EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/PLAN/364/2023 feedback 
ANNEX (POOL/G5/2023/364/364 -EN 
ANNEX.docx)  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Delegated Regulation  
amending Annexes II et III of Regulation (EC) No 853/2004 of the European Parliament 
and of the Council on specific hygiene requirements for certain fresh meat, fishery 
products, dairy products and eggs    
EN 1  EN ANNEX  
Regulation (EC) No 853/2004 as amended as follows:  
(1) Annex II is amended as follows:  
(a)  in Section I, Part B is amended as follows:  
(i) point 8 is replaced by  the following : 
‘8.  When applied in an establishment located within the Union, the mark 
must be oval in shape and include the abbreviation of European Union 
(‘EU’) in one of the  official languages of the Union as follows: EC, EU, 
EL, UE, EE, AE, ES , EÚ.’  
(ii)  the following point is added : 
‘8a. The requirements on the form of the identification mark in this Part B may 
be replaced by the requirements for a special health or identification 
mark  in accordance  with Article 65(1) , point (h), of Regulation (EU) 
2016/429 of the European Parliament and of the Council*,  and the rules 
adopted in accordance with Article s 67, point (a)  ,71(3) or (4), or 259(1) 
or (2)  of that Regulation . 
_______________________________________________  
* Regulatio n (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) .’; 
 
(2) Annex III is  amended as  follows:  
(a) Section I is amended as follows : 
(i) in Chapter II, the following point is added : 
‘10. Mobile slaughterhouse shall not operate in a Member State unless 
the competent authority of each Member State where it operates, 
has approved them in accordance with Article 4.2 based at least on 
compliance with the requirements in this Chapter.  
Mobile partial slaughtering facilities operating temporar ily in 
cooperation with complementary permanent slaughter ing facilities 
shall not operate unless the competent authority has approved the 
combination as a slaughterhouse in accordance with Article 4.2 
based at least on compliance with the requirements in this Chapter. 
Such approval shall be reviewed after a peri od of one year of 
inactivity of the combination .’; 
(ii) in Chapter IV , point 1  is replaced by the following:  
‘1. After arrival at the slaughterhouse, the slaughter of the animals must 
not be unduly delayed. However, where required for welfare 
reasons, anim als must be given a resting period before slaughter. 
Animals that are presented at a slaughterhouse for slaughter shall 
be slaughtered there  and direct movements to another 
slaughterhouse may be allowed only in exceptional cases in  
EN 2  EN accordance with Article 43(6) , second subparagraph, of Regulation 
(EU) 2019/627.’ ; 
(b) Chapter VIa  is amended as follows :  
(1) the heading is replaced by  the following : 
‘Chapter VIa: SLAUGHTER AT THE HOLDING OF PROVENANCE 
OF DOMESTIC BOVINE  ANIMALS , OTHERS THAN BISONS, 
AND OVINE, CAPRINE  AND PORCINE ANIMALS AND 
DOMESTIC SOLIPEDS OTHER THAN EMERGENCY 
SLAUGHTER’ ; 
(2) the introductory phrase is replaced by the following:  
‘Up to three domestic bovine  animals , other than bisons, up to three 
domestic solipeds, up to six domestic porcine animals or up to nine 
ovine or caprine animals may be slaughtered at the same occasion 
at the holding of provenance, when authorised by the competent 
authority in accordance with the following requirements:’ ; 
(iii)  point (a) is deleted ; 
(c) Chapter VII  is amended as follows : 
(i) the following point is inserted after point 2 : 
‘ 2a. For the purpose s of this point, ‘dry-ageing ’ means the storage of 
fresh meat  in aerobic conditions of hanging carcasses or cuts either 
unpacked or packed in bags permeable to water vapour in a 
refrigerated room or cabinet and left to age for several weeks at 
controlled environmental conditions of temperature, relative 
humidity and airflow . 
  Before placing on the market or freezing, b ovine meat subject to 
dry-ageing must be sto red at a surface temperature of −0 ,5 to 
3,0°C, with a relative humidity of 75  to 85% and an airflow of 0 ,2 
to 0,5 m/s in a dedicated room  or cabinet for a maximum of 35 
days. However,  food business operators  may apply other 
combinations of surface temperature, relative humidity, airflow and 
time, or do dry-ageing o f meat of other species, if they demonstrate 
to the satisfaction of the competent authority that equivalent 
guarantees are provided on the safety of  the meat.  
