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) (Text with EEA relevance)

• (e) By way of derogation of point (c)(i), during their transport to the slaughterhouse, consignments of poultry may pass through a zone of a third country or territory not listed for entry into the Union of fresh meat of poultry other than ratites, subject to the following conditions:
• (i) the establishment of origin of the poultry, the zone of the third country or territory not listed for entry into the Union and the slaughterhouse are located in the same third country or territory;
• (ii) the passing through of that zone of the third country or territory is performed without stopping or unloading in that zone;
• (iii) the passing through of that zone of the third country or territory is performed prioritising major highways or mainline railways;
• (iv) the passing through of that zone of the third country or territory is performed avoiding the vicinity of establishments keeping animals of listed species for the relevant diseases of poultry;
• (v) the passing through of that zone of the third country or territory is performed after depopulation and cleaning and disinfection of the establishment(s) affected by outbreak(s) of highly pathogenic avian influenza or infection with Newcastle disease virus;
• (vi) following the passing through of that zone of the third country or territory, the poultry shall be brought directly to the slaughterhouse and be slaughtered within a period of 6 hours from the time of their arrival at the slaughterhouse. If no suitable alternatives are possible and provided that all the conditions listed in (i) to (vi) of this point are complied with, poultry transported to the slaughterhouse may pass through more than one zone referred to in this point.

Article 125

Dispatch of carcasses of wild animals or animals kept as farmed game killed on the spot

Consignments of fresh meat of wild animals or animals kept as farmed game that have been killed on-the-spot shall only be permitted to enter the Union if the fresh meat of the consignment has been obtained from carcasses which comply with the following requirements:

• (a) the carcasses were dispatched directly from the place of killing to a game handling establishment situated in the same listed third country or territory or zone;

• (b) during the transport to the game handling establishment referred to in point (a), the carcasses:
• (i) did not pass through a third country or territory or zone thereof not listed for entry into the Union of the particular species and category of fresh meat;
• (ii) did not come into contact with animals or carcasses of a lower health status;

• (c) the carcasses were transported to the game handling establishment referred to in point (a) in means of transport and containers which comply with the following requirements:
• (i) they were cleaned and disinfected, with a disinfectant authorised by the competent authority of the third country or territory of origin, before the loading of the carcasses for dispatch to the game handling establishment;
• (ii) they were constructed in such a way that the health status of the carcasses was not jeopardised during the transport.

Article 126

The ante-mortem and post-mortem inspections

Consignments of fresh meat of kept and wild animals shall only be permitted to enter the Union if the fresh meat of the consignment has been obtained from animals which have undergone the following inspections:

• (a) in the case of kept animals:
• (i) an ante-mortem inspection within the period of 24 hours prior to the time of slaughter;
• (ii) a post-mortem inspection carried out, without delay, after their killing or slaughter.

• (b) in the case of wild animals, a post-mortem inspection carried out, without delay, after their killing.

The inspections referred to in the first paragraph must have been carried out by an official veterinarian in the third country or territory of origin or zone thereof in order to exclude the presence of the relevant diseases referred to in Annex I and of emerging diseases.

Article 127

Handling of the animals of origin of the fresh meat during killing or slaughter

Consignments of fresh meat shall only be permitted to enter the Union if the fresh meat of the consignment originates from animals which had no contact with animals of a lower health status during their killing or slaughter.

Article 128

Handling and preparation of fresh meat in the establishment of origin of the fresh meat

Consignments of fresh meat must be kept strictly segregated from fresh meat not complying with the relevant animal health requirements for entry into the Union of fresh meat, provided for in Articles 124 to 146, throughout the operations of slaughter, cutting and until either:

• (a) it was packed for further storage or dispatch to the Union; or

• (b) its arrival to the Union, in the case of unpacked fresh meat.

CHAPTER 2 Animal health requirements for fresh meat of ungulates

SECTION 1 GENERAL ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF KEPT AND WILD UNGULATES

Article 129

The species of animals of origin of the fresh meat of ungulates

Consignments of fresh meat from ungulates shall only be permitted to enter the Union if the fresh meat of the consignment originates from the following species:

• (a) in the case of kept ungulates, from all species of ungulates;

• (b) in the case of wild ungulates and ungulates kept as farmed game, from all species of ungulates except from bovine animals, ovine animals, caprine animals and domestic breeds of porcine animals

Article 130

Prohibition as regards the entry of fresh blood

Consignments of fresh blood of ungulates for human consumption shall not be permitted to enter the Union.

SECTION 2 SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF KEPT UNGULATES

Article 131

The residency period prior to slaughter or killing of the kept ungulates of origin of the fresh meat

• (a) another third country or territory or zone which is listed for entry into the Union of fresh meat from the same species of ungulates and the kept ungulates remained there for at least 3 months prior to slaughter; or

• (b) a Member State.

• (a) remained in the third country or territory of origin or zone thereof;

• (b) remained in the establishment of origin;

• (c) had no contact with ungulates of a lower health status.

