European legislation

Regulation (EC) No 853/2004 (OJ L 226, p22, 25.06.2004) of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

Corrected by:
Corrigendum to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139 of 30.4.2004. Corrected version in OJ L 226, p22, 25.06.2004)

Amended by:

Commission Regulation (EC) No 2074/2005 (OJ L 338, p27, 22.12.2005) of 5 December 2005
Commission Regulation (EC) No 2076/2005 (OJ L 338, p83, 22/12/2005) of 5 December 2005
Commission Regulation (EC) No 1662/2006 (No longer in force) (OJ L 320, p1, 18/11/2006) of 6 November 2006
Council Regulation (EC) No 1791/2006 (No longer in force) (OJ L 363, p1, 20/12/2006) of 20 November 2006
Commission Regulation (EC) No 1243/2007 (OJ L 281, p8, 25/10/2007) of 24 October 2007 amending Annex III to Regulation (EC) No 853/2004
Commission Regulation (EC) No 1020/2008 (OJ L 277, p8, 18/10/2008) of 17 October 2008 amending Annexes II and III to Regulation (EC) No 853/2004
Commission Regulation (EC) No 1161/2009 (OJ L 314, p8, 30/11/2009 amending Annex II to Regulation (EC) No 853/2004 as regards food chain information to be provided to food business operators operating slaughterhouses
Commission Regulation (EU) No 558/2010 (OJ L 159, p18, 25/06/2010) of 24 June 2010 amending Annex III to Regulation (EC) No 853/2004
Commission Regulation (EU) No 150/2011 (OJ L 46, p14, 19/02/2011) of 18 February 2011 amending Annex III to Regulation (EC) No 853/2004 as regards farmed and wild game and farmed and wild game meat
Commission Regulation (EU) No 1276/2011 (OJ L 327, p39, 09/12/2011) of 8 December 2011
Commission Regulation (EU) No 16/2012 of 11 January 2012 (OJ L 29, p8, 12/01/2012) amending Annex II to Regulation (EC) No 853/2004 as regards the requirements concerning frozen food of animal origin intended for human consumption
Council Regulation (EU) No 517/2013 of 13 May 2013 (OJ L 158, p1, 10/06/2013) adapting Regulation (EC) No 853/2004 by reason of the accession of the Republic of Croatia
Commission Regulation (EU) No 786/2013 (OJ L 220, p14, 17/08/2013) of 16 August 2013 amending Annex III to Regulation (EC) No 853/2004 as regards the permitted limits of yessotoxins in live bivalve molluscs
Commission Regulation (EU) No 218/2014 (OJ L 69, p95, 08/03/2014) of 7 March 2014 amending Annexes to Regulations (EC) No 853/2004 and (EC) No 854/2004 and Commission Regulation (EC) No 2074/2005
Commission Regulation (EU) No 633/2014 (OJ L 175, p6, 14/06/2014) of 13 June 2014 amending Annex III to Regulation (EC) No 853/2004 of and Annex I to Regulation (EC) No 854/2004 as regards the specific requirements for handling large wild game and for the post-mortem inspection of wild game
Commission Regulation (EU) No 1137/2014 (OJ L 307, p28, 28/10/2015) of 27 October 2014 amending Annex III of Regulation (EC) No 853/2004 as regards the handling of certain offal from animals intended for human consumption
Commission Regulation (EU) 2016/355 (OJ L 67, p22, 12.03.2016) of 11 March 2016 amending Annex III to Regulation (EC) No 853/2004 as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption
Commission Regulation (EU) 2017/185 (no longer in force) (OJ L 29, 3.2.2017, p. 21–23) of 2 February 2017 laying down transitional measures for the application of certain provisions of Regulations (EC) No 853/2004 and (EC) No 854/2004
Commission Regulation (EU) 2017/1978 (OJ L 285, 1.11.2017, p. 3–5) of 31 October 2017 amending Annex III to Regulation (EC) No 853/2004 as regard echinoderms harvested outside classified production areas
Commission Regulation (EU) 2017/1981 (OJ L 285, 1.11.2017, p. 10–13) of 31 October 2017 amending Annex III to Regulation (EC) No 853/2004 as regards temperature conditions during transport of meat
Commission Regulation (EU) 2019/759 (no longer in force) (OJ L 125, 14.05.2019, p. 11-12) laying down transitional measures for the application of public health requirements of imports of food containing both products of plant origin and processed products of animal origin (composite products)
Regulation (EU) 2019/1243 (OJ L 198, 25.07.2019, p. 241-344) adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union

Consolidated version of Regulation (EC) No 853/2004 (as at 15 February 2023)

Directive 2004/41/EC repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption

Commission Regulation (EU) 2015/1474 (NO LONGER IN FORCE) (OJ L 225, p7, 28/08/2015) of 27 August 2015 concerning the use of recycled hot water to remove microbiological surface contamination from carcases

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National legislation

European Union (Food and Feed Hygiene) Regulations 2020, S.I. No. 22 of 2020

Guidance on certain provisions of Regulation (EC) No 853/2004 published by the European Commission

General provisions

Regulation (EC) No. 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They apply to unprocessed and processed products of animal origin. In most cases Regulation (EC) No. 853/2004 does not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food must be obtained and handled in accordance with the requirements of Regulation (EC) No 853/2004.

Products of animal origin are defined by Regulation (EC) No. 853/2004 as meaning;

food of animal origin, including honey and blood;
live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and
other animals destined to be prepared with a view to being supplied live to the final consumer.

Regulation (EC) No. 853/2004 does not apply to:

(a) primary production for private domestic use;
(b) the domestic preparation, handling or storage of food for private domestic consumption;
(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;
(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat;
(e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

Generally Regulation (EC) No. 853/2004 does not apply to retail. However, it will apply when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:

(i) the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III will apply;
(ii) the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised
and restricted activity. (The Department of Agriculture, Food and Marine (DAFM) are currently working on legislation which will define these terms i.e. marginal, localised and restricted)

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General Obligations on Food Business Operators

Food business operators must comply with the relevant provisions of Annexes II and III of Regulation (EC) No. 853/2004. Annex II sets out a number of requirements for the following:

Annex II

Section I: Identification marking
  A. Application of the identification mark
  B. Form of the identification mark
  C. Method of marking

Section II: Objectives of HACCP-based procedures
Section III: Food chain information

While Annex III sets out specific requirements for the following:

Section I: Meat of domestic ungulates (i.e., domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine animals, and domestic solipeds (e.g., horses).
Section II: Meat from poultry and lagomorphs (rabbits, hares, and rodents)
Section III: Meat of farmed game
Section IV: Wild Game
Section V: Minced Meat, meat preparations, mechanically separated meat (MSM)
Section VI: Meat Products
Section VII: Live bivalve molluscs
Section VII: Fishery products
Section IX: Raw milk, colostrum, dairy products and colostrum-based products
Section X: Eggs and egg products
Section XI: Frogs' legs and snails
Section XII: Rendered Animal fats and greaves
Section XIV: Gelatine
Section XV: Collagen

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Food Business Registration and Approval

Establishments handling those products for which Annex III of Regulation (EC) No. 853/2004 lays down requirements must be 'approved'. However, establishments carrying out only primary production, transport operations, the storage of products not requiring temperature controlled storage conditions or retail operations other than those to which Regulation (EC) No. 853/2004 applies pursuant to Article 1(5)(b) of that Regulation are exempt from this requirement but are subject to Article 6 of Regulation (EC) 852/2004, i.e., they must be registered with the competent authority. S.I. No. 22 of 2020 sets out the requirements for both registration and approval for food businesses subject to Regulation (EC) No 853/2004.

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Health and identification marking

Food business operators must not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) of Regulation (EC) No. 853/2004 unless it has either:

(a) a health mark applied in accordance with Implementing Regulation (EU) 2019/627
or
(b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I to Regulation (EC) No. 853/2004

Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with Regulation (EC) No. 853/2004 in establishments meeting the requirements of Article 4 of that Regulation.

Food business operators may not remove a health mark applied in accordance with Implementing Regulation (EU) 2019/627 from meat unless they cut or process it or work upon it in another manner.

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