COMMISSION IMPLEMENTING REGUL ATION (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 
(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(5) thereof,
Whereas:
(1) Regulation (EU) 2019/6 sets a broad rang e of concrete measures to fight antimicrobial resistance and to promot e a 
more prudent and responsible use of antimicrobial medicinal products in animals, including very strict rules on 
their veterinar y prescr iption for prophylactic and metaphylactic use. That Regulation also recalls that antimicrobial 
medicinal products should not be administe red routinely nor used to compen sate for poor hygiene, inadequat e 
animal husbandr y, lack of care or to compensat e for poor farm manag ement.
(2) Certain antimicrobial medicinal products or groups of antimicrobial medicinal products should be reser ved for 
treatment of certain infections in humans, with a view to bette r preser ve their efficacy for human medicine and to 
suppor ting the fight against antimicrobial resistance, whic h is a major threat to global health.
(3) The antimicrobial medicinal products or groups of antimicrobial medicinal products to be reser ved for treatment of 
certain infections in humans are to be designat ed on the basis of the criteria set for this purpose in Commission 
Delegat ed Regulation (EU) 2021/1760 (2).
(4) The European Medicines Agen cy (‘the Agen cy’) evaluated (3)antimicrobials and groups of antimicrobials used in 
medicinal products author ised in Member State s and in third countr ies. It identified whic h antimicrobials and 
groups of antimicrobials fulfilled the criteria set in Delegat ed Regulation (EU) 2021/1760, taking into consideration 
the latest available scientifi c evidence. The Agen cy’s advice is based, in accordance with Article 37(6) of Regulation 
(EU) 2019/6, on the joint opinion of exper ts in human medicine and of exper ts in vete rinar y medicine from 
national compet ent author ities, the European Food Safet y Authority, the European Centre for Disease Prevention 
and Control and the Agency itself, as well as of external exper ts on human infectious diseases from learned societies 
and academia.
(5) Pursuant to the Agen cy’s advice, several antibiotics, several antivirals and one antiprotozoal fulfilled the criteria 
established under Deleg ated Regulation (EU) 2021/1760 and should theref ore be reser ved for the treatment of 
certain infections in humans. Pursuant to the Agency’s advice, none of the antifungals evaluated met those criteria.
(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)Advice on the designation of antimicrobials or groups of antimicrobials reser ved for treatment of certain infections in humans – in 
relation to implementi ng measures under Article 37(5) of Regulation (EU) 2019/6 on veterinar y medicinal products (EMA/CVMP/ 
678496/2021, 16 Febr uary 2022).EN Offi cial Jour nal of the European Union L 191/58 20.7.2022  (6) The antimicrobials and group of antimicrobials listed in this Regulation should not be used in veterinar y medicinal 
products. Thus, marketing author isation applications for veteri nary medicinal products that contain any of the 
antimicrobials or groups of antimicrobials listed in this Regulation should be refused. In addition, existing 
mark eting author isations of veterinar y medicinal products containing such antimicrobials or groups of 
antimicrobials should cease to be valid.
(7) Veterinar y medicinal products are sometimes administe red to animals through medicated feed. The use of veterinar y 
medicinal products that contain antimicrobials or groups of antimicrobials listed in this Regulation in medicat ed 
feed should not be possible.
(8) Moreover , medicinal products that contain any of the antimicrobials or groups of antimicrobials liste d in this 
Regulation should not be used in animals, even under the conditions set in Articles 112, 113 and 114 of 
Regulation (EU) 2019/6.
(9) With a view to giving veterinar ians, owners of animals and economic operators concer ned the necessar y time to 
adjust to the consequences refer red to above, this Regulation should apply six months after its entr y into force.
(10) The list of antimicrobials or groups of antimicrobials to be reser ved for treatment of certain infections in humans, as 
provid ed for in this Regulation should be kept under continual review in the light of new scientific evidence or 
emerging information, including the emergence of new diseases, changes in the epidemiology of existing diseases, 
changes in antimicrobial drug resistance or changes in availability or patt erns of antimicrobial use.
(11) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products refer red to in Article 145 of Regulation (EU) 2019/6,
HAS ADOPTED THIS REGUL ATION:
Article 1
Antimicrobials or groups of antimicrobials designated as reser ved for treatment of certain infections in humans
1. The antimicrobials and groups of antimicrobials liste d in the Annex shall not be used in veteri nary medicinal 
products or medicat ed feed.
2. The use in animals of medicinal products for human use that contain any of the antimicrobials or groups of 
antimicrobials listed in the Annex is prohibited.
Article 2
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.
It shall apply from 9 Febr uary 2023 .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 July 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 20.7.2022 L 191/59  ANNEX 
Antimicrobials or groups of antimicrobials reser ved for treatment of certain infections in humans 
(1) Antibiotics
(a) Carbo xypenicillins
(b) Ureidopenicillins
(c) Ceftobiprol e
(d) Ceftaroline
(e) Combinations of cephalospor ins with beta-lactamase inhibitors
(f) Siderophore cephalospor ins
(g) Carbapenems
(h) Pene ms
(i) Monobactams
(j) Phosphonic acid derivates
(k) Glycopepti des
(l) Lipopeptides
(m) Oxazolidinones
(n) Fidax omicin
(o) Plazomicin
(p) Glycylcy clines
(q) Eravacy cline
(r) Omadacy cline
(2) Antivirals
(a) Amantadine
(b) Balo xavir marbo xil
(c) Celgosivir
(d) Favipirav ir
(e) Galidesivir
(f) Lactimidomy cin
(g) Laninamivir
(h) Methisazone/metisazone
(i) Molnupiravir
(j) Nitazo xanide
(k) Oseltamivir
(l) Peramivir
(m) Ribavir in
(n) Rimantadine
(o) Tizo xanide
(p) Triaza virin
(q) Umifeno vir
(r) Zanamivir
(3) Antiprotozoals
(a) Nitazo xanideEN Offi cial Jour nal of the European Union L 191/60 20.7.2022