II
(Non-legislative acts)
REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2023/905 
of 27 Febr uary 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 expor ted from third countr ies into the Union 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on 
veteri nary medicinal products and repealing Directive 2001/82/EC (1), and in particular Article 118(2) thereof,
Whereas:
(1) Antimicrobial resistance is a major threat to public health. When resistance develops to an antimicrobial agent used 
to treat a specific infection for whic h there are no altern ative treatments and that resistance spreads, it has serious 
and poten tially life-thr eatening consequences for humans. Human health, animal health and the environment are 
inter linked. Theref ore, one of the objectives of Regulation (EU) 2019/6 is to contain the spread of antimicrobial 
resistance with concrete measures to promote the prudent and responsible use of antimicrobial medicinal products 
in animals.
(2) The use of antimicrobial medicinal products to promote growth or to increase yield is neither prudent nor 
responsible. An extensi ve body of scientifi c literature has shown that the use of antimicrobials for such purposes 
can trigger antimicrobial resistance. Theref ore, by Regulation (EU) 2019/6, the use of antimicrobial medicinal 
products for the purpose of promoting growth or to increase yield is prohibit ed, whic h includes antimicrobials 
contained in veteri nary medicinal products as well as antimicrobials contained in human medicinal products.
(3) Moreover , Regulation (EU) 2019/6 provides for the procedure to designat e certain antimicrobials to be reser ved for 
the treatment of infections in humans. Such antimicrobials are not to be used in antimicrobial medicinal products 
administe red to animals. That measure aims to preser ve the efficacy of certain antimicrobials used to treat infections 
in humans, especially those considered treatments of last resor t. Criteria for the designation of antimicrobials 
reser ved for the treatment of certain infections in humans are laid down in Commission Delegat ed Regulation 
(EU) 2021/1760 (2)and the list of antimicrobials reser ved for treatment of certain infections in humans is set out in 
Commission Implementing Regulation (EU) 2022/1255 (3).
(1)OJ L 4, 7.1.2019, p. 43.
(2)Commission Delegat ed Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European 
Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reser ved for the treatment of 
certain infections in humans (OJ L 353, 6.10.2021, p. 1).
(3)Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials 
reser ved 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).EN Offi cial Jour nal of the European Union 4.5.2023 L 116/1  (4) The internati onal dimension of the development of antimicrobial resistance should also be considered. Specifically , 
Article 118(1) of Regulation (EU) 2019/6 provides that, in respect of animals or products of animal origin that are 
expor ted from third countr ies into the Union, operators in third countr ies are not to use antimicrobial medicinal 
products to promote growth or to increase yield, and are not to use the designate d antimicrobials or groups of 
antimicrobials reser ved for treatment of infections in humans.
(5) Medicated feed is one of the routes for the oral administration of medicinal products to animals. Theref ore, the 
prohibition of use of certain antimicrobial medicinal products in respect of animals or products of animal origin 
that are expor ted from third countr ies into the Union should also apply when such antimicrobial medicinal 
products are administ ered via medicate d feed.
(6) A robust system of controls regar ding animals or products of animal origin that are expor ted from third countr ies 
into the Union is essential to ensure compliance with the requirements laid down in Regulation (EU) 2019/6. No 
specifi c system of controls on impor ts of animals or products of animal origin exists under the Union framew ork 
on veteri nary medicinal products. The setting up of such dedicate d framework of controls would have necessitate d 
signif icant amount of resources and time. Moreover , it would have led to duplications at the level of the compe tent 
author ities and also on the operat ors concer ned. For reasons of effectiveness and reduction of administrative 
burden, the existing Union framework on official controls is to be used to verify compl iance of animals or products 
of animal origin entering the Union from third countr ies with Regulation (EU) 2019/6. To this effect, Regulation 
(EU) 2017/625 of the European Parliament and of the Council (4)has been amended by Regulation 
(EU) 2021/1756 (5). Theref ore, the verification of compliance with the requirements set out in Article 118(1) of 
Regulation (EU) 2019/6 is to be done in accordance with Regulation (EU) 2017/625.
(7) The consignments of animals or products of animal origin enteri ng the Union that are subject to the prohibition on 
the use of antimicrobial medicinal products to promot e growth or to increase yield and on the use of antimicrobials 
reser ved for treatment of certain infections in humans should be clearly set out. Theref ore, this Delegat ed Regulation 
should provid e detailed rules on the prohibition laid down in Article 118(1) of Regulation (EU) 2019/6.
(8) The vast major ity of the consump tion of antimicrobials in animals (in volume) relat es to food-producing animals. In 
addition, there is increasing scientifi c evidence that the use of antimicrobials in food-producing animals has an 
imp act on the development of antimicrobial resistance. Theref ore, addressing antimicrobial resistance requires 
particular action on the use of antimicrobial medicinal products in food-producing animals or products of animal 
origin intended for human consum ption. In accordance with the principle of propor tionality , taking such action 
will contr ibut e effectively to address the international dimension of the development of antimicrobial resistance 
while minimising the imp acts on trade.
(4)Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official 
activities perfor med to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant 
prot ection 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) (OJ L 95, 7.4.2017, p. 1).
(5)Regulation (EU) 2021/1756 of the European Parliament and of the Council of 6 October 2021 amending Regulation (EU) 2017/625 
as regar ds official controls on animals and products of animal origin expor ted from third countr ies to the Union in order to ensure 
com pliance with the prohibition of certain uses of antimicrobials and Regulation (EC) No 853/2004 as regar ds the direct supply of 
meat from poultr y and lagomor phs (OJ L 357, 8.10.2021, p. 27).EN Offi cial Jour nal of the European Union L 116/2 4.5.2023  (9) Moreover , it should be clarified that the prohibition of use of certain antimicrobials set out in Article 118(1) of 
Regulation (EU) 2019/6 concer ns food-producing animals or products of animal origin intended for human 
consum ption that are expor ted from third countr ies into the Union. To ensure legal certainty , the animals and 
products of animal origin concer ned should be identif ied by means of references to the Combined Nomenclature 
codes set out in Council Regulation (EEC) No 2658/87 (6).
(10) Consignments of animals or products concer ned that are only intended for transit, as well as products concer ned 
intended for the purpose of sam ples for product analysis and quality testing that are not placed on the mark et, 
should not be covered by this Regulation.
(11) Consignments of the animals or products concer ned that are expor ted from third countr ies into the Union should 
compl y with the same restr ictions that apply in the Union in relation to the objectives pursued by Articles 107(2) 
and 37(5) of Regulation (EU) 2019/6. To that effect, consignments of the animals or products concer ned should 
only be allowed to enter the Union in the case that the third countr ies or regions thereof, from which those animals 
or products originate, can ensure compl iance with the prohibition on the use of antimicrobial medicinal products 
for the purpose of promoting growth or to increase yield, and on the use of antimicrobials that have been reser ved 
for the treatment of certain infections in humans.
(12) Third countr ies -or regions- thereof that meet those requirements are to be included in a list that is to be drawn up 
by the Commission, by means of implemen ting acts, in accordance with Article 127 of Regulation (EU) 2017/625. 
Third countr ies or regions thereof are to be included on that list on the basis of available evidence and guarantees 
that the concer ned animals or products originating in them compl y with the Union’s prohibition on the use of 
antimicrobial medicinal products for the purpose of promoting growth or to increase yield, and on use of 
antimicrobials that have been reser ved for the treatment of certain infections in humans.
(13) Consignments of animals or products concer ned enter ing the Union from third countr ies liste d in accordance with 
Article 127 of Regulation (EU) 2017/625 should also be accompanied by an official certificate conf irming 
compl iance with the Union’s prohibition on the use of antimicrobial medicinal products for the purpose of 
promoting growth or to increase yield, and on use of antimicrobials that have been reser ved for the treatment of 
certain infections in humans.
(14) The Commission should adopt specif ic requirements on the official certificates required, by means of implementing 
acts, in accordance with Regulation (EU) 2017/625.
(15) The conditions for entr y into the Union of consignments of animals or products concer ned will be kno wn to third 
countr y operators as from the date of publication of this Regulation. Howe ver, the practical application of the 
framewor k laid down in this Regulation will necessitate the adoptio n of further implementing measures. For 
reasons of predictability and legal certainty and with a view to allow stake holders concer ned suffi cient time to 
compl y with the Union requirements, the conditions for the entr y into the Union of consignments of animals or 
products set out in this Regulation should be defe rred,
HAS ADOPTED THIS REGUL ATION:
Article 1
Subject matter and scope
1. This Regulation lays down detailed rules on the application of the prohibition of use, in animals or products of 
animal origin that are expor ted from third countr ies into the Union, of antimicrobial medicinal products for growth 
promotion and yield increase, and antimicrobials reser ved for treatment of certain infections in humans.
(6)Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Cust oms Tariff 
(OJ L 256, 7.9.1987, p. 1).EN Offi cial Jour nal of the European Union 4.5.2023 L 116/3  2. This Regulation applies to live food-producing animals for whic h Combined Nomenclature codes (‘CN codes ’) have 
been laid down in Part Two, Chapt er 1, of Annex I to Regulation (EEC) No 2658/87.
This Regulation also applies to products of animal origin intended for human consum ption, for which CN codes have been 
laid down in Part Two, Chapt ers 2 to 5, 15 and 16, of Annex I to Regulation (EEC) No 2658/87, and for which Harmonised 
System subheadings have been laid down under headings 3501 , 3502 and 3504 .
3. This Regulation does not apply to the followi ng:
(a) gelatine and raw mater ials for the production thereof refer red to in Section XIV, Chapt er I, point 1, of Annex III to 
Regulation (EC) No 853/2004 of the European Parliament and of the Council (7);
(b) collagen and raw mater ials for the production thereof referred to in Section XV, Chapt er I, point 1, of Annex III to 
Regulation (EC) No 853/2004;
(c) highly refined products referred to in Section XVI, Chapt er I, point 1, of Annex III to Regulation (EC) No 853/2004;
(d) wild animals and products derived therefrom;
(e) insects, frogs, snails and rept iles, including products derived therefrom;
(f) compo site products;
(g) animals or products of animal origin not intended for human consum ption, unless the destination of the animals or 
products has not been decided at entr y into the Union;
(h) animals or products of animal origin intended for human consum ption only for transit through the Union without 
being placed on the mark et;
(i) products of animal origin intended for human consump tion for the purpose of samples for product analysis and 
quality testin g without being placed on the mark et.
Article 2
Def initions
For the purposes of this Regulation, the followi ng definitions shall apply:
(1) ‘antimicrobial medicinal product’ means a medicinal product that contains or consists of one or more antimicrobials;
(2) ‘medicinal product’ means a medicinal product that is administered to animals, including when it is administered in 
medicat ed feed as defined in Article 3(2), point (a), of Regulation (EU) 2019/4 of the European Parliament and of the 
Council (8);
(3) ‘food-producing animal’ means food producing animal as defined in Article 2, point (b), of Regulation (EC) 
No 470/2009 of the European Parliament and of the Council (9);
(4) ‘consignment’ means consignment as defined in Article 3, point (37), of Regulation (EU) 2017/625;
(5) ‘transit’ means transit as defined in Article 3, point (44), of Regulation (EU) 2017/625.
(7)Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down specific hygiene rules for 
food of animal origin (OJ L 139, 30.4.2004, p. 55).
(8)Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the 
market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and 
repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).
(9)Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for 
the establishment of residue limits of phar macologically active substances in foodstuffs of animal origin, repealing Council Regulation 
(EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) 
No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).EN Offi cial Jour nal of the European Union L 116/4 4.5.2023  Article 3
Res trictions on the use of certain antimicrobial medicinal products in animals or products derived therefrom 
enter ing the Union
Animals or products referred to in Article 1(2) that are expor ted from third countr ies into the Union shall not have been 
administe red, or originate from animals that have been administe red any of the followi ng:
(a) an antimicrobial medicinal product used for the purpose of promoting growth or to increase yield;
(b) an antimicrobial medicinal product containing an antimicrobial that is included in the list of antimicrobials reser ved for 
treatment of certain infections in humans laid down in Implementing Regulation (EU) 2022/1255.
Article 4
Conditions for the entr y into the Union
1. Consignments of the animals or products refer red to in Article 1(2) shall only enter the Union where the following 
conditions are met:
(a) they originat e from a third countr y or region thereof included in the list of countr ies refer red to in Article 5; and
(b) they are accompanied by an official certificate referred to in Article 6 attesting that the consignment complies with the 
requirements in Article 3.
2. By way of derogation from paragraph 1, point (a), consignments of the animals or products refer red to in Article 1(2) 
may enter the Union from third countr ies that are not included in the list refer red to in Article 5(1), where such third 
countr ies ensure that the consignments entering the Union originate from a Member State or from a third countr y 
included in the list.
Article 5
List of appro ved third countr ies
1. The list referred to in Article 4(1), point (a), is to be established by means of an implementing act adopt ed by the 
Commission in accordance with Article 127 of Regulation (EU) 2017/625. If appropr iate, that list may be combined with 
other lists developed under Article 127 of Regulation (EU) 2017/625.
2. The Commission shall decide on the inclusion of third countr ies in the list in accordance with the requirements laid 
down in Article 127(3), points (a) to (d), and points (f) and (g), of Regulation (EU) 2017/625, on the basis of available 
evidence and guarantees that the requirements laid down in Article 3 are compl ied with, including information received 
on the procedures in place to guarant ee the traceability and origin of animals or products referred to Article 1(2).
3. In accordance with Article 127(4) of Regulation (EU) 2017/625, the Commission shall delet e the reference to a third 
countr y or a region of a third countr y from the list if the conditions for inclusion in the list cease to be met.
Article 6
Cer tification of compliance
1. Specific requirements on the official certificates refer red in point (b) of Article 4(1) are to be laid down by the 
Commission, by means of implementing acts, in accordance with the examination procedure refer red to in Article 126(3) 
of Regulation (EU) 2017/625.
2. The official certificates may include details required in accordance with other Union legislation on public and animal 
health matt ers.EN Offi cial Jour nal of the European Union 4.5.2023 L 116/5  Article 7
Controls
Controls to verify compliance of consignments of the animals or products refer red to in Article 1(2) with Article 3 shall be 
carried out in accordance with Regulation (EU) 2017/625.
Article 8
Entr y into force and application
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
The conditions for entr y into the Union of consignments of animals or products set out in this delega ted act shall apply as 
from 24 months after the date of application of the implementing act refer red to in Article 6(1).
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels, 27 Febr uary 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 116/6 4.5.2023