29.3.2022

Official Journal of the European Union

L 101/6

COMMISSION IMPLEMENTING REGULATION (EU) 2022/497

of 28 March 2022

amending and correcting Annexes I and II to Implementing Regulation (EU) 2021/403 as regards certain model animal health certificates, animal health/official certificates and declarations for the movements between Member States and the entry into the Union of consignments of certain species and categories of terrestrial animals and germinal products thereof

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 146(2), Article 156(2), first subparagraph, point (a), and Articles 162(5), 238(3) and 239(3) thereof,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (2), and in particular Article 90, first paragraph, points (a) and (b), and Article 126(3) thereof,

Whereas:

(1)

Commission Implementing Regulation (EU) 2021/403 (3) establishes model certificates, in the form of animal health certificates, animal health/official certificates and declarations for movements between Member States, and the entry into the Union, of consignments of certain categories of terrestrial animals and germinal products thereof. Those consignments include those falling within the scope of Commission Delegated Regulations (EU) 2020/686 (4), (EU) 2020/688 (5) and (EU) 2020/692 (6).

(2)

Article 6 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the movements between Member States of certain categories of ungulates are to correspond to one of the models set out in Annex I thereto, and referred to in that Article, depending on the species concerned. Chapters 7 and 8 of that Annex set out respectively, model animal health certificates for the movements between Member States of an individual equine animal not intended for slaughter (model ‘EQUI-INTRA-IND’), and of a consignment of equine animals (model ‘EQUI-INTRA-CON’). In order to clarify that the clinical examination required before the movement of equine animals to other Member States may be carried out on the last working day prior to their departure only in respect of equine animals referred in Article 92(2) of Delegated Regulation (EU) 2020/688, the respective footnotes (2) and (3) to Part II of the Notes in those models should be corrected.

(3)

Article 7 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and the animal health/official certificates to be used for the movements between Member States of certain categories of birds and germinal products thereof are to correspond to one of the models set out in Annex I thereto, and referred to in that Article, depending on the categories of birds and products concerned. Chapters 17 and 18 of that Annex set out respectively, model animal health/official certificates for the movements between Member States of breeding poultry and productive poultry (model ‘POU-INTRA-X’), and for the movements between Member States of less than 20 heads of poultry other than ratites or less than 20 hatching eggs of poultry other than ratites (model ‘POU-INTRA-LT20’). The erroneous references to the entry into the Union in points II.2.1 and II.2.1.1 of those respective models should be corrected.

(4)

In addition, Chapters 16 and 18 of Annex I to Implementing Regulation (EU) 2021/403, referred to in Article 7 thereof, set out respectively the model animal health/official certificate for the movement between Member States of day-old chicks (model ‘POU-INTRA-DOC’), and the model animal health/official certificate for the movement between Member States of less than 20 heads of poultry other than ratites or less than 20 hatching eggs of poultry other than ratites (model ‘POU-INTRA-LT20’). Footnote (4) of the Notes to Part II of those models should be corrected to clarify that the measures referred to in Part III, Title 2, Chapter 5, of Delegated Regulation (EU) 2020/692 must be respected in the Member State of destination. Additionally, an obvious mistake as regards the age of birds to be indicated in point II.1.4 of the model POU-INTRA-DOC in Chapter 16 should be corrected.

(5)

Article 8 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for movements between Member States of certain types of germinal products of bovine animals are to correspond to one of the models set out in Annex I thereto, and referred to in that Article, depending on the type of products concerned. Chapters 23 (model ‘BOV-SEM-A-INTRA’), 26 (model ‘BOV-OOCYTES-EMB-A-INTRA’), 30 (model ‘OV/CAP-SEM-A-INTRA’), and 33 (model ‘OV/CAP-OOCYTES-EMB-A-INTRA’) of that Annex set out model animal health certificates for the movements between Member States of consignments of certain germinal products. Box reference I.30 of the Notes to Part I of those models should be amended to include a description of the tests for infection with bluetongue virus and for epizootic haemorrhagic disease.

(6)

In addition, model ‘BOV-OOCYTES-EMB-A-INTRA’, set out in Chapter 26 of Annex I to Implementing Regulation (EU) 2021/403, is to be used for the movements between Member States of consignments of oocytes and embryos of bovine animals collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/686 after 20 April 2021, dispatched by the embryo collection or production team that collected or produced the oocytes or embryos. The erroneous references to ovine and caprine animals in point II.2.5.1 and in Box reference I.30 of the Notes to Part I of that model should be corrected.

(7)

Article 11 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the movements between Member States of certain types of germinal products of equine animals are to correspond to one of the models set out in Annex I thereto, and referred to in that Article, depending on the type of products concerned. Chapters 45 and 49 of that Annex set out the model animal health certificates for the movements between Member States respectively, of consignments of semen of equine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/686 after 20 April 2021, dispatched from the semen collection centre where the semen was collected (model ‘EQUI-SEM-A-INTRA’), and of consignments of oocytes and embryos of equine animals collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/686 after 20 April 2021, dispatched by the embryo collection or production team that collected or produced the oocytes or embryos (model ‘EQUI-OOCYTES-EMB-A-INTRA’). Point II.2.5.2 of those models should be corrected to clarify that donor equine animals of semen, oocytes and embryos must be kept on establishments, instead of on a single establishment, where Venezuelan equine encephalomyelitis, dourine, surra (Trypanosoma evansi), equine infections anaemia, contagious equine metritis (Taylorella equigenitalis), infection with rabies virus and anthrax have not been reported, for a period of at least 30 days prior to the date of first collection of the semen, oocytes or embryos and during the collection period. In addition, Box reference I.30 of the Notes to Part I of model ‘EQUI-SEM-A-INTRA’ should be amended to include a description of the tests.

(8)

Article 13 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and declarations to be used for the movements between Member States of certain categories of terrestrial animals and certain germinal products thereof are to correspond to one of the models set out in Annex I thereto, and referred to in that Article, depending on the species and categories of products concerned. Chapter 61 of that Annex sets out the model animal health certificate and model declaration for the movement between Member States of dogs, cats and ferrets. Point II.2.2 of that model certificate contains obvious mistakes and requires clarification. It is therefore necessary to correct that model accordingly.

(9)	Annex I to Implementing Regulation (EU) 2021/403 should therefore be amended and corrected accordingly.

(10)

Article 14 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and animal health/official certificates to be used for the entry into the Union of certain categories of ungulates are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the species concerned. Chapter 4 of that Annex sets out the model animal health/official certificate for the entry into the Union of ovine and caprine animals (model ‘OV/CAP-X’). Points II.2.2 and II.2.11.6 of the animal health attestation of that model contain obvious mistakes and require clarification. It is therefore necessary to correct that model accordingly.

(11)

Article 15 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and animal health/official certificates and declarations accompanying those certificates, to be used for the entry into the Union or transit through the Union of certain categories of equine animals are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the movements concerned. Chapters 12 to 15 of that Annex set out respectively the model animal health/official certificate and model declaration for the entry into the Union of equine animals not intended for slaughter (model ‘EQUI-X’), the model animal health/official certificate and the model declaration for the entry into the Union of equine animals intended for slaughter (model ‘EQUI-Y’), the model animal health certificate and the model declaration for transit through the Union of equine animals not intended for slaughter (model ‘EQUI-TRANSIT-X’), and the model animal health certificate and the model declaration for transit through the Union of equine animals intended for slaughter (model ‘EQUI-TRANSIT-Y’). In accordance with Article 13 of Delegated Regulation (EU) 2020/692, the period that may elapse between the clinical examination and departure of equine animals, other than registered equine animals, is set at 24 hours for that category of animals. In accordance with Article 3 of Delegated Regulation (EU) 2020/692, the certificate must be issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; in the case of transport by sea, the period may be extended by an additional period corresponding to the duration of the journey by sea. It is therefore necessary to correct those models accordingly.

(12)

In addition, Chapters 16, 17 and 18 of Annex II to Implementing Regulation (EU) 2021/403, referred to in Article 15 thereof, set out respectively the model animal health certificate and model declaration for the re-entry into the Union of registered horses for racing, competition and cultural events after temporary export for a period of not more than 30 days (model ‘EQUI-RE-ENTRY-30’), the model animal health certificate and model declaration for the re-entry into the Union of registered horses for competition after temporary export for a period of not more than 90 days to participate in equestrian events organised under the auspices of the Fédération Equestre Internationale (FEI) (model ‘EQUI-RE-ENTRY-90-COMP’), and the model animal health certificate and model declaration for the re-entry into the Union of registered horses for racing after temporary export for a period of not more than 90 days to participate in specific race events in Australia, Canada, the United States of America, Hong Kong, Japan, Singapore, the United Arab Emirates or Qatar (model ‘EQUI-RE-ENTRY-90-RACE’). In accordance with Article 3 of Delegated Regulation (EU) 2020/692, the certificate must be issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; in the case of transport by sea, the period may be extended by an additional period corresponding to the duration of the journey by sea. It is therefore necessary to correct those models accordingly.

(13)

Article 16 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the entry into the Union of ungulates intended for a confined establishment are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the species concerned. Chapters 19 to 22 of that Annex set out model animal health certificates for the entry into the Union of animals listed in Section 1 of Chapter 19 of Annex II to Implementing Regulation (EU) 2021/403 that are originating from and intended for a confined establishment (model ‘CONFINED-RUM’), animals listed in Section 1 of Chapter 20 of Annex II to Implementing Regulation (EU) 2021/403 that are originating from and intended for a confined establishment (model ‘CONFINED-SUI’), animals listed in Section 1 of Chapter 21 of Annex II to Implementing Regulation (EU) 2021/403 that are originating from and intended for a confined establishment (model ‘CONFINED-TRE’), and animals of the family of Hippopotamidae that are originating from and intended for a confined establishment (model ‘CONFINED-HIPPO’). Point II.1.2 of Part II (Health information) of those models should be amended by the insertion of the missing animal health requirements provided for in Article 34, point (b), of Delegated Regulation (EU) 2020/692, and some other obvious mistakes and unintentional omissions corrected.

(14)

Article 17 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates and animal health/official certificates to be used for the entry into the Union of certain categories of birds and germinal products thereof are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the categories of birds and products concerned. Chapter 34a of that Annex sets out a model animal health certificate for entry into the Union of racing pigeons immediately released after entry (model ‘RACING PIGEONS-IMMEDIATE RELEASE’). Points II.1.2 and II.1.6 of that model should be corrected to clarify respectively the registration requirement of the establishments of origin as referred to in Article 62(2), point (b), of Delegated Regulation (EU) 2020/692 and the transport conditions for the racing pigeons.

(15)

Article 20 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the entry into the Union of certain types of germinal products are to correspond to one of the models set out in Annex II thereto, and referred to in that Article, depending on the type of products concerned. Chapters 39 (model ‘BOV-SEM-A-ENTRY’), 42 (model ‘BOV-OOCYTES-EMB-A-ENTRY’), 48 (‘OV/CAP-SEM-A-ENTRY’), and 50 (model ‘OV/CAP-OOCYTES-EMB-A-ENTRY’) of that Annex set out model animal health certificates for the entry into the Union of consignments of certain germinal products. Box reference I.27 of the Notes to Part I of those models should be amended to include a description of the tests for infection with bluetongue virus and for epizootic haemorrhagic disease.

(16)	In addition, the erroneous numbering in point II.2. of model ‘BOV-OOCYTES-EMB-A-ENTRY’, set out in Chapter 42 of Annex II to Implementing Regulation (EU) 2021/403, should be corrected.

(17)

Additionally, Article 20 of Implementing Regulation (EU) 2021/403 refers to the model animal health certificate for the entry into the Union of consignments of certain germinal products dispatched after 20 April 2021 from the germinal product storage centre (model ‘BOV-GP-STORAGE-ENTRY’), set out in Annex II thereto. The Notes in that model should be corrected so as to cover not only semen of bovine animals, but also oocytes and embryos of those animals.

(18)

Article 21 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the entry into the Union of certain types of germinal products of ovine and caprine animals are to correspond to one of the models set out in Annex II thereto, and referred to in that Article. Chapter 53 of that Annex sets out the model animal health certificate for the entry into the Union of consignments of certain germinal products dispatched after 20 April 2021 from the germinal product storage centre (model ‘OV/CAP-GP-STORAGE-ENTRY’). The Notes in that model should be corrected so as to cover semen, oocytes and embryos not only of ovine animals, but also of caprine animals.

(19)

Article 22 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the entry into the Union of certain types of germinal products of porcine animals are to correspond to one of the models set out in Annex II thereto, and referred to in that Article. Chapter 54 of that Annex sets out the model animal health certificate for the entry into the Union of consignments of semen of porcine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021, dispatched from the semen collection centre where the semen was collected (model ‘POR-SEM-A-ENTRY’). The erroneous references to a Member State, instead of to a third country or territory, in points II.4.8.3 and II.4.9.3, of that model should be corrected.

(20)

Article 23 of Implementing Regulation (EU) 2021/403 provides that the animal health certificates to be used for the entry into the Union of certain types of germinal products of equine animals are to correspond to one of the models set out in Annex II thereto, and referred to in that Article. Chapters 59 and 63 of that Annex set out model animal health certificates for the entry into the Union of consignments of semen of equine animals collected, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021, dispatched from the semen collection centre where the semen was collected (model ‘EQUI-SEM-A-ENTRY’), and of oocytes and embryos of equine animals collected or produced, processed and stored in accordance with Regulation (EU) 2016/429 and Delegated Regulation (EU) 2020/692 after 20 April 2021, dispatched by the embryo collection or production team that collected or produced the oocytes or embryos (model ‘EQUI-OOCYTES-EMB-A-ENTRY’). Point II.4.4.2 of those models should be corrected to clarify that donor equine animals of semen, oocytes and embryos must be kept on establishments, instead of on a single establishment, where Venezuelan equine encephalomyelitis, dourine, surra (Trypanosoma evansi), equine infections anaemia, contagious equine metritis (Taylorella equigenitalis), infection with rabies virus and anthrax have not been reported, for a period of at least 30 days prior to the date of first collection of the semen, oocytes or embryos and during the collection period. In addition, Box reference I.27 of the Notes to Part I of model ‘EQUI-SEM-A-ENTRY’ should be amended to include a description of the tests.

(21)	Annex II to Implementing Regulation (EU) 2021/403 should be amended and corrected accordingly.

(22)	Implementing Regulation (EU) 2021/403 should therefore be amended and corrected accordingly.

(23)

In order to avoid any disruption to trade as regards the entry into the Union of consignments concerned by the amendments to be made to Annex II to Implementing Regulation (EU) 2021/403 by this Regulation, the use of animal health certificates, animal health/official certificates and declarations issued in accordance with Implementing Regulation (EU) 2021/403 as applicable prior to the amendments made by this Regulation, should continue to be authorised during a transitional period subject to certain conditions.

(24)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Implementing Regulation (EU) 2021/403 are amended and corrected in accordance with the Annex to this Regulation.

Article 2

For a transitional period until 15 December 2022, consignments of certain species and categories of terrestrial animals and germinal products thereof, accompanied by appropriate animal health certificates, animal health/official certificates and declarations issued in accordance with the models set out in Chapters 4, 12 to 22, 34a, 39, 42, 47, 48, 50, 53, 54, 59 and 63 of Annex II to Implementing Regulation (EU) 2021/403, as applicable before the amendments made to that Implementing Regulation by this Regulation, shall continue to be authorised for the entry into the Union provided that those certificates and declarations were issued no later than 15 September 2022.

Article 3

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

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

Done at Brussels, 28 March 2022.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 84, 31.3.2016, p. 1.

(2) OJ L 95, 7.4.2017, p. 1.

(3) Commission Implementing Regulation (EU) 2021/403 of 24 March 2021 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates and model animal health/official certificates, for the entry into the Union and movements between Member States of consignments of certain categories of terrestrial animals and germinal products thereof, official certification regarding such certificates and repealing Decision 2010/470/EU (OJ L 113, 31.3.2021, p. 1).

(4) Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1).

(5) Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140).

(6) 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 (OJ L 174, 3.6.2020, p. 379).

ANNEX

Annexes I and II to Implementing Regulation (EU) 2021/403 are amended and corrected as follows:

(1)

Annex I is amended and corrected as follows:

(a)

in Chapter 7, in model EQUI-INTRA-IND, in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)

Option only available in the case of either:

(a)	an equine animal accompanied by its single lifetime identification document as provided for in Article 114(1), point (c), of Regulation (EU) 2016/429, which includes a valid validation mark referred to in Article 92(2), point (a), of Delegated Regulation (EU) 2020/688; or

(b)

a registered equine animal accompanied by its single lifetime identification document as provided for in Article 114(1), point (c), of Regulation (EU) 2016/429 which includes a valid license referred to in Article 92(2), point (b), of Delegated Regulation (EU) 2020/688, or by its single lifetime identification document accompanied by the FEI Recognition Card together with the validation sticker.’;

(b)

in Chapter 8, in model EQUI-INTRA-CON, in the Notes to Part II, footnote (3) is replaced by the following:

‘(3)

Option only available in the case of either:

(a)	equine animals which are each accompanied by their single lifetime identification document as provided for in Article 114(1), point (c), of Regulation (EU) 2016/429 which includes a valid validation mark referred to in Article 92(2), point (a), of Delegated Regulation (EU) 2020/688; or

(b)

registered equine animals which are each accompanied by their single lifetime identification document as provided for in Article 114(1), point (c), of Regulation (EU) 2016/429 which includes a valid license referred to in Article 92(2), point (b), of Delegated Regulation (EU) 2020/688, or by its single lifetime identification document accompanied by the FEI Recognition Card together with the validation sticker.’;

(c)

in Chapter 16, model POU-INTRA-DOC is corrected as follows:

(i)

point II.1.4 is replaced by the following:

‘II.1.4.

the day-old chicks described in Part I:

(a)	show no clinical signs or reason for suspicion of listed diseases relevant for the species;

(2)(3)either

[(b) have not been vaccinated against infection with Newcastle disease virus;]

(2)(3)or

[(b) have been vaccinated against infection with Newcastle disease virus with [inactivated vaccines](2) [live attenuated vaccines that comply with the criteria of Annex VI to Delegated Regulation (EU) 2020/688](2)

…

(name of strain used in the vaccine)

on … (date) at the age of … days;]’;

(ii)

in the Notes to Part II, footnote (4) is replaced by the following:

‘(4)

As the day-old chicks referred to in this animal health/official certificate have hatched from eggs which have entered the Union from a third country or territory, or zone thereof, the specific animal health requirements for movement and handling of those animals in the establishment of destination, laid down in Articles 112, 113 and 114 of Delegated Regulation (EU) 2020/692, must be respected in the Member State of destination.’;

(d)

in Chapter 17, in model POU-INTRA-X, point II.2.1 is replaced by the following:

‘(10)[II.2.1.

The Salmonella control programme referred to in Article 5 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council, and the specific requirements for the use of antimicrobials and vaccines laid down in Commission Regulation (EC) No 1177/2006, have been applied to the flock of origin and the flock has been tested for Salmonella serotypes of public health significance:

Identification of the flock	Age of the birds	Date of last sampling of the flock from which the testing result is known [dd/mm/yyyy]	Result of all testing in the flock(11)
			positive	negative

For reasons other than the Salmonella control programme, within the period of 21 days prior to the date of movement of the consignment between Member States:

(2)either

[antimicrobials were not administered to the breeding and productive poultry other than ratites;]

(2)(12)or

[the following antimicrobials were administered to the breeding and productive poultry other than ratites: …;]]’;

(e)

in Chapter 18, model POU-INTRA-LT20 is corrected as follows:

(i)

in Part II, point II.2.1.1 is replaced by the following:

‘(10)[II.2.1.1.

Identification of the flock	Age of the birds	Date of last sampling of the flock from which the testing result is known [dd/mm/yyyy]	Result of all testing in the flock(11)
			positive	negative

For reasons other than the Salmonella control programme, within the period of 21 days prior to the date of movement of the consignment between Member States:

(1) either

[antimicrobials were not administered to the breeding and productive poultry other than ratites;]

(1)(12) or

[the following antimicrobials were administered to the breeding and productive poultry other than ratites: …;]]’;

(ii)

in the Notes to Part II, footnote (14) is replaced by the following:

‘(14)

(f)

in Chapter 23, in model BOV-SEM-A-INTRA, in the Notes to Part I, Box reference I.30 is replaced by the following:

‘Box reference I.30

“Type” : Indicate semen.

“Species” : Select amongst “ Bos taurus ”, “ Bison ” or “ Bubalus bubalis ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.2.8.5. and/or II.2.8.6., and/or for EHD-test: II.2.9.3.1. and/or II.2.9.3.2., if relevant.’;

(g)

in Chapter 26, model BOV-OOCYTES-EMB-A-INTRA is corrected as follows:

(i)

in Part II, point II.2.5.1 is replaced by the following:

‘II.2.5.1.

were kept on establishments not situated in a restricted zone established due to the occurrence of foot-and-mouth disease, infection with rinderpest virus, infection with Rift Valley fever virus, contagious bovine pleuropneumonia or lumpy skin disease or of an emerging disease relevant for bovine animals;’;

(ii)

in the Notes to Part I, Box reference I.30 is replaced by the following:

‘Box reference I.30

“ Species” : Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate.

“Type” : Specify if oocytes, in vivo derived embryos, in vitro produced embryos or micromanipulated embryos.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed.

“Date of collection/production” : Indicate the date on which oocytes or embryos of the consignment were collected or produced.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos were collected or produced.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.2.7.5. and/or II.2.7.6., and/or for EHD-test: II.2.8.3.1. and/or II.2.8.3.2., if relevant.’;

(h)

in Chapter 30, in model OV/CAP-SEM-A-INTRA, in the Notes to Part I, Box reference I.30 is replaced by the following:

‘Box reference I.30

“Type” : Indicate semen.

“Species” : Select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre or, in the case of an establishment as referred in Article 13 of Delegated Regulation (EU) 2020/686, the unique registration number of the establishment where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.2.8.5. and/or II.2.8.6., and/or for EHD-test: II.2.9.3.1. and/or II.2.9.3.2., if relevant.’;

(i)

in Chapter 33, in model OV/CAP-OOCYTES-EMB-A-INTRA, in the Notes to Part I, Box reference I.30 is replaced by the following:

‘Box reference I.30

“Type” : Specify if in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos.

“Species” : Select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed.

“Date of collection/production” : Indicate the date on which oocytes or embryos of the consignment were collected or produced.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.3.7.5. and/or II.3.7.6., and/or for EHD-test: II.3.8.3.1. and/or II.3.8.3.2., if relevant.’;

(j)

in Chapter 45, model EQUI-SEM-A-INTRA is corrected and amended as follows:

(i)

in Part II, point II.2.5.2 is replaced by the following:

‘II.2.5.2.

were kept on establishments where Venezuelan equine encephalomyelitis, dourine, surra (Trypanosoma evansi), equine infections anaemia, contagious equine metritis (Taylorella equigenitalis), infection with rabies virus and anthrax have not been reported;’;

(ii)

in the Notes to Part I, Box reference I.30 is replaced by the following:

‘Box reference I.30

“Type” : Indicate semen.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate ‘Yes, see points II.2.8. and II.2.9’.’;

(k)

in Chapter 49, in model EQUI-OOCYTES-EMB-A-INTRA, point II.2.5.2 is replaced by the following:

‘II.2.5.2.

(l)

in Chapter 61, in model CANIS-FELIS-FERRETS-INTRA, point II.2.2 is replaced by the following:

‘(2) either

[II.2.2. The dogs, due to their intended destination(5) indicated in Box I.9, or in Box I.10 where regionalisation is applied:

(2) either

[have been treated against Echinococcus multilocularis in accordance with Article 6 of Commission Delegated Regulation (EU) 2018/772.]

(2) or

[have not been treated against(6) Echinococcus multilocularis.]]

(2) or

[II.2.2. The animals are intended for direct transport in accordance with Article 54(2) of Delegated Regulation (EU) 2020/688 to the confined establishment indicated in Box I.12 of Part I.]’;

(2)

Annex II is amended and corrected as follows:

(a)

in Chapter 4, model OV/CAP-X is corrected as follows:

(i)

points II.2.2 and II.2.3 are replaced by the following:

‘II.2.2.

have remained continuously:

(i)	in the zone referred to in point II.2.1 since birth or for a period of at least six months prior to the date of their dispatch to the Union, and

(ii)	in the establishment of origin since birth or for a period of at least 40 days prior to the date of their dispatch to the Union, into which during this period no ovine and caprine animals and no animals of other species listed for the same diseases as ovine and caprine animals have been introduced.

II.2.3.

had no contact with animals of a lower health status since birth or for a period of at least 30 days prior to the date of their dispatch to the Union.’;

(ii)

point II.2.11.6 is replaced by the following:

‘either [II.2.11.6.

in which infection with Mycobacterium tuberculosis complex (M.bovis, M.caprae and M.tuberculosis) has not been reported during a period of at least 42 days prior to the date of dispatch of the animals to the Union](1)(8)

or [II.2.11.6.

subjected to surveillance to detect infection with Mycobacterium tuberculosis complex (M.bovis, M.caprae and M.tuberculosis) in accordance with the procedures set out in points (1) and (2) of Part 1 of Annex II to Commission Delegated Regulation (EU) 2020/688 during a period of at least 12 months prior to the date of dispatch of the animals to the Union and during this period:

(i)	only caprine animals from establishments applying such surveillance have been introduced into the establishment;

(ii)	in the case where infection with Mycobacterium tuberculosis complex (M.bovis, M.caprae and M.tuberculosis) has been reported in caprine animals kept on the establishment, measures were taken in accordance with point (3) of Part 1 of Annex II to Delegated Regulation (EU) 2020/688].(1)(9)’;

(iii)

points II.2.11.9 and II.2.11.10 are replaced by the following:

‘II.2.11.9.

in which anthrax has not been reported for a period of at least 15 days prior to the date of dispatch of the animals to the Union;

either [II.2.11.10.

in which surra (Trypanosoma evansi) has not been reported for a period of at least 2 years prior to the date of dispatch of the animals to the Union.] (1)

or [II.2.11.10.

in which surra (Trypanosoma evansi) has not been reported for a period of at least 30 days prior to the date of dispatch of the animals to the Union and where that disease was reported in the establishment of origin during the 2 years prior to the date of dispatch of the animals to the Union, the establishment remained under restrictions until the infected animals were removed from the establishment and the remaining animals on the establishment were subjected with negative results to a test for surra (Trypanosoma evansi) as described in Article 9, point (b)(i), of Delegated Regulation (EU) 2020/692 carried out on samples taken at least 6 months after the date the infected animals were removed from the establishment.] (1)

[II.2.11.11.

in which Burkholderia mallei (glanders) has not been reported for a period of at least 6 months prior to the date of dispatch of the animals to the Union.](9)’;

(iv)

the footnotes to Part II are replaced by the following:

‘(1)	Keep as appropriate.

(2)	Code of the zone as it appears in column 2 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(3)	Date of loading: it must not be a date prior to the date of authorisation of the zone for entry into the Union, or a date in a period when restriction measures have been adopted by the Union against the entry into the Union of these animals from this zone.

(4)	For zones with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(5)	For zones with entry BTV in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(6)	For zones with entry SF-BTV in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(7)	For zones with entry SF-EHD in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(8)	Only for ovine animals.

(9)	Only for caprine animals.

(10)	In accordance with Article 10 of Delegated Regulation (EU) 2020/692.

(11)	Zones with entry BRU for ovine and caprine animals in column 7 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’

(b)

in Chapter 12, model EQUI-X is corrected as follows:

(i)

points II.1.1 and II.1.2 are replaced by the following:

‘II.1.1.

is not intended for slaughter for human consumption and not intended for slaughter in the framework of the eradication of a disease communicable to equine animals, and

(1) either

[is a registered equine animal, as defined in Article 2, point (12), of Commission Delegated Regulation (EU) 2020/692.]

(1) or

[is a registered horse as defined in Article 2, point (12), of Delegated Regulation (EU) 2020/692]

(1) or

[is an equine animal other than a registered equine animal or a registered horse.]

II.1.2.

has not shown signs or symptoms of diseases listed for equine animals in Commission Implementing Regulation (EU) 2018/1882 during the clinical examination carried out on … (insert date dd/mm/yyyy)(2), this date being within the 24 hour period or, in the case of a registered horse, within the 48 hour period or on the last working day prior to the departure of the animal from the registered establishment.’;

(ii)

the notes to Part I are replaced by the following:

‘Box reference I.8	:	Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.
Box reference I.27	:	“Identification system” : The animal must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692, or be identified by an alternative method provided it is recorded in the identification document (passport) of the animal as referred to in Article 21(2), point (b)(i), of Delegated Regulation (EU) 2020/692. Specify the identification system and the anatomic place used on the animal. If a passport accompanies the animal, its number must be stated and the name of the competent authority which validated it.’;

(iii)

in the Notes to Part II, footnotes (2) to (8) are replaced by the following:

‘(2)

The certificate must be issued within the period of 10 days prior to the date of arrival of the consignment at the border control post; in the case of transport by sea, the period may be extended by an additional period corresponding to the duration of the journey by sea.

The entry into the Union shall not be allowed when the animal was loaded either prior to the date of authorisation for entry into the Union from the respective country, territory or zone thereof referred to in point II.2.1., or during a period where restrictive measures have been adopted by the Union against the entry into the Union of equine animals from this country, territory or zone thereof. Check against columns 8 and 9 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(3)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(4)	Tests for glanders, surra, dourine, equine infectious anaemia and Venezuelan equine encephalomyelitis described by the European Union Reference Laboratory for Equine Diseases other than African horse sickness: https://sitesv2.anses.fr/en/minisite/equine-diseases/sop

(5)	Zone of the country or territory authorised for entry into the Union as appearing respectively in columns 2 and 5 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(6)	Only authorised if the country of dispatch is assigned to Sanitary Group G.

(7)	Statements that relate entirely and exclusively to a Sanitary Group different from the Sanitary Group to which the country, territory or zone thereof of dispatch is assigned, may be left out, provided that the numbering of the subsequent statements is maintained.

(8)	Tests for African horse sickness described by the European Union Reference Laboratory for African horse sickness: https://www.mapa.gob.es/en/ganaderia/temas/laboratorios/referencia-union-europea-oie/diagnostico/default.aspx’;

(iv)

in the Declaration by the operator responsible for the entry into the Union of the consignment of equine animal not intended for slaughter, footnote (1) is replaced by the following:

‘(1)

Identification system: The animal must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692, or be identified by an alternative method provided it is recorded in identification document (passport) of the animal as referred to in Article 21(2), point (b)(i), of Delegated Regulation (EU) 2020/692. Specify the identification system (such as ear tag, transponder) and the anatomic place used on the animal.

If a passport accompanies the animal, its number must be stated and the name of the competent authority which validated it.

Age: Date of birth (dd/mm/yyyy).

Sex (M = male, F = female, C = castrated).’;

(c)

in Chapter 13, model EQUI-Y is corrected as follows:

(i)

point II.1.2 is replaced by the following:

‘II.1.2.

have not shown signs or symptoms of diseases listed for equine animals in Commission Implementing Regulation (EU) 2018/1882 during the clinical examination carried out on … (insert date dd/mm/yyyy)(2), this date being within the 24 hour period prior to departure:

(3)either

[from the registered establishment of origin in the country, territory or zone thereof of dispatch;]

(3)or

[from the establishment approved for conducting assembly operations of equine animals by the competent authority in the country or territory of dispatch in accordance with requirements at least as stringent as those laid down in Article 5 of Commission Delegated Regulation (EU) 2019/2035;]’;

(ii)

the Notes to Part I are replaced by the following:

‘Box reference I.8	:	Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.
Box reference I.27	:	“Identification system” : The animals must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692 which permits to link the animals to the animal health/official certificate. Specify the identification system and the anatomic place used on the animals.’;

(iii)

in the Notes to Part II, footnotes (2) to (4) are replaced by the following:

‘(2)

The entry into the Union shall not be allowed when the animals were loaded either prior to the date of authorisation for entry into the Union from the respective country, territory or zone thereof referred to in point II.2.1., or during a period where restrictive measures have been adopted by the Union against the entry into the Union of equine animals from this country, territory or zone thereof. Check against columns 8 and 9 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(3)	Delete as appropriate.

(4)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.’;

(iv)

in the Notes to Part II, footnote (7) is replaced by the following:

‘(7)	Tests for African horse sickness described by the European Union Reference Laboratory for African horse sickness: https://www.mapa.gob.es/en/ganaderia/temas/laboratorios/referencia-union-europea-oie/diagnostico/default.aspx’;

(v)

in the Declaration by the operator responsible for the entry into the Union of the consignment of equine animals intended for slaughter, footnote (1) is replaced by the following:

‘(1)

Identification system: The animals must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692 which permits to link the animals to the animal health/official certificate. Specify the identification system (such as ear tag, transponder) and the anatomic place used on the animals.’;

(d)

in Chapter 14, model EQUI-TRANSIT-X is corrected as follows:

(i)

points II.1.1 and II.1.2 are replaced by the following:

‘II.1.1.

is not intended for slaughter for human consumption and not intended for slaughter in the framework of the eradication of a disease communicable to equine animals, and

(1) either

[is a registered equine animal, as defined in Article 2, point (12), of Commission Delegated Regulation (EU) 2020/692.]

(1) or

[is a registered horse as defined in Article 2, point (12), of Delegated Regulation (EU) 2020/692.]

(1) or

[is an equine animal other than a registered equine animal or a registered horse.]

II.1.2.

has not shown signs or symptoms of diseases listed for equine animals in Commission Implementing Regulation (EU) 2018/1882 during the clinical examination carried out on … (insert date dd/mm/yyyy)(2), this date being within the 24 hour period, or in the case of a registered horse within the 48 hour period or on the last working day, prior to departure from the registered establishment.’;

(ii)

the Notes to Part I are replaced by the following:

‘Box reference I.8	:	Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.
Box reference I.27	:	“Identification system” : The animal must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692, or be identified by an alternative method provided it is recorded in the identification document (passport) of the animal as referred to in Article 21(2), point (b)(i), of Delegated Regulation (EU) 2020/692. Specify the identification system and the anatomic place used on the animal. If a passport accompanies the animal, its number must be stated and the name of the competent authority which validated it.’;

(iii)

in the Notes to Part II, footnotes (2) to (8) are replaced by the following:

‘(2)

(3)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(4)	Tests for glanders, surra, dourine, equine infectious anaemia and Venezuelan equine encephalomyelitis described by the European Union Reference Laboratory for Equine Diseases other than African horse sickness: https://sitesv2.anses.fr/en/minisite/equine-diseases/sop

(5)	Zone of country or territory authorised for entry into the Union as appearing respectively in columns 2 and 5 of the table Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(6)	Only authorised if country of dispatch is assigned to Sanitary Group G.

(7)	Statements that relate entirely and exclusively to a Sanitary Group different from the Sanitary Group to which the country, territory or zone thereof of dispatch is assigned, may be left out, provided that the numbering of the subsequent statements is maintained.

(8)	Tests for African horse sickness described by the European Union Reference Laboratory for African horse sickness: https://www.mapa.gob.es/en/ganaderia/temas/laboratorios/referencia-union-europea-oie/diagnostico/default.aspx’;

(iv)

in the Declaration by the operator responsible for the transit through the Union of the consignment of equine animal not intended for slaughter, footnote (1) is replaced by the following:

‘(1)

Identification system: The animal must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692, or be identified by an alternative method provided it is recorded in the identification document (passport) of the animal as referred to in Article 21(2), point (b)(i), of Delegated Regulation (EU) 2020/692. Specify the identification system (such as ear tag, transponder) and the anatomic place used on the animal.

If a passport accompanies the animal, its number must be stated and the name of the competent authority which validated it.

Age: Date of birth (dd/mm/yyyy).

Sex (M = male, F = female, C = castrated).’;

(e)

in Chapter 15, model EQUI-TRANSIT-Y is corrected as follows:

(i)

point II.1.2 is replaced by the following:

‘II.1.2.

(3)either

[from the registered establishment of origin in the country, territory or zone thereof of dispatch;]

(3)or

[from the establishment approved for conducting assembly operations of equine animals by the competent authority in the country, territory or zone thereof of dispatch in accordance with requirements at least as stringent as those laid down in Article 5 of Commission Delegated Regulation (EU) 2019/2035;]’;

(ii)

the Notes to Part I are replaced by the following:

‘Box reference I.8	:	Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 to Annex IV to Commission Implementing Regulation (EU) 2021/404.
Box reference I.27	:	“Identification system”: The animals must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692 which permits to link the animals to the animal health/official certificate. Specify the identification system and the anatomic place used on the animals.’;

(iii)

in the Notes to Part II, footnotes (2) to (4) are replaced by the following:

‘(2)

The entry into the Union shall not be allowed when the animals were loaded either prior to the date of authorisation for entry into the Union from the respective country or territory, or zone thereof referred to in point II.2.1., or during a period where restrictive measures have been adopted by the Union against the entry into the Union of equine animals from this country, territory or zone thereof. Check against columns 8 and 9 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.

(3)	Delete as appropriate.

(4)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.’;

(iv)

in the Notes to Part II, footnote (7) is replaced by the following:

‘(7)	Tests for African horse sickness described by the European Union Reference Laboratory for African horse sickness: https://www.mapa.gob.es/en/ganaderia/temas/laboratorios/referencia-union-europea-oie/diagnostico/default.aspx’;

(v)

in the Declaration by the operator responsible for the transit through the Union of the consignment of equine animals intended for slaughter, footnote (1) is replaced by the following:

‘(1)

Identification system: The animals must be individually identified with one of the methods of identification laid down in Article 21(2), point (a), of Delegated Regulation (EU) 2020/692, which permits to link the animals to the animal health/official certificate. Specify the identification system (such as ear tag, transponder) and the anatomic place used on the animal.’;

(f)

in Chapter 16, model EQUI-RE-ENTRY-30 is corrected as follows:

(i)

points II.2.4 to II.2.7 are replaced by the following:

‘II.2.4.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[infection with Burkholderia mallei (glanders) has not been reported during the 36 month period prior to the date of departure of the animal.]

(3)or

[a surveillance and eradication programme for infection with Burkholderia mallei (glanders) recognised by the Union(1) has been carried out during the 36 month period prior to the date of departure, and

(3)either

[infection with Burkholderia mallei (glanders) has not been reported in the establishment of dispatch during the 36 month period prior to the date of departure of the animal.]]

(3)or

[infection with Burkholderia mallei (glanders) has been reported in the establishment during the 36 month period prior to the date of departure of the animal and following the last outbreak, the establishment has remained under movement restrictions:

(3)either

[until the remaining equine animals in the establishment have been subjected to a complement fixation test for infection with Burkholderia mallei (glanders)(4), carried out, with negative results at a serum dilution of 1 in 5, on samples taken at least six months after the date the infected animals have been killed and destroyed.]]]

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was killed and destroyed.]]]

II.2.5.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[surra has not been reported during the 24 month period prior to the date of departure of the animal.]

(3)or

[a surveillance and eradication programme for surra recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3)either

[surra has not been reported in the establishment during the 24 months period prior to the date of departure of the animal.]]

(3)or

[surra has been reported in the establishment during the 24 month period prior to the date of departure of the animal, and following the last outbreak the establishment has remained under movement restrictions:

(3)either

[until the remaining animals in the establishment have been subjected to an enzyme-linked immunosorbent assay (ELISA) for trypanosomosis or card agglutination test for trypanosomosis (CATT) at a serum dilution of 1 in 4(4) carried out, with negative results, on samples taken at least six months after the date the last infected animal has been removed from the establishment.]]]

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last animal of listed species on the establishment was either killed and destroyed or slaughtered.]]]

II.2.6.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[dourine has not been reported during the 24 month period prior to the date of departure of the animal.]

(3)or

[a surveillance and eradication programme for dourine recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3)either

[dourine has not been reported in the establishment during the 24 month period prior to the date of departure of the animal.]]

(3)or

[dourine has been reported in the establishment during the 24 month period prior to the date of departure of the animal, and following the last outbreak, the establishment has remained under movement restrictions:

(3)either

[until the remaining equine animals in the establishment, except castrated male equine animals, have been subjected to a complement fixation test for dourine, carried out with negative results at a serum dilution of 1 in 5(4) on samples taken at least six months after the date the infected animals have been killed and destroyed or slaughtered, or the infected entire male equine animals have been castrated.]]]

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was either killed and destroyed or slaughtered.]]]

II.2.7.

The equine animal described in Part I has not been vaccinated against Venezuelan equine encephalomyelitis during the 60 day period prior to the date of its departure, and

(3)either

[it comes from an establishment situated in a country or territory in which Venezuelan equine encephalomyelitis has not been reported during the 24 month period prior to the date of its departure.]

(3)or

[it comes from an establishment in which Venezuelan equine encephalomyelitis has not been reported during the six month period prior to the date of its departure and which is situated in a country, territory or zone thereof in which a surveillance and eradication programme for Venezuelan equine encephalomyelitis recognised by the Union(1) has been carried out during the 24 month period prior to the date of its departure.]’;

(ii)

in the Notes to Part I, Box reference I.8 is replaced by the following:

‘Box reference I.8

Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.’;

(iii)

in the Notes to Part II, footnotes (1) to (2) are replaced by the following:

‘(1)

(2)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.’;

(g)

in Chapter 17, model EQUI-RE-ENTRY-90-COMP is corrected as follows:

(i)

points II.2.4 to II.2.7 are replaced by the following:

‘II.2.4.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[infection with Burkholderia mallei (glanders) has not been reported during the 36 month period prior to the date of departure of the animal.]

(3)or

(3)either

[infection with Burkholderia mallei (glanders) has not been reported in the establishment of dispatch during the 36 month period prior to the date of departure of the animal.]]

(3)or

(3)either

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was killed and destroyed.]]]

II.2.5.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[surra has not been reported during the 24 month period prior to the date of departure.]

(3)or

[a surveillance and eradication programme for surra recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3)either

[surra has not been reported in the establishment during the 24 months period prior to the date of departure of the animal.]]

(3)or

(3)either

(3)or

II.2.6.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[dourine has not been reported during the 24 month period prior to the date of departure of the animal.]

(3)or

[a surveillance and eradication programme for dourine recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3)either

[dourine has not been reported in the establishment during the 24 month period prior to the date of departure of the animal.]]

(3)or

(3)either

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was either killed and destroyed or slaughtered.]]]

II.2.7.

The equine animal described in Part I has not been vaccinated against Venezuelan equine encephalomyelitis during the 60 day period prior to the date of its departure, and

(3)either

[it comes from an establishment situated in a country or territory in which Venezuelan equine encephalomyelitis has not been reported during the 24 month period prior to the date of its departure.]

(3)or

(ii)

in the Notes to Part I, Box reference I.8 is replaced by the following:

‘Box reference I.8

Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.’;

(iii)

in the Notes to Part II, footnotes (1) to (2) are replaced by the following:

‘(1)

(2)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.’;

(h)

in Chapter 18, model EQUI- RE-ENTRY-90-RACE is corrected as follows:

(i)

points II.2.4 to II.2.7 are replaced by the following:

‘II.2.4.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[infection with Burkholderia mallei (glanders) has not been reported during the 36 month period prior to the date of departure of the animal.]

(3)or

(3)either

[infection with Burkholderia mallei (glanders) has not been reported in the establishment of dispatch during the 36 month period prior to the date of departure of the animal.]]

(3)or

(3)either

(3)or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was killed and destroyed.]]]

II.2.5.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3)either

[surra has not been reported during the 24 month period prior to the date of departure.]

(3)or

[a surveillance and eradication programme for surra recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3)either

[surra has not been reported in the establishment during the 24 months period prior to the date of departure of the animal.]]

(3)or

(3)either

(3)or

II.2.6.

The equine animal described in Part I comes from an establishment situated in a country, territory or zone thereof in which:

(3) either

[dourine has not been reported during the 24 month period prior to the date of departure of the animal.]

(3) or

[a surveillance and eradication programme for dourine recognised by the Union(1) has been carried out during the 24 month period prior to the date of departure of the animal, and

(3) either

[dourine has not been reported in the establishment during the 24 month period prior to the date of departure of the animal.]]

(3) or

(3) either

(3) or

[for a period of at least 30 days from the date of cleaning and disinfection of the establishment, after the last equine animal on the establishment was either killed and destroyed or slaughtered.]]]

II.2.7.

The equine animal described in Part I has not been vaccinated against Venezuelan equine encephalomyelitis during the 60 day period prior to the date of its departure, and

(3) either

[it comes from an establishment situated in a country or territory in which Venezuelan equine encephalomyelitis has not been reported during the 24 month period prior to the date of its departure.]

(3) or

(ii)

in the Notes to Part I, Box reference I.8 is replaced by the following:

‘Box reference I.8

Provide the code of the country, territory or zone thereof of dispatch as appearing in column 2 of the table in Part 1 of Annex IV to Commission Implementing Regulation (EU) 2021/404.’;

(iii)

in the Notes to Part II, footnotes (1) and (2) are replaced by the following:

‘(1)

(2)	Code of the country, territory or zone thereof and the Sanitary Group as appearing respectively in columns 2 and 3 of the table in Part 1 of Annex IV to Implementing Regulation (EU) 2021/404.’;

(i)

in Chapter 19, in model CONFINED-RUM, Section 2 is corrected as follows:

(i)

points II.1.2 and II.1.3 are replaced by the following:

‘II.1.2.

have remained continuously in the establishment of origin since birth or for a period of at least six months prior to the date of dispatch to the Union.

II.1.3.

have not been in contact with animals of a lower health status for a period of 30 days prior to the date of dispatch to the Union, or since birth if the animals are less than 30 days of age, and during their transport from the approved confined establishment of origin to the place of dispatch to the Union.’;

(ii)

point II.1.6 is replaced by the following:

‘II.1.6.

have not been unloaded in any place that does not comply with the requirements laid down in point II.1.11. since they were dispatched from their establishment of origin until their dispatch to the Union and during that period they have not been in contact with animals of a lower health status.’;

(iii)

in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)	Code of the zone as it appears in column 2 of the table in Part 1 of Annex III to Implementing Regulation (EU) 2021/404.’;

(j)

in Chapter 20, in model CONFINED-SUI, Section 2 is corrected as follows:

(i)

points II.1.2 and II.1.3 are replaced by the following:

‘II.1.2.

have remained continuously in the establishment of origin since birth or for a period of at least six months prior to the date of dispatch to the Union.

II.1.3.

(ii)

point II.1.6 is replaced by the following:

‘II.1.6.

(iii)

point II.1.14 is replaced by the following:

‘ (1)(4) [ either (1) [II.1.14.

come from a zone in which at the date of issue of this certificate African swine fever has not been reported during the preceding 12 month period.]]

or (1) [II.1.14.

have undergone a virology and serology test for the detection of African swine fever and in accordance with the test prescribed for international trade in the OIE Terrestrial Manual, carried out on samples taken during the period of 30 days prior to the date of dispatch to the Union.]]’;

(iv)

in the Notes to Part II, footnote (2) is replace by the following:

‘(2)	Code of the zone as it appears in column 2 of the table in Part 1 of Annex III to Implementing Regulation (EU) 2021/404.’;

(k)

in Chapter 21, in model CONFINED-TRE, Section 2 is corrected as follows:

(i)

points II.1.2 and II.1.3 are replaced by the following:

‘II.1.2.

have remained continuously in the establishment of origin since birth or for a period of at least six months prior to the date of dispatch to the Union.

II.1.3.

(ii)

point II.1.6 is replaced by the following:

‘II.1.6.

(iii)

in the Notes to Part II, footnote (2) is replace by the following:

‘(2)	Code of the zone as it appears in column 2 of the table in Part 1 of Annex III to Implementing Regulation (EU) 2021/404.’;

(l)

in Chapter 22, model CONFINED-HIPPO is corrected as follows:

(i)

points II.1.2 and II.1.3 are replaced by the following:

‘II.1.2.

have remained continuously in the establishment of origin since birth or for a period of at least six months prior to the date of dispatch to the Union.

II.1.3.

(ii)

point II.1.6 is replaced by the following:

‘II.1.6.

(iii)

points II.1.11.3 to II.1.11.5 are replaced by the following:

‘II.1.11.3.

in which at the date of issue of this animal health certificate the following diseases have not been reported during the preceding six month period:

—	foot and mouth disease,

—	infection with rinderpest virus,

—	infection with Rift Valley fever virus,

—	infection with Brucella abortus, B. melitensis and B. suis,

—	infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae, M.Tuberculosis),

II.1.11.4.

in which at the date of issue of this animal health certificate surra (Trypanosoma evansi) and anthrax have not been reported during the period of 30 days prior to the date of dispatch to the Union.

II.1.11.5.

around which, in an area with a 10 km radius, including where appropriate the territory of a neighbouring country, none of the following listed diseases has been reported during the period of 30 days prior to the date of dispatch to the Union:

—	foot and mouth disease,

—	infection with rinderpest virus,

—	infection with Brucella abortus, B. melitensis and B. suis,

—	infection with Mycobacterium tuberculosis complex (M. bovis, M.caprae, M.Tuberculosis).

II.1.11.6.

around which, in an area with a 150 km radius, including where appropriate the territory of a neighbouring country, infection with Rift Valley fever virus has not been reported during the period of 30 days prior to the date of dispatch to the Union.’;

(iv)

in the Notes to Part II, footnote (2) is replace by the following:

‘(2)	Code of the zone as it appears in column 2 of the table in Part 1 of Annex III to Implementing Regulation (EU) 2021/404.’;

(m)

in Chapter 34a, model RACING PIGEONS-IMMEDIATE RELEASE is corrected as follows:

(i)

point I.18 is replaced by the following:

‘I.18

Transport conditions

☐

Ambient’

(ii)

point II.1.2 is replaced by the following:

‘II.1.2.

come from the establishment indicated in Box I.11 registered by the competent authority of the third country or territory of origin or zone thereof, and:

(a)	within a 10 km radius of which, 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 for a period of at least 30 days prior to the date of loading for dispatch to the Union;

(b)	in which the vaccination against infection with Newcastle disease virus is carried out.’;

(iii)

point II.1.6 is replaced by the following:

‘II.1.6.

are loaded for dispatch to the Union on ___/___/____ (dd/mm/yyyy)(2) in a means of transport which:

(a)

is constructed in such a way that:

(i)	animals cannot escape or fall out;

(ii)	visual inspection of the space where animals are kept is possible;

(iii)

the escape of animal excrements, litter, feed or feathers is prevented or minimised;

(b)	contains only racing pigeons;

(c)	was cleaned and disinfected prior to loading with a disinfectant authorised by the competent authority of the third country or territory of origin, or zone thereof.’;

(n)

in Chapter 39, model BOV-SEM-A-ENTRY is corrected as follows:

(i)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Type” : Indicate semen.

“Species” : Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.4.8.5. and/or II.4.8.6., and/or for EHD-test: II.4.9.3.1. and/or II.4.9.3.2., if relevant.’;

(ii)

in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(o)

in Chapter 42, model ‘BOV-OOCYTES-EMB-A-ENTRY is corrected and amended as follows:

(i)

in Part II, point II.2. is replaced by the following:

‘ (1) [II.2.

The in vivo derived embryos described in Part I have been collected, processed and stored, and dispatched by the embryo collection team(3) which:

II.2.1.

is approved and listed by the competent authority of the third country or territory;

II.2.2.

complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Part 2 of Annex I to Commission Delegated Regulation (EU) 2020/686.]

(1) [II.2.

The oocytes(1)/in vitro produced embryos(1) described in Part I have been collected or produced, processed and stored, and dispatched by the embryo production team(3) which:

II.2.1.

is approved and listed by the competent authority of the third country or territory;

II.2.2.

complies with requirements as regards responsibilities, operational procedures, facilities and equipment set out in Parts 2 and 3 of Annex I to Delegated Regulation (EU) 2020/686.]’;

(ii)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Species” : Select amongst “ Bos taurus ”, “ Bison bison ” or “ Bubalus bubalis ” as appropriate.

“Type” : Specify if oocytes, in vivo derived embryos, in vitro produced embryos or micromanipulated embryos.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed.

“Date of collection/production” : Indicate the date on which oocytes or embryos of the consignment were collected or produced.

“ Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the embryo collection or production team by which the oocytes or embryos were collected or produced.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.4.7.5. and/or II.4.7.6., and/or for EHD-test: II.4.8.3.1. and/or II.4.8.3.2., if relevant.’;

(iii)

in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(p)

in Chapter 47, model BOV-GP-STORAGE-ENTRY is corrected as follows:

(i)

the introductory Notes are replaced by the following:

‘ Notes

This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of bovine animals, including when the Union is not the final destination of the semen, oocytes and embryos.

In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, references to European Union in this animal health certificate include the United Kingdom in respect of Northern Ireland.

This animal health certificate shall be completed in accordance with the notes for the completion of certificates provided for in Chapter 4 of Annex I to Commission Implementing Regulation (EU) 2020/2235.’;

(ii)

in the Notes to Part II, footnote (3) is replaced by the following:

‘(3)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(q)

in Chapter 48, model OV/CAP-SEM-A-ENTRY is corrected and amended as follows:

(i)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Type” : Indicate semen.

“Species” : Select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.4.8.5. and/or II.4.8.6., and/or for EHD-test: II.4.9.3.1. and/or II.4.9.3.2., if relevant.’;

(ii)

in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(r)

in Chapter 50, model OV/CAP-OOCYTES-EMB-A-ENTRY is corrected an amended as follows:

(i)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Type” : specify if in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos.

“Species” : select amongst “ Ovis aries ” or “ Capra hircus ” as appropriate.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed.

“Date of collection/production” : Indicate the date on which oocytes or embryos of the consignment were collected or produced.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate for BTV-test: II.4.7.5. and/or II.4.7.6., and/or for EHD-test: II.4.8.3.1. and/or II.4.8.3.2., if relevant.’;

(ii)

in the Notes to Part II, footnote (2) is replaced by the following:

‘(2)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(s)

in Chapter 53, model OV/CAP-GP-STORAGE-ENTRY is corrected as follows:

(i)

the introductory Notes are replaced by the following:

‘ Notes

This animal health certificate is intended for the entry into the Union of semen, oocytes and embryos of ovine and caprine animals, including when the Union is not the final destination of the semen, oocytes and embryos.

(ii)

in the Notes to Part II, footnote (3) is replaced by the following:

‘(3)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(t)

in Chapter 54, model POR-SEM-A-ENTRY is corrected as follows:

(i)

point II.4.8.3 is replaced by the following:

‘(1)[II.4.8.3.

as regards classical swine fever, an antibody ELISA or serum neutralisation test, in the case of animals coming from a third country or territory or zone thereof where classical swine fever has been reported or vaccination against this disease has been practiced for the period of the preceding 12 months;]’;

(ii)

point II.4.9.3 is replaced by the following:

‘(1)[II.4.9.3.

as regards classical swine fever, an antibody ELISA or serum neutralisation test, in the case of animals coming from a third country or territory or zone thereof where classical swine fever has not been reported and vaccination against this disease has not been practiced for the period of the preceding 12 months;]’;

(iii)

in the Notes to Part II, footnotes (2) and (3) are replaced by the following:

‘(2)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.

(3)	Only for a third country, territory or zone thereof with an opening date in accordance with column 9 of the table in Part 1 of Annex II to Implementing Regulation (EU) 2021/404.’;

(u)

in Chapter 59, model EQUI-SEM-A-ENTRY is corrected and amended as follows:

(i)

in Part II, point II.4.4.2 is replaced by the following:

‘II.4.4.2.

(ii)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Type” : Indicate semen.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where semen of the consignment is placed.

“Date of collection/production” : Indicate the date on which semen of the consignment was collected in the following format: dd.mm.yyyy.

“Approval or registration number of plant/establishment/centre” : Indicate the unique approval number of the semen collection centre where the semen was collected.

“Quantity” : Indicate the number of straws or other packages with the same mark.

“Test” : Indicate ‘Yes, see points II.4.9. and II.4.10’.’;

(v)

in Chapter 63, model EQUI-OOCYTES-EMB-A-ENTRY is corrected as follows:

(i)

point II.4.4.2 is replaced by the following:

‘II.4.4.2.

(ii)

in the Notes to Part I, Box reference I.27 is replaced by the following:

‘Box reference I.27

“Type” : Specify if in vivo derived embryos, in vivo derived oocytes, in vitro produced embryos or micromanipulated embryos.

“Identification number” : Indicate the identification number of each donor animal.

“Identification mark” : Indicate the mark on the straw or other packages where oocytes or embryos of the consignment are placed.

“Date of collection/production” : Indicate the date on which oocytes or embryos of the consignment were collected or produced.

“Quantity” : Indicate the number of straws or other packages with the same mark.’.

29.3.2022

Official Journal of the European Union

L 101/34

COMMISSION IMPLEMENTING DECISION (EU) 2022/498

of 22 March 2022

amending Implementing Decision (EU) 2020/167 as regards harmonised standards for avalanche beacons, satellite earth stations and systems, land mobile earth stations, maritime mobile earth stations, IMT cellular networks equipment, fixed radio systems, digital terrestrial TV transmitters, mobile communication on board aircraft systems, multi Gbps radio equipment, broadcast sound receivers, audio frequency induction loop drivers, primary surveillance radars and TETRA radio equipment

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

(1)

In accordance with Article 16 of Directive 2014/53/EU of the European Parliament and of the Council (2), radio equipment which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, is to be presumed to be in conformity with the essential requirements set out in Article 3 of that Directive covered by those standards or parts thereof.

(2)

By Implementing Decision C(2015) 5376 (3), the Commission made a request to the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) for the drafting and revision of harmonised standards for radio equipment in support of Directive 2014/53/EU (‘the request’).

(3)

On the basis of the request, ETSI drafted the following new harmonised standards: EN 300 718-1 V2.2.1 for avalanche beacons, EN 303 345-3 V1.1.1 and EN 303 345-4 V1.1.1 for broadcast sound receivers, EN 303 348 V1.2.1 for audio frequency induction loop drivers, EN 303 364-2 V1.1.1 for primary surveillance radars, EN 303 372-1 V1.2.1, EN 303 372-2 V1.2.1, EN 303 413 V1.2.1, EN 303 980 V1.2.1 and EN 303 981 V1.2.1 for satellite stations and systems and EN 303 758 V1.1.1 for TETRA radio equipment.

(4)

On the basis of the request, ETSI revised the following harmonised standards: EN 301 444 V2.1.2, EN 301 908-15 V11.1.2, EN 302 296-2 V1.2.1, EN 302 480 V2.1.2 and EN 302 567 V1.2.1, the references of which have been published in the C series of the Official Journal of the European Union by Commission communication 2018/C 326/04 (4). This resulted in the adoption of the following revised harmonised standards: EN 301 444 V2.2.1 for satellite stations and systems, EN 301 908-15 V15.1.1 for IMT cellular networks, EN 302 296 V2.2.1 for digital terrestrial TV transmitters, EN 302 480 V2.2.1 for mobile communication on board aircraft systems and EN 302 567 V2.2.1 for multi Gbps radio equipment.

(5)

On the basis of the request, ETSI also revised the following harmonised standards for IMT cellular networks: EN 301 908-1 V13.1.1, EN 301 908-14 V13.1.1 and EN 301 908-18 V13.1.1, the references of which have been added in Annex I to Commission Implementing Decision (EU) 2020/167 (5). This resulted in the adoption of the following revised harmonised standards: EN 301 908-1 V15.1.1, EN 301 908-14 V15.1.1 and EN 301 908-18 V15.1.1. In addition, ETSI revised the harmonised standard EN 302 217-2 V3.2.2 for fixed radio systems, the reference of which has been added in Annex II to Implementing Decision (EU) 2020/167. This resulted in the adoption of the revised harmonised standard EN 302 217-2 V3.3.1.

(6)	The Commission, together with ETSI, has assessed whether those new and revised harmonised standards comply with the request.

(7)

Harmonised standards EN 301 908-14 V15.1.1, EN 301 908-15 V15.1.1, EN 301 908-18 V15.1.1, EN 302 217-2 V3.3.1, EN 302 480 V2.2.1, EN 302 567 V2.2.1, EN 303 345-3 V1.1.1, EN 303 345-4 V1.1.1, EN 303 348 V1.2.1, EN 303 372-2 V1.2.1, EN 303 413 V1.2.1 and EN 303 758 V1.1.1 satisfy the essential requirements which they aim to cover and which are set out in Article 3 of Directive 2014/53/EU. It is therefore appropriate to publish the references of those standards in the Official Journal of the European Union.

(8)

Harmonised standard EN 300 718-1 V2.2.1, in the last sentence of clause 5.1.3.1, does not specify all the conditions for verification mechanisms, allowing for a subjective interpretation of the specifications laid down therein. In addition, it does not lay down any requirements relating to the spurious response rejection, which is a receiver parameter that may be related to the production of harmful interferences. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(9)

Harmonised standard EN 301 444 V2.2.1, in second paragraph of clause 5.2.1, does not provide for any verification criteria for fulfilment of the specifications laid down therein, allowing uncertainty in terms of results. In addition, it provides, in clause 5.2.2.3.1, specifications as regards the installation of the equipment, which is not the objective of a harmonised standard. Finally, in the first paragraph of clause 5.2.3, the first paragraph of clause 5.2.4 and the first paragraph of clause 5.2.5, it allows the manufacturer to modify the equipment with the purpose of testing, which may lead to imprecise results and create a high degree of uncertainty. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(10)

Harmonised standard EN 301 908-1 V15.1.1, in note 3 to clause 5.3.2.1, allows the manufacturer to select an alternative testing methodology to the one laid down in that standard. This may lead to different testing results and creates legal uncertainty. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(11)

Harmonised standard EN 302 296 V2.2.1, in clause 5.4.2.5, describes an imprecise testing set-up by means of a coupling device, which creates a high degree of uncertainty in the interpretation of the results. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(12)

Harmonised standard EN 303 364-2 V1.1.1, in clauses 4.2.1.4 and 5.3.1.5, describes a particular scenario of power transfer between the transmitter and the antenna by means of WR284/WG10/R32 waveguides, which means that it covers only part of the scope of the essential requirements that it is intended to cover. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(13)

Harmonised standard EN 303 372-1 V1.2.1, in clause 4.3.5, provides that it is not applicable under certain technical conditions for which no mitigation measures are provided as regards the avoidance of harmful interferences. This may lead to harmful interference with satellite networks and other services. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(14)

Harmonised standard EN 303 980 V1.2.1, in the second sentence of clause 6.1.1, allows the manufacturer to select an alternative testing methodology to the one laid down in that standard. This may lead to different testing results and may create legal uncertainty. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(15)

Harmonised standard EN 303 981 V1.2.1, in the second sentence of clause 6.1.1, allows the manufacturer to select an alternative testing methodology to the one laid down in that standard. This may lead to different testing results and may create legal uncertainty. The reference of that harmonised standard should therefore be published in the Official Journal of the European Union with restriction.

(16)

Annex I to Implementing Decision (EU) 2020/167 lists the references of harmonised standards for radio equipment drafted in support of Directive 2014/53/EU that are published in the Official Journal of the European Union, while Annex II to that Implementing Decision lists the references of such harmonised standards that are published in the Official Journal of the European Union with restriction.

(17)

In order to ensure that the references of harmonised standards drafted in support of Directive 2014/53/EU are listed in one act, the references of harmonised standards EN 301 908-14 V15.1.1, EN 301 908-15 V15.1.1, EN 301 908-18 V15.1.1, EN 302 217-2 V3.3.1, EN 302 480 V2.2.1, EN 302 567 V2.2.1, EN 303 345-3 V1.1.1, EN 303 345-4 V1.1.1, EN 303 348 V1.2.1, EN 303 372-2 V1.2.1, EN 303 413 V1.2.1 and EN 303 758 V1.1.1 should be included in Annex I to Implementing Decision (EU) 2020/167 and the references of harmonised standards EN 300 718-1 V2.2.1, EN 301 444 V2.2.1, EN 301 908-1 V15.1.1, EN 302 296 V2.2.1, EN 303 364-2 V1.1.1, EN 303 372-1 V1.2.1, EN 303 980 V1.2.1 and EN 303 981 V1.2.1 should be included in Annex II to that Implementing Decision.

(18)

Harmonised standards EN 301 444 V2.2.1, EN 301 908-1 V15.1.1, EN 301 908-14 V15.1.1, EN 301 908-15 V15.1.1, EN 301 908-18 V15.1.1, EN 302 217-2 V3.3.1, EN 302 296 V2.2.1, EN 302 480 V2.2.1 and EN 302 567 V2.2.1 replace harmonised standards EN 301 444 V2.1.2, EN 301 908-1 V13.1.1, EN 301 908-14 V13.1.1, EN 301 908-15 V11.1.2, EN 301 908-18 V13.1.1, EN 302 217-2 V3.2.2, EN 302 296-2 V1.2.1, EN 302 480 V2.1.2 and EN 302 567 V1.2 respectively.

(19)

It is therefore necessary to withdraw the references of harmonised standards EN 301 444 V2.1.2, EN 301 908-15 V11.1.2, EN 302 296-2 V1.2.1, EN 302 480 V2.1.2 and EN 302 567 V1.2.1, from the C series of the Official Journal of the European Union (6). Annex III to Implementing Decision (EU) 2020/167 lists the references of harmonised standards for radio equipment drafted in support of Directive 2014/53/EU that are withdrawn from the C series of the Official Journal of the European Union. It is therefore appropriate to include those references in that Annex.

(20)

It is also necessary to withdraw the references of harmonised standards EN 301 908-1 V13.1.1, EN 301 908-14 V13.1.1, EN 301 908-18 V13.1.1 and EN 302 217-2 V3.2.2 from the L series of the Official Journal of the European Union. It is therefore appropriate to delete those references from Annexes I and II to Implementing Decision (EU) 2020/167.

(21)

In order to give manufacturers sufficient time to prepare for the application of harmonised standards EN 301 444 V2.2.1, EN 301 908-1 V15.1.1, EN 301 908-14 V15.1.1, EN 301 908-15 V15.1.1, EN 301 908-18 V15.1.1, EN 302 217-2 V3.3.1, EN 302 296 V2.2.1, EN 302 480 V2.2.1 and EN 302 567 V2.2.1, it is necessary to defer the withdrawal of the references of harmonised standards EN 301 444 V2.1.2, EN 301 908-1 V13.1.1, EN 301 908-14 V13.1.1, EN 301 908-15 V11.1.2, EN 301 908-18 V13.1.1, EN 302 217-2 V3.2.2, EN 302 296-2 V1.2.1, EN 302 480 V2.1.2 and EN 302 567 V1.2.1.

(22)	Implementing Decision (EU) 2020/167 should therefore be amended accordingly.

(23)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force as a matter of urgency,

HAS ADOPTED THIS DECISION:

Article 1

Implementing Decision (EU) 2020/167 is amended as follows:

(1)	Annex I is amended in accordance with Annex I to this Decision;

(2)	Annex II is amended in accordance with Annex II to this Decision;

(3)	Annex III is amended in accordance with Annex III to this Decision.

Article 2

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

Done at Brussels, 22 March 2022.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 316, 14.11.2012, p. 12.

(2) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).

(3) Commission Implementing Decision C(2015) 5376 of 4 August 2015 on a standardisation request to the European Committee for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in support of Directive 2014/53/EU of the European Parliament and of the Council.

(4) Commission communication in the framework of the implementation of Directive 1999/5/EC of the European Parliament and of the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity and Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (Publication of titles and references of harmonised standards under Union harmonisation legislation) (OJ C 326, 14.9.2018, p. 114).

(5) Commission Implementing Decision (EU) 2020/167 of 5 February 2020 on the harmonised standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council (OJ L 34, 6.2.2020, p. 46).

(6) OJ C 326, 14.9.2018, p. 114.

ANNEX I

Annex I to Implementing Decision (EU) 2020/167 is amended as follows:

(1)	entry 4 is deleted;

(2)

the following entry 4a is inserted:

‘4a.	EN 301 908-15 V15.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 15: Evolved Universal Terrestrial Radio Access (E-UTRA FDD) Repeaters’

(3)	entry 6 is deleted;

(4)

the following entry 6a is inserted:

‘6a.	EN 301 908-14 V15.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 14: Evolved Universal Terrestrial Radio Access (E-UTRA) Base Stations (BS)’

(5)	entry 7 is deleted;

(6)

the following entry 7a is inserted:

‘7a.	EN 301 908-18 V15.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 18: E-UTRA, UTRA and GSM/EDGE Multi-Standard Radio (MSR) Base Station (BS); Release 15’

(7)

the following entries are added:

No	Reference of the standard
‘12.	EN 302 217-2 V3.3.1 Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2: Digital systems operating in frequency bands from 1 GHz to 86 GHz; Harmonised Standard for access to radio spectrum
13.	EN 302 480 V2.2.1 Mobile Communication On Board Aircraft (MCOBA) systems; Harmonised Standard for access to radio spectrum
14.	EN 302 567 V2.2.1 Multiple-Gigabit/s radio equipment operating in the 60 GHz band
15.	EN 303 345-3 V1.1.1 Broadcast Sound Receivers; Part 3: FM broadcast sound service
16.	EN 303 345-4 V1.1.1 Broadcast Sound Receivers; Part 4: DAB broadcast sound service
17.	EN 303 348 V1.2.1 Audio frequency induction loop drivers up to 45 amperes in the frequency range 10 Hz to 9 kHz
18.	EN 303 372-2 V1.2.1 Satellite Earth Stations and Systems (SES); Satellite broadcast reception equipment; Part 2: Indoor unit
19.	EN 303 413 V1.2.1 Satellite Earth Stations and Systems (SES); Global Navigation Satellite System (GNSS) receivers; Radio equipment operating in the 1 164 MHz to 1 300 MHz and 1 559 MHz to 1 610 MHz frequency bands
20.	EN 303 758 V1.1.1 TETRA radio equipment using non-constant envelope modulation operating in a channel bandwidth of 25 kHz, 50 kHz, 100 kHz or 150 kHz.’

ANNEX II

Annex II to Implementing Decision (EU) 2020/167 is amended as follows:

(1)	entry 5 is deleted;

(2)

the following entries are added:

Reference of the standard

‘14.

EN 300 718-1 V2.2.1

Avalanche Beacons operating at 457 kHz; Transmitter-receiver systems; Part 1: Harmonised Standard for access to radio spectrum

Notice1: Compliance with this harmonised standard shall not confer a presumption of conformity with the essential requirement set out in Article 3(2) of Directive 2014/53/EU if the last sentence of clause 5.1.3.1 of this standard is applied.

Notice 2: This harmonised standard does not confer a presumption of conformity as regards spurious response rejection.

15.

EN 301 444 V2.2.1

Satellite Earth Stations and Systems (SES); Land Mobile Earth Stations (LMES) and Maritime Mobile Earth Stations (MMES) providing voice and/or data communications, operating in the 1,5 GHz and 1,6 GHz frequency bands

(a)	the second paragraph of clause 5.2.1 of this standard;

(b)	clause 5.2.2.3.1 of that standard;

(c)	the first paragraph of clause 5.2.3 of this standard;

(d)	the first paragraph of clause 5.2.4 of this standard;

(e)	the first paragraph of clause 5.2.5 of this standard.

16.

EN 301 908-1 V15.1.1

IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 1: Introduction and common requirements

17.

EN 302 296 V2.2.1

Digital Terrestrial TV Transmitters

Notice: Compliance with this harmonised standard shall not confer a presumption of conformity with the essential requirement set out in Article 3(2) of Directive 2014/53/EU if a coupling device is used within the test arrangement laid down in clause 5.4.2.5 of this standard.

18.

EN 303 364-2 V1.1.1

Primary Surveillance Radar (PSR); Harmonised Standard for access to radio spectrum; Part 2: Air Traffic Control (ATC) PSR sensors operating in the frequency band 2 700 MHz to 3 100 MHz (S band)

Notice: As regards clauses 4.2.1.4 and 5.3.1.5 of this harmonised standard, compliance with this harmonised standard shall not confer a presumption of conformity with the essential requirement set out in Article 3(2) of Directive 2014/53/EU to equipment not using WR284/WG10/R32 waveguides to transfer power between the transmitter and the antenna.

19.

EN 303 372-1 V1.2.1

Satellite Earth Stations and Systems (SES); Satellite broadcast reception equipment; Part 1: Outdoor unit receiving in the 10,7 GHz to 12,75 GHz frequency band

Notice: Compliance with this harmonised standard shall not confer a presumption of conformity with the essential requirement set out in Article 3(2) of Directive 2014/53/EU if the following sentence in clause 4.3.5 of this standard is applied: “This requirement does not apply in case the ODU is designed for a specific satellite network that makes use of both polarizations”.

20.

EN 303 980 V1.2.1

Satellite Earth Stations and Systems (SES); Fixed and in-motion Earth Stations communicating with non-geostationary satellite systems (NEST) in the 11 GHz to 14 GHz frequency bands

21.

EN 303 981 V1.2.1

Satellite Earth Stations and Systems (SES); Fixed and in-motion Wide Band Earth Stations communicating with non-geostationary satellite systems (WBES) in the 11 GHz to 14 GHz frequency bands

ANNEX III

In Annex III to Implementing Decision (EU) 2020/167, the following entries are added:

No	Reference of the standard	Date of withdrawal
‘22.	EN 301 444 V2.1.2 Satellite Earth Stations and Systems (SES); Harmonised Standard for Land Mobile Earth Stations (LMES) providing voice and/or data communications, operating in the 1,5 GHz and 1,6 GHz frequency bands covering the essential requirements of article 3.2 of the Directive 2014/53/EU	29 September 2023
23.	EN 301 908-1 V13.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 1: Introduction and common requirements	29 September 2023
24.	EN 301 908-14 V13.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 14: Evolved Universal Terrestrial Radio Access (E-UTRA) Base Stations (BS)	29 September 2023
25.	EN 301 908-15 V11.1.2 IMT cellular networks; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU; Part 15: Evolved Universal Terrestrial Radio Access (E-UTRA FDD) Repeaters	29 September 2023
26.	EN 301 908-18 V13.1.1 IMT cellular networks; Harmonised Standard for access to radio spectrum; Part 18: E-UTRA, UTRA and GSM/EDGE Multi-Standard Radio (MSR) Base Station (BS)	29 September 2023
27.	EN 302 217-2 V3.2.2 Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 2: Digital systems operating in frequency bands from 1 GHz to 86 GHz; Harmonised Standard for access to radio spectrum	29 September 2023
28.	EN 302 296-2 V1.2.1 Electromagnetic compatibility and Radio spectrum Matters (ERM); Transmitting equipment for the digital television broadcast service, Terrestrial (DVB-T); Part 2: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive	29 September 2023
29.	EN 302 480 V2.1.2 Mobile Communication On Board Aircraft (MCOBA) systems; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU	29 September 2023
30.	EN 302 567 V1.2.1 Broadband Radio Access Networks (BRAN); 60 GHz Multiple-Gigabit WAS/RLAN Systems; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive	29 September 2023’

		ISSN 1977-0677
Official Journal of the European Union		L 101

English edition	Legislation	Volume 65 29 March 2022

Contents		II Non-legislative acts	page
		REGULATIONS
	*	Commission Implementing Regulation (EU) 2022/496 of 28 March 2022 approving the low-risk active substance Spodoptera exigua multicapsid nucleopolyhedrovirus (SeMNPV), isolate BV-0004 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 ( 1 )	1
	*	Commission Implementing Regulation (EU) 2022/497 of 28 March 2022 amending and correcting Annexes I and II to Implementing Regulation (EU) 2021/403 as regards certain model animal health certificates, animal health/official certificates and declarations for the movements between Member States and the entry into the Union of consignments of certain species and categories of terrestrial animals and germinal products thereof ( 1 )	6
		DECISIONS
	*	Commission Implementing Decision (EU) 2022/498 of 22 March 2022 amending Implementing Decision (EU) 2020/167 as regards harmonised standards for avalanche beacons, satellite earth stations and systems, land mobile earth stations, maritime mobile earth stations, IMT cellular networks equipment, fixed radio systems, digital terrestrial TV transmitters, mobile communication on board aircraft systems, multi Gbps radio equipment, broadcast sound receivers, audio frequency induction loop drivers, primary surveillance radars and TETRA radio equipment ( 1 )	34
	*	Commission Implementing Decision (EU) 2022/499 of 23 March 2022 approving amendments to national plans, as regards Cyprus and Slovenia, for the implementation of the validation systems in accordance with Council Regulation (EC) No 1224/2009 (notified under document C(2022)1844) (Only the Greek and Slovenian texts are authentic)	43
	*	Commission Implementing Decision (EU) 2022/500 of 25 March 2022 establishing the military aggression of Russia against Ukraine as the occurrence of an exceptional event causing a significant disruption of markets	45