In addition , the following specific measures must be applied:  
(i) the meat shall not be loaded  into the  room  or the cabinet  until 
the temperature and relative humidity  referred to in the 
second subparagraph  have been achieved;  
(ii) the meat mus t be hang ed from the bone or , if using a shelf, 
sufficient perforation to facilitate air  flow with regular 
turning using hygienic methods  must be ensured ;  
(iii) a high  airflow must be applied at the start of the dry-ageing  
process to facilitate early crust development and reduce the 
surface water  activity ;  
EN 3  EN (iv) the room  or the cabinet  and air conditioning refrigeration 
system components must be regularly cleaned and 
disinfected ;  
(v) calibrated thermometers, relative humidit y probes  and other 
equipment to accurately monitor and facilitate control of 
room or cabinet conditions  must be used ; 
(vi) the air in contact with the beef  must be filtered or UV treated;  
(vii) the crust must be trimmed in a hygienic manner in a dedicated 
air controlled environment .’; 
(ii) in point 3(b) , (iv) to (viii) are replaced by the following:  
‘(iv) per transport, the vehicle transporting the carcases, half carcases, 
quarters, or half carcases cut into three wholesale cuts collects meat 
from a maximum  of three  slaughterhouse or from one cold store  
collecting directly from slaughterhouses;  all the requirements laid 
down in this point (b) shall apply from the first loading of the 
carcases, half carcases, quarters, or half carcases cut into three 
wholesale cuts in a slaughterhouse;  
(v) carcases, half carcases, quarters, or half carcases cut into three 
wholesale cuts must ha ve a core temperature of 15 degrees at the 
start of the transport if they are to be transported in the same 
compartment as meat which meets the temperature requirement set 
out in p oint 1 for offal and 7 °C for other meat;  
(vi) a declaration by the food busi ness operator accompanies the 
consignment; that declaration must state the duration of chilling 
before loading, the time at which loading of the carcases, half 
carcases, quarters, or half carcases cut into three wholesale cuts 
was started, the surface temp erature at that time, the maximum 
transportation air temperature to which the carcases, half carcases, 
quarters, or half carcases cut into three wholesale cuts may be 
subjected, the maximum transport time permitted, the date of 
authorisation and the name o f the competent authority authorising 
the transport in accordance with point (ii);  
(vii) the food business operator of destination must notify the competent 
authority before receiving  for the first time carcases, half carcases, 
quarters, or half carcases c ut into three wholesale cuts, not attaining 
the temperature referred to in point 1 before transport;  
(viii)  the meat must be transported in accordance with the following 
parameters:   
EN 4  EN – For a maximum transport time1 of six hours:  
Species Surface 
temperature2  Maximum 
time to chill to 
surface 
temperature3 Maximum 
transportation 
air 
temperature4 Maximum daily 
mean carcase 
aerobic colony 
count5 
Ovine and caprine 
animals  
7°C 8 hours  
6°C log 10 3,5 cfu/cm2 
Bovine animals  20 hours  log 10 3,5 cfu/cm2 
Porcine animals  16 hours  log 10 4 cfu/cm2 
The maximum transport time may be extended to 30 hours if 
a core temperature below 15°C is reached before the start of 
the transport.  
– For a maximum transport time1 of 60 hours:  
Species  Surface 
temperature2 Maximum 
time to chill 
to surface 
temperature3 Core 
temperature6 Maximum 
transportation 
air 
temperature4 Maximum 
daily mean 
carcase 
aerobic colony 
count5 
Ovine and 
caprine 
animals  4°C 12 hours  
15°C  3°C log 10 3 cfu/cm2 
Bovine 
animals  24 hours  
(ix) methods for measuring the surface temperature shall be validated 
and the following method shall be used as reference method:  
– a thermometer calibrated in accordance with the latest 
version of ISO 13485 shall be used ; 
– the sensor shall be penetrated perpendicu larly in the thickest 
part at a depth of 0 ,5 to 1 cm of  the external part of:   
(a) the shoulder ; or 
(b) the leg for bovine, ovine and caprine animals or of 
the ham, or the internal surface of the ham in the 
middle upper part for porcine animals ; 
– five temperature m easurements shall be carried out as 
follows:  
 
 
EN 5  EN – at least one of the five measure ments must be  below the 
surface temperature requirement s laid down in point (viii). ’; 
(d) in Section II , in Chapter II,  the following  point is added:  
‘8. Mobile slaughterhouse shall not operate in a Member State unless the 
competent authority of each Member State where it operates, has approved 
them in accordance with Article 4.2 based at least on compliance with the 
requirements in this Chapter.  
