COMMISSION DELEGATED REGULATION (EU) 2020/692

of 30 January 2020

supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products 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 (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’) (1), and in particular Articles 234(2), 237(4) and 239(2) thereof,

Whereas:

(1) Union legislation in the area of animal health was recently updated by the adoption of the ‘Animal Health Law’. That Regulation, which came into force on 20 April 2016, and which applies from 21 April 2021, repealed and replaced around 40 basic acts. It also requires the adoption of many Commission delegated and implementing regulations to repeal and replace around 400 Commission acts that existed in the area of animal health before the new legal framework established by the ‘Animal Health Law’.

(2) Trading conditions have evolved since the adoption of the first animal health rules at Union level, with the volume of trade in animals, germinal products and products of animal origin increasing significantly, both within the Union and with third countries. During the same period, as a result of Union animal health policies and rules, certain diseases have been eradicated in the Union and other diseases have been prevented or controlled in many Member States. However, on several occasions, emerging diseases have posed new challenges for the Union animal health status, trade and the local economy in the areas affected by those diseases.

(3) The rules laid down in this act, supplement those already laid down in the ‘Animal Health Law’. They should provide the necessary guarantees to ensure that consignments of animals, germinal products and products of animal origin entering the Union do not present an animal health risk for kept and wild animals that could jeopardise the Union health status as regards animal diseases and have a detrimental economic impact on the sectors involved.

(4) Article 234 of the ‘Animal Health Law’ provides that pending the adoption of delegated acts laying down animal health requirements as regards a particular species and category of animal, germinal product or product of animal origin, Member States may, following evaluation of the risks involved, apply national rules if they comply with certain requirements laid down in that Regulation. Therefore, the entry into the Union of species and categories of animals, germinal products and products of animal origin not covered by this Regulation may be subject to such national rules applied by Member States.

(5) The existing animal health rules, laid down in previous Commission acts concerning the entry into the Union of animals, germinal products and products of animal origin have proved to be effective, therefore the aim and substance of those existing rules should be maintained in this Regulation, but updated to take account of the rules on better regulation, of the new animal health framework laid down in the ‘Animal Health Law’ and of newly available scientific knowledge, international standards and experience in applying previous Union acts.

(6) To avoid unnecessary trade disruptions, the animal health requirements for entry into the Union of consignments falling within the scope of this Regulation should ensure a smooth transition from the requirements laid down in pre-existing Union acts.

(7) The ‘Animal Health Law’ lays down rules for the prevention and control of animal diseases transmissible to animals or to humans. In particular, Chapter 1 of Part V of that Regulation, which lays down the animal health requirements for entry into the Union of consignments of animals, germinal products and products of animal origin, provides for the Commission to adopt delegated acts to supplement the animal health requirements already laid down in it.

(8) Article 229(1) of the ‘Animal Health Law’ lays down the requirements under which Member States are to permit the entry into the Union of consignments of animals, germinal products and products of animal origin. The requirements cover conditions concerning the third country or territory of origin, the establishment of origin, the animal health requirements that those consignments are required to comply with, as well as the animal health certificate, declarations or other document that should accompany such consignments.

(9) In addition, Article 234(1) of the ‘Animal Health Law’ stipulates that the animal health requirements for entry into the Union of consignments of species and categories of animals, germinal products and products of animal origin from third countries or territories or zones thereof must be at least as stringent as those laid down in that Regulation, and in delegated acts adopted pursuant to it, applicable to movements within the Union of those species and categories of those commodities. If the requirements are not as stringent as those in the Regulation, they must offer equivalent guarantees to the animal health requirements provided for in Part IV of that Regulation.

(10) Article 234(2) of the ‘Animal Health Law’ provides for delegated acts to be adopted to supplement the rules laid down in that Regulation, as regards the animal health requirements for entry into the Union of species and categories of animals, germinal products and products of animal origin from third countries and territories, and for the movement within the Union and handling of those commodities after their entry into the Union, in order to mitigate the possible risks involved.

(11) Article 237(1) of the ‘Animal Health Law’ provides that Member States are only to permit the entry into the Union of consignments of animals, germinal products and products of animal origin if such consignments are accompanied by the animal health certificates and the declarations or other documents required under that Regulation. Article 237(2) of that Regulation stipulates that the animal health certificate must have been verified and signed by an official veterinarian in the third country or territory of origin. In this context, Article 237(4) of the ‘Animal Health Law’ provides for the Commission to adopt delegated acts concerning derogations from the animal health certificate requirements laid down in Article 237(1) and Article 237(2) of that Regulation, and to lay down rules requiring such consignments to be accompanied by declarations or other documents.

(12) Article 239(2) of the ‘Animal Health Law’ provides for the Commission to adopt delegated acts concerning special rules and additional requirements for certain specific types of entry into the Union of consignments of animals, germinal products and products of animal origin, and provides for derogations from the general animal health requirements laid down in Articles 229(1) and 237(1) of that Regulation, and in the supplementing rules laid down in delegated acts adopted pursuant to Articles 234(2) and 237(4) thereof.

(13) The supplementing rules to be laid down in this Regulation pursuant to Articles 234(2) and 239(2) of the ‘Animal Health Law’ are interrelated. Article 234(2) provides for the Commission to lay down the general requirements for entry into the Union of consignments of animals, germinal products and products of animal origin, while Article 239(2) provides for the Commission to lay down the special rules and additional requirements for derogations from those general requirements.

(14) The animal health certificate requirements provided for in Article 237 of the ‘Animal Health Law’ are part of the framework of rules relating to the entry into the Union of consignments of animals, germinal products and products of animal origin. The empowerment granted to the Commission under Article 237(4) of that Regulation to grant derogations from the animal health requirements is part of that general framework of rules.

(15) The ‘Animal Health Law’ already provides a number of definitions. In addition, this Regulation should also have regard to the definitions laid down in other Union acts in the related areas of food hygiene and official controls, such as the definitions laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council (2). However, for the purpose of laying down the animal health requirements for entry into the Union of animals, germinal products and products of animal origin it is appropriate to include particular definitions, including definitions for certain categories of animals, germinal products and products of animal origin. These definitions are needed to clarify which categories of animals, germinal products and products of animal origin represent an animal health risk and are therefore subject to the animal health requirements for entry into the Union.

(16) In the interests of consistency of Union legislation, and based on the animal health risk they represent, the definition for ‘fresh meat’ for the purpose of this Regulation should incorporate the definitions for ‘fresh meat’, ‘minced meat’ and ‘meat preparations’ laid down in Annex I to Regulation (EC) No 853/2004.

(17) In addition, the definition for ‘meat products’ for the purpose of this Regulation should incorporate the definitions for ‘meat products’, ‘treated stomachs’, ‘bladders’, ‘intestines’, ‘rendered animal fats’ and ‘meat extracts’ laid down in Regulation (EC) No 853/2004. This is because from an animal health point of view, all of those commodities represent the same animal health risk and should be subjected to the same risk-mitigating measures.

(18) The definition for ‘carcase’ laid down in Regulation (EC) No 853/2004 should be adapted to define ‘carcase of an ungulate’ in order to differentiate it from ‘offal’. This is because those two commodities represent different animal health risks, with ‘offal’ representing a higher risk.

(19) ‘Casings’ should be defined in this Regulation and that definition should take into account the definition included in the glossary of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE). The definition should clarify which products of animal origin must be considered as casings and therefore undergo the specific risk-mitigating treatments provided for in this Regulation.

(20) Article 229(1) of the ‘Animal Health Law’ provides that consignments of animals, germinal products and products of animal origin are only to be permitted to enter into the Union if they come from third countries or territories listed for entry into the Union of the particular species and category of animals, germinal products or products of animal origin, in accordance with the criteria laid down in Article 230(1), and if the consignments comply with the animal health requirements provided for in Article 234 and subsequent delegated acts. This Regulation should make it the responsibility of the competent authority to verify that such consignments entering the Union comply with those requirements.

(21) Article 237(1) the ‘Animal Health Law’ provides that the entry into the Union of consignments of species and categories of animals, germinal products and products of animal origin from third countries or territories is only to be permitted where those consignments are accompanied either by an animal health certificate, issued by the competent authority of the third country or territory, or by declarations or other documents, or by all of those documents. This Regulation should, therefore, clarify which documents are required in each case and should make it the responsibility of the competent authority to verify that such consignments entering the Union comply with that general requirement.

(22) The information to be contained in the animal health certificates, declarations and other documents accompanying consignments of animals, germinal products and products of animal origin must accurately reflect whether or not those consignments comply with the general requirements provided for in the ‘Animal Health Law’ and the relevant requirements laid down in this Regulation. This Regulation should, therefore, lay down the obligations for operators responsible for entry into the Union of such consignments and for the competent authorities of the Member State of entry into the Union, as regards the validity of the documents accompanying the consignments and the eligibility of such consignments to enter the Union.

(23) Taking into account animal health risks such as incubation periods for diseases, and in order to avoid the misuse of animal health certificates, it is necessary to establish a time limit for the validity of those certificates only in the case of animals and hatching eggs. This is because these pose a higher animal health risk than products of animal origin, which may have undergone risk-mitigating measures, and germinal products which are transported frozen in closed and sealed containers. However, as the transport by sea of live animals and hatching eggs may take long time, the validity period of the certificate in this case should be extended provided that certain risk-mitigating measures have been taken.

(24) The animal health requirements that need to be complied with, and the guarantees to be provided by third countries and territories, for entry into the Union of consignments of animals, germinal products and products of animal origin depend on the diseases listed in Article 5 and in Annex II to the ‘Animal Health Law’ and their categorisation as provided for in Article 9(1) of that Regulation and in the Annex to Commission Implementing Regulation (EU) 2018/1882 (3). That Regulation lays down the definitions of category A, B, C, D and E diseases and states that the disease prevention and control rules for the listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 are to be applied to listed species and groups of listed species referred to in its Annex.

(25) Chapter 1 of Part II of the ‘Animal Health Law’ lays down the rules on disease notification and reporting to ensure early detection and effective disease control in the Union. This Regulation should specify the details on the notification and reporting systems to be in place in the third countries or territories to guarantee equivalent systems to those implemented in the Union, including the diseases that should be notifiable and reportable. In this sense, while live animals can transmit the diseases for which they are a listed species in Implementing Regulation (EU) 2018/1882, not all products of animal origin and germinal products obtained from those animals can transmit all those diseases. This Regulation should clarify which are the animal diseases of concern and therefore notifiable and reportable for each particular species and category of animals, germinal products and products of animal origin intended for entry into the Union.

(26) The animal health requirements laid down in this Regulation should be based on different levels of protection from the animal health risks. The different requirements vary depending on whether they relate to a third country of origin, to a territory of origin, to a zone within that third country or territory, to a compartment within that third country or territory in the case of aquaculture animals, to the establishment of origin of the animals or the products of animal origin, or to the establishment or centre for collection of germinal products.

(27) Disease surveillance and traceability in the establishments are key elements of the disease control policy in the Union. This Regulation should include certain basic requirements on traceability and animal health visits in the establishments of origin of the animals intended for entry into the Union, and in the establishment of origin of the animals from which the germinal products and products of animal origin intended for entry into the Union were obtained. These requirements should be equivalent to those laid down in Regulation (EU) 2016/429, and in delegated and implementing acts adopted pursuant to that Regulation.

(28) Furthermore, where a certain type of establishment keeping animals or germinal products in a third country or territory poses a particular animal health risk, it should obtain specific approval by the competent authority in the third country or territory in order to export to the Union, providing equivalent guarantees as those provided in Articles 92 to 100 of Regulation (EU) 2016/429 for certain establishments in the Union.

(29) Consignments of animals, germinal products and products of animal origin intended for entry into the Union should not be considered as representing an animal health risk in their country or territory of origin and should not be subject to national eradication programmes or any other national restrictions based on animal health concerns.

(30) The animal health requirements for entry into the Union of consignments of animals, germinal products and products of animal origin must provide effective protection against the introduction and spread of transmissible animal diseases in the Union. The entry into the Union of those consignments should not be permitted from third countries or territories or zones or in the case of aquaculture animals, compartments thereof, infected with certain listed diseases for which the Union has disease-free status, and which consequently present a serious risk for the health of animals within the Union.

(31) It is for the Union to assess whether a third country, territory or zone or, in the case of aquaculture animals, compartment of origin is free from a specific disease. The Union’s assessment should be based on information related to disease surveillance provided by the competent authority of the third country or territory, and taking into account Union animal health rules as provided for in Part II of the ‘Animal Health Law’ and Commission Delegated Regulation (EU) 2020/689 (4). Specific conditions for certain diseases and circumstances may be required as additional risk-mitigating measures.

(32) The freedom from a particular disease of a third country or territory or zone thereof must be based on internationally recognised diagnostic tests and methods performed under the same standards and procedures as those applied within the Union.

(33) It is necessary to ensure that the health status of animals, germinal products and products of animal origin intended for entry into the Union complies with the guarantees provided by the third country, territory or zone of origin. This Regulation should therefore provide for a minimum residency period for animals in the third country, territory, zone or establishment of origin, and a minimum period without contact with commodities of a lower health status, before being dispatched to the Union. The length of the minimum period of residency should take into account the incubation period of relevant diseases, and the intended destination and use of the animals, germinal products and products of animal origin.

(34) In the case of dogs, cats and ferrets, the residency period is unnecessary as vaccination against rabies, the disease of greatest concern for those species, is required in all cases. Registered horses intended for competitions, races and equestrian cultural events should also be exempted from certain requirements as regards the residency period, if they comply with additional guarantees. This exemption is based on the expectation that such horses will have a high level of health.

(35) The health status of animals, germinal products and products of animal origin intended for entry into the Union may be jeopardised during transport from the place of origin to the place of entry into the Union if they enter into contact with animals or products not complying with the same requirements or if they transit through third countries, territories or zones with a lower health status than the country or territory of origin or zone thereof. Therefore certain preventive measures should be applied in order to preserve their health status.

(36) To ensure that only healthy animals are dispatched to the Union, animals in consignments should undergo an clinical inspection carried out by an official veterinarian before they are dispatched. The time frame for performing this inspection should be adapted for certain species and their inherent risk.

(37) Terrestrial animals, hatching eggs and aquatic animals intended for entry into the Union should only be transported through, or unloaded in, third countries, territories or zones also listed for entry into the Union of the same species and categories of animals and hatching eggs. Those countries, territories or zones’ inclusion on the list indicates that they provide equivalent animal health guarantees as the third country or territory of origin or zone thereof.

(38) The transport of terrestrial animals and hatching eggs by means of aircraft or vessel could encounter unforeseen events such as mechanical problems in the means of transport, strikes in airports and seaports or unforeseen delays. It is therefore appropriate to provide for derogations in those cases where guarantees can be given. This will allow the transport of the terrestrial animals and hatching eggs to the Union to continue, while ensuring the health status of those commodities and preventing additional animal health risks.

(39) In the case of equine animals, as transhipments and stopovers in non-listed countries are part of the usual transport operations, they should be allowed under certain preventive measures.

(40) Cleaning and disinfection of means of transport is a key activity to prevent the risk of spreading animal diseases. When transporting consignments of live animals destined for the Union, cleaning and disinfection of means of transport should be carried out immediately before the loading of the animals for their dispatch to the Union.

(41) Assembly operations of animals in third countries or territories of origin may pose an additional risk to the health status of animals intended for entry into the Union, as a result of the animals mixing with and coming into contact with animals of different origins. Therefore, the number, duration of such operations and species allowed to undergo them should be limited to a minimum and to those species with reliable traceability systems.

(42) In addition to general animal health requirements, it is necessary to provide specific requirements taking into account the animal health risks linked to the different species and categories of terrestrial animals falling within the scope of this Regulation.

(43) Different species of ungulates, as defined in the ‘Animal Health Law’, are listed as susceptible species for different listed diseases in Implementing Regulation (EU) 2018/1882. Listed diseases are also set out in different categories for different species of ungulates in the same Regulation. Therefore this Regulation should clearly establish the specific requirements and guarantees in relation to listed diseases for the different species and categories of ungulates.

(44) To prevent the occurrence of category A diseases, from which the Union is considered free, the general requirement for the third country or territory of origin or zone thereof of ungulates should be an equivalent freedom from disease for a period of time that guarantees that the entry of animals from the third country, territory or zone does not jeopardise the Union’s disease freedom. For category B diseases, for which the Union has compulsory eradication programmes, this Regulation should provide for risk-mitigating measures where the third country or territory of origin is not completely free of such diseases.

(45) Where consignments of ungulates are intended for entry into Member States which are officially disease-free, or which have an approved eradication programme for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea or infection with Aujeszky’s disease virus, those consignments should comply with additional requirements to ensure that the animals do not jeopardise the health status of those specific Member States as regards those diseases.

(46) Special rules as regards the third country or territory of origin and additional animal health requirements should apply where ungulates originate from a confined establishment and are intended for entry into a confined establishment in the Union. The special rules should take into account the specificity of those confined establishments and the specific conditions they comply with in order to be approved by the competent authority of the third country or territory of origin and by the competent authority of the Member States of destination.

