COMMISSION STAFF WORKING DOCUMENT EVALUATION of 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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 28.2.2024  SWD(2024) 46 final  COMMISSION STAFF WORKING DOCUMENT  EVALUATION         of Regulation (EC) No 1831/2003 on additives for use in animal nutrition {SWD(2024) 47 final}  
 
 
Table of contents 

1. 

INTRODUCTION ................................................................................................................................ 7 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? ....................................... 8 

2.1. Description of the intervention and its objectives ................................................................ 8 

2.2. Point(s) of comparison ....................................................................................................... 18 

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? ....................... 19 

3.1. Current state of play ........................................................................................................... 19 

3.1.1 Reduction of antimicrobial resistance threats to citizens, animals and the environment
 ............................................................................................................................................... 19 

3.1.2 Placing innovative and efficacious FA on the market. ................................................. 19 

3.1.3 Simplifying and harmonising authorisation and labelling rules and processes and 
ensuring a rigorous risk assessment. ..................................................................................... 21 

3.1.4 Addressing specific interests of pet owners and their animals. .................................... 22 

3.2. External factors or market developments affecting the results of the intervention. ........... 23 

3.2.1 Increase of industrial development in third countries .................................................. 23 

3.2.2 Frequency of mergers and acquisitions ........................................................................ 23 

3.2.3 Scientific and technical developments in safety/efficacy assessment .......................... 23 

3.2.4 New challenges related to pollution associated with animal production. ..................... 24 

4. 

EVALUATION FINDINGS (ANALYTICAL PART) ....................................................................... 24 

4.1. To what extent was the intervention successful and why? ................................................. 24 

4.1.1 Reduce AMR threats to citizens, animals and the environment. .................................. 24 

4.1.2. Simplifying and harmonising the authorisation, risk assessment, risk management 
processes ................................................................................................................................ 26 

4.1.3 Coherence ..................................................................................................................... 33 

4.1.4 Overview of costs and benefits (efficiency) ................................................................. 35 

4.1.5 Comprehensive and harmonised labelling rules ........................................................... 44 

4.1.6 Information to feed business operators, other users of FA and consumers. ................. 45 

4.1.7 Control, traceability and enforcement rules ................................................................. 46 

4.1.8 Specific interests for pet owners and their animals ...................................................... 48 

4.1.9 Innovative and efficacious FA ..................................................................................... 49 

4.2. How did the EU intervention make the difference? ........................................................... 52 

4.3. Is the intervention still relevant? ........................................................................................ 52 

4.3.1. Relevance of the objectives ......................................................................................... 52 

4.3.2. Are the current rules still adequate to support scientific and technological progress? 53 

4.3.3. New needs ................................................................................................................... 54 

4.3.4. Societal expectations ................................................................................................... 55 

 
 
 
5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? ................................................. 57 

ANNEX I: PROCEDURAL INFORMATION............................................................................................. 62 

ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED ................................................... 65 

ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS 

TO THE EVALUATION QUESTIONS (BY CRITERION) ............................................................. 73 

EVALUATION MATRIX ...................................................................................................... 145 

Evaluation criterion: Effectiveness – EQ1 .......................................................................... 146 

Evaluation criterion: Effectiveness – EQ2 .......................................................................... 167 

Evaluation criterion: Efficiency – EQ3 ............................................................................... 178 

Evaluation criterion: Coherence – EQ4 ............................................................................... 195 

Evaluation criterion: Coherence – EQ5 ............................................................................... 207 

Evaluation criterion: Coherence – EQ6 ............................................................................... 212 

Evaluation criterion: relevance – EQ7 (EQ8 → EQ7.1) ..................................................... 223 

Evaluation criterion: relevance – EQ8 ................................................................................ 228 

Evaluation criterion: added value – EQ 9............................................................................ 238 

ANNEX IV. OVERVIEW OF BENEFITS AND COSTS AND TABLE ON SIMPLIFICATION 

AND BURDEN REDUCTION ......................................................................................................... 241 

ANNEX V-STAKEHOLDERS CONSULTATION – SYNOPSIS REPORT ........................................... 259 

1. - CONSULTATION STRATEGY ......................................................................................................... 259 

2.- METHODOLOGY AND ANALYSIS .............................................................................. 259 

3. - RESULTS OF THE CONSULTATION ACTIVITIES .................................................... 260 

3.1. - ROADMAP ................................................................................................................ 260 

3.2.- PUBLIC CONSULTATION ....................................................................................... 260 

3.3. - STAKEHOLDERS SURVEY ................................................................................... 264 

3.4. SURVEY TO MS NCA ............................................................................................... 268 

3.5 - NON-EU COUNTRIES SURVEY ............................................................................. 270 

3.6 INTERVIEWS AND CASE STUDIES ........................................................................ 272 

ANNEX VI- SUPPORTING TABLES OR DIAGRAMS.......................................................................... 275 

ANNEX VII- FA MARKET DATA........................................................................................................... 277 

ANNEX VIII- AUTHORISATION PROCESS AND LABELLING REQUIREMENTS ......................... 280 

ANNEX IX- DETAILED ANALYSIS OF MISSING DEFINITIONS AND PROVISIONS OPEN 

TO SOME CLARIFICATIONS ........................................................................................................ 286 

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Glossary 

TERM OR ACRONYM 
AFIA 
AH Europe 
AMR 
ANAC 
ANTIBIOTIC 

MEANING OR DEFINITION 
American Feed Industry Association 
Animal Health Europe (ex IFAH-Europe; ex FEDESA) 
Antimicrobial resistance 
Animal Nutrition Association of Canada 
Means antimicrobials produced by or derived from a micro-organism, which destroys or 
inhibits the growth of other micro-organisms. 

ANTIMICROBIALS  Means substances produced either synthetically or naturally used to kill or inhibit the 

growth of micro-organisms, including bacteria, viruses or fungi, or of parasites, in particular 
protozoa. 
The authorisation of additives can be linked to the specific legal person applying for the 
authorisation, who is the ‘holder’ of the authorisation (holder-specific authorisations), or 
not (non-holder specific, or generic, authorisations). In the case of additives belonging to 
categories d) (zootechnical) and e) (coccidiostats and histomonostats) referred to in Article 
6(1) of Regulation (EC) No 1831/2003, and of additives consisting of/containing/produced 
from genetically modified organisms (GMOs), no person may place the product on the 
market other than the authorisation holder named in the authorisation Regulation, his legal 
successor(s) or a person acting under his written authority. The authorisation holder has 
obligations for the supervision of conditions of marketing of the additive, including post-
market monitoring in the case of some additives (e.g. coccidiostats). 
European Consumers Organisation 
Better Regulation 
Coccidiostats and histomonostats 
Compound Annual Growth Rate  
According to Article 6 of Regulation (EC) No 1831/2003, additives may belong to one or 
more of five categories, depending on their functions and properties: 
➢  Technological additives: any substance added to feed for a technological purpose, e.g., 
preservatives, antioxidants, emulsifiers, stabilising agents, acidity regulators, silage 
additives. 
➢  Sensory additives: any substance, the addition of which to feed improves or changes 
the organoleptic properties of the feed, or the visual characteristics of the food derived 
from animals, e.g., flavourings, colourants. 
➢  Nutritional additives: any substance added to feed to improve nutritional values, e.g., 
vitamins, minerals, amino acids, trace elements. 
➢  Zootechnical additives: any additive used to affect favourably the performance of 
animals in good health or used to affect favourably the environment, e.g., digestibility 
enhancers, gut flora stabilisers. 
➢  Coccidiostats and histomonostats: substances intended to kill or inhibit protozoa 
Regulation on the classification, labelling and packaging of substances and mixtures 
(Regulation (EC) No 1272/2008). 
Means substances intended to kill or inhibit protozoa. 

AUTHORISATION 
HOLDER 

BEUC 
BR 
C&Hs 
CAGR 
CATEGORIES OF 
FEED ADDITIVES 

CLP Regulation 

COCCIDIOSTATS 
AND 
HISTOMONOSTATS 
COCERAL 

Comité du Commerce des céréales, aliments du bétail, oléagineux, huile d'olive, huiles et 
graisses et agrofournitures. 
Means a compound feed which has a high content of certain substances but which, because 
of its composition, is sufficient for a daily ration only if used in combination with other feed. 
Means a compound feed that, due to its composition, is sufficient for a daily ration. 

COMPLEMENTARY 
FEED 
COMPLETE FEED 
COMPOUND FEED  Means a mixture of at least two feed materials, whether or not containing FA, for oral 
animal feeding in the form of complete or complementary feed. 
European farmers and European Agri-Cooperatives 

COPA-COGECA 

3 

 
 
 
DFID 
DG SANTE 
EAAP 
EC 
ECDC 
ECHA 
EFARO 
EFISC-GTP  
EFSA 
ENDPOINTS 

EMFEMA 
ENSSER 
ESVAC 
EURL 
EUVEPRO 
FCEC  
FEAP 
FEDESA  
FEDIAF 
FEED 

FEED ADDITIVES 

FA 
FEED ADDITIVES / 
PREMIXTURES ONLY 
INTENDED FOR 
EXPORT 

FEED BUSINESS 
OPERATORS (FeBOs) 

FEED MATERIALS 

FEEDAP 
FEFAC 
FEFANA 
FESASS 
FIC 

UK Department for International Development 
Directorate-General for Health and Food Safety 
European Federation for Animal Science 
European Commission 
European Centre for Disease Prevention and Control 
European Chemicals Agency 
European Fisheries and Aquaculture Research Organisations 
European Feed and Food Ingredient Safety Certification 
European Food Safety Authority  
Is what you have to measure to demonstrate an effect. For example, if you want to 
demonstrate performance in laying hens you measure the number of eggs during the 
period of the trial.  
European Manufacturers of Feed Minerals Association 
European Network of Scientists for Social and Environmental Responsibility 
European Surveillance of Veterinary Antimicrobial Consumption 
European Union Reference Laboratory for FA 
European Vegetable Protein Association 
Food Chain Evaluation Consortium 
Federation of European Aquaculture Producers 
European Federation of Animal Health (now, Animal Health Europe) 
European Pet Food Industry Federation 
Any substance or product, including additives whether processed, partially processed or 
unprocessed, intended to be used for oral feeding to animals. 
Substances, micro-organisms or preparations, other than feed material and premixtures, 
which are intentionally added to feed or water in order to perform one or more of the 
functions to improve the quality of feed and the quality of food of animal origin, or to 
improve animal performance, animal health and animal welfare. 
Feed Additives 
These additives are produced only for export in accordance with Article 12 of the General 
Food Law. They must be safe and must comply with the relevant requirements of food law, 
unless otherwise requested by the authorities of the importing country or established by 
the laws, regulations, standards, codes of practice and other legal and administrative 
procedures as may be in force in the importing country. They can be exported if the 
competent authorities of the country of destination have expressly agreed, after having 
been fully informed of the reasons for which and the circumstances in which the food or 
feed concerned could not be placed on the market in the Community.  
The natural or legal persons responsible for ensuring that the requirements of food law are 
met within the feed business under their control (Article 3.6 of Regulation (EC) No 
178/2002). This encompasses all FeBOs along the feed supply chain: feed additives 
producers and business FeBOs that are users of additives (manufacturers of compound feed 
and pre-mixes; and pet food manufacturers). 
Means products of vegetable or animal origin, whose principal purpose is to meet animal’s 
nutritional needs, in their natural state, fresh or preserved, and products derived from the 
industrial processing thereof, and organic or inorganic substances, whether or not 
containing FA, which are intended for use in oral animal-feeding either directly as such, or 
after processing, or in the preparation of compound feed, or as carrier of premixtures. 
Panel on Additives and Products or Substances used in Animal Feed 
European Feed Manufacturers’ Federation 
EU Association of Specialty Feed Ingredients and their Mixtures 
European Federation of Farmers’ Animal Health Services 
Regulation (EU) No 1169/2011 on Food Information to Consumers 

4 

 
 
FUNCTIONAL 
GROUPS 

Within a category of FA, the additives are classified into functional groups in accordance 
with the function they perform – e.g., within the category “sensory additives”, there are 
two functional groups: colourants and flavourings. 
Federation of Veterinarians of Europe 

FVE 
GENERIC ADDITIVES  This term “generic” is used in the additives’ sector to name additives not linked to an 

GFL 

GMI 
GMOs  
HACCP 
IFIF 
IFOAM EU 

LABELLING 
TOLERANCES IN 
PREMIXTURES 

MCA 
MINOR SPECIES 

MS 
NCA 
OIE 
POST–MARKET 
MONITORING 
(PMM) 

PREMIXTURES 

PREPARATIONS 

R&D 
RASFF 
REACH 

REFIT 
SDGs 
SCM 
SCoPAFF 
STDF 
TARGET ANIMALS 

authorisation holder, belonging to the technological, sensory and nutritional categories, 
except if those additives consist of, contain or are produced from GMOs. In that case, they 
should be linked to an authorisation holder and are not “generic”. 
Regulation on the General Food Law (Regulation (EC) No 178/2002 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). 
Global Market Intelligence 
Genetically modified organisms  
Hazard Analysis and Critical Control Points  
International Feed Industry Federation 
International Federation of Organic Agriculture Movements (European umbrella 
organisation for organic food and farming)  
Premixtures may contain different additives. The level of incorporation of each additive is 
to be declared on the label. For different reasons, those levels are not stable (interaction 
with other additives, degradation by light), therefore, during the commercial life of the 
premixture the levels may change over the time. This is why tolerances might be necessary. 
For example, if for ascorbic acid the tolerance was (1%), in case of analysis, a variation of 
1% on the quantity declared on the label would then be acceptable.  
Multi-criteria analysis 
Means food-producing animals other than bovines (dairy and meat animals, including 
calves), sheep (meat animals), pigs, chickens (including laying hens), turkeys and fish 
belonging to the Salmonidae. 
Member States 
National Competent Authority(ies) 
World Organisation for Animal Health 
After the assessment, EFSA may propose to the applicant to carry out a PMM plan to trace 
and identify any direct, indirect, immediate, delayed, or unforeseen effect – resulting from 
the use of feed additives – on human or animal health or the environment, by using a 
product tracing framework similar to the one already existing in other sectors and in line 
with the traceability requirements laid down in the General Food Law. A proposal for PMM 
is requested for nutritional, zootechnical additives, coccidiostats and histomonostats and 
for additives consisting of, containing or produced from GMOs. 
Means mixtures of feed additives, or mixtures of one or more feed additive(s) with feed 
materials or water used as carriers, not intended for direct feeding to animals. 
Are feed additives composed of one or several active substances and other components 
(technological additives, feed materials or carriers) that are incorporated to facilitate the 
stability or the administration of the active substance – e.g., vitamin A as the active 
substance and one antioxidant to stabilise the vitamin and prevent its oxidation. 
Research and development 
Rapid Alert System for Food and Feed 
Regulation on Registration, Evaluation, Authorisation, and Restriction of Chemicals 
(Regulation (EC) No 1907/2006) 
The European Commission’s regulatory fitness and performance programme 
United Nations’ Sustainable Development Goals (SDGs) 
Standard Cost Model 
Standing Committee on Plants, Animals, Food and Feed  
Standards and Trade Development Facility 
Animals for which the additive is intended – e.g., if an additive is intended for dairy cows, 
the target animal will be dairy cows. 

5 

 
 
MICROTRACERS 

ToR 
WTO 

Substances used to trace other substances with a reliable and accurate method and to 
ensure that ingredients are present (or not) at the formulated and desired levels within the 
feed. This can contribute to preventing cross-contamination – e.g., to ensure that in a feed 
intended for pigs there are no traces of coccidiostats, used in the previous manufacturing 
batches for poultry. 
Terms of Reference 
World Trade Organisation 

Abbreviations to legal references: 

Regulation (EC) No 1831/2003:  

FA Regulation 

Commission Regulation (EC) No 429/2008: 

Commission Rules for Applications 

Directive 70/524/EEC:  

1970 FA Directive 

Regulation (EC) No 178/2002:  

General Food Law (‘GFL’) 

Regulation (EC) No 767/2009:  

Feed Marketing Regulation 

Regulation (EC) No 183/2005:  

Feed Hygiene Regulation 

Directive 2002/32/EC:  

Regulation (EC) No 1829/2003:  

Directive on Undesirable Substances in Animal 
Feed 

Regulation on Genetically Modified (GM) Food 
and Feed  

Council Directive 90/167/EEC:  

Directive on Medicated Feed1 

Directive 2001/82/EC: 

VMP Directive (veterinary medicinal products)1 

Regulation (EU) No 528/2012: 

Biocidal Products Regulation 

Regulation (EC) No 1907/2006:   

Regulation (EC) No 1272/2008:  

REACH Regulation (Registration, Evaluation, 
Authorisation and Restriction of Chemicals)  

CLP Regulation (classification, labelling and 
packaging of substances and mixtures) 

Regulation (EU) 2017/625:  

   Official Controls Regulation 

Other abbreviations 

EM 

Evaluation Matrix 

1  

It is noted that the current legal framework for veterinary medicinal products and medicated feed (Directive 2001/82/EC and 
Directive  90/167/EEC)  has  been  replaced  by  Regulation  (EU)  2019/6  on  veterinary  medicinal  products  and  Regulation  (EU) 
2019/4 on medicated feed; the new regulations apply from 28 January 2022. 

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1. 

INTRODUCTION 

The  purpose  of  this  evaluation  is  to  assess  how  well  the  2003  FA  Regulation2  has  performed 
based  on  the  five  evaluation  criteria  of  the  Better  Regulation  Guidelines:  effectiveness, 
efficiency, coherence, relevance and added value. The FA Regulation is based on Article 433 and 
Article 168(4) (b) of the TFEU with its primary aims of protecting human health as well as animal 
health and the environment and contributing to the well-functioning of the Single Market. 

The FA Regulation has not been evaluated since its adoption in 2003. More than 7764 FA have 
been authorised since then. An evaluation is thus justified.  

This evaluation is part of the combined evaluation/impact assessment that will inform decisions 
on the revision of the FA Regulation, as announced under the Farm to Fork Strategy. The Farm 
to Fork Strategy for a fair, healthy and environmentally friendly food system was adopted on 20 
May 20205 as one of the key actions of the European Green Deal6, an ambitious EU initiative to 
move towards a clean circular economy, restore biodiversity and cut pollution. 

The  evaluation  addresses the  legal obligations  laid  down  in  the  2003  FA  Regulation,  including 
the conditions and procedures  for the authorisation, the conditions for placing on the market 
and use of FA, including labelling and packaging, the enforcement of those rules and the phasing 
out  of  antibiotics  (see  more  details  in  Annex  III).  It  also  covers  implementing  rules,  including 
detailed rules for the preparation and presentation of applications (Commission Regulation No 
429/20087) and EFSA guidance for the assessment of FA. 

The evaluation covers the period 2004 to 2021. It draws on data collected through an external 
study  which  focused  on  the  period  2004-2017,  a  period  that  is  largely  representative  of  the 
questions  raised  by  the  new  authorisation  and  assessment  regime  that  had  been  introduced. 
The findings of the study are complemented by additional more recent information (see details 
in Annex II) wherever needed, especially on the question of authorisation renewals, as the first 
renewals only occurred in 2017. References to the evaluation matrix (EM) presented in Annex III 

2     Regulation (EC) No 1831/2003 of the European Parliament and of  the Council of 22 September 2003 on additives for use in 

3  

4   
5  

6  

7  

animal nutrition. OJ L 268, 18.10.2003, p. 29. 
All EU legislation concerning animal feed is based on both Article 43(2) and Article 168(4) (b) of the TFEU. Article 43(2) TFEU 
refers to provisions necessary for the pursuit of the objectives of the Common Agricultural Policy. To aim for harmonised and 
adequate  production  conditions  for  the  EU  livestock  farmers  can  be  also  derived  from  this  Article.  Livestock  production 
occupies a very important place in the agriculture of the EU and satisfactory results depend to a large extent on the use of safe 
and good quality feedingstuffs. 
SANTE database. 
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. 
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. 
Commission  Regulation  (EC)  No  429/2008  of  25  April  2008  on  detailed  rules  for  the  implementation  of  Regulation  (EC)  No 
1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and 
the assessment and the authorisation of FA. OJ L 133, 22.5.2008, p. 1. 

7 

 
 
 
which was used  to collect evidence  to support the analysis are  included  where appropriate in 
the text. The evaluation covers all the 27 MS plus the UK 8 and EEA countries.  

As regards  the  COVID 19 pandemic, a COPA-COGECA report9  refers to the increasing prices in 
some  feed  materials  (by  25%  to  35%  on  average)  but  FA  are  not  specifically  mentioned  as 
affected. The FA industry has not reported any specific problem with FA and the authorisation 
procedure  was not too much affected  as meetings of the SCoPAFF were organised  online  and 
EFSA replaced physical meetings by online meetings. 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? 

2.1. Description of the intervention and its objectives 

The EU first legislated in this area in 1970 with the adoption of Council Directive 70/524/EEC on 
FA10, in recognition of the potential risks to animal or human health. Following the 2000 White 
Paper  on  Food  Safety11  which  advanced  a  strategy  to  ensure  the  highest  possible  food  safety 
standards  in  Europe,  the  legislative  framework  was  reconsidered,  and  in  2003  the  legislation 
was  revised,  replacing  the  Directive  with  a  Regulation.  The  general  objectives  of  the  new 
Regulation  were  to  enhance  protection  of  human  health,  animal  health  and  welfare,  and  the 
environment; to improve the functioning of the EU’s internal market; to facilitate innovation in 
the sector; and to protect the interests of consumers (GOs 1-4).  

This  section  outlines  how  the  Regulation  sought  to  contribute  to  these  general  objectives  by 
pursuing more narrowly focused objectives specific to the FA sector. In the absence of any prior 
impact  assessment,  the  2003  intervention  logic  has  been  reconstructed  based  on  available 
information  (primarily,  the  text  of  the  Regulation  itself  and  the  accompanying  explanatory 
memorandum). The intervention logic set out in the narrative below is summarised visually in a 
diagram  at  the  end  of  the  section  (Figure  1).  References  to  the  diagram  elements  (problems, 
drivers,  actions,  objectives)  are  provided  in  parentheses  were  appropriate  (P1,  P2…  D1,  D2… 
etc), to facilitate cross-referencing.   

Specific  Objective  1  (SO1).  Reduction  of  antimicrobial  resistance  threats  to  citizens,  animals 
and the environment (AMR) 

Antimicrobials are substances that act directly to reduce or eliminate unwanted microorganisms 
or  parasites  within  animals  (and  humans)  and  that  are  primarily  used  to  treat  or  prevent 
infectious diseases. Over the years, however, their efficacity has been undermined, as rising and 
sometimes  indiscriminate  use  of  antibiotics  in  both  humans  and  animals  has  led  to  the 
proliferation of strains of bacteria that are resistant to such treatments. Existing antibiotics have 
thus  been  rendered  ineffective,  while  alternative  or  replacement  treatments  are  not  always 
available.  This  trend  has  constituted  an  obstacle  to  the  EU’s  high-level  commitment  to 
continuously improve the protection of public health (GO2). 

8  
9  

The evaluation includes the UK as the study performed by the contractor was made before the BREXIT took place. 
Impact  Of  Covid-19  on  the  Agricultural,  Forestry  and  Fisheries  Sectors  COPA  AND  COGECA  Assessment  November  2021  – 
February 2022 (COV (22)313:1. 

10   Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1). 
11  

https://op.europa.eu/en/publication-detail/-/publication/6d4b523b-dad8-4449-b2b4-9fa9b0d6e2be. 

8 

 
 
Antibiotics have in the past been used as FA because, in addition to their medicinal effects, they 
can also function as growth promoters. By the 1990s, such FA accounted for 15% of the volume 
of  antibiotics  consumed  in  the  EU  (by  active  substance).  This  use  of  antibiotics  is  now 
considered to have been a serious error for its deleterious effect on public health. Following a 
scientific opinion12, at the end of the 1990s the EU withdrew the majority of these substances 
from the list of authorised FA but did not go so far as to introduce a general ban. As a result, the 
use of antibiotics as growth promoters in FA continued, albeit on a much smaller scale (D1.1). 
While  some  MS,  citing  the  precautionary  principle,  had  already  banned  all  such  uses  of 
antibiotics by the late 1990s, policy at EU level lagged behind in this regard13. 

This situation was exacerbated by the fact that the authorisation process for FA under the 1970 
FA  Directive  did  not  include  a  comprehensive  risk  assessment  that  would  have  examined 
whether  such  continued  use  in  animals  might  not  fuel  the  continued  spread  of  AMR,  for 
example  by  looking  carefully  at  the  consequences  of  aggregate  dosing  levels  (feed  +  medical) 
(D1.2).  These  gaps  in  the  legislative  framework,  combined  with  competitive  pressure  on 
livestock  farmers  to  continually  seek  greater  productivity,  created  a  situation  in  which  certain 
FA authorised under the 1970 FA Directive may have continued to contribute to the spread of 
AMR (P1). 

To address this problem, the FA Regulation introduced a general ban on the use of antibiotics as 
FA  (A1.1).  A  special  regime  was  granted  to  coccidiostats  and  histomonostats14  which  allowed 
their continued use on the basis that they were important to prevent coccidiosis in poultry and 
histomoniasis  in turkeys  (not  for  growing  effect  purposes),  and  the  fact  that  their  AMR  effect 
was  relatively  weak15.  The  authorisation  process  was  also  adapted  to  include  a  preventive 
assessment  to  ensure  that  coccidiostats  and  histomonostats  that  remained  authorised  under 
the special regime did not in fact pose any risk of increasing the spread of AMR (A1.2). To this 
end,  FeBOs  requesting  authorisation  for  such  substances  now  need  to  demonstrate  their 
potential  antibiotic  action  and  to  provide  scientific  evidence  on  the  risk  of  AMR  that  they 
represent16.  

By  eliminating  the  continuing  use  of  antibiotics  as  growth  promoters17  in  FA  (O1),  it  was 
expected that these  actions would  substantially  reduce  any remaining risk of  AMR  due  to  the 
use of FA (R1) and would thus have a positive impact on the protection of public health (I1). 

12   Opinion 

of 

the 

Scientific 

Steering 

Committee 

on 

Antimicrobial 

Resistance 

28  May 

1999 

13  

https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_ssc_out50_en.pdf 
Sweden banned all antibiotics used as growth promoters in 1986 and Denmark banned avoparcin and virginiamycin in 1995 
and 1998, respectively. See: The European ban on growth-promoting antibiotics and emerging consequences for human and 
animal  health.  Mark  Casewell1,  Christian  Friis,  Enric  Marco,  Paul  McMullin  and  Ian  Phillips.  Journal  of  Antimicrobial 
Chemotherapy (2003) 52, 159–161. 

14   Although histomonostats were covered by the special regime, no histomonostats have been approved, therefore, for the time 

15  

16  
17  

being only coccidiostats are concerned.  
Ionophore  coccidiostats  (derived  from  micro-organisms)  have  demonstrated  a  low  antibiotic  effect  as  opposed  to  non- 
ionophore coccidiostats (synthetically produced). 
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R0429&from=EN  
The sole use of antibiotics in animal feed was as growth promoters. Coccidiostats and histomonostats are substances used to 
kill or inhibit protozoa, thereby preventing the diseases produced by those parasites. 

9 

 
 
 
 
Specific Objective 2 (SO2). Simplification and harmonisation of the FA authorisation process 

As specific objectives 2 and 3 address a common problem  set, and the drivers they address to 
some extent overlap, this sub-section and the next should be read together. 

Under  the  1970  FA  Directive,  the  rules  governing  the  authorisation  system  for  FA  were  very 
complex  and  tended  to  make  the  outcome  sometimes  difficult  for  applicants  to  predict  (P2). 
This can be an obstacle to the proper functioning of the EU internal market and can undermine 
the possibility of a level playing field for the operators concerned (GO1). 

This situation was due to a number of reasons. The process was not standardised, and central 
guidance  was  lacking  (D2.1,  D2.3).  The  low  level of harmonisation was  aggravated by the fact 
that, if MS feared a FA might pose a safety risk, they could act in a wide range of ways to reduce 
this risk, including by suspending the authorisation of the FA in question, whether for a limited 
or  an  unlimited  period  of  time,  and/or  restricting  the  conditions  of  its  use  by  imposing 
additional requirements (D2.3). It was the case for a vitamin D from the Netherlands that was 
not  permitted  in  Denmark  based  on  the  argument  that  the  presence  of  impurities  in  such 
vitamin  might  pose  serious  risks  to  public  health.  When  seeking  authorisation,  applications 
needed  to  be  addressed  to  a  MS  rapporteur  following  the  instructions  provided  by  that  MS 
(D2.1,  D2.3).  No  deadlines  were  set  for  some  steps  of  the  procedure,  which  could  result  in 
undue  delays  (D2.2).  Nor  was  there  an  open  and  readily  accessible  list  of  FA  that  had  been 
authorised  which  stakeholders  could  consult  before  launching  their  own  application  (D2.1, 
D2.4).  

The rules established by the 1970 FA Directive were also burdensome for the Commission and 
MS  (D2.5).  The  Directive  allowed  for  the  provisional  authorisation  of  products  whose  efficacy 
was simply declared by the applicant without the need to fully demonstrate it: the Commission 
and MS would then need to re-examine these authorisations, creating additional workload and 
delays.  

To address these drivers and resolve the problem, the 2003 FA Regulation aimed at simplifying 
the authorisation process by establishing: 

–  a single harmonised authorisation procedure at EU level (A2.1); 
–  a centralised risk assessment by EFSA (A2.1); 
–  timelines to be respected at the different steps of the procedure (A2.1); 
–  more  detailed  and  comprehensive  rules  to  help  applicants  prepare  their  dossiers, 

including strict data requirements (A2.2);  

–  a single application form (A2.2); and, 
–  a public register of FA (A3.2). 

These actions were expected to create a more transparent, simpler, faster and more predictable 
authorisation  process  (O2),  which  would  therefore  place  far  less  burden  on  all  the  parties 
involved,  including  public  authorities  (R2.1).  In  this  way,  these  actions  would  have  a  positive 
impact  on  the  functioning  of  the  internal  market  and  so  help  ensure  a  level  playing  field 
between FeBOs (I2).  

10 

 
 
 
Specific Objective 3 (SO3). Set up clear/comprehensive rules for FA authorisation and 
labelling. 

While  part  of  the  complexity  of  the  authorisation  process  was  due  to  a  low  level  of 
harmonisation,  it  was  also  the  case  that  the  rules  laid  down  in  the  1970  FA  Directive  were 
inherently complicated. This was also true concerning the labelling rules (P2). 

Authorisation 

The authorisation system was organised around the classification of FA into different types. This 
classification  was  complicated  both  by  the  intrinsic  opacity  of  some  of  the  rules,  and  the 
insufficient clarity as to which safety criteria should be applied to which categories of FA, and 
how. Thus, FA could for example be authorised under generic entries without it being clear how 
many FA were covered by those entries (D2.1). There were also cases, as mentioned above, in 
which MS imposed restrictions on the circulation of FA authorised through another MS because 
they  argued  that  the  appropriate  safety  criteria  had  not  been  adequately  taken  into  account 
(D2.4).  

In response to these drivers, the 2003 FA Regulation sought to solve this concern by introducing 
a new classification system  based on  clearly defined  functional groups which would  allow  the 
risk assessment  process  to be  rigorously  performed according to the  type  and function of the 
substance (A3.1). New functional groups could always be added to those initially identified, as 
science evolved, and new technological developments emerged (see table 1 in Annex VII). 

The  FA  Regulation  introduced  a  comprehensive  set  of  safety  criteria.  These  are  defined 
according  to  the  categories  of  FA  and  the  functional  groups  to  which  they  are  assigned  and 
correspond  to  different  dimensions  of  risk  to  be  assessed  for  humans,  animals  and  the 
environment. For each category, the safety criteria are risk-based (A3.1).  

The  FA  Regulation  also  introduced  an  obligation  for  each  substance  to  be  authorised  on  an 
individual basis so as to ensure that the proper safety/efficacy assessment is applied. It removed 
the  generic  group  authorisation  process  that  had  previously  applied  for  certain  FA  under  the 
former  1970  FA  Directive  (e.g.,  flavourings,  some  vitamins)  (A3.1).  Transparency  was  also 
enhanced through the creation of the Register of FA (A3.2), as discussed above under SO2.  

Defining clear and comprehensive rules for the FA authorisation process was expected to lead 
to  a  more  transparent,  simpler,  clearer  and  more  predictable  process  (O2,  R2.1,  2.2;  cf  SO2 
above), which in turn would have a positive impact on the functioning of the EU single market 
(I2).  

Labelling 

It is necessary to know very precisely how a given feedstuff should be used, given the FA that it 
contains,  in  order  to  ensure  the  safety  of  animals,  consumers,  workers  and  all  other  persons 
who  may  come  into  contact  with  it  along  the  feed  chain,  as  well  as  to  avoid  any  potential 
negative impacts on the environment.  Accurate and precise labelling of premixtures  and FA  is 
therefore  vital.  However,  the  labelling  rules  laid  down  by  the  1970  FA  Directive  were  not 
appropriate for some of the FA and premixtures that were authorised. For example, the batch 

11 

 
numbers  were  not  required  for  all  FA  (D2.1).  The  2003  FA  Regulation  therefore  specifically 
sought  to  avoid  potentially  harmful  confusion  on  the  part  of  users  by  establishing  detailed 
labelling rules that would mirror those already applicable to food (A3.1).  

The  establishment  of  clear  and  comprehensive  labelling  rules  was  designed  to  improve 
information on FA for those who handled them and thus facilitate their safer use along the feed 
chain (O2, R2.3). In this way, these measures were expected to have a positive impact on the 
functioning  of  the  internal  market  (I2)  and  to  promote  a  better  level  of  protection  of  human 
health, animal health, animal welfare and the environment (I1, I3, I4). 

Specific Objective 4 (SO4). Ensure rigorous and independent risk assessment. 

As specific objectives 4 and 5 address a common problem set, and the  drivers they address to 
some extent overlap, this sub-section and the next one should be read together. 

FA safety is a multi-dimensional challenge. Animals are exposed to FA directly through the feed 
they eat, and FA residues may persist in the food that is made from them, thus possibly posing a 
risk  to  human  health.  When  manipulating  FA  or  the  products  in  which  they  are  contained, 
workers  and  farmers18  may  also  be  negatively  impacted  through  direct  exposure  to  these 
substances. Finally, FA may pose environmental risks depending on how the active substance(s) 
they  contain  are  metabolised  by  the  animal,  and  whether  they  are  administered  over  long 
periods  of  time  and/or  to  large  groups  of  animals  (P3).  All  of  these  can  stand  in  the  way  of 
ensuring  that  human  and  animal  health,  and  the  state  of  the  environment,  are  properly 
protected (GO2). 

In the 1990s, a sequence of major food crises19 highlighted a number of weaknesses in the EU 
food  and  feed  systems  that  compromised  safety  on  several  levels.  Among  the  high-level 
legislative  drivers  that  were  singled  out  were:  a  lack  of  transparency  in  the  central  decision-
making  procedure;  the  sometimes  unclear  and  unbalanced  relationship  between  scientific 
opinions and political decisions; and the lack of a global and high-quality scientific overview of 
the food chain as a whole20. 

The 1970 FA Directive had its own shortcomings, which exemplified or aggravated the high-level 
drivers outlined here. The risk assessment process was clearly incomplete (D3.1): some key FA, 
such  as  amino  acids, enzymes  and  microorganisms,  were  not  subject  to  a  full evaluation,  and 
there was  no requirement for a  comprehensive  assessment  of the environmental risks posed. 
Nor was there any provision for a comprehensive evaluation of worker safety. The process as it 
was defined was weakened by the widely varying levels of scientific expertise that participants 
brought to the table (whether at MS level, or in the composition of the Scientific Committee on 
Animal Nutrition (SCAN) (D3.2) and there was no formal separation between risk management 
and risk assessment, with both the Commission and MS performing both tasks (D3.3). 

18  

In principle,  pet  owners  do  not  use/directly  manipulate  FA/premixtures,  only  feed materials and compound feed containing 
them. Farmers may only manipulate/use FA if they are registered as FeBOs. 

19   Notably the BSE crisis in 1995 and the dioxin crisis in 1999. 
20   Commission Staff Working Document on the Refit Evaluation of the General Food Law (Regulation (EC) No 178/2002)  - SWD 

(2018) 38 final. 

12 

 
 
To address these drivers, and in compliance with the requirements introduced by the General 
Food  Law  of  200221,  the  2003  FA  Regulation  established  a  clear  separation  between  risk 
management and risk assessment (A4.1). Risk assessment was henceforth to be carried out by 
an independent agency (EFSA), of which the members of the scientific panel to perform the FA 
risk assessment (FEEDAP Panel) would be specifically nominated for their high level of scientific 
expertise  and  independence,  while  risk  management  would  be  the  responsibility  of  the 
Commission,  which  would take  the  final  decision on  whether  or  not  to  authorise  a  FA  on  the 
basis of the EFSA’s opinion. 

A  complete  set  of  requirements  for  the  authorisation  of  FA  was  introduced,  including  a 
comprehensive environmental risk assessment and specific measures to address safe handling 
of FA, with the goal of covering all the gaps in the existing risk assessment process (A4.2). A 10-
year time limit was also introduced for all authorisations, to ensure that products are regularly 
reassessed  in  light  of  evolving  scientific  knowledge  on  their  effects  and  impacts,  and  to 
encourage the development of safer and more efficient FA (A4.3). 

Taken  together,  it  was  expected  that  those  measures  would  result  in  a  far  more  rigorous 
assessment of the risks posed by FA (O3, R3), and tangible improvements in worker safety (O4, 
R4). These measures were thus expected to have a positive impact on the protection of human 
health, animal health, animal welfare and the environment (I1, I3, I4). 

Specific Objective 5 (SO5). Improve FA control, traceability and enforcement rules.  

Safety  of  FA  depends  not  only  on  rigorous  and  precise  rules,  but  also  on  procedures  for 
effectively monitoring and enforcing their implementation.  When carrying out controls, public 
authorities  must  be  able  to  identify  and  quantify  the  presence  of  FA,  including  when  used  as 
ingredients  in  compound  feed.  This  requires  methods  of  analysis  that  are  robust,  reliable  and 
easy to implement.  

Under  the  1970  FA  Directive,  applicants  had  to  propose  a  method  of  analysis  when  they 
requested authorisation of a FA, but this method did not have to be independently validated. In 
addition,  the  methods  of  analysis  approved  were  not  harmonised  at  EU  level,  so  national 
control authorities  did not have  easy access  to them  as they were  not  placed in a centralised 
database or register (D3.4). This undermined the reliability and comparability of the results of 
controls across MS.  

The  2003  FA  Regulation  addressed  this  issue  by  setting  up  a  European  Union  Reference 
Laboratory  for  FA  (EURL),  supported  by  a  network  of  National  Reference  Laboratories  (NRLs) 
(A5.1).  The  main  roles  of  the  EURL  are  to  validate  the  methods  of  analysis  proposed  by 
applicants  for  FA,  and  to  store  and  maintain  reference  samples  of  those  FA.  It  also  provides 
scientific  and  technical  support  to  the  Commission  and  is  an  important  forum  for  discussion 
with  MS  to  address  challenges  related  to  these  methods.  All  the  methods  of  analysis  are 
available to the public in the database kept by the EURL.  

21   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). 

13 

 
 
Under  the  1970  FA  Directive,  there  were  some  limited  provisions  to  ensure  traceability.  Yet 
without  seamless  traceability,  a  rapid,  targeted  and  effective  reaction  in  case  a  safety  issue 
arises  may  be  difficult  (D3.5).  Restricting  authorisation  to  a  specific  holder  is  one  way  to 
facilitate more traceability in case of necessity to implement a Post-Market Monitoring (PMM) 
Plan  for  possible  unforeseen  effects  resulting  from  the  use  of  FA  (A5.2).  Under  the  Directive, 
holder-specific authorisations were limited to antibiotics, coccidiostats and growth promoters. 
The  FA  Regulation  extended  these  authorisations  to  zootechnical  FA  and  FA  containing, 
consisting  of  or  produced  from  genetically  modified  organisms  (GMOs).  In  this  way,  the  FA 
Regulation  aimed to increase  traceability while  also promoting  innovation by ensuring market 
exclusivity for those FA which are potentially the most innovative (see further, SO 7 below). 

Under  the  FA  Directive,  MS  could  request  the  person  responsible  for  placing  the  FA  on  the 
market to monitor undesirable interactions with other  FA, so as to record and report them to 
the  NCA,  but  this  possibility  was  restricted  to  FA  having  an  antimicrobial  effect.  The  FA 
Regulation enlarged the scope of such PMM to additional categories of FA22 (A5.3). These PMM 
plans are intended to trace any direct, indirect, immediate, delayed, or unforeseen effects. 

In these ways, the 2003 FA Regulation sought to ensure early detection of potentially harmful 
effects and timely implementation of corrective measures, including removing unsafe FA from 
the  market,  through  improved  control,  traceability  and  enforcement  mechanisms  (O5,  R5).  It 
was  thus  expected  that  the  FA  Regulation  would  further  enhance  the  protection  of  human, 
animal health and the environment. (I1, I2, I4). 

Specific Objective 6 (SO6). Address specific interests of pet owners and their animals. 

Under the 1970 FA Directive, the needs of pets and their owners were not taken sufficiently into 
account, neither with respect to safety nor to efficacy (D4). The 2003 FA Regulation considered 
that since  pet food is not part of the  human food chain and has no environmental impact  on 
arable land, specific provisions should be developed in this regard. In order to ensure that the 
health of domestic animals was properly protected (GO2), the FA Regulation addressed this by 
setting  detailed  rules  for  FA  destined  for  use  in  pet  food  (A6).  New  obligations  to  perform 
specific toxicity studies (using either laboratory animals or in vitro tests)23 were introduced. The 
obligation to demonstrate the efficacy of substances was also established, together with specific 
provisions24  on  data  requirements  related  to  applications.  For  animal  welfare  reasons,  the 
requirements  reduced  the  need  for  testing on  pets  themselves,  for example  by  implementing 
alternative  testing  strategies.  These  provisions  were  complemented  with  strict  labelling 
obligations.  

It was expected that the new rules would result in greater availability of safe and efficacious FA 
on the market specifically for use in pet food (O6, R6), which should have a positive impact on 
animal health and consequently meet pet owners’ expectation to be able to provide a safe and 
nutritious diet for their companion animals (I3). 

22  

Including:  nutritional  FA,  zootechnical  FA,  coccidiostats,  histomonostats  and  FA  consisting  of/containing/produced  from 
genetically modified organisms (GMOs). 
In particular: on chronic toxicity, reproductive toxicity, mutagenicity and carcinogenicity of substances.  

23  
24   Regulation (EC) No 429/2008 (‘Commission Rules for Applications’). 

14 

 
 
Specific Objective 7 (SO7). Encourage the placing on the market of innovative and efficacious 
FA. 

FA  can  significantly  contribute  to  achieving  a  positive  balance  between  animal  nutrition  and 
well-being,  environmental  protection,  increased  productivity  and  improved  quality  of  animal-
based  food  products.  In  doing  so,  they  can  make  a  tangible  contribution  to  innovation  in  the 
sector (GO3).  

However, under the 1970 FA Directive, this potential remained under-realised in the EU: many 
opportunities  for  FA  that  could  support  productivity,  animal  welfare  and  environmental 
protection  were  missed,  and  the  market  as  a  whole  did  not  reflect  the  actual  state  of 
technological progress (P4). The reluctance of FA producers to invest in innovation depends not 
only  on  market  conditions  and  opportunities  (D5),  but  also  on  the  regulatory  environment 
within which they have to operate (D6).  

The  regulatory  drivers  (D6)  behind  this  problem  were  linked  to  the  fact  that  once  functional 
groups and categories were defined in legislation, they were not easily revised, and so tended 
not to evolve and adapt to scientific and technical progress. The 2003 FA Regulation set out to 
address this issue by creating new functional groups and categories specifically to address this 
concern  (A7.1).  More  recently  (in  2015)25,  the  FA  Regulation  was  further  adapted  so  that 
categories may be more easily modified wherever necessary, in line with technological progress 
and scientific developments, in order to ensure that the existing classification does not become 
an obstacle to innovation (e.g., the case of hygiene condition enhancers26). 

The  concerns  created  by  the  classification  of  FA  were  exacerbated  when  the  marketing 
authorisation  associated  with  a  category  did  not  provide  for  any  period  of  market  exclusivity 
during  which  investments made  in  innovation  could be  reliably  recovered  by  the  original  firm 
that carried out the R&D. Prior to the FA 2003 Regulation, significant segments of the FA market 
were failing to attract investment in innovation, in part because new FA did not receive holder-
specific authorisations. This was the case for enzymes and microorganisms (currently classified 
mostly as zootechnical FA). In order to promote innovation, the 2003 FA Regulation introduced 
market exclusivity (i.e.,  holder-specific  authorisation) for the  full duration of the authorisation 
(10 years) a newly created category of zootechnical additives, which introduce new mechanisms 
of  action  or  new  functions"  (A7.2).  These  “zootechnical  additives”  included  essentially  the 
categories  of  enzymes  and  microorganisms  as  defined  in  the  1970  FA  Directive,  but  also 
embraced  other  types  of  FA  which  can  have  positive  effects  on  animal  welfare  and  the 
environment. 

Under the 1970 FA Directive, there was also no requirement to demonstrate efficacy in certain 
cases – not only for provisional authorisations, but also for some entire categories of FA (e.g., 
certain  vitamins  and  flavourings).  The  2003  FA  Regulation  introduced  an  obligation  to 

25  

Regulation (EU) 2019/1243 of the European Parliament and of the Council of  20  June 2019 adapting a number of legal acts 
providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the 
European Union. OJ L 198, 25.7.2019, p. 241. 

26   A new functional group was created for hygiene condition enhancers that are substances or, when applicable, microorganisms 

which favourably affect the hygienic characteristics of feed by reducing a specific microbiological contamination. 

15 

 
 
demonstrate efficacy for all FA (A7.1). This helps protect FA against unfair competition from FA 
whose claimed benefits may not in fact be scientifically demonstrated. 

The establishment of clear criteria and accurate definitions of categories and functional groups 
in  the  2003  FA  Regulation,  together  with  the  data  requirements  specifically  required  to 
demonstrate  efficacy  as  set  out  in  the  Commission Rules  for  Applications,  were  key elements 
intended to encourage firms to develop new and efficacious FA for placing on the EU market.  

It  was  also  expected  that  the  obligation  to  renew  an  authorisation  after  10  years  would 
promote innovation, as it would provide an additional incentive for producers to ensure their FA 
incorporate  the  benefits  of  the  latest  science  and  are  clearly  differentiated  from  their 
competitors. 

One particular area in which innovation had been blocked under the 1970 FA Directive was the 
use of FA in water for drinking, which was simply not permitted. By 2003, this prohibition was 
no  longer  aligned  with  the  best  technical  and  scientific  evidence,  and  the  FA  Regulation 
therefore  included  provisions  to  allow  the  authorisation  of  new  and  innovative  FA  that  were 
most efficient when administered in drinking water (A7.3). 

Taken  together,  these  measures  were  designed  to  make  it  easier  to  authorise  and  market 
innovative and efficacious FA  in the EU, while maintaining high standards of safety  (O7). They 
were  thus  expected  to  have  a  beneficial  impact  on  European  innovation,  and  thus  on  the 
economics  of  the  EU  livestock  sector  more  generally  (R7,  I7),  in  addition  to  the  positive 
contributions 
individual  FA  might  make  to  other  objectives,  especially  environmental 
protection, and animal health and well-being (I1, I3, I4). 

Specific Objective 8 (SO8). Ensure FA cannot mislead consumers on the quality of food. 

The interests of consumers (GO4) were already taken into account in the 1970 FA Directive to 
some extent,  as  the need to prevent  FA  from  impairing the  characteristics of animal products 
was  already an element to be  considered during the authorisation process.  However, this still 
left  the  door  open  to  using  FA  to  disguise  or  conceal  the  nature  or  origin  of  animal  food 
products  that  are  offered for sale  (P5), due  to  a  lack of precision in the  rules concerned (D7). 
The  2003  FA  Regulation  therefore  took  steps  to  further  extend  the  protection  offered  to 
consumers by explicitly prohibiting the use of FA to mislead people as to the distinctive features 
of the animal products they eat (A8). In other words, FA may not be authorised if they serve to 
falsify the quality of the food product, for example by changing the characteristic flavouring of a 
food in such a way as to disguise its animal origin. In addition, appropriate labelling rules were 
laid  down  to  ensure  that  relevant  information  on  the  use  of  FA  is  available  throughout  the 
whole chain, so that livestock farmers and feed producers know how the FA they use may alter 
the character of the food that is produced, and so ensure that they do nothing which may lead 
consumers to purchase and consume food on the basis of false assumptions as to what they are 
actually eating. 

Through  the  establishment  of  these  rules  (O8),  it  was  expected  that  it  would  become  more 
difficult for FA to be used in ways that would mislead the consumers of animal products (R8).  

16 

 
 
United Nations’ Sustainable Development Goals (SDGs) 

The  concept  of  sustainability  did  not  have  the  central  place  in  EU  policy  in  2003  that  it  has 
today,  and  the  UN  Sustainable  Development  Goals  were  not  themselves  declared  until  2015. 
Nevertheless, many of the measures introduced by the 2003 revision of the  FA legislation can 
be  understood  as  seeking  to  ensure  that  the  European  livestock  industry  would  operate on  a 
more sustainable basis. 

More  specifically,  the  FA  Regulation  contains  measures  that  implicitly  address  certain  of  the 
sustainable  development  goals  (SDG),  in  particular  by  creating  a  more  sustainable  system  for 
livestock  farming  (SDG  12),  one  that  will  be  more  economically  prosperous  and  more 
environmentally  secure.  The  opportunities  for  businesses  to  invest  in  innovative  FA  that 
improve  animal  welfare  conditions  and  reduce  the  impact  of  livestock  farming  on  the 
environment  are  clearly  related  to  SDGs  2,  3,  9,  13,  14  and  15.  The  comprehensive 
environmental risk assessment for all FA intended for farmed animals should reduce pollution of 
waters  and  soils,  in  line  with  SDGs  13,  14  and  15.  The  measures  intended  to  reduce 
antimicrobial resistance and ensure a rigorous risk assessment of FA with regard to human and 
animal  health  directly  promote  the  health  and  well-being  of  animals,  consumers  and 
workers/users  along  the  food  chain  (SDG  3).  Driving  sustainability  objectives  throughout  the 
supply chain can thus be seen as an overarching (though largely implicit) objective of the 2003 
FA Regulation, which sought to enable a more responsible animal production system, and which 
in this way was already to some extent already pre-aligned with the UN SDGs even before they 
had been formally articulated and accepted by the EU. 

Figure 1 - Diagram of the intervention logic

17 

PROBLEMSSPECIFIC OBJECTIVESACTIONSIMPACTSP2: Unpredict-ability and complexity of autorisation system P3: Safety risks for humans, animals and the environmentI1: Better protection of public health and human healthI3: Better protection of animal health and welfareI4: Better protection of the environmentI5: More innovation in the EU8P1: Risk of contributing to AMR2 RESULTSSO1: Reduce AMR threats to citizens, animals, environmentSO2: Simplify and harmonise the FA authorisation process SO4: Ensure rigorous risk assessment of FA SO3: Set up clear/comprehensive rules for the autorisation and labelling  SO5: Improve FA control, traceability and enforcement rules   SO6: Address specific interests of pet owners and their animalsSO7: Encourage the placing on the market of FA which are innovative and efficacious  SO8: Ensure FA cannot be used to mislead consumers on the quality of foodA1.1: Ban antibiotics as growth promotersA1.2: Comprehensive  assessment of potential AMR impactA2.1: New EU3 level authorisation procedure A2.2: Detailed common rules for applicationsA4.1: Establish division of competence  (EFSA4 assess, EC5 decides)A4.2: Clear and adequate safety criteria including comprehensive environmental assessment and safe handling of FA. A4.3: 10-year authorisation period. A3.1: New harmonised, clear  and comprehensive authorisation and  labelling rules. A3.2: Set up the Register of FA.A5.1: Create the EURL6 supported by a consortium of NRLs7 with specific functions and setting validation of method of analysis.A5.2: Link certain additives to an authorisation holder and extent PMM9A6: Specific rules on FA for petsA7.1: Establish a comprehensive classification system of FA with criteria for efficacy, including new types of additives.A7.2: Market exclusivity for innovative feed additives.A7.3: Use of FA in water for drinkingA8: Establish authorisation criteria and labelling rules that specifically address misleading use of FAR1: Minimise risk of AMR due to FAR2.1: Less burden and uncertainty for FA producersR2.2: Additives authorised are available in the Register of FAR2.3: Labelling more informativeR3: Fewer safety risks / no adverse effects for humans, animals and the environment R4: Health of FA users is better protectedR5: Harmful FA effects are detected earlier, and the FA unsafe removed from the market more quicklyR6: Safe and efficacious FA for pet food are availableR7: More FA available in EU which improve animal productivity, animal welfare and the environment. R8: Consumers are not misled on the quality of food1 Feed Additive2 Anti-Microbial Resistance3 European Union4 European Food Safety Authority5 European Commission6 European Union Reference Laboratory7 National Reference Laboratories8 Feed Business Operators9 Post-Marketing Monitoring PlanP5: Consumers   interests not sufficiently protectedP4: Limited innovation for new types of FA (productivity, animal welfare and environment). Inadequate adaptation to technological progressDIAGRAM-INTERVENTION LOGICOUTPUTSGENERAL OBJECTIVESDRIVERSGO2: Improve protection of human  health,  animal health and welfare and the environment and better functioning of the internal market.GO3: Improve innovation O1: No use of antibiotics as FAD1.1: Antibiotics authorised as  FA1 to promote growth.D1.2: Non-comprehensive assessment of AMR in the authorisationD2.1: opaque rules;D2.2: absence some  deadlines; D2.3: not sufficiently harmonised;D2.4: lack of transparency around which additives are authorisedD2.5: administrative burden on public authoritiesD3.1: incomplete overly generic risk assessment;D3.2: variable level of scientific expertise;D3.3: risk assessment and management not separated D3.4: missing  tool for control;D3.5: limited traceability.D6: efficacy is not always guaranteed; FA not allowed in drinking water.D7: Possibility of  misleading uses of certain FAO2: Improved authorisation process (simpler, faster, more predictable, better harmonised and more transparent)O3: More rigorous risk assessment processO7: Easier to authorise and market innovative FAO8: Rules in place to protect consumer interests O4: Improved worker safety assessmentO5: Improved control and traceability rulesD4: Specific needs of pets not taken sufficiently  into account.D5: Certain market segments unattractive,  poor return on investment  GO4: Protection of consumer s  interests O6: Pets better protectedGO1: Better functioning of the internal market and level playing fieldI2: Better Functioning of the internal marketT and level playing fieldI6: Better protection of consumer s interests 
2.2. Point(s) of comparison  

The  point  of  comparison  for  the  evaluation  is  the  situation  before  the  FA  Regulation  became 
applicable (October 2004) when the rules governing FA were essentially those laid down in the 
1970  FA  Directive.  These  rules  covered  the  authorisation,  placing  on  the  market  and  control 
(inspection)  of  FA,  as  well  as  labelling  provisions  for  FA  incorporated  into  feed  materials  and 
compound  feed,  and  safeguard  measures,  control  measures  and  provisions  applicable  to 
establishments and intermediaries.  

Several  types  of  FA  (including  silage  additives,  amino  acids  and  urea)  were  either  subject  to 
other  legislative  frameworks,  or  simply  not  regulated.  A  centralised,  though  not  fully 
harmonised, authorisation system at the Community level existed with authorisation decisions 
in  the  assessment  procedure.  Antibiotics, 
adopted  by  Commission  acts, 
coccidiostats  and  growth  promoters  were  authorised  on  a  holder-basis  for  a  10-year  period, 
after which they would need to be renewed (each renewal also being valid for ten years). The 
majority of FA (technological additives, colourants, vitamins, enzymes and microorganisms) had 
an unlimited authorisation period and were not linked to an authorisation holder. More details 
on  the  situation  preceding  the  introduction  of  the  FA  Regulation  are  described  under  the 
intervention logic (Section 2.1). 

involving  MS 

In the context of the transition to the new regime established by the 2003 FA Regulation, FeBOs 
notified 2,567 FA which had been either authorised individually or by group under the 1970 FA 
Directive  or which  were  outside  the  scope  of  the  Directive  (amino  acids  and silage  additives). 
Upon  the  adoption  of  the  2003  FA  Regulation,  FeBOs  presented  applications  for  the  re-
evaluation  of  830  FA.  The  FA  that  were  notified  but  for  which  no  application  was  introduced 
were withdrawn from the market. 

From  1997  to  200227,  18  antibiotics28  used  as  growth  promoters  were  banned.  Before  the 
adoption of the FA Regulation, four remaining antibiotics were still used as growth promoters29 
(EM 1.4.18). 

In terms of innovation, from 1979 to 2003 there were 104 patent applications for FA (EM 2.2.5). 

Information from Argentina, Canada, Chile, China, Japan and the USA was used to compare their 
respective  authorisation  procedures  with  the  EU  system  and  to  assess  to  what  extent  EU 
authorisations are recognised in those countries.  

27   Commission Directive 97/6/EC, Commission Directive 98/19/EC, Council Regulation (EC) 2821/98, Commission Regulation (EC) 
2788/98, Commission Regulation (EC) 45/1999, Commission Regulation (EC) 2205/2001, Council Regulation (EC) 1756/2002. 

28   Amprolium,  ethopabate,  arprinocide,  avoparcin,  bacitracin  zinc,  carbadox,  dinitolmide,  dimetridazole, 

ipronidazole, 
meticlorpindol,  methylbenzoquate,  nicarbazin,  nifursol,  olaquindox,  ronidazole,  spiramycin,  tylosin  phosphate  and 
virginiamycin. 
Flavophospholipol, avilamycin, monensin sodium and salinomycin sodium (no substance used in human medicine). 

29  

18 

 
 
 
3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

3.1. Current state of play 

3.1.1 Reduction of antimicrobial resistance threats to citizens, animals and the environment 

With  the  entry  into  force  of  the  FA  Regulation,  the  four  remaining  antibiotics  still  in  use  as 
growth  promoters  were  taken  off  the  EU  market  in  January  2006.  Furthermore,  the 
authorisation  of  FA  that  directly  enhance  performance  (zootechnical  additives)  indirectly 
contributed to reducing the need for the therapeutic use of antibiotics. During the 2004-2021 
period30, 99 new FA were authorised for this purpose - 84 “gut flora stabilisers” and 15 “other 
zootechnical additives” (EM1.4.19). 

3.1.2 Placing innovative and efficacious FA on the market. 

Global and EU markets31 

The global FA market was valued at approximately $21.77 billion in 2015 and is expected to 
reach $28.22 billion by 2022. The EU represents some 40% of the global market with Argentina, 
Canada, Chile, China, Japan and the USA also accounting for an estimated 40%. 

Figure 2 - Worldwide FA market 

Worlwide feed additive market
(sales)

100%

80%

60%

40%

20%

0%

5
8
19

39

7

22

6
7
18

39

7

23

2015 E

2025 F

SHARE OF WORLDWIDE MARKET (%)

NORTH AMERICA
ASIA-PACIFIC (EX JAPAN)

LATIN AMERICA
JAPAN

EU-28
MIDDLE EAST & AFRICA

The EU-28 market is estimated at around €15.732 billion in 2020, which represent around 35% 
of the total (see table 1 below). Market data do not include coccidiostats and histomonostats, 
but  these  have  been  estimated  based  on  industry  information  which  points  to  them 
representing around 35% of the total market by value. 

30  
31  

32  

Each time that this period is mentioned it refers to May 2021. 
2018 Report by RM Associates Ltd carried out for the organisation representing the EU FA industry (FEFANA) based mainly on 
industry insights/interviews, cross-checked with data from various market research providers. 
Based on data of Mordor Intelligence but adding an estimation of coccidiostats value.  

19 

 
 
 
Structure of the EU market 

Table 1 - Estimations of economic value 2021-2026. EUR millions in EU market. 

Vitamins 
Antioxidants 
Amino Acids 
Enzymes 
Mycotoxin Detoxifiers 
Prebiotics** 
Probiotics (microorganisms)  
Flavours and Sweeteners 
Pigments 
Binders 
Minerals 
Acidifiers 
Others 
Total without prebiotics 
Estimation of coccidiostats *** 
TOTAL  
(with coccidiostats but excluding prebiotics) *** 

2020 

2021E 

2026E 

803 
1,150  
1,572  
460  
390  
1,289  
930  
272  
1,029  
1,150  
865  
1,005  
599  
10,227  
5,507 

 836 
 1,189 
 1,639 
 481 
 408 
 1,344 
 969 
 283 
 1,073 
 1,193 
894 
1,050 
609 
10,621 
5,719 

 988 
1,379 
2,145 
585  
471  
1,776  
1,268  
330  
1,299  
1,396  
1,132  
1,314  
728  
13,001  
7,000 

15,734 

16,340 

20,001 

CAGR* % 
(2021-2026) 
3.0 
2.6 
4.8 
3.5 
2.5 
5.0 
4.8 
2.7 
3.4 
2.8 
4.2 
4.0 
3.2 
3.8 

Source Mordor Intelligence, 2022. 
* Compound annual growth rate (CAGR) including prebiotics.  
** They are regarded as speciality feed ingredients although from the legal point of view they are feed materials.  
*** Commission estimation considering that 35% of the value are coccidiostats. 
Note: Data provided by Mordor Intelligence have been converted from USD to Euro at the exchange rate of 1 USD = 0.87 Euro. 
Projection of 2021-2026 calculated based on the base year 2020.  

The pet food sector has an annual sales volume of 8.8 mt. and the turnover is estimated at €21 
billion  (2018),  providing  an  estimated 80 million  EU  households33.  The  sector  is  growing  at  an 
annual rate of 2.5%34. 

The  FA  sector  as  a  whole  is  relatively  concentrated  with  94  companies  accounting  for  an 
estimated 80% of EU production value35. 60% of them are SMEs, which tend to focus on specific 
(niche)  segments  of  the  market  and  to  mainly  produce  FA  which  are  not  linked  to  an 
authorisation holder.  

33  

34   
35  

Latest data available from the association representing the pet food industry (FEDIAF): at least 25% of EU households own one 
dog and at least 23% own one cat. 
FEDIAF: European Pet Food Industry. 
Source: FEFANA Data 2018. 

20 

 
 
 
 
 
 
 
 
Trade and competitiveness 

According  to  a  FEFANA  survey  of  their  members  carried  out  in  2018,  innovation  is  the  most 
significant part of overall investment. EU companies are also very important exporters: exports 
account for 60% of annual turnover for SMEs and 42% for large businesses. 

Imports from non-EU countries play an important role across all FA categories. For some specific 
FA, such as vitamin B12 or amino acids, imports may account for more than 75% of EU supply36. 
Although the main countries of origin differ per functional group, six countries play a major role 
across all categories (USA, China, India, Brazil, Japan and Canada), in particular the United States 
and China (EM 2.2.1). 

More precisely, the Asia-Pacific is expected to continue to dominate the FA market in terms of 
volume and value and is projected to exhibit the highest annual growth rate until 202537. In this 
region, China is the major producer and exporter of FA. 

Innovation 

Some  trends  at  global  level  show  a  growing  interest  in  FA  that  can  prevent  the  use  of 
antibiotics.  Those  additives  may  improve  digestion  and  conversion  e.g.,  microorganisms.  In 
addition, there is interest in FA intended for the organic sector that are more natural in origin 
(e.g., plant extracts)38. 

In  the  EU,  during  the  period  2004-17,  the  largest  number  of  innovations  were  in  the 
zootechnical  additives  category  and,  specifically,  in  the  functional  group  ‘other  zootechnical 
additives’; 61 out of 79 applications and 28 out of 35 authorisations were in this category. The 
other  two  innovative  groups  are  ‘reduction  of  contamination  by  mycotoxins’  (12  applications 
and  6  authorisations)  and  ‘hygiene  conditions  enhancers’  (6  applications  and  1  authorisation) 
(EM 2.1.1). In the period between 2004 and 2019, the number of patent applications increased 
to 207 (compared to 104 during the preceding 24 years) (EM 2.2.5).  

According to industry data, large and medium size companies seem to be less specialised in FA 
than  smaller  companies:  FA  account  for  less  than  half  of  the  turnover  for  70%  of  large 
companies and 60% of medium size companies as compared to some 30% of small companies. 
The same survey results also indicate a total investment in R&D ranging from 26% to 14% of the 
turnover  for  small  and  large  companies,  respectively,  compared  to  8%  for  medium-size 
businesses (EM 2.1.7). 

3.1.3 Simplifying and harmonising authorisation and labelling rules and processes and ensuring 
a rigorous risk assessment.  

Authorisation process 

The  authorisation  process  is  a  centralised  system and  unfolded  in  figure  1,  ANNEX  VIII,  which 
involves the Commission, the MS, EFSA and the EURL.  

36  
vi Case studies, page 23. 
37   Allied Market Research. 
38  

Future market insights. Animal FA Market Forecast. March 2020 

21 

 
 
The  Commission  is  responsible  for  receiving  applications  for  authorisation  and,  under  the 
control  of  MS  via  the  ‘comitology’  procedure,  taking  the  risk  management  decision  together 
with  MS  through  decisions  that  are  adopted  in  the  form  of  Implementing  Regulations.  Risk 
assessment is performed independently by EFSA. The EURL has a role in assessing and validating 
the  detection  methods  for  FA  during  the  risk  assessment  step,  to  ensure  traceability  and 
effective controls by MS. Details of the authorisation process are described in Annex VIII. There 
are several steps in the authorisation process: 

–  Submission  of  applications:  During  the  period  2004-2017,  791  applications  for 

authorisation were presented to the Commission (SANTE applications).  

–  Risk  assessment:  during  the  same  period,  EFSA  processed  969  applications  (EFSA 
applications)  resulting  in  613  opinions.  20%  of  all  opinions  issued  under  Article  4(1) 
applications  (new  authorisation)  and  12%  of  all  opinions  issued  under  Article  10(2) 
applications  (re-evaluation)  were  issued  within  the  six  months  deadline.  The  average 
period to issue an opinion was 27 months for Article 4(1) applications and 36 months 
for Article 10(2) applications (EM 1.3.5). During the period 2004-2019, the EURL issued 
628 validation reports on detection methods (EM 1.4.8). 

–  Risk management: During the same period, the Commission authorised 775 FA through 
482  authorising  Regulations.  37%  and  31%  of  authorisations  were  granted  for  Article 
4(1)  and  Article  10(2)  applications,  respectively  within  six  months  of  receipt  of  the 
opinion. 

More  detailed  information  on  the  number  of  authorisations  by  type  of  authorisation  (holder-
specific or non-holder specific) and by type of purpose is presented in Annex VIII. 

Labelling  

The 2003 FA Regulation laid down much more detailed labelling rules than the 1970 Directive. 
For  instance,  to  improve  safety  and  traceability,  it  became  mandatory  to  include  the 
identification  number  of  the  FA  and  the  batch  number  for  all  FA.  More  details  on  labelling 
requirements for FA and premixtures are presented in Annex VIII. 

3.1.4 Addressing specific interests of pet owners and their animals. 

The  FA  Regulation  established  some  provisions  concerning  pets,  which  were  detailed  by  the 
Commission Rules for Applications. EFSA set out specific guidance for applicants: “Guidance on 
the  assessment  of  additives  intended  to  be  used  in  pets  and  other  non-food  producing 
animals”39. The 2003 FA Regulation also took into account the potential hazards of FA for pet 
owners and provided a comprehensive set of labelling rules to ensure proper information along 
the feed chain. 

39  

This guidance  was applicable  for  many  years but  now  has been replaced  by  a more  generic  guidance  that  also  includes  the 
pet’s specifications.  

22 

 
 
3.2. External factors or market developments affecting the results of the intervention. 

3.2.1 Increase of industrial development in third countries 

The Asia-Pacific region has shown significant growth patterns not only in relation to growth of 
economic and industrial activity, but also in population growth and the shift from a plant-based 
diet  to  a  diet  including  more  food  from  animal  origin.  For  instance,  China  and  India  have 
implemented modern husbandry practices with a standardisation of livestock production which 
generates  increasing  demand  for  feed,  and  thus  for  FA.  Lower  labour  costs  and  looser 
environmental restrictions allowed those countries to develop an important FA industry and to 
increase exports to the EU, though this cannot be quantified as no reliable data exist specifically 
on the production and trade of FA. India, China and Japan are very present in the medicine and 
health  technologies  sector,  which  uses  similar  production  techniques  to  FA.  Global 
pharmaceutical  companies  are  also  important  producers  of  FA  and  many  of  them  have 
research/development centres40 and production sites in these countries. 

Figure 3 - Livestock production index and industry value added in China and India 

LIVESTOCK PRODUCTION INDEX
(2014-2016=100)
Source World Bank

INDUSTRY (Including construction) 
VALUE ADDED (% Annual growth)
Source World Bank

150

100

50

0

0
9
9
1

0
0
0
2

1
1
0
2

2
1
0
2

3
1
0
2

4
1
0
2

5
1
0
2

6
1
0
2

7
1
0
2

8
1
0
2

%

20

10

0

-10

1
1
0
2

2
1
0
2

3
1
0
2

4
1
0
2

5
1
0
2

+
6
1
0
2

YEAR

7
1
0
2

8
1
0
2

9
1
0
2

0
2
0
2

CHN

IND

CHINA

INDIA

3.2.2 Frequency of mergers and acquisitions 

Another significant external factor influencing the FA sector is mergers and acquisitions activity. 
This  has  a  direct  impact  on  the  functioning  of  the  2003  FA  Regulation,  since  changes  to  the 
holder  of  an  authorisation  due  to  mergers  and/or  acquisitions  required  the  adoption  of  28 
(Implementing) Regulations by the Commission during the period 2004-2018. 

3.2.3 Scientific and technical developments in safety/efficacy assessment 

Finally,  another  factor  influencing  the  preparation  of  dossiers  for  applications  was  the  2016 
decision  of  the  EFSA’s  FEEDAP  panel  to  update  most  of  the  guidance  documents  it  had 
produced. Six guidance documents for assessment of safety, efficacy and characterisation of FA 
were updated between 2016 and 2019 (see Table 1 in Annex III). This revision ensured a higher 
level of safety than before but required applicants to invest in the production of additional data 

40  

The Converging Technology Revolution and Human Capital Potential and Implications for South Asia. 2021 International Bank 
for Reconstruction and Development / The World Bank. 

23 

 
 
 
sets,  in  particular  regarding  environmental  safety  and  the  characterisation  of  microorganisms 
used as, or for the production of, FA.  

3.2.4 New challenges related to pollution associated with animal production. 

Environmental impact is at the top of many legal initiatives, strategies and actions such as the 
Biodiversity Strategy41, the Chemicals Strategy for Sustainability42, the Organic Action Plan43, or 
the  Zero  Pollution  Action  Plan44.  This  latter  plan  intends  to  review  the  Industrial  Emissions 
Directive to curb ammonia emissions from the intensive rearing of livestock. In addition, further 
measures  to  reduce  ammonia  emissions  may  be  needed,  inter  alia  under  the  Common 
Agricultural  Policy.  Governments  have  prioritised  actions  in  key  sectors  driving  environmental 
impacts  such as agriculture  activities. Those  changes in the regulatory framework and science 
are  challenging  for  the  livestock  sector  and  consequently  for  FA.  Recent  innovations  in 
environmental concepts, processes and tools may also cause changes in the data requirements 
for the assessment. 

4. 

EVALUATION FINDINGS (ANALYTICAL PART) 

4.1. To what extent was the intervention successful and why?  

4.1.1 Reduce AMR threats to citizens, animals and the environment. 

The  FA  Regulation  has  been  effective  in  banning  antibiotics  as  growth  promoters  (four 
remaining  antibiotics  as  growth  promoters were  banned  in  2006  (EM  1.4.18).  The  pre-market 
assessment  of  all  FA  for  their  potential  antimicrobial  effects  also  helped  reduce  the  risks  of 
placing  FA  on  the  market  which  would  have  AMR  effects.  In  addition,  a  comprehensive  post-
market monitoring (PMM) was introduced for certain categories of FA.  

Microorganisms used as FA could potentially also induce antimicrobial resistance45. Even though 
a PMM for those FA is not required for all micro-organisms as such, EFSA examined carefully this 
aspect. In the 15 renewals of authorisation carried out from 2019 to 2021, no safety hazards or 
issues were discovered by EFSA in relation to AMR. The evaluation of AMR performed by EFSA is 
also  relevant  for  FA  intended  for  pets.  Due  to  their  close  contact  with  humans,  medicinal 
products,  FA  or  other  substances  used  in  pets  may  easily  spread  AMR  in  humans46.  The  pre-
market approval process led the Commission to withdraw or deny the authorisation of five FA 
and  led  applicants  to  withdraw  applications  as  they  could  not  prove  absence  of  antimicrobial 
resistance development.  

41  

42  

43  

44  

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee 
and the Committee of the Regions EU Biodiversity Strategy for 2030. COM (2020) 380 final. 
Communication the Commission to the European Parliament, the Council, the European Economic and Social Committee and 
the Committee of Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. COM (2020) 667 final. 
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee 
and the Committee of the Regions on an Action Plan for The Development of Organic Production COM/2021/141 final/2. 
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee 
and the Committee of the Regions Pathway to a Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Water 
and Soil. COM/2021/400 final. 

45   Microorganisms are widely used as FA under different categories. For the authorisation of microorganisms, specific data are 
required to ensure that they do not contain in their genome genes that codify for antimicrobial resistance so they can spread 
resistance to animals but also to the environment and finally to human beings. Regulation (EC) No 429/2008 contains specific 
data requirements to permit a full assessment on AMR for all additives. 
Reflection  paper  on  the  risk  of  antimicrobial  resistance  transfer  from  companion  animals.  15  January  2015  - 
EMA/CVMP/AWP/401740/2013. 

46  

24 

 
 
The  trend  visible  in  the  few  existing  studies47  indicates  a  positive  correlation  between  the 
reduction  of  antibiotics  used  as  growth  promoters  and  the  reduction  of  cases  of  specific 
antibiotic-resistant  microorganisms  present  in  livestock  farming.  In  a  few  examples48,  specific 
measures to reduce antimicrobial use have been associated with a reduction of AMR in bacteria 
from  food-producing  animals  or  foods  derived  therefrom.  A  positive  impact  on  animal  health 
parameters  was  demonstrated  for  certain  alternatives  such  as  organic  acids  or  probiotics 
(microorganisms)  that  are  regarded  as  FA.  These  FA  (microorganisms)  have  positive  effects 
through different mechanisms on the intestinal flora (e.g., maintenance of the epithelial barrier 
of the intestine). The physiological status of animals improves, and they become more resistant 
to infections (EM 1.4.21). 

Use  of  antibiotics  decreased  and  is  now  lower  in  food-producing  animals  than  in  humans,  as 
reported by EFSA, EMA and ECDC49. The fall in antibiotic use in food-producing animals suggests 
that  the  measures  taken  to  reduce  their  use  are  proving  to  be  effective.  These  results  can 
however  not  be  clearly  associated  with  the  FA  Regulation  as  other  measures  impacted  the 
reduction  of  antibiotic  use  in  food-producing  animals:  the  Commission's  Action  Plan  (2011-
2016), the EU One Health Action Plan Against AMR adopted in 2017, the EU Guidelines on the 
Prudent  use  of  Antimicrobials  in  Animal  Health,  the  different  National  Action  Plans  and 
Strategies, and the surveillance and audits. EMA and EFSA concluded that “assessing the impact 
of  measures  to reduce  antimicrobial  use  on  the  occurrence  of  AMR  in  food-producing  animals 
and food is difficult for several reasons. For example, several measures may have been applied 
simultaneously, trends  can only be observed where there is a sustained period of longitudinal, 
standardised monitoring data (which is not available from all MS) and it is difficult to establish 
causality in such complex systems.”50 

The ban of antibiotics as FA encouraged innovation in FA by developing alternatives (EM 1.4.19). 
The EU has demonstrated that the ban of antibiotics has not reduced animal production for the 
most relevant species (figures 2 and 3 of Annex VII). By May 2021, there were 84 authorised FA 
(microorganisms)  and 15  authorised “other zootechnical additives” contributing to reduce  the 
use of antibiotics51. They were authorised following a stable growth pattern (figure 3 of Annex 
VII). The value is around 930 million euros (table 1). 

48 

47   Graveland  H,  Wagenaar  JA,  Heesterbeek  H,  Mevius  D,  van  Duijkeren  E  and  Heederik  D,  2010.  Methicillin  resistant 
Staphylococcus  aureus  ST398  in  veal  calf  farming:  human  MRSA  carriage  related  with  animal  antimicrobial  usage  and  farm 
hygiene. PLoS ONE, 5, e10990; Torneke K, Torren-Edo J, Grave K and Mackay DK, 2015. The management of risk arising from 
the use of antimicrobial agents in veterinary medicine in EU/EEA countries - a review. Journal of Veterinary Pharmacology and 
Therapeutics, 38, 519–528; DANMAP, 2016. Use of antimicrobial agents and occurrence of antimicrobial resistance in bacteria 
from  food  animals,  food  and  humans  in  Denmark.  ISSN  1600-2032;  DANMAP,  2018.  Use  of  antimicrobial  agents  and 
occurrence of antimicrobial resistance in bacteria from food animals, food and humans in Denmark. ISSN 1600-2032; Swedres-
Svarm, 2017. Consumption of antibiotics and occurrence of resistance in Sweden. Solna/Uppsala ISSN1650-6332.  
EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the 
(RONAFA) 
European 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4666  
Third joint inter‐agency report on integrated analysis of consumption of antimicrobial agents and occurrence of antimicrobial 
resistance 
EU/EEA. 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6712  
EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the 
European 
(RONAFA) 
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4666  
SANTE  database  does not  permit  to do  statistics as  those  FA  are  under  the  functional  group  “other  zootechnical  additives”. 
This  group  includes  FA  having  many  different  functions;  therefore,  it  is  not  possible  segregate  the  data  for  those  that 
contribute to reduce the use of antibiotics.  

food‐producing 

resulting 

resulting 

bacteria 

humans 

impacts 

impacts 

animals 

Union, 

Union, 

safety 

safety 

from 

food 

food 

and 

and 

and 

the 

the 

the 

on 

on 

49  

51  

in 

in 

50 

25 

 
 
Stakeholders,  including  some  MS,  the  industry,  FA  users  and  veterinary  professionals,  have 
recognised  the  effectiveness  of  the  FA  Regulation  in  banning  antibiotics  used  as  growth 
promoters and in reducing the risks for developing antimicrobial resistance stemming from FA 
placed on the market.  

The different measures set up by the FA Regulation for that specific objective provide benefits 
not only  for  human health  but  also  for pets and their owners.  In terms of benefits for human 
health,  72%  of  respondents  agree  that  the  ban  on  the  use  of  antibiotics  played  an  important 
role in preventing AMR (WPC). FA will not pose risks of AMR for pets and their owners as those 
FA are subject to pre-market assessment to eliminate any AMR effect.  

The  ban  of  antibiotics  as  FA  fostered  innovation  for  sustainable  alternatives  contributing  to  a 
reduction  in  the  use  of  antibiotics  that  directly  benefits  farmers  by  facilitating the  conversion 
pathway to more sustainable methods of livestock farming. 

4.1.2.  Simplifying  and  harmonising  the  authorisation,  risk  assessment,  risk  management 
processes 

4.1.2.1 Credibility of the risk assessment and risk management process 

The 2003 FA Regulation lays down a comprehensive set of safety requirements so as to fill the 
gaps  left  by  the  1970  FA Directive.  Some  of  these  gaps  were  specific to certain  groups  of  FA, 
others were more general (see 1.3 Annex III). 

The  clear  separation  of  risk  assessment  and  risk  management  established  in  line  with  the 
General Food Law, led to a more independent, objective and transparent risk assessment. The 
underlying  basis  of  the  EU  authorisation  process  is  the  credibility  of  the  safety  and  efficacy 
assessment  performed  by  EFSA.  The  results  of  the  surveys  carried  out  for  this  evaluation 
showed  that  the  safety  assessment  was  not  contested,  and  a  strong  consensus  was  achieved 
across all categories of stakeholders.  

In addition, EFSA’s assessment is also valued at international level. Some elements of the EFSA 
safety  assessment  are  recognised  in  the  authorisation  process  carried  out  by  some  third 
countries  for  fast-track  registration  of  EU  products,  particularly  in  the  South-East  Asian  and 
African regions.  

Even though EFSA’s risk assessments were challenged in five cases, the administrative review by 
the  Commission52  each  time  dismissed  the  allegations  (EM  1.5.1).  In  relation  to  the 
Commission’s  risk management decisions,  only one case was  lodged at the Court of Justice of 
the EU against a Commission decision to suspend a FA authorisation. The Court ruled in favour 
of the Commission and thus confirmed the original decision53 (EM 1.5.2). At international level, 

52   Article 19 of the FA Regulation: “Administrative review - Any decision taken under, or failure to exercise, the powers vested in 
the Authority by this Regulation may be reviewed by the Commission on its own initiative or in response to a request from a 
Member  State  or  from  any  person  directly  and  individually  concerned.  (…)  The  Commission  shall  take  a  decision  within  two 
months (…)”. 
Case  T-201/13  (“Toyocerin”):  judgment  of  the  General  Court  of  21  May  2015  (Rubinum  v.  Commission).  Application  for 
annulment  of  Commission  Implementing  Regulation  (EU)  No  288/2013  of  25  March  2013  concerning  the  suspension  of  the 
authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012). The action was dismissed by the 
Court (i.e., ruling in favour of the Commission). 

53  

26 

 
 
there were three cases54 during the period 2004-2021 that led to comments in the context of 
the  mandatory  notification  of  draft  acts  to  the  World  Trade  Organisation  (WTO-SPS). 
Commission  arguments  responding  to  relevant  comments  were  not  further  contested  (EM 
1.5.3). 

4.1.2.2 Effectiveness of the authorisation system 

As a result of the revised risk assessment and risk management process introduced by the 2003 
FA  Regulation,  positive  effects  on  human  health,  animal  health,  animal  welfare  and  the 
environment can be observed. 90% of respondents to the Public Consultation, who were mainly 
business representatives, consider that the safety assessment carried out by EFSA can be relied 
upon to ensure that FA are safe for human health, animal health and the environment (see PC). 
A majority of NCAs also considers that FA are safe for animals, workers, consumers and for the 
environment  (EM  1.2.6).  In addition, 75% of respondents see  benefits  from the  FA Regulation 
for  human  health  (see  SH  survey).  The  FA  Regulation  is  believed  to  have  a  positive  effect  for 
farmers (83% of respondents noted such benefits), especially in terms of preventing losses from 
animal  diseases  (e.g.  due  to  the  safe  use  of  vitamins,  trace  elements,  coccidiostats),  making 
animals  more  resistant  to  diseases  (e.g.  due  to  the  safe  use  of  microorganisms  as  gut  flora 
stabilisers)  and  reducing  the  environmental  impact  of  animal  production  (e.g.  due  to  the  safe 
use of enzymes or amino acids). Consumers  also benefit  from food of animal origin that  does 
not contain residues that may compromise their health (92% of respondents believe that FA are 
safe  for  consumers).  Benefits  for  workers  /  users  were  also  identified:  84%  of  stakeholders 
consider that FA are safe for workers/users and a majority of users have the same opinion (EM 
1.2.5). Users of FA also consider that FA are efficacious (59 out of 63 respondents (EM 1.1.9)). 
Pets  and  their  owners  benefit  from  FA  that  are  evaluated  following  a  complete  set  of  safety 
requirements  that  take  the  specificities  of  pets  into  account  and,  in  particular,  their  longer 
lifespan.  The  surveys  indicated  that  85%  of  respondents  considered  that  FA  have  benefits  for 
animal  welfare,  although  according  to  some  FA  producers  and  pet  food 
industry 
representatives, those benefits have not been fully exploited, as the studies are mainly targeted 
on  performance  criteria55.  Although  there  are  many  FA  that  have  indirect  effects  on  animal 
welfare,  no  FA  have  been  authorised  under  the  FA  Regulation  with  the  specific  purpose  of 
having a direct effect on animal welfare. Finally, many  FA authorised such as amino acids and 
enzymes  have  clear  positive  effects  in  terms of  mitigating  the  impact  of  livestock  farming  on 
the environment (e.g., greenhouse gas emissions, excess of nitrogen and phosphorous in soils 
and waters, etc.).  

In  2003,  the  scope  of  the  legislation  was  extended  to  cover  additional  categories  of  FA  not 
covered  by  the  1970  FA  Directive  (amino  acids,  urea  and  silage  substances).  140  applications 
were submitted for those FA during the period 2004-2017. This allowed for the safety of these 
substances to be established. There were still FA however for which safety was not at all or only 
partially  assessed (some sensory  FA, the majority of vitamins, amino acids, enzymes, gut flora 
stabilisers,  coccidiostats  and  histomonostats,  corresponding  to  458  applications,  352  opinions 

54   G/SPS/N/EU/455, G/SPS/N/EU/190 and G/SPS/N/EU/420. 
55  

ii FA Final Report _FCEC, page 84. 

27 

 
 
and 1136 FA. Those FA are fully evaluated under the 2003 FA Regulation (EM 1.2.1, 1.2.2, 1.2.3 
and 1.2.4). 

There were  FA  for which efficacy  was not  at all or only  partially evaluated  under the 1970  FA 
Directive,  and  that  are  now  fully  evaluated  under  the  2003  FA  Regulation.  In  total,  these 
represent 339 authorised FA corresponding to 432 applications (EM 1.1.1, 1.1.2 and 1.1.3). Eight 
Regulations were adopted to withdraw FA from the market (EM 1.1.6). 

The  FA  Register  allowed  for  greater  transparency  of  the  market,  providing  FeBOs  with  open 
access  to  information  about  all  FA  that  have  been  authorised,  and  their  conditions  of 
authorisation. 

In response to the lessons from the food/feed crises of the 1990s (cf. BSE and dioxins), a 10-year 
authorisation  period  for  FA  was  established.  Even  though  those  crises  did  not  involve  the  FA 
sector  directly,  political  leaders  acted  to  reduce  mistrust  towards  the  feeding  of  animals  in 
general, and to improve the public perception of the safety of the food chain, which had been 
seriously  damaged.  It  was  expected  that  setting  a  time  limit  on  authorisations  would  also 
encourage the development of FA with a better safety and/or efficacy profile.  

The  10-year  authorisation  period  was  perceived  as  effective  for  safety  purposes  by  a  slight 
majority of MS authorities (17 out of 27). Six MS authorities did not respond and four disagreed 
(NCAs  survey).  FeBOs  were  divided  on  the  effectiveness  of  this  10-year  period  for  safety  and 
innovation purpose (see SH survey). Business associations and FA producers find that this period 
is  too  short  to  make  it  worthwhile  developing  innovative  FA  that  require  substantial  upfront 
investment. The possibility to extend the authorisation period for FA with a long history of safe 
use was mentioned in particular by some MS authorities, business associations and companies. 
Some of the MS authorities that disagreed or did not provide responses noted that the 10-year 
limit is not sufficient to encourage innovation by SMEs. 

4.1.2.3 Drivers and barriers to effectiveness of authorisations 

The different steps in the authorisation procedure concerning FA were analysed to identify what 
elements  drive  or  hinder  effectiveness  in  the  authorisation,  re-evaluation  and  renewal  of 
authorisation,  and  which are  the  most  relevant  procedures.  It was  also  analysed  whether  the 
provisions introduced to simplify  and harmonise  the authorisation  system had been  effective. 
Elements to further simplify and reduce costs were identified. 

In general, FeBOs understand the administrative procedures put in place. Stakeholders (mainly 
FeBOs) and MS recognised that the measures were simplified and better harmonised compared 
to  the  1970  FA  Directive.  Stakeholders,  including  NCAs,  the  industry  (i.e.,  FA  and  compound 
feed  producers),  FA  users  and  veterinary  professionals,  recognised  that  the  authorisation 
procedure set out in the FA Regulation is central to the achievement of a high safety standard. 
As regards timelines, they were considered as appropriate by the MS authorities, whereas the 
industry tends to consider that delays were such as to hamper competitiveness and innovation.  

Some  delays  in  the  authorisation  process  for  new  authorisations  and  for  the  re-evaluation  of 
existing authorisations could be observed during the risk assessment carried out by EFSA and to 
a  lesser  extent  during  the  adoption  process  of  the  Commission  Implementing  Regulations 

28 

 
authorising the FA (see 1.4.2. Annex III). While delays during the re-evaluation process did not 
affect the sale of those FA, they might have a more pronounced effect on new FA for which the 
placing  on  the  market  was  somehow  delayed,  thus  potentially  triggering  a  loss  of  market 
opportunities. 

Time periods at the risk assessment step 

78% of applications for the authorisation of new FA and 88% of applications for re-evaluation of 
authorised  FA  suffered  from  some  delays  during  the  risk  assessment  process,  which  were 
caused  by  missing  and/or  incomplete  information  presented  in  the  application  dossiers. 
Incomplete dossiers triggered the request for additional information by EFSA56.  

The  reasons  behind  the  possible  delays  during  the  assessment  period  are  mainly  related  to 
missing information in the application dossiers:  

–  different  interpretation  of  EFSA  guidance  documents,  in  particular  for  the  design  of 
studies. This is particularly complex for studies to demonstrate efficacy of innovative FA 
(understanding of endpoints or end points not defined); 

–  the update of EFSA guidance documents (see table 1, Annex III); 
–  a  lack  of  pre-submission meetings57  with  EFSA  until  these  were  set  up  by the GFL  (to 
provide advice on the rules applicable to, and the content required for, the application 
dossier,  prior  to  its  submission),  which  could  be  an  important  handicap  that  reduced 
the applicants’ capacity to prevent future shortcomings;  

–  a  lack  of  experience  in  the  preparation  of  application  dossiers  for  FA  that  had  never 

been evaluated before (see 1.4.2.1 Annex III). 

While simplification of the risk assessment process in comparison to the previous legislation was 
recognised,  FeBOs  perceived  the  regular  revision  of  the  EFSA  guidance  as  burdensome.  The 
achievement of a high food and feed safety level clearly demands  the  continuous updating of 
the guidance by EFSA. Although the adoption of revised EFSA guidance documents may reduce 
the  capacity  of  FeBOs  to  adapt  in  time,  different  mitigation  measures  were  already  put  in 
place58 some years ago by EFSA to minimise the burden on FeBOs. More information in 1.4.2. 
Annex III. 

Time periods at the risk management step 

Possible delays during the risk management step were mainly caused by the complexity of 
some of the dossiers, but maybe also by the need to bring more clarity as regards the 
application of some of the provisions (see below under “internal and external coherence”). 
These triggered lengthy discussions at several SCoPAFF meetings to come to an agreement or 
internal discussions within the Commission. 

56  
57  
58  

“Stop the clock” mechanism, referred to in Article 8(2) of the FA Regulation. 
Those are meetings with EFSA before the application is lodged, as referred to in Article 32a of Regulation (EC) No 178/2002. 
https://www.efsa.europa.eu/en/engage/stakeholders; 
https://www.efsa.europa.eu/en/applications/about/services  

29 

 
 
 
 
Risk management and risk assessment process 

The observed time period for the whole authorisation process of FA (risk assessment and risk 
management) are indicated in the table below: 

Table 2 – Time period for the whole authorisation process 

PERIOD 
12 months  
≥ 12-18 months 
≥ 18-24 months 
≥ 24 months 

ARTICLE 4(1) APPLICATIONS 
7% 
19% 
25% 
50% 

ARTICLE 10(2) APPLICATIONS 
2% 
8% 
7% 
84% 

The  average  time  period  across  all  applications  during  2004-2017  has  been  3.3  years  (1,218 
days)  (EM  3.2.5).  A  majority  of  MS  authorities  and  only  32%  of  FeBOs  consider  that  the 
procedure of authorisation does not need to be modified. In relation to the timelines, a majority 
of MS authorities and FeBOs find them proportionate (EM 3.2.3 and 3.2.4). A detailed analysis 
of the time frame at the different steps of the authorisation procedure (risk assessment by EFSA 
and risk management by Commission and PAFF Committee) is presented in Annex III 1.4.2. 

Modification and renewal of authorisations  

The  rules  on modification  and  renewal  of  authorisations  might  be  considered  as  burdensome 
for  both  applicants,  users  and  authorities  and  a  lack  of  transition  provisions  might  lead  to 
unintended shortages. 

–  In case of holder-specific authorisations, the current system requires an EFSA opinion 
and the adoption of an Implementing Regulation each time the authorisation holder of 
a  FA  changes,  such  as  in  case  of  mergers/acquisitions  of  companies.  These  represent 
10% of the acts adopted for holder-specific authorisations. 

–  Article 13(3) of the FA Regulation only addresses the modification process introduced 
by  the  holder  of  an  authorisation  but  does  not  foresee  rules  for  requests  for 
modifications  of  non-holder  specific  authorisations.  In  such  cases,  a  full  evaluation  is 
not required, but instead only a verification whether the modification may give rise to a 
safety concern or may undermine efficacy. This situation has been largely mitigated by 
using Article 13(1) and (2) of the FA Regulation, that permits the Commission to modify 
any  authorisation  (including  non-holder  specific  authorisations)  on  its  own  initiative, 
after consultation of EFSA. A clarification of the FA Regulation should be considered as 
it affects around 1214 FA59 that are not linked to an authorisation holder.  

–  If  the  application  for  renewal  is  presented  in  due  time,  the  FA  will  remain  on  the 
market until a decision on the renewal is taken by the Commission (even if the 10-year 
period  has  expired),  provided  that  the  reasons  for  the  possible  delay  are  beyond  the 
control  of  the  applicant.  When  an  applicant  withdraws  the  application  during  the 
renewal process, the FA concerned is no longer authorised. Feed producers thus face a 
“sudden”  expiry  of  the  authorisation,  without  any  transitional  period  allowing  an 

59  

FA Register, May 2021. 

30 

 
 
 
adaptation of the products concerned on the market. As the renewal process of FA only 
started in 2017, there have been few cases, but this might become a challenge as more 
generic FA – that are currently widely used – are starting to come up for renewal. The 
procedure to renew the authorisation is not considered efficient by 66% of FeBOs (EM 
3.2.2). 

During  the  period  2017-2021,  considering  that  the  applications  for  renewal  started  to  be 
submitted in 2017, 65 applications for renewal were received by the Commission. The average 
time taken for the risk assessment of those applications was around 10 months. The clock was 
stopped  91  times  to  request  complementary  information  (EM  1.3.9).  The  authorisation 
procedure (risk management) did not suffer major delays as normally there are no contentious 
issues to consider in such cases. 

4.1.2.4 Simplification – extrapolation of study results for FA 

Elements to reduce costs and to incentivise applicants were included in the 2003 FA legislation. 

–  Elements to incentivise the submission of applications for authorisation of FA for minor 
animal species, for which the return on investment is limited, were not successful. The 
legislation  allows  to  extrapolate  the  results  of  some  data  generated  for  the 
authorisation  of  a  FA  for  a  major  animal  species  (e.g.,  chicken)  to  a  minor  animal 
species  which  is  physiologically  comparable  (e.g.,  quail),  to  avoid  duplication of  tests. 
Applicants  requesting  an  authorisation  for  minor  species  are  further  incentivised  by 
extending the data protection period by one additional year for each minor species for 
which a use extension authorisation is granted. Many FA may be authorised for minor 
species  because  they  are  authorised  for  all  animal  species  (947  in  May  2021)  or 
because one or several minor species were included in the  authorisation (358 in May 
2021). The Commission Rules for Applications set up the principle of extrapolation but 
did  not  develop  very  detailed  requirements.  The  procedure  to  request  extrapolation 
from  major  to  minor  species  did  not  work  well60,  according  to  stakeholders  (mainly 
FeBOs)  (SH survey  and  EM  1.3.11).  The  reasons  given  are  the  following:  1)  the  target 
market is limited and there is a lack of involvement of users further down the chain in 
the process to ensure that minor species of interest are covered by an application; 2) it 
requires investment in data generation and the users do not contribute to the costs; 3) 
the  return  on  investment  is  not  clear,  in  particular  for  small  markets.  Some  MS 
authorities (NCA  Survey) share some  of the  stakeholders’  views, although  18 of them 
felt that the extrapolation worked well. Some MS authorities noted that extrapolation 
is difficult for certain pets as they are physiologically different from other species, and 
for  those  species  that  do  not  have  a  'major  species'  counterpart  (so-called  ‘orphan 
species’,  e.g.,  insects,  snails,  rabbits).  For  some  species  such  as  rabbits,  there  is 
consequently  a  limited  number  of  specific  FA  (e.g.,  zootechnical  additives)  available. 
One NCA indicated that the assessment of efficacy should not be an obstacle to extend 
an authorisation to minor species, as long as safety is ensured. See 1.4.2.3 Annex III. 

60  

ii FA Final Report _FCEC, pages 41 and 42. 

31 

 
 
–  Extrapolation from food to feed: the legislation allows to extrapolate to a certain extent 
the  results  of  data  generated  for  additives  already  authorised  for  food  use  to  FA.  A 
majority  of  applicants  (23  out  of  43)  considers  that  this  extrapolation  does  not  work 
well (EM 1.3.10 , SH Survey). In contrast, 16 out of 25 national authorities consider that 
it works well, eight regard it as neutral and one considers that it does not work (NCA 
Survey).  As  the  quantities  of  FA  to  which  animals  are  exposed  are  much  higher  than 
those to which humans are exposed, the extrapolation from food to feed is not possible 
for  many  applications  for  safety  reasons61.  As  for  efficacy  studies,  the  extrapolation 
works  well  for  flavouring  compounds  but  there  is  room  for  improvement  for  other 
functional  groups,  such  as  some  technological  additives  or  colourants,  provided  that 
the  specifications  of  the  FA  and  the  function  that  the  product  performs  in  food  and 
feed  are  the  same.  A  simplification  of  that  system  could  consist  of  the  recognition of 
the efficacy of certain categories of additives already authorised  for food use without 
any longer the necessity to extrapolate or to provide additional information. This could 
work  for  the  efficacy  for  new  colourants  or  for  certain  technological  additives  but  is 
unlikely  to produce  major savings as those  groups remain quite  stable,  and therefore 
not  many  new  FA  would  probably  benefit  from  that  suggested  simplification  in  the 
provisions of the FA legislation. The costs of efficacy studies for those FA are in any case 
not very high as the efficacy needs to be demonstrated on the feed (e.g., if the feed is 
coloured) and is not related to the animal species. A range of € 20,000 - € 100,000 per 
application is estimated as reasonable, but it is not possible to evaluate how many new 
FA will be authorised in these groups and  indeed whether  they will be authorised  for 
food use so as to make the extrapolation possible. 

Although  some  progress  in  simplifying  and  harmonising  the  authorisation  process  has  been 
achieved,  the  process  might  still  be  considered  as  burdensome  for  some  applicants  and  MS 
authorities. A majority of stakeholders, especially FeBOs, and in particular applicants, observe in 
some  cases  insufficiently  precise  predictability  in  the  authorisation  procedure,  requesting  i.a. 
improved coherence/clarity of some provisions. 

4.1.2.5 Attractiveness of the EU authorisation system and comparison with major global players 

It is not possible to establish with certainty whether the EU authorisation procedure is attractive 
to third countries as Commission data do not make it possible to identify all the operators from 
non-EU  countries  who  requested  an  authorisation.  However,  it  has  been  established  that 
operators from at least seven non-EU countries have requested an authorisation to place their 
products on the EU market. These countries  are the USA (13 companies), Japan (8), China (3), 
India (2), Australia (2), Switzerland (1), Turkey (1) and Korea (1). These figures however do not 
reflect the level of attractiveness of the EU authorisation system for non-EU operators as many 
multinational companies have direct access to the EU market through their subsidiaries located 
in the EU (EM 2.3.2). 

A comparison of the EU system with systems in place in third countries, based on the results of 
a  targeted  survey  addressed  to  NCAs  of  six  third  countries  accounting  for  around  40%  of  the 

61  

ii FA Final Report _FCEC, page 40. 

32 

 
 
world FA market (Argentina, Canada, Chile, China, Japan, and the USA) (EM 2.3.3), revealed the 
following:  

–  FA are not always defined as a distinct category and tend to be classified less precisely 
than in the EU. In some countries, certain EU FA are regarded as feed materials and as 
such do not need authorisation. 

–  All  countries  have  a  process  in  place  for  FA  approval,  which  includes  a  scientific  risk 
assessment,  though  generally  with  lighter  requirements  which  vary  significantly  from 
country to country. 

–  The time taken to process an application for authorisation can vary considerably from 
one country to another, from a few months (in the case of three countries) to about a 
year (in the case of two countries). 

–  EU  authorisations  of  FA  are  not  fully  recognised  by  these  countries  due  to  different 
approaches  taken  to  authorisation.  However,  Chinese  authorities  indicated  that 
technical  data  on  FA  authorised  in  the  EU  are  used  as  a  reference  for  technical 
assessments  in  their  country.  Two  countries  (Chile  and  Canada)  appraise  substantial 
parts of the EU authorisation procedure, largely because their approaches are relatively 
aligned. 

More details on the different aspects examined are developed in point 3.5.3 of Annex V. 

4.1.3 Coherence 

Internal coherence  

The following points have been noticed as regards coherence: 

Data sharing: the rules and procedures on data sharing in the 2003 FA Regulation have had only 
a  limited  effect  on  reducing  animal  testing.  Even  though  the  applicants  needs  to  take  all 
measures to reach agreement on sharing the use of information in order to prevent repetition 
of toxicological tests on vertebrates, in case of disagreement between the present applicant and 
the other party  concerned  (i.e.  the previous applicant), the Commission  is neither obliged nor 
does  it have  the tools to take  a  decision based  on objective  parameters (more information in 
1.4.3.2  Annex  III).  Only  three  requests  on  data  sharing  were  made  and  in  those  three  no 
agreement could be reached. Respondents expressing a negative view (30%) on this topic in the 
public consultation indicated that data sharing is not being used to its full potential (see PC). 

The absence of certain definitions or the possible need to improve clarity of certain provisions 
or definitions as observed by MS national authorities but also by FeBOs, may hamper:  

–  the correct categorisation of FA in relation to “processing aids”. 
–  the establishment of additional conditions of authorisation of FA regarding “maximum 

recommended levels” or “recommended levels” (see 1.4.3.4 Annex III). 

–  the  legal  status  for  certain  FA:  “preparations”  are  not  defined  as  such  and  the 
introduction of such definition could not be done by implementing rules and required a 
modification of the FA Regulation. To mitigate this absence of formal definition, some 
provisions on the compositional and labelling requirements were introduced in 2015 by 
implementing rules (more information in 3.1.1 Annex III). 

33 

 
Use of FA in drinking water: clarity on the use of FA in drinking water could be improved. The 
definition  of  FA  refers  to  the  use  of  all  FA  in  drinking  water,  but  Article  6  and  Annex  I  of  the 
Regulation restrict the use of  FA  in drinking water to certain functional groups.  Consequently, 
applicants  withdrew  their  applications  for  789  flavouring  compounds  for  use  in  water  for 
drinking that were only authorised in feed (EM 6.6). This unveiled a need to improve coherence 
between  the  general  definition  and  the  specific  provisions  of  Article  6  and  Annex  I  of  the  FA 
Regulation.  In  addition,  FeBOs  have  requested  more  technical  clarity  on  the  practical 
implementation of the use of FA in drinking water (see 1.4.3.1 and 1.8.4 of Annex III).  

The comprehensive evaluation of few FA that may be intended for farmed non-food producing 
animals:  it  would  be  appropriate  to  introduce  some  clarification  regarding  the  environmental 
safety requirements applicable to the use of FA for farmed non-food producing animals (e.g., fur 
animals) in order to accommodate the requirements related to the safety criteria laid down in 
the  FA  Regulation  and  in  EFSA  Guidance62.  This  situation  did  not  affect  the  safety  for  the 
environment  as  EFSA  already  performed  this  assessment  and  no  application  specifically 
addressing this type of animals was submitted. The authorisations granted for all animal species 
(including  non-food  producing  animals)  have  considered  the  environmental  impact  of  the  FA 
concerned.  Nevertheless,  for  future  possible  applications  specifically  targeting  those  animals, 
this point needs to be examined. 

Finally, the absence of specific and harmonised labelling requirements for FA and premixtures 
only intended for export is another issue that does not bring lightness to the system (see 1.4.3.7 
Annex III). 

External coherence 

Figure 4 - Coherence with other legislation 

The coherence with the following legal texts on feed and chemical substances was analysed: 

62 

Guidance on the assessment of the safety of FA for the environment. EFSA Journal 2019;17(4):5648. 

34 

 
 
 
Legislation  on  feed:  General  Food  Law,  Feed  Hygiene  Regulation,  Feed  Marketing  Regulation, 
Regulation  on  Genetically  Modified  (GM)  Food  and  Feed,  Regulation  on  Medicated  Feed  and 
Directive on Undesirable Substances in Animal Feed (see abbreviations). 

Legislation  on  chemical  substances:  CLP  Regulation,  REACH  Regulation,  Biocidal  Products 
Regulation, Regulation on Veterinary Medicinal products (see abbreviations). 

While  no  inconsistencies  were  found  with  the  Regulations  on  Medicated  Feed,  GM  Food  and 
Feed, with the Directive on Undesirable Substances in Animal Feed (EM 4.7.4.8, 4.9, 4.10, 4.11, 
4.12)63  or  with  the  REACH  Regulation  (EM  5.7-5.10)64,  different  concerns  were  identified  in 
relation to the following pieces of legislation:  

–  Feed Marketing Regulation 
–  Feed Hygiene Regulation 
–  Biocidal Products Regulation 
–  General Food Law 
–  CLP Regulation 

All the details may be found in Annex III 3.2.  

Conclusions 

Several definitions or questions on the relationship between the FA Regulation and other pieces 
of legislation may be a source of difficulties at various levels in the preparation of applications 
for  authorisation,  during  the  processing  of  those  applications,  in  the  renewal  or  modification 
process  of  authorisations  and/or  in  the  circulation  of  FA  within  the  EU  or  during  import  or 
export.  Those  points  do  not  seriously  impair  the  effectiveness  of  the  Regulation  but 
nevertheless  could  usefully  be  addressed  should  the  legislation  be  revised  (EM  4.16  to  4.19, 
5.11 to 5.14 and 6.1 to 6.3). 

4.1.4 Overview of costs and benefits (efficiency) 

The estimated costs compared to those expected at the time of adoption of the FA Regulation 
were  not  calculated  as  there  was  no  impact  assessment  performed  at  that  time.  Unless 
specifically  indicated,  the  different  figures  are  calculated  over  the  period  2004-2017.  Those 
figures are collected from the surveys, interviews and case studies. In each case, the source of 
the information is indicated. 

4.1.4.1 Overview of costs 

Costs for consumers 

No significant costs for consumers have been identified. There is no evidence on whether the FA 
Regulation has led to an increase in terms of prices. 

63  
64  

FA Final Report _FCEC, pages 99-101. 
FA Final Report _FCEC, pages 100 and 103-104). 

35 

 
 
 
Costs for businesses  

The  costs  for  businesses  to  prepare  an  application  for  a  new  authorisation  or  re-evaluation 
depend on the type of FA, on whether the FA represents an important innovation and on the 
type of animal species covered by the application.  

On average, the  direct costs  of an application for authorisation  are €1.1 million, of which the 
major  components  are  safety  and  efficacy  studies  (37%  and  32%,  respectively),  followed  by 
internal staff costs (22%). In particular, the following cases have been identified:  

–  €50,000 for certain FA with a substantial history of consumption for feed use; 
–  €373,000 for FA requested by a consortium of companies under Article 10(2) of the FA 

Regulation; 

–  €2.6 million for a zootechnical FA (i.e., important innovations); 
–  €3.4 million per application for coccidiostats. 

With regard to  studies, the  direct costs  vary  between species.  In vitro  study  costs  range  from 
less than €10,000 to €50,000, studies on laboratory animals from less than €10,000 to €400,000, 
studies on ruminants can vary between €18,000 and €200,000 and studies on pigs, poultry and 
fish range from less than €10,000 to €400,000. The use of non-animal tests (e.g., in vitro tests 
using human/animal cells and tissues or computer-modelling techniques) has been identified as 
a factor that may reduce the cost of applications, especially for the demonstration of efficacy. 
This was pointed out during the case studies by one NCA and some applicants65. 

No  significant  differences  in  average  costs  for  SMEs  and  large  companies  were  identified. 
Therefore, the costs for the preparation of an application for authorisation have an important 
impact  on  SMEs,  in  particular  as  SMEs  tend  to  focus  on  fewer  animal  species  in  the  case  of 
innovative  FA  (in  view  of  a  holder-specific  authorisation).  In  the  case  of  FA  with  non-holder 
specific authorisation, new trials on target animals or laboratory animals may not be required, 
as scientific literature may provide the necessary evidence.  

Operators  indicated  that  there  are  indirect  costs  derived  from  the  time  required  for  the 
authorisation process,  both during the EFSA evaluation (“stop the clock” mechanism) and the 
Commission decision for the authorisation. For instance, the period of time devoted to the risk 
management procedure is now shorter than under the 1970 FA Directive as 37% of applications 
are  processed  within  a  period  of  6  months66  and  41%  within  10  months.  However,  operators 
were not  able to estimate these indirect  costs  in monetary  terms.  When it comes to renewal 
procedures, the costs for the preparation of the dossier are on average €216,000. 

In  terms  of  labelling  costs,  the  direct  costs  for  producers  of  FA  are  negligible,  however  for 
premixtures  they  range  between  €80,000  and  €223,000  per  plant  per  year.  For  pet  food 
manufacturers, costs occur in a few cases where a FA must be withdrawn from the market and 
the  transitional  period  is  shorter  than  the  period  before  the  expiry  date  of  their  existing 

65  
66 

FCEC Final Report, EQ1.3, “5.1.2 Conclusion”. 
According to Article 9(1) of the FA Regulation, “Within three months of receipt of the opinion of the Authority, the Commission 
shall  prepare  a  draft  Regulation  to  grant  authorisation  or  to  deny  authorisation.”.  This period  may  be  extended in complex 
cases. There is no legal period established for the final adoption of the act by the Commission. The indicated 6-month period is 
not a legal period, it has been used as a reference to evaluate the effectiveness of the management process. 

36 

 
 
inventory.  The  estimated  costs  for  re-labelling  compound  feeds  are  for  2,000  references  €1 
million (a reference is the form by which the feed is placed on the market, e.g., if the product is 
presented in three different packages, each presentation is a reference so that the product has 
three references). For feed intended for food-producing animals, the costs are negligible. 

There are also compliance costs due to regulatory changes (new conditions introduced when a 
new  authorising  Regulation  or  implementing  measures  are  adopted)  which  require  labels 
adaptation or disposal or products to be removed from the market. These costs are estimated 
at  around  €2,000  for  disposal  of  labels  for  premixtures  when  applying  the  usual  transitional 
period. The compliance costs can be estimated between €24,000 and €40,000 per product and 
€13,500  for  labels  for  premixtures  when  the  change  affects  an  important  widely  used  FA  and 
the transitional period is shorter than the usual transitional period. However, the occurrence of 
this possibility is very low67.  

Finally, the administrative costs which relate to notifications to the Commission are negligible. 
More details on costs for businesses can be found in point 2.1 of Annex III. 

Costs for MS  

Costs  for  MS  authorities  involve  their  participation  in  the  SCoPAFF  meetings  and,  more 
generally, performance of their duties deriving from the implementation of the FA Regulation, 
in particular with regard to the authorisation process concerning FA. The staff time dedicated to 
those activities has been calculated based on data available for 14 MS68 over the period 2016-
2018. The total costs per MS are less than € 29,00069 per year on average. The total costs per 
MS  over  the  2004-2017  period  are  therefore  estimated  at  €405,000.  These  can  be  broken 
down as follows: 

–  791  applications  processed  by  the  Commission  during  the  period  2004-2017, 
corresponding to 454 standard Regulations over the same period. Considering that the 
application is the most relevant step that triggers all the different actions, the costs per 
MS are estimated at:  
o  €500 per application for both new authorisation and re-evaluation. 
o  €860 per standard authorising Regulation. 

–  There  were  28  Regulations  changing  the  authorisation  holder  over  the  period  2004-

2017. The costs are estimated at: 
o  €500 per Regulation changing the authorisation holder.  

In  addition,  it  is  estimated  that  each  MS  spent  on  average  €74,000  per  year  for  enforcement 
actions  under  the  Official  Controls  Regulation70.  Thus,  when  the  official  control  activities  are 
considered, the total costs per MS per year can amount to €103,000 on average. More details 
on costs for MS are in point 2.2.4 of Annex III. 

67   Annex IV Case studies, page 24. 
68   Other Member States cannot estimate the costs of the FA Regulation versus other feed legislation. 
69  
70   Although the  costs of the Official Controls Regulation are not under the  scope of  the  FA Regulation, it has been considered 

Figures are rounded.  

important to do those calculations in order to provide an overview on how the FA Regulation works.   

37 

 
 
Costs for the European Commission, EURL and EFSA 

European Commission 

The  costs  for  the  Commission  relating  to  the  authorisation  process  refer  to  staff  costs 
encompassing  all  the  activities  required  to  process  the  applications  for  authorisation 
(breakdown  of  costs  is  available  in  point  2.2.1  Annex  III).  On  average,  the  yearly  costs  are 
estimated at €756,000.  

–  Considering that the application is the key step that triggers all the subsequent actions, 

the costs for the Commission are estimated at: 

o  €13,400 per application for both new authorisations and re-evaluation. 
o  €22,400 per standard authorisation Regulation. 

–  In case of change of authorisation holder (28 implementing Regulations), the costs are 
estimated at €13,400 per Implementing Regulation. This amounted to €375,200 for the 
period 2004-2017 (corresponding to €26,800 per year). 

As the number of new applications increased during the period 2012-2017, increased efficiency 
in  the  management  of  these  applications  can  be  observed.  The  number  of  meetings  of  the 
SCoPAFF has been reduced but their duration has been extended, resulting in a stable number 
of days of meetings per year. This has permitted savings in travel expenses, interpretation costs 
and administrative support.  

EURL 

The  costs  for  the  European  Union  Reference  Laboratory  for  FA  (EURL)  are  calculated  on  the 
basis of the duties and tasks assigned to the EURL by the FA Regulation, in particular Article 21 
thereof,  for  its  implementation.  The  main  obligation  of  the  EURL  is  the  evaluation  of  the 
analytical  methods  proposed  by  applicants.  Another  important  task  is  to  maintain  a  bank  of 
reference  samples  of  all  the  authorised  FA  in  their  facilities.  Other  tasks  considered  when 
estimating  their  costs  are  participation  in  SCoPAFF  meetings  and  in  the  annual  coordination 
meeting with the consortium of National Reference Laboratories (NRLs) organised by the EURL. 
The  average  annual  costs  for  the  EURL  are  estimated  at  €684,000.  These  mainly  stem  from 
evaluation  reports  on  analytical  methods.  37  evaluation  reports  per  year  were  prepared  on 
average  during  the  2004-2017  period,  at  an  estimated  cost  of  €18,500  in  staff  costs  per 
validation  report.  This  cost  is  considered  justified  as  the  validation  process  entails,  on  some 
occasions,  the  organisation  of  an  inter-laboratory  comparison  study  to  verify  whether  the 
different  laboratories have the same results in the implementation of the method of analysis. 
More details on EURL’s costs are available in point 2.2.2 of Annex III. 

EFSA 

During  the  period  2004-2017,  EFSA  processed  969  applications,  corresponding  to  69.2 
applications  per  year  on  average.  The  cost  per  application  is  estimated  at  €27,450  (new 
authorisation and re-evaluation), €15,900 of which are internal staff costs. The average cost for 
a  renewal  is  estimated  to  be  around  €16,470.  More  details  on  EFSA’s  costs  are  available  in 
point 2.2.3 of Annex III. EFSA has implemented some measures to increase efficiency, including 
reduction in the  number of physical meetings, increase  in the number of assistants  instead of 

38 

 
increasing  administrators  (AD)  staff,  changes  to  the  operational  procedures  and  increase  in 
digitalisation. 

Overview of costs 

Table 3 - Overall costs per year for the implementation of the FA Regulation 

TOTAL COSTS (EUROS) PER YEAR 

FeBOs71 
NCAs of MS  
COMMISSION 
EURL  
EFSA 

TOTAL  

62,700,000 
2,884,000 
756,000 
684,000 
1,900,000 
68,924,000 

The costs of labelling are not included as they cannot be calculated annually.  

Costs on health and the environment  

The costs for health, animal welfare or the environment could not be quantified (see Annex II). 

4.1.4.2 Overview of benefits   

Quantification  of  the  benefits  of  the  use  of  FA  for  animal  health  and  welfare  and  for  the 
environment  was  not  possible.  Some  benefits  are  evident,  as  they  directly  result  from  the 
implementation  of  strict  safety  and  efficacy  requirements  and  from  the  definition  of  the 
functions  for  which  FA  may  be  authorised.  However,  clear  causal  links  could  not  be  firmly 
established  as  there  is  no data  on  the  actual  use  of  FA  by  the  farming  sector  which  could  be 
used  to  measure  the  extent  to  which  such  benefits  have  materialised.  In  addition,  it  was  not 
possible to single out the impact of any single FA as opposed to the simultaneous use of several 
FA together (see Annex II). 

Benefits for animal health and animal welfare (EM 3.1.9) 

The benefits for animal health and welfare are associated with the placing on the market of FA 
that are safe and efficacious, and that are used in accordance with the labelling requirements. 
The absence of adverse effects on animal health is one of the basic conditions for authorisation 
of  all  FA  under  the  2003  FA  Regulation.  Many  FA  such  as  vitamins,  trace  elements,  gut  flora 
stabilisers  and  coccidiostats  have  a  positive  impact  on  animal  health  and  welfare  by  directly 
addressing  the  physiological  status of  animals.  A  new  functional  group  was  created  in  2019  – 
‘physiological  condition  stabilisers’  –  to  provide  specific  benefits  on  animal  welfare  (e.g., 
resilience to stress). Three applications have been submitted under that functional group but no 
FA belonging thereto have been authorised yet.  

Another important element is the fact that with the application of the FA Regulation, 1743 FA 
that were potentially unsafe or inefficacious were withdrawn from the market, thus minimising 
any negative effect on animals.   

71 €1,1000,000 per application (57 applications year). 

39 

 
 
 
The benefits for animal health from FA vary according to the functional group under which they 
are authorised: for instance, vitamins (category of nutritional FA) bring benefits to the health of 
animals by  satisfying  their nutritional needs. The benefits  for  animal welfare  as they currently 
exist  and  can  be  estimated  are  closely  linked  to  benefits  for  animal  health,  as  the  welfare  of 
animals is de facto impaired when they are unhealthy. In addition, specific functional groups of 
instance,  the  functional  group 
improvement  of  animal  welfare:  for 
FA  focus  on  the 
“physiological condition stabilisers” (e.g., resilience to stress). 

The qualitative benefits for animal health and animal welfare are related to the improvement of 
the physiological status of the animals and consequently animal health and welfare: 

–  The needs of animals for vitamins or trace elements can be satisfied via FA preventing 
diseases or deficiencies in animals. Animal welfare may be compromised for example if 
animals  do  not  take  sufficient  levels  of  vitamin  D:  lameness,  difficulty  walking,  a 
tendency to sit on their haunches occuring in growing pigs.72 

–  Preventing  occurrence  of  coccidiosis  in  poultry,  one  of  the  most  important  parasitic 

diseases.  

–  Preventing the occurrence of diseases by promoting a desirable gut ecosystem through 

administration of animals’ beneficial species of microorganisms. 

–  Preventing the occurrence of antimicrobial resistance via for example administration of 
microorganisms that improve the beneficial flora in the gut. Also, the safety evaluation 
to  prevent  any  AMR  effect  of  the  FA  contribute  to  this  aim.  In  this  regard,  by 
Commission  Implementing  Regulation  (EU)  2015/1399,  the  authorisation  of  Bacillus 
toyonensis (NCIMB 14858) was denied as it posed a risk for the spread of genes coding 
for resistance to tetracycline and chloramphenicol, which are antibiotics of human and 
veterinary importance. 

–  Improving animal welfare: some amino acids that reduce nitrogen excretion contribute 
to reduce ammonia in urine and improve animal welfare of animals, as ammonia may 
increase the respiratory stress73. 

Benefits for human health (consumers and workers) (EM 3.1.10) 

For consumers 

FA are assessed to make sure that they do not transfer to food of animal origin microorganisms, 
toxins,  residues  or  other  substances  that  may  pose  a  risk  to  consumers.  For  instance,  in  the 
authorisation of some colourants used as FA, maximum residue levels are established. Labelling 
provisions ensure that FA are properly used, e.g., the indication of the maximum level of use is 
mandatory for certain FA that may pose a risk if those levels are exceeded. Consumers are also 
protected  from  the  risk  of  FA  spreading  AMR  by  the  general  ban  introduced  concerning 

72  

The pathology of vitamin D deficiency in domesticated animals: An evolutionary and comparative overview. Elizabeth W Uhl. 
Int J Paleopathol. 2018 Dec; 23:100-109. doi: 10.1016/j.ijpp.2018.03.001. 

73   Acute  and  prolonged  effects  of  ammonia  on  haematological  variables,  stress  responses,  performance,  and  behaviour  of 
nursery  pigs.  E.  von  Borell,  PhD;  A.  Özpinar,  PhD;  K.  M.  Eslinger;  A.  L.  Schnitz;  Y.  Zhao,  PhD;  F.  M.  Mitloehner,  PhD.  EVB: 
Institute  of  Agricultural  and  Nutritional  Sciences,  Martin-Luther-University  Halle-Wittenberg,  Halle,  Germany.  AO:  Western 
Institute for Food Safety and Security, University of California, Davis, California. KME, YZ, FMM: Department of Animal Science, 
University of California, Davis, California. 

40 

 
 
antibiotics  as  FA  and  by  the  safety  assessment  done  during  the  authorisation  process74.  The 
withdrawal from the market of 1,743  FA may also be assumed to have contributed to protect 
consumers from potentially unsafe products, though this cannot be definitively established. 

For workers and users 

Risks  for  workers  and  users  are  strictly  assessed  and  authorisations  may  include  specific 
protection measures to be respected. If the use of a FA gives rise to unacceptable consequences 
that cannot  be mitigated by  protection measures,  then it  will  not  be authorised.  This was  the 
case with the denial of the authorisation of formaldehyde in 201875.   

Environmental benefits (EM 3.1.11) 

The  environmental  risk  assessment  of  FA  used  for  farmed  animals  (food-  and  non-food 
producing  animals)  ensures  that  they  do  not  have  any  adverse  effects  on  the  environment. 
Labelling  requirements  are  also  important  in  this  respect.  For  example,  if  a  maximum  limit  is 
established for a FA in order to prevent any adverse effects on the environment, the indication 
of this level on the label will help operators use the FA properly throughout the feed chain. 

In  addition,  certain  FA  have  beneficial  effects  on  the  environment,  for  example,  by  reducing 
nitrogen or phosphorous excretion through the use of phytases that improve the assimilation of 
phosphorus  by  animals,  or  by  using  essential  amino  acids  to  promote  better  assimilation  of 
proteins. FA may also help reduce feed losses. FA may have qualitative environmental benefits 
that can be summarised as follows76: 

–  Better  use  of  resources  reduces  environmental  footprint  of  animal-sourced  products, 
considering that more  than 50% of the  animal production footprint  is related to feed 
ingredients (Wideman et al., 2012). Feed materials that are generated at local level may 
increase  their  quality  by  reducing  the  indigestible  nutrients  (e.g.,  fibres),  thereby 
increasing  either  their  energy,  amino  acids  and/or  mineral  values  or  by  ensuring  the 
necessary  level  of  essential  FA.  Enzymes,  amino  acids  and  microorganisms  may 
facilitate those actions. 

–  Modification  of  emissions  that  have  a  negative  impact  on  the  environment,  thus 

reducing pollution and mitigate climate change impacts.  
There are three main sources of emissions from animal production: 

•  enteric methane emissions; 
•  gaseous emissions from manure storage (ammonia and nitrous oxide); 
•  nutrients, minerals, FA metabolites concentrations in the manure. 

Livestock systems, particularly ruminants, contribute to greenhouse gas emissions, and 
particularly in the form of enteric methane. A review of mitigation options for enteric 
methane  from  ruminants  showed  some  of  the  effective  strategies  including  the 
increase forage digestibility for which some FA have been proved efficacious. Also, the 

74  

75  

76  

For example, the denial of authorisation in 2012 of one microorganism as silage additive “Lactobacillus pentosus (DSM 14025)” 
and  two  microorganisms  in  2014  “Pediococcus  pentosaceus  (NCIMB  30068)  and  Pediococcus  pentosaceus  (NCIMB  30044)”. 
Those FA spread resistance to antibiotics used in humans. 
Commission  Implementing  Regulation  (EU)  2018/183  of  7  February  2018  concerning  the  denial  of  authorisation  of 
formaldehyde as a feed additive belonging to the functional groups of preservatives and hygiene condition enhancers. 
Environmental performance of FA in livestock supply chains. Guidelines for assessment. FAO 2019. 

41 

 
 
authorisation  of  a  specific  FA  reducing  the  methane  emission  in  milking  cows  is  an 
example of this mitigation effect for reducing the impact on climate change. 
Manure management, including storage, handling, and field application can be a source 
of emission of nitrous oxide and ammonia. Methane emissions from manure accounts 
for  12-41%  of  total  agricultural  CH4  emissions  for  most  countries  (Chadwick  et  al., 
2011)  and  emissions  depend  on  the  storage  duration,  temperature  and  manure 
composition.  The  modification  of  the  physico-chemical  characteristics  of  the  manure 
through FA enables the reduction of ammonia and N2O emissions. 

–  Reduction of pollution: for example, the addition of phytase to feed results in a lower 
excretion of phosphorous in manure, contributing to reduce  eutrophication in waters 
(meaning  a  reduction  of  dissolved  oxygen  in  water  bodies  caused  by  an  increase  of 
mineral and organic nutrients that increase algae production). 

–  Reduction  of  feed  losses:  feed  production  is  one  of  the  most  impacting  aspects  of 
animal production. Hence, it is important to ensure that the large majority of the feed 
ingredients and feeds produced are delivered to the animal. For this purpose, the use 
of  FA  such  as  antioxidants,  preservatives  and  silage  additives  provide  tools  to reduce 
feed losses along the feed chain and contributes to reduce the environmental effect of 
livestock production. Reduction of feed loses has a positive effect on the environment 
as  the  disposal  or  destruction  of  products  may  require,  for  example,  consumption  of 
energy to treat the feed for those purposes.  

Benefits for businesses (EM 3.1.6) 

The  benefits  for  FeBOs  (producers  of  FA,  producers  of  premixtures  and  feed  compounders) 
stem  from  the  comprehensive  risk  and  efficacy  evaluation  of  FA  and  the  implementation  of 
clear labelling rules that facilitate the use of those FA along the feed chain77. Certain FA which 
help preserve the quality of FA and premixtures thus minimise the risk of disposal or destruction 
of products (e.g., Vitamin A must be placed on the market in combination with an antioxidant to 
prevent  oxidisation).  The  efficacy  assessment  ensures  a  level  playing  field  amongst  operators 
reducing the possibility that fraudulent FA would be placed on the market. Greater clarity in the 
authorisation  process  is  another  element  that  benefits  FeBOs  when  they  seek  authorisation. 
The  withdrawal from the market of 1743  FA that were  potentially unsafe or inefficacious also 
has  a  positive  impact  on  FeBOs.  The  safety  evaluation  and  banning  of  antibiotics  as  growth 
promoters contribute to minimise AMR threats. FeBOs also benefit from easy access to non-EU 
markets78 and from a high variety of FA that can meet market demand in terms of innovation, 
presentation  of  FA  (e.g.,  liquid,  pellets,  etc.)  or  specific  animal  needs  (e.g.,  specific  FA  for 
lactating sows or piglets). 

The qualitative benefits for farmers can be summarised as follows: 
–  reduction of losses resulting from animal diseases or AMR;  
–  availability of innovative FA; 
–  more balanced diets for animals; 
–  better use of resources; 

77  
78  

FA Final Report _FCEC, pages 77 and 78. 
FA Final Report _FCEC, page 64. 

42 

 
 
–  increase of animal performance or of animal resilience to heat or stress; 
–  contribute  to  reducing  the  negative  impact  of  livestock  farming  on  the  environment 

(phytases, amino acids and methane reduction); 

–  protection  of  the  farmers’  economic  interests  as  FA  are  efficacious  for  the  intended 

purpose. 

Benefits for MS 

The  centralised  authorisation  process  and  the  establishment  of  clear  rules  for  authorisation 
have  reduced  the  administrative  burden  for  MS,  in  particular,  because  they  do  not  need  to 
perform the risk assessment. Labelling and traceability rules facilitate MS’ control activities.  

Benefits for pets and pet owners (EM 3.1.8) 

Pet  owners  benefit  from  having  safe  and  more  efficacious  FA  on  the  market  that  take  into 
account the specificities of pet animals. The comprehensive risk assessment on animal health, 
covering  chronic  toxicity,  mutagenicity  and  carcinogenicity  aspects  is  very  relevant  to  those 
animals that have a long lifespan.  

The qualitative benefits for pet owners and pets can be summarised as follows: 

–  Reduction in the occurrence of diseases and intoxications. An example is the denial to 
authorise titanium dioxide in 2021, mainly for use in feed for cats and dogs, due to its 
mutagenic and carcinogenic effects. 

–  Reduction in the risk of spreading AMR to pets and pet owners. 
–  Protection of  pet owners’ economic interests as only  FA  which  are efficacious for the 

intended purpose may be authorised. 

–  Availability of efficacious and innovative FA that meet the nutritional needs of pets. 

In general, the authorisation process under the 2003 FA Regulation can be seen to have  been 
efficient  as  demonstrated  by:  1)  the  high  number  of  applications  submitted,  with  an  upward 
trend  since  2015;  2)  the  large  number  of  FA  authorised,  including  innovative  FA  (34%  of 
applications); 3) the low number of RASFF notifications (Rapid Alert System for Food and Feed) 
concerning FA and acceptable results of Commission Audits; 4) the recognition of the value of 
EU authorisations in third countries; and 5) the global position of the EU FA market (35% of the 
world FA market by value). 

The benefits for FeBOs can be seen throughout the food chain. In general, stakeholders (mainly 
FeBOs) consider that the FA Regulation has benefits for FA producers (including applicants) and 
for compound feed producers (82% and 80% of respondents see benefits for FA producers and 
compound feed producers, respectively). 

Nevertheless there are elements of the 2003 FA Regulation that are viewed by stakeholders as 
reducing the efficiency of the authorisation process and increasing the costs of applications: 1) 
the insufficient use of extrapolation procedures and of non-animal models as an alternative to 
animal testing; 2) the failure to implement data sharing to help avoid the need for toxicological 
tests  on  vertebrates;  3)  the  insufficient  understanding  of  some  elements  of  EFSA  guidance 
concerning applications for authorisation and in particular in relation to the definition of clear 
endpoints to demonstrate efficacy; and 4) the short duration of the authorisation period. Only 

43 

 
12% of respondents to the SH survey find the costs of applications for getting a FA authorised in 
the EU market as really proportionate to the benefits (EM 3.2). 

A majority of FeBOs considered that the safety/efficacy requirements of the re-evaluation were 
not proportionate to the benefits. The burden of the new safety and efficacy requirements for 
re-evaluation has been proportionate to the  benefits, according to 15 and 13 NCAs out of 24, 
respectively for safety and efficacy (EM 8.2.5 and 8.2.6).  

The guidance prepared by the EURL for the validation of the method of analysis has been a very 
efficient instrument for stakeholders (mainly FeBOs). As a result, the validation of the method of 
analysis, except for a few complex cases (e.g., some botanical flavourings and a few colourants), 
is  ready  before  EFSA  finalises  the  assessment;  therefore,  this  requirement  does  not  interfere 
negatively with progress through the authorisation process. In general, the EURL has been very 
efficient in implementing all its tasks.  

The  European  safety  assessment  system  for  FA  is  widely  recognised  in  Europe  and  third 
countries  and  has  been  little  challenged  before  the  Courts  or  under  the  procedures  set  by 
multilateral international agreements (WTO).  

4.1.5 Comprehensive and harmonised labelling rules  

There is a consensus that appropriate labelling prevents the misuse of FA along the feed chain, 
which thereby contributes to food and feed safety (ensuring in particular that appropriate doses 
and the proper use in the animal species concerned are respected)79. The results of the controls 
performed  by  the  MS  authorities  do  not  raise  major  concerns  in  this  regard.  From  the  PC 
(efficiency /costs benefits), 36% of the respondents, including a majority of NCAs, consider that 
the labelling costs are justified. Those that do not agree argue that the obligation to indicate all 
information  on  the  physical  label  is  a  burdensome  requirement.  In  the  SH survey,  53  out  of 
110 respondents consider that labelling requirements are fit for purpose but 45 disagreed  and 
pointed to the need to modernise the labelling provisions by conveying the information through 
other means (currently, the FA Regulation only provides for a physical label), such as electronic 
means,  QR  Code  trademark,  separate  documents,  etc.,  as  it  is  already  the  case  for  some 
compound feeds and feed materials. In the case studies, the same arguments were articulated 
by  FeBOs  who  consider  this  obligation  to  be  disproportionate  (vi  Case  studies,  page  20).  In 
addition, three MS authorities consider that it is necessary to change the system (NCA Survey). 

The absence of harmonised and specific labelling requirements for FA only intended for export 
to third countries  in accordance  with Article 12 of the  General Food Law,  in  order  to indicate 
that they are only intended for such purpose, can be another element of distortion. According 
to  the  industry,  the  diverse  national  approaches  that  currently  exist  lead  to  competitive 
disadvantages between companies within the EU (see 1.4.3.7 Annex III).   

The  absence  of  labelling  tolerances  (see  glossary)  for  FA  in  premixtures  adds  more  room  for 
interpretation of the labelling rules. This situation creates a certain burden for FeBOs when the 

79  

vii Consultation Synopsis Report, point 3.4.2.3. 
FCEC Final report, 7.2, EQ5 Judgement criteria: "Lack of contradiction / inconsistency between the FA Regulation and the CLP". 

44 

 
 
 
FA  circulate  within  the  EU,  since  the  conditions  in  relation  to  labelling  tolerances  may  be 
different from one MS to another, and they therefore need to change the labels used in order 
to accommodate these variations.  

In  summary,  the  labelling  provisions  laid  down  in  the  FA  Regulation  have  been  effective  in 
ensuring a safe and efficient use of FA and premixtures along the feed chain, but their efficiency 
has been slightly reduced due to an absence of harmonisation in certain specific areas.  

The efficiency of the labelling system considers the costs associated with compliance with the 
labelling requirements.  

The costs for labelling considered are those that are triggered by a change in the authorisation 
of a FA, which then requires that the labelling of that FA also be changed.  

The factors that affect labelling costs are the linguistic regime, as labels have to be translated at 
least  into  the  national  language(s)  of  the  MS(s)  where  the  product  is  placed  on  the  market; 
regulatory changes; certain specific requests from MS; and market-driven factors.  

The costs of labels for FA are negligible. The estimated costs for manufacturers of premixtures 
range  from  €80,000  to  approximately  €223,000  per  plant,  per  year.  This  is  most  likely  an 
overestimation as it is not possible to separate costs triggered by regulatory changes from those 
made due to other reasons. The increasing use of automatic labelling systems  further reduces 
those costs, which may explain the differences between costs at different plants. 

The transitional periods provided for in the authorisation acts for the re-evaluation of “existing” 
FA allow time for the labels to be adapted to fit the new authorisation. These time periods are 
considered adequate by FeBOs. 

Labelling  rules  are,  in  general,  efficient  as  the  costs  derived  from  regulatory  changes  are  not 
significant  compared  to  the  benefits  provided,  especially  in  terms of  providing  information  to 
minimise  safety  risks  along  the  feed  chain.  This  analysis  is  supported  by  a  majority  of 
respondents in the PC. Nevertheless, three relevant concerns have been identified that create 
some degree of burden, thereby reducing the efficiency of the system: the obligation to indicate 
all the information on a physical label; the absence of labelling tolerances in premixtures; and 
the  simultaneous  implementation  of  the  FA  Regulation  and  CLP  Regulation,  in  particular  for 
premixtures of FA.  

4.1.6 Information to feed business operators, other users of FA and consumers. 

To FeBOs 

As regards workers’ safety provisions, the combination of CLP labelling requirements  with the 
specific requirements set out in the authorising Regulation has created different understandings 
amongst MS authorities, and this in turn has affected the circulation of FA and premixtures (on 
this, see 1.5.2 Annex III). 

To consumers 

In  addition  to  being  safe  and  efficacious,  FA  must  not  “harm  the  consumer  by  impairing  the 
distinctive  features  of  animal  products  or  mislead  the  consumer  with  regard  to  the  distinctive 

45 

 
features  of  animal  products”.  Specific  criteria  were  set  up  to  address  all  possible  consumer 
concerns  and  assess  whether  a  FA  could  give  the  food  derived  from  the  animal  a  misleading 
feature regarding its expected properties, e.g., a flavouring that gives the meat a flavour that is 
not characteristic of that meat. This aspect has been raised by EFSA in a few cases, all of which 
led to a positive conclusion in favour of the authorisation. 

Though  FeBOs  have  indicated  that  consumers  are  not  aware  that  FA  can  modify  the 
organoleptic (i.e., qualitative-sensory) characteristics of food, no evidence could be gathered to 
confirm this due to the very  low  response rate of consumers and their representatives  to the 
consultations carried out, despite the efforts made to involve them in surveys and interviews. 

To FeBOs and users of FA 

The Register of FA is considered by a majority of stakeholders (59 out of 110) to be an efficient 
tool to ensure  FeBOs  are  aware of all  the  FA  that have  been  authorised. Nevertheless,  for 26 
operators  out  of  110,  the  Register  could  be  improved  to  make  it  more  informative  and  user-
friendly (see PC). The pdf format does not allow them to easily find the information they need, 
and for certain  aspects, there  is  no  direct  link to  the  relevant information (e.g.,  EFSA opinion) 
permitting its rapid retrieval.  

4.1.7 Control, traceability and enforcement rules  

The Rapid Alert System for Food and Feed (RASFF) shows the level of compliance regarding the 
presence  of  FA  or  their  residues  in  food  of  animal  origin.  During  the  period  2004-2020,  82 
notifications out of 16,634 were linked to the presence of unauthorised FA or a high level of FA 
residues in food from animal origin, representing only 0.5% of the total number of notifications 
over the  period.  Twelve  RASFF  notifications  for  FA  and  premixtures  were  reported  during  the 
period 2004-2017 out of a total of 517 notifications on feed (i.e., 2.3% of the total number of 
feed notifications (EM 1.2.7)). 

The 2020 Commission Audits on Official Controls of FA and Traceability80 found that robust and 
risk-based  systems  are  in  place  for  the  planning  of  official  inspections  and  sampling  in  the 
FA/premixtures  sector.  Inspectors  generally  adhered  to  this  planning  and  were  able  to 
adequately verify operators’ fulfilment of the main requirements concerning hygiene, facilities, 
equipment,  maintenance  and  traceability.  Some  weaknesses  were  identified  for  labelling  that 
did  not  affect  in  general  the  safe  use  of  FA  and  premixtures,  and  for  retained  samples  of  the 
manufactured products that FeBOs must keep.  

As  regards  the  audits  performed  to  FeBOs  producing  compound  feed  and  feed  materials,  the 
report  entitled  “Overview  report  -  Hazards  and  Management  of  Risks  in  the  Feed  Sector”81 
states  “In  the  majority  of  Member  States  (12)  relevant  requirements  were  satisfactorily  or 
largely  satisfactorily  taken  into  account  during  official  controls.  In  these  Member  States, 
similarly  to  the  above  section,  a  number  of  arrangements  (namely,  guidelines  and  checklists) 
had  been  put  in  place  by  competent  authorities.  These  contributed  to  ensuring  that  feed 

80  
81  

https://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=139  
https://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=100 

46 

 
 
(feed  materials  and 

feed  additives)  and  compound 

ingredients 
(complete  or 
complementary)  were  labelled  in  compliance  with  relevant  requirements.  However,  in  seven 
Member States the audit teams noted that the label on some feed materials did not include the 
required indication of “feed material”. It can be assumed that instructions on the use of FA are 
followed correctly as the report did not refer to any problem on this issue.  

feed 

One of the questions raised during the evaluation was whether the method of analysis of a FA 
which is used for official controls should be updated when the authorisation of a FA is renewed, 
as  this  is  not  required  by  the  2003  FA  Regulation.  MS  authorities  consider this  necessary,  but 
FeBOs did not express a clear position, while pointing out that the Official Controls Regulation 
allows MS authorities to use more updated methods which are validated at international or EU 
level, where necessary. 

A clear majority of both MS authorities and business stakeholders perceive that the role of the 
EURL, which is in charge of the validation of the method of analysis, is adequately defined in the 
2003  FA  Regulation  (EM  1.4.9).  The  EURL,  supported  by  the  network  of  National  Reference 
Laboratories  (NRLs),  can  effectively  carry  out  its  tasks  despite  their  complexity.  A  majority  of 
NCAs and a small majority of FeBOs considered that the method of analysis must be updated on 
the occasion of the renewal of authorisations. A majority of both also consider that the role of 
the EURL is still properly addressed in the FA Regulation (EM 8.4.1 and 8.4.2). 

The 2003 FA Regulation allows EFSA to propose a Post-Market Monitoring (PMM). At present, 
there  is  only  one  FA  (lantharenol)  for  which  EFSA  has  assessed  its  PMM  plan,  along  with 
additional evidence provided by the applicant, confirming that this FA was safe. As this was the 
sole  case  of  a  PMM  being  required  and  assessed,  no  solid  conclusion  on  this  subject  can  be 
drawn. As indicated before, the PMM is on-going for all coccidiostats (EM 1.4.12). 

Traceability  is  also  an  important  element  of  effective  enforcement  of  the  legislation.  No 
significant criticism on the relevance of traceability requirements emerged from the stakeholder 
consultation.  Some  manufacturers  and  business  associations  observed  that  other  Regulations 
(especially  the  Feed  Hygiene  Regulation  and  the  General  Food  Law)  play  an  important  role  in 
ensuring FA traceability. Some FeBOs also stated that traceability is fully ensured by the systems 
and codes of practices already in place. In the roadmap consultation, one NCA considered that 
traceability  requirements  should  be  laid  down  in  the  FA  Regulation  instead  of  in  the  General 
Food Law.  

is  not  sufficiently  ensured  for 

MS  authorities  highlighted  that  traceability 
imports  of 
FA/premixtures and for  FA/premixtures only  intended for export  to third countries. There  are 
several reasons which account for this: a) the lack of a clear identification of imported products 
(no import code);  b) the difficulties  for  MS  to control establishments in third countries, c) the 
lack  of  harmonisation  of  control  requirements  for  the  third-country  establishment’s 
representatives  in  the  EU,  and  d)  the  absence  of  harmonised  labelling  to  identify  FA  only 
intended for export  to third countries. The absence of specific  relevant  provisions in the Feed 
Hygiene Regulation aggravates this situation for both imports and exports.  

There is no customs code that enables the identification of FA and premixtures on their entry 
into  the  EU.  These  products  might  be  imported  as  chemical  substances  because  the  exporter 

47 

 
does  not  know  the  final  destination  of  the  product  or  because  more  advantageous  customs 
codes  can  therefore  be  used  (lower  tariffs).  Although  there  is  a  generic  customs  code  “2309 
preparations  of  a  kind  used  in  animal  feeding”,  it  is  not  always  used.  This  point  has  been 
highlighted by the NCAs (ii FA Final Report FCEC, page 46). A majority of respondents (40 out of 
62  –  excluding  17  ‘do  not  know’  responses)  considers  imports  of  FA  into  the  EU  to  be 
adequately  controlled,  while 14  respondents  disagree  (SH  survey). 11  MS  authorities  consider 
imports of FA into the EU to be adequately controlled, while 14 partially controlled (EM 1.4.1). 

In  addition,  the  current  definition  of  “placing  on  the  market”,  determining  the  scope  of 
application  of  the  FA  Regulation  (including  the  authorisation  requirement),  basically  excludes 
the intended export to third countries of products provided that they have a limited circulation 
in the EU that does not imply transfer of ownership. These restrictions may result in a burden 
for FeBOs and could negatively impact their competitiveness, especially for SMEs for which this 
is  a  very  important  market  (EM  2.2.2  and  2.2.3).  See  more  information  in  section  1.4.3.7  of 
annex III, in the SH survey and the NCA Survey). 

MS authorities and other stakeholders (mainly FeBOs) also pointed out a possible inconsistency 
between  the  Feed  Hygiene  Regulation  and  the  FA  Regulation  (see  FCEC  Final  Report,  Section 
7.3.1), as in practice controls of the FA requirements applicable to EU establishments would be 
more  stringent  than  for  establishments  in  third  countries  and  than  for  the  control  of  FA 
intended  for  export  in  relation  to  the  implementation  of  the  provisions  of  the  General  Food 
Law. See more information in 3.2.2 Annex III and in 1.4.3.7 Annex III.  

In  summary,  controls  and  traceability  of  FA  are,  in  general,  satisfactory  (see  EM  1.4.3,  1.4.4, 
1.4.5, 1.4.6, 1.4.7, 1.4.11) although some weaknesses have been identified for imports and for 
FA only intended for export. Enforcement of the 2003 FA Regulation is mainly ensured through 
controls and penalties imposed in case of infringements. The available data also noted the high 
compliance of sampling and analysis in the context of official controls, despite some weaknesses 
that  have  been  identified  in  Commission  Audits.  The  limited  number  of  RASFF  notifications 
specifically concerning FA may indicate that the enforcement is effective in general, except for 
imports  (no  import  code  for  FA)  and  for  FA  only  intended  for  export  (no  specific  labelling 
indication / no harmonised rules for tracing and control). The fact that no list of third  country 
establishments  has  been  established  under  the  Feed  Hygiene  Regulation  nor  specific 
requirements  to  trace  and  control  FA  only  intended  for  export,  may  undermine  the 
effectiveness of certain aspects of the FA Regulation. 

4.1.8 Specific interests for pet owners and their animals  

1,017 FA were authorised in 2017 for pets. The  FA legislation, including the Commission Rules 
for  Applications,  establishes  specific  provisions  concerning  FA  intended  for  pets,  and  EFSA 
subsequently developed specific guidance (EM 1.28 to 1.2.10).  

Nearly  all  respondents  to  the  stakeholder  survey  who  provided  an  opinion  agree  that  FA  are 
efficacious and safe for pet animals (74 and 76, respectively, out of 78 respondents), excluding 
28 and 30 respondents, respectively, who did not provide an answer as pet food is not relevant 
for their organisation (SH survey) (EM 1.2.11 and 1.2.12). 

48 

 
For a majority of stakeholders (mainly FeBOs), the 2003 FA Regulation provides benefits for pets 
and pet owners (SH survey) though it should be noted that animal welfare organisations did 
not  contribute  to  the  survey,  despite  the  efforts  to  involve  them.  One  citizen  indicated  that 
there is an increasing consumer demand for “aesthetic” appearance of pet food that needs to 
be  considered  (many  compound  feeds  are  grey  in  colour  and  this  is  not  accepted  by  pet 
owners).  

45  out  of  107  respondents  consider  the  authorisation  procedure  to  fall  short  in  addressing 
scientific  and  technical  developments  in  feed  for  pets  and  livestock,  due  to  the  time  period 
incurred  during  the  authorisation  process  (EM  8.1.3).  This  contrasts  with  a  majority  of  MS 
authorities  which  consider  that  the  2003  Regulation  does  a  good  job  in  addressing  those 
technical  developments  (for  both  livestock  and  pets)82  (EM  8.1.2).  If  there  is  a  point  to  be 
considered  here,  then,  it  is  probably  not  connected  to  FA  intended  for  pets  specifically,  but 
rather to the authorisation process in general. 

To conclude, the FA Regulation has considered the specificities of pet owners and their animals 
by setting up a comprehensive set of rules. FA are also regarded as safe, efficacious and relevant 
to provide benefits for pets and their owners. 

4.1.9 Innovative and efficacious FA 

Innovation may affect the evolution of different aspects of FA, including FA that can be better 
digested by animals,  and new preparations that can for instance  increase  storage  capabilities, 
reduce  dusting  potential  or  facilitate  specific  uses  (spray,  drying,  pelleting  or  liquid  forms). 
However,  the  most  important  innovations  are  those  that  involve  the  discovery  of  new 
compounds with innovative actions or new effect mechanisms.  

The promotion of innovation under the 2003 FA Regulation is not perceived as effective by the 
industry, especially in the case of new FA, although a majority of MS authorities disagree. Some 
MS  authorities,  however,  noted  that  the  authorisation  period  is  too  short  to  encourage 
innovation  specifically  by  SMEs,  as  the  period  of  market  exclusivity  is  not  long  enough  to 
recover  the  investment  made.  Applicants  identified  a  difficulty  of  interpreting  some  EFSA 
guidance  and  an  insufficient  definition  of  endpoints  (what  needs  to  be  measured  to 
demonstrate  an  effect)  as  the  most  prominent  barriers  to  innovation.  Under  current  EFSA 
guidance,  endpoints  can  be  proposed,  but  applicants  do  not  receive  validation  from  EFSA  to 
inform them that those endpoints are indeed appropriate. 

There  is  a  growing  demand  for  new  FA  which  would  specifically  support  more  sustainable 
farming methods through new functions that did not exist before. This does not mean that all 
sustainable FA are by definition innovative or that innovation does not exist for other types of 
FA.  As  sustainability  was  not  an  explicit  objective  of  the  2003  FA  Regulation  when  it  was 
adopted, this issue is discussed further below under new needs (see section 4.3.3).  

FA that can have favourable effects on the environment or on animal welfare can be authorised 
under  specific  functional  groups  which  fall  under  the  wider  category  “zootechnical  additives”. 

82  

ii FA Final Report _FCEC, pages 47 and 48. 

49 

 
 
However,  the  criteria  defining  the  ‘zootechnical’  category,  which  includes  probiotics  and 
enzymes, are generally linked to the performance or productivity of livestock production (e.g., 
substances  or  micro-organisms  that  increase  digestibility  of  feed  or  positively  influence  gut 
flora).  The  sole  FA  authorised  to  date  under  the  2003  FA  Regulation  for  its  positive 
environmental effects is a FA that reduces methane emission by dairy cows (Bovaer®10). Here, 
the requirement was in particular the demonstration that it had no negative zootechnical effect 
(significant reduction in milk production). It would have been legally feasible to remove such a 
product from the “zootechnical additives” category and authorise it under another category but 
in  that  case,  it  would  not  have  been  possible  to  grant  market  exclusivity  to  the  applicant,  as 
holder-specific  authorisations  may  only  be  granted  for  certain  categories  of  FA,  including  the 
zootechnical  FA83.  These  constraints  might  be  seen  as  obstacles  to  innovation  in  the  specific 
area of sustainability, though this case also shows that such FA can indeed be authorised under 
the existing legislation. To establish a holder-specific authorisation system for a new category of 
FA, a modification of the 2003 Regulation by ordinary legislative procedure would be needed. 

The  restrictions  on  the  use  of  FA  in  water  for  drinking  were  also  identified  during  the 
consultation  as  a  potential  barrier  to  innovation.  Water  could  be  an  efficient  route  of 
administration for FA that could increase the performance of certain FA. Innovation in the form 
of  new  FA  specifically  designed  for  administration  through  drinking  water  would  make  it 
possible  to  take  full  advantage  of  this  route.  Such  innovation  has  to  date  focused  mainly  on 
nutritional FA such as amino acids and vitamins. 

The  rules  governing  the  renewal  of  authorisation  of  FA  were  initially  designed  to  encourage 
technological progress,  as it was  assumed that  applicants  would not  seek  renewal for  FA  that 
have  been  replaced  on  the  market  by  more  innovative  forms.  However,  stakeholders  do  not 
perceive  these  rules  as  promoting  technological  progress.  They  claim  that  such  rules  are  not 
needed, as the market is self-regulating  and works to  remove  those  FA  that are  less efficient. 
The  evaluation  does  not  show  a  clear  link  between  innovation  (technological  progress)  and 
renewal of authorisation. In the case studies, FeBOs questioned the authorisation period of 10 
years followed by a renewal of the authorisation for all types of products, and in particular for 
FA  for  which  there  is  an extensive  body of  scientific knowledge  on their  adverse  impacts  and 
low  identified  risk.  In  such  cases,  according  to  operators,  the  renewal  obligation  creates 
unnecessary burden not only for operators but also for EFSA and the Commission. In their view, 
the short period for renewal reduces their capacity to invest in new FA and it is not justified on 
safety  grounds.  Only  29  out  of  110  FeBOs  consider  that  the  10-year  authorisation  promotes 
innovation.  For  NCAs,  the  response  was  more  nuanced:  18  find  this  period  good  to  promote 
innovation (EM 8.3.1 and 6.11). Most FeBOs do not agree that the 10-year period is necessary 
to  ensure  safety.  Most  NCAs  (17),  however,  thought  that  this  period  is  necessary,  although 
three  NCAs  disagreed.  For  each  of  the  above  aspects,  it  is  noted  that  several  NCAs  (4  to  6, 
depending on the aspect) did not provide a definite answer. FeBOs considered that for holder-
specific  FA  and  non-holder  specific  FA,  the  10-year  period  is  not  adequate,  while  a  small 
majority of NCAs felt that this period is adequate (EM 8.3.3 and 8.3.4). 

83   Holder-specific authorisations may only be granted for zootechnical additives, coccidiostats and histomonostats and FA that 

are genetically modified or produced from GMOs. 

50 

 
 
The establishment of a holder-specific authorisation status for certain FA has been a clear tool 
to improve innovation. The increasing number of applications and  FA authorisations using this 
tool  confirms  this.  Feed  business  operators  claimed  that  non-holder  specific  authorisations 
reduce  innovation  and  an  extension  of  the  holder-specific  authorisation  regime  to  other  FA 
should be facilitated (see PC). In the SH survey, a majority of respondents (59%) want to keep 
the  current  regime,  while  23%  of  respondents  want  holder-specific  authorisation  status 
extended to other FA. No significant difference in terms of the cost-benefit balance can be seen 
between  SMEs  and  non-SMEs.  However,  the  required  upfront 
investment  (R&D  and 
authorisation costs) is high, and access to finance to support this is generally an issue for smaller 
companies,  when  these  are  not  part  of  larger  entities  (EM  3.1.12).  The  results  of  the  case 
studies and interviews revealed that SMEs are very active in placing on the market FA not linked 
to an authorisation holder as this reduces the costs they need to bear (EM 2.2.6). They are also 
active  in  submitting  applications  which  are  supported  by  available  scientific  literature.  For 
holder-specific authorisations, SMEs are also active, but they tend to focus on a few species to 
reduce costs. There are currently 1,214 non-holder specific FA authorised in the EU, compared 
to  236  holder-specific  FA  authorisations.  Although  the  major  innovation  occurs  among  those 
236  FA  (new  functions  and  actions),  innovation may also take place in  non-holder  specific  FA. 
Nevertheless, the impact of this matter on SMEs needs careful attention (EM 3.2.7).   

In  addition,  the  concerns  associated  with  a  low  supply  of  vitamins  on  the  EU  market  and 
dependency  on  imports  from  third  countries  for  certain  FA  (vitamins,  amino  acids  and  trace 
elements) raise the question whether it might be necessary to extend this exclusivity to other 
categories or functional groups of FA in order to incentivise applicants to apply for authorisation 
for  those  essential  FA  that  are  very  important  for  animal  welfare  and  health.  Therefore,  the 
possible extension of market exclusivity to other categories of  FA should be considered in any 
future revision of the legislation, as it may have a positive influence on innovation, especially for 
more sustainable FA, as well as improving the availability of certain FA. Again, the impact of any 
changes to these provisions on SMEs needs to be carefully considered. 

The barriers described above are real, but they did not prevent innovation from being pursued 
in  the  EU  FA  sector.  Four  new  functional  groups  were  established  by  the  2003  Regulation  to 
allow  new  types  of  FA  to  be  authorised,  and  a  large  number  of  innovative  FA  (210)  were 
authorised  under  the  “zootechnical  additives”  group.  However,  few  FA  have  been  authorised 
with  positive  effects  on  animal  welfare  (three  applications  by  December  2021)  or  on  the 
environment (only one FA authorised). The number of patent applications for FA submitted to 
the  European  Patent  Office  doubled  under  the  2003  Regulation  compared  to  the  previous 
period (207 applications were received between 2004 and 2019 compared to 104 applications 
between 1979 and 2003). The share of EU applicants versus non-EU applicants remained almost 
the same for the two periods (44% EU applicants and 56% non-EU applicants).  

Though  no evidence  could  be  collected  on  the  amount  and  trend of  R&D  investments  by EU-
based  companies  to  develop  new  FA  since  the  2003  FA  Regulation  came  into  force,  some 
respondents from the industry sector noted that costs have been reduced by investing in non-

51 

 
EU  research  facilities  or  sub-contracting  R&D84  activities  (including  trials)  to  facilities  based in 
non-EU countries (EM 2.2.4). 

4.2. How did the EU intervention make the difference? 

All stakeholder groups perceive a harmonised authorisation procedure at EU level as achieving 
better  results  than  national  level  authorisations.  This  view  was  confirmed  in  all  consultation 
activities;  by  101 out  of 110  respondents  (mainly  FeBOs)  in  the  targeted  consultation,  96%  of 
respondents  covering  all  stakeholder  groups  in  the  public  consultation,  and  26  out  of  27 
national authorities in the targeted consultation (EM 9.1). 

The  smooth  operation  of  the  EU’s  Single  Market  was  seen  as  the  key  advantage  by  business 
stakeholders and supported by the views of two national authorities considering that the intra-
EU trade of FA is facilitated by a central approach. In addition, this system is considered more 
economic  as  there  is  no  need  to  replicate  the  scientific  assessments  by  different  national 
authorities  across  more  than  one  authorisation  process.  It  also  prevents  applicants  from 
“authorisation  tourism”  where  they  make  applications  to  what  they  perceive  as  the  least 
rigorous MS. 

The added value of harmonised labelling rules was recognised by stakeholders (mainly FeBOs) 
(105  out  of  110)  as  well  as  by  all  national  authorities.  This  harmonisation  is  perceived  as  an 
element  that  facilitates  the  smooth  operation  of  the  EU  market  by  reducing  complexity  and 
costs for both FeBOs and national authorities (EM 9.2). 

A  wide  but  not  so  clear  consensus  prevailed  among  all  stakeholder  groups  that  the  EU-level 
intervention  in  the  FA  area  is  still  warranted  and  needs  to  continue  (unanimity  for  MS 
competent authorities, and support from 71 out of 110 mainly business stakeholders, with 31 
respondents,  mainly  manufacturers  of  FA/premixtures  and  traders,  not  providing  an  opinion) 
(EM 9.3). 

The  result  of  the  evaluation  shows  that  the  EU  intervention  is  perceived  positively  by  all 
stakeholders,  including  MS  authorities. This intervention  has  reduced  costs  and  facilitated  the 
smooth functioning of the EU single market.  

4.3. Is the intervention still relevant? 

The objectives identified in the  FA  Regulation continue  to be  pertinent to the evolving needs, 
problems and issues related to the placing on the market and use of FA and premixtures. 

4.3.1. Relevance of the objectives 

The  objective  “reduce  AMR  threats”  is  still  relevant,  as  the  EU  is  fully  committed  to  further 
strengthen the  EU’s response  to AMR  risks.  The reduction of AMR  threats to citizens, animals 
and the environment is still considered relevant by 26 MS authorities out of 27 and by 104 out 
of 111 other stakeholders (mainly FeBOs)85 (EM 7.1). 

84  
85  

ii FA Final Report _FCEC, pages 68 and 69.  
vii Consultation Synopsis Report, pages 14 and 22. 

52 

 
 
The objective “simplify and harmonise the authorisation process” is still relevant according to a 
majority  of  MS  authorities  (24)  and  a  majority  of  stakeholders,  mainly  FeBOs).  The  positive 
responses accounted for 91% (EM 7.2). 

The  objective  “ensure  a  rigorous  risk  assessment”  is  still  considered  relevant  by  all  the  MS 
authorities and by 88% of other stakeholders (mainly FeBOs)86. A sound scientific assessment is 
the basis to ensure a high level of food and feed safety as well as to reinforce public health (EM 
7.4).  As  regards  the  relevance  of ensuring  the  protection of  human  health,  animal  health and 
the  environment,  there  is a  majority of  FeBOs  in  favour  (96%)  of  that  general objective  while 
support from MS authorities was unanimous (26) (EM 7.3). 

The objective “establish clear/comprehensive rules for authorisation and labelling of additives” 
is  still  relevant  for  97  %  of  stakeholders87.  There  is  a  quasi-unanimous  consensus  among  MS 
authorities (24) and stakeholders (mainly FeBOs) on this matter (EM 7.6). 

The  objective  “improve  FA  control,  traceability  and  enforcement  rules”  is  still  relevant  for  the 
majority of MS authorities (25) and for 93 % of stakeholders (mainly FeBOs) (EM 7.5). 

The objective  “addressing specific interests  for pet owners and their animals”  is relevant for a 
majority of MS authorities (23). For other stakeholders (mainly FeBOs), this objective is widely 
seen as still relevant (63% of respondents), although some of them did not express any opinion, 
as this was not their area of expertise (34%). We can conclude that this objective is still relevant 
and of growing importance, taking into account the increasing market for pet food (EM 7.7). 

As  regards  the  objective  “encouraging  placing  on  the  market  of  FA  that  are  innovative  and 
efficacious”,  there  is  a  wide  consensus  among  MS  authorities  (26  out  of  26).  For  most 
stakeholders consulted via interviews (FeBOs), this objective remains relevant (103 out of 107). 
Nevertheless,  many  industry  respondents  also  claimed  that  further  efforts  are  required  to 
promote the authorisation of innovative FA, in particular by SMEs88(EM 7.8). 

The objective “ensuring that FA do not mislead consumers on food quality” is still relevant for a 
majority  of  MS  authorities  (22  out  of  26).  61%  of  stakeholders  (mainly  FeBOs)  agreed  on  the 
relevance of this objective whereas 31% did not express any judgement (EM 7.9). 

4.3.2. Are the current rules still adequate to support scientific and technological progress? 

A majority of NCAs considers that the rules and definitions used in the 2003 Regulation are still 
appropriate to the current state of scientific and technical knowledge, while FeBOs are divided 
with a slight majority  disagreeing  (EM 8.1.2).  The authorisation procedure is considered to be 
suitable to address scientific and technological progress by a majority of NCAs while a majority 
of FeBOs disagrees (EM 8.1.3). The criteria for authorisation are still relevant for scientific and 
technological  progress  for a majority of  NCAs  but  not  for  the  FeBOs (EM 8.1.3).  A majority of 
FeBOs and NCAs considers that the re-evaluation process gives flexibility to adapt to scientific 
and technological progress (EM 8.2.2). 

86  
87  
88  

vii Consultation Synopsis Report, pages 14 and 22. 
vii Consultation Synopsis Report, page 14. 
ii FA Final Report _FCEC, page 114. 

53 

 
 
4.3.3. New needs 

The majority of respondents to the surveys -- 16 MS authorities (out of 27) and 66 % of other 
stakeholders  (mainly  FeBOs)  --  considered  that  new  needs  that  had  emerged  since  the  2003 
Regulation  was  adopted  need  to  be  addressed  by  a  revision  of  the  legislation  (EM  8.5.3  and 
7.10). 

However, analysis of the new needs identified revealed that very few of those identified could 
be regarded as genuinely new.  

The concept of ‘sustainability’ was not as central to EU legislation in 2003 as it is today and was 
not  explicitly  included  in  the  2003  Regulation  since  it  had  not  then  been  defined  at  EU  level. 
Nevertheless the 2003 FA Regulation did include some aspects related to this concept such as 
positive  effects  on  the  environment  or  animal  welfare.    The  FAO  has  defined  sustainable  
agriculture  development  as  "the  management  and  conservation  of  the  natural  resource  base, 
and the orientation of technological and institutional change in such a manner as to ensure the 
attainment and continued satisfaction of human needs for present and future generations. Such 
sustainable  development  (in  the  agriculture,  forestry,  and  fisheries  sectors)  conserves  land, 
water,  plant  and  animal  genetic  resources,  and 
is  environmentally  non-degrading, 
technologically appropriate, economically viable and socially acceptable89". 

The  revision  of  the  FA  Regulation  is  listed  amongst  the  actions  of  the  Farm  to  Fork  Strategy, 
where  it  is  stated  that:  “to  help  reduce  the  environmental  and  climate  impact  of  animal 
production,  avoid  carbon  leakage  through  imports  and  to  support  the  ongoing  transition 
towards  more  sustainable  livestock  farming,  the  Commission  will  facilitate  the  placing  on  the 
market of sustainable and innovative FA”. A revised FA Regulation should be coherent with the 
emerging definitions of sustainability by providing the necessary flexibility to take into account a 
possibly new framework and should therefore consider other sustainability effects beyond the 
animal welfare or environmental effects, e.g., better use of resources.  

According to all groups of stakeholders,  FA have the potential to improve the sustainability of 
EU livestock farming by reducing the sector’s carbon footprint, including methane emissions, as 
well  as  water  pollution  (nitrates  and  phosphates)90.  The  FA  Regulation  already  refers  to 
objectives  and  criteria  related  to  the  sustainability  of  livestock  farming,  such  as  protection  of 
animal  welfare  or  protection  of  the  environment.  Nevertheless,  the  FA  Regulation  does  not 
encompass  the  broad  concept  of  sustainability  which  can  be  regarded  as  only  partially 
addressed in that Regulation (EM 7.11). 

The possibility of claims for FA was a new need identified by FA producers91 in the PC. Claims 
are allowed for feed materials and compound feed under the conditions of the Feed Marketing 
Regulation, but not for FA and premixtures (see 4.2 Annex III). This point was further explored 
as  the  EFSA assessment on efficacy regulates  the specific function that can be claimed on the 
label, e.g., a preservative. The current FA Regulation only allows the labelling of the functional 
group  for  the  FA  as  laid  down  in  the  authorisation.  In  the  case,  for  example,  of  the  recent 

89   https://www.fao.org/3/u8480e/u8480e0l.htm 
90  
91  

ii FA Final Report _FCEC, page 85. 
FEFANA contribution to the PC. 

54 

 
 
authorisation  of  the  FA  that  reduces  methane  emissions,  it  would  be  possible  to  say  that  it 
provides  “reduction  of  methane  emission”  but  not  that  it  “contributes  to  the  reduction  of 
greenhouse gases” or “contributes to mitigate climate change”, a language that would be more 
easily and more widely understood. This limitation in the FA Regulation reduces the possibility 
to convey messages more effectively along the feed chain. Such claims could be a good tool to 
raise awareness of the sustainable benefits of FA and could be considered in any future revision 
of the FA Regulation.  

Under the Common Agricultural Policy, farmers are encouraged to adopt or maintain practices 
that benefit environment and climate (under the first Pillar “Direct payments” and the second 
Pillar  “support  of  rural  development”)  and  groups  of  farmers  may  commit  to  a  collective 
implementation of practices that reduce the impact of livestock farming on the environment -- 
for  example  by  using  an  appropriate  formulation  of  feed  including  certain  amino  acids  that 
reduce  nitrogen  excretion.  Providing  clear  and  easily  accessible  information  in  this  regard  via 
claims would support the farmers in this regard. 

Different alternatives could be envisaged to ensure that those claims are not misleading (see 4.2 
Annex III).  

The  capacity  of  the  2003  FA  Regulation  to  adapt  to  scientific  and  technological  progress  is 
questioned  by  the  SH  (SH  survey)  and  by  some  MS  authorities,  though  most  MS  authorities 
consider  the  FA  Regulation  is  suitable  to  address  scientific  and  technological  progress.  The 
arguments  raised  by  FeBOs  were:  1)  science  evolves  faster  than  the  FA  Regulation  can  timely 
adapt; 2) the demonstration of efficacy for  FA having environmental or animal welfare effects 
requires generally the demonstration of performance functions in addition to those effects, thus 
discouraging applicants; and 3) some definitions should be better adapted to the current state 
of art.  

4.3.4. Societal expectations 

About half (49%) of the respondents in the PC considered that societal needs were sufficiently 
taken into account by the 2003 FA Regulation, compared to 25% who thought they were not. 
Citizens  were  more  inclined  to  indicate  that  societal  factors  are  not  sufficiently  taken  into 
consideration  (8  responses  out  of  16  citizens  that  responded).  Despite  the  efforts  made  to 
gather the views of consumers, animal welfare organisations and environmental organisations, 
in particular on societal expectations, it was not possible to get their contribution92. 

The  development  of  new  products  (especially  by  SMEs)  is  considered  an  important  tool  to 
address evolving societal needs, in terms of further reducing the preventive use of antibiotics, 
improving  meat  quality,  addressing  animal  welfare  and  conditions  of  breeding,  improving 
sustainability, and reducing the environmental impact of livestock farming93. 

The role of FA in providing affordable food is very limited, but they can contribute to a better 
use  of  resources  and  to  an  increase  in  the  performance  of  animals,  thus  reducing  production 
costs.  

92  
93  

ii FA Final Report _FCEC, page 22. 
vii Consultation Synopsis Report, page 30-31.  

55 

 
 
FA can have a clear and positive effect on animal welfare through several different channels: by 
improving  the  physiological  status  of  animals,  reducing  the  stress  due  to  adverse  climate 
conditions, and facilitating the transition to different production stages in the life cycle. 

All  these  positive  benefits  will  reduce  the  production  costs/losses  for  farmers  and  modestly 
contribute to providing affordable food of animal origin.  

The  direct  contribution  of  FA  to  provide  healthy  and  nutritious  food  is  difficult  to  establish, 
although  there  are  some  elements  that  should  be  noted.  Healthy  aspects  of  food  of  animal 
origin  are  linked to  minimum  levels  –  or  zero,  if  possible  –  of  pathogens,  toxins,  contaminant 
residues  and  other  agents  that  can  cause  foodborne  disease.  The  safety  assessment  of  FA 
ensures  that  FA  will  not  cause  hazards  in  food  from  animal  origin  and  will  not  contribute  to 
increase the level of contaminants or residues in that food. 

FA  have  not  successfully  improved  the  nutritional  profile  of  food  of  animal  origin,  e.g.,  by 
reducing saturated fats in monogastrics, or bio-fortification of food of animal origin. The 2003 
Regulation does not have any specific functional group to which additives pursuing this type of 
effects could be allocated. In any case, this possibility would require much more examination, as 
such actions might also have serious negative effects on animal health, animal welfare and may 
raise  ethical  considerations.  The  promotion  of  those  additives  intended  to  improve  the 
nutritional profile of food of animal origin cannot be regarded as a sustainable practice in the 
global context of the food chain. The shift to healthier diets should be facilitated by stimulating 
product reformulations and improving consumers’ information. 

The protection of natural resources is very relevant in animal farming, mainly due to the effect 
that  livestock  farming  may  have  on  the  terrestrial  and  water  compartments  (freshwater, 
groundwater  and  marine  water).  Furthermore,  the  protection  of  biodiversity  through  the 
protection  of  non-target  plant  and  animal  species,  microbes,  and  protozoans  is  an  additional 
aspect  to  consider.  During  the  implementation  of  the  2003  FA  Regulation,  the  environmental 
risk  assessment  has  been  improved  to  cover  all  these  elements  and  to  prevent  FA  or  their 
metabolites  from  harming  the  soil,  water  and  biodiversity.  In  addition,  many  authorised  FA 
having positive effects on the environment have been authorised under functional groups not 
directly  related  to  these  actions.  One  example  is  FA  which  are  authorised  as  nutritional 
additives,  but  also  serve  to  reduce  phosphorous  excretion  (phytases),  or  nitrogen  excretion 
(amino acids).  

As regards climate action, FA can contribute to reducing greenhouse emissions of methane and 
nitrous  oxide  and  have  other  environmental  benefits  by  mitigating  the  negative  effects  of 
livestock production.  

Factors linked to agricultural production are better management of soil and water quality, or an 
improvement in biodiversity. The effects of FA described above may have a moderate impact on 
this objective and so help ensure a more attractive environment for farmers and citizens in rural 
areas. 

Any  revision  of  the  2003  FA  Regulation  should  ensure  that  FA  having  positive  effects  on 
sustainability  can  be  authorised  without  the  requirement  to  also  demonstrate  an  animal 
performance effect.   

56 

 
 
5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? 

In general, the objectives of the 2003 FA Regulation, underlying in particular the authorisation 
system  and  the  labelling  requirements  provided  therein,  were  found  still  relevant  to  the 
evolving  needs  and  practical  issues  related  to  the  placing  on  the  market  and  use  of  FA  and 
premixtures.  

The  evaluation  found  that  sustainability  in  animal  farming  could  maybe  be  better  addressed 
through the Regulation, though there was room for improvement  in this regard. In particular, 
the potential of FA to contribute to a reduction in the negative impacts of livestock farming on 
the  environment  or  to  improve  animal  welfare  is  presently  under-exploited.  However,  the 
potential  of  the  Regulation  to  contribute  to  more  sustainable  farming  in  these  areas  already 
exists,  though  it  is  maybe  not  fully  realised.  The  main  obstacle  is  the  limitation  of  the 
categorisation  system  for  FA,  which  is  focused  exclusively  on  performance.  The  existing 
categorisation system should ideally be modified so as to encourage the marketing of safe  FA 
that are shown to have a favourable impact on sustainability, for example by creating a specific 
category of additives promoting sustainability. 

The FA Regulation contributed positively to the fight against antimicrobial resistance (AMR), a 
major  public  health objective,  by  banning  antibiotics  as  growth  promoters  and  by  introducing 
pre-market assessment  to identify  any potential risk of AMR effect. The evaluation shows the 
potential of the FA Regulation to reduce AMR further and acknowledges that this objective still 
has  a  high  level  of  relevance  and  should  therefore  continue  to  be  pursued,  in  particular  by 
facilitating and encouraging the authorisation of innovative  FA that can provide an alternative 
approach to the use of antibiotics.  

The  evaluation  also  finds  that  the  authorisation  system,  including  the  independent  risk 
assessment  by  EFSA  and  the  risk  management  process,  is  both  credible  and  effective,  thus 
providing the means to assure a high level of protection of human health, animal health and the 
environment, and effectively increasing the level of safety all along the food and feed chain.  

The  efficiency  and  effectiveness  of  the  authorisation  system  were  demonstrated  by  the  very 
small  number of  complaints  and  legal  actions  lodged  against  authorisation measures,  and  the 
low  number  of  RASFF  notifications  concerning  FA.  These  are  even  more  impressive  when  set 
against  the  high  number  of  applications  for  authorisation  submitted  under the  FA  Regulation, 
and the large  number  of authorised  FA, including innovative  FA. These  quantitative  indicators 
are reflected at a more qualitative level by the recognition in third countries of the value of EU 
authorisations of FA, and the strong global position of the EU FA market. 

Although  the  authorisation  of  FA  is  now  harmonised  and  simplified  in  comparison  to  the 
previous 1970 FA Directive, stakeholders continue to find that the authorisation procedure is in 
some  cases  not  fully predictable and that the system overall remains too complex,  costly and 
time consuming. This is mainly due to a small number of specific points:  

–  Some  delays  in  the  authorisation  of  FA  occur  during  the  assessment  carried  out  by 
EFSA  and  to  a  lesser  extent  during  the  adoption  procedure  of  the  authorisation 
measures by the Commission. The main cause of delay is the fact that many application 
dossiers  submitted  are  incomplete.  This  may  be  due  to  a  different  interpretation  by 

57 

 
applicants of EFSA guidance documents, regular updates of those documents to adapt 
to new scientific knowledge or failure to take up the possibility of meetings with EFSA 
before the application is lodged.   
While updates to requirements on data that should be submitted by applicants may not 
be  avoided,  so  as  to  ensure  the  safety  of  the  FA,  improvements  have  already  been 
implemented such as the possibility of pre-submission advice from EFSA provided for in 
the  ‘Transparency  Regulation’94  and  other  mitigation  measures.  Any  benefits  from 
those recent measures and provisions are expected to manifest in the medium term. 
–  The establishment of a 10-year authorisation period allows for a timely safety/efficacy 
re-assessment of FA, as scientific/technical knowledge evolves. The renewal process for 
FA authorisations was also designed to encourage technological progress as applicants 
would not be interested in seeking a renewal if the FA has meanwhile been replaced on 
the  market  by  a  more  innovative  product  that  fills  the  same  market  need.  However, 
this  is  not  perceived  by  stakeholders  as  a measure  promoting  technological  progress. 
They  claim  that  the  market  is  self–regulating  and  removes  the  less  efficient  or  less 
innovative  FA.  The  evaluation  suggests  that  the  renewal  process  for  authorisations  is 
not  clearly  linked  with  positive  effects  on  innovation.  While  a  prolongation  of  the 
authorisation period would reduce administrative and regulatory burden, this needs to 
be balanced against a possible impact on safety. 

–  The effectiveness of the authorisation system and of specific related provisions of the 
FA  Regulation  could  be  improved  in  terms  of  clarity  and  coherence,  including 
coherence in relation to other legislation, which may have impacted somehow both the 
successful  implementation  of  some  measures,  and  the  general  effectiveness  and 
efficiency  of the  authorisation  process  as  such.  In  this  regard,  the  following  areas  for 
improvement have been identified: 
•  Establish  clear  rules  on  data  sharing  in  order  to  avoid  duplication  of  toxicological 
tests on vertebrates. The setting up of alternative testing methodologies that could 
help reduce the need for animal testing should also be explored further. 
Improve clarity of the rules on the use of FA in water for drinking, so as to facilitate 
their  practical 
implementation  by  operators  and  their  coherence  with  the 
legislation on biocidal products. 

• 

•  Further  specify  the  definition  of  ‘FA’  so  as  to  better  distinguish  them  from  other 

types of feed, and define certain terms used, such as ‘preparations’. 

•  Provide for transitional periods in case of withdrawal of an application for renewal, 

in order to allow operators to adapt to the expiry of the authorisation. 

•  Clarify the legal status of ‘recommended or maximum recommended levels of use’ 

of FA, which are provided for in certain authorisation acts. 

•  Clarify  the  requirements  for  the  environmental  risk  assessment  of  FA  intended 

specifically for farmed non-food producing animals. 

Certain provisions of the FA Regulation are considered as not sufficiently efficient, due to some 
administrative burden or complexity involved in their implementation. The following areas for 

94  

Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019, which amended the General Food 
Law and several legislative acts in the food safety sector. That Regulation entered into application on 27 March 2021. 

58 

 
 
simplification  and  reduction  of  administrative  costs  and  regulatory  burden  have  been 
identified:  

–  Establish a simpler procedure when the authorisation holder changes, with respect to 

holder-specific authorisations. 

–  Extend the duration of the authorisation period, at least for certain types of FA. 
–  Facilitate the extrapolation of study results from major to minor species and from food 

to feed.  

–  Review  the  existing  restrictions  on  the  circulation  of  FA  only  intended  for  export  to 

third countries, in the context of a possible harmonisation of the applicable rules.  

The  FA  Regulation  is  resulting  in  substantial  costs  for  business  and  public  authorities  which 
however seem to be justified by the resulting benefits.  

Costs  for  businesses  mainly  stem  from  the  preparation  of  application  dossiers.  Certain 
simplification  or  clarification  measures  as  indicated  above  may  reduce  costs  to  a  certain  but 
limited  extent.  Extending  holder-specific  authorisations to more  categories of  FA  may  provide 
market  exclusivity  to  those  applicants,  improving  the  availability  of  certain  essential  FA. 
Nevertheless,  this  change  would  need  to  be  carefully  considered  as  it  might  negatively  affect 
SMEs. In addition, ensuring better coherence with the CLP Regulation as regards the labelling of 
FA and premixtures concerning users’ safety may further reduce costs and burden. 

Costs for the risk managers could be reduced through a simplification of the procedure in case 
of modification  of  an  authorisation  holder,  the  extension of  the  duration  of  the  authorisation 
period, and the clarification and/or better definition of concepts used in the FA Regulation. 

Benefits of the provisions of the FA Regulation  have been identified for human health, animal 
health  and  the  environment  and  also  for  consumers,  pet  owners,  farmers  and  feed  business 
operators along the feed chain. 

The FA Regulation was successful in conveying necessary safety messages and allowing the safe 
and  appropriate  use  of  FA.  However,  the  simultaneous  implementation  of  the  FA  Regulation 
and  the CLP  Regulation  has  led  to  different  interpretations  by  MS,  creating  a  possible  burden 
and  a  potential  negative  impact  on  workers’  safety,  although  the  evaluation  was  not  able  to 
identify  any  concrete  instance  of  such  negative  impact.  More  coherence  with  the  labelling 
provisions applicable to feed materials and compound feed, by creating the possibility of using 
modern  alternatives  to  the  physical  label,  such  as  electronic  means,  could  be  a  significant 
improvement. Furthermore, a demand exists to harmonise the labelling of safe FA only intended 
for  export  to third countries  and the establishment of  labelling tolerances  for FA contained in 
premixtures.  

An  adaptation  of  the  Register  of  FA,  by  making  it  more  informative  and  more  user-friendly, 
would improve the information on the authorisation status of FA. 

Enforcement  of  the  FA  legislation  is  mainly  ensured  at  MS  level  through  official  controls  and 
penalties  imposed  in  case  of  infringements.  Available  data  from  MS’  official  controls, 
Commission  Audits  and  the  limited  number of RASFF  notifications  in relation to  FA  point  to a 
good level of compliance with the FA Regulation and may indicate that enforcement is generally 

59 

 
effective. In this context, the role of the EURL-FA in contributing to the effective control of FA is 
essential. 

Nevertheless,  some  weaknesses  in  enforcement  and  traceability  of  imports  from  third 
countries  have  been  identified.  A  problem  arises  due  to  the  lack  of  a  specific  import  code  to 
identify FA/premixtures. The fact that such harmonised traceability rules, but also lists of third 
country  establishments  of  dispatch  have  not  been  established  under  the  Feed  Hygiene 
Regulation negatively impacts enforcement and traceability. 

As  indicated  above,  another  area  for  improvement  concerns  the  situation  of  FA/premixtures 
only intended for export to third countries, due to a lack of appropriate labelling indications and 
of harmonised rules for tracing and control of such products. 

The FA Regulation has addressed the specific needs of pet animals and their owners by setting 
up  a  comprehensive  set  of  rules  that  are  adapted  to  this  somewhat  different  context,  in 
particular during the FA risk assessment phase. The evaluation shows that  FA for pet food are 
regarded as safe, efficacious and relevant and that they thus provide real benefits for pets and 
their owners. The FA Regulation has thus achieved its objective of addressing the specific needs 
and  interests  of  this  sub-sector,  but  it  should  be  noted  that  animal  welfare/pet  animals 
organisations  did  not  contribute  to  the  different  consultation  activities,  despite  the  efforts  to 
involve them. 

The FA Regulation allows the placing on the market of efficacious FA where efficacy is defined 
in relation to their functional group classification.  

The FA Regulation achieved a high level of innovation in FA that are used as an alternative to 
antibiotics, and in FA improving the digestibility of feed (better use of resources) and increasing 
animal  performance.  However,  the  FA  Regulation  was  perceived  as  failing  to  keep  pace  with 
innovation  in  sustainability  effects,  such  as  reducing  the  environmental  impact  of  livestock 
farming or improving animal welfare. This was attributed to the limitations of the categorisation 
system for  FA. In addition, many authorised  FA (such as amino acids)  have positive effects on 
the  environment  but  there  is  a  lack  of  “visibility”  of  this  effect  as  they  are  authorised  under 
functional  groups  which  are  not  related  to  those  environmental  effects  (e.g.,  as  nutritional 
additives). 

Other identified barriers to innovation include an insufficient understanding of certain elements 
of  EFSA  guidance,  in  particular  in  relation  to  the  definition of  clear  endpoints  to  demonstrate 
the efficacy of new FA, and the fact that some FA may not be administered via drinking water. 
Water could be an efficient route of administration of FA that could increase the performance 
of  certain  FA,  and  any  revision  of  the  FA  Regulation  should  help  promote  innovation.  In  this 
regard, the current restrictions on certain FA should be re-examined.   

The  10-year  duration  of  the  authorisation  period  is  considered  too  short  and  discourages 
industry  from  investing  resources  in  developing  new  FA.  It  should  be  assessed  whether  it  is 
always  justified  on  safety  grounds.  Finally,  the  establishment  of  holder-specific  authorisations 
for  a  wider  range  of  FA  has  been  identified  as  a  measure  that  might  foster  innovation.  The 
increasing number of applications for authorisations of this type  confirms this  finding,  though 
the impact on SMEs also needs to be considered.  

60 

 
Feed business operators may have no interest in investing in non-holder specific authorisations 
as they bear the authorisation costs while others may place the products on the market once 
they  are  authorised.  This  has  generated  a  number  of  unintended  negative  effects,  including 
notably a shortage in the supply of certain essential FA such as vitamins that are very important 
for animal health and welfare.  

Accordingly,  potential  areas  for  improvement  to  promote  innovative  FA,  notably  related  to 
sustainability aspects, could include: 

–  A review of the classification of FA into categories/functional groups, so as to allow the 
authorisation  of  FA  with  positive  effects  on  sustainability  aspects  and  animal  welfare 
and provide more flexibility for potential future modifications of that classification. 
–  The  introduction  of  a  claims  system  for  FA,  highlighting  innovative  and  sustainable 

characteristics thereof.  

–  An  extension  of  the  holder-specific  authorisation  status  to  more  FA,  in  order  to 
encourage the submission of applications for innovative or sustainable FA contributing 
to improve  the  supply of certain FA that are  important  for animal  health and welfare 
and may reduce dependency on third countries. 
–  A clarification of the use of FA in water for drinking.  
–  A  consideration  of  the  extension  of  the  duration  of  the  authorisation  period  (the 
resources  currently  invested  in  obtaining  a  renewal  of  authorisation  could  then  be 
allocated to the development of new FA). 

The  EU  intervention  in  the  area  of  FA  is  considered  as  bringing  added  value  through  the 
harmonised EU-level authorisation procedure and labelling rules. 

The evaluation showed that additional harmonisation as regards the rules concerning labelling 
tolerances  of  FA  in  premixtures,  labelling  of  FA  or  premixtures  intended  for  export  only,  and 
new labelling means for FA and premixtures could bring further benefits. 

61 

 
 
ANNEX I: PROCEDURAL INFORMATION 

1.  Lead DG, Decide Planning/CWP references 

The  evaluation  of  the  FA  Regulation  (‘the  evaluation’)  was  prepared  under  the  lead  of  the 
Directorate-General  for  Health  and  Food  Safety.  In  the  Decide  Planning  of  the  Commission,  the 
process  is  referred  to  under  item  PLAN/2017/988.  The  evaluation  was  mentioned  in  the  2017 
Regulatory  Fitness  and  Performance  Programme  REFIT  and  the  10  Priorities  of  the  Commission95 
accompanying  the  Commission  Work  Programme  for  2017.    The  evaluation  is  also  linked  to  the 
Fitness check on the General Food Law mentioned in the Commission Work Programme for 201596, 
which was carried out in 2017. 

2.  Organisation and timing 

The evaluation started in 2017 with the publication of the Evaluation Roadmap on 28 August 201797. 
The evaluation is based on a Public Consultation which run from 12 December 2018 to 3 April 2019, 
with the factual summary report of the PC published in November 2019. The evaluation is also based 
on a study performed by an external contractor which was finalised in June 2020. 

An Inter-Service Steering Group (ISSG) assisted DG Health and Food Safety in the evaluation process, 
which  was  created  in  February  2017  and  included  Commission  services  of  Directorate-Generals 
GROW,  AGRI, ENV,  EMPL, MARE  and  JRC,  together with  the  Commission’s  Secretariat  General  and 
Legal  Service.  The  ISSG  met  4  times  during  the  evaluation  process  from  March  2017  to  February 
2019.  

The  draft  Staff  Working  Document  (‘SWD’)  on  the  evaluation  and  all  supporting  documents  were 
submitted to the Regulatory Scrutiny Board (‘RSB’) on 4 March 2022, in view of a meeting on 6 April 
2022. The RSB issued a positive opinion on 8 April 2022. 

3.  Consultation of the RSB 

The  draft  SWD  on  the  evaluation  was  reviewed  by  the  RSB  which  issued  a  positive  opinion.  The 
opinion  includes  recommendations  on  how  the  SWD  could  be  further  improved  and  which  were 
addressed as explained below: 

Table 1: How recommendations of the RSB have been addressed. 

Recommendations  of  the 
RSB 
report 
should 
(1)  The 
the  data  and 
improve 
information 
to 
used 
support  the  conclusions  of 
in 
the  evaluation,  e.g., 
relation  to  the  evaluated 
time  period,  the  costs  and 

Modifications  in  the  SWD  on  the  evaluation  in  response  to  the 
Board’s recommendations 
Data and information improved: 
•  Updating  of  statistics  on  FA,  premixtures,  compound  feed,  feed 

materials and livestock production. 

•  Clarification  of  the  structure  of  the  market  and  differences 
between  FA  and  specialty  feed  ingredients.  Limitations  and 
caveats  have  been  included  (point  3.1  and  new  Annex  VII  on 
market data). 

95 
96  
97 

REFIT – making EU law simpler, less costly and future proof - European Commission (europa.eu) 
Commission Work Programme for 2015. A New Start. COM (2014) 910. 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1483-Evaluation-of-the-feed-additives-Regulation_en  

62 

 
 
 
is 

still 

benefits,  and  the  potential 
for  burden  reduction. 
It 
justify  the 
should  better 
use  of  relatively  old  data 
(2004-2017)  and  how  this 
representative. 
is 
Where  new  data  is  added, 
it  should  be  clarified  if  this 
supporting  or 
data 
the 
contradicting 
conclusions,  and  to  what 
extent.  In  the  absence  of 
more quantitative data, the 
report  should  provide  a 
robust  qualitative 
more 
analysis, 
in 
in  particular 
the  benefit 
support  of 
assessment, 
clearly 
outlining 
limitations 
and uncertainties. 

the 

report 

related 

specific 

(2)  The 
should 
ensure coherence between 
the data and conclusions in 
Annex  III  and  in  the  main 
the 
text, 
outlining 
to 
difficulties 
causal 
isolating 
and, 
relationships 
consequently, 
better 
calibrating  the  conclusions 
that can be drawn from the 
available  evidence.  The 
evaluation  matrix  in  Annex 
III  should  be  completed, 
making clear the difference 
between 
formal 
compliance  and  verifiable 
or  verified  outcomes. 
It 
should  be  clear  where  the 
answers  to  the  evaluation 
questions  can  be  found  in 
the report. 

•  Consequences of increasing development of FA production in the 

Asian Pacific region (3.2.1). 

•  Additional information on R&D (3.1.2). 

Justification of the period 2004-2017 used to analyse and explain that 
this period is still representative and that this does not contradict the 
conclusions (section 1). 

As for benefits, a qualitative analysis has been done with references 
to  studies  or  documents  supporting  it  where  possible (4.1.4.2  and 
Annex III). Caveat has been introduced to explain limitations in order 
to establish causal links and lack of data on actual use of FA (Annex II). 

The methodology of costs calculations has been included in Annex II 
and more detailed information has been specified in the main part of 
the  report,  including  the  overall  costs  of  the  Regulation  (4.1.4.1),  as 
well as in point 2.1.1 of Annex III. 

Some  parts  have  been  summarised  to  avoid  too  many  technical 
details and repetitions. 

Some  data  of  Annex  III  have  been  transferred  to  the  main  text 
ensuring  coherence  between  the  data/conclusions  of  the  main  text 
and the Annex. 
The intervention logic (‘IL’) has been modified to indicate the general 
objectives,  to  disentangle  drivers,  problems  and  needs,  to  indicate 
how the intervention was expected and the expected outcomes. The 
links  to the  IL were clarified by separating the authorisation process 
from aspects related to labelling (section 2). 
The  evaluation matrix has been completed and all references to the 
evaluation  matrix  have  been  included  in  the  main  text  where 
appropriate. 
The  evaluation  matrix  includes  the  sources  of  data  and  makes  a 
distinction between formal compliance and verified outcomes. 
The  authorisation  process  has  been  clarified:  the  definition  of 
different steps and the reasons for the delays have been pointed out. 
(4.1.2.3 and Annex VIII). 
Further explanations have been provided for: 

✓  How  the  re-evaluation  process  worked  and  how  additives 

were assessed (Annex VIII). 

✓  When the second opinion from EFSA is requested (3.1.3). 
✓  The  labelling  rules  and  how  they  contribute  to  the  safety  of 
FA and how operators follow the label instructions (3.1.3 and 
4.1.7). The link with CLP is described better (3.1.3). 

✓  The  restrictions  on  administering  additives  in  water  and  the 

reasons why such restrictions were introduced (4.1.3). 

✓  The  difference  between  applications,  authorisation  and 

number of additives (Annex VIII). 

✓  The  performance  of  the  EU  system  compared  to  third 

countries (4.1.2.5). 

✓  A specific section for internal and external coherence (4.1.3). 
✓ 

Import codes (4.1.7). 

63 

 
✓  Claims (4.3.3). 
✓  Relationship  between  animal  health  and  animal  welfare 

benefits (4.1.4.2). 

The  report  includes  several  explanations  to  distinguish  innovation 
from  sustainability  and  to  explain  the  bottlenecks  encountered  for 
this type of additives (4.1.9). 
The  report  explains  what  the  elements  that  influence  the  rate  of 
innovation  are  and  how  innovation  succeeded  in  some  aspects  but 
not in others. The length of the authorisation period is also analysed 
comparing  the  expected  results  when  the  2003  FA  Regulation  was 
adopted  and  the  real  effect  of  this  period  in  relation  to  innovation 
and burden (4.1.9). 
The 
holder 
differences 
authorisation have been included (3.1.3). 

non-holder-specific 

between 

and 

types 

report 

should 
(3)  The 
distinguish 
between 
innovative  and  sustainable 
FA  and clarify  the different 
encountered 
bottlenecks 
for 
of 
these 
additives.  It  should  clarify 
different 
how 
aspects 
influence 
rate  of 
the 
innovation,  e.g.,  the  trade-
off behind extension of the 
length  of  the  authorisation 
period  or  the  differences 
between  holder  and  non-
holder-specific 
authorisations. 

4.  Evidence and sources 

The  evaluation  is  based  on  an  external  support  study  conducted  by  the  Food  Chain  Evaluation 
Consortium  (‘FCEC’)  -  Brussels  from  May  2018  to  June  2020.  This  support  study  answered  10 
evaluation  questions  linked  to  the  five  evaluation  criteria.  Several  reports  and  documents  recently 
published have also been considered in the evaluation process: 
−  The REFIT evaluation of the General Food Law98. 
−  The Farm to Fork Strategy99, which was adopted on 20 May 2020 as one of the key actions of the 

European Green Deal100. 

−  FAO and WHO 2019 Sustainable healthy diets – Guiding principles101. 
−  Non-animal Methods in Science and Regulation, Non-animal Methods102. 
−  EU aquaculture report: sales value goes up while the volume remains steady103. 
−  WEBINAR  Innovation  to  tackle  climate  change.  Generating  facts  about  FA  and  livestock 

production104. 

−  The Green Deal and the CAP: policy implications to adapt farming practices and to preserve the 

EU’s natural resources. European Parliament Think Thank105. 

−  Farm  to  Fork  strategy  -  An  overview  of  Parliament’s  positions.  European  Parliament  Think 

Thank106. 

−  What if we could fight antibiotic resistance with probiotics? European Parliament Think Thank107. 

European Commission (2018) the REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002) SWD (2018) 38.  
https://ec.europa.eu/food/horizontal-topics/farm-fork-strategy_en 

98  
99  
100   https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en  
101   http://www.fao.org/home/en/  
102   EU SCIENCE HUB.  https://ec.europa.eu/jrc/en  
103   EU SCIENCE HUB.  https://ec.europa.eu/jrc/en  
104   http://www.fao.org/partnerships/leap/news-and-events/news/detail/en/c/1312668/  
105   http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2020)629214  
106   http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_BRI(2020)658206  

64 

 
 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED 

This Annex presents the methodological approach used in this evaluation, including the general 
approach followed in the study supporting the evaluation. 

Evaluation Matrix 

The development of an Evaluation Matrix (‘EM’), which linked Evaluation Questions (‘EQs’) to a series 
of  judgement  criteria  and  indicators,  is  a  well-recognised  approach  and  ensures  that  appropriate 
methodologies are used to gather the required data to form the evaluation evidence base. The EM 
was fine-tuned through discussion with the Steering Group. 

Data collection 

For the enforcement of the Regulation by the MS authorities, the period for the analysis was based 
on the Multiannual Control Plan of the years 2011-2015. For many other aspects, the data-gathering 
and analysis was extended until the end of 2019, where possible. 

In  the  case  of  renewals  of  authorisation,  the  data  collected  covered  the  period  2017-2020,  as  the 
majority  of  the  renewals  were  requested  during  this  time  frame.  The  reason  is  that  the  first 
authorisation act adopted under the FA Regulation was in 2005, followed by 5 authorisation acts in 
2006  and  increasing  Regulations  subsequently.  Taking  into  account  that  the  process  leading  to  the 
adoption  of  the  first  authorisation  took  more  than  16  months,  the  first  renewal  processes  were 
concluded in 2017. 

For specific issues that were relevant for the evaluation, information up to 2021 was included: Rapid 
Alert  System  for  Food  and  Feed  concerning  residues  in  food  of  animal  origin,  results  of  the 
Commission Audits on Official Controls of  FA and Traceability. The new information did not change 
the conclusions of the report but provides additional information. 

The following methodologies were used and implemented: 

−  First, an extensive desk research and literature review was performed. All relevant literature 
and databases were screened to establish a list of relevant material, which was then mapped 
to the indicators in the EM. Nearly 5,000 initial results were reduced to 500 upon screening 
for relevance to the EQs, and these were further reduced when screened for relevance to the 
indicators. 

− 

In addition, the data collection comprises targeted consultation activities, including targeted 
surveys, interviews and case studies, which are presented into details in the synopsis report 
annexed to this SWD (vii Consultation Synopsis Report). The targeted consultation activities 
were conducted by the contractor performing the evaluation study: 

o  The three surveys were addressed, respectively, to NCA, to stakeholders involved in 

the FA field and to stakeholders from third countries. 

o  The interviews were developed to complement the data gathered in surveys. 

o  Case studies were performed in order to understand the concrete application of the 
FA  Regulation,  identify  and  justify  the  factors  that  underpin  the  observed  impacts, 

107   http://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2020)641545  

65 

 
 
and collect qualitative and quantitative data that cannot be collected from the other 
sources.  The  authorisation  process  and  the  labelling  of  FA  were  the  two  thematic 
areas covered.  

External study 

An external study108  was  commissioned to support this evaluation  covering 2004 to 2017, a period 
that  is  largely  representative  of  the  experience  encountered  with  the  new  authorisation  and 
assessment  process  that  had  been  introduced.  This  study  was  desk-based  and  supported  by  an 
extensive consultation strategy as described above.  

Limitation and robustness of findings 

The  significant  challenges  outlined  below  are  exogenous  to  the  evaluation  methodology  and  were 
identified  from  the  outset.  These  were  addressed  by  expanding  the  data  collection  exercise  and 
broadening  the  consultation  strategy  to  ensure  that  the  study  could  gather  an  appropriate  and 
objective evidence base in particular given the number of indicators used to address the evaluation 
questions.  Specific  caveats  in  the  data  and  estimates  presented  in  this  Report  are  indicated  and 
explained in the text.  

More  in  detail,  several  challenges  needed  to  be  overcome  or  mitigated  in  carrying  out  this 
evaluation: 

−  Categorisation  of  FA:  The  classification  of  FA  in  the  FA  Regulation  does  not  necessarily  match 
with some commercial categories. This situation was addressed by developing a consolidated list 
of  the  commercial  categorisation  based  on  a  variety  of  commercial  sources  and  then  mapping 
this consolidated list to the regulatory categories. 

−  The  data  on  the  market  and  market  trends  is  very  scarce.  There  is  no  official  information 
available in EUROSTAT (no trade/industrial classification) on the market (e.g., level of production, 
turnover, production prices, labour input,  import  prices, market prices, or the quantification of 
imports or exports) allowing to characterise the sector and to know the level of competitiveness 
of  the  EU  industries  or  the  EU  market  share.  Therefore,  various  other  sources  (Report  by  RM 
Associates Ltd, Mordor Intelligence, Allied Market Research, FEFANA, FEFAC FEDIAF or FAO) were 
examined  in  order  to  estimate  the  market  of  FA  in  the  EU  and  worldwide,  the  relation  to 
compound  feed  and  feed  materials  and  to  identify  key  market  trends.  The  classification  of 
additives  is  different  depending  on  the  source,  some  sources  include  “prebiotics”  that  are 
normally  regarded  as  “speciality  feed  ingredients“  but  in  fact  are  feed  materials.  Also, 
microorganisms  are  called  “probiotics” 
is  no  data  since  the 
implementation of the FA Regulation in 2004 and some of the following years.    

in  some  sources.  There 

−  Due to the lack of identification at the entry point in the EU, it is not possible to  estimate how 
many  additives  are  produced  in  third  countries,  considering  the  increasing  production  in  those 
countries and the delocalisation of the production sites.  

−  The lack of data required additional primary and secondary data collection from a wide range of 
sources,  including  commercial  sources.  Where  quantitative  data  could  not  be  identified  or 
developed, qualitative approaches were used with extensive triangulation to produce the most 
reliable estimates. 

108   Conducted by the Food Chain Evaluation Consortium – FCEC and published together with this Staff Working Document 

66 

 
 
−  Temporal scope of the study and baseline: The baseline for the study is the situation at the time 
of the entry into application of the FA Regulation in 2004. In 2004, the situation was related to 
the implementation of the former FA Directive. However, no impact assessment or evaluation of 
the 1970 FA Directive were performed for the adoption of the FA Regulation. Furthermore, the 
industry was not sufficiently organised as an association at European level109.  In particular, the 
baseline  was  developed  based  on  data  from  the  EU  Register  of  FA,  the  list  of  FA  notified  as 
existing products under the 1970 FA Directive, the list of authorised FA under that Directive110, 
the  list  of  products  authorised  under  Council  Directive  82/471/EEC111,  and  limited  documents 
from  academic  or/scientific  publications.  Qualitative  approaches  were  used  to  fill  quantitative 
data gaps. 

−  Estimation of costs and benefits: Providing estimates of costs and benefits in a uniform manner 
to allow unit cost comparisons required considerable input from stakeholders, especially FeBOs.  
✓  The efficiency has been particularly challenging to assess, given the absence of an impact 

assessment and the lack of precise data on current costs.  

✓  When 

it  comes  to  authorisation  costs,  the  data  collection  has  met 

important 
confidentiality constraints, particularly for holder-specific authorisations, where a single 
company  holds  the  authorisation  for  a  product,  and  it  was  important  to  ensure  that 
single  companies  could  not  be  identified.  To  address  this  challenge,  the  Standard  Cost 
Model  was  applied.  This  allowed  us  to  isolate  key  obligations  arising  from  the  FA 
Regulation  and  then,  to  quantify  these  by  using  a  combination  of  required  staff 
time/grade  and  cost  per  unit.  It was  necessary  to extend  the  data  collection  to  a  large 
range  of  companies,  in  order  to  address  gaps,  improve  the  estimations  and  overcome 
confidentiality concerns. 

−  Enforcement  data:  Evidence  on  enforcement  from  MS  authorities  was  rationalised  by  aligning 
the survey to the results of the Multi-Annual National Control Plan (MANCP) 2012-2015 required 
by the Official Controls Regulation. Only 16 MS, out of the 25 who responded to the survey, were 
able  to  provide  data.  For  the  remaining  MS,  the  results  could  not  be  specifically  identified,  as 
they were merged with other outcomes from different legislative provisions. 

−  Representativeness  of  stakeholder  groups:  The  views  of  competent  authorities  and  the  feed 
industry  are  well  reflected  in  this  report  due  to  their  active  participation  in  the  consultations 
activities  organised  as  part  of  the  study.  However,  organisations  representing  pet  owners, 
consumers,  animal  welfare  and  environmental  NGOs,  did  not  participate  in  the  consultations 
despite the efforts developed by the study team and the Commission to involve them. Therefore, 
their views could not be considered in the analysis. 

−  Comparability  of  databases:  The  SANTE  and  EFSA  databases  were  used  to  analyse  the 

authorisation and evaluation procedures. Several shortcomings were identified: 

✓ 

It  is  not  possible  to  match  the  SANTE  and  EFSA  applications  as  they  refer  to  different 
administrative procedures. This does not necessarily affect the analysis, as it is possible 
to analyse the different steps in the procedure. However, it may lead to some difficulties 
in processing the data and understand the tracking of an application. 

109   FEFANA  was  created  in  1963  with  five  national  associations  of  five  countries.  In  1990,  associations  from  Spain  and  Scandinavian 
countries  joined  the  organisation.  In  2004,  FEFANA  established  itself  as  a  European  association  with  direct  affiliation  of  member 
companies. 

110   List of the authorised additives in feedingstuffs published in application of Article 9t (b) of Council Directive 70/524/EEC concerning 

additives in feedingstuffs (2004/C 50/01). OJ C 50, 25.2.2004, p. 1. 

111   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition OJ L 213, 21.7.1982, p. 8. 

67 

 
 
✓  There  is  no  accessible  collection  of  data  on  the  results  of  the  EFSA  opinions,  whether 
they  are  positive,  positive  with  restrictions,  negative  or  inconclusive.  An  estimation 
based on different data has been made112. 

−  Quantification  of  benefits:  The  actual  benefits  are  generally  not  possible  to  quantify,  and even 
less  to  monetise.  This  is  due  both  to  their  non-quantifiable  nature,  and  the  presence  of 
confounding factors which mean that lack of a basis for attributing causality cannot be isolated 
and  attributed  to  the  FA  Regulation  alone.  This  is  the  case  for  all  of  the  expected  benefits  for 
human  health,  animal  health  and  welfare,  and the environment:  for  all these aspects,  benefits 
were  analysed  qualitatively,  in  terms of  the  extent  to  which  they  are  considered  to  have  been 
achieved by the different groups of stakeholders, bearing in mind the need to attribute causality 
to the FA Regulation. Benefits generated by the FA Regulation could not be quantified because as 
they don’t arise directly in monetary terms, expressing them in such terms would requires a two-
steps  process:  a)  quantifying  them  in  physical  terms;  b)  converting  those  physical  quantities  in 
monetary  terms.  Both  steps  of  this  process  are  unfeasible.  To  quantify  in  physical  terms  the 
effects  of  the  FA  Regulation,  it  would  be  necessary  to  take  a  ‘with-and-without’  approach 
comparing  the  relevant  figures  in  the  ‘with’  scenario  (the  actual  scenario  in  which  the  FA 
Regulation and other relevant policy measures coexist), and in one  ‘without’ the FA Regulation 
but  with  all  the  other  relevant  policy  measures 
implemented  during  the  period  of 
implementation  of  the  FA  Regulation.  Unfortunately,  since  the  FA  Regulation  was  actually 
implemented, figures for the latter scenario are not available. For instance, it is not possible to 
associate the significant fall in antibiotic use in food-producing animals with the FA regulation as 
several  other  measures  have  impacted  this  reduction  such  as:  the  Commission’s  Action  Plans 
against  the  rising  threats  from  AMR  (2011-2016),  the  EU  One  Health  Action  Plan  Against  AMR 
adopted in 2017, the EU Guidelines on the Prudent use of Antimicrobials in Animal Health, and 
the different National Action Plans and Strategies. Furthermore, little or no relevant quantitative 
data are available. 

−  This analysis was  supported, where  possible, by evidence  provided on an exemplary basis (i.e., 
best examples of benefits actually obtained). Efforts were also made to collect more quantitative 
indicators of the benefits of the  FA Regulation for FeBOs and for MS Competent Authorities, in 
terms of potential costs savings and generated market value. Only in few cases, FeBOs provided 
data in terms of the share of regulatory costs as a percentage of production costs or turnover. 

−  Quantification of costs of human health, animal health and the environment: This is not possible 
as  linking  the  use  of  an  additive  with  a  certain  health  or  environmental  effect  having  costs  on 
health,  welfare  of  animals  or  the  environment  is  not  feasible  due  to  the  lack  of  a  basis  for 
attributing causality. This causality cannot be isolated and attributed to the FA Regulation alone. 
In addition, to assess the costs of the FA Regulation using the usual ‘with-and-without’ approach 
is unfeasible because no impact assessment and evaluation of the former 1970 FA Directive were 
performed before the adoption of the FA Regulation. With regard to the comparison of costs and 
benefits of the FA Regulation, it is necessary to notice again that neither the impact assessment 
nor the evaluation of the previous 1970 FA Directive has been performed before the adoption of 
that Regulation. As a consequence, it is not possible to calculate its cost effects by comparing the 
costs of the FA Regulation with the costs of the previous 1970 FA Directive using the usual ‘with-
and-without’  approach. As it is not  possible to calculate the costs effects of  the  FA  Regulation, 
obviously it is also not possible to compare in any way its costs and its benefits. 

Methodology for the analysis of costs  

112   Details on the methodology to make this estimation in FCEC Final Report, 1, EQ 1.5. 

68 

 
 
The  methodology  for  the  analysis  of  the  regulatory  costs  for  the  affected  stakeholders,  MS-MS 
authorities,  EU  institutions,  and  the  analysis  of  benefits  is  described  in  document  vii  Cost 
methodology (Annex 6 to the FCEC Final Report). 

−  Costs for businesses:  

✓  The  assessment  of  administrative  and  compliance  costs  stemming  from  the  FA 
Regulation was based on the identification of relevant obligations and required actions, 
as defined in the standard cost model (‘SCM’).  

✓  Costs for applicants are calculated on ‘business as usual’ (‘BAU’) and on additional basis. 
✓  Labelling  costs  for  BAU  are  negligible,  so  the  calculation  was  made  on  the  basis  of 

additional costs (BAU excluded). 

✓  The  obligations  defined  in  the  FA  Regulation  were  classified  in  accordance  with  their 
importance. Costs were monetised using the Eurostat dataset on mean annual earnings 
by economic activity and educational attainment [dataset: earn_ses14_30]113 for industry 
(except construction), as an average across the EU-28 and for each of the staff categories 
1 to 4 (adjusted for overhead costs). The use of the average EU-28 earnings neutralises 
the impact of the location of companies’ operations on costs. 

✓  The direct costs of the obligations were estimated as an average over the last three years 
2016-2018 on  the  basis of  detailed  information  provided  by  the  operators  on the  case 
studies  and  on  the  surveys  for  the  main  activities  identified  having  relevant  impact  on 
costs. 

−  Costs for MS: The SCM was followed to identify the administrative obligations, identification of 
target  groups  within  NCAs  that  perform  the  different  actions  (implementation  of  the  FA 
Regulation  and  control  activities),  frequency  of  required  action  (attendance  to  meetings  of 
SCoPAFF,  number  of  inspections  per  year/establishment),  identification  of  relevant  costs  and 
burdens  (attendance  to  SCoPAFF  meetings,  control  activities  and  other  legal  obligations).  The 
performance was assessed by the staff time114 devoted to these activities. It has been estimated 
as an average over the last three years by the NCA (2016-18).  

−  Costs  for  the  European  Commission:  The  SCM  was  followed  to  identify  the  administrative 
obligations,  the  frequency  of  certain  actions  (e.g.  attendance  to  meetings  of  SCoPAFF),  the 
identification of the cost parameters that refer only to labour costs, the data sources, i.e. SANTE 
database, Unit Management Plan to determine the  allocated human resources, EFSA database, 
Register  of  FA  and  SANTE  web  for  the  meetings  of  the  SCoPAFF.  The  costs  cover  BAU  and 
additional costs.  

−  Costs  for  the  EURL:  The  SCM  was  followed  to  identify  the  administrative  obligations,  the 
frequency of certain actions (SCoPAFF meetings), the identification of the cost parameters that 
refer only to labour costs, the data sources, i.e. EURL database, the unit resources dedicated to 
FA, and SANTE web for the meetings of the SCoPAFF. The costs cover BAU and additional costs. 

−  Costs for EFSA: The SCM was followed to identify the administrative obligations, the frequency of 
certain  actions  (EFSA  panel  and  working  groups  meetings),  the  identification  of  the  cost 
parameters  that  refer  only  to  labour  costs,  the  data  sources,  i.e.  EFSA  database,  and  the  unit 
resources dedicated to FA. The costs cover BAU and additional costs. 

Some important elements of the costs methodology are described in the tables below:  

113   Statistics | Eurostat (europa.eu) 
114   EUROSTAT average annual earnings in the public sector, by economic activity and educational attainment (staff categories 1 to 4), per 
Member  State  (latest  data:  2014),  adjusted for  overhead  costs (addition  of  25%) in accordance  with the  Better  Regulation toolbox 
#60. 

69 

 
 
Table 1: Identification of costs according to the Standard Cost Model (SCM) 

A.  TYPES OF OBLIGATION  
1.  Notification of (specific) activities or events  
2.  Submission of (recurring) reports 
3. 
Information labelling for third parties  
4.  Non labelling information for third parties 
5.  Application 

individual  authorisation  or 
exemption,  i.e.,  obligation  to  fulfil  each  time  a 
particular task has to be carried out 

for 

6.  Application 
exemption 

for  general  authorisation  or 

7.  Registration 
8.  Certification  of  products  or  processes, 

i.e., 
obligation  to  deliver  a  certificate  or  to  get  a 
certificate  
9. 
Inspection on behalf of public authorities  
10. Cooperation with audits & inspection by public 
including 

authorities  or 
their  appointees 
maintenance of appropriate records.  

11. Application for subsidy or grant  
12. Other 

B.  TYPES OF REQUIRED ACTION  
1.  Familiarising with the information obligation 
2.  Training members and employees about the 

information obligations 

3.  Retrieving relevant information from existing data 
4.  Adjusting existing data 
5.  Producing new data 
6.  Designing information material 
7.  Filling forms and tables (including recordkeeping 
8.  Holding meetings (internal/external with an 

9. 

auditor, lawyer etc.) 
Inspecting and checking (including assistance to 
inspection by public authorities) 

10.  Copying (reproducing reports, producing labels or 

leaflets) 

11.  Submitting the information to the relevant 

authority 

12.  Filing the information 
13.  Buying (IT) equipment & supplies to specifically 

used to fulfil information obligation. 

14.  Other 

Table 2: Obligations for FBOs, as defined in Regulation (EC) No 1831/2003 

The  purpose  of  this  table  has  been  to  provide  an  initial  understanding  of  the  importance  of  these 
costs  for  operators.  Source:  Agra  CEAS,  based  on  the  SCM  and  exploratory  interviews  with  the 
industry. 

OPERATOR 

OBLIGATION 

REFERENCE 
(REG. (EC) NO 
1831/2003) (A) 

Any  person  seeking  an 
authorisation 

Applicant 

Applicant 

Applicant 

Submit an application  

Authorisation 

Article 4 
Conditions for 
authorisation 

Article 5 
Application for 
authorisation 
Article 7 
Opinion of the Authority 

Adequate  and  sufficient 
demonstration  of 
the 
conditions set out  by  the 
FA Regulation 

Deliver 
the  necessary 
documents/data to EFSA 

the 

Deliver 
supplementary 
information  to  EFSA  (if 
requested)  

Article 8 

70 

IMPORTANCE 
(COST-WISE) 
(MAJOR/MINOR) 
(B) 
Minor 

Major 

Major 

Major/Minor 
(depends on 
questions or not 
from EFSA) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
The  holder  of 
authorisation 

the 

The  holder  of 
the 
authorisation/applicant 

Producer, 
packer, 
or 
importer, 
distributor  (within  the 
EU) 

seller 

Applicant 

Applicant 

Applicant 

MS 

Ensure  that  post-market 
monitoring  is  carried  out 
and submit reports to the 
Commission 
(rarely 
requested) 

Re-submit an application, 
if  changing  the  terms  of 
the  authorisation  +  data 
supporting  the  request 
for the change 

Responsibility  for  proper 
labelling actions 

Take  all  necessary  steps 
to  reach  agreement  on 
sharing 
of 
the 
information 

use 

Contribute  to  supporting 
the  cost  of  the  tasks  of 
Community 
the 
Reference 
Laboratory 
and  the  consortium  of 
Reference 
National 
Laboratories 

Adequate  and  sufficient 
information for renewal 

on 

MS  shall  lay  down  the 
rules 
penalties 
to 
applicable 
infringements  of  the  FA 
Regulation 

Supervision 

Minor 

Article 12(2) 
Modification, suspension 
and revocation of 
authorisations 

Major 

Article 13 
Labelling and packaging 

Article 16 
Data protection 

Major/Minor 
(depends on 
producer 
logistics) 

Minor 

Article 20 
Reference laboratories 

Minor 

Article 21 
Renewal of authorisation 

Major 

Article 14 
Penalties 

Article 24 

This is not a cost 
as such for 
operators. The 
analysis covered 
the extent to 
which penalties 
apply and 
severity of 
penalty. 

(a) 

(b) 

Article 10(2) of the FA Regulation (re-evaluation of existing products) and Article 15 of the FA Regulation (urgent 
authorisation): these aspects were not considered to incur ‘major’ costs by the industry. 
Minor/major costs in this context is meant to provide the relative importance of the costs (i.e., whether they constitute 
‘major’ or ‘minor’ costs for an operator).  

71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3 - Obligations for applicants 

ARTICLE / OBLIGATION 

4 (Submit an application) 
5 (Demonstration of conditions) 
7 (Deliver documents/data to EFSA) 
8 (Deliver supplementary info) 
12 (Ensure monitoring) 
13 (Re-submit application and data) 
14 (Renewal of authorisation) 

SUBMISSION 
OF FEES 

X 

X 
X 

SUBMISSION 
OF 
APPLICATION 
X 

DOSSIER PREPARATION 
AND COMPLETION  
(TESTS / STUDIES) 

X 
X 
X 

X 
X 

X 
X 

Table 4: Activities related to costs 

INTERNAL COSTS (A) 

EXTERNAL COSTS (B) 

Applicants:  

Staff time, by staff category (c): 
preparation of application dossiers 

•  authorisation costs 
(Article 4+10)  
•  renewal costs  

FeBOs:  

•  labelling costs 

Staff time, by staff category (c): 
label translation, redesign and 
application per label change 

•  Safety studies 
•  Efficacy studies 
•  External consultants 
•  Other costs (including 
post-monitoring) 

•  Purchase of equipment 

and services 

72 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

This Annex is not exhaustive in the response to the evaluation questions and intends to complement the main part of the document, in particular section 4. 

1. - EFFECTIVENESS  

1.1 REDUCE ANTIMICROBIAL RESISTANCE (AMR) THREATS TO ANIMALS, CITIZENS AND ENVIRONMENT. 
With the entry into force of the FA Regulation, the four remaining antibiotics still in use as growth promoters were taken off the EU market in January 
2006. 

Given the decreased use of specific antibiotics before and after the EU general ban from 1996 to 2008, some studies demonstrated a positive impact on 
the  reduction  of  AMR,  which  has  been  documented  in  various  EU  countries  (e.g.,  in  Denmark  from  1996  to  2008,  or  studies  conducted  by  WHO). 
Specifically, an overall positive impact of the ban of antibiotics in feed, previously used as FA in farm animals and humans, has been reported in some 
Scandinavian countries – e.g., Denmark and Sweden (Grave et al., 2006; DANMAP, 2009a,b; SVA, 2009, 2010, 2011; DANMAP, 2011)115. 

After  the  ban,  despite  initial  promising  observations  showing  a  reduction  in  the  antibiotic  resistance  (Boerlin  et  al.,  2001),  larger  data  sets  were  not 
initially indicative of a decrease in multi-resistance of the livestock species of concern in the Netherlands (MARAN, 2012). Later, however, the same 
author reported some reductions (MARAN, 2015) in relation to changes in the use of antimicrobials, but mainly as veterinary drugs116.  

Although the antibiotics authorised by the former 1970 FA Directive were addressed to food-producing animals, companion animals due to their close 
contact  with  humans  may  contribute  to  spread  AMR  to  humans.  Use  of  antimicrobials  that  are  critically  important  for  human  health  in  companion 
animals is an additional risk factor for emergence and transmission of antimicrobial resistance117. This risk is limited by the pre-market assessment. 

In addition, the Commission has withdrawn or denied the authorisation of five additives and applicants withdrew applications for which they were unable 
to provide the necessary proof of absence of antimicrobial resistance development. 

115   https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4666  
116   https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2017.4666  
117   Reflection paper on the risk of antimicrobial resistance transfer from companion animals. 15 January 2015 EMA/CVMP/AWP/401740/2013. 

73 

 
 
 
Furthermore, although a post-market monitoring for microorganisms used as FA is not required for all microorganisms as such, EFSA examined carefully 
this  aspect  as  they  may  have  antimicrobial  resistance  effects.  In  the  15  renewals  carried  out  from  2019-2021,  no  safety  hazards  or  issues  have  been 
noticed by EFSA in  relation to  AMR.  The effect  of the more comprehensive and harmonised post-market  monitoring for certain  FA118 to  prevent  the 
development of antimicrobial resistance could not yet be assessed. Applicants have to provide information on post-market monitoring in their application 
for renewal  of the authorisation (which has to  be submitted at  the latest  1 year before  the end of the 10-year period of authorisation). At present, the 
renewal  process  for  the  concerned  additives  is  ongoing  or  has  not  started  yet.  For  all  coccidiostats  authorised,  a  post-market  monitoring  the  PMM  is 
ongoing, but the results are not yet available. 

The  ban  of  antibiotics  as  FA  encouraged  innovation  in  FA  by  developing  alternatives,  acting,  in  the  majority  of  cases,  on  the  beneficial  interaction 
between  the  microbiota  (mainly  gut  bacteria)  and  host.  During  the  2004-2021  period,  99  new  additives  (84  “gut  flora  stabilisers”  and  15  “other 
zootechnical additives”) were authorised for this purpose. 

Some important insights have already been gained about how the microbiota might have an influence on a number of disease processes, both within and 
distant from the gut. 

In addition, the ban of antibiotics as FA is accompanied by a general trend in the reduction of antibiotic sales for therapeutic use, as proved by the data 
from ESVAC (European Surveillance of Veterinary Antimicrobial Consumption). Back in the 2005-2009 surveillance, a certain decrease in the antibiotic 
sales was evident, although not for all active substances and homogenously in all EU countries. This trend was confirmed in the following years119. The 
FA  Regulation  has  been  effective  in  banning  antibiotics  as  growth  promoters,  in  reducing  the  risks  of  placing  additives  having  AMR  effects  on  the 
market through pre-market assessment and renewals of authorisations, in encouraging innovation reducing the need for antibiotics for therapeutic use. 
The results of the Public Consultation recognised the suitability of the FA Regulation, for its contribution to reduce AMR has been confirmed.  

1.2 SIMPLIFY AND HARMONISE THE FA AUTHORISATION PROCESS  

The new measures defined by the FA Regulation were addressed to modify the 1970 FA Directive’s procedures which were considered too complicated 
and not always predictable. Furthermore, the need for simplification, harmonisation, and better predictability of the procedures were addressed to reduce 
administrative burden. The FA Regulation aimed at setting an EU authorisation procedure and detailed common rules for applications so as to permit a 
comprehensive assessment of all aspects that may affect safety and efficacy of FA. 

118   To trace and identify any direct, indirect, immediate, delayed, or unforeseen effects applies in particular to all coccidiostats and histomonostats. For the time being, no request for 

authorisation of histomonostats have been submitted or authorised.  

119  https://www.ema.europa.eu/en/documents/report/trends-sales-veterinary-antimicrobial-agents-nine-european-countries_en.pdf  

74 

 
 
The FA Regulation introduced a series of provisions to set: 

−  single and harmonised procedures for the authorisation, renewal and modification of authorisation of FA,  

−  an EU-level centralised and independent risk assessment performed by EFSA, 

− 

the definition of timelines and steps to be respected in the procedures, 

−  more comprehensive and detailed rules to prepare application dossiers, including an application form120, 

−  a  well-structured  system  to  categorise  FA  according  to  their  properties  and  the  functions  that  they  perform,  i.e.,  safety  and  efficacy  criteria 
accompanied  by  a  precise  definition  of  categories  and  functional  groups  (e.g.,  nutritional  additives  as  a  category  that  includes  different  functional 
groups: vitamins, amino acids or trace elements). 

In addition, the FA Regulation introduced a comprehensive set of safety/efficacy criteria which are defined according to clear categories and functional 
groups.  This  seeks  to  provide  clarity  to  applicants  on  classification  and  facilitate  safety  and  efficacy  assessment  by  designing  specific  requirements 
adapted to each specific functional group or category, when required. 

The new provisions have some clear positive effects on the achievement of the objectives:   

−  extend the assessment to new functional groups (Evaluation Matrix (EM)1.1.1)). 

−  ensure full assessment for 432 applications (EM 1.1.2) of which, 140 corresponded to silage additives, urea and amino acids. 

−  ensure  that  1,743  additives,  which  were  placed  on  the  market  by  the  former  FA  Directive,  are  totally  or  partially  withdrawn  as  there  is  not 

comprehensive safety/efficacy assessment performed (EM 1.1.4 and 1.1.5). 

Commission  Regulation  (EC)  No  429/2008  includes  detailed  rules  concerning  the  preparation  and  the  presentation  of  applications.  EFSA  developed 
guidance documents to further assist applicants in the preparation of dossiers by introducing more detailed information and requirements. Technological 
and scientific progress triggered the adoption of new or revised EFSA guidance over the time (including new requirements), which however may have 

120 Commission Regulation (EC) No 429/2008. 

75 

 
 
increased the complexity of the process, and ultimately, could lead to increased delays in preparing dossiers for some applications (see table 1 on EFSA 
guidance changes and related impact). This is the case in particular of the EFSA Guidance on the assessment of the safety of FA for the environment and 
the  Guidance  on  the  characterisation  of  microorganisms  used  as  FA  or  as  production  organisms,  which  impacted  many  applications.  However,  other 
EFSA guidance documents were revised in order to reduce the number of required studies or data, resulting in a beneficial impact for applicants. 

Table :1 Overview of the changes in EFSA guidance and their consequences: 

DATE OF 
ADOPTION 
OF THE 
NEW 
MODIFIED 
GUIDANCE 

26/09/2017 

GUIDANCE 

Guidance on the 
assessment of the 
safety of FA for the 
target species 

27/09/2017 

Guidance on the 
assessment of the 
safety of FA for the 
consumer 

MODIFICATIONS INTRODUCED IN RELATION TO THE 
FORMER GUIDANCE 

NUMBER OF FAD 
APLICATIONS AFFECTED BY 
GUIDANCE CHANGES 

The modifications done in the guidance were clearly focused on trying to 
reduce the number of studies generated by the applicant in the target 
species either by establishing a clear list of exceptions (some of those 
where already considered in the previous guidance, e.g., QPS micros), 
including approaches to use already existing data, toxicological data or by 
broadening the extrapolation rules (with the exception of fish). There is a 
benefit in terms of reduction of studies for the applicants (overall). 
No major modifications regarding the dataset needed, some more waivers 
for data were considered (e.g., enzymes produced by a QPS) Nearly no 
impact compared to the previous guidance or reduction in the need for 
studies. 

Around 160 applications121 since 
implementation of the guidance 
(around 40% of the total number of 
applications) 

Around 160 applications since 
implementation of the guidance 
(around 40% of the total number of 
EFSA applications) 

121   This  refers  to  applications  processed  by  EFSA  (‘FAD’  applications).  These  applications  do  not  correspond  to  the  administrative  applications  (SANTE  applications)  as  for  one 
SANTE application there may be more than one FAD numbers. Each time the Commission asks for an opinion to EFSA for a specific SANTE application, EFSA allocates a new 
FAD number. The current informatics system does not allow to systematically link EFSA (FAD) applications with SANTE applications. 

76 

 
 
GUIDANCE 

Guidance on the 
identity, 
characterisation and 
conditions of use of 
FA  
Guidance on the 
characterisation of 
microorganisms used 
as FA or as production 
organisms 

21/02/2018 

17/04/2018 

27/02/2019 

Guidance on the 
assessment of the 
efficacy of FA 

Guidance on the 
assessment of the 
safety of FA for the 
environment  

DATE OF 
ADOPTION 
OF THE 
NEW 
MODIFIED 
GUIDANCE 

MODIFICATIONS INTRODUCED IN RELATION TO THE 
FORMER GUIDANCE 

NUMBER OF FAD 
APLICATIONS AFFECTED BY 
GUIDANCE CHANGES 

27/09/2017 

Nearly no impact compared to the previous guidance.  

Around 400 applications since the 
implementation of the guidance (all 
EFSA applications) 

Around 200-230 applications (60-
70% of all dossiers) since the 
implementation of the guidance  

Around 190 (around 60%) of EFSA 
applications since the implementation 
of the guidance 

Around 25 (10%) EFSA applications 
since the implementation of the 
guidance  

The major modifications done affected three main aspects, introduction of 
the WGS based data for the characterisation of bacteria and yeasts 
(recommended for fungi) and need to use the data to the relevant chapters 
of the guidance, namely: identification, characterisation of the strain in 
terms of AMR and toxins and virulence factors, structure of the genetic 
modification and provision of the raw data, the update on the MIC values 
for the antimicrobial susceptibility and the modifications related to the 
testing on the absence of cells and DNA. Increased requirements in the 
generation of the data which may address relevant aspects of the safety of 
the products (e.g., AMR). 
Reduce the amount of studies/data by establishing clear rules on the use of 
already existing data/authorisations (some already taken in previous 
guidance documents) and broadening the extrapolation rules. There is a 
benefit in terms of reduction of studies for the applicants (overall). 
The tiered approach is considered. The new guidance may have increased 
the requirements in the generation of the data. 

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The major business organisations raised this issue of updated guidance in the Roadmap consultation and also in the context of re-evaluation of FA 
(Article 10(2))122. Mitigation measures set up by EFSA to reduce the negative effects of those revisions are: 

−  procedures  set  up by EFSA to  engage FeBOs  during the development  of guidance documents contributing to  facilitate better understanding  of 

− 

new demands and to provide inputs by FeBOs. 
the pre-submission advice mechanism (Article 32a of the GFL) allows EFSA to explain any novelties before an application is submitted (since 27 
March 2021). 

−  access to dedicated support for SMEs from EFSA when preparing, submitting and monitoring their applications. 

Timelines set up by the FA Regulation were considered appropriate by a majority of MS authorities (see Annex V), whereas there was a low response 
rate from other stakeholder groups and their opinions were divided (see Annex V). 

A large majority of the respondents agreed on the effectiveness of the new simplification and harmonisation rules, especially due to the centralised 
procedure (PC, NCA survey ), however a loss in the procedural smoothness 123 has been noted.  

1.3 ENSURING A RIGOROUS RISK ASSESSMENT  

The immediate consequence of developing a rigorous risk assessment is the placing on the market of safe additives. 

The new elements improving risk assessment introduced by the FA Regulation are the independent assessment carried out by EFSA, the separation 
between evaluation and management and the general principles and procedures laid down in the General Food Law. Altogether, the implementation of 
those elements led to the achievement of specific objectives related to a rigorous FA risk assessment. This is supported by the results of the surveys124 , 
not only for food-producing animals, but also for pets. (See PC, SH survey and NCA survey). More specifically, a strong consensus (80% or more) was 
identified for a rigorous assessment for consumers, animals, workers and environmental safety. As regards efficacy, a majority of users of FA (53 out of 
63) consider that FA are efficacious. 

The FA Regulation lays down a comprehensive set of safety requirements to fill the gaps of the previous 1970 FA Directive affecting all additives or 
certain groups of additives: 

122   FCEC Final report, Judgment criteria: EQ9.2: “A majority of stakeholders consider that the reauthorisation (Article 10 2) process has helped adapt future renewal of authorisations 

to new requirements”. 

123   FCEC Final report, EQ 7, Judgment criteria: “Relevance of the simplification of the feed additive authorisation process in comparison to the previous process under the directive”. 
124   vii Consultation Synopsis Report sections, pages 8, 19, 26 and 27. 

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−  amino acids (were partially evaluated by Directive 82/471/EEC125 ) and silage additives were not evaluated before. Both were not under the scope 

of the former 1970 FA Directive. 

−  as  for  enzymes  and  microorganisms,  some  gaps  were  addressed  by  requesting  more  data  to  complete  the  safety  assessment,  in  particular 

concerning transfer of resistance to antibiotics, risk to consumers and risk for the environment and workers. 

−  as  for  all  the  vitamins,  except  vitamin  A  and  D,  there  were  no  safety  assessment  in  the  former  FA  Directive.  The  same  applies  for  many 

colourants and the majority of flavourings. 

−  as for coccidiostats and histomonostats, the FA Regulation introduced new criteria to assess the risk of antimicrobial resistance. 
−  as  for  FA  intended  for  pets,  the  FA  Regulation  introduced  the  obligation  to  carry  out  studies  for  chronic  toxicity,  mutagenicity  and 

carcinogenicity. This concerned 1.017 additives. 

−  comprehensive worker safety requirements for all additives. 

The achievement of the objective is supported by several indicators. The most relevant are listed below:  

− 
− 

− 

few RASFF126 notifications (EM 1.2.7); 
the presence of safe FA on the market has increased: new substances are fully evaluated as FA (EM 1.2.1), this corresponds to 458 applications 
(EM 1.2.2) and 1,136 additives (EM 1.2.4); 
the  presence  of  efficacious  additives  has  increased  on  the  market:  substances  are  fully  evaluated  as  FA  (EM1.1.1),  this  corresponds  to  300 
applications of existing additives under the former 1970 FA Directive (EM 1.1.2); 

−  1,623 additives are out of the market as they were not assessed for safety and/or efficacy according to the new requirements (EM1.1.4 and 1.1.5); 
−  eight Regulations were adopted to achieve this aim (EM 1.1.6).  In addition, 120 additives were totally or partially withdrawn by applicants. In 

total 1,743 additives;   
− 
five requests of administrative review of EFSA evaluation were dismissed (EM 1.5.1); 
−  1,017 additives intended for pets are now fully evaluated for safety and efficacy (EM.1.2.8). 

During  the  period  2004-2020,  the  RASFF  notifications  showed  the  level  of  compliance  as  for  the  presence  of  FA  or  their  residues  in  food  of  animal 
origin. 82 notifications – out of 16,634 – were linked to the presence of unauthorised additives or a high level of residues. This represented 0.5% of the 
total number of notifications. As regards RASFF notifications for the period 2004-2017, out of a total of 517 notifications on feed only seven relate to FA 
and five to premixtures. These represented 2.3´% of the total number of feed notifications (EM 1.2.7). 

125   Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition. Official Journal L 213, 21/07/1982, p. 8. 
126   ii FA Final Report _FCEC page 31. 

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Some elements of the safety assessment performed by EFSA are recognised in the authorisation process carried out by some third countries such as Chile, 
Canada or China. The industry also indicated that EU approvals are generally a major advantage for  fast-track registration of EU products imported in 
many other parts of the world, particularly in the SE Asian and in African regions127. The main element in EU authorisation lies on the credibility of the 
safety and efficacy assessment performed by EFSA, which is recognised not only at EU level but at international level as well. 

1.4 SET UP CLEAR /COMPREHENSIVE RULES FOR THE AUTHORISATION AND LABELLING OF FA (OBJECTIVE 4) 

1.4.1 Duration of authorisation period 

The unlimited authorisation period and other types of authorisations set up in the former 1970 FA Directive has been replaced by a 10-year authorisation 
that simplified the authorisation process and allows for a timely reassessment of the safety of FAs, as scientific knowledge  of their effects and impacts 
evolves. It was expected that this time limit would also encourage the development of FAs with a better safety and/or efficacy profile. As to the 10-year 
authorisation  being  efficient  in  promoting  the  placing  on  the  market  of  innovative  additives  with  a  better  efficacy  profile128,  the  majority  of  MS 
authorities (17 out of 27) considered to be adequate, although some comments, from those that disagree or did not provide response (don’t know), noted 
that this period could not encourage innovation for SMEs. Stakeholders are divided but business associations and feed additive producers deemed that 
this period is too short for innovative additives that entailed a high investment. The 10-year authorisation period was perceived as effective for safety 
purposes by a slight majority of MS authorities (17 out of 27). Six MS authorities did not respond and 4 disagree. Stakeholders (mainly FeBOs) were 
divided on the adequacy of this period. Some  MS authorities, business  associations  and  companies mentioned the possibility to  extend the period for 
additives with a long history of safe use. 

