REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant 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/EEC
Date: 2023-02-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, animal feedingstuffs, animal health, delegated legislation, drug surveillance, health control, market approval, powers of the institutions (EU), veterinary inspection, veterinary medicinal product

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  EN 

   EUROPEAN COMMISSION  Brussels, 17.2.2023  COM(2023) 78 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant 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/EEC  
 
 
1. 

INTRODUCTION AND LEGAL BASIS 

The Regulation on medicated feed (MF)1  lays down a robust legal  framework for the 
safe manufacture, storage, transport, placing on the market, including import from third 
countries,  use  and  export  to  third  countries  of  medicated  feed  and  intermediate 
products.  The  MF  is  essential  to  protect  animal  health  by  providing  instruments  to 
safely use veterinary medicinal products in medicated feed and intermediate products, 
while  at  the  same  time  taking  into  account  the  serious  animal  and  public  health  risk 
posed by antimicrobial resistance. 

The  MF  empowers  the  Commission  to  adopt  delegated  acts  as  referred  to  in  Article 
20(1), with a view to: 

  supplement  the  MF  by  establishing  specific  maximum  levels  of  cross-
contamination for active substances in non-target feed, unless such levels are 
already established in accordance with Directive 2002/32/EC2, as provided for 
in Article 7(2); those delegated acts may also set out methods of analysis for 
active substances in feed; 

  supplement  the  MF  by  establishing,  as  regards  the  antimicrobial  active 
substances  in  Annex  II  of  the  MF,  specific  maximum  levels  of  cross-
contamination for active substances in non-target feed and methods of analysis 
for such active substances, as provided for in Article 7(3); and, 

  amend  Annexes  I  to  V  of  the  MF,  in  order  to  take  into  account  technical 

progress and scientific developments, as provided for in Article 19. 

The present report is required under Article 20(2) of the MF. Under Article 20(2) the 
Commission has the power to adopt delegated acts referred to in Articles 7 and 19 for a 
period  of  five  years  from  27  January  2019.  The  Commission  is  required  to  prepare  a 
report in respect to this delegation of power not later than nine months before the end of 
the five-year period. 

2.  Exercise of the delegation 

2.1  Supplementing the MF to establish specific maximum levels of cross-contamination for 
active  substances  in  non-target  feed  unless  such  levels  are  already  established  in 
accordance with  Directive 2002/32/EC,  and methods  of analysis for active substances 
(Article 7, paragraph 2) 

The empowerment under this Article 7(2) has not been used during the reporting period 
because  priority  was  given  to  establishing  specific  maximum  levels  of  cross-
contamination  for  active  antimicrobial  substances  in  non-target  feed  and  methods  of 
analysis for these active substances (Article 7(3)). The adoption of delegated acts under 
both empowerments needs to be based on a scientific risk assessment carried out by the 

1  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/EEC (OJ L 4, 7.1.2019, p. 1). 
2 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances 
in animal feed. (OJ L 140, 30.5.2002, p. 10). 

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European  Food  Safety  Authority  (EFSA).  Such  assessment  in  view  of  a  delegated 
Regulation in accordance with Article 7(3) was very time and resource consuming for 
EFSA (see 2.2). 

2.2  Supplementing the MF to establish specific maximum levels of cross-contamination for 
active antimicrobial substances, listed in Annex II of the MF in non-target feed and 
methods of analysis for these active substances (Article 7, paragraph 3) 

At the request of the Commission, EFSA delivered its opinion needed for establishing 
specific maximum levels of cross-contamination for active antimicrobial substances in 
non-target  feed,  in  133  different  parts:  one  regarding  “methodology,  general  data  and 
uncertainties” and another twelve for the 24 antimicrobials of Annex II of the MF to be 
assessed. 

The  assessment  for  each  of  the  24  antimicrobials  was  composed  of  two  parts, 
considered essential to establish the specific maximum level of cross-contamination, in 
particular  related to  antimicrobial  resistance and to  growth  promotion/increase.  Based 
on the scientific data available, 

  EFSA  was  able  to  determine  the  “feed  antimicrobial  resistance  selection 
concentration” for six of the 24 antimicrobials; this  is the concentration of the 
antimicrobial  in  the  non-target  feed  that  would  no  longer  select  for  resistant 
bacteria; 

  EFSA  was  also  able  to  identify  the  levels  below  which  14  of  the  24 
antimicrobials would no longer cause an effect on growth promotion/increased 
yield. 

In addition, the European Reference Laboratory for Feed Additives was mandated and 
provided  recommended  methods  of  analysis  in  feed  for  all  24  antimicrobials.  Each 
method has a minimum limit of quantification, being the lowest concentration that can 
be detected. 

All  this  information  only  became  available  mid-2022  and,  unfortunately,  does  not 
provide  a  straight  way  forward  to  address  the  empowerment  delegated  to  the 
Commission under Article 7(3) since data were missing to assess several antimicrobials 
and since the lowest concentrations that can be detected were significantly higher than 
the feed antimicrobial resistance selection concentrations of the same antimicrobial.  

Based  on  additional  consultations  of  all  relevant  stakeholders,  the  Commission  is 
currently  preparing  a  Delegated  Regulation  establishing  specific  maximum  levels  of 
cross-contamination for active antimicrobial substances in non-target feed and methods 
of  analysis  for  these  active  substances,  being  as  strict  as  possible.  However, 
requirements  should  still  be  feasible  and  practical,  including  in  case  of  small  feed 
business operators. A balance needs to be sought between the possible development of 
some antimicrobial resistance and the availability of appropriate treatments for animals 
which depends on the availability of medicated feed. Future revisions might be needed 
when currently missing scientific information becomes available. In addition, technical 

3 https://efsa.onlinelibrary.wiley.com/doi/toc/10.1002/(ISSN)1831-4732.cross-contamination  

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progress  in  the  coming  years  may  allow  to  detect  lower  concentrations  of 
antimicrobials,  providing  input  to  reconsider  specific  maximum  levels  of  cross-
contamination. 

2.3 

Amendments to Annexes I to V (Article 19) 

The empowerment under this Article 19 has not been used during the reporting period 
because the period between the date of application (27 January 2022) and the deadline 
for  the  reporting  period  (27  April  2023)  is  very  short.  Experiences  in  the  practical 
implementation,  technical  progress  and  scientific  developments  are  therefore  still 
limited. 

3. 

Conclusion 

The  Commission  sees  the  need  for  the  tacit  extension  of  the  delegation  of  power  as 
provided for in Article 20(2) of the MF for a period of five years, in accordance with 
that  Article.  This  is  due  to  the  fact  that  the  need  to  develop  rules  based  on  the 
empowerments  referred  to  by  Article  20(2)  of  the  MF  will  continue  to  exist  in  the 
future.  The  extension  of  the  delegation  of  powers  will  be  particularly  important  to 
provide the necessary flexibility in the new legal framework, to complement and adjust 
it  regularly, 
latest  scientific 
developments, and to allow the Commission to act in the areas where it did not act to 
this moment, but may need to do so in the future. 

technical  progress  and 

into  account 

taking 

the 

With  this  report,  the  Commission  complies  with  the  reporting  requirement  under 
Article 20(2) of Regulation (EU) 2019/4 and  invites the European Parliament and the 
Council to take note of this report. 

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