Article 132

Derogation from direct dispatch of the kept animals of origin of the fresh meat to a slaughterhouse

By way of derogation from Article 124(b), consignments of fresh meat of kept ungulates not complying with those requirements shall be permitted to enter the Union provided that the fresh meat of the consignment was obtained from bovine animals, ovine animals or caprine animals, and:

• (a) the ungulates passed through one single establishment conducting assembly operations, which complies with the requirements laid down in Article 20(b), after leaving their establishment of origin and prior to their arrival at the slaughterhouse;

• (b) the competent authority of the third country or territory of origin has provided additional guarantees to ensure the animal health status of the ungulates during their movement from their establishment of origin to their arrival at the slaughterhouse has not been jeopardised;

• (c) the third country, territory or zone thereof referred to in point (b) is authorised in the list for such derogation.

Article 133

The third country or territory of origin or zone thereof of the fresh meat of kept ungulates

The minimum periods referred to in the first subparagraph may be reduced for the diseases listed in Part B of Annex XXIV subject to compliance with the specific conditions provided for therein; these specific conditions must be specifically assigned by the Union in the list, to that third country or territory or zone thereof and to the particular species of origin of the fresh meat.

Article 134

The establishment of origin of the kept ungulates from which the fresh meat has been obtained

• (a) in and around which, including where appropriate the territory of a neighbouring country, none of the listed diseases referred to in Part A of Annex XXIV, for which the species of ungulates of origin of the fresh meat intended for entry into the Union are listed, has been reported in an area of 10 km radius and for a period of 30 days prior to the date of slaughter; or

• (b) which complies with the specific conditions to be provided by the competent authorities where vaccination against foot and mouth disease has been carried out in the third country or territory or zone thereof less than 12 months prior to the date of slaughter set out in points 1(b) or 3.1(a) of Part B of Annex XXV which must have been specifically assigned by the Commission in the list to the third country or territory or zone thereof authorised for entry into the Union of fresh meat of ungulates and to the species of origin of the fresh meat.

• (a) where no animals have been vaccinated according to Part A of Annex XXV; or

• (b) which is located in a third country, territory or zone thereof which complies with the specific conditions set out in point 1 of Part B of Annex XXIV; these conditions must have been specifically assigned by the Commission in the list to the third country or territory or zone thereof listed for entry into the Union of fresh meat of ungulates and to the species of origin of the fresh meat.

Article 135

Specific requirement for fresh meat obtained from kept ungulates of the species Sus scrofa

Consignments of fresh meat of kept ungulates of the species Sus scrofa shall only be permitted to enter the Union if the fresh meat of the consignment originates from animals which have been kept separated from wild ungulates since birth.

Article 136

The establishment of origin of the fresh meat of kept ungulates

Consignments of fresh meat of kept ungulates shall only be permitted to enter the Union if the fresh meat of the consignment was obtained in a slaughterhouse, or in a game handling establishment, in and around which none of the listed diseases referred to in Part A of Annex XXIV has been reported in an area of 10 km radius, including, where appropriate, the territory of a neighbouring country, for a period of 30 days prior to the date of slaughter or to the date of killing.

SECTION 3 SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF WILD UNGULATES

Article 137

The country or territory of origin or zone thereof of the fresh meat of wild ungulates

Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the fresh meat of the consignment originates from a third country or territory or zone thereof which complies with the animal health requirements laid down in Article 133.

Article 138

The wild ungulates of origin of the fresh meat

Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the fresh meat of the consignment was obtained from animals which comply with the following requirements:

• (a) they were killed at a distance that exceeds 20 km from the border of any third country or territory or zone thereof which at that time was not listed for entry into the Union of fresh meat of the species of wild ungulates;

• (b) they were killed in an area of 20 km radius, where, during the preceding 60 days, the diseases referred to in Part A of Annex XXIV have not been reported.

Article 139

The game handling establishment of origin of fresh meat of wild ungulates

Consignments of fresh meat of wild ungulates shall only be permitted to enter the Union if the fresh meat of the consignment has been obtained in a game handling establishment in and around which none of the listed diseases referred to in Part A of Annex XXIV has been reported in an area of 10 km radius, including where appropriate the territory of a neighbouring country, for a period of 30 days prior to the date of killing.

CHAPTER 3 Animal health requirements for fresh meat of poultry and game birds

SECTION 1 SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF POULTRY

Article 140

The residency period of poultry

Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh meat of the consignment has been obtained from poultry which:

• (a) have been kept since hatching and until the date of slaughter in the third country or territory of origin of the fresh meat or zone thereof; or

• (b) were imported as day-old chicks, breeding poultry, productive poultry or poultry intended for slaughter from a third country or territory or zone thereof which is listed for entry into the Union for those commodities or from a Member State and the import took place in accordance with animal health requirements at least as stringent as the relevant requirements of this Regulation.

Article 141

The third country or territory of origin or zone thereof of the fresh meat of poultry

Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh meat of the consignment originates from a third country or territory or zone thereof which complies with the following requirements:

• (a) it has a disease surveillance programme for highly pathogenic avian influenza in place for a period of at least 6 months prior to the date of dispatch of the consignment to the Union and that surveillance programme complies with the requirements laid down in either:
• (i) Annex II to this Regulation; or
• (ii) the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE);

• (b) it is considered to be free from highly pathogenic avian influenza in accordance with Article 38;

• (c) where it carried out vaccination against highly pathogenic avian influenza, the competent authority of the third country or territory of origin has provided guarantees that:
• (i) the vaccination programme complies with the requirements set out in Annex XIII;
• (ii) the surveillance programme referred to in point (a) of this Article, in addition to the requirements set out in Annex II, complies with the requirements set out in point 2 of Annex XIII;
• (iii) it has undertaken to inform the Commission of any change to the vaccination programme in the third country or territory or zone thereof;

• (d) which:
• (i) in the case of fresh meat of poultry other than ratites, it is considered to be free from infection with Newcastle disease virus in accordance with Article 39;
• (ii) in the case of fresh meat of ratites, is either:
• — considered to be free from infection with Newcastle disease virus in accordance with Article 39, or
• — not considered to be free from infection with Newcastle disease virus in accordance with Article 39, but the competent authority of the third country or territory of origin has provided guarantees regarding compliance with the requirements for infection with Newcastle disease virus in relation to isolation, surveillance and testing, as set out in Annex XIV;

• (e) where vaccination against infection with Newcastle disease virus is carried out, the competent authority of the third country or territory has provided guarantees that:
• (i) the vaccines used comply with the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV; or
• (ii) the vaccines used comply with the general criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV and the poultry from which the fresh meat has been obtained meet the animal health requirements set out in point 3 of Annex XV for fresh meat of poultry originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV;

• (f) it has undertaken that following an outbreak of highly pathogenic avian influenza or an outbreak of infection with Newcastle disease virus, to submit the following information to the Commission:
• (i) information on the disease situation within 24 hours of confirmation of any initial outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus;
• (ii) regular updates of the disease situation;

• (g) which has undertaken to submit virus isolates from initial outbreaks of highly pathogenic avian influenza and infection with Newcastle disease virus to the European Union Reference Laboratory for Avian Influenza and Newcastle disease.

Article 142

The establishment of origin of the poultry

Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh meat of the consignment originates from poultry which come from an establishment:

• (a) in which and within a 10 km radius of the establishment, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of slaughter;

• (b) which, in the case of fresh meat of ratites originating in a third country or territory or zone thereof not free from infection with Newcastle disease virus, complies with the animal health requirements for ratites, hatching eggs thereof and fresh meat of ratites originating in a third country or territory or zone thereof not free from infection with Newcastle disease virus, set out in points 3(b) and (c) of Annex XIV.

Article 143

The poultry of origin of the fresh meat

• (a) where they have been vaccinated against highly pathogenic avian influenza, guarantees for compliance with the minimum requirements for vaccination programmes and additional surveillance set out in Annex XIII, have been provided by the third country or territory of origin;

• (b) where they have been vaccinated against infection with Newcastle disease virus:
• (i) guarantees have been provided by the competent authority of the third country or territory of origin that the vaccines used comply with:
• — the general and the specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV, or
• — the general criteria for recognised vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV and the poultry from which the fresh meat has been obtained meet the animal health requirements set out in point 3 of Annex XV for fresh meat of poultry originating from a third country or territory or zone thereof where vaccines used against infection with Newcastle disease virus do not meet the specific criteria set out in point 1 of Annex XV;
• (ii) the information set out in point 4 of Annex XV must be provided for the consignment.

Article 144

The establishment of origin for the fresh meat of poultry

Consignments of fresh meat of poultry shall only be permitted to enter the Union if the fresh meat of the consignment originates from a slaughterhouse which:

• (a) at the time of slaughter, was not under restrictions due to an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus or under official restrictions under national legislation for animal health reasons;

• (b) within a 10 km radius of the slaughterhouse, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the date of slaughter.

SECTION 2 SPECIFIC ANIMAL HEALTH REQUIREMENTS FOR FRESH MEAT OF GAME BIRDS

Article 145

The third country or territory of origin or zone thereof of the fresh meat of game birds

Consignments of fresh meat of game birds shall only be permitted to enter the Union if the fresh meat of the consignment originates from a third country or territory or zone thereof which complies with the following requirements:

• (a) it has a disease surveillance programme for highly pathogenic avian influenza in place for a period of at least 6 months prior to the date of dispatch of the consignment to the Union and that surveillance programme complies with the requirements established in either:
• (i) Annex II to this Regulation; or
• (ii) the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE);

• (b) where there have been no animal health restrictions due to an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least 30 days prior to the time of killing.

Article 146

The establishment of origin of the fresh meat of game birds

Consignments of fresh meat of game birds shall only be permitted to enter the Union if the fresh meat of the consignment originates from a game handling establishment:

• (a) which, at the time of dressing, was not under restrictions due to an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus or under official restrictions for animal health reasons;

• (b) within a 10 km radius of the game handling establishment, including, where appropriate, the territory of a neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus during the period of at least the 30 days prior to the date of reception of the carcasses.

TITLE 3 ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF MEAT PRODUCTS AND CASINGS

Article 147

Treatment of meat products

Consignments of meat products shall only be permitted to enter the Union if the meat products of the consignment have been treated in accordance with Article 121 as required in Articles 148 or 149.

Article 148

Meat products not subject to a risk-mitigating treatment

Consignments of meat products shall only be permitted to enter the Union if the meat products of the consignment have not undergone a risk-mitigating treatment in accordance with Annex XXVI where:

• (a) the third country or territory or zone thereof of origin is listed for entry into the Union of fresh meat of the relevant species, and specific conditions in accordance with Title 2, Chapters 1 and 2 of Part IV, are not required for entry into the Union of such fresh meat;

• (b) the fresh meat used for the processing of the meat product complied with all the requirements for entry into the Union of fresh meat and therefore was eligible for entry into the Union and originated from at least one of the following:
• (i) the third country or territory or zone thereof where the meat product was processed;
• (ii) a third country or territory or zone thereof which is listed for entry into the Union of fresh meat of the relevant species without the obligation to apply specific conditions referred to in Part B of Annex XXV;
• (iii) a Member State.

Article 149

Meat products subject to a risk-mitigating treatment

• (a) the third country or territory or zone thereof where the meat product has been processed;

• (b) a listed third country or territory or zone thereof authorised for entry into the Union of fresh meat of the relevant species without the obligation to apply specific conditions referred to in Part B of Annex XXV;

• (c) a Member State.

• (a) other than the third country or territory or zone thereof in which the meat product is obtained;

• (b) which is also listed for entry into the Union of meat products of the relevant species, subject to a risk-mitigating treatment specifically assigned by the Union in the list, to that third country or territory or zone thereof and to the relevant species, in accordance with Article 121.

• (a) listed for entry into the Union of fresh meat of poultry;

• (b) in which there has been a case or an outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus.

• (a) the meat products must have undergone the most severe of the risk-mitigating treatments assigned in the list to the third country or territory or zone thereof, in accordance with Article 121, for the different species of animals of origin, where the fresh meat is mixed before the final processing of the meat product takes place; or

• (b) the meat products must have undergone the risk-mitigating treatment assigned in the list to the third country or territory or zone thereof, in accordance with Article 121, for each different species of animals of origin, where the mixing of the meat products have taken place after processing of each ingredient of the meat product.

Article 150

The establishment of origin of the animals from which the fresh meat was obtained

Consignments of meat products shall only be permitted to enter the Union if they have been processed from fresh meat which originates from animals coming from an establishment, or, in the case of wild animals, from a place in and around which, in an area of a 10 km radius, including, where appropriate, the territory of a neighbouring country, none of the listed diseases, relevant for the species of origin of the meat products in accordance with the list set out in Annex I, has been reported during the period of 30 days prior to the date of slaughter or killing of the animals.

Article 151

The entry into Member States with status free from infection with Newcastle disease virus without vaccination

Consignments of meat products of poultry intended for a Member State or territory thereof with a status free from infection with Newcastle disease virus without vaccination shall only be permitted to enter into the Union if they have obtained from poultry which have not been vaccinated with a live vaccine against infection with Newcastle disease virus, during the period of 30 days prior to the date of slaughter.

Article 152

Specific requirements for entry into the Union of casings

Consignments of casings that do not fulfil the requirements provided for in Article 148 shall only be permitted to enter the Union if they have undergone the following risk-mitigating treatments set out in Part 2 of Annex XXVI:

• (a) treatments ‘Casing 1’ or ‘Casing 2’, where the bladders and intestines used for the processing of the casings originate from bovine animals, ovine animals, caprine animals or kept porcine animals;

• (b) treatments ‘Casing 3’, ‘Casing 4’ or ‘Casing 5’ where the bladders and intestines used for the processing of the casings originate from animals of species other than those referred to in point (a).

TITLE 4 ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF MILK, DAIRY PRODUCTS, COLOSTRUM AND COLOSTRUM-BASED PRODUCTS

CHAPTER 1 Specific animal health requirements for raw milk, colostrum and colostrum-based products

Article 153

The country of origin of the raw milk, colostrum and colostrum-based products

Consignments of raw milk, colostrum or colostrum-based products shall only be permitted to enter the Union if the raw milk, colostrum and colostrum-based products of the consignment originate from a third country or territory or zone thereof which has been free from foot and mouth disease and infection with rinderpest virus for a period of at least 12 months prior to the date of milking and, during that period, no vaccination against those diseases has been carried out.

Article 154

The animals of origin of the raw milk, colostrum and colostrum-based products

• (a) another third country or territory or zone thereof which is listed for entry into the Union of raw milk, colostrum or colostrum-based products and the animals remained there for at least 3 months prior to milking; or

• (b) a Member State.

CHAPTER 2 Specific animal health requirements for dairy products

Article 155

Treatment of dairy products

Consignments of dairy products shall only be permitted to enter into the Union if the dairy products of the consignment have been treated in accordance with Article 121 as required in Articles 156 or 157.

Article 156

Dairy products not subject to a risk-mitigating treatment

Consignments of dairy products originating from a third country or territory, or zone thereof, which is listed for entry into the Union of raw milk shall be permitted to enter the Union without having undergone a specific risk-mitigating treatment provided for in Annex XXVII, if the dairy products of the consignment comply with following requirements:

• (a) the raw milk or dairy product therefrom, from which they were processed, were obtained from animals of the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis and Camelus dromedarius;

• (b) the raw milk or dairy product therefrom, used for the processing of the dairy products complied with the relevant general animal health requirements for the entry into the Union of products of animal origin laid down in Articles 3 to 10 and the specific animal health requirements for the entry into the Union of raw milk laid down in Articles 153 and 154, and therefore was eligible for entry into the Union and it originates from one of the following:
• (i) a listed third country or territory, or zone thereof, where the dairy products were processed;
• (ii) a third country or territory, or zone thereof, other than a listed third country or territory, or zone thereof, where the dairy products were processed and which is authorised for entry into the Union of raw milk; or
• (iii) a Member State.

Article 157

Dairy products subject to a risk-mitigating treatment

• (a) they were processed from milk obtained from the species Bos Taurus, Ovis aries, Capra hircus, Bubalus bubalis or Camelus dromedarius;

• (b) the third country or territory of origin or zone thereof has not been free from foot and mouth disease and infection with rinderpest virus for a period of at least 12 months prior to the date of milking, or if during that period vaccination against those diseases has been carried out.

• (a) at least the most severe of the risk-mitigating treatments assigned to the each species of animals of origin, where the mixing of raw milk or dairy products takes place before the final processing of the product; or

• (b) the risk-mitigating treatment assigned to each species of animals of origin, where the mixing of the products takes place after processing of each ingredient of the dairy product.

TITLE 5 **Article 157

Dairy products subject to a risk-mitigating treatment

(a) they were processed from raw milk or dairy products therefrom, and obtained from the species Bos taurus, Ovis aries, Capra hircus, Bubalus bubalis or Camelus dromedarius; (b) the third country or territory of origin, or zone thereof was not free from foot and mouth disease and infection with rinderpest virus for at least 12 months prior to the date of milking or if vaccination against those diseases was carried out during that period.

(a) at least the most severe of the risk-mitigating treatments assigned to each species of animals of origin where the mixing of raw milk or dairy products takes place before the final processing of the dairy product; or (b) the risk-mitigating treatment assigned to each species of animals of origin where the mixing of the products takes place after processing of each ingredient of the dairy product.**

CHAPTER 1 Specific animal health requirements for eggs

Article 158

The third country or territory of origin or zone thereof of the eggs

Consignments of eggs shall only be permitted to enter the Union if the eggs of the consignment originate from a third country or territory or zone thereof which applies a disease surveillance programme for highly pathogenic avian influenza that complies with the requirements established in either:

• (a) Annex II to this Regulation; or

• (b) the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE).

Article 159

The establishment of origin of the eggs

Consignments of eggs shall only be permitted to enter the Union if the eggs of the consignment originate from an establishment that complies with the following requirements:

• (a) during the period of 30 days prior to the date of collection of the eggs and until the date of issue of the certificate for entry into the Union, no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus occurred; and

• (b) within a 10 km radius of the establishment, including, where appropriate, the territory of a neighbouring country there was no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus for a period of at least 30 days prior to the date of collection of eggs and until the date of issue of the certificate for entry into the Union.

CHAPTER 2 Specific animal health requirements for egg products

Article 160

The third country or territory of origin, or zone thereof of the egg products

Consignments of egg products shall only be permitted to enter into the Union if the egg products of the consignment either:

• (a) originate from a third country or territory, or zone thereof listed for the entry into the Union of eggs, and which applies a disease surveillance programme for highly pathogenic avian influenza that complies with the requirements established in either:
• (i) Annex II to this Regulation; or
• (ii) the relevant Chapter of the Terrestrial Animal Health Code of the World Organisation for Animal Health (WOAH); or if they

• (b) originate from a third country or territory, or zone thereof listed for the entry into the Union of egg products and where they have undergone an appropriate risk-mitigating treatment as set out for that particular egg product in the tables in points 1 and 2 in Annex XXVIII, to achieve the inactivation of the highly pathogenic avian influenza virus and the Newcastle disease virus.

Article 161

The establishment of origin of the eggs

Consignments of egg products shall only be permitted to enter the Union if the egg products of the consignment have been processed from eggs that originated in an establishment:

• (a) in which, during the period of 30 days prior to the date of collection of the eggs, no outbreak of highly pathogenic avian influenza and infection with Newcastle disease virus has occurred;

• (b) within a 10 km radius of the establishment, including, where appropriate, the territory of a neighbouring country, there has either been:
• (i) no outbreak of highly pathogenic avian influenza for a period of at least 30 days prior to the date of collection of eggs; or
• (ii) an outbreak of highly pathogenic avian influenza within the period of 30 days prior to the date of collection of eggs and the egg product has undergone one of the risk-mitigating treatments for egg products set out in point 1 of Annex XXVIII;

• (c) within a 10 km radius of the establishments, including, where appropriate, the territory of a neighbouring country, there has either been:
• (i) no outbreak of infection with Newcastle disease virus for a period of at least 30 days prior to the date of collection of eggs; or
• (ii) an outbreak of infection with Newcastle disease virus within the period of 30 days prior to the date of collection of eggs and the egg product, has undergone one of the risk-mitigating treatments for egg products set out in point 2 of Annex XXVIII.

TITLE 6 ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF PROCESSED PRODUCTS OF ANIMAL ORIGIN CONTAINED IN COMPOSITE PRODUCTS

Article 162

Composite products containing meat products, dairy products, colostrum-based products and/or egg products

• (a) composite products containing meat products;

• (b) non-shelf stable composite products containing dairy products, and/or egg products

• (c) composite products containing colostrum-based products.

• (a) comply with:
• (i) the relevant general animal health requirements for entry into the Union of products of animal origin laid down in Part 1 of this Regulation;
• (ii) the animal health requirements for entry into the Union of the specific product of animal origin, as laid down in Titles 1, 3, 4 and 5 of this Part;

• (b) they have been obtained either:
• (i) in the same listed third country or territory of origin or zone thereof of the composite product;
• (ii) in a Member State; or
• (iii) in a third country or territory or zone thereof listed for entry into the Union of those products without undergoing a specific risk-mitigating treatment, in accordance with Articles 148 and 156, if the third country or territory or zone thereof where the composite product is produced is also listed for entry into the Union of those products without the obligation to apply a specific risk-mitigating treatment.

Article 163

Specific requirements for certain composite products containing dairy products, or egg products, or both

• (a) dairy products that comply with one of the following conditions:
• (i) the dairy products have been obtained either in a Member State or in a third country or territory, or zone thereof listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment; and the third country or territory, or zone thereof where the composite product is produced, if different, is also listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment;
• (ii) the dairy products have undergone a risk-mitigating treatment referred to in column A or B of the table in Annex XXVII, relevant for the species of origin of the milk, provided that the dairy products have been obtained either in a Member State or in a third country or territory, or zone thereof listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment where that risk-mitigating treatment was applied; and the third country or territory, or zone thereof where the composite product is produced is listed for the entry into the Union of dairy products that have undergone a specific risk-mitigating treatment;
• (iii) the dairy products have undergone a risk-mitigating treatment referred to in column A or B of the table in Annex XXVII, relevant for the species of origin of the milk, provided that the dairy products have been obtained in a third country or territory, or zone thereof listed for the entry into the Union of dairy products that have undergone a specific risk-mitigating treatment where that risk-mitigating treatment was applied; and the third country or territory, or zone thereof where the composite product is produced, if different, is also listed for the entry into the Union of dairy products that have undergone a specific risk-mitigating treatment;
• (iv) the dairy products have undergone a risk-mitigating treatment referred to in column B of the table in Annex XXVII, regardless of the species of origin of the milk, provided that the dairy products have been obtained either in a Member State where that risk-mitigating treatment was applied, or in a third country or territory, or zone thereof listed for the entry into the Union of dairy products without undergoing a specific risk-mitigating treatment where that risk-mitigating treatment was applied, or in a third country or territory, or zone thereof listed for the entry into the Union of dairy products where that risk-mitigating treatment was applied; and the third country or territory, or zone thereof where the composite product is produced is listed for the entry into the Union of dairy products;

• (b) egg products that have undergone an appropriate risk-mitigating treatment as set out for that particular egg product in the tables in points 1 and 2 in Annex XXVIII, to achieve the inactivation of highly pathogenic avian influenza virus and Newcastle disease virus; and the third country or territory, or zone thereof where the composite product is produced, if different, is also listed for entry into the Union of egg products.

• (a) only accompany consignments of composite products where the final destination of the composite products is in the Union;

• (b) be prepared and signed by the food business operator as defined in Article 3, point (3), of Regulation (EC) No 178/2002 of the European Parliament and of the Council ([^E0012]), responsible for entry into the Union of the consignment of composite products, attesting that the composite products in the consignment comply with the requirements laid down in paragraph 1 or 2, or both.

TITLE 7 SPECIAL RULES FOR ENTRY INTO THE UNION OF PRODUCTS OF ANIMAL ORIGIN INTENDED FOR PERSONAL USE

Article 164

Derogation from animal health requirements and additional requirements for entry of infant milk, infant food and special foods intended for personal use

By way of derogation from the requirements laid down in Articles 3 to 10 of Part I and Articles 120 to 163, consignments of powdered infant milk, infant food and special foods required for medical reasons, containing products of animal origin which do not comply with those requirements shall be permitted to enter the Union if those products:

• (a) are intended for personal use;

• (b) do not exceed a combined quantity of 2 kilogramme per person;

• (c) do not require refrigeration before opening;

• (d) are packaged proprietary brand products for direct sale to the final consumer;

• (e) maintain the packaging unbroken, unless in current use.

Article 165

Derogation from animal health requirements for products of animal origin intended for personal use originating from certain third countries or territories or zones thereof

PART V

ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION AS REFERRED TO IN ARTICLES 3 AND 5 OF AQUATIC ANIMALS OF LISTED SPECIES AND THEIR PRODUCTS OF ANIMAL ORIGIN, AND FOR THEIR MOVEMENT AND HANDLING AFTER THE ENTRY

TITLE 1 GENERAL ANIMAL HEALTH REQUIREMENTS FOR ENTRY INTO THE UNION OF THE AQUATIC ANIMALS REFERRED TO IN ARTICLE 1(6) AND THEIR PRODUCTS

Article 166

Inspection of aquatic animals prior to dispatch

Consignments of aquatic animals other than those referred to in points (d), (e) and (f) of Article 172 shall only be permitted to enter the Union if those aquatic animals have been subjected to a clinical inspection by an official veterinarian in the exporting third country or territory, zone or compartment thereof within a period of 72 hours prior to the time of loading for dispatch of the consignment to the Union for the purpose of detection of symptoms of disease and abnormal mortalities.

However, the clinical inspection referred to in the first paragraph may be performed by an aquatic animal health professional, provided that the aquatic animal health professional is authorised to undertake that activity by the third country or territory concerned under its national law.

Article 167

Dispatch to the Union of aquatic animals

Consignments of aquatic animals shall only be permitted to enter the Union if the aquatic animals of the consignment comply with the following requirements:

• (a) other than in the case of the aquatic animals referred to in of Article 172, points (d), (e) and (f), they were dispatched directly from their place of origin to the Union;

• (b) they were not unloaded from their container when transported by air, sea, railway or by road, and the water in which they are transported was not changed, in a third country or territory, zone or compartment which is not listed for entry of the particular species and category of aquatic animals into the Union;

• (c) they have not been transported under conditions that have jeopardised their health status, in particular:
• (i) where relevant, they must have been loaded and transported in water which did not alter their health status;
• (ii) the means of transport and the containers must have been constructed in such a way that the health status of the aquatic animals was not jeopardised during the transport;
• (iii) the container or well boat must have been cleaned and disinfected, in accordance with a protocol and with products approved by the competent authority of the third country or territory of origin, prior to loading for dispatch to the Union, which ensure that the health status of the aquatic animals is not jeopardised during transport;

• (d) from the time of loading at the place of origin until the time of arrival in the Union, they must not have been transported in the same water or container or well-boat together with aquatic animals which were of a lower health status or which were not intended for entry into the Union;

• (e) where a water exchange is necessary in a third country, territory, zone or compartment which is listed for entry of the particular species and category of aquatic animals into the Union, it must not have jeopardised the health status of the animals being transported and it must have only occurred:
• (i) in the case of transport on land, at water exchange points approved by the competent authority of the third country or territory where the water exchange takes place;
• (ii) in the case of transport by well-boat, at a distance which is at least 10 km from any aquaculture establishments which are located en-route from the place of origin to the place of destination in the Union.

Article 168

Transport by vessel of aquatic animals

Other than in the case of the aquatic animals referred to in Article 172, points (d), (e) and (f), where the dispatch to the Union of consignments of aquatic animals includes transport by vessel or well-boat even for part of the journey, those consignments of aquatic animals transported in accordance with Article 167 shall only be permitted to enter the Union if the aquatic animals of the consignment are accompanied by a declaration, attached to the animal health certificate and signed by the master of the vessel on the day of arrival of the vessel at its port of destination, providing the following information:

• (a) the port of departure in the third country or territory;

• (b) the port of arrival in the Union;

• (c) the ports of call, in the case the vessel called at ports outside the third country or territory of origin or zone thereof;

• (d) confirmation of compliance of the consignment of aquatic animals with the relevant requirements set out in Article 167 throughout the journey from the port of departure in the third country or territory to the port of arrival in the Union.

Article 169

Specific transport and labelling requirements

• (a) the number of containers in the consignment;

• (b) the name of the species present in each container;

• (c) the number of animals in each container for each of the species present;

• (d) the purpose for which they are intended.

• (a) they must be identified by a legible label on the exterior of the container, which refers to the certificate that has been issued for that consignment;

• (b) the legible label referred to in point (a) must also contain the following statements, as relevant:
• (i) ‘products of animal origin from fish, other than live fish, intended for further processing in the European Union’;
• (ii) ‘products of animal origin from molluscs, other than live molluscs, intended for further processing in the European Union’;
• (iii) ‘products of animal origin from crustaceans, other than live crustaceans, intended for further processing in the European Union’.

