II
(Non-legislative acts)
REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2021/1374 
of 12 Apr il 2021
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council 
on specif ic hygiene requirements for food of animal origin 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying 
down specifi c hygiene rules for food of animal origin (1), and in particular Article 10(1) thereof,
Whereas:
(1) Annex III to Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food 
business operat ors.
(2) Rennet is a compl ex of enzymes used for the production of certain cheeses. It is collected from the stomac hs of 
young ruminants. Based on the exper ience gained by food business operators, the specific hygi ene requirements on 
stomac hs for the production of rennet, laid down in Point 18(a) of Chapt er IV to Section I to Annex III of 
Regulation (EC) No 853/2004, should be amended in order to optimise the collection of rennet from young sheep 
and goats. In particular , it is appropr iate to allow such stomac hs to leav e the slaughterhouse without being emp tied 
or cleaned.
(3) Techn ological developments have resulted in a demand for heads and feet of domestic ungulates to be permitted to 
be skinned or scalded and depilate d outside the slaughter house in specialised approved establishments for further 
processing of food. As a practical consequence, heads and feet of domestic ungulate s should theref ore be allowed to 
be transpor ted to these establishments under certain conditions that ensure food safety . Point 18(c) of Chapt er IV to 
Section I of Annex III to Regulation (EC) No 853/2004 should theref ore be amended.
(4) In accordance with Article 4 of Commission Delegat ed Regulation (EU) 2019/624 (2), the official veterinar ian may 
perform ante-mor tem inspection outside a slaughter house in the case of emergency slaughter of domestic 
ungulates. Point 2 of Chapt er VI of Section I of Annex III to Regulation (EC) No 853/2004 requires a veterinar ian to 
carry out ante mor tem inspection in the case of emergency slaughter . That requirement should be amended so as to 
be consist ent with that Article 4 of Delegat ed Regulation (EU) 2019/624 and refer inste ad to the official vete rinar ian.
(1)OJ L 139, 30.4.2004, p. 55.
(2)Commission Delegat ed Regulation (EU) 2019/624 of 8 Febr uary 2019 concer ning specific rules for the perf ormance 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 Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                           L 297/1  (5) Imp roving animal welfare is one of the actions proposed in the Commission’s Farm to Fork Strateg y(3)for a fair, 
health y and environmentally-fr iendly food system, as part of the European Green Deal. There is, in particular , a change 
in patterns of meat consump tion with an increasing demand by the European Parliam ent, farmers and consumers that 
slaught er of certain domestic ungulate s on the holding of provenance be author ised in order to avoid possible animal 
welfare concer ns during collection and transpor t thereof.
(6) Apar t from emergency slaughter , domestic ungulat es are required to be slaught ered in a slaughterhouse approved in 
accordance with Article 4(2) of Regulation (EC) No 853/2004 to ensure complianc e with the hygiene requirements laid 
dow n in Chapt ers II and IV of Section I of Annex III to that Regulation. The compet ent author ities of Member States can 
approve mobile slaughterhouses in accordance with that Article. These mobile facilities may be placed in all appropr iate 
locations, including farms, where groups of healthy animals can be slaught ered. In other circumstances, the transpor t of 
certain animals may create a risk for the handler or for the welf are of the animals. Slaught er and bleeding should 
theref ore be permitte d at the holding of provenance for a limited number of domestic bovine and porcine animals and 
domestic solipeds. 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 slaughtere d on the holding of provenance, should be 
accompan ied by an official certificate, attesting that the hygiene requirements for slaughter have been complied 
with. Such an official certificate is provid ed for in Commission Imple menting Regulation (EU) 2020/2235 (4).
(8) On 27 Septembe r 2018 , the European Food Safet y Author ity (EFSA ) adopt ed a second scientific opinion on hazard 
analysis approac hes for certain small retail establishments and food donations (5). That Opinion recommends 
freezing at retail level as an additional tool for guarant eeing the safe redistr ibution of food to those in need. The 
facilitation of safe food donation practices, both prevents food waste and contr ibutes to food secur ity, in line with 
the objectives laid down in the Commission’s Farm to Fork strateg y and its overall aim to establish a fair, healthy 
and environmentally-fr iendly food system as part of the European Green Deal. The freezing of food can be an 
imp ortant means of ensur ing its safe redistr ibution by food banks and other chari ties. 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 dela y after slaughter or cutting in accordance with point 4 of Chapt er VII of Section I of Annex III to 
Regulation (EC) No 853/2004, as regards domestic ungulates and point 5 of Chapt er V of Section II of that Annex as 
regards poultr y and lagomor phs. The freezing of meat should theref ore be allowed in the case of retail to retail 
activity under certain conditions to ensure the safe distr ibution for food donations.
(9) Regulation (EC) No 854/2004 of the European Parliament and of the Council (6)defined ‘approv ed vete rinar ian’. 
Regulation (EU) 2017/625 of the European Parliament and of the Council (7)repealed Regulation (EC) 
No 854/2004, and defined ‘official veter inar ian’. As the definition of ‘official veteri narian’ in Regulation (EU) 
2017/625 encom passes ‘approv ed veterinar ian’, the references to ‘approve d veteri narian’ in Annex III to Regulation 
(EC) No 853/2004 should be amended to refer instead to ‘official veteri narian’
(3)https://ec.europa.eu/f ood/sites/f ood/fil es/safety/d ocs/f2f_action-plan_2020_strategy-inf o_en.pdf
(4)Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 
2016/429 and (EU) No 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model 
official certificates and model animal health/official certificates, for the entr y into the Union and movements within the Union of 
consignments of certain categori es of animals and goods, official certification regarding such certificates and repealing Regulation (EC) 
No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) No 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 
2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).
(5)EFSA Journal 2018; 16(11):5432
(6)Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific rules for the 
organisation of official controls on products of animal origin intended for human consump tion (OJ L 139, 30.4.2004, p. 206).
(7)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 
prot ection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) 
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 Controls Regulation) (OJ L 95, 7.4.2017, p. 1).EN Offi cial Jour nal of the European Union L 297/2                                                                                                                                           20.8.2021  (10) The specifi c hygiene requirements for the production and placing on the market of meat from even-t oed farmed 
gam e 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 apply to meat from other even-t oed farmed game mammals 
such as lamas to avoid a possible food safety risk from changes in consum ption patte rns due to an increased 
consum ption of such meat.
(11) The bodies and viscera of hunt ed wild gam e may be transpor ted to and stored in a collection centre before transpor t 
to a game- handling establishment. Specifi c 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 transpor ted as soon as possible to a game handling establishment after examination by a 
trained person in accordance with point 3 of Chapt er II of Section IV of Annex III to Regulation (EC) No 853/2004 
as regards large wild game and point 3 of Chapt er III of that Section as regards small wild gam e 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 Chapt er I of Section VII of Annex III to Regulation (EC) No 853/2004, provides that whenever a food 
business operator move s a batch of live bivalve molluscs between establishments, the batc h is required to be 
accompan ied by a registration document. In order to harmonise the information required by point 4 of Chapt er I of 
Section VII of Annex III to Regulation (EC) No 853/2004, a common model of the registration document for the 
mov ement 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 operat ors, theref ore the registration document 
should also include this possibility .
(14) In accordance with point 1 of Part A of Chapt er IV of Section VII of Annex III to Regulation (EC) No 853/2004, live 
bivalve molluscs are to be washed with clean water , free of mud and accumulated debr is before purification 
commences. However , in order to save water , washing of clean bivalve molluscs should not be mandatory . The 
point 1 of Part A of Chapt er IV of Section VII should be modifi ed according ly.
(15) Live bivalve molluscs placed on the mark et may not contain mar ine biot oxins that exce ed the limits set out in point 
2 of Chapt er V of Section VII of Annex III to Regulation (EC) No 853/2004. The EFSA has concluded in its Opinion 
on Mar ine bioto xins in shellfish – Pectenot oxin group (8)that there are no repor ts of adverse effects in humans 
associated with Pectenot oxins (PTX) group toxins. In addition, PTX in shellf ish are alwa ys accompanied by toxins 
from the Okadaic acid group. It is theref ore appropr iate to delet e the reference to PTX from point 2(c) of Chapt er V 
of Section VII of Annex III to Regulation (EC) No 853/2004.
(16) Article 11 of Delegat ed Regulation 2019/624 provides that the classif ication of production and relaying areas is not 
required in relation to the harvesting of holothuroidea when the compet ent author ities carry out official controls on 
such animals in fish auctions, dispatch centres and processing establishments. Chapt er 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 
classifie d production and relaying areas.
(17) Vessels should be designed and constr ucted so as not to cause contamination of fisher y products with bilge-wat er, 
sewage, smoke, fuel, oil, grease or other objectionable substances. Also holds, tank s or containers used for storing, 
cooling or freezing fisher y products should not be used for other purposes than the storage of fisher y products. 
Freezer vessels and reefer vessels should be equipped with freezing equipment with sufficient capacity to freeze as 
quic kly as possible in a continuous process and with a ther mal arrest period as shor t as possible, so as to achieve a 
core temperature of not more than – 18 °C. Storag e holds should not be used for freezing products. The same 
requirements for freezing and storag e equipment should also apply to cold store s on land. Part I of Chapt er I and 
part B of Chapt er III of Section VIII of Annex III to Regulation (EC) No 853/2004 should theref ore be amended 
according ly.
(8)https://doi.org/10.2903/j.efsa.2009.1109EN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                           L 297/3  (18) Following recent frauds concer ning tuna initially frozen in brine at – 9 °C and destined for the canning industr y but 
diver ted to be consumed as fresh fisher y products, it is appropr iate to clarify in point 7 of Part II of Chapt er I of 
Section VIII of Annex III to Regulation (EC) No 853/2004 that whole fisher y products initially frozen in brine at – 
9 °C and destined for the canning industr y even if further frozen at a temperature of – 18 °C must not have a 
differ ent destination than the canning industr y.
(19) Livers and roes of fisher y products intende d for human consump tion are to be preser ved under ice, at a temperature 
approach ing that of melting ice, or are to be frozen. It is appropr iate to allow that livers and roes be also refrigerat ed 
under differ ent conditions than under ice, at a temperature approaching that of melting ice. According ly, point 6 of 
Part II of Chapt er I of Section VIII of Annex III to Regulation (EC) No 853/2004 should be amended in order to 
allow that livers and roes of fisher y products intended for human consump tion may also be refrigerated not only 
under ice but under differ ent conditions of refrigeration.
(20) It is appropr iate that in containers used for the dispatch or storage of unpac kaged prepared fresh fisher y products 
store d under ice, the melting water should not remain in contact with any fisher y products. It is impor tant, for 
hygiene reasons, to clarify that melt water not only should not remain in contact with fisher y products but should 
be drained awa y. According ly, point 4 of part A of Chapt er III of Section VIII of Annex III to Regulation (EC) 
No 853/2004 should be amended in order to clarify that melt ed water not only should not remain in contact with 
fisher y products but should be drained awa y.
(21) Specifi c hygiene rules on frogs’ legs laid down in Section XI of Annex III to Regulation (EC) No 853/2004 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 Annex I to that Regulation. Specific hygiene rules for snails in that Section only apply to terrestr ial gastropods 
of the species Helix pomatia Linné, Helix aspersa Muller , Helix lucor um and species of the family Achatinidae in 
accordance with the definit ion 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 mark et for human 
consum ption. The specific hygiene rules should theref ore be exte nded to cover those species to ensure the safety of 
food derived from these species.
(22) Section XII of Annex III to Regulation (EC) No 853/2004 lays down specifi c temperature requirements for the 
storag e of greav es intended for human consump tion. Technological developments have allowed certain packag ing 
techniques, such as vacuum-pac kaging for which the specifi c temperature requirements are not needed to ensure 
the safety of food derived from greaves. Those temperature conditions should theref ore be delet ed while the food 
business operat or should ensure the safety of food derived from the grea ves by good hygiene practices and 
procedures based on Hazard Analysis and Critical Control Point (HA CCP) principles in accordance with Article 5 of 
Regulation (EC) No 852/2004 of the European Parliament and of the Council (9).
(23) Annex III to Regulation (EC) No 853/2004 should theref ore be amended according ly,
HAS ADOPTED THIS REGUL ATION:
Article 1
Annex III of Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
(9)Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 Apr il 2004 on the hygiene of foodstuffs (OJ L 139, 
30.4.2004, p. 1).EN Offi cial Jour nal of the European Union L 297/4                                                                                                                                           20.8.2021  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 Apr il 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                           L 297/5  ANNEX 
Annex III to Regulation (EC) No 853/2004 is amended as follows:
(1) Section I is amended as follows:
(a) Chapt er IV is amended as follows:
(i) point 2(b)(ii) is replaced by the follo wing:
‘(ii) animals slaughtere d at the holding of proven ance in accordance with Chapt er VIa of this Section or in 
accordance with point 3 of Section III;’
(ii) point 18 is replaced by the followi ng:
‘18. Unless intended for use as animal by-product in accordance with Regulation (EC) No 1069/2009 of the 
European Parliament and of the Council *:
(a) stomac hs must be scalded or cleaned; however , when intended for rennet production, the stomachs:
(i) are only required to be emp tied in the case of young bovine animals
(ii) are not required to be emptied, scalded or cleaned in the case of young ovine and capr ine animals;
(b) intestines must be emp tied and cleaned;
(c) heads and feet must be skinned or scalded and depilate d; however , when author ised by the compet ent 
author ity, visibly clean heads, not containing specified risk mate rials in accordance with Article 8 of 
Regulation (EC) No 999/2001 of the European Parliament and of the Council **, and visibly clean 
feet, intended for processing into food, may be transpor ted to and skinned or scalded and depilate d 
in an approved establishment.
_____________
*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 
consum ption and repealing Regulation (EC) No 1774/2002 (Animal by-pro ducts Regulation) (OJ L 300, 
14.11.2009, p. 1).
** 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 spongif orm 
encephalopathies (OJ L 147, 31.5.2001, p. 1).’
(b) Chapt er VI is amended as follows:
(i) points 2 and 3 are replaced by the followi ng:
‘2. The official veteri narian must carry out an ante- mor tem inspection of the animal.
3. The slaughtered and bled animal must be transpor ted to the slaughterh ouse hygienically and without 
undue dela y. Remov al of the stomac h and intest ines, but no other dressing, may take place on the spot, 
under the super vision of the official veterinar ian. Any viscera removed must accompan y the slaughter ed 
animal to the slaughter house and be identif ied as belonging to that animal.’
(ii) point 6 is replaced by the followi ng:
‘The official certificate set out in Chapt er 5 of Annex IV to Commission Implementing Regulation (EU) 
2020/2235 * shall accompan y the slaughter ed animal to the slaughte rhouse or be sent in advance in any 
format.
_____________
*Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the 
application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the 
Council as regards model animal health certificates, model official certificates and model animal 
health/official certificates, for the entr y into the Union and mov ements within the Union of consignments 
of certain catego ries of animals and goods, official certification regar ding such certificates and repealing 
Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 
98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).’EN Offi cial Jour nal of the European Union L 297/6                                                                                                                                           20.8.2021  (c) The followi ng Chapt er VIa is inser ted after Chapt er VI:
‘CHAPTER VIa: SLAUGHTER AT THE HOLDING OF PROVENANCE OF DOMESTIC BOVINE, OTHERS 
THAN BISONS, AND POR CINE ANIMALS AND DOMESTIC SOLIPEDS OTHER THAN EMER GENCY 
SLAUGHTER
Up to three domestic bovine, others than bisons, or up to six domestic porcine animals or up to three domestic 
solipeds may be slaughter ed at the same occasion at the holding of proven ance, when author ised by the 
compet ent author ity in accordance with the followi ng requirements:
(a) the animals cannot be transpor ted to the slaughterh ouse, to avoid any risk for the handler and to prevent any 
injur ies to the animals during transpor t;
(b) there is an agreement between the slaughterhouse and the owner of the animal intended for slaughte r; the 
owner must inform the compet ent author ity in writing of such an agreement ;
(c) the slaughter house or the owner of the animals intended for slaughter must inform the official veteri narian at 
least three days in advance of the date and time of intende d slaughter of the animals;
(d) the official veteri narian who carries out the ante-mor tem inspection of the animal intended for slaughter must 
be present at the time of slaughter;
(e) the mobile unit to be used for the bleeding and transpor t of the slaughter ed animals to the slaughter house 
must allow their hygienic handling and bleeding, and the proper disposal of their blood and must be part of a 
slaughterh ouse approved by the compet ent author ity in accordance with Article 4(2); however the compet ent 
author ity may allow bleeding outside the mobile unit if the blood is not intended for human consump tion and 
the slaughter does not take place in restr icted zones as defined in Article 4(41) of Regulation (EU) 2016/429 of 
the European Parliament and of the Council * or establishments in whic h animal health restr ictions are applied 
in accordance with Regulation (EU) 2016/429 and any acts adopt ed on its basis;
(f) the slaughter ed and bled animals must be transpor ted directly to the slaughterhouse hygienically and without 
undue dela y; removal of the stomac h and intestines, but no other dressing, may take place on the spot, under 
the super vision of the official veterinar ian; any viscera remo ved must accompan y the slaughter ed animal to 
the slaughterh ouse and be identified as belonging to each individual animal;
(g) if more than two hours elapse between the time of slaughter of the first animal and the time of arrival at the 
slaughterh ouse of the slaughtered animals, the slaughte red animals must be refrigerat ed; where climatic 
conditions so permit, active chilling is not necessar y;
(h) the owner of the animal must inform the slaughterh ouse in advance of the intende d time of arrival of the 
slaughtere d animals, whic h must be handled without undue dela y after arrival at the slaughte rhouse;
(i) in addition to the food chain information to be submitt ed in accordance with Section III of Annex II to this 
Regulation, the official certificate set out in Chapt er 3 of Annex IV to Implementing Regulation (EU) 
2020/2235 must accompan y the slaughter ed animals to the slaughterhouse or be sent in advance in any 
format.
_____________
*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).’
(d) In Chapt er VII, point 4 is replaced by the follo wing:
‘4. Meat intende d for freezing must be frozen without undue dela y, taking into account where necessar y a 
stabilisation period before freezing.
However , food business operat ors carrying out a retail activity may freeze meat in view of its redistr ibution for 
the purpose of food donations in accordance with the following conditions:
(i) in the case of meat for whic h a ‘use by’ date is applied in accordance with Article 24 of Regulation (EU) 
No 1169/2011 of the European Parliament and of the Council *, before the expir y of that date;EN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                           L 297/7  (ii) without undue dela y to a temperature of – 18 °C or lower;
(iii) ensur ing that the date of freezing is documented and provid ed either on the label or by other means;
(iv) excluding meat that has been frozen before (defrost ed meat); and,
(v) in accordance with any condition laid down by the compet ent author ities for freezing and further use as 
food.
_____________
*Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the 
provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) 
No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 
87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the 
European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).’
(2) Section II is amended as follows :
(a) In Chapt er V, point 5 is replaced by the following:
‘5. Meat intended for freezing must be frozen without undue dela y.
However , food business operat ors carrying out a retail activity may freeze meat in view of its redistr ibution for 
the purpose of food donations in accordance with the following conditions:
(i) in the case of meat for whic h a ‘use by’ date is applied in accordance with Article 24 of Regulation (EU) 
No 1169/2011, before the expir y of that date;
(ii) without undue dela y to a temperature of – 18 °C or lower;
(iii) ensur ing that the date of freezing is documented and provid ed either on the label or by other means;
(iv) excluding meat that has been frozen before (defrost ed meat); and,
(v) in accordance with any condition laid down by the compet ent author ities for freezing and further use as 
food.’
(b) Chapt er VI is amended as follows:
(i) point 6 is delet ed;
(ii) point 7 is replaced by the followi ng:
‘7. In addition to the food chain information to be submitted in accordance with Section III of Annex II to this 
Regulation, the official certificate set out in Chapt er 3 of Annex IV to Implementing Regulation (EU) 
2020/2235 must accompan y the slaughter ed animal to the slaughter house or cutting plant, or be sent in 
advance in any format.’
