EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/4503 feedback 
(POOL/D4/2022/4503/4503 -EN 
feedback.docx)  
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 t he 
Union  
 
(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 EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) 2019/6, replaces the legal framework for veterinary medicinal products 
established by Directive 2001/82/EC and Regulation (EC) No 726/2004.  One of the main 
objectives of the Regulation is to mitigate the risk of development of antimicrobia l resistance, 
including by strengthening the prudent use of antimicrobial medicinal products.  Among 
others, the Regulation prohibits the use of antimicrobial medicinal products for growth 
promotion and yield increase, and it forbids the use in animals of medicinal products 
containing antimicrobials that are reserved for treatment of infections in humans.  
The criteria for the designation of antimicrobials reserved for treatment of certain infections in 
humans are laid down in Commission Delegated Regulation  (EU) 2021/1760.  The specific 
list of antimicrobials reserved for human use is contained in Commission Implementing 
Regulation (EU) 2022/1255.  
Article 118(1) of the Regulation (EU) 2019/6 requires third country operators exporting 
animals or products of a nimal origin to the Union to respect 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 reserved for the treatment of certain infections 
in humans .  Article 118(2) of the Regulation (EU) 2019/6 empowers the Commission to adopt 
delegated acts providing detailed rules on the application of t he above -referred prohibitions.  
The application of the prohibition  of use of certain antimicrobial medic inal products in 
animals or products of animal origin that are exported from third countries into the Union 
requires the setting up of an effective enforcement system.  As a system permitting controls of 
animals or products of animal origin imported into the Union does not exist under the 
Regulation (EU) 2019/6 , resort has been made to the Union framework on official controls.  
Specifically, the Regulation (EU) 2017/625 was amended in 2021 to include the verificatio n 
of compliance with the prohibition  in Article 118(1) of the Regulation (EU) 2019/6  within the 
scope of the Union f ramework on official controls.  
The purpose of this Delegated Regulation is to supplement Regulation (EU) 2019/6 by 
establishing detailed rul es necessary for the application of the prohibition  foreseen in Article 
118(1) thereof, including  the setting of the conditions to be respected by animals or products 
of animal origin that are exported from third countries into the Union . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Member States’ experts were consulted within the Expert Group on Veterinary Medicinal 
Products1, which met on the subject on 16 February, 4 May and 22 June 2022.  
Third countries have been  consulted by means of a notificatio n to the World Trade 
Organisation within the framework of the Agreement on the Application of Sanitary and 
Phytosanitary Measures.  
Finally, before adopting this Delegated Regulation, the Commission has conducted open and 
transparent public consultations in  accordance with the procedures laid down in the Inter -
institutional Agreement on Better Law -Making.2 
                                                 
1 Reference E02792  in the Register of Commission Expert Groups and other similar entities. 
2 http://ec.europa.eu/smart -regulation/better_regulation/documents/iia_blm_final_en.pdf.   
EN 2  EN This Delegated Regulation provides for details on the application of the prohibition  of use of 
certain antimicrobial medicinal products in animals or products of animal origin that are 
exported from third countries into the Union,  which is set out in Article 118(1) of the 
Regulation (EU) 2019/6. Among others, it provides details on the specific requirements that 
are to be met by consignments of animals or product s of animal origin imported into the 
Union to be deemed compliant with Article 118(1) of the Regulation (EU) 2019/6.  
As the delegated Regulation is designed to enable the application of a prohibition  that has 
been established in a Regulation of the European Parliament and of the Council no impact 
assessment has been carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis for the De legated Regulation is Article 118(2) of Regulation (EU) 2019/6. 
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council 
as regards the application of the prohibition of use of cer tain antimicrobial medicinal 
products in animals or products of animal origin exported from third countries into the 
Union  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having rega rd 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 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 which there are no 
alternative treatment s and that resistance spreads, it has serious and potentially life -
threatening consequenc es for humans.  Human health, animal health and the 
environment are interlinked. Therefore,  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 u se 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 extensive body of scientific literature has shown  
that the use of antimicrobials fo r such purposes can trigger antimicrobial resistance. 
Therefore, by Regulation (EU) 2019/6, the use of antimicrobial medicinal products for 
the purpose of promoting growth or to increase yield is prohibited, which includes 
antimicrobials contained in veter inary medicinal products as well as antimicrobials 
contained in human medicinal products . 
(3) Moreover, Regulation (EU) 2019/6 provides for the procedure to designate  certain 
antimicrobials to be reserved for the treatment of infections in humans . Such 
antimic robials are not to be used in antimicrobial medicinal products administered to 
animals. That measure aims to preserve the efficacy of certain antimicrobials used to 
treat infections in humans, especially those considered treatments  of last resort . 
Criteria  for the designation of antimicrobials reserved for the treatment of certain 
infections in humans are laid down in Commission Delegated Regulation (EU) 
                                                 
1 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 L4, 7.1.2919, p.4 3).  
EN 4  EN 2021/17602 and t he list of antimicrobials reserved for treatment of certain infections in 
humans is set out in Commission Implementing Regulation (EU) 2022/12553. 
(4) The international dimension of the development of antimicrobial resist ance 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 exported  from third 
countries  into the Union, operators in third countries are not to use antimicrobial 
medicinal products to promote growth or to increase yield, and are not to use the 
designated antimicrobials or group s of antimicrobials reserved for treatment of 
infections in humans.  
(5) Medicated feed is one of the routes for the oral administration of medicinal products to 
animals. Therefore, t he prohibition  of use of certain antimicrobial medicinal products 
in respect of animals or products of animal origin that are exported from third 
countries in to the Union should also apply when such antimicrobial medicinal 
products are administered via medicated feed.  
(6) A robust system of controls regarding animals or products  of ani mal origin  that are 
exported  from third countries into the Union  from third countries  is essential to ensure 
compliance with the  requirements  laid down in Regulation (EU) 2019 /6.  No specific 
system  of controls on imports of animals or products of animal origin exists under the 
Union framework on veterinary medicina l products.  The setting up of  such dedicated 
framework of controls would have necessitated significant amount of resources and 
time.  Moreover, it would have led to duplications at th e level of the competent 
authorities and also on the operators concerned.   For reasons of effectiveness and 
reduction of administrative burden, the existing Union framework on official controls 
is to be used to verify compliance of animals or products of a nimal origin entering the 
Union  from third countries  with Regulation (EU) 2019/6 .  To this effect, Regulation 
(EU) 2017/625 has been amended4.  Therefore, the verification of compliance with the 
requirements set out in Article 118(1) of Regulation (EU) 201 9/6 is to be done in 
accordance with Regulation  (EU) 2017/625 of the European Parliament and of the 
Council .  
(7) The consignments of animals or products of animal origin entering the Union that are 
subject to  the prohibition  on the  use of antimicrobial medicinal products to promote  
growth  or to increase  yield and on the use of antimicrobials reserved for treatment of 
certain infections in humans should be clearly set out . Therefore, this Delegated 
Regulation  should provide detail ed rules on the prohibition  laid down in Article 118(1) 
of Regulation (EU) 2019/6.  
(8) The vast majority of the consumption of antimicrobials in animals (in volume) rel ates 
to food -producing animals.  In addition, there is increasing scientific evidence that the 
use of antimicrobials in food -producing animals has an impact on the development of 
                                                 
2 Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplement ing 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  (OJ L353, 6.10.2021, p.1 ). 
3 Commission Implementin g 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 191/58,  20.7.2022, p.58 ). 
4 Regulation (EU) 2021/1756 of the European Parliament and of the Council of 6 October 2021 amending 
Regulation (EU) 2017/625 as regards official controls on animals and products of animal origin exported 
from third countries to the Unio n in order to ensure compliance with the prohibition of certain uses of 
antimicrobials and Regulation  (EC) No 853/2004 as regards the direct supply of meat from poultry and 
lagomorphs, (OJ L357,  8.10.2021, p. 27 ).  
EN 5  EN antimicrobial resistance. Therefore, 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 consumption.  In accordance 
with the principle of proportionality, taking such action  will contribute effectively to 
address the international dimension of the development of antimicrobial resistance 
while mi nimising the impacts on trade.  
(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 concerns  food-producing animals or 
products of animal origin intended for human consumption that are exported from 
third countries into the Union.  To ensure legal certainty, the animals and products of 
animal origin  concerned should be identified  by means of references to the Combined 
Nom enclature codes set out in Council Regulation (EEC) No  2658/875. 
(10) Consignments of animals or products concerned that are only intended for transit, as 
well as products  concerned intended for the purpose of samples for product analysis 
and quality testing th at are not placed on the market, should not be covered by this 
Regulation.  
(11) Consignments of the animals or products concerned that are exported from third 
countries into the Union should comply with the same restrictions  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 concerned 
should only be allowed to enter the Union in the case that  the third countries or regions 
thereof, from whi ch th ose animals or products originate, can ensure compliance 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 
reserved for the treatment of certain infections in humans.  
(12) Third countries -or regions - thereof that meet th ose requirements are to be included in 
a list that is to be drawn up by the Commission, by means of implementing acts, in 
accordance with Article 127 of Regulation (EU) 2017/625  of the European Parliament 
and of the Council6.  Third countries or regions thereof  are to  be included on that list 
on the basis of available evidence and guarantees that the concerned animals or 
products originating in them comply with the U nion’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 reserved for the treatment of certain 
infections in humans.  
(13) Consignments of animals or products concerned entering the Union from third 
countries listed in accordance with Article 127 of Regulation (EU) 2017/625 should 
also be accompanied by an official certificate confirming compliance with the Union’s 
                                                 
5 Council Regulation (EEC) No 2658/87 of 2 3 July 1987 on the tariff and statistical nomenclature and on the 
Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).  
6 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 Regu lations (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 L95, 7.4.2017, p.1 ).  
EN 6  EN 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 
reserved for the treatment of certain infections in humans.  
(14) The Commission should adopt specific requirements on the official certific ates 
required, by means of implementing acts, in accordance with Regulation (EU) 
2017/625.  
(15) The conditions for entry into the Union  of consignments of animals or products 
concerned will be known to third country operators as from the date of publication of 
this Regulation.  However, the practical application of the framework laid down in this 
Regulation will necessitate the adoption of further implementing measures. For 
reasons of pr edictability and legal certainty and with a view to allow stakeholders 
concerned sufficient time to comply with the Union requirements, the conditions for 
the entry into the Union of consignments of animals or product s set out in this 
Regulation should be deferred.  
HAS ADOPTED THIS REGULATION:  
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 exported from third countries into the 
Union, of antimicrobial medicinal products for growth promotion and yield increase, 
and antimicrobials reserved for treatment of certain infections in humans.  
2. This Regulation applies to  live food-producing animals for which Combined 
Nomenclature codes ('CN codes' ) have been laid down in Part Two, Chapter 1 , of 
Annex I to Regulation (EEC) No 2658/87 .  
This Regulation also applies to products of animal origin  intended for human 
consumption , for which CN codes have been laid down in Part Two, Chapters 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 following : 
(a) gelatine and raw materials for the production thereof referred to in Section 
XIV, Chapter I, point 1 , of Annex III to Regulation (EC) No 853/2004  of the 
European Parliament and of the Council7;  
(b) collagen and raw materials for the production thereof referred to in Section 
XV, Chapter I, point 1 , of Annex III t o Regulation (EC) No 853/2004;  
(c) highly refined products referred to in Section XVI, Chapter I, point 1 , of Annex 
III to Regulation (EC) No 853/2004;  
(d) wild animals and products derived therefrom;  
(e) insects, frogs, snails and reptiles, including products derived therefrom;  
(f) composite products;  
                                                 
7 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down 
specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).   
EN 7  EN (g) animals or products  of animal origin  not intended for human consumption , 
unless  the destination of the animals or products  has not been decided at entry 
into the  Union;  
(h) animals or products  of animal origin intended for human consumption only for 
transit through the Union without being placed on the market;  
(i) products  of animal origin intended for human consumption for the purpose of 
samples for product analysis and  quality testing without being placed on the 
market.  
Article  2 
Definitions  
For the purposes of this Regulation, the fol lowing 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 medicated feed  as defined in Article 3(2), point 
(a), of Regulation (EU) 2019/4 of the European Parliament and of the Council8; 
(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  of the European Parliament and of the Council ; 
(5) ‘transit’ means transit as defined in Article 3, point (44), of Regulat ion (EU) 
2017/625  of the Europe an Parl iament and of the Counci . 
Article 3  
Restrictions on the use of certain antimicrobial medicinal products in animals or 
products derived therefrom  entering the Union  
Animals or products referred t o in Article 1(2) that are exported from third countries into the 
Union shall not have been administered, or originate from animals that have been 
administered  any of the following : 
(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 reserved for treatment of certain infections in 
humans laid down in Implementing Regulation (EU) No 2022/1255.  
                                                 
8 Regulation  (EU) 2019/4 o f 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 L4, 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 pharmacologically 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 L52,  16.6.2009, p.11).   
EN 8  EN Article 4  
Conditions for the entry into the Union  
1. Consignments of the animals or products referred to in Article 1(2 ) shall only enter 
the Union where  the following conditions are met:  
(a) they originate from a third country or region thereof included in the list of 
countries referred 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 referred to in Article 1(2)  may enter the Union from  third countries  that are 
not included in the list referred to in Article 5(1) , where such third countries  ensure 
that the consignments entering the Union  originate from a Member State or from a 
third country included in the  list. 
Article 5  
List of approved third countries  
1. The list referred to in Article 4(1) , point (a),  is to be established by means of an 
implementing act adopted by the Commission in accordance with Article 127 of 
Regulation (EU) 2017/625.   If appropri ate, 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 countries in the list i n 
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 complied with, 
including information received on the procedures in place to guarantee the 
trace ability 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 delete the reference to a third country or a region of a third country from the list 
if the conditions f or inclusion in the list cease to be met.  
Article 6  
Certification of compliance  
1. Specific requirements on the official certificates referred in point (b) of Article 4(1)  
are to be laid down by the Commission, by means of implementing acts, in 
accordance wi th the examination procedure referred 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 matters.  
Article 7  
Controls  
Controls to ve rify compliance of consignments of the animals or products  referred to in 
Article 1(2) with Article 3 shall be carried out in accordance with Regulation (EU) 2017/625.   
EN 9  EN Article 8  
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 . 
The conditions for entry into the Union of consignments of animals or product s set out in this 
delegated act shall apply as from 24 months after the date of application of the implementing 
act referred to in Article 6(1).    
This Regulation shall be binding in its entirety and directly applicable in the Member States.  
Done at Brusse ls, 
 For the Commission  
 The President  
 Ursula VON DER LEYEN