Commission Implementing Regulation (EU) 2024/2598 of 4 October 2024 laying down the list of third countries or regions thereof authorised for the entry into the Union of certain animals and products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the application of the prohibition on the use of certain antimicrobial medicinal products
Date: 2024-10-04
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, antimicrobial resistance, food inspection, import (EU), import restriction, live animal, pharmaceutical legislation, surveillance concerning imports, third country, veterinary inspection, veterinary medicinal product




L_202402598EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2598


7.10.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2598
of 4 October 2024
         
laying down the list of third countries or regions thereof authorised for the entry into the Union of certain animals and products of animal origin intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council as regards the application of the prohibition on the use of certain antimicrobial medicinal products
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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


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) (1), and in particular Article 127(2) thereof,


Having regard to Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union (2), and in particular Article 5(1) thereof,

Whereas:







(1)


Regulation (EU) 2017/625 lays down rules for official controls and other control activities performed by the competent authorities of the Member States in order to verify compliance with Union legislation in specific areas. In particular, Article 1(4) of Regulation (EU) 2017/625 provides that that Regulation is to apply to official controls for the verification of compliance with Article 118(1) of Regulation (EU) 2019/6 of the European Parliament and of the Council (3). Regulation (EU) 2017/625 also provides that the Commission may require that consignments of certain animals and goods are only to enter the Union from third countries or regions thereof which appear on a list drawn up by the Commission for that purpose.












(2)


Article 118(1) of Regulation (EU) 2019/6 requires that, as regards animals or products of animal origin exported from third countries to the Union, the following products are not to be used: (i) antimicrobial medicinal products for the purpose of promoting growth or to increase yield; and (ii) antimicrobial medicinal products containing an antimicrobial that is included in the list of antimicrobials reserved for the treatment of certain infections in humans laid down in Commission Implementing Regulation (EU) 2022/1255 (4).












(3)


Delegated Regulation (EU) 2023/905 supplements Regulation (EU) 2019/6 as regards, among other things, the conditions for the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption from third countries or regions thereof, in order to ensure that they comply with the prohibition on the use of antimicrobial medicinal products for growth promotion and yield increase and of antimicrobials reserved for the treatment of certain infections in humans. Those conditions include that the consignments of animals and products of animal origin concerned may only enter the Union if they originate from a third country or a region thereof that is included in a list drawn up by the Commission for that purpose.












(4)


In accordance with Article 5(2) of Delegated Regulation (EU) 2023/905, that list should only include third countries or regions thereof, which have submitted appropriate evidence and guarantees that the animals and products of animal origin concerned comply with the prohibition on the use of antimicrobial medicinal products for growth promotion and yield increase and of antimicrobials reserved for treatment of certain infections in humans, including information received on the procedures in place to guarantee traceability and origin.












(5)


The third countries or regions thereof which have submitted the evidence and guarantees referred to in Article 5(2) of Delegated Regulation (EU) 2023/905 should therefore be included in the list of authorised third countries or regions thereof from which animals and products of animal origin may enter into the Union.












(6)


The conditions for entry into the Union of consignments of animals or products of animal origin laid down in Delegated Regulation (EU) 2023/905 apply as from 24 months after the date of application of Commission Implementing Regulation (EU) 2024/399 (5). Therefore, this Regulation should also apply from 3 September 2026.












(7)


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

Subject matter and scope

This Regulation establishes the list of third countries or regions thereof referred to in Article 4(1), point (a), of Delegated Regulation (EU) 2023/905 from which the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption is permitted as regards the application of the prohibition on the use of certain antimicrobial medicinal products laid down in Article 118(1) of Regulation (EU) 2019/6.


Article 2

List of third countries or regions thereof authorised for the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption


1.   The third countries or regions thereof in which, as regards animals and products of animal origin intended for export to the Union, the requirements laid down in Article 3 of Delegated Regulation (EU) 2023/905 are complied with, are marked with ‘X’, for the relevant species or commodities, in the Annex to this Regulation.


2.   The third countries or regions thereof, which, for the production of products intended for export to the Union, intend to process only animals or products of animal origin originating either from Member States or from other third countries listed in the Annex in accordance with paragraph 1 of this Article, are marked with ‘Δ’, for the relevant species or commodities, in the Annex.



Article 3

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 3 September 2026.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 October 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj.

(2)  
            OJ L 116, 4.5.2023, p. 1, ELI: http://data.europa.eu/eli/reg_del/2023/905/oj.

(3)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43, ELI: http://data.europa.eu/eli/reg/2019/6/oj).

(4)  Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (OJ L 191, 20.7.2022, p. 58, ELI: http://data.europa.eu/eli/reg_impl/2022/1255/oj).

