EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN /2023/1707 sps  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2019/4 of the European Parliament and of the Council 
by establishing specific maximum levels of cross -contamination of antimicrobial active 
substances in non -target feed and methods of analysis for these substances in feed  
(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) 2019/4 of the European Parliament and of the Council 
by establishing specific maximum levels of cross -contamination of antimicrobial active 
substances in non -target feed and methods of analysis for these substances in feed  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to 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/EEC1, and in particular Article 7(3) thereof,  
Whereas:  
(1) Regulation (EU) 2019/4 lays down specifi c provisions regarding medicated feed and 
intermediate products. Cross -contamination of non -target feed with antimicrobials has 
been identified as a core issue of the Union in the context of protecting animal health, 
human health and the environment, and should be avoided or kept as low as possible.  
(2) In accordance with Article 7(3) of Regulation (EU) 2019/4, the Commission must 
adopt delegated acts to supplement that Regulation by establishing, as regards the 24 
antimicrobial active substances listed in Annex II thereto (‘the 24 antimicrobial active 
substances’), specific maximum levels of cross -contamination for active substances in 
non-target feed, and methods of analysis for these antimicrobial active substances in 
feed. Pursuant to Article 7(3) of tha t Regulation, those delegated acts which establish 
maximum levels of cross -contamination must be based on a scientific risk assessment 
carried out by the European Food Safety Authority (‘the Authority’).  
(3) At the Commission’s request, the Authority assessed,  in cooperation with the 
European Medicines Agency (‘EMA’), the specific concentrations of the 24 
antimicrobial active substances resulting from cross -contamination in non -target feed 
for food -producing animals, below which there would be no effect on the emergence 
of, and/or selection for, resistance in antimicrobial active substances relevant for 
human and animal health (‘antimicrobial resistance’, ‘AMR’).  
(4) The Authority was also requested by the Commission to assess the levels of the 24 
antimicrobial act ive substances which could have a growth promotion or increased 
yield effect taking into account that the use of antibiotics other than coccidiostats or 
histomonostats used as feed additives, has been phased out as from 1 January 2006 in 
accordance with Ar ticle 11(2) of Regulation (EC) No 1831/2003 of the European 
Parliament and of the Council2. The specific maximum level of each antimicrobial 
 
1 OJ L 4, 7.1.2019, p. 1.  
2 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).  EN 2  EN active substance in non -target feed should be below the level that causes a growth 
promotion or increased yield ef fect. 
(5) In addition, the Commission requested the Reference Laboratory, set up pursuant to 
Regulation (EC) No 1831/2003 (‘the Reference Laboratory’), to recommend methods 
of analysis for the 24 antimicrobial active substances in feed.  
(6) In its 13 Opinions of 15 September 2021 on maximum levels of cross‐contamination 
for the 24 antimicrobial active substances in non‐target feed3 (‘Opinions of 15 
September 2021’), the Authority could only establish specific concentrations 
concerning AMR for six of the 24 antimi crobial active substances and not for all 
relevant animal species, due to a lack of data. In addition, the Authority identified 
levels causing effects on growth promotion or increased yield for only 14 of the 24 
antimicrobial active substances and not for all relevant animal species, due to an 
absence of relevant data.  
(7) In April 2022 and February 2023, the Reference Laboratory issued two reports on the 
methods of analysis and minimum achievable levels of quantification (‘LOQ’) in feed 
for the 24 antimicrobia l active substances4 (‘Reports of April 2022 and February 
2023’).  
(8) The specific concentrations concerning AMR established by the Authority for six 
antimicrobial active substances, in the Opinions of 15 September 2021, are 
significantly lower than the mini mum LOQs established by the Reference Laboratory 
in the Reports of April 2022 and February 2023. This means, in practice, that the 
specific concentrations are not measurable and would therefore not be enforceable by 
the Member States in accordance with Art icle 17(2) of Regulation (EC) No 178/2002 
of the European Parliament and of the Council5. 
(9) The lowest levels of the 14 antimicrobial active substances, for which the Authority 
could indicate in its Opinions of 15 September 2021 as causing a growth promotio n or 
increased yield effect, are significantly higher than the LOQ of the same substance and 
are therefore measurable and enforceable by the Member States in accordance with 
Article 17(2) of Regulation (EC) No 178/2002. To avoid a growth promoting or 
incre ased yield effect, the maximum levels of cross -contamination for the 
antimicrobial active substances in non -target feed should be below the lowest levels 
causing a growth promotion or increased yield effect.   
(10) High economic investment and increased logistic  costs to comply with the maximum 
levels of cross -contamination in non -target feed if such levels are very low is likely to 
result in a reduction of the production of medicated feed. In addition, EMA Advice of 
28 August 2020 on implementing measures under Article 106(6) of Regulation (EU) 
2019/6 on veterinary medicinal products – scientific problem analysis and 
recommendations to ensure a safe and efficient administration of oral veterinary 
medicinal products via routes other than medicated feed6, conclude s that it may also 
result in an increased recourse to methods of oral administration of antimicrobial 
 
3 EFSA  Journal 2021;19(10):6852  to 6865.   
4 [a reference will be added when published ] [DG: This must, of course, be done before adoption of the 
draft delegated regulation.]                                 
5 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002  laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety  (OJ L 31, 1.2.2002, p. 1 ). 
6 EMA/CVMP/508559/2019  EN 3  EN active substances other than medicated feed, such as the administration on the surface 
of solid feed, that may increase the risk of AMR and the inability to treat certain 
bacterial infections in certain species due to the absence of other appropriate routes of 
administration, for example, in aquaculture. The maximum levels of cross -
contamination should, therefore, not be detrimental to the production of med icated 
feed, in particular, by small and medium size feed manufacturing plants, excluding 
them in practice from the production of medicated feed, which would result in possible 
issues for public health, and animal health and welfare. It is therefore approp riate to 
establish a maximum level of cross -contamination that is strict but also feasible to 
achieve by applying good practices to minimise cross -contamination. In addition to the 
Opinions of 15 September 2021, the experience gained in Member States in ap plying 
national law indicates that a cross -contamination level in the non -target feed of 1% of 
the active substance in the medicated feed, represents a good balance between 
feasibility and AMR control.  
(11) The maximum levels of cross -contamination for some ant imicrobial active substances 
in non -target feed should be reviewed if new scientific evidence becomes available, 
allowing to further control antimicrobial resistance in the non -target feed with 
enforceable maximum levels and which are achievable by applyin g good practices to 
minimise cross -contamination.  
(12) Medicated feed intended for fish often contains substantially higher doses of 
antimicrobial active substances than medicated feed intended for food -producing 
animals other than fish. In addition, no levels of antimicrobial active substances 
creating a grow th promotion or increased yield effect in fish, have been identified in 
the Opinions of 15 September 2021.  Stricter specific maximum levels of cross -
contamination in non -target feed intended for food -producing animals other than fish 
therefore are needed where the cross -contamination originates from medicated feed 
intended for fish, in order to avoid a growth promotion or increased yield effect in 
food-producing animals other than fish. Since these stricter specific maximum levels 
of cross -contamination in  non-target feed intended for food -producing animals other 
than fish, should be measurable and enforceable by the Member States, they should be 
set at the LOQ.  
(13) It should be ensured that food derived from animals fed with the non -target feed 
complies with the maximum residue levels in food laid down in Table 1 set out in the 
Annex to Commission Regulation (EU) 37/20107. Stricter specific maximum levels of 
cross -contamination for antimicrobial active substances in non -target feed should 
therefore be laid do wn in this Regulation, in particular for milk - or egg -producing 
animals and for animals close to the date of slaughter. Since these stricter specific 
maximum levels of cross -contamination in non -target feed should be measurable and 
enforceable by the Membe r States, they should be set at the LOQ.  
(14) Manufacturing, processing, storage or transport facilities might be flushed with feed 
materials to remove left -overs from the medicated feed in these facilities. To avoid 
disposal, namely feed waste, it should be al lowed to use these feed materials from 
flushing in non -target feed provided that such non -target feed complies with the 
maximum levels of cross -contamination for active substances laid down in this 
Regulation.  
 
7 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ 
L 15, 20.1.2010, p. 1).   EN 4  EN (15) The methods of analysis recommended by the Ref erence Laboratory in the Reports of 
April 2022 and February 2023 should be used as reference methods for the analysis of 
the 24 antimicrobial active substances. Alternative methods of analysis should only be 
allowed when validated and considered as equival ent by the competent authorities of 
the Member States.  
(16) It is appropriate to provide official laboratories carrying out the methods of analysis 
with sufficient time to adapt to the set LOQs and prove their competence for their 
analysis by generally accepted  means e.g., by accreditation, sound in -house validation 
or proficiency test data targeting a timely accreditation. Therefore, this Regulation 
should apply 6 months from the date of entry into force of this Regulation.  
HAS ADOPTED THIS REGULATION:  
Article 1 
This Regulation establishes, for the antimicrobial active substances listed in Annex II to 
Regulation (EU) 2019/4, specific maximum levels of cross -contamination of antimicrobial 
active substances in non -target feed and methods of analysis for active sub stances in feed, as 
provided for in Article 7(3) of that Regulation.  
Article 2  
1. The specific maximum levels of cross -contamination in non -target feed for the 
antimicrobial active substances listed in Annex II to Regulation (EU) 2019/4 shall be 
set at 1% o f the active substance in the last batch of medicated feed or the 
intermediate product manufactured, processed, stored or transported before the 
manufacturing, processing, storage or transport of the non -target feed.  
2. By way of derogation from paragraph 1, the specific maximum levels of cross -
contamination in non -target feed for the antimicrobial active substances shall be set 
at the limit of quantification (‘LOQ’), laid down in the Annex to this Regulation for 
the following animals:  
(a) food-producing animals other than fish where the non -target feed is 
manufactured, processed, stored or transported after the manufacturing, 
processing, storage or transport of medicated feed intended for aquaculture;  
(b) animals during the production of eggs or milk intended for hu man 
consumption;   
(c) food-producing animals intended for slaughter in the period for slaughter 
corresponding to the longest withdrawal period for target animal species.  
3. By way of derogation from paragraph 1, feed materials, used in the flushing of the 
manufa cturing, processing, storage or transport facilities after the manufacturing, 
processing, storage or transport of medicated feed, even if not complying with the 
specific maximum levels of cross -contamination laid down in paragraphs 1 or 2, may 
be used for the production of non -target feed, but only if such non -target feed 
complies with the specific maximum levels of cross -contamination laid down in 
paragraphs 1 or 2.  EN 5  EN  Article 3  
The reference methods of analysis for the quantification of the level of cross -contamination of 
each antimicrobial active substance listed in Annex II to Regulation (EU) 2019/4, in the non -
target feed referred to in Article 2(1) and (2), are laid down in the Annex to this Regulation.  
However, alternative methods of analysis may be u sed provided they are validated in 
accordance with internationally accepted scientific protocols and have the same or a lower 
LOQ as the LOQ of the same antimicrobial active substance laid down in the Annex to this 
Regulation.  
Article 4  
This Regulation sha ll enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from … [ 6 months from the date of entry into force of this Regulation ].  
This Regulation shall be binding in its entire ty and directly applicable in all Member States.  
This Regulation shall be binding in its entirety and directly applicable in the Member States in 
accordance with the Treaties.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN