EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/PLAN/364/2023 feedback 
(POOL/G5/2023/364/364 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II and III to Regulation (EC) No 853/2004 of the European 
Parliament and of the Council as regards specific hygiene requirements for certain fresh 
meat, fishery products, dairy products and eggs  
(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 1  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II and III to Regulation (EC) No 853/2004 of the European 
Parliament and of the Council as regards specific hygiene requirements for certain fresh 
meat, fishery products, dairy products and eggs  
(Text with EEA relevance)  
THE EUROPEAN COMMI SSION,  
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 origin1, and in 
particular Article 10(1), second subparagraph, points  (a), (c), (d) , (e) and (f) , thereof,  
Whereas:  
(1) Regulation (EC) No  853/2004 lays down specific rules on the hygiene of food of 
animal origin for food business operators . In particular, Annex II  to that Regulation 
lays down requirements concerning several products of animal origin, and Annex III 
thereto lays down specific requirements.  Section I of Annex II to Regulation (EC) No 
853/2004 lays down requirements on the application of an identificat ion mark  to 
products of animal origin . Part B of Section I of Annex II to Regulation (EC) No 
853/2004 refers to the European Community, instead of the European Union. 
Abbreviations of the identification mark which refer to the ‘European Union’ should 
there fore replace reference s to the ‘European Community’. However, such 
replacement creates a substantial administrative burden . A transitional period should  
therefore  be provided for during which the products bearing an identification mark 
with the abbreviation for the ‘European Community’  before the end of the transitional 
period  may remain on the market . 
(2) In addition, clarification is needed on the link between the form of the identif ication 
mark required by  (EC) No 853/2004 , and the requirements for a special health or 
identification mark  laid down for the control of certain animal diseases in Regulation 
(EU) 2016/429 of the European Parliament and of the Council2. Part B of Section I  of 
Annex II to Regulation (EC) No 853/2004 should be amended to clarify  which form 
should be applied in specific circumstances . 
(3) Mobile slaughterhouses are increasingly used to avoid possible animal welfare issues 
during transport , for exam ple, due to long  transport times of animals reared in remote 
areas. Mobile slaughterhouses are subject to approval like any other slaughterhouse in 
accordance with Article 4(2) of Regulation (EC) No 853/2004. There is , however , a 
need to clarify how this approval should b e applied , for example , in the case of cross -
                                                 
1 OJ L 139, 30.4.2004, p. 55.  
2 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 ).  
EN 2  EN border activities of the mobile slaughterhouse or for the temporary interruption of a 
combination of different parts of the slaughterhouse.  Approval of slaughterhouses is 
mainly based on compliance with requirem ents on the construction, layout and 
equipment of th ose slaughterhouses provided for in Chapter II of Sections I and II of 
Annex III to Regulation (EC) No 853/2004.  
(4) Article 43(6) of Commission Implementing Regulation (EU) 2019/6273 allows , in 
exceptional circumstances , that live animals may be moved to another slaughterhouse. 
Regulation (EC) No 853/2004 does not provide for this possibility. For consistency  of 
Union legislation , Regulation (EC) No 853/2004 should be aligned in this respect with 
Implementing Regulation (EU) 2019/627 . Chapter IV of Section I of Annex III to 
Regulation (EC) No 853/2004 should therefore be amended accordingly.  
(5) Regulation (EC) 853/2004 allows the stunning and bleeding of a limited number of 
certain ungulates on t he farm subject to specific requirements including that the 
animals cannot be transported to the slaughterhouse to avoid any risk to the handler 
and to prevent any injuries to the animals during transport. This requirement limits this 
possibility for stunn ing and bleeding on the farm largely to extensively reared animals 
and excludes most animals regularly  handled by farmers  and therefore easily 
transport ed without risk . Based on the experience gained by food business operators 
and competent authorities and  taking into account the increasing demand to prevent 
any animal welfare issue during transport, it is appropriate to extend that possibility to 
stun and bleed ungulates on the farm in accordance with specific requirements to ovine 
and caprine animals and other ungulates reared under any condition of housing.  
(6) On 19 January 2023, the European Food Safety Authority published a Scientific 
Opinion on Microbiological Hazards of Aged Meat4 (‘the EFSA Opinion ’). The EFSA 
Opinion indicates that aged meat does not create a higher public health risk than fresh 
meat if certain requirements are complied with. Taking into account the increasing 
consumption of aged meat, it is appropriate to lay down specific requirements 
recommended in the EFSA Opinion i n Regulation (EC ) No 853/2004, in particular as 
regards dry -aged meat from bovine animals.   
(7) Regulation (EC) No 853/2004 provides for  alternative transport conditions for 
carcases, half carcases, quarters or half carcases cut into three wholesale cuts of ovine, 
caprine ani mals, bovine and porcine animals  in Chapter VII of Section I of Annex III 
to Regulation (EC) No 853/2004 . These transport conditions are based on the control 
of the surface temperature of the meat instead of its core temperature and need to 
comply with specific requirements.  
(8) Based on the experience gained by food business operators and competent authorities, 
it is appropriate to amend those specific requirements laid down in Chapter VII of 
Section I of Annex III to Regulation (EC) No 853/2004 in particul ar to allow the 
collection of the meat from a cold store and a limited number of slaughterhouses , to 
allow the transport in the same compartment with more kinds of meat complying with 
final temperature requirements  of such meat , and to provide additional temperature  
                                                 
3 Commission Implementing Regulation of 15 March 2019  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  (OJ L 131, 
17.5.2019, p. 51 ). 
4 EFSA Journal 2023;21(1):774 5.  
EN 3  EN and time conditions for transport of carcases, half carcases, quarters or half carcases 
cut into three wholesale cuts of ovine, caprine animals and bovine animals during a 
maximum transport time on 30 hours.  
(9) Different outcomes have been signalle d by competent authorities on the measurement 
of the surface temperature when using different methods. It is therefore appropriate to 
lay down a reference method based on  the experience gained  by food business 
operators and technological developments  while  maintaining the possibility to use 
alternative methods .  
(10) Section III of Annex III to Regulation (EC) No 853/2004 requires  that farmed ratites 
and farmed ungulates slaughtered on the farm are to be  transported to the 
slaughterhouse for further processing. Also, game -handling establishments have 
appropriate  facilities to hygienically handl e such farmed game  slaughtered on the 
farm , they  should also be authorised to receive and handle farmed ratites and farmed 
ungulates .  
(11) Third countries exporting to the Union farmed game, domestic bovine, porcine and 
equine animals slaughtered at the holding of provenance must certify compliance with 
the requirements set out in Section III, point 3(j) , of Annex III to Regulation (EC) 
853/2004 , using the m odel health certificate set out  in Chapter 3 of Annex IV to 
Commission Implementing Regulation (EU) 2020/22355. To avoid any ambiguity 
between the legal requirement laid down in Regulation (EC) No 853/2004 and the 
model health certificate set out in Implem enting Regulation (EU) 2020/2235 , the 
wording  of the health certificate in both these Regulations  needs to be fully consistent .  
(12) In order to comply with the production requirements  laid down in Chapter VII of 
Section VIII of Annex III to Regulation (EC) No  853/2004 , the fishery  product  sector 
deploys machines that slice and can build the slices again by using automatically 
placed interleaving sheets. In this case, the fishery product is placed in a cold room to 
decrease  or, in case of already frozen products, increase,  the temperature to 
approximatively -7°C to -11°C  for permitting the cutting  or the slicing .  
(13) To avoid abusive practices consisting  in using such production requirements  for 
storing  fishery products at a te mperature not in compliance with Chapter VII , point 2 , 
of Section VIII of Annex III to Regulation (EC) 853/2004,  the decreasing, or for 
already frozen products, the increasing, of temperature should be done as quick ly as 
possible and the storage of fishery  products at a temperature facilitating the cutting or 
slicing  should  be limited  in time . 
(14) Part I of Chapter I  of Section IX of Annex III to Regulation (EC) No 853/2004 lays 
down health requirements for raw milk and colostrum production in herds of farmed 
animals from which the milk and colostrum are collected with a view to placing them 
on the market. Point 3 of  that Part I p rovides  that raw milk from cows, buffaloes, 
sheep or goats that do not come from herds free or officially free of brucellosis and 
tuberculosis are to undergo a heat treatment such as one to show a negative reaction to 
the alkaline phosphatase test.  However, alkaline phosphatase testing is not a suitable 
method to verify heat treatment of raw milk  from non -bovine species or raw milk 
separated in different fractions before being heat -treated in modern proce ssing plants. 
Alternative options based on hazard analysis and critical control points (HACCP) 
principles laid down in  Regulation (EC) No 852/2004  of the European Parliament and 
                                                 
5 Please insert the reference here.   
EN 4  EN of the Council6 should therefore be offered to food business operators to demonstrate 
the effectiveness of the heat treatment applied.  
(15) Part II of Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004 lays 
down the requirements for heat treatmen t for raw milk, colostrum, dairy or colostrum -
based products. Point  1(a) of that Part II provides that pasteurised products must show, 
where applicable, a negative reaction to an alkaline phosphatase test immediately after 
such treatment.  Owing to the unsu itability of  alkaline phosphatase testing to verify 
heat treatment of raw milk from non -bovine species or raw milk separated in different 
fractions  before being heat -treated , alternative options based on HACCP principles 
should also be offered to food busi ness operators to demonstrate the effectiveness of 
the pasteurisation.  
(16) Chapter I of Section X of Annex III to Regulation (EC) No 853/2004 lays down 
hygiene rules for the production of eggs and in particular provides  that, at the 
producer's premises until sale to the consumer, eggs must be kept free of extraneous 
odour  as such an odour may be indicative of an alteration of egg s which would render 
them unsuitable for direct consumption by the final consumer. However, where a n 
extraneous odour has been intent ionally applied to eggs by a food business operator in 
order to flavour them with particular tastes, the presence of such an odour does not 
mean that the eggs present a risk to the consumer. The placing on the market of eggs 
to which an odour has been appl ied intentionally should therefore be permitted , 
provided that such practice is not intended to hide the pre -existence of an y foreign 
odour of the eggs.   
(17) It is appropriate to provide  food business operators with sufficient time to adapt to the 
new requirements on the dry -ageing of beef or to demonstrate to the satisfaction of the 
competent authorities the safety of alternative approaches.  Therefore, these new 
requirements laid down in Chapter VII of Section I of Annex III to Regu lation (EC) 
No 853/2004 , as amended by this Regulation should apply 6 months from the date of 
entry into force of this Regulation.  
(18) Therefore, Regulation (EC) No 853/2004 should be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II and I II to Regulation (EC) No 853/2004 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
The identification mark on products of animal origin may continue to include the 
abbreviation s of ‘European Community ’ set out  in Annex II, Section I, Part B , point 8,  of 
Regulation (EC) No 853/2004 as it stood  before the amendments made by this Regulation, 
until 31 December 2028 , and the products of animal origin with such identification marks 
applied before that date may remain  on the market.  
                                                 
6 Regulation (EC) No 852/2004 of the European Parliament and the Council of 29 April 2004 on the 
hygiene of foodstuffs  (OJ L 139, 30.4.2004, p. 1).   
EN 5  EN Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Point (2)(c)(i)  of the Annex,  shall apply from … [ 6 months from the date of entry into fo rce of 
this Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN