Commission Delegated Regulation (EU) 2021/1374 of 12 April 2021 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)
Date: 2021-04-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, food inspection, food safety, foodstuff, health control, health legislation




L_2021297EN.01000101.xml










20.8.2021   


EN


Official Journal of the European Union


L 297/1








            COMMISSION DELEGATED REGULATION (EU) 2021/1374
of 12 April 2021
         
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 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 operators.












(2)


Rennet is a complex of enzymes used for the production of certain cheeses. It is collected from the stomachs 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 853/2004, 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 resulted in a demand for heads and feet of domestic ungulates to be permitted to be skinned or scalded and depilated outside the slaughterhouse in specialised approved establishments for further processing of food. As a practical consequence, heads and feet of domestic ungulates should therefore be allowed to be transported 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 Article 4 of Commission Delegated Regulation (EU) 2019/624 (2), 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 Regulation (EC) No 853/2004 requires a veterinarian to carry out ante mortem inspection in the case of emergency slaughter. That requirement should be amended so as to be consistent with that Article 4 of Delegated Regulation (EU) 2019/624 and refer instead to the official veterinarian.












(5)


Improving animal welfare is one of the actions proposed in the Commission’s Farm to Fork Strategy (3) 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 that slaughter of certain domestic ungulates on the holding of provenance be authorised in order to avoid possible animal welfare concerns during collection and transport thereof.












(6)


Apart from emergency slaughter, domestic ungulates are required to be slaughtered in a slaughterhouse approved in accordance with Article 4(2) of Regulation (EC) No 853/2004 to ensure compliance with the hygiene 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 appropriate 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 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 slaughtered on the holding of provenance, should be accompanied by an official certificate, attesting that the hygiene requirements for slaughter have been complied with. Such an official certificate is provided for in Commission Implementing Regulation (EU) 2020/2235 (4).












(8)


On 27 September 2018, the European Food Safety Authority (EFSA) adopted a second scientific opinion on hazard analysis approaches for certain small retail establishments and food donations (5). That Opinion recommends freezing at retail level as an additional tool for guaranteeing the safe redistribution of food to those in need. The facilitation 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 system as part of the European Green Deal. The freezing 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 Section II of that Annex as regards poultry and lagomorphs. The freezing of meat should therefore be allowed in the case of retail to retail activity under certain conditions to ensure the safe distribution for food donations.












(9)


Regulation (EC) No 854/2004 of the European Parliament and of the Council (6) defined ‘approved veterinarian’. Regulation (EU) 2017/625 of the European Parliament and of the Council (7) repealed Regulation (EC) No 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 apply 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 may be transported to and stored 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 with 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 molluscs 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 registration 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 also include this possibility.












(14)


In accordance with point 1 of Part A of Chapter 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 debris 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 Chapter IV of Section VII should be modified accordingly.












(15)


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 Opinion on Marine biotoxins in shellfish – Pectenotoxin group (8) that there are no reports of 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 2(c) of Chapter V of Section VII of Annex III to Regulation (EC) No 853/2004.












(16)


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.












(17)


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 holds, tanks or containers used for storing, cooling or freezing fishery products should not be used for other purposes than the storage of fishery products. Freezer vessels and reefer vessels should be equipped with freezing equipment with sufficient capacity to freeze as quickly as possible in a continuous process and with a thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C. Storage holds should not be used for freezing products. The same requirements for freezing and storage equipment should also apply to cold stores on land. 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.












(18)


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.












(19)


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, point 6 of Part II of Chapter 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 fishery products intended for human consumption may also be refrigerated not only under ice but under different conditions of refrigeration.












(20)


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, point 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.












(21)


Specific 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 terrestrial gastropods 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.












(22)


Section XII of Annex III to Regulation (EC) No 853/2004 lays down specific 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 based 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 Council (9).












(23)


Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly,





HAS ADOPTED THIS REGULATION:



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 following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 April 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 139, 30.4.2004, p. 55.

(2)  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).

(3)  https://ec.europa.eu/food/sites/food/files/safety/docs/f2f_action-plan_2020_strategy-info_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 entry into the Union and movements within the Union of consignments of certain categories 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 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (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 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, (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).

(8)  https://doi.org/10.2903/j.efsa.2009.1109

(9)  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).




ANNEX
Annex III to Regulation (EC) No 853/2004 is amended as follows:






(1)


Section I is amended as follows:






(a)


Chapter IV is amended as follows:






(i)


point 2(b)(ii) is replaced by the following:






‘(ii)


animals slaughtered at the holding of provenance in accordance with Chapter VIa of this Section or in accordance with point 3 of Section III;’














(ii)


point 18 is replaced by the following:






‘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)


stomachs must be scalded or cleaned; however, when intended for rennet production, the stomachs:






(i)


are only required to be emptied in the case of young bovine animals










(ii)


are not required to be emptied, scalded or cleaned in the case of young ovine and caprine animals;














(b)


intestines must be emptied and cleaned;










(c)


heads and feet must be skinned or scalded and depilated; however, when authorised by the competent authority, visibly clean heads, not containing specified risk materials 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 transported to and skinned or scalded and depilated 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 consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products 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 spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).’
                                                                        "
                        














(b)


Chapter VI is amended as follows:






(i)


points 2 and 3 are replaced by the following:






‘2.


The official veterinarian must carry out an ante-mortem inspection of the animal.










3.


The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay. Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the official veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be identified as belonging to that animal.’














(ii)


point 6 is replaced by the following:

                                                ‘The official certificate set out in Chapter 5 of Annex IV to Commission Implementing Regulation (EU) 2020/2235 (*) shall accompany the slaughtered animal to the slaughterhouse 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 entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding 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).’
                                                   "
                        














(c)


The following Chapter VIa is inserted after Chapter VI:

                                             ‘CHAPTER VIa: SLAUGHTER AT THE HOLDING OF PROVENANCE OF DOMESTIC BOVINE, OTHERS THAN BISONS, AND PORCINE ANIMALS AND DOMESTIC SOLIPEDS OTHER THAN EMERGENCY SLAUGHTER
Up to three domestic bovine, others than bisons, or up to six domestic porcine animals or up to three domestic solipeds may be slaughtered at the same occasion at the holding of provenance, when authorised by the competent authority in accordance with the following requirements:






(a)


the animals cannot be transported to the slaughterhouse, to avoid any risk for the handler and to prevent any injuries to the animals during transport;










(b)


there is an agreement between the slaughterhouse and the owner of the animal intended for slaughter; the owner must inform the competent authority in writing of such an agreement;










(c)


the slaughterhouse or the owner of the animals intended for slaughter must inform the official veterinarian at least three days in advance of the date and time of intended slaughter of the animals;










(d)


the official veterinarian who carries out the ante-mortem 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 transport of the slaughtered animals to the slaughterhouse must allow their hygienic handling and bleeding, and the proper disposal of their blood and must be part of a slaughterhouse approved by the competent authority in accordance with Article 4(2); however the competent authority may allow bleeding outside the mobile unit if the blood is not intended for human consumption and the slaughter does not take place in restricted zones as defined in Article 4(41) of Regulation (EU) 2016/429 of the European Parliament and of the Council (*) or establishments in which animal health restrictions are applied in accordance with Regulation (EU) 2016/429 and any acts adopted on its basis;










(f)


the slaughtered and bled animals must be transported directly to the slaughterhouse hygienically and without undue delay; removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of the official veterinarian; any viscera removed must accompany the slaughtered animal to the slaughterhouse 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 slaughterhouse of the slaughtered animals, the slaughtered animals must be refrigerated; where climatic conditions so permit, active chilling is not necessary;










(h)


the owner of the animal must inform the slaughterhouse in advance of the intended time of arrival of the slaughtered animals, which must be handled without undue delay after arrival at the slaughterhouse;










(i)


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 Chapter 3 of Annex IV to Implementing Regulation (EU) 2020/2235 must accompany the slaughtered 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 Chapter VII, point 4 is replaced by the following:






‘4.


Meat intended for freezing must be frozen without undue delay, taking into account where necessary a stabilisation period before freezing.
However, food business operators carrying out a retail activity may freeze meat in view of its redistribution for the purpose of food donations in accordance with the following conditions:






(i)


in the case of meat for which 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 expiry of that date;










(ii)


without undue delay to a temperature of – 18 °C or lower;










(iii)


ensuring that the date of freezing is documented and provided either on the label or by other means;










(iv)


excluding meat that has been frozen before (defrosted meat); and,










(v)


in accordance with any condition laid down by the competent authorities 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 Chapter V, point 5 is replaced by the following:






‘5.


Meat intended for freezing must be frozen without undue delay.
However, food business operators carrying out a retail activity may freeze meat in view of its redistribution for the purpose of food donations in accordance with the following conditions:






(i)


in the case of meat for which a ‘use by’ date is applied in accordance with Article 24 of Regulation (EU) No 1169/2011, before the expiry of that date;










(ii)


without undue delay to a temperature of – 18 °C or lower;










(iii)


ensuring that the date of freezing is documented and provided either on the label or by other means;










(iv)


excluding meat that has been frozen before (defrosted meat); and,










(v)


in accordance with any condition laid down by the competent authorities for freezing and further use as food.’


















(b)


Chapter VI is amended as follows:






(i)


point 6 is deleted;










(ii)


point 7 is replaced by the following:






‘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 Chapter 3 of Annex IV to Implementing Regulation (EU) 2020/2235 must accompany the slaughtered animal to the slaughterhouse 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 provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game mammals, unless the competent authority considers them inappropriate.’














(b)


point 3(j) is replaced by the following:






‘(j)


the official certificate set out in Chapter 3 of Annex IV to Commission Implementing Regulation (EU) 2020/2235, 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 was sent in advance in any format.’


















(4)


Section IV is amended as follows:






(a)


the following introductory sentence 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 transport to a game handling establishment.’
                                 










(b)


Chapter II is amended as follows:






(i)


point 4(c) is replaced by the following:






‘(c)


If no trained person is available to carry out the examination referred to in point 2 in a particular case, the head, except for tusks, antlers and horns, and all the viscera, except for the stomach and the intestines, must accompany the body which must be transported to a game handling-establishment as soon as possible after killing.’














(ii)


in point 8(b), the first subparagraph is replaced by the following:






‘(b)


may be sent to a game handling establishment in another Member State only if, during transport to that game-handling establishment, it is accompanied by an official certificate set out in Chapter 2 of Annex II to Implementing Regulation (EU) 2020/2235 issued and signed by an official veterinarian, attesting that the requirements set out in point 4 of this Chapter as regards the availability of a declaration, when relevant, and the accompaniment of relevant parts of the body, have been complied with.’














(iii)


the following point 10 is added:






‘10.


The bodies and viscera of large wild game may be transported 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 competent authority as a food business carrying out primary production as referred to in Article 4(2)(a) when only receiving bodies as first collection centre, or










(2)


approved by the competent authority 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 prohibited during transport to and storage in the collection centre;










(c)


killed animals are transported to the collection centre hygienically and without delay;










(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 game; however the examination by a trained person and the removal of viscera may take place under the conditions laid down in points 2, 3 and 4.’






















(c)


Chapter III is amended as follows:






(i)


point 3 is replaced by the following:






‘3


Meat of small wild game may be placed on the market only if the body is transported to a game-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 following point 8 is added:






‘8.


The bodies, including viscera, of small wild game may be transported 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 competent authority as a food business carrying out primary production as referred to in Article 4(2)(a) when only receiving bodies as first collection centre, or










(2)


approved by the competent authority 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 prohibited during transport to and storage in the collection centre;










(c)


killed animals are transported to the collection centre hygienically and without delay;










(d)


the temperature conditions laid down in point 4 are complied with;










(e)


storage 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 removal 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 introductory part, the following point 1a is inserted:






‘1a.


For the purpose of this Section, ‘intermediary operator’ means a food business operator, 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)


Chapter I is amended as follows:






(i)


point 3 is replaced by the following:






‘3.


Whenever a food business operator moves a batch of live bivalve molluscs between production areas, relaying areas or any establishments, a registration document must accompany the batch.’














(ii)


in point 4, the following point (d) is added:






‘(d)


Where a batch of live bivalve molluscs is sent by an intermediary operator, a new registration document, filled-in by the intermediary operator, must accompany 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 intermediary operator;










(ii)


in the case of conditioning or in the case of re-immersion for storing 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 intermediary operator must confirm 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 intermediary operator must confirm that the natural site where the re-immersion took place was classified at the time of re-immersion with the same classification of the production area where the live bivalve molluscs were harvested.










(v)


if a re-immersion was carried out in an establishment, the intermediary operator must confirm 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 always consists of the same species, captured on the same date, and in the same production area.’


















(iii)


the following points 8 and 9 are added:






‘8.


Intermediary operators must be:






(a)


registered with the competent authority as a food business carrying out primary 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, or










(b)


approved by the competent authority as a food business operator in accordance with Article 4(2) if, in addition to carrying out the activities referred 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.


Intermediary operators may receive live bivalve molluscs from production areas classified as A, B or C, from relaying areas or from other intermediary operators. Intermediary operators can send live bivalve molluscs:






(a)


from class A production areas to dispatch centres or another intermediary operator;










(b)


from class B production areas only to purification centres, processing establishments or to another intermediary operator;










(c)


from class C production areas to processing establishments or to another intermediary operator with premises.’






















(c)


In Chapter IV point 1 of Part A is replaced by the following:






‘1.


Before purification commences, live bivalve molluscs must be free of mud and accumulated debris and washed if necessary, using clean water.’














(d)


In Chapter V, point 2:






a)


point (a) is replaced by: ‘(a) for paralytic shellfish poison (PSP), 800 micrograms of saxitoxin equivalents diHCl per kilogram;’










(b)


point (c) is replaced by: ‘(c) for okadaic acid and dinophysistoxins together 160 micrograms of okadaic acid equivalents per kilogram;’














(e)


Chapter IX is replaced by the following:

                                             ‘CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE, MARINE GASTROPODS AND HOLOTHUROIDEA WHICH ARE NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS
Food business operators harvesting pectinidae, marine gastropods and holothuroidea which are not filter feeders, outside classified production areas or handling such pectinidae, and/or such marine gastropods and/or holothuroidea must comply with the following requirements:






1.


Pectinidae, marine gastropods and holothuroidea which are not filter feeders, must not be placed on the market unless they are harvested and handled in accordance with Part B of Chapter II and meet the standards laid down in Chapter V, as demonstrated by a system of own-checks 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 monitoring programmes enable the competent authority to classify fishing grounds – where appropriate, in cooperation with food business operators – the provisions of Part A of Chapter II apply by analogy to pectinidae;










3.


Pectinidae, marine gastropods and holothuroidea which are not filter feeders, must not be placed on the market for human consumption otherwise than via a fish auction, a dispatch centre or a processing establishment. When they handle pectinidae and/or such marine gastropods, and/or holothuroidea food business operators operating such establishments must inform the competent authority and, as regards dispatch centres, comply with the relevant requirements of Chapters III and IV;










4.


Food business operators handling pectinidae, marine gastropods and holothuroidea which are not filter feeders, must comply with the following requirements:






(a)


with the documentary requirements of points 3 to 7 of Chapter I, where applicable. In this case, the registration document must clearly indicate the location of the area, indicating the system used to describe the coordinates, where the live pectinidae and/or live marine gastropods and/or live holothuroidea were harvested; or










(b)


with the requirements of point 2 of Chapter VI concerning the closing of all packages of live pectinidae, live marine gastropods and live holothuroidea dispatched for retail sale and Chapter VII concerning identification marking and labelling.’


















(f)


The following Chapter X is added:

                                             ‘CHAPTER X MODEL OF REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS










REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS, LIVE TUNICATES AND LIVE MARINE GASTROPODS






Part I – Supplier










I.1



IMSOC Reference number













I.2



Internal reference number















I.3



Supplier
Name
Address
Registration or Approval No
Country ISO Country code
Activity













I.4



Receiving food business operator
Name
Address
Registration or Approval No
Country ISO Country code
Activity















I.5



Description of goods

Aquaculture ☐ Natural Banks ☐
• CN code or FAO 3-Alpha code | species | quantity | package | 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☐
Relaying area
Duration of relaying
Date of starting
Date of end













I.7



From purification/dispatch centre

Auction hall Yes ☐
No☐


Purification/dispatch centre/auction hall approval number


Date of entry


Date of exit


Duration of purification
















I.8



From Intermediary operator

Yes ☐ No ☐


Name


Address


Registration or Approval No


Country


ISO Country code


Activity


Date of arrival


Date of exit







 











I.9



Declaration of the supplier
I, the undersigned food business operator responsible for dispatching the consignment declare that, to the best of my knowledge and belief, the information provided in Part I of this document is true and complete.








 


Date


Name of signatory


Signature





Part II – Receiving operator










II.1



Internal reference 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 signatory


Signature





Explanatory notes








Box




Description






Part I – Supplier

This part of the document shall be filled by the food business operator dispatching a batch of live bivalve molluscs.





I.1




IMSOC reference number

This is the unique alpha-numeric code assigned by the IMSOC





I.2




Internal reference number

This box may be used by the dispatching food business operator to indicate an internal reference number.





I.3




Supplier

Indicate the name and address (street, city and region/province/state, as appropriate), country and ISO country code of the establishment of origin. In the case of production areas, please indicate the area as authorised by the competent authorities (CAs). In the case of live pectinidae, marine gastropods or holothuroidea, indicate the location of the harvesting area.
Where applicable, indicate the registration or approval number of the establishment. Indicate the activity (gatherer, purification centre, dispatch centre, auction hall or intermediary activities).
Where the batch of live bivalve molluscs is sent from a purification centre/dispatch centre, or, in case of pectinidae, marine 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/state, as appropriate), country and ISO country code of the establishment of destination. In the case of production or relaying areas please indicate the area as authorised 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 intermediary activities).





I.5




Description of goods

Indicate 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 classification of the production area and its location or the approval number of the establishment, when applicable), date of starting and end of re-immersion (when applicable), place of re-immersion (indicate the classification 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 performed, the batch must refer to bivalves of the same species, harvested on the same day and coming from the same production area.
Delete as appropriate





I.6




From relaying area

Where the batch of live bivalve molluscs is sent from a relaying area, indicate the relaying area, as authorised by the CAs, and the duration of the relaying (date of starting and end).





I.7




From purification 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, marine gastropods and holothuroidea which are not filter feeders harvested outside classified production areas, from an auction hall, indicate the approval 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 dates on which the batch entered and left the purification centre. Delete as appropriate





I.8




From intermediary operator

Indicate the name and address (street, city and region/province/state, as appropriate), country and ISO country code of the intermediary operator.
Where applicable, indicate the registration or approval number and the activity.





1.9




Declaration of the supplier

Include the date, name of the signatory and the signature.





Part II – Receiving food business operator

This part of the document shall be filled by the food business operator receiving a batch of live bivalve molluscs.





II.1




Internal reference number (receiving)

This box may be used by the food business operator receiving the batch to indicate an internal reference 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 operator. In the case of an intermediary operator without premises indicate the date of purchase of the batch.
Include the name of the signatory and the signature.’


















(6)


Section VIII is amended as follows:






(a)


Chapter I is amended as follows:






(i)


Point 1 is replaced by the following:






‘1.


vessels used to harvest fishery products from their natural environment, or to handle or process them after harvesting, and reefer vessels comply 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 constructed so as not to cause contamination of the fishery products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances. Holds, tanks, or containers used for storing, cooling or freezing unprotected fishery products including those destined for the production of feed, shall not be used for other purposes than the storing, cooling or freezing those products, as well as ice or brine used for such purposes. In the case of reefer vessels, the provisions applicable to unprotected fishery products apply to all the products transported.’














(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 thermal arrest period as short as possible, so as to achieve a core temperature of not more than – 18 °C;










2.


have refrigeration equipment with sufficient capacity to maintain fishery products in the storage 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 reefer vessels
Reefer vessels transporting and/or storing frozen fishery products in bulk must have equipment meeting the requirements for freezer vessels laid down in point 2 of part C concerning their capacity to maintain the temperature.’
                                                         














(v)


In Part II, point 6 is replaced by the following






‘6.


Where fish are headed and/or gutted on board, such operations must be carried out hygienically as soon as possible after capture, and the fishery products must be washed immediately. The viscera and parts that may constitute a danger to public health must be removed as soon as possible and kept apart from fishery products intended for human consumption. Livers and roes intended for human consumption must be refrigerated or preserved under ice, at a temperature approaching that of melting ice, or be frozen.’














(vi)


in Part II, point 7 is replaced by the following:






‘7.


Where freezing in brine of the whole fish intended for canning is practiced, a temperature of not more than – 9 °C must be achieved for the fishery 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)


Chapter III is amended as follows:






(i)


In Part A, point 4.is replaced by the following:






‘4.


Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must ensure that melt water is drained away and does not remain in contact with any fishery products.’














(ii)


Part B is replaced by the following:






‘B.


REQUIREMENTS FOR FROZEN PRODUCTS
Establishments on land that freeze or store frozen fishery products must have equipment, adapted to the activity carried out, that satisfies the requirements for freezer vessels laid down in Section VIII, Chapter I part I.C, points 1 and 2 and.’
                                                         






















(7)


In Section XI, the following 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 Family of Helicidae, Hygromiidae or Sphincterochilidae, when intended for human consumption.










8.


The requirements laid down in points 1 to 5 also apply to frogs’ legs of the genus Pelophylax from the Family of Ranidae, and the genus Fejervarya,
Limnonectes and Hoplobatrachus from the Family of Dicroglossidae, when intended for human consumption.’














(8)


In Section XII, in Chapter II, point 5 is deleted.






(*)  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 consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products 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 spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).’
         

(*)  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 entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding 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).’
         

(*)  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).’
         

(*)  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).’
         ’