Article 170

Requirements regarding the third country or territory of origin or zone or compartment thereof and the establishment of origin

• (a) it must be free from the following listed diseases:
• (i) category A diseases and category B diseases of aquatic animals;
• (ii) relevant category C diseases when the aquatic animals or products of animal origin are destined for Member States, zones or compartments which have disease-free status or an approved eradication programme for the specific diseases;
• (iii) category C diseases in all cases when the aquatic animals are intended for release into the wild;
• (iv) diseases for which certain Member States have taken the national measures referred to in Article 175 of this Regulation, when a consignment contains relevant species listed in Annex XXIX hereto and it is destined for a Member State, zone or compartment which is listed in Annex I or II to Commission Implementing Decision (EU) 2021/260 ([^E0013]);

• (b) all the entries of aquatic animals of listed species into the third country or territory, zone or compartment exporting to the Union must originate from a different third country or territory or zone or compartment thereof which is free from the diseases referred to in point (a);

• (c) vaccination of aquatic animals of listed species against category A diseases, category B or where relevant category C diseases, has not been carried out in the third country or territory of origin.

• (a) registered in accordance with requirements which are at least as stringent as to those laid down in Section 1 of Chapter 1, Title II of Part IV of Regulation (EU) 2016/429; or

• (b) approved in accordance with requirements which are at least as stringent as to those laid down in Section 2 of Chapter 1, Title II of Part IV of Regulation (EU) 2016/429 and Title I of Part II of Commission Delegated Regulation (EU) 2020/691 ([^E0014]).

Article 171

Vector species

Article 172

Derogations for certain categories of aquatic animals of listed species

By way of derogation from Article 170(1), the requirements laid down in that Article shall not apply to the following categories of aquatic animals:

• (a) aquatic animals which are destined for a disease control aquatic food establishment where they are to be processed for human consumption;

• (b) aquatic animals intended for research purposes which are destined for confined establishments which have been approved for that purpose by the competent authority of the Member State of destination;

• (c) wild aquatic animals other than those referred to in point (b) of this Article provided that they have been subject to quarantine in a quarantine establishment which has been approved for that purpose by the competent authority in:
• (i) the third country of origin; or
• (ii) the Union;

• (d) molluscs or crustacea which are packed and labelled for human consumption in accordance with Regulation (EC) No 853/2004 and which are no longer able to survive as living animals if returned to the aquatic environment;

• (e) molluscs or crustacea which are packaged and labelled for human consumption in accordance with Regulation (EC) No 853/2004 and which are intended for further processing without temporary storage at the place of processing;

• (f) live bivalve molluscs or crustacea which are intended for human consumption without further processing, provided that they are packaged for retail sale in compliance with the provisions of Regulation (EC) No 853/2004.

Article 173

Derogations for certain products of animal origin from aquatic animals other than live aquatic animals

By way of derogation from Article 170(1), the requirements laid down in that Article shall not apply to the following products of animal origin from aquatic animals, other than live aquatic animals:

• (a) products of animal origin from aquatic animals, other than live aquatic animals, which are destined for a disease control aquatic food establishment where they are to be processed for human consumption;

• (b) fish intended for human consumption after further processing in the Union which were slaughtered and eviscerated prior to dispatch to the Union.

Article 174

Handling of aquatic animals and products of animal origin from aquatic animals other than live aquatic animals after entry into the Union

• (a) aquatic animals other than those referred to in Article 172, points (d), (e), and (f), shall be transported directly to their place of destination in the Union;

• (b) aquatic animals and products of animal origin from aquatic animals shall be handled appropriately to ensure that natural waters are not contaminated.

TITLE 2 ANIMAL HEALTH REQUIREMENTS TO LIMIT THE IMPACT OF CERTAIN DISEASES OTHER THAN THOSE WHICH ARE REFERRED TO IN ARTICLE 9(1), POINT (D), OF REGULATION (EU) 2016/429

Article 175

Additional animal health requirements to limit the impact of diseases for which Member States have national measures approved in accordance with Article 226(3) of Regulation (EU) 2016/429

PART VI

SPECIAL RULES FOR ENTRY OF CERTAIN COMMODITIES AS REFERRED TO IN ARTICLES 3 AND 5 FOR WHICH THE UNION IS NOT THE FINAL DESTINATION AND FOR ENTRY OF CERTAIN COMMODITIES ORIGINATING FROM AND RETURNING TO THE UNION

Article 176

Requirements for transit through the Union

• (a) they comply with all the relevant requirements for entry into the Union of the particular species and category of animals, germinal products or products of animal origin in question laid down in Parts I to V; or

• (b) they fall within the scope of specific conditions, specifically assigned by the Union in the list to the listed third country or territory or zone of origin and to the particular species and category of animals, germinal products and products of animal origin, to mitigate any potential animal health risk involved in such movements.

• (a) the additional requirements laid down in Articles 177 to 182; or

• (b) specific conditions, specifically assigned by the Union in the list to the listed third country or territory or zone of transit and to the particular species and category of animals, germinal products and products of animal origin, to mitigate any potential animal health risk involved in such movements.

• (a) the criteria laid down in Article 230 of Regulation (EU) 2016/429;

• (b) the particular species and category of animals, germinal products and products of animal origin intended for transit and the related animal health risks;

• (c) geographical constraints;

• (d) established trade routes;

• (e) other relevant factors.

Article 177