EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10432/2020 feedback 
(POOL/G4/2020/10432/10432 -EN 
feedback.docx)  
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of 
the Council on specific hygiene requirements for food of animal origin  
(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 EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the 
Council1 lays down specific hygiene rules for different food of animal origin. In 
order to maintain a high level of food safety for consumers, these rules need to be 
kept up to date taking into account the experience gained from the implementation, 
technological d evelopments and their practical consequences and changes in patterns 
of consumption.  
The following amendments are therefore proposed by this Delegated Regulation:  
– introduction of more flexibility for slaughter of bovine and equine animals at 
the holding o f provenance for animal welfare reasons and to avoid risks for the 
handler (e.g. in case of free range animals), under strict conditions of hygiene 
and official controls.  This action will support continued improvement of 
animal wel fare standards as called for by  the European  Green Deal and ‘Farm 
to Fork’ Strategy ; 
– sorting out practical difficulties/inconsistencies in the handling of stomachs for 
rennet production, the handling of heads and feet, including temperature 
conditions for storage ; 
– aligning the role of the official veterinarian in case of emergency slaughter 
with the new requirements in Delegated Regulation (EU) 2019/624 ;  
– allowing freezing of meat at retail level for the purpose of facilitating food 
donation, thereby preventing food waste and promoting food security , in line 
with the objectives laid down in the Commission’s Farm to Fork strategy;  
– deleting the wording “approved veterinarian” in the section o n farmed game 
since the definition of such veterinaria n was merged with the definition of  
official veterinarian by Regulation (EU) 2017/625;  
– introduction of specific hygiene conditions in collection centres for wild game ; 
– extension of hygiene requirements for farmed game, snails and frogs’ legs to 
new specie s/families placed on the market for human consumption ; 
– adaptation of storage conditions for grease and animal fat to new technologies 
such as vacuum packaging ; 
– deletion of pectenotoxins from the list of marine biotoxins to be analysed in 
live bivalve mollu scs based on an EFSA opinion ;  
– establishing a specific model of the registration document that must accompany 
movements of live bivalve molluscs after harvesting and until their placing on 
the market ; 
– aligning the rules for echinoderms fixed in  Delegated R egulation (EU) 
2019/624  to the limitations in derogation established by the Parliament and the 
Council in Regulation (EU) 2017/625 ; 
                                                 
1 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) .  
EN 2  EN – fixing specific temperature requirements for fishery products handled on board 
of fishing vessels, specific hygiene requirem ents for reefer vessels as regards 
transport temperature and cold store maintenance, obligation on board vessels 
that containers used for fishery products are not used for other purposes.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Several of the proposed amendments were requested by competent authorities of 
Member States and certain private stakeholders' organisations. They have been 
discussed during several meetings of the relevant expert group, representing 
competent authorities o f all Member States, and are largely supported by these 
experts.   
In addition, private stakeholders’ organisations were consulted within the framework 
of the Advisory Group on the Food Cha in and Animal and Plant Health.  
Before adopting this Delegated Regu lation , the Commission conducted public 
consultations in an open and transparent way in accordance with the procedures laid 
down in the Interinstitutional Agreement on Better Law -Making . 
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Amendments to Annex III of Reg ulation (EC) No 853/2004 should be made by a 
Delegated Regulation in accordance with Article 10 (1) of Regulation (EC) No 
853/2004.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of 
the Council on specific hygiene requirements for food of animal origin  
(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 origin2, and in 
particular Article  10(1) thereof,  
Whereas:  
(1) Annex III to Regulation (EC)  No 853/2004 of the European Parliament and of the 
Council lays down specific rules on the hygiene of food of animal origin  for food 
business operators .  
(2) Rennet is a complex of enzymes used for the production of certain cheeses. It is 
collected from the st omachs of young ruminants. Based on the experience gained by 
food business operators, the specific hygiene requirements on stomachs for the 
production of rennet , laid down in Point 18(a) of Chapter IV to Section I to Annex III 
of Regulation (EC) No 853/200 4, should be amended in order to optimise the 
collection of rennet from young sheep and goats . In particular, it is appropriate to 
allow such stomachs to leave the slaughterhouse without being emptied or cleaned.  
(3) Technological developments have result ed in a demand for heads and feet of domestic 
ungulates to be skinned or scalded and depilated outside the slaughterhouse in 
specialised approved establishments for further processing of food. As a practical 
consequence, h eads and feet of domestic ungulates should therefore be allowed to be  
transport ed to these establishments under certain conditions that ensure food  safety . 
