II
(Non-legislative acts)
REGUL ATIONS
COMMISSION DELEGA TED REGUL ATION (EU) 2021/1760 
of 26 May 2021
supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by 
establishing the criter ia for the designation of antimicrobials to be reser ved for the treatment of 
certain infections in humans 
(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 37(4) thereof,
Whereas:
(1) Regulation (EU) 2019/6 of the European Parliament and of the Council aims to enhance the intern al mark et and 
increase the availability of veterinar y medicinal products, while guarant eeing the highest level of public and animal 
health and environmental prot ection. In particular , it aims to contain the spread of antimicrobial resistance with 
concrete measures to promote a prudent and responsible use of antimicrobials in animals, in line with the ‘One 
Health’ approach (2).
(2) Although the efficacy of all antimicrobials is important to preser ve public health, some antimicrobials are deemed 
more crucial than others, based on being pref erred options for the treatment of serious infections in humans and 
the availability or lack of altern ative treatment options. When antimicrobial resistance develops to an antimicrobial 
agent used to treat a specific infection for whic h there are no treatment alternati ves and that resistance spreads, the 
consequences to public health are signif icant and poten tially life-threat ening. Human health, animal health and the 
environment are interlink ed and are all essential parts of the ‘One Health’ approach , thus antimicrobial 
manage ment in one sector may affect antimicrobial resistance in the other sector s.
(3) Article 37(4) of Regulation (EU) 2019/6 requires the Commission to adopt delegat ed acts establishing criteria that 
will allow the Commission to determi ne whic h antimicrobials or groups of antimicrobials should be reser ved for 
human use.
(4) Various intern ational organisations and countr ies have developed criteria for specifying or ranking the impor tance 
of antimicrobials or antimicrobial classes for human and veterinar y medicine. Those criteria were developed for use 
in risk manag ement strategies relat ed to antimicrobial use in human healthcare settings and animal use. Prioritising 
critically important antimicrobials for humans is a valuable tool to suppor t an evidence-based approach to risk 
manage ment.
(1)OJ L 4, 7.1.2019, p. 43.
(2)Commission Communication of 29 June 2017 on a European One Health Action Plan against Antimicrobial Resistance (COM(2017) 
339).EN Offi cial Jour nal of the European Union 6.10.2021 L 353/1  (5) The criteria to deter mine which antimicrobials are to be reser ved for human use should be clear and pertinent whilst 
reflecting the lates t scientific evidence. Pursuant to Article 37(6), the Commission received advice from the European 
Medicines Agency (‘the Agen cy’) on 31 October 2019 (3). The Agen cy’s advice has taken account of exper t opinions 
from national compet ent author ities, the European Food Safety Author ity and the European Centre for Disease 
Prevention and Control. In the cont ext of the preparation of that advice, a scientific workshop involving members 
of the Agen cy’s exper t group and intern ational orga nisations was organised in Brussels on 14 June 2019 . The 
workshop allowed participants to exchange views and share exper tise from a global perspective on the topic of how 
to establish such criteria. The outcome of those discussions was take n into consideration by the Agency’s exper t 
group in compl eting its advice and the Commission has taken into account that advice in accordance with Article 
37(6) of Regulation (EU) 2019/6.
(6) While a number of countr ies within and outside the Union have implement ed measures to restr ict the use of certain 
antimicrobials, few have specific legislation for banning their use in veteri nary medicine. Banning the use of an 
antimicrobial in animals is one of the most severe risk managemen t measures that can be taken, thus such measures 
should be taken cautiously . Whenever possible, other existing risk management measures should be favoured, such 
as impro ving animal husbandr y, biosecur ity and herd or flock manag ement, making a better use of vaccination and 
restr icting the use of antimicrobials to specifi c circumstances.
(7) Antimicrobials to be used only for treatment of certain infections in humans should be designated on the basis of 
sound criteria. Those criteria should allow to identify those antimicrobials that are of high impor tance to preser ve 
human health and that should theref ore be considered for use in human medicine excl usively . The criteria should 
also enable to identify those antimicrobials, whose use in animals could accelerat e the spread of antimicrobial 
resistance, or present a risk thereof, by allowing for the transmission of resistance, which may include cross- 
resistance or co-selection of resistance to other antimicrobials, from animals to humans. Finally , the criteria should 
allow to identify antimicrobials that do not represent an essential need for animal health, and whose absence of use 
in veterinar y medicine would not lead to any signif icant negativ e impact on animal health.
(8) While assessing whether an antimicrobial could be reser ved for the treatment of certain infections in humans, it is 
imp ortant to determine whether its absence of use in veteri nary medicine would result in signif icant morbidity or 
signif icant mor tality or would have a major impact on animal welf are and public health. In the latte r case, the 
availability of adequat e alternati ve medicinal products for the treatment of the diseases concer ned in the animals 
species concer ned should be considered.
(9) When consider ing the use of alternative medicinal products instead of certain antimicrobial medicinal products, it is 
imp ortant that those products are adequat e and available. Such alternatives should be author ised medicinal products 
in suitable formulations for the treatment of the disease in the animal species requir ing treatment. Their use should 
lead to a lower risk to public health in term s of antimicrobial resistance than the antimicrobial medicinal product it 
aims to replace.
(10) In excep tional cases where there is scientific evidence showi ng an overriding public health interest, the criterion of 
non-essential need to animal health should envisag e the possibility for an antimicrobial to be reser ved for human 
use, even if no altern ative medicinal product is available for veteri nary medicine, provid ed that not using such an 
antimicrobial would only result in limite d morbidity or limite d mor tality . In such excep tional cases, the fulfilme nt 
of the other two criteria (high impor tance to human health and risk of transmission of resistance) should be still 
required for such an antimicrobial to be reser ved for human use.
(11) Article 152(1) of Regulation (EU) 2019/6 indicate s that existing products author ised in accordance with the previous 
legislation is to be deemed to be author ised in accordance with the Regulation, with the excep tion of author isations 
of veterinar y medicinal products containing antimicrobials that have been reser ved for human use only . The criteria 
in the present act apply to antimicrobials that have not yet been author ised for the veteri nary market but also apply 
to antimicrobials in existing veterinar y medicinal products.
(3)Advice on impl ementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinar y medicinal products – Criteria for the 
designation of antimicrobials to be reser ved for treatment of certain infections in humans (EMA/CVMP/158366/2019).EN Offi cial Jour nal of the European Union L 353/2 6.10.2021  (12) It is recognised that the necessar y available evidence to assess the fulfilment of the criteria may vary depending on 
the mark eting author isation status of the antimicrobial or group of antimicrobials considered: (1) author ised in 
human medicine only ; (2) author ised in veteri nary medicine only ; (3) author ised both in human and veteri nary 
medicine; (4) author ised neither in human nor veterinar y medicine. For that reason, the available evidence should 
be taken into account while applying the criteria.
(13) This Regulation should apply from 28 Januar y 2022 in accordance with Article 153(2) of Regulation (EU) 2019/6,
HAS ADOPTED THIS REGUL ATION:
Article 1
1. The criteria for the designation of antimicrobials to be reser ved for the treatment of certain infections in humans are 
set out in the Annex.
2. An antimicrobial or a group of antimicrobials shall meet all three criteria set out in Parts A, B and C in the Annex in 
order to be designat ed as reser ved for treatment of certain infections in humans.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
It shall apply from 28 Januar y 2022 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 May 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 6.10.2021 L 353/3  ANNEX 
Criter ia for the designation of the antimicrobials which are to be reser ved for treatment of certain 
infections in humans 
PART A
CRITERION OF HIGH IMPORT ANCE TO HUMAN HEAL TH
1.The antimicrobial or group of antimicrobials meets this criterion if any of the following applies:
(a) it is the sole or last-resor t antimicrobial or group of antimicrobials available in a patient manag ement treatment 
approach for serious, life-threatening infections in humans whic h, if inappropr iately treated, would lead to 
signif icant debilitating morbidity or significant mor tality ;
(b) it is an essential compo nent of the limited treatment altern atives available in a patient manag ement treatment 
approach for serious, life-threatening infections in humans whic h, if inappropr iately treated, would lead to 
signif icant debilitating morbidity or significant mor tality ;
(c) it is an antimicrobial or a group of antimicrobials, which is author ised in the Union for the treatment of serious 
microbial infec tions in patients with limit ed treatment options, indicating that the antimicrobial or the group of 
antimicrobials considered is recognised as addressing an unmet medical need related to antimicrobial resistance.
2.Fact ors considered responsible for limite d treatment alternati ves for patients, as refer red to in point 1(b), include:
— the virulence and antimicrobial resistant phenotype(s) of the microorganisms causing infection, including multidr ug 
resistance,
— the charact eristics of the patients (for exam ple, immunocompromised, paediatr ic, elderly) and disease (for exam ple, 
site of infection concer ned) under treatment,
— the propor tion of patients requir ing treatment and the impact on healthcare services.
PART B
CRITERION OF RISK OF TRANSMISSION OF RESIST ANCE
1.The antimicrobial or group of antimicrobials meets this criterion if any of the following applies:
(a) for an antimicrobial or group of antimicrobials author ised for use in animals, scientifi c evidence, including 
epidemiological evidence where available, exists showi ng that:
— there is an actual emerg ence, dissemination and transmission of resistance to this antimicrobial or group of 
antimicrobials, or induction of cross-resistance or co-selection of resistance to other antimicrobials, and
— transmission of such resistance from animal sources to humans is signif icant and linke d to the use of this 
antimicrobial or group of antimicrobial in animals, whether it occurs through microorg anisms resistant to the 
antimicrobial or group of antimicrobials considered or through the transmission of genes conferr ing resistance 
to the antimicrobial or group of antimicrobials considered;
(b) for an antimicrobial or group of antimicrobials not author ised for use in animals, scientific evidence exists showi ng 
that:
— there is the pote ntial for emergence, dissemination and transmission of resistance to this antimicrobial or group 
of antimicrobials or poten tial for inducing cross-resistance or co-selection of resistance to other antimicrobials, 
andEN Offi cial Jour nal of the European Union L 353/4 6.10.2021  — this transmission from animal sources to humans would likely be signif icant and linked to the use of this 
antimicrobial or group of antimicrobials in animals, whether it would occur through microorg anisms resistant 
to the antimicrobial or group of antimicrobials considered or through the transmission of genes conferr ing 
resistance to the antimicrobial or group of antimicrobials considered.
2.Fact ors triggering signif icant transmission of resistance between animals and humans linked to the use of an 
antimicrobial or group of antimicrobials in animals include:
— use selects for resistance, cross-resistance or co-selection of resistance to antimicrobials that are crucial for human 
medicine,
— transmission of resistance occurs by vertical as well as horizontal transmission,
— transmission of resistance involves zoonotic pathogens,
— transmission can take place by diffe rent route s of exposure,
— transmission occurs through a number of differ ent animal species.
PART C
CRITERION OF NON-ESSENTIAL NEED FOR ANIMAL HEAL TH
1.The antimicrobial or group of antimicrobials meets this criterion if any of the following applies:
(a) there is no robust evidence of the need for the antimicrobial or group of antimicrobials in veteri nary medicine;
(b) the antimicrobial or group of antimicrobials is used to treat serious, life-threat ening infections in animals which , if 
inappropr iately treated , would lead to signif icant morbidity or significant mor tality , or would have a major impact 
on animal welfa re or public health, but adequat e altern ative medicinal products are available for the treatment of 
those infec tions in the animal species concer ned;
(c) the antimicrobial or group of antimicrobials is used to treat serious, life-threat ening infections in animals which , if 
inappropr iately treated, would lead to limited morbidity or limited mor tality and there is scientifi c evidence 
showing an over riding public health interest in not using it.
2.The provisions laid down in point 1 apply when the antimicrobial or group of antimicrobials considered is either of the 
follo wing:
(a) an antimicrobial or group of antimicrobials present within author ised veteri nary medicinal products;
(b) an antimicrobial or group of antimicrobials present within medicinal products author ised for use in humans, that 
may be administ ered to animals outside the term s of their mark eting author isation.EN Offi cial Jour nal of the European Union 6.10.2021 L 353/5