a food business of a class or description specified in paragraph (2) where the amount produced is greater than the amount specified for that type of business in that paragraph,

(b) a food business importing or producing novel foods of animal origin, including but not limited to, reptile meat or insects intended for human consumption,

(c) a food business engaged in the production of sprouts (as defined in Regulation No 210/2013),

(d) a food business where-

(i) Regulation No 853/2004, Annex III, Section IX, which refers to Raw Milk, Colostrum, Dairy Products and Colostrum-Based Products, or

(ii) Regulation No 853/2004, Annex III, Section X, which refers to Eggs and Egg Products,

applies,

(e) a food business engaged in the slaughter of animals not otherwise referred to in this Regulation, or

(f) a feed business,

shall be in a form and contain any information that the Minister may require.

(4) An application in respect of a food business to which –

(i) Regulation No 853/2004, Annex III, Section VII, which refers to Live Bivalve Molluscs, or

(ii) Regulation No 853/2004, Annex III, Section VIII, which refers to Fishery Products,

applies, shall be in a form and contain any information that the Sea Fisheries Protection Authority may require.

(5) An application for approval in respect of a food business to which this Regulation relates that is not referred to in paragraphs (2), (3) or (4), and

(a) in respect of which the Health Service Executive exercised statutory functions prior to the making of these Regulations, or

(b) is of a class or type of food business assigned to the Health Service Executive by the Food Safety Authority of Ireland’s inter-agency agreement on supervisory arrangements,

shall be in a form and contain any information that the Executive may require.

(6) An application for approval in respect of-

(a) a food business establishment operating as a cold storage plant, or

(b) a food business not otherwise specified in this Regulation

shall be made to the registering authority to which the Food Safety Authority of Ireland directs the application.

(7) If an establishment is –

(a) engaged in more than one activity to which this Regulation relates, or

(b) engaged in an activity to which this Regulation relates, and is, at the same time, engaged in an activity subject to application for approval under ( S.I. No. 369 of 2006 ), and

(c) those activities would, but for this paragraph, be subject to application to different registering authorities,

the application may be determined by one registering authority agreed between the registering authorities concerned.

(8) Notwithstanding paragraphs (2), (3), (4) and (5), a registering authority may transfer an application for approval to another registering authority by agreement between the registering authorities.

(9) A registering authority shall not consider an application unless the application contains all the material and particulars sought by the authority and is accompanied by the fee (if any) set in accordance with Regulation 20.

(10) A registering authority may grant a food business approval or a feed business approval, attach a condition to a food business approval or a feed business approval, vary or revoke a condition, suspend or revoke a food business approval or a feed business approval or refuse an application for approval in accordance with Regulation 6.

(11) A registering authority may, for good and sufficient reason, make a food business approval or a feed business approval valid for a limited period.

(12) A registering authority may, in respect of an application for a food business approval or a feed business approval, grant a conditional approval for up to 2 periods of not more than 3 months (or where the approval concerns a fishing vessel, conditional approval for a period of 12 months).

(13) The holder of a food business approval or a feed business approval shall make such returns to the Minister or registering authority as the Minister or registering authority may require.

(14) In this Regulation:

(a) 1 livestock unit is the equivalent of an adult bovine animal with a live weight of 300 kg or more;

(b) 0.5 livestock units is the equivalent of a reptile or a bovine other than a bovine referred to in subparagraph (a);

(c) 0.2 livestock units is the equivalent of a pig with a live weight of 100 kg or more or a large game (including deer) with a live weight of 100 kg or more;

(d) 0.15 livestock units is the equivalent of a pig other than a pig referred to in subparagraph (c);

(e) 0.1 livestock units is the equivalent of a ratite;

(f) 0.05 livestock units is the equivalent of a sheep or goat, or a deer other than a deer referred to in subparagraph (c).

Suspension or revocation of a food or feed business registration or approval

6. (1) Without prejudice to the generality of Regulation 4(5), a registering authority may, in respect of an application or registration made under Regulation 4-

(a) refuse to accept an application from a food business operator or a feed business operator for registration if it is satisfied that information required has not been furnished or information that is false or misleading in a material respect has been furnished, or

(b) remove from a register a food business operator or a feed business operator, if it is satisfied that a registered person has ceased to carry out the activity to which the registration relates on the premises to which the registration relates.

(2) If a registering authority proposes to refuse an application or to revoke a registration under paragraph (1), it shall-

(a) notify the applicant or registered food business operator or feed business operator of the proposal and the reasons for the proposal, and that he or she may make representations in relation to the proposal to the registering authority within 14 days of notification,

(b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and

(c) notify the applicant or registered person of the decision and the reasons for the decision.

(3) Without prejudice to the generality of Regulation 5(10), a registering authority may refuse an application or suspend or revoke a food business approval or feed business approval if it is satisfied that—

(a) an act of the institutions of the European Union or these Regulations have not, are not or will not be, complied with,

(b) the applicant or holder of a food business approval or a feed business approval has contravened a provision of an enactment, whether he or she has been convicted or not, relating to food, feed, animal or public health, animal welfare or the environment,

(c) the applicant or holder of a food business approval or a feed business approval has failed to comply with a condition of a food business approval or a feed business approval,

(d) in relation to an application, information required has not been furnished or information that is false or misleading in a material respect has been furnished,

(e) the premises to which the application or food business approval or a feed business approval relates is not, or has ceased to be, a premises that meets the structural, operational and hygiene requirements of the European legislation on food and feed relevant to the form of premises to be approved,

(f) the applicant or holder of a food business approval or a feed business approval is not a fit and proper person to be approved,

(g) the holder of a food business approval or a feed business approval has ceased to carry out the activity to which approval relates at the premises to which approval relates,

(h) the applicant or registered person, having been given 28 days to do so, fails to pay a fee under Regulation 20,

(i) it is necessary for the protection of human health, animal health or welfare or the environment, including the prevention, control or eradication of a disease, or

(j) it is necessary, ancillary or supplementary for an act of the institutions of the European Union to have full effect.

(4) Other than in the case of paragraph (3)(i) or (j), if a registering authority proposes to refuse an application or to suspend or revoke an approval, it shall-

(a) notify the applicant or holder of the food business approval or feed business approval of the proposal and the reasons for the proposal, and that he or she may make representations in relation to the proposal to the registering authority within 14 days of notification,

(b) consider a representation duly made before deciding whether to proceed with, modify or annul the proposal, and

(c) notify the applicant or registered person of the decision and the reasons for the decision.

(5) If a registering authority is of the opinion that—

(a) it is necessary for the protection of human health, animal health or welfare or the environment, including the prevention, control or eradication of a disease, or

(b) it is necessary, ancillary or supplementary for an act of the institutions of the European Union to have full effect,

it may refuse an application, suspend or revoke an approval in accordance with paragraph (6).

(6) If a registering authority refuses an application or suspends or revokes an approval in accordance with this paragraph, it shall—

(a) notify the applicant or registered person of the decision and the reasons for the decision, and that he or she may make representations in relation to the decision to the registering authority within 14 days of notification,

(b) consider a representation made, and

(c) confirm, modify or annul the decision and notify the applicant or holder of the authorization of the decision and the reasons for the decision.

(7) If a registering authority—

(a) suspends a food business approval or a feed business approval, the approval and the entry in the register of food businesses or register of feed businesses relating to the person and establishment suspended has no effect for the duration of the suspension, or

(b) revokes a food business approval or a feed business approval or the approval expires by effluxion of time, the approval and the entry in the register of food businesses or feed businesses relating to the person to whom, and establishment to which, approval formerly related has no effect.

