COMMISSION STAFF WORKING DOCUMENT ... Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the overall operation of official controls performed in Member States (2017-2018) to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
Date: 2020-11-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal welfare, food inspection, food safety, marketing standard, organic farming, plant health legislation, public health, veterinary legislation

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 24.11.2020  SWD(2020) 283 final  COMMISSION STAFF WORKING DOCUMENT ... Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the overall operation of official controls performed in Member States (2017-2018) to   ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products {COM(2020) 756 final}  
 
 
Table of contents 

1. 

INTRODUCTION ....................................................................................................... 1 

2.  COMMISSION CONTROLS IN MEMBER STATES .............................................. 1 

2.1.  Horizontal issues ............................................................................................... 3 
2.2.  Food safety ........................................................................................................ 4 
2.3.  Feed safety ......................................................................................................... 9 
2.4.  Animal health .................................................................................................. 11 
2.5.  Animal welfare ................................................................................................ 12 
2.6.  Plant health ...................................................................................................... 14 
2.7.  Pesticides ......................................................................................................... 16 
2.8.  Antimicrobial resistance (AMR) ..................................................................... 19 
2.8.1.  Monitoring  of  residues  of  veterinary  medicinal  products  and 
environmental  contaminants  in  animals  and  products  of 
animal origin ...................................................................................... 20 
2.9.  Organic production .......................................................................................... 20 
2.10.  Quality schemes for agricultural products and foodstuffs ............................... 21 
2.11.  Import controls ................................................................................................ 21 
2.12.  Genetically Modified Organisms .................................................................... 22 

3.  BTSF ......................................................................................................................... 23 

4.  FOLLOW UP OF AUDIT RECOMMENDATIONS ............................................... 24 

 
 
 
 
 
 
1. 

INTRODUCTION 

The  Commission  is  required  to  publish  an  annual  report  on  the  overall  operation  of 
official  controls  in  Member  States1.  The  report  is  to  be  based  on  the  annual  reports 
submitted  by  the  national  authorities  on  their  control  activities2  and  on  the  results  of 
Commission controls carried out in Member States.  

This staff working document provides further detail on Commission controls in the areas 
of  food  and  feed  safety,  animal  and  plant  health,  animal  welfare,  pesticides,  organic 
farming and quality schemes3. 

The  following  chapters  present  issues  of  particular  interest  from  the  above  mentioned 
controls undertaken by Commission services during 2017 and 2018. 

The  Better Training  for  Safer  Food  (BTSF) programme is  one of the tools  used by the 
Commission  to  share  information  on  conclusions,  good  practices  or  lessons  learned 
during its control activities.  

2.  COMMISSION CONTROLS IN MEMBER STATES 

Within  the  framework  for  European  Union  (EU)  controls,  Commission  services 
undertake audits to verify compliance with feed and food law, animal health and welfare, 
and the requirements for official controls.  

The Directorate-General for Health and Food Safety establishes a multi-annual audit and 
analysis programme in line with the key Commission strategic priorities. The 2017-2018 
audit and analysis programmes focused on: 

antimicrobial resistance (AMR) management; 

• 
•  better  preparedness,  prevention  and  response  to  human,  animal  and  plant  health 

threats; 
safe and sustainable food and food production systems; 
effective implementation of EU food legislation; 
a sustainable food production that improves the welfare of animals; 
effective, efficient and reliable controls. 

• 
• 
• 
• 

Audit  reports  contain  recommendations  to  address  identified  shortcomings.  The  audit 
reports,  Member  States’  action  plans  to  address  the  recommendations,  and  country 
profiles  documenting  progress  with  the  delivery  of  these  plans  are  published  on  the 

1  Article 114 of Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 
2017  on  official  controls  and  other  official  activities  performed  to  ensure  the  application  of  food  and 
feed law, rules on animal health and welfare, plant health and plant protection products. 

2  Article 113(1) of Regulation (EU) 2017/625. 
3  Report from the  Commission to the  European Parliament  and the  Council  On  the overall operation of 
official  controls  performed  in  Member  States  (2017-2018)  to  ensure  the  application  of  food  and  feed 
law, rules on animal health and welfare, plant health and plant protection products. 

1 

 
                                                           
Commission website4, providing stakeholders and citizens with a factual and transparent 
account of how Member States deliver on correct implementation of EU law. 

In  addition,  overview  reports  are  produced  for  most  audit  series.  Their  purpose  is  to 
provide  a  comprehensive  picture  of  controls  carried  out  by  Member  States  in  a  given 
area,  and  to  identify  issues  that  are  relevant  to  all  Member  States.  Moreover,  they 
highlight  good  practices  as  well  as  difficulties  encountered  with  the  implementation  of 
the relevant legislation. These overview reports are published and an overview and links 
can be found online5. 

In 2017 and 2018, the Commission published 22 overview reports on its audit and non-
audit  activities  in  the  areas  of  food  safety  and  quality,  animal  health  and  welfare,  and 
plant health: 

• Use of slaughterhouse data to monitor welfare of broilers on farm 

• Educating professionals on animal welfare 

• Study visits on rearing pigs with intact tails 

• Hazards and management of risks in the feed sector 

• Rabies eradication in the EU 

• Pesticide residue control in organic production 

• Animal health controls in zoos and laboratories 

• Audits of official controls in EU-Member States 

• Authorisation of plant protection products 

• Antimicrobial resistance monitoring in zoonotic and commensal bacteria 

• Marketing and use of plant protection products 

• Identification and response to new plant health risks 

• Sustainable use of pesticides 

• Official control systems in place for food additives and smoke flavourings 

• Welfare of dairy cattle 

• Private assurance schemes in the feed sector 

• Mitigation measures in place for Campylobacter spp. in poultry 

• Welfare of commercially farmed rabbits in the EU 

• Antimicrobial Resistance - Prudent use of antimicrobials in animals 

• Third countries’ National Policies and Measures on Antimicrobial Resistance 

• Veterinary Preparedness for Natural Disasters 

4  https://ec.europa.eu/food/audits_analysis_en 
5  https://ec.europa.eu/food/audits-analysis/overview_reports/index.cfm 

2 

 
                                                           
• Animal Health Controls for Bivalve Mollusc Aquaculture 

2.1.  Horizontal issues 

National audit systems: audits of official control systems 

Between  2016  and  2018,  the  Commission  Services  conducted  a  series  of  25  audits  in 
Member States, to evaluate their systems for auditing6 their official control programmes. 

The vast majority of relevant competent authorities had put audit arrangements in place 
covering most official control activities concerned, and, in some cases, going beyond this 
scope.  

The  overall  conclusion  of  the  audit  series  was  that  effectively  implemented  audit 
arrangements  contribute  to  ensuring  the  quality,  and  improving  the  consistency  and 
effectiveness  of  official  controls,  if  there  is  strong  management  commitment  to  the 
follow-up of audit recommendations.  

The  audit  series  showed  that  competent  authorities  still  faced  some  challenges  in 
optimising  audit  arrangements  to  provide  credible,  reliable  results  that  have  a  positive 
impact on the effectiveness and consistency of official controls. 

The  Commission  audits  were  well  accepted  and  appreciated  by  the  auditees  and  the 
outputs were helpful to improve the consistency and effectiveness of official controls. 

The identified areas for improvement were ensuring the independent scrutiny of the audit 
process, auditing effective implementation and suitability of official controls, effectively 
following-up  audit  results,  planning  the  audit  programmes  using  a  risk-based  approach 
the  organisation. 
and  guaranteeing 
Improvements  in  these  areas  would  further  contribute  to  the  credibility,  reliability, 
relevance and impact of national audit systems. 

the  audit  process  outside 

transparency  of 

In addition, the overview report7 highlighted useful practices, which may be of interest to 
the Member States. The outcome of this audit series influenced the forthcoming revision 
of the guidelines for the conduct of these audits of official control systems8. 

6  Article 4(6) of Regulation (EC) No 882/2004 of the European Parliament and of the Council  of 29 April 
2004  required  that  competent  authorities  carry  out  internal  audits  or  may  have  external  audits  carried 
out,  and  respond  appropriately  in  the  light  of  their  results,  to  ensure  that  they  are  achieving  the 
objectives  of  Regulation  (EC)  No  882/2004.  This  requirement  has  been  taken  over  by  Article  6  of 
Regulation (EU) 2017/625. 

7  Overview report 2018-6810 Audits of official controls in EU Member States. 
8  Commission  Decision  2006/677/EC  of  29  September  2006  setting  out  the  guidelines  laying  down 
criteria for the conduct of audits under Regulation (EC) No 882/2004 of the European Parliament and of 
the Council on official controls to verify compliance with feed and food law, animal health and animal 
welfare rules. 

3 

 
 
  
                                                           
2.2. 

Food safety 

Fipronil 

During  2017,  and  in  the  wake  of  the  fipronil  contamination  incident9,  the  Commission 
services carried out four fact-finding missions.   

The  main  objective  was  to  gather  information  regarding  the  incident,  the  operation  of 
official controls and the actions taken by the Member States during this incident.  

The  missions  also  sought  to  identify  the  challenges  and  difficulties  encountered  by  the 
Member  States  concerned,  including  the  communication  with  other  relevant  Member 
States  and  with  the  Commission.  The  overall  aim  was  to  contribute,  with  information 
obtained on-the-ground, to a complete picture of the incident and to identify the lessons 
to be learned with a view to improving, where necessary, the tools10 available at EU level 
for the management and containment of similar incidents. 

In  the  four  Member  States  concerned,  the  contingency  plans  in  place  satisfactorily 
addressed the incident. Equally, and despite considerable difficulties, traceability of eggs 
back to the farms of origin was overall successful. Nonetheless, certain factors affected 
the  speed  of  response  to  the  incident,  notably  initial  delays  in  communication  between 
Member States and subsequent difficulties, at different stages of the incident, including 
the need to rapidly respond to and disseminate updated information. These factors may 
have contributed to the extent of the impact of this incident. 

Competent  authorities  as  well  as  food  business  operators  devoted  significant  efforts  to 
address  the  incident.  A  number  of  key  challenges  encountered  throughout  the 
management of the incident included the interpretation of laboratory results, the handling 
of  large  amounts  of  information  updates,  and  issues  related  to  the  destruction  of  the 
contaminated products and materials. 

The  Commission  introduced  a  number  of  concrete  initiatives  aimed  at  supporting  and 
ensuring  a  harmonised  approach  among  Member  States  in  the  management  of  the 
incident.  These  initiatives,  agreed  by  the  Member  States  at  the  Ministerial  conference 
that took place in Brussels on 26 September 2017, addressed a number of the challenges 
as  subsequently  confirmed  by  the  fact-finding  missions.  The  initiatives  included  the 
enhancement  and  coordination  of  the  risk  assessment,  risk  management  and  risk 
communication  for  such  incidents,  the  development  of  provisions  to  strengthen  the 
existing  flexibility  in  residue  monitoring,  the  enhancement  of  the  exchange  of 
information and maximising the potential of the RASFF and AAC systems at EU level. 

9  The  2017  Fipronil  eggs  contamination  was  a  fraud  incident  leading  to  the  contamination  of  chicken 

eggs and egg products by the insecticide fipronil. 

10  Tools such as the Rapid Alert System for Food and Feed (RASFF), the Administrative Assistance and 

Cooperation System (AAC) and the Food Fraud network. 

4 

 
                                                           
Slaughter hygiene 

The slaughter hygiene project, which concluded in 2017, consisted of study visits in 15 
Member  States  and  Norway  and  a  series  of  associated  workshops  attended  by 
representatives of Member States, Switzerland, Norway, Iceland and the European Free 
Trade Association Surveillance Authority. The project identified and shared a number of 
competent authorities' working practices with a positive impact on slaughter hygiene, and 
thus on consumer protection.  

The  study  visits  and  workshops  presented  working  practices  in  place  in  the  countries 
visited,  aimed  at  addressing  problems  encountered  by  all  competent  authorities  and 
ensuring  optimal  slaughter  hygiene  and  minimum  levels  of  carcass  contamination.  The 
experts  reported  that  they  appreciated  the  opportunity  to  see  how  other  competent 
authorities worked and to share ideas and experiences. The Commission noted that some 
particularly  effective  working  methods  were  subsequently  taken  up  by  a  number  of 
Member States.   

The  participating  Member  States  shared  a  number  of  their  working  arrangements  and 
practices to support their verification and controls such as: "clean livestock policy”11, on-
line clipping of livestock, carcass  contamination recording systems, official verification 
procedures for carcass contamination, pooling technical and managerial responsibilities, 
sampling  and  analysis  performed  by  competent  authorities  on  microbiological  criteria, 
risk profiling of slaughterhouses and publication of official control results.  

In  addition,  this  series  of  study  visits  highlighted  a  number  of  key  elements  found  in 
environments  that  are  conducive  to  good  slaughter  hygiene.  These  elements  include 
among others the existence of well-organized and committed processors' associations, the 
availability  of  strong  vocational  education  in  the  sector  and  company  policies  to  retain 
skilled staff. Also underlined was the importance of slaughterhouse operators having well 
thought-out  and developed slaughtering techniques,  and for  competent  authorities to  be 
aware of these and to have a positive attitude towards new developments in this area. 

Labelling 

The objective of this audit series, carried out  in  eight  Member States, was to  obtain an 
overview  of  the  performance  of  Member  States'  official  control  systems  on  the 
implementation  of  the  relevant  national  and  EU  legislation12  on  food  information  to 
consumers and nutrition and health claims made on foods at producers, importers and all 
points of entry in the market.  

While the majority of the Member States audited perform official controls in this area, in 
a  number  of  cases,  the  coverage  of  such  controls  on  food  information  was  limited.  In 

11  See the COMMISSION STAFF WORKING DOCUMENT Guidance document on the implementation 
of  certain  provisions  of  Regulation  (EC)  No  853/2004  on  the  hygiene  of  food  of  animal  origin 
(paragraph 5.2) for more background to the cleanliness of the animals going to slaughter. 

12  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the  provision  of  food  information  to  consumers  and  Regulation  (EC)  No  1924/2006  of the  European 
Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. 

5 

 
                                                           
some  cases,  there  were  no  controls  on  nutrition  and  health  claims  at  all  or  not  to  the 
extent necessary for a satisfactory assessment that the claims used comply with EU rules. 
This can lead to the non-detection of relevant non-compliances and consequently lack of 
subsequent  enforcement  measures.  This  could  in  turn  lead  to  insufficient  protection  of 
consumers  from  fraudulent  practices.  The  individual  audit  reports  identify  the  reasons, 
ranging from issues related to the designation and organisation of competent authorities 
to insufficient training and knowledge of officials. 

In practice, the authorities perform official controls at all stages of the food chain both on 
prepacked  and  non-prepacked  foods.  The  assessment  of  food  information  provided  and 
nutrition  and  health  claims  made  can  be  very  time-consuming.  In  addition,  it  requires 
specific knowledge and experience due to the complexity of these areas. The verification 
of  the  correlation  between  the  content  and  the  information  provided  for  foods  is  only 
possible if all relevant supporting documentation and records related to the raw materials 
used  as  ingredients  and  semi-finished  products  are  available.  In  addition,  sampling  and 
analysing for different parameters can be of assistance for verification purposes. 

National  legislation  for  substances  causing  allergies  and  intolerance  in  non-prepacked 
foods  and  on  country  of  origin  information  for  certain  foods  is  in  force  in  several 
Member States. However, two Member States did not follow the notification procedures 
of these to the Commission. 

Ready-to-eat (RTE) 

During 2017 and 2018, the Commission experts undertook a targeted series of five audits 
in  the  RTE  area,  due  to  the  number  and  significance  of  foodborne  outbreaks  linked  to 
such foods.  

The  findings  of  these  audits  point  to  some  common  areas  among  the  official  controls 
systems  of  most  of  the  Member  States  audited  that  need  to  be  reinforced  in  order  to 
achieve effective systems.   

The most significant issues fall into two main areas:  

a)  the  under-detection  of  non-compliances,  mainly  due  to  controls  not  effectively 
targeting  these  riskier  foods,  making  limited  use  of  systematic  audits  and  reviews 
during  these  controls  and  particularly    the  lack  of  or  ineffective  training  of  and 
understanding by inspectors of the requirements and of the impact of certain detected 
issues in RTE food production; and  

b)  ineffective actions taken to ensure the timely correction of non-compliances, mainly 
due  to  issues  related  to  the  classification  and  weighting  of  non-compliances 
(including those relating to procedures to prevent cross-contamination), not taking the 
specific  risks  linked  to  RTE  food  products  into  account  and  inadequate  procedures 
which either limit or do not support effective follow-up of inspection results. 

The audits also identified an array of good practices that could be helpful for competent 
authorities in the design and implementation of the official control system, including  

6 

 
  guidelines  and  advice  for  food  business  operators  and  authorities  in  the 

implementation of key legal requirements;  

  access  by  officials  at  local  level  to  experts  in  complex  technical  areas  such  as 

shelf life studies assessment; 

  availability  of  adequate  information  to  officials  supporting  the  evaluation  of 

product process validation; 

  use of guidelines, set by the EU reference laboratories, for sampling of processing 
areas  and  equipment  and  specific  support  for  the  evaluation  of  operators' 
compliance with the required microbiological analytical methods. 

E-Commerce 

E-commerce in  the EU  has grown steadily in  recent  years. Today the EU is  one of the 
largest  e-commerce  markets  in  the  world.  The  online  marketplace  offers  all  kinds  of 
food,  including  fresh  meat  and  fish.  Moreover,  an  ever-increasing  variety  of  food 
supplements  is  available  online.  Among  those  are  products  that  regularly  give  rise  to 
serious health concerns. The range of products available and the fast growth of internet 
sales  of  food  create  challenges  for  the  official  control  of  food  sold  via  this  medium. 
Therefore,  the  Directorate-General  for  Health  and  Food  Safety  undertook  a  number  of 
actions  aimed  at  assisting  Member  States  in  their  control  tasks  and  to  contribute  to 
enhanced cooperation, effective controls and enforcement. 

As part of these actions, a series of fact-finding missions in seven Member States, carried 
out in 2017, evaluated how the competent authorities had integrated controls on the sales 
of food via the Internet into their official control systems. 

The  competent  authorities  in  all  Member  States  visited  recognised  the  necessity  to 
enhance  their  controls  related  to  the  online  sales  of  food,  and  had  taken  steps  to  adapt 
their  traditional  inspection  activities  in  order  to  verify  that  food  supplied  online  is  safe 
and subject to an appropriate level of official controls. The approach taken varied in the 
Member States visited due to different set-ups and priorities.  

The missions showed that official controls of food sold online are relatively limited, and 
mainly  focused  on  the  registered  food  business  operators.  Non-compliances  identified 
during controls mostly related to labelling and health claim requirements.  A few cases 
revealed the online marketing of dangerous substances as food supplements.  

The identification of non-registered food business operators with an online presence has 
proven challenging due to the relatively limited resources assigned to this area, and the 
fact that a considerable number of these operators can easily and rapidly enter and exit 
the  online  marketplace,  without  being  aware  of  their  responsibilities.  Moreover,  the 
presence  of  online  sellers  who  actively  try  to  avoid  official  controls  by  changing  their 
digital identity is an additional hurdle for competent authorities. 

Cooperation  and  intelligence  sharing  between  different  authorities  within  and  across 
Member States was shown to be crucial. Finally, enforcement and cooperation with non-

7 

 
EU countries  have proved, so far, to  be the main constraints for an effective control of 
food sold via the Internet. 

Nonetheless,  the  competent  authorities  in  the  Member  States  are  making  continuous 
efforts  to  respond  to  the  challenges  brought  about  in  the  food  sector  by  the  digital 
economy, and are equally eager to share their experiences and to learn from others. The 
mission  series  provided  an  opportunity  to  bring  together  all  involved  in  these  types  of 
controls.    Some  Member  States  have  carried  out  exchange  visits  for  their  staff  and  are 
cooperating  successfully.  The  published  overview  report13  provides  more  detail  on  this 
matter. 

Food contact materials (FCM)  

With a series of fact-finding missions and audits in seven Member States in 2017-2018, 
the Commission evaluated the effectiveness, efficiency, relevance, coherence and added 
value of EU legislation concerning FCM. The objectives were to establish how Member 
States  have  integrated  FCM  controls  into  their  official  control  systems  and  to  identify 
challenges,  good  practices,  as  well  as  any  measures  needed  to  improve  these  official 
controls where necessary. A Commission workshop complemented the series in 2017.  

The  series  established  that,  in  general,  the  Member  States  visited  have  designated 
competent authorities and official control laboratories in charge of FCM, and that some 
competent authorities have set up a registration system to identify the business operators 
involved in the FCM chain. As with controls over E-commerce, approaches vary, partly 
depending on the level of priority given to this area. 

Furthermore,  the  series  found  that  in  terms  of  effectiveness,  controls  in  this  area  face 
some serious challenges, crucially the lack of laboratory analytical methods and technical 
knowledge  and  expertise  amongst  official  control  staff,  in  what  is  acknowledged  as  a 
very  technical  area.  In  addition,  health  risks  associated  with  FCM  are  perceived  as 
relatively low, with an associated minimal level of priority being attributed to this area. 
Therefore,  controls  are  generally  limited  to  a  verification  of  the  presence  of  generic 
declarations of compliance or indication of suitability for use.  

This, in combination with an absence of systems for hands-on training for control staff, 
leads to inspectors not being able to build up technical knowledge.  Hence, they are not 
in  a  position to  evaluate  specific  and  relevant  details  of  the  declarations  of  compliance 
and supporting documentation, as required by legislation.  

As  a  result,  fundamental  aspects  may  be  and,  indeed,  are,  overlooked  during  controls. 
Together  with  the  already  relatively  low  frequency  of  controls,  this  results  in  limited 
findings and consequently, in a failure to identify potential risks. This hampers risk-based 
and targeted controls and reinforces the perception that it concerns a low-risk or in any 
event low priority area.   

13  Overview report 2018-6537 Overview report on internet sales of food. 

8 

 
                                                           
Currently,  in  the  majority  of  the  cases,  inspectors  cannot  reliably  establish  compliance 
with  the  general  requirements  of  the  relevant  EU  legislation14  covering  the  safety  of 
FCM, or provisions in EU legislation for specific types of FCM and substances used, or 
in national legislation. 

This does not mean or suggest that the products  are unsafe, but that the official control 
systems  in  place  are  not  or,  at  least,  not  sufficiently  capable  of  identifying  non-
compliances and their associated food safety risks. 

2.3. 

Feed safety 

Risk-based official controls in the feed sector 

In  2017,  the  Commission  services  carried  out  nine  fact-finding  missions  in  Member 
States  on  the  risk-based  approach  implemented  by  competent  authorities  for  the 
organisation  of  official  feed  controls.  A  2016  overview  report15  based  on  a  series  of 
audits  carried  out  between  2012  and  2014  had  concluded  that  in  a  general  context  of 
resource constraints, risk prioritisation of official controls in the feed sector was weak or 
at an early stage of development.   

The  fact-finding  missions  sought  to  establish  whether  there  had  been  positive 
developments  in  the  application  of  risk-based  principles  and  identify  any  examples  of 
good practice or mechanisms, which, if adopted by more Member States, would improve 
the risk-basis for official controls on feed. The overall conclusion of these missions was 
that Member States largely apply a risk-based approach for organising official controls, 
although with a variation in how the different criteria set out in the legislation form the 
basis for these assessments. The inspection frequency and feed sampling programmes are 
mainly based on the risk inherent in the activities of the operator and to a lesser extent on 
other  criteria  (such  as  past  record  of  compliance,  reliability  of  own-checks  or 
participation  in  private  quality  assurance  schemes).  While  many  Member  States 
established  advanced  risk-scoring  systems  for  compound  feed  producers,  risk  scoring 
applicable  to  other  operators  (primary  producers  or  traders)  is  less  developed.  A  BTSF 
workshop  in  September  2018  enabled  a  discussion  with  Member  States  representatives 
on the outcomes of this series, including good practices identified. 

Evaluation of official controls on feed additives, their ingredients and traceability 

In 2018, the Commission audited five Member States' implementation of official controls 
on feed additives and ingredients for their production in the EU. Feed additives and their 
mixtures  (premixtures)  are  the  essential  ingredients  in  modern  compound  feed 
manufacture. A substantial quantity of feed additives and ingredients for their production 
is  sourced  from  third  countries  and  it  is  important  to  be  able  to  demonstrate  that  such 
imports  do  not  contain  undesirable  substances.    The  main  issues  detected  during  these 

14  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 

materials and articles intended to come into contact with food. 

15  Overview report 2016-8965 Hazards and Management of Risks in the Feed Sector. 

9 

 
                                                           
audits  concerned  the  competent  authorities'  assessment  of  operators'  HACCP16-plans, 
actions  taken  to  correct  and  prevent  non-compliances,  implementation  of  appropriate 
sampling  protocols  and  labelling.  Recommendations  were  made  accordingly  and 
corrective  actions  undertaken  to  improve  the  effectiveness  of  the  control  systems  in 
place.   

Evaluation of the implementation of hygiene, traceability and trade requirements of 
processed animal proteins, including exports, imports and intra-union trade 

In 2018, a series  of five audits evaluated the measures put  in  place by  Member States’ 
competent authorities to verify and ensure that relevant business operators implement the 
legal requirements on the hygiene, traceability and the trade of processed animal protein 
(PAP)17.  The  audits  focused  on  PAP  produced  and  traded  between  Member  States, 
imported and exported to and from  the EU and on the traceability and trade of organic 
fertilizers and soil improvers. Attention was paid to the practical implementation of the 
export procedure of PAP containing ruminant protein following a relaxation of the feed 
ban  rules  in  July  2017.  Common  problems  identified  included  poor  or  limited 
implementation  of  official  controls  on  channelling  of  consignments  of  ruminant  PAP 
intended  for  export  and  as  regards  intra-union  trade  of  PAP,  failure  of  the  competent 
authority of destination to inform the competent authority of origin on the arrival of PAP 
consignments,  thus  undermining  traceability  of  these  consignments.  The  audit  series 
established that corrective actions were taken to improve the effectiveness of the control 
systems in place in the Member States visited.   

2.4.  Animal health 

African swine fever  

This animal disease with important social and economic impact entered the EU in 2014 
and spread to several EU countries. The Commission audited affected Member States to 
verify  the  effectiveness  of  the  control  measures  applied  by  national  authorities  and  to 
trigger  constant  improvement.    The  audits  indicated  that  most  Member  States  were 
applying appropriate measures to contain the disease. The audits have an important role 
in reassuring trade partners about the reliability of the EU system for regionalisation18. 

The  Commission  also  started  fact-finding  visits  to  Member  States  at  risk  but  free  from 
the disease (i.e. with common borders with affected countries) to get an overview of their 
preparedness and response capacity, especially in the areas related to wild boar. 

16  HACCP  –  Hazard  Analysis  Critical  Control  Points,  a  management  tool  used  to  control  food  safety 

hazards, Codex Alimentarius Standard CAC/RCP 1-1969 provides more background.  

17  PAP are by-products from parts of slaughtered animals that are in principle fit for human consumption 
but are not used for production of food (e.g. udder, ovary, bones). If properly sterilised, these products 
are  seen  as  a  valuable  protein  source  in  animal  nutrition.  In  the  aftermath  of  the  mad  cow  disease 
crisis, the feed ban was introduced to limit these Transmissible Spongiform Encephalopathies. It bans 
the use of PAP in feed for farmed animals. 

18  The classification of Member States’ territories  or  parts  thereof related to the  local epidemiological 

situation and its  evolution of the disease in domestic pigs and wild boars. 

10 

 
                                                           
Highly pathogenic avian influenza 

The  Commission  carried  out  two  projects  in  this  area.  The  first  (2017)  covered 
surveillance  and  preparedness  for  the  disease.  The  results  of  the  fact-finding  visits  and 
meetings fed the discussions of experts for the implementing and delegated acts related to 
the disease, developed under the Animal Health Law (AHL)19. The published overview 
report provides more detail20. 

In the second project (2018), The Commission audited   Member States affected by the 
avian influenza epidemics in 2016-2017 to check the effectiveness of the measures they 
took  to  control  outbreaks  of  the  disease.  The  audits  also  looked  at  what  lessons  the 
authorities  learned  from  that  crisis  and  if  they  used  them  to  improve  their  contingency 
plans. 

Bivalve mollusc aquaculture 

In  2018,  a  project  based  on  fact-finding  missions  to  the  main  EU  producing  countries 
assessed the implementation of the EU animal health rules in this € 1 billion EU sector. 
The  project  also  assessed  the  legislation  and  possible  improvements  for  appropriate 
prevention, surveillance and control measures of diseases in bivalve molluscs facilitating 
safe movements within EU waters. The analysis of the findings provided a solid basis to 
identify  what  was  working  or  not,  in  relation  to  the  enforcement  of  controls  and  the 
implementation of legislation within this area. This fed the drafting of the new delegated 
and implementing acts of the AHL. 

The  main  findings  are  currently  being  reviewed  in  the  process  of  drafting  the  new 
delegated and implementing acts of the AHL.  The Commission published an overview 
report21. 

2.5.  Animal welfare 

Animal welfare during transport  

The  Commission  carried  out  a  project  (2016-2018)  focused  on  the  transport  of  live 
animals destined for export outside the EU. It covered road and sea transport. 

For road transport, the project had a significant impact:  

  The  export  of  live  animals  by  road  to  Turkey  decreased  significantly  (72% 

decrease in two years). 

  Most  Member  States  took  actions  to  limit  transport  of  live  animals  during  hot 

days22.  

19  Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council  of  9  March  2016  on 
transmissible  animal  diseases  and  amending  and  repealing  certain  acts  in  the  area  of  animal  health 
(‘Animal Health Law’) 

20  Overview report 2017-6304 Avian Influenza. 
21  Overview report 2018-6568 on bivalve mollusc aquaculture 
22  At least 13 Member States took actions and there were another five Member States that did not export 

animals by road. 

11 

 
                                                           
  The  number  of  animal  welfare  incidents  at  the  Bulgarian-Turkish  border  during 

the summer months decreased, having zero incidents in 2018. 

  The  compliance  rate  (measured  at  the  last  EU  border)  increased,  reaching  over 

97% in 2018. 

There are still big challenges regarding monitoring and enforcing EU rules for the non-
EU  part  of  the  journeys.  There  are  no  systems  to  check  the  actual  route  followed  by 
livestock  trucks  and  Member  States  have  no  means  to  check  the  availability  and 
adequacy  of  resting  points  along  the  route  outside  the  EU.  The  published  report23 
provides an overview of the good practices and problems that the project identified. 

Regarding  sea  transport,  the  project  included  audits  on  the  official  control  systems  to 
ensure  welfare  of  live  animals  transported  in  livestock  vessels.  The  results  showed  a 
defective  system  of  checks  in  most  Member  States,  ineffective  to  minimise  animal 
welfare issues during the trip. The Commission is working to get the European Maritime 
Safety Agency involved in the checks for livestock vessels, with the aim to improve the 
quality  of  the  checks,  increase  compliance  of  livestock  vessels  with  the  relevant  EU 
legislation24 and improve communication between Member States in this area.  

For  sea  transport  of  animals,  there  are  currently  no  mechanisms  to  gather  information 
about  the  welfare  of  the  animals  during  the  journey  and  at  arrival.  This  makes  it 
impossible  to  establish  the  welfare  quality  of  the  journeys  and  hinders  continuous 
improvement. 

The Commission published an overview report that contains the good practices and main 
problems identified during the project25. 

Animal welfare on farm 

Pigs 

The Commission made pig welfare one of its priorities for enforcement and implemented 
a two-year work programme in this area. There are 26 Member States that routinely tail 
dock pigs, although the EU legislation prohibits this as a routine26. The 26 non-compliant 
Member  States  presented  and  refined  action  plans  to  move  towards  compliance,  which 
constitutes a shift in the correct direction. Even though the quality of the plans is highly 
variable,  there  is  some  progress  and  some  Member  States  have  started  to  trial  rearing 
batches  of  pigs  with  intact  tails.  Member  States  are  not  near  full  compliance  and 
conditions on farm must improve if the number of tail docked pigs is to start to decrease.  

The  biggest  challenge  for  stopping  routine  tail  docking  of  pigs  is  serious  and  uniform 
enforcement. Another challenge is the very active internal market for live pigs. Member 

23  Overview report 2019-6834 Welfare of animals exported by road. 
24  Council  Regulation  (EC)  No  1/2005  of  22  December  2004  on  the  protection  of  animals  during 

transport and related operations. 

25  Overview report 2019-6835 Welfare of animals exported by sea  
26  Council  Directive  2008/120/EC  of  18  December  2008  laying  down  minimum  standards  for  the 

protection of pigs. 

12 

 
                                                           
States’  authorities  and  producers  are  afraid  of  losing  competitiveness  if  they  enforce 
before others who are competitors and/or clients. 

Rabbits 

Following  a  request  from  the  European  Parliament27,  information  was  gathered  during 
2017 about the health and welfare of farmed domestic rabbits. 

The  objective  of  this  work  was  to  further  understand  the  rabbit  production  sector  and 
identify  good  practices  relating  to  the  health,  welfare  and  housing  of  rabbits  reared  for 
meat production.  

It showed that the actual size of rabbit farming in the EU is just over a third of previously 
available figures and it is highly concentrated in Spain, France and Italy. The overview 
report28 outlined the factors that contribute to the animal welfare of rabbits at the time of 
production and their impact in the different production systems. It included pros and cons 
for animal health and welfare of the different rearing systems and it concluded that the 
rabbit  farming  sector  is  broadly  in  line  with  existing  EU  legislative  requirements 
regarding protection of rabbits at the time of production. 

2.6. 

Plant health 

Plant  health  is  of  global  importance  for  sustainable  agriculture  and  horticultural 
production, food security and protection of the natural environment. These are all at risk 
from  the  combined  effects  of  the  increasing  globalisation  of  trade  in  plants  and  plant 
products  and  climate  change,  which  increases  the  likelihood  of  introduction  and 
establishment  of  pests  not  previously  present  in  the  EU.  To  verify  that  EU  rules  are 
adhered  to,  the  Commission  services  continued  conducting  a  wide  range  of  audit  and 
analysis activities in the field of plant health.  

EUROPHYT-Interceptions  

Based  on  data  from  the  EUROPHYT-Interceptions29  system,  to  which  Member  States 
and  Switzerland  notify  the  occurrence  of  pests  in  imported  consignments  of  plants  and 
other objects, and a monthly alert list30, audits were focused on those non-EU countries 
from  which  a  high  number  of  import  consignments  containing  pests  were  intercepted. 
The impact of Commission measures and audits based on the EUROPHYT-Interceptions 
system  may  be  illustrated  by  the  trend  in  the  number  of  interceptions  made  due  to  the 
presence  of  pests.  Thus,  the  number  of  annual  pest  interceptions  indicated  by  the 
mentioned trade alert list has been reduced by over 30% over the five years (from 2,310 
on the first list in 2014 to 1,597 on the list for 2018).  

27  Follow  up  to  the  European  Parliament  resolution  of  14  March  2017  on  minimum  standards  for  the 

protection of farm rabbits (2016/2077(INI)). 

28  Overview report 2017-6303 Commercial farming of Rabbits  in the EU. 
29  https://ec.europa.eu/food/plant/plant_health_biosecurity/europhyt_en 
30  https://ec.europa.eu/food/plant/plant_health_biosecurity/non_eu_trade/alert_list_en 

13 

 
                                                           
The  annual  EUROPHYT-Interceptions  reports  present  further  statistics  and  analysis  of 
the interceptions of consignments31. 

Europhyt-Outbreaks 

There is a continuous need for better identification and assessment of the risk factors and 
for  better  targeting  of  the  Member  States  activities,  in  particular  in  the  light  of  new 
outbreaks  and  spread  of  pests  in  the  EU.  In  relation  to  the  identification  of  pests  in 
Member  States,  a  new  module  under  the  EUROPHYT  system  was  developed  for 
Member States to notify outbreaks in the EU. The launch of the web-based notification 
system  EUROPHYT-Outbreaks  at  the  beginning  of  2017  and  the  development  of  a 
the 
common  protocol  for  notifications  facilitated  rapid  reporting  and  fostered 
harmonisation of practices to control the outbreaks between Member States. This in turn 
has contributed to timely decision-making at EU level for an increased level of protection 
of  the  EU  territory  against  phytosanitary  risks.  The  annual  reports  on  the  outbreak 
notifications are available online32. 

Import Controls on plant health 

The EU’s import controls on plants and plant products aim to minimise the plant health 
risks,  using  a  combination  of  prohibitions  on  import  of  pests  and  the  highest-risk 
commodities, imposition of special requirements for other commodities to be certified by 
the  plant  health  authorities  of  the  exporting  countries  and  including  official  checks  on 
their  import  into  the  EU.  A  project  was  organised  to  evaluate  Member  States'  capacity 
and  performance  of  import  controls  on  plant  health  against  the  requirements  of  the 
relevant  EU  legislation,  and  to  identify  and  promote  best  practices  across  the  EU.  The 
findings of the project were taken into account during the negotiation process of the Plant 
Health Law and Official Controls Regulation. The project findings also shaped many of 
the  implementing  and  delegated  acts  for  the  application  of  the  import  procedures  and 
controls  provided  for  under  the  new  legislation.  An  overview  report  on  the  project  is 
available online33. 

Export controls for plants for planting and seeds from non-EU countries 

An  overview  report  describes  a  further  project34  to  evaluate  the  official  plant  health 
controls for the export of plants for planting and seeds from non-EU countries to the EU. 
Many  quarantine  pests  of  concern  are  widespread  in  the  exporting  countries.  The 
production technologies in non-EU countries audited can reduce the plant health risk but 
cannot ensure that the places of production or the consignments are free from pests. The 
majority  of  the  exporting  countries  audited  did  not  adequately  observe  the  EU 
requirements,  and  there  is  a  plant  health  risk  that  quarantine  pests  are  present  in  the 
growing  medium  of  the  imported  plants.  Additional  efforts  are  needed  to  inform  the 

31  EUROPHYT – interceptions annual reports.  
32  https://ec.europa.eu/food/sites/food/files/plant/docs/phb_ho_annual_report_2015-6_en.pdf 
33  Overview report 2019-6876 Plant Health – Import Controls. 
34  http://ec.europa.eu/food/audits-analysis/overview_reports/details.cfm?rep_id=133 

14 

 
                                                           
exporting countries about the EU rules in commonly understandable form and about the 
practical aspects of achieving conformity. To protect the health of plants in the EU, the 
Commission  services  continue  to  conduct  audits  in  these  countries,  train  staff  from 
exporting countries and regularly update EU legislation to limit the potential risks. 

Xylella fastidiosa 

Xylella  fastidiosa, is  a destructive bacterium that has done serious damage to  olive and 
almond trees in Italy and Spain. The pathogen has a wide host range and endangers many 
agricultural,  horticultural  and  forest  species,  in  particular  in  the  southern  and  central 
regions of Europe.  The Commission has closely followed this pest’s outbreaks in various 
Member States, not least by frequent audits since the first discovery in Italy at the end of 
2013.  The  audits’  results  and  the  Commission  services'  follow-up  have  contributed 
significantly  to  improving  the  controls  in  the  countries  with  outbreaks  and  also 
contributed to the improvement of the relevant EU legislation. As the Italian authorities 
failed to control the spread of the pest, the Commission sent  Italy two letters of formal 
notice in 2015 and 2016 and a reasoned opinion in July 2017, and in May 2018 it referred 
Italy to the Court of Justice of the EU35. In September 2019, the Court declared that Italy 
had failed to comply with its obligation to implement measures to prevent the spread of 
the bacterium36. The Commission services continued their audit and follow-up activity in 
Italy and other Member States to address this plant health risk. 

2.7. 

Pesticides  

Authorisation of Plant Protection Products (PPPs) and controls on their marketing 
and use  

An overview report37 on an audit series carried out in 2016 and 2017 showed delayed or 
reduced access to new pest control tools for growers, due to Member States failing to use 
the  zonal  authorisation  system  envisaged  in  EU  legislation38,  and  failing  to  meet  legal 
deadlines  in  a  majority  of  cases.  In  addition,  it  showed  that  the  re-evaluation  of  PPPs 
already  on the market,  in light  of new scientific and technical  knowledge, was delayed 
and  finally,  that  delays  in  processing  requests  for  authorisation  contributed  to  more 
emergency authorisations being granted by Member States. 

In order to  help  Member States address  the weaknesses in  the system, the Commission 
services  created  two  working  groups,  on  PPP  Formulation  Analysis  and  on  PPP 
enforcement.  Representatives  of  over  twenty  Member  States  routinely  attended  the 
meeting of the Working Group for PPP Formulation Analysis and the three meetings of 
the PPP Enforcement Working Group organised by the Commission in 2017 and 2018.  

35  https://ec.europa.eu/commission/presscorner/detail/en/IP_18_3805 
36  https://curia.europa.eu/jcms/upload/docs/application/pdf/2019-09/cp190106en.pdf 
37  Overview report 2017-6250 Plant Protection Products - Authorisation. 
38  Regulation  (EC)  No 1107/2009  of  the  European  Parliament  and  of  the  Council  of  21 October  2009 

concerning the placing of plant protection products on the market. 

15 

 
                                                           
The Sustainable Use of Pesticides  

The broad range of measures set out in the Directive on the Sustainable Use of Pesticides 
(SUD)39 provides the basis for reducing the risks and impacts of pesticide use on human 
health  and  the  environment,  in  particular  by  promoting  the  use  of  Integrated  Pest 
Management (IPM) and alternatives to pesticides.  

In 2017, the Commission submitted a report to the European Parliament and the Council 
on  Member  States’  National  Action  Plans  (NAPs)  and  on  the  implementation  of  the 
SUD40,  which  concluded  that  despite  the  substantial  progress  made  by  Member  States, 
significant  gaps  remained.    As  IPM  is  a  cornerstone  of  the  SUD,  it  was  of  particular 
concern  that  Member  States  had  not  yet  set  clear  targets  for  its  implementation.  More 
generally,  the  report  noted  the  need  for  Member  States  to  improve  the  quality  of  their 
NAPs,  primarily  by  establishing  specific  and  measurable  targets  and  indicators  for  a 
long-term strategy for the reduction of risks and impacts from pesticide use. 

In  response  to  the  weaknesses  identified,  the  Commission  has  taken  various  actions 
aimed  at  improving  implementation  of  the  SUD.    In  2017,  these  included  the 
establishment of the SUD web-portal41 to provide a source of relevant information and to 
facilitate  the  exchange  of  information.  Following  an  assessment  of  NAPs,  letters  were 
sent  to  all  Member  States  highlighting  where  improvements  should  be  made.  In  2018, 
further  letters  were  sent  to  some  Member  States  and  four  targeted  audits  on  the 
implementation of SUD were carried out. In addition to the audits, web-based surveys are 
used to collect data on SUD implementation. In December 2018 a survey was organised 
to  collect  additional  information  on  NAP  implementation  and  experience  gained  by 
Member States. Two meetings of the SUD Working Group were organised each year to 
discuss  and  exchange  information  on  SUD  related  issues.  In  late  2018,  a  BTSF 
programme  was launched on the control of  IPM implementation  at  farm level,  with  14 
training sessions to take place between December 2018 and June 2020.   

Harmonised risk indicators 

Following  the  commitment  given  in  response  to  the  European  Citizens  Initiative  "Ban 
glyphosate  and  protect  people  and  the  environment  from  toxic  pesticides"  and,  as 
required by the EU legislation42, Harmonised risk indicators have been established. These 
indicators  provide  a  basis  for  quantifying  trends  over  time  in  reducing  the  risks 
associated with the use of PPP.  

The  first  Harmonised  risk  indicator  is  based  on  the  quantities  of  PPP  placed  on  the 
market  (sold)  in  each  Member  State,  while  the  second  is  based  on  the  number  of 

39  Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing 

a framework for Community action to achieve the sustainable use of pesticides. 

40  https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_sup_report-overview_en.pdf 
41  https://ec.europa.eu/food/plant/pesticides/sustainable_use_pesticides_en 
42  Article 15 of the SUD (Directive 2009/128/EC). 

16 

 
                                                           
emergency  authorisations  granted  by  each  Member  State43.  Both  indicators  include 
weightings that reflect the intrinsic properties of the different active substances. A three-
year baseline is used in calculating these indicators to take account of yearly fluctuations 
in the quantity and type of PPP used due to variations in the extent and severity of pest 
outbreaks between years. Member States are obliged to calculate and make available to 
the public their harmonised risk indicators and links to this information, along with the 
overall  EU  harmonised  risk  indicators,  are  published  on  the  Commission's  SUD  web–
portal44. A number of Member States  are not  making their information available to  the 
public. The Commission has repeatedly reminded Member States of their obligations in 
this area. 

The  Harmonised  risk  indicator  I  for  the  EU28  results  show  there  has  been  a  20% 
reduction in risk in the period from 2011 to 2017 even though the quantity of PPP placed 
on  the  market  during  this  time  remained  relatively  constant45.  The  Harmonised  risk 
indicator II results show a 50% increase from 2011 to 2017. However, it is problematic to 
calculate and interpret this indicator, as there is no harmonised way to record information 
on  the  quantities  of  PPP  used  under  each  emergency  authorisation,  so  this  can  vary 
substantially.  

Biocides 

Biocidal  products  are  substances  or  mixtures  of  substances  used  to  control  harmful 
organisms in areas other than those related to agricultural production. Biocides include a 
wide  range  of  products  commonly  used  by  both  professionals  and  non-professionals, 
such as disinfectants, wood preservatives and those for pest control such as rodenticides. 
They  comprise  products  containing  both  chemicals  and  microorganisms  as  active 
substances. 

The  Biocidal  Products  Regulation  (BPR)46  that  became  applicable  from  1  September 
2013  regulates  the  marketing  and  use  of  biocidal  products.  The  majority  of  biocidal 
products on the market are currently undergoing re-evaluation for approval of all biocidal 
active  substances  used  in  them  under  the  BPR.  Transitional  arrangements  allow  the 
availability  of  biocidal  products  containing  biocidal  active  substances  that  have  not  yet 
been re-evaluated on the market in Member States47.  

