EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/10667/2012 
(POOL/G4/2012/10667/10667-EN.doc) […](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amendin g Annexes to Re gulations (EC) No 853/2004 , (EC)  No 854/2004 of the European 
Parliament and of the Council a nd Regulation (EC) No 2074/2005 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annexes to Regulations (EC) No  853/2004 , (EC) No 854/2004 of the European 
Parliament and of the Council a nd Regulation (EC) No 2074/2005 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
1, and in 
particular Article 10(1) thereof, 
Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the 
Council of 29 April 2004 laying down specific rules for the organisation of official controls 
on products of animal origin intended for human consumption2, and in particular Article 17(1) 
and points 3 and 10 of Article 18 thereof, 
Whereas: (1) Regulation (EC) No 853/2004 lays down spec ific rules on the hygiene of food of 
animal origin for food business operator s. In accordance with Annex II to that 
Regulation food business operators operating slaughterhouses are t o, request, receive, 
check and act upon food chain information in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse. Such information includes the 
status of the holding of provenance. 
(2) Commission Regulation (EU)  No …/…. amending Regul ation (EC) No 2075/2005 
laying down specific rules on official controls for Trichinella in meat
3 grants 
derogation from testing provisions to holdings which apply controlled housing 
conditions. Such information should ther efore be included in the food chain 
information to be provided to the slaughterhous e, in order to enable  the Member States 
to apply the appropriate Tr ichinella testing regime. 
(3) Regulation (EC) No 853/2004 lays down conditions under which meat from animals 
having undergone emergency slaughter outsid e a slaughterhouse, is fit for human 
consumption. As emergency slaughter meat which has successfully passed meat inspection, does not constitute a risk to publ ic health, the requirement for a special 
                                                
 
1 OJ L 139, 30.4.2004, p. 55.  
2 OJ L 139, 30.4.2004, p. 206.  
3 C(2013)…. (SANCO/11157/2012) EN 3   EN health mark and the restricti on to the national market for the emergency slaughter meat 
should be deleted from that Regulation and the requirement for a special health mark 
for the emergency slaughter meat al so from Regulation (EC) No 854/2004. 
(4) Regulation (EC) No 854/2004 lays down specifi c rules for the organisation of official 
controls on products of animal  origin. In particular, Anne x I to that Regulation lays 
down rules for ante-mortem and post-mortem  inspection, including visual inspection, 
and for specific hazards in fresh meat.  
(5) Regulation (EC) No 854/2004 provi des that official auxiliarie s may assist the official 
veterinarian with official controls subject to certain restrictions . In relation to ante-
mortem inspection and checks concerning the we lfare of animals, official auxiliaries 
should be allowed to help the official vete rinarian with the pr eselection of animals 
with abnormalities.  
(6) The European Food Safety Authority (EFSA) adopted on 3 October 2011 a Scientific 
Opinion on the public health hazards to be covered by in spection of meat (swine)4, 
which concluded that the currently required palpations and incisi ons in post-mortem 
inspection, involve a risk of cross contamination. To prevent that cross contamination, 
those palpations and incisions should not be required anymore for normal animals, but 
only when abnormalities are identified. In that opinion EFSA identifies that the pathogens causing endocarditis in pigs are not relevant for public health. Since the 
routine incision of the heart is not neces sary for safety reasons, it should not be 
required anymore. 
(7) In the same opinion EFSA identifies Salmonella  as a high risk for public health related 
to the consumption of pig meat, and reco mmends to prevent contamination of pig 
carcases with Salmonella.  
(8) In Chapter IX of Section IV of Annex I to Regulation (EC) No 854/2004, provisions 
are laid down on the tasks of the official  veterinarian for specific hazards. Salmonella  
should also be subject of specifi c task of the official veterina rian, in particular in case 
of non-compliance with specific Union legisl ation. In particular supervision of the 
existing process hygiene criterion for Salmonella  on carcases, laid down in 
Commission Regulation (EC)  No 2073/2005 of 15 Novemb er 2005 on microbiological 
criteria for foodstuffs
5 and enforcement of action by th e food business operator in case 
of non-compliance with specific Union legisl ation, should be integr ated in pig meat 
inspection. The supervision also provides a cost-efficient tool to provide the 
information on the mandatory monitoring of Salmonella in the pig meat production 
chain in accordance with Directive 2003/99/EC of the European Parliament and of the 
Council of 17 November 2003 on the monitoring of zoonose s and zoonotic agents, 
amending Council Decision 90/424/EEC and repealing Council Directive 
92/117/EEC6. 
(9) In Commission Regulation (EC) No  2074/2005 of 5 December 2005 laying down 
implementing measures for certain produc ts under Regulation (EC) No 853/2004 of 
the European Parliament and of the Counc il and for the organisation of official 
                                                 