(47) The confined establishment of origin could be located in a third country or territory which is not listed for entry into the Union of the specific species of ungulates. However, the national legislation and the veterinary services of the third country or territory will need to have been assessed. In addition, the establishment of origin should comply with additional requirements as regards disease surveillance, veterinary supervision, record keeping and operations. To ensure that those guarantees can be provided, this Regulation should lay down specific conditions for the approval of those confined establishments by the competent authority in the third country or territory. A list of such confined establishments should be drawn up by the Member State of destination, following the favourable outcome of a risk assessment by the competent authority in that Member State of all relevant information provided by the establishment as regards the animal health risks involved.

(48) Specific animal health requirements should apply for entry into the Union of poultry and captive birds to address the particular risks posed by the relevant listed diseases for those animals. These requirements should take account of the category, species and intended use of poultry and captive birds, and provide effective protection against the spread into the Union of diseases of concern from third countries or territories.

(49) To facilitate the trade of consignments of small amounts of poultry, specific requirements and derogations should be established for consignments with less than 20 heads of poultry other than ratites.

(50) Taking into account the activities and animal health risks associated with captive birds, consignments of those animals should only be permitted to enter the Union if they come from establishments approved by the competent authorities in the third country or territory of origin of the captive birds or zone thereof. The captive birds should be quarantined upon their arrival in the Union in order to confirm the absence of any disease of concern.

(51) In addition, where consignments of birds and hatching eggs are intended for Member States with status free from infection with Newcastle disease virus without vaccination, such consignments should comply with additional requirements to ensure that those consignments do not jeopardise the health status for that disease of those specific Member States.

(52) The infestation with the small hive beetle (Aethina tumida) is one of the diseases of most concern for bees. It is largely exotic to the Union but has spread globally in recent decades, creating serious problems for the apiculture industry and potentially also affecting bumble bees. Tropilaelaps mites (Tropilaelaps spp.) are potentially devastating pathogens of honeybees. They are also exotic to the Union. Effective and safe treatments against these diseases are at present not available. If these diseases entered the Union by entering consignments, they would pose a risk to the sustainability of the apiculture sector and beyond, potentially affecting agriculture and the environment which benefits from pollination services by kept and wild bees.

(53) American foulbrood occasionally occurs in the Union but is controlled with regard to trade of honeybees, while certain areas in the Union have been recognised as free of Varroa mites and protected by additional trade guarantees to keep places of destination in the Union safe. Rules at Union level have been and remain essential to mitigate the risk of entry into the Union of the above pathogens as associated with consignments of honeybees and bumble bees. Therefore such rules should be laid down in this Regulation.

(54) Only queen honeybees without a brood and accompanied by a small number of attendants in single queen cages can be easily checked for infestation with small hive beetle or with Tropilaelaps mites, therefore the entry into the Union of honeybees should be limited to such consignments.

(55) Colonies of bumble bees bred and reared in environmentally isolated establishments are often traded for the horticultural industry. Given the commonly used facilities, procedures and closed containers used for the shipped colonies, the entry into the Union of bumble bees (Bombus spp.) should be permitted only for colonies that are bred, reared and packaged solely under environmentally controlled conditions in establishments and which can be checked to ensure that they are free of the small hive beetle.

(56) Because of its potential effects on humans and animals, rabies is the listed disease of most concern in the Union affecting dogs, cats and ferrets. Member States are therefore required to carry out a compulsory eradication programme against rabies infection in accordance with Delegated Regulation (EU) 2020/689. To prevent any possibility of rabies being introduced into the Union, vaccination should be required for all consignments of dogs, cats and ferrets entering it, taking into account the availability and effectiveness of existing vaccines against the disease.

(57) Dogs intended for entry into a Member State with disease-free status or with an approved eradication programme for Echinococcus multilocularis should comply with additional requirements to ensure the protection of that status in those Member States. In this regard, a preventive treatment should be applied to such dogs before they enter the Union. However, where dogs, cats and ferrets are intended for a confined establishment in the Union, special rules as regards rabies and infestation with Echinococcus multilocularis and additional animal health requirements should apply, taking into account the specificity of such establishments’ activities and the specific conditions under which animals are kept in them.

(58) Germinal products may pose a significant risk for the spread of animal diseases. This is particularly true for semen, but also to a less extent to oocytes and embryos. As germinal products are collected or produced from a limited number of donors but used widely in the general animal population they can, if not handled properly or not classified with the correct health status, be a source of diseases for many animals. Such cases have occurred in the past and have caused substantial economic losses. Therefore, animal health requirements need to be put in place for entry into the Union of germinal products of certain kept terrestrial animals.

(59) The requirements for entry into the Union of germinal products of ungulates should be based on the requirements for entry into the Union of live animals.

(60) Specific requirements for germinal product establishments where germinal products of ungulates eligible for entry into the Union are collected, produced, processed and stored should reflect those established for the movements within the Union. The same approach applies to the traceability and animal health requirements for germinal products.

(61) Due to the need to move germinal products from confined establishments located in third countries to confined establishments located in the Union, this Regulation should lay down special traceability and animal health requirements for such entry.

(62) Animal health requirements for entry into the Union of hatching eggs should address the risks as regards listed diseases that the different categories of hatching eggs could introduce into the Union. Therefore such requirements should correspond to those for entry into the Union of the respective species or categories of birds.

(63) Where hatching eggs of poultry are intended for entry into Member States with status-free from infection with Newcastle disease virus without vaccination, the eggs should comply with additional requirements to ensure that they do not jeopardise the status of those specific Member States.

(64) Products of animal origin can transmit disease agents to animals and products. The animal health risk linked to fresh and raw products of animal origin is obviously higher that those that have been processed and treated. Therefore the animal health requirements for the third country or territory of origin of fresh meat, raw milk, colostrum and colostrum-based products should be stricter than those for meat products and dairy products. However, the treatment applied to those treated products needs to be effective in order to mitigate the risk they pose depending on the species of origin of the product and the country or territory of origin.

(65) The risk-mitigating treatments applicable for products of animal origin originating in restricted zones established in the event of confirmation of category A diseases in the Union are laid down in Commission Delegated Regulation (EU) 2020/687 (5), based on the available scientific knowledge and experience gained in the application of previous legislation. Therefore, the same risk-mitigating treatments should apply to those products originating in third countries, territories or zones thereof posing an equivalent animal health risk.

(66) The risks linked to fresh meat entering the Union should be mitigated by requirements on the freedom from diseases of the third country or territory of origin and by requirements on animal diseases for the live animals from which the meat is obtained, on the dispatch of the kept animals to slaughter, on slaughter and killing operations, and on handling and preparation operations.

(67) Fresh meat of terrestrial animals can be obtained from kept animals, including farmed game as defined in Regulation (EC) No 853/2004, and from wild animals. However, in the Union, meat obtained from animals kept as production animals, particularly, animals belonging to the species Bos taurus, Capra hirchus, Ovis aries and Sus scrofa, must be obtained in a slaughterhouse. To provide adequate and equivalent guarantees, it is therefore appropriate to exclude those species from the possibility to be categorised as farmed game or wild animals when fresh meat intended for entry into the Union originates from them.

(68) When an outbreak of a relevant animal disease occurs in a third country or territory, the date and location of slaughter of kept animals or the date of killing of wild animals or farmed game are key to establishing the possible animal health risks associated with those animals and products of animal origin obtained from them. Therefore, the date of slaughter or killing needs to be established, in order to verify that the animals have been slaughtered or killed in a period of time without outbreaks of disease and when the third country or territory was listed as being authorised to enter fresh meat into the Union.

(69) The type of treatment to be applied to products of animal origin should be in line with the risk posed by the third country or territory or zone thereof manufacturing the product. Entry into the Union of processed products of animal origin which have undergone treatments whose effectiveness in eliminating the risks linked to the listed diseases of concern for the particular category of product of animal origin has not been proven, should only be authorised from third countries or territories or zones thereof that provide all guarantees of freedom from the relevant diseases. For third countries or territories or zones thereof that do not provide all those guarantees, the entry into the Union of products of animal origin should be permitted only if those products have undergone a specific treatment.

(70) In some cases, a third country or territory or zone thereof will source raw meat to produce meat products from a third country or territory or zone thereof listed for entry into the Union of meat products of the relevant species subject to a specific treatment. In such cases, the meat product should always undergo the most severe specific treatment in order to mitigate all possible animal health risks.

(71) Meat products containing poultry meat from a third country or territory or zone thereof where there has been an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus should undergo a treatment that is effective at mitigating the risk in the third country or territory or zone thereof listed for entry into the Union. In this way, trade can be allowed to continue before measures for control such as regionalisation are implemented. The immediate application of a risk-mitigating treatment after an outbreak decreases the animal health risks and at the same time reduces the impact on trade.

(72) When meat products are manufactured from fresh meat from different species the treatment applied should eliminate any possible animal health risks. Therefore, if the treatment is applied before mixing, the different types of fresh meat should receive the relevant treatment assigned to the species of origin of the fresh meat. However, if the treatment is applied after mixing, the final meat product should undergo the treatment assigned to the fresh meat ingredient with the highest animal health risk.

(73) Treatments to mitigate specific animal health risks linked to the entry of casings should be reviewed and updated taking into account the conclusions and recommendations of the latest scientific evidence assessed by the European Food Safety Authority (EFSA) Panel on Animal Health and Welfare (6).

(74) The conditions for entry into the Union of raw milk, dairy products, colostrum and colostrum-based products are based on the animal health risks represented by these products. Such risks are linked to the country or territory of origin or zone thereof and to the species of animals from which they were obtained. Foot and mouth disease and infection with rinderpest virus are the two diseases of concern in the case of milk and colostrum, therefore raw milk and colostrum should only enter from third countries or territories or zones thereof which are free from those diseases. Colostrum-based products should also only originate from those third countries, territories or zones as there are no scientific-based risk-mitigating treatments to ensure the destruction of the disease agent in that category of products.

(75) For milk obtained from Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius, the risk related to foot and mouth disease can be mitigated with the application of well-known specific risk-mitigating treatments. However, as the effectiveness of certain of those treatments for dairy products from animal species other than Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius cannot be ensured, they should undergo the most severe risk-mitigating treatment.

(76) Treatments for products of animal origin should always be carried out in the third country or territory of origin or zone thereof listed for entry of those products into the Union.

(77) Aquatic animals of listed species are sometimes transported by sea in vessels, including well-boats which may exchange water during the journey. In such cases, in addition to a health certificate, the animals should also be accompanied by a declaration signed by the master of the vessel outlining details of the ports of origin and destination and of any other ports visited during the journey. This declaration should confirm that the animals of listed species on board the vessel have not been exposed to any conditions that could have altered their health status during the journey to their final destination.

(78) Aquatic animals may enter the Union for many different purposes. Given the disease risk associated with the movement of live animals, such animals entering the Union for human consumption should be treated in the same way as if they were entering the Union for other purposes such as farming or release into the wild. Products of animal origin from aquatic animals other than live aquatic animals represent a lower risk than aquatic animals, and the measures to be taken in relation to such products entering the Union for further processing, are therefore, less rigorous than those which apply to live animals.

(79) Releasing aquatic animals into the wild in natural waters is a high-risk activity if those animals are infected with a listed disease. For that reason, for category A and B diseases specifically, the third country or territory of origin or zone or compartment thereof should be free of those diseases when aquatic animals are intended for release into the wild in natural waters of the Union. In addition, aquatic animals brought into the Union to be released into the wild in natural waters should in all cases, originate from a third country or territory or zone or compartment declared free of a category C disease even when the Member State or zone or compartment of destination is not free from that disease.

(80) In the case of aquatic diseases, Member States may take national measures under Article 226 of the ‘Animal Health Law’ designed to limit the impact of diseases other than listed diseases, within their own territory. In such cases, consignments of species susceptible to the diseases to which those national measures apply will also need to originate from third countries, territories, zones or compartments thereof, which are free of those diseases.

(81) Article 226 of the ‘Animal Health Law’ reflects the same intent as Article 43 of Council Directive 2006/88/EC (7) as it allows Member States to take national measures against diseases which are not listed. It is therefore appropriate, to continue to recognise the list of diseases and the relevant species for which those measures have been put in place. These details should be set out in this Regulation.

(82) Certain rules apply within the Union in relation to the registration and approval of aquaculture establishments. The differentiation between whether an establishment can be registered or whether it should be approved depends upon the risk it presents of contracting or spreading disease. It is important therefore, that aquaculture animals which enter the Union from aquaculture establishments in a third country, territory, zone or compartment thereof, should originate from aquaculture establishments which are assessed in a similar way. In that context, such establishments should comply with registration or approval requirements which are at least as stringent as those laid down for such establishments within the Union.

(83) It is not mandatory in all situations to apply the requirement that aquatic animals of listed species and products of animal origin from those animals originate from a third country or territory or zone or compartment thereof free from disease. Certain risk-mitigation measures can be taken to facilitate the entry into the Union of aquatic animals and certain products of animal origin thereof which do not have such an origin. Certain risk-mitigation measures are acceptable for aquatic animals of listed species and given the lower level of risk associated with such movements, different, less stringent risk-mitigation measures are acceptable for products of animal origin from aquatic animals other than live aquatic animals.

(84) The mitigation measures that apply to aquatic animals include their being consigned to a disease control aquatic food establishment, a confined establishment or an approved quarantine establishment after entry into the Union. A number of other risk-mitigating measures apply to molluscs and crustaceans of listed species which enter the Union alive and in compliance with Regulation (EU) No 853/2004 but which represent an acceptable risk because of how they were treated or packaged before dispatch or because they are not intended for storage in the Union, prior to processing.

(85) It is possible to derogate from the requirements that certain products of animal origin from aquatic animals other than live aquatic animals, have to originate in a third country or territory or zone or compartment thereof which is free from the relevant listed diseases. The risk-mitigation measures allowing such trade to occur may consist of consigning the products of animal origin to a disease control aquatic food establishment in the Union for further processing, or of ensuring that the products of animal origin consist of fish which were slaughtered and eviscerated before being dispatch to the Union. In either case, the risk posed by the products of animal origin is assessed as negligible.

(86) Implementing Regulation (EU) 2018/1882 establishes a list of aquatic species and groups of species that pose a considerable risk for the spread of the diseases listed in Article 5 and Annex II to the ‘Animal Health Law’. The list also includes a list of vector species, which is set out in column 4 of the table in the Annex to that Regulation. Many of those species do not, however, act as vectors in all circumstances. In relation to movements, details of the circumstances in which those species are considered to be vectors of the listed diseases are set out in Annex XXX to this Regulation. In circumstances where aquatic animals of listed species do not fulfil the conditions to be vectors, they are not covered by the rules set out in this Regulation. In addition, given the lower level of risk posed by products of animal origin from aquatic animals other than live aquatic animals, the measures set out in this Regulation in relation to these products do not apply to the species listed in column 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882.

(87) All derogations and handling requirements provided for in this Regulation in relation to aquatic animals of listed species and to products of animal origin from those listed species other than live aquatic animals, should also apply to the species listed in column 4 of the table in the Annex to Implementing Regulation (EU) 2018/1882 for which Member States have taken national measures under Article 226 of the ‘Animal Health Law’. Likewise, these derogations and handling requirements should also apply to certain susceptible species.

(88) It is important that aquatic animals of listed species, and the water in which they are transported, are handled appropriately after entry into the Union to ensure that they do not pose a disease risk. Appropriate handling includes ensuring that the animals are transported directly to the place of destination and are not released or otherwise immersed in natural waters of the Union, where they could cause a potential disease risk.

(89) In certain cases, however, the competent authority at the place of destination may allow authorisation for such animals to be released into natural waters. In all such cases, it should be for the competent authority to ensure that the release or immersion does not jeopardise the health status at the place of release. Furthermore, even if the receiving waters are not free of a specific category C disease, the animals to be released should be disease-free, in order to ensure the best overall health status is achieved for wild populations in natural waters of the Union.

(90) In relation to the animal health risk involved, all transit movements through the Union should be considered as movements for entry into the Union as they imply the same level of risk. Transit movements should therefore comply with all the relevant requirements for entry into the Union. However, derogations and special rules for transit should be established under specific risk-mitigating conditions linked to the place of origin. Such derogations and special rules are intended to cover situations where the Union is not the final destination for the animals and products thereof and to take into account geographical constraints and geopolitical factors.

(91) Derogations and special rules should also be established for the transit of consignments of animals and products thereof via a third country or territory between Member States. This is to cover situations where such type of entry into the Union is required by a Member State.

(92) In some cases commodities originating in the Union are refused by the competent authorities of a third country or territory following controls carried out at their border. Special rules should be adopted under Article 239 of the ‘Animal Health Law’ to allow the return of those commodities on the grounds that they have been produced under the Union’s animal health legislation.

(93) Special rules are also necessary for the return to the Union of registered horses after temporary export to third countries in order to participate in races, competitions and equestrian cultural events.

(94) With a view to the uniform application of Union legislation on entry into the Union of animals, germinal products and products of animal origin and to ensure that the legislation is clear and transparent, this Regulation should repeal Commission Regulation (EU) No 206/2010 (8), Commission Implementing Regulation (EU) No 139/2013 (9), Commission Regulation (EU) No 605/2010 (10), Commission Regulation (EC) No 798/2008 (11), Commission Decision 2007/777/EC (12), Commission Regulation (EC) No 119/2009 (13), Commission Regulation (EU) No 28/2012 (14) and Commission Implementing Regulation (EU) 2016/759 (15).

(95) The rules contained in this regulation are linked and complement those of the ‘Animal Health Law’ that applies from 21 April 2021. For this reason and to facilitate the application of the new animal health legal framework this Regulation should also apply from 21 April 2021,

HAS ADOPTED THIS REGULATION:

PART I

GENERAL RULES

TITLE 1

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter and scope 1. This Regulation lays down supplementing animal health rules concerning the entry into the Union of consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories or zones thereof, or compartments in the case of aquaculture animals. It also lays down rules concerning the movement and handling of those consignments after their entry in the Union. 2. Part I lays down: (a) the obligations on the competent authority of Member States to permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories of animals covered by Parts II to VI (Articles 3 and 4); (b) the obligations on the operators regarding the entry into the Union, and the movement and handling after entry, of consignments of animals, germinal products and products of animal origin covered by Parts II to VI (Article 5); (c) the general animal health requirements for entry into the Union, and the movement and handling after the entry of the consignments referred to in points (a) and (b), and derogations from those general requirements, applicable to all the species and categories of animals, germinal products and products of animal origin covered by Parts II to VI (Articles 6 to 10). 3. Part II lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for certain terrestrial animals (Title 1). In addition, it lays down specific animal health requirements that are also applicable to the each of those species and categories of terrestrial animals, in particular: (a) kept ungulates of listed species (Title 2); (b) poultry and captive birds, except captive birds imported for conservation programmes approved by the competent authority of the Member State of destination (Title 3); (c) honeybees (Apis mellifera) and bumble bees (Bombus spp.) (Title 4); (d) dogs, cats and ferrets (Title 5). 4. Part III lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from such requirements for germinal products of the following species and categories of kept terrestrial animals: (a) bovine, porcine, ovine, caprine and equine animals (Title 1); (b) poultry and captive birds (Title 2); (c) animals other than those listed in points (a) and (b) (Title 3). 5. Part IV lays down the general animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for products of animal origin of the following species and categories of terrestrial animals: (a) kept and wild ungulates of listed species; (b) poultry; (c) game birds. 6. Part V lays down the animal health requirements for entry into the Union, as well as the movement and handling after the entry, and derogations from those requirements for the following species of aquatic animals at all life stages as well as their products of animal origin, other than wild aquatic animals and products of animal origin from those wild aquatic animals landed from fishing vessels for direct human consumption: (a) fish of listed species belonging to the superclass Agnatha and to the classes Chondrichthyes, Sarcopterygii and Actinopterygii; (b) aquatic molluscs of listed species belonging to the phylum Mollusca; (c) aquatic crustaceans of listed species belonging to the subphylum Crustacea; (d) aquatic animals of species listed in Annex XXIX which are susceptible to the aquatic diseases for which certain Member States have national measures to limit the impact of diseases other than listed diseases, as provided for in Article 226 of Regulation (EU) 2016/429. 7. Part VI lays down the general rules, certain derogations and additional requirements for transit through the Union and for the return to the Union of certain species and categories of animals, germinal products and products of animal origin. 8. Part VII lays down final provisions.

Article 2 Definitions For the purposes of this Regulation, the definitions laid down in Implementing Regulation (EU) 2018/1882 and Annex I to Regulation (EC) No 853/2004 shall apply, except where those definitions cover terms that are defined in the second paragraph of this Article. In addition, the following definitions shall also apply: (1) ‘listed third country, territory or zone thereof’ means a third country, territory or zone thereof included in a list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, from which the entry into the Union of a particular species and category of animals, germinal products and products of animal origin is permitted in accordance with implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429; (2) ‘the list’ means the list of third countries, territories or zones thereof, or compartments in the case of aquaculture animals, authorised for entry into the Union of consignments of a particular species and category of animals, germinal products or products of animal origin by implementing acts adopted pursuant to Article 230(1) of Regulation (EU) 2016/429; (3) ‘means of transport’ means road or rail vehicle, vessels and aircrafts; (4) ‘container’ means any crate, box, receptacle or other rigid structure used for the transport of animals, germinal products or products of animal origin which is not the means of transport; (5) ‘bovine animal’ means an animal of the species of ungulates belonging to the genera Bison, Bos (including the subgenera Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa) and the offspring of crossings of those species; (6) ‘ovine animal’ means an animal of the species of ungulates belonging to the genus Ovis and the offspring of crossings of those species; (7) ‘caprine animal’ means an animal of the species of ungulates belonging to the genus Capra and the offspring of crossings of those species; (8) ‘porcine animal’ means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429; (9) ‘equine animal’ means an animal of species of solipeds belonging to the genus Equus (including horses, asses, and zebras) and the offspring of crossings of those species; (10) ‘camelid animal’ means an animal of the species of ungulates belonging to the family Camelidae listed in Annex III to Regulation (EU) 2016/429; (11) ‘cervid animal’ means an animal of the species of ungulates belonging to the family Cervidae listed in Annex III to Regulation (EU) 2016/429; (12) ‘registered equine animal’ means: (a) a purebred breeding animal of the species Equus caballus and Equus asinus entered or eligible for entry in the main section of a breeding book established by a breed society or breeding body recognised in accordance with Article 4 or 34 of Regulation (EU) 2016/1012; (b) a kept animal of the species Equus caballus registered with an international association or organisation, either directly or through its national federation or branches, which manages horses for competition or racing (‘registered horse’); (13) ‘animals intended for slaughter’ means kept terrestrial animals to be transported, either directly or after undergoing an assembly operation, to a slaughterhouse; (14) ‘disease has not been reported’ means that no animal or group of animals of relevant species kept on the establishment has been classified as a confirmed case of that disease and any suspect case of that disease has been ruled out; (15) ‘sanitary group’ means a group of listed third countries in which common animal health risks as regards diseases listed for equine animals prevail that require specific risk-mitigating measures and health guarantees when equine animals enter into the Union; (16) ‘flock’ means all poultry or captive birds of the same health status kept on the same premises or in the same enclosure and constituting a single epidemiological unit; in housed poultry, this includes all birds sharing the same airspace. (17) ‘breeding poultry’ means poultry 72 hours old or more, intended for the production of hatching eggs; (18) ‘productive poultry’ means poultry 72 hours old or more, reared for the production of meat, eggs for consumption or other products or for restocking supplies of game birds; (19) ‘day-old chicks’ means poultry less than 72 hours old; (20) ‘honeybee’ means an animal of the Apis mellifera species; (21) ‘bumble bee’ means an animal of the species belonging to the genus Bombus; (22) ‘dog’ means a kept animal of the Canis lupus species; (23) ‘cat’ means a kept animal of the Felis silvestris species; (24) ‘ferret’ means a kept animal of the Mustela putorius furo species; (25) ‘unique approval number’ means a number assigned by the competent authority; (26) ‘specified pathogen-free eggs’ means hatching eggs derived from ‘chicken flocks free from specified pathogens’, as described in the European Pharmacopoeia and which are intended solely for diagnostic, research or pharmaceutical use; (27) ‘consignment of semen, oocytes or embryos’ or ‘consignment of germinal products’ means a quantity of semen, oocytes, in vivo derived embryos or in vitro produced embryos dispatched from a single approved germinal product establishment covered by a single animal health certificate; (28) ‘semen’ means the ejaculate of an animal or animals, either in the unaltered state or prepared or diluted; (29) ‘oocytes’ means the haploid stages of the ootidogenesis including secondary oocytes and ova; (30) ‘embryo’ means the initial stage of development of an animal while it is capable of being transferred to a recipient dam; (31) ‘approved germinal product establishment’ means a semen collection centre, an embryo collection team, an embryo production team, a germinal product processing establishment or a germinal product storage centre; (32) ‘centre veterinarian’ means the veterinarian responsible for the activities carried out at the semen collection centre, at the germinal product processing establishment or at the germinal product storage centre as provided for in this Regulation; (33) ‘team veterinarian’ means the veterinarian responsible for the activities carried out by an embryo collection team or by an embryo production team as provided for in this Regulation; (34) ‘quarantine accommodation’ means a facility authorised by the competent authority for the purpose of the isolation of bovine, porcine, ovine or caprine animals for a period of at least 28 days before they are admitted to a semen collection centre; (35) ‘semen collection centre’ means a germinal product establishment approved by the competent authority for the collection, processing, storage and transport of semen of bovine, porcine, ovine, caprine or equine animals intended for entry into the Union; (36) ‘embryo collection team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of in vivo derived embryos intended for entry into the Union; (37) ‘embryo production team’ means a germinal product establishment comprised of a group of professionals or structure approved by the competent authority for the collection, processing, storage and transport of oocytes, and the in vitro production, where applicable with stored semen, processing, storage and transport of embryos, both intended for entry into the Union; (38) ‘germinal product processing establishment’ means a germinal product establishment approved by the competent authority for the processing, including semen sex-sorting where appropriate, and the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union; (39) ‘germinal product storage centre’ means a germinal product establishment approved by the competent authority for the storage of semen, oocytes or embryos of one or more species, or any combination of those types of germinal products or species, intended for entry into the Union; (40) ‘meat’ means all parts of ungulates, poultry and game birds which are suitable for human consumption, including blood; (41) ‘fresh meat’ means meat, minced meat and meat preparations, including vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any preserving process other than chilling, freezing or quick-freezing; (42) ‘carcase of an ungulate’ means the whole body of a slaughtered or killed ungulate after: (a) bleeding, in the case of slaughtered animals; (b) evisceration; (c) removal of the limbs at the carpus and tarsus; (d) removal of the tail, the udder, the head and the skin, except in porcine animals. (43) ‘offal’ means fresh meat other than that of a carcase of an ungulate even if it remains naturally connected to the carcase; (44) ‘meat products’ means processed products, including treated stomachs, bladders, intestines, rendered animal fats and meat extracts, resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat; (45) ‘casings’ means the bladders and intestines that after cleaning have been processed by tissue scraping, defatting and washing and have been treated with salt or dried; (46) ‘colostrum’ means the fluid secreted by the mammary glands of kept animals up to 3 to 5 days post-parturition that is rich in antibodies and minerals, and precedes the production of raw milk; (47) ‘colostrum-based products’ means processed products resulting from the processing of colostrum or from the further processing of such processed products; (48) ‘well-boat’ means a vessel used by the aquaculture industry which has a well or tank for the storage and transport of live fish in water; (49) ‘IMSOC’ means the information management system for official controls provided for in Article 131 of Regulation (EU) 2017/625 (16).