Certificate of approval

7. (1) If a registering authority grants a feed business approval or a food business approval, it shall issue a certificate to the holder of the feed business approval or food business approval (“certificate of approval”).

(2) A certificate of approval shall contain-

(a) the name of the holder of the feed business approval or food business approval,

(b) the address of the premises to which the feed business approval or food business approval relates,

(c) the nature of the activity to which the feed business approval or food business approval relates,

(d) the conditions to which the feed business approval or food business approval is subject,

(e) the period of validity (if any) of the feed business approval or food business approval,

(f) a unique reference number that identifies the feed business or food business, and

(g) the name of the registering authority.

(3) If a feed business approval or food business approval is suspended or revoked, the holder of the certificate of approval shall surrender it on request to the registering authority or an authorised officer.

(4) If a certificate of approval is surrendered to a registering authority or an authorised officer, the authority or officer shall return it to the holder on expiry of a period of suspension.

(5) The holder of a feed business approval or a food business approval shall cause the certificate of approval to be displayed prominently on the premises to which the approval relates during business hours.

Maintenance of register etc

8. (1) The Food Safety Authority of Ireland shall maintain and publish, in a manner that the Authority considers appropriate, the register of approved food businesses on the basis of information furnished by registering authorities.

(2) The Minister shall maintain and publish, in a manner that he or she considers appropriate—

(a) the register of feed businesses, and

(b) a list of feed business approvals.

Undesirable substances in feedingstuffs

9. (1) A person shall not import, export, put into circulation, manufacture, incorporate in a feedingstuff, feed to an animal or have in his or her possession or under his or her control a product unless—

(a) it is of sound merchantable quality, and

(b) if the product is mentioned in Annex I to the Directive, the amount of an undesirable substance mentioned in column (1) of that Annex opposite the mention in column (2) of the product does not exceed the level specified in column (3) opposite the mention of the product in column (2).

(2) A person shall not, for dilution purposes, mix a product that does not comply with paragraph (1) with another product or a further quantity of the same product.

(3) Paragraph (1) does not apply to a complementary feedingstuff taking into account the proportion of the complementary product prescribed for use in a daily ration.

(4) Annex I to the Directive is construed and has effect as if each maximum level referred to in footnotes (1), (3) and (4) is prescribed.

(5) A person shall not have in his or her possession or under his or her control, sell or supply an animal to which a product has been administered in contravention of paragraph (1).

(6) A person who imports, exports, puts into circulation, manufactures, incorporates a product in a feedingstuff, shall maintain a record of each transaction relating to a product or a feedingstuff, maintain the record for not less than 8 years and make it available on request to an authorised officer.

(7) The Minister may determine the form and manner in which a record maintained under paragraph (1) is to be maintained and, if he or she does so, a person shall comply with the determination.

(8) In this Regulation—

“Directive” means Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 as amended by Commission Directive 2003/57/EC of 17 June 2003, Commission Directive 2003/100/EC of 31 October 2003, Commission Directive 2005/8/EC of 27 January 2005, Commission Directive 2005/86/EC of 5 December 2005, Commission Directive 2005/87/EC of 5 December 2005, Commission Directive 2006/13/EC of 3 February 2006, Commission Directive 2006/77/EC of 29 September 2006, Commission Directive 2008/76/EC of 25 July 2008 and Commission Directive 2009/8/EC of 10 February 2009, Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009, Commission Directive 2009/141/EC of 23 November 2009, Commission Directive 2010/6/EC of 9 February 2010, Commission Regulation (EU) No 574/2011 of 16 June 2011, Commission Regulation (EU) No 277/2012 of 28 March 2012, Commission Regulation (EU) No 744/2012 of 16 August 2012, Commission Regulation (EU) No 107/2013 of 5 February 2013, Commission Regulation (EU) No 1275/2013 of 6 December 2013, Commission Regulation (EU) No 2015/186 of 6 February 2015 and Commission Regulation (EU) 2017/2229 of 4 December 2017;

“product” means a product intended for animal feed, including an additive, feedingstuff or premixture.

(9) A word or expression that is used in this Regulation and is also used in the Directive has, in this Regulation, the same meaning as it has in the Directive.

Notice of import of feed

10. (1) A person shall not bring an animal feed into the State from a country other than a Member State unless he or she has given notice to the Minister, in a form approved by the Minister, at least 24 hours before the animal feed is brought into the State, of—

(a) the nature and quantity of animal feed including its GM and Organic Status,

(b) the place where it is intended to bring the animal feed into the State,

(c) the date and time that the animal feed is to be brought into the State,

and the animal feed is brought into the State in accordance with the notice.

(2) A person who gives notice under paragraph (1) shall advise the Minister of any change of circumstances relating to the importation or proposed importation of the animal feed to which the notice relates within 24 hours of becoming aware of the change and at least 24 hours before the product enters the State.

Records

11. (1) A person who is required to maintain a record pursuant to the European legislation on food and feed or as a condition of registration or approval under these Regulations shall maintain the record for a period of not less than 3 years (or where, in relation to a particular type or class of record, a longer period is specified in the European legislation on food and feed, for that specified period) and make it available on request to an authorised officer.

(2) Without prejudice to paragraph (1), where a record relates to food of animal origin and the shelf life of the food is greater than 3 years, the record shall be maintained for the period of the shelf life of the food.

Forgery including fraudulent or deceptive activity

12. (1) A person shall not forge or utter knowing it to be forged—

(a) a document or record referred to in Article 5(2)(g) or (4), or Part III of Annex I to, Regulation No 852/2004,

(b) a health mark or identification mark referred to in Article 5 of Regulation No 853/2004,

(c) documentation or certification referred to in Article 6(4) of Regulation No 853/2004,

(d) a certificate or document referred to in Article 7 of Regulation No 853/2004,

(e) a form or document referred to in Article 3 of Regulation No 931/2011,

(f) a certificate referred to in Article 88 of Regulation No 2017/625,

(g) an attestation referred to in Article 91 of Regulation No 2017/625 or a private attestation,

(h) an entry in the register of food businesses or register of feed businesses, a food business approval, a feed business approval, a record purporting to be maintained under Regulation 11, a requirement or direction of an authorised officer under Regulation 14 (if the requirement or direction is in writing), a compliance notice or notice under Regulation 29, a certificate or other document purporting to be issued, granted or given under these Regulations,

(in this Regulation referred to as “a forged document”).

(2) A person shall not alter with intent to defraud or deceive, or to utter knowing it to be so altered—

(a) a document or record referred to in Article 5(2)(g) or (4), or Part III of Annex I to, Regulation No 852/2004,

(b) a health mark or identification mark referred to in Article 5 of Regulation No 853/2004,

(c) documentation or certification referred to in Article 6(4) of Regulation No 853/2004,

(d) a certificate or document referred to in Article 7 of Regulation No 853/2004,

(e) a form or document referred to in Article 3 of Regulation No 931/2011,

(f) a certificate referred to in Article 88 of Regulation No 2017/625,

(g) an attestation referred to in Article 91 of Regulation No 2017/625 or a private attestation,

(h) an entry in the register of food businesses or register of feed businesses, a feed business approval, a food business approval, a record purporting to be maintained under Regulation 11, a requirement or direction of an authorised officer under Regulation 14 (if the requirement or direction is in writing), a compliance notice or notice under Regulation 29, a certificate or other document purporting to be issued, granted or given under these Regulations,

(in this Regulation referred to as “an altered document”).

(3) A person shall not have, without lawful authority, in his or her possession or under his or her control a forged document or an altered document.

(4) A person, either directly or indirectly, by himself or herself or with another person shall not knowingly-

(a) sell or supply food or feed to another food business operator, feed business operator or member of the general public where the marketing, indication or labelling of such food or feed is false, deceptive or misleading or is likely to create an erroneous impression about the character, composition, quality, origin, value or authenticity of such food or feed,

(b) make false, incorrect or incomplete statements to deceive or attempt to deceive in relation to the character, composition, quality, origin, value or authenticity of food or feed, or

(c) contravene the marketing standards relating to food or feed including the marketing standards referred to in Articles 73 to 91 of Regulation (EU) No 1308/2013.

(5) Without prejudice to the generality of paragraph (4), a person shall not knowingly misrepresent the status of a food or feed in relation to, but not limited to, its nature, identity, properties, composition, quantity, durability, content, freshness, provenance, method of production or manufacture, organics, genetic modification, membership of a quality assurance scheme or where the food derived from an animal or plant, the species or variety of animal or plant the food derived from.

Appointment of authorised officer

13. (1) The Minister may appoint in writing such persons or classes of persons as he or she considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under these Regulations, as specified in the appointment.

(2) The Minister for Culture, Heritage and the Gaeltacht may appoint in writing such persons or classes of persons as he or she considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under these Regulations, as specified in the appointment.

(3) The chief executive of a local authority may appoint in writing such persons or classes of persons as he or she considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under these Regulations, as specified in the appointment.

(4) The Sea-Fisheries Protection Authority may appoint in writing such persons or classes of persons as it considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under these Regulations, as specified in the appointment.

(5) The Chief Executive of the Health Service Executive may appoint in writing such persons or classes of persons as he or she considers appropriate to be authorised officers for the exercise of all or any of the functions conferred on an authorised officer under these Regulations, as specified in the appointment.

(6) The Minister, Minister for Culture, Heritage and the Gaeltacht, the chief executive of a local authority, the Sea Fisheries Protection Authority or the Chief Executive of the Health Service Executive may terminate the appointment of an authorised officer appointed by him or her, whether or not the appointment was for a fixed period or specified purpose.

(7) An appointment as an authorised officer ceases—

(a) if it is terminated pursuant to paragraph (6),

(b) if it is for a fixed period, on the expiry of that period,

(c) if it is for a specified purpose, on the completion of that purpose, or

(d) if the person appointed is an officer of the Minister, Minister for Culture, Heritage and the Gaeltacht, a local authority, the Sea Fisheries Protection Authority or the Health Service Executive upon the person ceasing to be such an officer.

(8) Nothing in paragraph (7) is to be construed so as to prevent the Minister, the Minister for Culture, Heritage and the Gaeltacht, the chief executive of a local authority, the Sea Fisheries Protection Authority or the Chief Executive of the Health Service Executive from reappointing as an authorised officer a person to whom that paragraph relates.

(9) An authorised officer appointed under this Regulation shall be furnished with a warrant of his or her appointment and, when exercising a power conferred on him or her, the officer, an authorised officer within the meaning of the Animal Health and Welfare Act 2013 , an authorised officer within the meaning of the Act of 1998, an authorised officer within the meaning of the European Communities (Marketing Standards for eggs) Regulations 2009, a sea-fisheries protection officer (within the meaning of section 16 of the Sea-Fisheries and Maritime Jurisdiction Act 2006 ), an officer of Customs and Excise or a member of the Garda Síochána shall, if requested by a person affected, produce the warrant or evidence that he or she is such an officer or member to the person.

Functions of authorised officer

14. (1) For the purposes of these Regulations or the European legislation on food and feed an authorised officer may—

(a) enter and inspect, at all reasonable times, any premises if he or she is carrying out an official control or other official activity for the purposes of these Regulations or the European legislation on food and feed or where he or she has reasonable grounds for believing that—

(i) an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates is, may be or has been present,

(ii) a record relating to an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates is, may be or has been present,

(iii) equipment, machinery, a vehicle, a vessel or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates is, may be or has been present,

(b) examine an animal, animal product, equipment, machinery or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates,

(c) require the name and address of the owner, or person in possession or control of an animal, animal product, equipment, machinery, a document, a vehicle or a vessel used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates, or require details of place of departure, journey or destination,

(d) inspect a vehicle, a vessel, an aircraft, a railway wagon, a container, equipment, machinery, a computerised information management system or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates and require the person in charge or control of such to refrain from moving it,

(e) require the owner, person in possession or control of any premises, equipment, machinery, a computerised information management system, a vehicle, a vessel or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates, to produce to the officer such records (and in the case of a record stored in non-legible form, produce to him or her a copy in a legible form) that are in the person’s possession or procurement, or under the person’s control, as the officer may reasonably require,

(f) inspect and take copies of any record (including a legible reproduction of one stored in non-legible form) or extracts from the record that the officer finds or is produced to him or her during an inspection,

(g) make a record, including by means of writing, sound recording, photograph, video or other means,

(h) take, without making a payment, samples from an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates, or any article, substance or liquid as he or she may reasonably require and carry out or cause to be carried out on the samples such tests, analyses, examinations or inspections as he or she considers necessary or expedient and mark or otherwise identify it,

(i) obtain samples of an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates by way of anonymously placed orders or mystery shopping, whether in person, remotely or over the internet, and carry out or cause to be carried out on the samples such tests, analyses, examinations or inspections as he or she considers necessary or expedient and mark or otherwise identify it.

(2) An authorised officer may require a person to give information regarding the ownership and identity of an animal, animal product, food, feed, equipment, machinery, a vehicle, a vessel or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates as is in the person’s knowledge or procurement.

(3) Where an authorised officer has reasonable grounds for believing that—

(a) a premises is entered in the register of feed businesses or register of food businesses, is subject to a feed business approval or a food business approval, is the subject of an application for registration or approval, is required to be registered or approved or is ancillary to a premises registered or approved, subject to an application for registration or approval or required to be registered or approved,

(b) an offence is being or has been committed under these Regulations, or

(c) evidence of an offence to which subparagraph (b) relates may be, is or has been on any land or premises, or in a vehicle, a vessel, an aircraft, a railway wagon, a container, equipment or machinery,

the officer may, in addition to the powers exercisable by him or her under paragraph (1):

(i) search the land or premises;

(ii) search the vehicle, vessel, aircraft, railway wagon, container, equipment or machinery (including any computerised information management system);

(iii) require a person in charge or control of the vehicle, vessel, aircraft, railway wagon, container, equipment or machinery to—

(I) refrain from moving it, or move it to a location where it may be searched,

(II) give information regarding its place of departure, journey or destination, and

(III) where the equipment or machinery is part of a computerised information management system, provide assistance (including passwords) to enable access to such devices or systems;

(iv) seize and detain an animal, animal product, food or feed and mark or otherwise identify it;

(v) detain the vehicle, vessel, aircraft, railway wagon, equipment, machinery or container for such reasonable period necessary for the purposes of permitting an inspection or a search under this Regulation either at the place where it was first detained or require it to be moved to such other location as the authorised officer requires;

(vi) remove any equipment or machinery or books, documents or records and detain them for such reasonable period necessary for the purpose of his or her functions under these Regulations;

(vii) give such direction to a person who has an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates, or who has equipment, machinery, vehicle or vessel or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates in his or her possession or under his or her control or who has information relating to such, as the authorised officer may reasonably consider necessary for the purposes of these Regulations.

(4) An authorised officer shall not enter, except with the consent of the occupier, a private dwelling unless he or she has obtained a search warrant under Regulation 15 other than where he or she has reasonable grounds for believing that before a search warrant could be sought in relation to the dwelling under Regulation 15, any evidence of an offence referred to in paragraph (3)(b) is being or is likely to be disposed of or destroyed.

(5) An authorised officer, when exercising a function under this Regulation, may be accompanied by other persons and may take with him or her, or those persons may take with them, any equipment or materials to assist the officer in the exercise of the function.

(6) An authorised officer may use reasonable force, if necessary, to exercise his or her functions under these Regulations.

(7) Where, in the course of exercising a function under these Regulations, an authorised officer finds or comes into possession of anything that the officer has reasonable grounds for believing to be evidence of an offence or suspected offence under these Regulations, the officer may seize and retain it for use in evidence in proceedings for an offence under these Regulations.

(8) An authorised officer is not liable in any proceedings for anything done in the purported exercise of his or her powers under these Regulations if the court is satisfied that the act was done in good faith and that there were reasonable grounds for doing it.

(9) A member of the Garda Síochána may stop a vehicle or vessel, for the purposes of these Regulations and may require it to be moved for inspection to such place as he or she directs.

(10) A person who has—

(a) an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates, or

(b) equipment, machinery, a vehicle, a vessel or other thing used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates in his or her possession or under his or her control, or information or a record relating to any of them, shall give such—

(i) assistance to an authorised officer, or person who accompanies the officer, and

(ii) information to an authorised officer on request being made, in that behalf by the officer, as the officer may reasonably require for the exercise of his or her functions under these Regulations.

(11) The owner or person in charge of any premises used in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates shall, if required by an authorised officer, where it is practicable and possible, provide suitable equipment or facilities or a suitable part of the plant or establishment for the officer to carry out his or her functions under these Regulations.

(12) An authorised officer may require a person to give to the officer such information as is in the person’s power or procurement as regards any premises specified by the officer including—

(a) whether or not the premises is used, either partly or wholly, for or in connection with an animal, animal product, food, feed or other thing to which these Regulations or the European legislation on food and feed relates,

(b) the name of the owner, occupier or person who is in charge of the premises, and

(c) whether or not the premises is let and, if let, the name and address of the person to whom, and the period of time for which, it is let.

(13) Nothing in section 17 of the Industrial and Provident Societies Act 1893 prevents an authorised officer from exercising a function conferred on him or her by these Regulations.

Search warrant

15. (1) If a judge of the District Court is satisfied by information on oath of an authorised officer that there are reasonable grounds for believing-

(a) evidence of or relating to the commission or intended commission of an offence under these Regulations is to be found on a premises,

(b) there is or was feed, food or equipment or other thing made, used or adapted for use (including manufacture and transport) in connection with feed or food, or

(c) a document or other record related to a thing to which subparagraph (a) refers is or may be on the premises,

the judge may issue a search warrant.

(2) A search warrant under this Regulation shall be expressed and operate to authorise a named authorised officer, accompanied by such authorised officers or other persons as the named authorised officer thinks necessary, at any time, within one month from the date of issue of the warrant, on production if so requested of the warrant, to enter (if necessary by use of reasonable force) the premises, vehicle, vessel or aircraft named in the warrant.

(3) If a premises is entered under a warrant issued under this Regulation, an authorised officer so entering may exercise all or any of the powers conferred on an authorised officer under these Regulations.

Compliance notice

16. (1) Where an authorised officer is of the opinion that—

(a) these Regulations or the European legislation on food and feed is not being or has not been complied with, or there are reasons to believe that these Regulations or the European legislation on food and feed will not be complied with,

(b) it is necessary for the protection of human health, animal health or welfare or the environment including the prevention, control or eradication of a disease or contamination of food or feed, or

(c) it is necessary, ancillary or supplementary for European legislation on food and feed to have full effect,

the officer may serve a notice (“compliance notice”) stating that opinion to the person—

(i) who appears to be the owner, occupier, or person in charge of the premises, or

(ii) in possession or control of an animal, animal product, food, feed or other thing to which the notice relates.

(2) A compliance notice shall—

(a) require the person to whom it is served to take such action as specified in the notice,

(b) inform the person to whom it is served that he or she may appeal the notice in the District Court under Regulation 17, and

(c) state that if the person to whom it is served fails to comply with the notice, he or she commits an offence and is liable to a penalty set out in Regulation 35(1).

(3) A compliance notice may require that—

(a) an animal, animal product, food or feed be dealt with in a manner specified in the notice,

(b) such alterations be made to a premises or operations at a premises as the officer specifies in the notice,

(c) an animal, animal product, food or feed be disposed of in such manner as the officer specifies in the notice,

(d) a specified operation or activity cease on a premises,

(e) a specified operation or activity take place only in a manner specified in the notice,

(f) a specified type or level of sampling and analysis be undertaken for a period specified in the notice,

(g) a measure within the meaning of Article 138(2) of Regulation No 2017/625 be taken as specified in the notice,

(h) a specified operation or activity may only be carried out under and in accordance with such terms and conditions as are specified in the notice, or

(i) require a person to make such changes to a label, packaging or marketing material including re-labelling of an animal product, food, feed or other thing as may be specified in the notice.

(4) A person to whom a compliance notice is served shall comply with it until the notice expires, is withdrawn under paragraph (6) or is annulled under Regulation 17, and not cause or permit another person to contravene the terms of the notice.

(5) A compliance notice may specify a time limit within which it is to be complied with.

(6) A compliance notice may be modified or withdrawn in a further notice and the earlier notice has effect subject to the modification or withdrawal.

(7) A compliance notice may require the owner, occupier, operator or person in charge of any premises, an animal, animal product, food, feed, vehicle, vessel, machinery, equipment or other thing to which the European legislation on food and feed relates to choose between two or more of the requirements specified in the notice.

(8) A compliance notice shall include an address for service of an appeal under Regulation 17.

(9) A person on whom a compliance notice is served who fails to comply with, or causes or permits another person to contravene the notice, commits an offence.

Appeal against compliance notice

17. (1) A person to whom a compliance notice is served may, within 7 days from the date of service of the notice, appeal the notice to the Judge of the District Court having jurisdiction in the District Court district—

(a) where the animal, animal product, food, feed, premises, vehicle, machinery, equipment, vessel or other thing to which the European legislation on food and feed relates which is the subject of the notice, is situated, or

(b) where the person bringing the appeal ordinarily resides or carries on business,

on the grounds that the notice is unreasonable having regard to these Regulations or the European legislation on food and feed.

(2) Notice of an appeal shall contain a statement on the grounds upon which it is alleged that the notice or any of the terms of the notice are unreasonable and shall be served on the authorised officer who served the compliance notice at the address included on the notice in accordance with Regulation 16 not later than 48 hours prior to the hearing of the appeal.

(3) A person bringing an appeal shall lodge a copy of the notice or appeal with the District Court Clerk concerned not later than 48 hours prior to the hearing of the appeal.

(4) On the hearing of an appeal a Judge of the District Court may confirm, modify or annul a notice.

(5) A person, including a person on whom a compliance notice has been served, shall not—

(a) pending the determination of an appeal, deal with an animal, animal product, food, feed, premises, vehicle, vessel, machinery, equipment or other thing to which the notice relates, other than in accordance with the terms of the compliance notice, or

(b) if the notice is confirmed or modified on appeal, deal with an animal, animal product, food, feed, any premises, vehicle, vessel, equipment, machinery or other thing to which the notice relates other than in accordance with the terms of the compliance notice as confirmed or modified.

(6) In this Regulation “appeal” means an appeal under paragraph (1).

Seizure and detention for non-compliance with a compliance notice

18. (1) Without prejudice to an appeal under Regulation 17, if—

(a) a person in control of an animal, animal product, feed or food or other thing to which a compliance notice relates, or in control of a premises, vessel, vehicle, equipment, machinery or other thing used in connection with an animal, animal product, feed or food or other thing to which a compliance notice relates fails to comply with the terms of a compliance notice within the time specified,

(b) an authorised officer has reasonable grounds for believing that the terms of a compliance notice, whether or not modified under Regulation 17 (4), will not be complied with, or

(c) a compliance notice has been confirmed with or without modification under Regulation 17(4) and the notice has not been complied with,

an authorised officer may at any time seize the animal, feed or food or other thing to which a compliance notice relates, or seize the vessel, vehicle, equipment, machinery or other thing used in connection with an animal, animal product, feed or food or other thing to which a compliance notice relates.

(2) If the animal, feed or food or other thing to which a compliance notice relates, a vessel, vehicle, equipment, machinery or other thing used in connection with an animal, animal product, feed or food or other thing to which a compliance notice relates is seized in accordance with paragraph (1), an authorised officer may—

(a) sell, destroy or dispose of the animal, feed or food or other thing to which a compliance notice relates or cause it to be sold, destroyed or be disposed of, or

(b) take such other measures in relation to the animal, feed or food or other thing to which a compliance notice relates, or in relation to the vessel, vehicle, equipment, machinery or other thing used in connection with an animal, animal product, feed or food or other thing to which a compliance notice relates as the authorised officer considers appropriate in the circumstances.

(3) Any profits arising out of the sale, destruction or disposal of an animal, animal product, feed or food or other thing to which a compliance notice relates in accordance with paragraph (2) shall be paid to the owner of the animal, feed or food or other thing to which a compliance notice relates less any expenses incurred in connection with the seizure, sale, destruction or disposal.

(4) The costs (including ancillary costs) of a measure taken under this Regulation are recoverable by the Registering Authority—

(a) as a simple contract debt in a court of competent jurisdiction from the person who was the owner of the animal, feed or food or other thing to which these Regulations or the European legislation on food and feed relates or from the person who was the owner of the means of transport at the time the measure was carried out, or

(b) by deducting the costs from any sum payable from the Registering Authority to a person on whom a notice has been served.

(5) The costs of any action required by a compliance notice shall be borne by the owner of a premises, animal, feed or food to which the notice relates.

Fixed Payment Notice

19. (1) If an officer of a registering authority authorised by the authority in that behalf has reasonable grounds for suspecting that a person is committing or has committed an offence under these Regulations (other than an offence under Regulation 12(1), (2), (4) or (5)), he or she may serve a notice in writing (“fixed payment notice”) on that person stating that—

(a) the person is alleged to have committed the offence,

(b) the person may during the period of 28 days beginning on the date of the notice make to the registering authority, at the address specified in the notice, a payment of €250 accompanied by the notice,

(c) the person is not obliged to make the payment, and

(d) a prosecution in respect of the alleged offence will not be instituted during the period specified in the notice and, if the payment specified in the notice is made during that period, no prosecution in respect of the alleged offence will be instituted.

(2) Where a fixed payment notice is served under paragraph (1)—

(a) the person to whom the notice applies may, during the period specified in the notice, make to the registering authority, at the address specified in the notice, the payment specified in the notice accompanied by the notice,

(b) the registering authority may receive the payment, issue a receipt for it and retain the money so paid, and any payment so received shall not be recoverable in any circumstances by the person who made it, and

(c) a prosecution in respect of the alleged offence shall not be instituted in the period specified in the notice, and if the payment so specified is made during that period, no prosecution in respect of the alleged offence shall be instituted.

(3) In proceedings for an offence under these Regulations, the onus of proving that a payment pursuant to a notice under this Regulation has been made lies on the person on whom the fixed payment notice was served.

(4) In proceedings for an offence referred to in paragraph (1) it is a defence for the accused to show that he or she has made a payment in accordance with this Regulation pursuant to a fixed payment notice issued in respect of that offence.

Fees

20. (1) A registering authority may, from time to time, set and charge a fee in respect of—

(a) an application for entry onto, or amendment to, the register of feed businesses,

(b) an application for entry onto, or amendment to, the register of food businesses,

(c) an application for approval under Regulation 5,

(d) registration, a licence, authorisation, approval, attestation or certificate (or amendment to registration, a licence, authorisation, approval, attestation or certificate) which is in force for a definite or indefinite period of more than 12 months, such annual fee (if any), or

(e) the performance by the authority of a function under the European legislation on food and feed or under these Regulations,

and different fees (having regard to Chapter VI of, and Annex IV to, Regulation No 2017/625 and not exceeding the cost, estimated by the registering authority charging the fee, of performing the function to which the fee relates) may be set and charged having regard to the cost to the authority of performing a particular function.

(2) Notwithstanding paragraph (1), a registering authority shall charge a fee for an activity referred to -

(a) in Article 79(1), in respect of which a fee is set under Annex IV to that Regulation unless it sets a different fee in accordance with Article 81, and

(b) in Article 79(2), in accordance with Article 81 of Regulation No 2017/625.

(3) A fee payable pursuant to this Regulation may be recovered by a registering authority from the person by whom it is payable as a simple contract debt in a court of competent jurisdiction.

(4) Moneys received by a Minister of the Government under this Regulation or Regulation 19 shall be paid into or disposed of for the benefit of the Exchequer in accordance with the directions of the Minister for Public Expenditure and Reform.

(5) A fee set under the Regulations revoked by Regulation 37 remains payable and may be recovered by a registering authority from the person by whom it is payable as a simple contract debt in a court of competent jurisdiction.

Obstruction and false statements

21. A person who—

(a) obstructs, interferes with or impedes an authorised officer, or any person who accompanies an authorised officer, in the course of exercising a function conferred on the officer under these Regulations,

(b) fails or refuses, without reasonable cause, to comply with a requirement of an authorised officer under Regulation 14,

(c) fails, without reasonable cause, to give assistance or requested information to an authorised officer in accordance with Regulation 14, or

(d) in making a notification for registration under Regulation 4 or an application for approval under Regulation 5 or in purporting to give information to an authorised officer for the exercise of the officer’s functions under these Regulations—

(i) makes a statement that he or she knows to be false or misleading in a material particular or recklessly makes a statement which is false or misleading in a material particular, or

(ii) intentionally fails to disclose a material particular,

(e) tampers or otherwise interferes with a sample taken under Regulation 14,

(f) aids or abets a contravention of these Regulations or the European legislation on food and feed, commits an offence.

Data Sharing

22. (1) Information, including personal data (within the meaning of Article 4 of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 and section 69 of the Data Protection Act 2018) held by—

(a) the Minister,

(b) the Food Safety Authority of Ireland,

(c) a registering authority,

(d) a body or individual to whom a function under these Regulations or the European legislation on food and feed has been delegated,

(e) the operator of a laboratory for the analysis of samples,

(f) the operator of a database recognised, approved or established under regulations made under sections 36 of the Animal Health and Welfare Act 2013 , or

(g) the Minister under the animal tracing systems database established under section 63 of that Act,

for the purposes of these Regulations, an act of the institutions of the European Union, the Act of 1998 or the Animal Health and Welfare Act 2013 may be exchanged by them with each other for the performance by them of their functions under those Acts or Regulations.

(2) Paragraph (1) is without prejudice to any other power of registering authorities to disclose information by or under an act of the institutions of the European Union.

Contravention of Regulation No 178/2002

23. A person who, by act or omission-

(a) imports feed or food other than in accordance with Article 11,

(b) exports or re-exports feed or food other than in accordance with Article 12,

(c) places unsafe food on the market in contravention of Article 14(1),

(d) places unsafe feed on the market or feeds it to an animal in contravention of Article 15(1),

(e) misleads or attempts to mislead consumers in contravention of Article 16,

(f) fails to ensure that food or feed satisfies food law in contravention of Article 17(1),

(g) fails to identify a person from whom he or she has been supplied with an animal, animal product, food, feed, a food producing animal or a substance intended to be or expected to be incorporated into food or feed in contravention of Article 18(2),

(h) fails to identify a person to whom a product marketed by him or her has been supplied or fails to have in place systems and procedures to identify persons to whom products marketed by him or her have been supplied in contravention of Article 18(3),

(i) places food on the market in contravention of Article 18(4),

(j) fails to initiate procedures to withdraw food from the market in contravention of Article 19(1) or (2),

(k) fails to inform the registering authority with whom the food business is registered as required by Article 19(3),

(l) fails to collaborate with a registering authority or an authorised officer in contravention of Article 19(4) or 20(4),

(m) fails to initiate procedures to withdraw feed from the market in contravention of Article 20(1) or (2),

(n) fails to inform the registering authority with whom the feed business is registered as required by Article 20(3), or

(o) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 178/2002 commits an offence.

Contravention of Regulation No 852/2004

24. (1) A person who, by act or omission—

(a) fails to ensure that all stages of production, processing and distribution complies with Article 3,

(b) fails to comply with the general hygiene requirements, or any specific requirements referred to in Article 4(1) or (2),

(c) fails to adopt specific hygiene measures in contravention of Article 4(3),

(d) fails to use appropriate sampling and analytical methods in contravention of Article 4(5),

(e) fails to put in place, implement and maintain procedures based on the HACCP principles in contravention of Article 5(1),

(f) fails to provide a registering authority or authorised officer with evidence in contravention of Article 5(4)(a),

(g) fails to ensure that documents comply with Article 5(4)(b),

(h) fails to retain documents in contravention of Article 5(4)(c),

(i) fails to co-operate with a registering authority in contravention of Article 6(1),

(j) fails to make notification or ensure that a registering authority has up to date information in contravention of Article 6(2),

(k) fails to ensure that an establishment is approved in contravention of Article 6(3),

(l) imports food in contravention of Article 10,

(m) exports or re-exports food in contravention of Article 11, or

(n) otherwise contravenes a provision (mentioned in this paragraph) of Regulation No 852/2004 commits an offence.

(2) A person who, by act or omission-

(a) having adopted a specific hygiene measure referred to in Article 4(3) of Regulation No 852/2004, fails to comply with that measure,

(b) contravenes a criteria, requirement or target referred to in Article 4(4) of Regulation No 852/2004 that is adopted in accordance with Article 14 (2) of that Regulation,

(c) having adopted a principle referred to in the first subparagraph of Article 5(2) of Regulation No 852/2004, fails to comply with the principle,

(d) contravenes a detailed arrangement referred to in Article 5(5) of Regulation No 852/2004, or

(e) otherwise contravenes a provision (mentioned in this paragraph) commits an offence.

Contravention of Regulation No 853/2004

25. A person who, by act or omission-

(a) fails to comply with a relevant provision in contravention of Article 3(1),

(b) uses a substance in contravention of Article 3(2), or in a manner prohibited by Article 3(2),

(c) places a product of animal origin on the market other than in accordance with Article 4(1) or 5(1),

(d) operates in contravention of Article 4(2) or (3),

(e) fails to co-operate with a registering authority or an authorised officer, or operates in contravention of Article 4(4),

(f) removes a health mark in contravention of Article 5(3),

(g) imports a product of animal origin in contravention of Article 6,

(h) does not ensure that certificates or other documents accompany a consignment in contravention of Article 7(1),

(i) does not comply with an implementing measure or transitional arrangement in contravention of Article 9,

(j) places live bivalve molluscs on the market in contravention of the requirements of Section VII of Annex III,

(k) places fishery products on the market in contravention of the requirements of Section VII of Annex III, or

(l) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 853/2004 commits an offence.

Contravention of Regulation No 183/2005

26. (1) A person who, by act or omission-

(a) fails to comply with a general obligation in contravention of Article 4,

(b) fails to comply with a specific obligation in contravention of Article 5,

(c) fails to put in place, implement or maintain a HACCP system in contravention of Article 6(1),

(d) fails to make necessary changes in contravention of Article 6(3),

(e) fails to comply with documentary requirements in contravention of Article 7(1),

(f) fails to submit proof of cover by financial guarantees in contravention of Article 8(2),

(g) fails to co-operate with a registering authority or an authorised officer in contravention of Article 9(1),

(h) fails to notify or provide up to date information to a registering authority in contravention of Article 9(2),

(i) fails to ensure that a feed business is approved in contravention of Article 10,

(j) operates in contravention of Article 11,

(k) fails to submit a declaration in contravention of Article 17(2),

(l) fails to make a declaration in contravention of Article 18(3),

(m) imports feed in contravention of Article 23,

(n) exports feed in contravention of Article 25, or

(o) otherwise contravenes a provision (mentioned in this paragraph) of Regulation No 183/2005 commits an offence.

(2) A person who, by act or omission—

(a) contravenes a criteria or target referred to in Article 5(3) of Regulation No 183/2005 that is adopted in accordance with Article 31 (2) of that Regulation,

(b) contravenes a measure referred to in Article 6(5) of Regulation No 183/2005 that is adopted in accordance with Article 31(2) of that Regulation,

(c) contravenes an arrangement referred to in Article 7(3) of Regulation No 183/2005 that is adopted in accordance with Article 31(2) of that Regulation, or

(d) otherwise contravenes a provision mentioned in this paragraph commits an offence.

(3) Subject to Article 24 of Regulation No 183/2005, the Minister may authorise the import from third countries of products referred to in Articles 3 and 4 of the Commission Directive from establishments which have a representative established within the European Union.

(4) A representative referred to in paragraph (3) who intends to import into the State any product referred to in Article 3 or 4 of the Commission Directive shall submit a declaration to the Minister in which the representative undertakes—

(a) to ensure that the establishment he represents fulfils the conditions laid down in Article 3(2) second indent or Article 4(2) second indent of the Commission Directive, as applicable,

(b) to keep a register of products referred to in Articles 3 and 4 of the Commission Directive, as applicable, that the establishment he represents has put into circulation within the Community, according to the Annex.

(5) A person shall not import from any third country any product referred to in Article 3 or 4 of the Commission Directive unless he or she is so authorised under paragraph (1).

(6) A person who contravenes paragraph (5) commits an offence.

(7) In this Regulation “Commission Directive” means Commission Directive 98/51/EC of 9 July 1998¹²⁰ .

Contravention of Regulation No 2073/2005

27. A person who, by act or omission—

(a) fails to comply with a general requirement in contravention of Article 3,

(b) fails to perform testing in contravention of Article 4,

(c) fails to comply with a specific rule in contravention of Article 5,

(d) fails to comply with a labelling requirement in contravention of Article 6,

(e) fails to take a measure in contravention of Article 7(1),

(f) deals with a product in contravention of Article 7(2) or 7(3),

(g) fails to take action, in contravention of Article 7(4),

(h) fails to analyse trends, in contravention of Article 9, or

(i) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 2073/2005 commits an offence.

Contravention of Regulation No 2074/2005

28. A person who by act or omission-

(a) contravenes a requirement concerning food chain information in contravention of Article 1,

(b) contravenes a requirement concerning a fishery product in contravention of Article 2, or

(c) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 2074/2005 commits an offence.

Contravention of Regulation 2015/1375

29. A person who, by act or omission-

(a) fails to sample carcases, in contravention of Article 2,

(b) deals with a carcase, other parts of an animal, animal product, or animal waste or a by-product in contravention of Article 4,

(c) applies the health mark in contravention of Article 4(3),

(d) uses a method of detection in contravention of Article 6(1),

(e) fails to forward a sample, in contravention of Article 6(2),

(f) fails to inform the Minister, in contravention of Article 9, or

(g) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 2015/1375 commits an offence.

Contravention of Regulation No 767/2009 of the European Parliament and of the Council

30. A person who, by act or omission-

(a) places feed on the market or uses feed other than in accordance with the safety and marketing requirements in Article 4,

(b) being a feed business operator fails to comply with the obligations referred to in Article 5(1) or (2),

(c) places on the market feed that consists of or contains a material the use of which for animal nutrition purposes is restricted or prohibited in contravention of Article 6(1),

(d) has in his or her possession, uses or places on the market feed or a complementary feed that contains a feed additive in excess of the quantities specified in Article 8,

(e) places on the market or uses feed intended for particular nutritional purposes in contravention of Article 9,

(f) places on the market feed that is labelled or presented other than as provided in Article 11 or Annex II,

(g) being the person responsible for labelling, fails to ensure that the labelling does not contravene Article 12 or 13(3),

(h) causes or permits claims to be made on the labelling in contravention of Article 13(1) or (2),

(i) presents labelling particulars other than as provided for in Article 14,

(j) places a feed material on the market without the label showing the indications specified in Articles 15 and 16,

(k) places a compound feed on the market without the label showing the indications specified in Articles 15 and 17,

(l) places feed intended for particular nutritional purposes on the market without the label showing the indications specified in Articles 15, 16, 17 and 18,

(m) places petfood on the market unless labelled in accordance with Articles 15, 16, 17, 18 and 19,

(n) has in his or her possession or under his or her control, in contravention of Article 20, feed which does not comply with Annex VIII labelled in accordance with that Annex,

(o) places a feed material or compound feed on the market with voluntary labelling which does not comply with Article 22,

(p) places a feed material or compound feed on the market other than in a package that complies with Article 23,

(q) places on the market feed that includes on the label the name of a feed material listed in the Catalogue other than in accordance with Article 24(5),

(r) fails to notify a feed material that is not listed in the Community Catalogue as required by Article 24(6), or

(s) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 767/2009 commits an offence.

Contravention of Commission Implementing Regulation No 208/2013 of 11 March 2013

31. A person who, by act or omission-

(a) fails to keep and transmit records at all stages of production, processing and distribution of batches of sprouts or of batches of seeds intended for the production of sprouts in contravention of Article 3(1), (2) and (3),

(b) fails to co-operate with a registering authority or an authorised officer in contravention of Article 3(4),

(c) imports seeds intended for the production of sprouts or consignments of sprouts, other than in accordance with Article 4(1),

(d) fails to keep the certificate relating to importation in contravention of Article 4(2), or

(e) fails to provide copies of certificates to food business operators in contravention of Article 4(3) of Commission Implementing Regulation No 208/2013 of 11 March 2013, commits an offence.

Contravention of Regulation No 2017/625

32. A person who, by act or omission—

(a) being an organic control authority, delegated body or natural person to which specific official control tasks have been delegated or an official laboratory, fails to comply with an obligation of confidentiality in contravention of Article 8,

(b) being an operator, fails to report the arrival of an animal or goods in contravention of Article 9(7),

(c) being an operator, fails to comply with a requirement (obligations of operators) in contravention of Article 15,

(d) being a body or natural person to which certain official control tasks or certain tasks related to other official activities have been delegated, fails to comply with an obligation in contravention of Article 32,

(e) being an operator of an official laboratory, fails to comply with an obligation in contravention of Article 38,

(f) being an operator, fails to present a consignment of the category of animal or goods referred to in Article 47(1) at a border control post in contravention of Article 47(5),

(g) being an operator, fails to present original official certificates or documents at a border control post in contravention of Article 50(1),

(h) being an operator, splits a consignment in contravention of Article 50(3),

(i) being an operator, fails to complete the Common Health Entry Document (CHED) in contravention of Article 56(1) or (3),

(j) being an operator, fails to provide prior notification in contravention of Article 56(4),

(k) being an operator, fails to comply with a direction in contravention of Article 69(1),

(l) being an operator, re-dispatches a consignment in contravention of Article 72,

(m) being an operator, fails to issue an official attestation in contravention of Article 91, or

(n) otherwise contravenes a provision (mentioned in this Regulation) of Regulation No 2017/625 commits an offence.

Contravention of these Regulations

33. (1) A person who, by act or omission-

(a) contravenes Regulation 4(1) or (11), 5(1) or (13), 7(3) or (5), 9(1), (2), (5) or (6), 10, 11, 12(3), 16(4) or (9), 17(5), 21 of these Regulations,

(b) fails to give assistance to an authorised officer, or person who accompanies the officer, or

(c) contravenes a condition of-

(i) a feed business registration,

(ii) a food business registration,

(iii) a feed business approval, or

(iv) a food business approval,

commits an offence.

(2) A person who contravenes Regulation 12(1), (2), (4) or (5) commits an offence.

(3) A statement or admission made by a person pursuant to a requirement under Regulation 14(10)(ii) is not admissible in evidence in proceedings brought against the person for an offence (other than an offence under this Regulation for failing to give information or giving false information) under these Regulations.

Service

34. (1) A notification under Regulation 6(4) or (6) or a compliance notice shall, subject to paragraph (2), be addressed to the person concerned by name and may be served on or given to the person—

(a) by giving it to the person, his or her employee, servant or agent,

(b) by leaving it at the address at which the person ordinarily resides, normally carries out business, or, if an address for service has been furnished, at that address,

(c) by sending it by post in a prepaid registered letter to the address at which the person ordinarily resides or, if an address for service has been furnished, at that address,

(d) if the address at which the person ordinarily resides cannot be ascertained by reasonable enquiry and the compliance notice relates to a premises, by delivering it to the premises or by affixing it in a conspicuous position on or near the premises,

(e) by sending it by means of electronic mail to a device or facility for the reception of electronic mail where such an electronic mail address has been furnished by the person, but only if the sender’s facility for the reception of electronic mail generates a message confirming a receipt of the electronic mail confirming successful transmission of the notification, notice or document.

(2) If a notification under Regulation 6 (4) or (6) or a compliance notice is to be served on or given to a person who is the owner or occupier of a premises and the name of the person cannot be ascertained by reasonable enquiry, it may be addressed to the person by using the words “the owner” or “the occupier”.

(3) A person shall not, at any time within 6 months after a notification under Regulation 6 (4) or (6) or a compliance notice is affixed under paragraph (1)(d), remove, damage or deface the notification or compliance notice without lawful authority.