4 EFSA Journal 2011; 9(10):2351. 
5 OJ L 338, 22.12.2005, p. 1. 
6 OJ L 325, 12.12.2003, p. 31. EN 4   EN controls under Regulation (E C) 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 Regulat ions (EC) No 853/2004 and (EC) No 
854/20047, specific requirements are laid dow n for optional visual post-mortem 
inspection of pigs. The amendments propos ed in the present Regulation of the 
standard post-mortem inspection requirem ents in Regulation (EC) No 854/2004 make 
the requirements for optional visual inspect ion of pigs laid down in Regulation (EC) 
No 2074/2005 irrelevant for pigs and cons equently those requirements should be 
amended. 
(10) The requirements provided for in the Regulat ion involve an adaptation of current 
practices both for food busine ss operators and competent aut horities. It is therefore 
appropriate to allow a delayed application of this Regulation. 
(11) Regulations (EC) No 853/2004, No 854/ 2004 and No 2074/2005 should be therefore 
amended accordingly. 
(12) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Amendments to Regulation (EC) No 853/2004 
Regulation (EC) No 853/2004 is amended as follows: 
(1) Point 3(a) of Section III of A nnex II is replaced by the following: 
"(a) the status of the holding of provenance or the regional animal health status, and 
whether the holding is officially rec ognized to apply controlled housing 
conditions in relation to Trichinella  in accordance with Point A of Chapter I of 
Annex IV to Commission Regulation (EC) No 2075/2005*; 
_______________________ 
* OJ L 338, 22.12.2005, p. 60." 
(2) In Chapter VI of Section I of  Annex III, Point 9 is deleted.  
Article 2 
Amendments to Regulation (EC) No 854/2004 
Annex I to Regulation (EC) No 854/2004 is amended as follows: 
(1) In Chapter III of Section I, Point 7 is deleted. 
                                                 
7 OJ L 338, 22.12.2005, p. 27. EN 5   EN (2) In Chapter I of Section III, Poin t 2 is replaced by the following: 
"2. in relation to ante-mortem inspecti on and checks concerning the welfare of 
animals, official auxiliaries may only help with purely practical tasks which 
may include a preselection of  animals with abnormalities;"  
(3) In part B of Chapter IV of Section IV, Points 1 and 2 are replaced by the following: 
"1. Carcases and offal of pigs are to undergo the following post-mortem inspection 
procedures:  
(a) visual inspection of the head and th roat; visual inspection of the mouth, 
fauces and tongue;  
(b) visual inspection of the lungs, trachea and oesophagus; 
(c) visual inspection of the pericardium and heart; (d) visual inspection of the diaphragm; (e) visual inspection of the liver and the hepatic and panc reatic lymph nodes, 
(Lnn portales ); 
(f) visual inspection of th e gastro-intestinal tract, the mesentery, the gastric 
and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and 
caudales ); 
(g) visual inspection of the spleen; (h) visual inspection of the kidneys;  (i) visual inspection of th e pleura and peritoneum; 
(j) visual inspection of the genital orga ns (except for the penis, if already 
discarded);  
(k) visual inspection of the udder and its lymph nodes ( Lnn. 
supramammarii );  
(l) visual inspection of the umbilical  region and joints of young animals. 
2. When the epidemiological or other data  from the holding of provenance of the 
animals, the food chain information or the findings of ante-mortem inspection 
and/or post-mortem visual detection of  relevant abnormalities indicate possible 
risks to public health, animal health or an imal welfare, the carcases and offal of 
pigs are to undergo additional post-m ortem procedures using incision and 
palpation. Depending on th e identified risks these procedures may include: 
(a) incision and examination of the submaxillary lymph nodes ( Lnn 
mandibulares ); 
(b) palpation of the lungs and the bronchial and mediastinal lymph nodes 
(Lnn. bifucationes, eparteriales and mediastinales ). The trachea and the EN 6   EN main branches of the bronchi must  be opened lengthw ise and the lungs 
must be incised in their posterior th ird, perpendicular to their main axes; 
those incisions are not necessary where the lungs are excluded from 
human consumption; 
(c) incision of the heart lengthwise so  as to open the ventricles and cut 
through the interventricular septum; 
(d) palpation of the liver and its lymph nodes; (e) palpation and, if necessary, incision of the gastric and mesenteric lymph 
nodes; 
(f) palpation of the spleen; (g) incision of the kidneys and the renal lymph nodes ( Lnn. renales ); 
(h) incision of the supramammary lymph nodes; (i) palpation of the umbilical region and joints of young animals and, if 
necessary incision of the umbilical region and opening of the joints." 
(4) In Chapter IX of Section IV, th e following part G is added: 
"G. Salmonella 
1. Without prejudice to the first pa ragraph of Articl e 1 to Commission 
Regulation (EC) No 2073/2005*, the compet ent authority shall verify the 
correct implementation by food busi ness operators of the point 2.1.4 
(process hygiene criterion for Salmonella  on pig carcases) of Annex I to 
that Regulation 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; 
And/or 
(b) collecting all information on th e total number and the number of 
Salmonella  positive samples taken by f ood business operators in 
accordance with Article 5(5) of  Regulation (EC) No 2073/2005, 
within the frame of point 2.1.4 of Annex I thereof; 
And/or (c) collecting all information on th e total number and the number of 
Salmonella  positive samples taken within the frame of national 
control programmes in Member Stat es 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 pork 
production; EN 7   EN 2. If the process hygiene cr iterion is not complied with  at several occasions, 
the competent authority shall requir e an action plan from the food 
business operator concerned and st rictly supervise its outcome. 
3. The total number and the number of Salmonella positive samples, 
differentiating between samples take n under 1(a), (b) and (c), when 
applied, shall be reported in accord ance with Article 9( 1) of Directive 
2003/99/EC of the European Parl iament and of the Council***. 
________________ 
* OJ L 338, 22.12.2005, p. 1. 
** If all negative, 95% statistical certainty is provided that the prevalence is below 6%. 
*** OJ L 325, 12.12.2003, p. 31." 
Article 3 
Amendments to Regulation (EC) No 2074/2005 
In Point 3 of Annex VIb to Regulation (EC) No 2074/2005, point (a) is deleted. 
Article 4 
Entry into force 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from 1 June 2014. However, Part G (3) in Chapter IX of Secti on IV to Annex I of Re gulation (EC) No 854/2004 
will apply from 1 January 2015. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO