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  COM(2020) 756 final  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 {SWD(2020) 283 final}  
 
 
TABLE OF CONTENTS 

1.  EXECUTIVE SUMMARY ......................................................................................... 1 

2. 

INTRODUCTION ....................................................................................................... 2 

3.  LEGAL FRAMEWORK ............................................................................................. 3 

4.  REVIEW OF MEMBER STATES' ANNUAL REPORTS ........................................ 4 

4.1.  Receipt and review of Member States' annual reports ...................................... 4 
4.2.  Organisation and performance of official controls ............................................ 5 
4.2.1.  Operational targets and strategic objectives ........................................ 5 
4.2.2.  Planned and ongoing official controls ................................................. 5 
4.2.3.  Specific control activities .................................................................... 6 
4.2.4.  Resources ............................................................................................. 7 

4.3.  Overall compliance with feed and food law, animal health and animal 

welfare rules and organic farming rules ............................................................ 7 
4.3.1.  Types of non-compliance .................................................................... 7 
4.3.2.  Analysis of non-compliances .............................................................. 7 
4.4.  National Audit Systems ..................................................................................... 8 
4.4.1. 
Internal and/or external audits on official controls .............................. 8 
4.4.2.  Audits and inspections of control bodies ............................................. 8 
4.5.  Actions to ensure effectiveness in operating the national control plans ........... 9 
4.5.1.  Actions  to  ensure  compliance  by  food  and  feed  business 

operators and other relevant producers and business owners .............. 9 
4.5.2.  Enforcement: action taken in case of non-compliance ........................ 9 
4.5.3.  Actions  taken  to  ensure  the  effective  operation  of  official 

control services .................................................................................. 10 

4.6.  Overall  performance  of  the  control  system  in  operating  the  national 

control plans .................................................................................................... 10 
4.7.  Amendments to the MANCP ........................................................................... 10 

5.  COMMISSION  SERVICES'  CONTROL  ACTIVITIES  IN  MEMBER 

STATES .................................................................................................................... 11 

5.1.  Audits .............................................................................................................. 11 
5.1.1.  Overview reports ............................................................................... 13 
5.1.2.  Some points to highlight .................................................................... 13 

6.  COMMISSION FOLLOW-UP AND ENFORCEMENT ......................................... 14 

6.1.  Systematic follow-up of recommendations ..................................................... 14 
6.2.  Support to Member States ............................................................................... 15 
6.2.1.  Networks ............................................................................................ 15 
6.2.2.  Better Training for Safer Food (BTSF) ............................................. 17 
6.3.  Enforcement .................................................................................................... 17 

7.  CONCLUSIONS ....................................................................................................... 18 

 
 
 
 
List of charts 

Chart 1: number of missions carried out in Member States in 2017-2018 ............................... 12 
Chart 2: number and type of missions performed per topic 2017-2018 ................................... 12 

ii 

 
 
 
 
1.  EXECUTIVE SUMMARY 

This  report  describes  the  overall  outcome  of  the  national  and  Commission  control 
activities  carried  out  in  2017  and  2018  to  ensure  a  high  level  of  health  protection  and 
trust in the areas of food and feed law, animal health and welfare, plant health and plant 
protection  products,  organic  farming  and  quality  schemes.  These  areas  are  critically 
important  in  the  daily  lives  of  European  Union  (EU)  citizens.  They  are  also  key  to 
enabling the smooth operation of trade in food, animals and plants, both within the EU 
itself and with non-EU countries. 

Member  States  are  responsible  for  the  implementation  of  risk-based  official  controls, 
which  are  detailed  and  planned  in  their  multi-annual  national  control  plans  (MANCP). 
Official controls aim to verify that operators along the food and feed chain comply with 
applicable  legislation  and,  where  this  is  not  the  case,  Member  States  are  expected  to 
enforce the said legislation and take steps to bring those operators back into compliance. 
Through  audits,  the  Commission  services  verify  Member  States’  implementation  of 
official controls and associated enforcement activities.  

Most  Member  States  reported  that  staffing  levels,  financial  and/or  equipment  resources 
were the key issues  having an impact  on the implementation  of their MANCPs. Whilst 
improved data analysis, the use of IT tools and desk-based controls helped in overcoming 
these  challenges  in  some  Member  States,  others  reported  that  they  could  not  fully 
implement their control plans. 

The  Commission  considers  that  adequate  resources  must  be  made  available  for  on-the-
spot inspections.  When it comes to issues as diverse as food fraud1, verifying the correct 
labelling of food and feed, implementation of good hygiene practices at slaughter and the 
appropriate use of plant protection products, on-site inspections in the field are vital. 

Commission  controls  on  Member  States’  implementation  of  official  controls  along  the 
food and feed chain provide a clear picture of Member States’ performance in verifying 
and enforcing operators’ compliance with food and feed law, rules on animal health and 
welfare, plant health and plant protection products.  As such, they contribute significantly 
to  the  legislative  review  process  aimed  at  ensuring  that  the  EU  legislation  is  “fit  for 
purpose”.   

On  the  basis  of  the  Commission’s  controls  on  Member  States,  it  is  concluded  that, 
overall,  Member  States  have  the  requisite  control  systems  in  place  to  ensure  the 
implementation  of  EU  requirements.  In  some  countries  the  Commission  controls 
identified deficiencies in the implementation of official controls, indicating that there was 
still  room  for 
its 
recommendations  to  the  Member  States  and,  where  necessary,  employed  other 
enforcement tools.  In addition, the Commission supported Member States (and non-EU 

  The  Commission  systematically  followed-up 

improvement. 

1  Fraud is an intentional action taken by businesses or individuals for the purpose of deceiving purchasers 
and gaining an undue advantage therefrom. Such actions may also constitute a risk to human, animal or 
plant health, or to animal welfare or the environment. The  webpages on the EU Food Fraud Network 
provide more background information. 

1 

 
                                                           
countries)  via  the  provision  of  technical  assistance  and  training  through  the  Better 
Training  for  Safer  Food  (BTSF)  initiative  and  technical  meetings  of  Member  States’ 
experts.   

This report makes some recommendations to further enhance the official control systems 
through information networks for officials, the use of information from private assurance 
schemes and the publication of results of official controls. 

2. 

INTRODUCTION 

The EU aims to ensure a high level of health protection and trust in the areas of food and 
feed  safety,  animal  and  plant  health,  animal  welfare,  organic  farming  and  quality 
schemes. EU citizens rightly expect high standards in these fields. 

There  is  a  comprehensive  EU  legal  framework  in  place  aimed  at  ensuring  coherent 
controls throughout the food and feed chain, from farm to fork, and adequate monitoring, 
while ensuring an effective internal market and trade with non-EU countries. 

One  of  the  pillars  of  the  EU’s  integrated  food  safety  policy  from  farm  to  fork  is  an 
effective  official  control2  system  to  verify  operators’  compliance  with  EU  standards 
throughout the food and feed chain. 

The Commission plays an important role in the overall control framework at EU level3 
and performs controls, including audits, in the Member States.  

Member States submit an annual report on the implementation of their official controls to 
the Commission4, which in turn reports5 to the public, the European Parliament and the 
Council, on the overall operation of controls in Member States in light of: 

 
 

the annual reports submitted by the national authorities on their control activities; 
the outcome of Commission controls carried out in the Member States. 

The current report covers the years 2017 and 2018. 

3.  LEGAL FRAMEWORK 

The "General Food Law"6 attributes the primary responsibility for ensuring that food is 
safe  to  the  food/feed  business  operators.  Specific  EU  regulations  deal  with  the 

2  “official  control”  means  any  activity  performed  by  EU  Member  State  competent  authority  to  verify 
compliance  with  food  and  feed  law,  rules  on  animal  health  and  welfare,  plant  health  and  plant 
protection products and that animals and goods meet the requirements. 

3  Article 116 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 animal welfare, plant health and plant protection products  - OJ L 
95, 7.4.2017, p.1. 

4  Article 113(1) of Regulation (EU) 2017/625. 
5  Article 114 of Regulation (EU) 2017/625. 
6  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. 

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requirements for organic production and the labelling of organic products7 and for quality 
schemes  for  agricultural  products  and  foodstuffs  (protected  designations  of  origin, 
protected geographical indications and traditional specialities guaranteed)8. 

Member States  are obliged to  verify that business operators respect  applicable EU law. 
Their MANCPs describe the systems of official controls for this purpose.  

From 14 December 2019, changes to the legislation relating to these requirements under 
the  Official  Controls  Regulation  (OCR),  became  applicable9.  The  OCR  describes  the 
requirements  for  these  control  systems,  the  MANCP  and  the  performance  of  official 
controls10.  The  most  relevant  requirements  introduced  by  the  new  OCR  related  to  the 
official control systems and MANCP are that: 

- 

the scope now also includes official controls on animal by-products, plant health, 
plant  protection  products,  organic  production  and  labelling  of  protected 
designations  of  origin,  protected  geographical  indications  and  traditional 
specialities; 

-  Member  States  are  required  to  designate  a  single  body  to  coordinate  the 

- 

- 
- 

preparation, coherence, review, updating of and reporting on the MANCP; 
the  MANCP  is  to  describe  its  strategic  objectives  and  the  risk  categorisation  of 
the official controls detailed therein; 
the MANCP needs to be made public, with certain limited exceptions; 
relevant information concerning the organisation and the performance of official 
controls  is  to  be  made  available  to  the  public,  ensuring  a  high  level  of 
transparency;  this  obligation  can  be  met  through  the  publication  of  the  annual 
report submitted by each Member State to the Commission11. 

The  OCR  requires  the  Commission12  to  perform  controls,  including  audits,  in  the 
Member  States  and  the  Member  States  are  required  to  take  appropriate  follow-up 
measures to remedy the shortcomings identified in these controls13. 

7  Council  Regulation  (EC)  No  834/2007  on  organic  production  and  labelling  of  organic  products  and 

repealing Regulation (EEC) No 2092/91 - OJ L 189, 20.7.2007, p.1. 

8  Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 

on quality schemes for agricultural products and foodstuffs - OJ L 343, 14.12.2012, p. 1. 

9  Regulation (EU) 2017/625 repealed Regulation (EC) No 882/2004 of the European Parliament and of 
the  Council  of  29  April  2004  on  official  controls  performed  to  ensure  the  verification  of  compliance 
with feed and food law, animal health and animal welfare rules. 

10  Articles 109, 110 and 111 of Regulation (EU) 2017/625. 
11  Article 11 of Regulation (EU) 2017/625. 
12  Article 116 of Regulation (EU) 2017/625. 
13  Article 119 of Regulation (EU) 2017/625.  

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4.  REVIEW OF MEMBER STATES' ANNUAL REPORTS 

4.1.  Receipt and review of Member States' annual reports 

The  Member  States  submitted  their  2017  and  2018  annual  reports  under  the  earlier 
Regulation  on  official  controls,  which  was  repealed  and  replaced  by  the  OCR14.  The 
recommended structure for reports detailed in the Commission’s guidelines, applicable to 
those years15, formed the basis for this assessment. 

Relatively few Member States submitted their annual reports to the Commission services 
within the deadline prescribed. Only Czech Republic, Estonia, Finland, Latvia, Lithuania 
and Slovak Republic submitted their 2017 and 2018 reports in time. Some countries were 
very late in their reporting- e.g. the Commission received the last annual report covering 
2017 in April 2019 and in June 2020, it had still not received one annual report covering 
2018.  

The  reports  vary  significantly  in  the  presentation  of  data  and  in  the  nature  of  the  data 
presented.  This  makes  their  analysis  and  comparison  difficult,  and  poses  a  significant 
challenge to the Commission for the production of this annual report. 

In  relation  to  organic  production,  the  Commission  addressed  the  comments  from  the 
European Court of Auditors16  and, in  2018, began to  send follow-up letters to  Member 
States  requesting  clarifications  and  additional  information  regarding  the  annual  reports 
on organic production. For the reporting year 2017, a letter was sent to 14 Member States 
and one European Free Trade Association (EFTA) Country. For the 2018 reporting year, 
24 Member States and one EFTA Country17. 

The  OCR  has  introduced  a  standard  model  form  for  the  annual  reports  and  Member 
States18  will  also  have  to  submit  them  electronically.  The  OCR  extends  the  deadline 
(from 30 June to 31 August) for the submission of such information and data. Reporting 
the outcome of official controls, the type and number of cases of non-compliance and the 
measures  taken  to  ensure  the  effective  operation  of  the  Member  States’  MANCP  by 
electronic  means  and  in  a  uniform  way  will  facilitate  the  Commission’s  analysis  and 
comparison of such data within and between Member States. 

14  Article 44 of Regulation (EC) No 882/2004.  
15  Commission Decision 2008/654/EC of 24 July 2008 on guidelines to assist Member States in preparing 
the annual report on the single integrated multiannual national control plan provided for in Regulation 
(EC) No 882/2004 - OJ L 214, 9.8.2008, p. 56. 

16  See  the  Special report no 04/2019: The control system  for organic products has improved, but some 

challenges remain 

17  2017 :  Belgium,  Czech  Republic,  Denmark,  Germany,  Estonia,  Finland,  Croatia,  Hungary,  Italy, 
Lithuania, Luxembourg, Poland, Portugal, Sweden, Norway ; 2018: Belgium, Bulgaria, Cyprus, Czech 
Republic,  Denmark,  Germany,  Estonia,  Ireland,  Greece,  Spain,  Finland,  France,  Croatia,  Hungary, 
Italy,  Lithuania,  Luxembourg,  Malta,  Netherlands,  Austria,  Poland,  Portugal,  Romania,  Slovenia, 
Sweden, Norway  

18  Commission  Implementing  Regulation  (EU)  2019/723  of  2  May  2019  laying  down  rules  for  the 
application  of  Regulation  (EU)  2017/625  of  the  European  Parliament  and  the  Council  as  regards  the 
standard  model  form  to  be  used  in  the  annual  reports  submitted  by  Member  States  –  OJ  L  124, 
13.5.2019, p. 1; adopted under Article 113(2) of Regulation (EU) 2017/625. 

4 

 
                                                           
4.2.  Organisation and performance of official controls 

Member  States  have  established  official  control  systems,  which  largely  enable  them  to 
ensure  the  application  of  the  legal  framework  by  food  and  feed  business  operators. 
Specific  aspects  of  these  systems  are  highlighted  below  to  illustrate  some  of  the 
challenges and initiatives presented by Member States.  

4.2.1.  Operational targets and strategic objectives 

In  their  MANCPs,  Member  States  should  define  the  strategic  objectives  for  the 
organisation  of  official  controls19.  However,  less  than  a  third  (Belgium,  Cyprus, 
Denmark, Estonia, Ireland, Finland, France, Germany and Italy) reported on specific key 
performance indicators (KPIs) used in the assessment of the effectiveness of their official 
controls. The inclusion of the results of such KPIs would provide a better understanding 
of how each Member State would use the outcome of the controls to amend the MANCP 
as necessary. 