(4) For the purposes of this Regulation, a company within the meaning of the Companies Act 2014 is considered to be ordinarily resident at its registered office and every other body corporate or unincorporated body is considered to be ordinarily resident at its principal office or place of business.

Penalties & prosecutions

35. (1) A person who commits an offence under these Regulations (other than an offence under Regulation 12(1), (2), (4) or (5)) is liable-

(a) on summary conviction, to a class A fine, or

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

(2) A person who commits an offence under Regulation 12(1), (2), (4) or (5) is liable—

(a) on summary conviction, to—

(i) a class A fine,

(ii) imprisonment for a term not exceeding 6 months,

(iii) the forfeiture of any consideration or advantage obtained in connection with the offence or, in the alternative, the forfeiture of land, cash or other property of an equivalent value to such consideration or advantage, or

(iv) any combination of the penalties referred to in subparagraphs (i) to (iii), or

(b) on conviction on indictment, to—

(i) a fine not exceeding €500,000,

(ii) imprisonment for a term not exceeding 3 years,

(iii) the forfeiture of any consideration or advantage obtained in connection with the offence or, in the alternative, the forfeiture of land, cash or other property of an equivalent value to such consideration or advantage, or

(iv) any combination of the penalties referred to in subparagraphs (i) to (iii).

(3) An offence under these Regulations may be prosecuted summarily by a registering authority or by the Food Safety Authority of Ireland.

(4) If an offence under these Regulations is committed by a body corporate and is proven to have been so committed with the consent, connivance or approval of or to have been attributable to the wilful neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate or a person who was purported 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 he or she was guilty of the offence.

(5) If the affairs of a body corporate are managed by its members, paragraph (4) applies in relation to the acts and defaults of a member in connection with the functions of management as if the member were a director or manager of the body corporate.

(6) In proceedings alleging a contravention of these Regulations, it is a defence for the defendant to show he or she acted in accordance with a derogation or transitional measure laid down by an act of an institution of the European Union relevant to the subject of the offence it is alleged that he or she committed.

Evidence on certificate etc

36. (1) In proceedings for an offence under these Regulations, a certificate purported to be signed by a person employed at a laboratory where a sample taken under these Regulations is analysed stating the capacity in which the person is employed and stating—

(a) that the person received a sample,

(b) that, for the period specified in the certificate, the person had the sample in his or her possession,

(c) that the person gave the sample to another person named in the certificate, or

(d) the person carried out a procedure for the purpose of detecting in the sample, a substance or contamination or that the sample contained a substance as is, or was contaminated in a manner, specified in the certificate,

is (without proof of the signature of the person or that he or she is employed at the laboratory), unless the contrary is proved, evidence of the matters stated in the certificate.

(2) A certificate purporting to be signed by an officer of a registering authority and to certify that on a specific day or days or during the whole of a specified period-

(a) a particular person or establishment did not stand registered in the register of feed businesses or the register of food businesses,

(b) the registration of a person or establishment in the register of feed businesses or the register of food businesses is suspended or has been revoked,

(c) a person was or was not the holder of an approval granted under Regulation 5,

(d) an establishment was or was not approved under Regulation 5, or

(e) that a particular approval or registration, referred to in this paragraph, was subject to a particular condition or conditions,

is, without proof of the signature of the person purporting to sign the certificate or that he or she is an officer of the registering authority, evidence, unless the contrary is shown, of the matters stated in the certificate.

(3) In proceedings for an offence under these Regulations the court may, if it considers that the interests of justice so require, direct that oral evidence of any matter stated in a certificate under paragraph (1) or (2) be given, and the court may for the purpose of receiving oral evidence adjourn the matter.

(4) In proceedings, evidence of an act of the institutions of the European Communities may be given by production of a copy of the act certified by an officer of a registering authority to be a copy of the act, and it is not necessary to prove the signature of the officer or that he or she is an officer of the authority.

(5) Paragraph (4) is in addition to and not in substitution for the European Communities (Judicial Notice and Documentary Evidence) Regulations 1972 ( S.I. No. 341 of 1972 ).

Revocations, savers etc

37. (1) The following are revoked:

(a) European Communities (Food and Feed Hygiene) Regulations 2009 ( S.I. No. 432 of 2009 );

(b) European Communities (Food and Feed Hygiene) (Amendment) Regulations 2010 ( S.I. No. 312 of 2010 );

(c) European Communities (Food and Feed Hygiene) (Amendment) (No. 2) Regulations 2010 ( S.I. No. 488 of 2010 );

(d) European Communities (Food and Feed Hygiene) (Amendment) (No. 3) Regulations 2010 ( S.I. No. 587 of 2010 );

(e) European Communities (Food and Feed Hygiene) (Amendment) Regulations 2012 ( S.I. No. 164 of 2012 );

(f) European Communities (Food and Feed Hygiene) (Amendment) (No 2) Regulations 2012 ( S.I. No. 362 of 2012 );

(g) European Communities (Food and Feed Hygiene)(Amendment) Regulations 2015 ( S.I. No. 68 of 2015 );

(h) European Communities (Food and Feed Hygiene) (Amendment) (No. 2) Regulations 2015( S.I. No. 306 of 2015 ).

(2) These Regulations apply in place of—

(a) the Dairy Produce Acts 1924 to 1984,

(b) the Creamery Acts 1928 to 1934, and

(c) the Milk and Dairies Acts 1935 to 1956,

in relation to the hygienic production and placing on the market of raw milk, heat-treated milk and milk-based products.

(3) Subject to Regulation 5(7), the European Communities (Hygiene of Foodstuffs) Regulations 2006 ( S.I. No. 369 of 2006 ) and the European Communities (General Food Law) Regulations 2007 ( S.I. No. 747 of 2007 ) do not apply to a primary producer or other food business to which these Regulations apply.

(4) An entry in the register of food businesses or an entry in the register of feed businesses (within the meaning of the Regulations revoked by paragraph (1)) that is in force immediately before the making of these Regulations remains in force, is considered to be an entry in the register of food businesses or an entry in the register of feed businesses and may be dealt with by the registering authority specified in these Regulations as if it is an entry in the register of food businesses or an entry in the register of feed businesses granted by that registering authority.

(5) A food business approval or a feed business approval (within the meaning of the Regulations revoked by paragraph (1)) that is in force immediately before the making of these Regulations remains in force, is considered to be a food business approval or a feed business approval and may be dealt with by the registering authority specified in these Regulations as if it is a food business approval or a feed business approval granted by that registering authority.

(6) An application for entry in the register of food businesses or for entry in the register of feed businesses or an application for a food business approval or for a feed business approval (within the meaning of the Regulations revoked by paragraph (1)) that remains to be determined on commencement of these Regulations is, after the commencement of these Regulations considered to be an application for entry in the register of food businesses or an entry in the register of feed businesses or an application for a food business approval or a feed business approval and may be determined as if made under these Regulations.

(7) A person who engages in the transport of animals and is required to hold a food business registration is deemed to hold that registration if he or she is the holder of an animal transport authorisation (within the meaning of the European Communities (Animal Transport and Control Post) Regulations 2006 ( S.I. No. 675 of 2006 )).

(8) Any reference made in an instrument to Regulations revoked by paragraph (1) shall be construed as a reference to these Regulations.

GIVEN under my Official Seal,

19 December, 2019.

MICHAEL CREED,

Minister for Agriculture, Food and the Marine.

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