COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION of the Regulation (EC) No 1831/2003 on additives for use in animal nutrition
Date: 2024-02-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal nutrition, antimicrobial resistance, food additive, food inspection, innovation, labelling, market approval, risk management, traceability, veterinary medicinal product

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   EUROPEAN COMMISSION  Brussels, 28.2.2024  SWD(2024) 47 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE EVALUATION   of the Regulation (EC) No 1831/2003 on additives for use in animal nutrition {SWD(2024) 46 final}  
 
 
The purpose of the evaluation is to assess how well the Feed Additives (FA) Regulation1 has 
performed  based  on  the  five  evaluation  criteria  of  the  Better  Regulation  Guidelines: 
effectiveness, efficiency, coherence, relevance and added value.  

This  analysis  is  based  on  data  gathered  through  a  public  consultation,  an  external  study,  a 
literature  review,  targeted  surveys,  case  studies  and  interviews  with  stakeholders,  national 
competent authorities and representative associations. The main limitations encountered were: 
the lack of official  statistical  data on production, value and trade of feed additives and feed 
products  including  them;  the  difficulty  of  obtaining  economic  data  from  industry;  and  the 
absence of a previous evaluation/impact assessment of the relevant legislation to better define 
the baseline. 

This evaluation is part of the combined evaluation/impact assessment to inform decisions on 
the revision of the FA Regulation, which is one of the actions foreseen under the Farm to Fork 
Strategy.  The  Farm  to  Fork  Strategy  for  a  fair,  healthy  and  environmentally-friendly  food 
system2 is one of the key actions of the European Green Deal3, an ambitious EU initiative to 
move towards a clean circular economy, restore biodiversity and cut pollution. 

Feed  additives  are  products  such  as  vitamins,  antioxidants,  microorganisms,  amino  acids  or 
enzymes,  used  in  animal  nutrition  to  keep  animals  in  good  health,  to  improve  their 
productivity  and  welfare  or  to  reduce  the  environmental  impacts  of  animal  farming.  Feed 
additives can in particular exert positive effects on animal welfare, for instance, by reducing 
the  stress  for  farm  animals  when  transitioning  to  a  different  production  stage  (e.g.  lactating 
pigs  to  fattening  pigs),  and  on  animals’  health  and  well-being,  by  stabilising  their  intestinal 
flora and reducing the need for medicinal treatments  (e.g. antimicrobials) and the likelihood 
of manure contamination.  

Before  they  can  be  placed  on  the  EU  market,  feed  additives  must  undergo  a  safety  and 
efficacy assessment by the European Food Safety Authority, through a centralised procedure 
aiming to protect animals, humans and the environment from potentially harmful effects and 
to ensure that EU farmers and animal keepers can access safe, nutritious and high-quality feed 
products.  The  2003  FA  Regulation  replaced  a  Council  Directive  of  1970,  and  particularly 
sought  to  improve  feed  additives’  safety  for  humans,  animals  and  the  environment. 
Combating the rise of antimicrobial resistance was a key objective of the FA Regulation, as 
was  fostering  innovation  in  livestock  farming.  The  Regulation  also  sought  to  simplify  the 
authorisation process, while ensuring rigorous and independent risk assessment, and setting-
up clear rules for the labelling of feed additives. Finally, the Regulation also sought to address 
the specific needs of pets and their owners. 

1 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. 
2 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social Committee and the Committee of the Regions - A Farm to Fork Strategy for a fair, healthy and 
environmentally-friendly food system. COM (2020) 381 final. 
3 Communication from the Commission to the European Parliament, the European Council, the Council, the 
European Economic and Social Committee and the Committee of the Regions - The European Green Deal. COM 
(2019) 640 final. 

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The  evaluation  shows  that  the  FA  Regulation  has  generally  functioned  well,  and  that  its 
objectives  remain  relevant.  There  are  three  main  areas  in  which  there  is  clearly  room  for 
improvement:  more  could  be  done  to  encourage  innovation  in  feed  additives,  in  particular 
those  that  can  improve  the  sustainability  of  livestock  farming;  there  is  still  scope  to  reduce 
administrative and regulatory burden generated by the authorisation process; and steps should 
be taken to further enhance animal welfare.  

Fostering  sustainability  of  animal  farming  is  a  new  overarching  objective  that  was  not 
prominent  when  the  2003  FA  Regulation  was  framed.  The  existing  Regulation  has  largely 
addressed  sustainability  in  livestock  production  although  the  potential  of  the  Regulation  to 
contribute  to  a  more  sustainable  farming  was  not  maybe  fully  realised.  There  is  room  for 
improvement,  for  instance  by  creating  a  specific  category  of  additives  promoting 
sustainability and decoupling zootechnical effects from sustainability effects and thus, raising 
more awareness on the positive effects of some additives for a sustainable livestock farming. 

The  FA  Regulation  has  clearly  made  a  significant  positive  contribution  to  the  fight  against 
antimicrobial  resistance.  However,  there  remains  more  to  be  done  in  this  area,  so  this 
objective is still of relevance, and the measures addressing this problem should be developed 
further. 

In general, the authorisation system for feed additives has proven efficient and effective and 
ensures a high level of protection of human health, animal health and the environment, along 
the food and feed chain. 

Although  the  FA  Regulation  has  brought  significant  progress  towards  the  objective  of 
simplification  and  harmonisation  of  the  authorisation  system  when  compared  to  the 
situation  under  the  1970  Directive,  the  evaluation  identifies  a  number  of  possible  measures 
that  could  help  reduce  delays  further  and  improve  the  clarity  and  coherence  of  the 
authorisation process.   

The reduction of administrative and regulatory burden could also be pursued further. For 
example,  changes  in  the  holder  of  an  authorisation  should  be  handled  through  a  simpler 
procedure. Also, extending the duration of the authorisation period, at least for certain types 
of additives, could bring benefits of this kind. 

In  addition,  a  number  of  provisions  in  the  relevant  legislation  would  benefit  from  some 
improvement  in  terms  of  clarity  and  coherence,  which  would  also  help  reduce  burden  by 
avoiding  possible  divergent  interpretations  of  those  provisions.  Better  coherence  with  other 
legislative provisions, such as the CLP Regulation4, could also reduce both time periods in the 
authorisation  process  and  costs  for  operators.  As  an  example  of  improved  clarity  to  be 
provided, the FA Regulation should better clarify that the environmental risk assessment for 
farmed  non-food  producing  animals  is  to  be  carried  out  in  the  same  manner  as  for  food-
producing animals. 

4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, p. 1. 

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There  are  certain  areas  where  reduction  of  costs  would  be  possible  (e.g.  extending  the 
duration  of  the  authorisation  period,  or  reforming  the  system  of  non-holder-specific 
authorisations). A  review of the non-holder specific authorisation  system  could  increase  the 
availability of certain essential additives, but its impact on SMEs would need to be assessed. 
There is also room to reduce administrative costs for the Commission and Member States.  

As regards information and labelling, the FA Regulation has been successful in conveying 
safety messages, and in general worked well. A number of areas would benefit from greater 
coherence  with  other  legislation,  or  from  more  modern  alternatives  to  physical  labels. 
Harmonised rules (e.g. labelling, identification) for feed additives that are imported/exported 
should also be considered when revising the Regulation. 

The  enforcement  of  the  FA  Regulation  has  been  generally  successful.  Nevertheless,  some 
weaknesses with regard to enforcement and traceability were identified concerning imports 
from third countries, and feed additives only intended for export to third countries.  

The FA Regulation addresses the specific needs of pet animals and their owners through a 
comprehensive  set  of  rules  that  are  tailored  to  this  particular  sub-sector,  especially  those 
governing the risk assessment phase of the authorisation process. 

As regards the encouragement to innovation, the evaluation found a high level of innovation 
in  certain  areas  –  in  particular,  additives  used  as  an  alternative  to  antibiotics,  additives 
improving  the  digestibility  of  feed  (better  use  of  resources),  and  additives  increasing  the 
performance  of  animals.  However,  the  FA  Regulation  has  not  kept  pace  with  innovation  in 
other areas, and in particular with the potential of feed additives to promote sustainability, by 
helping mitigate the environmental impact of livestock farming, or improving animal welfare.  

This is mainly due to the limitations of the current additives’ categorisation system.  

A number of other barriers to innovation have also been identified (e.g., some difficulties with 
the  interpretation  of  EFSA  guidance,  some  insufficient  definition  of  endpoints  for  new 
additives,  etc.),  while  some  measures,  such  as  the  establishment  of  holder-specific 
authorisations,  have  clearly  encouraged  greater  investment  in  innovation  (with  some 
limitations  for  SMEs  however).  A  number  of  possible  areas  for  improvement  to  promote 
innovative  additives,  notably  related  to  sustainability  aspects,  are  clearly  identified  in  the 
report.  

On the other hand, it is also clear that non-holder specific authorisations have generated some 
unintended  negative  effects,  and  this  has led  to  a  shortage  in  the  supply of  certain  essential 
additives, such as vitamins, that are very important for animal health and welfare. This matter 
would need to be addressed on the occasion of the revision of the FA Regulation. 

It  is  clear,  then,  that  the  FA  Regulation  has  brought  significant  added  value  through  the 
harmonised  EU  authorisation  procedure  and  labelling  rules,  and  has  substantially  advanced 
the objectives pursued by the legislation. In order to strengthen the functioning of the internal 
market  and  ensure  a  level-playing  field,  however,  there  remains  scope  for  additional 
harmonisation/clarification in certain areas.  

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