In 2017 and 2018, fact-finding missions in Hungary, Germany, Spain, Belgium and the 
Netherlands  assessed  their  implementation  and  enforcement  of  the  BPR.  The  main 
objective was to collect information about why the re-evaluation of biocidal products is 

43  Article 53 of Regulation (EC) No 1107/2009. 
44  https://ec.europa.eu/food/plant/pesticides/sustainable_use_pesticides/harmonised-risk-indicators_en 
45  https://ec.europa.eu/eurostat/statistics-explained/index.php/Agri-environmental_indicator_-

_consumption_of_pesticides#Key_messages 

46  Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  of  22  May  2012 
concerning the making available on the market and use of biocidal products  - OJ L 167, 27.6.2012, p. 
1–123. 

47  Art. 89 of Regulation (EU) 528/2012.  

17 

 
                                                           
slow. The main challenges identified were the complexity of the review processes, poor 
quality  of  dossiers  submitted  by  applicants,  the  lack  of  synchronised  procedures  and 
insufficient staff resources including resources wasted on applications withdrawn during 
the evaluation process.  

The use of planning and forecasting tools and improving the quality of dossiers through 
awareness raising and additional pre-submission meetings with applicants were some of 
the  potential  good  practices  found  to  have  minimised  delays.    Further  enhancing 
cooperation and coordination within and between the authorities involved with biocides 
and adopting additional harmonised EU guidance would facilitate the evaluation process 
and  save  time  and  resources  in  the  long  run.  In  the  meantime,  triggering  consultations 
between  Member  States  would  help  to  establish  a  harmonised  approach  and  avoid 
disagreements at a later stage.  

The  significant  amount  of  biocidal  products  which  are  not  authorised  for  the  market 
where they are available shows that further attention should be paid to the enforcement of 
the  BPR,  particularly  aimed  at  products  containing  active  substances  still  under 
evaluation  in  the  Review  Programme.  More  information  can  be  found  in  the  published 
overview report48. 

2.8.  Antimicrobial resistance (AMR) 

The development of AMR poses a rising threat to human and animal health. Each year, 
drug  resistant  infections  result  in  a  significant  number  of  patient  deaths  and  cause 
substantial  healthcare and productivity losses  in  the EU. The urgent  need for concerted 
action  to  limit  its  development  and  maintain  an  arsenal  of  effective  antimicrobials  is 
recognised worldwide. 

In  2015,  the  European  Commission  published  guidelines  for  the  prudent  use  of 
antimicrobials in animals49. These define the prudent use of antimicrobials as leading to 
more rational and targeted use of these substances, thereby maximising their therapeutic 
effect and minimising the development of AMR. 

In  June  2017,  the  Commission  published  a  European  One  Health  Action  Plan  against 
AMR with an emphasised 'One Health' approach50, acknowledging the interconnections 
between  animal  health,  human  health  and  the  environment,  as  well  as  the  common 
danger posed by the development of AMR. 

Two overview reports provide further background and information on the prudent use of 
antimicrobials in animals and on the systems for the monitoring of AMR in zoonotic and 
commensal  bacteria51.  The  EU  AMR  One-Health  Network,  chaired  by  the  European 

48  Overview report 2018-6780 Biocides. 
49  Guidelines for the prudent use of antimicrobials in veterinary medicine. OJ C 299, 11.9.2015, p. 7. 
50  https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf  
51  Overview  reports  2019-6788  Final  Overview  Report  -  Measures  to  tackle  Antimicrobial  Resistance 
through  the  Prudent  Use  of  Antimicrobials  in  Animals  and  2019-6789  Final  Overview  Report  - 
Antimicrobial Resistance Monitoring in Zoonotic and Commensal Bacteria 

18 

 
                                                           
Commission, consists of government experts on human health and animal health, the EU 
scientific agencies (the European Centre for Disease Prevention and Control (ECDC), the 
European  Food Safety  Authority  (EFSA) and the European Medicines Agency (EMA)) 
and Commission experts. This network holds bi-annual meetings that provide members 
with a platform to present national action plans and strategies and keep each other up to 
date on their progress, to share best practices, and to discuss policy options and how to 
enhance cooperation and coordination. 

The  Commission  and  the  ECDC  organise  One  Health  AMR  joint  country  visits.  The 
overall  objective  of  these  country  visits  is  to  assist  the  Member  States  in  further 
developing  and  implementing  their  national  strategies  and  policies  to  tackle  AMR  in  a 
One Health context.  The scope of visits  encompasses the human health,  veterinary  and 
environmental  aspects  of  AMR,  as  well  as  inter-sectoral  coordination  and  cooperation 
aspects. 

2.8.1.  Monitoring  of  residues  of  veterinary  medicinal  products  and 
environmental  contaminants  in  animals  and  products  of  animal 
origin 

Veterinary  medicinal  products  are  widely  used  in  animal  breeding  to  either  prevent  or 
cure  diseases.  These  substances  may  leave  residues  in  the  food  products  derived  from 
treated animals. Member States implement annual monitoring programmes to verify that 
the  use  of  veterinary  medicinal  products  is  in  accordance  with  the  applicable  EU  rules 
and  to  detect  their  potential  misuse  or  illegal  use.  These  programmes  also  include 
monitoring  of  environmental  contamination,  either  from  the  use  of  pesticides  or 
contaminants,  to  which  animals  may  be  exposed.  Competent  authorities  take  official 
samples from live animals or products of animal origin such as meat, eggs, milk, honey 
or  aquaculture  fish.  In  2017,  as  part  of  these  monitoring  programmes,  the  28  Member 
States  took  more  than  410,000  samples  to  analyse  for  the  presence  of  residues.    The 
proportion  of  non-compliant  results  remained  low  (0.35%),  at  a  level  comparable  to 
previous years. 

In  the  area  of  residue  monitoring,  the  Commission  actions  are  two-fold.  Firstly,  every 
year, the Health and Food, Audits and Analysis Directorate, together with the responsible 
European  Union  Reference  Laboratories,  reviews  all  the  Member  States'  residue 
monitoring  plans,  making  comments  and  recommendations  to  the  Member  States  to 
ensure continuous improvement of the plans. The plans are then formally approved (by a 
Member States’ vote) by comitology52. Secondly, Commission audits in Member States 
verify  the  implementation  of  the  plans.  Elements  such  as  laboratory  performance  and 
effectiveness of follow-up investigations of non-compliant results are examined in detail. 
In  2017  and  2018,  seven  audits  were  carried  out  in  Member  States  resulting  in  a 
relatively small number of recommendations to improve the control systems in place.  

52  https://ec.europa.eu/info/implementing-and-delegated-acts/comitology_en 

19 

 
                                                           
2.9.  Organic production 

The area under organic farming in the EU has increased by 70% in the last ten years and 
currently covers 7,5% of the total Utilised Agricultural Area53. Imports of organic agri-
food  products  are  also  significant,  reaching  3.3  million  tonnes  in  201854.  The 
Commission continues to carry out an annual programme of audits of the control systems 
for  organic  products  produced  and/or  marketed  in  the  EU.  Imports  from  most  non-EU 
countries  are  certified  by  private  control  bodies  that  are  directly  supervised  by  the 
Commission.  Since 2017, the majority of the Commission  audits in  the organics sector 
have been dedicated to auditing these control bodies. Thus, in the period 2017-2018, 12 
audits  were  carried  out  of  control  bodies  operating  in  non-EU  countries,  while  seven 
audits were of controls in Member States. In 2017 the Commission carried out audits in 3 
MS (AT, BE and SI) and the same in 2018 (RO, IT and SK). A main difference between 
the two cases is that control bodies in non-EU countries may apply group certification if 
the  group  has  an  internal  control  system.  This  is  mainly  intended  to  facilitate  exports 
from  small  farmers  in  developing  countries  that  cannot  afford  individual  certification. 
Many  of  the  non-compliances  found  in  non-EU  countries  relate  to  inadequate 
implementation  of  this  system.  In  Member  States,  the  audits  found  a  variation  of 
approaches  as regards the organisation and implementation  of controls  and the national 
catalogue of  measures in cases of non-compliances.  The most frequent findings concern 
the supervision of control bodies, the respect of  minimum control requirements from the 
control bodies, the notification of non-compliances of operators from the control bodies 
to  the  competent  authorities  and  the  enforcement  of  measures  in  cases  of  non-
compliances. 

2.10.  Quality  schemes  for  agricultural  products  and  foodstuffs  and  Spirit 

Drinks  

EU geographical indications legally protect more than 3,400 names of products in order 
to  promote  their  unique  characteristics  and  defend  the  traditional  expertise  of  their 
producers. Each geographical indication has specific legal standards on how the product 
is made, while also serving as a guarantee for the quality and authenticity of the products. 
The Commission continued to carry out a limited annual programme of audits in Member 
States  of  their  control  systems  for  geographical  indications.  Thus  in  2017-2018,  six 
Member  States  were  audited.  The  main  issues  found  were  weak  market  controls  of 
products  from  other  Member  States  and  non-EU  countries.  For  their  own  products,  the 
Member States often failed to cover all the elements of the product specifications when 
carrying out controls at the producers. 

2.11.  Import controls 

The  EU  and  its  Member  States  are  committed  to  ensuring  that  official  controls  on 
imports of animals and goods are fit for purpose and provide the necessary assurances to 

53  https://ec.europa.eu/eurostat/statistics-explained/index.php/Organic_farming_statistics 
54  EU  Agricultural  Markets  Briefs  No  13,  March  2019:  "Organic  farming  in  the  EU.  A  fast  growing 

sector". 

20 

 
                                                           
European citizens that imported animals, food and feed meet the same high standards as 
for animals and goods produced within the EU.   

Commission  oversight  of  Member  States'  performance  of  import  controls  continued  in 
the  period  2017-2018,  the  results  confirming  Member  States'  efforts  to  continuously 
improve  the  way  in  which  import  controls  are  carried  out.  The  Commission  also 
continued  to  carry  out  inspections  of  new  or  modified  border  inspection  posts  in  the 
context of their approval and subsequent listing55.  

In  2018,  an  overview  report56  on  how  Member  States  implement  official  controls  on 
goods  subject  to  special  import  conditions  collated  the  main  findings  of  audits  in  12 
Member  States  in  2015  and  2016.  The  audits  focused  on  how  Member  States  were 
implementing  two  particular  types  of  import  controls:  “enhanced  controls”57  and  “re-
enforced checks”58.  Whilst the overall results of these audits were positive, the overview 
report  highlighted  opportunities  for  improvement  in  the  way  in  which  certain  Member 
States  developed  and  implemented  their  monitoring  plans  used  to  target  high-risk 
commodities for laboratory  analyses.  It  also  highlighted that recommendations made to 
the respective Member States had been acted on, resulting in strengthened import control 
systems  in  those  Member  States.  The  results  were  shared  with  all  Member  States  in  a 
Commission-organised workshop, designed to share experiences and good practices. 

2.12.  Genetically Modified Organisms 

Four  audits  assessed  the  official  controls  of  genetically  modified  organisms  (GMO) 
including their deliberate release into the environment.  

The  audits  looked  into  the  organisation  of  the  controls  including  staffing,  planning, 
documented  procedures,  and  the  implementation  of  those  controls  including  sampling, 
testing and enforcement measures. 

The  audits  concluded  that  the  official  control  systems  for  GMO,  including  their 
deliberate release and cultivation, were well organised. Weaknesses were identified in the 
areas of sampling and testing. 

55  2009/821/EC:  Commission  Decision  of  28  September  2009  drawing  up  a  list  of  approved  border 
inspection  posts,  laying  down  certain  rules  on  the  inspections  carried  out  by  Commission  veterinary 
experts and laying down the veterinary units in Traces. 

56  Overview report 2018-6525 Overview report on the safety of imported food. 
57  Where there is a possibility that imports of certain food or feed, be it of animal or non-animal origin, 
present a risk to the consumer, special import conditions can be set. These “enhanced controls” often 
require an increased number of samples of the food or feed in question to be taken at the EU borders 
for testing in an EU laboratory. 

58  Where  import  controls  on  food  or  feed  of  animal  origin  from  a  certain  third  country  or  a  certain 
producer in a third country give grounds to believe that EU veterinary legislation has been seriously or 
repeatedly infringed, ”re-enforced checks” must be applied by Member States. 

21 

 
 
 
                                                           
3.  BTSF 

BTSF is a Commission training initiative covering food and feed law, animal health and 
welfare and plant health rules and also organic farming and quality schemes. . 

BTSF  held  275  training  courses  in  the  Member  States  covering  a  whole  spectrum  of 
subjects from food and feed law to animal health and welfare to plant health rules during 
2017-2018.  A  range  of  courses  is  also  offered  in  non-EU  countries.  Ten  e-learning 
modules are available in five languages59.  

In  this  context,  it  is  worth  highlighting  the  awareness-raising  work  done  on  AMR.  A 
series of 15 workshops on the prevention and control of AMR in the context of an overall 
“One Health” approach60 started at the end of 2017.  

The workshops  aimed to spread knowledge to  government  officials  in  all EU countries 
working in the human health and veterinary sectors with the following main objectives: 

  spreading  knowledge  on  methods  of  prevention  and  control  of  AMR  in  the 

 

 

 

veterinary and human medicine sectors with a "One health" approach; 
further harmonising Member States' approaches and sharing best practices in the 
field of use of antimicrobials; 
increasing  the  efficacy  of  the  competent  authority  in  the  field  of  AMR 
monitoring, reporting and control; 
increasing  the  compatibility  of  procedures  and  practices  between  public  health 
authorities and veterinary/food safety authorities across the EU. 

In December 2018, the Commission organised a workshop on preparedness of veterinary 
services for natural disasters. Based on the results of a questionnaire sent to all veterinary 
services  in  the  EU  and  a  fact-finding  mission  to  two  Member  States61,  representatives 
from  all  Member  States  were  invited  to  discuss  good  practices,  similarities  and 
differences.  The  objective  was  to  enable  them  to  better  prepare  for  the  sometimes-
devastating effects of natural disasters such as forest fires, floods and earthquakes.  

59  Reports on the BTSF activities can be found online. 
60  More information on One Health can be found on the WHO website. 
61  Overview report 2018-6518 Veterinary Preparedness for Natural Disasters. 

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4.  FOLLOW UP OF AUDIT RECOMMENDATIONS 

The focus of the Commission control activities in the Member States is to check whether 
their competent authorities have in place the necessary control systems and enforcement 
measures to ensure the safety of the food placed on the EU market, the respect of animal 
welfare rules, and to keep important animal and plant diseases under control. Audits are 
generally  accompanied  by  recommendations  for  corrective  action.  Audit  reports  are 
published  and  provide  important  insight  into  the  effectiveness  of  controls  and  whether 
the relevant Union legislation is fit for purpose.  

DG  SANTE  systematically  follows  up  on  actions  taken  by  competent  authorities  to 
respond to recommendations made in audit reports. For the Member States, this is done 
mainly  through  package  meetings  known  as  General  Follow-up  Audits.  The  General 
Follow-up  Audits  cover  all  open  recommendations  across  all  'food'  sectors  and  are 
regularly carried out in all Member States. In order to ensure transparency, the results of 
these audits are published on the Commission website through updates of Member State 
country profiles62. 

62  https://ec.europa.eu/food/audits-analysis/country_profiles/index.cfm  

23