EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10274/2021 feedback 
(POOL/E5/2021/10274/10274 -EN 
feedback.docx)  
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council 
by establishing the criteria for the designation of antimicrobials to be reserved for the 
treatment of certain infections in humans  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.  
  
EN 1  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX 
supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council 
by establishing the criteria for the designation of antimicrobials to be reserved for the 
treatment of certain infections in humans  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having r egard to the Treaty on the Functioning of the European Union, 
Having regard to 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/EC1, 
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 internal market and increase the availability of veterinary medicinal 
products , while guaranteeing the highest level of public and animal health and 
environmental protection . In particular, i t 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 ’ approach2.  
(1) Although the efficacy of all antimicrobials is important to preserve public health, some 
antimicrobials are deemed more crucial than others, based on being preferred options for the treatment of serious infections in humans and the availability or lack of alternative treatment options. When antimicrobial resistance develops to an 
antimicrobial agent used to treat a specific infection for which there are no treatment alternatives and that resistance spreads, the consequences to public health are 
significant and  potentially life -threatening. Human health, animal health and the 
environment are interlinked and are all essential parts of the ‘One Health’ approach, 
thus antimicrobial management in one sector may affect antimicrobial resistance in the other sectors.  
(2) Article 37(4) of Regulation (EU) 2019/6 requires the Commission to adopt delegated 
acts establishing criteria that will allow the Commission to determine which 
antimicrobials or groups of antimicrobials should be reserved for human use. 
(3) Various international organisations and countries have developed criteria for 
specifying or ranking the importance of antimicrobials or antimicrobial classes for human and veterinary medicine. Th ose criter ia were developed for use in risk 
management strate gies related to antimicrobial use in human healthcare settings and 
animal use. Prioritising critically important antimicrobials for humans  is a valuable 
tool to support  an evidence- based approach to risk management . 
                                                 
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)0339).   
EN 2  EN (4) The criteria to determine which antimicrobials are to be reserved for human use should 
be clear and pertinent whilst reflect ing the latest scientific evidence. Pursuant to 
Article 37(6), the Commission received advice from the European Medicines Agency (‘the Agency ’) on 31 October 2019
3. The Agency’s advice  has taken  account of expert  
opinions  from national competent authorities , the European Food Saf ety Authority  and 
the European Centre for Disease Prevention and Control. In the context of  the 
preparation of th at advice, a scientific workshop involving members of the Agency’s 
expert group and international organisations was organised in Brussels on 14 June 2019. The workshop allowed participants to exchange views and share expertise from 
a global perspectiv e on the topic of how to establish such criteria . The outcome of 
those  discussions was taken into consideration by the Agency’s expert group in 
completing its advice  and t he Commission has taken into account that  advice in 
accordance with  Article 37(6) of  Regulation (EU) 2019/6.  
(5) While a number of countries within and outside the Union have implemented  
measures to restrict the use of certain antimicrobials, few have specific legislation for 
banning the ir use in veterinary medicine . Banning the use of an antimicrobial in 
animals is one of the  most severe risk management measures  that can be taken , thus 
such measures should be taken cautiously . Whenever possible, other existing risk 
management measures  should be favoured, such as improving animal husbandry , 
biosecurity  and herd or flock management, making a better use of vaccination and 
restricting the use of antimicrobials to specific  circumstances . 
(6) Antimicrobials to be used only for treatment of certain infections in humans shoul d be 
designated on the basis of sound criteria . Those criteria should allow to identify those 
antimicrobials that are of high importance to preserve human healt h and that should 
therefore be considered for use in human medicine exclusively . The criteria should 
also enable to identify those antimicrobials, whose  use in animals could accelerate 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 antimic robials , 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 veterinary medicine would not lead to any 
significant negative impact on a nimal health . 
(7) While assessing whether an antimicrobial could be reserved for the treatment  of 
certain infections in hum ans, it is important to determine whether its absence of use in 
veterinary  medicine would result in significant morbidity or  significant mortality or 
would have a major impact on animal welfare and public health . In the latter case, the 
availability of adequate alternative medicinal products  for the treatment of the diseases 
concerned in the animals  species  concerned should be  considered .  
(8) When considering the use of alternative medicinal products instead  of certain 
antimicrobial medicinal products, it is important that th ose products  are adequate and 
available. Such alternatives should be authorised medicinal products in suitable formulatio ns for the treatment of the disease in the animal species requiring treatment. 
Their use should lead to a lower risk to public health in terms of antimicrobial resistance than the antimicrobial medicinal product it aims to replace.  
                                                 
3 Advice on implementing measures under Article 37(4) of Regulation (EU)  2019/6 on veterinary 
medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain 
infections in humans  (EMA/CVMP/158366/2019 )  
EN 3  EN (9) In exceptional cases  where there is scientific evidence show ing an overriding public 
health  interest , the criterion of non- essent ial need to animal health should envisage  the 
possibility for an antimicrobial to be reserved for human use, even if no alternative 
medicinal product  is available for veterinary medicine , provided that not using such an 
antimicrobial would only result in limited morbidity or limited mortality . In such 
exceptional cases, t he fulfilment of the other two criteria (high importance to human 
health and risk of transmission of resistance) should be  still required for such an 
antimicrobial to be reserved for human use.  
(10) Article 152(1) of Regulation (EU) 2019/6 indicates that existing products authorised in 
accordance with the previous  legislation is to  be deemed to be authorised in 
accord ance with  the Regulation, with the exception of authorisations of veterinary 
medicinal products  containing antimicrobials that have been reserved for human use 
only. The criteria in th e present  act apply to  antimicrobials that hav e not yet been 
authorised for the veterinary market but also  apply to antimicrobials in existing 
veterinary medicinal products. 
(11) It is recognised that the necessary availab le evidence to assess the fulfilment of the 
criteria may vary depending on the marketing authorisation status of the antimicrobial or group of antimicrobials considered: (1) authorised in human medicine only; (2) 
authorised in veterinary medicine only; (3) authorised both in human and veterinary medicine; (4) authorised neithe r in human nor veterinary medicine. For that reason , the 
availab le evidence should be taken into account while applying the criteria. 
(12) This Regulation should apply from 28 January 2022 in accordance with Article 153(2) 
of Regulation (EU) 2019/6,  
HAS ADOPTE D THIS REGULATION:  
Article 1  
1. The criteria for the designation of antimicrobials to be reserved 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 designated as reserved for treatment of 
certain infections in humans. 
Article  2 
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 28 January 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission 
 The President  
 Ursula VON DER LEYEN