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EXPLANATORY MEMORANDUM

1.CONTEXT OF THE DELEGATED ACT

Regulation (EC) No 853/2004 of the European Parliament and of the Council 1 lays down specific rules on the hygiene of food of animal origin for food business operators. It empowers the Commission to adopt delegated acts amending Annexes II and III thereto.

Based on experience gained in the application of Regulation (EC) No 853/2004 and new scientific advice published by the European Food Safety Authority, it is proposed to amend Annexes II and III to that Regulation in order to:

·allow the stunning and bleeding on the farm of a limited number of ovine and caprine animals under certain conditions and amend the conditions for all ungulates;

·introduce specific requirements for dry-ageing of beef, subject to a transitional period;

·amend the transport conditions of carcases and certain cuts of domestic ungulates and harmonise the testing of the surface temperature of such meat;

·allow the transport of farmed game slaughtered on the farm, to be transported to a game handing establishment;

·introduce alternative options to demonstrate the effectiveness of heat treatments of milk;

·allow the flavouring of eggs under certain conditions.

It is also appropriate to use this opportunity to clarify certain requirements laid down in Annexes II and III to Regulation (EC) No 853/2004 in order to avoid any ambiguity, in particular as regards:

·the identification marking of products of animal origin;

·the certification requirements at the point of entry into the Union of certain meat of ungulates;

·the operation to slightly decrease the temperature for slicing fresh or processed fishery products or to increase the temperature of frozen fishery products and the prohibition to store or transport fishery products at that temporarily technologically-required temperature.

2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE DELEGATED REGULATION

Certain of the proposed amendments to Annexes II and III to Regulation (EC) No 853/2004 were requested by the competent authorities of Member States and certain private stakeholders' organisations. They have been discussed during meetings of the relevant expert group, representing the competent authorities of all Member States, and are largely supported by those experts.

In addition, private stakeholders’ organisations were consulted within the framework of the Advisory Group on the Food Chain and Animal and Plant Health.

Before adopting this Delegated Regulation, the Commission conducted public consultations in an open and transparent way in accordance with the procedures laid down in the Interinstitutional Agreement of 13 April 2016 between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making 2 .

3.LEGAL ELEMENTS OF THE DELEGATED ACT

The amendments to Annexes II and III to Regulation (EC) No 853/2004 should be made by a Delegated Regulation adopted pursuant to Article 10(1), second subparagraph, points (a), (c), (d), (e) and (f), of Regulation (EC) No 853/2004.

COMMISSION DELEGATED REGULATION (EU) …/...

of XXX

amending Annexes II and III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards specific hygiene requirements for certain fresh meat, fishery products, dairy products and eggs

(Text with EEA relevance)

THE EUROPEAN 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 3 , and in particular Article 10(1), second subparagraph, points (a), (c), (d), (e) and (f), thereof,

Whereas:

(1)Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. In particular, Annex II to that Regulation lays down requirements concerning several products of animal origin, and Annex III thereto lays down specific requirements. Section I of Annex II to Regulation (EC) No 853/2004 lays down requirements on the application of an identification mark to products of animal origin. Part B of Section I of Annex II to Regulation (EC) No 853/2004 refers to the European Community, instead of the European Union. Abbreviations of the identification mark which refer to the ‘European Union’ should therefore replace references to the ‘European Community’. However, such replacement creates a substantial administrative burden. A transitional period should therefore be provided for during which the products bearing an identification mark with the abbreviation for the ‘European Community’ before the end of the transitional period may remain on the market.

(2)In addition, clarification is needed on the link between the form of the identification mark required by (EC) No 853/2004, and the requirements for a special health or identification mark laid down for the control of certain animal diseases in Regulation (EU) 2016/429 of the European Parliament and of the Council 4 . Part B of Section I of Annex II to Regulation (EC) No 853/2004 should be amended to clarify which form should be applied in specific circumstances.

(3)Mobile slaughterhouses are increasingly used to avoid possible animal welfare issues during transport, for example, due to long transport times of animals reared in remote areas. Mobile slaughterhouses are subject to approval like any other slaughterhouse in accordance with Article 4(2) of Regulation (EC) No 853/2004. There is, however, a need to clarify how this approval should be applied, for example, in the case of cross-border activities of the mobile slaughterhouse or for the temporary interruption of a combination of different parts of the slaughterhouse. Approval of slaughterhouses is mainly based on compliance with requirements on the construction, layout and equipment of those slaughterhouses provided for in Chapter II of Sections I and II of Annex III to Regulation (EC) No 853/2004.

(4)Article 43(6) of Commission Implementing Regulation (EU) 2019/627 5 allows, in exceptional circumstances, that live animals may be moved to another slaughterhouse. Regulation (EC) No 853/2004 does not provide for this possibility. For consistency of Union legislation, Regulation (EC) No 853/2004 should be aligned in this respect with Implementing Regulation (EU) 2019/627. Chapter IV of Section I of Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.

(5)Regulation (EC) 853/2004 allows the stunning and bleeding of a limited number of certain ungulates on the farm subject to specific requirements including that the animals cannot be transported to the slaughterhouse to avoid any risk to the handler and to prevent any injuries to the animals during transport. This requirement limits this possibility for stunning and bleeding on the farm largely to extensively reared animals and excludes most animals regularly handled by farmers and therefore easily transported without risk. Based on the experience gained by food business operators and competent authorities and taking into account the increasing demand to prevent any animal welfare issue during transport, it is appropriate to extend that possibility to stun and bleed ungulates on the farm in accordance with specific requirements to ovine and caprine animals and other ungulates reared under any condition of housing.

(6)On 19 January 2023, the European Food Safety Authority published a Scientific Opinion on Microbiological Hazards of Aged Meat 6 (‘the EFSA Opinion’). The EFSA Opinion indicates that aged meat does not create a higher public health risk than fresh meat if certain requirements are complied with. Taking into account the increasing consumption of aged meat, it is appropriate to lay down specific requirements recommended in the EFSA Opinion in Regulation (EC) No 853/2004, in particular as regards dry-aged meat from bovine animals.

(7)Regulation (EC) No 853/2004 provides for alternative transport conditions for carcases, half carcases, quarters or half carcases cut into three wholesale cuts of ovine, caprine animals, bovine and porcine animals in Chapter VII of Section I of Annex III to Regulation (EC) No 853/2004. These transport conditions are based on the control of the surface temperature of the meat instead of its core temperature and need to comply with specific requirements.

(8)Based on the experience gained by food business operators and competent authorities, it is appropriate to amend those specific requirements laid down in Chapter VII of Section I of Annex III to Regulation (EC) No 853/2004 in particular to allow the collection of the meat from a cold store and a limited number of slaughterhouses, to allow the transport in the same compartment with more kinds of meat complying with final temperature requirements of such meat, and to provide additional temperature and time conditions for transport of carcases, half carcases, quarters or half carcases cut into three wholesale cuts of ovine, caprine animals and bovine animals during a maximum transport time on 30 hours.

(9)Different outcomes have been signalled by competent authorities on the measurement of the surface temperature when using different methods. It is therefore appropriate to lay down a reference method based on the experience gained by food business operators and technological developments while maintaining the possibility to use alternative methods.

(10)Section III of Annex III to Regulation (EC) No 853/2004 requires that farmed ratites and farmed ungulates slaughtered on the farm are to be transported to the slaughterhouse for further processing. Also, game-handling establishments have appropriate facilities to hygienically handle such farmed game slaughtered on the farm, they should also be authorised to receive and handle farmed ratites and farmed ungulates.

(11)Third countries exporting to the Union farmed game, domestic bovine, porcine and equine animals slaughtered at the holding of provenance must certify compliance with the requirements set out in Section III, point 3(j), of Annex III to Regulation (EC) 853/2004, using the model health certificate set out in Chapter 3 of Annex IV to Commission Implementing Regulation (EU) 2020/2235 7 . To avoid any ambiguity between the legal requirement laid down in Regulation (EC) No 853/2004 and the model health certificate set out in Implementing Regulation (EU) 2020/2235, the wording of the health certificate in both these Regulations needs to be fully consistent.

(12)In order to comply with the production requirements laid down in Chapter VII of Section VIII of Annex III to Regulation (EC) No 853/2004, the fishery product sector deploys machines that slice and can build the slices again by using automatically placed interleaving sheets. In this case, the fishery product is placed in a cold room to decrease or, in case of already frozen products, increase, the temperature to approximatively -7°C to -11°C for permitting the cutting or the slicing.

(13)To avoid abusive practices consisting in using such production requirements for storing fishery products at a temperature not in compliance with Chapter VII, point 2, of Section VIII of Annex III to Regulation (EC) 853/2004, the decreasing, or for already frozen products, the increasing, of temperature should be done as quickly as possible and the storage of fishery products at a temperature facilitating the cutting or slicing should be limited in time.

(14)Part I of Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 lays down health requirements for raw milk and colostrum production in herds of farmed animals from which the milk and colostrum are collected with a view to placing them on the market. Point 3 of that Part I provides that raw milk from cows, buffaloes, sheep or goats that do not come from herds free or officially free of brucellosis and tuberculosis are to undergo a heat treatment such as one to show a negative reaction to the alkaline phosphatase test. However, alkaline phosphatase testing is not a suitable method to verify heat treatment of raw milk from non-bovine species or raw milk separated in different fractions before being heat-treated in modern processing plants. Alternative options based on hazard analysis and critical control points (HACCP) principles laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council 8 should therefore be offered to food business operators to demonstrate the effectiveness of the heat treatment applied.

(15)Part II of Chapter II of Section IX of Annex III to Regulation (EC) No 853/2004 lays down the requirements for heat treatment for raw milk, colostrum, dairy or colostrum-based products. Point 1(a) of that Part II provides that pasteurised products must show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment. Owing to the unsuitability of alkaline phosphatase testing to verify heat treatment of raw milk from non-bovine species or raw milk separated in different fractions before being heat-treated, alternative options based on HACCP principles should also be offered to food business operators to demonstrate the effectiveness of the pasteurisation.

(16)Chapter I of Section X of Annex III to Regulation (EC) No 853/2004 lays down hygiene rules for the production of eggs and in particular provides that, at the producer's premises until sale to the consumer, eggs must be kept free of extraneous odour as such an odour may be indicative of an alteration of eggs which would render them unsuitable for direct consumption by the final consumer. However, where an extraneous odour has been intentionally applied to eggs by a food business operator in order to flavour them with particular tastes, the presence of such an odour does not mean that the eggs present a risk to the consumer. The placing on the market of eggs to which an odour has been applied intentionally should therefore be permitted, provided that such practice is not intended to hide the pre-existence of any foreign odour of the eggs.

(17)It is appropriate to provide food business operators with sufficient time to adapt to the new requirements on the dry-ageing of beef or to demonstrate to the satisfaction of the competent authorities the safety of alternative approaches. Therefore, these new requirements laid down in Chapter VII of Section I of Annex III to Regulation (EC) No 853/2004, as amended by this Regulation should apply 6 months from the date of entry into force of this Regulation.

(18)Therefore, Regulation (EC) No 853/2004 should be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and III to Regulation (EC) No 853/2004 are amended in accordance with the Annex to this Regulation.

Article 2

The identification mark on products of animal origin may continue to include the abbreviations of ‘European Community’ set out in Annex II, Section I, Part B, point 8, of Regulation (EC) No 853/2004 as it stood before the amendments made by this Regulation, until 31 December 2028, and the products of animal origin with such identification marks applied before that date may remain on the market.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Point (2)(c)(i) of the Annex, shall apply from … [6 months from the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Commission

The President
Ursula VON DER LEYEN

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ANNEX

Regulation (EC) No 853/2004 as amended as follows:

(1)Annex II is amended as follows:

(a) in Section I, Part B is amended as follows:

(i) point 8 is replaced by the following:

‘8. When applied in an establishment located within the Union, the mark must be oval in shape and include the abbreviation of European Union (‘EU’) in one of the official languages of the Union as follows: EC, EU, EL, UE, EE, AE, ES, EÚ.’

(ii) the following point is added:

‘8a. The requirements on the form of the identification mark in this Part B may be replaced by the requirements for a special health or identification mark in accordance with Article 65(1), point (h), of Regulation (EU) 2016/429 of the European Parliament and of the Council*, and the rules adopted in accordance with Articles 67, point (a) ,71(3) or (4), or 259(1) or (2) of that Regulation.

_______________________________________________

*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).’;

(2)Annex III is amended as follows:

(a)Section I is amended as follows:

(i)in Chapter II, the following point is added:

‘10. Mobile slaughterhouse shall not operate in a Member State unless the competent authority of each Member State where it operates, has approved them in accordance with Article 4.2 based at least on compliance with the requirements in this Chapter.

Mobile partial slaughtering facilities operating temporarily in cooperation with complementary permanent slaughtering facilities shall not operate unless the competent authority has approved the combination as a slaughterhouse in accordance with Article 4.2 based at least on compliance with the requirements in this Chapter. Such approval shall be reviewed after a period of one year of inactivity of the combination.’;

(ii) in Chapter IV, point 1 is replaced by the following:

‘1. After arrival at the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where required for welfare reasons, animals must be given a resting period before slaughter. Animals that are presented at a slaughterhouse for slaughter shall be slaughtered there and direct movements to another slaughterhouse may be allowed only in exceptional cases in accordance with Article 43(6), second subparagraph, of Regulation (EU) 2019/627.’;

(a)Chapter VIa is amended as follows:

(1)the heading is replaced by the following:

‘Chapter VIa: SLAUGHTER AT THE HOLDING OF PROVENANCE OF DOMESTIC BOVINE ANIMALS, OTHERS THAN BISONS, AND OVINE, CAPRINE AND PORCINE ANIMALS AND DOMESTIC SOLIPEDS OTHER THAN EMERGENCY SLAUGHTER’;

(2)the introductory phrase is replaced by the following:

‘Up to three domestic bovine animals, other than bisons, up to three domestic solipeds, up to six domestic porcine animals or up to nine ovine or caprine animals may be slaughtered at the same occasion at the holding of provenance, when authorised by the competent authority in accordance with the following requirements:’;

(iii) point (a) is deleted;

(b)Chapter VII is amended as follows:

(i) the following point is inserted after point 2:

‘ 2a.For the purposes of this point, ‘dry-ageing’ means the storage of fresh meat in aerobic conditions of hanging carcasses or cuts either unpacked or packed in bags permeable to water vapour in a refrigerated room or cabinet and left to age for several weeks at controlled environmental conditions of temperature, relative humidity and airflow.

Before placing on the market or freezing, bovine meat subject to dry-ageing must be stored at a surface temperature of −0,5 to 3,0°C, with a relative humidity of 75 to 85% and an airflow of 0,2 to 0,5 m/s in a dedicated room or cabinet for a maximum of 35 days. However, food business operators may apply other combinations of surface temperature, relative humidity, airflow and time, or do dry-ageing of meat of other species, if they demonstrate to the satisfaction of the competent authority that equivalent guarantees are provided on the safety of the meat.

In addition, the following specific measures must be applied:

(i) the meat shall not be loaded into the room or the cabinet until the temperature and relative humidity referred to in the second subparagraph have been achieved;

(ii) the meat must be hanged from the bone or, if using a shelf, sufficient perforation to facilitate air flow with regular turning using hygienic methods must be ensured;

(iii) a high airflow must be applied at the start of the dry-ageing process to facilitate early crust development and reduce the surface water activity;

(iv) the room or the cabinet and air conditioning refrigeration system components must be regularly cleaned and disinfected;

(v) calibrated thermometers, relative humidity probes and other equipment to accurately monitor and facilitate control of room or cabinet conditions must be used;

(vi) the air in contact with the beef must be filtered or UV treated;

(vii) the crust must be trimmed in a hygienic manner in a dedicated air controlled environment.’;

(ii) in point 3(b), (iv) to (viii) are replaced by the following:

‘(iv)per transport, the vehicle transporting the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts collects meat from a maximum of three slaughterhouse or from one cold store collecting directly from slaughterhouses; all the requirements laid down in this point (b) shall apply from the first loading of the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts in a slaughterhouse;

(v)carcases, half carcases, quarters, or half carcases cut into three wholesale cuts must have a core temperature of 15 degrees at the start of the transport if they are to be transported in the same compartment as meat which meets the temperature requirement set out in point 1 for offal and 7°C for other meat;

(vi)a declaration by the food business operator accompanies the consignment; that declaration must state the duration of chilling before loading, the time at which loading of the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts was started, the surface temperature at that time, the maximum transportation air temperature to which the carcases, half carcases, quarters, or half carcases cut into three wholesale cuts may be subjected, the maximum transport time permitted, the date of authorisation and the name of the competent authority authorising the transport in accordance with point (ii);

(vii)the food business operator of destination must notify the competent authority before receiving for the first time carcases, half carcases, quarters, or half carcases cut into three wholesale cuts, not attaining the temperature referred to in point 1 before transport;

(viii)the meat must be transported in accordance with the following parameters:

–For a maximum transport time1 of six hours:

Species	Surface temperature2	Maximum time to chill to surface temperature3	Maximum transportation air temperature4	Maximum daily mean carcase aerobic colony count5
Ovine and caprine animals	7°C	8 hours	6°C	log10 3,5 cfu/cm2
Bovine animals		20 hours		log10 3,5 cfu/cm2
Porcine animals		16 hours		log10 4 cfu/cm2

The maximum transport time may be extended to 30 hours if a core temperature below 15°C is reached before the start of the transport.

–For a maximum transport time1 of 60 hours:

Species	Surface temperature2	Maximum time to chill to surface temperature3	Core temperature6	Maximum transportation air temperature4	Maximum daily mean carcase aerobic colony count5
Ovine and caprine animals	4°C	12 hours	15°C	3°C	log10 3 cfu/cm2
Bovine animals		24 hours

(ix)methods for measuring the surface temperature shall be validated and the following method shall be used as reference method:

a thermometer calibrated in accordance with the latest version of ISO 13485shall be used;

the sensor shall be penetrated perpendicularly in the thickest part at a depth of 0,5 to 1 cm of the external part of:

(a)the shoulder; or

(b)the leg for bovine, ovine and caprine animals or of the ham, or the internal surface of the ham in the middle upper part for porcine animals;

five temperature measurements shall be carried out as follows:

at least one of the five measurements must be below the surface temperature requirements laid down in point (viii).’;

(c)in Section II, in Chapter II, the following point is added:

‘8. Mobile slaughterhouse shall not operate in a Member State unless the competent authority of each Member State where it operates, has approved them in accordance with Article 4.2 based at least on compliance with the requirements in this Chapter.

(d)in Section III, point 3 (h)(i) and (j) are replaced by the following:

‘(h) slaughtered and bled animals are transported to the slaughterhouse or to a game-handling establishment hygienically and without undue delay; if transport takes more than two hours, the animals must be refrigerated; where climatic conditions so permit, active chilling is not necessary; evisceration may take place on the spot, under the supervision of the official veterinarian;

(i) a declaration by the food business operator who reared the animals, stating their identity and indicating any veterinary products or other treatments administered, dates of administration and withdrawal periods, accompanies the slaughtered animals to the slaughterhouse or the game-handling establishment;

and

(j) the health certificate set out in Chapter 3 of Annex IV to 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 to a game-handling establishment, or was sent in advance in any format.’;

(e)in Section VIII, in Chapter VII, the following point is added:

‘4. In the case that the temperature of fresh or processed fishery products needs to be temporarily decreased, or in the case that the temperature of frozen fishery products needs to be temporarily increased, to a temperature higher than -18°C to permit the use of machines that slice or cut fishery products, the change of temperature to reach that required for the cutting or slicing of fishery products, and the subsequent return to the storage temperature of the fishery products, shall be as short as possible. The total time of the operation of cutting or slicing at the technologically-required temperature shall not exceed 96 hours. Storage or transportation of fishery products at that temperature shall not be allowed.’;

(f)Section IX is amended as follows:

(i) in Chapter I, in Part I, point 3 is replaced by the following:

‘3. However, raw milk or colostrum from animals that does not meet the requirements set out in point 2 may be used with the authorisation of the competent authority:

(a)in the case of cows, buffaloes, sheep or goats or females from other species that do not show a positive reaction to tests for tuberculosis or brucellosis, nor any symptoms of these diseases, and in the case of sheep or goats which have been vaccinated against brucellosis as part of an approved eradication programme and do not show any symptom of that disease, after having undergone a heat treatment such as to show, where applicable, a negative reaction to the alkaline phosphatase test or otherwise treated to ensure its safety. When the alkaline phosphatase test is not suitable to demonstrate the effectiveness of the heat treatment applied, such as situations where raw milk is produced from non-bovine species or separated in different fractions before being heat-treated, food business operators shall be able to provide the competent authority with the necessary assurances and keep associated records as part of their procedures based on hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004 ;

(b) in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been vaccinated against brucellosis as part of an approved eradication programme, and which do not show any symptom of that disease, for the manufacture of cheese with a maturation period of at least two months.’;

(ii) in Chapter II, in Part II, point 1(a) is replaced by the following:

‘(a) Pasteurisation is achieved by a treatment involving:

(i) a high temperature for a short time: at least 72 oC for 15 seconds;

(ii) a low temperature for a long time: at least 63 oC for 30 minutes; or

(iii) any other combination of time-temperature conditions to obtain an equivalent effect.

The treatment referred to in (i), (ii) and (iii) shall ensure that the products show, where applicable, a negative reaction to an alkaline phosphatase test immediately after such treatment When the alkaline phosphatase test is not suitable to demonstrate the effectiveness of the pasteurisation, such as situations where products are derived from non-bovine species or separated in different fractions before being pasteurised, food business operators shall be able to provide the competent authority with the necessary assurances and keep associated records as part of their procedures based on hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004.’;

(g)in Section X, in Chapter I, point 1 is replaced by the following:

‘1. At the producer's premises, and until sale to the consumer, eggs must be kept clean, dry, free of unintended extraneous odour, effectively protected from shocks and out of direct sunshine. Any intentional application of extraneous odour to eggs must not be aimed at hiding a pre-existing extraneous odour.’.

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