COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/627 
of 15 March 2019 
laying down unifo rm practical arrangements for the perfor mance of official controls on products 
of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of 
the European Parliament and of the Council and amending Commission Regulation (EC) 
No 2074/2005 as regards official controls 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 Marc h 2017 on 
official controls and other official activities performe d to ensure the application of food and feed law, rules on animal 
health and welfa re, plant health and plant prote ction products, amending Regulations (EC) No 999/2001, (EC) 
No 396/2005, (EC) No 1069/2009, (EC) 1107/2009, (EU) 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 
2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) 
No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and 
repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, 
Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council 
Decision 92/438/EEC (Off icial Controls Regulation) (1), and in particular Article 18(8) thereof, 
Whereas: 
(1)  Regulation (EU) 2017/625 lays down rules for the official controls and other official activities performe d by the 
compet ent author ities of the Member States to verify compliance with Union legislation, inter alia, in the area of 
food safety at all stages of production, processing and distr ibution. In particular , it provides for official controls in 
relation to products of animal origin intended for human consump tion. In addition, it repeals Regulation (EC) 
No 854/2004 of the European Parliament and of the Council (2) with effect from 14 December 2019. That 
Regulation currently lays down specific rules for official controls on products of animal origin intende d for 
human consump tion, including requirements on unif orm practical arrange ments for the performa nce of the 
controls. 
(2)  The rules laid down in this Regulation should ensure a continuation of the requirements to ensure the 
verification of food business operators' compl iance with the rules for the safe handling of products of animal 
origin, in particular as laid down in: 
—  Council Directive 96/23/EC (3) as regar ds measures to monitor certain substances and residues; 
—  Regulation (EC) No 999/2001 of the European Parliament and of the Council (4) as regards controls on 
transmissible spongif orm encephalopathies; 
—  Council Directive 2002/99/EC (5) as regards animal health rules on products of animal origin; 
—  Regulation (EC) No 178/2002 of the European Parliament and of the Council (6) as regards the general 
principles and requirements of food law; 17.5.2019 L 131/51 Official Jour nal of the European Union EN     
(1)OJ L 95, 7.4.2017, p. 1. 
(2)Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific rules for the 
orga nisation of official controls on products of animal origin intended for human consump tion (OJ L 139, 30.4.2004, p. 206). 
(3)Council Directive 96/23/EC of 29 Apr il 1996 on measures to monitor certain substances and residues thereof in live animals and 
animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 
23.5.1996, p. 10). 
(4)Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, 
control and eradication of certain transmissible spongif orm encephalopathies (OJ L 147, 31.5.2001, p. 1). 
(5)Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, 
distr ibution and introduction of products of animal origin for human consump tion (OJ L 18, 23.1.2003, p. 11). 
(6)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safet y 
(OJ L 31, 1.2.2002, p. 1). —  Directive 2003/99/EC of the European Parliament and of the Council (7) as regar ds the monitor ing of 
zoonoses and zoonotic agents; 
—  Commission Decision 2003/467/EC (8) as regards control of tuberculosis, brucellosis and enzootic-bov ine- 
leuk osis; 
—  Regulation (EC) No 2160/2003 of the European Parliament and of the Council (9) as regards Salmonella 
controls; 
—  Regulation (EC) No 852/2004 of the European Parliament and of the Council (10) as regar ds the hygiene of 
foodstuffs; 
—  Regulation (EC) No 853/2004 of the European Parliament and of the Council (11) as regards the specifi c 
hygiene rules for food of animal origin; 
—  Council Regulation (EC) No 1/2005 (12) as regards the protection of animals during transpor t and relat ed 
operations; 
—  Commission Regulation (EC) No 2073/2005 (13) as regar ds microbiological criteria in foodstuffs; 
—  Commission Regulations (EC) No 1881/2006 (14) and (EC) No 124/2009 (15) as regar ds maximum levels for 
certain contaminants in foodstuffs; 
—  Council Directive 2007/43/EC (16) as regar ds the prote ction of chick ens; 
—  Regulation (EC) No 1069/2009 of the European Parliament and of the Council (17) as regards health rules on 
animal by-products; 
—  Council Regulation (EC) No 1099/2009 (18) as regards the protect ion of animals at the time of killing; 
—  Directive 2010/63/EU of the European Parliament and of the Council (19) as regar ds the protection of animals 
used for scientific purposes; 
—  Commission Implementing Regulation (EU) No 636/2014 (20) as regar ds trade in unskinned large wild gam e; 17.5.2019 L 131/52 Official Jour nal of the European Union EN     
(7)Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monit oring of zoonoses and 
zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12.12.2003, p. 31). 
(8)Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis and enzootic-bov ine-leuk osis- 
free status of certain Member States and regions of Member States as regar ds bovin e herds (OJ L 156, 25.6.2003, p. 74). 
(9)Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and 
other specified food-bor ne zoonotic agents (OJ L 325, 12.12.2003, p. 1). 
(10)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 
30.4.2004, p. 1). 
(11)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene rules for 
food of animal origin (OJ L 139, 30.4.2004, p. 55). 
(12)Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transpor t and related operations and 
amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1). 
(13)Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, 
p. 1). 
(14)Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs 
(OJ L 364, 20.12.2006, p. 5). 
(15)Commission Regulation (EC) No 124/2009 of 10 Febr uary 2009 setting maximum levels for the presence of coccidiostats or histomo ­
nostats in food resulting from the unav oidable carry-over of these substances in non-target feed (OJ L 40, 11.2.2009, p. 7). 
(16)Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the prot ection of chic kens kept for meat production 
(OJ L 182, 12.7.2007, p. 19). 
(17)Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 Octo ber 2009 laying down health rules as regar ds 
animal by-products and derived products not inten ded for human consump tion and repealing Regulation (EC) No 1774/2002 (Animal 
By-products Regulation) (OJ L 300, 14.11.2009, p. 1). 
(18)Council Regulation (EC) No 1099/2009 of 24 September 2009 on the prot ection of animals at the time of killing (OJ L 303, 
18.11.2009, p. 1). 
(19)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for 
scientific purposes (OJ L 276, 20.10.2010, p. 33). 
(20)Commission Implementing Regulation (EU) No 636/2014 of 13 June 2014 on a model certificate for the trade of unskinned large wild 
gam e (OL L 175, 14.6.2014, p. 16). —  Commission Implementing Regulation (EU) 2015/1375 (21) as regar ds official controls for Trichinella; and 
—  Regulation (EU) 2016/429 of the European Parliament and of the Council (22) as regar ds animal health rules. 
(3)  The practical arrange ments for the performance of official controls on products of animal origin should be 
considered where a minimum level of official controls is necessar y to respond to recognised unif orm hazards and 
risks that might be posed by products of animal origin, covering all aspects that are impor tant for protectin g 
human health and, where appropr iate, animal health and animal welfa re. They should be based on the most 
recent relevant information available and scientific evidence from opinions of the European Food Safe ty 
Author ity (EFSA ). 
(4)  On 31 August 2011, EFSA adop ted a scientific opinion on the human health hazards to be covered by the 
inspection of meat (swine) (23). The recommendations of that opinion were taken into account in the 
requirements for pig meat inspections laid down in Regulation (EC) No 854/2004 and should be maintained in 
the requirements laid down in this Regulation. 
(5)  On 23 May 2012, EFSA adop ted a scientifi c opinion on the human health hazards to be covered by the 
inspection of meat (poultr y) (24). That opinion identifies Campylobacter spp. and Salmonella spp. as the main 
hazards to be covered in poultr y meat inspections through an integrated food safet y assurance syste m, achi evable 
through impro ved food chain information (FCI) and risk-based inter ventions. 
(6)  On 6 June 2013, EFSA adopt ed a scientific opinion on the human health hazards to be covered by the inspection 
of meat (bovine animals) (25). That opinion identifies Salmonella spp. and pathogen ic verocyt otoxin-producing 
Escher ichia coli (E. coli) as the most relevant hazards for meat inspections in bovine animals. It recommends the 
omission of palpation and incision during the post-mor tem inspection of animals subjected to routine slaughter , 
since it may reduce spreading and cross-contamination with the high-pr iority biological hazards. However , 
palpations and incisions during post-mor tem inspection, necessar y to survey the occur rence of tuberculosis and 
Taenia saginata (tapeworm) cysticercosis, should be maintained. 
(7)  Also on 6 June 2013, EFSA adopt ed a scientific opinion on the human health hazards to be covered by the 
inspection of meat from sheep and goats (26). That opinion identifies pathogen ic verocyt otoxin-producing E. coli 
as the most relevant hazard for meat inspections in sheep and goats. It also recommends omitting palpation and 
incisions to the extent possible from the post-mor tem inspection of sheep and goats subject to routine slaughter . 
Howe ver, palpation and incisions for the surveillance of tuberculosis and fascioliasis should be maintained in 
older animals for reasons of animal and human health surveillance. 
(8)  Also on 6 June 2013, EFSA adopt ed a scientific opinion on the human health hazards to be covered by the 
inspection of meat (solipeds) (27). That opinion recommends the use of visual-only inspection in solipeds, which 
may have a signif icant favourable effect on the microbiological status of soliped carcase meat. Such inspection is 
considered unlikely to affect the overall surveillance of animal diseases. 
(9)  Also on 6 June 2013, EFSA adop ted a scientific opinion on the meat inspection of farmed gam e. That opinion 
recommends omitting palpation and incision unless abnor malities are detected, while at the same time 
underlining that such omission might have consequences for the overall surveillance of tuberculosis. 
(10)  The recommendations set out in these EFSA opinions should be taken into account when laying down unif orm 
practical arrange ments for the performa nce of official controls on products of animal origin intended for human 
consum ption. The possible impact on trade with third countr ies should also be taken into account. At the same 
time, a smooth transition from the current requirements, as laid down in Regulation (EC) No 854/2004, should 
be ensured. 17.5.2019 L 131/53 Official Jour nal of the European Union EN     
(21)Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella 
in meat (OJ L 212, 11.8.2015, p. 7). 
(22)Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and 
amending and repealing certain acts in the area of animal health (Animal Health Law) (OJ L 84, 31.3.2016, p. 1). 
(23)EFSA Journal 2011;9(10):2351 
(24)EFSA Journal 2012;10(6):2741. 
(25)EFSA Journal 2013;11(6):3266. 
(26)EFSA Journal 2013;11(6):3265. 
(27)EFSA Journal 2013;11(6):3263. (11)  These practical arrang ements should apply to official controls on products of animal origin laid down in 
Article 18 of Regulation (EU) 2017/625 and in Commission Delegat ed Regulation (EU) 2019/624 (28). These 
practical arrang ements for the performa nce of official controls should be unif orm and facilitate the application of 
the requirements for a minimum level of official controls, taking into account the size of small businesses as laid 
down in Article 16 of Regulation (EU) 2017/625 by the use of a threshold in a non-discr iminato ry way. 
(12)  Since the structure of slaughterh ouses and game-handling establishments diffe rs across Member States, 
a threshold should be based on the number of animals slaughtere d or handled, or on the demonstration that it 
represents a limited and fixed percentage of the meat placed on the market. Article 17(6) of Regulation (EC) 
No 1099/2009 defines livestoc k units and lays down conversion rates to express the number of animals of 
a certain species in such livest ock units. These provi sions should be used to set thresholds and harmonise 
deroga tions from certain requirements based on the size of a slaughter house to the extent possible. 
(13)  Specific requirements for auditing by the compet ent author ities should also be maintained to ensure the unif orm 
practical verification of compl iance with Union requirements on products of animal origin. Auditing is of 
particular interest for the verification of general and specific hygiene requirements and the application of 
procedures based on hazard analysis and critical control points (HA CCP). 
(14)  Verification of compliance with the requirements on identif ication marking in Section I of Annex II to Regulation 
(EC) No 853/2004, as currently laid down in Regulation (EC) No 854/2004, should be maintained to allow 
tracing back the animals. 
(15)  Ante -mor tem and post-mor tem inspections are essential to verify compliance with requirements on human and 
animal health and animal welf are. In order to ensure at least the same level of human and animal health and 
animal welf are prote ction as provi ded by Regulation (EC) No 854/2004 and fair trade in an open mark et, it is 
necessar y to lay down unif orm practical requirements for such inspections, including cases where official controls 
are performed under the responsibility of the official veteri narian. As regards official controls on fresh meat, 
these inspections should be supplemented by appropr iate documentar y checks, controls on the safe disposal of 
specified risk mater ial, as defined in Article 3(1)(g) of Regulation (EC) No 999/2001, and other animal 
by-products, and laborat ory testing where appropr iate. 
(16)  It is impor tant to identify cases of suspect ed and established non-comp liance where compet ent author ities must 
take measures with respect to certain products of animal origin. Non-compliance with good hygiene practices 
should also result in corrective action by compet ent author ities. 
(17)  The health mark defined in point 51 in Article 3 of Regulation (EU) 2017/625 covers meat of certain species and 
attests that the meat is fit for human consum ption. Techn ical requirements of the health mark and practical 
arrang ements for its application should be laid down in a specif ic and unif orm way in order to indicate the 
fitness of the meat for human consum ption and to prevent any trade disruption. 
(18)  Commission Regulation (EC) No 2074/2005 (29) lays down , inter alia, implementing measures for the 
organisation of official controls under Regulation (EC) No 854/2004 as regar ds recognised testing methods for 
mar ine biot oxins in live bivalve molluscs, testing methods for raw milk and heat-treat ed milk, official controls in 
fisher y products and the inspection of meat. It is appropr iate to merge all implementing measures for the 
organisation of official controls and include the ones from Regulation (EC) No 2074/2005 in this Regulation. 
They should be delet ed in Regulation (EC) No 2074/2005. 
(19)  The current conditions for the classification and monitori ng of classified production and relaying areas for live 
bivalve molluscs have proven to be effective and ensure a high level of consumer protection. They should 
theref ore be maintained. 17.5.2019 L 131/54 Official Jour nal of the European Union EN     
(28)Commission Delegat ed Regulation (EU) 2019/624 of 8 Febr uary 2019 concer ning specific rules for the perf ormance of official controls 
on the production of meat and for production and relaying areas of live bivalve molluscs in accordance with Regulation (EU) 2017/625 
of the European Parliament and of the Council (see page 1 of this Official Jour nal). 
(29)Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under 
Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under 
Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European 
Parliament and of the Council, derogatin g from Regulation (EC) No 852/2004 of the European Parliament and of the Council and 
amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27). (20)  A reference method for the analysis of E. coli in live bivalve molluscs, as currently laid down in Regulation (EC) 
No 854/2004, should be maintained. 
(21)  The limits for mar ine biot oxins are laid down in Regulation (EC) No 853/2004. In particular , point 2 in 
Chapt er V of Section VII of Annex III to that Regulation provides that live bivalve molluscs must not contain 
mar ine bioto xins in total quantities (measured in the whole body or any part edible separately ) that exceed the 
limits established in that Chapt er. 
(22)  Specific requirements for the performa nce of official controls and the unif orm minimum frequency for such 
controls on raw milk and dair y products should be laid down to ensure a high level of consumer protect ion and 
fair competition between food business operators. 
(23)  Specific requirements for the performa nce of official controls and the unif orm minimum frequency for such 
controls on fisher y products should be laid down to ensure a high level of consumer protection and fair 
competiti on between food business operators. Those controls should include at least regular checks on the 
hygiene conditions of landing and first sale, regular inspections of vessels and establishments, including fish 
auctions and wholesale markets, and chec ks on stora ge and transpor t. Specifi c requirements for the control of 
vessels should also be established. 
(24)  Those controls should also include practical arrang ements as regar ds organolep tic examinations, freshness 
indicators , controls on histamine, residues and contaminants, microbiological checks. Special attention should be 
paid to the controls of parasite s and on poisonous fisher y products. Fisher y products not meeting those hygiene 
requirements should be declared as unfit for human consum ption. 
(25)  Special requirements concer ning the official controls on fisher y products caught by vessels flying the flag of 
Member States entering the Union after being transferr ed in a third countr y with or without storage should also 
be established. 
(26)  There is an increasing interest in the production and placing on the mark et of reptile meat. In order to ensure the 
safety of reptile meat, it is relevant to introduce specific official controls at slaughter in addition to the existing 
general hygiene rules laid down in Regulation (EC) No 852/2004 and the Trichinella controls laid down in 
Implementing Regulation (EU) 2015/1375. 
(27)  Regulation (EC) No 2074/2005 should be amended according ly. 
(28)  As Regulation (EU) 2017/625 repeals Regulation (EC) No 854/2004 with effect from 14 December 2019, this 
Regulation should also apply from that date. 
(29)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
TITLE I 
SUBJECT MA TTER, SCOPE AND DEFINITIONS 
Article 1 
Subject matter and scope 
This Regulation lays down unif orm practical arrangements for the performa nce of official controls and actions in 
relation to the production of products of animal origin intended for human consum ption. These offici al controls and 
actions shall be performe d by the compet ent author ities taking into account the requirements of Article 18(2), (3) 
and (5) of Regulation (EU) 2017/625 and Deleg ated Regulation (EU) 2019/624. 
The specif ic rules cover: 
(a)  specifi c requirements and unif orm minimum frequency of official controls on any product of animal origin, as 
regards audits and identif ication marking; 
(b)  specifi c requirements and unif orm minimum frequency of official controls on fresh meat, including specifi c 
requirements for audits and specific tasks as regards controls on fresh meat ; 17.5.2019 L 131/55 Official Jour nal of the European Union EN     (c)  measures to be taken in cases of non-compliance of fresh meat with Union requirements for the prot ection of 
human health and animal health and welf are; 
(d)  technical requirements and practical arrang ements as regards the health mark refer red to in Article 5 of Regulation 
(EC) No 853/2004; 
(e)  specifi c requirements and unif orm minimum frequency of official controls on milk, colostr um, dair y products and 
colostr um-based products; 
(f)  conditions for the classificat ion and monitori ng of classified production and relaying areas for live bivalve molluscs, 
including decisions to be take n after monitoring classifie d production and relaying areas; 
(g)  specifi c requirements and unif orm minimum frequency of official controls on fisher y products. 
Article 2 
Def initions 
The followi ng definitions shall apply for the purpose of this Regulation:  
(1) ‘fresh meat’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;  
(2) ‘colostr um’ means colostr um as defined in point 1 of Section IX of Annex III of Regulation (EC) No 853/2004;  
(3) ‘dair y products’ means dair y products as defined in point 7.2. of Annex I to Regulation (EC) No 853/2004;  
(4) ‘colostr um-based products’ means colostr um-based products as defined in point 2 of Section IX of Annex III of 
Regulation (EC) No 853/2004;  
(5) ‘production area’ means a production area as defined in point 2.5 of Annex I of Regulation (EC) No 853/2004;  
(6) ‘rela ying area’ means relaying area as defined in point 2.6 of Annex I of Regulation (EC) No 853/2004;  
(7) ‘bivalve molluscs’ means bivalve molluscs as defined in point 2.1 of Annex I of Regulation (EC) No 853/2004;  
(8) ‘fisher y products’ means fisher y products as defined in point 3.1 of Annex I to Regulation (EC) No 853/2004;  
(9) ‘establishment’ means an establishment as defined in Article 2(1)(c) of Regulation (EC) No 852/2004;  
(10) ‘food business operator ’ means a food business operator as defined in Article 3(3) of Regulation (EC) No 178/2002 
of the European Parliament and of the Council (30);  
(11) ‘microbiological criterion’ means microbiological criterion as defined in Article 2(b) of Regulation (EC) 
No 2073/2005;  
(12) ‘slaught erhouse ’ means slaughte rhouse as defined in point 1.16 of Annex I of Regulation (EC) No 853/2004;  
(13) ‘traceability’ means traceability as defined in Article 3(15) of Regulation (EC) No 178/2002;  
(14) ‘specified risk mate rial’ means specified risk mat erial as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;  
(15) ‘contamination’ means contamination as defined in Article 2(1)(f) of Regulation (EC) No 852/2004;  
(16) ‘holding of proven ance’ means a holding of proven ance as defined in point 2 of Article 2 of Delegat ed Regulation 
(EU) 2019/624;  
(17) ‘primar y production’ means primar y production as defined in Article 3(17) of Regulation (EC) No 178/2002; 17.5.2019 L 131/56 Official Jour nal of the European Union EN     
(30)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles 
and requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety 
(OJ L 31, 1.2.2002, p. 1). (18) ‘domestic ungulate s’ means domestic ungulates as defined in point 1.2 of Annex I of Regulation (EC) 
No 853/2004;  
(19) ‘gam e-handling establishment’ means a game-handling establishment as defined in point 1.18 of Annex I of 
Regulation (EC) No 853/2004;  
(20) ‘larg e wild gam e’ means large wild game as defined in point 1.8 of Annex I to Regulation (EC) No 853/2004;  
(21) ‘flock ’ means a flock as defined in Article 2(3)(b) of Regulation (EC) No 2160/2003;  
(22) ‘lagomor phs’ means lagomor phs as defined in point 1.4 of Annex I of Regulation (EC) No 853/2004;  
(23) ‘carcase’ means a carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;  
(24) ‘offal’ means offal as defined in point 1.11 of Annex I to Regulation (EC) No 853/2004;  
(25) ‘low-capaci ty slaughter house’ means a low-capacity slaughter house as defined in Article 2(17) of Deleg ated 
Regulation (EU) 2019/624;  
(26) ‘low-capaci ty game-handling establishment’ means a game-handling establishment as defined in Article 2(18) of 
Deleg ated Regulation (EU) 2019/624;  
(27) ‘livestoc k unit’ means a livest ock unit as defined in Article 17(6) of Regulation (EC) No 1099/2009;  
(28) ‘small wild game ’ means small wild gam e as defined in point 1.7 of Annex I of Regulation (EC) No 853/2004;  
(29) ‘poultr y’ means poultr y as defined in point 1.3 of Annex I of Regulation (EC) No 853/2004;  
(30) ‘cutting plant’ means a cutting plant as defined in point 1.17 of Annex I of Regulation (EC) No 853/2004;  
(31) ‘viscera’ means viscera as defined in point 1.12 of Annex I of Regulation (EC) No 853/2004;  
(32) ‘meat’ means meat as defined in point 1.1 of Annex I of Regulation (EC) No 853/2004;  
(33) ‘farmed game’ means farmed game as defined in point 1.6 of Annex I of Regulation (EC) No 853/2004;  
(34) ‘wild game’ means wild game as defined in point 1.5 of Annex I to Regulation (EC) No 853/2004;  
(35) ‘milk production holding’ means a milk production holding as defined in point 4.2 of Annex I of Regulation (EC) 
No 853/2004;  
(36) ‘raw milk’ means raw milk as defined in point 4.1 of Annex I to Regulation (EC) No 853/2004;  
(37) ‘pur ification centre’ means a purification centre as defined in point 2.8 of Annex I to Regulation (EC) 
No 853/2004;  
(38) ‘mar ine bioto xins ’ means mar ine bioto xins as defined in point 2.2 of Annex I to Regulation (EC) No 853/2004;  
(39) ‘stag es of production, processing and distr ibution’ means stages of production, processing and distr ibution as 
defined in Article 3(16) of Regulation (EC) No 178/2002;  
(40) ‘dispatc h centre’ means a dispatch centre as defined in point 2.7 of Annex I of Regulation (EC) No 853/2004;  
(41) ‘placing on the mark et’ means placing on the mark et as defined in Article 3(8) of Regulation (EC) No 178/2002;  
(42) ‘factor y vessel’ means factory vessel as defined in point 3.2 of Annex I to Regulation (EC) No 853/2004;  
(43) ‘freezer vessel’ means freezer vessel as defined in point 3.3 of Annex I to Regulation (EC) No 853/2004;  
(44) ‘rept iles’ means reptiles as defined in point 15 of Article 2 of Commission Delegat ed Regulation (EU) 
2019/625 (31); 17.5.2019 L 131/57 Official Jour nal of the European Union EN     
(31)Commission Delegat ed Regulation (EU) 2019/625 of 4 March 2019 supplementing Regulation (EU) 2017/625 of the European 
Parliament and of the Council with regard to requirements for the entr y into the Union of consignments of certain animals and goods 
inten ded for human consump tion (see page 18 of this Official Jour nal). (45) ‘rept ile meat’ means reptile meat as defined in point 16 of Article 2 of Delegat ed Regulation (EU) 2019/625;  
(46) ‘fresh fisher y products’ means fresh fisher y products as defined in point 3.5 of Annex I to Regulation (EC) 
No 853/2004;  
(47) ‘prepared fisher y products’ means prepared fisher y products as defined in point 3.6 of Annex I to Regulation (EC) 
No 853/2004;  
(48) ‘processed fisher y products’ means processed fisher y products as defined in point 7.4 of Annex I to Regulation (EC) 
No 853/2004. 
TITLE II 
SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTR OLS AND THE UNIFORM 
MINIMUM FREQUENCY FOR OFFICIAL CONTR OLS ON PRODUCTS OF ANIMAL ORIGIN 
CHAPTER I 
Specific requir ements for audits by the compe tent author ities in establishments handling produ cts of 
animal origin 
Article 3 
Requirements subject to auditing 
1. When auditing good hygiene practices in establishments, the compe tent author ities shall verify that food business 
operat ors handling products of animal origin apply procedures continuously and properly concer ning at least the 
follo wing: 
(a)  the design and maintenanc e of premises and equipment ; 
(b)  pre-operational, operational and post-operational hygiene; 
(c)  personal hygiene; 
(d)  training in hygiene and in work procedures; 
(e)  pest control; 
(f)  water quality ; 
(g)  temperature control; 
(h)  controls on animals or food entering and leaving the establishment, and any accompan ying documentation. 
2. When auditing procedures based on hazard analysis and critical control points (HA CCP), as laid down in Article 5 
of Regulation (EC) No 852/2004, the compet ent author ities shall verify that food business operat ors handling products 
of animal origin apply such procedures continuously and properly . 
3. They shall, in particular , deter mine whether the procedures guarant ee, to the extent possible, that products of 
animal origin: 
(a)  compl y with Article 3 of Regulation (EC) No 2073/2005 as regards microbiological criteria; 
(b)  compl y with Union legislation on: 
—  the monitori ng of chemical residues, in accordance with Council Directive 96/23/EC and Commission Decision 
97/747/EC (32); 
—  maximum residue limits for phar macologically active substances, in accordance with Commission Regulation 
(EU) No 37/2010 (33) and Commission Implementing Regulation (EU) 2018/470 (34); 17.5.2019 L 131/58 Official Jour nal of the European Union EN     
(32)Commission Decision 97/747/EC of 27 Octo ber 1997 fixing the levels and frequencies of sampling provided for by Council Directive 
96/23/EC for the monit oring of certain substances and residues thereof in certain animal products (OJ L 303, 6.11.1997, p. 12). 
(33)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1). 
(34)Commission Implementing Regulation (EU) 2018/470 of 21 March 2018 on detailed rules on the maximum residue limit to be 
considered for control purposes for foodstuffs derived from animals whic h have been treated in the EU under Article 11 of Directive 
2001/82/EC (OJ L 79, 22.3.2018, p. 16). —  prohibit ed and unauthor ised substances, in accordance with Commission Regulation (EU) No 37/2010, Council 
Directive 96/22/EC (35), Commission Decision 2005/34/EC (36); 
—  contaminants, in accordance with Regulations (EC) No 1881/2006 and (EC) No 124/2009 setting maximum 
levels for certain contaminants in food; 
—  pesticide residues, in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the 
Council (37); 
(c)  do not contain physical hazards, such as foreign bodies. 
4. Where a food business operat or uses procedures set out in guides to the application of HACCP -based principles, in 
accordance with Article 5(5) of Regulation (EC) No 852/2004, the audit shall cover the correct use of those guides. 
5. When carrying out auditing tasks, the compet ent author ities shall take special care: 
(a)  to deter mine whether staff and staff activities in the establishment at all stages of the production process comply 
with the requirements, as regards hygi enic practices and HACCP laid down in Article 3 of Regulation (EC) 
No 2073/2005, Articles 4 and 5 of Regulation (EC) No 852/2004 and Article 3(1) of Regulation (EC) No 853/2004. 
To compl ement the audit, the compet ent author ities may carry out perf ormance tests , in order to ascer tain that staff 
are suffi ciently skilled; 
(b)  to verify the food business operat or's relevant records; 
(c)  to take samples for laborat ory analysis where necessar y; 
(d)  to document elements take n into account and the findings of the audit. 
Article 4 
Nature and frequency of auditing 
1. The nature and frequency of auditing tasks in respect of individual establishments shall depend on the assessed 
risk. To this end, the compet ent author ities shall regularly assess: 
(a)  human and, where appropr iate, animal health risks; 
(b)  in the case of slaughterhouses, animal welfa re aspects; 
(c)  the type and throughput of the processes carried out; 
(d)  the food business operator's past record as regar ds compl iance with food law. 
2. Where food business operat ors in the food chain take additional measures to guarant ee food safet y by 
implementing integrat ed syste ms, private control systems or independent third-par ty certification, or by other means, 
and where these measures are documented and animals covered by such schemes are clearly identif iable, the compet ent 
author ities may take such measures into account when carrying out audits to review good hygiene practices and the 
HACCP -based procedures. 
CHAPTER II 
Specific requir ements for identification marking 
Article 5 
Com pliance with the requirements of Regulation (EC) No 853/2004 concer ning the application of identif ication marks 
shall be verified in all establishments appro ved in accordance with that Regulation, in addition to verification of 
compl iance with other traceability requirements in accordance with Article 18 of Regulation (EC) No 178/2002. 17.5.2019 L 131/59 Official Jour nal of the European Union EN     
(35)Council Directive 96/22/EC of 29 Apr il 1996 concer ning the prohibition on the use in stoc k farm ing of certain substances having 
a hormonal or thyrostatic action and of β-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 
23.5.1996, p. 3). 
(36)Commission Decision 2005/34/EC of 11 Januar y 2005 laying down harmonised standards for the testing for certain residues in 
products of animal origin impor ted from third countr ies (OJ L 16, 20.1.2005, p. 61). 
(37)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 Febr uary 2005 on maximum residue levels of 
pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). CHAPTER III 
Scientific and techn ological developments 
Article 6 
The Member State s shall inform the Commission and other Member State s on scientifi c and technological developments, 
as refer red to in Article 16(2)(b) of Regulation (EU) 2017/625 for consideration and further action as appropr iate. 
TITLE III 
SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTR OLS AND THE UNIFORM 
MINIMUM FREQUENCY FOR OFFICIAL CONTR OLS ON FRESH MEA T 
CHAPTER I 
Audits 
Article 7 
Additional requirements for audits in establishments handling fresh meat 
1. In addition to the requirements for audits laid down in Articles 3 and 4, the compet ent author ities shall, when 
carrying out an audit in establishments handling fresh meat, verify continuous compl iance with food business operat ors' 
own procedures concer ning the collection, transpor t, storag e and handling of fresh meat, and the use or disposal of 
animal by-products, including specifi ed risk mater ial, for which they are responsible. 
2. In the course of audits in slaughterhouses, the compet ent author ities shall verify the evaluation of food chain 
information, as laid down in Section III of Annex II to Regulation (EC) No 853/2004. 
3. When carrying out audits of HACCP -based procedures, the compet ent author ities shall chec k that due regar d is 
given to the procedures set out in Section II of Annex II to Regulation (EC) No 853/2004 and that the food business 
operat ors' procedures guarant ee, to the extent possible, that fresh meat: 
(a)  does not contain pathological abnor malities or changes; 
(b)  does not bear 
(i)  faecal contamination; or, 
(ii)  any other contamination considered to pose an unacceptable human health risk; 
(c)  compl ies with the microbiological criteria in Article 3 of Regulation (EC) No 2073/2005; 
(d)  does not contain specifi ed risk mater ial, in accordance with the requirements in Regulation (EC) No 999/2001. 
CHAPTER II 
Official controls on fresh meat 
Article 8 
Relevance of audit results 
When carrying out official controls in accordance with this Chapt er, the official veteri narian shall take into account the 
results of the audits carried out in accordance with Chapt er I. Where appropr iate, the official veterinar ian shall target 
official controls to deficien cies detected during previous audits. 
Section 1 
Check s of documents 
Article 9 
Obligations of the competent author ities as regards check s of documents 
1. The compe tent author ities shall inform the food business operator of the holding of provena nce of the minimum 
elements of food chain information to be supplied to the slaughter house operator in accordance with Section III of 
Annex II to Regulation (EC) No 853/2004. 17.5.2019 L 131/60 Official Jour nal of the European Union EN     2. The compet ent author ities shall perf orm the necessar y checks of documents to verify that: 
(a)  the food chain information is consistently and effectively communicated between the food business operat or who 
raised or kept the animals before dispatch and the slaughterhouse operator; 
(b)  the food chain information is valid and reliable; 
(c)  feedback of relevant information to the holding of provenance, if applicable, is provided in accordance with 
Article 39(5). 
3. Where animals are dispatc hed for slaughter to another Member State, the compet ent author ities at the holding of 
proven ance and the place of slaughter shall cooperat e to ensure that the food chain information provided by the food 
business operat or of the holding of provenance is easily accessible to the slaughte rhouse operator receiving it. 
Article 10 
Obligations of the official veter inar ian as regards check s of documents 
1. The official veterinar ian shall verify the results of the checks and evaluations of food chain information provided 
by the slaughterhouse operat or in accordance with Section III of Annex II to Regulation (EC) No 853/2004. The offici al 
veterinar ian shall take those checks and evaluations into account when carrying out ante-mor tem and post-mor tem 
inspections, together with any other relevant information from the records of the animals' holding of proven ance. 
2. When carrying out ante-mor tem and post-mor tem inspections, the official veteri narian shall take into account 
official certificates provided for in accordance with Article 29 of Commission Implementing Regulation 
(EU) 2019/628 (38), and any declarations by veteri narians carrying out official controls or other checks at the level of 
primar y production. 
3. In the case of the emerg ency slaughter of domestic ungulates outside the slaughter house, the official veteri narian at 
the slaughterh ouse shall examine the certification provid ed for in accordance with Article 29 of Implementing 
Regulation (EU) 2019/628 and issued by the official veteri narian who carried out the ante-mor tem inspection in 
accordance with point 6 of Chapt er VI of Section I of Annex III to Regulation (EC) No 853/2004 and any other relevant 
information provided by the food business operator . 
4. In the case of large wild game, the offici al veteri narian at the game-handling establishment shall examine and take 
into account the declaration accompan ying the body of the animal, as issued by a trained person in accordance with 
point 4(a) of Chapt er II of Section IV of Annex III to Regulation (EC) No 853/2004. 
Section 2 
Ante-mor tem inspection 
Article 11 
Requirements as regards ante-mor tem inspection at the slaughterhouse 
1. All animals shall be subjected to ante-mor tem inspection before slaughter . Howe ver, inspection can be limited to 
a representative sample of birds from each flock and a representative sample of lagomor phs from each holding of 
proven ance of lagomor phs. 
2. Ante -mor tem inspection shall take place within 24 hours of arrival of the animals at the slaughter house and less 
than 24 hours before slaughter . The official veteri narian may require an additional ante-mor tem inspection at any other 
time. 
3. Ante -mor tem inspections shall deter mine whether , as regards the particular animal inspecte d, there is any sign: 
(a)  that the health and welf are of the animal has been compr omised; 17.5.2019 L 131/61 Official Jour nal of the European Union EN     
(38)Commission Implementin g Regulation (EU) 2019/628 of 8 Apr il 2019 concer ning model official certificates for certain animals and 
goods and amending Regulation (EC) No 2074/2005 and Implementing Regulation (EU) 2016/759 as regards these model certificates 
(see page 101 of this Offi cial Jour nal). (b)  of any condition, abnor malities or disease that make the fresh meat unfit for human consum ption or that might 
adversely affect animal health, paying particular attention to the detec tion of zoonotic diseases and animal diseases 
for whic h animal health rules are laid down in Regulation (EU) 2016/429; 
(c)  of the use of prohibit ed or unauthor ised substances, misuse of veterinar y medicinal products or the presence of 
chemical residues or contaminants. 
4. Ante -mor tem inspection shall include verification of food business operators' compl iance with their obligation to 
ensure that animals have a clean hide, skin or fleece, so as to avoid any unaccep table risk of contamination of the fresh 
meat during slaughter . 
5. The official veteri narian shall carry out a clinical inspection of all animals that the food business operat or or an 
official auxiliar y may have put aside for a more thorough ante-mor tem inspection. 
6. Where the ante-mor tem inspection is carried out at the holding of provenance in accordance with Article 5 of 
Delegat ed Regulation (EU) 2019/624, the official veteri narian at the slaughter house shall carry out ante-mor tem 
inspection only when and to the extent specifi ed. 
Section 3 
Post-mor tem inspection 
Article 12 
Requirements for pos t-mor tem inspection 
1. Subject to the derog ation stipulat ed in Point 4 of Chapt er II of Section IV to Annex III of Regulation (EC) 
No 853/2004, carcases and accompan ying offals, shall be subjecte d to post-mor tem inspection: 
(a)  without dela y after slaughter , or 
(b)  as soon as possible after arrival at the game-handling establishment. 
2. The compet ent author ities may require the food business operator to provide special technical facilities and 
suffi cient space to check offal. 
3. The compet ent author ities shall: 
(a)  check all exte rnal surfaces, including those of body caviti es of carcases, as well as offal; 
(b)  pay particular attenti on to the detection of zoonotic diseases and animal diseases for which animal health rules are 
laid down in Regulation (EU) 2016/429. 
4. The speed of the slaughter line and the number of inspection staff present shall be such as to allow for proper 
inspection. 
Article 13 
Derogation on the timing of pos t-mor tem inspection 
1. By way of derog ation from Article 12(1), the compet ent author ities may allow that, when neither the official 
veterinar ian nor the official auxiliar y are present in the game-handling establishment or slaughter house during slaughter 
and dressing, the post-mor tem inspection is dela yed by a maximum period of 24 hours from slaughter or arrival in the 
game-handling establishment, provid ed that: 
(a)  the animals concer ned are slaughter ed in a low-capacity slaughterh ouse or handled in a low-capacity game-handling 
establishment that slaughters or handles: 
(i)  fewer than 1 000 livestoc k units per year; or 
(ii)  fewer than 150 000 poultr y, lagomor phs and small wild game per year; 
(b)  suffi cient facilities exist within an establishment to store the fresh meat and offal so that they can be examined; 
(c)  the post-mor tem inspection is carried out by the official veterinar ian. 17.5.2019 L 131/62 Official Jour nal of the European Union EN     2. The compet ent author ities may increase the thresholds laid down in point (a) (i) and (ii) of paragraph 1 ensur ing 
that the derogation is applied in the smallest slaughter houses and game-handling establishments compl ying with the 
definit ion of low-capacity slaughterh ouse or low-capacity game-handling establishment and provid ed that the combined 
annual production of these establishments does not excee d 5 % of the total amount of fresh meat produced in 
a Member State : 
(a)  for the species concer ned; 
(b)  or for all ungulate s together; 
(c)  of all poultr y together; or, 
(d)  of all birds and lagomor phs together . 
In such case, the compe tent author ities shall notify this derogation and the evidence to suppor t it in accordance with 
the procedure laid down in Directive (EU) 2015/1535 of the European Parliament and of the Council (39); 
3. For the purpose of point (a) (i) of paragraph 1, the convers ion rates laid down in Article 17(6) of Regulation (EC) 
No 1099/2009 shall be used. However in case of ovine and capr ine animals and small (< 100 kg life weight) Cervidae 
a conversion rate of 0,05 livestoc k units, and in case of other large game a conver sion rate of 0,2 livestoc k units shall be 
used. 
Article 14 
Additional examination requirements for pos t-mor tem inspection 
1. Additional examinations, such as palpation and incision of parts of the carcase and offal, and laboratory tests, shall 
be carried out if needed to: 
(a)  reach a definitive diagnosis of a suspect ed hazard; or 
(b)  detec t the presence of: 
(i)  an animal disease for whic h animal health rules are laid down in Regulation (EU) 2016/429; 
(ii)  chemical residues or contaminants as refer red to in Directive 96/23/EC and Decision 97/747/EC, especially: 
—  chemical residues in excess of the levels laid down in Regulations (EU) No 37/2010 and (EC) No 396/2005; 
—  contaminants exceed ing the maximum levels laid down in Regulations (EC) No 1881/2006 and (EC) 
No 124/2009; or 
—  residues of substances that are prohibit ed or unauthor ised in accordance with Regulation (EU) No 37/2010 
or Directive 96/22/EC; 
(iii)  non-com pliance with the microbiological criteria refer red to in Article 3(1)(b) of Regulation (EC) No 2073/2005 
or the possible presence of other microbiological hazards that would make the fresh meat unfit for human 
consum ption; 
(iv)  other factors that might require the fresh meat to be declared unfit for human consum ption or restr ictions to be 
placed on its use. 
2. Dur ing the post-mor tem inspection, precautions shall be taken to ensure that contamination of fresh meat by 
actions such as palpation, cutting or incision is kept to a minimum. 
Article 15 
Requirements for pos t-mor tem inspection of domest ic solipeds, bovine animals over eight months 
old and domestic swine more than five weeks old, and large wild game 
1. The requirements in this Article shall apply in addition to the requirements in Articles 12 and 14. 17.5.2019 L 131/63 Official Jour nal of the European Union EN     
(39)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 Sept ember 2015 laying down a procedure for the 
provi sion of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1). 2. The official veteri narian shall require that carcases of domestic solipeds, bovine animals over eight months old and 
domestic swine more than five week s old are submitted for post-mor tem inspection split lengthwa ys into half carcases 
down the spinal column. 
3. If the post-mor tem inspection so necessitates, the official vete rinar ian may require any head or any carcase to be 
split lengthwa ys. Howe ver, to take account of particular eating habits, technological developments or specifi c sanitar y 
situations, the official vete rinar ian may author ise the submission for post-mor tem inspection of carcases of domestic 
solipeds, bovine animals more than eight months old and domestic swine more than five weeks old that are not split in 
half. 
4. In low-capacity slaughterh ouses or low-capacity game-handling establishments handling fewer than 
1 000 livestoc k units per year, the official veteri narian may, for sanitar y reasons, author ise the cutting into quar ter 
carcases of adult domestic solipeds, adult bovine animals and adult large wild game before post-mor tem inspection. 
Article 16 
Addition al requirements for pos t-mor tem inspection in cases of emergency slaughter 
In the event of emerge ncy slaughter , the carcase shall be subjecte d to post-mor tem inspection as soon as possible in 
accordance with Articles 12, 13, 14 and 15 before it is released for human consump tion. 
Article 17 
Practical arrangements for post-mor tem inspection of domes tic bovine animals, domes tic sheep 
and goats, domestic solipeds and domest ic swine 
Where the post-mor tem inspection is perf ormed by an official veterinar ian, under the super vision of the official 
veterinar ian or, where sufficient guarant ees are in place, under the responsibility of the official veterinar ian in 
accordance with Article 18(2)(c) of Regulation (EU) 2017/625 and Article 7 of Delegat ed Regulation (EU) 2019/624, the 
compet ent author ities shall ensure that the practical arrang ements laid down in the followi ng Articles 18 to 24 are 
compl ied with in the cases of domestic bovine animals, domestic sheep and goats, domestic solipeds and domestic 
swine in addition to the requirements laid down in Articles 12, 14 and 15. 
Article 18 
Young bovine animals 
1. Carcases and offal of the following bovine animals shall undergo the post-mor tem inspection procedures laid 
down in paragraph 2: 
(a)  animals under eight months old; and, 
(b)  animals under 20 months old if reared without access to pasture land during their whole life in an officiall y 
tuberculosis-free Member State or region of a Member State in accordance with Article 1 of Decision 2003/467/EC. 
2. The post-mor tem inspection procedures shall include at least a visual inspection of the follo wing: 
(a) the head and throat ; together with palpation and examination of the retrophar yngeal lymph nodes (Lnn. retro­
phar yngiales), however , in order to ensure the surveillance of the officially tuberculosis free status, Member States 
may decide to carry out further investig ations; inspection of the mouth and fauces; 
(b)  the lungs, trachea and oesophagus; palpation of the lungs; palpation and examination of the bronc hial and 
mediastinal lymph nodes (Lnn. bifurc ationes, epar teriales and mediastinales); 
(c)  the pericardium and hear t; 
(d)  the diaphragm; 
(e)  the liver and the hepatic and pancreatic lymph nodes, (Lnn. portales); 17.5.2019 L 131/64 Official Jour nal of the European Union EN     (f)  the gastro-intestinal tract, the mesenter y and gastric and mesente ric lymph nodes (Lnn. gastrici, mesenter ici, craniales 
and caudales); 
(g)  the spleen; 
(h)  the kidne ys; 
(i)  the pleura and peritoneum; 
(j)  the umbilical region and the joints of young animals. 
3. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or 
animal welfare indicated in accordance with Article 24: 
(a)  incision of the retrophar yngeal lymph nodes (Lnn. retrophar yngiales); palpation of the tongue; 
(b)  incision of the bronchial and mediastinal lymp h nodes (Lnn. bifurc ationes, epar teriales and mediastinales); lengthwise 
opening of the trachea and the main branches of the bronc hi; the lungs shall be incised in their poste rior third, 
perpendicular to their main axes; these incisions are not necessar y where the lungs are excl uded from human 
consump tion; 
(c)  lengthwa ys incision of the hear t so as to open the ventr icles and cut through the inter ventr icular septum; 
(d)  incision of the gastric and mesenter ic lymph nodes; 
(e)  palpation of the spleen; 
(f)  incision of the kidne ys and the renal lymph nodes (Lnn. renales); 
(g)  palpation of the umbilical region and the joints. The umbilical region shall be incised and the joints opened; the 
synov ial fluid must be examined. 
Article 19 
Other bovine animals 
1. Carcases and offal of bovine animals other than those referred to in Article 18(1) shall undergo the followi ng 
post-mor tem inspection procedures: 
(a)  a visual inspection of the head and throat ; incision and examination of the retrophar yngeal lymph nodes 
(Lnn. retrophar yngiales); examination of the external masseters, in which two incisions shall be made parallel to the 
mandible, and the intern al masseter s (intern al pterygoid muscles), whic h shall be incised along one plane. The 
tongue shall be freed to permit a detailed visual inspection of the mouth and the fauce s; 
(b)  an inspection of the trach ea and oesophagus; visual inspection and palpation of the lungs; incision and examination 
of the bronc hial and mediastinal lymph nodes (Lnn. bifurc ationes, epar teriales and mediastinales); 
(c)  a visual inspection of the pericardium and hear t, the latter being incised lengthwa ys so as to open the ventr icles and 
cut through the inter ventr icular septum; 
(d)  a visual inspection of the diaphragm; 
(e)  a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); 
(f)  a visual inspection of the gastro-intestinal tract, the mesent ery, the gastr ic and mesent eric lymph nodes (Lnn. gastrici, 
mesenter ici, craniales and caudales); palpation of the gastric and mesenter ic lymph nodes; 
(g)  a visual inspection of the spleen; 
(h)  a visual inspection of the kidneys; 
(i)  a visual inspection of the pleura and the peritoneum; 
(j)  a visual inspection of the genital organs (except for the penis, if already discarded); 
(k)  a visual inspection of the udder and its lymph nodes (Lnn. supramammar ii). 17.5.2019 L 131/65 Official Jour nal of the European Union EN     2. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or 
animal welfare indicated in accordance with Article 24: 
(a)  an incision and examination of the sub-maxillar y and parotid lymph nodes (Lnn. mandibulares and parotidei); 
palpation of the tongue and the fauces; 
(b)  an incision of the bronc hial and mediastinal lymph nodes (Lnn. bifurc ationes, epar teriales and mediastinales); lengthwise 
opening of the trachea and the main branches of the bronc hi; the lungs shall be incised in their poste rior third, 
perpendicular to their main axes; these incisions are not necessar y where the lungs are excl uded from human 
consump tion; 
(c)  a palpation of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); incision of the gastr ic surface of 
the liver and at the base of the caudat e lobe to examine the bile ducts; 
(d)  an incision of the gastric and mesenter ic lymph nodes; 
(e)  a palpation of the spleen; 
(f)  an incision of the kidne ys and the renal lymph nodes (Lnn. renales); 
(g)  a palpation and incision of the udder and its lymph nodes (Lnn. supramammar ii) in cows. Each half of the udder shall 
be opened by a long, deep incision as far as the lactifer ous sinuses (sinus lactifer es) and the lymph nodes of the udder 
shall be incised, excep t where the udder is excl uded from human consump tion. 
Article 20 
Young domest ic sheep and goats and sheep with no eruption of permanent incisors 
1. Carcases and offal of sheep not having any permanent incisor erupted or less than 12 months of age, and goats 
less than six months of age, shall undergo the followi ng post-mor tem inspection procedures: 
(a)  a visual inspection of the head, including the throat, mouth, tongue and parotid and retrophar yngeal lymph 
nodes. These examinations are not necessar y if the compet ent author ities are able to guarant ee that the head, 
including the tongue and the brains, will be excl uded from human consump tion; 
(b)  a visual inspection of the lungs, trachea and oesophagus and the bronc hial and mediastinal lymph nodes 
(Lnn. bifurc ationes, epar teriales and mediastinales); 
(c)  a visual inspection of the pericardium and hear t; 
(d)  a visual inspection of the diaphragm; 
(e)  a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); 
(f)  a visual inspection of the gastro-int estinal tract, the mesent ery and the gastr ic and mesent eric lymph nodes 
(Lnn. gastrici, mesenter ici, craniales and caudales); 
(g)  a visual inspection of the spleen; 
(h)  a visual inspection of the kidneys; 
(i)  a visual inspection of the pleura and peritoneum; 
(j)  a visual inspection of the umbilical region and joints. 
2. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or 
animal welfare indicated in accordance with Article 24: 
(a)  a palpation of the throat, mouth, tongue and parotid lymph nodes. Unless animal-health rules provid e other wise, 
these examinations are not necessar y if the compet ent author ities are able to guarant ee that the head, including the 
tongue and the brains, will be excl uded from human consump tion; 
(b)  a palpation of the lungs; incision of the lungs, trachea, oesophagus, bronchial and mediastinal lymph nodes; 17.5.2019 L 131/66 Official Jour nal of the European Union EN     (c)  an incision of the hear t; 
(d)  a palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts; 
(e)  a palpation of the spleen; 
(f)  an incision of the kidne ys and the renal lymph nodes (Lnn. renales); 
(g)  a palpation of the umbilical region and joints; the umbilical region shall be incised and the joints opened; the 
synov ial fluid shall be examined. 
Article 21 
Other domest ic sheep and goats 
1. Carcases and offal of sheep having a permanent incisor erupted or 12 months of age or more, and goats six 
months of age or more, shall undergo the followi ng post-mor tem inspection procedures: 
(a)  a visual inspection of the head, including the throat, mouth, tongue and parotid lymph nodes and palpation of the 
retrophar yngeal lymp h nodes. These examinations are not necessar y if the compet ent author ities are able to 
guarant ee that the head, including the tongue and the brains, will be excluded from human consum ption; 
(b)  a visual inspection of the lungs, trachea and oesophagus; palpation of the lungs, the bronc hial and mediastinal 
lymph nodes (Lnn. bifurc ationes, epar teriales and mediastinales); 
(c)  a visual inspection of the pericardium and hear t; 
(d)  a visual inspection of the diaphragm; 
(e)  a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); palpation of the liver and 
its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts; 
(f)  a visual inspection of the gastro-int estinal tract, the mesent ery and the gastr ic and mesent eric lymph nodes 
(Lnn. gastrici, mesenter ici, craniales and caudales); 
(g)  a visual inspection of the spleen; 
(h)  a visual inspection of the kidneys; 
(i)  a visual inspection of the pleura and peritoneum; 
(j)  a visual inspection of the genital organs (except for the penis, if already discarded); 
(k)  a visual inspection of the udder and its lymph nodes. 
2. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal when there are indications of a possible risk to human health, animal health or animal 
welf are indicated in accordance with Article 24: 
(a)  a palpation of the throat, mouth, tongue and parotid lymph nodes. Unless animal-health rules provid e other wise, 
these examinations are not necessar y if the compet ent author ities are able to guarant ee that the head, including the 
tongue and the brains, will be excl uded from human consump tion; 
(b)  an incision of the lungs, trachea, oesophagus and the bronchial and mediastinal lymph nodes; 
(c)  an incision of the hear t; 
(d)  a palpation of the spleen; 
(e)  an incision of the kidne ys and the renal lymph nodes (Lnn. renales). 
Article 22 
Domes tic solipeds 
1. Carcases and offal of domestic solipeds shall undergo the following post-mor tem inspection procedures: 
(a)  a visual inspection of the head and, after freeing the tongue, the throat ; the tongue shall be freed to permit 
a detailed visual inspection of the mouth and the fauce s and must itself be visually examined; 17.5.2019 L 131/67 Official Jour nal of the European Union EN     (b)  a visual inspection of the lungs, trach ea, oesophagus and the bronc hial and mediastinal lymph nodes 
(Lnn. bifurc ationes, epar teriales and mediastinales); 
(c)  a visual inspection of the pericardium and the hear t; 
(d)  a visual inspection of the diaphragm; 
(e)  a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn portales); 
(f)  a visual inspection of the gastro-intestinal tract, the mesent ery and the gastric and mesent eric lymph nodes 
(Lnn. gastrici, mesenter ici, craniales and caudales); 
(g)  a visual inspection of the spleen; 
(h)  a visual inspection of the kidneys; 
(i)  a visual inspection of the pleura and peritoneum; 
(j)  a visual inspection of the genital organs of stallions (excep t for the penis, if already discarded) and mares; 
(k)  a visual inspection of the udder and its lymph nodes (Lnn. supramammar ii); 
(l)  a visual inspection of the umbilical region and joints of young animals; 
(m)  examination of the muscles and lymp h nodes (Lnn. subrhomboidei) of the shoulders beneath the scapular cartilage 
after loosening the attachm ent of one shoulder , in the case grey horses, in order to inspect for melanosis and 
melanomata. The kidne ys shall be exposed. 
2. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or 
animal welfare indicated in accordance with Article 24: 
(a)  a palpation and incision of the sub-maxillar y, retrophar yngeal and parotid lymph nodes (Lnn. retrophar yngiales, 
mandibulares and parotidei); palpation of the tongue; 
(b)  a palpation of the lungs; palpation and incision of the bronchial and mediastinal lymph nodes. The trachea and the 
main branche s of the bronchi shall be opened lengthwise and the lungs shall be incised in their posterior third, 
perpendicular to their main axes ; however , these incisions are not necessar y where the lungs are excl uded from 
human consum ption; 
(c)  an incision of the hear t lengthwise, so as to open the ventr icles and cut through the interventr icular septum; 
(d)  a palpation and incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn. portales); 
(e)  an incision of the gastric and mesenter ic lymph nodes; 
(f)  a palpation of the spleen; 
(g)  a palpation of the kidne ys and incision of the kidne ys and the renal lymph nodes (Lnn. renales); 
(h)  an incision of the supramammar y lymph nodes; 
(i)  a palpation of the umbilical region and joints of young animals. In cases of doubt, the umbilical region shall be 
incised and the joints opened; the synovial fluid must be examined; 
(j)  an incision through the entire kidney in grey horses. 
Article 23 
Domes tic swine 
1. Carcases and offal of domestic swine shall undergo the followi ng post-mor tem inspection procedures: 
(a)  a visual inspection of the head and throat ; 
(b)  a visual inspection of the mouth, fauces and tongue; 
(c)  a visual inspection of the lungs, trachea and oesophagus; 
(d)  a visual inspection of the pericardium and hear t; 17.5.2019 L 131/68 Official Jour nal of the European Union EN     (e)  a visual inspection of the diaphragm; 
(f)  a visual inspection of the liver and the hepatic and pancreatic lymph nodes (Lnn. portales); visual inspection of the 
gastro-intestinal tract, the mesente ry, the gastric and mesenter ic lymph nodes (Lnn. gastrici, mesenter ici, craniales and 
caudales); 
(g)  a visual inspection of the spleen; visual inspection of the kidne ys; visual inspection of the pleura and peritoneum; 
(h)  a visual inspection of the genital organs (except for the penis, if already discarded); 
(i)  a visual inspection of the udder and its lymph nodes (Lnn. supramammar ii); 
(j)  a visual inspection of the umbilical region and joints of young animals. 
2. The official veteri narian shall proceed with the followi ng post-mor tem inspection procedures using incision and 
palpation of the carcase and offal, when there are indications of a possible risk to human health, animal health or 
animal welfare indicated in accordance with Article 24: 
(a)  an incision and examination of the submaxillar y lymph nodes (Lnn. mandibulares); 
(b)  a palpation of the lungs and the bronc hial and mediastinal lymp h nodes (Lnn. bifurcationes, epar teriales and 
mediastinales). The trachea and the main branch es of the bronchi shall be opened lengthwise and the lungs shall be 
incised in their poste rior third, perpendicular to their main axes; those incisions are not necessar y where the lungs 
are excl uded from human consump tion; 
(c)  an incision of the hear t lengthwise so as to open the ventr icles and cut through the inter ventr icular septum ; 
(d)  a palpation of the liver and its lymph nodes; 
(e)  a palpation and, if necessar y, incision of the gastric and mesente ric lymph nodes; 
(f)  a palpation of the spleen; 
(g)  an incision of the kidne ys and the renal lymph nodes (Lnn. renales); 
(h)  an incision of the supramammar y lymph nodes; 
(i)  a palpation of the umbilical region and joints of young animals and, if necessar y, incision of the umbilical region 
and opening of the joints. 
Article 24 
Indications of a possible risks to human health, animal health or animal welfare in domes tic bovine 
animals, domestic sheep and goats, domes tic solipeds and domest ic swine 
The official veterinar ian shall proceed with the additional post-mor tem inspection procedures refer red to in 
Articles 18(3), 19(2), 20(2), 21(2), 22(2) and 23(2) using incision and palpation of the carcase and offal, where, in 
his/her opinion, one of the follo wing indicate s a possible risk to human health, animal health or animal welf are: 
(a)  the checks and analysis of the checks of documents carried out in accordance with Articles 9 and 10; 
(b)  the findings of the ante-mor tem inspection carried out in accordance with Article 11; 
(c)  the results of the verifications of compl iance with animal welf are rules carried out in accordance with Article 38; 
(d)  the findings of post-mor tem inspection carried out in accordance with Articles 12 to 24; 
(e)  additional epidemiological data or other data from the holding of provenance of the animals. 
Article 25 
Practical arrangements for pos t-mor tem inspection of poultr y 
1. All poultr y shall undergo post-mor tem inspection whic h may include the assistance of slaughte rhouse staff in 
accordance with Article 18(3) of Regulation (EU) 2017/625. The official vete rinar ian or official auxiliar y, in accordance 
with Article 18(2)(c) of that Regulation shall personally carry out the followi ng checks: 
(a)  daily inspection of the viscera and body caviti es of a representative sample of each flock; 17.5.2019 L 131/69 Official Jour nal of the European Union EN     (b)  a detailed inspection of a random samp le of parts of birds or entire birds declared unfit for human consump tion 
followi ng post-mor tem inspection from each flock; 
(c)  any further investigat ions necessar y where there is reason to suspect that the meat from the birds concer ned could 
be unfit for human consum ption. 
2. By way of derogation from paragraph 1, the compet ent author ities may decide that only a representative sample of 
poultr y from each flock undergoes post-mor tem inspection if: 
(a)  food business operat ors have a syste m in place to the satisf action of the official veteri narian, that allows the 
detec tion and the separation of birds with abnor malities, contamination or defe cts; 
(b)  the slaughterh ouse has a longstanding histo ry of compl iance with the requirements as regards: 
(i)  general and specifi c requirements in accordance with Article 4 of Regulation (EC) No 852/2004, including the 
microbiological criteria applicable to Point 1.28 and 2.1.5 of Annex I to Regulation (EC) No 2073/2005; 
(ii)  procedures based on the HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004; and 
(iii)  specific hygiene rules in accordance with Article 5 and Section II of Annex III to Regulation (EC) No 853/2004; 
(c)  no abnor malities that may indicate a serious problem for human or animal health that may indicate the need for 
measures laid down in Articles 40 to 44, have been found during ante-mor tem inspection or verification of food 
chain information. 
3. In case of poultr y reared for the production of foie gras and dela yed eviscerat ed poultr y obtained at the holding of 
proven ance in accordance with Points 8 and 9 of Chapt er VI to Section II of Annex III to Regulation (EC) No 853/2004, 
post-mor tem inspection shall take place at the cutting plant where such carcases are transpor ted directly from the 
holding of proven ance. 
Article 26 
Practical arrangements for post-mo rtem inspection of farmed lagomor phs 
The practical arrang ements for post-mor tem inspection in poultr y in accordance with Article 25, shall apply to farmed 
lagomor phs. The provisions applicable to a sing le poultr y flock in Article 25 shall apply to farmed lagomor phs 
slaughter ed the same day from a sing le holding of provenance. 
Article 27 
Practical arrangements for pos t-mor tem inspection of farmed game 
1. The followi ng post-mor tem inspection procedures shall apply to farmed game: 
(a)  in the case of small (< 100 kg) Cervidae, the post-mor tem procedures for ovine animals laid down in Article 21, 
however in the case of reindeer the post-mor tem procedures for ovine animals laid down in Article 20 shall be used 
and the tongue may be used for human consump tion without inspection of the head; 
(b)  in the case of game of the family Suidae, the post-mor tem procedures for domestic swine laid down in Article 23; 
(c)  in the case of large game of the family Cervidae and other large gam e, not covered by paragraph (a) and in the case 
of large game of the family Suidae not covered by paragraph (b), the post-mor tem procedures for bovine animals 
laid down in Article 19; 
(d)  in the case of ratites, the post-mor tem procedures for poultr y laid down in Article 25(1). 
2. Where the animals have been slaughtered outside the slaughter house, the official vete rinar ian at the slaughter house 
shall verify the certificate. 17.5.2019 L 131/70 Official Jour nal of the European Union EN     Article 28 
Practical arrangements for pos t-mor tem inspection of wild game 
1. The official vete rinar ian shall verify that a health certificate conf orming to the specimen set out in the Annex to 
Regulation (EU) No 636/2014, or the declaration(s) in accordance with point 8(b) of Chapt er II of Section IV of 
Annex III to Regulation (EC) No 853/2004, accompanies unskinned large wild game transpor ted to the gam e-handling 
establishment from the territory of another Member State. The official veterinar ian shall take into account the cont ent of 
that certificate or declaration(s). 
2. Dur ing post-mor tem inspection, the official veterinar ian shall carry out: 
(a)  a visual inspection of the carcase, its caviti es and, where appropr iate, organs with a view to: 
(i)  detecting any abnor malities not resulting from the hunting process. For this purpose, the diagnosis may be based 
on any information that the trained person has provid ed concer ning the beha viour of the animal before killing; 
(ii)  chec king that death was not due to reasons other than hunting; 
(b)  an inve stigation of organolep tic abnor malities; 
(c)  palpation and incisions of organs, where appropr iate; 
(d)  where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sam pling of 
residues not resulting from the hunting process, including envi ronmental contaminants. Where a more extensive 
inspection is made on the basis of such suspicions, the veteri narian shall wait until that inspection has been 
concluded before assessing all the wild game killed during a specifi c hunt, or those parts suspect ed of showing the 
same abnor malities; 
(e)  examination for charact eristics indicating that the meat presents a health risk, including: 
(i)  abnor mal behaviour or disturbance of the general condition of the live animal, as repor ted by the hunt er; 
(ii)  the generalised presence of tumours or abscesses affecting differ ent internal organs or muscles; 
(iii)  arthritis, orchitis, pathological change s in the liver or the spleen, inflammation of the intestines or the 
umbilical region; 
(iv)  the presence of foreign bodies not resulting from the hunting process in the body cavities, stomac h, intes tines 
or urine, where the pleura or peritoneum are discoloured (when relevant viscera are present); 
(v)  the presence of parasites; 
(vi)  formation of a signif icant amount of gas in the gastro-int estinal tract with discolour ing of the internal organs 
(when these viscera are present); 
(vii)  signif icant abnor malities of colour , consistency or odour of muscle tissue or organs; 
(viii)  aged open fractures; 
(ix)  emaciation and/or general or localised oedema; 
(x)  recent pleural or peritoneal adhesions; 
(xi)  other obvious extensive changes , such as putrefaction. 
3. Where the official veteri narian so requires, the vertebral column and the head shall be split lengthwise. 
4. In the case of small wild gam e not eviscerated immediately after killing, the official veteri narian shall carry out 
a post-mor tem inspection on a representative sam ple of animals from the same source. Where inspection reveals 
a disease transmissible to humans or any of the character istics liste d in point (e) in paragraph 2, the official veteri narian 
shall carry out more checks on the entire batc h to deter mine whether it shall be declared unfit for human consum ption 
or whether each carcase shall be inspected individually . 
5. The official veterinar ian may perf orm any further cuts and inspections of the relevant parts of the animals that are 
necessar y to reac h a final diagnosis. If an assessment cannot be made on the basis of the practical arrang ements in 
paragraph 2, additional investigat ions shall be carried out in a laboratory . 17.5.2019 L 131/71 Official Jour nal of the European Union EN     6. In addition to the cases provid ed for in Article 45, meat presenting during post-mor tem inspection any of the 
characteri stics listed in point (e) in paragraph 2 shall be declared unfit for human consump tion. 
Section 4 
Off icial controls on specif ic hazards and laborat ory testi ng 
Article 29 
Practical arrangements for official controls for transmissible spongiform encephalopathies (TSEs) 
1. In addition to the requirements of Regulation (EC) No 999/2001 concer ning the official controls to be carried out 
in relation to TSEs, the official veterinar ian shall check the removal, separation and, where appropr iate, marking of 
specified risk mate rial also in accordance with the rules laid down in Article 8(1) of that Regulation and in Article 12 of 
Regulation (EC) No 1069/2009 on animal by-products. 
2. The official veteri narian shall ensure that the food business operat or take s all necessar y measures to avoid con­
taminating meat with specifi ed risk mater ial during slaughter , including stunning. This includes the remo val of specified 
risk mate rial. 
Article 30 
Practical arrangements for official controls for cystice rcosis dur ing post-mo rtem inspection in 
domestic bovine animals and Suidae 
1. The post-mor tem inspection procedures descr ibed in Articles 18, 19 and 23 shall be the minimum requirements 
for the examination for cysticercosis in bovine animals and Suidae (domestic swine, farmed gam e and wild gam e). In the 
case of bovine animals refer red to in Article 19, the compet ent author ities may decide that incision of the masseters at 
post-mor tem inspection is not compulsor y if: 
(a)  a specific serological test is used; 
(b)  the animals have been raised on a holding of proven ance official ly certified to be free of cysticercosis; or, 
(c)  the prevalence of the source population or in a well-def ined subpopulation is below one in a million, has been 
demonstrated with 95 % certainty or no cases have been detected in all slaughter ed animals in the past five years (or 
two years where suppor ted and justif ied by the compet ent author ities' risk analysis) based on data from repor ting 
carried out in accordance with Article 9(1) of Directive 2003/99/EC. 
2. Meat infect ed with cysticerci shall be declared unfit for human consump tion. Howe ver, where the animal is not 
generally infect ed with cysticercus, the parts not infected may be declared fit for human consum ption after having 
undergone a cold treatment. 
Article 31 
Practical arrangements for official controls for Trichinella dur ing post-mo rtem inspection 
1. Carcases of Suidae, solipeds and other species susceptible to Trichinella shall be examined for Trichinella in 
accordance with Regulation (EU) 2015/1375 unless one of the derogations set out in Article 3 of that Regulation 
applies. 
2. Meat from animals infected with trichina e shall be declared unfit for human consum ption. 
Article 32 
Practical arrangements for official controls for glanders dur ing pos t-mor tem inspection of solipeds 
1. Fresh meat of solipeds shall be placed on the mark et only if it was produced from solipeds kept for at least 
90 days prior to the date of slaughter in a Member State or in a third countr y or region thereof from whic h it is 
author ised to bring solipeds into the Union. 17.5.2019 L 131/72 Official Jour nal of the European Union EN     2. In the case of solipeds originating from a Member State or third countr y or region thereof not meeting the World 
Org anisation for Animal Health criteria for a glanders-free countr y, solipeds shall be inspecte d for glanders by a careful 
examination of the mucous membranes of the trachea, larynx, nasal cavities and sinuses and their ramificatio ns, after 
splitting the head in the median plane and exci sing the nasal septum. 
3. Meat produced from solipeds in which glanders has been diagnosed shall be declared unfit for human 
consum ption. 
Article 33 
Practical arrangements for official controls for tuberculosis dur ing pos t-mor tem inspection 
1. Where animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting 
infection, they shall be slaughter ed separat ely from other animals, taking precautions to avoid the risk of contamination 
of other carcases, the slaughter line and staff present in the slaughterh ouse. 
2. All meat from animals in which post-mor tem inspection has revealed localised lesions similar to tuberculoid 
lesions in a number of organs or a number of areas of the carcase shall be declared unfit for human consum ption. 
Howe ver, where a tuberculoid lesion has been found in the lymph nodes of only one organ or part of the carcase, only 
the affect ed organ or part of the carcase and the associated lymph nodes shall be declared unfit for human 
consum ption. 
Article 34 
Practical arrangements for official controls for brucellosis dur ing pos t-mor tem inspection 
1. Where animals have react ed positively or inconclusively to a brucellosis test, or there are other grounds for 
suspecting infection, they shall be slaughter ed separately from other animals, taking precautions to avoid the risk of con­
tamination of other carcases, the slaughter line and staff present in the slaughterh ouse. 
2. Meat from animals in which post-mor tem inspection has revealed lesions indicating acute brucellosis shall be 
declared unfit for human consum ption. In the case of animals reacting positively or inconclusively to a brucellosis test, 
the udder , genital tract and blood shall be declared unfit for human consump tion even if no such lesion is found. 
Article 35 
Practical arrangements for official controls for Salmonella 
1. The compet ent author ities shall verify the correct implementation by food business operat ors of points 2.1.3, 
2.1.4 and 2.1.5 of Chapt er 2 of Annex I of Regulation (EC) No 2073/2005 by applying one or more of the follo wing 
measures: 
(a)  official sampling using the same method and sampli ng area as food business operat ors. At least 49 random 
samples (40) shall be taken in each slaughterh ouse each year . This number of samples may be reduced in small 
slaughterh ouses based on a risk evaluation; 
(b)  collecting all information on the total number and the number of Salmonella-positive sam ples taken by food business 
operat ors in accordance with Article 5 of Regulation (EC) No 2073/2005, in the framew ork of points 2.1.3, 2.1.4 
and 2.1.5 of Chapt er 2 of Annex I thereto; 
(c)  collecting all information on the total number and the number of Salmonella-positive samples take n in the 
framewor k of national control programmes in Member States or regions of Member States for whic h special 
guarant ees have been approved in accordance with Article 8 of Regulation (EC) No 853/2004 as regar ds ruminant, 
equine, swine and poultr y production. 
2. Where the food business operator fails on several occasions to compl y with the process hygiene criterion, the 
compet ent author ities shall require it to submit an action plan and shall strictly super vise its outcome. 17.5.2019 L 131/73 Official Jour nal of the European Union EN     
(40)If all are negative, 95 % statistical certainty is provided that the prevalence is below 6 %. 3. The total number and the number of Salmonella-positive samples, diffe rentiating between sam ples taken under 
points (a), (b) and (c) in paragraph 1, when applied, shall be repor ted in accordance with Article 9(1) of Directive 
2003/99/EC. 
Article 36 
Practical arrangements for official controls for Campylobacter 
1. The compet ent author ities shall verify the correct implementation by food business operat ors of point 2.1.9 
(process hygiene criterion for Campylobacter on carcases of broilers) of Chapt er 2 of Annex I of Regulation (EC) 
No 2073/2005 by applying the followi ng measures: 
(a)  official sampli ng using the same method and sampli ng area as food business operators. At least 49 random samples 
shall be taken in each slaughter house each year. This number of samples may be reduced in small slaughter houses 
based on a risk evaluation; or 
(b)  collecting all information on the total number and the number of Campylobacter samples with more than 
1 000 cfu/g taken by food business operat ors in accordance with Article 5 of Regulation (EC) No 2073/2005, in the 
framewor k of point 2.1.9 of Chapt er 2 of Annex I thereto. 
2. Where the food business operator fails on several occasions to compl y with the process hygiene criterion, the 
compet ent author ities shall require it to submit an action plan and shall strictly super vise its outcome. 
3. The total number and the number of Campylobacter samples with more than 1 000 cfu/g, differentiating between 
sample s taken under points (a) and (b) in paragraph 1, when applied, shall be repor ted in accordance with Article 9(1) 
of Directive 2003/99/EC. 
Article 37 
Specif ic requirements as regards laborat ory tests 
1. When performin g laboratory tests in accordance with Article 18(2)(d)(ii) and (iv) of Regulation (EU) 2017/625, the 
official veterinar ian shall ensure that, when sam pling takes place, samples are appropr iately identif ied and handled and 
sent to the appropr iate laboratory in the framew ork of: 
(a)  the monitori ng and control of zoonoses and zoonotic agents; 
(b)  the annual programme for the monitori ng of TSEs in accordance with Article 6 of Regulation (EC) No 999/2001; 
(c)  the detection of phar macologically active substances or products either prohibited or unauthor ised, and controls for 
regulated phar macologically active substances, pesticides, feed additives and contaminants excee ding applicable 
maximum Union limits, in particular in the framew ork of the national plans for the detec tion of residues or 
substances refer red to in Article 110(2) of Regulation (EU) 2017/625 and in Article 5 of Directive 96/23/EC; 
(d)  the detec tion of animal diseases for which animal health rules are laid down in Regulation (EU) 2016/429. 
2. The official veteri narian shall ensure that any additional laborat ory testing deemed necessar y for the fulfilme nt the 
oblig ations under Article 18(2) of Regulation (EU) 2017/625 take s place as required. 
Section 5 
Off icial controls on animal welfare 
Article 38 
Official controls on animal welfare at transpor t and slaughter 
The official veter inar ian shall verify compl iance with the rules concer ning the prot ection of animals during transpor t in 
accordance with Regulation (EC) No 1/2005 and at the time of slaughter in accordance with Regulation (EC) 
No 1099/2009 and national rules on animal welfare. 17.5.2019 L 131/74 Official Jour nal of the European Union EN     CHAPTER III 
Communication of inspection results and measur es to be taken by compe tent author ities in cases of 
specific non-compliance with requir ements for fresh meat and for animal welfare 
Article 39 
Measures concer ning the communication of the results of official controls 
1. The official veterinar ian shall record and evaluate the results of official controls carried out in accordance with 
Articles 7 to Article 38. 
2. The follo wing actions shall be taken by the official veteri narian where inspections reveal the presence of any 
disease or condition that might affect human or animal health, or compr omise animal welf are: 
(a)  the official veter inar ian shall inform the slaughterhous e operat or; 
(b)  where the problem referred to in this paragraph arose during primar y production and relates to human health, 
animal health, animal welf are or residues of veteri nary medicinal products, unauthor ised or prohibited substances, 
pesticide residues, feed additives or contaminants, the official veter inar ian shall inform: 
(i)  the veterinar ian attending the holding of provenance; 
(ii)  the official veteri narian who carried out any ante-mor tem inspection at the holding of provenance, where 
diffe rent from (i); 
(iii)  the food business operat or responsible for the holding of proven ance (prov ided that such information would 
not prejudice subsequent lega l proceedings); and, 
(iv)  the compet ent author ities responsible for super vising the holding of proven ance or the hunting area; 
(c)  where the animals concer ned were raised in another countr y, the official veterinar ian shall ensure that the countr y's 
compet ent author ities are informed. 
3. The compet ent author ities shall enter the results of official controls in relevant databases, at least where the 
collection of such information is required under Article 4 of Directive 2003/99/EC, Article 8 of Council Directive 
64/432/EEC (41) and Annex III to Directive 2007/43/EC. 
4. Where the official veteri narian, while carrying out ante-mor tem or post-mor tem inspection or any other official 
control, suspects the presence of an animal disease for whic h animal health rules are laid down in Regulation 
(EU) 2016/429, he/she shall notify the compet ent author ities. The official veterinar ian and compet ent author ities, within 
their respective areas of compet ence, shall take all necessar y measures and precautions to prevent the possible spread of 
the disease agent. 
5. The official veterinar ian may use the model document in Annex I for the purpose of communicating the relevant 
results of ante-mor tem and post-mor tem inspections to the holding of provenance where the animals were kept before 
slaughter . 
6. Where the animals were kept on a holding of proven ance in another Member State, the compe tent author ities of 
the Member State in which they were slaughter ed shall communicat e the relevant results of ante-mor tem and 
post-mor tem inspections to the compet ent author ities in the Member State of provena nce. They shall use the model 
document in Annex I in the official language s of both Member States involved or in a language agreed between both 
Member States. 
Article 40 
Measures in cases of non-compliance with requirements for food chain informa tion 
1. The official veterinar ian shall ensure that animals are not slaughtered unless the slaughterhouse operat or has been 
provid ed with, check ed and evaluated relevant food chain information in accordance with Article 9(2)(a) and (b). 17.5.2019 L 131/75 Official Jour nal of the European Union EN     
(41)Council Directive 64/432/EEC of 26 June 1964 on animal health problems affec ting intra-Community trade in bovine animals and 
swine (OJ L 121, 29.7.1964, p. 1977). 2. By way of derogat ion from paragraph 1, the official veteri narian may allow animals to undergo slaughter in the 
slaughter house if the relevant food chain information is not available. In such cases, the information shall be supplied 
before the meat is declared fit for human consum ption and carcases and related offal shall be stored separate ly from 
other meat pending that declaration. 
3. Where relevant food chain information is not available within 24 hours of an animal's arrival at the slaugh ­
terhouse, the official vete rinar ian shall declare all meat from the animal unfit for human consump tion. If the animal has 
not yet been slaughtered, it shall be killed separate ly from other animals taking all necessar y precautions to safeguard 
animal and human health. 
Article 41 
Measures in cases of non-compliance recorded in food chain information 
1. The official veteri narian shall verify that the slaughte rhouse operat or does not accept animals for slaughter when 
the food chain information or any other accompan ying records, documentation or information shows that: 
(a)  the animals come from a holding of provenance or an area subject to a movement prohibition or other restr iction 
for reasons of animal or human health; 
(b)  rules on the use of veterinar y medicinal products have not been complied with, animals have been treated with 
prohibit ed or unauthor ised substances, or the legal limits for chemical residues or contaminants have not been 
compl ied with; or 
(c)  any other condition whic h might adversely affect human or animal health is present. 
2. If the animals are already present at the slaughterh ouse, they shall be killed separately and declared unfit for 
human consum ption, taking precautions to safegua rd animal and human health. Where the official veterinar ian 
considers it necessar y, official controls shall be carried out on the holding of provenance. 
Article 42 
Measures in cases of misleading food chain informa tion 
1. The compet ent author ities shall take appropr iate action if they discover that the accompan ying records, documen ­
tation or other information do not correspond to the true situation of the holding of proven ance or the true condition 
of the animals, or aim deliberately to mislead the official veteri narian. 
2. They shall take action against the food business operator responsible for the holding of provenance of the animals, 
or any other person involved, including the slaughter house operator . In particular , this action may consist of extra 
controls. The food business operator responsible for the holding of provena nce or any other person involved shall bear 
the costs of such extra controls. 
Article 43 
Measures in cases of non-compliance with requirements for live animals 
1. The official veteri narian shall verify the food business operat or's compl iance with its duty under point 3 in 
Chapt er IV of Section I of Annex III to Regulation (EC) No 853/2004 to ensure that animals accept ed for slaughter for 
human consump tion are properly identified. The official veteri narian shall ensure that animals whose identity is not 
ascer tainable are killed separate ly and declared unfit for human consum ption. Where the offici al veteri narian considers it 
necessar y, official controls shall be carried out on the holding of proven ance. 
2. The official veterinar ian shall ensure that animals subject to an unaccep table risk of contamination of the meat 
during slaughter , as laid down in Article 11(4), are not slaughtered for human consump tion unless they are cleaned 
beforehand. 
3. The official vete rinar ian shall ensure that animals with a disease or condition that may be transmitte d to animals 
or humans handling or eating the meat and, in general, animals showi ng clinical signs of systemic disease or emaciation, 
or any other condition render ing meat unfit for human consump tion, are not slaughtered for human consum ption. Such 
animals shall be killed separate ly under such conditions that other animals or carcases cannot be contaminated , and 
declared unfit for human consum ption. 17.5.2019 L 131/76 Official Jour nal of the European Union EN     4. The offici al veteri narian shall defe r the slaughter of animals suspecte d of having a disease or condition that may 
adversely affect human or animal health. Such animals shall undergo detailed ante-mor tem examination by the official 
veterinar ian in order to make a diagnosis. In addition, the official veteri narian may decide that sam pling and laborat ory 
examinations must take place to supplement post-mor tem inspection. If necessar y to avoid contamination of other 
meat, the animals shall be slaughtered separately or at the end of normal slaughteri ng, taking all other necessar y 
precautions. 
5. The official veteri narian shall ensure that animals that might contain residues of prohibited or unauthor ised 
phar macologically active substances or residues of author ised phar macologically active substances, pesticides or 
contaminants in excess of the levels laid down in accordance with Union legislation, are dealt with in accordance with 
Articles 16 to 19 of Directive 96/23/EC. 
6. The official veterinar ian shall impose the conditions under whic h animals shall be dealt with under a specifi c 
schem e for the eradication or control of a specifi c disease, such as brucellosis or tuberculosis, or zoonotic agents such as 
salmonella, under his/her direct super vision. The compet ent author ities shall determine the conditions under whic h such 
animals may be slaughter ed. These conditions shall be designed to minimise the contamination of other animals and the 
meat of other animals. 
As a rule, animals that are present ed to a slaughterhouse for slaughter shall be slaughter ed there. However , in 
excep tional circumstances, such as a serious breakdown of the slaughter facilities, the official veteri narian may allow 
direct move ments to another slaughter house. 
Where non-complian ce which results in a risk to animal or human health, or animal welfa re, is detec ted during 
ante-mor tem inspection at the holding of provenance, the official veterinar ian shall not allow the animals to be 
transpor ted to the slaughter house and the relevant measures regarding the communication of inspection results in 
accordance with Article 39(2)(b)(i) and (iii) shall apply . 
Article 44 
Measures in cases of non-compliance with requirements for animal welfare 
1. In cases of non-comp liance with the rules concer ning the protection of animals at the time of slaughter or killing 
laid down in Articles 3 to 9 and Articles 14 to 17, 19 and 22 of Council Regulation (EC) No 1099/2009, the offici al 
veterinar ian shall verify that the food business operator immediat ely takes the necessar y corrective measures and 
prevents recur rence. 
2. The official veterinar ian shall take a propor tionate and stepped approach to enforcement action, ranging from 
issuing directions to slowing down and stopping production, depending on the nature and grav ity of the problem. 
3. Where appropr iate, the offici al veteri narian shall inform other compet ent author ities of welf are problems. 
4. Where the official vete rinar ian discovers non-com pliance with the rules concer ning the prot ection of animals 
during transpor t laid down in Regulation (EC) No 1/2005, he/she shall take the requisit e measures in accordance with 
the relevant Union legislation. 
5. Where an official auxiliar y carries out checks on animal welfare and those checks identify non-com pliance with 
the rules on the prot ection of animals, he/she shall immediately inform the official veterinar ian. If necessar y in urgent 
cases, he/she shall take the necessar y measures refer red to in paragraphs 1 to 4 pending the arrival of the offici al 
veterinar ian. 
Article 45 
Measures in cases of non-compliance with requirements for fresh meat 
The official veterinar ian shall declare fresh meat unfit for human consump tion if it: 
(a)  derives from animals that have not undergone ante-mor tem inspection in accordance with Article 18(2)(a) or (b) of 
Regulation (EU) 2017/625, excep t for wild game and stray reindeer refer red to in Article 12(1)(b) of Delegat ed 
Regulation (EU) 2019/624; 17.5.2019 L 131/77 Official Jour nal of the European Union EN     (b)  derives from animals whose offal has not undergone post-mor tem inspection in accordance with Article 18(2)(c) of 
Regulation (EU) 2017/625, excep t in case of viscera of large wild game that do not need to accompan y the body to 
a game- handling establishment in accordance with point 4 of Chapt er II of Section IV in Annex III of Regulation 
(EC) No 853/2004; 
(c)  derives from animals that are dead before slaughter , stillbor n, unbor n or slaughter ed under the age of seven days; 
(d)  results from the trimming of sticking points; 
(e)  derives from animals affected by animal diseases for which animal health rules are laid down in the Union 
legislation listed in Annex I to Directive 2002/99/EC, excep t if it is obtained in conf ormity with the specifi c 
requirements provided for in that Directive; this excep tion shall not apply if other wise provided for in the 
requirements on the official controls of tuberculosis and brucellosis provi ded for in Articles 33 and 34 of this 
Regulation; 
(f)  derives from animals affected by a general ised disease, such as generalised septicaemia, pyaemia, toxaemia or 
viraemia; 
(g)  is not in conf ormity with the food safety criteria laid down in Chapt er I of Annex I to Regulation (EC) 
No 2073/2005 for determining whether food may be placed on the mark et; 
(h)  exhibits parasitic infestation, unless other wise provi ded for in the requirements on the official controls for 
cysticercosis provid ed for in Article 30; 
(i)  contains chemical residues or contaminants in exce ss of the levels laid down in Regulations (EU) No 37/2010, (EC) 
No 396/2005, (EC) No 1881/2006 and (EC) No 124/2009 or residues of substances that are prohibit ed or 
unauthor ised under Regulation (EU) No 37/2010 or Directive 96/22/EC; 
(j)  consists of the liver and kidne ys of animals more than two years old from regions where implementation of plans 
approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals 
in the environment ; 
(k)  has been treated illegal ly with decontaminating substances; 
(l)  has been treated illegal ly with ionising radiation, including UV-radiation; 
(m)  contains foreign bodies, excep t, in the case of wild gam e, mat erial used to hunt the animal; 
(n)  exceed s maximum permitted radioactivity levels laid down under Union legislation or, in the absence of Union 
legislation, under national rules; 
(o)  indicates pathological or organoleptic chang es, in particular a pronounced sexual odour or insufficient bleeding 
(except for wild game); 
(p)  derives from emaciated animals; 
(q)  contains specified risk mate rial unless remo val is allowed in another establishment in accordance with Point 4.3 of 
Annex V to Regulation (EC) No 999/2001 and the fresh meat remains under the control of the compet ent 
author ities; 
(r)  shows soiling, faecal or other contamination; 
(s)  consists of blood that may constitut e a risk to human or animal health owing to the health status of any animal 
from whic h it derives or contamination arising during the slaughter process; 
(t)  in the opinion of the official veterinar ian, after examination of all the relevant information, may constitute a risk to 
human or animal health or is for any other reason not suitable for human consump tion; 
(u)  gives rise to specif ic hazards in accordance with Articles 29 to 36. 17.5.2019 L 131/78 Official Jour nal of the European Union EN     Article 46 
Measures in cases of non-compliance with requirements on good hygiene practices 
1. The compet ent author ities may instr uct the food business operat or to take immediate corrective action, including 
a reduction in the speed of slaughter , where this is considered necessar y by the official present in the following cases: 
(a)  where contamination is detect ed on exte rnal surfaces of a carcase or its cavities and the food business operat or does 
not take appropr iate action to rectify the situation; or 
(b)  if the compet ent author ities consider that good hygiene practices are jeopardised. 
2. In such cases, the compet ent author ities shall increase the intensity of inspection until such time as they are 
satisfied that the food business operat or has regai ned control of the process. 
CHAPTER IV 
Restr ictions 
Article 47 
Restr ictions for certain fresh meat 
The official veterinar ian may impose requirements concer ning the use of fresh meat derived from animals: 
(a)  that have undergone emerg ency slaughter outside the slaughter house; or 
(b)  from flocks where a treatment of the meat is applied in accordance with Part E of Annex II to Regulation (EC) 
No 2160/2003 before the meat is placed on the mark et. 
CHAPTER V 
Health marking of meat fit for human consumption after ante-mor tem and post-mor tem inspection 
Article 48 
Technical requirements of the health mark and practical arrangements for its application 
1. The official veterinar ian shall super vise health marking and the marks used. 
2. The official veterinar ian shall ensure, in particular , that: 
(a)  the health mark is applied only to domestic ungulate s and farmed game mammals other than lagomor phs, having 
undergone ante-mor tem and post-mor tem inspection, and large wild game having undergone post mor tem 
inspection, in accordance with Article 18(2)(a), (b) and (c) of Regulation (EU) 2017/625, where there are no grounds 
for declar ing the meat unfit for human consump tion. However , the mark may be applied before the results of any 
examination for Trichinella and/or TSE testin g are available, provi ded that the compet ent author ities introduced 
a syste m in place in the slaughterhouse or game- handling establishment ensur ing that all parts of the animal can be 
traced, and no parts of the examined animals bear ing the mark leav e the slaughter house or game- handling 
establishment until a negativ e result has been obtained exce pt when provi ded for in accordance with Article 2(3) of 
Regulation (EU) 2015/1375; 
(b)  the health mark is applied on the exte rnal surface of the carcase, by stamping in ink or hot branding, in such 
a manner that, if carcases are cut in the slaughter house into half carcases or quar ters, or half carcases are cut into 
three pieces, each piece bears a health mark. 
3. The compet ent author ities shall ensure that the practical arrangements for the health mark are applied in 
accordance with Annex II. 
4. The compet ent author ities shall ensure that meat from unskinned wild game does not bear a health mark until, 
after skinning in a gam e-handling establishment, it has undergone post-mor tem inspection and been declared fit for 
human consum ption. 17.5.2019 L 131/79 Official Jour nal of the European Union EN     TITLE IV 
SPECIFIC REQUIREMENTS AND UNIF ORM MINIMUM FREQUENCY OF OFFICIAL CONTR OLS WITH 
RESPECT TO RAW MILK, COL OSTR UM, DAIR Y PRODUCTS AND COL OSTR UM-BASED PRODUCTS, AS 
NECESSAR Y TO RESPOND TO RECOGNISED UNIF ORM HAZARDS AND RISK S 
Article 49 
Control of milk and colostr um production holdings 
1. The official veterinar ian shall verify that the health requirements for raw milk and colostr um production as laid 
down in Part I of Chapt er I of Section IX of Annex III to Regulation (EC) No 853/2004 are compl ied with. In particular , 
the official veteri narian shall verify: 
(a)  the health status of the animals; 
(b)  the absence of the use of prohibit ed or unauthor ised phar macologically active substances; and 
(c)  that the possible presence of residues of author ised phar macologically active substances, pesticides or contaminants 
does not exce ed the levels laid down in Regulations (EU) No 37/2010, (EC) No 396/2005 or (EC) No 1881/2006. 
2. The official controls refer red to in paragraph 1 may take place at the occasion of vete rinar y chec ks carried out 
pursuant to Union provisions on animal or human health or animal welfa re. 
3. If there are grounds for suspecting that the health requirements refer red to in paragraph 1 are not being compl ied 
with, the official veterinar ian shall check the general health status of the animals. 
4. Milk and colostr um production holdings shall undergo official controls by the compet ent author ities to verify that 
hygiene requirements laid down in Part II of Chapt er I of Section IX of Annex III to Regulation (EC) No 853/2004 are 
being complied with. These controls may involve inspections and the monitor ing of controls carried out by professional 
organisations. If it is demonstrate d that the hygiene is inadequat e, the compet ent author ities shall verify that appropr iate 
step s are taken to correct the situation. 
Article 50 
Control of milk and colostr um 
1. In the case of raw milk and colostr um, the compet ent author ities shall monitor the checks carried out in 
accordance with Part III of Chapt er I, Section IX of Annex III to Regulation (EC) No 853/2004. When testing is used, the 
compet ent author ities shall use the analytical methods set out in Annex III to this Regulation to chec k compl iance with 
the limits laid down for raw milk and colostr um in Part III of Chapt er I, Section IX of Annex III to Regulation (EC) 
No 853/2004. 
2. If the food business operat or of the production holding has not corrected the situation within three months of the 
first notifi cation to the compe tent author ities of non-com pliance with the plate count and/or somatic cell count criteria 
for raw milk and colostr um, the compe tent author ities shall verify that: 
(a)  deliver y of raw milk and colostr um from the production holding is suspended, or 
(b)  the raw milk and colostr um is subject ed to requirements concer ning its treatment and use necessar y to protect 
human health in accordance with a specifi c author isation of, or general instr uctions from the compet ent author ities. 
This suspension or these requirements shall remain in place by the compet ent author ities until the food business 
operat or has proved that the raw milk and colostr um again compl y with the criteria. 
3. The compet ent author ities shall use the analytical methods set out in Annex III of this Regulation to verify 
appropr iate application of a past eurisation process to dair y products as referred to in Part II of Chapt er II, Section IX of 
Annex III to Regulation (EC) No 853/2004. 17.5.2019 L 131/80 Official Jour nal of the European Union EN     TITLE V 
SPECIFIC REQUIREMENTS FOR OFFICIAL CONTR OLS CONC ERNING LIVE BIVALVE MOLLUSCS FROM 
CLASSIFIED PRODUCTION AND REL AYING AREAS 
Article 51 
Exclusion 
This Title applies to live bivalve molluscs. It also applies to live echinoder ms, live tunicate s and live mar ine 
gastropods. This Title does not apply to live mar ine gastropods and live Holothuro idea that are not filter feeders. 
Article 52 
Classif ication of production and relaying areas for live bivalv e molluscs 
1. The compet ent author ities shall fix the location and boundar ies of the production and relaying areas that they 
classify in accordance with Article 18(6) of Regulation (EU) 2017/625. They may, where appropr iate, do so in 
cooperation with the food business operator . 
2. The compet ent author ities shall classify production and relaying areas from which they author ise the harvesting of 
live bivalve molluscs as Class A, Class B and Class C areas according to the level of faecal contamination. They may, 
where appropr iate, do so in cooperation with the food business operator . 
3. In order to classify production and relaying areas, the compet ent author ities shall fix a review period for samp ling 
data from each production and relaying area in order to determine compliance with the standards refer red to in 
Articles 53, 54 and 55. 
CHAPTER I 
Specific requir ements for the classification of production and relaying areas for live bivalve molluscs 
Article 53 
Requirements for Class A areas 
1. The compet ent author ities may classify as Class A areas those from which live bivalve molluscs may be collect ed 
for direct human consum ption. 
2. Live bivalve molluscs placed on the market from such areas shall meet the health standards for live bivalve 
molluscs set out in Chapt er V of Section VII of Annex III to Regulation (EC) No 853/2004. 
3. Sam ples of live bivalve molluscs from Class A areas shall not exceed , in 80 % of sample s collect ed during the 
review period, 230 E. coli per 100 g of flesh and intra valvular liquid. 
4. The remaining 20 % of samp les shall not exceed 700 E. coli per 100 g of flesh and intra valvular liquid. 
5. When evaluating the results for the fixed review period for maintenance of a Class A area, the compet ent 
author ities may, on the basis of a risk assessment based on an inve stigation, decide to disregard an anomalous result 
exceed ing the level of 700 E. coli per 100 g of flesh and intravalv ular liquid. 
Article 54 
Requirements for Class B areas 
1. The compet ent author ities may classify as Class B areas those from whic h live bivalve molluscs may be collected 
and placed on the market for human consump tion only after treatment in a purification centre or after relaying so as to 
meet the health standards refer red to in Article 53. 
2. Live bivalve molluscs from Class B areas shall not exceed , in 90 % of the samples , 4 600 E. coli per 100 g of flesh 
and intra valvular liquid. 17.5.2019 L 131/81 Official Jour nal of the European Union EN     3. The remaining 10 % of samp les shall not exceed 46 000 E. coli per 100 g of flesh and intravalvular liquid. 
Article 55 
Requirements for Class C areas 
1. The compet ent author ities may classify as Class C areas those from which live bivalve molluscs may be collected 
and placed on the market only after relaying over a long period so as to meet the health standards referred to in 
Article 53. 
2. Live bivalve molluscs from Class C areas shall not exceed 46 000 E. coli per 100 g of flesh and intra valvular liquid. 
Article 56 
Sanit ary survey requirements 
1. Before classifying a production or relaying area, the compet ent author ities shall carry out a sanitar y survey that 
includes: 
(a)  an inve ntor y of the sources of pollution of human or animal origin likely to be a source of contamination for the 
production area; 
(b)  an examination of the quantities of organic pollutants released during the different periods of the year, according to 
the seasonal variations of human and animal populations in the catchm ent area, rainfall readings, waste -water 
treatment, etc.; 
(c)  determi nation of the charact eristics of the circulation of pollutants by virtue of current patt erns, bathyme try and the 
tidal cycle in the production area. 
2. The compet ent author ities shall carry out a sanitar y survey fulfilling the requirements set out in paragraph 1 in all 
classified production and relaying areas, unless carried out previously . 
3. The compet ent author ities may be assisted by other official bodies or food business operat ors under conditions 
established by the compet ent author ities in relation to the performa nce of this survey. 
Article 57 
Monit oring prog ramme 
The compet ent author ities shall establish a monitori ng programme for live bivalve mollusc production areas that is 
based on an examination of the sanitar y survey refer red to in Article 56. The number of samples, geographical 
distr ibution of sampling points and sampling frequency for the programme shall ensure that the results of the analysis 
are representative of the area in question. 
Article 58 
The compet ent author ities shall establish a procedure to ensure that the sanitar y survey refer red to in Article 56 and the 
monitoring programme referred to in Article 57 are representative of the area considered. 
CHAPTER II 
Conditions for the monitor ing of classified production and relaying areas for live bivalve molluscs 
Article 59 
Monitori ng of classif ied production and relayi ng areas 
The compet ent author ities shall periodically monitor production and relaying areas classified in accordance with 
Article 18(6) of Regulation (EU) 2017/625 in order to chec k: 
(a)  that there is no malpractice with regard to the origin, proven ance and destination of live bivalve molluscs; 17.5.2019 L 131/82 Official Jour nal of the European Union EN     (b)  the microbiological quality of live bivalve molluscs in relation to the classified production and relaying areas; 
(c)  for the presence of toxin-producing plankt on in production and relaying water s and mar ine biot oxins in live bivalve 
molluscs; 
(d)  for the presence of chemical contaminants in live bivalve molluscs. 
Article 60 
Recognised methods for the detection of mar ine bioto xins in live bivalv e molluscs 
1. The compet ent author ities shall use the analytical methods laid down in Annex V to check compl iance with the 
limits laid down in point 2 of Chapt er V of Section VII of Annex III to Regulation (EC) No 853/2004 and, where 
appropr iate, to verify compl iance by food business operat ors. Food business operat ors shall use these methods where 
appropr iate. 
2. In accordance with Article 4 of Directive 2010/63/EU, a scientific ally satisfact ory method or testing strate gy, not 
entailing the use of live animals, shall be used where possible, instead of a procedure as defined in Article 3(1) of that 
Directive. 
3. In accordance with Article 4 of Directive 2010/63/EU, elements of replacement, refinement and reduction must be 
take n into account when biological methods are used. 
Article 61 
Sampling plans 
1. For the purposes of the checks provid ed for in points (b), (c) and (d) of Article 59, the compet ent author ities shall 
draw up sam pling plans providin g for such chec ks to take place at regular inter vals, or on a case-by- case basis if 
harvesting periods are irregular . The geographical distr ibution of the sampling points and the sam pling frequency shall 
ensure that the results of the analysis are representative of the classified production and relaying area concer ned. 
2. Sam pling plans to check the microbiological quality of live bivalve molluscs shall take particular account of: 
(a)  the likely variation in faecal contamination; 
(b)  the parameter s refer red to in Article 56(1). 
3. Sam pling plans to chec k for the presence of toxin-producing plankt on in the water in classifie d production and 
relaying areas and for mar ine bioto xins in live bivalve molluscs shall take particular account of possible variations in the 
presence of plankt on containing mar ine bioto xins. Sam pling shall compris e: 
(a)  periodic sampli ng to detect changes in the composition of plankton containing toxins and their geographical 
distr ibution. Results suggesting an accumulation of toxins in live bivalve mollusc flesh shall be follo wed by intensive 
sampli ng; 
(b)  periodic toxicity tests using live bivalve molluscs from the affect ed area most susceptible to contamination. 
4. The sam pling frequency for toxin analysis in live bivalve molluscs shall be weekly during harvesting periods, 
excep t when: 
(a)  the sampli ng frequency may be reduced in specif ic classified relaying or production areas, or for specifi c types of 
live bivalve mollusc, if a risk assessment of toxins or phyt oplankt on occur rence sugges ts a very low risk of toxic 
episodes; 
(b)  the sampli ng frequency shall be increased where such an assessment sugge sts that weekly sam pling would not be 
suffi cient. 
5. The risk assessment referred to in paragraph 4 shall be reviewed periodically in order to assess the risk of toxins 
occur ring in the live bivalve molluscs from these areas. 17.5.2019 L 131/83 Official Jour nal of the European Union EN     6. Where knowledg e of toxin accumulation rates is available for a group of species growing in the same classif ied 
production or relaying area, the species with the highest rate may be used as an indicator species. This will allow the 
exploitation of all species in the group if toxin levels in the indicator species are below the regulator y limits. Where 
toxin levels in the indicator species are abov e the regulat ory limits, the harvesting of the other species may be allowed 
only if further analysis of the other species shows toxin levels below the limits. 
7. With regar d to the monitoring of plankt on, the samples shall be representative of the wate r column in the 
classified production or relaying area and provid e information on the presence of toxic species and on population 
trends. If any changes in toxic populations that may lead to toxin accumulation are detected , the sampli ng frequency for 
live bivalve molluscs shall be increased or precautionar y closures of the areas established until results of toxin analysis 
are obtained. 
8. Sam pling plans to check for the presence of chemical contaminants shall enable the detection of any overshooting 
of the levels laid down in Regulation (EC) No 1881/2006. 
CHAPTER III 
Manag ement of classified produ ction and relaying areas after monitor ing 
Article 62 
Decisions following monit oring 
1. Where the results of the monitoring provid ed for in Article 59 indicate that the health standards for live bivalve 
molluscs are not met or that there may other wise be a risk to human health, the compet ent author ities shall close the 
classified production or relaying area concer ned, preventing the harvesting of live bivalve molluscs. However , they may 
reclassify a production or relaying area as being of Class B or C if it meets the relevant criteria set out in Articles 54 
and 55 and presents no other risk to human health. 
2. Where the results of microbiological monitor ing show that the health standards for live bivalve molluscs refer red 
to in Article 53 not met, compet ent author ities may, on the basis of a risk assessment, and only on a temporar y and 
non-recur ring basis, permit continued harvesting without closure or reclassif ication subject to the followi ng conditions: 
(a)  the classified production area concer ned and all appro ved establishments receiving live bivalve molluscs from it are 
under the official control of the same compet ent author ities; 
(b)  the live bivalve molluscs concer ned are subjected to appropr iate restr ictive measures such as purification, relaying or 
processing. 
3. The accompan ying registration document, as refer red to in Chapt er I of Section VII of Annex III to Regulation (EC) 
No 853/2004, shall include all the information concer ning the application of paragraph 2. 
4. The compet ent author ities shall establish the conditions under which paragraph 2 can be availed of in order to 
ensure, for the production area concer ned, maintenanc e of the compl iance with the criteria established in Article 53. 
Article 63 
Re-opening of production areas 
1. The compet ent author ities may re-open a closed production or relaying area only if the health standards for live 
bivalve molluscs compl y once again with the relevant requirements of Chapt er V of Section VII of Annex III to 
Regulation (EC) No 853/2004 and present no other risk to human health. 
2. Where the compet ent author ities have closed a production or relaying area because of the presence of plankt on or 
levels of toxins in live bivalve molluscs that exce ed the regulatory limit for mar ine bioto xins laid down in point 2 of 
Chapt er V of Section VII of Annex III to Regulation (EC) No 853/2004, they may re-open it only if at least two 
consecutive analytical results separated by at least 48 hours are below the regulatory limit. 
3. When deciding whether to re-open a production or relaying area, the compe tent author ities may take account of 
information on phytopl ankton trends. 17.5.2019 L 131/84 Official Jour nal of the European Union EN     4. Where there are robust data on the dynamic of the toxicity for a given area, and provi ded that recent data on 
decreasing trends of toxicity are available, the compet ent author ities may decide to re-open an area with results below 
the regulatory limit in point 2 of Chapt er V of Section VII of Annex III to Regulation (EC) No 853/2004 obtained from 
a sing le sampli ng. 
Article 64 
Control system 
1. The compet ent author ities shall set up a control system to ensure that products of animal origin harmful to 
human health are not placed on the mark et. The control syste m shall comprise laborat ory tests to verify food business 
operat ors' compl iance with the requirements for the end product, including live bivalve molluscs and any products 
derived from them, at all stages of production, processing and distr ibution. 
2. This control system shall verify, where applicable, that the levels of mar ine bioto xins and contaminants do not 
exceed safety limits and that the microbiological quality of the molluscs does not constitute a hazard to human health. 
Article 65 
Decision by the competent author ities 
1. The compet ent author ities shall act promp tly where a production area must be closed or reclassified, or may be 
re-opened, or where live bivalve molluscs are subject to the application of measures as refer red to in Article 62(2). 
2. When deciding on the classif ication, reclassif ication, opening or closure of production areas in accordance with 
Articles 52, 62 and 63, compet ent author ities may take into account the results of checks carried out by food business 
operat ors or organisations representing food business operators, only if the laborat ory carrying out the analysis is 
designat ed by the compet ent author ities, and the sampling and analysis are perf ormed in accordance with a prot ocol 
agreed upon jointly by the compet ent author ities and food business operators or organisation concer ned. 
CHAPTER IV 
Other requir ements 
Article 66 
Recording and exchange of information 
The compet ent author ities shall: 
(a)  establish and keep up to date a list of classified production and relaying areas, with details of their location, and 
boundar ies, as well as the Class in whic h the area is classified, from which live bivalve molluscs may be taken in 
accordance with the requirements of Article 52. This list shall be communicated to interest ed parties affected by this 
Regulation, such as producers, gatherers and operat ors of purification centres and dispatch centres; 
(b)  immediately inform the interest ed parties such as producers, gatherers and operat ors of purification centres and 
dispatch centres, of any change to the location, boundar ies or Class of a production area, of its temporar y or final 
closure, or of the application of measures as refer red to in Article 60(2). 
TITLE VI 
SPECIFIC REQUIREMENTS AND UNIF ORM MINIMUM FREQUENCY OF OFFICIAL CONTR OLS WITH 
RESPECT TO FISHER Y PRODUCTS 
Article 67 
Official controls on production and placing on the market 
Offi cial controls on the production and placing on the mark et of fisher y products shall include verification of 
compl iance with the requirements set out in Section VIII of Annex III to Regulation (EC) No 853/2004, in particular: 
(a)  a regular check on the hygiene conditions of landing and first sale; 17.5.2019 L 131/85 Official Jour nal of the European Union EN     (b)  regular inspections of vessels and establishments on land, including fish auctions and wholesale mark ets, in 
particular to check: 
(i)  whether the conditions for approval are still fulfilled; 
(ii)  whether the fisher y products are handled correctly ; 
(iii)  compl iance with hygiene and temperature requirements; 
(iv)  the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene; 
(c)  checks on storage and transpor t conditions. 
Article 68 
Site of official controls 
1. The compet ent author ities shall carry out official controls on vessels when these call at a port in a Member State . 
These controls shall concer n all vessels landing fisher y products at EU ports, irrespective of flag. 
2. Flag state compet ent author ities may carry out official controls on vessels under their flag while the vessel is at sea 
or in a port in another Member State or a third countr y. 
Article 69 
Appro val of facto ry, freezer or reefer vessels 
1. Where a factory, freezer or reefe r vessel flying the flag of a Member State is inspecte d with a view to granting 
approval of the vessel, the compe tent author ities of the flag Member State shall carry out official controls in accordance 
with Article 148 of Regulation (EU) 2017/625, particularly the time limits refer red to in Article 148(4). If necessar y, 
they may inspect the vessel while it is at sea or in a port in another Member State or a third countr y. 
2. Where the compet ent author ities of the flag Member State have granted the vessel conditional approval in 
accordance with Article 148 of Regulation (EU) 2017/625, they may author ise the compet ent author ities of another 
Member State, or of a third countr y to carry out follow-up controls with a view to granting full approval, prolonging 
conditional appro val or keeping approval under review , provi ded that, in the case of a third countr y, such countr y 
appears on a list of third countr ies from which impor ts of fisher y products are permitted pursuant to Article 127 of 
Regulation (EU) 2017/625. If necessar y, these compet ent author ities may inspect the vessel while it is at sea or in a port 
in another Member State or third countr y. 
3. Where the compet ent author ities of a Member State author ise the compet ent author ities of another Member State 
or of a third countr y to carry out controls on their behalf in accordance with this Article, the two compet ent author ities 
shall agree on the conditions govern ing such controls. These conditions shall ensure, in particular , that the compet ent 
author ities of the flag Member State receive repor ts on the results of the controls and on any suspect ed non-com pliance 
without dela y, so as to enable them to take the necessar y measures. 
Article 70 
Official controls of fisher y products 
Offi cial controls of fisher y products shall include at least the practical arrang ements laid down in Annex VI as regards: 
(a)  organoleptic examinations; 
(b)  freshness indicators ; 
(c)  histamine; 
(d)  residues and contaminants; 
(e)  microbiological checks; 
(f)  parasites ; 
(g)  poisonous fisher y products. 17.5.2019 L 131/86 Official Jour nal of the European Union EN     Article 71 
Decisions after controls 
The compet ent author ities shall declare fisher y products unfit for human consum ption if: 
(a)  official controls carried out in accordance with Article 70 reveal they are not in compl iance with organolept ic, 
chemical, physical or microbiological requirements or requirements for parasite s as established in Section VII of 
Annex III of Regulation (EC) No 853/2004 and/or Regulation (EC) No 2073/2005; 
(b)  they contain in their edible parts chemical residues or contaminants in excess of the levels laid down in Regulations 
(EU) No 37/2010, (EC) No 396/2005, (EC) No 1881/2006, or residues of substances that are prohibit ed or 
unauthor ised in accordance with Regulation (EU) No 37/2010 or Directive 96/22/EC, or are not in compl iance with 
any other relevant Union legislation on phar macologically active substances; 
(c)  they derive from: 
(i)  poisonous fish; 
(ii)  fisher y products not compl ying with the requirements on mar ine bioto xins; 
(iii)  live bivalve molluscs, echinoder ms, tunicate s or mar ine gastropods containing mar ine biot oxins in total 
quantities excee ding the limits referred to in Regulation (EC) No 853/2004; or 
(d)  the compet ent author ities consider that they may constitut e a risk to human or animal health or are for any other 
reason not suitable for human consump tion. 
Article 72 
Requirements concer ning the official controls on fisher y products caught by vessels flying the flag 
of Member States enter ing the Union after being transfe rred in third countr ies with or without 
storage 
1. Fisher y products intended for human consump tion caught by vessels flying the flag of a Member State , unloaded, 
with or without storag e, in third countr ies liste d as provid ed for in Article 126(2)(a) of Regulation (EU) 2017/625 
before entering the Union by a diffe rent means of transpor tation, shall be accompan ied by a health certificate issued by 
the compet ent author ities of that third countr y and compl eted in accordance with the model health certificate set out in 
Chapt er B of Part II to Annex III to Implementing Regulation (EU) 2019/628. 
2. If the fisher y products refer red to in paragraph 1 are unloaded and transpor ted to a storage facility locat ed in the 
third countr y refer red to in that paragraph, that storag e facility shall appear in a list as provided for in Article 5 of 
Delegat ed Regulation (EU) 2019/625. 
3. If the fisher y products refer red to in paragraph 1 are loaded in a vessel flying the flag of a third countr y, that third 
countr y shall be listed as provided for in Article 3 of Delegat ed Regulation (EU) 2019/625 and the vessel shall appear in 
a list as provid ed for in Article 5 of Deleg ated Regulation (EU) 2019/625. 
4. Container vessels used to transpor t container ised fisher y products are excl uded from this requirement. 
TITLE VII 
SPECIFIC REQUIREMENTS FOR THE PERFORMANCE OF OFFICIAL CONTR OLS AND UNIFORM MINIMUM 
FREQUENCY FOR OFFICIAL CONTR OLS ON REPTILE MEA T 
Article 73 
Ante-mor tem and post-mor tem inspection of reptiles 
Article 11 shall apply to the ante-mor tem inspection of rept iles. 
Articles 12, 13 and 14 shall apply to the post-mor tem inspection of reptiles. For the purpose of Article 13 (a)(i), 
a reptile will be considered as 0,5 livest ock units. 17.5.2019 L 131/87 Official Jour nal of the European Union EN     TITLE VIII 
FINAL PROVISIONS 
Article 74 
Amendments to Regulation (EC) No 2074/2005 
Regulation (EC) No 2074/2005 is amended as follo ws:  
1. Articles 5, 6b and 6c are deleted.  
2. In Annex I, Section II and the Appendix are deleted.  
3. In Annex II, Section II is delet ed.  
4. Annex es III and V are delet ed.  
5. Annex VIa is delet ed.  
6. Annex VIb and its Appendix are delet ed. 
Article 75 
Entr y in force and application 
This Regulation shall enter into force on the 20th day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 14 December 2019. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 15 Marc h 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  17.5.2019 L 131/88 Official Jour nal of the European Union EN     ANNEX I 
MODEL DOCUMENT FOR COMMUNIC ATION WITH THE HOLDING OF PROVENANCE IN ACCORD ANCE 
WITH ART ICLE 39(5) 
1. Identif ication deta ils   
1.1. Holding of provenance (owner or manage r)    
Name/number    
Full address    
Telephone number    
Electronic address if available   
1.2. Identification numbers of ............ [please specify]  
or attach list    
Total number of animals (by species)    
Identif ication problems (if any)   
1.3. Herd/f lock/cage identif ication number (if 
applicable)   
1.4. Animal species   
1.5. Reference number of health certificate (if 
applicable)  
2. Ante-mor tem findings   
2.1. Welfare    
Number of animals affect ed    
Type/class/age    
Obser vations   
2.2. Animals were delivered dirty   
2.3. Clinical findings of disease    
Number of animals affect ed    
Type/class/age    
Obser vations    
Date of inspection   
2.4. Laboratory results (1)  17.5.2019 L 131/89 Official Jour nal of the European Union EN     
(1)Microbiological, chemical, serological, etc. (include results as attached). 3. Post-mor tem findings   
3.1. Macroscopic findings    
Number of animals affect ed    
Type/class/age    
Organ or site of animal(s) affect ed    
Date of slaughter   
3.2. Disease (codes may be used (2))    
Number of animals affect ed    
Type/class/age    
Org an or site of the animal(s) affect ed    
Partially or totally condemned carcase (give reason)    
Date of slaughter   
3.3. Laboratory results (3)   
3.4. Other results   
3.5. Welfare findings  
4. Additional information  
5. Cont act deta ils of slaughterhouse (appro val number)    
Name    
Full address    
Telephone number    
Electronic address if available  
6. Official veter inar ian (print name)    
Signature and stam p  
7. Date  
8. Number of pages attached to this form:    17.5.2019 L 131/90 Official Jour nal of the European Union EN     
(2)The compet ent author ities may introduce the follo wing codes: code A for OIE-listed diseases; codes B100 and B200 for welfare issues 
and C100 to C290 for decisions concer ning meat. The coding system can, if necessar y, include further subdivisions (e.g. C141 for a mild 
generalised disease, C142 for a more severe disease, etc.). If codes are used, they must be readily avail able to the food business operat or 
with a suitable explanation of their meaning. 
(3)Microbiological, chemical, serological, etc. (include results as attached). ANNEX II 
PRA CTIC AL ARRANGEMENTS FOR THE HEAL TH MARK IN ACCORD ANCE WITH ART ICLE 48 
1.  The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bear ing the followi ng information in 
perfectly legible charact ers: 
(a)  the name of the countr y in which the establishment is locat ed, which may be written out in full in capitals or 
shown as a two-lett er code in accordance with the relevant ISO code. In the case of Member States, howe ver, 
these codes are BE, BG, CZ, DK, DE, EE, IE, GR, ES, FR, HR, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, RO, SI, 
SK, FI, SE and UK; 
(b)  the approval number of the slaughter house; and 
(c)  (when the mark is applied in an establishment locat ed in the Union) the abbreviation CE, EC, EF, EG, EK, EO, EY, 
ES, EÜ, EB, EZ, KE or WE. Those abbreviations must not appear on marks applied on meat imported into the 
Union from slaughterh ouses locat ed outside the Union. 
2.  Letter s must be at least 0,8 cm high and figures at least 1 cm high. The dimensions of the charact ers and the mark 
may be reduced for the health marking of lamb, kids and piglets. 
3.  The ink used for health marking must be author ised in accordance with Union rules on the use of colour ing 
substances in foodstuffs. 
4.  The health mark may also include an indication of the official veteri narian who carried out the health inspection of 
the meat.  17.5.2019 L 131/91 Official Jour nal of the European Union EN     ANNEX III 
TESTING METHODS FOR RAW MILK AND HEA T-TREA TED COW'S MILK IN ACCORD ANCE WITH 
ART ICLE 50 
CHAPTER I 
DETERMINA TION OF PLATE COUNT AND SOMA TIC CELL COUNT 
A.  When verifying compl iance with the criteria laid down in Part III of Section IX, Chapt er I of Annex III to Regulation 
(EC) No 853/2004, the followi ng standards must be applied as reference methods:  
1. EN ISO 4833-1 for the plate count at 30 °C;  
2. EN ISO 13366-1 for the somatic cell count. 
B.  The use of alternati ve analytical methods is acceptable:  
1. for the plate count at 30 °C, where the methods are validat ed against the reference method mentioned in point 1 
of Part A in accordance with the protocol set out in standard EN ISO 16140-2, supplement ed by standard 
EN ISO 16297 for the specific case of plate count in raw milk. 
In particular , the convers ion relationship between an altern ative method and the reference method mentioned in 
point 1 of Part A is established according to standard EN ISO 21187.  
2. for the somatic cell count, where the methods are validat ed against the reference method mentioned in point 2 of 
Part A in accordance with the protocol set out in standard ISO 8196-3 and operated in accordance with standard 
EN ISO 13366-2 or other similar intern ationally accept ed protocols. 
CHA PTER II 
DETERMINA TION OF ALKALINE PHOSPHA TASE ACTIVIT Y IN COW'S MILK 
A.  To deter mine alkaline phosphatase activity in pasteur ised cow's milk, standard EN ISO 11816-1 must be applied as 
the referen ce method. 
B.  The alkaline phosphatase activity in pasteur ised cow's milk is expressed as milli units of enzyme activity per 
litre (mU/l). A unit of alkaline phosphatase activity is the amount of alkaline phosphatase enzyme that catalyses the 
transf ormation of 1 micromole of substrate per minute . 
C.  An alkaline phosphatase test is considered to give a negative result if the measured activity in cow's milk is not 
higher than 350 mU/l. 
D.  The use of alternative analytical methods is acceptable where they are validat ed against the reference methods 
mentioned in Part A in accordance with intern ationally accept ed protocols and rules of good laboratory practices.  17.5.2019 L 131/92 Official Jour nal of the European Union EN     ANNEX IV 
REFERENCE TESTING METHOD FOR ANAL YSIS OF E. COL I IN LIVE BIVALVE MOLL USCS FOR 
CLASSIFIC ATION OF PRODUCTION AND REL AYING AREAS IN ACCORD ANCE WITH ART ICLE 52(2) 
The reference method for analysis of E. coli in live bivalve molluscs shall be the detec tion and ‘most probable number ’ 
(MPN) technique specified in ISO 16649-3. Alternative methods may be used if they are validat ed against this reference 
method in accordance with the criteria in ISO 16140.  17.5.2019 L 131/93 Official Jour nal of the European Union EN     ANNEX V 
RECOGNISED METHODS FOR THE DETECTION OF MARINE BIOTO XINS IN ACCORD ANCE WITH 
ART ICLE 60 
CHAPTER I 
PARAL YTIC SHELLFISH POISON DETECTION METHOD 
A.  The paralytic shellf ish poisoning (PSP) toxins content of the whole body or any part edible separately of bivalve 
molluscs shall be determined using AOAC official method OMA 2005.06, as published in AOAC Inter national 
Journal 88(6), 1714-1732 (Lawrence method), the mouse bioassa y or any other intern ationally recognised validate d 
method. 
B.  If the results are challeng ed, the reference method shall be AOAC official method OMA 2005.06 as refer red in 
Part A. 
CHA PTER II 
AMNESIC SHELLFISH POISON DETECTION METHOD 
A.  The amnesic shellf ish poisoning (ASP) toxins conte nt of the entire body or any part edible separately of bivalve 
molluscs shall be determi ned using the high-per formance liquid chromatograph y with ultraviolet detection 
(HPL C/UV) method or any other intern ationally recognised validat ed method. 
B.  However , for screening purposes, AOAC official method 2006.02, as published in AOAC Inter national Journal 90, 
1011-1027 (ASP enzyme-linked immunosorbent assa y (ELISA ) method), or any other internationally recognised 
validat ed method may also be used. 
C.  If the results are challenge d, the reference method shall be the HPLC/UV method. 
CHAPTER III 
LIPOPHILIC TOXIN DETECTION METHODS 
A.  The reference method for the detection of mar ine toxins as refer red to in points (c), (d) and (e) in Chapt er V(2) of 
Section VII of Annex III to Regulation (EC) No 853/2004 shall be the EU reference laboratory liquid chromato ­
graph y-mass spectrometr y/mass spectrometr y (EURL LC-MS/MS) method. This method shall determine at least the 
following compo unds: 
(a)  okadaic acid group toxins: OA, DTX1 and DTX2, including their esters (DTX3); 
(b)  pecte noto xins group toxins: PTX1 and PTX2; 
(c)  yessoto xins group toxins: YTX, 45 OH YTX, homo YTX and 45 OH homo YTX; 
(d)  azaspiracids group toxins: AZA 1, AZA 2 and AZA 3. 
If new analogues of the abov e toxins appear , for whic h a toxicity equivalent factor (TEF) has been established, they 
shall be included in the analysis. 
Total toxicity equivalence shall be calculat ed using TEFs as recommended by the European Food Safe ty Author ity 
(EFSA ) in Jour nal (2008) 589, 1-62 or any updated EFSA advice. 
B.  Methods other than those refer red to in Part A, such as the LC-MS method, HPLC with appropr iate detec tion, 
immunoassa ys and functional assa ys, such as the phosphatase inhibition assa y, may be used as alternatives to, or as 
well as, the EURL LC-MS/MS method, provi ded that: 
(a)  either alone or combined they can detec t at least the analogues identif ied in Part A; more appropr iate criteria 
shall be defined where necessar y; 17.5.2019 L 131/94 Official Jour nal of the European Union EN     (b)  they meet the method performa nce criteria stipulat ed by the EURL LC-MS/MS method. Such methods must be 
intra-laboratory validat ed and successfully tested under a recognised prof iciency test scheme. The European 
Reference Laboratory for mar ine biot oxins shall suppor t activities toward inter -laboratory validation of the 
technique to allow for formal standardisation; 
(c)  their implementation provides an equivalent level of public health prote ction. 
CHAPTER IV 
DETECTION OF NEW OR EMER GING MARINE TOXINS 
Chemical methods, alternati ve methods with appropr iate detection, or the mouse bioassa y can be used during the 
periodic monitori ng of production areas and relaying areas for detecting new or emerging mar ine toxins on the basis of 
the national control programmes elaborat ed by the Member State s.  17.5.2019 L 131/95 Official Jour nal of the European Union EN     ANNEX VI 
PRA CTIC AL ARRANGEMENTS FOR OFFICIAL CONTR OLS ON FISHER Y PRODUCTS IN ACCORD ANCE 
WITH ART ICLE 70 
CHAPTER I 
GENERAL PROVISIONS 
A.Organoleptic examinations 
Random orga noleptic controls shall be carried out at all stages of production, processing and distr ibution. One aim of 
the controls is to verify compl iance with the freshness criteria established in accordance with this Regulation. In 
particular , this includes verifying, at all stages of production, processing and distr ibution, that fisher y products at least 
meet the baselines of freshness criteria established in accordance with Council Regulation (EC) No 2406/96 (1). 
B.Freshness indicators 
When the organolep tic examination gives rise to any doubt as to the freshness of the fisher y products, sample s may 
be taken and subjected to laboratory tests to deter mine the levels of total volatile basic nitroge n (TVB-N) and 
trimethyl amine nitrogen (TMA-N) in accordance with the technical arrangements in Chapt er II. 
The compet ent author ities shall use the criteria laid down in this Regulation. 
When the organoleptic examination gives cause to suspect the presence of other conditions that may affect human 
health, appropr iate samples shall be taken for verification purposes. 
C.Hist amine 
Random testin g for histamine shall be carried out to verify compl iance with the permitted levels laid down in 
Regulation (EC) No 2073/2005. 
D.Residues and cont aminants 
Monitoring arrang ements shall be established in accordance with Directive 96/23/EC and Decision 97/747/EC to control 
compl iance with the EU legislation on: 
—  maximum residue limits for phar macologically active substances, in accordance with Regulations (EU) No 37/2010 
and (EU) No 2018/470; 
—  prohibit ed and non-author ised substances, in accordance with Regulation (EU) No 37/2010, Directive 96/22/EC and 
Decision 2005/34/EC; 
—  contaminants, in accordance with Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants 
in food; and 
—  pesticide residues, in accordance with Regulation (EC) No 396/2005. 
E.Microbiological checks 
Where necessar y, microbiological controls shall be perf ormed in accordance with the relevant rules and criteria laid 
down in Regulation (EC) No 2073/2005. 
F.Parasites 
Risk -based testing shall take place to verify compl iance with Part D of Chapt er III of Section VIII of Annex III to 
Regulation (EC) No 853/2004 and Section I of Annex II to Regulation (EC) No 2074/2005. 17.5.2019 L 131/96 Official Jour nal of the European Union EN     
(1)Council Regulation (EC) No 2406/96 of 26 November 1996 laying down common marketing standards for certain fisher y products 
(OJ L 334, 23.12.1996, p. 1). G.Poisonous fisher y products 
Controls shall take place to ensure that:  
1. fisher y products derived from poisonous fish of the follo wing families are not placed on the mark et: Tetraodontidae, 
Molidae, Diodontidae and Canthig aster idae;  
2. fresh, prepared, frozen and processed fisher y products belonging to the family Gempylidae, in particular Ruvettus 
pretiosus and Lepidocybium flavobrunneum, may be placed on the market only in wrapped/packag ed form and are 
appropr iately labelled to inform the consumer about preparation/cooking methods and the risk relat ed to the 
presence of substances with adverse gastrointestinal effects. The scientific names of the fisher y products and the 
common names shall appear on the label;  
3. fisher y products containing bioto xins such as ciguate ra or other toxins dangerous to human health are not placed on 
the mark et. However , fisher y products derived from live bivalve molluscs, echinoder ms, tunicates and mar ine 
gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to 
Regulation (EC) No 853/2004 and compl y with the standards laid down in point 2 of Chapt er V of that Section. 
CHA PTER II 
CONTR OLS ON TOT AL VOLATILE BASIC NITR OGEN (TVB-N) 
A.TVB-N limit values for certain categor ies of fisher y products and analysis methods to be used 
1.  Unpro cessed fisher y products shall be regar ded as unfit for human consump tion where organolep tic assessment has 
raised doubts as to their freshness and chemical checks reveal that the following TVB-N limits are exceeded: 
(a)  25 mg of nitrogen/100 g of flesh for the species refer red to in point 1 of Part B of this Chapt er; 
(b)  30 mg of nitrogen/100 g of flesh for the species refer red to in point 2 of Part B of this Chapt er; 
(c)  35 mg of nitrogen/100 g of flesh for the species refer red to in point 3 of Part B of this Chapt er; 
(d)  60 mg of nitroge n/100 g of whole fisher y product used directly for the preparation of fish oil for human 
consum ption, as referred to in the second paragraph of point 1 of Chapt er IV.B of Section VIII of Annex III to 
Regulation (EC) No 853/2004; however , where the raw mate rial compl ies with points (a), (b) and (c) of the first 
paragraph of that point, Member States may set limits at a higher level for certain species pending the 
establishment of specifi c Union legislation. 
The reference method to be used for chec king the TVB-N limits involves distilling an extract deprotei nised by 
perc hlor ic acid as set out in Part C below . 
2.  Distillation as referred to in point 1 shall be performe d using apparatus whic h compl ies with the diagram in Part D 
below . 
3.  The routine methods that may be used to check the TVB-N limit are as follows : 
(a)  microdiffusion method descr ibed by Conwa y and Byrne (1933); 
(b)  direct distillation method descr ibed by Anton acopoulos (1968); 
(c)  distillation of an extract deproteinised by trichloracetic acid (Codex Alimentar ius Committee on Fish and Fisher y 
Products, 1968). 
4.  The sample shall consist of about 100 g of flesh, taken from at least three different points and mixe d together by 
grinding. 
Member States shall recommend that official laborat ories use, as a matt er of routine, the methods refer red to abov e. 
Where the results are dubious or in the event of dispute regarding the results of analysis performed by one of the 
routine methods, only the referen ce method may be used to chec k the results. 17.5.2019 L 131/97 Official Jour nal of the European Union EN     B.Species categor ies for which TVB-N limit values are fixed 
TVB-N limit values are fixed for the following species cate gories:  
1. Sebastes spp., Helicolenus dactylopteru s, Sebastichthys capensis;  
2. species belonging to the Pleuronectidae family (with the excep tion of halibut: Hippog lossus spp.);  
3. Salmo salar , species belonging to the Merlucciidae family , species belonging to the Gadidae family . 
C.Reference procedure for deter mining the concentration of TVB-N in fish and fisher y products  
1. Purpose and area of application 
This method descr ibes a reference procedure for identifying the nitrogen concentration of TVB-N in fish and fisher y 
products. The procedure is applicable at TVB-N concentrations of 5 mg/100 g to at least 100 mg/100 g.  
2. Definitions 
‘TVB-N concentration’ means the nitrogen content of volatile nitrogen ous bases as determined by the reference 
procedure descr ibed. 
‘Solution’ means an aqueous solution as follo ws: 
(a)  perc hlor ic acid solution = 6 g/100 ml; 
(b)  sodium hydroxide solution = 20 g/100 ml; 
(c)  hydrochlori c acid standard solution 0,05 mol/l (0,05 N). When using an automatic distillation apparatus, titration 
must take place with a hydroch loric acid standard solution of 0,01 mol/l (0,01 N); 
(d)  boric acid solution = 3 g/100 ml; 
(e)  silicone anti-f oaming agent; 
(f)  phenolphtalein solution = 1 g/100 ml 95 % ethanol; 
(g)  indicator solution (Tashiro mixe d indicator) = 2 g methyl-red and 1 g meth ylene-blue dissolved in 1 000 ml 
95 % ethanol.  
3. Brief descr iption 
The volatile nitrogen ous bases are extract ed from a sam ple using a solution of 0,6 mol/l perchlori c acid. After 
alkalinisation, the extract undergoes steam distillation and the volatile base compo nents are absorbed by an acid 
receiver . The TVB-N concentration is determined by titration of the absorbed bases. The concentration is expressed in 
mg/100 g.  
4. Chemicals 
Unless other wise indicated, reagent-g rade chemicals shall be used. The water used shall be either distilled or 
demineralised and of at least the same purity.  
5. The followi ng instr uments and accessor ies shall be used: 
(a)  a meat grinder to produce a sufficiently homogenous fish mince; 
(b)  high-speed blender with a speed of 8 000 to 45 000 revolutions/min; 
(c)  fluted filter, diamet er 150 mm, quic k-filtering; 
(d)  burette, 5 ml, graduat ed to 0,01 ml; 
(e)  apparatus for steam distillation. The apparatus must be able to regulat e various amounts of steam and produce 
a constant amount of steam over a given period of time. It must ensure that, during the addition of alkalising 
substances, the resulting free bases cannot escape. 17.5.2019 L 131/98 Official Jour nal of the European Union EN     6. Execution of the reference procedure 
When working with perchlori c acid, which is strong ly corrosive, necessar y caution and preventive measures shall be 
taken. The samples shall be prepared as soon as possible after their arrival, in accordance with the followi ng 
instr uctions: 
(a)  Prepar ing the sam ple 
The sample to be analysed is ground carefully using a meat grinder as descr ibed in point 5(a). An amount of 
10 g ± 0,1 g of the ground sample is weighed out into a suitable container . This is mixed with 90,0 ml 
perc hlor ic acid solution, homog enised for two minutes with a blender as descr ibed in point 5(b), and then 
filtered. 
The extract thereby obtained can be kept for at least seven days at a temperature of between appro ximately 2 °C 
and 6 °C; 
(b)  Steam distillation 
50,0 ml of the extract obtained in accordance with point (a) is put into an apparatus for steam distillation as 
descr ibed in point 5(e). For a later check on the extract's alkalinisation, several drops of phenolphtalein solution 
are added. After adding a few drops of silicone anti-f oaming agent, 6,5 ml of sodium hydroxide solution is added 
to the extract and steam distillation begins immediately . 
The steam distillation is regulate d so that around 100 ml of distillate is produced in 10 minute s. The distillation 
outf low tube is submerg ed in a receiver with 100 ml boric acid solution, to which three to five drops of the 
indicator solution have been added. After exactly 10 minutes, distillation is ended. The distillation outf low tube is 
remo ved from the receiver and washed out with water . The volatile bases contained in the receiver solution are 
determined by titration with hydroch loric acid standard solution. 
The pH of the end point must be 5,0 ± 0,1; 
(c)  Titration 
Duplicate analyses are required. The applied method is correct if the diffe rence between the duplicat es is not 
greate r than 2 mg/100 g; 
(d)  Blank 
A blind test is carried out as descr ibed in point (b). Instead of the extract, 50,0 ml perc hlor ic acid solution is 
used.  
7. Calculation of TVB-N concentration 
By titration of the receiver solution with hydrochlori c acid standard solution, the TVB-N concentration is calculat ed 
using the follo wing equation: 
TVB-N ðexpressed in mg=100 g sampleÞ ¼ðV 1 − V 0Þ�0,14 �2�100
M 
where: 
V1  =volume of 0,01 mol hydroch loric acid standard solution in ml for sample ; 
V0  =volume of 0,01 mol hydroch loric acid standard solution in ml for blank; 
M  =mass of sample in g. 
In addition, the followi ng is required: 
(a)  duplicat e analyses. The applied method is correct if the difference between duplicat es is not greate r than 
2 mg/100 g; 
(b)  equipment check. The equipment is chec ked by distilling solutions of NH4Cl equivalent to 50 mg TVB-N/100 g; 
(c)  standard deviations. The standard deviation for repeatability Sr = 1,20 mg/100 g and the standard deviation for 
reproducibility SR = 2,50 mg/100 g are calculat ed. 17.5.2019 L 131/99 Official Jour nal of the European Union EN     D.TVB-N steam distillation apparatus 
17.5.2019 L 131/100 Official Jour nal of the European Union EN     