To  summarise,  the  10-year  authorisation  period  was  perceived  as  effective  for  a  slight  majority  of  MS  authorities,  although  for  stakeholders  (mainly 
FeBOs)  opinions  on  this  issue  were  divided.  In  both  groups,  there  are  voices  claiming  for  a  longer  period  in  the  case  of  additives  with  a  high  safety 
profile. The promotion of innovation is not perceived as effective for the industry, especially in the case of new FA. In addition, for some MS authorities 
the period reduces innovation for SMEs for which the effort to invest in getting authorisation for novel FA does not compensate the revenues. 

1.4.2 Authorisation procedures 

As regards effectiveness of the different authorisation procedures, the following elements should be considered. 

127   ii FA Final Report _FCEC, page 69. 
128   ii FA Final Report _FCEC pages 122-123. 

80 

 
 
The  different  steps  in  the  authorisation  procedure  were  analysed  to  identify  what  elements  drive  or  hinder  effectiveness.  In  some  cases,  there  is  a 
segregation of data depending on whether we refer to applications for a new authorisation (Article 4) or for re-evaluation Article 10(2). The consequences 
on possible delays in the authorisation are different since as regards applications under Article 4, the additive is not yet on the market whereas for those 
under Article 10(2), the additives are already on the market as they had been authorised by the former 1970 FA Directive. For FeBOs, the impact  on 
effectiveness is much higher if some delays occur for an application under Article 4 as they may lose competitiveness.  

1.4.2.1 The authorisation procedure in the context of Article 4 (new authorisation) and Article 10(2) (re-evaluation of existing products) 

The main steps in the authorisation process are summarised below129. 

−  Completeness check (30 working days to validate the dossier by EFSA): 31 working days for nearly half of dossiers submitted under Article 
4(1); and one third of dossiers submitted under Article 10(2). For the remaining dossiers, the completeness check is carried out within 41 working 
days (EM 1.3.3). The completeness check is in general effective as no major delays are incurred. 

Completeness check is the time from the date of reception of the mandate from the Commission  until the consideration that the application is 
valid. EFSA verifies that all the information has been submitted by the applicant. It is a formal verification (the quality of the information is not 
verified). If there is missing information, EFSA requests the applicant to provide it. 30 working days is the period established by EFSA for this 
verification. This is not a legal deadline but an administrative deadline. In practice, the period runs from 31 working days to 41 working days (EM 
1.3.3). 

Table 2: Time for completeness check 

PERIOD FOR 
COMPLETENESS 
CHECK 
31 days 
32-35 days 
31-35 days 

ARTICLE 4(1) 
APPLICATIONS 

ARTICLE 10(2) 
APPLICATIONS 

47% 
34% 
81% 

32% 
39% 
71% 

The time periods are not too impactful and are closed to the 30 working days administrative deadline. 

129   FCEC Final report and SANTE database. 

81 

 
 
 
−  Assessment period by EFSA (6 months): The average period taken for EFSA to issue its opinion was 438 days for Article 4(1) applications and 
830 days for Article 10(2) applications. Only 20% of all opinions issued under Article 4(1) and 12% of all opinions issued under Article 10(2) are 
in accordance with the six-month deadline. The average time period does not reflect the situation for a large number of applications.  

Assessment period is the time since the application is considered valid until the opinion is adopted by the FEEDAP panel. The legal deadline for 
this period is 6 months, which is extended whenever EFSA seeks supplementary information from the applicant. 78% of applications for new FA 
and 88% of applications for re-evaluation of authorised FA suffered delays during this process caused by missing and/or incomplete information 
presented in the application dossiers. Incomplete dossiers triggered the request for additional information by EFSA130 (IL1.3.4).  

Table 3: Time for adoption of EFSA opinion  

EVALUATION PERIOD 
(EM 1.3) 

ARTICLE 4(1) 
APPLICATIONS 

ARTICLE 10(2) 
APPLICATIONS 

6 months 
>6-8 months 
>8-12 months 
>12-18 months 
>18 months 

22% 
13% 
19% 
20% 
27% 

12% 
4% 
9% 
16% 
59% 

Despite these time periods, applicants consider that they have sufficient time to respond to the questions from EFSA (EM1.3.7). 

−  Commission  decision  issued  within  a  reasonable  deadline  (6  months).  On  average,  the  time  taken  extends  by  about  additional  189  days 
(roughly 6 months) for Article 4(1) applications and additional 379 days (roughly 12 months) for Article 10(2) applications. The average period 
thus is 12 months for Article 4(1) and 18 months for Article 10(2). The average time period does not reflect the situation for a large number of 
cases: as for Article 4(1) applications, 37% of the decisions are published in the  Official Journal of the EU within 180 days since the moment 
EFSA opinions are issued and 41% within ≥6-10; for Article 10 (2) applications, the 6 months deadline is met in 31% of authorisations and 15% 
of  the  cases  within  ≥6-10.  The  time  periods  may  be  explained  by  the  frequency  level  of  the  PAFF  Committee  meetings,  besides,  some 
authorisations are complex and require several discussions at the PAFF Committee and the procedural steps for the publication and adoption by 

130   “Stop the clock” mechanism, referred to in Article 8(2) of the FA Regulation. 

82 

 
 
 
the Commission are time consuming131. For Article 10(2) applications, the Commission grouped different ones for the same additive to reduce 
administrative burden and this may explain part of the longer time periods of Article 10(2) applications compared to those under Article 4(1) (EM 
1.3.6). 

The  time  periods  in  the  re-evaluation  of  FA  are  also  explained  by  the  implementation  of  the  provision  set  out  in  Article  10(2)  by  which  the 
Commission  sets  out  a  detailed  calendar  (in  consultation  with  EFSA)  listing  in  order  of  the  priority  the  different  classes  of  additives  to  be  re-
evaluated. This measure was included in the FA Regulation as the deadline to present the applications for re-evaluation of FA authorised without a 
time limit was 8 November 2010 and it was expected that the majority of the applications would occur around that date. This would not allow 
EFSA and the Commission to process all the applications in this short period of time. This prioritisation differed the authorisation period for some 
additives such as colourants or flavourings that were not considered as first priorities.  

There  is  no  legal  deadline  for  the  time  between  adoption  of  the  EFSA’s  opinion  and  publication  in  the  EFSA  Journal,  but  an  administrative 
deadline of 25 working days has been established. 

Table 4: Time publication in the EFSA Journal 

PUBLICATION PERIOD 

25 working days  

ARTICE 4(1) 
APPLICATIONS 
90% 

ARTICLE 10(2) 
APPLICATIONS 
87% 

Overall, these time periods are not considered limiting the effectiveness  of the authorisation process and EFSA complies satisfactorily with the 
expected deadlines. 

In the risk management process, there are three steps: 

1.-  The  period  since  the  application  is  submitted  until  EFSA’s  opinion  is  requested  by  the  Commission.  For  this  period  there  is  no  statistical 
information available, but an estimation was made and in the majority of the cases the letter to request complementary information is sent within one 
month. Sometimes there are delays if the applicant does not send the complete application or there are formal aspects not respected (e.g., application 
not signed). There is no legal deadline for this period. 

131   7-21 days after positive conclusion at the SCoPAFF to process the outcome of the vote, 25-37 days translations and Cabinet agreement, 12-13 days adoption by the College and 

publication in the Official Journal of the EU. 

83 

 
 
2.- The period since the Commission receives the opinion from EFSA (normally two or three days before its publication in the EFSA Journal) until it 
prepares a draft authorisation Regulation, the Commission has in principle a legal deadline of three months, which is respected in more than 95% of 
cases. The time period beyond the three months may result from the fact that during the Christmas and summer period the SCoPAFF is not convened 
so frequently. 

3.-The period since the draft proposal is discussed for the first time in the SCoPAFF until the authorisation Regulation is published in the Official 
Journal of the EU. This information is not available, therefore, the reference to calculate the  time periods is the period from the publication of the 
EFSA’s opinion in the EFSA Journal until the authorisation Regulation is published in the Official Journal of the EU (see below). 

A reasonable time period since the EFSA opinion is published until the authorisation Regulation is published in the Official Journal is six months. For 
37% of new applications the 6 months period is respected and for 41% the period is ≥ 6-10 months (see table below). In addition to the discussions at 
the SCoPAFF, the time required for the procedural steps between voting in the Committee meeting, adoption by the Commission and publication in 
the Official Journal, is 5 to 7 weeks on average132. 

Table 5: Time for the publication of the authorising Regulation in the Official Journal 

PERIOD 

6 months  
≥6-10 months 

ARTICLE 4(1) 
APPLICATIONS 
37% 
41% 

ARTICLE 10(2) 
APPLICATIONS 
31% 
15% 

Time periods for the whole process 

The time periods in the authorisation procedures are very relevant for the assessment process as the missing and/or incomplete information presented in 
the dossiers triggered the request of additional information by EFSA (“stop the clock”). A substantial majority of dossiers submitted by applicants (78% 
of  applications  for  new  authorisations  under  Article  4(1)  and  88%  of  applications  for  re-authorisation  under  Article  10(2))  present  important  missing 

132   7-21 days after positive conclusion at the SCoPAFF’s meeting to process the delivery of the formal opinion of the Committee, 25-37 days for the translations of the draft act and 

obtaining the Cabinet’s agreement, 12-13 days for the adoption by the College and publication in the Official Journal of the EU. 

84 

 
 
 
and/or incomplete information during the assessment. This triggered the clock stopping process 1,320 times in the 2004-2017 period, with an average of 
1.73 requests for complementary information per finished dossier during this period133.  

The FA Regulation allows an extension of the authorisation period until the adoption of the renewal measure, provided that the application for renewal 
has been submitted in due time and that the applicant cooperates properly during the process (cfr. EFSA’s requests for complementary information). 

Missing and/or incomplete information in application dossiers can be explained by the following: 

−  Applicants are not familiar with the EFSA guidance or with the changes of EFSA guidance. That guidance can provide a strong support in the 
development  of  studies  but  cannot  substitute  the  interpretation  of  the  guidance  itself  and  the  appropriate  study  design  made  by  the  applicant. 
These issues tend to  be  more common in  the case of efficacy studies, due to  the complexity involved, especially for innovative  FA  where the 
design of studies and end points to consider are challenging.  

−  Applicants claimed that the lack of pre-submission meetings with EFSA to clarify uncertainties or queries limited their capacity to prevent future 
shortcomings.  In  this  regard,  the  2019  amendment  of  the  General  Food  law  (Regulation  (EU)  2019/1381,  so-called  “the  Transparency 
Regulation”) provided for the possibility of pre-submission advice (Article 32a of the General Food Law) on the rules applicable to, and on the 
content  required  for,  the  application,  and  prior  to  its  submission.  This  should  mitigate  the  concerns  expressed  by  applicants  although  it  is 
premature to know the results of that new mechanism.  

−  Lack of experience in preparation of dossiers for additives that were never evaluated is another reason considered for this issue. It can be the case 
for the re-evaluation of several colourants or botanical flavourings that were not previously assessed as they were authorised by the former 1970 
FA Directive under a generic entry including many substances that were not identified (e.g., other colourants). For example, characterisation of 
botanical flavourings required a huge effort to applicants as those substances may contain more than 30 components and there was not much data 
in  literature  on  the  composition  of  those  additives.  As  a  consequence,  a  full  analysis  needs  to  be  performed  by  applicants.  For  colourants,  the 
method of analysis was a big challenge due to its complexity. 

Even though the timelines for the different steps were considered reasonable, it was noticed that the authorisation procedure suffered from some delays, 
especially in the assessment process, but also, to a lesser extent, in the management procedure. 

1.4.2.2 Renewal of authorisation (Article 14)  

Almost all applications (for the period 2017-2021134, 64 out of 65) required an extension beyond the one-year deadline provided in the FA Regulation for 
their authorisation.  The average time for the EFSA assessment period was 314 days, which  exceeds the normal  period of 6 months by 134 days. The 

133   ii FA Final Report _FCEC, page 37. 

85 

 
 
number of “stop the clock” set up for 65 applications was 91 times, with an average of 1.4 times per application. Only 5 out  of 65 applications did not 
require a “stop the clock” (EM 1.3.8 and 1.3.9). 

1.4.2.3 Incentivise applicants regarding minor species and extrapolation to minor species. 

The procedure for extrapolation from major to minor species allows to extrapolate the results of data generated for a major species (e.g., chicken) to a 
minor species (e.g., quail), avoiding duplication of relevant tests. The FA Regulation provides also for incentives to applicants requesting an authorisation 
for minor species to extend the data protection period by one additional year for each minor species for which a use extension authorisation is granted. 
The extrapolation however presents limitations since it cannot be considered for species that are physiologically different. The extrapolation is possible, 
for example, from a chicken for fattening to a guinea fowl for fattening but it is not possible from a chicken to a rabbit. There are minor species that do 
not have a counterpart as “major species” (snails species, insects species or rabbits). In that case, a complete set of studies is required as regards the minor 
species considered and the sole incentive is related to the extension of the data protection period.  

The extension of the use of additives from major to minor species is an important aspect to give full coverage to additives intended for animals of low 
economic interest (see glossary). This extension was promoted in the FA Regulation: 

−  by extending the data sharing protection one additional year for each minor species for which the authorisation is granted  
−  by setting up the principle of extrapolation to facilitate that extrapolation in the Commission Rules for Applications (Regulation (EC) 429/2008) and 
EFSA  guidance.  This  extrapolation  has  limitations  as  it  is  only  possible  for  species  that  are  physiologically  comparable  (e.g.,  laying  hens  can  be 
physiological comparable to other laying poultry animals from the following species guinea fowl, geese, quail or pigeons). 

The procedure to request extrapolation from major to minor species did not work well135, according to stakeholders -mainly FeBOs- (SH survey and EM 
1.3.11) The reasons are the following:   

− 

− 
− 

the target market is limited and the needs to extend the use of additives to those species are not well understood, there is  a lack of involvement of 
users further down the chain in the process to ensure that minor species of interest are covered by an application.  
it requires investment in data generation and the users does not contribute to the costs.  
the return on investment is not clear, in particular for small markets. 

134   The period 2017-2021 has been selected as the majority of renewals occurred as from 2017. 
135   ii FA Final Report _FCEC, page 43. 

86 

 
 
Some MS authorities (NCA survey) share some SH views, although the extrapolation worked well according to 18 MS authorities. Some MS authorities 
noted that extrapolation is difficult for some pets as they are physiologically different from other species or for those species that do not have a 'major 
species' counterpart (so-called ‘orphan species’, e.g., insects, snails, rabbits). For some species such as rabbits, there is consequently a limited number 
of  specific  FA  (e.g.,  zootechnical  additives)  available.  One  NCA  indicated  that  the  assessment  of  efficacy  should  not  be  an  obstacle  to  extend  the 
authorisation to minor species, as long as safety is ensured. 

The FA Regulation was not successful in promoting the authorisation of additives intended to those minor species, considering that where extrapolation 
was not possible, applicants were not sufficiently incentivised by the one-year extension of the data protection period, lacking a guarantee of return on 
investment. The extrapolation as such has not been either successful and there is room for improvement in the Commission  Rules for Applications for 
increasing the possibilities of extrapolation for efficacy. Applications in order to facilitate the extension of applications for certain species or categories of 
animals to physiologically similar minor species having equivalent age or type of production (fattening, laying etc.).  

1.4.2.4 Extrapolation from food to feed 

A majority of applicants (23 out of 43) consider that the extrapolation from food to feed does not work well (EM 1.3.10, SH Survey). On the contrary, for 
MS authorities a small majority consider that it works well (16), whereas eight remain neutral and one is against this statement (NCA Survey). The major 
exposure of animals to the additive compared to the human exposure does not allow, for safety reasons, to make extrapolation from food to feed in many 
applications136. This is an aspect for which there is no room for manoeuvre. For efficacy studies, the extrapolation works well for flavourings but there is 
room for improvement for other functional groups, providing that the specifications of the additive and the function that the additive performs in food and 
feed are the same. 

1.4.3 Other provisions that may create some burden and/or may reduce effectiveness in the authorisation and placing on the market of FA 

1.4.3.1 Water for drinking 

The coherence of the provisions related to the use of additives in drinking water should be assessed on the one hand, the definition of FA refers to this use 
for all additives but on the other hand this use is restricted to certain functional groups in Article 6 and in Annex I of the  FA Regulation, which set the 
definitions of the categories and functional groups of additives. In the definition of certain functional groups, the function of the additive refers only to its 
effect on feedingstuffs but not on water, such as acidity regulators which are described as substances which adjust the pH of feedingstuffs, while nothing 
is mentioned about their effect on drinking water. For 789 flavourings, the applicants withdrew the application for use in water for drinking. The different 
feeding/drinking  systems  introduced  technical  challenges  in  its  implementation.  The  distinction  in  the  routes  of  administration  for  liquid  feed  (to  use 

136   ii FA Final Report _FCEC, page 40  

87 

 
 
complementary feed) and for water for drinking (to use additives) is not evident in some feeding systems and this may create different interpretations in 
the MS137. During the 2004-2017 period, those questions were raised several times (35), directly or indirectly, at the level of SCoPAFF. Those aspects 
have been noticed by some MS authorities and by stakeholder –mainly FeBOs- (PC).  

1.4.3.2. Data sharing 

Data  sharing  between  applicants  will  reduce  tests  and  costs  of  applications  and  will  be  consistent  with  the  EU  policy  on  animal  welfare.  The  FA 
Regulation lays down requirements for data sharing to prevent repetition of toxicological tests on vertebrates (Article 20).  The applicants must take all 
the  necessary  measures  to  reach  an  agreement.  If  such  an  agreement  is  not  reached,  the  Commission  may  decide  to  disclose  the  information  while 
ensuring  a  reasonable  balance  between  the  interests  of  the  parties  concerned.  The  FA  Regulation  does  not  provide  the  Commission  with  tools  or 
mechanisms to ensure a reasonable balance between the parties. Consequently, few requests of data sharing occurred (three) and it was not possible to 
draw any conclusions. In the PC two thirds of respondents were not able to indicate whether or not data sharing rules are effective in reducing costs and 
animal testing. Those that have a negative view, have three different arguments: data sharing is not fully exploited, there is room for reduction of costs or 
the market should decide. Nonetheless, some of these respondents argued that data sharing is a useful concept for reducing costs138. 

1.4.3.3 Applicant’s withdrawal of application during the renewal process 

There is no sufficient information for FeBOs about the renewal process – e.g., if an applicant has withdrawn the application during its assessment. This 
created  a  certain  level  of  unpredictability  for  the  feed  chain  on  the  availability  of  FA.  The  applicant  for  renewal  must  introduce  the  application  for 
renewal  at  the latest  one year before its expiry, FeBOs know if this  application has been submitted once EFSA processes the application (Register of 
questions) or where an indication is introduced in the Register of FA that an application for renewal has been submitted (this could take some time). In 
addition,  if  an  applicant  withdraws  the  application  during  the  assessment  process,  the  additive  must  be  immediately  withdrawn  from  the  market,  but 
FeBOs are not informed in advance, so they do not have time to react.  On the occasion of certain SCoPAFF meetings, some MS have also raised this 
issue. 

1.4.3.4 Recommended levels  

Levels  and  maximum  recommended  levels.  Clarity  on  how  to  establish  recommended  levels  could  be  improved.  Whilst  for  some  FA  levels  are 
established as  conditions  for  authorisation,  for others, recommended levels are established  within the labelling  provisions.  The possibility to  establish 
recommended  levels  should  be  re-examined,  so  that  those  levels  are  set  as  conditions  for  authorisation  but  not  as  labelling  provisions.  Some  area  for 

137   ii FA Final Report __FCEC, pages 74 and 75. 
138   vii Consultation Synopsis Report, page 28.  

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improvement should be considered in terms of coherence. For some additives, the recommendation is to use “Maximum Recommended Levels”. These 
are limits for the use of FA providing a certain flexibility as opposed to maximum limits, which are mandatory and should be indicated on the label of the 
premixtures, compound feed and feed materials. Those maximum recommended levels have been recently set as the labelling provisions for some FA, for 
example  for  flavourings.  The  Feed  Marketing  Regulation  lays  down  the  obligation  to  indicate  the  level  used  on  the  label  of  the  compound  feed/feed 
material  if  the  respective  Maximum  Recommended  Level  has  been  exceeded.  If  this  level  is  not  exceeded,  then  the  level  used  is  not  required  to  be 
indicated on the label of the premixture, compound feed or feed material. This is very important for premixtures of flavourings as the disclosure of their 
composition may harm the competitiveness of the company. The know-how about the composition of those premixtures is very important and it requires 
a  lot  of  experience  and  investment.  A  clarification  of  this  concept  would  ensure  a  harmonised  implementation  across  the  EU  and  could  reduce  some 
burden for FeBOs and MS authorities that have to ensure enforcement of the legislation. MS authorities signalled the necessity to improve the definitions 
of processing aids in relation to FA, as well as to establish a harmonised definition for maximum recommended levels or recommended levels. 

1.4.3.5. Preparations 

The FA Regulation has established the requirements for preparations (see glossary) and labelling provisions. According to MS authorities, a definition is 
necessary to ensure harmonised implementation that reduces disparities in the implementation of the legislation and to increase clarity in the FA 
Regulation when those preparations are authorised139 . 

1.4.3.6. Modification of non-holder specific authorisations 

Article  13(3)  of  the  FA  Regulation  only  covers  the  modification  process  introduced  by  the  holder  of  an  authorisation  but  does  not  foresee  rules  for 
requests for  modifications  of  a non-holder specific authorisation.  In such cases, a full evaluation is  not  required, but instead only  a verification if the 
modification may rise a safety concern or may undermine the efficacy. This situation has been largely mitigated by using Article 13(1) and (2) of the FA 
Regulation  that  permits  the  Commission  to  modify  any  authorisation  (including  non-holder  specific  authorisations)  on  its  own  initiative,  after 
consultation  of  EFSA.  A  clarification  of  the  FA  Regulation  should  be  considered  as  it  affects  around  1,214  additives  that  are  not  linked  to  an 
authorisation holder. 

1.4.3.7 Additives only intended for export 

FA only intended for exports to third countries are subject to the provisions of Article 12 of the General Food Law, which imposes compliance with the 
relevant  requirements  of  food  law,  unless  otherwise  requested  by  the  authorities  of  the  importing  country  or  established  by  the  laws,  regulations, 
standards, codes of practice and other legal and administrative procedures as may be in force in the importing country. In other circumstances, except if 

139   ii FA Final Report _FCEC, page 107 

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the products  are unsafe,  they can be exported if the competent authorities of the country of destination have expressly agreed, after having been fully 
informed  of  the  reasons  for  which  and  the  circumstances  in  which  the  products  concerned  could  not  be  placed  on  the  market  in  the  EU.  The  current 
definition  of  “placing  on  the  market”,  determining  the  scope  of  application  of  the  FA  Regulation  (including  the  authorisation  requirement),  basically 
excludes the export to third countries of those products from the producing establishment provided that they have a limited circulation in the EU that does 
not implies transfer of ownership140. The limitations in the circulation may produce a burden for FeBOs as they cannot process/incorporate the additives 
to premixtures or compound feed using different establishments of the EU that can be more effective or economically advantageous. This  may reduce 
competitiveness and may not be fully coherent with the objective of the FA Regulation for a better functioning of the internal market. This limitation to 
the circulation in the EU needs to be addressed in the FA legislation in conjunction with the labelling of those products. 

The absence of harmonised labelling for those products, indicating that they are only intended for export can be another element of distortion. According 
to the industry, there are diverse national approaches, which leads to competitive disadvantages amongst companies in the MS141. Nineteen MS 
authorities have taken measures to control those exports.  

Control measures are framed within the scope of the Feed Hygiene Regulation and the Official Controls Regulation (registration, notification, random 
controls etc). The FA Regulation does not regulate the requirements applicable for the control of importers. The fact that the Feed Hygiene Regulation 
does not establish a list of third countries’ establishments or specific requirements to trace and control additives only intended for export, undermines the 
effectiveness  of  certain  aspects  of  the  FA  Regulation.  MS  did  not  identify  major  problems,  even  though  this  matter  was  not  specifically  harmonised. 
Nevertheless, several NCAs (Spain, France, Belgium and The Netherlands) requested harmonisation in the context of exchanges within the SCoPAFF 
with  a  view  to  harmonise  the  requirements  for  all  EU  FeBOs  and  improve  communication  between  competent  authorities.  Although  those  control 
requirements are related to the Feed Hygiene Regulation, this request shows that this issue needs to be better addressed. For FA and premixtures intended 
for  export,  19  MS  have  taken  preventive  measures  to  control  that  those  products  do  not  end  up  on  the  EU  market.  However,  the  approach  varies 
considerably  between  MS.  One  MS  stated  that  additives  not  authorised  or  withdrawn  in  the  EU  for  safety  purposes  should  not  be  exported  to  third 
countries even though they are accepted by those countries. As regards FeBOs, a small majority of respondents (35 out of 65; excluding 19 ‘do not know’ 
responses) consider the rules applicable to the export of FA to be properly addressed in the FA Regulation, while 20 consider them not (EM 8.4.3). 

1.4.3.8 Change of the authorisation holder  

140   The determining criterion to ascertain that there is no intra-EU transfer should be the existence of a sale contract between the EU operator concerned and an operator established in 
the third country of destination. Other contracts concluded by the EU operator concerned with another EU operator, for instance with a transporter, exclusively for the execution of 
that sale contract and thus leaving no room for the latter operator to decide to change the destination of the products (i.e., to the EU or to third countries) should not be regarded as 
implying a transfer. The notion of transfer does not refer to the physical movement of goods, but to the transfer of ownership of goods to another person within the EU. 

141   ii FA Final Report _FCEC, pages 66-67. 

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The current system requires the adoption of an implementing Regulation (including a request to EFSA for an opinion) for any change of the authorisation 
holder of an additive (mergers or acquisitions). Therefore, some internal administrative arrangements between EFSA and the Commission have been set 
up as the Commission only informs EFSA of this administrative change without the need to issue a new EFSA opinion as it is not related to a safety 
assessment. The change of the authorisation holder represents 10% of the Regulations adopted in relation to holder-specific authorisations. However, the 
obligation  to  adopt  an  implementing  Regulation  remains.  It  entails  a  certain  burden  for  the  Commission,  EFSA  and  MS.  In  the  NCA  Survey,  11  MS 
authorities agree that this simplified approach is necessary although 12 did not express an opinion and three did not agree. 

1.4.3.9 Requirements for environment applicable to farmed non-food producing animals 

This  aspect  was  raised  after  the  evaluation  study  during  the  discussion  for  the  revision  of  Commission  Rules  for  Applications.  It  refers  to  non-food 
producing animals, such as fur animals. Although there are not applications specifically addressed to those animals and the authorisation for all animal 
species including those animals have been carried out with an environmental risk assessment, the FA Regulation would need to be modified to clearly 
state that those animals are covered by the environmental risk assessment. 

1.4.3.10 The Register of FA 

Although the register has been an excellent tool for FeBOs to be aware of all additives authorised and their conditions of authorisation, the Register of FA 
is not considered sufficiently “user-friendly”. A majority of respondents to the PC consider that this is an efficient tool, but it needs to be improved to 
become more informative and user friendly. For instance, the current pdf format does not allow to search information in a straightforward manner (e.g., 
the EFSA opinion). 

1.5 ADEQUATE, CLEAR AND COMPREHENSIVE LABELLING RULES, INCLUDING ADEQUATE RULES FOR SAFE HANDLING OF FA 

In relation to labelling, there are several aspects to consider:  

−  Whether the labelling rules have been effective to protect human health, animal health and the environment along the food chain. 
−  Whether there are aspects not addressed or not sufficiently addressed that may reduce the effectiveness  

1.5.1 Labelling provisions 

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There is a consensus that labelling prevents the misuse of FA along the food chain (doses and the proper use in the species concerned are respected).142 
The results of the controls performed by the MS authorities do not rise major concerns in this regard. From the surveys and the case studies emerged the 
necessity  to  modernise  the  labelling  provisions  by  conveying  the  information  through  other  means  (currently  it  is  only  possible  through  the  physical 
label) such as electronic means, QR Code trademark, separate documents, etc. This  demand is  to a certain  extent  in  line with  the labelling  provisions 
applicable  to  compound  feed  and  feed  materials.  This  issue  has  been  raised  by  a  majority  of  stakeholders  but  also  by  some  MS  authorities  (see  SH 
survey, NCA Survey). 

1.5.2 The Classification, Labelling and Packaging (CLP) Regulation 

The CLP Regulation harmonises the criteria for classification and the rules for labelling and packaging of chemical hazardous substances and mixtures. 
The combination of CLP labelling requirements and specific requirements set out in the authorising Regulation, created different understandings amongst 
MS  authorities.  The  authorisation  of  FA  does  not  usually  introduce  labelling  provisions  for  workers’  safety  but  generally  provide  for  workers’  safety 
requirements  to  be  respected,  as  conditions  of  use  of  the  authorised  additives.  However,  some  MS  authorities  require  the  introduction  of  those  safety 
requirements on the label. In addition, these labelling indications are not harmonised in the different MS. Furthermore, it is being considered that the CLP 
Regulation applies also to FA and premixtures, thereby introducing additional labelling requirements for workers’ safety. This introduces complexity on 
the labels, in particular for premixtures. Although the surveys did not reveal a high rate of positive response on whether the CLP Regulation is coherent 
with the FA Regulation, the case studies143 provided a clearer picture on the effects of the simultaneous application of both Regulations, especially in 
premixtures. On the one hand, MS have different understandings on how worker safety provisions can be indicated on the label to ensure respect for both 
Regulations;  on  the  other  hand,  labelling  requirements  for  user  safety  might  be  redundant  or  even  conflicting  in  both  Regulations.  This  could  be 
aggravated  in  premixtures,  where  different  additives  are  incorporated.  As  regards  workers’  safety  provisions,  the  simultaneous  implementation  of  the 
CLP Regulation and of the FA Regulation has been reported as one aspect that may undermine workers’ safety (in case of contradictory directions of 
use), although no clear evidence has been provided (for more information see PC).  

1.5.3 Other aspects related to labelling rules 

Another aspect that reduced the effectiveness of the FA Regulation is the absence of labelling tolerances for FA in premixtures. This situation creates a 
certain burden for FeBOs (change of labels to accommodate to MS requirements) when the additives circulated within the EU, since tolerances  may be 

142   vii Consultation Synopsis Report, page 29 
ii FA Final Report _FCEC, page 104     

143   vi Case studies, pages 20,21 and 23  

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different from one MS to other. Nevertheless, this issue was not raised in the study which emerged from the discussions at the SCoPAFF and from some 
events organised by stakeholders.  

Finally, as indicated above, the absence of a harmonised labelling for FA and premixtures only intended for export is another concern that does not bring 
lightness to the system. 

1.6 IMPROVE FA CONTROL, TRACEABILITY AND ENFORCEMENT RULES (OBJECTIVE 5) 

The FA Regulation seeks to improve control and traceability  by establishing validated methods of analysis to be used for official  controls, by linking 
certain additives to an authorisation holder and extending the scope of the PMM. 

1.6.1. Method of analysis 

One of the points raised during the evaluation was the necessity of updating the method of analysis in the renewal. Updating the method of analysis for 
the renewal is considered necessary for 22 MS authorities – while only one of them disagrees. A majority of respondents do not consider the update of 
the method of analysis for the authorisation renewal to be necessary (51 out of 101); whereas it is considered necessary by 26 respondents. Some FeBOs 
pointed that the Official Controls Regulation allows MS authorities to use more updated methods which are validated at international or EU level, where 
necessary. On the other hand, the role of the EURL is adequately defined in the FA Regulation according to the majority of respondents.  

More  information  is  included  in  the  FCEC  Final  study144.  The  available  evidence  indicates  that  the  EURL  for  FA  can  effectively  carry  out  its  tasks, 
supported by the network of NRLs, despite its complexity and challenges. A clear majority of both MS authorities and business stakeholders perceive that 
the role of the EURL is properly addressed in the FA Regulation. 

1.6.2 Post-Market Monitoring 

Another element introduced in the FA Regulation is the possibility that EFSA decides, upon assessment, the establishment of a post-market monitoring 
(PMM) to ensure surveillance. However, it cannot be fully evaluated since the results of the PMM are submitted by the applicant to EFSA, when the 
renewal  takes  place.  Currently,  there  is  no  data  to  assess  if  the  PMM  has  been  useful  to  identify  any  unforeseen  effect  or  to  confirm  that  the  initial 
authorisation was adequate to protect health. There is only one additive (lantharenol) for which the PMM has been evaluated by EFSA. After examination 
of the PMM and additional evidence provided by the applicant, EFSA concluded that this additive was safe.  

144ii FA Final Report _FCEC   pages 48 and 49. 

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1.6.3 Traceability 

No significant criticism was raised by stakeholders on the relevance of traceability provisions. Some manufacturers and business associations observed 
that other Regulations (especially the Feed Hygiene Regulation and the General Food Law) play an important role in ensuring FA traceability. Some 
FeBOs also stated that traceability is fully ensured by the systems and codes of practices already in place. In the feedback to the evaluation roadmap, one 
NCA also considered that traceability requirements should be laid down in the FA Regulation rather than in the General Food Law. 

MS  authorities  however  consider  that  traceability  is  not  fully  accomplished145  when  it  comes  to  additives/premixtures  for  imports  and 
additives/premixtures only intended for export. There are several reasons which account for it:  

a)  the absence of a clear identification of imported products. 
b)  the difficulties for MS to control establishments in third countries. 
c)  the absence of harmonisation of control requirements for the third country establishment’s representatives in the EU. 
d)  the absence of harmonised labelling to identify additives only intended for export.  

The absence of specific provisions in the Feed Hygiene Regulation aggravates this situation for both imports and exports.   

1.6.4 Enforcement 

Enforcement of the FA legislation is mainly ensured through controls and sanctions imposed in case of infringements. The data on controls performed in 
16  MS  indicated  an  average  frequency  of  one  control  of  FA  and  premixtures  per  year/per  establishment.  The  available  data  also  showed  the  high 
compliance of samples and analysis. All MS have put in place sanctions applicable to infringements that went from a financial penalty to the withdrawal 
of  approval  or  registration  of  the  establishment.  This  suggests  that  the  controls  worked  well  in  general  although,  due  to  the  different 
administrations/procedures involved, the data collected could not provide a complete picture of the situation. Information on controls is provided in the 
context of the Official Controls Regulation, which does not make always segregation for FA and premixtures in relation to other feeds.  

The limited number of RASFF notifications may indicate that the enforcement is effective in general except for imports (no import code) and for feed 
additive  only  intended  for  export  (no  labelling  indication  /  no  harmonised  rules  for  tracing  and  control).  It  should  be  noted  that  despite  the  concerns 
expressed  by  the  MS  authorities  for  control  of  imports,  there  were  only  few  RASFF  notifications.  In  the  period  2004-2017  only  7  notifications  were 
reported for imports of FA and premixtures from third countries.146. For FA and premixtures intended for export, 19 MS have taken preventive measures 

145   ii FA Final Report _FCEC, pages 98-99 and 102     
146   ii FA Final Report _FCEC, pages44-46.  

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to control that those products do not  end up on the EU market, however, the approach varies considerably between MS. The  FA Regulation does not 
regulate the requirements applicable for the control of importers. The fact that the feed Hygiene Regulation does not establish a list of third countries’ 
establishments or specific requirements to trace and control additives only intended for export, undermines the effectiveness of certain aspects of the FA 
Regulation. 

1.7 ADDRESS SPECIFIC INTERESTS FOR PET OWNERS AND THEIR ANIMALS  

The  FA  Regulation  introduced  a  comprehensive  set  of  requirements  compared  to  the  previous  Directive.  Taking  into  account  that  pets  have  a  long 
lifespan, the evaluation takes new aspects into consideration, in comparison to the previous Directive, the assessment of chronic toxicity, mutagenicity 
and  carcinogenicity  effects  so  as  to  prevent  any  negative  impact  on  pets’  health.  The  efficacy/safety  assessment  were  also  improved  by  introducing 
statistical power limits to reduce the possibility of having erroneous results in experiments. EFSA adopted a specific guidance for pet animals to address 
their specificities in the assessment. These comprehensive set of rules affect 1,017 FA, which were not evaluated or were insufficiently evaluated under 
the previous 1970 FA Directive (EM 1.2.8, 1.2.9, 1.2.10).147 In addition, labelling requirements ensure that these additives are used in accordance with 
the conditions of authorisation (e.g., maximum doses) along the feed chain. Safety of owners is also considered in the Regulation insofar as FA cannot be 
given directly to the animals by pet owners, they should always be incorporated in a compound feed or in a feed material by a professional operator.  

For a majority of respondents across all stakeholder groups, the Regulation provides benefits for pets and pet owners (SH survey); however, it is noted 
that animal  welfare organisations did  not contribute to  the survey, despite the efforts to  involve them. One citizen expressed the view that there is  an 
increasing  consumer  demand  for  cosmetic  appearance  of  pet  food  that  needs  to  be  considered.  This  issue  may  be  related,  for  example,  to  the  use  of 
colourants  so  as  to  meet  the  requirements  of  pet  owners  (many  compounds  feed  is  grey  colour,  and  this  is  not  accepted  by  pet  owners).  Nearly  all 
respondents agree that FA are efficacious and safe for pet animals (74 and 76, respectively, out of 78 respondents); excluding 28 and 30 respondents, 
respectively, who did not provide an answer as pet food is not relevant for their organisation). 

1.8 INNOVATION 

As regards the capacity of the FA Regulation to address scientific and technical developments for pets, a majority of respondents (45 out of 107) across 
all  stakeholder  groups  consider  the  authorisation  procedure  not  to  be  suitable  to  address  scientific  and  technical  developments  for  pets  and  livestock 
production, due to the time periods incurred during the authorisation (suitability of the Regulation). This contrasts with a majority of MS authorities that 
consider that the  FA  Regulation  is  suitable to  address  those technical  developments  in  general  (livestock and pets)148 This  is  not  an issue that  can be 

147 ii FA Final Report _FCEC, page 32. 
148 ii FA Final Report _FCEC, page 47. 

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attributed to pet additives but to the authorisation process in general and does not change the fact that specific interests of pet owners and their animals 
have been considered in the Regulation. 

This objective is driven by different provisions that were intended to encourage innovation and the placing on the market of safe and efficacious FA. 

1.8.1 R&D 

Innovation may occur in all additives, for example by looking at new forms of additives that are better digested by animals (trace elements are linked to 
an  organic  molecule,  such  as  an  amino  acid),  at  preparations  of  FA  that  protect  against  thermal  of  physical  treatments,  increase  storage  capabilities, 
improve  safety  handling  (reducing  dusting  potential)  or  by  facilitating  specific  uses  (spray  drying,  pelleting  or  liquid  forms).  Nevertheless,  the  most 
important innovations are those that entails the discovery of new compounds with innovative action/effect mechanisms that may trigger, in some cases, 
the necessity to create a new functional group and to establish new end points to measure those actions or effects. The number of patents applications for 
FA submitted to the European Patent Office doubled compared to the previous period: 207 applications were received between 2004 and 2019 compared 
to 104 applications between 1979 and 2003. The share of EU applicants versus non-EU applicants remained almost the same for the two periods (44% 
EU applicants and 56 non-EU applicants). This suggests that innovation occurred and that it had some positive effect for both EU and non-EU applicants. 

Despite  the  extensive  consultation  undertaken  for  the  FCEC  study,  there  is  no  indication  (quantitative  or  qualitative)  of  the  R&D  trend  by  EU-based 
companies active in the FA sector. It is therefore not possible to establish with certainty whether R&D investment to develop new FA has increased or 
decreased since the Regulation came into force. It was also noticed by some respondents from the industry that costs are reduced by investing in non-EU 
research  facilities  or  sub-contracting  R&D149  activities  (including  trials)  to  facilities  based  in  non-EU  countries.  More  information  is  available  in  the 
FCEC Final study. 

1.8.2 Functional groups and categories 

The largest number of innovations during the period 2004-17 are in the zootechnical additives category and functional group ‘other zootechnical 
additives’ as well as in the new 4 functional groups created after the adoption of the FA Regulation, which are: 

−  1(m) substances for reduction of the contamination of feed by mycotoxins (Commission Regulation (EC) No 386/2009). 
−  1(n) hygiene condition enhancers (Commission Regulation (EU) 2015/2294) ; 
−  1(o) other technological additives (Commission Regulation (EU) 2019/962). 

149 ii FA Final Report _FCEC, page 68 

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−  4 (e) physiological condition stabilisers (Commission Regulation (EU) 2019/962).  

In May 2021 there were 9 additives authorised for those groups. There were 18 applications for the period 2004-2017. For the last adopted functional 
groups the applications are very few. In particular, as for the physiological condition stabilisers EFSA is in discussion with the FA sector to examine what 
are  the  most  adequate  end  points  that  should  be  considered  in  the  assessment  of  the  efficacy.  The  adoption  of  new  functional  groups  entails  further 
research  for  EFSA  and  FeBOs  in  order  to  establish  clear  requirements  that  allow  to  performing  studies  intended  to  demonstrate  that  the  additive  is 
efficacious for a specific function. 

As for the functional group “other zootechnical additives” there were 61 applications during the period 2004-2017 and there were 34 additives authorised 
in May 2021. 

The data suggests that the FA Regulation has enabled innovation compared to the previous 1970 FA Directive in new emerging segments of FA, and in 
general,  in  the  design  of  new  forms  of  additives  that  improve  their  efficiency  and  are  more  adapted  to  the  changing  conditions  of  the  market. 
Nevertheless, some aspects of the Regulation did not achieve the expected results in terms of innovation.  

1.8.3 Classification system for FA 

The classification system of FA and provision to be taken into account to favour technological progress: 

FA used to affect favourably animal welfare or the environment may only be allocated within the category ‘zootechnical additives’. The FA Regulation 
does not  allow the creation of other  categories of additives for which the  authorisation  is  issued to  a specific holder150. The applicant  is  requested by 
EFSA guidance to  demonstrate a  zootechnical  effect  of the additive (e.g., improvement of performance- increase egg/meat  production). However, the 
actions performed by these additives are not related to an increase of performance in animals, but to a specific improvement in the well-being of animals 
(e.g., reduction of stress) or positive effects on the environment. This discrepancy discourages applicants from applying for those kinds of additives. 

150   Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with 
scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union, (OJ L 198, 25.7.2019, p. 241) permitted to adopt delegated acts to amending Annex I, to 
adapt the categories and functional groups as a result of technological progress or scientific development. A new category not linked to an authorisation holder can may therefore be 
created. Indeed, the provision to determine the categories of additives that are linked to an authorisation holder is placed in Article 3(3) of Regulation (EC) No 1831/20039(6). Any 
modification  of  this  provision  would  require  the  modification  of  the  Regulation.  Consequently,  although  new  categories  were  possible,  they  could  not  be  linked  to  a  holder 
authorisation. 

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Article 6(1) of the FA Regulation, refers, in the definition of “zootechnical additives”, to their use to affect  favourably the performance of animals in 
good health or to affect favourably the environment. Article 5(3) of the same Regulation, listing the possible effects of FA, provides in particular that 
they  may  affect  favourably  the  environmental  consequences  of  animal  production  (Article  5(3)(e))  or  that  they  may  affect  favourably  animal  welfare 
(Article  5(3)(f)).  In  addition,  Commission  Regulation  (EC)  No  429/2008  recognises  those  favourably  affecting  animal  welfare  under  the  category  of 
zootechnical additives. Despite the fact that the legislation does not link the zootechnical effect exclusively to the improvement of animal performance, 
but also to other effects (on the environment or on animal welfare), there might be some room for interpretation as EFSA requires the demonstration of 
animal performance even where the additive is intended to affect favourably the environment or animal welfare. 

This situation is relevant also to the innovation aspect151. In comparison with the previous Directive, specific measures were introduced to meet the new 
needs of modern animal production. This was achieved through the introduction of elements that affect favourably both the environmental consequences 
of animal production and animal welfare (Article 5). In addition, the possibility to update the additive categories when necessary was foreseen (Article 6), 
based  on  technological  or  scientific  development.  The  absence  of  FA  authorisations  for  environmental  and  animal  welfare  effects  shows  that  the 
objective was not  fully achieved due to certain  provisions in  the FA Regulation  open to  some clarifications and possibly  leading  to  misinterpretation, 
insufficient guidance and insufficient mechanisms for communication applicant-assessor in the assessment of efficacy, especially for innovative FA. This 
aspect of innovation emerged in the consultations and case studies. Innovation is not perceived for stakeholders (mainly FeBOs) as sufficiently achieved 
while the survey showed no definite answer for many MS authorities and only 12 agree that the Regulation promoted innovation. The Regulation is not 
considered  sufficiently  flexible  by  an  important  share  (38%)  of  the  PC  respondents152,  especially  among  business  associations  (41%)  and 
companies/business  organisations  (52%).According  to  disagreeing  respondents,  science  and  technology  evolves  at  a  much  faster  pace  than  regulatory 
developments, with the industry research and development efforts focusing on innovative new products to meet current challenges (e.g. alternatives to 
use of antibiotics, more sustainable food production, reducing the impact of farming practices on the environment, improving animal welfare, etc.). The 
current framework lacks the flexibility to adapt to scientific and technological advancements.   

1.8.4 The use of additives in water for drinking.  

One of the most important innovations introduced in the FA Regulation was the possibility to use additives in water for drinking. The innovation in the 
use  of  additives  in  water  for  drinking  has  occurred  mainly  in  nutritional  additives  such  as  amino  acids  and  vitamins,  increasing  their  efficiency  and 
contributing  to  improving  animal  welfare,  as  the  distribution  of  certain  additives  via  water  can  be  more  efficient.  In  general,  innovation  in  water  for 
drinking could have been affected due to the fact that many additives  may not be used in water for drinking and the technical aspects related to their 
implementation created divergent views amongst MS authorities. 

151   vii Consultation Synopsis Report, pages 14,15,22 and 23  
152   vii Consultation Synopsis Report, pages 30-31 

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1.8.5 Renewal of authorisation 

The renewal was intended to allow technological progress and scientific development. Applicants should consider whether the investment for a renewal 
is  worthwhile  or  not  in  case  that  more  efficient  or  safer  additives  are  already  placed  on  the  market.  According  to  the  data  of  renewal  of  applications 
provided  by  EFSA  (end  of  2021),  at  least  12  applications  for  renewal  out  of  65,  were  introduced  in  combination  in  accordance  Article  4  (new 
authorisation) or with Article 13 (modification). This means that the additive application may extend the initial authorisation to further species/animal 
categories, that there is a more efficient/safer method of production of the additive to be evaluated, that the composition of the additive may change to 
become more efficient or safer etc. It should be highlighted that 10 of those applications corresponded to zootechnical additives. Nevertheless, due to the 
low number of renewals, it is not possible to draw a clear conclusion from the existing data. For a majority of MS authorities, the renewal is adequate to 
promote innovation (17 in favour). For stakeholders (mainly FeBOs) the opinions are divided: is considered adequate by 29 and not adequate by 27 out of 
99 respondents (43 neither agree not disagree).153. It is not possible to establish a link between innovation and the renewal process. 

1.8.6 Market exclusivity for innovative FA.  

This  refers  to  those  additives  linked  to  an  authorisation  holder  (see  glossary  and  EM)  The  number  of  authorisations  granted  for  FA  linked  to  an 
authorisation  holder  showed  that  this  measure  was  effective  in  promoting  innovation.  The  concerns  associated  to  low  supply  of  vitamins  on  the  EU 
market raised the question whether it is necessary to extend this exclusivity to other categories or functional groups to incentivise applicants to apply for 
those authorisations. Under the existing regime for non-holder specific authorisations, the costs of obtaining an authorisation are borne by one applicant 
while others may benefit from  the “generic”  authorisation,  provided that their products  comply with  the authorisation’s specifications. This  issue  was 
raised in the case studies in the context of the renewal: FeBOs have to assume the burden of renewal for the benefit of the wider industry. For a majority 
of respondents (59%), non-holder-specific authorisations for nutritional additives, technological additives and sensory additives should not be replaced by 
authorisations  linked  to  a  specific  holder;  whereas,  for  23%  of  respondents,  they  should  (8%  don’t  know).  Non-holder  specific  authorisations  are 
particularly important for SMEs, as this allows them to place their products on the EU market, while making important savings in terms of the investment 
for preparing the required research and studies in view of applications for authorisation154. Although the possible extension of market exclusivity to other 
additives may have positive influence on innovation and may improve the availability of certain additives, this issue needs to be carefully considered as it 
may affect the activity of SMEs. 

1.9 ENSURE THAT FEED ADITIVES CANNOT MISLEAD CONSUMERS ON THE QUALITY OF FOOD  

153   vii Consultation Synopsis Report, pages 11and 21. 
154   ii FA Final Report _FCEC, page 87     

99 

 
 
The  FAs  are  addressed  to  all  animals,  but  certainly,  the  impact  is  mainly  on  food-producing  animals.  Article  5  of  the  Regulation  established  the 
conditions to be met to get the authorisation. In addition to being safe and efficacious, they must not mislead the consumer by impairing the distinctive 
features of animal products. The implementation of the rules led to the development of specific criteria to address all possible consumer’s concerns.155. 
Stakeholders and MS authorities widely recognised the ability of the FA Regulation to ensure safety for consumers (EM 1.2.6). This is also supported by 
RASFF notifications. During the period 2004-2020, the RASFF notifications showed the level of compliance as for the presence of FA or their residues 
in  food  of  animal  origin.  82  notifications  –  out  of  16,634  –  were  linked  to  the  presence  of  unauthorised  additives  or  a  high  level  of  residues.  These 
represented 0.5% of the total number of notifications (EM 1.2.7). 

In addition, the feed additive assessment must consider whether an additive could give the food a misleading feature regarding its expected properties – 
e.g.,  a  flavouring  that  gives  the  meat  a  flavour  that  is  not  characteristic  of  that  meat.  This  aspect  has  been  raised  by  EFSA  in  very  few  cases  with  a 
positive conclusion in favour of the authorisation. 

Feed business FeBOs have indicated that consumers are not aware of the role of  FA in modifying the organoleptic characteristics of food from animal 
origin.  This  aspect  has  not  been  sufficiently  analysed,  as  the  consumers’  participation  in  different  surveys  and  interviews  was  too  low.  No  consumer 
organisation participated in the consultations, despite the efforts developed by the study team. 

As regards those labelling provisions that may have impact on the safety or quality of food (e.g., the indication on the label of the level authorised for a 
colourant giving colour to poultry meat), the Regulation has been effective in the implementation of labelling provisions. This is supported by the high 
rate of conformity reported by the MS authorities during the controls. 

2.-.EFFICIENCY 

2.1. COST-BENEFITS ANALYSIS FOR FEED BUSINESS FEBOS  

FeBOs need to fulfil two main legal obligations stemming from the FA Regulation that have significant impacts on the costs for the industry:  

−  Authorisation process 
−  Labelling of FA and premixtures of additives (Article). 

155   Commission Regulation (EC) No 429/2008 of 25 April 2008  on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the 
Council as regards the preparation and the presentation of applications and the assessment and the authorisation of FA (OJ L 133, 22.5.2008, p. 1–65) and Guidance for establishing 
the safety of additives for the consumer (EFSA Journal 2012;10(1):2537) 

100 

 
 
The analysis has been extended to the implications for compound feed and pet food (compound feed intended for pets). The information on the additives 
that need to  be included in  the labelling  of compound feed may also  impact  on the production of the compound  feed.  For example, if  we change the 
maximum dose of an additive, this triggers changes in the labelling of compound feed. 

The section on the authorisation process includes the costs for a new authorisation (Article 4) and costs for re-evaluation of those additives authorised by 
the former 1970 FA Directive (Article 10(2)). 

2.1.1 Costs for the authorisation process:  

The major obligations generating costs were identified as follows: 

a)  Payment of fees is a fixed cost: €6,000 paid to the EURL, plus the cost of sample (which has been indicated by the industry as relatively ‘minor’). 

b)  The submission of an application is an administrative obligation which can be quantified on the basis of staff time, staff category and unit costs. 

c)  The extent of costs for dossier preparation and completion is driven by (i) the number of tests / studies requested, and (ii) the complexity of tests / 
studies  required.  In  order  to  quantify  this,  efforts  were  made  to  determine  the  average  unit  cost  of  studies  and  identify  the  average  number  of 
requested studies. This included the additional costs created by requests for supplementary data. 

The  costs  for  businesses  to  prepare  an  application  for  new  authorisation  or  re-evaluation  depend  on  the  type  of  additive,  on  whether  the  additive 
supports an important innovation and on the type of species covered by the application. 

− 

type of additive: new additives, such as those on the category “zootechnical additives”, for which new substances or new uses are requested, entail 
a number of high-cost efficacy and safety studies as there is no previous experience or scientific publications to support the request. Coccidiostats 
is  another  category  that  requires  very  demanding  safety  and  efficacy  studies.  For  other  additives,  such  as  vitamins,  the  costs  tend  to  be  much 
lower as there is extensive safety/ efficacy data and the innovations introduced are less sophisticated.  

−  species and categories covered by the application: For example, for ruminants the costs of efficacy studies are much higher than for poultry or 

fish.  

The costs involved vary considerably between FeBOs. To some extent, this reflects the type of feed additive in which the operator specialises.156 . 

156   ii FA Final Report _FCEC, pages 74 and 75  

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The costs examined are the costs for different studies (safety and efficacy studies), internal staff time costs, costs of consultants and other costs such as 
EURL fee for the validation of the method of analysis, identity and characterisation of the additive (e.g., analysis to determine chemical composition and 
impurities). 

102 

 
 
 
Table 6: Number of tests and range of costs necessary to perform the study (FCEC elaboration, based on stakeholder survey and case studies) 157 

TYPE OF STUDIES 

NUMBER OF SAFETY STUDIES 

IN VITRO 
LABORATORY 
ANIMALS 
RUMINANTS  
PIGS/POULTRY/FISH 
OTHER SPECIES 

TYPE OF STUDIES 

RUMINANTS  
PIGS/POULTRY/FISH 
OTHER SPECIES 

1-8 
1-7 

1-6 
1-6 
1-6 
NUMBER OF EFFICACY 
STUDIES 
1-12 
1-18 
1-6 

COSTS RANGE FOR ALL SAFETY 
STUDIES (€) 
≤10,000 - 50,000 
≤10,000 - 400.000 

18,000 – 200,000 
≤ 10,000 - 400,000 
≤ 30,000 - 150,000 
COSTS RANGE FOR ALL EFFICACY 
STUDIES (€) 
50,000 – 200,000 
20,000 – 120,000 
20,000 - 150,000 

The average  costs estimated for an  applicant  to  obtain an authorisation  is  €1.1 million  across all applicants  that provided complete data to  the survey 
(n=31) and all types of FA for which an authorisation dossier was submitted in 2016-18. This cost includes the initial application and the administrative 
cost  of  replying  to  supplementary  EFSA  questions  during  the  authorisation  procedure.  The  costs  per  year  for  an  average  of  57  applications  is 
€62,700,000.  

The major component of the authorisation costs (i.e., direct costs) is safety and efficacy studies (37% and 32%, respectively), followed by internal staff 
costs  (22%).  No  significant  differences  in  average  costs  for  SMEs  vs  large  companies  were  identified.  Costs  vary  over  a  very  wide  range  of  values: 
€50,000 for some additives with a substantial history of consumption for feed use, €373,000 for additives requested by a consortium of companies under 
Article 10(2), €2.6 million for a zootechnical additive and €3.4 million per application for coccidiostats. 158 

157   vi Case studies   
158   vi Case studies pages 3-15. 

103 

 
 
 
The  costs  for  SMEs  are  the  same  as  those  for  large  companies.  The  high  expenses  derived  from  an  authorisation  have  impact  on  SMEs  applications 
(SMEs not part of a larger entity) that tends to focus on fewer animal species in the case of innovative additives (linked to an authorisation holder) or for 
generic additives (see glossary), for which scientific literature is available. In this case, new trials on target animals (see glossary) or laboratory animals 
are not required, as scientific literature may provide the necessary information. 

Applicants  raised  that  the  cost  increase  is  mainly  due  to  the  EFSA  request  of  complementary  information  (‘stop  the  clock’)  and  the  delays  in  the 
SCoPAFF. 159 

The time periods in the authorisation process (management procedure) only have business impact on new applications, as the applicant cannot place the 
additive  on  the  market.  37%  of  applications  are  processed  within  the  expected  deadlines.  Those  periods  may  reduce  the  efficiency  of  the  process. 
Although some longer time periods affect few applications, it has a big impact on the calculation of the average period for the adoption of the authorising 
Regulations. The discussions in SCoPAFF meetings, normally convened every two months, are one of the reasons for some longer periods.  

The use of non-animal tests (e.g., in vitro tests using human/animal cells and tissues or computer-modelling techniques) has been identified as a factor 
that  may  reduce  costs  in  the  applications,  especially  for  the  demonstration  of  efficacy.  This  was  pointed  in  the  case  studies  by  one  NCA  and  some 
applicants.160 

Extrapolation  from  major  to  minor  species161:  This  may  contribute  to  reduce  costs  for  authorisation  and  address  the  shortage  of  additives  for  those 
species. The 1-year extension of data protection for each minor species has not been successful in promoting the authorisation of FA for minor species. 

Extrapolation from food additives to feed for additives performing the same functions in food and feed is one of the aspects  that can reduce costs. The 
major  exposure  of  animals  to  the  additive  compared  to  the  human  exposure  does  not  allow,  for  safety  reasons,  to  make  this  extrapolation  in  many 
applications. For efficacy studies, the extrapolation works well for flavourings but162 there is room for improvement for other functional groups163. 

FA are authorised for a 10-year period. One year before the expiration of the authorisation, the applicant has to apply for a renewal (Article 14) 

159   ii FA Final Report _FCEC, page 75 
160   ii FA Final Report _FCEC, page 60 
161   See definition in glossary. 
162   ii FA Final Report _FCEC, page 40                 
163   ii FA Final Report _FCEC, page 40-41        

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The average cost for the renewal of an authorisation is €216,000, which represents 20% of the authorisation costs. The bulk of this is spent on safety 
studies followed by internal staff costs (9%). 

The duration of the authorisation is considered too short for some additives having a safety record of use. The renewal of an authorisation entails costs for 
the Commission, EFSA and for applicants. There is potential for reduction of costs if the duration of authorisation is extended for certain additives so that 
the costs for renewal are spread evenly over a larger number of years. 

It is possible to conclude that the process for authorisation of FA has been efficient. The following evidence confirms this statement. 

−  The  highest  number  of  applications  during  the  period  2004-2017  correspond  to  zootechnical  additives  (34%  of  all  applications164),  the  most 

expensive applications, with an upward trend since 2015. 

−  The large number of additives authorised in the 2004-2017 period with an upward trend over that period. 
−  The RASFF notifications for FA are low, 12 notifications on 2004-2017 and no significant feed safety crisis having negative effects on stakeholders 

along the food chain has been reported. 

−  The recognition of some elements of the EU authorisation procedure by some non-EU countries. This is identified as an important strength for the 

competitiveness of EU products in world markets (see EQ2.3 of FCEC final report). 

−  Although there are no statistical data on the increasing value of the feed additive market, the EU position is relevant (approximately 35% of the 

world FA market value). 

−  The return of investment for the most expensive dossiers (zootechnical additives) is high165. 
−  The benefits for FeBOs are spread along the food chain. In general, FeBOs consider than the FA Regulation have positive benefits for feed additive 
producers (including applicants) and for compound feed producers (82% and 80% of respondents see benefits for FA producers and compound feed 
producers, respectively). 

Nevertheless, some issues that reduce the efficiency of the process and subsequently increase the costs of the applications, have been identified:  

−  extrapolation for major to minor species was not sufficiently exploited.  
−  applications for minor species were not sufficiently incentivised. 
−  extrapolation from food to feed, especially for the demonstration of efficacy, could be implemented more widely. 
−  data-sharing rules to reduce tests on vertebrates were not implemented. 

164   Considering administrative applications (SANTE applications). 
165 

ii FA Final Report _FCEC, page 88.  

105 

 
 
 
−  Some extra-time in the assessment of some additives due to a lack of understanding by applicants of the guidance or not sufficient information in 

the guidance to establish endpoints for certain new actions. This applies especially for demonstration of efficacy in innovative additives. 

−  some extra-time in the adoption of authorisation Regulations by the Commission.   
− 
− 

insufficient development and use of non-animal models as an alternative for tests using animals.   
the duration of authorisation period increases the costs as the costs for renewal must be borne after 9 years of the authorisation.   

For  SMEs  the  high  costs  of  some  applications  are  a  significant  barrier,  so  they  tend  to  focus  on  holder–specific  additives  for  specific  categories  of 
animals rather than for all species. Generic (non-holder specific) authorisations are also important for SMEs as their additives can be placed in the EU 
market without bearing the costs of applications166. 

2.1.2 Labelling costs  

The costs considered are the administrative costs that are triggered by the changes in the authorisation of a feed additive, which requires modification of 
labels. The specific information on this issue was provided through the case studies167. 

For FA and premixtures, the information needs to be included in a label attached to the product. This fact reduces flexibility and increases the labelling 
costs vis-à -vis other types of feeds (for compound feed and feed materials, relevant provisions allow for some flexibility in certain cases).   

The  factors  that  affect  labelling  costs  are  the  number  of  additives  contained  in  the  premixture  and  the  linguistic  regime.  Labels  for  FA  have  to  be 
translated into all EU languages while premixtures have a more limited distribution and they are translated into 3-4 languages. A majority of consulted 
FeBOs  (22  out  of  30  respondents  to  the  survey  and  all  FeBOs  interviewed)  find  that  changes  in  the  authorisation  of  FA  mainly  refer  to  the  species 
covered or to the conditions of use. Other reasons, not related to regulatory changes, are requests by MS authorities and market-driven factors. 

The  costs  of  labels  for  FA  are  negligible.  For  premixtures,  the  estimated  average  costs  for  manufacturers  of  premixtures  range  from  €80,000  to 
approximately €223,000 per plant, per year; this is an overestimation as it is not possible to separate costs triggered by regulatory changes from other 
reasons. The increasing use of automation labelling systems reduce those costs, which may explain the differences between different plants. These costs 
include costs of labels, translation services, design and printing of labels and reformulation when required. 

166   ii FA Final Report _FCEC, page 88 
167   vi Case studies, pages 17-23 

106 

 
 
 
Indirect  costs are the  compliance costs due  regulatory changes.  Those regulatory changes  are  normally:  changes in  the level  of use of the additive, 
change  in  the  identification  number  of  the  additive  (for  additives  re–evaluated  a  new  number  is  assigned  under  the  new  classification  system),  the 
specification of the substance may change (e.g., purity). Normally those changes must be introduced after a transitional period that is always granted if 
there are no safety reasons that justify the contrary. This transitional period (6 months for additives and premixtures, 12 months for compound feed/feed 
materials  intended for food-producing  animals  and 24 months for compound  feed/feed materials  intended for non-food producing  animals) suffices to 
ensure a smooth transition for FA already on the market (Article 10(2) of the FA Regulation),168 as it significantly reduces the need to change the labels. 
Those measures are considered adequate for FA. Only for premixtures, few FeBOs have indicated that the period is too short as they need 3-4 months for 
stock clearance. For compound feed, including pet food, the case studies have not identified significant problems with the usual transitional period of 12 
months for food-producing animals and 24 months for non-food producing animals. Costs are around €2,000 for the disposal of labels for premixtures 
applying  the  usual  transitional  period.  The  compliance  costs  can  be  estimated  between  €24,000  and  €40,000  per  product  and  €13,500  in  labels  for 
premixtures when the change affects an important additive widely used and the transitional period is shorter than the usual transitional period. However, 
the occurrence of this possibility is very low (see vi Case studies, page 24). 

Stakeholders  appear  divided  on  whether  labelling  requirements  are  fit  for  purpose  or  not,  with  a  majority  of  manufacturers  of  FA  and  premixtures 
considering them not fit169. They are also divided as to the negative impact of labelling costs, although there is a majority considering that there is  no 
impact. For those indicating a negative impact, one of main problems mentioned is the necessity to include the information on the physical label and the 
necessity to regularly review this information, particularly in premixtures170.  

MS authorities have identified issues that led to different interpretation of labelling rules across the EU, which triggered changes on the labelling at MS 
level. The issues reported are the use of claims (only the claims stated in the authorising regulations are possible), the use in water for drinking and the 
declaration of carriers in premixtures171. Nevertheless, those issues were not related to EU regulatory changes. 

Another issue that may increase costs is the absence of harmonised labelling tolerances of FA in premixtures. This causes different interpretations by the 
MS and may trigger additional costs related to the change of label or the refusal to place the premixture on the market by a MS authority.  

Stakeholders largely think that the current labelling rules are informative and help to prevent misuse (e.g., exceed the maximum level permitted) along 
the food chain. As regards the role of labelling to ensure worker protection, the opinions are more divided 55% agree and 24 % disagree172. The reason 

168   vii  Consultation  Synopsis  Report  Re-evaluation  of  additives  authorised  by  the  former  Directive  that  remains  on  the  market  until  the  re-evaluation  is  completed  and  a  new 

authorisation is granted. This new authorisation may entail changes in relation with the previous authorisation. 

169   vii Consultation Synopsis Report, page 8 
170   vii Consultation Synopsis Report, pages 13 and 35 
171   ii FA Final Report _FCEC, page 77 

107 

 
 
for this is that the simultaneous application of the FA Regulation  and CLP Regulation  may reduce efficiency, as this  could result in different or even 
conflicting provisions, which can have major impact on premixtures173.   

Labelling rules are, in general, efficient, as the costs derived from regulatory changes are not significant compared with the benefits provided, especially 
on their role to provide information to minimise safety risks along the food chain. Furthermore, this claim is substantiated by the high level of conformity 
(96-98%)  of  the  samples  and  analysis  performed  by  the  MS  in  FA  and  premixtures.  Nevertheless,  three  relevant  concerns  have  been  identified  that 
created a burden, thus reducing the efficiency of the system: the obligation to indicate all the information on a physical label, the  absence of labelling 
tolerances in premixtures and the simultaneous implementation of the FA Regulation and CLP Regulation, in particular as for premixtures of FA. 

2.1.3. Regulatory costs compared to production costs  

The total costs of authorisation as % of total regulatory costs and/or as % of total cost of production of this product or product price were not possible to 
estimate.  Two  companies  indicated  that  the  total  regulatory  costs  stemming  from  the  Regulation,  of  which  the  main  component  are  the  authorisation 
costs, are estimated at 2% and less than 5%, respectively, of the cost of production for this product. This estimation was based on a 10-year authorisation 
period.  As  a  comparison,  another  company  that  is  a  major  FA  and  compound  feed  manufacturer  indicated  that  regulatory  costs  stemming  from  all 
legislation are 15% of all costs of the entire company's animal nutrition portfolio (EM 2.1.6) 

2.2 COSTS FOR EU INSTITUTIONS AND AGENCIES AND PUBLIC ADMINISTRATIONS (COMMISSION (DG SANTE AND EURL), EFSA 
AND MS NCA).  

2.2.1 Costs for DG SANTE 

The costs refer to the staff costs and cover all the activities required for FA approval and maintenance the FA Register. Those activities are summarised 
as follows for the period 2004-2017:  

a)  Administrative procedure related to FA approval:  

−  Verification of the compliance of applications: 791 174 applications. 
−  Mandates to EFSA: 1,066  
−  Evaluation of EFSA opinions: 613 opinions. 

172   vii Consultation Synopsis Report, page 29 
173   ii FA Final Report, page 104 
174  Administrative applications for Article 4(1) and Article 10(2). 

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b) Adoption of legal decisions:  

•  Regulations for the obligations derived from the FA Regulation: 444175 
•  Confidentiality  decisions:  (515)  Applicants  may  ask  for  confidentiality  of  certain  parts  of  the  dossier  when  they  submit  the  application  but  also 
when submitting complementary information (“stop the clock” by EFSA or possibility to submit complementary information to the Commission if 
the EFSA opinion is inconclusive). For each request of confidentiality, the Commission needs to take a formal decision and verify if this request 
complies  with  the  provisions  of  the  FA  Regulation.  As  there  is  some  information  that  may  not  be  kept  as  confidential;  the  examination  of  the 
requests may require a technical knowledge. This may also create some extra-time in the adoption of EFSA opinions (no synchronisation between 
the  decision  on  confidentiality  and  the  EFSA  opinion).  Regulation  (EU)  2019/1381  (“the  Transparency  Regulation”)176,  which  applies  to 
applications  submitted  since  27  March  2021,  has  transferred  this  obligation  to  EFSA.  It  provides  for  specific  rules  on  confidentiality  decisions, 
standardises the procedure for such decisions and allows synchronicity of the decision on confidentiality with the EFSA opinion. 

•  Meetings of the SCoPAFF section Animal Nutrition: 235 days (period 2004-20017) 

c)  Maintenance of the Register of FA. Number of versions published: 259. 

The performance is  calculated over the 2004-2017 period, these tasks have  involved a total  of 15,426 working  days of AD177 staff (or 1,102 working 
days/year, of which 46 working days per year are dedicated to participation in SCoPAFF meetings) and 4,000 working days of AST staff (or 250 working 
days per year). These inputs have involved, on average, 4.6 FTE178s of AD staff and 1.1 FTE of AST/SC1 staff per year over the period. The daily cost of 
the European Commission staff below is considered equal to € 620 for AD staff and € 255 for AST staff.179 

The table below shows that the total cost of the administrative obligations of the European Commission, calculated using the cost parameters specified 
above, amounts to € 10,584,000. Average yearly costs over the 2004-2017 period for all the  above-mentioned tasks are estimated at €756,000, 90% of 
which covers AD staff and 10% AST staff. 

175  According to the date of publication 
176   Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and 
amending  Regulations (EC) No  178/2002,  (EC)  No  1829/2003,  (EC)  No 1831/2003, (EC)  No  2065/2003,  (EC)  No  1935/2004,  (EC)  No  1331/2008,  (EC)  No  1107/2009,  (EU) 
2015/2283 and Directive 2001/18/EC. OJ L 231, 6.9.2019, p. 1. 
177 AD: administrators. AST: assistants. AST/SC: secretaries and clerks. 
178 Full time equivalent. One full time equivalent is equal to 8 working hours/day. 
179 Monetised on the basis of 2019 rates of remuneration of EU officials, OJ C 420/09, Volume 62, 13 December 2019, adjusted for overhead costs. AD rate is based on AD/AST, grade 

10, step 1; AST rate is based on AST/SC, grade 4, step 1. The same rates are assumed for all institutions (Commission, EFSA and EURL). 

109 

 
 
 
 
 
Table 7: Total Costs for the European Commission 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

Commission total costs of the Regulation 

15,426 working days AD STAFF 
4,000 working days AST STAFF  

TOTAL ESTIMATED COST  

€ 9,564,120 
€ 1,020,000  
€ 10,584,000 

Considering that the application is the most relevant step that triggers all the different actions (791 applications were processed by SANTE during the 
period 2004-2017 (on average 56 applications per year), a calculation is made to estimate the staffs’ costs per application, which rises to €13,400.  

Table 8: Commission average cost per application 

TYPE OF COST 

Commission average cost 
per application 

DESCRIPTION OF 
ESTIMATED EFFORT 
19.5 working days AD STAFF 
5 working days AST STAFF  

TOTAL ESTIMATED COST  

ESTIMATED 
COST 

€ 12,091 
€ 1,290  
€ 13,400  

The number of working days spent on the tasks has been relatively stable year-on-year, since the main phase of the implementation period (2012-2017) 
i.e., processing mainly applications for new authorisations, having increased by about 10% since the previous phase (2007-2011) when applications for 
re-authorisations peaked (see section 3.1.1). The same human resources have borne the increase of applications, which shows an increase of efficiency in 
the applications management.  

The Commission’s participation in meetings of the SCoPAFF (average 16.7 days/year) has involve on average 46 working days/year of AD staff time. 
The number of applications during the period 2012-2017 increased efficiency in the application management. In order to reduce costs on travel expenses 
and other costs derived from the organisation of meetings (interpretations and administrative support of  meetings), in 2017 the Commission started to 
reduce the number of meetings extending its duration, so the number of days per year remains stable. 

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On the one hand, the system has been efficient as the authorisations granted were not contested (only one case at the Court of Justice), a few cases were 
reported in the RASFF system (12 cases) and there were only  five cases of administrative review (Article 19). This allowed to allocate almost all the 
resources to the authorisation process.  

On the other hand, several issues hampered the Commission’s efficiency diverting resources to actions that could be improved: 

−  Decisions on confidentiality of application dossiers (515 decisions) 
−  The modification of authorisation Regulations when the authorisation holder changes, as regards holder-specific authorisations (see EM). 
−  The complexity of certain applications. 
−  The adoption of inconclusive EFSA opinions that triggers a new request of supplementary information by the Commission to the applicant.  
−  The too short duration of the authorisation.  
FeBOs  claim  that  the  need  to  have  physical  discussion  within  the  SCoPAFF  might  delay  the  adoption  of  some  authorisation  Regulations.  The 
Commission considers that the discussions within the SCoPAFF are necessary due to the complexity of many applications.  

There are three areas for improvement identified: 

−  Establish a simple administrative procedure for the change of authorisation holder. 
−  Extend the authorisation for certain additives if there are not safety grounds that justify keeping the existing authorisation period. 

Costs for the standard authorising Regulations and for Regulations changing the authorisation holder:  

Regulations where the authorisation holder changes represent 10% of the Regulations linked to an authorisation holder. During the period 2004-2017, this 
accounts for 28 Regulations for which the authorisation holder changed. The administrative costs are lower than the one for an authorising Regulation 
because it does not require any further elaboration of the Regulation, there is no EFSA opinion and the discussions at the SCoPAFF are minimum.  

Although it is difficult to quantify the costs, an estimation can be done considering that the time and resources dedicated to this activity are about 60% of 
the resources dedicated to a standard authorising Regulation.  

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Table 9: Commission average cost per standard authorising Regulation 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

Commission average cost per standard 
authorising Regulation 

32.7 working days AD STAFF 
8.5 working days AST STAFF  

TOTAL ESTIMATED COST  

€ 20,274 
€ 2,168 

€ 22,400 

For the standard authorising Regulations, the costs are €22,400 per Regulation. In case of change of authorisation holder, the costs are estimated 
at €13,400 per implementing Regulation.180 For the Commission during the period 2004-2017, the total costs of Regulations changing the authorisation 
holder amount to €375,200 which accounts for €26,800 per year (2 Regulations per year).  

Table 10: Commission average cost per Regulation changing the authorisation holder 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

Commission average cost per Regulation 
changing the authorisation holder 

19.5 working days AD STAFF 
5 working days AST STAFF 

TOTAL ESTIMATED COST  

€ 12.091 
€ 1,290 

€ 13,400 

2.2.2. Costs for the EU reference laboratory (EURL) 

The duties and tasks of the EURL are assigned by the FA Regulation, in particular Article 21 thereof. The main obligation of the EURL for FA is the 
evaluation of the analytical methods proposed by the applicant to determine the active substance(s)/agent(s) in the feed additive (as finished product), in 

180   There are for the whole period 482 Regulations adopted, 454  standard Authorising Regulations and 28 Regulations changing the authorisation holder If the costs of Regulations 
changing the authorisation holder are 60% of the costs of a normal authorising Regulation: 454 x Y+28 x 0.6Y=€10,584,000; Y= €22,400 (where Y is the average cost of a standard 
authorising regulation). The reference here is the number of authorising Regulations that is lower than the number of applications, this explains why this figure is higher than the 
€13,400 cost per application. In case of change of authorisation holder, the costs are estimated at 0.6 x €22,400 = €13,400. 

112 

 
 
 
 
premixtures, in feed, and in water (if applicable). Other important task is to maintain in their facilities a bank of reference samples of all the authorised 
additives. Other tasks considered for the estimation of the costs is the participation in the SCoPAFF meetings and the annual coordination meeting with 
the National Reference Laboratories (NRLs) organised by the EURL.  

The  performance  is  calculated  over  the  2004-17  period,  these  tasks  have  involved  a  total  of  14,008  working  days  of  AD  staff  (or  1,000  working 
days/year) and 3,500 working days of AST staff (or 250 working days per year). These inputs have involved 4 FTEs of AD staff and 1 FTE of AST staff 
per year over the period. The number of working days spent on all the above describe tasks has been relatively stable year-on-year throughout the period. 
Average annual costs over the 2004-2017 period are estimated at €684,000, 90.5% of which is the cost of AD staff and 9.5% of which is the cost for AST 
staff.  The  majority  of  the  time  is  devoted  to  the  preparation  of  the  validation  reports  and  keeping  of  samples  (94%).  On  the  other  hand,  the  EURL 
participation  in  meetings  of  the  Standing  Committee  and  the  annual  coordination  meeting  with  NRLs  have  involved  on  average  34  and  22  working 
days/year, respectively, of AD staff time. 

Table11: EURL costs 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

EURL average annual costs 

TOTAL ESTIMATED COST  

1,000 working days AD STAFF 
250 working days AST STAFF 

€ 620,000 
€ 63,750  
€ 684,000 

Considering the evaluation report as the main output that triggers the majority of the actions performed by the EURL, 37 evaluation reports per year were 
prepared  on  average  during  the  2004-2017  period,  at  an  estimated  cost  of  €18,500  in  staff  costs  per  validation  report.  This  cost  is  justified  as  the 
validation process entails on some occasions the organisation of an inter-laboratory comparison study.  

Table 12: EURL costs per validation report 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

EURL average cost per validation report 

27 working days AD STAFF 
7 working days AST STAFF 

TOTAL ESTIMATED COST  

€16,740  
€ 1,785 
18,500€  

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The  guidance  prepared  for  the  validation  of  the  method  of  analysis  has  been  a  very  efficient  instrument  for  FeBOs.  As  a  result,  the  validation  of  the 
method  of  analysis,  except  for  few  complex  cases  (e.g.,  some  botanical  flavourings  and  some  few  colourants),  is  ready  before  EFSA  finalises  the 
assessment, therefore it does not interfere negatively in the authorisation process. 

A majority of stakeholders and competent181 authorities agree that the role of the EURL is adequately defined in the Regulation182 

In general, the EURL has been very efficient in implementing all its tasks.  

2.2.3 Costs for EFSA 

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP-Panel) provides scientific advice on the safety and/or efficacy 
of additives and products or substances used in animal feed. It is composed of 17 scientists from across Europe. 

The costs related to the EFSA tasks during the period 2004-2017 183involved:  

a) the cost of the FEEDAP Panel/working groups (WG) meetings; and,  

b) staff time to meet the legal and administrative obligations related to the risk assessment of FA. EFSA has processed 969 applications during the period 
2004-2017. 

Those costs were estimated on the basis of the costs for which EFSA had data 2014-2018 for the categories AD, AST/FG staff categories. No data was 
available for the period 2004-2013. During the period 2004-2013 human resources were quite stable and increased in 2014 for the AST/FG staff while the 
AD staff remained relatively stable. 

Average annual costs for EFSA over this period are estimated at €1.9 million of which, €1.1 million per year are staff costs.  

During the period of 2014-2018 EFSA has processed 346 applications, corresponding to 69.2 applications per year on average at an estimated cost of 
€27,450 per application (new and re-evaluation), €15,900 of which are internal staff costs. The average cost for a renewal is estimated to be around 
€16,470 (60% compared to a standard application for authorisation). 

181   A total of 969 applications for Articles 4(1), 10(2) 13, 14 and 15 of the FA Regulation and 71 applications for Article 29 of the GFL. 
182  vii Consultation Synopsis Report page 11 and 21 
183   Due to major system changes, EFSA were not able to provide data for the period 2004-13. 

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Table 13: EFSA costs  

Annual cost of FEED Panel/WG meetings 
No. of expert days/year  
Total staff hours/year  
EFSA AD staff involved  
EFSA AST/FG staff involved  

2014 
€ 861,159.47 
1,279.9 
9,873.75 
14 (proxy) 
7 (proxy) 

2015 
€ 864,168.89 
1,284.5 
11,819 
14 
7 

2016 
€ 819,368.94 
1,225 
26,477.75 
16 
10 

2017 
€751,778.14 
1,077.2 
24,713.5 
16 
14 

Over the 2014-18 period, the cost of the FEEDAP Panel/WG meetings has fallen by 40%, from €861,000 in 2014 to €515,000 in 2017 This is due to a 
decrease in the number of expert days per year, from 1,280 in 2014 to 824 in 2018, which resulted in a reduction in the costs involved (the cost of expert 
days themselves and also reimbursable). This task has involved 5,690 expert days over the five years, or 1,138 working days/year on average. Dividing 
this number by the 69.2 applications per year processed it is possible to obtain an average work effort of 16.5 expert days per application. An average 
total labour cost  (travel  included) of the  external experts of € 700 is  considered. The significant  cut  in  the budget  dedicated to  feed-related  activities, 
particularly between 2017 and 2018, is in line with the overall EFSA budget cut and reflects efforts to streamline costs by: 

−  using digital tools to work (i.e., phone meetings, web conferences) which is more cost-effective and time efficient. The physical meetings were 

reduced by 40%; and,  

−  centralising some aspects of the work, e.g., costs covering experts’ flights were transferred to a different, common budget line dedicated only 

to flights for all EFSA. 

On the other hand, during the same period, the requirements for internal  staff time to  fulfil the legal  and administrative obligations related to  the risk 
assessment of FA have increased by nearly 2.5 times: from an estimated 1,234 working days in 2014 to 3,153 days in 2018. This task has involved a total 
of  12,263  working  days  over  the  five-year  period,  or  an  average  of  2,453  working  days/year.  Dividing  this  number  by  the  69.2  applications  per  year 
processed it is possible to obtain an average work effort of 35.4 working days per application. An average total labour cost (overheads included) of € 450 
per working day is considered.  

Although the required internal staff time has increased substantially, the increase was for the AST/FG staff was from 7 in 2014/15 to 15 in 2018, while 
the number of AD staff has remained relatively stable through the period (14 AD staff in 2018, the similar as in 2014/15).  

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Table14: EFSA cost per application processed 

TYPE OF COST 

DESCRIPTION OF ESTIMATED EFFORT 

ESTIMATED COST 

EFSA average cost per application 
processed 

35.4 working days internal staff 
16.5 working days external experts 

TOTAL ESTIMATED COST 

€ 15,900 
€ 11,550 
€ 27,450 

Again, the shift towards a higher share of AST/FG staff involved in feed-related activities reflects efforts to reduce costs, e.g., some administrative tasks 
have been taken away from the scientific units and are now performed at the central level. Furthermore, the increase in internal staff time reflects a shift 
from using external experts towards in sourcing some of the work to EFSA staff. The benefits of this strategy include: 

i. 

increases in quality and harmonization of outputs.  

ii.  shorter timelines.  

iii. improved control of the entire process. 

iv.  increased number of adopted outputs per year. 

The increase of quality and harmonisation of outputs reduced the number of publications with errata or editorial corrections, from 9 publications in 2014 
to two in 2018. The harmonization of outputs has been improved by increased preparation of opinions by staff members who ensured the use of the same 
approaches  and  same  wording  across  the  opinions  wherever  possible,  based  on  a  so  purposed  designed  opinion  template.  Also,  the  creation  of  cross-
cutting meetings across EFSA units helped to streamline the assessment methodologies and implementations for substances used in different food & feed 
domains. 

The timing between accepting a mandate and the adoption of the corresponding scientific output (opinion) has been reduced from 640 days on average in 
2014 to 342 days in 2018. In order to improve the entire process, draft opinions have been elaborated by assigning staff members and Panel experts, who 
are knowledgeable on the topic but not involved in drafting the assessment, for a deep review of draft opinions before they are discussed by the Panel for 
possible  adoption.  This  involvement  of  ‘fresh  eyes’  allows  an  increased  identification  of  errors  and/or  items  so  as  to  be  clarified,  which  often  can  be 
addressed before the upcoming Panel meeting. 

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Further efficiency of the process is expected to be achieved through increasing digitalisation. Improve electronic submission of data using agreed data 
formats  would  facilitate  the  automation  of  some  administrative  steps  and  the  development  of  algorithms  for  data  extraction  and  analysis.  In  addition, 
improving  EFSA’s  expert  capacity  to  draft  risk  assessments  would  be  needed  to  further  increase  the  efficiency  of  the  process.  This  is  expected  to  be 
achieved by establishing collaborations with individual experts and partnerships with scientific institutions who could support EFSA staff, the working 
groups and Panel in performing preparatory work. 

With this strategy, the staff costs increased by 2.2 times between 2014 and 2018, i.e., at a lower rate than the increase in required staff time due to the 
increasing number of opinions.  

Total annual costs for EFSA over the 2014-18 period are, on average, at €1, 9 million per year (staff costs + travel costs for panel and experts). 

2.2.4 Costs for MS 

The standard cost model was followed to identify the administrative duties, identification of target groups within NCAs that perform the different actions 
(implementation of the Regulation and control activities), frequency of required action (attendance to meetings of SCoPAFF, number of inspections per 
year/ establishment), identification of relevant costs and burdens (attendance to SCoPAFF meetings, control activities and other  legal obligations). The 
performance was assessed by the staff time184 devoted to these activities. It has been estimated as an average over the last three years by the NCA (2016-
18).  

The costs in terms of staff time185 related to the MS CA tasks involve:  

a) participation in the meetings of the Standing Committee in Brussels. This includes preparation of meetings and any administrative procedure related to 
the participation in those meetings.  

b)  control activities carried out for inspections and verification checks; and,  

c)  other legal and administrative obligations, e.g., setting administrative procedures. 

The staff time dedicated to a) c) activities (participation in the meetings of the Standing Committee and other legal and administrative obligations) has 
been calculated for MS CAs186 over the period 2016-2018 (60 working days per MS per year for preparation/attendance of the meetings of the Standing 

184 EUROSTAT average annual earnings in the public sector, by economic activity and educational attainment (staff categories 1 to 4), per Member State (latest data: 2014), adjusted 

for overhead costs (addition of 25%) in accordance with the Better Regulation toolbox #60. 
185   Other Member States cannot estimate the costs of the Regulation versus other feed legislation. 

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Committee in Brussels and 92 working days per MS per year for the fulfilment of legal and administrative obligations.) Multiplying this work effort by 
an average cost of € 190 per working day is possible to obtain an average total cost per MS of € 29,000.   

Table 15: costs for NCAs 

TYPE OF COST 

Meetings of the Standing 
Committee in Brussels 
Legal/administrative 
obligations 

DESCRIPTION OF 
ESTIMATED EFFORT 
60 working days per year 

ESTIMATED 
COST 
€ 11,450 

92 working days per year 

€ 17,550 

TOTAL ESTIMATED COST 

€ 29,000 

Considering that the application is the most relevant step that triggers all the different actions, the costs (791 applications processed by SANTE during the 
period  2004-2017=  56  applications  per  year)  for  each  MS  per  application  amount  to  €500  both  per  application  for  new  authorisation  and  renewals 
(calculated based on the € 29,000 per year per MS). For the whole EU, this amounts to €14,000 per year per application. 

The number of Regulations where the authorisation holder changes represent 10% of the Regulations linked to an authorisation holder (281). During the 
period 2004-2017, this accounts for 28 Regulations for which the authorisation holder changed (EM 3.2.6 and 6.7). The administrative costs are lower 
than that for an authorising Regulation because it does not require further elaboration of the Regulation, there is no EFSA opinion and the discussions at 
the SCoPAFF are minimum. Furthermore, during the same period 454 standard authorising Regulations have also been adopted. 

Although it is difficult to quantify costs, an estimation can be done considering that the time and resources dedicated to this activity are about 60% of the 
resources dedicated to  a standard authorising Regulation.  The cost  for a standard authorising Regulation  is  €860187 and for a Regulation  changing  the 
authorisation holder is €500 per MS. Therefore, the average total cost for a standard authorising Regulation is €860x28=€24,088, while the average total 
cost for a Regulation changing the authorisation holder is €500x28=€14,000. The costs associated with the latter procedure were €14,490 per MS for the 
whole period.188. For all MS during the period 2004-2017, this amount to €405,600 which accounts for €28,900 per year for all EU MS. 

186 Other Member States cannot estimate the costs of the Regulation versus other feed legislation. 
187 The reference here is the number of authorising Regulations that is lower than the total number of applications, explaining that this figure is higher than the €500 cost per application. 
188  €29,000  per  year  x  14  years=€406,000  total  costs  per  MS.  There  are  for  the  whole  period  482  Regulations  adopted,  454  standard  authorising  Regulations  and  28  changing  the 
authorisation holder. If the costs of Regulations changing the authorisation holder are 60% less than a standard authorising Regulation: 454 x Y+28 x 0.6Y=€406,000; Y=  €862. 

118 

 
 
 
Several MS could not provide estimates of time spent on legal/administrative obligations for controls for  FA and premixtures as this information  was 
available for all feed in general but does not distinguish additives and premixtures from other feeds. To allow for the differences in the estimates provided 
by MS, the staff time has been calculated for all the task ‘b’) as an average across those MS that provided complete data (14 MS). 

The staff time dedicated to enforcement control tasks (b) has been calculated for MS CAs189 over the same period 2016-2017 in 344 working days per 
MS per year. Multiplying this work effort by an average cost of € 215 per working day190 is possible to obtain an average total cost per MS of € 74,000. 

Table 16: costs of enforcement and control tasks 

TYPE OF COST 

Enforcement and control 
tasks 

DESCRIPTION OF 
ESTIMATED EFFORT 
344 working days per year 

ESTIMATED 
COST 
€ 74,000 

TOTAL ESTIMATED COST 

€ 74,000 

In total, the costs for each MS CAs are €103.000 (29,000+74,000) euros per year on average which amounts to €2,884,000 per year for all EU MS. 

2.3 BENEFITS FOR HUMAN HEALTH 

Benefits for human health refer to three main aspects: 

−  Additives are safe because food from animal origin does not contain feed additive’s residues that may compromise consumer safety. FA cannot 

contain microorganisms, toxins or other substances that may be transferred to food. 

−  FA do not contribute to increase AMR. 
−  Workers/users of FA are safe. 

(Where Y is the average cost per MS of a standard authorising regulation); average total cost of Regulations changing the authorisation holder for the whole 2004-2017 period: 28 x 
0.6 x 862=€14,490 

189   Other Member States cannot estimate the costs of the Regulation versus other feed legislation. 
190  The  average  daily  cost  of  the  staff  involved  in  the  implementation  of  the  control  activities  (€  215)  is  different  from  the  one  of  the  staff  involved  in  the  attendance  of  Standing 

Committee meetings and in the execution of the administrative/legal obligations (€ 190) due to the different staff category mixes involved in these activities.  

119 

 
 
 
Those  three  aspects  are  evaluated  by  EFSA  to  ensure  that  no  health  concerns  arise  when  an  additive  is  authorised.  In  addition  to  the  rigorous  EFSA 
assessment, the labelling provisions ensure that the relevant information to protect consumers or workers is transmitted along the feed chain. This role of 
EFSA is widely recognised, 90% of respondents  consider that the safety assessment carried out by EFSA makes  FA safe for human health191. 75% of 
respondents see benefits of the FA Regulation for human health. FA are safe for consumers according to 92% of respondents192. 

The reduction of AMR goes beyond consumers or users and provides benefits for the society in general. 72% of all respondents agree that the ban on the 
use of antibiotics introduced by the Regulation played an important role in preventing AMR193.  

As regards worker/user safety, 84% of respondents agree that FA are safe for users. A majority of MS authorities agree on this although three MS 
authorities, did not provide a definite answer.194. 

In the PC, 15 respondents (from the FA industry, consultants and one citizen) indicated in the open fields that there is a lack of coherence with worker 
safety  regulations (FA Regulation  and CLP), leading  to  overlapping  labelling  requirements.  For some industry respondents  the rules laid  down in  the 
CLP  Regulation  are  sufficient195.  This  is  pointed  in  the  NCAs  survey,  where  4  MS  indicated  that  there  were  at  least  one  or  two 
contradictions/inconsistencies  between  both  Regulations  (CLP  and  FA  Regulation).  Although 
indicate  such 
contradictions/inconsistencies  for  the  specific  question  (28  out  35  indicate  “don’t  know”,  6  do  not  see  contradictions/inconsistencies  and  1  see 
contradictions/inconsistencies), the same survey shows that one of the main reasons for changing the labels is the request for additional worker safety 
requirements from MS authorities. Although the surveys did not reveal a high rate of positive response on whether the CLP Regulation is coherent with 
the  FA  Regulation,  the  case  studies  provided  a  clearer  picture  on  the  effects  of  the  simultaneous  application  of  both  Regulations.  The  duplication  of 
worker safety requirements increases costs, especially in premixtures, which normally contain many additives for which the indication of all the safety 
requirements for the individual additives and for the mixture as a whole may be a problem for small packages. In general, this duplication of rules can 
possibly lead to complex directions for users. CLP applies horizontally to feed additives and other sectors (including medicinal products, food additives 
or food flavourings) for substances and mixtures of such products that are not in the final state for the final user. Workers’ requirements should therefore 
be set according to consistent criteria across all the sectors in order to provide clarity and avoid inconsistencies, at least for premixtures of feed additives, 

the  SH  survey  did  not 

191  vii Consultation Synopsis Report, page 27. 
192   SH Survey 
193   Public consultation 
194   vii Consultation Synopsis Report, pages 8 and 19   
195   vii Consultation Synopsis Report, page 29. 

120 

 
 
where a problem has been identified due to the simultaneous implementation of the FA Regulation and CLP Regulation196. In addition to the increasing 
costs for some premixtures, insufficient clarity may undermine the proper understanding of the worker safety directions on the label.  

For the worker safety requirements there is room for simplification, for instance by applying only CLP Regulation for premixtures of additives while 
keeping the implementation of both Regulations for FA. 

2.4 BENEFITS FOR ANIMAL HEALTH AND ANIMAL WELFARE 

The benefits for animal health are clear for all FeBOs and MS authorities and is one of the elements of the current framework that is not questioned.  

The surveys indicated that 85% of respondents considered that FA have benefits for animal welfare, although those benefits have not been fully exploited 
according to some feed additive producers and pet food industry. There are many additives that have indirect effects on animal welfare, such as vitamins, 
trace  elements,  gut  flora  stabilisers  or  coccidiostats,  but  there  was  no  authorisation  of  additives  with  the  specific  purpose  of  having  a  direct  effect  on 
animal welfare.  

FA favourably affecting animal welfare can only be allocated under the category ‘zootechnical additives’. EFSA requests the applicant to demonstrate a 
zootechnical effect (e.g., improvement of performance - increase egg/meat production). However, the actions performed by these additives are not related 
to  an  increase  of  the  animal  performance,  but  to  a  specific  improvement  in  the  well-being  of  the  animal  (e.g.,  a  stress  reduction).  This  discrepancy 
discourages  applicants  from  applying  for  those  kinds  of  additives.  Furthermore,  the  establishment  of  endpoints  (see  glossary)  to  demonstrate  animal 
welfare effects requires additional input in EFSA guidance to facilitate those applications. 

Despite the establishment of a specific functional group in 2019 – ‘physiological condition stabilisers’, which are intended to develop additives having 
beneficial effects on animal welfare – no additives have been authorised so far197. 

In general, a majority of respondents see benefits of the  FA Regulation for animal welfare, for instance, 78% of respondents consider that  FA help to 
improve animal welfare and several respondents showed the importance of having additives intended to improve animal welfare in the future. One MS 
authorities  responsible  for  animal  feed  neither  agree  nor  disagree  with  the  statement  that  FA  help  to  improve  animal  welfare.  This  MS  authorities 
expressed  the  views  that  very  few  additives  have  been  developed  expressly  to  promote  animal  welfare,  in  line  with  some  other  respondents.  It  also 

196   See also the relevant Occupational Safety and Health legislation and in particular Council Directive of 12 June 1989 on the introduction of measures to encourage improvements in 
the safety and health of workers at work and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical 
agents at work (89/391/EEC) 

197   FA Register updated on 19/05/2021. 

121 

 
 
indicated that increasing the performance and growth of animals does not contribute necessarily to improve animal well-being. Another MS authorities of 
the same country contradicted this position and responded that they agree that additives help to improve animal welfare.  

A citizen that neither agrees nor disagrees with the statement that FA help to improve animal welfare, indicated: “animal welfare is a societal concern. 
Additives which are used must not have a negative effect on welfare. It is perhaps worth noting that in the case of non-food animals, e.g., pets there is a 
consumer demand on cosmetic appearance of feeds which also needs to be taken into consideration”.  

After several years of discussion, the functional group ‘physiological condition stabilisers’ was created, that is to say, substances or, when applicable, 
microorganisms, which, when given as feed to animals in good health, favourably affect their physiological condition, including their resilience to stress 
factors. The Regulation authorising this functional group also seeks to respect good farming practices that ensure the wellbeing of animals and the respect 
of animal welfare provisions, by including a specific recital on the matter. 

The FA Regulation needs to be more efficient so that the authorisation of FA has positive effects on animal welfare by excluding the demonstration of 
performance. The costs incurred to demonstrate efficacy will be limited to those positive effects on animal welfare, excluding those aspects related to the 
demonstration of performance. The authorisation should not undermine the respect for good farming practices and animal welfare provisions.  

2.5 BENEFITS FOR THE ENVIRONMENT 

Many additives, not authorised under the functional group having benefits on the environment, have clear positive effects mitigating the impact of 
livestock farming on the environment, in addition to effects under the functional group for which they were authorised. More details on this point are in 
the main text.  

EFSA performs a risk assessment to evaluate the impact of FA on the environment and may include restrictions on their use, e.g., maximum limits, and if 
necessary, a post-market monitoring plan. 

The benefits on the environment have been recognised by the stakeholders (mainly FeBOs) 71% of respondents see benefits for the environment198.  

The post-market monitoring, which also includes the unforeseen effects on the environment, depends on the EFSA outcome performed on a case-by-case 
basis. Other environmental monitoring is not under the remit of the Regulation. The controls performed by MS cover all the aspects related to safety and 
placing on the market, including labelling, to ensure that additives/premixtures comply with safety requirements (for animals, consumers, workers and 
the environment) and with directions for their use, and to subsequently prevent a misuse along the feed chain.  

198   SH survey 

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The effects on the environment are considered adequately assessed and the level of compliance of additives and premixtures is high. This means that, 
where applicable, the maximum levels are respected and the information on the label is passed properly throughout the food chain.  

123 

 
 
 
2.6 BENEFITS FOR FARMERS 

The benefits for farmers stem from the placing of safe and efficacious FA on the market. Those benefits are related to their specific functions. 83% of 
respondents noticed benefits of the FA Regulation for farmers. The details on those benefits are in the main text. 

2.7 BENEFITS FOR CONSUMERS. 

There are two elements to consider when dealing with benefits for consumers: 

−  Additives are safe because food of animal origin does not contain FA or its residues, which may compromise consumer safety. 
−  FA contribute to reducing AMR. 

The EFSA evaluation must ensure that no health concerns arise when an additive is authorised. In addition to the rigorous EFSA assessment, the labelling 
provisions  ensure  that  the  relevant  information  to  protect  consumers  is  conveyed  along  the  feed  chain.  During  the  period  2004-2020,  the  RASFF 
notifications showed the level of compliance as for the presence of FA or their residues in food of animal origin. 82 out of 16,634 notifications were 
linked to the presence of unauthorised additives or high level of residues, representing 0.5% of the total number of notifications. 

This role of EFSA is widely recognised, 92% of respondents consider that FA are safe for consumers199. 

The  reduction  of  AMR  goes  beyond  consumers  or  users  and  provides  benefits  for  the  society  in  general.  72%  of  respondents  agree  that  the  ban  on 
antibiotics introduced by the Regulation played an important role in preventing AMR. 

2.8 BENEFITS FOR WORKERS/USERS  

The  benefits  for  workers  are  related  to  the  evaluation  performed  by  EFSA  on  worker  safety  and  the  measures  that  are  adopted  in  the  authorising 
Regulation to protect workers200. An appropriate labelling with the directions of use of the additives/ premixtures ensures that the information is conveyed 
along the feed chain. 

199   SH survey. 
200   See also the relevant Occupational Safety and Health legislation and in particular Council Directive of 12 June 1989 on the introduction of measures to encourage improvements in 
the safety and health of workers at work and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical 
agents at work (89/391/EEC) 

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This role of EFSA is widely recognised, 90%201 of respondents consider that the safety assessment carried out by EFSA make FA safe for human health. 
In this regard, 84% of stakeholders also consider that FA are safe for workers/users and 11% neither agree nor disagree with this statement. 

The current system demanding the inclusion of all the information on a physical label in relation to worker/safety directions of use reduces the efficiency 
as it increases costs. One of the factors identified that triggers the costs increase of changing labels is the difference in interpretations of worker safety 
information  by  MS.  The  information  about  worker/safety  requirements  is  quite  extensive  as  two  Regulations  apply:  the  FA  Regulation  and  the  CLP 
Regulation; the latter requires information to be put on the label and in the Safety Data Sheet (Annex II to REACH). As for premixtures, the information 
required  by  the  FA  Regulation  and  CLP  legislation  may  cause  concerns  related  to  available  room  on  the  labels  and  readability  of  the  information. 
Generally,  the  complexity/cost  is  expected  to  be  proportionately  higher  for  smaller  packs  than  for  larger  packs.  Another  element  raised  during  the 
evaluation202 that may reduce the efficiency in the implementation of worker safety provisions is related to the coherence with worker safety provisions 
(FA and CLP) leading to possible overlapping or complex labelling requirements. This issue is more detrimental to premixtures.  

2.9. BENEFITS FOR PETS AND THEIR OWNERS 

The benefits for pets and their owners can be summarised as follows: 

−  Additives are safe for pets. The Regulation introduced a comprehensive set of requirements compared to the previous 1970 FA Directive to ensure 
that  they  are  safe.  Taking  into  account  that  those  animals  have  a  long  lifespan,  the  evaluation  takes  into  consideration  chronic  toxicity, 
mutagenicity and carcinogenicity effects to prevent any negative effect on pets’ health.  

−  Labelling requirements ensure that those additives are used in accordance with conditions of authorisation (e.g., maximum doses) along the feed 

chain.  

−  The safety of the owner is considered in the assessment. Since FA cannot be given directly to the animals by pet owners, they should always be 
incorporated in a compound feed or in a feed material.  In addition, additives will not pose risks of AMR for pets and their owners as they are 
subject  to  pre-market  assessment  to  eliminate  any  AMR  effect.  Although  the  antibiotics  authorised  by  the  former  1970  FA  Directive  were 
addressed to food-producing animals, companion animals, due to their close contact with humans, may contribute to spread AMR in humans. Use 
of antimicrobials that are critically important for human health in companion animals is an additional risk factor for emergence and transmission 
of antimicrobial resistance. Although the contribution of FA is negligible, the premarket assessment will ensure that FA intended for companion 
animal will not have any AMR effects.  

201   SH survey. 
202   PC. FEFANA response 

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For  a  majority  of  respondents  from  all  stakeholder  groups,  the  FA  Regulation  provides  benefits  for  pets  and  pet  owners.  However,  animal  welfare 
organisations did not contribute to the survey, despite the efforts to involve them. One citizen expressed the view that there is an increasing consumer 
demand for cosmetic appearance of pet food that needs to be considered. This issue may be related, for example, to the use of colourants so as to meet the 
requirements of pet owners (many compound feeds are grey colour and this is not accepted by pet owners)  

Nearly  all  respondents  agree  that  FA  are  efficacious  and  safe  for  pet  animals  (74  and  76,  respectively,  out  of  78  respondents);  excluding  28  and  30 
respondents, respectively that did not provide an answer as pet food is not relevant for their organisation) 203. 

As regards the capacity of the FA Regulation to address scientific and technical developments for pets, a majority (45 out of 107 respondents) consider 
the authorisation procedure not to be suitable to address scientific and technical developments for pets and livestock production, due to the time periods 
incurred during the authorisation.  

3. - COHERENCE 

3.1 INTERNAL COHERENCE 

The effectiveness of certain provisions of the FA Regulation could be improved in terms of internal coherence, which may also have affected the 
simplification and harmonisation of the authorisation process:  

The information collected during the study identified some possible gaps in the definitions; in particular, MS authorities signalled the necessity to 
improve the definitions of “processing aids” in relation to FA, as well as to establish a harmonised definition for “maximum recommended levels” or 
“recommended levels”.  

3.1.1 Preparations  

MS  authorities  also  noticed  the  necessity  to  establish  a  definition  of  “preparations”  of  FA  (a  feed  additive  composed  by  different  substances). 
Preparations are not defined as such although their compositional and labelling requirements were specified in the FA Regulation by the adoption in 2015 
of implementing rules modifying Annex III of the FA Regulation204. A formal definition of “preparation” would be useful, as this would allow a better 

203   vii Consultation Synopsis Report, page 9. 
204   Commission Regulation (EU) 2015/327 of 2 March 2015 amending Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards requirements for the 

placing on the market and conditions of use of additives consisting of preparations OJ L 58, 3.3.2015, p. 46. 

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distinction  between  preparations  of  FA  and  premixtures  (mixtures  of  FA  or  of  FA  with  feed  materials  or  water).  Both  are  intermediate  products  that 
cannot be given directly to animals, but which are incorporated in compound feed or feed materials (e.g., wheat). 

3.1.2 Drinking water 

The coherence of the provisions related to the use of additives in drinking water should be assessed: the coexistence of the definition of FA, which allows 
the use of additives in water for drinking, and the limitations of the use for certain categories and functional groups as referred to in Article 6 and Annex I 
of the FA Regulation, has reduced clarity in relation to the possible scope of the applications. Some applicants requested the authorisation of use in water 
for drinking  for the majority of chemical  flavourings and for  certain  preservatives, but  the  FA Regulation  does not  allow this use.  In the  case of  789 
flavourings and eight preservatives, the applicants withdrew the application for their use in water for drinking. In addition, the different feeding/drinking 
systems introduced technical challenges for the correct implementation of the rules laid down in the FA Regulation. For example, premixtures may have 
a  composition  similar  to  a  complementary  feed  that  is  allowed  as  liquid  feed.  The  distinction  in  the  routes  of  administration  for  liquid  feed  (to  use 
complementary feed) and for water for drinking (to use additives) is not evident in some feeding systems and this may create different interpretations in 
the MS. During the 2004-2017 period, these issues were raised several times (35), directly or indirectly, at the level of SCoPAFF. Those aspects have 
been noticed by some MS authorities and by stakeholders –mainly FeBOs- (PC and NCA Survey).  

Technical questions about the practical implementation of the use of additives in water for drinking are relevant for the MS authorities and stakeholders -
mainly FeBOs- (ii FA Final Report _FCEC, page 77) as it may create different understandings across the EU. 

3.1.3 Data sharing  

Data sharing between applicants should reduce tests and costs of applications and be consistent with the EU policy on animal welfare. The FA Regulation 
lays down requirements for data sharing to prevent repetition of toxicological tests on vertebrates (Article 20). The applicants must take all the necessary 
measures to reach an agreement. If such an agreement is not reached, the Commission may decide to disclose the information while ensuring a reasonable 
balance  between  the  interests  of  the  parties  concerned.  The  FA  Regulation  does  not  provide  the  Commission  with  tools  or  mechanisms  to  ensure  a 
reasonable balance between the parties. Consequently, few requests of data sharing occurred (three) and it was not possible to draw any conclusions. In 
the PC two thirds of respondents were not able to indicate whether or not data sharing rules are effective in reducing costs and animal testing. Those that 
have a negative view, have three different arguments: data sharing is not fully exploited, there is room for reduction of costs or the market should decide. 
Nonetheless, some of these respondents argued that data sharing is a useful concept for reducing costs205. 

3.1.4 Withdrawal of the application during the renewal process 

205   vii Consultation Synopsis Report, page 26.  

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The  FA  Regulation  provides  for  a  procedure  for  the  renewal  of  authorisation  of  FA.  If  the  application  for  renewal  is  presented  in  due  time,  the  feed 
additive  will  remain  on  the  market  until  a  decision  on  the  renewal  is  taken  by  the  Commission,  provided  that  the  reasons  for  the  possible  delay  for 
granting  the  renewal  of  authorisation  are  beyond  the  control  of  the  applicant.  It  may  happen  that  the  applicant  withdraws  the  application  for  renewal 
during the process. In this case, the additive is no longer authorised if the original authorisation has already expired. The FA Regulation is not consistent 
in  this  regard,  as  FeBOs  must  face  a  “sudden”  expiry  of  the  authorisation,  without  any  transitional  period  allowing  an  adaptation  of  the  products 
concerned on the market. 

3.1.5 Change of the authorisation holder 

The current system requires the adoption of an implementing Regulation (including a request for an EFSA opinion) for each change of the authorisation 
holder  concerning  holder-specific  authorisations  (due  for  instance  to  mergers  or  acquisitions  of  companies).  In  order  to  address  this  administrative 
burden,  the  Commission  and  EFSA  agreed  on  some  internal  administrative  arrangements  allowing  EFSA  to  be  informed  on  the  modification  of  the 
authorisation holder rather than to be requested to deliver an opinion on a purely administrative issue. This represents 10% of the Regulations adopted in 
relation  to  holder-specific  authorisations  (see  FCEC  Final  Report:  section  6.1.1,  EQ3.2  and  section  7.3.1).  The  obligation  to  adopt  an  implementing 
Regulation entails a burden for the Commission, EFSA and MS. 

3.1.6 The category of “zootechnical “does not necessarily match with the expected functions 

One of the issues  raised during the evaluation  was the fact  that some categories of  FA did  not  necessarily  match with  the expected functions of  such 
additives. This affects certain innovative additives intended to have benefits for animal welfare or the environment. These additives were allocated in the 
category ‘zootechnical additives’ and applicants were required to demonstrate performance, in addition to the beneficial effects for animal well-being or 
the  environment.  Some  additives  may  however  have  positive  effects  on  animal  welfare/environment,  without  necessarily  leading  to  an  increased 
performance or productivity of the animals (see FCEC Final Report, section 5.1.1, EQ 1.4). This finding needs to be further explored as in principle the 
FA Regulation provides for the possibility to demonstrate an environmental effect or an animal welfare effect, but the fact that those functional groups 
are under the category “zootechnical additives” triggered different interpretations by EFSA, according to the applicants. 

3.1.7 Environmental risk assessment for non-food producing animals 

The  safety  criteria  and  data  requirements  introduced  in  the  FA  Regulation  were  effective  to  ensure  a  comprehensive  environmental  assessment. 
Nevertheless, it is necessary to introduce some clarification regarding the environmental safety requirements applicable to farmed non-food producing 
animals  (e.g.,  fur  animals)  in  order  to  accommodate  the  requirements  related  to  the  safety  criteria  laid  down  in  the  FA  Regulation.  Although  no 
application specifically addressing this type of animals was submitted and authorisations granted for all animal species (including non-food producing 
animals) have considered the environmental impact of the additives concerned, the FA Regulation would need to be modified in order to clearly state that 
those specific animals are covered by the environmental risk assessment. 

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3.1.8 Additives only intended for export 

The FA Regulation does not provide specific labelling provisions to identify additives and premixtures intended only for export, nevertheless, some MS 
have imposed labelling obligations – e.g., ‘only for export’. In addition to the absence of harmonised labelling, the definition of the  FA Regulation of 
“placing on the market” only allows the export from the producing establishment and very limited circulation within the EU to the third country. This 
reduces  the  circulation  of  those  products,  and  it  is  not  necessarily  consistent  with  the  normal  activity  of  FeBOs,  which  may  require,  for  example, 
producing  certain  additives  in  one  or  several  establishments  with  a  view  to  incorporate  those  additives  in  a  premixture  manufactured  in  another 
establishment. A large number of respondents to the MS authorities and stakeholders surveys were aware of those products, which are produced in the 
EU only for export206. For the specific sector of FA, 33% of manufacturers and traders of FA and premixtures exported those additives. Several of the 
consulted  companies  (including  SMEs)  indicated  that  the  export  of  those  products  is  an  important  segment  of  their  business.  In  cases  where  the 
authorisation/approval  process  in  the  non-EU  country  is  less  burdensome  than  in  the  EU,  this  market  option  enables  EU  companies  to  maintain  their 
global competitiveness, particularly SMEs producing a diverse product range, for which the burden of authorisation costs can be particularly dissuasive in 
view of their small scale of business.207. 

3.1.9 Imports of FA 

As regards imports, the lack of a code permitting to identify FA at the time of import reduces the capacity of MS to control imports, as additives are often 
imported  as  chemical  substances  using  different  customs  codes.  FeBOs  do  not  have  a  specific  code  or  system  in  place  that  allows  to  classify  their 
products as FA at custom level. A significant share of stakeholders considers imports not to be adequately controlled and a majority of MS authorities 
consider them only to be partially controlled (see ii FA Final Report _FCEC, page 45). 

3.1.10 Modification of non-holder specific authorisations 

The modification of  non-holder specific  authorisations is  not  sufficiently clear in  the  FA Regulation.  Whereas for additives linked to  an authorisation 
holder, the FA Regulation specifically mentions the possibility to request a modification of the authorisation, it is not so evident for additives not linked 
to an authorisation holder. Greater clarity and coherence in relation to this matter would therefore be appropriate. 

3.2 COHERENCE WITH OTHER FEED LEGISLATION 

3.2.1 Feed marketing Regulation. The Feed Marketing Regulation covers feed in general, without prejudice to specific rules concerning FA: 

206   vii Consultation Synopsis Report pages 16 and 23)  
207   ii FA Final Report, page 67 

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-  provides  for  general  safety  and  labelling  requirements  (in  line  with  the  General  Food  Law)  and  for  specific  labelling  rules  concerning  feed 

materials and compound feed, including detailed rules where they contain FA (references to the authorisation acts where appropriate).  

-  distinction  between  feed  materials  and  FA  may  be  subject  to  some  uncertainties  for  certain  products,  despite  the  respective  legal  definitions; 
Guidelines  clarifying  this  distinction  have  been  adopted  (Commission  Recommendation  2011/25/EU  of  14/01/2011  –  legal  basis  in  the  Feed 
Marketing Regulation) and regulations may be adopted by the Commission to decide on the status of certain products as FA (legal basis in the FA 
Regulation).  

One of the major findings identified is the coherence with the Feed Marketing Regulation in relation to the distinction between feed materials and FA. 
This is a recurrent issue in the discussions at the SCoPAFF meetings (see FCEC Final Report, section 7.1.1). Several MS authorities and manufacturers 
of FA and feed materials indicated that the classification of a substance as a feed material or a feed additive is one of the biggest challenges posed by the 
current  EU  regulatory  framework  for  feed.  The  situation  may  undermine  the  level  playing  field  as  the  authorisation  of  FA  entails  a  high  regulatory 
burden, whereas no pre-market authorisation procedure is required for feed materials. As the legal requirements for feed materials in the Feed Marketing 
Regulation are substantially lower (no pre-market authorisation) than for FA, in case of doubt FeBOs may tend to categorise them as feed material. This 
may pose a threat when actually a risk assessment and the more stringent rules of the FA Regulation would be required. In case of products considered on 
the borderline between the feed material and FA status, a clarification of that legal status can be sought via the SCoPAFF (e.g., if a sugar beet extract rich 
in betaine is an additive or not, taking into account that betaine is regarded as a nutritional feed additive). However, this takes a long time and resources 
from  national  and  EU  authorities.  This  topic  was  discussed  50  times  at  the  SCoPAFF  meetings  during  the  period  2004-2017.  Therefore,  MS  and 
stakeholders  (mainly  FeBOs)  are  of  the  opinion  that  more  clarification  in  the  products’  regulatory  definitions  could  minimise  any  possible 
inconsistency/insufficient certainty. 

The Feed Marketing Regulation makes a distinction between the concept of ‘label’ (information present on the packaging) and ‘labelling’ (information 
present on any medium and in any form accompanying the product, including e.g., on the internet and advertising). The FA Regulation provides that the 
information must be contained on the label on the package or container of the FA or premixture; the possibility to pass the information by other means 
e.g., electronic means is excluded. A majority of manufacturers and also some MS did not consider those requirements to be fit for purpose and well 
aligned with the provisions of the Feed Marketing Regulation (ii FA Final Report _FCEC, page 44). This situation prevents manufacturers of FA and 
premixtures from using state-of-the-art technologies to pass the information, which results in some costs/burden, especially for premixtures. 

Unlike provided for in the Feed Marketing Regulation (cfr Article 11(5)), the absence of labelling tolerances (see glossary) for FA in premixtures adds 
some room for interpretation of the labelling rules laid down in the FA Regulation. This situation creates a certain burden for FeBOs (change of labels to 
accommodate to MS specific requirements) when the additives circulate within the EU, since the conditions  in relation to labelling tolerances may be 
different from one MS to another.  

3.2.2 Feed Hygiene Regulation 

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The Feed Hygiene Regulation lays down general rules on feed hygiene also covering FA:  traceability conditions and arrangements; rules on registration 
and approval of establishments; imports and exports requirements. It also covers activities of feed business operators related to FA, from the production 
stage, while the FA Regulation applies to the placing on the market and use of FA. 

As regards imports, the MS authorities and FeBOs pointed out a possible inconsistency between the Feed Hygiene Regulation and the FA Regulation (ii 
FA Final Report FCEC, pages 98 and 99). No list of third country of dispatch nor of feed establishments of dispatch in third countries (including FA and 
premixtures) has been established in accordance with Article 23(1) of the Feed Hygiene Regulation.  Interim measures set up in Article 24 of the Feed 
Hygiene Regulation, referring to Article 6 of Directive 98/51/EC, provide that establishments in third countries must have a representative established 
within  the  EU  in  order  to  be  allowed  to  import  products.  This  person  must  ensure  that  these  establishments  have  implemented  measures  at  least 
equivalent to those applicable in the EU. The FeBOs identified a possible lack of coherence between the two Regulations as in practice the controls of the 
feed additive requirements applicable to the EU establishments  would be more stringent than for establishments in third countries.  There are different 
approaches in the MS on how to assess whether an imported feed additive and the commercial documentation accompanying it (product specifications, 
certificates of analyses, etc.) provide sufficient guarantees that the imported product satisfies EU requirements. All those different approaches have been 
reported in the Commission Audits (EM 4.15).  

As regards additives only intended for export, MS authorities did not identify major problems although this matter was not specifically harmonised (MS 
apply  different  measures  to  set  up  requirements  for  establishments  producing  additives/premixtures  only)  intended  for  export.  This  issue  could  be 
harmonised at EU level by including additional requirements in the Feed Hygiene Regulation. The FeBOs identified a possible lack of coherence between 
the two Regulations as the controls of the feed additive requirements applicable to the EU establishments would be more stringent than for establishments 
in third countries. MS authorities recognised that they do not have the capacity to control establishments in third countries. This undermines the level 
playing  field  for  EU  FeBOs.  Although  this  matter  concerns  the  Feed  Hygiene  Regulation,  the  establishment  of  a  specific  import  code  in  the  FA 
Regulation  for  FA  and  premixtures  at  the  point  of  entry  in  the  EU,  may  facilitate  a  better  traceability  and  control  of  these  products,  thus  slightly 
improving the coherence between the two Regulations. 

Industry has identified the circulation of FA/premixtures only intended for export as another inconsistency with the Feed Hygiene Regulation. However, 
this point is void, as this is an aspect related to the definition of “placing on the market” in the FA Regulation and not to any provision on feed hygiene.  

3.2.3 Medicated feed and veterinary medicinal products Regulations 

In  general,  MS  authorities  and  feed  business  FeBOs  did  not  point  out  any  inconsistency  with  the  medicated  feed  and  veterinary  medicinal  products 
legislation. Veterinary medicinal products (VMPs) exclude FA from their scope (ii FA Final Report _FCEC, pages 100). There have been some few cases 
where doubts about the nature of a specific substance were raised but they were solved. For some FeBOs, the notion of VMPs as products contributing to 
the prevention of animal diseases was too vague in the former Directive, thus not allowing a clear distinction of VMPs from FA with nutritional functions 

131 

 
that  help  maintain  animals  in  good  health.  This  issue  has  been  clarified  with  the  new  definition  of  VMPs  included  in  Regulation  (EU)  2019/6  that 
replaces the former Directive. The use of zinc oxide has been also reported as an inconsistency, due to the fact that this substance is going to be phased 
out in 2022 for the negative impact on the environment. Its use as an additive is necessary, as it is an essential trace element for animals that cannot be 
replaced, whereas in the case of VMPs alternatives to this use with a lower environmental impact exist. The use of new chelated forms (zinc bounded to 
an organic substance) permits a high assimilation by the animals reducing the disposal on the manure, and consequently, the impact on the environment.  

3.2.4 GM Food Feed Regulation 

No inconsistencies have been identified between the FA Regulation and GMO legislation. 

3.2.5 Directive on Undesirable Substances 

The information collected during the study did not point to any major inconsistency or contradiction between the  FA Regulation and EU legislation on 
undesirable substances. Undesirable substances are substances or products, apart from pathogenic agents, present in and/or on the product intended for 
animal feed, which may constitute a danger to human or animal health, to the environment or adversely affect livestock production. Those substances are, 
for example, heavy metals,  mycotoxins,  plant toxins, organochlorine  compounds and dioxins and  PCBs that may be found in  feed  (including  FA and 
premixtures). Maximum limits are laid down for each of the listed substances, which, if exceeded, do not allow the placing of the feed product on the EU 
market.  

3.2.6 Biocidal Products Regulation  

Finally, another point has been raised as regards the coherence with the Biocidal Products Regulation. The use of certain substances in water, such as 
preservatives, is regarded as a “biocidal products” use. This use, having a preservative effect on water, is envisaged in the Biocidal Products Regulation 
and is not foreseen in the FA Regulation, while the Biocidal Products Regulation refers to the “disinfection” (and not “preservation”) of drinking water (ii 
FA Final Report _FCEC, pages 104-105). The Biocidal Products Regulation concerns the making available on the market and use of biocidal products, 
which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances 
contained in the biocidal product. The Biocidal Products Regulation excludes from its scope the products regulated under Regulation (EC) No 1831/2003 
but  this is limited by the provisions of Article 2(2), second paragraph,  of the Biocidal  Products  Regulation:  ”Notwithstanding  the first subparagraph, 
when  a  biocidal  product  falls  within  the  scope  of  one  of  the  abovementioned  instruments  (including  FA  Regulation)  and  is  intended  to  be  used  for 
purposes not covered by those instruments, this Regulation shall also apply to that biocidal product insofar as those purposes are not addressed by those 
instruments". For some MS, the use of preservatives in water is a use not included in the FA Regulation as the FA Regulation does not permit this use, 
therefore, this use is a biocidal use.  

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This different interpretation is regarded as an area for improvement concerning the interplay between the two Regulations. There are eight feed additive 
applications under the functional  group of preservatives (within  the  category of technological  additives) for use in  drinking water. Those  applications 
were  not  processed,  as  the  current  legislation  does  not  provide  for  the  use  of  technological  additives  in  drinking  water  (as  explained  before,  certain 
functional  groups  only  refer  to  the  use  of  additives  in  feedingstuffs  in  their  definition).  The  extension  of  use  of  additives  in  drinking  water  to  other 
categories or functional groups needs to be examined and clarified (40% of respondents agreed to that need). This clarification should also better define 
the distinction between biocidal products and FA for certain uses in drinking water. For 24% of the MS authorities, the two legislations are not coherent. 
During the 2004-2017 period, this issue was raised several times (35), directly or indirectly, at the level of the SCoPAFF. 

3.2.7 General Food Law 

The General Food Law establishes notably the definition of feed, the definition of placing on the market and the general obligations for FeBOs. 

Considerations on the interplay with the General Food Law refer to the requirements applicable for additives only intended for export and the different 
approaches applied in MS. Those requirements are set up in Article 12 of the General Food Law. This Article establishes the obligations for the exporting 
country to ensure that the products comply with the General Food Law, unless otherwise requested by the laws, regulations, standards, codes of practice 
and other legal and administrative procedures as may be in force in the importing country. In other circumstances, except if the products are unsafe, they 
can be exported if the competent authorities of the country of destination have expressly agreed, after having been fully informed of the reasons for which 
and  the  circumstances  in  which  the  food  or  feed  concerned  could  not  be  placed  on  the  market  in  the  EU.  This  may  be  the  case  of  a  vitamin  that  is 
authorised in the EU for certain species but not for others, as there has been no application for authorisation. It may be possible that the levels of use in 
the EU are different from the ones authorised in the exporting country, since those levels are regarded as safe in this country’s legislation by limiting the 
export of certain FA and premixtures that may pose a global risk. 

3.2.8 CLP 

The CLP Regulation harmonises the criteria for classification and the rules for labelling and packaging of chemical hazardous substances and mixtures. 
This labelling concerns the environment and worker safety directions and applies to FA and premixtures. The combination of CLP labelling requirements 
and specific requirements set out in the authorising Regulation, created different understanding amongst MS authorities. This introduces complexity on 
the labels, in particular for premixtures. The authorisation of FA does not usually introduce labelling provisions for workers’ safety but generally provide 
for workers’ safety requirements to be respected, as conditions of use of the authorised additives. Some MS authorities require the introduction of those 
safety requirements on the label. Those labelling indications are not harmonised in the different MS.  Furthermore, it is being considered that the CLP 
Regulation applies also to FA and premixtures, thereby introducing additional labelling requirements for workers’ safety. This introduces complexity on 
the labels, in particular for premixtures. Although the surveys did not reveal a high rate of positive response on whether the CLP Regulation is coherent 

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with the FA Regulation, the case studies208 provided a clearer picture on the effects of the simultaneous application of both Regulations, especially in 
premixtures. On the one hand, MS have different understandings on how worker safety provisions can be indicated on the label in order to ensure respect 
for both Regulations; on the other hand, labelling requirements for user safety might be redundant or even conflicting in both Regulations. This could be 
aggravated  in  premixtures,  where  different  additives  are  incorporated.  As  regards  workers’  safety  provisions,  the  simultaneous  implementation  of  the 
CLP Regulation and of the FA Regulation has been reported as one aspect that may undermine workers’ safety (in case of contradictory directions of 
use), although no clear evidence has been provided.  

Considering that the CLP Regulation applies widely for any chemical substance placed on the market and taking into account that effects of the mixtures 
are also regulated as a whole by that Regulation, the possibility to apply only the CLP Regulation for worker safety labelling provisions in premixtures 
should be examined. This would contribute to passing clear messages to workers, to improving worker safety and to aligning the labelling with similar or 
the same substances used in other areas: food, cosmetics, biocidal products etc. 

3.2.9 REACH Regulation 

The information collected during the study did not point to the existence of any inconsistencies between REACH Regulation and the FA Regulation. The 
study supporting the Fitness Check on REACH (EFTEC, 2017) and the Commission’s report (EC, 2018a) did not point to any issues of contradiction / 
inconsistency with the FA Regulation either (see ii FA Final Report _FCEC, pages 103-104) 

4.- RELEVANCE 

4.1 DO THE ORIGINAL OBJECTIVES OF THE FA REGULATION STILL CORRESPOND TO THE EU’S CURRENT NEEDS/PROBLEMS? 

This question tries to determine if the objectives of the FA Regulation are pertinent to the evolving needs, problems and issues related to the 
authorisation, placing on the market and use of FA and premixtures. The objectives identified in the regulation were: 

1.  Reducing antimicrobial resistance (AMR) threats to citizens, animals and the environment. 
2.  Simplifying and harmonise the FA authorisation system. 
3.  Set up clear/comprehensive rules for the authorisation and labelling 

208   vi Case studies, sections 4.3.4 and 4.3.5 

134 

 
 
 
4.  Ensuring rigorous risk assessment. 
5.  Improving FA control, traceability and enforcement rules. 
6.  Addressing specific interests of pet owners and their animals.  
7.  Encouraging the placing on the market of FA which are innovative and efficacious. 
8.  Ensure that FA cannot be used to mislead consumers on the quality of food 

The relationship between the identified needs and the objectives are described in the Intervention logic (see section 2.1). 

4.1.1 1.  Reducing antimicrobial resistance (AMR) threats to citizens, animals and the environment. 

This  objective  is  still  relevant.  In  June  2017,  the  European  Commission  adopted  the  EU  One  Health  Action  Plan  against  AMR.  In  May  2020,  the 
European  Commission  adopted  the  Farm  to  Fork  Strategy,  a  tool  to  help  shape  the  EU’s  path  towards  sustainable  food  systems.  Its  objective  is  the 
reduction by 50% of the overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. 

The revision of the  FA Regulation,  one of the actions of the strategy, will favour the placing  on the market  of  FA having  a positive effect  on animal 
health by improving their physiological status, thus reducing the use of antimicrobials in animal farming. All public authorities responding to the PC and 
academia considered that the ban on the use of antibiotics in feed introduced by the FA Regulation plays an important role in preventing AMR. Literature 
shows the contribution of the EU’s ban on antibiotics as FA in the global fight against antimicrobial resistance.209 

The reduction of AMR threats to citizens, animals and the environment is still considered relevant by 26 MS authorities out of 27 and by 104 out of 111 
other stakeholders.210 The use of coccidiostats as FA in poultry does not pose any risk related to AMR. AMR is one of the aspects evaluated by EFSA in 
the authorisation process. A post-market monitoring plan is required to ensure that the authorisation of coccidiostats does not have unintended effects. 
The Commission’s audits on official controls carried out by MS in feed, as well as the results of the monitoring of coccidiostats residues in live animals 
and animal products carried out by MS, showed an effective control of the use of coccidiostats. A substantial majority of stakeholders (other than  MS 
authorities) also consider that the use of coccidiostats and histomonostats as FA is important to ensure health and welfare of poultry and rabbits (61 out of 
71). In addition, their use is well adapted to current farming practices (65 out of 72) and effectively controlled (63 out of 70) (in all cases, excluding a 
significant number of respondents that did not answer as they did not have knowledge of the issue)211. Nearly all MS authorities consider that the use of 
coccidiostats and histomonostats as FA is important to ensure health and welfare of poultry and rabbits (24 MS authorities; no NCA disagreed) and that it 

209   ii FA Final Report _FCEC, page 112. 
210   vii Consultation Synopsis Report, page 14. 
211   vii Consultation Synopsis Report, page 9 

135 

 
 
is  well  adapted  to  current  farming  practices  (20  MS  authorities;  1  NCA  disagreed)  and  effectively  controlled  (19  MS  authorities;  2  MS  authorities 
disagreed).212 

4.1.2. 2.  Simplifying and harmonise the FA authorisation system 

A majority of MS authorities (24) and of other stakeholders (91%) consider this objective still relevant.  

There is also a wide consensus amongst MS authorities and industry representatives that the authorisation process should be simple and predictable213. 
The simplification of the feed additive authorisation process, in comparison to the previous process under the Directive, is still considered relevant by 23 
MS authorities out of 26, and by 89% of other stakeholders.214 The authorisation process has been quite efficient in permitting the authorisation of an 
increasing number of additives over time. Nevertheless, some inefficiencies have been identified. 

4.1.3   Set up clear/comprehensive rules for the authorisation and labelling. 

For 97 % of stakeholders, clear rules for authorisation and labelling are still relevant215. There is a quasi- unanimous consensus between MS authorities 
and FeBOs on this matter. Although, in general, the FA Regulation provides clear rules on authorisation and labelling, some aspects lacked sufficient 
clarity and reduced the efficiency of the process. 

Improving labelling was an essential element to ensure the proper use of FA and it is an objective that remains relevant. For 58% of stakeholders, the 
current labelling is informative along the feed chain and for 81% the labelling prevents misuse along the feed chain – the maximum doses and the species 
concerned are respected.216   

As for worker safety, just over half of respondents considers that the information is clear and effective, while about a quarter considers that it is not, 
particularly amongst companies/business organisations, business associations, and EU citizens.  

The information provided in the labelling is widely recognised as useful to prevent misuse of FA. Nevertheless, different elements may decrease the 
efficiency of the system: the obligation to indicate all the information on a physical label, the absence of labelling tolerances in premixtures, and the 
simultaneous implementation of the FA Regulation and CLP Regulation, in particular for premixtures of FA. 

212   vii Consultation Synopsis Report, page 19 
213   ii FA Final Report _FCEC, page 112  
214   vii Consultation Synopsis Report, pages 14 and 22 
215   vii Consultation Synopsis Report, page 15 
216   vii Consultation Synopsis Report, pages 15 and 22           

136 

 
 
4.1.4 4.  Ensuring rigorous risk assessment.  

Providing a rigorous risk assessment of FA is still considered relevant by all the MS authorities responding to the survey and by 88% of other 
stakeholders.217 A sound scientific assessment is the basis to ensure a high level of food and feed safety as well as to reinforce public health.  

An  extremely  wide  consensus  about  the  current  relevance  of  a  rigorous  risk  assessment  of  FA  emerged  among  all  the  categories  of  consulted 
stakeholders. The Farm to Fork Strategy stresses the importance of protecting health and safety in building fair, strong and sustainable food systems. The 
reliability of the EU risk assessment used as the basis for EU authorisations is considered by the FeBOs as a major advantage for fast-track registration in 
several third countries, particularly in SE Asia and in African regions. A survey carried out in six third countries showed that at least three third-countries 
consider  the  risk  assessment  and  the  technical  data  required  in  the  EU  applications  as  valuable  elements  for  their  own  authorisation  process218.  The 
soundness  of the risk assessment performed by  EFSA is  not  questioned in  the administrative reviews for EFSA’s procedure and in the Commission’s 
decisions based on the outcome of the risk assessment.219 This objective is thus still relevant and it is the cornerstone for developing a more sustainable 
food system. 

4.1.5   Improving FA control, traceability and enforcement rules. 

Consensus on the matter is quasi-unanimous among MS authorities, and extremely wide among other stakeholders since 93 % of stakeholders consider 
that ensuring traceability of FA is still relevant.220 No significant criticism on the relevance of traceability emerged from the stakeholder consultation. 
Some manufacturers and business associations observed that other Regulations (especially the Feed Hygiene Regulation and the General Food Law) 
play an important role in ensuring traceability for FA. 

Improving  FA  control  was  one  of  the  objectives  that  remains  relevant.  The  validation  of  the  method  of  FA  analysis  was  one  of  the  key  measures 
introduced in the FA Regulation. Updating the method of analysis for the renewal is considered necessary for 22 MS authorities – while only one of them 
disagree.  Other  stakeholders  do  not  have  the  same  position:  23%  agree  that  updating  the  method  of  analysis  in  the  renewal  of  the  authorisation  is 
necessary, 21% do not have a position on this matter, and 38% do not agree. The different positions showed the relevance and the importance of having a 
method of analysis for control purposes, as well as the necessity to update such method when the authorisation is renewed, even if stakeholders do not 

217   vii Consultation Synopsis Report, pages 14 and 22   
218   ii FA Final Report _FCEC, page 133  
219   ii FA Final Report _FCEC, page 52 
220   vii Consultation Synopsis Report, pages 15 and 22 

137 

 
 
completely agree, as this entails additional costs for the renewal221. For a majority of MS authorities, the role of the EURL, which is in charge of the 
validation of the method of analysis, is still adequately defined in the Regulation. 

Another element introduced in the FA Regulation is the possibility that EFSA decides, upon assessment, the establishment of a post-market monitoring 
plan  (PMM)  for  nutritional,  zootechnical,  coccidiostats,  histomonostats  and  additives  consisting of,  containing  or  produced  from  genetically  modified 
organisms (GMOs). This traces or identifies unforeseen effects of the additives and contributes to control the effects of FA once they are placed on the 
market.  

The PMM is always required for coccidiostats to allow the identification of unknown antimicrobial and coccidian resistance effects. 

All the actions related to control (method of analysis and PMM) are still relevant to improve the control of FA. In general, the control performed by the 
MS is considered to be effective, except for imports.222 

4.1.6 Addressing specific interests of pet owners and their animals 

The FA Regulation recognised the specificities of pet food and the necessities associated with pet owners. The pet industry has been growing with an 
annual rate of 2.6% in the last 3 years.223  

Europeans tend to humanise their pets. Pet owners try to find pet food that reflects their taste and are more concerned about the specific requirements of 
different life stages or situations; therefore, premium feeds and feed intended for particular nutritional purposes (e.g., support heart functions in dogs and 
cats) are very important in this market segment. This reality is supported by the increasing requests for authorisation of feeds intended to satisfy particular 
nutritional purposes for pets, as well as the availability of premium products in the pet food market. 

Twenty-three (23) MS authorities considered this objective as relevant, whereas it was slightly relevant or irrelevant for three. It is important to note that 
one NCA highlighted that some additives such as colourants are used make the feed more attractive to pet owners by conferring organoleptic properties 
that are not present in the feed ingredients.  

For other stakeholders, this objective is still relevant (63% of respondents), although some of them do not express any opinion, as this was not their area 
of expertise (34%). 

221   vii Consultation Synopsis Report, pages 15 and 22  
222   ii FA Final Report _FCEC pages 60 and 61 
223   FEDIAF European Facts & Figures 2019 

138 

 
 
We can conclude that this objective is still relevant and of growing importance, taking into account the increasing market for pet food. 

4.1.7 7.  Encouraging the placing on the market of FA which are innovative and efficacious. 

There is a wide consensus for MS authorities (23 out of 26) and other stakeholders (94% of respondents) that this objective remains relevant.224 
Nevertheless, industry respondents largely claim that further efforts are required to promote the authorisation of innovative additives.  

Innovation is regarded as the way to address societal needs by the industry, and in particular, by SMEs. Some needs have been identified in this regard: 
reduction  of  antibiotic  use,  improving  meat  quality,  addressing  animal  welfare  and  conditions  of  breeding,  improving  sustainability,  and  reducing  the 
environmental  impact  of  livestock  farming.  For  some  MS  authorities,  there  are  aspects  that  reduce  the  capacity  of  innovation:  outdated  definitions, 
criteria for authorisation which are not adapted to address current needs (use in water for drinking, lack of endpoints (see glossary) to define efficacy, 
functional groups do not match with the expected functions). The EFSA guidance permit to propose endpoints, but the issue is that applicants do not have 
a validation from EFSA side whether those endpoints are appropriate or not. EFSA does not have the legal basis to give study-specific pre-submission 
advice as for instance EMA is doing.  

While the FA Regulation has been in general efficient in permitting the authorisation of innovative additives, there is a consensus amongst stakeholders 
and MS authorities that innovation has not been sufficiently addressed by the FA Regulation.  

4.1.8 8.  Ensure that FA cannot be used to mislead consumers on the quality of food. 

This objective aims at not misleading consumers on the quality of food of animal origin (e.g., a flavour that is not characteristic of such food). 

For MS authorities, this objective is still relevant (22 out of 26); as for other stakeholders, 61% considered that this objective is still relevant, although 
31% did not express any judgement. For those stakeholders who did not express a favourable opinion on the relevance of this objective (13%), different 
arguments supported their position. For instance, there is a weak or non-existing link between FA and the characteristics of food of animal origin, and 
consumers do not have any specific knowledge or understanding on the role that FA play and how they can modify the organoleptic characteristics of 
food of animal origin.225 

This objective is still relevant for all stakeholders. 

224   vii Consultation Synopsis Report, pages 15 and 22 
225 

ii FA Final Report _FCEC, page 114 

139 

 
 
4.2 ARE THERE NEW NEEDS/PROBLEMS EMERGING SINCE THE FA REGULATION WAS ADOPTED? 

For  16  MS  authorities  (out  of  27)  and  for  66  %  of  other  stakeholders,  there  were  new  needs  that  emerged  since  the  Feed  Additive  Regulation  was 
adopted.  

Amongst the new needs identified in the surveys, very few could be regarded as genuine new needs. Improving the sustainability of animal farming using 
innovative  FA  was  one  new  need  identified.  The  FA  Regulation  contained  several  aspects  related  to  the  sustainability  of  livestock  farming,  such  as 
protection  of  animal  welfare  or  protection  of  the  environment.  Nevertheless,  the  Feed  Additive  Regulation  did  not  encompass  the  broad  concept  of 
sustainability which can be regarded as a new need partially addressed in the FA Regulation. 

Claims was another of the new needs identified. The FA producers226 ask for better coherence along the feed chain.  

Claims are authorised for feed materials and compound feed, but not for FA. The only possible claim in FA is the claim related to the function performed 
by  the  additive  following  the  corresponding  authorisation.  MS  authorities  noticed  that  this  limited  approach  created  different  interpretations  of  the 
labelling  rules  by  stakeholders.  Claims  are  useful  to  communicate  some  benefits  of  the  feed  additive  and  to  differentiate  and  highlight  an  innovative 
product. This is also applicable to premixtures of FA. 

The industry supports the approach followed in the Feed Marketing Regulation: the person responsible for the labelling provides, at the request of the 
competent authority, scientific substantiation of the claim, either by reference to publicly available scientific evidence or through documented company 
research.  

Several  business  stakeholders  and  some  MS  authorities  refer  to  the  environment  and  animal  welfare  issues  as  “new  needs”,  even  though  they  were 
considered in the existing FA Regulation. They spotted those issues as not sufficiently addressed in the Regulation. For some respondents (some business 
stakeholders and some MS authorities), animal welfare and the environment were regarded as broadly related to the concept of sustainability and hence 
considered as new needs. Other MS authorities or business stakeholders considered that greater emphasis should be put on the environment and animal 
welfare issues, although they were not able to identify the environmental benefits of using FA.227 

4.3 HOW WELL IS THE FA REGULATION ADAPTED TO SUBSEQUENT TECHNOLOGICAL OR SCIENTIFIC ADVANCES? 

226   FEFANA contribution to the PC 
227   ii FA Final Report _FCEC, pages 115-116  

140 

 
 
Several aspects are related to the capacity of the FA Regulation to adapt to scientific and technological progress: the existing definitions, the criteria for 
authorisation, and the authorisation procedure that requires allocating additives within pre-established categories and functional groups. 

The results of the stakeholder survey showed that the Regulation was not considered totally suitable to address scientific and technological progress. For 
the suitability of the definitions, respondents were divided with a slight majority (44 out of 108) finding them not to be suitable (compared to 39 that 
consider them to be).  

As for the criteria for authorisation, the majority against the suitability of the Regulation was more evident, since 28 out of 44 respondents considered that 
those criteria are not relevant nowadays (13 considered them still relevant).228 

For most MS authorities, the Regulation is suitable to address the scientific and technological progress, but a few MS authorities expressed concerns 
about the definitions (3 MS authorities) and the criteria for authorisation (2 MS authorities ).229 

In  the  PC,  a  small  minority  (18%)  of  respondents  consider  that  the  Regulation  is  sufficiently  flexible  to  adapt  to  new  scientific  and  technical 
developments,  while  38%  of  respondents  disagree.  Public  authorities  and  academia  (only  one  respondent)  fully  supported  the  suitability  of  the  FA 
Regulation to adapt to scientific and technical developments. As for FeBOs and their organisations and associations, 38% of respondents consider the 
Regulation to be sufficiently flexible, especially among business associations (41%) and companies/business organisations (52%). 

The arguments raised by those who disagree with the suitability of the FA Regulation can be summarised as follows: 

−  science and technology evolve faster than the Regulation to permit timely adaptation to new challenges. 
−  efficacy  assessment  of  new  products  with  a  new  mode  of  action  included  in  the  EFSA  guidance  is  not  fully  reflected  in  the  conditions  for 
authorisation  (Article  5)  of  the  Regulation  (no  functional  group  is  allocated  to  that  function,  or  the  requirements  of  the  category  in  which  the 
additive  is  located  do  not  match  the  actions  performed  by  the  additive,  e.g.  additives  intended  to  have  benefits  on  the  environment  or  animal 
welfare have to demonstrate an improvement of the performance); 

−  definitions not adapted to the state of the art of the FA sector.  
− 

the establishment of new functional groups to allocate new additives takes a long time.  

4.4 HOW RELEVANT IS THE FA REGULATION TO ADDRESS CURRENT SOCIETAL CHALLENGES? 

228   vii Consultation Synopsis Report, page 22 
229   vii Consultation Synopsis Report, page 22  

141 

 
 
One  of  the  questions  posed  in  the  PC  was  the  consideration  of  societal  needs  for  the  authorisation  of  FA.  Just  under  half  (49%)  of  the  participants 
considered societal needs were taken into account, compared to 25% who  thought they were not. Citizens were more inclined to indicate that societal 
factors are not sufficiently taken into consideration (8 responses out of 16 citizens that responded). 

Innovation in the area of FA is seen as a tool to satisfy societal expectations. The development of new products (especially by SMEs) is considered to be 
important in order to address evolving societal needs, in terms of further reducing the preventive use of antibiotics, improving meat quality, addressing 
animal welfare and conditions of breeding, improving sustainability, and reducing the environmental impact of livestock farming.230 

It  is  important  to  note  that  despite  the  efforts  to  consult  a  wider  range  of  stakeholders,  such  as  consumers,  animal  welfare  organisations  and 
environmental organisations that may contribute to give visibility to other societal expectations, it was not possible to have their contribution.231  

The Farm to Fork Strategy is framed in the European Green Deal and aims at addressing comprehensively all the challenges of sustainable food systems.  

The Farm to Fork Strategy introduces in a very explicit manner the importance of sustainable food systems and the social aspects of food products. It 
recognises the social dimension of reducing food loss and waste, the social benefits that a sustainable food system may bring, the increasing attention that 
people pay to social issues, such as concerns about antimicrobials, pollutants or food additives, the social impact that the production of commodities may 
have in third countries, the protection of health in workers and the social aspects of food products (labelling, claims or food information). FA are part of 
the food chain since they are used in the production of food of animal origin. They may have an impact on the wellbeing and health of pets and farmed 
animals,  and  their  use  may  have  an  impact  on  consumers,  workers  and  the  environment.  There  are  several  aspects  related  to  social  expectations  that 
should be considered concerning FA: 

−  supplying affordable, healthy and nutritious food in the face of a growing world food demand. 
−  ensuring sustainable management of livestock farming, natural resources and climate action. 
−  contributing to a balanced territorial development of the EU’s rural areas and their communities. 

Currently, the concept of ‘sustainability’ has not yet been defined, nor the criteria determining to what extent food is ‘sustainable’. However, the concept 
encompasses various elements of environmental, social and economic nature, such as climate change mitigation, animal welfare, use of resources, 
reduction of waste, healthy diets and food affordability. In this context, FA play a role in improving the sustainability of food systems.  

230 vii Consultation Synopsis Report, page 30  
231 ii FA Final Report _FCEC, page 23 

142 

 
 
The accomplishment of the multiple objectives of sustainable livestock farming requires policy interventions that consider all the elements intervening in 
the process.  

The role of FA to provide affordable food is very limited, but FA contribute to a better use of resources and to an increase in the performance of animals, 
reducing production costs. Farmers may use FA to reduce losses in the production by keeping animals in good health status. FA permit better assimilation 
of feed materials that can be closer to the farmer and contribute to reducing waste in livestock production by facilitating the preservation of crop products 
during storage.  

The effects on animal welfare by improving the physiological status of animals, reducing the stress due to adverse climate conditions, or facilitating the 
transition to different production stages in the life cycle are additional factors that reduce losses in animal farming. 

All these positive benefits will reduce the production costs/losses for farmers, modestly contributing to providing affordable food of animal origin. 

The protection of natural resources is very relevant in animal farming, mainly due to the effect that livestock farming may have on the terrestrial and 
water compartments (freshwater, groundwater and marine water). Furthermore, the protection of biodiversity through the protection of non-target plant 
and animal species, microbes, and protozoans is an additional aspect to consider. Over the years, the environmental risk assessment has been improved to 
cover all these elements and to prevent FA or their metabolites from harming the soil, water and biodiversity. The option of PMM is considered in the 
case that negative effects of the feed additive on the environment could not be undoubtedly excluded.  

FA may have some positive effects on the environment, for instance: 

− 

reducing the potential contamination of livestock farming by reducing phosphorous and nitrogen excretion from animals, therefore, reducing risks 
of soil leaching and water eutrophication. 

−  Reducing manure deposition using additives that change feed composition, decrease soil and water contamination, and cut down emissions related 

to the storage and reuse of manure as organic fertilizer. 

Many authorised additives having positive effects on the environment or on animal welfare have been authorised under other functional groups not 
related to these actions (e.g., amino acids as nutritional additives). The FA Regulation has not been effective in establishing authorisation criteria that 
match these effects and has contributed to reduce innovation in this area. 

The contribution of FA to provide healthy and nutritious food is difficult to establish, although there are some elements that can be considered. Healthy 
aspects of food of animal origin are linked to minimum levels – or null, if possible –of pathogens, toxins, contaminants and other agents that can cause 
foodborne disease. Food production must also minimize the use of antimicrobials. 

143 

 
FA have not successfully improved the nutritional patterns of feed of animal origin, e.g., reducing saturated fats in monogastrics, or bio fortification of 
foods of animal origin. The FA Regulation does not have any functional group to allocate those additives. In any case, this aspect deserve full attention as 
those actions may entail negative effects on animal health that need to be seriously considered. 

FA are assessed in order to prevent the presence of any substance or microorganism that may have a negative impact on consumer’s health. FA also 
contribute to minimise the use of antimicrobials in animal farming. 

As regards climate actions, FA can contribute to reducing greenhouse emissions of methane and nitrous oxide and have other environmental benefits by 
mitigating the negative effects of livestock production. 

Factors linked to the agricultural production are better management of soil and water quality, or an improvement of biodiversity. The effects of FA 
described above may have a moderate impact on this objective to ensure an attractive environment for farmers and citizens in rural areas. 

5 ADDED VALUE  

5.1 WHAT IS THE ADDED VALUE OF REGULATING THE AUTHORISATION AND PLACING ON THE MARKET OF FA AT THE EU 
LEVEL?  

This question seeks to determine if a harmonised procedure at the EU level is perceived as achieving better results than a national level authorisation 
process  or  labelling  requirements,  trying  to  understand  whether  harmonisation  is  perceived  as  being  more  advantageous  than  non-harmonisation  and 
whether an EU level approach is still warranted. 

All the parties consulted (citizens, MS authorities, industry and other private stakeholders) unanimously agreed that there is an added value in having a 
harmonised authorisation procedure.232 

The reasons supporting this statement were:  

− 
− 
− 

it facilitates intracommunity trade.   
it is economically advantageous for the scientific assessment in order to avoid duplication of assessment by different countries.  
it reduces “authorisation tourism” (FeBOs make an application to which they perceive as the least rigorous MS). 

232  vii Consultation Synopsis Report, page 17 and 24 

144 

 
 
The  harmonisation  of  labelling  rules  is  relevant  to  the  placing  on  the  market  of  FA.  There  was  also  a  wide  consensus  amongst  all  consulted  parties 
(citizens,  MS  authorities,  industry  and  other  private  stakeholders)  that  harmonisation  at  the  EU  level  is  more  advantageous  than  having  different 
provisions in MS. This harmonisation reduces complexity, costs and facilitates EU trade. 

Finally, there is also a wide consensus that the EU level of intervention in the feed additive area is still warranted and needs to continue. 

5.2 ARE THERE ANY NEW ASPECTS NOT HARMONISED THAT REQUIRE AN EU INTERVENTION? 

During the consultation process, the following aspects on which EU harmonisation is further requested, were identified: 

− 
− 
− 
− 

a definition of the concept of “preparation”;233 
the establishment of labelling tolerances of FA in premixtures. 
the labelling of additives only intended for export.  
the labelling of workers’ safety provisions. The authorising Regulations do not set labelling provisions for workers’ safety but lay down requirements 
for this purpose, e.g., use of masks for breathing protection. Some MS requested to include on the label of additives and premixtures, those workers’ 
safety  requirements  set  out  in  the  authorising  Regulations.  This  creates  different  interpretations  by  MS  on  how  to  convey  to  the  label  those 
requirements and, consequently, can create market distortion within the EU and a burden for FeBOs. 

------------------------------------------------------------------------------------------------------------------------------------------- 

EVALUATION MATRIX  

Note: the data refer to the period 2004-2017.  If the period is extended, then, it will be indicated. 

Column headings 
FeBOs  Feed business FeBOs 
SH sv  Stakeholder survey 

Sources 

FAR 

FA register234 

233 vii Consultation Synopsis Report, points 3.3.2.5 and 3.4.2.2. 
234 FA Register (FAR) : 

•  Reference 1: Register December 2006 (rev. 7) 
•  Reference 2: Register December 2017 (rev. 259) - since the implementation up to 31/12/2017 

145 

 
 
 
 
NCA 
sv 
Int 
CS 

NCA survey 

Interviews 
Case studies 

Literature review 
Lit 
COM  Commission indicated they 
will provide data 

OJ 

Official Journal of the EU-EURLEX 

SAN-F  SANTE-F (reports or interviews; as applicable) 
DG SANTE database on authorisations 
SAN-
DB 
EFSA 
EU-RL  EU reference lab for FA 

European Food Safety Authority 

RASSF 
European Court of Justice 
European Patent Office 
Specific request of DG SANTE to MS authorities  

RSF 
ECJ 
EPO 
NCA-
req 
TC-sur  Third country survey to be requested through SANTE international relations unit 
FEF 
RM 

FEFAC data 
RM associates report 

Evaluation criterion: Effectiveness – EQ1 

Evaluation question 1: 

To what extent did the Regulation meet its objectives (e.g., ensure that FA placed on the market are efficacious, safe and ensure the protection of 
animal health and welfare, human health and the environment)? 

1.1To which extent did the efficacy assessment of FA ensure that FA are effective? How do the achievements compare to Directive 70/524? 

1.2 To which extent did the safety assessment of FA ensure safeguarding human and animal health and the environment? How do the 
achievements compare to Directive 70/524/EEC? 

1.3 What elements of the authorisation procedure of FA are key drivers for its effectiveness and what elements hinder its effectiveness? Why? 

1.4 What role does the risk assessment versus other provisions play in meeting the objectives of the Regulation? Which other  key 

146 

 
 
 
provisions/actions foreseen by the Regulation play a key role? 

1.5 To which extent did the risk assessment allow sound decision-making? 

1.6. To which extent did coccidiostats and histomonostats produce the best results for poultry/rabbits farmers (health and welfare en sured, 
adaptation to farming practices, control)? 

Legislation concerned 

Regulation (EC) No 1831/2003 

Evaluation question 1: 

To what extent did the Regulation meet its objectives (e.g., ensure that FA placed on the market are efficacious, safe and ensure the 
protection of animal health and welfare, human health and the environment)? 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT 

COM 

RESULTS 

1.1.1  Listing of such 

categories  

RM; 
FEF 

FAR 

1.1 FA categories for 
which efficacy was 
not at all or partially 
evaluated are now 
fully evaluated. 

•  Technological additives, silage additives; 
substances for reduction of the contamination 
of feed by mycotoxins; and hygiene condition 
enhancers.  
•  Amino acids (an important category of 
nutritional additives) and most zootechnical 
additives (enzymes, gut flora stabilisers) and 
other zootechnical additives. In total 339 
additives authorised. 
Reference: ii FA Final Report _FCEC pages 
25-26).    

1.1.2  Number of 

applications for 

SAN-DB  432 applications: 132 for article 4(new 

additives) and 300 article 10(2) re-evaluation 

147 

 
 
 
 
 
 
 
 
 
 
 
 
authorisation (separate 
data for Article10 and 
4) (Ref 2) 
1.1.3  Number of EFSA 

opinions (separate data 
for Article10 and 4) 
(Ref 2)  

Number of FAs 
notified under Art 10 
for which no 
application was 
introduced at expiry 
date  
Number of FA 
withdrawn or partially 
withdrawn (Ref. 2) 
Number of Com 
Regulations requiring 
withdrawal of FA from 
market (Ref 2) 
Number of additives 
for which new 
authorisation was not 
granted because 
efficacy/safety was not 
demonstrated 
Number of FAs 
applications 
withdrawn or partially 

1.1.4 

1.1.5 

1.1.6 

1.1.7 

1.1.8 

1.1 FA for which 
efficacy/safety was not 
demonstrated under 
Regulation 1831/2003 
(Art 10) were 
withdrawn from the 
market  

1.1 New FA for which 
efficacy/safety is not 
demonstrated and the 
authorisation is denied, 
or the application 
withdrawn (Art 4). 

(ii FA Final Report _FCEC, page 26) 

EFSA 

EFSA opinions:  

−  102  for  out  of  116  FAD  applications 

for article 4. 

−  231  out  of  301  FAD  applications  for 

Article 10(2) 

Reference: ii FA Final Report _FCEC, pages 
26 and 27) 
1,743 additives 
Reference: ii FA Final Report _FCEC, page 27 

SAN-
DB; FAR 

SAN-DB  120 additives partially withdrawn or totally 
withdrawn during the assessment. 
ii FA Final Report _FCEC, page 27 
8 Commission Regulations period 2004-2017 
Reference: ii FA Final Report _FCEC, page 27 
footnote 50 

SAN-
DB; OJ 

SAN-DB  6 additives 

Reference SANTE WEB 

SAN-DB  89 requests for total or partial withdrawal 

Reference: ii FA Final Report _FCEC, page 28 

148 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
withdrawn (Article 4) 
(Ref. 2) 

X 

X 

1.1 FA on the EU 
market are considered 
efficacious 

1.1.9 

Positive opinion of FA 
users  

1.2.1 

Listing of such 
categories  Ref1 

1.2 FA categories for 
which safety was not 
at all or partially 
evaluated are now 
fully evaluated 

1.2.2 

Number of 
applications for 
authorisation of such 
categories (separate 
data for Article10 and 

63 users* out of 59 have positive opinion. 
* Manufacturer of FAs/premixtures; 
manufacturer of compound feed; manufacturer 
of both FAs and compound feed. 
SH SURVEY- ix Accompanying document: 
survey and PC results235, page 11. 

FEF 

FAR  •  Sensory additives (certain colourants; nearly all 
flavouring 
nutritional 
compounds); 
additives  (all  vitamins,  except  A  and  D)  were 
not assessed by the Directive 

and 

•  Safety was partially assessed for: amino acids 
and  zootechnical  additives  (enzymes,  gut  flora 
stabilisers).  In  the  case  of  coccidiostats  and 
histomonostats,  antimicrobial  resistance  and 
Maximum  Residue  Levels  were  not  fully 
addressed by the Directive. 

•  Estimation  Reference:  ii  FA  Final  Report  _FCEC,  page  29. 

footnote 50 

SAN-DB  458 applications: 251for article 4(new additives) 
and 207 article 10(2) re-evaluations 
Reference: ii FA Final Report _FCEC, page 30 

235 This document is part of the study conducted by the Food Chain Evaluation Consortium (‘FCEC’) and contains raw data of the surveys. This document is not disclosed as the main 

conclusions from the surveys are included in the document “vii Consultation Synopsis Report”. 

149 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
4) Ref 2 

1.2.3 

Number of EFSA 
opinions of such 
categories (separate 
data for Article10 and 
4) Ref 2 

1.2.4 

Number of additives of 
such categories Ref 1  

1.2.5 

POSITIVE opinion of 
FA users  

X 

X 

X 

X 

1.2 FA on the EU 
market are safe for 
humans(users/workers) 
of additives, animals 
and the environment  

1.2.6 

Positive opinion of 
NCAs  

1.2.7 

Number of RASFF 
notifications involving 
FA/ compared to total 
feed notifications 

EFSA 

EFSA opinions:  
-  202 for out of 233 FAD applications for 
article 4. 
-  151 out of 208 FAD applications for Article 
10(2) 

SAN-
DB; OJ 

Reference: ii FA Final Report _FCEC, page 30 
1,136 additives 
Reference: ii FA Final Report _FCEC, page 30 
SH Survey:  
Safety for  
46 out of 62 
Animals  
55 out of 62 
Workers 
Environment  49 out of 63 
65 out of 63 
Consumers 
SH Survey:   NCA Survey 
Safety for  
27 out of 27 
Animals  
21 out of 27 
Workers 
24 out of 27 
Environment 
26 out of 27 
Consumers 

Reference: ix Accompanying document: 
survey and PC results, page 56 

During the period 2004-2020, the RASFF 
notifications showed the level of compliance as 
for the presence of FA or their residues in 
food of animal origin. 82 notifications – out of 
16,634 – were linked to the presence of 
unauthorised additives or a high level of 
residues. These represented 0.5% of the total 
number of notifications. 

RSF 

150 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.2.8 

Number of additives 
authorised for pet 
animals not evaluated 
for safety or not 
sufficiently evaluated) 
Ref. Register 
December 2017 (rev. 
259) 

1.2.9 

Number and extent of 
revisions of EFSA 
scientific guidance for 
the assessment of pet 
food. 

1.2 Pet food additives 
are safer and 
efficacious  

As regards the notifications for the period 2004-
2017 out of a total of 517 notifications on feed 
only seven relate to FA and five to premixtures. 
These represented 2.3´% of the total number of 
feed notifications. 
Reference: ii FA Final Report _FCEC, page 31 
and further elaboration by the Commission  
1,017 additives 
Reference: ii FA Final Report _FCEC, page 32 

SAN-
DB; FAR 

X 

EFS 

151 

EFSA set up scientific guidance for applicants 
regarding the assessment of additives intended 
for use in pet food, including clear and 
comprehensive data requirements. The aim has 
been to reduce the need for testing on pets by 
implementing other testing strategies, and to 
take into account the potential hazards of 
additives for pet owners. EFSA first adopted the 
“Guidance on the assessment of additives 
intended to be used in pets and other non-food-
producing animals” on 1 February 2011, updated 
on 18 January 2012. Following an analysis by 
EFSA of the need for a further update of the 
guidance documents (EFSA, 2016), new 
guidance documents were adopted; all aspects 
related to pets were included in these 
documents, thus replacing the specific guidance 
document for pets. Currently, five guidance 

 
 
 
 
 
 
 
 
 
 
documents covering different aspects of the 
EFSA assessment have specific provisions 
and/or apply for additives intended for pet 
animals. 
Reference: ii FA Final Report _FCEC, page 32 
Furthermore, the assessment is based on specific 
requirements for additives destined to non-food 
producing animals. More generally, compared to 
the previous legislation and guidelines, the 
current regulatory framework introduced 
specific provisions on FA for pet food in view of 
the specificities of this segment:  
•  The Regulation established a definition of 
‘pet animals and other non-food producing 
animals’, while in the 1970 FA Directive these 
two types of animals were included in one 
definition as “pet animals” except fur animals 
that were considered separately.  
•  The specific requirements for pet animals 
and farmed non-food producing animals were 
allocated in a specific Annex. As regards the 
environment, (EC) No 429/2008 provides for the 
obligation to perform Phase I of the assessment 
to determine if there is a significant 
environmental effect. Non- food producing 
animals are exempted from Phase II assessment 
unless there is scientifically-based evidence of a 
concern. In that case, the exemption does not 
apply. For farmed non-food producing animals, 
the FA Regulation and Regulation (EC) No 
429/2008 were not sufficiently accurate but the 
EFSA guidance clarified that those animals are 
considered as food producing animals for the 

1.2.10 

Identification of 
specific provisions in 
the legislation 
addressed to pet food 
(Regulation (EC) No 
1831/2003 and 
Regulation (EC) No 
429/2008 – compared 
to Directive 70/524 

152 

 
 
 
 
 
 
 
environmental assessment. Therefore, this aspect 
needs to be clarified in the Regulation. 
•  Specific requirements were set out for 
assessing certain safety aspects of additives 
destined to pet animals, as well as to non-food 
producing animals more generally. Studies on 
chronic toxicity, reproductive toxicity, 
mutagenicity and carcinogenicity are mandatory 
while in the 1970 FA Directive those studies 
were dispensed with the presentation of other 
data. This was not sufficient to ensure complete 
full safety. 
•  The full demonstration of the efficacy of FA 
destined to pet animals is required under the 
Regulation. 
•  Specific statistical power limits became a 
requirement. The statistical power limits 
minimised the possibility to lead to an erroneous 
indication of safety/efficacy, for experiments 
that are not sensitive enough to detect adverse 
effects. This ensures that the protocols for 
studies met the objectives. 
Reference: ii FA Final Report _FCEC, page 32 
With regard specifically to pet food additives on 
the EU market, nearly all respondents agree that 
they are efficacious and safe for pet animals (74 
and 76, respectively, out of 78 respondents; 
excluding, respectively 28 and 30 respondents 
that did not provide an answer as pet food is not 
relevant for their organisation) 
As regards specifically pet food additives on the 
EU market, nearly all respondents agree that 
they are efficacious and safe for pet animals (3 

X 

X 

1.2.11 

Positive opinion of 
respondents   

153 

 
 
 
 
 
1.2 FA are safe for 
consumers 

X 

X 

1.2.12 

Positive opinions of 
respondents  

1.3 The information to 
be provided by 
applicants in their 
dossier is fit to assess 
efficacy (e.g., enables 
EFSA to assess 
efficacy in an effective 
manner) 
1.3 The information to 
be provided by 
applicants in their 
dossier is fit to assess 
safety (e.g., enables 
EFSA to assess safety 
in an effective manner) 

1.3.1 

EFSA feedback in 
interviews 

1.3.2 

EFSA opinion in 
interviews 

1.3. Dossiers of 
applicants are 
complete  

1.3.3 

Dossiers fully 
corresponding to 
requirements at the 
submission 
(completeness check) 
Two different 

X 

X 

154 

MS authorities neither agreed nor disagreed that 
they are efficacious). 
Reference: ii FA Final Report _FCEC, page 32 
Consumers  103 out of 111- SH SURVEY 
Reference: ix Accompanying document: survey 
and PC results, pages 12 and 13 
26 out of 27 NCA SURVEY 
Reference: ix Accompanying document: survey 
and PC results, page 56 

− 

 “The information provided by applicants in 
their  dossier  to  EFSA  is  fit  to  assess  safety 
and efficacy” 
−  “Fitness  of 
assessment” 

information 

efficacy 

for 

−  “Dossiers of applicants are complete” 
Reference: ii FA Final Report _FCEC, pages 34, 
35 and 37  
− 

 “The information provided by applicants in 
their dossier to EFSA is fit to assess safety 
and efficacy”. 

−  “Fitness of information for safety 

assessment” 

−  “Dossiers of applicants are complete” 
Reference: ii FA Final Report _FCEC, pages 34, 
35 and 37 

EFSA  All of the 392 FAD applications submitted under 

Article 4(1) (new authorisations), and all of the 
398 FAD applications submitted under Article 
10(2) (reauthorisations), for which EFSA 
received a mandate from the Commission during 
the 2004-17 period passed the completeness 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
calculations one for 
Article 4 and one for 
Article 10. Ref 2 

1.3.4 

Dossiers pending due 
to missing/incomplete 
information during the 
assessment Two 
different calculations 
one for Article 4 and 
one for Article 10. Ref 
2 

1.3.5 

Dossiers within 6 
months deadline Two 
different calculations 
one for Article 4 and 
one for Article 10. Ref 
2 

1.3. EFSA’s opinions 
are issued within legal 
deadlines (6 months 
from valid application)  

check 
The completeness check is completed within 31 
working days for: nearly half of dossiers 
submitted during 2004-17 under Article 4(1); 
and, one third of dossiers submitted under 
Article 10(2). For the remaining dossiers, the 
completeness check is carried out within 41 
working days. 
Reference: ii FA Final Report _FCEC, page 37 

EFSA  A substantial majority of dossiers (78% of 

applications submitted under Article 4(1); and, 
88% of applications submitted under Article 
10(2)), are pending due to missing/incomplete 
information. 
Reference: ii FA Final Report _FCEC, page 37 

EFSA 

20% of all opinions issued under Article 4(1) 
and 12% of all opinions issued under Article 
10(2)  
In the case of Article 4(1) applications, 20% of 
EFSA opinions were adopted within ≥6-9 
months 12% within ≥9-12 months and 21 % 
within ≥12-18 months. In the case of Article 
10(2) applications, 13% of EFSA opinions were 
adopted within ≥6-12 months and 16% within 
≥12-18 months 
The average period to issue the opinions was 27 
months for Article 4(1) applications and 36 
months for Article 10(2) applications. 
Reference: ii FA Final Report _FCEC, page 38 

1.3 Commission’s 
decisions are issued 

1.3.6  

Commission’s 
decisions are issued 

SAN-DB  37% and 31´% of authorisations were granted 
for Article 4(1) and Article 10(2), respectively 

155 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
within reasonable 
deadlines (6 months 
from publication of 
EFSA opinion and 
publication of the 
Regulation) 
1.3 Applicants can ask 
questions and receive 
answers to complete 
their dossiers within 
reasonable deadlines 

1.3 Commission acts 
within required 
deadlines on renewal 
(Art. 14) of 
authorisation  

within reasonable 
deadlines. Two 
different calculations 
one for Article 4 and 
one for Article 10. Ref 
2 

X 

1.3.7 

Positive opinion 
among FeBOs 

1.3.8 

Number of cases with 
automatic extension of 
authorisation due to 
absence of 
Commission decision 

1.3.9 

Timelines in the 
evaluation period: 
average time, number 
of clock stops, average 
of clock stops  

X  X 

X 

EFSA 

1.3 The simplified 
procedure for FAs 
already authorised in 

1.3.10 

Positive opinion 
among FeBOs 
applicants 

X 

X 

X  X 

156 

within six months of receipt of the opinion 
Reference: ii FA Final Report _FCEC, page 39 

Applicants did not complain of any significant 
delays in receiving answers 
More than 82% of FeBOs consider that 
applicants have sufficient time to complete 
dossiers when EFSA requires so 
Reference: ii FA Final Report _FCEC, pages 39 
and 40 
Period 2017-2021 for 65 applications for 
renewal 
64 applications out of 65 required extension 
A large number of renewals are expected for the 
following years based on the expiry date for 
their authorisation (2023: 32, and 2024: 56). 
Reference: SANTE database  
Period 2017-2021 for 65 EFSA applications  
The average time for the assessment period is 
314 days, which exceeds the normal period of 6 
months in 134 days. 
The number of clock stops for the 65 
applications was 91 times with an average for 
application of 1.4 times. Only 5 out of 65 
applications did not require to ask for additional 
information and to stop the clock.  
Reference: SANTE internal calculations 
A majority of applicants indicating that 
procedure does not work well (23 out of 42). A 
large number of don’t know responses. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
food works well 

1.3 The procedure to 
extend authorisation to 
minor species works 
well 

X 

X 

X  X 

1.3.11 

Positive opinion 
among FeBOs 

1.4 Imports of FA are 
adequately controlled 

X 

X 

X 

1.4.1 

Positive opinion 
among FeBOs and MS 

157 

Reference: 
− 
ii FA Final Report _FCEC, page 40  
−  vii Consultation Synopsis Report, page 10 
− 

ix Accompanying document:  survey and PC 
results, page 15 

A majority of applicants 18 out of 42 indicated 
that does not work but there was a high number 
13 that do not know or do not have experience. 
FCEC Final Report, EQ 1.3., judgement criteria: 
“The procedure to extend authorisation to minor 
species works well” 
Reference: 
− 
ii FA Final Report _FCEC, page 41  
−  vii Consultation Synopsis Report, page 10 
− 

ix Accompanying document:  survey and PC 
results, page 16 

A majority of respondents (40 out of 62 – 
excluding 17 ‘do not know’ responses) consider 
imports of FA into the EU to be adequately 
controlled, while 14 respondents believe they are 
not 
11 MS authorities consider imports of FA into 
the EU to be adequately controlled, and 14 MS 
authorities consider them to be partially 
controlled. The main concerns raised by the 
latter MS authorities are linked to the absence of 
an EU list of third countries from which FA can 
be imported and the lack of CN codes 
Reference: 
− 
−  vii  Consultation  Synopsis  Report,  pages  16 

ii FA Final Report _FCEC, page 45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.4.2 

Number of RASFF 
notifications involving 
FA imported/ 
compared to total feed 
notifications 

1.4.3 

Results of multi-
annual national control 
plan and annual 
reports of MS (2011-
2015) include control 
of imports of FA. 

RSF 

and 23. 

See 1.2.7 

x 

NCA-
REQ 

Data provided by authorities in 16 MS indicate 
that, each year during the 2012-15 period, an 
average 3,182 controls were performed in 2,979 
registered establishments producing 
FA/premixtures (total for the 16 MS), i.e., 
average control frequency is just over once per 
year per establishment. There are some 
differences between MS, with 8 of the 16 MS 
having a control frequency higher than once per 
year. During controls performed in 17 MS in the 
period 2012-15, an average 7,980 samples were 
taken for analysis each year and 24,000 analyses 
were conducted. The conformity of samples and 
the conformity of analyses each year was 
generally high (median: 96-98%, for both). 
For imports, 11 MS authorities consider 
imports of FA into the EU to be adequately 
controlled, and 14 MS authorities consider them 
to be partially controlled. The main concerns 
raised by the latter MS authorities are linked to 
the absence of an EU list of third countries from 
which FA can be imported and the lack of CN 
codes. 
The controls performed by MS authorities shows 
a good level of control and high conformity of 
samples.  

158 

 
 
 
 
 
 
 
 
 
 
 
1.4 MS have put in 
place adequate 
sanctions to address 
non-compliance. 

1.4 Fraudulent/non-
compliant FA are 
rapidly identified and 
withdrawn from 
market 

1.4.4 

1.4.5 

1.4.6 

1.4.7 

Number of MS have 
established provisions 
on sanction and 
infringements 
- Administrative or 
criminal – sanctions?  
- Minimum and 
maximum sanctions 
- Are sanctions 
enforced? 
Number of sanctions 
imposed for FA and 
feed additive 
premixtures Results of 
multi-annual national 
control plan and 
annual reports of MS 
Period 2011-2015 

Number of cases 
where products have 
been withdrawn from 
the market 

X 

X 

X 

X 

1.4 FA-EURL can 
effectively carry out its 
tasks (storing of 

1.4.8 

Number of validation 
reports 

EU-
RL 

159 

Infringements and penalties have been 
established in all MS, but they diverge.   
Additional information. 
Reference: 
− 

ii FA Final Report _FCEC, pages 44, 45, 46 
and 47. 

All MS  
Reference: 
Reference: ii FA Final Report _FCEC, pages 44, 
45, 46, and 47. 
No data  

NCA-
REQ 

“No sufficient information on sanction 
enforcement due to different administrations 
involved that difficult to collect data 
Reference: ii FA Final Report _FCEC, pages 44, 
45, 46, and 47. 

No sufficient information on sanction 
enforcement due to different administrations 
involved that difficult to collect data 
Reference: ii FA Final Report _FCEC, pages 44, 
45, 46 and 47. 
2004-19, the EURL issued 628 validation 
reports 
FCEC Final Report, 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
samples, validating 
method of analysis 
etc…)  

X 

X 

1.4.9 

Feedback from FA-
EURL 

1.4 Conditions and 
restrictions imposed on 
the marketing of FAs 
are respected by 
FeBOs.  

1.4.10 

1.4.11 

Ms control of the 
respect of the 
authorisation 
conditions and 
restrictions of FA in 
feed. Results of multi-
annual national control 
plan and annual 
reports of MS Period 
2011-2015 
Number of non-
compliance/ number of 
total controls. Of 
samples taken. Results 
of multi-annual 
national control plan 
and annual reports of 
MS Period 2011-2015 

160 

Reference: ii FA Final Report _FCEC, page 48.  
The role of the EU-RL is adequately defined in 
the Regulation according to the majority of 
respondents (61 out of 92). 
The role of the EU-RL is adequately defined in 
the Regulation according to 22 MS authorities; 
only one NCA disagreed, commenting that the 
EU-RL competence could be enhanced, e.g., to 
support the national laboratories with the 
development and/or execution of analysis, as 
well as the MS authorities whenever needed 
Reference: vii Consultation Synopsis Report, 
pages 11 and 21 
See 1.4.3, 1.4.4 and 1.4.5 

NCA-
REQ 

NCA-
REQ 

The conformity of samples and the conformity 
of analyses each year was generally high 
(median: 96-98%, for both). 
Reference: ii FA Final Report _FCEC, page 45 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.4 Post-market 
monitoring plans 
enable to identify 
negative impacts and 
to take corrective 
actions 
1.4 Labelling 
requirements are fit for 
purpose 

1.4.12 

Number of negative 
impacts identified by 
the monitoring plans   

X 

X 

X 

Positive opinion 
among respondents 

1.4.13 

1.4 Innovative FA can 
be placed on the 
market 

1.4.14 

Outcome of case 
studies 

1.4.15 

Positive opinion 
among respondents 

X 

X 

X 

X 

161 

SAN-DB  The sole monitoring plan prepared is under 

EFSA assessment (date 17-11-2021) 
Reference: SANTE database 

A majority of respondents (53 out of 111) 
consider labelling requirements to be fit for 
purpose, although, a large number of 
respondents (45), particularly manufacturers of 
FA and premixtures, followed by manufacturers 
of compound feed and FA do not agree with this 
statement. 
Most MS authorities (19) consider labelling 
requirements to be fit for purpose, only 3 MS 
authorities disagreed, and the remaining 3 MS 
authorities did not provide a definite answer. A 
key comment by the MS authorities who 
disagreed or did not provide a definite answer is 
that the labelling could be modernised, with 
certain indications potentially provided in a 
separate document (other than the label). 
Reference: vii Consultation Synopsis Report, 
pages 11 and 21 
Reference: 
vi Case studies 
ii FA Final Report _FCEC, page 44 
Just over half of respondents believes that the 
Regulation does not make it easier to place new 
innovative additives on the market when 
compared with the former 1970 FA Directive. 
12 MS authorities believe that innovative FA 
can be placed on the market, 4 MS authorities 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.4.16 

Number of new 
categories/functional 
groups in the 
Regulation and added 
after the Regulation 
came into force 

1.4.17 

Number of 
applications and 
authorisations of FA 
for new categories 
(REF 2 total and per 
year) 

X 

SAN-
DB; FR 

disagreed, and 9 MS authorities did not provide 
a definite answer. The cost and complexity of 
the authorisation procedure are the main issues 
raised, especially for new FA for which 
functional groups or performance criteria 
(endpoints) may not be readily available. 
Reference: 
ii FA Final Report _FCEC, pages 47 and 48 
vii Consultation Synopsis Report, pages 14 and 
21. 
Period 2004-2021 
New categories: none 
Functional groups: 4 

Zootechnical additives category and functional 
group ‘other zootechnical additives’: 61 out of 
79 applications and 28 out of 35 authorisations 
were in this category (functional group 4(d)).  
The other two innovative groups are: ‘reduction 
of contamination by mycotoxins’ (12 
applications and 6 authorisations) and ‘hygiene 
conditions enhancers’ (6 applications and 1 
authorisation). 
In May 2021 there were 206 zootechnical 
additives authorised, of which 90 were 
digestibility enhancers, 86 gut flora stabilisers 
and 34 other zootechnical additives. 
Reference: 
ii FA Final Report _FCEC, page 47 

162 

 
 
 
 
 
 
 
 
 
 
 
1.4 The Regulation 
contributes to reduce 
the likelihood of 
antimicrobial 
resistance 

1.4.18 

1.4.19 

Number of antibiotics 
banned as growth 
promoters 
Number of additives 
authorised that are 
alternatives to the use 
of antibiotics (gut flora 
stabilisers + other 
zootechnical additives) 
(Ref1) 

1.4.20 

The assessment of 
additives examines 
any effect on AMR 

1.4.21 

1.5 EFSA opinions are 
not challenged 
(administrative 
reasons) 

1.5.1 

Use of 
antibiotics/reduction 
AMR  

Cases of request of 
administrative review 
(Art. 19)/cases 
favourable to 
EFSA/total opinions 
(Ref 2) 

 1.5 Commission 
decisions are not 
challenged 

1.5.2 

Cases at the court of 
Justice/ cases ruling in 
favour of the European 
Commission (Ref 2)  

OJ 

22 of which 4 were banned in 2006 
Reference: SANTE WEB 

SAN-
DB; FR 

Period 2004- May 2021 
Gut flora stabilisers:84 
Other zootechnical additives:15 
Reference: SANTE database 

Regulation 429/2008 includes the evaluation of 
antimicrobial effects for FA, this led to the 
withdrawal or denial of 5 additives in the period 
2004-2021 

x 

Mainly documents from EFSA, EMA, ECDC, 
WHO and ESVAC 

ECJ 

SAN-DB  During the period 2004-17, there have been five 
requests for administrative review under Article 
19.  In all five cases, the Commission decided 
that EFSA’s scientific opinion was validly 
adopted, and the allegations put forward by the 
requestor were dismissed. 
Reference: ii FA Final Report _FCEC, page 52 
During the period 2004-17, there has been one 
case at the Court of Justice of the EU, which 
ruled in favour of the European Commission: 
•  T-201/13 (“Toyocerin”): judgment of the 
General Court of 21 May 2015 (Rubinum v. 
Commission). Application for annulment of 
Commission Implementing Regulation (EU) No 
288/2013 of 25 March 2013 concerning the 

163 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  WTO 

1.5.3 

Comments from third 
countries in the 
WORLD Trade 
Organisation (SPS 
Agreement) (Ref 2)   

1.5 EFSA has enough 
and adequate 
information to give an 
informed opinion 
1.5 Elements other 
than risks related 
(social, economic, 
environmental) are 
enough taken into 
account by 
Commission 

1.5.4 

Number of 
inconclusive opinions/ 
total opinions  
(Ref 2) 

X 

X 

X 

1.5.5 

Positive opinions of 
respondents 

164 

suspension of the authorisations of the 
preparation of Bacillus cereus var. toyoi 
(NCIMB 40112/CNCM I-1012). The action was 
dismissed by the Court (i.e., ruling in favour of 
the Commission). 
Reference: ii FA Final Report _FCEC, page 52 
Comments in one notification. USA and India 
have submitted comments to the WTO - under 
the SPS Agreement. These comments were 
made in the context of SPS notification 
G/SPS/N/EU/190 of 6 February 2017 
concerning the (draft) Commission 
Implementing Regulation suspending the 
authorisation of ethoxyquin as a feed additive 
for all animal species and categories. The EU 
replied to those comments on 15 May 2017 and 
the act was adopted by the Commission on 7 
June 2017. 
Reference: ii FA Final Report _FCEC, page 52 
EFSA  An estimation is made concluding that around 

15 % of EFSA opinions are inconclusive. 
Reference: ii FA Final Report _FCEC, page 53 

FeBOs negatively perceived whether the 
authorisation took into account legitimate factors 
(58% of negative responses and only 24% of 
positive responses). 
Most MS authorities (16) believe that elements 
other than safety and efficacy (e.g., social, 
economic, and environmental) are sufficiently 
taken into account by the Commission during 
authorisation (e.g., transitional periods to adapt 
to changes) 

 
 
 
 
 
 
 
 
 
 
 
 
 
1.6 Use of 
coccidiostats and 
histomonostats as FA 
is important to ensure 
health and welfare of 
poultry and rabbits  

1.6 The use of 
coccidiostats and 
histomonostats as FA 
is well adapted to 
current farming 
practices 

1.6 The use of 
coccidiostats and 
histomonostats as FA 
is effectively 
controlled 

Authorisations taking 
into account legitimate 
factors (Ref. 2)  

1.5.6 

1.6.1 

X 

X 

X 

OJ-
EURLEX 

Positive opinions from 
respondents 

X 

X 

X 

Positive opinions from 
respondents  

1.6.2 

1.6.3 

Positive opinions 
competent authorities 

X 

X 

165 

Reference: vii Consultation Synopsis Report, 
pages 10 and 19 
ii FA Final Report _FCEC pages 53 and 54 
159 Regulations took into account legitimate 
factors, in the majority of the cases economic 
aspects linked to the cost of labelling for 
existing products that were re-evaluated  
Nearly all MS authorities consider that the use 
of coccidiostats and histomonostats as FA is 
important to ensure health and welfare of poultry 
and rabbits (24 MS authorities; no NCA 
disagreed), the remaining few MS authorities did 
not provide a definite answer (i.e., neither agreed 
nor disagreed with the above statements. 
Reference:  
vii Synopsis Report, page 19  
Nearly all MS authorities consider that the use 
of coccidiostats and histomonostats as FA are 
well adapted to current farming practices (20; 1 
NCA disagreed); the remaining few MS 
authorities did not provide a definite answer 
(i.e., neither agreed nor disagreed with the above 
statements. 
Reference:  
vii Consultation Synopsis Report, page 19 
Nearly all MS authorities consider that the use 
of coccidiostats and histomonostats as FA is 
effectively controlled (19; 2 MS authorities 
disagreed); the remaining few MS authorities 
did not provide a definite answer (i.e., neither 
agreed nor disagreed with the above statements. 
vii Synopsis Report, page 19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

X 

Positive opinions of 
FeBOs  

A substantial majority of respondents, including 
farmers, also consider the use of coccidiostats 
and histomonostats to be important as FA to 
ensure the health and welfare of poultry and 
rabbits (61 out of 71); are well adapted to 
current farming practices (65 out of 72) and 
effectively controlled (63 out of 70) 
vii Consultation Synopsis Report, page 9 

Primary sources 

Secondary sources 

Surveys 
Interviews 
Case studies 
SANTE request to MS  

Yes 
Yes  
Yes   
Yes 

1.  SANTE data base 
2.  FA Register (FAR) 
3.  OJ Publications 
4.  EFSA data base 
5.  Literature review 
6.  MS Multi-Annual National Control Plans (MANCPs) and Annual Reports 

(2011-15) 

7.  SANTE-F Audits Reports  
8.  FEFAC/Eurostat statistics 
9.  RASFF data base 
10. EFSA guidance 
11. FA-EURL data base 
12. EURLEX/Court of Justice database 
13. WTO data base 
14. RM Associates Report 

Methods for analysis. 
The aspects covered by this EQ are multiple due to its wide, high-level scope (i.e., reference to the overall objectives). Hence the large number 
of sub-questions and indicators feeding into the analysis. The analysis involves the identification of the relative contribution of  key provisions of 
Regulation (EC) No 1831/2003, in terms of meeting objectives. The key provisions are: authorisation procedure (safety assessment; efficacy 
assessment; decision-making); labelling; other provisions/ actions (imports; sanctions; role of EURL etc.). This requires:  

166 

 
 
 
 
 
 
 
 
 
 
-  Quantitative analysis of available data from the various secondary sources, including at first level, official data sources ( e.g., FAR, SANTE 

database, EFSA, MANCPs, ECJ decisions etc.) and at second level, unofficial data/estimates ( e.g., FEFAC; RM associates).  

Intervention logic analysis. 

-  Stakeholder consultation analysis. 
- 
-  Benchmarking against the achievements of Directive 70/524/EEC 
-  Analysis of the use of coccidiostats and histomonostats for poultry/rabbits  
Approach to answering the evaluation question and potential limitations 
The analysis will be based on: 
-  The FA register (FAR), SANTE database and EFSA database will be used to the extent possible to provide quantitative data to some 

indicators. This will include some quantitative benchmarking against the baseline, where such data exists.  

-  Some additional literature sourced will be used to provide additional data/ information. For the Multi -annual National Control Plans the 

period chosen is 2011-2015 (latest complete plan).  

-  Stakeholder consultation analysis will be used to feed into indicators for which quantitative  data do not exist and/or their experience and 

opinions are important. 

The large number of indicators is inevitable in view of the wide scope of this EQ; it allows a comprehensive approach to answ ering the EQ. On 
the other hand, this also poses some limitations. 
Limitations are mainly posed in terms of data availability: some of the data required to feed certain indicators (in relation  to number of 
additives) are not systematically recorded in SANTE database and it is not certain that all parameters are possible to establish the data required 
by the indicators. 

Evaluation criterion: Effectiveness – EQ2 

Evaluation question 2: 
How did the Regulation contribute to develop a competitive and innovative EU feed additive industry?  
2.1 How does the authorisation procedure for FA affect the competitiveness between EU and non-EU feed business FeBOs? 
2.2 What factors support or hinder the competitiveness? 
2.3 Which Non–EU countries recognise the EU authorisation procedure to allow companies to directly enter their market and why?  
Legislation concerned 
Regulation (EC) No 1831/2003 

167 

 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

2.1 The 
Regulation has 
encouraged the 
development of 
innovative FAs 
to cover new 
needs of the 
livestock sector  

2.1 The 
Regulation has 
encouraged the 
development of 
new FAs to 
replace growth 
promoters. 
2.1 Identification 
of major factors 
affecting 
competitiveness 
of the FA 

2.1.1  Number of additive 

authorisations of such 
types of FA since 
2004 (e.g., number of 
authorisation for new 
functional groups)  

2.1.2  Number of additives 
of such types of FA 
since 2004 (e.g., 
number of 
authorisation for new 
functional groups).  

RM; 
FEF 

FAR  Zootechnical additives category and functional group ‘other 

zootechnical additives’: 61 out of 79 applications and 28 out of 
35 authorisations were in this category (functional group 4(d)).  
The other two innovative groups are: ‘reduction of 
contamination by mycotoxins’ (12 applications and 6 
authorisations) and ‘hygiene conditions enhancers’ (6 
applications and 1 authorisation). 
FCEC Final Report, EQ 1.4., judgement criteria: “Innovative FA 
can be placed on the market. 
Reference: ii FA Final Report _FCEC, page 49 

RM; 
FEF 

FAR  Period 2004- May 2021 
Gut flora stabilisers: 84 
Oher zootechnical additives:15 
Reference: SANTE database 

2.1.3  Identification and 

X 

X 

Reference: ii FA Final Report _FCEC, pages 61 and 62 

qualification of costs 
for major cost 
categories (inputs, 
capital, labour)  

168 

 
 
 
 
 
 
 
 
 
 
 
 
 
industry (EU vs 
non-EU FeBOs) 

2.1.4  Relative importance 

X 

X 

of non-monetary 
factors (technical and 
regulatory barriers)  

x 

Limited circulation for FA only intended for export Reference: ii 
FA Final Report _FCEC. 

Insufficient clarity of certain provisions creates a burden for 
FeBOs: 

−  Definition  of  FA/  versus  biocidal  products  Reference:  ii 

FA Final Report _FCEC, pages 104-105 

−  Use of additives in drinking water  
−  Labelling tolerances of FA in premixtures 
−  Absence  of  definition  for  preparations  Reference:  ii  FA 

Final Report _FCEC, page 110 

−  No  clear  status  for  recommended  levels.  Commission 
insufficient  clarity  in  the 
experience  derived  from 
Regulation.  They  can  be  indicated  only  as  a  labelling 
provision.  Reference:  ii  FA  Final  Report  _FCEC,  page 
107 

−  Simultaneous  application  of  CLP  and  FA  legislation  for 
worker safety provision in premixtures.  Reference: ii FA 
Final Report _FCEC, page 102 and vi Case studies) 
−  No possibility to use digital tools for labelling of FA (all 
information must be in a physical label. Reference: ii FA 
Final Report _FCEC, page 94 and vi Case studies) 

−  No sufficient clarity on how to modify authorisations not 

linked to an authorisation holder 

Authorisation costs 
Labelling costs  
Other regulatory requirements not linked to the FA legislation; 
labour costs, environmental requirements etc.  
Reference: ii FA Final Report _FCEC, Judgement criteria pages 
63-66 

2.1 Impact of the 
Regulation on 
relative 
competitiveness 
of the FA 
industry (EU vs 

2.1.5  Identification of 

X 

X 

impacts and 
qualitative 
assessment.  

169 

 
 
 
 
 
 
 
 
non-EU FeBOs) 

2.1.6  Relative contribution 
of regulatory costs to 
total cost of 
production or price. 

X 

X 

2.1.7  % Of sales of FA in 
the overall turnover 

X 

2.1 Significance 
of FAs in the 
economic 
activity of FA 
FeBOs  

The total costs of authorisation as % of total regulatory costs 
and/or as % of total cost of production of this product or product 
price were not possible to estimate. Two companies indicated 
that the total regulatory costs stemming from the Regulation, of 
which the main component are the authorisation costs, are 
estimated at 2% and less than 5%, respectively, of the cost of 
production for this product. This estimation was based on a 10-
year authorisation period. As a comparison, another company 
that is a major FA and compound feed manufacturer indicated 
that regulatory costs stemming from all legislation are 15% of all 
costs of the entire company's animal nutrition portfolio. 
According to all companies, the costs of authorisation in the EU 
are considerably higher than in non-EU markets due to the high 
level of requirements in safety and efficacy studies. One 
company indicated that registration costs for this enzyme in non-
EU countries vary from country to country, but in their 
experience costs range between €500 and €3,000 per dossier and 
each application process takes between 2 months and up to 18 
months to be completed. 
Reference: vi Case Studies, page 7 
According to industry data, large and medium size companies 
seem to be less specialized in FA than smaller companies: FA 
account for less than half of the turnover for 70% of large 
companies and 60% of medium size companies as compared to 
some 30% of small companies236. The same survey results also 
indicate a total investment on R&D ranging from 26% to 14% of 
the turnover for the small and the large companies, respectively, 

236 Source: FEFANA (2018) Caveats: there is an over-representation of large companies that responded to the FEFANA survey. Of the total FEFANA membership (94 companies), 59 
replied to the survey. Of these, 32 are large (according to the EU classification of ‘large company’, based on annual turnover > €50 million; but 26, based on annual balance sheet > 
€43 million); 11 are medium and 8 small, despite the fact that SMEs account for >60% of members.  

170 

 
 
 
 
 
 
 
 
 
 
 
2.1.8  % Of volume /value 

X 

of fa in relation to 
feed  

2.2 Relative 
importance of 
imports on the 
EU market 

2.2.1  Importance of 
imports on EU 
market by category of 
FA.  

X 

X 

2.2 Relative 
importance of 
EU exports to 
non-EU markets  

2.2 Some FAs 
not authorized in 
the EU are still 
produced for 

2.2.2  Importance of EU 

X 

X 

production destined 
for exports (volume 
& value; qualitative) 

2.2.3  Identification of non-

X 

X 

X 

authorised FA that 
are now exported 
outside the EU 

171 

compared to 8% for the medium-size businesses. 

in  2019  amounts 

Reference: ii FA Final Report _FCEC, page 65 
In 2020,  FA had a turnover of €15 billion. The compound  feed 
production 
to  55.6  billion  euros,  FA 
represented  around  25%  of  the  value  of  compound  feed  in  that 
year. 
Imports from non-EU countries play an important role, across all 
categories.  In  one  commercially  ‘major’  group  (trace/micro 
minerals)  only  products  from  non-EU  countries  are  present  on 
the EU market. The main countries of origin differ per functional 
group, but across categories, six non-EU countries are identified 
to  play  a  major  role  (USA,  China,  India,  Brazil,  Japan  and 
Canada),  with  the  USA  and  China  the  most  commonly 
identified. Reference: ii FA Final Report _FCEC, page 18  
 Other  additives  imported  in  large  extend  are  amino  acids  and 
vitamins. 
Reference Feed info insights 
Limitations:  there  are  no  official  statistics  to  quantify  the 
imports.  
Although,  no  figures  are  presented  in  this  report  it  is  a  known 
fact that significant quantities of premixtures, mineral feeds and 
some  compound  feeds  are  exported  to  for  instance  the  Middle 
East. 
Reference Report RM associated  
Some additional information in 2.2.3 
No more information is available as there are no official statistics 
available. 
Although no data exist on the actual volume/value of exports of 
NAFA  products,  several  of  the  consulted  companies  (including 
SMEs),  indicated  that  the  export  of  NAFA  products  is  an 
important segment of their business. This option, in compliance 
with  applicable  requirements  in  non-EU  countries,  allows  EU-

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
exports. 

(volume & value) 

based companies to produce for non-EU countries in cases where 
the authorisation/approval process in the non-EU country is less 
burdensome  than  in  the  EU.  This  enables  EU  companies  to 
maintain 
their  global  competitiveness;  particularly  SMEs 
producing  a  diverse  product  range,  for  which  the  burden  of 
authorisation costs can be particularly important in view of their 
small scale of business.  
Reference ii FA Final Report _FCEC, page 67 

is  Spain 

that  have  30 
The  sole  country  having  data 
establishments  registered  for  the  activity  of  producing  FA  or 
premixtures  intended  for  export,  with  approximately  4,000  t  of 
those  FA  and  premixtures  in  2021  from  304  consignments.  As 
there are not statistics on the production of FA and premixtures, 
the  reference  could  be  the  production  of  compound  feed  in  the 
EU, as this production is proportionate to  the production of  FA 
and  premixtures  that  are  incorporated  in  compound  feed.  An 
estimation  based  on  the  information  from  Spain  is  that  this 
market  may  have  a  volume  around  18,000  t.  This  is  an 
estimation that cannot be confirmed statistically. 
Reference: Commission data based on Spanish information. 
Despite  the  extensive  consultation  undertaken  for  the  study, 
there  is  no  indication  (quantitative  or  qualitative)  of  the  R&D 
trend  by  EU-based  companies  active  in  the  FA  sector.  It  is 
therefore  not  possible  to  establish  with  certainty  whether  R&D 
investment to develop new FA has increased or decreased since 
the  Regulation  came  into  force.  As  already  indicated  under 
EQ2.1, the share of turnover earmarked to R&D varies between 
companies, largely depending on whether FA are a core sector of 
their business. Furthermore, some industry respondents indicated 
that, 
investing  or 
considering  investing  in  non-EU  based  R&D  facilities,  or  sub-
contracting R&D activities (including trials) to facilities based in 

to  curtail  costs, 

increasingly 

they  are 

2.2 R&D 
invested to 
develop new 
FAs is 
increasing  

2.2.4  Trend in share of 

X 

X 

X 

R&D on FA in total 
R&D of companies 
active in the FA 
industry 

172 

 
 
 
 
non-EU  countries.  Therefore,  the  trend  in  the  value  of  R&D 
spending within the EU as such may not be capturing the actual 
total R&D effort.  
As explained in the authorisation case study (Annex 4), the start-
up  costs  can  be  a  significant  barrier,  particularly  for  SMEs 
(depending on the financial support a company may have). In the 
first few years of the investment the company needs to invest in 
the  R&D  and  authorisation  costs  involved  with  no  revenue. 
Hence,  due  to  the  considerable  costs  involved,  it  is  rare  for  a 
company  to  have  more  than  one  product  going  through  an 
application  for  authorisation  process  at  any  time.  Ultimately, 
each  company  has  to  make  a  strategic  decision  based  on  its 
structure  and  funding  support,  e.g.,  to  start  with  an  application 
for authorisation covering fewer species to save on costs (as this 
requires  fewer  studies)  and  expand  to  more  species  when 
possible 
Reference: ii FA Final Report _FCEC, page 68 
The  number  of  patents  applications  for  FA  submitted  to  the 
European Patent Office doubled compared to the previous period 
(207  applications  were  received  between  2004  and  2019 
compared  to  104  applications  between  1979  and  2003).  The 
share  of  EU  applicants  versus  non-EU  applicants  remained 
almost  the  same  for  the  two  periods  (44%  EU  applicants  and 
56% non-EU applicants). 
Reference:  European  Commission.  Elaborated  with  the  data  of 
the European Patent Office. The data were updated up 2019   
No significant difference in terms of the cost: benefit balance can 
be  seen  between  SMEs  and  non-SMEs.  However,  the  required 
upfront  investment  (R&D  and  authorisation  costs)  is  high,  and 

EPO 

173 

2.2.5  Number of patents by 
non-EU 
(REF 

EU 
FeBOs 
30/04/2019) 

vs 

2.2 Extent to 
which the 
authorisation 

2.2.6  How important have 

X 

X 

X 

generic authorisations 
been for SMEs 

 
 
 
 
 
 
 
 
 
procedure more 
specifically 
affects SMEs 

placing the products 
on the market? 

237 See Annex 4, authorisation case study. 

174 

access to finance to support this is generally an issue for smaller 
companies, when these are not part of larger entities237. For these 
reasons, SMEs - particularly the smaller companies - either tend 
to specialise in a few FA or a few categories/species of animals 
to  reduce costs and develop  a niche, or tend to  rely  on generic, 
non-holder-specific authorisations to save on costs. Therefore, to 
the  extent 
the  non-holder-specific 
rely  on 
authorisations,  their  drawbacks  as  a  disincentive  to  apply  for 
such authorisation may penalise more SMEs. 
Reference: ii FA Final Report FCEC, pages 88-89. 

that  SMEs 

The presence of SMEs in the FA/premixtures sector is important. 
As  highlighted  under  EQ2.1,  60%  of  company  members  of 
FEFANA  are  SMEs.  SMEs  are  actively  involved  in  the 
authorisation  process.  For instance, 14 of the 38  respondents  to 
the  stakeholder  survey  that  filed  an  application  for  a  new 
authorisation under Article 4 are SMEs (of which, four are part 
of  a  larger  company).  Similarly,  9  of  the  24  respondents  that 
filed  an  application  for  renewal  of  authorisation  are  SMEs  (of 
which,  2  are  part  of  a  larger  company).  Furthermore,  of  the  45 
companies  that  responded  to  the  survey,  25  have  placed  one  or 
more  generic  FA  on  the  EU  market;  of  these,  11  are  SMEs  (of 
which,  3  are  part  of  a  larger  company)  and  14  are  large 
companies. (SH SURVEY) 

As explained in the authorisation case study (Annex 4), the start-
up  costs  can  be  a  significant  barrier,  particularly  for  SMEs 
(depending on the financial support a company may have). In the 
first few years of the investment the company needs to invest in 

 
 
the  R&D  and  authorisation  costs  involved  with  no  revenue. 
Hence,  due  to  the  considerable  costs  involved,  it  is  rare  for  a 
company  to  have  more  than  one  product  going  through  an 
application  for  authorisation  process  at  any  time.  Ultimately, 
each  company  has  to  make  a  strategic  decision  based  on  its 
structure  and  funding  support,  e.g.,  to  start  with  an  application 
for authorisation covering fewer species to save on costs (as this 
requires  fewer  studies)  and  expand  to  more  species  when 
possible. 

According  to  the  industry,  SMEs  are  active  in  the  sector  of 
holder-specific FA, such as zootechnical additives, but they tend 
to focus authorisation requests to a specific category of animals 
rather  than  all  animal  species,  to  reduce  the  costs  of  R&D  and 
authorisation  (case  study  on  authorisation,  Annex  4).  Generic 
(non-holder-specific) authorisations are also important for SMEs 
placing their products on the EU market, as they do not have to 
bear  the  costs  of  an  application.  With  the  exception  of 
zootechnical additives, for which the holder of the authorisation 
benefits  from  marketing  exclusivity  for  the  whole  period  of 
authorisation, most other additives are non-holder-specific. 
Reference: ii FA Final Report FCEC, pages 68-69. 
Of the six countries that responded to the survey, two countries 
(Chile  and  Canada)  recognise  substantial  parts  of  the  EU 
authorisation  procedure,  largely  because  their  approaches  are 
relatively  aligned.  In  particular  China  indicated  that  technical 
data of FA authorised in the EU are being used as a reference for 
the technical assessment of these substances by the authorities in 
China. 
Reference: ii FA Final Report FCEC, page 70. 

2.3.1  Identification of 
countries... 

X 

X 

RM 

TC-
sur 

2.3 Extent to 
which the EU 
authorisation 
process is 
recognized in 
non-EU 
countries (China, 
USA, Canada, 
Australia, Japan, 
Brazil, 
Argentina and 

175 

 
 
 
Chile)  

2.3 Extent to 
which the EU 
authorisation 
system is 
attractive to non-
EU FeBOs  

2.3.2  Identification of 

applicants from third 
countries. Ref 2 

SAN-
DB 

2.3 Major 
differences in 
the authorisation 
procedure in 
non-EU 
countries (China, 
USA, Canada, 
Australia, Japan 
Brazil, 
Argentina and 
Chile) compared 

2.3.3  Time from 

application to 
authorisation  

Identification of 
major differences in 
safety requirements  

X 

TC-
sur 

X 

TC-
sur 

176 

It  is  not  possible  to  establish  with  certainty  whether  the  EU 
authorisation  procedure  is  attractive  to  non-EU  operators.    In 
particular, it is not possible to identify with sufficient detail from 
the  Commission  internal  database  the  operators  from  non-EU 
countries involved in a request for authorisation, as they usually 
have an EU representative that acts as an applicant.  

(2004-2019) 

identified  several  non-EU 
Commission  data 
company applicants, but not an exhaustive list. This information 
indicates  that  companies  based  in  at  least  seven  non-EU 
countries have requested an authorisation to place their products 
on the EU market. These countries are: the USA (13 companies), 
Japan (8), China (3), India (2) and Australia (2), Switzerland (1), 
Turkey (1) and  Korea (1  These figures however do not reflect 
the  level  of  attractiveness  of  the  EU  authorisation  system  for 
non-EU operators as many multinational companies have a direct 
access  to  the  EU  market  through  their  subsidiaries  located  in 
Europe.   

Reference: ii FA Final Report FCEC, page 71 
The  time  taken  to  process  an  application  for  authorisation  can 
vary  considerably  from  one  country  to  another,  from  a  few 
months  (in  the  case  of  three  countries)  to  about  a  year  (in  the 
case  of  two  countries).  Only  in  one  country,  the  procedure  can 
take up to several years. 
Reference: ii FA Final Report FCEC, page 71 
Authorisation process: All countries have a process in  place for 
feed  additive  approval,  which 
includes  a  scientific  risk 
assessment. When compared to the EU authorisation process, the 
components  of  the  process  followed  in  non-EU  countries  have 
generally  lighter  requirements,  which  significantly  vary  per 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
with the EU 
(duration, safety 
requirements 
etc…)  

country. One of the six countries appears to be the most aligned 
to  the  EU  since  all  requirements  for  safety  and  efficacy 
assessment need to be met. It is followed by three countries. In 
most cases, these impose similar requirements as in the EU. The 
remaining  two  countries  generally  apply  requirements  based  on 
the product’s process monograph. One of these also applies more 
detailed  requirements  on  safety,  namely  the  identification  and 
characterisation  of  the  additive  (e.g.,  purity,  presence  of 
impurities, contaminants, etc.), but no specific tests on the target 
animals.  Furthermore,  in  all  countries,  applicants  can  submit 
additional information  during the assessment process,  and, with 
the  exception  of  one  country,  they  can  hold  meetings  before 
formally  submitting  the  application,  mainly  for  clarification 
purposes. 
Reference: ii FA Final Report FCEC, page 71 

Primary sources 
Surveys 
Interviews 
Case studies 
SANTE request to MS  
TC survey (via SANTE) 

Yes 
Yes  
Yes  
Yes 
Yes - tbc 

Methods for analysis. 

Secondary sources 

1.  SANTE data base 
2.  FA Register 
3.  Literature review 
4.  FEFAC/Eurostat statistics 
5.  RM Associates Report 
6.  European Patent Register 
7.  Company data (to the extent available from external provider – 

arranged by SANTE) 

-  Stakeholder consultation analysis  
-  Benchmarking against third countries authorisation procedure (China, USA, Canada, Australia, Japan, Brazil, Argentina and Chile), 

descriptive statistics, and analysis of company data (to the extent available).  

Approach to answering the evaluation question and potential limitations 

177 

 
 
 
The identification  of  major  factors  affecting  competitiveness of  FA  FeBOs in the EU  and in  main  competing  countries  (China,  USA, Canada, 
Australia,  Japan  Brazil  Argentina  and  Chile)  aims  to  provide  an  overview  for  comparison  purposes,  to  identify  the  relative  im portance  of  the 
Regulation’s impact on competitiveness of  FA FeBOs. If available, company data will be used to assess the major economic factors impacting 
competitiveness in relation to costs and innovation.    

Evaluation criterion: Efficiency – EQ3 

3.1 What are the compliance costs and administrative costs linked to the requirements of the Regulation (labelling, monitoring, etc.…)? 
3.2 To what extent are the risk assessment and the risk management process sufficiently cost -effective, efficient and flexible (e.g.: in terms of 
procedural timeliness)? 
Legislation concerned 
Regulation (EC) No 1831/2003 

NCA 

SV 

SH 

SV 

X 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

3.1. Benefits 
justified costs 

3.1.1.  Costs (direct 
and indirect) 
for FeBOs 
(applicants and 
others) 
including 
authorisation, 
labelling, 
monitoring 

INT  CS 

LIT 

COM 

RESULTS 

X 

X 

X 

Total direct costs on average per year €62,700,000  
€1,100,000 per authorisation 
 €216,000per renewal 
In  terms  of  labelling  costs,  the  direct  costs  for 
producers  of  FA  are  negligible  however  for 
premixtures 
in  average  between 
€80,000  and  €223,000  per  plant  per  year.  These 
costs  include  costs  of  labels,  translation  services, 
design  and  printing  of  labels  and  reformulation 
when  required.  For  pet  food  manufacturers  costs 
occur  for  a  few  cases  when  an  additive  is 
withdrawn,  and  the  transitional  period  is  shorter 

these  reach 

178 

 
 
 
 
 
 
 
 
packaging 

adaptation 

than  the  period  of  expiry  of  the  feed.  The 
estimations for re-labelling compound feeds are €1 
million  for  2,000  references.  For  food-producing 
animals, the costs are negligible 
The  main  costs  analysed  are  additional  costs  of 
labelling  when  label  changes  due  to  regulatory 
changes: 
and/or 
of 
labels/labelling  process.  This  includes  labelling, 
packaging and storage costs, stock management of 
labels/final  packaged  products,  label/packaging 
waste. 
These costs include both time required (staff time; 
staff  category;  unit  costs)  and  the  costs  of 
materials and equipment. 
In  terms  of  labelling  costs,  the  direct  costs  for 
producers  of  FA  are  negligible  however  for 
in  average  between 
premixtures 
€80,000  and  €223,000  per  plant  per  year.  These 
costs  include  costs  of  labels,  translation  services, 
design  and  printing  of  labels  and  reformulation 
when  required.  For  pet  food  manufacturers  costs 
occur  for  a  few  cases  when  an  additive  is 
withdrawn  and  the  transitional  period  is  shorter 
than  the  period  of  expiry  of  the  feed.  The 
estimations for re-labelling compound feeds are €1 
million  for  2,000  references.  For  food-producing 
animals, the costs are negligible. 
Indirect costs 
Operators indicated that indirect  costs are derived 
from 
the 
authorisation  process  in  the  two  steps:  EFSA 
the 
evaluation  (stop 
the  authorisation. 
Commission  decision 

the  clock)  and  during 

incurred  during 

time  periods 

these  reach 

the 

for 

179 

 
Operators were not  able to  estimate these indirect 
costs in monetary terms. 
The costs are around €2,000 for disposal of labels 
for  premixtures  applying  the  usual  transitional 
period.  The  compliance  costs  can  be  estimated 
between  €24,000  and  €40,000  per  product  and 
€13,500 in labels for premixtures when the change 
affects  an  important  additive  widely  used  and  the 
transitional  period 
the  usual 
transitional  period.  However,  the  occurrence  of 
this possibility is very low. 
References: 
ii FA Final Report _FCEC, pages 75-80 
vi: Case studies, pages 5-11 
viii Costs methodology, pages :7-9 

is  shorter 

than 

3.1.2  Costs for EFSA 

EFSA 

EFSA  Total costs on average per year are 1,900,000  

the  period  of  2014-2018  EFSA  has 
During 
processed 346 applications, corresponding to 69.2 
applications  per  year  on  average  at  an  estimated 
cost  of  €27,450  per  application  (new  and  re-
evaluation),  €15,900  of  which  are  internal  staff 
costs. 
References:  
ii FA Final Report _FCEC, pages 82-83vi:  
In total the costs on average per year are €756,000  
Considering  that  the  application  is  the  most 
relevant step that triggers all the different actions, 
an estimate of the staffs’ costs per application for 
new  authorisations  and  renewals  amounts 
to 
€13,400.  The  number  of  applications  during  the 
period  2012-2017  increased  efficiency  in  the 
applications  management.  The  number  of 
meetings  of  the  SCoPAFF  has  been  reduced  but 

3.1.3  Costs for COM 

COM 

X 

180 

 
 
 
 
 
 
 
 
 
in 

the 

savings 

standard 

their  duration  has  been  extended,  resulting  in  a 
stable  number  of  days  of  meetings  per  year.  This 
travel  expenses, 
has  permitted 
interpretations  and  administrative  support  of 
meetings. 
In case of change of authorisation holder, the costs 
implementing 
are  estimated  at  €13,400  per 
Regulation.  For 
authorising 
Regulations, the costs are €22,400 per Regulation. 
For the Commission during the period 2004-2017, 
the costs of Regulations changing the authorisation 
holder  amount  to  €375,200  which  accounts  for 
€26,800 per year (2 Regulations per year). 
Reference: 
ii FA Final Report _FCEC, pages 81-82 
viii Costs methodology, page 19 
The total costs for the EURL per year on average 
are €684,000. 
During 
the  period  of  2014-2018  EFSA  has 
processed 346 applications, corresponding to 69.2 
applications  per  year  on  average  at  an  estimated 
cost  of  €27,450  per  application  (new  and  re-
evaluation),  €15,900  of  which  are  internal  staff 
costs. 
Reference: 
ii FA Final Report _FCEC, pages 80-81 
viii Costs methodology, page 10 
The total costs the EURL per year on average are 
€2,884,000 
It is estimated that each MS CAs spent on average 
€74,000 
and 
administrative  tasks  (‘a’  and  ‘c’).  Several  MS 
could  not  provide  estimates  of  time  spent  on 

enforcement 

year 

per 

for 

3.1.4  Costs for EURL 

EU-
RL 

EU-
RL 
COM 

3.1.5  Costs for MS 

CAs (controls) 

X 

X 

X 

181 

 
 
 
 
 
 
 
 
legal/administrative  obligations  and  controls  for 
FA  and  premixtures  as  this  information  was 
available  for  all  feed  in  general  but  does  not 
distinguish  additives  and  premixtures  from  other 
feeds. To allow for the differences in the estimates 
provided by MS, the staff time has been calculated 
for  all  the  tasks  (‘a’,  ‘b’  and  ‘c’)  as  an  average 
across  those  MS  that  provided  complete  data  (14 
MS). 
It is estimated that each MS CAs spent on average 
€74,000 per year for enforcement control tasks (b) 
over the 2016-17 period. 
In  total  the  costs  for  each  MS  CAs  are  €103,000 
(29,000+74,000) euros per year on average which 
accounts to €2,884,000 per year for all EU MS. 
ii FA Final Report _FCEC, pages 83-84 
viii Costs methodology, page 10 
The  qualitative  benefits  for  producers  of  FA  and 
premixtures and feed compounders are: 
−  Minimise  disposal  or  destruction  of  products 
by additives permitting the preservation of the 
quality  of  additives  and  premixtures  (e.g.,  an 
additive such as vitamin A must  be placed on 
the market in combination with an antioxidant 
to  prevent  oxidisation)  and  by  the  pre-market 
the  safety  assessment  and  comprehensive 
labelling rules;( see ii FA Final Report _FCEC, 
see pages 77 and 78). 

−  Good  reputation  of  the  EU  companies  as  the 
products that they place on the market are safe 
and  efficacious  and  have  carried  out  a 
comprehensive safety and efficacy evaluation. 
−  Easy  access  to  non-EU  markets  (ii  FA  Final 

X 

X 

X 

X 

3.1.6  Benefits for 
FBOs 
(applicants and 
others) – mainly 
qualitative 

182 

 
 
 
Report _FCEC, see page 64). 

−  High variety of additives that allows to satisfy 
the market expectations in terms of innovation, 
presentation of FA (e.g., liquid, pellets, etc.) or 
specific  requirements  for  certain  types  of 
animals  (e.g.,  specific  additives  of  lactating 
sows or piglets). 

Reference FA Final Report _FCEC, see pages 64, 
77, 78, 84 and 86. 
The  qualitative  benefits  for  farmers  can  be 
summarised as follows: 

  Reduction  of  losses  resulting  from  animal 

diseases or AMR.  

  Availability of efficacious and innovative FA 
  More balanced diets for animals.  
  Better use of resources. 
  Increase  of  animal  performance  or  of  animal 

resilience to heat or stress. 

  Contribute  to  reduce  the  negative  impact  of 
livestock  farming  on  the  environment  (phytases, 
amino acids and methane reduction). 

  Protect  the  farmers’  economic  interests  as 
additives are efficacious for the intended purpose. 
Reference: 
ii FA Final Report _FCEC, page 85. 
The qualitative benefits of pet owners and pets can 
be summarised as follows: 

  Reduce 

the  occurrence  of  diseases  or 
intoxications FA are safe for pets. As an example, 
the  authorisation  of  titanium  dioxide  in  2021, 
mainly used in cats and dogs, was denied as it was 
mutagenic and carcinogenic. 

  Reduce  the  occurrence  of  spreading  AMR  to 

3.1.7  Benefits for 

X 

X 

farmers - 
qualitative 

FAO 
RM 

X 

3.1.8  Benefits for pet 
owners – 
mainly 
qualitative 

X 

X 

FFDIAF 

X 

183 

 
 
 
 
 
 
3.1.9  Benefits for 

X 

X 

animal welfare 
and animal 
health – mainly 
qualitative 

FAO 
RM 

pets and pet owners. 

  Protect  the  pet  owners’  economic  interests  as 
additives are efficacious for the intended purpose. 
  Availability  of  efficacious  and  innovative  FA 

that satisfy the necessities of pets. 
Reference:  
ii FA Final Report _FCEC, page 86 
The  qualitative  benefits  for  animal  health  and 
animal  welfare  are  related  to  the  improvement  of 
the  animals  and 
the  physiological  status  of 
consequently animal health and welfare: 

−  The  necessities  of  animals  for  vitamins  or 
trace  elements  can  be  satisfied  via  FA 
in 
preventing  diseases  or  deficiencies 
animals.  Animal  welfare  may 
be 
compromised  for  example  if  animals  do  not 
take sufficient levels of vitamin D: lameness, 
difficulty  walking, a tendency to  sit on their 
haunches will occur in growing pigs.238 
−  Prevent  the  occurrence  of  coccidiosis  in 
poultry  one  of  the  most  important  parasitic 
diseases.  
 Prevent the occurrence of intoxications with 
undesirable  residues  in  feed  from  animal 
origin.  
−  Prevent 

the  occurrence  of  diseases  as 
promotes  a  desirable  gut  ecosystem  by 
giving  to  the  animals’  beneficial  species  of 
microorganisms. 

− 

238  The  pathology  of  vitamin  D  deficiency  in  domesticated  animals:  An  evolutionary  and  comparative  overview.  Elizabeth  W  Uhl.  Int  J  Paleopathol.  2018  Dec;  23:100-109.  doi: 

10.1016/j.ijpp.2018.03.001. 

184 

 
 
 
 
 
−  Prevent 

the  occurrence  of  antimicrobial 
resistance via for example of microorganisms 
that  improve  the  beneficial  flora  in  the  gut. 
Also,  the  safety  evaluation  to  prevent  any 
AMR effect of the additives contribute to this 
aim. In this regard, in 2015, the authorisation 
of  Bacillus  toyonensis  (NCIMB  14858  was 
denied as posed a risk for the spread of genes 
coding  for  resistance  to  tetracycline  and 
chloramphenicol,  which  are  antibiotics  of 
human and veterinary importance. 

− Improve  animal  welfare:  some  amino  acids 
that reduce nitrogen excretion will contribute 
to  reduce  ammonia  in  urine  and  improve 
animal  welfare  of  animals  as  ammonia  may 
increase the respiratory stress.239 

ii FA Final Report _FCEC, page 86 

239 Acute and prolonged effects of ammonia on haematological variables, stress responses, performance, and behaviour of nursery pigs. E. von Borell, PhD; A. Özpinar, PhD; K. M. 
Eslinger;  A.  L.  Schnitz;  Y.  Zhao,  PhD;  F.  M.  Mitloehner,  PhD.  EVB:  Institute  of  Agricultural  and  Nutritional  Sciences,  Martin-Luther-University  Halle-Wittenberg,  Halle, 
Germany.  AO:  Western  Institute  for  Food  Safety  and  Security,  University  of  California,  Davis,  California.  KME,  YZ,  FMM:  Department  of  Animal  Science,  University  of 
California, Davis, California. 

185 

 
 
 
3.1.10 

Benefits for 
human health – 
mainly 
qualitative 

X 

X 

The qualitative benefits for human health are: 

  Prevent 

from  animal  origin, 

the  occurrence  of  diseases  or 
intoxications  derived  from  the  consumption  of 
feed 
the 
establishment  of  maximum  residue  levels  for  a 
colourant  astaxanthin prevent  that residues of this 
colorant may affect the consumer health. 

for  example 

  Prevent  the  occurrence  of  AMR:  indirectly  by 
contributing  to  reduce  treatments  with  antibiotics 
in  animals  and  directly  by  the  evaluation  of 
additives  to  prevent  that  they  transfer  AMR  to 
animals,  the  environment,  and  to  humans,  for 
example the denial of authorisation in 2012 of one 
microorganism  as  silage  additive  “Lactobacillus 
pentosus  (DSM  14025)”  and  two  microorganisms 
in  2014  “Pediococcus  pentosaceus 
(NCIMB 
30068)  and  Pediococcus  pentosaceus  (NCIMB 
30044)”.  Those  additives  spread  resistance  to 
antibiotics used in humans. 

3.1.11  Benefits for the 
environment – 
mainly 
qualitative 

X 

X 

186 

from 

  Prevent 

the  occurrence  of  occupational 
the  manipulation  of 
diseases  derived 
additives.  It  was  the  case  of  the  denial  of 
formaldehyde  for  poultry  in  2019.  This  additive 
was carcinogenic for workers. 
Reference:  
ii FA Final Report _FCEC, page 86 
The  environmental  benefits  are  derived  from  the 
risk assessment performed and the labelling rules. 
The  environmental  assessment  performed  for 
additives  used  famed  animals  (food  and  no-food 
producing  animals)  ensures  that  they  do  not  have 
adverse  effects  on  the  environment.  Labelling 
requirements are also important to ensure a proper 

 
 
 
 
 
 
 
 
 
 
 
 
 
use;  for  example,  if  a  maximum  limit  of  an 
additive  is  established  to  prevent  any  adverse 
effect  on  the  environment,  the  indication  of  this 
level on the label will facilitate that operators will 
use the additive properly along the feed chain. 

of 

have 

sourced 

footprint 

addition, 

FA  may 

In 
qualitative 
environmental benefits that may be summarised as 
follows240: 
−  Better use of resources reduces  environmental 
footprint 
products, 
animal 
considering  that more than 50% of the animal 
production 
feed 
ingredients  (Wideman  et  al.,  2012).  Feed 
materials that are generated at local level may 
increase 
the 
indigestible  nutrients  (e.g.,  fibers),  thereby 
increasing  either  their  energy,  amino  acids 
and/or mineral values or by ensuring the level 
necessary  of  essential  additives.  Enzymes, 
amino acids and microorganisms may facilitate 
those actions. 

their  quality  by 

reducing 

related 

to 

is 

−  Modification  of  emissions  that  have  negative 
impact  on  the  environment  thus  reducing 
pollution and mitigate climate change impacts  
There  are  three  main  sources  of  emissions 

from animal production: 

✓  Enteric methane emissions 
✓  Gaseous 

emissions 

from  manure 

240 Environmental performance of FA in livestock supply chains. Guidelines for assessment. FAO 2019. 

187 

storage (ammonia and nitrous oxide) 

 
 
 
✓  Nutrients,  minerals, 

feed 
concentrations 

additive 
the 
in 

metabolites 
manure 

including 

Livestock  systems,  particularly  ruminants, 
contribute to greenhouse gas emissions, and 
particularly in the form of enteric methane. 
A  review  of  mitigation  options  for  enteric 
methane  from  ruminants  showed  some  of 
the  effective 
the 
strategies 
increase forage digestibility for which some 
additives have been proved efficacious. The 
authorisation of a specific additive reducing 
the methane emission in milking cows is an 
this  mitigation  effect  for 
example  of 
reducing the impact on climate change. 
Manure  management,  including  storage, 
handling,  and  field  application  can  be  a 
source  of  emission  of  nitrous  oxide  and 
ammonia. Methane emissions from manure 
accounts  for  12-41%  of  total  agricultural 
countries 
CH4 
(Chadwick  et  al.,  2011)  and  emissions 
depend on the storage duration, temperature 
and manure composition. The modification 
of the physic-chemical characteristics of the 
manure  through  FA  enables  in  particular 
the 
reduction  of  ammonia  and  N2O 
emissions. 
The reduction of pollution: for example, the 
addition  of  phytase  to  feed  results  in  a 
lower  excretion  of  the  phosphorous  in 
reduce 
manure, 
eutrophication  in  waters.  Eutrophication  (a 

contributing 

for  most 

emissions 

to 

188 

 
reduction  in  dissolved  oxygen  in  water 
bodies caused by an increase of mineral and 
increase  algae 
organic  nutrients 
production). 

that 

−  Reduction  of  feed  losses.  Feed  production  is 
one  of  the  most  impacting  aspects  of  animal 
production.  Hence,  it  is  important  to  ensure 
that  the  large  majority  of  the  feed  ingredients 
and feeds produced are delivered to the animal. 
For  this  purpose,  the  use  of  FA  such  as 
antioxidants, 
silage 
preservatives, 
additives  provide  tools  to  reduce  feed  losses 
along  the  feed  chain  and  contribute  to  reduce 
the 
livestock 
production.  Reduction  of  feed  loses  have 
positive  effect  on  the  environment  as  the 
disposal  or  destruction  of  products  may 
require, for example, consumption of energy to 
treat the feed for those purposes.  

environmental 

effect 

and 

of 

to 
the 

3.1  Extend 
which 
cost/benefit 
ratio 
discriminates 
against SMEs 

3.1.12  Costs/benefits 

X 

X 

ratio  for  SMEs 
compared 
to 
costs/benefits 
ratio  for  non-
SMEs. 
Qualitative. 

the 

Reference:  ii  FA  Final  Report  _FCEC,  pages  86-
87 
No  significant  difference  in  terms  of  the  cost: 
benefit  balance  can  be  seen  between  SMEs  and 
non-SMEs.  However, 
required  upfront 
investment (R&D and authorisation costs) is high, 
and  access  to  finance  to  support  this  is  generally 
an issue for smaller companies, when these are not 
part  of  larger  entities.  For  these  reasons,  SMEs  - 
particularly the smaller companies - either tend to 
specialise in a few FA or a few categories/species 
of animals to reduce costs and develop a niche, or 
to  rely  on  generic,  non-holder-specific 
tend 

189 

 
 
 
 
 
 
3.1  Transitional 
measures 
for 
existing 
products  reduce 
the 
administrative 
costs 
labelling 

for 

of 

3.1.13  Number 
additives 
(existing 
products  Article 
10(2) authorized 
compared  with 
number 
of 
additives having 
transitional 
measures 
adapt 
labelling 
requirements 
Ref1 

to 
to 

The 
3.2 
procedure 
for 
placing  new  FA 
the  market 
on 
is 
4) 
(Art 

3.2.1  %  Of  positive 
opinions 
(Costs/benefits 
ratio) 

X 

X 

X 

190 

SAN-
DB; 
FAR 

legitimate  factors 

authorisations  to  save  on  costs.  Therefore,  to  the 
extent  that  SMEs  rely  on  the  non-holder-specific 
authorisations, their drawbacks as a disincentive to 
apply  for  such  authorisation  may  penalise  more 
SMEs 
Reference: ii FA Final Report _FCEC, page 90. 
All  additives  authorised  under  Article  10(2) 
“existing products “have transitional measures  
Beyond  the  risk  assessment  outcome  (EFSA 
opinion  on  safety  and  efficacy  of  the  additive), 
other 
including  social  and 
economic  considerations,  need  to  be  taken  into 
account  by  the  Commission/PAFF  in  the  final 
decision.  This  is  for  example  manifested  in  the 
case  of  reauthorisations  by  the  provision  of 
sufficient 
transitional  periods  for  pre-existing 
products  (under  the  former  legislation),  to  allow 
the market to adapt to a change in the authorisation 
status of an additive. 
According  to  the  Commission,  for  Article  10 
authorisations,  it  can  be  considered  that  100%  of 
the  opinions  take  into  account  legitimate  factors 
such  as  costs,  as  all  opinions  issued  provide 
transitional  periods  for  adaptation  to  the  labelling 
rules.  However,  it  is  difficult  to  evaluate  whether 
legitimate factors are taken into account for Article 
4 authorisations. 
Reference: ii FA Final Report _FCEC, page 53 
Only  12%  of  respondents  find 
the  cost  of 
applications  for  getting  a  feed  additive  authorised 
in the EU market is proportionate to the benefits. 

 
 
 
 
 
 
 
 
 
is 

the 
for 

The 
for 
an 

considered 
efficient 
3.2 
procedure 
renewing 
authorisation 
(Art 
14) 
considered 
efficient 
3.2  Majority  of 
stakeholders 
consider 
procedure 
authorisation 
(article  4)  does 
not  need  to  be 
modified 
significantly 
3.2 
different 
deadlines 
foreseen  by  the 
Regulation 
in 
the 
authorisation 
process 
proportionate  
3.2 
deadlines 
applied 
in 
practice  (Art  4) 
not 
do 
significantly 

The 

The 

are 

3.2.2  %  Of  positive 
opinions 
(Costs/benefits 
ratio) 

X 

X 

X 

66% of FeBOs stakeholders 
ix  Accompanying  document:  survey  and  PC 
results page 56 

3.2.3  %  Of  positive 
opinions 

X  X 

X 

X 

68% NCAs 
32% of FeBOs stakeholders 
ix  Accompanying  document:  survey  and  PC 
results pages 56 and 60 

3.2.4  %  Of  positive 
opinions 

X  X 

X 

X 

74% NCAs 
67% of FeBOs stakeholders 
ix  Accompanying  document:  survey  and  PC 
results page 56 and 60 

3.2.5  Time 

from 
to 

application 
authorisation 
(average,  min) 
(Ref 2)  

SAN-
DB 

Although  the  minimum  period  involved  has  been 
significantly  lower  in  some  cases  (minimum  224 
days),  the  average  period  across  all  applications 
during 2004-17 has been 3.3 years (1,218 days)  
Reference: ii FA Final Report _FCEC, page 91 

191 

 
 
 
 
 
 
 
 
 
 
 
 
 
The 
to 
an 

deviate from the 
legal deadlines 
3.2 
procedure 
modify 
authorisation 
when 
authorisation 
holder  changes 
imply 
do  not 
too 
much 
burden. 

the 

3.2.6  Number 

of 

FAR 

of 

Regulations 
adopted/ 
number 
authorisations 
granted 
to 
authorisation 
holder (Ref. 2) 

linked 
an 

3.2.7  Balance of costs 
vs  benefits  for 
authorisation 
holder(s)  

on 
of 

Based 
analysis 
previous 
indicators. 

192 

482 period 2004-2017 
28 period 2004-2017 
Reference: ii FA Final Report _FCEC pages 108 
For the number of Regulations, the data elaborated 
by the Commission on the basis of the publication 
in the Official Journal (EURLEX) 

in  specific 

  The  ROI 

the  authorisation  process, 

The  cost:  benefit  balance  for  applicants  (i.e.,  the 
return  on  their  investment,  ROI)  depends  on  the 
its 
efficiency  of 
outcome,  and  the  market  significance  of  the  feed 
additive  i.e.,  expected  sales  over  the  10-year 
is  particularly  high  for 
period. 
companies  specialising 
‘flagship’ 
products  that  account  for  a  significant  share  of  a 
company’s  sales.  However,  in  the  case  of  non-
holder-specific  authorisations  there  are  definite 
drawbacks for applicants as a ‘free-rider’ effect is 
observed, whereby other companies, not incurring 
the 
authorisation  costs,  can  benefit 
authorisation.  
The  costs  of  authorisation/labelling  and 
the 
Regulation’s  overall  cost:  benefit  balance  is  not 
significantly  different  between  SMEs  and  large 
companies  as  the  underlying  factors  determining 
costs tend to be independent of company size. 
Reference: ii FA Final Report _FCEC, page 90 

from 

 
 
 
 
 
 
 
 
 
 
 
 
 
Primary sources 
Surveys 
Interviews 
Case studies 
SANTE request to MS, EURL 
and EFSA  

Yes  
Yes  
Yes  
Yes 

Secondary sources 

1.  Company data 
2.  SANTE data base 
3.  SANTE internal assessment 
4.  RM associates Report 
5.  FA Register 

Methods for analysis  
-  Mapping of benefits and costs arising from the Regulation (Direct costs, enforcement costs, indirect costs) by type of stakeh older (cf toolbox 

N°58) including public authorities (EU and national).  

-  Assessment of compliance costs, administrative burden, implementation/enforcement costs (cf toolbox N°59) 
Approach to answering the evaluation question and potential limitations 
Costs and benefits will be identified and  described, and their importance will be assessed over period 2014-2017. Two main areas of costs for 
FA FeBOs have already been identified: authorisation/re-authorisation process and labelling; the areas of major cost stemming from these have 
been identified in the inception report. The assessment of costs will mainly be based on quantitative criteria, following  the methodology set out 
in the inception report; the assessment of benefits will mainly be based on qualitative criteria. Costs arising from the Regu lation will be put in 
perspective with the economic benefits from the sales of FA.  

Evaluation criterion: Coherence – EQ4 

Legislation concerned: 
Regulation on feed hygiene (R. (EC) No 183/2005)  
Legislation on undesirable substances (D. 2002/32/EC) 
Regulation on feed marketing and use (R. (EC) No 767/2009)  
The Catalogue of Feed Materials (R. (EU) No 68/2013)  
Regulation on genetically modified food and feed (R. (EC) No 1829/2003)  
Legislation on medicated feed (D. 90/167/EEC). 

193 

 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

X 

X 

tba  X 

of 

Identification 
contradictory 
requirements/measures  –  if 
any 
-  between  EC  No 
1831/2003  and  EC  No 
and  EU  No 
767/2009 
68/2013, 
including 
inconsistency  of  definitions 
or key terms left undefined 

4.1 

of 

Lack 
contradiction 
between 
the 
Regulation  and 
legislation 
EU 
feed 
on 
in 
materials 
general  (EC  No 
and 
767/2009 
EU 
No 
68/2013) 

regulatory 

Several MS competent authorities and manufacturers 
of  FA  and  feed  materials  indicated  the  classification 
of a substance as a feed material or a feed additive as 
one of the biggest challenges posed by the current EU 
regulatory framework for feed. The classification has 
important 
implications  as  FA  must 
undergo  an  authorisation  process  at  EU  level  to 
assess their safety and efficacy, whilst feed materials 
do  not.  While  specific  EU  guidance  on  how  to 
distinguish  between  feed  materials  and  FA  has  been 
laid down by the Commission.  
MS  and  FeBOs  confront  the  situation  referred  to 
above  regularly  and,  in  some  instances,  request  a 
clarification at EU level 
inconsistencies 
The  views 
deriving  from  the  legal  definitions  of  feed  additive 
and feed material as currently set at EU level, which 
do  not  provide  clear  criteria  to  distinguish  one  from 
the other.  
Reference: ii FA Final Report _FCEC, pages 96 and 
97 

expressed 

indicate 

4.2 

of 

items 
Identification 
placed  on  PAFF  agenda 
regarding 
such 
inconsistencies,  taking  into 
account  whether  and  how 
they have been addressed   

PAFF  For  this  reason,  this  issue  has  been  discussed 
frequently  at 
level  of  SCOFCAH/PAFF 
Committee  with  a  view  to  reaching  a  common 
position  on  specific  products.  In  particular,  the 
analysis of the issues discussed at  SCOFCAH/PAFF 
level  during  the  period  covered  by  the  study  shows 

the 

194 

 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

that  out  of  224  items  that  have  appeared  in  the 
agenda of those committees, the largest number (61) 
concerned the interaction between the FA Regulation 
and  the  Feed  Marketing  Regulation  and  notably  the 
classification of a given substance as a feed additive 
or a feed material. 
Accordingly,  at  EU  level,  specific  provisions  have 
been  adopted  during  the  application  of  the  FA 
Regulation  in  order  to  facilitate  the  differentiation 
between  these  two  feed  product  categories:  these 
include  Commission  Recommendation  2011/25/EU 
and  Commission  Regulation  (EU)  No  892/2010. 
Nonetheless, based on the findings of the study, there 
is still area for improvement in terms of clarity in this 
matter.  
Reference:  ii  FA  Final  Report  _FCEC,  page  97  and 
101 
Overview  Report  of  Audits  Carried  Out  in  Certain 
MS  In  2018-2019  In  Order  to  Evaluate  Official 
Controls  On  FA  Their  Ingredients  And  Traceability 
(DGSANTE  2020-7100).  The  scope  of  this  report 
does  not  cover  inconsistencies  between  the  two 
focus  on  how  MS  were 
Regulations 
and 
controls  on  FA 
implementing  official 
premixtures,  therefore  it  has  not  been  highlighted 
between SANTE auditors. 
The issue is addressed in the SCoPAFF and resolved 
on a case-by-case basis 
Views  expressed  by  consulted  parties  point  to  the 

and 

SAN-
F 

SAN-
F 

4.3 

of 

such 
Identification 
inconsistencies 
as 
highlighted  by  SANTE-F 
auditors, taking into account 
whether  and  how  they  have 
been addressed 

Lack 

of  4.4 

Identification 

of 

X 

X 

X  X 

195 

 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

contradiction 
between 
the 
Regulation  and 
EU 
legislation 
on  labelling  of 
feed  materials 
and  compound 
feed 
(EC  No 
767/2009) 

contradictory 
labelling 
requirements/measures  –  if 
-  between  EC  No 
any 
1831/2003  and  EC  No 
767/2009, 
including 
inconsistency  of  definitions 
or key terms left undefined 

of 

Identification 
items 
placed  on  PAFF  agenda 
such 
regarding 
inconsistencies,  taking  into 
account  whether  and  how 
they have been addressed   
Identification 
inconsistencies 

such 
as 

of 

4.5 

4.6 

existence of one major inconsistency.  
Several  NCA  and  manufacturers  of  FA  and  feed 
materials  identified  an  overall  lack  of  alignment  of 
labelling  requirements  under  the  two  frameworks 
(notably, article 16 of the FA Regulation as opposed 
to Articles 11-23 of the Feed Marketing Regulation): 
•  The  FA  Regulation  only  allows  provision  of 
information  on the packaging  of  FA, while the  Feed 
Marketing  Regulation  also  foresees  the  use  of 
modern  communication  (e.g.,  internet-based)  tools 
for  the  labelling  of  feed  materials  and  compound 
feed.   
•  EU legislation on the marketing of feed provides 
for  a  legal  basis  for  the  development  of  Community 
Codes  of  good  labelling  practice,  while  a  similar 
provision is not laid down for FA. 
Reference: ii FA Final Report _FCEC, page 97I 
Tolerances: the FA Regulation tolerances are not set 
into 
up  for  premixtures 
compound 
is 
feed  or 
inconsistency with the Feed Marketing Regulation. 

feed  materials.  This 

incorporated 

that  are 

PAFF  Those  issues  cannot  be  addressed  as  it  requires 
changes in the Regulation of FA to align the labelling 
provisions  to  the  provision  of  the  Feed  Marketing 
Regulation 

SAN-
F 

SAN-
F 

This has not been highlighted as it was not under the 
scope of F audits   

196 

 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

of 

of 

highlighted  by  SANTE-F 
auditors, taking into account 
whether  and  how  they  have 
been addressed 
Identification 
contradictory 
requirements/measures 
between  EC  No  1831/2003 
and  EU  GMO  legislation, 
including  inconsistency  of 
definitions or key terms left 
undefined 
items 
Identification 
placed  on  PAFF  agenda 
regarding 
such 
inconsistencies  taking  into 
account  whether  and  how 
they have been addressed 
Identification  of  as  such 
inconsistencies 
as 
highlighted  by  SANTE-F 
auditors, taking into account 
whether  and  how  they  have 
been addressed 
Identification 
of 
contradictory  requirements/ 
measures  between  EC  No 
1831/2003, EEC 90/167 and 
including 
EC 

2001/82, 

of 

Lack 
contradiction 
between 
the 
Regulation  and 
EU 
legislation 
on GMOs 

4.7 

4.8 

4.9 

of 

Lack 
contradiction 
between 
the 
Regulation  and 
legislation 
EU 

4.10 

X 

X 

tba  X 

Information  collected  during  the  study  did  not 
identify  inconsistencies  between  the  FA  Regulation 
and EU GMO legislation on food and feed. 

Reference:  ii  FA  Final  Report  _FCEC,  pages  99  to 
100 

PAFF  1  item  in  the  agenda  for  a  clarification  of  the  GMO 

feed legislation 

SAN-
F 

SAN-
F 

Not  highlighted  as  there  are  no  inconsistencies  and 
this issue was not under the scope of F audits  

X 

X 

tbc  X 

197 

Views expressed by NCA and industry did not point 
to  any  major  inconsistency  or  contradiction  between 
the  FA  Regulation  and  EU  legislation  on  medicated 
feed and VMPs. 
However,  some  respondents  from  the  FA  industry 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

inconsistency  of  definitions 
or key terms left undefined 

on  medicated 
(EEC 
feed 
and 
90/167) 
VMPs 
(EC 
2001/82) 

4.11 

4.12 

4.13 

of 

Lack 
contradiction 
between 
the 
Regulation  and 
legislation 
EU 

of 

Identification 
items 
placed  on  PAFF  agenda 
regarding 
such 
inconsistencies,  taking  into 
account  whether  and  how 
they have been addressed 

of 

such 
Identification 
inconsistencies 
as 
highlighted  by  SANTE-F 
auditors taking into account 
whether  and  how  they  have 
been addressed 
Identification 
of 
contradictory  requirements/ 
measures  between  EC  No 
EU 
1831/2003 
legislation  on  feed  hygiene 

and 

indicated that further legal clarity would be desirable 
in  relation  to  borderline  cases  with  a  view  to 
determining whether a given substance / product is a 
feed additive or a VMP. According to industry, this is 
because  the  current  notion  of  VMP  as  products 
contributing towards prevention of animal diseases is 
too  vague, not  allowing  to  clearly distinguish VMPs 
from FA with nutritional functions that help maintain 
animals in good health. 
Reference: ii FA Final Report _FCEC, page 100 

PAFF  This issue of zinc, the sole case of inconsistency was 
discussed  several  times  in  the  SCoPAFF  on  the 
occasion  of  the  authorisations  of  different  forms  of 
Zinc  as  FA.  The  problem  for  the  environment  was 
addressed  by  authorising  chelated  forms  that  permit 
better  assimilation  by  the  animals  and  reduce  its 
excretion and by reducing to the maximum the levels 
of Zinc authorised. 
Not highlighted as this issue was not under the scope 
of F audits 

Views  expressed  by  NCA  and  industry  point  to  one 
imports)  and  one 
inconsistency  (in  relation 
difference 
to  exports) 
in  approach  (in  relation 
between the FA Regulation and the EU legislation on 
feed hygiene. 

to 

SAN-
F 

SAN-
F 

X 

X 

tbc  X 

198 

 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

on  feed  hygiene 
and safety 

safety, 

and 
including 
inconsistency  of  definitions 
or key terms left undefined 

INT  CS  LIT  COM 

RESULTS 

interim  measures 

In  particular,  the  inconsistency  pointed  out  by  both 
NCA and industry stakeholders lies with  imports of 
feed,  including  FA,  as  the  lists  of  non-EU  countries 
and  establishments  from  which  import  of  feed  is 
permitted,  pursuant  to  Article  23  of  Feed  Hygiene 
Regulation, have not been established to date. In that 
context, the application of interim measures pursuant 
to  Article  24  of  the  same  Regulation  has  led  to  the 
identification  of  several  difficulties  and  divergences 
in  the implementation  of import requirements  across 
MS241.  The 
that 
establishments must have a representative in the EU. 
the 
This 
establishments 
hygiene 
comply  with 
requirements  at  least  equivalent  to  those  established 
in the EU and must keep a register of products placed 
on  the  EU  market.  Under  the  current  circumstances, 
it is for instance difficult to establish for which feed 
products  –  i.e.,  all  or  only  some  of  them  such  as 
certain  FA  or  premixtures  or  compound  feed 
containing  them  -  a  representative  in  the  EU  is 
required.  In  addition  to  that,  there  is  a  lack  of 
harmonised approach on how to assess the reliability 
of  the  feed  representative’s  declarations  on  the 

representative  must 

lay  down 

ensure 

feed 

that 

241 This emerges from a series of fact-finding missions that the European Commission services have carried out in nine Member States over the period 2015-2016. See, in this respect, 

e.g., DG(SANTE) 2015-7618 Final Report Lithuania, DG (SANTE) 2016-8903 Final Report France and DG (SANTE) 2016-8906 Final Report Spain.  

199 

 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

compliance  of  feed  manufacturing  establishments  in 
non-EU  countries  and  as  regards  the  guarantees 
needed to support those declarations. 
The  other  major  issue,  perceived  to  constitute  an 
inconsistency from an industry perspective, lies with 
export  rules.  Notably,  while  Article  25  of  the  Feed 
Hygiene  Regulation  allows,  under  the  conditions  set 
out in Article 12 of the General Food Law (GFL), the 
export  to  non-EU  countries  of  FA  and  premixtures 
not authorised to be placed on the EU market (NAFA 
products),  the  FA  Regulation  has  no  provisions  laid 
down for export. 
Reference: ii FA Final Report _FCEC, pages 98-99 

There  is  no  import  code  for  FA  and  premixtures 
and.  Reference:  Survey  to  NCAs  and  ii  FA  Final 
Report _FCEC, page 46 

PAFF  The  interaction  between  these  two  legal  frameworks 
has  been  discussed  and  clarified  by  the  European 
Commission on a number of occasions (15 times) at 
the level of SCOFCAH/PAFF meetings. 

Imported  FA  and  premix  res  are  subject  to  feed 
operators’ own-checks and to official controls carried 
out by competent authorities on feed importers and/or 
manufacturers  using  imported  feedingstuffs.  MS’ 
competent  authorities  have  different  approaches  on 
how to assess whether an imported feed additive and 

SAN-
F 

SAN-
F 

200 

4.14 

4.15 

of 

Identification 
items 
placed  on  PAFF  agenda 
regarding 
such 
inconsistencies,  taking  into 
account  whether  and  how 
they have been addressed 
such 
Identification 
inconsistencies 
as 
highlighted  by  SANTE-F 
auditors, taking into account 
whether  and  how  they  have 
been addressed 

of 

 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

is 

in 

the  commercial  documentation  accompanying 
it 
(product  specifications,  certificates  of  analyses,  etc.) 
provides  sufficient  guarantees  that  the  imported 
product  satisfies  EU  requirements.  For  example, 
when  carrying  out  documentary  checks,  several  MS 
do  not  check/require  that  the  method  used  for  the 
analysis 
respective 
the  one  mentioned 
Regulation  for  the  authorisation  of  the  feed  additive 
and/or that the laboratory that provides the certificate 
of  analyses  is  accredited  to  ISO/IEC  17025.  Some 
MS  only  accept  certificates  of  analysis  if  the 
laboratory  and/or  the  method  is  accredited,  and  the 
feed  business  operator  can  provide  adequate 
evidence.  Finally,  while  some  MS  limit  the  controls 
on imported additives to checks of the accompanying 
commercial  documents,  others  carry  out  physical 
checks and take samples for analysis. 
In six  of the ten  MS visited, there are relatively  low 
numbers  of  establishments  producing  non-EU 
authorised  FA/premixtures  destined 
third 
countries.  Even  though  EU  legislation  does  not 
expressly  require  feed  business  operators  to  inform 
the  competent  authority  of  this  activity,  when  the 
such 
competent 
establishments  are  approved  and  are  subject  to 
regular  official  controls.  In  one  MS,  the  central 
competent  authorities  stated  that  they  were  aware 
about  such  activities  but  at  the  time  of  the  audit  did 
not  have  a list  of  relevant  operators. However, there 

authorities  know 

about 

for 

it, 

201 

 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

was  an  ongoing  effort 
to  obtain  necessary 
information.  The  audit  teams  noted  that  the  official 
controls  on  relevant  establishments  did  not  always 
verify whether the operator producing  and  exporting 
the  non-EU  authorised  FA/premixtures  established 
that  the  relevant  requirements  had  been  met.  In  one 
MS, the central competent authority had established a 
robust  system  specifically  dedicated  to  controls  on 
operators 
non-EU 
and 
authorised products. The system included inspections 
carried  out  by  joint  teams  from  the  central  and  the 
significantly 
local 
the  official 
strengthening 
controls. 
Reference: 
Overview  report  Official  controls  on  feed  additives, 
their ingredients and traceability points 5.1 and 5.2 

the  effectiveness  of 

authorities, 

competent 

producing 

exporting 

in 

Difference 
interpretations 
made  by  MS 
CAs. 

4.16 

Identification  of  cases  of 
divergent/ 
contradictory 
interpretations  reported  by 
stakeholders / MS CAs. 

X 

X 

X 

202 

PAFF  Control of imports of  FA is not a harmonised at EU 
level  and  trigger  different  interpretations  by  MS  on 
how to control importers. 
Export  of  FA  only  intended  for  export  is  not 
harmonised  at  EU  level  creates  different  systems  to 
control  those  exports.  19  Ms  have  established  a 
system to control those exports. 
Those  issues  need  to  be  addressed  in  the  Feed 
Hygiene Regulation but affects the implementation of 
the FA Regulation. 
in 
The  absence 
premixtures triggers different MS’s interpretations on 

tolerances 

labelling 

for  FA 

 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

those tolerances.  

Impact  of  lack 
of  coherence  in 
EU 
feed 
legislation 

4.17 

Identification  of  cases  in 
contradictions/ 
which 
overlaps/gaps  in  legislation 
at  EU  level  led  to  some 
possible unclarity. 

4.18 

Identification  of  cases  in 
contradictions/ 
which 
overlaps /gaps in legislation 
at EU level led to regulatory 
burden. 

4.19 

Identification  of  cases  in 
which 
contradictions/overlaps/gaps 
in  legislation  at  EU  level 
create 
to 
achieving  the  objectives  of 
EC No 1831/2003. 

obstacles 

SAN-
F 

SAN-
F 

X 

203 

PAFF  While  most  issues  deriving  from  diverging  national 
interpretations  have  been  addressed  following  their 
identification, there are areas in which differences in 
interpretation and approaches across MS persist. This 
is mostly due to the absence of fully harmonised EU 
rules  in  commonly  acknowledged  complex  areas 
(e.g.,  export  of  non-authorised  FA 
to  non-EU 
countries and feed import requirements). These issues 
have  been  discussed  under  EQ1.4  (with  reference  to 
import  controls)  and  EQ2.2  (exports  of  NAFA 
products) 
Reference ii FA Final Report _FCEC, page 101. 
The  obligation  in  the  FA  Regulation  to  indicate  all 
the  labelling  information  in  the  physical  label  while 
in  the  case  of  feed  materials  and  compound  feed 
some  information  can  be  conveyed  by  other  means 
created a burden for FeBOs of FA. 
The  absence 
in 
premixtures  created  a  certain  burden  as  operators 
must adapt the labels to the particular requirements of 
MS 
The  issues  indicated  in  4.17  create  obstacle  in  full 
achievement of the objectives.  

PAFF 
REFT 

tolerances 

labelling 

for  FA 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 

NCA 

SV 

SV 

INT  CS  LIT  COM 

RESULTS 

Based  on  analysis  of 
previous indicators. 

Primary sources 
Surveys 
Interviews 
Case studies 

Yes 
Yes 
Yes (tbc) 

Secondary sources 

1.  All relevant EU legislation. 
2.  PAFF minute 
3.  SANTE F Audit reports242  
4.  Stakeholder survey 
5.  Documentary research 

Intervention logic analysis. 

Methods for analysis  
-  Mapping of legislation. 
-  Stakeholder consultation analysis 
- 
Approach to answering the evaluation question and potential limitations 
The  analysis  should  focus  on  the  following  aspects  of  1831/2003:  scope,  definitions,  authorisation  procedure  (risk  assessment   and  risk 
management), and labelling. It should  seek to determine in particular whether current EU feed legislation provides a clear distinction between 
different  feed  products  which  allows  the  appropriate  legal  regimes  to  be  applied,  and  whether  there  are  any  definitions  missi ng,  whether  any 
additional  feed  hygiene  requirements  are  necessary  to  ensure  the  safety  of  FA,  whether  labelling  provisions  ensure  the  information  needs  of 
stakeholders  throughout  the  feed  additive  chain,  and  whether  the  list  of  undesirable  substances  in  D.  2002/32/EC  is  fit  for  p urpose  and 
sufficiently  comprehensive.  Experience  of  national  authorities  and  industry  stakeholders  should  be  taken  into  account  through out.  Cases  of 
incoherence should be identified and described, and their causes and effects carefully analysed.  
Issues relating directly to thematic case studies (such as coherence of labelling provisions) will be directly addressed thro ugh the case studies. 
Other issues will not be directly addressed, but it is expected that some findings will nonetheless be identi fied. 

242 The SANTE-F audit reports to be analysed are those relevant time wise for the specific act being considered, e.g., audits as of 2010 for Reg. (EC) 767/2009 and as of 2013 for Reg. (EU) 68/2013.    

204 

 
 
 
 
 
 
 
 
Evaluation criterion: Coherence – EQ5 

Evaluation question 5: 
To  what  extent  are  the  provisions  of  the  Regulation  consistent  with  other  related  legislation  on  food  and  chemicals  allowing  for 
consistent assessment and management of  risk  (General  Food Law, Regulation on  classification,  labelling  and packaging of  subs tances 
and mixtures (CLP) and Regulation on Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH))?  What ar e the 
consequences of incoherencies, if any? 
5.1 Are there loopholes or grey zones to be addressed? How does this impact competitivity? 
5.2 Are there overlaps or inconsistencies which hinder effective and efficient application of the regulation? 
Legislation concerned – relevant provisions of: 
General Food Law (R. (EC) No 178/2002)  
CLP Regulation on classification, labelling and packaging of chemicals (R. (EC) No 1272/2008)  
REACH Regulation on the registration, evaluation, authorisation and restriction of chemicals (R.  (EC) No 1907/2006)   
The provisions on worker/user safety (D. 89/686/EEC; D. 89/391/EEC; D. 98/24/E C; D. 2004/37/EC) 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 
X 

Lack 
contradiction 
inconsistency 
between 
Regulation 
the GFL 

of 
/ 

5.1 

the 
and 

Identification  of  provisions 
(including  definitions,  feed 
and 
safety 
provisions, 
labelling  requirements) 
in 
GFL  that  are  inconsistent 
with  provisions  of  EC  No 
1831/2003  

5.2 

of 

Identification 
items 
placed  on  PAFF  agenda 
such 
regarding 
inconsistencies,  taking  into 

INT  CS  LIT  COM 

RESULTS 

X 

X 

There  is  a  contradiction  between  Article  12  of 
the  GFL  that  allows  for  export  additives  only 
intended for export and the limitations of the FA 
Regulation that only allows circulation from the 
production establishment or a limited circulation 
that does not implies transfer of ownership. 
Reference: ii FA Final Report _FCEC, page 99 
In  addition,  the  concept  of  safety  of  additives 
and premixtures only  intended for export is  not 
clear is not clear  

PAFF  The  implementation  of  Article  12  of  the  GFL 

has been discussed 16 times. 

205 

 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

5.3 

5.4 

5.5 

5.6 

5.7 

Lack of 
contradiction / 
inconsistency 
between the 
Regulation and 
the CLP 

Lack of 

RELEVANT 
INDICATORS 
account  whether  and  how 
they have been addressed 
such 
Identification 
as 
inconsistencies 
highlighted  by  SANTE-F 
auditors, taking into account 
whether  and  how  they  have 
been addressed 

of 

Identification of provisions 
(including definitions, 
notification procedures, and 
labelling requirements) in 
CLP that are inconsistent 
with provisions of EC No 
1831/2003 

Identification of items 
placed on PAFF agenda 
regarding such 
inconsistencies  
Identification of such 
inconsistencies as 
highlighted by SANTE-F 
auditors, taking into account 
whether and how they have 
been addressed 
Identification of provisions 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

SAN-
F 

SAN-
F 

Not reported in Audits 

X 

X 

X 

According to industry stakeholders, as labelling 
requirements regarding user safety or 
environmental risks can be laid down by both 
the CLP Regulation and authorisations of 
individual FA, this has occasionally resulted in 
redundant, different or even conflicting 
provisions243. 
Reference: ii FA Final Report _FCEC, page 104 

PAFF  Not raised  

SAN-
F 

SAN-
F 

Not raised in SANTE AUDITS  

X 

X 

X 

The information collected during the study did 

243 COPA-COGECA, FEFAC, EMFEMA, FEFANA common principles for labelling FA through the supply chain, 2014. 

206 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

contradiction / 
inconsistency 
between the 
Regulation and 
REACH 

RELEVANT 
INDICATORS 
(including definitions, 
notification procedures, and 
labelling requirements) in 
REACH that are 
inconsistent with provisions 
of EC No 1831/2003  

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

not point to the existence of any loopholes or 
grey zones in the interaction between REACH 
Regulation and the FA Regulation, or to any 
other major inconsistency. The study supporting 
the Fitness Check on REACH (EFTEC, 2017) 
and the Commission’s report (EC, 2018a) do not 
point to any issues of contradiction / 
inconsistency with the FA Regulation. No 
specific overlap or inconsistency was raised and 
discussed at the level of SCOFCAH/PAFF 
meetings during the period covered by the study. 

The information collected during the study did 
not point to the existence of any loopholes or 
grey zones in the interaction between REACH 
Regulation and the FA Regulation, or to any 
other major inconsistency. The study supporting 
the Fitness Check on REACH (EFTEC, 2017) 
and the Commission’s report (EC, 2018a) do not 
point to any issues of contradiction / 
inconsistency with the FA Regulation. No 
specific overlap or inconsistency was raised and 
discussed at the level of SCOFCAH/PAFF 
meetings during the period covered by the study. 
Reference: ii FA Final Report _FCEC, page 
102.    

5.8 

Identification of items 
placed on PAFF agenda 
regarding such 
inconsistencies, taking into 
account whether and how 

207 

PAFF  No items  

 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

they have been addressed 
Identification of such 
inconsistencies highlighted 
by SANTE-F auditors, 
taking into account whether 
and how they have been 
addressed 

5.9 

5.10 

Stakeholder perceptions of 
coherence/usefulness of the 
REACH data sheet 

5.11 

Identification of cases of 
divergent/contradictory 
interpretation reported by 
stakeholders. 

Difference in 
interpretations 
made by MS CAs. 

SAN-
F 

SAN-
F 

Not raised  

X 

This is a requirement set up for the application. 
Stakeholders did not raise any issues or 
incoherence on this request to provide the data 
sheet 

X 

X 

X 

PAFF  The authorisation of FA does not usually 

introduce labelling provisions for workers’ 
safety but generally provide for workers’ safety 
requirements to be respected, as conditions of 
use of the authorised additives244. Some MS 
authorities require the introduction of those 
safety requirements on the label. Those labelling 
indications are not harmonised in the different 
MS. In addition, the CLP Regulation, applies 
also to FA and premixtures, thereby introducing 
additional labelling requirements for workers’ 
safety. This introduces complexity on the labels, 
in particular for premixtures. 
Reference: 

244   See also the relevant Occupational Safety and Health legislation and in particular Council Directive of 12 June 1989 on the introduction of measures to encourage improvements in 
the safety and health of workers at work and Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical 
agents at work (89/391/EEC) 

208 

 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

ii FA Final Report _FCEC, page 104 
vi Case studies, page 22, first paragraph 

PAFF  Overlaps between FA Regulation and CLP may 

create some unclarity. Some MS requires to 
label the of FA while other no. 
Different interpretation of the CLP rules in 
combination with the feed additive provisions of 
worker safety. 
 Some MS requires to label FA while other no. 
Different interpretation of the CLP rules in 
combination with the feed additive provisions of 
worker safety. 
Those issues create burden for operators that 
need to change the labels upon request of NCAs 
especially when additives and premixtures 
circulate within different MS that have different 
interpretations. 
Some MS requires to label the of FA while other 
no. 
Different interpretation of the CLP rules in 
combination with the feed additive provisions of 
worker safety. 
This is again the objective improve the 
functioning of the internal market  

Impact of lack of 
coherence in 
legislation 

5.12 

Identification of cases in 
which 
contradictions/overlaps/gaps 
in legislation at EU level led 
to some possible unclarity. 

X  

SAN-
F 

5.13 

Identification of cases in 
which 
contradictions/overlaps/gaps 
in legislation at EU level led 
to regulatory burden. 

Identification of cases in 
which 
contradictions/overlaps/gaps 
in legislation at EU level 
create obstacles to 
achieving the objectives of 
EC No 1831/2003. 

5.14 

 Based on analysis of 
previous indicators. 

X 

REFT 

209 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary sources 
Surveys 
Interviews 
Case studies 

Yes 
Yes 
tbc 

Secondary sources 
-  All relevant EU legislation. 
-  PAFF minutes 
-  SANTE-F Audits reports 
-  Stakeholder survey/ interviews 
-  Documentary research 

Intervention logic analysis. 

Methods for analysis  
-  Mapping of legislation. 
-  Stakeholder consultation analysis. 
- 
Approach to answering the evaluation question and potential limitations 
The  analysis  should  focus  on  the  following  aspects  of  1831/2003:  scope,  definitions,  authorisation  procedure  (risk  assessment   and  risk 
management), and labelling. It should seek to determine in particular whether current EU feed legislation provides a clear di stinction between 
feed products and additives on the one hand, and food and chemical products on the other, especially in cases whe re related substances may be 
involved in their production, which allows the appropriate legal regimes to be applied with certainty, and to prevent loophol es and grey zones 
from arising. It should examine whether there are any definitions missing, and wheth er labelling provisions ensure that the information needs of 
stakeholders throughout the feed additive chain are clearly met. Experience of national authorities and industry stakeholders  should be taken into 
account throughout. Cases of incoherence should be identified and described, and their causes and effects carefully analysed.  

Evaluation criterion: Coherence – EQ6 

Evaluation question 6: 
To what extent are the provisions within the FA legislation internally coherent? What are the consequences of incoherencies, if any? 
Legislation concerned: 
Regulation (EC) No 1831/2003 

210 

 
 
 
 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

X 

X 

X 

Lack of 
internal 
inconsistency 
in the 
Regulation 

6.1 

Identification 
of 
contradictory 
requirements/
measures 
within EC No 
1831/2003  

-  Structure  of  categories  and  functional  groups  FA  can  only  be 
authorised  within  certain  categories  defined  by  the  Regulation. 
The  current  categories  are  not  adequate  for  new  functions  of 
innovative  FA  supporting  sustainable  agriculture  and  having 
positive effects on animal welfare or the environment and there is 
no  flexible  process  to  modify  or  add  such  categories  FA  used  to 
affect favourably animal welfare or the environment may only be 
allocated  within  the  category  ‘zootechnical  additives’.  The  FA 
Regulation  does  not  allow  the  creation  of  other  categories  of 
additives for which the authorisation is issued to a specific holder. 
The  applicant  is  requested  by  EFSA  guidance  to  demonstrate  a 
improvement  of 
zootechnical  effect  of 
performance- increase egg/meat production). However, the actions 
performed  by  these  additives  are  not  related  to  an  increase  of 
performance in animals, but to a specific improvement in the well-
being  of  animals  (e.g.,  reduction  of  stress)  or  positive  effects  on 
the  environment.  This  discrepancy  discourages  applicants  from 
applying  for  those  kinds  of  additives.  Reference:  ii  FA  Final 
Report _FCEC, page 47 las paragraph. 

the  additive  (e.g., 

-No  transitional  period  for  renewal  of  authorisations  if  the 
applicant withdraws the application. The FA Regulation provides 
for  a  procedure  for  the  renewal  of  authorisation  of  FA.  If  the 
application for renewal is presented in due time, the feed additive 
will remain on the market until a decision on the renewal is taken 
by  the  Commission,  provided  that  the  reasons  for  the  possible 
delay  for  granting  the  renewal  of  authorisation  are  beyond  the 

211 

 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

control  of  the  applicant.  It  may  happen  that  the  applicant 
withdraws  the  application  for  renewal  during  the  process.  In  this 
case,  the  additive  is  no  longer  authorised  if  the  original 
authorisation  has  already  expired.  The  FA  Regulation  is  not 
consistent in this regard, as FeBOs must face a “sudden” expiry of 
the  authorisation,  without  any  transitional  period  allowing  an 
adaptation of the products concerned on the market. 
Reference: few discussions at the SCoPAFF. 

-Data  sharing:  The  procedures  have  limited  effect  on  reducing 
animal  testing  because  of  incoherent  rules  on  data  sharing.  Even 
though  the  applicant  needs  to  take  all  measures  to  prevent 
in  case  of 
repetition  of  toxicological 
disagreement between the applicant and the other party (previous 
applicant), the Commission is neither obliged nor has the tools to 
take decision, based on objective parameters  
Reference: PC 

tests  on  vertebrates 

-Drinking  water:  The  definition  of  FA  refers  to  the  use  of  all 
additives  in  drinking  water,  but  Article  6  and  Annex  I  of  the 
Regulation  restrict  the  use  of  FA  in  drinking  water  to  certain 
functional  groups.  Therefore,  internal  coherence  between  the 
provisions  related  to  the  use  of  FA  in  drinking  water  should  be 
assessed.  In  addition,  FeBOs  and  NCAs  have  requested  more 
technical  clarity  on  the  practical  implementation  of  the  use  of 
additives in drinking water. 
Reference: ii FA Final Report _FCEC, pages 77, 108, 109,110 

212 

 
 
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

effective 

-  Environmental  assessment  for  non-food  producing  animals. 
The  safety  criteria  and  data  requirements  introduced  in  the  FA 
comprehensive 
Regulation  were 
ensure 
to 
environmental  assessment.  Nevertheless, 
to 
introduce  some  clarification  regarding  the  environmental  safety 
requirements  applicable  to  farmed  non-food  producing  animals 
(e.g.,  fur  animals)  in  order  to  accommodate  the  requirements 
related to the safety criteria laid down in the FA Regulation. 
Reference: comments DG ENVIRONMENT to the roadmap. 

is  necessary 

it 

a 

-Modification  of  authorisations  not  linked  to  an  authorisation 
holder.   Article  13(3)  only  covers  the  modification  process 
introduced by the holder of an authorisation  but  does not  foresee 
rules  for  requests  for  modifications  of  non-holder  specific 
authorisations. In such cases, a full evaluation is not required, but 
instead  only  a  verification  whether  the  modification  may  rise  a 
safety  concern  or  may  undermine  the  efficacy.  This  situation  has 
been  largely  mitigated  by  using  Article  13(1)  that  permits  the 
Commission  to  modify  any  authorisation  (including  non-holder 
specific authorisations) on its own initiative. The possibility for an 
operator  to  introduce  requests  for  modifications  of  a  non-holder 
specific authorisation should be further examined. 
Recommended levels and maximum recommended levels. There is 
insufficient  clarity  on  how  to  establish  recommended  levels. 
Whilst  for  some  FA  levels  are  established  as  conditions  for 
authorisation,  for  others,  recommended  levels  are  established  on 
the  labelling  provisions.  This  is  due  to  divergent  views  that 
triggered different  discussions over the time. For some  additives, 

X 

X 

X 

6.2 

Internal 
consistency of 
definitions 
used in EC No 
1831/2003, 
and number of 

213 

 
 
  
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

key terms not 
defined within 
the regulation 
itself 

the recommendation is to use “Maximum Recommended Levels”. 
These are limits for the use of FA providing a certain flexibility as 
opposed to  maximum limits,  which are mandatory and should be 
indicated on the label of the premixtures, compound feed and feed 
materials.  Those  maximum  recommended  levels  have  been 
recently set as the labelling provisions for some  FA, for example 
for  flavourings.  The  Feed  Marketing  Regulation  lays  down  the 
obligation to indicate the level used on the label of the compound 
feed/feed  material  if  the  respective  Maximum  Recommended 
Level  has  been  exceeded.  If  this  level  is  not  exceeded,  then  the 
level  used  is  not  required  to  be  indicated  on  the  label  of  the 
premixture, compound feed or feed material.  
Reference:  ii  FA  Final  Report  _FCEC,  page  107.  Discussions  at 
the SCoPAFF (2). 
Definition of preparations: preparations are not defined as such as 
the  introduction  of  such  definition  could  not  be  done  by 
Implementing  Rules  and 
the 
Regulation.  To  mitigate 
this  absence  of  definition,  some 
provisions  on  the  compositional  and  labelling  requirements  were 
introduced in 2015 by Implementing rules. 
Reference: ii FA Final Report _FCEC, page 6, 107, 110, 136 

required  a  modification  of 

214 

 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

Low number 
of gaps 
identified in 
the 
provisions of 
the 
Regulation 

6.3 

Identification 
of gaps in the 
provisions  

Number of 
legal 
complaints 
brought 
against the 
regulation, 
taking into 
account 
whether and 
how they have 
been addressed 
Number of 
audits 
addressing this 
issue, having 
regard to their 
outcome 

Low number 
of legal 
complaints 

6.4 

Few cases in 
which FA 
intended for 
export finds 
their way 
into the EU 

6.5 

X 

X 

X 

X 

X 

X 

There are several gaps identified: 
-No  transitional  period  for  renewal  of  authorisations  if  the 
applicant withdraws the application. 
--Data sharing: no objective parameters to decide on data sharing  
-  No  rules  on  how  to  apply  the  use  of  additives  in  water  for 
drinking 
-  No  rules  for  the  modification  of  authorisation  not  linked  to  an 
authorisation holder. 
-No definition of preparations 
-  No  definition  of  maximum  recommended  levels  or  maximum 
levels. 
No complains  

X 

SAN-
F 

No reference to these issues in the Commission Audits 
There are no precise data on the number of cases in which FA not 
authorised to be placed on the EU market and intended for export 
eventually end up on the EU market. As referred to under EQ1.4, 
the  number  of  RASFF  notifications  concerning  unauthorised  FA 
with  EU  origin  detected  by  MS  is  limited  during  the  period 

215 

 
 
 
 
 
 
 
 
 
 
 
 
ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

JUDGEME
NT 
CRITERIA 

market, in 
spite of lack 
of labelling 

covered by the study. Overall, the type of national measures aimed 
at  controlling  FeBOs  carrying  out  such  export  activities 
significantly vary across MS, taking also into account the number 
of  such  operators  and  the  volumes  produced  on  the  national 
territory. National measures may involve: the granting of specific 
authorisations  for  the  production  and  export  of  unauthorised  FA; 
the  performance  of  controls  (  by  means  of  random  or  risk-based 
routine  checks);  the  provision  of  assurances  by  the  concerned 
FeBOs that products  are properly labelled (e.g. ‘only  for export’, 
‘not  for  use  within  the  EU’);  the  issuance  of  official  export 
certificates by competent authorities or the mandatory notification 
by  FeBOs  of  export  dates  and  respective  quantities  to  such 
authorities. 
Reference: ii FA Final Report _FCEC, page 107-108 
789 flavourings 
Reference:  ii FA Final Report _FCEC, page 106 

X 

X 

FAR; 
SAN-
DB 

FAR 

28 Regulations period 2004-2017 
Reference: ii FA Final Report _FCEC, page 106 

216 

Few cases in 
which FA 
had to be 
withdrawn 
from market, 
because rules 
on use in 
water are not 
applicable to 
all additives 
Low number 
of 
regulations 
had to be 

Number of 
cases in which 
FA had to be 
withdrawn 
from market 
due to rules on 
use in water 

Number of 
regulations 
published 
because the 

6.6 

6.7 

 
 
 
 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

adopted 
because the 
authorisation 
holder had 
changed 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

authorisation 
holder had 
changed 

INT  CS  LIT  COM 

RESULTS 

X 

X 

X 

PAFF  Use  of  additives  in  water  for  drinking:  35  times  discussed  at  the 

Difference in 
interpretation
s made by 
MS CAs 

6.8 

Identification 
of cases of 
divergent/contr
adictory 
interpretation 
reported by 
stakeholders / 
MS CAs. 

Lack of 
significant 
divergences 
between the 
penalties set 

6.9 

Extent to 
which all MS 
foresee 
penalties for 
non-

X 

X 

217 

SCoPAFF 
Preparations: 6 times discussed at the SCoPAFF 
Recommended  levels:  2  times  for  clarification  but  also  in  the 
discussion of many Regulations where those levels are established 
Overall, the  information collected during the study point out  that 
the  provisions  of  the  FA  Regulation  have  given  rise  on  several 
occasions to diverging interpretations between MS. 
Discussions  at  the  level  of  SCOFCAH  /  PAFF  meetings  confirm 
that,  out  of  224  items  concerning  the  FA  Regulation,  102 
concerned,  amongst  others,  issues  stemming  from  diverging 
national  interpretations  over  the  provisions  of  the  Regulation. 
While the majority of issues raised in those committees have been 
addressed over time mainly through the provision of clarifications 
by  the  European  Commission,  adoption  of  amendments  of  the 
Regulation or opinions by EFSA, there are, however, a number of 
issues that have not been solved yet. 
Reference: ii FA Final Report _FCEC, page 108-109 
Sanctions  applied  by  MS  to  infringements  in  the  FA  and 
premixtures  sector  (in  application  of  Article  24  of  the  FA 
Regulation)  are  generally  financial  penalties  with  some  countries 
also foreseeing other administrative penalties. National approaches 
on the type and level of penalties vary to a significant extent. 

 
 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

out at MS 
level for non-
compliance 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

compliance 
with the 
Regulation and 
that the 
penalties 
foreseen vary 
from one MS 
to another. 

 Reference: ii FA Final Report _FCEC, page 109 

Failure to 
update the 
legislation on 
renewal of 
authorisation 
is not 
perceived as 
a major 
problem 

Number of 
additives due 
for renewal in 
next 5 years 

6.10 

SAN-
DB 

218 

to 

the 

reducing 

2017-2021: 65; 2022: 48; 2023: 32; and 2024: 56 
Against  this  background,  views  over  the  need  to  update  EU 
legislation  on  the  renewal  of  the  10-year  authorisation  for  FA 
slightly varies across consulted parties. Overall, FA manufacturers 
are  generally  more  inclined  towards  the  update  of  such  a 
legislation  with  a  view 
regulatory  and 
administrative burden on all parties involved (applicant, European 
Commission,  MS  and  EFSA).  A  few  MS  also  share  this  view. 
From  an  industry  perspective,  for  certain  FA  (e.g.,  those  used  in 
food  production  or  with  a  long  history  of  safe  use  in  animal 
nutrition)  the  requirement  of  the  renewal  does  not  appear  to  be 
fully risk-based. Also, in certain cases, the renewal procedure may 
create some uncertainty and unpredictability for the feed chain on 
the  availability  of  FA,  since  there  is  no  obligation  for  former 
applicant(s)  to  submit  an  application  for  renewal  in  the  case  of 
generic  authorisations.  Any  person  that  places  on  the  market  the 
additive may present an application for renewal but not necessarily 
the  former  applicant.  This  is  not  the  case  for  holder  specific 
authorisations  for  which  the  request  of  renewal  should  be 
submitted by the former applicant or his successor.  

 
 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

X 

X 

X 

6.11 

% Of 
positive/negati
ve opinions 
expressed by 
CAs of Ms and 
FeBOs on 
current 
procedure 

Impact of 
lack of 
coherence in 
legislation 

6.12 

Identification 
of cases in 
which 
inconsistency 
in the 
provisions of 
EC No 
1831/2003 led 
to some 
unclarity 

X 

SAN-
F 

219 

Reference: SANTE DATABASE 
Reference: ii FA Final Report _FCEC, page 109 
A majority of FeBOs (29 out of 110) does not consider that the 10-
year authorisation promote innovation. 
Opinions on the 10-year authorisation period are more varied. Key 
comments provided by the MS authorities who disagreed or did 
not provide a definite answer include that a 10-year authorisation 
can be too short to encourage innovation, particularly for smaller 
companies. For FA of lower risk, a period of 20 years could be 
more appropriate. For FA of higher risk (coccidiostats), the current 
10-year period is generally appropriate. The 10-year authorisation 
period was perceived as effective for safety purposes by a slight 
majority of MS authorities (17 out of 27). Six MS authorities did 
not respond and 4 disagree (NCA survey). 

PAFF  The following issues are identified: 

-No transitional period for renewal of authorisations if the 
applicant withdraws the application. 
--Data sharing: no objective parameters to decide on data sharing  
- No rules on how to apply the use of additives in water for 
drinking. No clear framework to determine which additives can be 
used in water for drinking 
- No rules for the modification of authorisation not linked to an 
authorisation holder. 
-No definition of preparations 
- No definition of maximum recommended levels or maximum 
levels 
-Structure of categories and functional groups not consistent 
Environmental assessment of non-food producing animals 

 
 
 
 
 
 
 
 
JUDGEME
NT 
CRITERIA 

ID 

RELEVANT 
INDICATOR
S 

SH 
SV 

NC
A 
SV 

INT  CS  LIT  COM 

RESULTS 

6.13 

6.14 

Identification 
of cases in 
which 
inconsistency 
in the 
provisions of 
Regulation 
(EC) No 
1831/2003 led 
to regulatory 
burden. 
Number (and 
identity) of 
cases in which 
inconsistency 
in the 
provisions of 
EC No 
1831/2003 led 
to obstacles to 
achieving the 
objectives of 
EC No 
1831/2003. 
Based on 
analysis of 
previous 
indicators. 

X 

The following issues are identified: 
-No transitional period for renewal of authorisations if the 
applicant withdraws the application. 
- No rules on how to apply the use of additives in water for 
drinking. No clear framework to determine which additives can be 
used in water for drinking 
- No definition of preparations 
- No definition of maximum recommended levels or maximum 
levels 

All the issues identified in this point 6 led to reduce the 
functioning of the internal market and create a certain burden 

220 

 
 
 
 
 
 
 
 
 
 
 
 
 
Primary sources 
Surveys 
Interviews 
Case studies  

Yes 
Yes 
tbc 

Secondary sources 
-  All relevant EU legislation. 
-  PAFF minutes 
-  SANTE-F Audits reports 
-  Stakeholder survey/ interviews 
-  Documentary research 

Intervention logic analysis. 

Methods for analysis  
-  Mapping of legislation. 
-  Stakeholder consultation analysis. 
- 
Approach to answering the evaluation question and potential limitations 
The  analysis  should  focus  on  the  internal  consistency,  without  regard  to  the  wider  legislative  context,  of  R.  1831/2003,  and  in  particular  its 
scope,  definitions,  authorisation  procedure  (risk  assessment  and  risk  management),  and  labelling.  In  addition,  it   should  seek  to  determine 
whether the Regulation provides a list of current functions and functional groups of  FA that still reflect the state of play of the market and of 
technological  progress  with  regard  to  FA;  whether  current  distinctions  for  use  in  water  between  different  categories  of  FA  are  still  justified; 
whether current distinctions between general and specific labelling requirements for  FA are still justified; and whether the current list of FA that 
may be covered by holder-specific authorisations is still justified. Experience of national authorities and industry stakeholders should be taken 
into account throughout. Cases of incoherence should be identified and described, and their causes and effects carefully anal ysed. 

Evaluation criterion: relevance – EQ7 (EQ8 → EQ7.1) 

Evaluation question 7:  
To what extent are the needs/objectives identified at the time of the drafting of Regulation (EC) No 1831/2003 still relevant ? Are there any new 
needs/objectives which have emerged since the original drafting of the Regulation, and (if any new needs/objectives exist) to what extent is the 
Regulation suitable for tackling these? 

RESPONSE 
Do the original objectives of the FA Regulation still correspond to the EU’s current needs/problems? 

221 

 
 
 
 
 
 
 
 
 
 
 
 
 
7.1 To what extent is the Regulation suitable for addressing the current needs of fight against antimicrobial resistance, susta inable livestock 
production, animal welfare, protection of the environment? 
Legislation concerned 
Regulation (EC) No 1831/2003 
Directive 70/524/EEC 

Judgement criteria 

ID 

Relevant 
indicators 

SH 

sv 

X 

NCA 
sv 

Int  CS  Lit  COM 

X 

X 

Relevance of the reduction of 
AMR threats to citizens, 
animals and the environment   

7.1 

Number of 
positive 
responses 

Relevance of the 
simplification of the feed 
additive authorisation process 
in comparison to the previous 
process under the directive 

7.2 

Number of 
positive 
responses 

Relevance of ensuring the 
safety of FA for human health, 
animal health and the 
environment (overarching 
need). 

7.3 

Number of 
positive 
responses 

X 

X 

X 

X 

X 

X 

222 

104 respondents out of 111- .SH SURVEY (vii 
Consultation Synopsis Report, page 15) 
26 NCA out of 27-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 60)  
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
91%- .SH SURVEY (vii Consultation Synopsis 
Report, page 15) 
24 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 60) 
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
106 respondents out of 110- .SH SURVEY (vii 
Consultation Synopsis Report, page 15) 
26 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 60)  
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Judgement criteria 

ID 

Relevant 
indicators 

SH 

sv 

X 

NCA 
sv 

Int  CS  Lit  COM 

X 

X 

Relevance of the rigorous risk 
assessment of FA (specific 
objective) 

7.4 

Number of 
positive 
responses 

Relevance of ensuring the 
traceability of FA (specific 
objective) 

7.5 

Number of 
positive 
responses 

Relevance of clear rules for 
authorisation and labelling 
(specific objective) 

7.6 

Number of 
positive 
responses 

Relevance of addressing 
specific interests of pet owners 
and their animals (specific 
objective) 

Relevance of facilitating the 
placing on the market of FA 
that are safe, innovative and 
efficacious  

7.7 

7.8 

Number of 
positive 
responses 

Number of 
positive 
responses 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

223 

88%- .SH SURVEY (vii Consultation Synopsis 
Report, page 15) 
26 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 60)  
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
 93%- .SH SURVEY (vii Consultation Synopsis 
Report, page 15) 
25 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 60) 
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
97% (vii Consultation Synopsis Report page 15) 
24 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 61). 
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
63%SH SURVEY (vii Consultation Synopsis 
Report page 15) 
23 NCA out of 26-NCA SURVEY (ix 
Accompanying document: survey and PC results, 
page 61) 
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
103 out of 107 SH SURVEY (vii Consultation 
Synopsis Report page 15) 
26 out of 26 -NCA SURVEY (ix Accompanying 
document: survey and PC results, page 61) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Judgement criteria 

ID 

Relevant 
indicators 

SH 

sv 

NCA 
sv 

Int  CS  Lit  COM 

Relevance of ensuring FA 
cannot mislead consumers on 
the quality of food 

7.9 

Number of 
positive 
responses 

X 

X 

X 

X 

X 

X 

New needs / objectives which 
emerged since the drafting of 
the Regulation  

7.10 

Additional 
needs / 
objectives 
identified. 

224 

Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
61% (vii Consultation Synopsis Report page 15) 
22 out of 26 -NCA SURVEY (ix Accompanying 
document: survey and PC results, page 61) 
Other Reference: ii FA Final Report _FCEC, 
pages 111-114 
At  the  same  time,  a  majority  of  respondents  (75 
out of 112) identify new needs/objectives for the 
EU  feed  additive  legislation,  which  emerged 
since the Regulation was adopted. An analysis of 
the  identified  needs  was  performed  to  classify 
them  by  broad  theme  and  the  extent  to  which 
stakeholders considered these needs to be fulfilled 
(vii Consultation Synopsis Report page 15) 
The  so-called  “new”  needs  identified  by  the 
highest  number  of  consulted  parties  are  issues 
related  to  the  authorisation  process;  need  to 
consider  environmental  aspects  and  promote  the 
sustainable  use  of  additives  and  sustainable 
farming/food production; need to consider animal 
welfare  aspects;  need  to  promote  innovation  (in 
terms  of  speeding  up 
introduction  of 
innovative  FA  and/or  feed  additive  production 
processes).  Since  most  survey  respondents  are 
directly  linked  with  the  FA  industry,  a  separate 
analysis  focused  on  the  “new”  needs  highlighted 
by 
two  most  significant  categories  of 
respondents  not  directly  linked  with  it,  i.e., 
manufacturers  of  compound  feed  that  use  FA; 
organisations/consultancies  that  complete/assist 

the 

the 

 
 
 
 
 
 
 
 
 
 
Judgement criteria 

ID 

Relevant 
indicators 

SH 

sv 

NCA 
sv 

Int  CS  Lit  COM 

7.11 

Extent to which 
additional 
needs/objectives 
are met by the 
regulation 

X 

X 

X 

225 

and 

sustainable 

clients  with  applications  for  authorisation  of  FA. 
The  “new”  needs  identified  by  manufacturers  of 
compound  feed  are  (in  decreasing  order  of 
prevalence):  i)  consideration  of  environmental 
aspects; 
ii)  consideration  of  animal  welfare 
aspects;  iii)  promotion  of  the  sustainable  use  of 
resources 
farming/food 
production.  By  contrast,  not  clearly  prevailing 
“new”  needs  could  be  identified  among  those 
highlighted  by  organisations/consultancies  that 
complete/assist  clients  with  applications  for 
authorisation of FA. 
Other  Reference:  ii  FA  Final  Report  _FCEC, 
pages 115-117 
As  explained,  only  some  of  the  “new”  needs 
identified by stakeholders were not considered in 
the original FA Regulation: in the first place, the 
need  to  consider  sustainability  aspects  in  the 
development,  approval  and  use  of  FA.  By 
contrast,  some  of  the  “new”  issues  in  the 
authorisation process were already considered (at 
least in part) in the FA Regulation; the same can 
be  said  for  environmental  and  animal  welfare 
aspects, as well as for the development of new FA 
as  a  result  of  scientific  and 
technological 
progress.  With  regard  to  this  group  of  “new” 
needs,  they  generally  refer  more  to  further 
improving the relevance, effectiveness, efficiency 
or coherence of the FA Regulation, than to taking 
into account needs that were not considered at the 
time of drafting. 

 
 
 
 
 
Judgement criteria 

ID 

Relevant 
indicators 

SH 

sv 

NCA 
sv 

Int  CS  Lit  COM 

Reference: ii FA Final Report _FCEC, pages 115-
117 

Primary sources 
Surveys 
Interviews 

Yes 
Yes 

Secondary sources 

Methods for analysis  

-  Mapping of legislation. 
-  Stakeholder consultation analysis. 
- 

Intervention logic analysis. 

Approach to answering the evaluation question and potential limitations 
The  relevance    looks  at  the  relationship  between  the  needs  and  problems    of  the  FA  sector  and  society  and  the  objectives  of  the  intervention 
(reduce  AMR,  harmonise  the  authorisation  procedure,  ensure  rigorous  assessment,  with  particular  attention  to  the  environment,  set  up  clear 
labelling rules, improve control and enforcement, address specific interests of pet owners and pets, increase transparency,   ensure  technological 
and scientific progress (innovation) and not mislead the consumers). This question seeks to clarify: (1) to what extent are ori ginal objectives still 
relevant; and (2) are there any new objectives.  
This  exercise  is  somewhat  subjective  and  dependent  on  the  opinions  of  all  different  stakeholders.  Based  on  their  experience,  the  perception  of 
national authorities and stakeholders along the supply chain will therefore form the basis of the analysis of this EQ. For an y new needs/objectives 
identified, explanation and justification will be sought.  

Evaluation criterion: relevance – EQ8 

Evaluation question 9:  
To what extent has the Regulation provided for the possibility and/or flexibility for adaptation to technical and scientific  progress, to 
minimise administrative burden or to adapt to new issues or necessities since the adoption of the Regulation? 

226 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.1 Are the definitions, procedures and criteria in the feed additive Regulation still clear and relevant in the light of scientific and technical developments, 
in the light of present needs of livestock production and pets?  
8.2 What conclusions may be drawn from the experience so far concerning the re-authorisation process?  
8.3 Is the provision for a '10-year authorisation period' considered to be still adequate?  
8.4 Have there been new issues/developments since the adoption of the Regulation that are not properly addressed by the Regulation (e.g., role of EURL, 
export of non-authorised FA, etc.)?  
8.5 Are there any provisions, which create too much administrative burden?  
Legislation concerned 
Regulation (EC) No 1831/2003 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

X  X 

X 

of 

 A  majority 
stakeholders 
perceive 
the 
definitions  to  be  in 
line  with  current 
state  of  scientific 
and 
technical 
progress 

8.1.2 

High 
score  of 
positive opinions 

In  particular,  respondents  are  divided  on  whether 
the 
definitions in  the  Regulation  are in  line with  the current  state 
of scientific and technical progress, with a slight majority (44 
out  of  108)  finding  them  not  to  be  (compared  to  39  that 
consider them to be). (vii Consultation Synopsis Report, page 
16) 
23  out  of  27  ix  Accompanying  document:  survey  and  PC 
results, page 61) 
The  Regulation  is  considered  by  most  NCAs  sufficiently 
suitable  in  its  current  form  to  address  scientific  and  technical 
progress. The aspect on which some concern was expressed by 
few  NCAs  was  whether  the  definitions  in  the  Regulation  (3 
NCAs) and criteria used for authorisation of FA (2 NCAs) are 
in  line  with  the  current  state  of  scientific  and  technical 
progress  (while 6 and 3  NCAs respectively  did  not  provide  a 
definite answer). Key comments provided by those NCAs that 
disagreed or did not provide a definite answer are:  
Definitions:  updating  the  definitions  in  the  Regulation  to 
update  reference  to  old  legislation,  align  with  other  recently 

227 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

X  X 

X 

8.1.3 

 High  score  of 
positive opinions 

revised  legislation  (e.g.,  Regulation  No.2019/6  on  veterinary 
medicinal products) and with scientific and technical progress; 
clarifying  definitions 
to  better  distinguish  between  FA, 
premixtures,  feed  material,  processing  aids  and  veterinary 
medicines;  and,  adding  a  definition  for  preparations  vii 
Consultation Synopsis Report, page 22) 
Other Reference: ii FA Final Report _FCEC, pages 119 
Similarly, a majority (45 out of 107) consider the authorisation 
procedure to be not suitable to address scientific and technical 
developments  for  pets  and  livestock  production,  due  to  the 
time  periods  incurred  (compared  to  34  that  consider  it 
suitable);  and,  in  the  light  of  scientific  and  technological 
developments, the criteria used for authorisation of FA are not 
considered  still  relevant  by  28  out  of  44  respondents 
(compared  to  13  that  consider  them  still  relevant).  SH-
SURVEY. (vii Consultation Synopsis Report, page 11) 
28  out  of  29  NCA  –NCA  SURVEY  (ix  Accompanying 
document: survey and PC results, page 61) 
In  the  views  of  business  stakeholders,  several  limitations 
hamper  the  FA  Regulation’s  possibility  and/or  flexibility  to 
adapt  to  technical  and  scientific  progress.  These  limitations 
would mainly derive from: i) lack of clarity/precision in some 
of the definitions provided by the FA Regulation, plus missing 
definitions for some key concepts (as discussed in EQ4 to 6); 
ii)  the  difficulties  and  the  long  time  needed  for  creating  new 
functional  groups  to  respond  to  emerging  needs,  as  well  as 
slow  adaptation  of  authorisation  criteria  vis-à-vis  rapid 
evolution of technical progress and scientific developments in 
the  field  of  animal  nutrition  (as  discussed  in  EQ1.4  and 
EQ2.1);  and,  iii)  lack  of  flexibility  in  the  reauthorisation 
process.  These  limitations  are  generally  not  identified  by  the 

228 

of 

the 

 A  majority 
stakeholders 
perceive 
authorisation 
to  be 
procedure 
suitable  to  address 
scientific 
and 
technical 
for 
developments 
pets  and  livestock 
production 

 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

reduction  were  put 

consulted  NCAs.  Also,  the  available  evidence  suggests  that 
innovation  in  new  types  of  FA  (e.g.,  zootechnical  category) 
takes place (EQ1.4 and EQ2.1). 
A  clear  majority  of  both  NCAs  and  (especially)  business 
stakeholders  perceive  that  the  administrative  burden  deriving 
from  the FA Regulation  can be reduced. Specific suggestions 
for  burden 
forward  by  business 
stakeholders:  i)  tailoring  the  duration  of  authorisation  periods 
to  the  safety  profile  of  functional  groups/individual  products; 
ii)  not  requiring  or  streamlining/fast  tracking  the  renewal  of 
authorisations  for  FA  with  a  low  risk  profile;  iii)  providing 
information through other media than physical labels, such as 
electronically 
labels.  A  majority  of  business 
stakeholders perceive that the burden of the new safety-related 
and  efficacy-related  requirements  for  reauthorisation  is  not 
proportionate 
largely 
considered  it  to  be  proportionate.  These,  and  some  other 
identified  opportunities  for  burden  reduction,  are  also 
discussed under EQ3.2 (ii FA Final Report _FCEC, page 128). 
In  the  light  of  scientific  and  technological  developments,  the 
criteria  used  for  authorisation  of  FA  are  not  considered  still 
relevant  by  28  out  of  44  respondents  (compared  to  13  that 
consider  them  still  relevant).  SH-SURVEY.  (vii  Consultation 
Synopsis Report, page 16). 
26  out  of  27  NCA  –NCA  SURVEY  (ix  Accompanying 
document: survey and PC results, page 61) 

the  benefits,  although  NCAs 

readable 

to 

8.1.4  High 

score  of 
positive opinions 

X  X 

X 

of 

A  majority 
stakeholders 
perceive the criteria 
for  authorisation  of 
FA  as  still  relevant 
light  of 
in 
and 
scientific 
technical 
developments 

the 

A  majority 
stakeholders 

of 

8.2.1 

score  of 
High 
positive opinions 

X  X 

X 

Of those that have applied for re-valuation under Article 10.2 
(41  respondents),  a  majority  agree  that  the  re-evaluation 

229 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

the 

that 

JUDGEMENT 
CRITERIA 
consider 
re-evaluation 
(Article 
2) 
10 
process  has  helped 
future 
adapt 
of 
renewal 
authorisations 
to 
new requirements 

process  has  helped  adapt  the  future  renewal  of  authorisations 
to  new  requirements  (25)  SH-SURVEY.  (vii  Consultation 
Synopsis Report, page 11). 
MS also appear overall satisfied with the re-evaluation process 
(Article  10.2).  In  particular,  the  process  has  helped  adapt  the 
future  renewal  of  authorisations  to  new  requirements  (21 
NCAs).  NCA  SURVEY.  (vii  Consultation  Synopsis  Report, 
page 20). 
A clear majority of the consulted parties (NCAs and business 
stakeholders;) agree that the reauthorisation process has helped 
adapt future renewal of authorisations to new requirements for 
the  presentation  of  the  dossiers  (operators  gained  experience 
on  how  to  prepare  the  dossiers  for  applications  and  how  to 
adapt  to  changes  in  the  requirements  during  the  evaluation 
when  new  guidance  are  adopted  as  a  result  of  scientific 
progress).  Although  no  NCA  expressed  a  negative  judgment 
on 
judgment  among  business 
stakeholders, despite being also positive, was less favourable. 
Some  business  stakeholders  reported  issues  deriving  from 
changes  to  requirements  (especially  for  what  concerns  set  up 
of trials and quality of data, e.g. to provide full composition of 
a botanical extract instead of partial composition or provide a 
specific  test  on  mutagenicity  that  was  not  requested  before) 
introduced  by  EFSA  guidance  documents  published  in  2012 
and  2018  :  those  changes  in  requirements  also  applied  to 
reauthorisation  dossiers  as  they  were  progressively  entering 
into the assessment process (ii FA Final Report _FCEC, page 
120). 
Of those that have applied for re-valuation under Article 10.2 
(41  respondents),  a  majority  agree  that  the  re-evaluation 
process  has  provided  applicants  with  enough  flexibility  to 

the  matter, 

the  overall 

A  majority 
stakeholders 
perceive 

that 

of 

the 

8.2.2 

 High  score  of 
positive opinions 

X  X 

X 

230 

 
 
 
 
JUDGEMENT 
CRITERIA 
re-evaluation 
process 
has 
provided applicants 
enough 
with 
flexibility  to  adapt 
technological 
to 
and 
scientific 
progress  

of 

the 

that 

A  majority 
stakeholders/MS 
perceive 
re-authorisation 
process  has  helped 
place on the market 
safer  additives  for 
farm animals  

of 

the 

that 

A  majority 
stakeholders 
perceive 
re-authorisation 
process  has  helped 
place on the market 
safer  additives  for 
pet animals. 

of 

A  majority 
stakeholders 
perceive 
the 
burden  of  the  new 
safety  requirements 

that 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

adapt  to  technological  and  scientific  progress  (23).  SH-
SURVEY (vii Consultation Synopsis Report, page 11). 
A majority of NCAs agree that the re-evaluation has provided 
applicants with enough flexibility to adapt to technological and 
scientific  progress  (20  NCAs;  1  NCA  disagreed).  NCA 
SURVEY. (vii Consultation Synopsis Report, page 20). 

Respondents  are  more  divided  on  whether  the  re-evaluation 
process  has  helped  additives  safer  for  animals  (whether  food 
producing  or  no-food  producing  animals)  to  be  placed  on  the 
market. SH-SURVEY (vii Consultation Synopsis Report, page 
11). 
A  majority  of  NCAs  agree  that  the  re-evaluation  has  helped 
additives that are safer for farm animals and for pet animals to 
be placed on the market (22 and 20 NCAs, respectively). NCA 
SURVEY (vii Consultation Synopsis Report, page 20). 
Respondents  are  more  divided  on  whether  the  re-evaluation 
process  has  helped  additives  safer  for  animals  (whether  food 
producing  or  no-food  producing  animals)  to  be  placed  on  the 
market.    SH-SURVEY  (vii  Consultation  Synopsis  Report, 
page 11). 
A  majority  of  NCAs  agree  that  the  re-evaluation  has  helped 
additives that are safer for farm animals and for pet animals to 
be placed on the market (22 and 20 NCAs, respectively). NCA 
SURVEY (vii Consultation Synopsis Report, page 20). 
Overall, a majority of respondents do not consider the burden 
of  new  safety  and  efficacy  assessment  required  for  re-
evaluation  to  have  been  proportionate  to  the  benefits  (19  and 
20  respondents,  respectively);  only  4  and  5  respondents, 
respectively,  consider  the  burden  to  have  been  proportionate. 

X  X 

X 

X  X 

X 

8.2.3 

High 
score  of 
positive opinions 

8.2.4 

 High  score  of 
positive opinions 

X  X 

X 

8.2.5 

High 
score  of 
positive opinions  

231 

 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 
re-evaluation 
for 
was  proportionate 
to the benefits 

of 

that 

A  majority 
stakeholders 
the 
perceive 
burden  of  the  new 
requirements 
for 
the re-evaluation as 
efficacy 
regards 
assessment 
was 
proportionate to the 
benefits 

of 

the 

that 

A  majority 
stakeholders 
perceive 
10-year 
authorisation 
period  is  adequate 
promote 
to 
innovation 
A  majority 
stakeholders 
perceive 
10-year 

that 

the 

of 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

SH-SURVEY (vii Consultation Synopsis Report, page 11). 
Furthermore,  the  burden  of  the  new  safety  and  efficacy 
requirements  for  re-evaluation  has  been  proportionate  to  the 
benefits, according to 15 and 13 NCAs, respectively; although 
1 NCA disagreed, and several  NCAs (9 and 11,  respectively) 
did  not  provide  a  definite  answer.  NCA  SURVEY  (vii 
Consultation Synopsis Report, page 20). 
Overall, a majority of respondents do not consider the burden 
of  new  safety  and  efficacy  assessment  required  for  re-
evaluation  to  have  been  proportionate  to  the  benefits  (19  and 
20  respondents,  respectively);  only  4  and  5  respondents, 
respectively,  consider  the  burden  to  have  been  proportionate. 
SH-SURVEY (vii Consultation Synopsis Report, page 11). 
Furthermore,  the  burden  of  the  new  safety  and  efficacy 
requirements  for  re-evaluation  has  been  proportionate  to  the 
benefits, according to 15 and 13 NCAs, respectively; although 
1 NCA disagreed, and several  NCAs (9 and 11,  respectively) 
did  not  provide  a  definite  answer.  NCA  SURVEY  (vii 
Consultation Synopsis Report, page 20). 
29  out  of  110  SH  SURVEY  (ix  Accompanying  document: 
survey and PC results, page 17) 
NCA  views  were  more  varied  on  the  10-year  authorisation 
period.  Although  a  majority  found  this  period  adequate  to 
promote innovation (18 NCAs) out of 25. NCA SURVEY (vii 
Consultation Synopsis Report, page 21).  

24  out  of  110  SH  SURVEY  (ix  Accompanying  document: 
survey and PC results, page 18) 
Also, the 10-year authorisation period is considered necessary 
to  ensure  safety  by  most  NCAs  (17),  although  3  NCAs 

X  X 

X 

8.2.6 

High 
score  of 
positive opinions 

X  X 

X 

8.3.1 

High 
score  of 
positive opinions 

8.3.2 

High 
score  of 
positive opinions 

X  X 

X 

232 

 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 
authorisation 
period  is  necessary 
to ensure safety 

of 

that 

A  majority 
stakeholders 
the 
perceive 
provision  for  a  10-
year  authorisation 
still 
period 
adequate 
for 
holder-specific 
additives 

is 

of 

that 

A  majority 
stakeholders 
perceive 
the 
provision  for  a  10-
year  authorisation 
period 
still 
adequate  for  non-
holder-specific 
additives 

is 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

disagreed.  For  each  of  the  above  aspects,  it  is  noted  that 
several NCAs (4 to 6, depending on the aspect) did not provide 
a  definite  answer.      Key  comments  provided  by  those  NCAs 
that  disagreed  or  did  not  provide  a  definite  answer  are  a  10-
year  authorisation  can  be  too  short  to  encourage  innovation, 
particularly for smaller companies in view of the difficulties to 
secure  funding;  the  period  could  be  adapted  by  type  of 
additive,  e.g.,  level  of  scientific/technical  progress  and  safety 
risk. For FA of lower risk, a period of 20 years could be more 
appropriate; for FA of higher risk, the current 10-year period is 
generally  appropriate.  NCA  SURVEY  (vii  Consultation 
Synopsis Report, page 21). 
20  out  of  110  SH  SURVEY  (ix  Accompanying  document: 
survey and PC results, page 18) 
It is considered particularly inadequate for non-holder-specific 
additives  (39  respondents;  compared  to  20  that  consider  it 
adequate  out  of  99).  NCA  SURVEY.  (vii  Consultation 
Synopsis Report, page 11) 
For holder-specific (18 NCAs) out of 27 agree and 3 disagree - 
NCA  SURVEY  (vii  Consultation  Synopsis  Report,  page  21 
and ix Accompanying document: survey and PC results, page 
57) 
24  out  of  110  SH  SURVEY  (ix  Accompanying  document: 
survey and PC results, page 19) 
For non-holder-specific additives 15 NCAs agree out of 27 and 
5 NCAs (ix Accompanying document: survey and PC results, 
page 19) 

X  X 

X 

X  X 

X 

8.3.3 

High 
score  of 
positive opinions 

8.3.4 

High 
score  of 
positive opinions 

233 

 
 
 
 
 
 
 
INT  CS  LIT  COM 

RESULTS 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

NCA 
SV 

SH 
SV 
X  X 

of 

A  majority 
stakeholders 
that 
perceive 
updating 
the 
method  of  analysis 
is necessary for the 
renewal 
of 
authorisation 

8.4.1 

High 
score  of 
positive opinions 

X 

of 

that 

A  majority 
stakeholders 
the 
perceive 
role of the EURL is 
properly 
still 
addressed 
the 
in 
Regulation  

of 

that 

A  majority 
stakeholders 
perceive 
the 
rules  applicable  to 
the  export  of  FA 
are  not  properly 
addressed 

X  X 

X 

X  X 

X 

8.4.2 

score  of 
High 
positive opinions 

8.4.3 

score  of 
High 
positive opinions 

234 

Updating  the  method  of  analysis  is  not  considered  necessary 
for  the  renewal  of  authorisation  by  a  majority  of  respondents 
(51 out of 101), while considered necessary by 26 respondents. 
SH SURVEY (vii Consultation Synopsis Report, page 11) 
Updating  the  method  of  analysis  is  considered  necessary  for 
the  renewal  of  authorisation  by  22  NCAs;  only  one  NCA 
disagreed,  commenting  that  the  aim  is  the  standardisation  of 
analytical  methods,  not  a  continuous  adaptation  to  new 
analytical  techniques  when  this  does  not  serve  a  specific 
purpose  e.g.,  to  allow  better  controls.  NCA  SURVEY  (vii 
Consultation Synopsis Report page 21) 
The role of the EURL is adequately defined in the Regulation 
according  to  the  majority  of  respondents  (61  out  of  92).  SH 
SURVEY (vii Consultation Synopsis Report, page 11) 
The  role  of  the  E-RL  is adequately  defined  in  the  Regulation 
according to 22 NCAs; only one NCA disagreed, commenting 
that the EURL competence could be enhanced, e.g., to support 
the  national 
the  development  and/or 
execution of analysis, as well as the NCAs whenever needed. 
NCA SURVEY (vii Consultation Synopsis Report, page 21) 
A  small  majority  of  respondents  (35  out  of  65;  excluding  19 
‘do  not  know’  responses)  consider  the  rules  applicable  to  the 
export of FA to be properly addressed in the Regulation; while 
20 consider them not  to  be properly addressed.  About a third 
of  respondents  (27  of  98),  including  manufacturers,  traders, 
and associations/organisations in the sector, were aware of FA 
and premixtures not authorised for placing on the EU market, 
which  are  produced  in  the  EU  only  for  export  to  non-EU 
countries.  SH  SURVEY  (vii  Consultation  Synopsis  Report, 
page 16) 
19 NCAs have taken action to prevent that FA and premixtures 

laboratories  with 

 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

such 

random  checks; 

non authorised in the EU and intended for export end up on the 
EU  market.  These  actions  include:  registration  of  operators 
handling 
additives;  monitoring  production,  use 
(incorporation  in  premixtures)  and  exports,  e.g.  through 
obligation for operators to report movement and/or risk-based 
routine  controls  and 
import  controls; 
obligation to notify all additives/premixtures before placing on 
the  market;  notification  to  the  NCA  of  destination  when 
sending  such  products  to  other  MS;  and,  obligation  to  label 
(‘only  for  export’).  The  actions  reported  by  NCAs  were 
generally  considered  effective  and  no  problems  were 
identified,  except  in  the  case  of  import  controls.  It  is  noted, 
however,  that  the  approach  varies  considerably  between  MS 
and  that  6  NCAs  indicated  they  have  not  taken  any  action  to 
control  these  exports  and  their  potential  re-entry  in  the  EU. 
NCA SURVEY (vii Consultation Synopsis Report, page 23) 
According  to  a  majority  of  respondents  (37  out  of  the  38 
applicants),  the  administrative  burden  (e.g.,  for  obligations 
relating  to  change  of  authorisation  holder,  modification  of 
authorisation 
for  non-holder-specific  additives)  can  be 
reduced.  SH  SURVEY  (vii  Consultation  Synopsis  Report, 
page 14) 

The  administrative  burden  (e.g.,  for  obligations  relating  to 
change  of  authorisation  holder,  modification  of  authorisation 
for  non-holder-specific  additives)  can  be  reduced  for  10 
NCAs;  although  12  NCAs  did  not  provide  a  definite  answer 
and  3  NCAs  disagreed  NCA  SURVEY  (vii  Consultation 
Synopsis Report, page 22) 
Improve the Register of FA  

X  X 

X 

8.5.1 

 High  score  of 
positive opinions 

8.5.2 

of 
Number 
issues/description 

X 

235 

of 

that 

(e.g., 
of 

A  majority 
stakeholders 
perceive 
administrative 
burden 
change 
authorisation 
holder, 
of 
modification 
for 
authorisation 
additives not holder 
specific)  can  be 
reduced. 
High  number  of 
not 
issues 

 
 
 
 
 
 
 
 
 
 
JUDGEMENT 
CRITERIA 
mentioned  before 
that  may  prevent 
Regulation 
the 
meeting 
from 
current needs  
High  number  of 
issues 
the 
that 
Regulation 
have  created  new 
needs  or  problems 
in the FA sector 

in 

ID 

RELEVANT 
INDICATORS 
that  are  not  very 
relevant 

SH 
SV 

NCA 
SV 

INT  CS  LIT  COM 

RESULTS 

X 

Sustainability as a whole is a new need partially addressed  

8.5.3 

Number 
of 
issues/description 
that  are  not  very 
relevant 

Primary sources 
Surveys 
Interviews 
Case studies  
Methods for analysis  

Yes 
Yes 
TBC 

-  Mapping of legislation. 
-  Stakeholder consultation analysis. 
- 

Intervention logic analysis. 

Secondary sources 

Approach to answering the evaluation question and potential limitations 
The relevance looks at the relationship between the needs and problems of the  FA sector and society and the objectives of the intervention (if the 
Regulation is still relevant to address scientific and technical developments, what are the conclusions drawn up concerning t he re-authorisation 
process,  if  the  10-year  authorisation  is  still  relevant,  if  there  are  issues  not  properly  addressed  in  the  R egulation  or  issues  that  have  created 
unexpected needs or problems). This question seeks to clarify if the intervention (Regulation) addresses the current needs of  the FA sector and 
society. In this case, the experience of national authorities and industry stakeholders should be taken into account throughout. 
Interviews  will  be  used,  where  relevant,  to  further  elaborate  on  findings  of  the  survey.  Subsequently,  they  will  focus  mainly   on  collecting 
information on cases that relevance is not confirmed by the survey findings. 
While  we  suggest  asking  all  questions  to  MS  authorities,  it  is  likely  that  some  will  not  be  able  to  comment  on  certain  aspects  of  relevance. 

236 

 
 
 
 
 
 
 
 
 
 
 
 
 
Therefore, we recommend offering a “Don’t know” answer for MS authorities for all questions. 

Evaluation criterion: added value – EQ 9 

Evaluation question 10:  
To  what  extent  has  the  Regulation  achieved  results  which  could  not  have  been  achieved  by  MS  action  alone  and  to  what  extent  i s  EU 
level intervention still warranted? 

Legislation concerned 
Regulation (EC) No 1831/2003 

JUDGEMENT 
CRITERIA 

ID 

RELEVANT 
INDICATORS 

NCA 
SV 

SH 
SV 
X  X 

X 

of 

the 

that 

than 

A  majority 
stakeholders 
perceive 
harmonised 
authorisation 
at  EU 
procedure 
level  achieves  better 
a 
results 
national 
level 
authorisation 
procedure 
A  majority 
stakeholders 
that 
perceive 
harmonisation 
of 
labelling rules at EU 
more 
is 
level 
than 
advantageous 

of 

9.1 

%  of  positive 
opinions 

X  X 

X 

9.2 

%  of  positive 
opinions 

237 

INT  CS  LIT  COM 

RESULTS 

For  a  substantial  majority  of  respondents,  harmonisation  of  the 
feed additive rules at EU level achieves better results than action 
at  national  level.  This  is the case both  with  the centralised EU-
level  authorisation  procedure  and  harmonised  labelling  rules 
(according to 101 and 105, respectively, out of 110 respondents). 
SH SURVEY (vii Consultation Synopsis Report, page 17) 
For nearly all NCAs, harmonisation of the authorization rules at 
EU level achieves better results than action at national level (26 
out  of  27).  NCA  SURVEY  (vii  Consultation  Synopsis  Report, 
page  24  and  vii  Consultation  Synopsis  Report,  page  24  and  ix 
Accompanying document: survey and PC results, page 63) 
For  a  substantial  majority  of  respondents,  harmonisation  of  the 
feed additive rules at EU level achieves better results than action 
at  national  level.  This  is the case both  with  the centralised EU-
level  authorisation  procedure  and  harmonised  labelling  rules 
(according to 101 and 105, respectively, out of 110 respondents). 
SH SURVEY (vii Consultation Synopsis Report, page 17) 
For nearly all NCAs, harmonisation of the authorization rules at 

 
 
 
 
 
 
 
 
 
 
 
 
 
non-harmonised 
rules  

X  X 

X 

of 

A  majority 
stakeholders 
perceive 
that  EU 
level  intervention  is 
still warranted 

9.3 

%  of  positive 
opinions 

EU level achieves better results than action at national level (27 
out  of  27).  NCA  SURVEY  (vii  Consultation  Synopsis  Report, 
page 24 and ix Accompanying document: survey and PC results, 
page 63) 
EU  level  intervention  in  the  area  of  FA  needs  to  continue, 
according  to  71  out  of  79  respondents  (excluding  31  ‘do  not 
know’  responses).  SH  SURVEY  (vii  Consultation  Synopsis 
Report, page 17) 
Hence,  EU  level  intervention  in  the  area  of  FA  needs  to 
continue, according to all 28  
NCAs. NCA SURVEY (vii Consultation Synopsis Report, page 
24 and ix Accompanying document: survey and PC results, page 
63) 

Primary sources 
Surveys 
Interviews 

Yes 
Yes 

Secondary sources 

Methods for analysis  

-  Mapping of legislation. 
-  Stakeholder consultation analysis. 
- 

Intervention logic analysis 

Approach to answering the evaluation question and potential limitations 
This question considers arguments about the value resulting from the EU intervention. There are two aspects of the Regulation to which 
EU added value is most relevant: the labelling rules and the authorisation procedure. In this question, the experience of the  national 
authorities and FeBOs should be taken into account throughout. 

238 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX IV. OVERVIEW OF BENEFITS AND COSTS AND TABLE ON SIMPLIFICATION AND BURDEN REDUCTION 

Overview of costs – benefits identified in the evaluation245 

Table 1 Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

[Others] 

Qualitative  Quantitative / 

Qualitative  Quantitative / 

Qualitative  Quantitative / 

Qualitative  Quantitative / 

Costs: 
Authorisa
tion of 
FA 

. 

One-off costs 
Economic cost for 
businesses 
(regulatory charges 
and compliance 
costs) in preparing a 
dossier: safety 
studies, efficacy 
studies,   
application fee for 
the method of 
analysis, 
consultancy, post 
monitoring, 
purchase of 

monetary 

monetary 

Direct costs 
application for 
authorisation of 
an additive. On 
average of €1.1 
million of 
which 37% are 
costs to 
demonstrate 
safety, 32% are 
costs to 
demonstrate 
efficacy and 
22% staff costs. 

monetary 

Direct costs 
−  Commission: 
per 
€13,400 
application. 
−  EURL: 
€18,500 
per 
validation  report 
for 
each 
application 
−  EFSA: 
per 
€27,450 
of 
application 
which 
€15,900 
are internal costs 
−  MS: 
€500 

monetary 

245 Identification of costs according to the Standard Cost Model (SCM). Methodology of costs can be found in the  FCEC Final Report, Annex 5. Information about different costs is 

where obtained through the stakeholder survey, NCAS survey, interviews and case studies. Information available in FCEC Final report, section 6 and Annex 4: Case Studies. 

239 

 
 
 
 
 
 
 
 
 
 
equipment/ services 
and staff costs246  
For EFSA and 
EURL covers the 
assessment and 
validation of the 
method of analysis, 
respectively, 
For the Commission 
the management 
procedure for the 
authorisation and 
participation in the 
SCoPAFF meetings. 
For MS attendance 
to the SCoPAFF 
meetings and 
obligations derived 
from the 
implementation of 
the FA Regulation  
Expected  

One-off costs 
Economic cost for 
businesses 
(compliance costs) 
for studies 

Costs for 
the 
studies 

per application  

Direct costs 
In vitro studies: 
€≤10,000 - 
50,000 
Laboratory 

246 The staff time provided by operators was monetised using EUROSTAT data. Four categories of staff were considered: senior managers (category 1); professionals with university 

education (category 2); technicians with vocational education (category 3); administrative staff (category 4). 

240 

 
 
 
 
 
 
 
 
 
necessary for 
preparing a dossier. 
Those costs are 
already included in 
the costs of 
application but due 
to their importance 
a breakdown is 
presented 
Expected. 

One-off costs 
Economic cost for 
businesses 
(compliance costs) 
in preparing a 
dossier, for renewal 
of authorisation: 
literature review, 
studies where 
necessary, analysis 
of batches, 
consultancy, report 
for post-market 
monitoring where 
necessary, purchase 

Cost: 
Renewal 
of 
authorisat
ion 

animals: 
€≤10,000 – 
400,000 
Ruminants: 
€18,000 – 
200,000 
Pigs/ 
poultry/fish €≤ 
10,000 - 
400,000 
Other species 
€30,000 - 
150,000 

Direct costs 
Renewal for an 
additive. 
Average 
€216,000 

241 

Direct costs 
−  Commission: 
per 
€13,400 
application 
−  EFSA: 
€16,470 
application 
−  MS:  €500  per 
application 
for 
each MS 

per 

 
 
 
 
 
 
 
Cost: 
Delays in 
the 
authorisat
ion 
(Article 
4) 

of equipment and 
services and staff 
costs247. 
Expected 

Recurrent costs 
Hassle costs 
Unexpected  

Direct costs 
It is not possible 
for applicants to 
monetise the 
costs and losses 
of the delays 
produced for 
the 
authorisation of 
a new additive. 
 7% of 
applications are 
processed 
within the 
reasonable 
deadline (1 
year):  19% 
between 12-18 
months, 25% 
between 18-24 
months and 
50% more than 

247 The staff time provided by operators was monetised using EUROSTAT data. Four categories of staff were considered: senior managers (category 1); professionals with university 

education (category 2); technicians with vocational education (category 3); administrative staff (category 4). 

242 

 
 
 
 
 
 
 
 
 
Cost: 
Labelling 
FA/premi
xtures 

One-off costs 
Economic costs for 
businesses 
(compliance costs). 
The costs 
considered in this 
case are those 
linked to label 
changes that are 
triggered by 
regulatory changes 
(i.e., changes in an 
authorisation under 
the FA Regulation 
requiring 
adaptations to 
labels). 
The costs include 
design labels, 
change formulation 
for premixtures, 
comply with 
traceability 
requirements, 
translate labels, 
print labels  
Expected  

248 vi Case studies 

24 months. 

248 Direct costs 
for producers of 
FA and 
premixtures  
For FA, the 
costs are 
negligible. 
For 
premixtures: 
€80,000- 
€223,000 per 
plant per year 
Direct costs 
relevant for pet 
food 
manufacturers 
for very few 
cases when an 
additive is 
withdrawn, and 
the transitional 
period is shorter 
than the usual 
period. The 
estimations for 
re-labelling 
compound feeds 

243 

 
 
 
 
 
 
 
 
 
Costs: 
Disposal  

One-off costs 
Economic costs for 
businesses 
(compliance costs). 
This refers to 
regulatory changes 
that require to 
dispose labels or 
products. 
Unexpected 

249 vi Case studies 

are €1 million 
to change the 
label of 2,000 
references.  
For food-
producing 
animals, the 
costs are 
negligible 

Direct costs 
249Disposal of 
labels €2,000-
for premixtures 
applying the 
usual 
transitional 
period; 
€24,000- 40,000 
in product value 
and €13,500 in 
labels for 
premixtures 
when the 
change affects 
an important 
additive widely 
used and the 
transitional 

244 

 
 
 
 
 
 
 
 
 
period is shorter 
than the usual 
transitional 
period – e.g., 
the suspension 
of the 
antioxidant 
ethoxyquin. The 
occurrence of 
this possibility 
is very low. 

Direct costs 
Negligible just 
a notification to 
the 
Commission. 

Direct costs 
- Commission: 
€13,400 per 
Regulation.  
- For the MS 
€14,000 per 
Regulation. 

Direct costs 
€ 74,000 per year 
on average MS to 
control the 
implementation 
of the Regulation. 

Direct 
benefits 
Increased 
worker 
safety 
through less 
development 

245 

Direct 
benefits for 
animal health 
(reducing 
AMR in 
livestock 
farming and 

Impossible to 
quantify in 
monetary 
terms in any 
widely 
accepted 
way. 

Costs: 
Administ
rative 
burden 

One-off costs 
Administrative 
burden.  
Costs to change the 
authorisation holder  
Expected  

Costs: 
Enforcem
ent 

Recurrent costs  
Enforcement costs 
to perform control 
activities by MS. 
Expected  

Benefits: 
reduction 
of cases 
of AMR 

Recurrent benefits 
Reduction of cases 
of specific 
antibiotic-resistant 
microorganisms in 
livestock farming. 
Expected 

Direct benefits 
Consumers 
and pet 
owners and 
society in 
general, as 
they will face 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
reduced 
AMR-related 
threats.  

Benefits: 
authorizat
ion 
process 

Recurrent benefits 
Simplification, 
harmonisation and 
predictability (not 
fully accomplished) 
of the authorization 
process 
Expected 

companion 
animals) and 
the 
environment 

Impossible to 
using accepted 
methodology. 

Impossible to 
quantify using 
accepted 
methodology. 

Direct 
benefits 
Reduced 
administrati
ve costs of 
the 
authorizatio
n process 
for MS. 

of AMR. 
Indirect 
benefits for 
farmers in 
preventing 
losses from 
animal 
diseases 

Direct 
benefits for 
applicants. 
Reduced 
uncertainty 
related to the 
authorization 
process 
Direct 
benefits for 
farmers 
availability 
of safe 
efficacious 
FA 

Benefits: 
risk 
assessme
nt 

Recurrent benefits 
Risk assessment 
performed by EFSA 
Expected 

Direct benefits 
for consumers 
from EFSA 
making sure 
that FA will 
not contain 
microorganis
ms, toxins or 

Impossible to 
quantify using 
accepted 
methodology, 
but 
presumably 
high. 

Direct 
benefits for 
farmers in: 
Preventing 
losses from 
animal 
diseases 
Increasing 

Direct benefits as 
MS do not need 
to perform risk 
assessment 

Impossible to 
quantify 
using 
accepted 
methodology 

Direct 
benefits on 
animal 
welfare. and 
animal health 
Benefits for 
consumers 
and workers 

246 

 
 
 
 
 
 
 
Direct 
benefits for 
society from 
reducing the 
environmenta
l impact of 
livestock 
production 
and ensure 
safe food. 

other 
substances 
that may be 
transferred to 
food 

animal 
performance. 
Better use of 
resources. 
Balanced 
diets.  
Direct 
benefits for 
FeBOs: 
-Prevent 
loses, due to 
recall or 
disposal, in 
particular, 
loses 
generated by 
1,743 
additives 
potentially 
unsafe or 
inefficacious 
out of the 
market - 
Ensure level 
playing field 
as only 
efficacious 
additives are 
placed on the 
market  

247 

 
Benefits: 
risk 
assessme
nt 

Benefits: 
labelling 

One-off benefits 
1,743 potentially 
unsafe or 
inefficacious 
additives out of the 
market as they were 
not assessed for 
safety and/or 
efficacy according 
to the new 
requirements 
Unexpected 

Recurrent benefits 
Prevention of the 
misuse of FA along 
the food chain 
through labelling 
provisions 
Expected 

Impossible to 
quantify using 
accepted 
methodology 

Direct benefits 
for consumer 
protection 
from the 
labelling 
provisions 
which 
contribute to 
control the 
presence of 
FA residues in 
food of animal 
origin.  

Impossible to 
quantify using 
accepted 
methodology 

Direct 
benefits for 
worker 
safety and 
for animal 
welfare and 
animal health 
from the 
labelling 
provisions.  

248 

Impossible to 
quantify 
using 
accepted 
methodology 

Direct 
benefits 
Reduce 
misused of 
FA lead to a 
reduced risk 
of 
environmenta
l impact and 
food threats 

Direct 
benefits for 
animals from 
safe and 
appropriate 
use of FA 

 
 
 
  
 
 
 
 
 
 
 
 
Indirect 
benefits for 
consumers 
from 
increasing 
safety of food 
of animal 
origin 

Indirect 
benefits for 
pet owners 
who have the 
possibility to 
use safe and 
efficacious 
products to 
care for their 
companion 
animals 

Benefits: 
Enforcem
ent 

Recurrent benefit  
Enforcement 
benefits to perform 
control activities by 
MS. 
Expected 

Benefits: 
specific 
interests 
of pet 
owners 
and their 
animals 

Recurrent benefits 
Assessment of 
chronic toxicity, 
mutagenicity and 
carcinogenicity 
effects of FA to 
prevent any 
negative impact on 
pets’ health. 
Expected 

Benefits:  
Holder 
Authorisa
tion  

Recurrent benefits 
Encourage 
innovation and 
improve 
traceability. 
Expected 

Direct benefits 

Indirect 
benefits for 
farmers in 
preventing 
losses from 
feed additive 
frauds and 
safety issues 

Impossible to 
quantify using 
accepted 
methodology 

Direct 
benefits to 
feed additive 
manufacturer
s in terms of 
exclusive 
profit. 

249 

Impossible to 
quantify 
using 
accepted 
methodology 

Direct 
benefits for 
pet welfare 
from safe, 
efficacious, 
and relevant 
FA available  

Indirect 
benefits  
Facilitates 
traceability  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TABLE 2:  Simplification and burden reduction (savings already achieved) 

Citizens/Consumers/Workers  Businesses 

Administrations 

[Other…] _ specify 

Quantitative 

Comment  Quantitative  Comment 

Quantitative 

Comment  Quantitative  Comment 

Type: recurrent / 
Reduction of feed/panel 
/working groups meetings at 
EFSA 

No 
quantification 
impossible  

Type: recurrent / 
Reduction of SCoPAFF 
meetings  

.   

EFSA changes in the 
system to organise 
meetings. The costs in 
2016 were € 819,368. In 
2017 there was a 
reduction of € 67,590 and 
in 2018 of € 303,938 

Reduction of two 
meetings per year for the 
Commission: € 600 per 
meting  
For MS reduction of travel 
costs could be minimum € 
27,000 per meeting. For a 
reduction of two meeting 
per year to amounts to 
€54,000 per year  

250 

 
 
               
 
 
 
 
 
 
 
 
 
 
 
 
 
PART II: II Potential simplification and burden reduction (savings) 

Citizens/Consumers/Workers 

Businesses 

Administrations 

[Other…] _ specify 

Quantitative  

Comment 

Quantitative 

Comment 

Quantitative 

Comment  Quantitative  Comment 

Description: 

Type:  One-off / recurrent 
(select) 

One-off 
Clarify the requirements to 
demonstrate efficacy for 
environmental and animal 
welfare effects  
Reduction of application costs. 

One-off 
Improve extrapolation from 
major to minor species will 
reduce application costs  

One-off 
Improve the extrapolation from 
food to feed will reduce 
application costs  

One-off 
Clarify definitions will reduce 
discussion at the SCoPAFF 

One-off 
Clarify the status of 
recommended levels, biocidal 
products versus FA in water for 
drinking and use of additives in 

X No 
quantification is 
possible 

X No 
quantification is 
possible 

X No 
quantification is 
possible 

X No 
quantification 
possible 

251 

X No 
quantificati
on is 
possible 

X No 
quantificati
on possible 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
water for drinking. Will reduce 
discussions at the SCoPAFF 
and application costs   

One-off 
Establish labelling tolerances 
for FA in premixtures will 
reduce costs derived from the 
necessity to change labels, 
additional storage costs if the 
circulation is impeded when 
problems arise in the 
circulation within the EU due 
to different interpretation by 
MS   

Recurrent  
Prohibit duplicative testing and 
explore new testing strategies 
to reduce animal testing may 
reduce application costs. 

Recurrent  
Extension of the authorisation 
period from 10 to 15 years 

X No 
quantification 
possible 

X No 
quantificati
on possible 

X No major 
savings are 
expected as there 
were only three 
cases occurred 
during the 
implementation of 
the Regulation 

252 

Average 
over 30 
years: -if 
extended to 
all 
additives 
=€ 889,000 
per year 
only for the 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Commissio
n 
-if extended 
only to 
additive 
having high 
level of 
safety: 
=€249,000 
per year 
only for the 
Commissio
n 

Commissio
n: €13,400 
per 
Regulation. 
- For the 
MS 
€14,000 per 
Regulation. 

l 

Recurrent 
Simplify the procedure to 
change the authorisation holder 
will reduce administrative 
burden for the Commission 

Clarify the labelling of worker 
safety provisions reduce costs 
derived from the necessity to 
change labels, additional 
storage costs if the circulation 
is impeded when problems 
arise in the circulation within 
the EU due to different 
interpretation by MS 

X 

X Not possible to 
quantify 

253 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX V-STAKEHOLDERS CONSULTATION – SYNOPSIS REPORT 

The synopsis report summarises the consultation activities carried out, the stakeholders 
who contributed, and their opinions and to inform stakeholders on how their views have 
been taken into account in the analysis. 

1. - CONSULTATION STRATEGY 

The consultation strategy was drawn up in the Roadmap launched in August 2017 and 
lately completed in the terms of reference of the support study. The consultation aimed at  

•  collecting information and data on the application of the Regulation.  
•  gathering  information  on  the  experience  of  different  stakeholders  with  the 

implementation of the relevant rights and obligations,  

•  collecting  views  on  the  different  provisions  of  the  Regulation  and  their  effects, 

including information on costs and benefits.  

Different stakeholder groups were identified in the consultation strategy, including public 
authorities,  Commission  representatives,  EFSA,  FA  industries  (producers  and  users), 
farmers,  veterinarians,  consultants’  associations,  food  additives’  associations,  citizens 
and  consumers,  NGOs  (e.g.,  environmental,  health,  and  animal  welfare  organisations), 
and the research and innovation community. Many stakeholders of the FA supply chain 
(including  manufacturers,  traders,  and  users)  are  represented  by  umbrella  associations. 
These  associations  actively  engaged  in  the  consultation  process.  Environmental 
organisations, animal welfare organisations and consumers did not contribute despite the 
efforts to involve them. For animal health the FVE participated and for farmers COPA-
COGECA. There were also 16 citizens responding the PC. 

The  consultation  strategy  included  feedback  to  the  Roadmap  and  to  the  Public 
Consultation. It also included the following activities conducted as part of the evaluation 
study:  exploratory  interviews  carried  out  during  the  inception  phase  of  the  evaluation 
study, targeted interviews, a survey to stakeholders, a survey to competent authorities, a 
survey to competent authorities from non-EU countries and case studies. 

In  addition,  there  were  three  documents  submitted  out  of  the  formal  consultation:  two 
from FEFANA and one from a group of nine FA/premixtures producers. The letters from 
FEFANA were very relevant to explain the claims issue that was not so evident from the 
study performed by the contractor although raised by this organisation during the PC. 

No campaigns have been identified to massively respond with suggested responses.  

The following sections summarise the outcomes of each consultation activity. 

2.- METHODOLOGY AND ANALYSIS 

For the ROADMAP and the Public Consultation, the EU Survey platform was used. The 
data  of  the  PC  were  processed  in  excel  files  that  contained  the  response  to  closed 
question  and  open  questions.  For  the  stakeholder  Survey  and  the  NCA  Survey,  the 
contractor  used  their  own  platform  and  provided  the  Commission  the  position  papers, 
and responses to the different questions. 

254 

 
 
3. - RESULTS OF THE CONSULTATION ACTIVITIES 

3.1. - ROADMAP 

3.1.1. Overview of the evaluation Roadmap and respondents 

The Roadmap was open for feedback from 28 August to 25 September 2017. Feedback 
was received from 13 stakeholders and published on the Have Your Say page250. 

3.1.2. Outcome 

Overall, respondents focused on the shortcomings of the legislation rather than on the 
planned evaluation methodology.  

Feedback  covered  the  challenges  related  to  definitions  in  the  FA  Regulation  (e.g., 
distinction  between  feed  materials  and  FA,  premixtures,  etc.)  and  to  the  different 
interpretation of the provisions of the FA Regulation by MS. Concerns were also shared 
on  the  authorisation  period  (too  short),  the  duration  of  the  renewal  process,  the 
demanding  procedure  of  the  modification  of  the  authorisation  and  on  the  low 
predictability  of  the  assessment  process,  including  the  frequent  revision  of  EFSA 
guidance. The necessity to revise the labelling rules was also raised as well as the need to 
improve coherence with the Regulation on the classification, labelling and packaging of 
substances and mixtures. Finally, some objectives of the FA Regulation were supported, 
including  the  need  to  facilitate  innovation  and  to  combat  antimicrobial  resistance  by 
developing new alternatives to the use of antibiotics. 

3.2.- PUBLIC CONSULTATION  

3.2.1. Overview of the Public Consultation  

The Commission held a public consultation (PC) which ran from 12 December 2018 to 3 
April 2019. The questionnaire was available in 24 languages and included 26 open and 
closed questions.  

The  PC  targeted  all  stakeholder  groups  identified  in  the  consultation  strategy  for  this 
evaluation.  

To  ensure  broad  coverage,  the  Commission  organised  communications  activities  to 
encourage stakeholders to respond to the PC, in particular by contacting the EU umbrella 
organisations  representing  the  different  stakeholder  groups.  The  targeted  organisations 
were  selected  based  on  their  outreach  to  the  wider  network  of  stakeholders  they 
represent.   

3.2.2. Respondents 

110  responses  were  recorded  and  7  of  them  provided  additional  documentation.  The 
number of respondents to the PC, by stakeholder group, is as follows: 

250 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1483-Evaluation-of-the-feed-

additives-Regulation_en 

255 

 
 
•  52 companies/business organisations (FA/premixtures producers, compound feed 

producers, pet food producers and feed materials producers). 

•  24  business  associations  representing  FA  /  premixtures  producers,  pet  food, 

compound feed, feed materials and farmers).  

•  16 EU citizens, 
•  12 public authorities.  
•  6  ‘other’  organisations  (2  consultants,  2  veterinarians,  1  academic/research 

organisation and 1 umbrella organisation representing veterinarians). 

There is a relatively high share of responses received from business stakeholders (70% of 
the  total).  Amongst  companies  (manufacturers  and  traders),  many  responses  were 
received from SMEs (29). 

Contributions  were  mainly  received  from  stakeholders  from  Belgium  (22251),  France 
(19), Germany (13), Spain (12) and the Netherlands (10) while stakeholders from other 
EU countries were less represented. 10 contributions from outside the EU were received: 
The USA (3), Japan and Switzerland (2 each) and Canada, China and Turkey (1 each). 

Seven supporting documents were received, including five position papers on the use of 
coccidiostats as FA (submitted by 6 respondents), and two proposals for revisions of the 
Regulation (submitted by one respondent).  

3.2.3. Outcome 

The factual summary report summarising the outcomes of the PC was published on the 
Have Your Say page 252 

Safety and efficacy of FA  

The  majority  of  respondents  find  FA  are  safe  and  efficacious.  72%  of  all  respondents 
agree that the ban on antibiotics introduced by the Regulation played an important role in 
preventing antimicrobial resistance (AMR). 

Similarly, 90% of respondents agree that the safety assessment of FA carried out by the 
European  Food  Safety  Authority  (EFSA)  has  helped  make  FA  safe  for  human  health, 
animal  health  and  the  environment.  One  third  of  citizens  responded  “neither  agree  nor 
disagree” or “don’t know” 

For most respondents (59%) – mainly public authorities and business associations – the 
Regulation has been effective in preventing food/feed crises and losses.  

Authorisation procedure and definitions of the FA Regulation 

Respondents  largely  agree  that  there  is  an  added  value  in  having  a  harmonised, 
centralised  authorisation  procedure  for  FA  at  the  EU  level,  however  they  are  divided 
when dealing with some aspects of the implementation of the Regulation.  

251 This includes international and pan-European organisations based in Belgium. 
252 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1483-Evaluation-of-the-feed-

additives-Regulation/public-consultation_en 

256 

 
 
Just  over  half  of  respondents  find  that  the  Regulation  does  not  make  it  easier  to  place 
new innovative additives on the market when compared with the former Directive. 

Respondents’  views  diverge  on  whether  the  definitions  in  the  Regulation  are  clear, 
relevant and up to date. Almost half of the respondents find they are, whereas just under 
30% disagree. Some definitions should be clarified and completed (e.g., preparations or 
use  in  water.),  as  well  as  better  aligned  with  the  feed  catalogue  and  other  feed 
regulations. 

Views  on  the  suitability  of  procedures  set  out  in  the  Regulation  vary.  Almost  3/4  of 
respondents  providing  an  answer  consider  that  having  a  centralised  authorisation 
procedure ensures equal treatment of all applicants and common requirements (only 5% 
consider it does not). Just under half find that the procedure for submitting an application 
is fit for purpose (14% consider it is not), with business associations particularly negative 
on the suitability of data requirements. Regarding the procedures for granting, modifying, 
suspending and revoking an authorisation, as well as the procedure for sharing data, the 
industry was much more equivocal on whether these are fit for purpose. A large number 
of  “Don’t  knows”  for  these  questions  (16-34%,  depending  on  the  procedure).  Around 
10% of all respondents provided no answer. 

Respondents  generally  find  that  the  authorisation  procedure  set  out  in  the  Regulation 
involving  EFSA  and  the  Commission  is  still  fit  for  purpose  and  the  risk  assessment 
carried out by EFSA allows for sound decision making.  

The Register of FA is considered by a majority of stakeholders (59 out of 110) to be an 
efficient  tool  for  FeBOs  to  be  aware  of  all  additives  authorised;  nevertheless,  for  26 
operators  out  of  110,  it  needs  to  be  improved  to  become  more  informative  and  user-
friendly.  The  main  negative  issue  commonly  identified  by  respondents  is  the  format  of 
the Register. 

Data protection 

Over  half  of  respondents  were  not  able  to  answer  whether  data  protection  rules  are 
effective in relation to the cost of preparing dossiers and the benefits provided by the 10-
year  protection,  and  if  data  sharing  rules  are  effective  in  reducing  costs  and  animal 
testing. 2/3 of total respondents find the implementation of these aspects is not effective, 
with a particularly negative response from industry about data protection rules. The main 
issue  identified  by  respondents  expressing  a  negative  view  is  that  data  sharing  is  not 
being used to its full potential.  

Labelling 

A  majority  of  respondents  find  that  FA  and  premixtures  labelling  is  informative  and 
helps prevent their misuse along the feed chain, but the Regulation should also allow for 
information  through  other  channels.  Those  respondents  that  expressed  negative  views 
consider  there  is  a  need  to  make  labelling  requirements  more  practical,  facilitating  the 
information flow along the feed chain, to be coherent with other legislation, for instance 
the  feed  marketing  legislation  (Regulation  (EC)  767/2009).  Labelling  rules  for  worker 
safety  provisions  were  contested  by  a  quarter  of  respondents,  especially  amongst 
companies/business organisations, business associations, and EU citizens. 

257 

 
36  industry  representatives  provided  precise  comments  indicated  the  importance  of 
setting  up  a  claims  system  to  raise  awareness  of  the  positive  benefits  of  FA  and 
premixtures  and  to  align  the  FA  Regulation  with  the  Feed  Marketing  Regulation  that 
regulate claims in fed materials and compound feed. 

Efficiency: cost /benefits 

Regarding  the  costs  and  benefits  of  the  Regulation,  respondents  views  vary,  with 
business associations particularly negative. For most respondents (59%) – mainly public 
authorities  and  business  associations  –  the  Regulation  has  been  effective  in  preventing 
food/feed crises and losses.  

Only 36% of respondents find the cost of FA/premixtures labelling is justified including 
a  majority  of  public  authorities  consider  it.  Business  associations  are  divided  and 
companies/business  organisations  tend  to  consider  that  the  cost  is  not  justified  (no 
possibility to transmit the information by means other than a physical label).  

Only  12%  of  respondents  find  the  cost  of  applications  for  getting  a  feed  additive 
authorised in the EU market is proportionate to the benefits. This is mainly due to the 10-
year  duration  of  the  authorisation,  which  is  considered  insufficient,  the  challenges  of 
completing the assessment of efficacy, and the non-holder-specific authorisations (costs 
borne by applicant/s and benefits enjoyed by all FeBOs when putting the authorised feed 
additive on the EU market).  

EU added value 

A harmonised authorisation procedure achieved better results at EU level than a national 
level  authorisation  according  96%  of  respondents.  Respondents  largely  find  that  EU 
harmonised conditions  for placing FA on the market ensure fair competition within the 
EU and facilitates trade and that the EU level intervention in this sector is still warranted. 

Relevance 

Respondents  are  divided  as  to  whether  the  authorisation  of  FA  should  consider  –  and 
sufficiently considers – (a) societal needs and (b) economic aspects, as well as safety and 
efficacy. For both questions there is a relevant “Don’t know” responses (25%). Citizens 
are slightly more inclined to indicate that societal factors are not sufficiently taken into 
consideration. Industry had a higher propensity, compared to other respondent groups to 
consider  economic  aspects  being  sufficiently  taken  into  account.  For  both  questions, 
there is a relevant number of ‘Don’t know’ responses, mainly from business associations, 
public authorities, citizens and NGOs. 

Needs  identified  by  several  respondents  (across  all  types  of  respondents)  as  not 
sufficiently considered by the current authorisation process are:  

−  Ensuring  innovation,  especially  by  SMEs,  on  new  product  development 

aiming to address evolving societal needs.  

−  Enabling  authorisations  that  do  not  have  large  commercial  support  (minor 

species). 

−  Avoiding  the  economic  impact  stemming  from  inconclusive  EFSA  opinions 

that requires to submit additional information.  

−  Avoiding unnecessary animal testing. 

258 

 
Innovation 

−  Only  half  of  the  respondents  could  answer  certain  questions  on  the  scope  of  the 
Regulation. From those respondents a small minority (18% of respondents) find that the 
Regulation  is  sufficiently  flexible  to  new  scientific  and  technical  developments.  Also, 
45% of those respondents think that new categories of FA and/or functional groups need 
to be considered by the Regulation. Almost 40% of those respondents find that the use of 
additives  in  drinking  water  needs  to  be  clarified,  especially  for  technological  additives 
(e.g., preservatives with the legislation on biocidal products. 

−  36 respondents from the industry were in favour of extending the holder authorisation 
to other additives to foster innovation. The main arguments were that the applicant bear 
the  authorisation  costs  but  other  operators  benefit  from  this  authorisation  when  the 
additive  is  authorised.  This  reduces  the  interest  of  applicants  to  apply  for  the 
authorisation of those additives.  

3.3. - STAKEHOLDERS SURVEY  

3.3.1. Overview of the survey 

A  stakeholder  survey  was  disseminated  between  July  and  September  2019  to  all 
stakeholders  affected  directly  or  indirectly  by  the  FA  Regulation.  The  Commission 
directly  invited  70  umbrella  organisations  representing  the  different  stakeholder  groups 
to  respond  to  the  survey,  including  from  the  fields  of  animal  welfare,  environmental 
NGOs, consumer organisations, farmer and trade associations. Information on the survey 
and  the  link  to  the  survey  were  also  available  on  SANTE  webpage.  In  addition,  EU 
umbrella organisations were asked to make the survey available to their members.  

In  some  cases,  a  large  number  of  respondents  did  not  provide  a  definite  answer  (i.e., 
‘neither agreed nor disagreed’). This may suggest that they do not have a strong opinion. 

3.3.2. Respondents 

Manufacturers of FA and premixtures account for the largest number of replies (36 out of 
112) (e.g., specialty feed ingredients business, compound feed and premix industry, and 
the  pet  food  industry.  Users  (e.g.,  farmers  and  cooperatives,  the  poultry  sector  and  the 
lecithin  industry)  also  participated  in  the  survey.  Consumers  and  animal  welfare 
organisations did not contribute to this survey. 

63  manufacturers  produce  FA  and  other  feeds,  of  which,  nearly  half  (30)  produce  FA 
and/or feed for both food producing and non-food producing animals.  

Between  48%  and  50%  of  manufacturers  of  FA,  premixtures,  and  compound  feed  had 
more than 75% of increase of the company turnover and company benefits. This means 
that for the remaining FeBOs the importance of FA for the company is shared with other 
activities. 

The  sample  of  responses  suggests  that  the  manufacturing  and  trading  operations  of  FA 
and/or  premixtures  tends  to  be  conducted  as  a  separate  business,  with  only  3 
manufacturers  indicating  they  are  involved  in  trading  (even  though,  this  question  was 
answered by only 37 respondents out of the 63 manufacturers and 14 traders). Amongst 

259 

 
manufacturers  and  traders,  almost  equal  numbers  of  responses  came  from  larger 
companies and SMEs. 

Few  users  (e.g.,  farmers  and  cooperatives,  the  poultry  sector  and  the  lecithin  industry) 
also  participated  in  the  survey.  Consumers  and  animal  welfare  organisations  did  not 
contribute to this survey. 

Finally,  three  additional  documents  were  shared  by  stakeholders  to  support  their 
contributions.  

3.3.3, Outcome 

Safety and efficacy of FA 

Stakeholders  generally  agree  that  FA  are  safe  (108  out  of  112  respondents)  and 
efficacious (103 out of 112 respondents). Nonetheless, over 90% of responses came from 
the FA/premixtures and feed sector. A substantial majority of respondents agree that FA 
on  the  EU  market  are  safe  for  animals  (108  out  of  110),  users  and  workers  (92  out  of 
109), the environment (92 out of 110), and consumers (103 out of 111). 

With regard specifically to pet food additives on the EU market, nearly all respondents 
agree that they are efficacious and safe for pet animals (74 and 76, respectively, out of 78 
respondents). Respectively 28 and 30 respondents did not provide an answer as pet food 
is not relevant for their organisation. 

A  majority  of  respondents,  including  farmers,  consider  the  use  of  coccidiostats  and 
histomonostats  to  be  important  as  FA  to  ensure  the  health  and  welfare  of  poultry  and 
rabbits  (61  out  of  71),  well  adapted  to  current  farming  practices  (65  out  of  72)  and 
effectively  controlled  (63  out  of  70).  In  all  cases  a  significant  number  of  respondents 
could not answer. Moreover, for farmers, this use is a prevention measure to control the 
potential spread of coccidiosis. This effectively leads to economic benefits for farmers by 
preventing  the  potential  costs  arising  in  terms  of  veterinary  costs  and  antibiotic 
treatments. 

A majority of respondents agree that FA on the EU market are safe for consumers (92%) 
and for users (84%) 

Authorisation procedure 

More  than  82%  of  FeBOs  consider  that  applicants  have  sufficient  time  to  complete 
dossiers when EFSA requires so.  

As regards the simplified procedure for FA authorised in food, a majority indicates that 
the procedure does not work well (54%).  

Almost half of respondents indicate that the extrapolation to minor species does not work 
well  (43%)  but  there  is  around  a  third  of  respondents  does  not  know  or  does  not  have 
experience. 

Applicants  find  that  the  authorisation  procedure  is  more  or  less  efficient.  There  are 
diverging  views  on  the  10-year  authorisation  period  and  the  re-evaluation  procedure. 

260 

 
Operators  negatively  perceived  whether  the  authorisation  took  into  account  legitimate 
factors (58% of negative responses and only 24% of positive responses). 

Respondents present divided views on the adequacy of the 10-year authorisation period 
to promote innovation. The measure is considered adequate by 27% of respondents and 
not  by  25%  of  respondents,  with  39%  of  respondents  who  neither  agree  nor  disagree. 
22%  of  respondents  find  that  the  10-year  authorisation  period  is  necessary  to  ensure 
safety;  whereas  25%  of  respondents  think  the  opposite  (35%  neither  agrees  nor 
disagrees).  

A majority of respondents do not consider the update of the method of analysis for  the 
authorisation renewal to be necessary (51 out of 101); whereas it is considered necessary 
by 26 respondents. On the other hand, the role of the EURL is adequately defined in the 
Regulation according to the majority of respondents.  

For  a  majority  of  respondents  (59%),  non-holder-specific  authorisations  for  nutritional 
additives,  technological  additives  and  sensory  additives  should  not  be  replaced  by 
authorisations linked to a specific holder; whereas, for 23% of respondents, they should 
(8% don’t know).  

Innovation and scientific/technological progress 

A majority of respondents (45 out of 107) consider the authorisation procedure to be not 
suitable  to  address  scientific  and  technical  developments  for  pets  and  livestock 
production, due to  the  time periods incurred  (compared to 34 that consider it suitable); 
and,  in  the  light  of  scientific  and  technological  developments,  the  criteria  used  for 
authorisation  of  FA  are  not  considered  as  still  relevant  by  28  out  of  44  respondents 
(compared to 13 that consider them still relevant). 

For  a  majority  of  respondents  (59%),  non-holder-specific  authorisations  for  nutritional 
additives,  technological  additives  and  sensory  additives  should  not  be  replaced  by 
authorisations linked to a specific holder; whereas, for 23% of respondents, they should 
(8% don’t know).  

Regarding  scientific  and  technical  progress,  respondents  –  especially  manufacturers  of 
FA and premixtures, and organisations/consultancies assisting them – do not find that the 
Regulation is sufficiently suitable. Beyond definitions not being apt to the current state of 
scientific and technical progress for a slight majority of respondents, missing functional 
groups  are  the  most  common  issues  identified  within  the  Regulation  (EC)  1831/2003 
(although, by less than a quarter of respondents).  

Labelling 

Almost as many respondents (53 out of 111) consider labelling requirements to be fit for 
purpose  and  not  being  fit  for  purpose  (45)  do  (particularly  manufacturers  of  FA  and 
premixtures,  followed  by  manufacturers  of  compound  feed  and  FA).  The  obligation  to 
indicate all the information in a physical label is perceived as a major constrain. 

Costs, benefits and competitiveness 

The majority (34 applicants out of 38) indicated that the regulatory costs of authorisation 
have  a  negative  impact  on  competitiveness.  For  20  of  them,  the  negative  impact  is 

261 

 
strong. This opinion was confirmed by the interviews conducted during the case study on 
the authorisation. The main elements of the authorisation process, which are identified as 
affecting  competitiveness,  are  costs,  especially  the  costs  of  efficacy  studies  which  are 
considered  disproportionate  to  real  market  needs,  and  the  time  required  from  the 
application to the approval, including the unpredictability of the process. 

The  majority  of  respondents,  across  all  groups,  consider  that  the  Regulation  provides 
benefits  for  farmers,  pet  owners,  animal  welfare,  human  health,  consumers  and  the 
environment, as well as for feed additive and compound feed producers.  

On the other hand, applicants expressed some concerns over the efficiency of the current 
implementation of the procedures laid down in Articles 4, 10 and 13, and they stress that 
there is scope for reduction of administrative burden. 

International trade  

On  exports,  a  majority  of  respondents  (35  out  of  65  –  excluding  19  ‘do  not  know’ 
responses) consider the rules applicable to the export of FA are properly addressed in the 
Regulation, while 20 respondents disagree.  

On  Imports,  a  majority  of  respondents  (40  out  of  62  –  excluding  17  ‘do  not  know’ 
responses)  consider  imports  of  FA  into  the  EU  to  be  adequately  controlled,  while  14 
respondents disagree. 

Relevance 

Most needs identified during the drafting of the Regulation are considered to have a high 
level of relevance, even though some new needs are also identified. Reduction of AMR 
threats  is  also  relevant  for  a  majority  of  respondents  (104  respondents  out  of  111). 
However, some of the “new needs” identified cannot  be regarded as  such since the  FA 
Regulation  already  covers  those  aspects;  it  is  the  case  of  the  environment,  animal 
welfare.  FeBOs  identify  some  of  them  as  “new  needs”  as  they  have  high  expectations 
placed upon those topics, which they considered were not fulfilled. 

Coherence 

Some  contradictions  and  inconsistencies  were  identified  with  the  Regulations  on  feed 
marketing (EC No 767/2009) and on the Catalogue of feed materials (EU No 68/2013). 
The  points  related  to  coherence  mainly  refer  to  the  labelling  provisions  of  the 
Regulations.  

EU added value  

The  harmonised  authorisation  procedure  achieved  better  results  at  EU  level  than  a 
national level authorisation (101 positive responses out of 110). For the harmonisation of 
labelling rules at EU level, the opinion was also positive (105 positive responses out of 
110). In addition, there is also a majority (71 positive responses out of 110) in favour of 
supporting that the EU level intervention in the FA area is still relevant. 

262 

 
3.4. SURVEY TO MS NCA 

3.4.1 Overview of the survey 

The  survey  was  sent  to  the  NCA  from  all  28  MS,  EEA  countries  and  Switzerland  and 
was open from July to September 2019. The objective was to collect data and insights on 
the implementation of the Regulation, focusing on the enforcement of the Regulation by 
the NCAS. Among others, the Commission made a presentation on the survey during the 
Standing  Committee  on  Plants,  Animals,  Food  and  Feed  in  July  2019  to  inform 
delegations on the survey. 

3.4.2. Respondents 

Altogether,  27  replies  were  received  from  25  EU  MS  (Hungary,  Romania  and  the  UK 
not participating) as well as Norway and Switzerland. 

The high rate of responses was considered very satisfactory, also taking into account that 
the  completion  of  the  questionnaire  required  coordination  of  the  NCA  in  charge  of  the 
feed legislation with other official instances (e.g., feed controls). 

5.3 Outcome 

The feedback provided in the open questions has been taken into account and synthesised 
when addressing the relevant judgement criteria and evaluation questions.   

Safety and efficacy 

MS authorities generally find that FA are safe and efficacious. 

Nearly all MS authorities consider important the use of coccidiostats and histomonostats 
as  FA to  ensure health and welfare of poultry and rabbits (24  MS authorities; no NCA 
disagreed),  well  adapted  to  current  farming  practices  (20;  1  NCA  disagreed),  and 
effectively controlled (19; 2 MS authorities disagreed); the remaining few MS authorities 
did  not  provide  a  definite  answer  (i.e.  neither  agreed  nor  disagreed  with  the  above 
statements). 

As  regards  specifically  pet  food  additives  on  the  EU  market,  nearly  all  MS  agree  that 
they  are  efficacious  and  safe  for  pet  animals  (3  MS  authorities  neither  agreed  nor 
disagreed that they are efficacious). Two of these MS authorities commented that it is not 
so  clear  what  efficacy  means  and  what  is  being  measured  in  the  case  of  pet  animals; 
adding that the efficacy of many additives used in pet food is extrapolated from their use 
in food. 

A majority of MS agree that FA on the EU market are safe for consumers  (26 NCA s) 
and one NCA does not agree neither disagree. 

Authorisation procedure 

The  authorisation  procedure  and  the  re-evaluation  procedure  are  seen  as  working  in  a 
better  way  than  the  Directive,  but  some  issues  and  scope  for  improvements  have  been 
identified.  

263 

 
Opinions on the 10-year authorisation  period are more varied. Key comments provided 
by the MS authorities who disagreed or did not provide a definite answer include that a 
10-year authorisation  can be too  short to  encourage innovation,  particularly for smaller 
companies. For FA of lower risk, a period of 20 years could be more appropriate. For FA 
of higher risk (coccidiostats), the current 10-year period is generally appropriate. The 10-
year  authorisation  period  was  perceived  as  effective  for  safety  purposes  by  a  slight 
majority  of  MS  authorities  (17  out  of  27).  Six  MS  authorities  did  not  respond  and  4 
disagree. 

The different deadlines foreseen by the Regulation are overall considered reasonable by a 
majority of MS authorities. 

A majority of MS authorities (18 out of 27) consider that the extrapolation from major to 
minor species worked well, although 3 strongly disagreed with this statement and 3 did 
not  have  an  opinion.  As  regards  the  procedure  of  extrapolation  from  food  to  feed,  a 
majority  agree  that  works  well  (16)  although,  8  neither  agree  nor  disagree  and  1 
disagrees. 

The  role  of  the  EU-RL  is  adequately  defined  in  the  Regulation  according  to  22  MS 
authorities. Only one NCA disagrees, commenting that the EU-RL competence could be 
enhanced,  e.g.,  to  support  the  national  laboratories  with  the  development  and/or 
execution of analysis, as well as the MS authorities whenever needed.  

Labelling  

Most  MS  authorities  (19)  consider  labelling  requirements  to  be  fit  for  purpose,  only  3 
MS  authorities  disagreed,  3  MS  authorities  did  not  provide  a  definite  answer.  A  key 
comment  by  the  MS  authorities  is  that  the  labelling  could  be  modernised,  with  certain 
indications potentially provided in a separate document (other than the label). 

Innovation 

 12  MS  authorities  consider  that  innovative  FA  can  be  placed  on  the  market,  4  MS 
authorities  disagreed,  and  9  MS  authorities  did  not  provide  a  definite  answer.  The  cost 
and complexity of the authorisation procedure are the main issues raised, especially for 
new  FA  for  which  functional  groups  or  performance  criteria  (endpoints)  may  not  be 
readily available. 

Efficiency 

Most  MS  authorities  consider  the  current  implementation  of  the  Regulation  to  be 
efficient although, according to 10 MS authorities, there is scope to reduce administrative 
costs.  

Relevance 

Most needs identified during the drafting of the Regulation are considered to have a high 
level of relevance, although some new needs have been identified. 

264 

 
Coherence 

Some  inconsistencies  between  the  FA  Regulation  and  the  legislation  on  feed 
materials/compound  feed,  the  CLP  legislation  and  the  biocides  legislation  were  found. 
Those  shortcomings  were  also  identified  by  stakeholders  in  the  SH  Survey  and  case 
studies. Within the FA Regulation, the main contradictions/issues identified by 9 NCAs 
were absent definitions and/or key terms. 

International trade 

Action has been taken by 19 MS to avoid that additives and premixtures not authorised in 
the EU, which are intended for export, end up on the EU market.  Six  (6)  MS have not 
taken any action. 

On  imports,  11  NCAs  consider  imports  of  FA  into  the  EU  to  be  adequately  controlled 
and  14  NCAs  consider  them  to  be  partially  controlled,  raising  concerns.  The  main 
concerns  raised  by  the  latter  NCAs  are  linked  on  to  the  absence  of  an  EU  list  of  third 
countries  from  which  FA  can  be  imported  and  on  the  lack  of  Combined  Nomenclature 
codes to identify products. 

Control 

The  controls  performed  by  MS  authorities  shows  a  good  level  of  control  and  high 
conformity.  

Infringements and penalties have been established in all MS, but they diverge.  Few MS 
provided  data  on  the  number  of  penalties  imposed  and  the  number  of  cases  where 
products  were  withdrawn  from  the  market  because  of  infringements  during  the  2011-
2015 period. This is partly due to the different administrations involved and the fact that 
there  is  no  readily  available  breakdown  of  sanctions  specifically  imposed  in  the 
FA/premixtures sector. (EM 6.9) 

EU added value 

All  MS  authorities  agreed  that  harmonisation  of  the  authorisation  procedure  at  the  EU 
level achieves better results than actions at the national level (26 MS authorities agreed 
and  one  did  not  provide  definite  answer).  For  the  harmonisation  of  labelling  rules,  MS 
authorities unanimously agreed. There was also unanimity that the EU level intervention 
in the FA area is still warranted and needs to continue. 

3.5 - NON-EU COUNTRIES SURVEY 

3.5.1 Overview of the survey 

The  targeted  survey  was  addressed  to  the  NCAs  of  eight  non-EU  countries,  which  are 
major  producers  of  FA.  These  included  Argentina,  Australia,  Brazil,  Canada,  Chile, 
China,  Japan,  and  the  USA,  as  well  as  the  representatives  from  the  industry  of  these 
countries. 

The objective of the survey is to collect information on the legal status of  coccidiostats 
and  histomonostats  (C&Hs),  how  the  procedure  of  authorisation  and  risk  assessment  is 

265 

 
conducted in third countries, and to what extent the EU system was recognised in these 
markets. The survey was open from July to September 2019. 

3.5.2 Respondents 

Six countries responded to the EU survey: Argentina, Canada, Chile, China, Japan, and 
the USA. These countries account for an estimated 40% of the world FA market, which 
is similar to the EU-28 share of the world market. 

3.5.3 Outcome 

The following aspects were examined: 

Definition and classification of FA: FA are not always defined as a distinct category and 
tend to be classified less precisely than in the EU. In some countries some EU additives 
are regarded as feed materials and do not need authorisation. In relation to the legal status 
of  coccidiostats  and  histomonostats,  they  are  regarded  as  FA  in  one  country  but  in  the 
rest  of  the  countries  they  are  veterinary  medicinal  products.  All  countries  classify 
additives but only 4 take into account the purpose of the additive (e.g., effect on the feed 
or  on  the  animal)  in  the  classification.  Those  different  approaches  on  the  scope  of  FA 
make the comparisons difficult as the evaluation and authorisation of FA may affect very 
different products depending on the jurisdiction. 

Authorisation process:  All countries have a process in place for feed additive approval, 
which  includes  a  scientific  risk  assessment.  When  compared  to  the  EU  authorisation 
process,  the  components  of  the  process  followed  in  non-EU  countries  have  generally 
lighter  requirements,  which  significantly  vary  per  country.  One  of  the  six  countries 
appears to be the most aligned to the EU, since all requirements for safety and efficacy 
assessment need to be met.  It is  followed by three countries. In most cases, these three 
countries impose similar requirements to those in the EU. The remaining two countries 
generally  apply  requirements  based  on  the  product’s  process  monograph.  One  of  these 
also  applies  more  detailed  requirements  on  safety,  namely  the  identification  and 
characterisation of the additive (e.g., purity, presence of impurities, contaminants, etc.), 
but no specific tests on the target animals. As regards worker safety, only two countries 
made test for this purpose. Furthermore, in all countries, applicants can submit additional 
information during the assessment process, and, with the exception of one country, they 
can  hold  meetings  before  formally  submitting  the  application,  mainly  for  clarification 
purposes. 

Table 1 Type of tests and aspects examined during the assessment 

ASPECTS EXAMINED-TESTS 

COUNTRIES 
4 
3 
2 

1 

Animal health 
Human health- consumers 
Human health (workers) 
Environment 
Efficacy 
Identification and characterisation additive 
Maximum residue levels in food when necessary  X  X  X 

5 
EU 
X  X  X  X  X  X 
X  X  X  X 
X  X 
X 
X  X  X  X 
X  X  X  X 
X 

X  X  X  X  X 
X  X 

X  X 
X 
X 
X 

6 

266 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
ASPECTS EXAMINED-TESTS 

Tests on target animals 
Tests for human safety 
Test for worker safety 
Tests for environmental safety 
In vitro studies 
Studies on Laboratory animals 
Studies on target animals 
Guidelines for applicants 

6 

1 

COUNTRIES 
5 
4 
3 
2 
EU 
X 
X  X  X  X 
X 
X  X  X  X 
X 
X 
X 
X 
X  X  X  X 
X 
X 
X  X 
X 
X 
X  X 
X  X  X  X  X  X 
X  X 

X  X  X  X 

Timelines:  The  time  taken  to  process  an  application  for  authorisation  can  vary 
considerably  from  one  country  to  another,  from  a  few  months  (in  the  case  of  three 
countries)  to  about  a  year  (in  the  case  of  two  countries).  Only  in  one  country,  the 
procedure can take up to several years. In this regard it seems that the EU system to get 
an  authorisation  is,  in  general,  more  time  demanding,  except  in  one  country  where  the 
deadlines may be similar or even higher. 

Renewal  of  authorisation:  The  authorisation  is  granted  on  an  indefinite  basis  in  three 
countries.  In  two  of  these  countries,  there  is  no  such  mandatory  requirement,  but  the 
authorisation  may  be  re-evaluated  based  on  the  applicant’s  request  or  new  information 
becoming available. A procedure for renewal is foreseen in the remaining three countries. 

Claims: three countries indicated that they permit claims that are proven by specific tests 
or scientific evidence during the evaluation. One country indicated that in addition to the 
clams evaluated during the authorisation they admit claims substantiated by the operator 
when the additive is placed on the market if they are in line with the regulated product. 
One country did not respond to this issue. 

Recognition to the EU authorisation: - Two  countries  (Chile  and  Canada)  appraise 
substantial parts of the EU authorisation procedure, largely because their approaches are 
relatively  aligned.  In  the  remaining  four  countries  (Argentina,  China,  Japan,  the  USA), 
the differences are considered to be too important to allow the EU authorisation process 
to be recognised when registering EU approved products in their markets. Nonetheless, 
China indicated that technical data on FA authorised in the EU is used as a reference for 
the technical assessment of these substances by the authorities in China. (EM 2.3.1) 

3.6 INTERVIEWS AND CASE STUDIES 

. 3.6.1. Overview and participants of interviews 

At the initial phase of the evaluation study, 8 exploratory interviews were carried out by 
the contractor with key stakeholders between June and September 2018 to ensure a good 
understanding  of  the  important  issues,  identify  data  gaps,  and  identify  any  challenges 
related  to  the  evaluation.  These  interviews  contributed  to  the  finalisation  of  the 
methodology and adjusting the data collection activities. Stakeholders taking part to these 
interviews  were  EU  organisations:  (EFSA,  EURL,  EC  services)  as  well  as  three 
European umbrella organisations representing FA and compound feed producers and one 
representing veterinary professionals. 

267 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In  addition,  and  in  order  to  complement  the  evidence  gathered  through  the  surveys,  12 
complementary  interviews  were  conducted  between  September  and  October  2019.  The 
interviews mainly aimed to collect further quantitative and qualitative data, especially on 
the  costs  and  impacts  of  the  FA  Regulation.  They  also  provided  stakeholders  with  the 
opportunity to highlight their experience, raise key issues that may not have been covered 
throughout  the  online  surveys,  and  clarify  some  information/data  already  provided. 
Stakeholders participating to these interviews were EU organisations (EFSA, EURL, and 
EC  services),  five  European  umbrella  organisations  representing  producers  and 
manufacturers  of  FA  and  compound  feed:  three  organisations  representing  farmers, 
poultry meat and aquaculture and one organisation representing veterinary professionals. 

Four additional interviews were made with four NCAs from Belgium, Germany, Spain 
and France). 

3.6.2. Overview and participants to the case studies 

The case studies covered two thematic areas:  

•  The authorisation process from the application to the market, covering all types of 
FA, focussing on three FA (selected from the Regulation’s functional groups, to 
represent three of the most important categories).  

•  The  labelling  of  FA,  covering  two  FA  and  two  pre-mixtures,  focussing  on  four 

MS.  

A  total  of  24  interviews  were  conducted  with  20  applicants  and  with  four  selected  MS 
(Belgium,  Germany,  Spain  and  France).  Detailed  information  on  the  case  studies  is 
available in the FCEC Final Report, Annex 4. 

3.6.3. Outcome  

Generally, all interviewed stakeholders and MS Competent Authorities consider that the 
current  FA Regulation  has been effective in  ensuring that  FA placed on the market  are 
efficacious and safe for animals, humans and the environment.  

They also agree that, in comparison to the former legislation (Directive 70/524/EEC), the 
implementation of the authorisation procedure set out in the Regulation is central to the 
achievement of a high safety standard.  

-  The  EU  industry  tends  to  consider  that  the  competitiveness  and  capacity  to 
innovate of the EU FA sector is undermined by the relatively strict requirements 
of  the  FA  Regulation,  the  time  periods  and  sometimes  ‘unpredictability’  of  the 
authorisation process. The functioning of the efficacy assessment was given as an 
example.  The  occurrence  of  some  delays  is  supported  by  the  quantitative  data 
available  from  EC/EFSA  data  on  the  timelines  of  approvals.  According  to 
applicants,  the  requirements  are  too  rigid  to  assess  the  efficacy  and  insufficient 
flexibility  in  the  Regulation  to  adapt  to  scientific  and  technical  progress  (e.g., 
creation of new functional groups takes too long, the definition of endpoints is too 
focused  on  performance  targets  etc.).  According  to  MS  Competent  Authorities, 
key  reasons  are  applicants’ 
the  (efficacy) 
requirements and data availability/cost to perform the required studies. 

insufficient  understanding  of 

268 

 
Concerns  for  EU  stakeholders  to  maintain  its  current  level  of  competitiveness  (e.g., 
livestock farmers and the aquaculture industry) fear that fewer products may be available 
for use in the future. 

The  absence  of  harmonisation  and  the  limitations  on  the  circulation  of  FA/premixtures 
only intended for export obstructs the level-playing field for all stakeholders. 

In addition, according to both the industry and MS Competent Authorities, EU producers 
are  particularly  disadvantaged  in  the  case  of  non-holder  specific  authorisations. 
Nevertheless,  SMEs  benefits  from  the  non  –holder  authorisation  as  they  do  not  bear 
authorisation costs. For additives linked to an authorisation holder SMEs try to focus on 
few species or categories of animals to reduce costs. 

From an efficiency perspective, the industry highlighted that the potential benefits are not 
yet fully realised. 10-year authorisation period: the time periods and additional requests 
for  information/data  may  lead  to  increased  costs  and  undermine  the  final  return  on 
investment (ROI).  

-  Regarding the labelling  rules (Article 16) and from  a practical  operational  point 
of  view,  the  amount  of  information  required  to  be  included  on  the  product’s 
physical label is not considered to be fit for purpose.  

-  Generally,  there  is  consensus  between  Competent  Authorities  and  business 
representatives that the Regulation is internally and externally coherent. However, 
some  issues  have  been  identified:  status  of  FA  versus  feed  materials,  the 
interaction  of  FA  legislation  with  CLP  and  Biocides  legislation,  and  lack  of 
resources in the Feed Hygiene Regulation to control imports (i.e., no list of Third-
country establishments for the NCAS and lack of efficient control of imports for 
FeBOs).  

-  Stakeholders  also  agree 

that 

the  Regulation  plays  a  positive  role 

in 
reducing/containing  anti-microbial  use,  hence  supporting  the  wider  policy 
targeted  to  reduce  AMR  threats  from  livestock  production.  However,  their 
opinions  are  different  when  dealing  with  the  technical  and  scientific  progress 
allowed  by  the  Regulation.  Business  stakeholders  remain  sceptical  on  this  last 
aspect,  which  is  also  in  line  with  their  views  on  the  negative  impacts  of  the 
authorisation procedure on competitiveness and innovation.  

-  Competent Authorities tend to have a more positive view on the implementation 

of the Regulation, including coherence and relevance of the objectives.  

-  There  is  unanimous  agreement  among  MS  Competent  Authorities  and  business 

stakeholders that the current legislation adds a great value. 

269 

 
 
 
 
ANNEX VI- SUPPORTING TABLES OR DIAGRAMS 

Table 1: list of categories and functional groups.  The new functional groups introduced 
after the adoption of the FA Regulation are indicated in bold and underlined.  

FUNCTIONAL GROUP 

1.  Preservatives 
2.  Antioxidants  
3.  Emulsifiers 
4.  Stabilisers 
5.  Thickeners 
6.  Gelling agents 
7.  Binders 
8.  Substances 

control 
radionuclide contamination 

for 

of 

9.  Anticaking agents 
10. Acidity regulators 
11. Silage additives 
12. Denaturants 
13. Substances  for  the  reduction  of 

feed by mycotoxins 

14. Hygiene condition enhancers 
15. Other technological additives 

1.  Colourants 
2.  Flavouring compounds 

1.  Vitamins, pro-vitamins and well-

defined substances having a similar 
effect 

2.  Compounds of trace elements 
3.  Amino acids, their salts and 

analogues 

4.  Urea and its derivatives. 
1.  Digestibility enhancers 
2.  Gut flora stabilizers 
3.  Substances that favourably affect the 

environment 

4.  Physiological condition stabilisers 
5.  Other zootechnical additives 

CATEGORY 

FUNCTION 
Substances added to 
feed for a 
technological 
purpose 

TECHNOLOGICAL 
ADDITIVES 

SENSORY 
ADDITIVES 

NUTRITIONAL 
ADDITIVES 

ZOOTECHNICAL 
ADDITIVES 

Substances that 
improve/change the 
organoleptic 
properties of feed or 
the visual 
characteristics of 
food derived from 
the animal 
Substances that 
improve the 
nutritional values of 
feed 

Substances that 
favourably affect the 
performance of 
animals in good 
health or the 
environment 

COCCIDIOSTATS 
AND 
HISTOMONOSTATS 

Substances intended 
to kill or inhibit 
protozoa (parasites) 

270 

 
 
 
Table 2 EFSA guidance 

GUIDANCE 

Guidance on the assessment of the safety of FA for the target species 
Guidance on the assessment of the safety of FA for the consumer 
Guidance on the identity, characterisation and conditions of use of FA  
Guidance on the characterisation of microorganisms used as FA or as 
production organisms 
Guidance on the assessment of the efficacy of FA 
Guidance on the assessment of the safety of FA for the environment  

DATE OF 
ADOPTION 
26/09/2017 
27/09/2017 
27/09/2017 
21/02/2018 

17/04/2018 
27/02/2019 

Figure 1: number of applications for microorganisms 

S
N
O
I
T
A
C
I
L
P
P
A
F
O
R
E
B
M
U
N

16

14

12

10

8

6

4

2

0

2015

2016

2017

2018

YEAR

2019

2020

2021

271 

 
 
 
 
 
 
 
ANNEX VII- FA MARKET DATA 

Figure 1: Estimated value for different types of FA in the EU in 2020. 

ESTIMATED VALUE IN 2020

E
V
I
T
I
D
D
A
F
O
E
P
Y
T

Others
Coccidiostats
Acidifiers
Minerals
Binders
Pigments
Flavours and Sweeteners
Probiotics
Mycotoxin Detoxifiers
Enzymes
Amino Acids
Antioxidants
Vitamins

5507

599

272

390
460

1005

865

1150

1029

930

1572

1150

803

1000

0

2000

3000

4000

5000

6000

MILLION EUROS

Source:  Mordor  Intelligence,  2022.  Note:  Data  provided  by  Mordor  Intelligence 
have been converted from USD to Euro at the exchange rate of 1 USD = 0.87 Euro. 
Coccidiostats are estimated by the Commission as 35% value of all additives 

Table 1.  Estimate of the value of the EU feed additive market by type of animal, 2016-
2026, EUR millions 

Animal Type 

2016 

2017 

2018 

2019 

2020 

2021E 

2026F 

Ruminant 

2,747  

2,818   2,894  

2,975   3,064  

3,165   3,928  

Poultry  

Swine 

3,352  

3,484   3,624  

3,775   3,938  

 4,117   5,034  

3,050  

3,167  

 3,292  

3,425   3,570  

3,724   4,640  

Aquaculture 

326  

 339  

352  

366  

381  

398  

507  

Other Animal Types 

563  

563  

563  

563  

 562  

561  

668  

Total 

10,038   10,371   10,725   11,103   11,516   11,965   14,777  

Source  Mordor  intelligence.  Note:  Data  provided  by  Mordor  Intelligence  have  been 
converted from USD to Euro at the exchange rate of 1 USD = 0.87 Euro. Projection of 
2021-2026 calculated based on the base year 2020.    

In the table above, the use of coccidiostats and histomonostats is not included, therefore 
the major consumption of FA is for poultry followed far behind by swine. 

Based on different data as indicated above: 

272 

 
 
 
 
• 

In  2020,  FA  had  a  turnover  of  €15,  7  billion.  The  compound  feed  production  in 
2019 amounts to 55.6 billion euros253, FA represented around 25% of the value of 
compound feed in that year.(EM 2.1.8) According to FEFAC, in 2020, the EU-27 
compound feed industry produced 150.2 mt. (mio ton) of feed, consuming 76 mt. 
of feed cereals, 37.9 mt. of cakes and meals, 17.7 mt. of co-products from food & 
bioethanol industries, 5.1 mt. of minerals, additives & vitamins, 2.5 mt. of oils & 
fats,  2.3  mt.  of  dried  forage,  2.2  mt.  of  pulses  and  5.7  mt.  t.  of  all  other  feed 
materials (e.g. former foodstuffs, straw, microbial biomass, etc.). If we made the 
assumption  that  the  production  of  FA  is  around  5  mt.,  this  represents  3,  3%  in 
volume  in  relation  to  compound  feed.  If  we  considered  that  in  2020,  109  mt.  of 
feed materials were used in the farm, the volume of additives represents 5% of all 
feed materials used in the farm in volume. The economic value of feed materials is 
not available and does not allow the calculation in relation to the value of FA.  
•  The current turnover of the EU-27 premixtures sector is estimated to be about €1.6 
billion  in  2021–  this  corresponds  to  about  a  volume  1  mt.  of  products.  254.  This 
represents  around  0.5%  in  volume  and  29´%  in  value  in  relation  to  compound 
feedingstuffs. 

The  feed  market  depends  on  the  livestock  products  market.  The  value  of  livestock 
production in 2020 – amounting to €151 billion – accounts for 41% of the total value of 
farm production. More than half of its amount (82 bio €) is then created by beef & veal, 
and dairy animal products, followed by pigs, poultry & eggs and other animal products 
(i.e.,  sheep,  goats,  etc.).  The  overall  EU-27  agricultural  output  production  was  €389 
billion in 2020.255: 

Figure 2: Production of meat from slaughterhouses, by species, EU27, 2010-2019 
(million tonnes carcass weight) 

253 Feed and Food. Statistical Yearbook 2021- FEFAC 
254 2018 Report by RM Associates Ltd 
255 Feed and Food. Statistical Yearbook 2021- FEFAC 

273 

 
 
 
Figure 3 Annual growth rates of EU milk production, fat and non-fat milk solids 
availability. 2010 and 2020 represent the 2008-2010 and 2018-2020 averages. 

Source EUROSTAT. EU AGRICULTURAL OUTLOOK 2020-2030 

274 

 
 
 
ANNEX VIII- AUTHORISATION PROCESS AND LABELLING REQUIREMENTS 

Figure 1: authorisation process 

An  application  may  contain  one  additive  (example  1)  or  several  additives  (example  3). 
During the authorisation process, the applicant may withdraw the authorisation of one or 
several additives included in the application (example 4). It is also possible that several 
applications  with  different  EFSA  opinions  are  grouped  and  adopted  through  one 
Regulation  (example  2).  One  authorising  Regulation  may,  therefore,  authorise  one 
additive  or  several  additives  from  the  same  application  (example  1)  or  from  different 
applications  (example  2).  The  number  assigned  by  the  Commission  to  an  application 
(SANTE  number)  is  different  from  the  number  assigned  by  EFSA  (FAD  number).  In 
addition,  if there is  a request  for a second opinion, EFSA assigns a new number to  the 
second request of opinion so that it regards this second request as a new application while 
for the Commission is the same application with the same SANTE number (example 3). 
See the figure below to understand the examples.  

The EFSA database and the SANTE database are developed independently, therefore the 
data have been analysed separately. 

275 

APPLICANT:  HOLDER AUTORISATION AND NON-HOLDER AUTHORISATION COMMISSIONEFSADOSSIERAPPLICATIONMANDATE TO EFSAPOSITIVE EFSA OPINION5IS (INCLUDING THE METHOD OF ANALYSIS)FAVOURABLE VOTE SCoPAFFADOPTION BY THE  COMMISION OF THE AUTHORISING REGULATION OF AN ADITIVE LINKED TO THE AUTHORISATION HOLDER ADOPTION BY THE  COMMISION OF THE AUTHORISING REGULATION NOT LINKED TO AN AUTHORISATION HOLDER DRAFT IMPLEMENTING REGULATIONRISK ASSESSMENTRISK MANAGEMENTEURLVALIDATED METHOD OF ANALYSISSAMPLES + METHOD OF ANALYSIS 
 
Figure 2: examples of authorisation process 

Re-evaluation of existing products:  

The  figure  below  illustrates  the  process  for  the  re-evaluation  of  ‘existing  products’. 
The deadline to submit applications for the re-evaluation of most of the products (i.e., 
additives which were authorised without a time limit) was 8/11/2010. In consultation 
with  EFSA,  a  detailed  calendar  listing  in  order  of  priority  the  different  classes  of 
additives to be re-evaluated was laid down, due to the high number of products to be 
re-evaluated.  This  prioritisation  de facto extended the authorisation  period for some 
FA such as colourants or flavourings that were not considered as first priorities. The 
re-evaluation  process  is  now  almost  completed,  except  for  some  colourants  and 
flavourings for which the re-evaluation started later. 

276 

APPLICATION SANTE No XX- (ONE ADDITIVE) POSITIVE OPINIONAPPLICATION-SANTE No XXX- (THREE ADDITIVES)EFSA APPLICATION  FAD No YYYONE AUTHORISING REGULATION INCONCLUSIVE OPINIONPOSITIVE OPINIONREQUEST OF OPINIONEFSA APPLICATION FAD No  ZZZZONE AUTHORISING REGULATIONREQUEST OF OPINIONREQUEST OF SECOND OPINION   ADDITIVES AUTHORISED   ADDITIVE AUTHORISEDAPPLICATION-SANTE No XXXX- (THREE ADDITIVES)REQUEST OF OPINIONEFSA APPLICATION  FAD No YYYYYPOSITIVE OPINION FOR TWO ADDITIVES AND INCONCLUSIVE OPINION FOR ONE ADDITIVETHE APPLICANT WITHDRAW THE APPLICATION FOR THE ADDITIVE WITH INCONCLUSIVE OPINIONEFSA APPLICATION FAD No YYONE AUTHORISING REGULATION  ADDITIVES AUTHORISEDAPPLICATION SANTE No XXD (ONE ADDITIVE)APPLICATION SANTE No XXM (ONE ADDITIVE)REQUEST OF OPINIONREQUEST OF OPINIONEFSA APPLICATION FAD No YYDEFSA APPLICATION FAD No YYMPOSITIVE OPINIONPOSITIVE OPINIONONE AUTHORISING REGULATION  ADDITIVES AUTHORISEDEXAMPLE 1EXAMPLE 2EXAMPLE 3EXAMPLE 4  ADDITIVE WITHDRAWN 
 
 
 
 
Figure 3: re-evaluation process. Article 10(2) of the FA Regulation  

DATA ON AUTHORISATIONS  

Authorisations by type of authorisation: holder-specific or non-holder specific 

236  of  the  additives  authorised  under  the  2003  FA  Regulation  by  May  2021256  were 
issued to a holder. These were zootechnical additives, coccidiostats or additives that are 
genetically modified or produced from GMOs. Linking of authorisations of these critical 
additives  to  an  authorisation  holder  significantly  improved  control  and  traceability  by 
allowing the person responsible for placing the additive on the market to be identified at 
every step along the feed chain.  

By  May  2021,  1,212  additives  had  received  a  ‘generic’  (i.e.,  non-holder  specific) 
authorisation  under  the  FA  Regulation.  These  generic  authorisations  covered  the 
following categories: technological, sensory and nutritional additives.   

Authorisation by type of purpose 

1.  Authorisation of new FA or new uses covered by a 10-year authorisation period: 
Over the period 2004-2017, there were 382 applications257 for new substances (e.g., a 
new  enzyme,  a  new  vitamin  etc.)  or  for  a  new  use  of  a  substance  already 
authorised258. EFSA evaluated 398 applications for a new feed additive or for a new 
use of a feed additive. 

The  authorisation  procedure  is  the  same  for  FA  with  or  without  holder-specific 
authorisation  status.  It  is  the  responsibility  of  the  applicants  for  authorisation  to 
present  a  dossier  with  all  the  data  required  to  demonstrate  that  the  authorisation 
conditions are met, to be assessed by EFSA. The sole difference is that in the case of 

256 Register of FA. Edition 292 May 2021: 1 nutritional additive produced from a GMO, 210 zootechnical 

additives and 25 coccidiostats. 

257   As  one  authorisation  may  cover  one  or  several  additives,  the  yearly  number  of  additives  authorised 
may be higher than the number of authorisations. Among the 382 applications,  4% were applications 
for  coccidiostats,  5%  for  sensory  additives,  14%  for  technological  additives,  18%  for  nutritional 
additives and 59% were zootechnical additives. 

258   Article 4(1) of the FA Regulation. 

277 

 
 
 
non-holder specific authorisations, any person complying with the specifications and 
requirements of the authorisation act, concerning that specific FA, is allowed to place 
the  additive  on  the  EU  market  and  use  it.  If  there  is  any  issue  with  an  ongoing 
application, the applicant is responsible (e.g., need to provide additional information 
to  EFSA  to  clarify  certain  issues,  deposit  three  samples  in  the  EU  Reference 
Laboratory for FA –EURL-etc.). If there is any issue with an authorised FA which is 
non-holder  specific  (e.g.,  in  the  authorising  Regulation  the  purity  is  95%  but  the 
additive  placed  on  the  market  by  an  operator  is  90%),  the  principle  of  primary 
responsibility of operators to comply with EU legislation applies (cfr. General Food 
Law and specific provision concerning the ‘Supervision’ in the FA Regulation). 

2.  Re-evaluation  of  existing  products:  409  applications  for  re-evaluation  of  existing 
products  were  submitted  during  the  period  2004-2017  to  the  Commission.  In 
addition, 1,743 additives were totally or partially withdrawn from the market259 as no 
application  for  their  re-evaluation  was  submitted  in  time  (1,623)  or  were  totally  or 
partially withdrawn during the re-evaluation process (120)260 (EM1.1.4, 1.1.5). 

3.  Modification  of  existing  authorisations261:  During  the  period  2004-2019,  62 
applications262  for  modifications  covering  91  additives  were  submitted  by 
authorisation holders, and 59263 related Regulations were adopted.  

4.  Inconclusive  opinions:  15%  of  EFSA  opinions  are  estimated  to  be  inconclusive 
(IL1.5.4). In those cases, the Commission informs the applicant about the outcome of 
the  opinion  and  asks  him  if  he  wants  to  submit  complementary  information.  If  the 
applicant  agrees, a second opinion is requested from  EFSA on the basis of the new 
information submitted by the applicant. In this case, the legal basis for requesting this 
second EFSA’s opinion is Article 29(1) of the General Food Law. 

5.  For  6  additives,  the  authorisation  was  denied  following  the  EFSA  opinion 

(EM1.1.7).  

6.  Renewal  of  authorisations264  after  the  10-year  authorisation  period:  The 
applications  for  renewal  started  in  2017.  During  the  period  2017-2021,  65 
applications  for  renewal  were  submitted.  The  average  time  for  the  assessment  was 
around 10 months (EM1.3.8). The authorisation procedure did not suffer from major 

259   ‘Partially withdrawn’ means that the applicant withdraws for one or more additives (if the application 
contains several additives), withdraws for certain species/categories of animals or for certain uses (e.g., 
use in water for drinking). 

260  Additives authorised before the entry into force of the FA Regulation (‘existing products’) had to be re-
evaluated according to the conditions of the  FA Regulation. To be kept on the market, an application 
for re-evaluation had to be submitted within 7 years after the entry into force of the FA Regulation or 1 
year before  the  expiry date  (for  those  authorised  with  a  time  limit)  and  could  be  kept on  the  market 
until  their  re-evaluation  was  completed.  EFSA  evaluated  423  applications  for  existing  products 
(Article  10(2)  of  the  FA  Regulation).  This  exercise  is  almost  completed  for  the  majority  of  the 
functional groups.  

261   According to Article 13 of the FA Regulation, the Commission - after examining the EFSA opinion -
may decide to modify, suspend or revoke an authorisation, if the authorisation does no longer meet the 
conditions set out by the FA Regulation. In addition, a holder of authorisation may propose to change 
the terms of that authorisation. 

262   Estimation based in EFSA database and data from EURLEX. 
263   The reference is the date of adoption of the act. 
264   Article 14 of the FA Regulation. 

278 

 
 
delays as normally there were no contentious issues to consider. A large number of 
renewals are expected to take place during the next few years given the expiry date 
of the existing corpus of authorisations (2023: 32, and 2024: 56).  

7.  Urgent  authorisations265:  2  applications  were  received  under  the  FA  Regulation, 
which allows “in specific cases, where urgent authorisation is needed to ensure the 
protection of animal welfare, to provisionally authorise the use of an additive for a 
maximum period of 5 years” (e.g., lack of a vitamin that may have a negative impact 
on an animal’s health of well-being). In both cases, MS rejected the request on the 
grounds that animal health and welfare were not deemed to be compromised.  

Figure 4: Regulations adopted/additives authorised266. 

N UMBE R  O F 
REG ULAT I O N S A DO PT E D

0
7

1
7

NUMBE R  O F  A DDI T I VES 
AUT HO RI SE D

4
7
2

1
6

4
5

0
5

3
4

0
4

S
N
O
I
T
A
L
U
G
E
R
F
O
R
E
B
M
U
N

9
2

4
2

3
2

1
1

5

1

5
0
0
2

6
0
0
2

7
0
0
2

8
0
0
2

9
0
0
2

0
1
0
2

1
1
0
2

2
1
0
2

3
1
0
2

4
1
0
2

5
1
0
2

6
1
0
2

7
1
0
2

YEAR OF ADOPTION OF THE REGULATION 
AUTHORISING THE ADDITIVES

S
E
V
I
T
I
D
D
A
F
O
R
E
B
M
U
N

6
0
1

3
8

9
9 6

0 5
5

1
4

4
2

9
3 2

1 2
1

1 5

YEAR OF ADOPTION OF THE REGULATION 
AUTHORISING THE ADDITIVES

LABELLING RULES (Article 16 of the FA Regulation) 

Labelling requirements for FA:  

The  labelling  must  be  done  by  way  of  a  physical  label  and  is  the  responsibility  of  a 
producer, packer, importer, seller or distributor which must be established in the EU. It 
must contain the following information:  

•  Name  of  the  additive  and  name  of  the  functional  group  as  mentioned  in  the 

authorisation 

•  Name and address of the business or person responsible for the label 
•  Weight or volume 
•  Approval number of the establishment267 (where appropriate) 

265   Article 15 of the FA Regulation. 
266   As  one  authorisation  may  cover  one  or  several  additives,  the  yearly  number  of  additives  authorised 

may be higher than the number of authorisations. 

267 Some Feed establishments need to be approved by the Member State competent authority in accordance 

with the Feed Hygiene Regulation  

279 

 
 
 
 
 
 
 
•  Directions for use, any safety recommendations on the use and specific labelling 

requirements mentioned in the authorisation 

•  Specific  requirements  mentioned  in  the  authorisation,  including  animal  species 

and categories for which the feed additive or the premixture is intended 
Identification number of the additive, batch reference and date of manufacture.  

• 

Additional requirements may apply depending on the type of additive (cfr. Annex III of 
the FA Regulation): for example, for microorganisms the number of colony-forming 
units per gram must be specified. When an additive may be affected by storage 
conditions over the time, an expiry date must be specified.   

Labelling requirements for premixtures:  

For premixtures, the same labelling obligations apply, but for additives incorporated into 
premixtures it is only necessary to indicate the name of the additive and of the functional 
group,  the  identification  number  of  each  additive  and  the  weight  or  volume  of  each 
additive in the premixture. In addition, the word “premixture” must appear on the label. 
If the premixture contains feed materials as carriers, those carriers need to be declared. If 
the  carrier  used  is  water,  the  moisture  content  of  the  premixture  is  mandatory.  Finally, 
only  one  minimum  storage  life  may  be  indicated  in  respect  of  each  premixture  as  a 
whole;  such  minimum  storage  life  shall  be  determined  on  the  basis  of  the  minimum 
storage life of each of its components. 

Relation between labelling and safety 

The  identification  of  the  additive,  the  indication  of  the  animal  species  for  which  the 
additive  or  premixture  is  intended,  the  level  of  incorporation  of  the  additive  in  the 
premixture (related to the maximum level permitted for certain additives) and the safety 
recommendations  on  the  use  of  the  additive  allow  using  those  additives  safely  and 
guarantee that the maximum doses are not exceeded as this may impact on the health of 
animals, workers, consumers (cfr. more residues than permitted) or the environment (cfr. 
excretion of metabolites or the additives at levels that are not safe for the environment). 
The safety of animals is thus warranted through the indication of the animal species for 
which the feed additive may be used (e.g., xylitol is toxic for dogs, but it can be used in 
other species) and the doses permitted for each species. 

280 

 
 
 
ANNEX  IX-  DETAILED  ANALYSIS  OF  MISSING  DEFINITIONS  AND  PROVISIONS 
OPEN TO SOME CLARIFICATIONS 

MS national authorities and FeBOs noted the absence of certain definitions and 
insufficient clarity of certain provisions namely:   

−  The correct categorisation of FA in relation to “processing aids”.  

−  The  establishment  of  additional  conditions  of  authorisation  regarding  “maximum 

recommended levels” or “recommended levels” (see 1.4.3.4 Annex III). 

−  The  legal  status  for  certain  additives:  preparations  are  not  defined  as  such  and  the 
introduction of such definition could not be done by implementing rules, requiring a 
modification  of  the  FA  Regulation.  To  mitigate  this  absence  of  formal  definition, 
some provisions on the compositional and labelling requirements were introduced in 
2015 by implementing rules (more information in 3.1.1 Annex III). 

−  Use of additives in drinking water: clarity on the use of FA in drinking water could 
be improved. The definition of FA refers to the use of all additives in drinking water, 
but  Article  6  and  Annex  I  of  the  FA  Regulation  restrict  the  use  of  FA  in  drinking 
water  to  certain  functional  groups.  Consequently,  applicants  withdrew  their 
applications  for  789  flavourings  for  use  in  water  for  drinking  that  were  only 
authorised in feed (EM 6.6). This unveiled a need to improve coherence between the 
definition  and  the  provisions  of  Article  6  and  Annex  I.  In  addition,  FeBOs  have 
requested  more  technical  clarity  on  the  practical  implementation  of  the  use  of 
additives in drinking water (see 1.4.3.1 and 1.8.4 of Annex III).  

−  Comprehensive evaluation of few additives that may be intended for farmed non-food 
producing animals: it could be necessary to introduce some clarification regarding the 
environmental safety requirements applicable to farmed non-food producing animals 
(e.g.,  fur  animals)  in  order  to  accommodate  the  requirements  related  to  the  safety 
criteria laid down in the FA Regulation and in EFSA Guidance268. This situation did 
not affect the safety for the environment as EFSA already performed this assessment 
and  no  application  specifically  addressing  this  type  of  animals  was  submitted.  The 
authorisations granted for all animal species (including non-food producing animals) 
have considered the environmental impact of the additives concerned. Nevertheless, 
for  future  possible  applications  addressed  specifically  to  those  animals  this  issue 
needs to be examined. 

−  Finally,  the  absence  of  harmonised  and  specific  labelling  requirements  for  FA  and 
premixtures only intended for export is another element that does not bring lightness 
to the system (see 1.4.3.7 Annex III). 

268  Guidance on the assessment of the safety of FA for the environment. EFSA Journal 2019;17(4):5648. 

281