Mobile partial slaughtering facilities operating temporarily in cooperation 
with complementary permanent slaughtering facilities shall not operate unless 
the competent authority has approved the combination as a slaughterhouse in 
accordance with Article 4.2 based  at least on compliance with the 
requirements in this Chapter. Such approval shall be reviewed after a period 
of one year of inactivity of the combination. ’; 
(e) in Section III , point 3  (h)(i) and  (j) are replaced by the following:  
‘(h) slaughtered and bled an imals are transported to the slaughterhouse or to  a 
game -handling establishment hygienically and without undue delay ; if 
transport takes more than two hours, the animals must be  refrigerated ; 
where climatic conditions so permit, active chilling is not nece ssary ; 
evisceration may take place on the spot, under the supervision of the 
official veterinarian;  
(i) a declaration by the food business operator who reared the animals, stating 
their identity and indicating any veterinary products or other treatments 
administered, dates of administration and withdrawal periods, 
accompanies the slaughtered animals to the slaughterhouse or the game -
handling establishment;  
and 
(j) the health certificate set out in Chapter 3 of Annex IV t o Implementing 
Regulation (EU) 2020/2 235, issued and signed by the official veterinarian, 
attesting to a favourable result of the ante -mortem inspection, correct 
slaughter and bleeding and the date and time of slaughter, accompanies the 
slaughtered animal to the slaughterhouse or to a game -handling 
establishment, or was sent in advance in any format. ’; 
(f) in Section VIII,  in Chapter VII , the following point is added:  
‘4.  In the case that the temperature of fresh or processed fishery products 
needs to be temporarily decreased , or in the case that the temperature of 
frozen fishery products needs to be temporarily increased , to a temperature 
higher than -18°C  to permit the use of machines that slice or cut fishery 
products, th e change of temperature to reach that required for the cutting 
or slicing  of fishery products, and the subsequent return to the storage 
temperature of the fishery products, shall be as short as possible . The total 
time of the operation of cutting or slicing at the technologically -required 
temperature shall not exceed  96 hours.  Storage or transportation  of fishery 
products  at that temperature  shall not be allowed. ’;  
(g) Section IX is amended as follows : 
(i) in Chapter I , in Part I, point 3 is replace d by the following:   
EN 6  EN ‘3. However, raw milk or colostrum from animals that does not meet the 
requirements set out in point 2 may be used with the authorisation 
of the competent authority:  
(a) in the case of cows, buffaloes, sheep or goats or females from 
other species that do not s how a positive reaction to tests for 
tuberculosis or brucellosis, nor any symptoms of these 
diseases, and in the case of sheep  or goats which have been 
vaccinated against brucellosis as part of an approved 
eradication programme and do not show any symptom of that 
disease, after having undergone a heat treatment such as to 
show , where applicable,  a negative reaction to the alkaline 
phosphatase test or otherwise treated to ensure its safety. When 
the alkaline phosphatase test is not suitable to demonstrate th e 
effectiveness  of the heat treatment applied, such as situations 
where raw milk is produced from non -bovine species or 
separated in different fractions before being heat -treated , food 
business operators shall be able to provide the competent 
authority with the n ecessary assurances  and keep associated 
records as part of their procedures based on hazard analysis 
and critical control points (HACCP) principles  in accordance 
with Article 5 of Regulation (EC) No 852/2004  ; 
(b) in the c ase of sheep or goats that do not show a positive reaction 
to tests for brucellosis, or which have been vaccinated against 
brucellosis as part of an approved eradication programme, and 
which do not show any symptom of that disease, for the 
manufacture of c heese with a maturation period of at least two 
months .’; 
(ii) in Chapter II , in Part II, point 1 (a) is replaced by the following:  
‘(a) Pasteurisation is achieved by a treatment involving:  
(i) a high temperature for a short time : at least 72  oC for 15 
seconds;  
(ii) a low temperature for a long time : at least 63  oC for 30 minutes; 
or 
(iii) any other combination of time -temperature conditions to obtain 
an equivalent effect . 
The treatment referred to in (i), (ii) and (iii) shall ensure that the 
products sh ow, where applicable, a negative reaction to an alkaline 
phosphatase test immediately after such treatment  When the 
alkaline phosphatase test is not suitable to demonstrate the 
effectiveness of the pasteurisation, such as situations where 
products are derived from non -bovine species or separated in 
different fractions before being pasteurised , food business operators 
shall be able to provide the competent authority with the necessary 
assurances and keep associated records as part of their procedures 
based o n hazard analysis and critical control points (HACCP) 
principles  in accordance with Article 5 of  Regulation (EC) No 
852/2004 .’;  
EN 7  EN (h) in Section X, in Chapter I , point 1 is replaced by the following:  
‘1.  At the producer's premises, and until sale to the consumer, eggs 
must be kept clean, dry, free of unintended extraneous odour, 
effectively protected from shocks and out of direct sunshine. Any 
intentional application of extraneous odour to eggs must not be  
aimed at hiding a pre -existing extraneous  odour.’ .