EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10194/2017 CIS Rev. 1 
(POOL/G4/2017/10194/10194R1 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down uniform practical arrangements for the performance 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 
Commissio n Regulation (EC) No 2074/2005 as regards official controls  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 0  EN    
EN 0  EN  COMMISSION IMPLEMENTING REGULATION (EU) …/...  
laying down uniform practical arrangements for the performance 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)  
 
Version of 25 September  2018   
EN 1  EN  COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down uniform practical arrangements for the performance 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 EUROPEAN COMMISSION,  
Having regard 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 March 2017 on official controls and other official activities perfor med to ensure the 
application of food and feed law, rules on animal health and welfare, plant health and plant 
protection products, amending Regulations (EC) No  999/2001, (EC) No  396/2005, (EC) 
No 1069/2009, (EC) 1107/2009, (EU) 1151/2012, (EU) No  652/2 014, (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 (E C) No 
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 (Official 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 performed by the competent authorities 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 distribution. In particular, it provides for official controls 
in relation to products of animal origin intended for human consumption . In addition, 
it repeals Regulation (EC) No 854/2 0042 with effect from 14  December  2019. That 
Regulation currently lays down specific rules for official controls on products of 
animal origin intended for human consumption, including requirements on uniform 
practical arrangements for the performance of th e controls.  
(2) The rules laid down in this Regulation should ensure a continuation of the 
requirements to ensure the verification of food business operators ’ compliance with 
the rules  for the safe handling of products of animal origin , in particular as laid down 
in: 
                                                 
1 OJ L 95, 7.4.2017, p. 1.  
2 Regulation (EC) No 854/2004 of the European Parliament and of the Coun cil of 29 April 2004 laying 
down specific rules for the organisation of official controls on products of animal origin intended for 
human consumption (OJ L 139, 30.4.2004, p. 206).   
EN 2  EN  – Council Directive 96/23/EC3 as regards measures to monitor certain substances 
and residues ; 
– Regulation (EC) No 999/2001 of the European Parliament and of the Council4 
as regards controls on transmissible spongiform encephalopathies ; 
– Council Directive 2002/99/EC5 as regards animal health rules on  products of 
animal origin ; 
– Regulation (EC) No 178/2002 of the European Parliament and of the Council6 
as regards the general principles and requirements of food law ; 
– Directive 2003/99/EC of the Europe an Parliament and of the Council7 as 
regards the monitoring of zoonoses and zoonotic agents ; 
– Commission Decision 2003/467/EC8 as regards control of tuberculosis, 
brucellosis and enzootic -bovine -leukosis ; 
– Regulation (EC) No 2160/2003 of the European Parliament and of the Council9 
as regards Salmonella  controls ; 
– Regulation s (EC) No 852/2004 of the European P arliament and of the 
Council10 as regards  the hygiene of foodstuffs ; 
– Regulation (EC) No  853/2004  of the European Parliament and of the Council11 
as regards the specific hygiene rules for food of animal origin ; 
– Council Regulation (EC) No 1/200512 as regards the protection of animals 
during transport and related operations ; 
– Commission Regulation (EC) No 2073/200513 as regards microbiological 
criteria in fo odstuffs ; 
                                                 
3 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certai n 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 spongiform 
encephalopathies (OJ L 147, 31.5.2001, p. 1).  
5 Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rule s governing the 
production, processing, distribution and introduction of products of animal origin for human 
consumption (OJ L 18, 23.1.2003, p. 11).  
6 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).  
7 Directive 2003/99/EC of the European Parliament and of the Council of 17  November 2003 on the 
monitoring of zoonoses and zoonotic agents, amending Council Directive 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 tu berculosis, brucellosis 
and enzootic -bovine -leukosis -free status of certain Member States and regions of Member States as 
regards bovine 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 -borne 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 April 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 April 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 on the protection of animals during transport 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) .  
EN 3  EN  – Commission Regulation s (EC) No 1881/200614 and (EC) No 124/200915 as 
regards maximum levels for certain contaminants in foodstuffs ; 
– Council Directive 2007/43/EC16 as regards the protection of chickens ; 
– Regulation (EC) No 1069/2009 of the European Parliament and of the 
Council17 as regards health rules on animal by -products ; 
–  Council Regulation (EC) No 1099/200918 as regards the protection of animals 
at the time of killing ; 
– Directive 2010/63/EU of the European Parliament and of the Council19 as 
regards  the protection of animals used for scientific purposes ; 
– Commission Implementing Regulation (EU) No 636/201420 as regards trade in 
unskinned large wild game ; 
– Commission Implementing Regulation (EU)  2015/137521 as regards official 
controls for Trichinella ; and  
– Regulation (EU) 2016/429 of the European Parliament and of the Council22 as 
regards animal health rules . 
(3) The practical arrangements for the performan ce of official controls on products of 
animal origin should be considered  where a minimum level of offi cial controls is 
necessary to respond to recognised uniform hazards and risks that might be posed by 
products of animal origin, covering all aspects that are important for protecting human 
health and, where appropriate, ani mal health and animal welfare. They should be 
based on the most recent relevant information available and scientific evidence from 
the EFSA opinions.  
(4) On 31 August 2011, EFSA adopted a scientific opinion on the human health hazards 
to be covered by the inspection of meat (swine)23. The reco mmendations of that  
opinion were taken into account in the requirements for pig meat inspections laid 
                                                                                                                                                         
13 Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for 
foodstuf fs (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 Regulation (EC) No 124/2009 setting maximum levels for the presence  of coccidiostats or 
histomonostats in food resulting from the unavoidable carry -over of these substances in non -target feed 
(OJ L 40, 11.2.2009, p. 1).  
16 Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of 
chickens  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 October 2009 
laying down health rules as regards animal by -products and derived products not intended for human 
consu mption 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 protection 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 mode l certificate for 
the trade of unskinned large wild game (OL L 175, 14.6.2014, p. 16).  
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   
EN 4  EN  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 adopted a scientific opinion on the human health hazards to 
be covered by the inspection of meat (poultry)24. That opinion identifies 
Campylobacter spp. and Salmonella  spp. as the main hazards to be covered in poultry 
meat inspections through an integrated food safety assurance  system, achievable 
through improved food chain information (FCI) and risk -based interventions.  
(6) On 6 June 2013 , the European Food Safety Authority ( EFSA ) adopted 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 pathogenic 
verocytotoxin -producing Escherichia 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-mortem inspection of animals subjected to routine slaughter, 
since it may reduce spreading and cross -contamination with the high -priority 
biological hazards. However, palpations and incisions during post -mortem inspection , 
necessary to survey the oc currence of tuberculosis and Taenia saginata  (tapeworm) 
cysticercosis, should be maintained.  
(7) Also on 6 June 2013 , EFSA adopted a scientific opinion on the human health hazards 
to be covered by the inspection of meat from sheep and goats26. That opinion iden tifies 
pathogenic verocytotoxin -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-mortem inspection  of sheep and goats  subject to 
routine slaughter. However, palpation and incisions for the surveillance of tuberculosis 
and fasciol iasis should be maintained in older animals for reasons of animal and 
human health surveillance.  
(8) Also on 6 June 2013, EFSA adopted 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 significant favourable effect 
on the microbiological status of soliped carcase m eat. Such inspection is considered 
unlikely to affect the overall surveillance of animal diseases.  
(9) Also o n 6 June 2013, EFSA adopted a scientific opinion on the  meat inspection of 
farmed game . That opinion recommends omitting palpation and incision unless 
abnormalities 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 the se EFSA opinions should be taken into account 
when laying down uniform  practical arrangements for the performance of official 
controls on products of animal origin intended for human consumption. The possible 
impact on trade with third  countries should also be taken into account. At the same 
time, a smooth transition from th e current requirements , as laid down in Regulation 
(EC) No 854/2004 , should be ensured.  
(11) The practical arrangements  for the performance of official controls on products of 
animal origin should be established  where a minimum level of official controls is 
                                                 
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.   
EN 5  EN  deemed necessary to respond to recognised uniform hazards and risks that might be 
posed by products of animal origin , covering all aspects that are important for 
protecting human health and, where appropriate, animal health and animal welfare. 
They should be based on the most recent relevant information available and scientific 
evidence from  the EFSA opinions.  
(12) These practical arrangements  should apply to official controls on products of animal 
origin laid down in Article  18 of Regulation (EU)  2017/625 and in Commission 
Delegated Regulation (EU) [SANTE /10193/ 2017]28. These practical arrangements for 
the application of official controls should be uniform and facilitate the application of 
the requirements  for a minimum level of official controls, taking into ac count the size 
of small businesses as laid down in Art 16 of Regulation (EU) 2017/625 by the use of 
a threshold in a non -discriminatory way.  
(13) Since the structure of slaughterhouses and game -handling establishments differs 
across  Member States, a threshold should be based on the number of animals 
slaughtered 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 R egulation (EC) No 
1099/2009 defines livestock units and lays down  conversion rates to express the 
number of animals of a certain species in such livestock units. These provisions should 
be used to set thresholds and harmonize derogations from certain requirements based 
on the size of a slaughterhouse  to the extent possi ble. 
(14) Specific requirements for auditing by the competent authorities should also be 
maintained to ensure the uniform practical verification of compliance with Union 
requirements on products of animal origin. Auditing is of particular interest for the 
verif ication of general and specific hygiene requirements and the application of 
procedures based on hazard analysis and critical control points (HACCP).  
(15) Verification of compliance with the requirements on identification marking in Section 
I of Annex II to Reg ulation (EC) No 853/2004, as currently laid down in Regulation 
(EC) No 854/2004, should be maintained to allow tracing back the animals.  
(16) Ante -mortem and post -mortem inspections are essential to verify compliance with 
requirements on human and animal healt h and animal welfare. In order to ensure at 
least the same level of human and animal health and animal welfare protection as 
provided by Regulation (EC) No 854/2004 and fair trade in an open market, it is 
necessary to lay down uniform practical requirement s for such inspections, including 
cases where official  controls are performed under the responsibility of the official 
veterinarian. As regards official controls on fresh meat, these inspections should be 
supplemented by appropriate documentary checks, con trols on the safe disposal of 
specified risk material, as defined in Article 3(g) of Regulation (EC) No 999/2001, and 
other animal by -products, and laboratory testing where appropriate.  
(17) It is important to identify cases of suspected and established non -compliance where 
competent authorities must take measures with respect to certain products of animal 
origin. Non -compliance with good hygiene practices should also result in corrective 
action by competent authorities.  
                                                 
28 Commission Delegated Regulation (EU) …/… of ../../…. concerning specific rules for the performance 
of offici al 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 
(OJ L …., ../../…., p. …).   
EN 6  EN  (18) The health mark defined in point 51 in Ar ticle 3 of Regulation (EU) 2017/625 covers 
meat of certain species and attests that the meat is fit for human consumption. 
Technical requirements of the health mark and practical arrangements for its 
application should be laid down in a specific and unifor m way in order to indicate the 
fitness of the meat for human consumption and to prevent any trade disruption.  
(19) Specific requirements for the performance of official controls and the uniform 
minimum frequency for such controls on raw milk, milk products and fishery products 
should be laid down to ensure a high level of consumer protection and fair competition 
between food business operators.  
(20) Commission Regulation (EC) No 2074/200529 lays down  inter alia  implementing 
measures for the organisation of official controls under Regulation (EC) No 854/2004 
as regards recognised methods for the detection of marine biotoxins in live bivalve 
molluscs, testing methods for raw milk and heat -treated milk, official co ntrols in 
fishery products and the inspection of meat. It is appropriate to  merge all 
implementing measures for the organisation of official controls and  include the  ones 
from Regulation (EC) N o 2074/2005  in this Regulation  in which they should be 
deleted .   
(21) The current conditions for the classification and monitoring of classified production 
and relaying areas for live bivalve molluscs have proven  to be effective and ensure a 
high level of consumer protection. The y should therefore be maintained.  
(22) A referen ce method for the analysis of E. coli  in live bivalve molluscs , as currently 
laid down in Regulation (EC) No 854/2004 , should be maintained . 
(23) The limits for marine biotoxins are laid down in Regulation (EC) No 853/2004. In 
particular, point 2 in Chapter V of Section VIII of Annex IV to that Regulation 
provides that live bivalve molluscs must not contain marine biotoxins in total 
quantities (measured in the whole body or any part edible separately) that exceed the 
limits established in that Chapter . 
(24) Specific requirements for the performance of official controls and the uniform 
minimum frequency for such controls on raw milk  and milk products should be laid 
down to ensure a high level of consumer protection and fair competition between food 
business operators.  
(25) Specific requirements for the performance of official controls and the uniform 
minimum frequency for such controls on fishery products should be laid down to 
ensure a high level of consumer protection and fair competition 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 auctio ns and wholesale markets,  and checks on storage and transport.  
Specific requirements for the control of vessels should also be envisaged . 
                                                 
29 Commission Regulation (EC) No 2074/2 005 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, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council 
and amending Regulations (EC) No 853/2004 and (EC) No 854/2 004 (OJ L 338, 22.12.2005, p. 27).   
EN 7  EN  (26) Those controls should  also include practical arrangements as regards organoleptic 
examinations, freshness indicators, controls on histamine, residues and contaminants, 
microbiological checks. Special attention should be paid to the controls of parasites 
and on poisonous fishery products. Fishery products not meeting those hygiene 
requirements should be declared as unfit for human consumption;  
(27) Special requirements concerning the official  controls on fishery products caught by 
vessels flying the flag of Member States entering the Union after being transferred in a 
third country with or without storage shall also be established ; 
(28) There is an increasing interest in the production and placing of the market of reptile 
meat. In order to ensure the safety of reptile meat, it is relevant to introduce specific 
official controls at slaughter in additional to the existing general hygiene rules laid 
down in Regulation (EC) No 852/2004 and the Trichinel la controls laid do wn in 
Implementing Regulation (EU) 2015/1375 . 
(29) Regulation (EC) No 2074/2005 should be amended accordingly.  
(30) As Regulation (EU) 2017/625 repeals Regulation (EC) No 854/2004  with effect from 
14 December 2019, this Regulation should also appl y from that date.  
(31) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
TITLE I 
SUBJECT MATTER , SCOPE AND DEFINITION S 
Article 1  
Subject matt er and scope  
This Regulation lays down uniform practical arrangements for the performance of official 
controls and action in relation to the production of products of animal origin intended for 
human consumption . These official controls and actions shall be performed  by the competent 
authorities  taking into account the requirements of Article 18(2), (3 and (5) of Regulation 
(EU) 2017/625 and Delegated Regulation (EU) …/…[SANTE/10193/2017] .  
The specific rules cover:  
(a) specific requirements and uniform mi nimum frequency of official controls on any 
product of animal origin, as regards audits and identification marking;  
(b) specific requirements and uniform minimum frequency of official controls on fresh 
meat , including specific requirements for audits  and specific tasks as regards controls 
on fresh meat;  
(c) measures to be taken in case s of non -compliance of fresh meat  with Union 
requirements for the protection of human  health and animal health and welfare ; 
(d) technical requirements and practical arrangemen ts as regards the health mark  referred 
to in Article 5 of Regulation (EC) No 853/2004 ; 
(e) specific requirements and uniform minimum frequency of official controls on milk, 
colostrum, dairy products and colostrum -based products;   
EN 8  EN  (f) conditions for the classification and monitoring of classified  production and relaying 
areas for live bivalve molluscs, including decisions to be taken after monitoring 
classified production and relaying areas;  
(g) specific requirements and uniform minimum frequency of official controls on fishery 
products.  
Article 2  
Definitions  
The following 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) ‘colostrum’ means colostrum as defined in point 1 of Section IX of Annex III of 
Regulation (EC) No 853/2004;  
(3) 'dairy products' means dairy products as defined in point 7.2. of Annex I to 
Regulation (EC) No 853/2004;  
(4) ‘colostrum -based products’ means colostrum -based products as defined  in points 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) 'relaying 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) 'fishery products' means fishery 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(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 Council30.  
(11) 'microbiological criterion' means microbiological criterion as defined in Article 2(b) 
of Regulation (EC) No 2073/2005;  
(12) 'slaughterhouse' means slaughterhouse as defined in point 1.16 o f 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) 'specific risk material' means specific risk material as defined in Article 3(1)(g) of 
Regulation (EC) No 999 /2001;  
(15) 'contamination ' means contamination  as defined in Article 2( f) of Regulation (EC) 
No 852/2004;  
                                                 
30  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).   
EN 9  EN  (16) 'holding  of provenance’ means a holding of provenance establishment as defined in 
Article point 2 of Article 2 of Delegated Regulation (EU) [SANTE/10193/2017] ; 
(17) 'primary production' means primary production  as defined in Article 3(17) of 
Regulation (EC) No 178/2002;  
(18) 'domestic ungulates' means domestic ungulates as defined in point 1.2 of Annex I of 
Regulation (EC) No 853/2004;  
(19) 'game -handling establishment' means a game -handling establishment as defined in 
point 1.18 of Annex I of Regulation (EC) No 853/2004;   
(20) 'large wild game' means large wild game as defined in point 1.8 of Annex I to 
Regulation (EC) No 853/2004;  
(21) 'poultry flock' means a poultry flock as defined in Article 2(3)(b) of Regulation (EC) 
No 2160/2003;  
(22) 'lagomorphs' means lagomorphs 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-capacity slaughterhouse’ means a low-capacity slaughterhouse as defined in 
Article 2(17) of Delegated Regulatio n (EU) [SANTE/10193/2017];  
(26) ‘low-capacity game -handling establishment’ means a game -handling establishment 
as defined in Arti cle 2(18) of Delegated Regulation (EU) [SANTE/10193/2017];  
(27) 'livestock unit' means a livestock unit as defined in Article 1 7(6) of Regulation (EC) 
No 1099/2009;  
(28) 'small wild game ' means small wild game  as defined in point 1. 7 of Annex I of 
Regulation (EC) No 853/2004;  
(29) 'poultry' means poultry 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;    
EN 10  EN  (37) 'purification centre' mean s a purification centre as defined in point 2.8 of Annex I to 
Regulation (EC) No 853/2004;  
(38) 'marine biotoxins' means marine biotoxins as defined in point 2.2 of Annex I to 
Regulation (EC) No 853/2004;  
(39) ‘stages of production, processing and distribu tion’ means stages of production, 
processing and distribution’ as defined in Article 3( 16) of Regulation (EC) No 
178/2002;  
(40) 'dispatch centre' means a dispatch centre as defined in point 2.7 of Annex I of 
Regulation (EC) No 853/2004  
(41) ‘placing on the  market’ means placing on the market as defined in Article 3(8) of 
Regulation (EC) No 178/2002;  
(42) 'factory vessel' means factory vessel as defined in point 3.2 of Annex I to Regulation 
(EC) No 853/2004;  
(43) 'freezer vessel' means freezing vessel as def ined in point 3.3 of Annex I to 
Regulation (EC) No 853/2004;   
(44) 'reptiles' means reptiles as defined in point 15 of Article 2 of Commission Delegated 
Regulation [SANTE/10279/2018 ]31;  
(45) 'reptile meat' means reptile meat  as defined i n point 16 of Article 2 of Delegated 
Regulation (EU) [SANTE/10279/2018];  
 (46) 'fresh fishery products' means fresh fishery products as defined in point 3.5  of Annex 
I to Regulation (EC) No 853/2004;  
(47) 'prepared fishery products ' means prepared fishery products as de fined in point 3.6  of 
Annex I to Regulation (EC) No 853/2004;  
(48) 'processed  fishery products' means pr ocessed  fishery products as defined in point 7.4 
of Annex I  to Regulation (EC) No 853/2004.  
TITLE II 
SPECIFIC REQUIREMENTS  FOR THE PERFORMANCE OF OFFICI AL CONTROLS AND 
THE UNIFORM MINIMUM FREQUENCY O N PRODUCTS OF ANIMAL O RIGIN  
CHAPTER  I 
SPECIFIC  REQUIREMENTS  FOR  AUDITS  BY THE  COMPETENT  AUTHORITIES  
IN ESTABLISHMENT S HANDLING  PRODUCT S OF ANIMAL  ORIGIN  
Article 3  
Requirements subject to auditing  
1. When auditing good hygiene practices in establishments, the competent authorities 
shall verify that food business operators handling products of animal origin apply 
procedures continuously and properly concerning at least the following:  
(a) the design and maint enance of premises and equipment;  
                                                 
31 Commission Delegated Regulation (EU) …/…. of ../../…. supplementing Regulation (EU) 2017/625 of 
the European Parliament and of the Council with regard to conditions to be respected by c onsignments 
of certain animals and goods intended for human consumption entering the Union  (OJ L …., ../../…., p. 
…).  
EN 11  EN  (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 
accompanying documentation.  
2. When a uditing procedures based on hazard analysis and critical control points 
(HACCP ), as laid down in Article 5 of Regulation (EC) No 852/2004,  the competent 
authorities  shall verify that food business operators handling products of animal 
origin apply such procedures continuously and properly . 
3. They shall, in particular,  determine whether the procedures guarantee, to the extent 
possible, that products of animal origin:  
(a) comply with Article 3 of Regulation (EC) No 2073/2005 as regards 
microbiological criteria ; 
(b) comply with Union  legislation on : 
– the monitoring of chemical residues , in accordance with Council 
Directive 96/23/EC and Commission Decision  97/747/EC32; 
– maximum residue limits for pharmacologically active substances , in 
accordance with Commission Regulation (EU) No 37/201033 and 
Commission Implementing Regulation (EU) 2018/47034; 
– prohibited and non -authorised substances , in accordance with 
Commission Regulat ion (EU) No 37/2010 , Council Directive 96/22/EC35, 
Commission Decision 2005/34/EC36; 
– contaminants , in accordance with Regulation s (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 Council37; 
                                                 
32 Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling 
provided for by Council Directive 96/23/E C for the monitoring 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 pharmacologically active 
substances and their classification regarding m aximum 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 which 
have been treated in the EU under Article 11 of Directive 2001/82/EC (OJ L  79, 22.3.2018, p.  16). 
35 Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stock  farming of 
certain substances having a hormon al or thyrostatic action and of ß -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 of 11 January 2005 laying down harmonised standards for the testing for 
certain residues i n products of animal origin imported from third countries (OJ L 16, 20.1.2055, p 16).   
EN 12  EN  (c) do not contain physical hazards, such as foreign bodies.  
4. Where  a food business operator 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 th ose guides.  
5. When carr ying out auditing tasks, the competent authorit ies shall take special care:  
(a) to determine whether staff and  staff activities in the establishment  at all stages 
of the production process comply with the requirements , as regards hygienic 
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 complement  the audit, the competent 
authorit ies may carry out performance tests, in order to ascertain that staff are 
sufficiently skilled ; 
(b) to verify the food business operator ’s relevant records;  
(c) to take samples for laboratory analysis where  necessary;  
(d) to document elements taken 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 competent authorit ies shall 
regularly assess:  
(a) human  and, where appropriate, animal health risks;  
(b) in the case of slaughterhouses, animal w elfare aspects;  
(c) the type and throughput of the processes carried out;  
(d) the food business operator ’s past record as regards compliance with food law.  
2. Where  food business operators in the food chain take additional measures to 
guarantee food safety  by implementing integrated systems, private control systems  or 
independent third -party certification , or by other means, and where  these measures 
are documented and animals covered by such schemes are clearly identifiable, the 
competent authorities  may ta ke such measures into account when carrying out audits 
to review good hygiene practices and the HACCP -based procedures.  
CHAPTER II  
SPECIFIC REQUIREMENTS FOR IDENTIFICATION MARKING  
Article 5 
Compliance with the requirements of Regulation (EC) No 853/2004 concerning the 
application of identification marks shall be v erified in all establishments approved in 
accordance with that Regulation, in addition to verification of compliance with other 
traceability requirements  in accordance with Article 18 of  Regulation (EC) No 178/2002 . 
                                                                                                                                                         
37 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant an d animal origin and amending 
Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1) .  
EN 13  EN  CHAPTER III  
Scientific and technological developments  
Article 6  
The Member States s hall inform the Commission and other Member States on scientific and 
technological developments, as referred to in  Article 16(2)(b) of Regulati on (EU) 2017/625  
for consideration and further action as appropriate . 
TITLE III 
SPECIFIC REQUIREMENTS  FOR THE PERFORMANCE OF OFFICIAL CONTROLS  AND 
THE UNIFORM MINIMUM FREQUENCY ON FRESH M EAT  
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 Article s 3 and 4, the 
competent authorities shall , when carrying out an audit in establishments handling 
fresh meat, verify continuous compliance  with food busine ss operators ’ own 
procedures concerning the collection, transport, storage  and handling of fresh meat, 
and the use or disposal of animal by -products , including specified risk material , for 
which the y are  responsible.  
2. In the course of audits in slaughter houses, the competent authorities shall verify  the 
evaluation of food  chain information , as laid down in Section II I of Annex II to 
Regulation (EC) No 853/2004 . 
3. When carrying out audits of HACCP -based procedures, the competent authorities  
shall check  that due regard  is given to the procedures set out in Section II of Annex II 
to Regulation (EC) No 853/2004 and that the food business operators ’ procedures 
guarantee, to the extent possible, that  fresh  meat:  
(a) does not contain pathological abnormalities  or changes;  
(b) does not bear faecal or other contamination  considered to pose an unacceptable 
human  health risk ; 
(c) complies with the microbiological criteria  in Article 3 of  Regulation (EC) 
No 2073/2005;  
(d) does not contain specified risk material , in accordance with the requirements in 
Regulation (EC) No 999/2001.  
CHAPTER II  
OFFICIAL CONTROLS ON FRESH MEAT  
Article 8 
Relevance of au dit results  
When carrying out official controls  in accordance with this Chapter , the official veterinarian 
shall take into account the results of the audits carried out in accordance with Chapter  I.  
EN 14  EN  Where appropriate , the official veterinarian  shall target official controls  to deficiencies 
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 competent authorities shall inform the food business operator of the holding of 
provenance  of the minimum elements of food chain information to be supplied to the 
slaughterhouse  operator in accordance with Section III of Annex II to Regulation 
(EC) No 853/2004.  
2. The competent authorities  shall perform the necessary checks  of documents  to verify 
that: 
(a) the food chain information is consistently and effectively communicated 
between the food business operator 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 dispatched for slaughter to another Member State, the competent 
authorities at the holding of provenance and the place of slaughter shall cooperate to 
ensure that the food chain information pr ovided by the food business operator of the 
holding of provenance  is easily accessible to the slaughterhouse operator  receiving it . 
Article 10 
Obligations of the official veterinarian as regards check s of documents  
1. The official veterinarian shall verify  the results of the checks  and evaluations of food 
chain information provided by the slaughterhouse operator in accordance with 
Section III of Annex II to Regulation (EC) No  853/2004. The official veterinarian 
shall take those checks and evaluations  into account when carrying out ante -mortem  
and post -mortem inspection s, together with any other  relevant information from the 
records of the animals ’ holding of provenance . 
2. When carrying out ante-mortem  and post -mortem inspection s, the official 
veterinarian shall  take into account official certificates  provided for in accordance 
with Article 2 9 of Commission Implementing Regulation (EU) 
[SANTE/10281/2018]38, and any declarations by veterinarians carrying out official 
controls or other checks  at the level of primary production . 
3. In the case of the emergency slaughter of domestic ungulates outside the 
slaughterhouse, the official veterinarian at the slaughterhouse shall examine the 
certification  provided for in accordance with Article 30 of Implementing Regul ation 
(EU) [SANTE/10281/2018] and issued by the official veterinarian who carried out 
the ante -mortem inspection  in accordance with point 6 of Chapter VI of Section I of 
                                                 
38  Commission Implementing Regulation (EU) …. of ../../…. . laying down model official certificates for 
the entry into the Union of certain animals and goods and amending  Regulation (EU) 2016/759 (OJ L 
…, ../../…., p. …)   
EN 15  EN  Annex III to Regulation (EC) No 853/2004  and any other relevant information 
provided b y the food business operator . 
4. In the case of large wild game, the official veterinarian at the game -handling 
establishment shall examine  and take into account the declaration accompanying the 
body of the animal , as issued by a trained person in accordan ce with point 4(a) of 
Chapter II of Section IV of Annex III to Regulation (EC) No 853/2004.  
SECTION  2: ANTE -MORTEM INSPECTION  
Article 11 
Requirements  as regards a nte-mortem inspection  at the slaughterhouse  
1. All animals shall be subjected to ante -mortem inspection before slaughter . However, 
inspection can be limited to a representative sample of each poultry flock, as defined 
in Article 2(3 )(b) of Regulation (EC) No 2160/2003 , and a representative sample of 
each holding of provenance of lagomorphs . 
2. Ante -mortem inspection shall take place within 24 hours of arrival of the animals at 
the slaughterhouse and less than 24 hours before slaughter. The official veterinarian 
may require an additional ante -mortem inspection  at any other time.  
3. Ante -mortem inspection s shall  determine whether, as regards the particular animal 
inspected, there is any sign:  
(a) that the health and welfare of the animal has been  compromised;  
(b) of any condition , abnormalities or disease  that make t he fresh meat unfit for 
human consumption or that might adversely affect animal health, paying 
particular attention to the detection of zoonotic diseases and animal diseases 
for which animal health rules are laid down in Regulation (EU) 2016/429 ;  
(c) of the use of prohibited  or unauthorised substances , misuse  of veterinary 
medicinal products  or the presence of chemical residues or contaminants . 
4. Ante -mortem inspection shall include verification of food business operators ’ 
compliance with their obligation to ensure that animals have a clean  hide, skin or 
fleece , so as  to avoid any unacceptable risk of contamination of the fresh meat during 
slaughter.  
5. The official veterinarian shall  carry out a clinical inspection of all a nimals that the 
food business operator or an official auxiliary may have put aside for a more 
thorough ante -mortem inspection . 
6. Where the ante-mortem inspection is carried out at the holding of provenance in 
accordance with Article 5 of  Delegated Regulation (EU) [SANTE /10193/ 2017] , the 
official veterinarian at the slaughterhouse shall  carry out ante -mortem inspection 
only when and to the extent specified.  
SECTION  3: POST -MORTEM INSPECTION  
Article 12 
Requirements for post -mortem inspection  
1. Subjec t to the derogation stipulated in Point 4 of Chapter II of Section IV to Annex 
III of Regulation (EC) No 853/2004 , carcases and accompanying offals, shall be 
subjected to post-mortem inspection :  
EN 16  EN  (a) without del ay after slaughter , or  
(b) as soon as possible after  arrival  at the game -handling establishment . 
2. The competent authorities  may require the food business operator  to provide special 
technical facilities and sufficient space to check  offal . 
3. The competent authorities shall:  
(a) check  all ex ternal surfaces , including those of body cavities  of carcases and 
offal ; 
(b) pay p articular attention 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 sla ughter line and the number of inspection staff present shall  be 
such as to allow for proper inspection.  
Article 13 
Derogation on the timing of post -mortem inspection  
(1) By way of derogation from Article 12(1), the competent authorities  may allow that, 
when neither the official veterinarian nor the official auxiliary are present in the 
game -handling establishment or slaughterhouse during slaughter and dressing,  the 
post-mortem inspection is delay ed by a maximum period of 24 hours  from slaughter 
or arri val in the game -handling establishment , provided that : 
(a) the animals concerned are slaughtered in a low-capacity slaughterhouse or 
handled in a low -capacity game -handling establishment that slaughters or 
handles : 
i. fewer  than 1 000 livestock units per year; or 
ii. fewer  than 150 000 poultry , lagomorphs and small wild game per 
year; 
(b) The competent authority may increase the threshold s laid down in point (a) (i) 
and (ii) ensuring that the derogation is applied in the smallest slaughterhouses 
and game -handling establis hments complying with the definition of low -
capacity slaughterhouse or game -handling establishment and provided that the 
combined annual production of these establishments does not exceed 5% of the 
total amount of fresh meat produced in a Member State  
(i) for the species concerned ;  
(ii) or for all ungulates together ; 
(iii) of all poultry together; or,  
(iv) of all birds and lagomorphs together;  
in such case, the competent authorities shall notify this derogation and the 
evidence to support it in accordance  with the procedure laid down in Directive 
(EU) 2015/1535 of the European Parliament and of the Council39; 
                                                 
39 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying 
down a procedure for the provision of information in the field of technical regulations and of rules on 
Information Society services (OJ L 241, 17.9.2015, p. 1) .  
EN 17  EN  (c) sufficient facilities exist within an establishment to store the fresh meat and 
offal so that it can be examined;  
(d) the post -mortem inspection is carried out by the official veterinarian . 
(2) For the purpose of point (a) (i) of paragraph 1, the conversion rates laid down in 
Article 17(6) of Regulation (EC) No 1099/2009 shall be used. However in case of 
ovine and caprine animals  and small (< 100 kg life weight) Cervid ae a conversion 
rate of 0.05 livestock units, and in case of other large g ame a conversion rate of 0.2 
livestock  units shall be used.  
Article 14 
Additional examination requirements for post-mortem 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 suspected hazard ; or 
(b) detect the presence of:  
(i) an animal disease  for which animal health rules are laid down in 
Regulation (EU) 2016/429 ; 
(ii) chemical residues or contaminants as referred to in  Directive  96/23/EC 
and Decision  97/747/EC , especially : 
– chemical  residues  in excess of the levels laid down in Regulation s 
(EU) No 37/2010  and (EC) No 396/200 5; 
– contaminants exceeding the maximum levels laid down in  
Regulation s (EC) No 1881/2006  and (EC) No 124/2009 ; or  
– residues of substances that are prohibited  or not authorised in 
accordance with Regulation (EU) No 37/2010 or 
Directive  96/22/EC ; 
(iii) non-compliance with the microbiological crit eria referred 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 consumption ;  
(iv) other factors that might require the fresh meat to be declared unfit for 
human consumption or restrictions to be placed on its use . 
2. During the post-mortem 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 post-mortem inspection of domestic 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 
Artic les 12 and 14.  
2. The official veterinarian shall require that carcases of domestic solipeds, bovine 
animals over eight months old and domestic swine  more than five weeks old are  
EN 18  EN  submitted for post -mortem inspection split lengthways into half carcases down  the 
spinal column.  
3. If the post-mortem inspection so necessitates, the official veterinarian  may require 
any head or any carcase to be split lengthways.  However, to take account of 
particular eating habits, technological developments or specific sanitar y situations, 
the official veterinarian  may authorise the submission for post-mortem 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 slaughter houses  or game -handling establishments handling fewer 
than 1  000 livestock units per year, the official veterinarian may , for sanitary reasons , 
authorise the cutting into quarter carcases of adult domestic solipeds, adult bovine 
animals an d adult large wild game before post -mortem inspection . 
Article 16 
Additional requirements for post -mortem inspection in case s of emergency slaughter  
In the event of emergency slaughter, the carcase shall be subjected to post -mortem inspection  
as soon as possible in accordance with Article s 12, 13, 14 and 15 before it is released for 
human consumption.  
Article 17 
Practical arrangements for post -mortem inspection of domestic bovine animals, 
domestic sheep and goats, domestic solipeds and domestic  swine  
Where  the post -mortem inspection is performed by an official veterinarian, under the 
supervision of the official veterinarian or, where sufficient guarantees are in place, under the 
responsibility of the official veterinarian  in accordance with Art icle 18(2)(c) of Regulation 
(EU) 2017/625  and Article 7 of Delegated Regulation [SANTE/10193/2017] , the competent 
authorities shall ensure that the practical arrangements laid down in the following Articles 18 
to 24 are complied with  in the cases of domest ic bovine animals , domestic sheep and goats , 
domestic solipeds  and domestic s wine  in addition to the requirements laid down in Articles 
12, 14 and 15 . 
Article 1 8 
Young bovine animals  
1. Carcases and offal of the following bovine animals shall undergo the post-mortem 
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 officially tuberculosis -free Member State or region of a 
Mem ber State in accordance with Article 1 of Decision 2003/467/EC.  
2. The post -mortem inspection procedures shall include at least a visual inspection of 
the following:  
(a) the head and throat; together with palpation and examination of the 
retropharyngeal lymph nodes ( Lnn. retropharyngiales ), however, in order to 
ensure the surveillance of the officially tuberculosis free status, Member States  
EN 19  EN  may decide to carry out further investigations; inspection of the mouth and 
fauces;  
(b) the lungs, trachea and oesophagus; pa lpation of the lungs; palpation and 
examination of the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, 
eparteriales and mediastinales ); 
(c) the pericardium and heart;  
(d) the diaphragm;  
(e) the liver and the hepatic and pancreatic lymph nodes, ( Lnn. portales ); 
(f) the gastro -intestinal tract, the mesentery and gastric and mesenteric lymph 
nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); 
(g) the spleen;  
(h) the kidneys;  
(i) the pleura and peritoneum;  
(j) the umbilical region and the joints of young animals.  
3. The official veterinarian shall proceed with the following post -mortem 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 retropharyngeal lymph nodes ( Lnn. retropharyngiales ); 
palpation of the tongue;  
(b)  incision of the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, 
eparteriales and mediastinales ); lengthwise opening of the  trachea and the 
main branches of the bronchi; the lungs shall be incised in their posterior third, 
perpendicular to their main axes; these incisions are not necessary where the 
lungs are excluded from human consumption;  
(c)  lengthways incision of the heart s o as to open the ventricles and cut through 
the interventricular septum;  
(d)  incision of the gastric and mesenteric lymph nodes;  
(e)  palpation of the spleen;  
(f)  incision of the kidneys and the renal lymph nodes ( Lnn. renales ); 
(g)  palpation of the umbilical region an d the joints. The umbilical region shall be 
incised and the joints opened; the synovial fluid must be examined.  
Article 19 
Other bovine animals  
1. Carcases  and offal of bovine animals others than those referred to in Article 1 8(1) 
shall undergo the followi ng post-mortem inspection procedures:  
(a) a visual inspection of the head and throat; incision and examination of the 
retropharyngeal lymph nodes ( Lnn. retropharyngiales ); examination of the 
external masseters, in which two incisions shall be made parallel to the 
mandible, and the internal masseters (internal pterygoid muscles), which shall  
EN 20  EN  be incised along one plane. The tongue shall be freed to permit a detailed 
visual inspection of the mouth and the fauces;  
(b)  an inspection of the trachea and oesophagus; visua l examination and palpation 
of the lungs; incision and examination of the bronchial and mediastinal lymph 
nodes ( Lnn. bifucationes, eparteriales and mediastinales ); 
(c)  a visual inspection of the pericardium and heart, the latter being incised 
lengthways so a s to open the ventricles and cut through the interventricular 
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 mesentery, the gastric and 
mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); 
palpation of the gastric and mesenteric 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. supramammarii ). 
2. The official veterinarian shall proceed with the follo wing post -mortem 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 examinatio n of the sub -maxillary and parotid lymph nodes 
(Lnn. mandibulares and parotidei ); palpation of the tongue and the fauces;  
(b)  an incision of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, 
eparteriales and mediastinales); lengthwise opening of t he trachea and the main 
branches of the bronchi; the lungs shall be incised in their posterior third, 
perpendicular to their main axes; these incisions are not necessary where the 
lungs are excluded from human consumption;  
(c)  a palpation of the liver and the  hepatic and pancreatic lymph nodes ( Lnn. 
portales ); incision of the gastric surface of the liver and at the base of the 
caudate lobe to examine the bile ducts;  
(d)  an incision of the gastric and mesenteric lymph nodes;  
(e)  a palpation of the spleen;  
(f)  an incisio n of the kidneys and the renal lymph nodes ( Lnn. renales ); 
(g)  a palpation and incision of the udder and its lymph nodes ( Lnn. 
supramammarii ) in cows. Each half of the udder shall be opened by a long, 
deep incision as far as the lactiferous sinuses ( sinus lac tiferes ) and the lymph 
nodes of the udder shall be incised, except where the udder is excluded from 
human consumption.   
EN 21  EN  Article 20 
Young domestic 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 following 
post-mortem inspection procedures :  
(a) a visual inspection of the head, including the throat, mouth, tongue and parotid 
and retropharyn geal lymph nodes. These examinations are not necessary if the 
competent authority is able to guarantee that the head, including the tongue and 
the brains, will be excluded from human consumption;  
(b)  a visual inspection of the lungs, trachea and oesophagus an d the bronchial and 
mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ); 
(c)  a visual inspection of the pericardium and heart;  
(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 mesentery and the gastric 
and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and 
caudales ); 
(g) a visual inspection of the spleen;  
(h) a visual inspection of the k idneys;  
(i) a visual inspection of the pleura and peritoneum;  
(j) a visual inspection of the umbilical region and joints.  
2. The official veterinarian shall proceed with the following post -mortem inspection 
procedures using incision and palpation of the carcase an d 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 provided otherwis e, these examinations are not necessary if 
the competent authority is able to guarantee that the head, including the tongue 
and the brains, will be excluded from human consumption;  
(b) a palpation of the lungs; incision of the lungs, trachea, oesophagus, bronchial 
and mediastinal lymph nodes;  
(c) an incision of the heart;  
(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 kidneys 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 synovial fluid shall be examined.   
EN 22  EN  Article 21 
Other domestic sheep and goats  
1. Carcases and offal of sheep having a per manent incisor erupted or 12 months of age 
or more, and goats six months of age or more , shall undergo the following post-
mortem inspection procedures :  
(a) a visual inspection of the head, including the throat, mouth, tongue and parotid 
lymph nodes and palpat ion of the retropharyngea l lymph nodes. These 
examinations are not necessary if the competent authority is able to guarantee 
that the head, including the tongue and the brains, will be excluded from 
human consumption;  
(b) a visual inspection of the lungs, trac hea and oesophagus; palpation of the lungs, 
the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and 
mediastinales ); 
(c) a visual inspection of the pericardium and heart;  
(d) a visual inspection of the diaphragm;  
(e) a visual inspection of the li ver 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 -intestinal tract, the mesentery and the ga stric 
and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, 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 (excep t for the penis, if already 
discarded);  
(k) a visual inspection of the udder and its lymph nodes.  
2. The official veterinarian shall proceed with the following post -mortem inspection 
procedures using incision and palpation of the carcase and offal  when there a re 
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 provided otherwise , these examinations  are not necessary if 
the competent authority is able to guarantee that the head, including the tongue 
and the brains, will be excluded from human consumption;  
(b) an incision of the lungs, trachea, oesophagus and the bronchial and mediastinal 
lymph nodes;  
(c) an incision of the heart;  
(d) a palpation of the spleen;  
(e) an incision of the kidneys and the renal lymph nodes ( Lnn. renales ).  
EN 23  EN  Article 22 
Domestic solipeds  
1. Carcases and offal of domestic solipeds shall undergo the following post-mortem 
inspectio n 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 
fauces and must itself be visually examined;  
(b) a visual inspection of the lungs, tr achea, oesophagus and the bronchial and 
mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ); 
(c) a visual inspection of the pericardium and the heart;  
(d) a visual inspection of the diaphragm;  
(e) a visual inspection of the liver and the hepati c and pancreatic lymph nodes 
(Lnn portales ); 
(f) a visual inspection of the gastro -intestinal tract, the mesentery and the gastric 
and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales  and 
caudales ); 
(g) a visual inspection of the spleen;  
(h) a visual insp ection of the kidneys;  
(i) a visual inspection of the pleura and peritoneum;  
(j) a visual inspection of the genital organs of stallions (except for the penis, if 
already discarded) and mares;  
(k) a visual inspection of the udder and its lymph nodes ( Lnn. supramammarii ); 
(l) a visual inspection of the umbilical region and joints of young animals;  
(m)  examination of the muscles and lymph nodes ( Lnn. subrhomboidei ) of the 
shoulders beneath the scapular cartilage after loosening the attachment of one 
shoulder, in the case grey horses, in order to inspect for melanosis and 
melanomata. The kidneys shall be exposed.  
2. The official veterinarian shall proceed with the following post -mortem 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 -maxillary, retropharyngeal and parotid 
lymph nodes ( Lnn. retropharyngiales, 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 branches of the bronchi shall be opened 
lengthwise and the lungs shall be incised in their posterio r third, perpendicular 
to their main axes; however, these incisions are not necessary where the lungs 
are excluded from human consumption;  
(c) an incision of the heart lengthwise, so as to open the ventricles and cut through 
the interventricular septum;   
EN 24  EN  (d) a palp ation and incision of the liver and the hepatic and pancreatic lymph 
nodes, ( Lnn. portales ); 
(e) an incision of the gastric and mesenteric lymph nodes;  
(f) a palpation of the spleen;  
(g) a palpation of the kidneys and incision of the kidneys and the renal lymph 
nodes (Lnn. renales ); 
(h) an incision of the supramammary 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 t hrough the entire kidney in grey horses.  
Article 2 3 
Domestic s wine  
1. Carcases and offal of domestic swine  shall undergo the  following  post-mortem 
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 heart;  
(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 mesentery, 
the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales 
and caudales ); 
(g) a visual inspection of the spleen; visual inspection of the kidneys; 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. supramammarii ); 
(j) a visual inspection of the umbilical reg ion and joints of young animals.  
2. The official veterinarian shall proceed with the following post -mortem inspection 
procedures using incision and palpation of the carcase and offal, when there are 
indications of a possible risk to human  health, animal he alth or animal welfare 
indicated in accordance with Article 24: 
(a) an incision and examination of the submaxillary lymph nodes ( Lnn. 
mandibulares ); 
(b) a palpation of the lungs and the bronchial and mediastinal lymph nodes ( Lnn. 
bifurcationes, eparteriale s and mediastinales ). The trachea and the main 
branches of the bronchi shall be opened lengthwise and the lungs shall be  
EN 25  EN  incised in their posterior third, perpendicular to their main axes; those incisions 
are not necessary where the lungs are excluded from  human consumption;  
(c) an incision of the heart lengthwise so as to open the ventricles and cut through 
the interventricular septum;  
(d) a palpation of the liver and its lymph nodes;  
(e) a palpation and, if necessary, incision of the gastric and mesenteri c lymph 
nodes;  
(f) a palpation of the spleen;  
(g) an incision of the kidneys and the renal lymph nodes ( Lnn. renales ); 
(h) an incision of the supramammary lymph nodes;  
(i) a palpation of the umbilical region and joints of young animals and, if 
necessary, i ncision 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 
domestic bovine animals, domestic sheep and goats, domestic solipeds and domestic 
swine  
The official veterinarian shall proceed with the additional post -mortem inspection procedures  
referred to in Articles 1 8(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 following indicates a possible 
risk to  human health, animal health or animal welfare:  
(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 -mortem inspection carried out in accordance with 
Article 11;  
(c) the results of the verifications of compliance with animal welfare rules carried 
out in accordance with Article 3 8; 
(d) the findings of post -mortem inspection carried out in accordance with Articles 
12 to  24 of this Regulation ; 
(e) additional epid emiological data or other data from the holding of provenance 
of the animals.  
Article 25 
Practical arrangements for post -mortem inspection of poultry  
1. All poultry shall undergo post -mortem inspection which may include the  assistance  
of slaughterhouse sta ff in accordance with Article 18(3) of Regulation 
(EU)  2017/625. The official veterinarian or official auxiliary, in accordance with 
Article 18(2)(c) of that Regulation shall personally carry out the following checks:  
(a) daily inspection of the viscera an d body cavities of a representative sample of 
each poultry flock ; 
(b) a detailed inspection of a random sample  of parts of birds or entire birds 
declared unfit for human consumption following post -mortem inspection from 
each poultry flock;   
EN 26  EN  (c) any further  investigations necessary where there is reason to suspect that the 
meat from the birds concerned could be unfit for human consumption.  
2. By way of derogation from paragraph 1, the competent  authorities may decide that 
only a representative sample of poultry from each flock undergoes post -mortem 
inspection if:  
a) food business operators have a system  in place to the satisfaction of  the official 
veterinarian,  that allows the detection and the sep aration of birds with 
abnormalities, contamination or defects ; 
b) the slaughterhouse has a longstanding history of compliance with the 
requirements as regards:  
(i) general and specific 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 rul es in accordance with Article 5  and Section II  of 
Annex III to Regulation (EC) No 853/2004;  
c) no abnormalities that may indicate a serious problem for human or animal 
health have been found during ante -mortem inspection and verification of food 
chain information  that may indicate the need for measures laid down in 
Articles 40 to 44. 
3. In case of  poultry reared for the production of foie gras  and delayed eviscerated 
poultry obtained at the holding of provenance  in accordance with Points 8 and 9 of 
Chap ter VI to Section II of Annex III to Regulation (EC) No 853/2004 , post-mortem 
inspection shall take place at the cutting plant  where  such carcases are transported 
directly from the holding  of provenance . 
Article 26 
Practical arrangements for post -mortem inspection of farmed lagomorphs  
The practical arrangements for post-mortem inspection in poultry  in accordance with Article 
25, shall apply to farmed lagomorphs . The provisions applicable to a single poultry flock in 
Article 25 shall apply to farmed lagomo rphs slaughtered the same day from a single holding 
of provenance .   
Article 27 
Practical arrangements for post -mortem inspection of farmed game  
1. The following post-mortem inspection procedures shall apply to farmed game:  
(a) in the case of small (< 100 kg) Cervidae , the post -mortem procedures for 
ovine animals  laid down in Articles 2 1, however  in the case of reindeer  the 
post-mortem procedures for ovine animals laid down in Articles 2 0 shall be 
used and the tongue may be used for human consumption without inspectio n 
of the head;  
(b) in the case of game of the family Suidae , the post -mortem procedures for 
domestic swine laid down in Article 23   
EN 27  EN  (c) in the case of large game of the family Cervidae  and other large game, not 
covered by paragraph (a) , and in the case of large game of the family Suidae  
not covered by paragraph ( b), the post -mortem  procedures for bovine animals 
laid down in Article 19;  
(d) in the case of birds , including ratites , the post -mortem procedures for poultry 
laid down in Article 2 5(1); 
2. Where the an imals  have been slaughtered outside the slaughterhouse, the official 
veterinarian at the slaughterhouse shall  verify  the certificate.  
Article 28 
Practical arrangements for post -mortem inspection of wild game  
1. The official veterinarian shall verify  that a health certificate conforming 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 Chapter II of Section IV of Annex III to Regulation 
(EC) No 853/2004 , accompanies unskinned lar ge wild game transported to the game -
handling establishment from the territory of another Member State. The official 
veterinarian shall take into account the content of that certificate or declaration(s).  
2. During post -mortem inspection , the official vete rinarian shall  carry out:  
(a) a visual examination of the carcase, its cavities and, where appropriate, organs 
with a view to:  
(i) detecting any abnormalities not resulting from the hunting process. For 
this purpose, the diagnosis may be based on any infor mation that the 
trained person has provided concerning the behaviour of the animal 
before killing ; 
(ii) checking that death was not due to reasons other than hunting.  
(b) an investigation of organoleptic abnormalities;  
(c) palpation and incisions of organs, where appropriate;  
(d) where there are serious grounds for suspecting the presence of residues or 
contaminants, an analysis by sampling of residues not resulting from the 
hunting process, including environmental contaminants. Where  a more 
extensive  inspection is made on the basis of such suspicions, the veterinarian 
shall wait until that inspection has been concluded before assessing all the 
game killed during a specific hunt, or those parts suspected of showing the 
same abnormalities;  
(e) examinati on for characteristics indicating that the meat presents a health risk, 
including:  
(i) abnormal behaviour or disturbance of the general condition of the live 
animal, as reported by the hunter ; 
(ii) the generalised presence of tumours or abscesses affecting  different 
internal organs or muscles ; 
(iii) arthritis, orchitis, pathological changes in the liver or the spleen, 
inflammation of the intestines or the umbilical region ;  
EN 28  EN  (iv) the presence of foreign bodies not resulting from the hunting process in 
the bod y cavities, stomach , intestines or urine, where the pleura or 
peritoneum are discoloured (when relevant viscera are present) ; 
(v) the presence of parasites ; 
(vi) formation of a significant amount of gas in the gastro -intestinal tract with 
discolouring of t he internal organs (when these viscera are present) ; 
(vii) significant abnormalities 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 veterinarian so requires, the vertebral column and the head shall 
be split lengthwise.  
4. In the case of small wild game not eviscerated immediately aft er killing, the official 
veterinarian shall carry out a post -mortem inspection on a representative sample of 
animals from the same source. Where inspection reveals a disease transmissible to 
humans  or any of the characteristics listed in point (e) in parag raph 2, the official 
veterinarian shall carry out more checks on the entire batch to determine whether it 
should  be declared unfit for human consumption or whether each carcase should  be 
inspected individually.  
5. The official veterinarian may perform any further cuts and inspections of the relevant 
parts of the animals that are necessary to reach a final diagnosi s. If an assessment 
cannot be made on the basis of the practical arrangements in paragraph 2 , additional 
investigations  shall be carried out in a laboratory . 
6. In addition to the cases provided for in Article 45, meat presenting during 
post-mortem inspection any of the characteristics listed in point (e) in paragraph  2 
shall be declared unfit for human consumption.  
SECTION  4: OFFICIAL CONTROLS ON SPECIFIC HAZARDS AND 
LABORATORY TESTING  
Article 29 
Practical arrangements for official control s for transmissible spongiform 
encephalopathies (TSEs)  
1. In addition to the requirements of Regulation (EC) No 999/2001 concerning the 
official controls to be ca rried out in relation to TSEs , the official veterinarian shall 
check the removal, separation and, where appropriate, marking of specified risk 
material also i n accordance with the rules laid down in Article 8(1) of that 
Regulation and in Article 12 of Regu lation (EC) No 1069/2009  on animal by -
products . 
2. The official veterinarian shall  ensure that the food business operator takes all 
necessary measures to avoid contaminating  meat with specified risk material during 
slaughter , including stunning . This inclu des the  removal of specified risk material.   
EN 29  EN  Article 30 
Practical arrangements for official control s for  cysticercosis during post -mortem 
inspection  in domestic bovine and Suidae  
1. The post -mortem inspection procedures described in Articles 18, 19 and 2 3 shall be 
the minimum requirements for the examination for cysticercosis in bovine animals 
and Suidae  (domestic swine, farmed game and wild game) . In the case of bovine  
animals referred to in Article 19 , the competent authority may decide that incision of 
the masseters at post -mortem inspection is not compulsory  where:  
a) a specific serological test is used ; 
b) the animals have been raised on a holding of provenance officially certified to 
be free of cysticercosis ; or, 
c) if the prevalence of the source population or  in a well -defined subpopulation is 
below one in a million has been demonstrated with 95 % certainty or no cases 
have been detected in all slaughtered animals in the past five years (or two 
years where supported and justified by the competent authorit ies' risk analysis) 
based on data from reporting carried out in accordance with Article 9(1) of 
Directive 2003/99/EC . 
2. Meat infected with cysticerci shall be declared unfit for human consumption. 
However, where  the animal is not generally infected with cysticercus, the parts not 
infected may be declared fit for human consumption after having undergone a cold 
treatment.  
Article 31 
Practical arrangements for official control s for  Trichinella  during post -mortem 
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 trichinae shall be de clared unfit for human 
consumption.  
Article 32 
Practical arrangements for official control s for  glanders during post -mortem inspection 
of solipeds  
1. Fresh meat of solipeds shall be placed on the market only if it was produced from 
equidae kept for at least 90 days prior to the date of slaughter in a Member State or in 
a third country or region thereof from which it is authorised to bring solipeds  into the 
Union.  
2. In the case of solipeds originating from a Member State or third  countries  and 
regions t hereof  not meeting the World Organisation for Animal Health  criteria for a 
glanders -free country, solipeds shall  be inspected for glanders by a careful 
examination of the mucous membranes of the trachea, larynx, nasal cavities and 
sinuses and their ramifi cations, after splitting the head in the median plane and 
excising the nasal septum.  
3. Meat produced from solipeds in which glanders has been diagnosed shall  be declared 
unfit for human consumption.   
EN 30  EN  Article 33 
Practical arrangements for official control s for tuberculosis during post -mortem 
inspection  
1. Where  animals have reacted positively or inconclusively to tuberculin, or there are 
other grounds for suspecting infection, they shall be slaughtered separately from 
other animals, taking precautions to avo id the risk of contamination of other 
carcases, the slaughter line and staff present in the slaughterhouse.  
2. All meat from animals in which post -mortem 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 consumption. However, where  a 
tuberculo id lesion has been found in the lymph nodes of only one organ or part of the 
carcase, only the affected organ or part of the carcase and the associated lymph nodes 
shall be declared unfit for human consumption.  
Article 34 
Practical arrangements for official control s for  brucellosis during post -mortem 
inspection  
1. Where  animals have reacted positively or inconclusively to a brucellosis test, or there 
are other grounds for suspecting infection, they shall be slaughtered separately from 
other animals, taking precautions to avoid the risk of contamination of other 
carcases, the slaughter line and staff present in the slaughterhouse.  
2. Meat from animals in wh ich post -mortem inspection has revealed lesions indicating 
acute infection with brucellosis shall be declared unfit for human consumption. In the 
case of animals reacting  positively or inconclusively to a brucellosis test, the udder, 
genital tract and bloo d shall be declared unfit for human consumption even if no such 
lesion is found.  
Article 35 
Practical arrangements for official control s for  Salmonella  
1. The competent authority shall verify the correct implementation by food business 
operators  of points 2.1.3, 2.1.4 and 2.1.5 of Chapter 2 of Annex I of Regulation (EC) 
No 2073/2005  by applying one or more  of the following measures:  
(a) official sampling using the same method and sampling area as food business 
operators. At least 49 random samples40 shall be taken in each slaughterhouse 
each year. This number of samples may be reduced in small slaughterhouses 
based on a risk evaluation;  
(b) collecting all information on the total number and the number of 
Salmonella -positive samples taken by food busi ness operators in accordance 
with Article  5 of Regulation (EC) No 2073/2005, in the framework of 
points  2.1.3, 2.1.4 and 2.1.5 of Chapter 2 of Annex I thereto;  
(c) collecting all information on the total number and the number of 
Salmonella -positive samples taken in the framework of national control 
programmes in Member States or regions of Member States for which special 
guarantees have been approved in accordance with Article 8 of Regulation 
(EC) No 853/2004 as regards ruminant, equine, por k and poultry production.  
                                                 
40 If all are negative, 95  % statistical certainty is provided that the prevalence is below 6  %.  
EN 31  EN  2. Where  the food business operator  fails on several occasions  to comply with  the 
process hygiene criterion, the competent authority shall require it to submit an action 
plan and shall strictly supervise its outcome.  
3. The total number and the number of Salmonella -positive samples, differentiating 
between samples taken under points (a), (b) and (c)  in paragraph  1, when applied, 
shall be reported in accordance with Article 9(1) of Directive 2003/99/EC . 
Article 36 
Practical arrangem ents for official control s for  Campylobacter  
1. The competent authority shall verify the correct implementation by food business 
operators of point 2.1.9 (process hygiene criterion for Campylobacter on carcases of 
broilers) of Chapter 2 of Annex I of Regulation (EC) No 2073/2005 by applying the 
following measures:  
(a) official sampling using the same method and sampling area as food business 
operators. At least 49 random samples shall be taken in each slaughterhouse 
each year. This number of samples may  be reduced in small slaughterhouses 
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 
operators in accordance with Article 5 of Regul ation (EC) No  2073/2005, in 
the framework of point 2.1.9 of Chapter 2 of Annex I thereto.  
2. Where the food business operator fails on several occasions to comply with  the 
process hygiene criterion, the competent authority shall require it to submit an act ion 
plan and shall strictly supervise its outcome.  
3. The total number and the number of Campylobacter  samples with more than 
1 000 cfu/g, differentiating between samples taken under points (a) and (b)  in 
paragraph  1, when applied, shall be reported in acc ordance with Article 9(1) of 
Directive 2003/99/EC.  
Article 37 
Specific requirements as regards laboratory tests  
1. When performing laboratory tests in accordance with Article 18(2)(d) (ii) and (iv) of 
Regulation (EU) 2017/625, the official veterinarian shall  ensure that , when sampling 
takes place , samples are appropriately identified and handled and sent to the 
appropriate laboratory in the framework of:  
(a) the monitoring and control of zoonoses and zoonotic agents;   
(b) the annual programme for the monitoring  of TSEs in accordance with Article 
6 of Regulation (EC) No  999/2001 ;  
(c) the detection of pharmacologically active substances or products either 
prohibited or not authorised,  and control s for  regulated pharmacologically 
active substances, pesticides  feed addi tives and contaminants exceeding 
applicable maximum Union limits , in particular in the framework of the 
national plans for the detection of residues or substances referred to in Article 
110(2) of Regulation (EU) 2017/625 and in Article 5 of Directive  96/23/EC ;  
(d) the detection of animal diseases for which animal health rules are laid down 
in Regulation (EU) 2016/429 .  
EN 32  EN  2. The official veterinarian shall ensure that any  additional labor atory testing deemed 
necessary for the fulfilment the obligations under Article 18(2) of Regulation (EU) 
2017/625 takes place as required.  
SECTION  5: OFFICIAL CONTROLS ON ANIMAL WELFARE  
Article 38 
Official controls  on animal welfare at transport and slaughter  
The official veterinarian shall  verify compliance with the rules concerning the protection of 
animals and during transport in accordance with Regulation (EC) No 1/2005  at the time of 
slaughter in accordance with Regulation (EC) No 1099/2009 and national rules on animal 
welfare . 
CHAPTER III  
COMMUNICATION OF INSPECT ION RESULTS AND MEASURES TO BE TAKEN 
BY COMPETENT AUTHORITIES IN CASE S OF SPECIFIC NON -COMPLIANCE 
WITH REQUIREMENTS FOR FRESH MEAT  AND FOR ANIMAL WELFARE  
Article 39 
Measures concerning the communication of the results of official controls  
1. The official veterinarian shall  record and evaluate the results of official controls 
carried out in accordance with Articles 7 to Article 38. 
2. The following actions shall be taken by the official veterinarian where inspections 
reveal the presence of any dise ase or condition that migh t affect human or animal 
health, or compromise animal welfare : 
(a) the official veterinarian shall inform the slaughterhouse  operator ; 
(b) where  the problem  referred to in this paragraph  arose during primary 
production  and relate s to human health, animal health, animal welfare or 
residues of veterinary medicinal products , unauthorised or prohibited 
substances, pesticide residues , feed additives  or contaminants , the official 
veterinarian shall inform : 
(i) the veterinarian attending the holding of provenance ; 
(ii. the official veterinarian who carried out  any ante-mortem inspection at 
the holding of provenance, where  different from (i);  
(iii) the food business operator responsible for the holding of provenance 
(provided that such information would not prejudice subsequent legal 
proceedings) ; and, 
(iv) the competent authority responsible for supervising the holding of 
provenance or the hunting area.  
(c) where  the animals concerned were raised in another country, the official 
veterin arian shall  ensure that the country’s competent authorit ies are informed . 
3. The competent authorities shall enter  the results of official controls  in relevant 
databases , at least where  the collection of such information is required under   
EN 33  EN  Article  4 of Dire ctive 2003/99/EC, Article 8 of Council Directive 64/432/EEC41 and 
Annex III to Directive 2007/43/EC.  
4. Where  the official veterinarian, while carrying out ante -mortem  or post -mortem 
inspection or any other official control , suspects the presence of an animal diseases 
for which animal health rules are laid down in Regulation (EU) 2016/429 , he/she  
shall  notify the competent authorit ies. The official veterinarian and competent 
authorities, within their respective areas of competence, shall  take all necessa ry 
measures and precautions to prevent the possible spread of the disease agent . 
5. The official veterinarian may use the model document in Annex I for the purpose of 
communicating the  relevant  results of a nte-mortem  and post -mortem inspections  to 
the hold ing of provenance where the animals were kept before slaughter.  
6. Where the animals were  kept on a holding of provenance in another Member State , 
the competent authorities of the Member State in which  they were slaughtered shall 
communicat e the relevant r esults of ante -mortem  and post -mortem inspections  to the 
competent authorities in the Member State of provenance . They shall  use the model 
document in Annex I in the official languages of both Member States involved  or in 
a language agreed between both Mem ber States . 
Article 40 
Measures in case s of non -compliance with requirements for food chain information  
1. The official veterinarian shall ensure  that animals are not slaughtered unless the 
slaughterhouse operator has been provided with , checked  and evaluated relevant food 
chain information  in accordance with Article 9(2)(a) and (b).  
2. By way of derogation from paragraph  1, the official veterinarian may allow animals 
to undergo slaughter in the slaughterhouse if the relevant food chain informatio n is 
not available. In such cases, the information shall  be supplied before the meat is 
declared fit  for human consumption  and carcases and related offal shall  be stored 
separately 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 slaughterhouse, the official veterinarian shall declare all meat 
from the animal unfit for human consumption. If the animal has not yet been 
slaughtered, it shall  be killed separate ly from other animals  taking all necessary 
precautions to safeguard animal and human health . 
Article 41 
Measures in cases of non -compliance recorded in food chain information  
1. The official veterinarian shall verify that the slaughterhouse operator does not accept 
animals  for slaughter when the food chain information or any other accompanying 
records, documentation or information show that:  
(a) the animals come from a holding  of provenance  or an area subject to a 
movement prohibition or other restriction for reasons of animal or human  
health;  
                                                 
41 Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra -Community 
trade in bovine animals and swine (OJ L 121, 29.7.1964, p. 1977) .  
EN 34  EN  (b) rules on the use of veterinary medicinal products have not been complied with , 
animals have been treated with prohibited or non -authorised substances , or the 
legal limits for chemical residues or contaminants have  not been complied 
with; or 
(c) any other condition which might adversely affect human or animal health is 
present . 
2. If the animals are already present at the slaughterhouse, they shall be killed 
separately and declared unfit for human consumption, taking precautions to 
safeguard animal and human health. Where  the official veterinarian considers it 
necessary, official co ntrols shall be carried out on the holding of provenance.  
Article  42 
Measures in cases of misleading food chain information  
1. The competent authorit ies shall  take appropriate action if they discover that the 
accompanying records, documentation or other in formation do not correspond to the 
true situation of the holding of provenance or the true condition of the animals , or 
aim deliberately to mislead the official veterinarian.  
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 
slaughterhouse operator . In particular , this action may consist of extra controls. The 
food business operator responsible for the holding of provenance or any other person 
involved shall  bear the costs of such extra controls.  
Article 43 
Measures in case s of non -compliance with requirements for live animals  
1. The official veterinarian shall  verify the food business operator ’s compliance with its 
duty under p oint 3 in Chapter IV of Section I of Annex III to Regulation (EC) 
No 853/2004 to ensure that animals accepted for slaughter for human consumption 
are properly identified. The official veterinarian shall  ensure that animals whose 
identity is not ascertainab le are killed separately and declared unfit for human 
consumption. Where  the official veterinarian considers it necessary, official controls 
shall  be carried out on the holding of provenance.  
2. The official veterinarian shall  ensure that animals subject t o an unacceptable risk of 
contamination of the meat during slaughter , as laid down in Article 11(4), are not 
slaughtered for human consumption unless they are cleaned beforehand.  
3. The official veterinarian shall ensure that a nimals with a disease or cond ition that 
may be transmitted to animals or humans handling or eating the meat and, in general, 
animals showing clinical  signs of systemic disease or emaciation , or any other 
condition rendering meat unfit for human consumption , are not slaughtered for 
human consumption. Such animals shall  be killed separately under such conditions 
that other animals or carcases cannot be contaminated, and declared unfit for human 
consumption.  
4. The official veterinarian shall defer t he slaughter of animals suspected of having a 
disease or condition that may adversely affect human or animal health . Such animals 
shall  undergo detailed ante -mortem examination by the official veterinarian in order 
to make a diagnosis. In addition, the official veterinarian may decide that sa mpling  
EN 35  EN  and laboratory examinations must  take place to supplement post -mortem inspection. 
If necessary  to avoid contamination of other meat , the animals shall  be slaughtered 
separately or at the end of normal slaughtering, taking all other necessary precaut ions 
to avoid contamination of other meat.  
5. The official veterinarian shall ensure that a nimals that might contain residues of 
prohibited or no n-authorised pharmacologically active substances or residues of 
authorised pharmacologically 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 veterinarian shall  impose the conditions under which animals shall be 
dealt with under a specific scheme for the eradication or control of a specific disease, 
such as brucellosis or tuberculosis, or zoonotic agents such as salmonella, under 
his/her direct supervision. The competent authorit ies shall  determine the condit ions 
under which such animals may be slaughtered. These conditions shall  be designed to 
minimis e the  contamination of other animals and the meat of other animals.  
As a rule , animals that are presented to a slaughterhouse for slaughter shall  be 
slaughtered there. However, in exceptional circumstances, such as a serious 
breakdown of the slaughter facilities, the official veterinarian may allow direct 
movements to another slaughterhouse.  
Where  non-compliance  which results in a risk to animal or human health, o r animal 
welfare, is detected during ante -mortem inspection at the holding of provenance, the 
official veterinarian shall not allow the animals to be  transport ed to the 
slaughterhouse 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 case s of non -compliance with requirements for animal welfare  
1. In cases of non -compliance with  the rules concerning 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) N o 1099/2009 , the official veterinarian shall  
verify that the food business operator  immediately takes the necessary corrective 
measures and prevents recurrence.  
2. The official veterinarian shall  take a proportionate and stepped  approach to 
enforcement action, ranging from issuing directions to slowing down and stopping 
production, depending on the nature and gravity of the problem.  
3. Where appropriate, the official veterinarian shall  inform other competent authorities 
of welfare problems.  
4. Where  the official veterinarian discovers non-compliance with the  rules concerning 
the prot ection of animals during transport  laid down in Regulation (EC) No  1/2005 , 
he/she  shall  take the requisite  measures in accordance with the relevant Union  
legislation.  
5. Where an official  auxiliary carr ies out checks on animal welfare  and those checks 
identify non -compliance with the rules on the protection of animals,  he/she shall  
immediately inform the official veterinarian . If necessary in urgen t cases, he/she  
shall  take the necessary measures referred to in points  1 to 4 pending the arrival of 
the offic ial veterinarian.   
EN 36  EN  Article 45 
Measures in case s of non -compliance with requirements for fresh meat  
The official veterinarian shall declare fresh meat unfit for human consumption if it:  
(a) derives from animals that have not undergone ante -mortem inspection  in accordance 
with Article 18(2)(a) or (b) of Regulation (EU) 2017/625 , except for wild game;  
(b) derives from animals whose offal has not undergone post -mortem inspection  in 
accordance with Article 18(2)(c) of Regulation (EU) 2017/625 , except in case of 
viscera of large wild game that do not need to accompany the body to a game -
handling establishment in accordance with point 4 to Chapter II of Section IV in 
Annex III of Regulation (EC) No 853/2004 ; 
(c) derives from animals that are dead before slaughter, stillborn, unborn or slaughtered 
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 D irective  2002/99/EC, except 
if it is obtained in conformity with the specific requirements provided for in that 
Directive  this exception shall not apply if  otherwise provided for  in the requirements 
on th e official controls of tubercul osis and brucellosis  provided for in Articles 33 and 
34 of this Regulation ;  
(f) derives from animals affected by a generalised disease, such as generalised 
septicaemia, pyaemia, toxaemia or viraemia;  
(g) is not in conformity with the food safety criteria laid down in Chapter I of Annex I to 
Regulation (EC) No  2073/2005 for determin ing whether food may be placed on the 
market;  
(h) exhibits parasitic infestation, unless otherwise provided for  in the requirements on 
the official controls of cysticercosis  provided for  in Article 30; 
(i) contains 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  and (EC) 
No 124/2009  or residues of substances that are prohibited  or not authorised under  
Regulation (EU) No 37/2010 or Directive 96/22/EC ; 
(k) consists of the liver and kidneys 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;  
(l) has been treated illegally with decontaminating substances;  
(m) has been treated illegally with ionising radiation , including UV-radiation ; 
(n) contains foreign bodies , except, in the case of wild game, material used to  hunt the 
animal;  
(o) exceeds maximum permitted radioactivity levels laid down under  Union legislation  
or, in the absence of Union legislation , under national rules ; 
(p) indicates pathological or organoleptic changes, in particular a pronounced sexual 
odour or insufficient bleeding (except for wild game ); 
(q) derives from emaciated animals;   
EN 37  EN  (r) contains specified risk material  unless removal is allowed in another establish ment in 
accordance with Point 4.3 of Annex V to Regulation (EC) No 999/2001 and remains 
under the control of the competent authority ; 
(s) shows soiling, faecal or other contamination;  
(t) consists of blood that may constitute a risk to human  or animal heal th owing to the 
health status of any animal from which it derives or contamination arising during the 
slaughter process;  
(u) in the opinion of the official veterinarian, 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 consumption ; 
(v) gives rise to specific hazards in accordance with Articles 29 to 36. 
Article 46 
Measures in case s of non -compliance with requirements on good hygiene practices  
1. The competent  authorities  may instruct the food business operator to take immediate 
corrective action, including a reduction in th e speed of slaughter , where this is 
considered necessary by the official present in the following cases:  
(a) where contamination is detected o n external surfaces of a carcase  or its cavities 
and the food business operator does not take appropriate action to rectify the 
situation ; or  
(b) if the competent authority considers that good hygiene practices are 
jeopardi sed.  
2. In such cases, t he competent authorities shall increase the intensity of inspection until 
such time as they are satisfied that the food business operator has regained control of 
the process.  
CHAPTER IV  
RESTRICTIONS  
Article 47 
Restrictions for certain fresh meat  
The offic ial veterinarian may impose requirements concerning the use of fresh meat derived 
from animals:  
(a) that have  undergone emergency slaughter outside the slaughterhouse; 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 market . 
  
EN 38  EN  CHAPTER  V 
HEALTH  MARKING  OF MEAT  FIT  FOR  HUMAN  CONSUMPTION  AFTER  ANTE -
MORTEM  AND  POST -MORTEM  INSPECTION  
Article 48 
Technical requirements  of the health mark  and practical arrangements for its 
application  
1. The official veterinarian shall  supervise health marking and the marks used.  
2. The official veterinarian shall  ensure, in particular, that:  
(a) the health mark is applied only to domestic ungulates  and farmed game 
mammals other than lagomorphs, having undergone ante -mortem  and 
post-mortem inspection , and large wild game having undergone post mortem 
inspection , in accordance with Article 18(2)(a), (b) and (c) of Regulation  (EU) 
2017/625 , where  there are n o grounds for declaring the meat unfit for human 
consumption. However, the mark may be applied before the results of any 
examination for Trichinella and/or TSE testing are  available, provided that the 
compet ent authorities introduced  a system in place in t he slaughterhouse or 
game -handling establishment ensuring that all parts of the animal can be 
traced , and no parts of the examined animals bearing the mark leave the 
slaughterhouse or game -handling establishment until a negative result has been 
obtained  except when provide d for in accordance with Article 2(3) of 
Regulation (EU) 2015/1375 ; 
(b) the health mark is applied  on the external surface of the carcase, by stamping in 
ink or hot branding, in such a manner that, if carcases are cut in the 
slaughterhouse  into half carcases or quarters, or half carcases are cut into three 
pieces, each piece bears a health mark.  
3. The c ompetent authorities shall ensure that the practical arrangements for the health 
mark are applied in accordance with Annex II. 
4. The competent authorities shall ensure that m eat from unskinned wild game does not  
bear a health mark unless, after skinning in a game -handling establishment, it has 
undergone post -mortem inspection and been declared fit for human consumption.  
TITLE IV 
SPECIFI C REQUIREMENTS AND U NIFORM MINIMUM FREQU ENCY OF OFFICIAL 
CONTROLS WITH RESPEC T TO RAW MILK , COLOSTRUM , DAIRY PRODUCTS  AND  
COLOSTRUM -BASED PRODUCTS , AS NECESSARY TO RESPOND  TO RECOGNISED 
UNIFORM HAZARDS AND RISKS  
Article 49 
Control of milk and colostrum pro duction holdings  
1. The official veterinarian shall verify that the health requirements for raw milk and 
colostrum  production  as laid down in Part I  of Chapter I of Section IX of Annex III 
to Regulation (EC) No 853/2004  are complied with . In particular,  the official 
veterinarian shall verify :  
(c) the health status of the animals ;   
EN 39  EN  (d) the absence of  the use of prohibited or no n-authorised pharmacologically active 
substances ; and  
(e) that the possible presence  of residues of authorised pharmacologically active 
substances , pesticides or contaminants  does not exceed  the levels laid down in 
accordance with Regulations (EU) No 37/2010, (EC) No 396/2005 or (EC) No 
1881/2006 . 
2. The official  controls referred to in paragraph 1 may take place at the occasion of 
veterin ary checks carried out pursuant to Union  provisions on animal or human  
health or animal welfare . 
3. If there are grounds for suspecting that the health requirements referred to in 
paragraph 1 are not being complied with, the official veterinarian shall che ck the 
general health status of the animals.  
4. Milk and colostrum production holdings shall  undergo official controls  by the 
competent authorities  to verify that hygiene requirements  laid down in Part II of  
Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004  are being 
complied with. These controls may involve inspections and the monitoring of 
controls carried out by professional organisations. If it is demonstrated that the 
hygiene is inadequate, the co mpetent authorit ies shall  verify that appropriate steps 
are taken to correct the situation.  
Article 50 
Control of milk and colostrum  
1. In the case of raw milk and colostrum, the competent authorities shall monitor the 
checks carried out in accordance with Part III of Chapter I, Section IX of Annex III 
to Regulation (EC) No 853/2004 . When testing is used, the competent authorities 
shall use the analytical methods set out in Annex III to this Regulation to check 
compliance with the limits laid down for raw milk and colostrum in Part III of 
Chapter  I, Section  IX of Annex III to Regulation (EC) No 853/2004.  
2. If the food business operator of the production holding has not corrected the situation  
within three months of the first notif ication to the competent authorities of non -
compliance with the plate count and/or somatic cell count  criteria  for raw milk and 
colostrum , the competent authorities shall verify that:  
(a) delivery of raw milk and colostrum from the production holding is suspended, 
or  
b) the raw milk and colostrum i s subjected to requirements con cerning its 
treatment and use necessary to protect human health in accordance with a 
specific authorisation of, or general instructions from the competent 
authorities. .  
This s uspension or these requirements shall remain in place by the competent 
authorities until the food business operator has proved that the raw milk and 
colostrum again compl y with the criteria.  
3. The competent authorities shall use the analytical methods set  out in Annex III of 
this Regulation to verify  appropriate application of a pasteurisation process to dairy 
products as referred to in Part II of Chapter II, Section IX of Annex III to Regulation  
(EC) No 853/2004 . 
  
EN 40  EN  TITLE  V 
SPECIFIC REQUIREMENTS  FOR OFFICIAL CONTROLS CO NCERNING LIVE 
BIVALVE MOLLUSCS FRO M CLASSIFIED PRODUCT ION AND RELAYING ARE AS 
Article 51 
Exclusion  
This Title applies to live bivalve molluscs. It also applies to live echinoderms, live tunicates 
and live marine gastropods. This Title does not apply to live marine gastropods and live 
Holot huridea  that are not filter feeders . 
Article 52 
Classification of production and relaying areas for live bivalve molluscs  
1. The competent authorities shall fix the location and boundaries of the production and 
relaying areas that they classify  in accordance with Article 18(6) of Regulation 
(EU)  2017 /625. They may, where appropriate, do so in cooperation with the food 
business o perator.  
2. The competent authorities shall classify production and relaying areas from which 
they authorise 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 appro priate, 
do so in cooperation with the food business operator.  
3. In order to classify  production and relaying areas, the competent authorities shall fix 
a review period for sampling data from each production and relaying area in order to 
determine complian ce with the standards referred to in Articles 53, 54 and 55.  
CHAPTER I  
SPECIFIC REQUIREMENTS FOR THE CLASSIFICATION OF PRODUCTION 
AND RELAYING AREAS  FOR LIVE BIVALVE MOLLUSCS  
Article 53 
Requirements for Class A areas  
1. The competent authorities may classify as Class A areas those from which live 
bivalve molluscs may be collected for direct human consumption.  
2. Live bivalve molluscs placed on the market from such areas shall meet the health 
standards for live  bivalve mollusc s set out in Chapter V of Section VII of Annex III 
to Regulation (EC) No 853/2004.  
3. Samples of live bivalve molluscs from Class A areas shall  not exceed, in 80  % of 
samples collected during the review period, 230 E. coli  per 100  g of flesh and 
intravalvular liquid.  
4. The remaining 20  % of samples shall  not exceed 700 E. coli  per 100  g of flesh and 
intravalvular liquid.  
5. When evaluating the results for the fixed review period for maintenance of a Class A 
area, the competent authorities may, on the basis of a risk assessment based on an 
investigation, decide to disregard an anomalous result exceeding the level of 700  
E. coli per 100 g of flesh and intravalvular liquid.   
EN 41  EN  Article 54 
Requirements for Class B areas  
1. The competent authorities may cl assify as Class B areas those from which live 
bivalve molluscs may be collected and placed on the market for human consumption 
only after treatment in a purification centre or after relaying so as to meet the health 
standards referred 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 intravalvular liquid.  
3. The remaining  10 % of samples shall  not exceed 46  000 E. coli per 100 g of flesh 
and intravalvular liquid.  
Article 55 
Requirements for Class C areas  
1. The competent authorities 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 intravalvular  liquid.  
Article 56 
Sanitary survey requirements  
1. Before  classify ing a production or relaying area, the competent authorities  shall  
carry out a sanitary survey that includes:  
(a) an inventory 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 r eleased during the 
different periods of the year, according to the seasonal variations of human and 
animal populations in the catchment area, rainfall readings, waste -water 
treatment, etc.;  
(c) determination of the characteristics of the circulation of pol lutants by virtue of 
current patterns, bathymetry and the tidal cycle in the production area.  
2. The competent  authorities  shall carry out a sanitary survey fulfilling the  
requirements set out in paragraph 1 in all classified production and relaying areas , 
unless carried out previously . 
3. The competent authorities may be assisted  by other official bodies or food business 
operators under conditions established by the competent authorities in relation to the 
performance of this survey.   
Article 57 
Monitoring programme  
The competent authorities shall establish a monitoring programme for live bivalve mollusc 
production areas that is based on an examination of the sanitary survey referred to in 
Article  56. The  number of samples, geographical distributi on of sampling points and sampling 
frequency for the programme  shall  ensure that the results of the analysis are  representative of 
the area in question .  
EN 42  EN  Article 58 
The competent authorities shall establish a procedure to ensure that the sanitary survey  
referred to in Article 56 and the monitoring programme referred to in Article  57 are 
representative of  the area considered . 
CHAPTER II  
CONDITIONS FOR THE MONITORING OF CLASSIFIED PRODUCTION AND 
RELAYING AREAS FOR LIVE BIVALVE MOLLUSCS  
Article 59 
Monitoring of classified production and relaying areas  
The competent authorities shall periodically monitor production and relaying areas classified 
in accordance with Article 18(6) of Regulation (EU) 2017/625 in order to check:  
(a) that there is no malpractice with regard to the origin, provenance and destination of 
live bivalve molluscs;  
(b) the microbiological quality of live bivalve molluscs in relation to the classified 
production and relaying areas;  
(c) for the presence of toxin -producing plankton in production and relaying waters and 
marine biotoxins in live bivalve molluscs;  
(d) for the presence of chemical contaminants in live bivalve molluscs.  
Article 60 
Recognised methods for the detection of marine biotoxins in live bivalve molluscs  
1. The competent authori ties shall use the analytical methods laid down in Annex V to 
check compliance with the limits laid down in point 2 of Chapter V of Section VII of 
Annex III to Regulation (EC) No 853/2004 and, where appropriate,  to verify 
compliance  by food business operat ors. Food business operators shall use these 
methods where appropriate  
2. In accordance with Article 4 of Directive 2010/63/EU, a scientifically satisfactory 
method or testing strategy, 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 on the protection of animals 
used for scientific purposes, elements of replacement, refinement and reduction must 
be taken into acco unt when biological methods are used  
. 
Article 61 
Sampling plans  
1. For the purposes of the checks provided for in point s (b), (c) and (d)  of Article 59, 
the competent authorities shall draw up sampling plans providing for such checks to 
take place at regu lar intervals, or on a case -by-case basis if harvesting periods are 
irregular. The geographical distribution of the sampling points and the sampling 
frequency shall ensure that the results of the analysis are  representative of the 
classified production or  monitoring area concerned .  
EN 43  EN  2. Sampling  plans to check the microbiological quality of live bivalve molluscs shall  
take particular account of:  
(a) the likely variation in faecal contamination;  
(b) the parameters referred to in Article 56(1). 
3. Sampling pla ns to check for the presence of toxin -producing plankton in the water in 
classified production and relaying areas and for marine biotoxins in live bivalve 
molluscs shall  take particular account of possible variations in the presence of 
plankton containing marine biotoxins. Sampling shall  comprise:  
(a) periodic sampling to detect changes in the composition of plankton containing 
toxins and their geographical distribution. Results suggesting an accumulation 
of toxins in live bivalve mollusc flesh shall  be followed by intensive sampling;  
(b) periodic toxicity tests using live bivalve molluscs from the affected area most 
susceptible to contamination.  
4. The sampling frequency for toxin analysis in live bivalve molluscs shall be weekly 
during harvesting period s, except when :  
(a) the sampling frequency may be reduced in specific classified monitoring or 
production areas, or for specific types of live bivalve mollusc, if a risk 
assessment of toxins or phytoplankton occurrence suggests a very low risk of 
toxic episod es; 
(b) the sampling frequency  shall  be increased where such an assessment suggests 
that weekly sampling would not be sufficient.  
5. The risk assessment referred to in paragraph 4 shall  be reviewed  periodically  in order 
to assess the risk of toxins occurring in the live bivalve molluscs from these areas.  
6. Where  knowledge of toxin accumulation rates is available for a group of species 
growing in the same classified production or relaying area, the species with the 
highest rate may be used as an indicator spec ies. This will allow the exploitation of 
all species in the group if toxin levels in the indicator species are below the 
regulatory limits. Where  toxin levels in the indicator species are above the regulatory 
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 regard to the monitoring of plankton, the samples shall  be representative of the 
water column in the classified production or relaying area and provide i nformation 
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 sampling frequency 
for live bivalve molluscs shall  be increased or precautionary closures of the  areas 
established until results of toxin analysis are obtained.  
8. Sampling 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 
MANAGEMENT OF CLASSIFIED PRODUCTION AND RELAYING AREAS 
AFTER MONITORING   
EN 44  EN  Article 62 
Decisions following monitoring  
1. Where the results of the monitoring provided for in Article 59 indicat e that the health 
standards for live bivalve molluscs  are not met  or that there may otherwise  be a risk 
to human health, the competent authorities shall close the classified production or 
relaying area concerned, preventing the harvesting of live bivalve molluscs. 
However, the y may reclassify a production or relaying area a s 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 monitoring show that the health standards for 
live bivalve molluscs referred to in  Article 53 are exceed ed, competent authorities 
may, on the basis of a risk assessment, and only on a temporary and non -recurring 
basis, permit continued harvesting without closure or reclassification subject to the 
following conditions : 
(a) the classified prod uction area concerned and all approved establishments 
receiving live bivalve molluscs from it are under the official control of the 
same competent authorities  ; 
(b) the live bivalve molluscs concerned are subjected to appropriate restrictive 
measures such as  purification, relaying or processing.  
3. The accompanying registration document , as referred to in Chapter I of Section VII 
of Annex III to Regulation (EC) No 853/2004 , shall include all the information  
concerning the application of paragraph 2 . 
4. The com petent  authorities shall establish the conditions under which paragraph 2 can 
be availed of  in order to ensure, for the production area concerned,  maintenance of 
the compliance with the criteria established in Article 53. 
 
Article 63 
Re-opening of production areas  
1. The competent authorities may re -open a closed production or relaying area only if 
the health standards for live bivalve molluscs comply once again with the relevant 
requirements  of Chapter V of Section VII of Annex III to Regulation (E C) 
No 853/2004 and present no other risk to human health.  
2. Where the competent authorities have close d a production or relaying area because 
of the presence of plankton or levels of toxins in live bivalve molluscs that exceed  
the regulatory limit  for mar ine biotoxins laid down in point 2 of Chapter V of Section 
VII of Annex III to Regulation (EC) No 853/2004 , they may re -open it only if at least 
two consecutive results separated by at least 48 hours are below the regulatory limit .  
3. When deciding whethe r to re -open a production or relaying area, t he competent 
authorities may take account of information on phytoplankton trends.  
4. Where there are robust data on the dynamic of the toxicity for a given area, and 
provided that recent  data on decreasing trends of toxicity are available, the competent 
authorities may decide to re -open an area with results below the regulatory limit in 
point  2 of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004  
obtained from a single sampling.   
EN 45  EN  Article 64 
Control system  
1. The competent authorities shall set up a control system to ensure that products of 
animal origin harmful to human heal th are not placed on the market . The control 
system shall compris e laboratory tests to verify food business operators ’ compliance 
with the requirements for the end product , including live bivalve molluscs and any 
products derived from them, at all stages of production, processing and distribution.  
2. This control system shall  verify, where applicable, t hat the levels of marine biotoxins 
and contaminants do not exceed safety limits and that the microbiological quality of 
the molluscs does not constitute a hazard to human health.  
Article 6 5 
Decision by the competent authorities  
1. The competent authorities  shall a ct promptly 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 referred to in Article 6 2(2). 
2. When deciding on the classification, reclassifica tion, opening or closure of production areas 
in accordance with Articles 52, 6 2 and 6 3,  competent authorities may take into account the 
results of checks  carried out by food  business operators or organisations representing food 
business operators , only if  the laboratory carrying out the analysis  is designated by the 
competent authorities , and the sampling and analysis are performed  in accordance with a 
protocol agreed upon jointly by  the competent authorities and  food business operators or 
organisation c oncerned.  
 
CHAPTER IV 
OTHER REQUIREMENTS  
Articl e 66 
Recording and exchange of information  
The competent authorities shall:  
(a) establish and keep up to date a list of classified production and relaying areas, with 
details of their location , and boundaries, as well as the Class in which 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 interested parties 
affected by this Regulation, such as producers, gatherers and operators of purification 
centres and dispatch centres;  
(b) immediately inform the interested parties such as producers, gatherers and operators 
of purification centres and dispatch centres, of any change to the location, bounda ries 
or Class of a production area, of its temporary or final  closure, or of the application 
of measures as referred to in Article  60(2);  
EN 46  EN  TITLE VI 
SPECIFIC REQUIREMENTS  AND UNIFORM MINIMUM FREQUENCY OF OFFICIA L 
CONTROLS WITH RESPEC T TO FISHERY PRODUCT S 
Article 67 
Official controls on production and placing on the market  
Official controls on the production and placing on the market of fishery products shall  include  
verif ication of  compliance with the requirements set out in Section VIII  of Annex II I to 
Regulation (EC) No 853/2004 , in particular:  
(a) a regular check on the hygiene conditions of landing and first sale;  
(b) regular  inspections of vessels and establishments on land, including fish auctions and 
wholesale markets, in particular  to check : 
(i) whether the conditions for approval are still fulfilled ; 
(ii) whether the fishery products are handled correctly ; 
(iii) compliance 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 transport conditions.  
Article 68 
Site of official controls  
1. The competent  authorities shall carry out official controls o n vessels when these  call at 
a port in a Member State . These controls shall concern all vessels landing fishery 
products at EU ports, irrespective of flag .  
2. Flag state competent authorities may carry out official controls o n vessels under their 
flag while the vessel is at sea or in a port in another Member State or a non-EU 
country. 
Article 69 
Approval of factory, freezer or reefer vessels  
1. Where a factory , freezer or reefer vessel flying the flag of a Member State is 
inspect ed with a view to granting  approval of the vessel, the competent authorit ies of 
the flag Member State shall  carry out official controls  in accordance  with Article 148 
of Regulation ( EU) 2017/625,  particularly the time limits referred to in  Article 
148(4). If necessary, they may inspect the vessel while it is at sea or in a port in 
another Member State or a  non-EU country.  
2. Where  the competent authorit ies of the flag Member State have  granted the vessel 
conditional approval in accordance with Article 148 of Regulation (EU) 2017/625 , 
they may authorise the competent authorit ies of another Member State , or of a 
non-EU country to carry out  follow -up control s with a view to granting full 
approval, prolonging conditional approval or keeping approval under review, 
provided that, in the case of a non -EU country, such country appears on a list  of 
non-EU countries from which imports of fishery products are permitted  pursuant to  
EN 47  EN  Article 127 of Regulation (EU) 2017/625 . If necessary, these competent authorit ies 
may inspect the vessel while it is at sea or in a port in another Member State or 
non-EU country.  
3. Where t he competent authorities of a Member State authorise the competent 
authorities of another Member State or of a non EU country to carry out controls on 
their behalf in accordance with this Article, the two competent authorities shall agree 
on the conditions  governing such controls. These conditions shall ensure, in 
particular, that the competent authorities of the flag Member State receive reports on 
the results of the controls and on any suspected non -compliance without delay, so as 
to enable them to take t he necessary measures.  
Article 70 
Official controls of fishery products  
Official controls of fishery products must  include at least the practical arrangements laid 
down in Annex V I as regards:  
(a) organoleptic examinations;  
(b) freshness indicators;  
(c) histamine;  
(d) residues and contaminants;  
(e) microbiological checks;  
(f) parasites ; 
(g) poisonous fishery products . 
Article 71 
Decisions after controls  
The competent authorities shall  declare fishery products unfit for human consumption if:  
(a) official controls carried out in accordance with Article 70 reveal they are not in 
compliance with organoleptic, chemical, physical or microbiological checks or 
checks for parasites as established in Section VII of Annex III of Regulation (EC) 
N°853/2004 a nd/or Regulation (EC) N°2073/2005 ; 
(b) they contain in their edible parts  chemical residues or contaminants in excess of the 
levels laid down in Regulation s (EU) No 37/2010 , (EC) No 396/2005 , (EC) 
No 1881/2006, or residues of substances that are prohibited or not authorised in 
accordance with Regulation (EU) No 37/2010 or Directive  96/22/EC, or are not in 
compliance with any other relevant Union legislation on pharmacologically active 
substances ; 
(c) they derive from:  
(i) poisonous fish ; 
(ii) fishery products not complying with the requirement s on marine biotoxins ; 
(iii) live bivalve molluscs, echinoderms, tunicates or marine gastropods containing 
marine biotoxins in total quantities exceeding the limits referred to in 
Regulation (EC) No 853/20 04; or  
EN 48  EN  (d) the competent authorit ies consider that they may constitute a risk to human  or animal 
health or are for any other reason not suitable for human consumption.  
Article 72 
Requirements concerning the official controls on fishery products caught by vessels 
flying the flag of Member States entering the Union after being transferred in third 
countries with or without storage  
1. Fishery products intended for human consumption caught by vessels flying the flag 
of a Member State, unloaded, with or without storage, in third countries listed as 
provided for in Article 126(2)(a)  of Regulation (EU) 2017/625 before entering the 
Union by a different means of transportation, shall be accompanied by a health 
certificate  issued by the competent authority of that third country and completed in 
accordance with the model health certificate set out in Annex I Part II Chapter B to 
Implementing Reg ulation (EU) [SANTE /10281/ 2018 ] 
2. If the fishery products referred to in paragraph 1 are unloaded and transported to a 
storage facility located in the third country referred to in that paragraph, that storage 
facility shall appear in a list as provided fo r in Article 5 of Delegated Regulation 
(EU) [SANTE /10279/2018 ]. 
3. If the fishery products referred to in paragraph 1 are loaded in a vessel flying the flag 
of a third country, that third country must be listed as provided for in Article 3 of 
Delegated Regulation (EU) [SANTE /10279/2018 ].and the vessel must appear in a 
list as provided for in Article 5 of Delegated Regulation (EU) [SANTE /10279/2018 ]. 
4. Container vessels used to transport containerised fishery products are excluded from 
this requirement.  
TITLE VII 
SPECIFIC REQUIREMENTS  FOR THE PERFORMANCE OF OFFICIAL CONTROLS  AND 
UNIFORM MINIMUM FREQ UENCY ON REPTILE MEA T  
Article 73 
Ante -mortem and post -mortem inspection of reptiles  
Article 1 1 shall apply to the ante -mortem inspection of reptiles.  
Articles  12, 13 and 14 shall apply to the post-mortem inspection of reptiles . For the purpose 
of Article 13 (a)(i), a reptile will be considered as 0.5 livestock units . 
TITLE VIII  
FINAL PROVISIONS  
Article 74 
Amendments to Regulation (EC) No 2074/2005  
Regulation (EC) No 2074/2005 is amended as follows:  
1. Article s 5, 6b and 6c are  deleted  
2. In Annex I , Section II and the Appendix are deleted.   
EN 49  EN  3. In Annex II,  Section II is deleted.  
4. Annex es III and V are deleted.  
5. Annexes VIa is deleted.  
6. Annex VIb and its Appendix are deleted.  
 
Article 75  
Entry in force and application  
This Regulation shall enter into force on the 20th day following 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 States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER