Commission Delegated Regulation (EU) 2021/1705 of 14 July 2021 amending Delegated Regulation (EU) 2020/692 supplementing Regulation (EU) 2016/429 of the European Parliament and 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)

Delegated Regulation (EU) 2020/692 is amended as follows:

1. Article 1 is amended as follows:

   1. in paragraph 6, the introductory phrase is replaced by the following:

      ‘6.

      Part V lays down the animal health requirements for the 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, excluding products of animal origin other than live aquatic animals which are intended for direct human consumption and wild aquatic animals and products of animal origin from those wild aquatic animals landed from fishing vessels intended for direct human consumption:’;

   2. paragraph 8 is replaced by the following:

      ‘8.

      Part VII lays down transitional and final provisions.’;

2. Article 2 is amended as follows:

   1. point (8) is replaced by the following:

      1. “porcine animal” means an animal of the species of ungulates belonging to the family Suidae listed in Annex III to Regulation (EU) 2016/429 for the purpose of entry into the Union of an animal or an animal of the species Sus scrofa, for the purpose of entry into the Union of germinal products;’;

   2. point (48) is replaced by the following:

      1. “well-boat” means a “well-boat” as defined in Article 2, point 2, of Commission Delegated Regulation (EU) 2020/990^(*);

3. in Article 3, point (a)(i) is replaced by the following:

   1. in the case of terrestrial animals, germinal products and products of animal origin, a listed third country or territory or zone thereof for the particular species and category of animals, germinal products and products of animal origin;’;

4. in Article 13(1), the second subparagraph is replaced by the following:

   ‘In the case of poultry, except day-old chicks, and captive birds, that inspection shall also cover the flock of origin of the animals intended for dispatch to the Union.’;

5. Article 26 is replaced by the following:

   Following their entry into the Union, ungulates, except equine animals, shall remain in their establishment of destination for a period of at least 30 days from the date of their arrival in that establishment, unless they are moved for slaughter.’;

6. Article 49 is amended as follows:

   1. the introductory phrase is replaced by the following:

      ‘By way of derogation from Article 14(3), Article 40 and Articles 43 to 48, consignments containing less than 20 heads of poultry other than ratites, shall be permitted to enter the Union provided that such consignments comply with the following requirements:’;

   2. point (c) is replaced by the following:

      1. as regards vaccination against highly pathogenic avian influenza:

         1. the poultry have not been vaccinated against highly pathogenic avian influenza;

         2. the flock of origin of the poultry, except day-old chicks, has not been vaccinated against highly pathogenic avian influenza;

         3. where the parent flocks of the day-old chicks 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;’;

   3. point (e)(iii) is replaced by the following:

      1. SalmonellaPullorum and SalmonellaGallinarum in case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;’;

   4. the following point (f) is added:

      1. the day-old chicks come from hatching eggs which prior to incubation have been disinfected in accordance with the instructions of the competent authority of the third country or territory of origin.’;

7. Article 57 is replaced by the following:

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

   1. they have not been vaccinated against highly pathogenic avian influenza;

   2. where they have been vaccinated against infection with Newcastle disease virus, the competent authority of the third country or territory of origin has provided guarantees that the vaccines used comply with the general and specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV;

   3. they have been subjected to a virus detection test for highly pathogenic avian influenza and infection with Newcastle disease virus with negative results, within a period of 7 to 14 days prior to the date of loading for dispatch to the Union.’;

8. in Article 60, point (b)(vi) is renumbered as point (c) as follows:

   1. release the captive birds from quarantine only on the written authorisation of an official veterinarian.’;

9. Article 62 is replaced by the following:

   1.

   By way of derogation from requirements laid down in Articles 3 to 10, except point (a)(i) of Article 3, Articles 11 to 19 and Articles 53 to 61, consignments of captive birds which do not comply with those requirements shall be permitted to enter the Union if they originate from third countries or territories specifically listed for the entry into the Union of captive birds based on equivalent guarantees.

   2.

   By way of derogation from the requirements laid down in Article 11 and Articles 54 to 58, consignments of racing pigeons which enter the Union from a third country or territory or zone thereof where they are normally kept, with the intention to be immediately released with the expectation that they will fly back to that third country or territory or zone thereof and which do not comply with those requirements, shall be permitted to enter the Union if they comply with the following requirements:

   1. the Member State of destination has determined that the racing pigeons may enter into its territory from that third country or territory or zone thereof in accordance with Article 230(2) of Regulation (EU) 2016/429;

   2. they come from a registered establishment, within a 10 km radius of which, including, where appropriate, the territory of any neighbouring country, there has been no outbreak of highly pathogenic avian influenza or infection with Newcastle disease virus for a period of at least the preceding 30 days prior to the date of loading for dispatch to the Union;

   3. they have not been vaccinated against highly pathogenic avian influenza;

   4. they have been vaccinated against infection with Newcastle disease virus and the competent authority of the third country or territory of origin has provided guarantees that the vaccines used comply with the general and specific criteria for vaccines against infection with Newcastle disease virus set out in point 1 of Annex XV;

   5. they come from an establishment where vaccination against infection with Newcastle disease virus is carried out.

   3.

   By way of derogation from the requirements laid down in Articles 59, 60 and 61, the competent authority of the Member State of entry into the Union may authorise the entry into the Union of racing pigeons which will not be transported directly to a quarantine establishment approved in accordance with Article 14 of Delegated Regulation (EU) 2019/2035 if they are:

   1. racing pigeons which have entered into the Union from a third country or territory or zone thereof where they are normally kept in accordance with paragraph 2;

   2. released immediately, under the control of the competent authority, with the expectation that they will fly back to the third country or territory of origin or zone thereof.’;

10. in Article 74, paragraph 1 is replaced by the following:

    ‘1.

    Consignments of dogs, cats and ferrets shall only be permitted to enter the Union if each animal in the consignment is individually identified by an injectable transponder as listed in point (e) of Annex III to Delegated Regulation (EU) 2019/2035, which was implanted by a veterinarian and which fulfils the technical requirements referred to in Annex II to Regulation (EU) No 576/2013.’;

11. in Article 80, point (a) is replaced by the following:

    1. prior to the date of collection, remained in a third country or territory or zone thereof which is listed for the entry into the Union of the particular species and category of germinal product:

       1. in the case of bovine, ovine and caprine animals, for a period of at least 6 months;

       2. in the case of porcine and equine animals, for a period of at least 3 months;’;

12. in Article 83, point (a)(iii) is replaced by the following:

    1. the unique approval number of the germinal product establishment of collection or production, processing and storage of those germinal products;’;

13. after Article 85, the following Article 85a is inserted:

    Consignments of semen, oocytes and embryos of bovine, porcine, ovine, caprine and equine animals shall only be permitted to enter the Union if those consignments were subjected to a visual examination and documentary check, carried out by an official veterinarian in the third country or territory of origin or zone thereof within the period of 72 hours prior to the time of dispatch to the Union as follows:

    1. a visual examination of the transport container in order to verify compliance with the requirements laid down in Article 84;

    2. a documentary check of the data submitted by the centre or team veterinarian to ensure that:

       1. the information to be certified is supported by the records kept in accordance with:

          • Article 8(1)(a) of Delegated Regulation (EU) 2020/686, and

          • point (d) of Article 8 of this Regulation;

       2. the mark on the straws or other packages, applied in accordance with point (a) of Article 83, corresponds with the number provided in the animal health certificate and on the container in which they are transported;

       3. the animal health requirements referred to in Part III, Title 1, have been fulfilled.’;

14. in Article 87, paragraph 2 is replaced by the following:

    ‘2.

    By way of derogation from point (b)(iii) of Article 86, consignments of oocytes and embryos of bovine animals shall be permitted to enter the Union if a donor animal comes from an establishment which is not free from enzootic bovine leukosis provided that the official veterinarian responsible for the establishment of origin has certified that there has been no clinical case of enzootic bovine leukosis in that establishment during a period of at least the preceding 3 years.’;

15. Article 91 is replaced by the following:

    Consignments of semen, oocytes and embryos of ovine and caprine animals shall only be permitted to enter the Union if they were collected from donor animals which come from an establishment that was free from infection with Brucella abortus, B. melitensis and B. suis and they were never previously in any establishment of a lower status.’;

16. in Article 100, point (b)(ii) is replaced by the following:

    1. the hatching eggs were transferred directly and as soon as possible to the vessel or aircraft to be used for onward travel to the Union, which complies with requirements laid down in point (a) of Article 102, without leaving the premises of the port or airport;’;

17. in Article 102, in point (a), the introductory phrase is replaced by the following:

    1. the hatching eggs must have been transported in means of transport which:’;

18. in Article 107, point (f) is replaced by the following:

    1. they have either:

       1. been subjected to a clinical inspection, carried out by an official veterinarian in the third country or territory of origin or zone thereof, within a period of 72 hours prior to the time of loading of the consignment of hatching eggs 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 and they showed no disease symptoms or grounds for suspecting the presence of any of those diseases;

          or

       2. had

          • monthly clinical inspections carried out by an official veterinarian in the third country or territory of origin or zone thereof, the most recent carried out within a period of 31 days prior to the time of loading of the consignment of hatching eggs 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 and they showed no disease symptoms or grounds for suspecting the presence of any of those diseases,

          • an evaluation of their current health status carried out by an official veterinarian in the third country or territory of origin or zone thereof, within a period of 72 hours prior to the time of loading of the consignment of hatching eggs for dispatch to the Union, as assessed by up-to-date information supplied by the operator and by documentary checks of the health and production records kept on the establishment, for the purpose of the detection of signs indicative of the occurrence of diseases, including emerging diseases and the relevant listed diseases referred to in Annex I.’;

19. Article 110 is amended as follows:

    1. the introductory phrase is replaced by the following:

       ‘By way of derogation from Articles 101, 106, 107 and 108, consignments of less than 20 hatching eggs of poultry other than ratites shall be permitted to enter the Union if they comply with the following requirements:’;

    2. point (d) is replaced by the following:

       1. they come from flocks which 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 a period of 24 hours prior to the time of loading of the consignments of hatching eggs 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, and the flocks showed no disease symptoms or grounds for suspecting the presence of any of those diseases;’;

    3. in point (e)(ii), the third hyphen is replaced by the following:

       • SalmonellaPullorum and SalmonellaGallinarum in the case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;’;

    4. the following point (f) is added:

       1. the hatching eggs must have been disinfected in accordance with the instructions of the competent authority of the third country or territory of origin.’;

20. in Article 111, point (a)(iii) is replaced by the following:

    1. have been kept for a continuous period of at least six weeks prior to the date of collection of the eggs for dispatch to the Union in establishments which:

       • comply with the conditions described in the European Pharmacopoeia,

       • are approved by the competent authority of the third country or territory of origin in accordance with requirements which are at least equivalent to those laid down in Article 8 of Delegated Regulation (EU) 2019/2035, the approval of which has not been suspended or withdrawn;’;

21. after Article 119, the following Article 119a is inserted:

    Consignments of semen, oocytes and embryos referred to in Article 117 shall only be permitted to enter the Union if those consignments have been subjected to visual examination and documentary check, carried out by an official veterinarian in the third country or territory of origin or zone thereof within the period of 72 hours prior to the time of dispatch to the Union as follows:

    1. a visual examination of the transport container in order to verify compliance with the requirements laid down in Article 119;

    2. a documentary check of the data submitted by the establishment veterinarian responsible for the activities carried out at the confined establishment to ensure that:

       1. the information to be certified is supported by the records kept at the confined establishment;

       2. the mark on the straws or other packages, applied in accordance with point (a) of Article 119, corresponds with the number provided in the animal health certificate and on the container in which they are transported;

       3. the animal health requirements referred to in Title 3 of Part III have been fulfilled.’;

22. in Article 125(c), point (i) is replaced by the following:

    1. 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;’;

23. in Article 154, the following paragraph 3 is added:

    ‘3.

    The animals of origin of raw milk, colostrum or colostrum-based products intended for entry into the Union shall not be required to comply with the residency period referred to in paragraph 2, provided that they were introduced into the third country or territory or zone thereof from:

    1. 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

    2. a Member State.’;

24. Article 167 is amended as follows:

    1. points (a) and (b) are replaced by the following:

       1. they were dispatched directly from their place of origin to the Union;

       2. 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;’;

    2. point (d) is replaced by the following:

       1. 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;’;

25. in Article 169(3), point (b) is replaced by the following:

    1. the legible label referred to in point (a) must also contain the following statements, as relevant:

       1. ‘fish intended for human consumption after further processing in the European Union’;

       2. ‘molluscs intended for human consumption after further processing in the European Union’;

       3. ‘crustaceans intended for human consumption after further processing in the European Union’.’;

26. in Article 172, the introductory phrase is replaced by the following:

    ‘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:’;

27. in Article 173, point (b) is replaced by the following:

    1. fish intended for human consumption after further processing in the Union which were slaughtered and eviscerated prior to dispatch to the Union.’;

28. in Article 174, paragraph 3 is replaced by the following:

    ‘3.

    The competent authority of the Member State may only grant the authorisation provided for in paragraph 2 of this Article where the release or immersion in natural waters does not jeopardise the health status of the aquatic animals at the place of release or immersion and in all cases, release into the wild shall comply with the requirement laid down in Article 170(1)(a)(iii).’;

29. Article 175 is amended as follows:

    1. the title is replaced by the following:

    2. paragraph 1 is replaced by the following:

       ‘1.

       The competent authorities of Member States that have national measures approved in accordance with Article 226(3) of Regulation (EU) 2016/429, against diseases other than the listed diseases which are referred to in Article 9(1)(d) of that Regulation, shall take measures to prevent the introduction of those diseases through the application of additional animal health requirements for the entry into those Member States, of consignments of aquatic animals and products of animal origin from aquatic animals other than live aquatic animals, of species listed in the second column of the table set out in Annex XXIX to this Regulation.’;

30. Part VII is amended as follows:

    1. the title of Part VII is replaced by the following:

    2. the following Article 182a is inserted after the title of Part VII and before Article 183:

       1.

       Semen collection centres, semen storage centres, embryo collection teams and embryo production teams which have been approved prior to 21 April 2021 in accordance with Council Directives 88/407/EEC^(*), 89/556/EEC^(**), 90/429/EEC^(***) and 92/65/EEC^(****) referred to in the 6th, 7th, 8th and 12th indents of Article 270(2) of Regulation (EU) 2016/429 shall be deemed to be approved germinal product establishments as referred to in Article 82(1) of this Regulation.

       In all other respects, they shall be subject to the rules provided for in Article 82(2) of this Regulation, and in Article 233 of Regulation (EU) 2016/429.

       2.

       Consignments of semen, oocytes and embryos collected, produced, processed and stored prior to 21 April 2021 shall be allowed to enter into the Union, provided they fulfil, as regards the collection, production, processing and storage of germinal products, animal health requirements of donor animals and laboratory and other tests carried out on donor animals and germinal products, the requirements laid down in Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC respectively to the species of donor animals.

       3.

       Straws and other packages in which semen, oocytes or embryos, whether or not separated into individual doses, are placed, stored and transported, marked prior to 21 April 2021 in accordance with Directives 88/407/EEC, 89/556/EEC, 90/429/EEC and 92/65/EEC respectively to the species of donor animals, shall be considered to have been marked in accordance with point (a) of Article 83 of this Regulation.

    3. in Article 184, the following title is added:

       ‘Entry into force and application’;

31. Annexes III, VIII, XV, XXVIII and XXIX are amended in accordance with the Annex to this Regulation.

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