(3) Section III is amended as follows:
(a) point 1 is replaced by the following:
‘1. The provis ions of Section I apply to the production and placing on the market of meat from even-t oed farmed 
game mammals, unless the compet ent author ity considers them inappropr iate.’
(b) point 3(j) is replaced by the followi ng:
‘(j) the official certificate set out in Chapt er 3 of Annex IV to Commission Implementing Regulation (EU) 
2020/2235, issued and signed by the official veterinar ian, attesting to a favourable result of the ante-mor tem 
inspection, correct slaughter and bleeding and the date and time of slaughter , accompan ies the slaughter ed 
animal to the slaughterhous e or was sent in advance in any format.’EN Offi cial Jour nal of the European Union L 297/8                                                                                                                                           20.8.2021  (4) Section IV is amended as follo ws:
(a) the follo wing introductor y senten ce is added:
‘For the purpose of this Section, ‘collection centre’ means an establishment used to store the bodies and viscera of 
wild game before their transpor t to a game handling establishment.’
(b) Chapt er II is amended as follows:
(i) point 4(c) is replaced by the followi ng:
‘(c) If no trained person is available to carry out the examination refer red to in point 2 in a particular case, the 
head, excep t for tusks, antlers and horns, and all the viscera, excep t for the stomac h and the intest ines, 
must accompan y the body whic h must be transpor ted to a gam e handling-establishment as soon as 
possible after killing.’
(ii) in point 8(b), the first subparagraph is replaced by the followi ng:
‘(b) may be sent to a gam e handling establishment in another Member State only if, during transpor t to that 
game-handling establishment, it is accompanied by an offici al certificate set out in Chapt er 2 of Annex II 
to Imple menting Regulation (EU) 2020/2235 issued and signed by an official veterinar ian, attesting that 
the requirements set out in point 4 of this Chapt er as regards the availability of a declaration, when 
relevant, and the accompaniment of relevant parts of the body , have been complied with.’
(iii) the follo wing point 10 is added:
‘10. The bodies and viscera of large wild gam e may be transpor ted to and stored in a collection centre before 
being sent to a game handling establishment provided that:
(a) the collection centre is either:
(1) registered with the compet ent author ity as a food business carrying out primar y production as 
refer red to in Article 4(2)(a) when only receiving bodies as first collection centre, or
(2) approved by the compet ent author ity as a food business in accordance with Article 4(2) when 
receiving bodies from other collection centres;
(b) if the animals are eviscerat ed, their heaping is prohibited during transpor t to and storage in the 
collection centre;
(c) killed animals are transpor ted to the collection centre hygienically and without dela y;
(d) the temperature conditions laid down in point 5 are complied with;
(e) storage time is kept to the minimum possible;
(f) no other handling takes place on the bodies and viscera of the large wild gam e; however the 
examination by a trained person and the remo val of viscera may take place under the conditions 
laid down in points 2, 3 and 4.’
(c) Chapt er III is amended as follo ws:
(i) point 3 is replaced by the followi ng:
‘3Meat of small wild game may be placed on the mark et only if the body is transpor ted to a gam e-handling 
establishment as soon as possible after the examination referred to in point 1 or, if no trained person is 
available to carry out that examination in a particular case, as soon as possible after killing’.
(ii) the followi ng point 8 is added:
‘8. The bodies, including viscera, of small wild game may be transpor ted to and stored in a collection centre 
before being sent to a game handling establishment provided that:
(a) the collection centre is either:
(1) register ed with the compet ent author ity as a food business carrying out primar y production as 
referred to in Article 4(2)(a) when only receiving bodies as first collection centre, orEN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                           L 297/9  (2) appro ved by the compet ent author ity as a food business in accordance with Article 4(2) when 
receiving bodies from other collection centres;
(b) if the animals are eviscerated, their heaping is prohibit ed during transpor t to and storag e in the 
collection centre;
(c) killed animals are transpor ted to the collection centre hygienically and without dela y;
(d) the temperature conditions laid down in point 4 are compl ied with;
(e) storag e time is kept to the minimum possible;
(f) no other handling takes place on the bodies, including viscera, of the small wild game; however the 
examination by a trained person and the remo val of viscera may take place under the conditions laid 
down in points 1 and 2.’
(5) Section VII is amended as follows:
(a) In the introductor y part, the follo wing point 1a is inser ted:
‘1a. For the purpose of this Section, ‘inter mediar y operat or’ means a food business operat or, including traders, 
other than the first supplier , with or without premises, who carries out its activities between production 
areas, relaying areas or any establishments.’
(b) Chapt er I is amended as follows :
(i) point 3 is replaced by the following:
‘3. Whenever a food business operat or mov es a batch of live bivalve molluscs between production areas, 
relaying areas or any establishments, a registration document must accompan y the batch.’
(ii) in point 4, the following point (d) is added:
‘(d) Where a batch of live bivalve molluscs is sent by an intermediar y operat or, a new registration document, 
filled-in by the interm ediar y operat or, must accompan y the batch. The registration document must 
contain at least the information referred to in points (a), (b) and (c) and the following information:
(i) the name and address of the intermediar y operat or;
(ii) in the case of conditioning or in the case of re-immersion for stori ng purpose, the date of starting, 
the date of end and the place of the conditioning or the re-immersion;
(iii) if a conditioning in a natural site was carried out, the intermediar y operator must confir m that the 
natural site where the conditioning took place was classified at the time of conditioning as an class 
A production area open for harvest ;
(iv) if a re-immersion in natural site was carried out, the interm ediar y operat or must confir m that the 
natural site where the re-immersion took place was classified at the time of re-immersion with the 
same classificat ion of the production area where the live bivalve molluscs were harvested .
(v) if a re-immersion was carried out in an establishment, the interm ediar y operat or must confir m that 
the establishment was approved at the time of the re-immersion. The re-immersion shall not cause 
additional contamination to the live bivalve molluscs.
(vi) in the case of grouping, the species, the date when the grouping started, the date of the end of the 
grouping, the status of the area where the live bivalve molluscs were harvested , and the batch of the 
grouping, that alwa ys consists of the same species, captur ed on the same date, and in the same 
production area.’
(iii) the follo wing points 8 and 9 are added:
‘8. Interm ediar y operators must be:
(a) registe red with the compet ent author ity as a food business carrying out primar y production as 
referred to in Article 4(2)(a) if they do not have premises or if they have premises where they only 
handle, wash and store at ambient temperature live bivalve molluscs, without grouping nor 
conditioning, orEN Offi cial Jour nal of the European Union L 297/10                                                                                                                                         20.8.2021  (b) appro ved by the compet ent author ity as a food business operat or in accordance with Article 4(2) if, in 
addition to carrying out the activities refer red to in point (a), they have a cold store or they group or 
split batches of live bivalve molluscs or they carry out conditioning or re-immersion.
9. Interm ediar y operat ors may receive live bivalve molluscs from production areas classified as A, B or C, 
from relaying areas or from other intermediar y operators. Intermediar y operators can send live bivalve 
molluscs:
(a) from class A production areas to dispatch centres or another intermediar y operat or;
(b) from class B production areas only to purification centres, processing establishments or to another 
intermediar y operat or;
(c) from class C production areas to processing establishments or to another intermediar y operat or with 
premises.’
(c) In Chapt er IV point 1 of Part A is replaced by the followi ng:
‘1. Before purification commences, live bivalve molluscs must be free of mud and accumulate d debr is and washed 
if necessar y, using clean water .’
(d) In Chapt er V, point 2:
a) point (a) is replaced by: ‘(a) for paralytic shellf ish poison (PSP), 800 micrograms of saxit oxin equivalents diHCl 
per kilogram;’
(b) point (c) is replaced by: ‘(c) for okadaic acid and dinophysist oxins together 160 micrograms of okadaic acid 
equivalents per kilogram;’
(e) Chapt er IX is replaced by the following:
‘CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINID AE, MARINE GASTR OPODS AND 
HOLOTHUR OIDEA WHICH ARE NOT FILTER FEEDERS HAR VESTED OUTSIDE CLASSIFIED 
PRODUCTION AREAS
Food business operat ors harvesting pectinidae, mar ine gastropods and holothuroidea which are not filter feeders, 
outside classified production areas or handling such pectinidae, and/or such mar ine gastropods and/or 
holothuroidea must compl y with the follo wing requirements:
1.Pectinidae, mar ine gastropods and holothuroidea whic h are not filter feeders, must not be placed on the mark et 
unless they are harvested and handled in accordance with Part B of Chapt er II and meet the standards laid down 
in Chapt er V, as demonstrated by a system of own-chec ks by the food business operators operating a fish 
auction, a dispatch centre or a processing establishment ;
2.In addition to point 1, where data from official monit oring programmes enable the compe tent author ity to 
classify fishing grounds – where appropr iate, in cooperation with food business operat ors – the provisions of 
Part A of Chapt er II apply by analogy to pectinidae;
3.Pectinidae, mar ine gastropods and holothuroidea whic h are not filter feeders, must not be placed on the mark et 
for human consum ption other wise than via a fish auction, a dispatch centre or a processing establishment. 
When they handle pectinidae and/or such mar ine gastropods, and/or holothuroidea food business operat ors 
operating such establishments must inform the compe tent author ity and, as regar ds dispatch centres, compl y 
with the relevant requirements of Chapt ers III and IV;
4.Food business operat ors handling pectinidae, mar ine gastropods and holothuroidea which are not filter feeders, 
must compl y with the follo wing requirements:
(a) with the documentar y requirements of points 3 to 7 of Chapt er I, where applicable. In this case, the 
registration document must clearly indicate the location of the area, indicating the syste m used to descr ibe 
the coordinat es, where the live pectinidae and/or live mar ine gastropods and/or live holothuroidea were 
harvested ; or
(b) with the requirements of point 2 of Chapt er VI concer ning the closing of all packag es of live pectinidae, live 
mar ine gastropods and live holothuroidea dispatc hed for retail sale and Chapt er VII concer ning 
identif ication marking and labelling.’EN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                         L 297/11  (f) The followi ng Chapt er X is added:
‘CHAPTER X MODEL OF REGISTRA TION DOCUMENT OF LIVE BIVALVE MOLLU SCS, LIVE 
ECHINODERMS, LIVE TUNICA TES AND LIVE MARINE GASTR OPODS
REGISTRA TION DOCUMENT OF LIVE BIVALVE MOLL USCS, LIVE ECHINODERMS, LIVE TUNIC ATES AND LIVE 
MARINE GASTR OPODSPart I – Supplier I.1 IMSOC Reference number I.2 Inter nal refe rence number
I.3 Supplier
Name
Address
Registration or Approv al No
Countr y ISO Countr y 
code
ActivityI.4 Receiving food business operator
Name
Address
Registration or Approv al No
Countr y ISO Countr y code
Activity
I.5 Descr iption of goods
Aqua culture ☐ Natural Bank s ☐
• CN code or FAO 3-Alpha code | species | quantity | packag e | batch | date of harvesting| date of starting 
of conditioning | date of end of conditioning | place of conditioning| date of starting of re-immersion | 
date of end of re-immersion |place of re-immersion| date of starting of grouping | date of end of 
grouping | production area | health status including, if applicable, harvested in accordance with Article  
62(2) of Implementing Regulation (EU) 2019/627
I.6 From relaying area Yes☐ No☐
Rela ying area
Duration of relaying
Date of starting
Date of endI.7 From pur ification/dispatch centre
Auction hall Yes ☐ No☐
Purification/dispatch centre/auction hall 
appro val number
Date of entr y
Date of exit
Duration of pur ification
I.8 From Inter mediar y operator
Yes ☐ No ☐
Name
Address
Registration or Appro val No
Countr y
ISO Countr y code
Acti vity
Date of arrival
Date of exit
I.9 Declaration of the supplier
I, the undersigned food business operat or responsible for dispatching the consignment declare that, to the 
best of my knowledg e and belief, the information provi ded in Part I of this document is true and 
compl ete.
Date Name of signato ry SignaturePart II – Receiving operator  II.1 Inter nal referenc e number (receiving)
II.2 Declaration of the receiving food business operator
I, the undersigned food business operator responsible for receiving the consignment declare that the 
consignment has arrived on [DATE] in my premises.
Name of signato ry SignatureEN Offi cial Jour nal of the European Union L 297/12                                                                                                                                         20.8.2021  Explanat ory notes
Box Descr iption
Part I – Supplier
This part of the document shall be filled by the food business operat or dispatching a batch of live bivalve molluscs.
I.1 IMSOC reference number
This is the unique alpha-numer ic code assigned by the IMSOC
I.2 Inter nal referen ce number
This box may be used by the dispatching food business operat or to indicate an intern al reference number .
I.3 Supplier
Indicate the name and address (street, city and region/province/stat e, as appropr iate), countr y and ISO countr y 
code of the establishment of origin. In the case of production areas, please indicate the area as author ised by the 
compet ent author ities (CAs). In the case of live pectinidae, mar ine gastropods or holothuroidea, indicate the 
location of the harvesting area.
Where applicable, indicate the registration or approval number of the establishment. Indicate the activity 
(gath erer, purification centre, dispatch centre, auction hall or intermediar y activities).
Where the batch of live bivalve molluscs is sent from a purification centre/dispatch centre, or, in case of 
pectinidae, mar ine gastropods and Holothuroidea which are not filter feeders harvested outside classified 
production areas, from a fish auction, indicate the approval number and the address of the purification  
centre/dispatch centre or fish auction.
I.4 Receiving food business operator
Indicate the name and address (street, city and region/province/stat e, as appropr iate), countr y and ISO countr y 
code of the establishment of destination. In the case of production or relaying areas please indicate the area as 
author ised by the CAs.
Where applicable, indicate the registration or approval number of the establishment Indicate the activity (gatherer , 
purification centre, dispatch centre, processing establishment or intermediar y activities).
I.5 Descr iption of goods
Indicat e as required, the Combined Nomenclature code or FAO 3-Alpha code, species, quantity , type of packaging 
(bags, bulk , etc.), batch, date of harvesting, date of starting and end of conditioning (when applicable), place of 
conditioning (indicate the classif ication of the production area and its location or the approv al number of the 
establishment, when applicable), date of starting and end of re-immersion (when applicable), place of re-immersion 
(indicate the classif ication of the production area and its location or the approval number of the establishment when 
applicable), date of starting and end of grouping (when applicable), production area and its health status (classification 
of the production area when applicable). When LBMs have been harvested in accordance with Article 62(2) of the 
Implementing Regulation 2019/627 then this should be explicitly stated.
When grouping of live bivalve molluscs is performe d, the batch must refer to bivalves of the same species, 
harveste d on the same day and coming from the same production area.
Delete as appropr iate
I.6 From relaying area
Where the batch of live bivalve molluscs is sent from a relaying area, indicate the relaying area, as author ised by 
the CAs, and the duration of the relaying (date of starting and end).
I.7 From pur ification centre/dispatch centre or fish auction
Where the batch of live bivalve molluscs is sent from a purification centre/dispatch centre, or, in case of 
pectinidae, mar ine gastropods and holothuroidea which are not filter feeders harvested outside classifie d 
production areas, from an auction hall, indicate the appro val number and the address of the purification  
centre/dispatch centre or auction hall.
If sent from a purification centre the duration of the purification and the date s on whic h the batch entered and left 
the purification centre. Delete as appropr iateEN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                         L 297/13  I.8 From inter mediar y operator
Indicate the name and address (street, city and region/province/stat e, as appropr iate), countr y and ISO countr y 
code of the intermediar y operat or.
Where applicable, indicate the registration or approval number and the activity .
1.9 Declaration of the supplier
Include the date, name of the signato ry and the signature.
Part II – Receiving food business operat or
This part of the document shall be filled by the food business operat or receiving a batch of live bivalve molluscs.
II.1 Inter nal referen ce number (receiving)
This box may be used by the food business operator receiving the batch to indicate an internal referen ce number .
II.2 Declaration of the receiving food business operator
Indicate the date of arrival of the batch of live bivalve molluscs at the premises of the receiving food business 
operat or. In the case of an interm ediar y operat or without premises indicate the date of purch ase of the batch.
Include the name of the signato ry and the signature.’
(6) Section VIII is amended as follows:
(a) Chapt er I is amended as follows :
(i) Point 1 is replaced by the followi ng:
‘1. vessels used to harvest fisher y products from their natural environment, or to handle or process them after 
harvesting, and reefer vessels compl y with the structural and equipment requirements laid down in Part I; 
and’
(ii) In Part I.A, the following point 5 is added:
‘5. Vessels must be designed and constr ucted so as not to cause contamination of the fisher y products with 
bilge-wat er, sewage, smoke, fuel, oil, grease or other objectionable substances. Holds, tank s, or containers 
used for stori ng, cooling or freezing unprotect ed fisher y products including those destined for the 
production of feed, shall not be used for other purposes than the stor ing, cooling or freezing those 
products, as well as ice or brine used for such purposes. In the case of reefe r vessels, the provisions 
applicable to unp rotect ed fisher y products apply to all the products transpor ted.’
(iii) In Part I.C, points 1 and 2 are replaced by the following:
‘1. have freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process 
and with a ther mal arrest period as shor t as possible, so as to achieve a core temperature of not more 
than – 18 °C;
2. have refrigeration equipment with sufficient capacity to maintain fisher y products in the storag e holds at 
not more than – 18 °C. Storage holds must not be used for freezing unless they fulfil the conditions laid 
down in point 1, and must be equipped with a temperature-recording device in a place where it can be 
easily read. The temperature sensor of the reader must be situated in the area where the temperature in 
the hold is the highest ;’
(iv) In Part I, the following point E is added:
‘E.Requirements for reefe r vessels
Reefer vessels transpor ting and/or storing frozen fisher y products in bulk must have equipment meeting 
the requirements for freezer vessels laid down in point 2 of part C concer ning their capacity to maintain 
the temperature.’EN Offi cial Jour nal of the European Union L 297/14                                                                                                                                         20.8.2021  (v) In Part II, point 6 is replaced by the follo wing
‘6. Where fish are headed and/or gutt ed on board, such operations must be carried out hygi enically as soon as 
possible after capture, and the fisher y products must be washed immediate ly. The viscera and parts that 
may constitute a danger to public health must be remo ved as soon as possible and kept apar t from fisher y 
products intended for human consum ption. Livers and roes intended for human consump tion must be 
refrigerated or preser ved under ice, at a temperature approaching that of melting ice, or be frozen.’
(vi) in Part II, point 7 is replaced by the follo wing:
‘7. Where freezing in brine of the whole fish intended for canning is practiced, a temperature of not more 
than – 9 °C must be achi eved for the fisher y product. Even if it is subsequently frozen at a temperature of 
– 18 °C, the whole fish initially frozen in brine at a temperature of not more than – 9 °C must be destined 
for canning. The brine must not be a source of contamination for the fish.’
(b) Chapt er III is amended as follo ws:
(i) In Part A, point 4.is replaced by the follo wing:
‘4. Containers used for the dispatch or stora ge of unp ackag ed prepared fresh fisher y products stored under ice 
must ensure that melt water is drained awa y and does not remain in contact with any fisher y products.’
(ii) Part B is replaced by the follo wing:
‘B. REQUIREMENTS FOR FROZEN PRODUCTS
Establishments on land that freeze or store frozen fisher y products must have equipment, adapt ed to the 
activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapt er I 
part I.C, points 1 and 2 and.’
(7) In Section XI, the followi ng points 7 and 8 are added:
‘7. The requirements laid down in points 1, 3, 4 and 6, also apply to any other snails of the Fami ly of Helicidae, 
Hyg romiidae or Sphincteroch ilidae, when intended for human consump tion.
8. The requirements laid down in points 1 to 5 also apply to frogs’ legs of the genus Pelophylax from the Fam ily of 
Ranidae, and the genus Fejer varya, Limnonectes and Hoplobatr achus from the Fami ly of Dicr oglossidae, when intended 
for human consum ption.’
(8) In Section XII, in Chapt er II, point 5 is delet ed.EN Offi cial Jour nal of the European Union 20.8.2021                                                                                                                                         L 297/15