TITLE 2

GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION, AND MOVEMENT AND HANDLING AFTER THE ENTRY OF CONSIGNMENTS OF ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN

Article 3 Obligations of the competent authorities of Member States The competent authority shall permit the entry into the Union of consignments of animals, germinal products and products of animal origin of species and categories covered by Parts II to VI, which are presented for the purpose of official controls as provided for in Article 47(1) of Regulation (EU) 2017/625, provided that: (a) the consignments come from: (i) in the case of terrestrial animals, a listed third country or territory or zone thereof for the particular species and category of animals, germinal products and products of animal origin; (ii) in the case of aquatic animals, a listed third country or territory or zone thereof for the particular species and category of animals and products of animal origin, and in the case of aquaculture animals, a listed third country or territory or zone or compartment thereof listed for that purpose; (b) the competent authority of the third country or territory of origin has certified that the consignments comply with: (i) the general animal health requirements for entry into the Union of animals, germinal products and products of animal origin laid down in this Article, Article 4 and Articles 6 to 10; (ii) the animal health requirements applicable to the particular species and category of animals, germinal products and products of animal origin and intended use, as laid down in Parts II to VI; (c) the consignments are accompanied by the following documents whereby the competent authority of the third country or territory of origin has provided the necessary guarantees as regards compliance with the animal health requirements referred to in point (b): (i) an animal health certificate issued by an official veterinarian of the third country or territory of origin, specific for the particular species and category of animals, germinal products and products of animal origin and their intended use; (ii) a declaration and other documents, where required in this Regulation. In the case of consignments of animals and hatching eggs, the animal health certificate, referred to in point (c)(i) must have been issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; however, in the case of transport by sea that period may be extended by an additional period corresponding to the duration of the journey by sea.

Article 4 The date of certification of consignments 1. Consignments of animals, germinal products and products of animal origin of species and categories falling within the scope of this Regulation shall only be permitted to enter the Union provided that such consignments were certified for dispatch to the Union not earlier than the date on which the third country or territory of origin or zone thereof, or compartment thereof in the case of aquaculture animals, was listed for entry into the Union of the particular species and category of animals, germinal products and products of animal origin. 2. Consignments of animals, hatching eggs and products of animal origin originating from a third country or territory or zone thereof, or compartment thereof in the case of aquaculture animals, shall not be permitted to enter the Union from the date on which it no longer complies with the animal health requirements for entry into the Union of the particular species and category of animals, hatching eggs or products of animal origin, unless specific conditions have been assigned by the Union in the list to the listed third country, territory or zone thereof and to the particular species and categories of animals, hatching eggs or products of animal origin.

Article 5 Obligations of operators 1. Operators responsible for entry into the Union of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation, shall present those consignments to the competent authority in the Union for the purpose of official controls, as provided for in Article 47(1) of Regulation (EU) 2017/625, and shall ensure that such consignments comply with the following requirements: (a) the general animal health requirements for entry into the Union of the animals, germinal products and products of animal origin laid down in Articles 3 and 4 and Articles 6 to 10; (b) the animal health requirements applicable to the particular species and category of the animals, germinal products and products of animal origin of the consignment and its intended use, as laid down in Parts II to VI. 2. Operators responsible for the movement of consignments of animals, germinal products and products of animal origin of the species and categories falling within the scope of this Regulation from the point of entry in the Union to their place of destination, and those responsible for the handling of such consignments after their entry into the Union shall ensure that the consignments: (a) are permitted to enter the Union by the competent authority in accordance with Article 3; (b) comply with the animal health requirements for the movement and handling of such consignments after the entry into the Union for the specific species and categories of animals, germinal products and products of animal origin laid down in Parts II to VI; (c) are not diverted for uses other than those for which they were certified by the competent authority of the third country or territory of origin for entry into the Union.

Article 6 National legislation and animal health systems of the third country or territory of origin 1. Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union from a third country or territory where: (a) any suspicion and confirmed case of a listed disease referred to in Annex I, relevant for the listed species of animals in the consignment or for the listed species of animals of origin of the germinal products or products of animal origin in the consignment authorised to enter the Union, are required by law to be notified and reported to the competent authority; (b) there are systems in place to detect emerging diseases; (c) there are systems in place to ensure that swill feeding is not a source of the listed diseases referred to in Annex I for: (i) the animals intended for entry into the Union; or (ii) the animals from which the germinal products intended for entry into the Union are obtained; or (iii) the animals from which the products of animal origin intended for entry into the Union are obtained. 2. Consignments of animals, germinal products and products of animal origin intended for entry into the Union shall only be permitted to enter the Union from a third country or territory or zone thereof where such consignments may be lawfully placed on the market and traded in that third country or territory of origin or zone thereof.

Article 7 General requirements as regards the health status of the animals, germinal products and products of animal origin 1. Consignments of animals shall only be permitted to enter the Union if the animals of the consignment: (a) are not animals to be killed under a national programme carried out in the third country or territory of origin for the eradication of diseases, including the relevant listed diseases referred to in Annex I and emerging diseases; (b) did not show symptoms of transmissible diseases at the time of loading for the dispatch to the Union; (c) originate from an establishment which, at the time of their dispatch from that establishment to the Union, was not subject to national restriction measures: (i) for animal health reasons; (ii) in the case of aquaculture animals, for animal health reasons or due to the occurrence of abnormal mortalities with an undetermined cause. 2. Consignments of germinal products shall only be permitted to enter the Union if they were obtained from animals which at the time of collection: (a) did not show symptoms of transmissible diseases; (b) were kept on an establishment which was not subject to national restriction measures for animal health reasons, including restrictions related to the relevant listed diseases referred to in Annex I and emerging diseases. 3. Consignments of products of animal origin shall only be permitted to enter the Union if they were obtained from animals which: (a) in the case of terrestrial animals, did not show symptoms of transmissible diseases at the time of: (i) killing or slaughter, for the production of fresh meat and meat products; or (ii) the collection of milk or eggs; (b) in the case of aquatic animals, did not show symptoms of transmissible diseases at the time of slaughter or collection for the production of products of animal origin. (c) were not killed, slaughtered or, in the case of molluscs and live crustaceans removed from the water, under a national programme for the eradication of diseases; (d) were kept on an establishment which was not subject to national restriction measures for animal health reasons, including where relevant, listed diseases referred to in Annex I and emerging diseases, at the time of: (i) the killing or slaughter of those animals for the production of fresh meat and meat products or products of animal origin from aquatic animals; or (ii) the collection of milk and eggs.

Article 8 General requirements as regards the establishment of origin of the animals In addition to the specific requirements laid down in Parts II to V, consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the establishment of origin of the kept animals, or the establishment of origin of the kept animals from which the germinal products or products of animal origin were obtained, complies with the following requirements: (a) it must be registered by the competent authority of the third country or territory of origin and assigned a unique registration number; (b) it must be approved by the competent authority of the third country or territory of origin, where required by and under the conditions provided for in this Regulation, and assigned a unique approval number; (c) it must be under the control of the competent authority of the third country or territory of origin; (d) it must have a system in place to maintain and to keep, for a minimum period of 3 years, up-to-date records containing at least the following information: (i) the species, categories, number and where relevant, identification of animals on the establishment; (ii) movements of animals into and out of the establishment; (iii) mortality in the establishment. (e) it must receive regular animal health visits from a veterinarian for the purpose of the detection of, and information on, signs indicative of the occurrence of diseases, including those listed diseases referred to in Annex I relevant for the particular species and category of animal, germinal product or product of animal origin and emerging diseases. Such animal health visits shall take place at frequencies that are proportionate to the risks posed by the establishment concerned.

Article 9 Sampling, laboratory tests and other tests Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if sampling, laboratory tests and other tests required by this Regulation have been carried out: (a) on samples taken by or under the control of the competent authority of: (i) the third country or territory of origin when sampling and testing are required prior to entry into the Union; or (ii) the Member State of destination when sampling and testing are required after the entry into the Union; (b) in accordance with: (i) the relevant procedures and methods set out in Delegated Regulation (EU) 2020/689 and Delegated Regulation (EU) 2020/688 (17); or (ii) for the purpose of entry into the Union of germinal products of bovine, porcine, ovine, caprine and equine animals, the procedures and methods set out in Annex II to Commission Delegated Regulation (EU) 2020/686 (18); or (iii) the procedures described in this Regulation, where specifically required; (c) in an official laboratory, designated in accordance with Article 37 of Regulation (EU) 2017/625.

Article 10 Disease freedom of the place of origin and specific conditions 1. Consignments of animals, germinal products and products of animal origin shall only be permitted to enter the Union if the freedom from particular diseases of the third country or territory of origin or zone thereof or of the establishment of origin of the animals, germinal products or products of animal origin, required by this Regulation has been demonstrated by the competent authority of the third country or territory of origin: (a) in accordance with Delegated Regulation (EU) 2020/689; or (b) for diseases not falling within the scope of Delegated Regulation (EU) 2020/689, in accordance with specific rules, where such rules are laid down in this Regulation, and the disease surveillance programme implemented by the third country or territory of origin, which must have been: (i) submitted to the Commission for assessment and contain at least the information referred to in Annex II; (ii) assessed by the Commission as providing the necessary guarantees as regards disease freedom based on: — the rules on disease surveillance laid down in Articles 24, 25, 26 and 27 of Regulation (EU) 2016/429, — the supplementing rules on surveillance design and the rules for disease confirmation and case definition laid down in Sections 1 and 2 and Article 10 of Chapter 1 of Part II of Delegated Regulation (EU) 2020/689; (iii) in place for a sufficient period of time for it to be fully implemented and properly supervised. 2. In the case of aquaculture animals and products of animal origin from aquaculture animals, where disease freedom from particular diseases is required for the compartment of origin, consignments of those commodities shall only be permitted to enter the Union if the competent authority of the third country of origin has demonstrated disease freedom in accordance with paragraph 1(a) and (b). 3. Where specific conditions related to the disease freedom from particular diseases of the third country or territory of origin, or zone thereof, are required in this Regulation: (a) the competent authority of the third country or territory of origin must have previously guaranteed its compliance; (b) those specific conditions shall have been specifically assigned by the Union in the list to the listed third country or territory, zone or compartment thereof and to the particular species and category of animals, germinal products and products of animal origin.

PART II

ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF KEPT TERRESTRIAL ANIMALS AS REFERRED TO IN ARTICLES 3 AND 5

TITLE 1

GENERAL ANIMAL HEALTH REQUIREMENTS FOR KEPT TERRESTRIAL ANIMALS

Article 11 The residency period required for kept terrestrial animals Consignments of kept terrestrial animals other than dogs, cats and ferrets, shall only be permitted to enter the Union subject to compliance with the following requirements: (a) the animals complied with the relevant residency period set out in the following tables of Annex III for a continuous period of time immediately prior to the date of dispatch to the Union: (i) Table 1 in the case of ungulates, honeybees and bumble bees; (ii) Table 2 in the case of poultry and captive birds; (b) the animals: (i) remained continuously in the third country or territory of origin or zone thereof during the period indicated in the second column of Table 1 in Annex III and the third column of Table 2 in Annex III; (ii) remained continuously in the establishment of origin, and no animals were introduced into that establishment during the period indicated in the third column of Table 1 in Annex III and the fourth column of Table 2 in Annex III; (iii) had no contact with animals of a lower health status during the period indicated in the fourth column of Table 1 in Annex III and the fifth column of Table 2 in Annex III.

Article 12 Derogations regarding the residency period for registered horses for competition, races and cultural events 1. By way of derogation of point (b)(i) of Article 11, equine animals other than equine animals intended for slaughter shall be regarded as complying with the residency period provided for in Table 1 of Annex III, if prior to their dispatch to the Union they have been resident during the period indicated in the second column of Table 1 of Annex III in addition to the third country or territory of origin or zone thereof also in: (a) a Member State; or (b) in case of registered horses, a listed third country or territory of intermediate residency, or zone thereof, from where the entry into the Union of registered horses is authorised for that purpose and provided that they were introduced into the third country or territory of origin, or zone thereof, in accordance with animal health requirements providing animal health guarantees at least as stringent as those applicable to the direct entry into the Union of registered horses for competition and races from that third country or territory of intermediate residence, or zone thereof. 2. By way of derogation from point (b)(ii) of Article 11, registered horses for competition, races and cultural equestrian events shall be regarded as complying with the residency requirements provided for in the third column of Table 1 of Annex III if they have been resident in the third country of origin or the third country of intermediate residence in establishments other than the establishment of origin provided that the other establishments: (a) have been under supervision of the official veterinarian in a third country or territory; (b) were not subject to national restriction measures for animal health reasons, including restrictions relating to the relevant diseases referred to in Annex I and relevant emerging diseases; (c) comply with the animal health requirements laid down in Article 23. 3. Also by way of derogation from point (b)(ii) of Article 11, registered horses for competition, races and cultural equestrian events that have had contact with equine animals which were entered into the third country, territory or zone thereof from another third country territory, or zone thereof, or from another zone in the third country or territory of origin shall be permitted to enter the Union provided that: (a) those equine animals were introduced into the third country or territory of origin or zone thereof in accordance with animal health requirements at least as stringent as those applicable to the direct entry into the Union of those equine animals; (b) the possibility of direct contact with other animals is limited to the period of the competition, races or cultural equestrian events and the related training, warm-up and pre-racing presentation.

Article 13 Inspection of terrestrial animals prior to dispatch to the Union 1. Consignments of terrestrial animals shall only be permitted to enter the Union if the animals of the consignment have been subjected to a clinical inspection, carried out by an official veterinarian in the third country or territory of origin or zone thereof within the period of 24 hours prior to the time of loading for dispatch to the Union for the purpose of the detection of signs indicative of the occurrence of diseases, including the relevant listed diseases referred to in Annex I and emerging diseases. In the case of poultry and captive birds, that inspection shall cover both the animals intended for dispatch to the Union and the flock of origin. 2. By way of derogation from the first subparagraph of paragraph 1, in the case of registered equine animals the inspection referred to therein may be carried out within 48 hours prior to the time of loading for dispatch to the Union or on the last working day prior to dispatch to the Union. 3. By way of derogation from the first subparagraph of paragraph 1, in the case of dogs, cats and ferrets the inspection referred to therein may be carried out within the period of 48 hours prior to the time of loading for dispatch to the Union.

Article 14 General rules for the dispatch to the Union of terrestrial animals 1. Consignments of terrestrial animals shall only be permitted to enter the Union if, from the time of loading at the establishment of origin for dispatch to the Union until the time of their arrival in the Union, the animals of the consignment have not been in contact with other terrestrial animals of: (a) the same species, not intended for entry into the Union; (b) other species listed for the same diseases, not intended for entry into the Union; (c) a lower health status. 2. When transported by air, sea, railway, road or on foot, the consignments referred to in paragraph 1 shall only be permitted to enter the Union if they have not been transported through, unloaded or transhipped in a third country or territory or zone thereof which is not listed for entry into the Union of the specific species and category of animals and their intended use in the Union. 3. When transported by sea, even for part of the journey, the consignments referred to in paragraph 1 shall only be permitted to enter the Union if they arrive to the Union accompanied by a declaration, attached to the animal health certificate accompanying the animals and signed by the master of the vessel, providing the following information: (a) the port of departure in the third country or territory of origin or zone thereof; (b) the port of arrival in the Union; (c) the ports of call, where the vessel called at ports outside the third country or territory of origin or zone thereof of the animals; (d) confirmation of compliance with the following requirements during the journey to the Union: (i) the animals have remained on board; (ii) the animals have not been into contact with animals of a lower health status while on board.