(5)  Commission Implementing Regulation (EU) 2024/399 of 29 January 2024 amending Annex III to Implementing Regulation (EU) 2020/2235 and Annex II to Implementing Regulation (EU) 2021/403 as regards model certificates for the entry into the Union of consignments of certain products of animal origin and certain categories of animals (OJ L, 2024/399, 12.2.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/399/oj).




ANNEX
List of third countries or regions thereof authorised for the entry into the Union of consignments of certain animals and products of animal origin intended for human consumption as regards the application of the prohibition on the use of certain antimicrobial medicinal products laid down in Article 118(1) of Regulation (EU) 2019/6:


















 


Animals and products of animal origin intended for human consumption (*1)





Country ISO Code


Third country (1) or regions thereof


Bovine


Ovine/ caprine


Porcine


Equine


Poultry


Aquaculture (14)



Milk


Eggs


Rabbit


Farmed game


Honey


Casings




AD


Andorra


X


X


Δ


X


 


 


 


 


 


 


X


 




AL


Albania


 


X


 


 


 


X (11)



 


X


 


 


 


X




AR


Argentina


X


X


 


X


X


X (11)



X


X


X


X


X


X




AU


Australia


X


X


 


X


 


X
M


X


X


 


X


X


X




AZE


Azerbaijan


 


 


 


 


 


X (13)



 


 


 


 


 


 




BA


Bosnia and Herzegovina


X


X


X


 


X


X (11)



X


X


 


 


X


 




BD


Bangladesh


 


 


 


 


 


X


 


 


 


 


 


 




BR


Brazil


X


 


 


X


X


X


 


 


 


 


X


X




BW


Botswana


X


 


 


 


 


 


 


 


 


 


 


 




BY


Belarus


 


 


 


X (5)



 


X (11)



X


X


 


 


X


X




CA


Canada


X


X


X


X


X


X
M


X


X


X


X


X


 




CH


Switzerland


X


X


X


X


X


X (11)

M


X


X


X


X


X


X




CL


Chile


X


X (3)



X


 


X


X (11)

M


X


 


 


 


X


X




CM


Cameroon


 


 


 


 


 


 


 


 


 


 


X


 




CN


China


 


 


 


 


X


X


 


X


X


 


X


X




CO


Colombia


 


 


 


 


 


X


 


 


 


 


 


 




CR


Costa Rica


 


 


 


 


 


X


 


 


 


 


 


 




CU


Cuba


 


 


 


 


 


X (12)



 


 


 


 


X


 




DO


Dominican Republic


 


 


 


 


 


 


 


 


 


 


X


 




EC


Ecuador


 


 


 


 


 


X


 


 


 


 


 


 




EG


Egypt


 


 


 


 


 


 


 


 


 


 


 


X




ET


Ethiopia


 


 


 


 


 


 


 


 


 


 


X


 




FK


Falkland Islands


X


X (3)



 


 


 


X (11)



 


 


 


 


 


 




FO


Faroes


 


 


 


 


 


X (11)



 


 


 


 


 


 




GB


United Kingdom (4)



X


X


X


X


X


X (11)

Δ
M


X


X


Δ


X


X


X




GE


Georgia


 


 


 


 


 


 


 


 


 


 


X


 




GL


Greenland


 


X (3)



 


 


 


 


 


 


 


X


 


 




GT


Guatemala


 


 


 


 


 


X (12)



 


 


 


 


X


 




HK


Hong Kong


 


 


 


 


 


Δ


 


Δ


 


 


 


 




HN


Honduras


 


 


 


 


 


X


 


 


 


 


 


 




IL


Israel (2)



 


 


 


 


X


X (11)



X


 


 


 


X


 




IM


Isle of Man


X


X (3)



X


 


 


X (11)

M


X


 


 


 


X


 




JE


Jersey


X


 


 


 


 


 


X


 


 


 


 


 




JP


Japan


X


 


Δ


 


X


X (11)

M


X


X


 


 


Δ


X




KR


South Korea


 


 


 


 


X


X
M


 


 


 


 


Δ


 




LB


Lebanon


 


 


 


 


 


 


 


 


 


 


X


X




MA


Morocco


 


 


 


 


X


X (11)

Δ
M


 


 


 


 


X


X




MD


Moldova


 


 


 


 


X


X (11)



X


X


 


 


X


 




ME


Montenegro


X


X


X


 


X


X (11)



X


X


 


 


X


X




MG


Madagascar


 


 


 


 


 


X


 


 


 


 


X


 




MK


North Macedonia


X


X


X


 


X


X (11)



X


X


 


 


X


 




MM


Myanmar/Burma


 


 


 


 


 


X


 


 


 


 


X


 




MN


Mongolia


 


 


 


 


 


 


 


 


 


 


 


X




MX


Mexico


 


 


Δ


 


 


X


 


X


 


 


X


 




MY


Malaysia


 


 


 


 


Δ


X


 


 


 


 


 


 




NA


Namibia


X


X (3)



 


 


 


 


 


 


 


 


 


 




NC


New Caledonia


 


 


 


 


 


X (12)



 


 


 


X


X


 




NI


Nicaragua


 


 


 


 


 


X (12)



 


 


 


 


X


 




NZ


New Zealand


X


X


 


 


 


X (11)

M


X


 


 


X


X


X




PE


Peru


 


 


 


 


 


X
M


 


 


 


 


 


 




PH


Philippines


 


 


 


 


 


X


 


 


 


 


 


 




PK


Pakistan


 


 


 


 


 


 


 


 


 


 


 


X




PM


Saint Pierre and Miquelon


 


 


 


 


X


 


 


 


 


 


 


 




PY


Paraguay


X


 


 


 


 


 


 


 


 


 


 


X




RU


Russia


X


X


X


 


X


 


X


X


 


X (6)



X


X




RW


Rwanda


 


 


 


 


 


 


 


 


 


 


X


 




SA


Saudi Arabia


 


 


 


 


 


X


 


 


 


 


 


 




SG


Singapore


Δ


Δ


Δ


 


Δ


X (11)



Δ


Δ


 


X (7)



 


 




SM


San Marino


X


 


Δ


 


 


 


X


 


 


 


X


 




SV


El Salvador


 


 


 


 


 


 


 


 


 


 


X


 




TG


Togo


 


 


 


 


 


 


 


 


 


 


X


 




TH


Thailand


 


 


 


 


X


X
M


Δ


Δ


 


 


X


 




TR


Türkiye


 


 


 


 


X


X (11)

M


X


X


 


 


X


X




TW


Taiwan


 


 


 


 


 


X


 


X


 


 


X


 




UA


Ukraine


X


 


X


 


X


X (11)

M


X


X


X


 


X


X




US


United States


X


X (8)



X


 


X


X
M


X


X


X


X


X


X




UY


Uruguay


X


X


 


X


 


 


X


 


 


 


X


X




VE


Venezuela


 


 


 


 


 


X (12)



 


 


 


 


 


 




VN


Viet Nam


 


 


 


 


 


X
M


 


 


 


 


X


 




XK


Kosovo (9)



 


 


 


 


Δ


 


 


 


 


 


 


 




ZA


South Africa


 


 


 


 


 


M


 


 


 


X (10)



 


 




ZM


Zambia


 


 


 


 


 


 


 


 


 


 


X


 






(*1)  Wild animals, products derived therefrom and composite products are excluded from this table as these commodities fall out of scope of Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union (OJ L 116, 4.5.2023, p. 1, ELI: http://data.europa.eu/eli/reg_del/2023/905/oj).

(1)  List of third countries and territories (not limited to third countries recognised by the Union).

(2)  Hereinafter understood as the State of Israel, excluding the territories under the administration of the State of Israel after 5 June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.

(3)  Ovine species only.

(4)  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 Windsor Framework (see Joint Declaration No 1/2023 of the Union and the United Kingdom in the Joint Committee established by 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 (OJ L 102, 17.4.2023, p. 87)) in conjunction with Annex 2 to that Framework, for the purposes of this Annex references to the United Kingdom do not include Northern Ireland.

(5)  Export to the Union of live equidae intended for slaughter (food-producing animals only).

(6)  Reindeer only.

(7)  Only for consignments of fresh meat originating from New Zealand, destined to the Union and being unloaded, with or without storage, in Singapore and being reloaded in an approved establishment during transit through Singapore.

(8)  Caprine species only.

(9)  This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

(10)  Ratites only.

(11)  Finfish and finfish products only.

(12)  Crustaceans only.

(13)  Finfish products only (for example, roes and caviar).

(14)  Aquaculture covers finfish, including eels, and products of finfish (such as roes and caviar), and crustaceans. The third countries or regions thereof listed for live, chilled, frozen or processed bivalve molluscs, echinoderms, tunicates and marine gastropods in Annex VIII to Implementing Regulation (EU) 2021/405 of 24 March 2021 laying down the lists of third countries or regions thereof authorised for the entry into the Union of certain animals and goods intended for human consumption in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (OJ L 114, 31.3.2021, p. 118, ELI: http://data.europa.eu/eli/reg_impl/2021/405/oj) are marked with an ‘M’ in this column. Third countries with the remark limited to ‘wild catch’ in Annex VIII to Commission Implementing Regulation (EU) 2021/405 are not marked with an ‘M’ in this column as those commodities fall outside the scope of Delegated Regulation (EU) 2023/905.



ELI: http://data.europa.eu/eli/reg_impl/2024/2598/oj
ISSN 1977-0677 (electronic edition)