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 originText with EEA relevance.

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:

(a) 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:;

(b) point (d) is replaced by the following:

(d) 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;;

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

—

Salmonella Pullorum and Salmonella Gallinarum in the case of Numida meleagris, Coturnix coturnix, Phasianus colchicus, Perdix perdix, Anas spp.;;

(d) the following point (f) is added:

(f) 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:

(iii) 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:

Article 119a

Inspection of consignments of germinal products prior to dispatch to the Union

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:

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

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

(i) the information to be certified is supported by the records kept at the confined establishment;

(ii) 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;

(iii) 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:

(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;;

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

1. 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:

(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.;

(24) Article 167 is amended as follows:

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

(a) 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;;

(b) point (d) is replaced by the following:

(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;;

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

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

(i) fish intended for human consumption after further processing in the European Union;

(ii) molluscs intended for human consumption after further processing in the European Union;

(iii) 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:

(b) 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:

1. 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:

(a) the title is replaced by the following:

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

(b) 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:

(a) the title of Part VII is replaced by the following:

PART VII

TRANSITIONAL AND FINAL PROVISIONS;

(b) the following Article 182a is inserted after the title of Part VII and before Article 183:

Article 182a

Transitional measures

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

Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (OJ L 194, 22.7.1988, p. 10).

, 89/556/EEC

Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species (OJ L 302, 19.10.1989, p. 1).

, 90/429/EEC

Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (OJ L 224, 18.8.1990, p. 62).

and 92/65/EEC

Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).;

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.

1. 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.

1. 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.

(c) 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.

Article 2

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

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

Done at Brussels, 14 July 2021.

For the Commission

The President

Ursula von der Leyen

Annex

ANNEX

Annexes III, VIII, XV, XXVIII and XXIX to Delegated Regulation (EU) 2020/692 are amended as follows:

(1) Annex III is amended as follows:

(a) in Table 1, in the third, fourth and fifth rows, the entries for equine animals other than registered equine animals, registered equine animals and registered horses re-entering after temporary export for competition, races or cultural equestrian events, are replaced by the following:

Species and category of animalsMinimum residency period in the third country or territory of origin or zone thereof, as referred to Article 11(b)(i)Minimum residency period in the establishment of origin, as referred to in Article 11(b)(ii)Minimum period without contact with animals of a lower health status as referred to in Article 11(b)(iii)Equine animals not intended for slaughter40 days or since birth, if the animals are less than 40 days of age, or since entry from the Union30 days (40 days from African horse sickness risk areas) or since birth, if the animals are less than 30 days (40 days) of age, or since entry from the Union15 daysRegistered horses40 days or since birth if the animals are less than 40 days of age or since entry from the Union or certain listed third countries30 days (40 days from African horse sickness risk areas) or since birth, if the animals are less than 30 days (40 days) of age, or since entry from the Union or certain listed third countries15 daysRegistered horses re-entering after temporary export for competition, races or cultural equestrian eventsup to 30 days or up to 90 days in case of specific competitions, races or cultural equestrian eventsNot establishedDuring the entire period of temporary exportEquine animals intended for slaughter90 days30 days (40 days from African horse sickness risk areas)30 days (40 days from African horse sickness risk areas)

(b) Table 2 is amended as follows:

(i) in the second row, the entry for productive poultry for the production of meat and eggs for consumption is replaced by the following:

Category of birdsThe residency period applies toMinimum residency period in the third country or territory of origin or zone thereof, as referred to Article 11(b)(i)Minimum residency period in the establishment of origin, as referred to Article 11(b)(ii)Minimum period without contact with animals of a lower health status as referred to in Article 11(b)(iii)Productive poultry for the production of meat, eggs for consumption and other productsAC3 months, or since hatching, if the animals are less than 3 months of age6 weeks, or since hatching, if the animals are less than 6 weeks of age6 weeks, or since hatching, if the animals are less than 6 weeks of age

(ii) in the fifth row, the entry for day-old chicks is replaced by the following:

Category of birdsThe residency period applies toMinimum residency period in the third country or territory of origin or zone thereof, as referred to Article 11(b)(i)Minimum residency period in the establishment of origin, as referred to Article 11(b)(ii)Minimum period without contact with animals of a lower health status as referred to in Article 11(b)(iii)Day-old chicksACSince hatchingSince hatchingSince hatchingFO3 months prior to the date of collection of the eggs from which the day-old chicks have hatched6 weeks prior to the date of collection of the eggs from which the day-old chicks have hatched-

(2) in Annex VIII, point 1, footnote () is replaced by the following:

()

not applicable if the animals originate from a third country, territory or zone recognised as free or seasonally free of the disease in the list of third countries or territories or zones thereof authorised for the entry into the Union of consignments of ungulates.;

(3) in Annex XV, point 2 is replaced by the following:

1. ANIMAL HEALTH REQUIREMENTS FOR POULTRY AND HATCHING EGGS 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

Poultry and hatching eggs 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 1.2 must meet the requirements set out below:

(a) poultry, the flock of origin of the day-old chicks and the flock of origin of hatching eggs must not have been vaccinated with such vaccines for a period of at least 12 months prior to the date the consignment is loaded for dispatch to the Union;

(b) the flock of origin of poultry and of hatching eggs must have undergone a virus isolation test for infection with Newcastle disease virus not earlier than 2 weeks prior to the date of loading of the consignment for dispatch to the Union or, in the case of hatching eggs, not earlier than 2 weeks prior to the date the eggs were collected. The test must have been carried out in an official laboratory on a random sample of cloacal swabs taken from at least 60 birds in each flock, and no avian paramyxoviruses with an ICPI of more than 0,4 have been found;

(c) poultry, except day-old chicks, the flock of origin of the day-old chicks and the flocks of origin of hatching eggs must have been kept in isolation under official surveillance on the establishment of origin during the two-week period referred to in point (b);

(d) poultry, except day-old chicks, the flock of origin of the day-old chicks and the flock of origin of hatching eggs must not have been in contact with poultry not meeting the requirements set out in points (a) and (b):

(i) in the case of poultry, during the period of 60 days prior to the date the consignment was loaded for dispatch to the Union;

(ii) in the case of hatching eggs, during the period of 60 days prior to the date the eggs were collected;

(e) the hatching eggs from which the day-old chicks are derived must not have been in contact in the hatchery or during transport to the hatchery with poultry or hatching eggs not meeting the requirements set out in points (a) to (d).;

(4) in Annex XXVIII, in point 1, in the table, in the third row, the entry for dried egg white is replaced by the following:

Egg productTreatmentCore temperature (in degrees Celsius (°C))Duration of treatment (in seconds (s) or hours (hr))Dried egg white67 °C20 hr54,4 °C50,4 hr

(5) in Annex XXIX, the table is amended by including the text below directly above the line which refers to the disease Spring viraemia of carp (SVC) and its susceptible species:

Koi herpes virus diseaseAs set out in column 3 of the table in the Annex to Commission Implementing Regulation (EU) 2018/1882