Article 15 Derogation for the transhipment of terrestrial animals other than equine animals in non-listed third countries or territories in the event of a technical problem or another unforeseen incident 1. By way of derogation from Article 14(2), the competent authority shall authorise the entry into the Union of consignments of terrestrial animals, other than equine animals, which have been transhipped from the original means of transport of dispatch into another means of transport for onward travel in a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular species and category of animals into the Union, only if the transhipment operation took place because of the occurrence of a technical problem or another unforeseen incident causing logistic problems during the transport of the animals to the Union by sea or by air, in order to complete the transport to the point of entry into Union, provided that: (a) the entry into the Union of the consignment of animals is authorised by the competent authority of the Member State of destination and, where applicable, any Member States of passage until their arrival at their place of destination in the Union; (b) the transhipment was supervised by an official veterinarian in the third country or territory throughout the operation to ensure that: (i) effective protection measures against vectors of relevant animal diseases were put in place; (ii) effective measures were put in place to avoid direct and indirect contact between the animals intended for entry into the Union and any other animals; (iii) no feed, water or bedding, originating from a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular species and category of animals into the Union, has been added in the means of transport for onward travel to the Union; (iv) the animals of the consignment were transferred directly and as quick as possible to a vessel or aircraft for onward travel to the Union, which complies with requirements laid down in Article 17, without leaving the boundaries of the port or airport; (c) the consignment of animals is accompanied by a declaration from the competent authority of the third country or territory where the transfer took place, providing information on the transfer operation and attesting that relevant measures were put in place to comply with the requirements laid down in point (b). 2. The derogation provided for in paragraph 1 shall not apply to consignments of honeybees and bumble bees.

Article 16 Derogation for the transhipment of equine animals in non-listed third countries or territories By way of derogation from Article 14(2), where consignments of equine animals have been transhipped to another means of transport during the transport of the animals to the Union in a third country or territory or zone thereof which is not a listed third country or territory or zone thereof for entry of the particular category of equine animals, those consignments shall only be permitted to enter the Union if they comply with the following requirements: (a) the animals of the consignment were transported to the Union by sea or by air; (b) the animals of the consignment were transhipped directly from the original means of transport of dispatch into the other means of transport for onward travel; (c) during the transhipment operation: (i) effective protection against vectors of relevant animal diseases was provided and the equine animals did not come into contact with equine animals of a lower health status; (ii) the animals of the consignment were transferred directly and as quickly as possible to the vessel or aircraft to be used for onward travel, which must have complied with the requirements laid down in Article 17, without leaving the boundaries of the port or airport under the direct supervision of an official veterinarian; (d) an official veterinarian must have certified that the consignment complied with the requirements laid down in point (a), (b) and (c).

Article 17 General requirements regarding means of transport of terrestrial animals 1. Consignments of kept terrestrial animals shall only be permitted to enter the Union if the means of transport used for their transport are: (a) constructed in such a way that: (i) the animals cannot escape or fall out; (ii) visual inspection of the space where animals are kept is possible; (iii) the escape of animal excrements, litter or feed is prevented or minimised; (iv) in the case of poultry and captive birds, the escape of feathers is prevented or minimised; (b) cleaned and disinfected, with a disinfectant authorised by the competent authority of the third country or territory of dispatch, and dried or allowed to dry immediately before every loading of animals intended for entry into the Union. 2. Paragraph 1 shall not apply to the transport of consignments of honeybees and bumble bees intended for entry into the Union.

Article 18 Requirements regarding containers in which terrestrial animals are transported to the Union Consignments of kept terrestrial animals shall only be permitted to enter the Union if the containers in which kept terrestrial animals are transported to the Union in the means of transport: (a) comply with the requirements in Article 17(1)(a); (b) contain only animals of the same species and category coming from the same establishment; (c) are either: (i) unused and purpose-designed disposable containers to be destroyed after first use; or (ii) cleaned and disinfected and dried or allowed to dry before loading of animals intended for entry into the Union.

Article 19 Movement and handling after entry of terrestrial animals 1. Following their entry into the Union, consignments of terrestrial animals shall be transported directly without delay to: (a) their establishment of destination in the Union, where they shall remain at least for the period of time required in the relevant specific articles in Parts II to V; (b) the slaughterhouse of destination in the Union, if they are intended for slaughter, where they must be slaughtered within a period of 5 days from the date of their arrival in the Union. 2. Where the destination of the consignments of terrestrial animals entered from a third country or territory or zone thereof is a slaughterhouse, an approved quarantine establishment or a confined establishment in the Union, the transport to and arrival at the place of the destination of the consignment shall be monitored in accordance with Article 2 and 3 of Commission Delegated Regulation (EU) 2019/1666 (19). 3. Paragraphs 1 and 2 shall not apply to the entry into the Union of registered equine animals from third countries and to the re-entry after temporary export of registered horses.

TITLE 2

ANIMAL HEALTH REQUIREMENTS FOR UNGULATES

CHAPTER 1

Specific animal health requirements for ungulates

Article 20 Dispatch of ungulates to the Union 1. Consignments of ungulates shall only be permitted to enter the Union if such consignments have been dispatched from the establishment of origin to the Union without passing through any other establishment. 2. By way of derogation of paragraph 1, consignments of ungulates coming from more than one establishment of origin may be permitted to enter the Union if the animals of the consignment have undergone a single assembly operation in the third country or territory of origin or zone thereof subject to compliance with the following conditions: (a) the ungulates belong to one of the following species and categories: (i) Bos taurus, Ovis aries, Capra hircus or Sus scrofa; or (ii) Equidae intended for slaughter; (b) the assembly operation took place in an establishment: (i) approved for conducting assembly operations of ungulates by the competent authority in the third country or territory in accordance with requirements which are at least as stringent as to those laid down with Article 5 of Commission Delegated Regulation (EU) 2019/2035 (20); (ii) listed for that purpose by the competent authority of the third country or territory of dispatch, including the information provided for in Article 21 of Delegated Regulation (EU) 2019/2035; (iii) where the following records are maintained up-to-date and kept for a period of at least 3 years: — the origin of the animals, — the dates of arrival and dispatch to and from the assembly centre, — the identification code of the animals, — the registration number of the establishment of origin of the animals, — the registration number of the transporters and the means of transport delivering or collecting the consignment of ungulates to and from that centre; (iv) which complies with the requirements provided for in Article 8 and Article 23(1); (c) the assembly operation in the assembly centre took no longer than 6 days; this period shall be considered as part of the timeframe for sampling for testing prior to dispatch to the Union, where such sampling is required by this Regulation; (d) the ungulates must have arrived in the Union within a period of 10 days from the date of dispatch from the establishment of origin.

Article 21 Identification of ungulates 1. Consignments of ungulates, other than equine animals, shall only be permitted to enter the Union if the animals of the consignment were individually identified prior to being dispatched from the establishment of origin, by a physical means of identification with a visible, legible and indelible display of: (a) the identification code of the animal which establishes an unequivocal link between the animal and the accompanying animal health certificate; (b) the code of the exporting country in accordance with ISO Standard 3166 in the format of two-letter code. 2. Consignments of equine animals shall only be permitted to enter the Union if the animals of the consignment were individually identified prior to being dispatched from the establishment of origin at least by one of the following methods: (a) an injectable transponder or ear tag, with a visible, legible and indelible display of: (i) the identification code of the animal which establishes an unequivocal link between the animal and the accompanying animal health certificate; (ii) the ISO-3166 two-digit alpha or three-digit numeric country code of the exporting country; (b) in the case of equine animals other than those intended for slaughter, an identification document, issued at the latest at the time of certification for entry into the Union, which: (i) describes and depicts the animal, including the alternative methods of identification, so as to establish an unequivocal link between the animal and the accompanying identification document; (ii) contains information on the individual code emitted by an implanted injectable transponder in the case where this code does not comply with the specifications in point (a). 3. By way of derogation from paragraph 1, consignments of ungulates intended for confined establishments may be permitted to enter the Union if those animals are individually identified by an injectable transponder or an alternative method of identification which ensures an unequivocal link between the animal and its accompanying entry documentation. 4. Where ungulates are identified with an electronic identifier which does not comply with ISO Standards 11784 and 11785 the operator responsible for entry into the Union of the consignments of ungulates shall provide the reading device which enables at any time the verification of the identification of the animal.

Article 22 The third country or territory of origin of ungulates or zone thereof 1. Consignments of ungulates, other than equine animals, shall only be permitted to enter the Union if the animals of the consignment originate from a third country or territory or zone thereof free from the category A diseases referred to in the table set out in point 1 of Part A of Annex IV for the period referred to in that table. 2. Consignments of equine animals shall only be permitted to enter the Union if the animals of the consignment originate from a third country or territory or zone thereof: (a) free from the listed diseases referred in the table set out in point 2 of Part A of Annex IV for the period referred to in that table; (b) where none of the listed diseases referred to in the table set out in point 3 of Part A of Annex IV has been reported during the referred period. 3. The periods referred to in paragraph 1 and 2 may be reduced for diseases included in Part B of Annex IV under the relevant specific conditions referred therein. 4. Consignments of un