Point 18( c) of Chapter IV to Section I of Annex III to Regulation (EC) No 853/2004  
should therefore be amended.  
(4) In accordance with Artic le 4 of Commission Delegated Regulation (EU) 2019/6243, 
the official veterinarian may perform ante-mortem inspection outside a slaughterhouse  
in the case of emergency slaughter  of domestic ungulates . Point 2 of Chapter VI of 
Section I of Annex III to Regul ation (EC) No 853/2004 requires a veterinarian to carry 
out ante mor tem inspection  in the case of emergency slaughter. That requirement 
should be  amended so as to be  consistent with th at Article 4 of Delegated Regulation 
(EU) 2019/624 and refer instead  to the official veterinarian .  
                                                 
2 OJ L 139, 30.4.2004, p. 55 . 
3 Commission Delegated Regulation (EU) 2019/624 of 8 February 2019 concerning specific rules for the 
performance of official controls on the production of meat and for production and  relaying areas of live 
bivalve molluscs in accordance with Regulation (EU) 2017/625 of the European Parliament and of the 
Council (OJ L 131, 17.5.2019, p. 1)   
EN 4  EN (5) Improving animal welfare is one of the actions proposed in the Commission’s Farm to 
Fork Strategy4 for a fair, healthy and environmentally -friendly food system, as part of 
the European Green Deal. There is , in particular , a change in patterns of meat 
consumption with an increasing demand by the European Parliament, farmers and 
consumers for meat of certain domestic ungulates  for which possible animal welfare 
concerns during collection and transport thereof , have  been avoided  by slaughter on 
the holding of provenance .     
(6) Apart from emergency slaughter, domestic ungulates are required to be slaughter ed in 
a slaughterhouse approved in accordance with Article 4(2) of Regulation (EC) No 
853/2004 to ensure compliance with the hygie ne requirements  laid down  in Chapters 
II and IV of Section I of Annex III to that Regulation.  The competent authorities of 
Member States can approve mobile slaughterhouses in accordance with that Article. 
These mobile facilities may be placed in all approp riate locations, including farms, 
where groups of  healthy animals  can be slaughtered . In other circumstances, the 
transport of certain animals may create a risk for the handler or for the welfare of the 
animals. Slaughter  and bleeding should therefore be permitted at the holding of 
provenance for a limited  number of domestic bovine and porcine anim als and 
domestic soliped s. Such practice should be subject to strict conditions to maintain a 
high level of food safety of the meat derived from such animal.  
(7) Domestic bovine and porcine animals and domestic solipeds slaughtered on the 
holding of provenance, should be accompanied by a n official certificate , attesting that 
the hygiene requirements for slaughter have been complied wi th. Such  an official 
certificate is provided for  in Commission Implementing Regulation [C (2020)8100 ]5.  
(8) On 27 September 2018, the European Food Safety Authority (EFSA ) adopted a second 
scientific opinion on hazard analysis approaches for certain small ret ail establishments 
and food donations6. That Opinion recommends freezing at retail level as an additional 
tool for guaranteeing the safe redistribution of food to those in need. The f acilitation of 
safe food donation practices, both prevents food waste and contributes to food 
security, in line with the objectives laid down in the Commission’s Farm to Fork 
strategy and its overall aim to establish a fair, healthy and environmentally -friendly 
food s ystem as part of the European Green Deal. The f reezing of food can be an 
important means of ensuring its safe redistribution by food banks and other charities . 
The freezing of meat is currently not allowed in the case of retail to retail activity  since 
meat intended for freezing is required to be frozen without undue delay after slaughter 
or cutting in accordance with point 4 of Chapter VII of Section I of Annex III to 
Regulation (EC) No 853/2004, as regards domestic ungulates  and point 5 of Chapter V 
of Se ction II  of that Annex as regards  poultry and lagomorphs . The freezing of meat 
should therefore be allowed at retail level  in the case of retail to retail activity  under 
certain conditions  to ensure the safe distribution for food donations .  
                                                 
4 https://ec.europa.eu/food/sites/food/files/safety/docs/f2f_action -plan_2020_strategy -info_en.pd f  
5 Commission Implementing Regulation (EU) 2020/XXX of ../../…. concerning model official 
certificates for certain categories of animals and goods and repealing Directive 98/68/EC, Decisions 
2000/572/EC, 2003/779/EC and 2007/240/EC, Regulation (EC) No 59 9/2004, Implementing 
Regulations (EU) No 636/2014 and (EU) 2019/628  (OJ L …, ../../…., p. ..) [C(2020)8100]  
6 EFSA Journal 2018; 16(11):5432   
EN 5  EN (9) Regulation (EC ) No 854/2004 of the European Parliament and of the Council7 defined 
‘approved veterinarian’. Regulation (EU) 2017/625  of the European Parliament and of 
the Council8 repealed Regulation (EC) 854/2004, and defined  ‘official veterinarian ’. 
As the definition of ‘official veterinarian’ in Regulation (EU) 2017/625 encompasses 
‘approved veterinarian’, the references to ‘approved veterinarian’ in Annex III to 
Regulation (EC) No 853/2004 should be amended to refer instead to ‘official 
veterinarian’  
(10) The specific hygiene requirements for  the production and placing on the market of 
meat from even -toed farmed game mammals laid down in Section III of Annex III to 
Regulation (EC) No 853/2004 only apply to meat  from Cervidae  or Suidae.  Similar 
requirements should also appl y to meat from other even -toed farmed game mammals 
such as lamas to avoid a possible food safety risk from changes in consumption 
patterns due to an increased consumption of such meat.  
(11) The bodies and viscera of hunted wild game m ay be transported to  and st ored in a 
collection centre before transport to a game -handling establishment. Specific hygiene 
rules on the handling and storage of these bodies and viscera in such collection centres 
should be introduced to ensure the food safety of that meat  by amending  the hygiene 
requirements for wild game laid down in Section IV of Annex III to Regulation (EC) 
No 853/2004 . 
(12) Wild game is required to be transported as soon as possible to a game handling 
establishment after examination by a trained person  in accordance wi th point 3 of 
Chapter II of Section IV of Annex III to Regulation (EC) No 853/2004 as regards 
large wild game and point 3 of Chapter III of that Section as regards small wild game  
in order to allow chilling to take place within a reasonable time after killing . That 
requirement should also apply to wild game where no examination took place.  
(13) Point 3 of Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004 , 
provides that whenever a food business operator moves a batch of live bivalve 
mollusc s between establishments , the batch is required to be accompanied by a 
registration document.  In order to harmonise the information required by  point 4 of 
Chapter I of Section VII of Annex III to Regulation (EC) No 853/2004 , a common 
model of the registrat ion document for the movement of live bivalve molluscs between 
establishments should be  established. Moreover it is a common practice that batches of  
bivalve molluscs may also be sent to intermediate operators, therefore the registration 
document should al so include this possibility.  
(14) Live bivalve molluscs placed on the market may not contain marine biotoxins that 
exceed the limits set out in point 2 of Chapter V of Section VII of Annex III to 
Regulation (EC) No 853/2004. The EFSA has concluded  in its Opinio n on Marine 
                                                 
7 Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying 
down specific ru les for the organisation of official controls on products of animal origin intended for 
human consumption  (OJ L 139, 30.4.2004, p. 206 ) 
8 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other  official activities performed 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) No 1107/2009, (E U) No 1151/2012, (EU) No 
652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council 
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 
2007/43/EC, 2008/119/EC and 2008/120/EC , and repealing Regulations (EC) No 854/2004 and (EC) 
No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 
92/438/EEC (Official Co ntrols Regulation)  (OJ L 95, 7.4.2017, p. 1 ).  
EN 6  EN biotoxins in shellfish – Pectenotoxin group9 that there are no reports o f adverse effects 
in humans associated with Pectenotoxins (PTX) group toxins. In addition, PTX in 
shellfish are always accompanied by toxins from the Okadaic acid group. It  is 
therefore appropriate to delete the reference to  PTX from point 4(c) of Chapter V of 
Section VII of Annex III to Regulation (EC) No 853/2004 . 
(15) Article 11 of Delegated Regulation 2019/624 provides  that the classification of 
production and relaying areas is not required in relation to the harvesting of 
holothuroidea  when the competent authorities carry out official controls on such 
animals in fish auctions, dispatch centres and processing establishments. Chapter IX  of 
Section VII of Annex III to Regulation (EC) No 853/2004 should be amended in order 
to allow the harvesting of Holothuroidea outside classified  production and relaying 
areas .  
(16) Vessels  should  be designed and constructed so as not to cause contamination of 
fishery products with bilge -water, sewage, smoke, fuel, oil, grease or other 
objectionable substances. Also h olds, tanks or containers used for storing, cooling or 
freez ing fishery products should not be used for other purposes than the storage of 
fishery pr oducts . Freezer vessels and reefer vessels should be equipped with freezing 
equipment fit for purpose and storage holds should not be used for freezing products. 
The same requirements for freezing and storage equipment should also apply  to cold 
stores on l and. Part I of Chapter I and part B of Chapter III of Section VIII of Annex 
III to Regulation (EC) No 853/2004  should therefore be amended  accordingly.  
(17) Following recent frauds concerning  tuna initially frozen in brine at -9°C and destined 
for the  canning industry but diverted to be consumed as fresh  fishery  products , it is 
appropriate to clarify  in point 7 of Part II of Chapter I of Section VIII of Annex III to 
Regulation (EC) No 853/2004 that whole fishery products initially frozen in brine  at -
9°C and destined for the canning industry even if further frozen at a temperature of -
18°C must not  have a different destination than the canning industry .  
(18) Livers and roes of fishery products intended for human consumption are to  be 
preserved under ice, at a temperature approaching that of melting ice, or are to be 
frozen. It is appropriate to allow that livers and roes be also refrigerated under  
different conditions  than under ice, at a temperature approaching that of melting ice . 
Accordingly, p oint 6 of Part I I of Chapter I of Section VIII of Annex III to Regulation 
(EC) No 853/2004 should be amended in order to allow that l ivers and roes of fishery 
products intended for human consumption may also be refrigerated not only under ice 
but under  differe nt conditions of refrigeration . 
(19) It is appropriate that in containers used for the dispatch or storage of unpackaged 
prepared fresh fishery products stored under ice , the melting water should not remain 
in contact with any  fishery  products. It is important, for hygiene reasons, to clarify that 
melt water not only should not  remain in contact with fishery products but should  be 
drained away . Accordingly, p oint 4 of part A of Chapter III of Section VIII of Annex 
III to Regulation (EC ) No 853/2004 should be amended  in order to clarify that melted 
water not only should not remain in contact with fishery products but should be 
drained away  
(20) Specific hygiene rules on frogs’ legs laid down in Section XI of Annex III to 
Regulation (EC) No 85 3/2004 only apply  to frogs' legs of the species RNA  (family 
Ranidae ) in accordance with the definition of frogs’ legs laid down in point 6.1 of 
                                                 
9 https://doi.org/10.2903/j.efsa.2009.1109   
EN 7  EN Annex I to that Regulation. Specific hygiene rules for snails in that Section  only apply 
to terrestrial gastropo ds of the species Helix pomatia  Linné , Helix aspersa  Muller , 
Helix lucorum  and species of the family  Achatinidae  in accordance with the definition 
of snails laid down in point 6. 2 of Annex I to Regulation (EC) No 853/2004 . Due to 
changes in eating habits, frogs' legs and snails of other species are also produced and 
placed on the market for human consumption. The specific hygiene rules should 
therefore be extended to cover those species to ensure the safety of food derived from 
these species.   
(21) Section XII of Annex III to Regulation (EC) No 853/2004 lays down s pecific 
temperature requirements for the storage of greaves intended for human consumption .  
Technological developments have allowed certain packaging techniques, such as  
vacuum -packaging for which the  specific temperature requirements are not needed to 
ensure the safety of food derived from greaves . Those temperature conditions should 
therefore be deleted while the food business operator should  ensure the safety of food 
derived from the greaves by good  hygiene practices and procedures base d on Hazard 
Analysis and Critical Control Point (HACCP) principles in accordance with Article 5 
of Regulation (EC) No 852/2004 of the European Parliament and of the Council10.   
(22) Since Implementing Regulation [C(2020)810 0], containing the  model  official 
certificate which is to accompany the domestic bovine animals  and domestic solipeds  
slaughtered on the holding of provenance , will only apply from 21 April 2021, criteria 
and conditions for ante -mortem inspection on the ho lding of provenance of such 
animals in Section I to Annex III of Regulation (EC) No 853/2004,  as amended by this 
Regulat ion, as well as requirements on certificates referred to in Implementing 
Regulation [C(2020)8100), should  also only apply from that date . 
(23) Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly,    
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III is amended in accordance with the Annex to this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
Point s 1(b)(ii), 1 (c), 2(b), 3(b), 3(c) and  4(b)(ii) of the Annex shall apply from 21 April 2021 
on. 
This Regulation shall be binding in its entirety and directl y applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
                                                 
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).   
EN 8  EN  Ursula VON DER LEYEN