Other Member States report more generally on how their controls impact on objectives. 
For  instance,  the  Netherlands  stated  that  it  uses  animal  welfare  indicators  to  define 
targets for official control programmes. The Dutch competent authorities also measured 
the  effectiveness  of  controls  through  specific  projects  such  as  the  “Meat  Supply  Chain 
Improvement  Plan”,  “Copper  in  Pig  Feed”  and  “Compliance  Monitor  for  Red  Meat 
Slaughterhouses  and  Poultry  Slaughterhouses”.  The  annual  report  stated  that  the  work 
carried  out  in  2017  on  target  group  analyses  and  the  development  of  monitoring 
strategies  in  anticipation  of  impact  assessments  provided  a  greater  insight  into 
compliance and, therefore, into the effectiveness of official controls. 

4.2.2.  Planned and ongoing official controls 

According  to  the  EU  legislation,  national  authorities  should  plan  their  official  controls 
according to  identified  risk-based priorities20. Although all Member States  stressed that 
they  define  the  frequency  of  official  controls  through  risk-based  assessments,  they  did 
not describe the methodology used.  

Third  party  conformity  assessment  bodies  certify  European  food  and  feed  businesses 
under  a  number  of  private  quality  assurance  schemes.  Austria,  Belgium,  Denmark,  the 
Netherlands and the United Kingdom reported on how they use information from these 
schemes in their risk assessments. As an example, the Netherlands held meetings with the 
owners of those schemes. 

4.2.3.  Specific control activities 

Besides the planned control activities, Member States react to arising issues with specific 
control  activities.  Denmark  and  Hungary  reported  that  where  the  number  of  regular 

19  Articles 42(2)(a) of Regulation (EC) No 882/2004 and 110(2)(a) of Regulation (EU) 2017/625. 
20  Articles 3(1) and 43(1)(b) of Regulation (EC) No 882/2004 and 9(1) of Regulation (EU) 2017/625. 

5 

 
                                                           
official  controls  was  lower  than  previous  years,  they  increased  the  number  of  ad-hoc 
specific control activities. 

In  the  Netherlands,  risk-based  monitoring  showed  that  targeted  monitoring  of  specific 
foods,  targeted  inspections  of  compliance  and  control  of  microbiological  hazards  can 
have  advantages,  and  can  provide  businesses  and  consumers  with  a  framework  to  base 
specific actions on. 

In 2017-2018, most Member States had to  deal  with  the effects  of the fipronil incident 
originating in the Netherlands and leading to the withdrawal and recall of eggs and egg 
products  throughout  the  EU  (the  issue  is  specifically  mentioned  in  the  reports  of 
Belgium,  Czech  Republic,  Denmark,  Finland,  France,  Hungary,  Italy,  the  Netherlands 
and Poland). 

Several Member States (Belgium, Denmark, Finland, Germany, Greece, Hungary, Italy, 
Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Spain, Sweden, Slovenia and the 
United  Kingdom)  mentioned  food  fraud  and  internet  sales  as  areas  posing  particular 
challenges.  The  new  possibility  under  the  OCR  for  sampling  goods  offered  for  sale  by 
distance communication21 and the rules on the level of financial penalties for food fraud22 
should assist Member States with enforcement in these areas.  

The  presence  of  African  swine  fever  required  significant  official  resources  in  the 
countries affected – to control the disease - or at risk – to prevent its entrance and ensure 
its  early  detection  -,  as  reported  by  Estonia,  Finland,  Germany,  Poland,  Romania  and 
Sweden.  

4.2.4.  Resources 

Member States  have to ensure adequate financial  resources are available to  provide the 
staff  and  other  resources  necessary  for  the  competent  authorities  to  perform  official 
controls and other official activities23.  

Belgium,  Bulgaria,  Cyprus,  Finland,  Germany,  Greece,  the  Netherlands,  Poland, 
Portugal,  Romania,  Slovakia,  Spain  and  Sweden  emphasised  that  budget  cuts  had 
resulted  in  reduced  staff  levels,  sometimes  declining  further  from  previous  years,  and 
insufficient  financial  and/or  material  resources.  Finland,  Germany,  Greece,  the 
Netherlands,  Poland,  Portugal,  Romania  and  Spain  acknowledged  that  they  could  not 
perform all of the tasks planned in their MANCPs. 

In the Czech Republic, France and the Netherlands, staff numbers were increased to deal 
with specific issues such as animal health (African swine fever, highly pathogenic Avian 
Influenza), plant health (Xylella fastidiosa), food fraud and preparation for Brexit.   

Malta,  Spain  and  Sweden  mentioned  difficulties  in  recruiting  suitably  qualified  staff,  a 
problem that food and feed business operators also faced. 

21  Article 36 of Regulation (EU) 2017/625. 
22  Article 139(2) of Regulation (EU) 2017/625. 
23  Articles 26 of Regulation (EC) No 882/2004 and 78 of Regulation (EU) 2017/625. 

6 

 
                                                           
Member  States  reported  that  the  main  strategies  helping  them  to  mitigate  reductions  in 
staff numbers were data analysis and improved IT-systems. 

The Member States’ competent authorities see sharing knowledge with national experts 
(within  and  between  Member  States)  as  a  key  element  for  improving  audit  procedures. 
All Member States welcomed the BTSF initiative. 

4.3.  Overall  compliance  with  feed  and  food  law,  animal  health  and  animal 

welfare rules and organic farming rules 

The  Annual  Reports  provide  information  on  and  an  analysis  of  the  non-compliances 
detected by the Member State competent authorities at food and feed business operators. 

4.3.1.  Types of non-compliance 

Most  non-compliances  reported  by  the  competent  authorities  across  the  Member  States 
concerned failures in good hygiene practices, maintenance of infrastructure and operators 
either failing to perform or register the results of own checks. 

Enforcement in the areas of the distribution, sale, labelling and use of pesticides and the 
labelling  of  food  products  destined  for  the  final  consumer  also  remained  significant 
challenges in the Member States.  

4.3.2.  Analysis of non-compliances 

Occurrence of non-compliance 

Some reports mentioned percentages of non-compliance. Using percentages to compare 
Member States’ performance can be misleading.  When comparing Member States’ data, 
a  high(er)  percentage  of  reported  non-compliance  in  a  given  Member  State  does  not 
necessarily  mean  that  the  situation  is  worse  in  this  Member  State.    On  the  contrary,  it 
may  indicate  that  there  is  better  risk-based  targeting  of  controls  and  resources  in  that 
Member State. Better-targeted controls can lead to a higher number of inspections (and 
identified non-compliances). 

Nature of the risk arising from non-compliance 

Only a minority of annual reports provided information on the risks associated with non-
compliances found during official controls. 

In  general,  the  risks  related  to  the  possible  spread  of  animal  or  plant  diseases  and/or 
difficulty  in  containing  them,  loss  of  traceability  and  food  safety  hazards  to  consumers 
such as allergens, food poisoning and chemical contamination.  

7 

 
Root cause(s) of non-compliance 

Most Member States indicated that food business operators still lack an understanding of 
the  legal  requirements.    Elements  such  as  a  high  rotation  of  workers,  difficulties  in 
finding qualified staff and insufficient training contribute to insufficient implementation 
of some legal requirements by operators. 

Lower profit margins were also mentioned as an underlying cause of non-compliances in 
operators’ infrastructure. 

4.4.  National Audit Systems 

4.4.1.  Internal and/or external audits on official controls  

Member States must carry out audits on their own control systems, or have audits carried 
out on themselves, to ensure their compliance with the Regulation24. 

The  Member  States’  annual  reports  included  limited  information  on  the  internal  audits 
performed on the official control systems. Most reports just mention the number of audits 
performed and a general statement on the follow-up of these (internal) audits.  None of 
the annual reports provided information on the effectiveness of official control systems.   

4.4.2.  Audits and inspections of control bodies 

Member States may delegate some of their official control activities25. In most Member 
States,  private  control  bodies  are  active  in  auditing  and  certification  of  food  business 
operators under the rules on organic production and the labelling of products under the 
quality schemes. The competent authorities are required to audit these bodies26. 

The Member States’ reports did not provide information on controls over private control 
bodies,  where  integrations  with  the  certification  of  private  assurance  schemes  with  the 
official control plan exist. 

Under  the  rules  on  organic  production,  Member  States  are  required  to  supervise  the 
control bodies to whom they delegate official control tasks and report the results of these 
supervision audits to the Commission. The supervision audits include office assessments, 
witnessed audits, where the competent authority observes the inspection by inspectors of 
the control body, review audits, where the competent authority directly inspects organic 
operators to verify compliance with the operating procedures of the control body and to 
assess its effectiveness, and market controls. The competent authorities impose sanctions 
where necessary, including the withdrawal of these bodies’ delegations. 

24  Articles 4(6) of Regulation (EC) No 882/2004 and 6 of Regulation (EU) 2017/625. 
25  Articles 5 of Regulation (EC) No 882/2004 and 28 of Regulation (EU) 2017/625.  
26  Articles 5(3) of Regulation (EC) No 882/2004 and 33(a) of Regulation (EU) 2017/625.  

8 

 
                                                           
4.5.  Actions to ensure effectiveness in operating the national control plans 

4.5.1.  Actions  to  ensure  compliance  by  food  and  feed  business  operators 

and other relevant producers and business owners 

Member States have developed tools, such as guidance notes, information campaigns and 
training, to help food business operators achieve compliance with food safety regulations. 
For example, Denmark introduced an animal welfare label and a “yellow card scheme” to 
reduce the use of antibiotics in pig farming.  

Enhanced knowledge of official control staff and food business operators leads to higher 
compliance rates (e.g. on microbiological contamination, how to define the shelf life of 
food and how to perform and understand Listeria challenge tests in the Netherlands). 

Competent  authorities  achieved  more  transparency  through  efforts  on  communication 
and awareness campaigns aimed at consumers. The Netherlands reported that publication 
of  the  results  of  official  controls  led  to  a  higher  level  of  compliance  by  food  business 
operators.   

4.5.2.  Enforcement: action taken in case of non-compliance 

Member  States  must  have  effective,  proportionate  and  dissuasive  sanctions/penalties  in 
place27.  

Member States applied a range of enforcement actions, ranging from verbal and written 
warnings,  through  to  seizure  and  destruction  of  goods  to  the  (temporary)  removal  or 
restriction  of  approvals  of  operators.  Some  used  administrative  fines  as  a  dissuasive 
measure. Referral to Court remained a last resort.  

Finland and Luxemburg restricted operators’ access to financial support systems whereas 
Belgium  operated  a  system  of  announced  official  controls  in  consumer-facing  food 
businesses in cities, with publication of the results.   

Austria, Croatia, Finland, Germany, Italy, Latvia, Luxembourg, Malta and Portugal noted 
that  cooperation  with  other  authorities  (e.g.  tax  authority,  police)  on  food  fraud  had 
improved over the years.  

4.5.3.  Actions  taken  to  ensure  the  effective  operation  of  official  control 

services 

A number of Member States reported the use of (improved) IT-systems and data analysis 
techniques  as  ways  of  improving  the  effectiveness  and  efficiency  of  official  controls. 
Other examples described in the reports included: 

- 

the  use  of  scientific  innovations,  e.g.  whole  genome  sequencing  for  analysis  of 
Listeria outbreaks; 

27  Articles  54  and  55  of  Regulation  (EC)  No  882/2004  and  137,  138  and  139  of  Regulation  (EU) 

2017/625. 

9 

 
                                                           
-  accreditation of competent authorities against international quality standards such 
as the ISO standards on Quality Management Systems (ISO 9001), the operation 
of  various  types  of  bodies  performing  inspection  (ISO  17020)  and  the 
requirements for bodies providing audit and certification of management systems 
(ISO 17021); 
the  creation  of  control  networks  in  certain  specialised  sectors  (e.g.  food 
improvement  agents  -  such  as  food  additives  and  food  flavorings,  food  contact 
materials,  export  control)  to  enhance  the  level  of  competence  of  both  official 
control staff within the sector and of operators. 

- 

4.6.  Overall  performance  of  the  control  system  in  operating  the  national 

control plans 

The  Member  States  state  in  their  annual  reports  that,  overall,  their  official  control 
systems  are  in  place  and  sufficient.  Most  also  report  on  plans  to  further  improve 
efficiency. The most frequently mentioned means of achieving this were IT systems, data 
analysis, quality manuals and training. 

4.7.  Amendments to the MANCP 

None  of  the  Member  States  reported  specific  changes  to  their  MANCPs.  The  only 
reported changes were based on results of official inspections and information obtained 
from laboratory analyses of food and feed products. 

10 

 
 
 
5.  COMMISSION SERVICES' CONTROL ACTIVITIES IN MEMBER STATES 

5.1.  Audits 

The Directorate for Health and Food Audits and Analysis of the European Commission’s 
Directorate  General  for  Health  and  Food  Safety  (DG  SANTE)  performs  verification 
activities  to  check  whether  the  EU  legislation  on  food  and  feed  safety,  animal  health, 
animal  welfare,  plant  health,  organic  farming  and  quality  schemes  and  some  areas  of 
human  health28  is  properly  implemented  and  enforced.  It  publishes  an  annual  work 
programme, and a mid-year update29 on the website of DG SANTE.  

The  Directorate  performs  these  controls  on  a  regular  basis  and  in  cooperation  with  the 
competent authorities of the Member States. 

One  element  of  the  audits  are  on-the-spot  verifications,  where  Commission  experts 
engage  with  competent  authorities  performing  official  controls.  Experts  from  the 
Member States regularly assist the Commission experts. 

The aim of the Commission controls is to30: 

  verify the application of food and feed law, rules on animal  health and welfare, 

plant health and plant protection products; 

  verify  the  functioning  and  organisation  of  national  control  systems  and  the 

competent authorities; 
investigate and collect information 

 

o  on official controls and enforcement practices 
o  on important or recurring problems with the application or enforcement of 

o 

the rules; 
in  relation 
developments. 

to  emergency  situations,  emerging  problems  or  new 

The reports of the individual audits are publicly available31 on the DG SANTE website. 

During 2017 and 2018, the Directorate Health and Food Audits and Analysis carried out 
a total of 264 missions (mainly audits and also country visits and fact-finding missions32) 
in  the  Member  States.  Chart  1  provides  an  overview  of  the  number  of  missions  per 
Member State. 

28  The  control  activities  in  the  areas  of  human  health  are  not  performed  under  Regulation  (EC)  No 

882/2004 or 2017/625, and therefore they are not included in this report.  
29  Available at:  https://ec.europa.eu/food/audits_analysis/audit_programmes_en 
30  Art. 116(1) of Regulation (EU) 2017/625.  
31  Available at:  http://ec.europa.eu/food/audits-analysis/audit_reports/index.cfm 
32  Audits verify the implementation of official controls while country visits and fact-finding missions are 

used to gather information on a country or on a topic across a number of Member States. 

11 

 
 
                                                           
Chart 1: number of missions carried out in Member States in 2017-2018 

Chart  2  provides  an  overview  of  the  type  of  mission  under  the  different  topics  of  the 
OCR.  

Chart 2: number and type of missions performed per topic 2017-2018 

12 

 
  
 
 
 
 
 
5.1.1.  Overview reports 

The  Commission  also  publishes33  overview  reports  which  provide  a  review  of  the  area 
covered  in  an  audit  series,  identifying  what  is  working,  or  not,  in  relation  to  the 
implementation  of  controls  and  the  application  of  legislation  and  giving  examples  of 
good  practices  in  Member  States.  These  reports  provide  the  basis  for  exchanges  with 
Member  State  experts  in  the  framework  of  the  BTSF  initiative  to  discuss  common 
problems identified and to share good practices. 

In 2017 and 2018, the Commission published 22 overview reports related to its control 
activities in the Member States in the areas of food safety and quality, animal health and 
welfare, and plant health. 

The  Staff  Working  Document  accompanying  this  report34  provides  a  more  detailed 
description of some of the main areas where the Commission performed controls in the 
Member States in 2017 and 2018. 

5.1.2.  Some points to highlight 

A  series  of  audits  on  the  National  Audit  Systems  found  that  the  outputs  of  these  audit 
activities  contribute  to  improvements  of  the  consistency  and  effectiveness  of  official 
controls. 

In  the  area  of  food  safety,  fact-finding  missions  in  the  wake  of  the  fipronil  incident, 
contributed  to  improving  the  tools  available  at  EU  level  for  the  management  and 
containment of similar incidents. 

Audit series on official controls on food labelling (information to consumers and health 
and nutrition claims), food contact materials, ready-to-eat foods and e-commerce in the 
food chain showed that these areas needed more attention in the official control plans. 

In the field of animal health, African swine fever and avian influenza epidemics were the 
main areas of concern where the Commission prioritised its controls. 

On animal welfare, the Commission concluded its project on the transport of animals by 
road  and  by  sea.  Although  there  were  observable  improvements  for  animal  welfare, 
important  problems  persist.  Regarding  sea  transport,  the  Commission  is  seeking 
cooperation  with  the  European  Maritime  Safety  Agency  to  improve  compliance  of 
livestock vessels with animal welfare requirements. 

A  two-year  work  programme  on  pig  welfare  looked  into  the  practices  of  routine  tail 
docking, where serious and uniform enforcement remains a big challenge.  

33  Available at: http://ec.europa.eu/food/audits-analysis/overview_reports/index.cfm 
34  Commission staff working document accompanying the document: Report from the Commission to the 
European  Parliament  and  to  the  Council  on  the  overall  operation  of  official  controls  performed  in 
Member  States  (2017-2018)  to  ensure  the  verification  of  compliance  with  food  and  feed  law,  animal 
health and welfare rules. 

13 

 
                                                           
Two  audits  on  the  monitoring  of  antimicrobial  resistance  in  commensal  and  zoonotic 
bacteria identified a number of possible improvements to the arrangements in place. 

Since  2013,  outbreaks  of  the  bacterium  Xylella  fastidiosa  has  caused  severe  economic 
damage  in  olive  and  almond  plantations  in  Italy  and  Spain.  The  pathogen  endangers  a 
wide range of  agricultural,  horticultural  and  forest  species in Europe. Regular audits in 
Member  States  with  outbreaks  aimed  at  verifying  whether  the  implemented  measures 
ensure  the  eradication,  or  if  this  is  not  possible,  containment,  in  order  to  minimise  the 
risk of further spread in the EU. 

The  Commission  observed  certain  improvements  in  the  authorisation,  marketing  and 
sustainable use of plant protection products (PPP). However, the Member States need to 
address  shortcomings  in  the  authorisation  process  of  PPP,  the  assessment  of  integrated 
pest  management  systems,  the  review  of  national  action  plans  and  the  testing  of 
application  equipment.  The  Commission  started  the  process  of  establishing  harmonised 
risk  indicators35,  in  conjunction  with  Member  States,  to  estimate  the  evolution  in  the 
risks associated with the use of plant protection products. 

Another  area  where  the  need  for  improvement  in  the  Member  States’  official  controls 
was identified, was in relation to controls on biocidal products, which are frequently not 
authorised for the market where they are used. 

6.  COMMISSION FOLLOW-UP AND ENFORCEMENT 

6.1. 

Systematic follow-up of recommendations 

The  Commission’s  audits  generally  lead  to  recommendations  for  corrective  action. 
Member States are required to take the necessary actions to address these36 and describe 
them in action plans.  

Through regular package meetings, known as General Follow-up Audits, DG SANTE’s 
Health  and  Food  Audits  and  Analysis  Directorate  systematically  follows-up  on  the 
actions taken by competent authorities to respond to the recommendations made in audit 
reports. These General Follow-up Audits cover all of the ‘open’ recommendations across 
all sectors and the results are published in country profiles (see below).  

This  process  continued  to  be  effective  in  dealing  with  the  vast  majority  of  identified 
shortcomings.  

In  a  small  number  of  cases,  when  the  outcome  of  the  audit  is  particularly  problematic, 
sector  specific  follow-up  audits  are  organised  to  follow  up  on  actions,  which  are  to  be 
urgently implemented by the Member States. 

35  Article 15(1) of Directive 2009/128/EC establishing a framework for Community action to achieve the 

sustainable use of pesticides - OJ L 309, 24.11.2009, p. 71–86. 

36  Articles 45(3) and 45(5) of Regulation (EC) No 882/2004 and 117(a) and 119(a) of Regulation (EU) 

2017/625. 

14 

 
                                                           
At the end of December 2018, Member States had taken corrective action, or provided 
satisfactory commitments to address shortcomings within acceptable timelines: 

for  96%  of  recommendations  resulting  from  audits  in  the  reporting  cycle  2014-

• 
2016; and 

for  95%  of  recommendations  resulting  from  audits  in  the  reporting  cycle  2015-

• 
201737. 

Specific country knowledge is important for the preparation of audits and for informing 
policy-making. Therefore, the Health and  Food  Audits and Analysis Directorate of DG 
SANTE  maintains  and  publishes  country  profiles.  The  updates  of  these  ensure  the 
transparency of this process. 

These  country  profiles  are  publicly  available38  and  give  an  overview  for  all  Member 
States of: 

 
 

 

 

the five most recently published audit reports; 
the  Commission's  assessment  of  the  actions  taken  by  the  Member  States  in 
response to its audits and audit recommendations; 
the organisation of controls in the Member States, based on information supplied 
by them; 
relevant links to Member States' websites, as supplied by them. 

6.2. 

Support to Member States  

The  Commission  supports  the  Member  States  to  improve  their  capacity  to  enforce  EU 
law, through networks and training. 

6.2.1.  Networks 

The Health and  Food Audits and Analysis Directorate hosts a number of networks  and 
workings groups comprised of officials from competent authorities of the Member States 
and member countries of the European Free Trade Association parties to the Agreement 
on  the  European  Economic  Area  to  discuss  and  promote  the  implementation  of  certain 
aspects of EU law.  

Since  2008,  two  networks  have  met  regularly  to  exchange  experiences  on  the 
preparation,  implementation  and  reporting  of  MANCPs  and  on  the  implementation  of 
national  audit systems  (NAS) on official controls. During 2017 and 2018, the MANCP 
Network met  nine times. The meetings were mostly dedicated to  the development,  and 
finalisation, of the standard model forms for annual reports39. One sub-group meeting in 

37  The  follow-up  indicator  is  based  on  a  three  year  rolling  cycle,  taking  account  of  the  time  needed  by 
Member States to devise an action plan in response to audit recommendations and the time needed for 
the implementation of the actions. 

38  Available at:  https://ec.europa.eu/food/audits-analysis/country_profiles/index.cfm 
39  Regulation (EU) 2019/723 - OJ L 124, 13.5.2019, p. 1–31. 

15 

 
                                                           
2018 was dedicated to the revision of the guidelines on the preparation of the MANCP40. 
The MANCP network also developed the electronic version of the standard model form 
for the annual reports, the “Annual Reporting on Official Controls – AROC” tool, to help 
Member States get ready for the OCR implementation. 

The  NAS  Network  met  four  times  during  2017  and  2018.  The  meetings  facilitated  the 
exchange of experiences, common problems, and identified good/best practices between 
members and the network initiated a review of the guidelines on conduct of audits41. 

The  network  of  Member  States’  national  contact  points  for  the  protection  of  animals 
during  transport  (NCPs)  meets  regularly  since  2010  to  share  knowledge  of  common 
issues  and  find  solution  to  implement  and  enforce  animal  welfare  requirements  during 
transport. Since 2014, this network has produced consensus Network Documents, which 
provide  guidance  on  the  practical  implementation  of  the  animal  welfare  requirements, 
and  identify  good  practices  for  controls.  In  2017  and  2018,  the  NCP  network  met  four 
times to discuss the changes to annual reports for animal welfare transport controls, the 
transport  of  unweaned  calves  and  the  transport  of  animals  to  non-EU  countries  and  in 
extreme  temperatures.  During  2017,  the  NCP  finalised  the  Network  Document  on  the 
export of live animal exports by road. 

The Working Group, on the sustainable use of pesticides, met four times in 2017-2018. 
In  2017,  the  Commission  published  its  first  report  on  the  implementation  of  the 
legislation on the sustainable use of pesticides (SUD)42. The group intensively discussed 
this report and the SUD implementation in individual Member States, together with the 
review  of  their  initial  National  Action  Plans43.  In  2018,  the  discussions  focused  on  the 
Harmonised  Risk  Indicators  as  prepared  by  the  Commission,  environmental  aspects  of 
the  SUD,  and 
the 
implementation of Integrated Pest Management and its assessment at farm level.  

the  challenges  encountered  by  Member  States  regarding 

Working Groups on formulation of Plant Protection Products (PPPs) and on enforcement 
of legislation in this area aim to address the main weaknesses identified in the audit series 
carried out from 2012 to 2016 regarding official controls on the placing on the market of 
PPP.  During  2017  and  2018,  one  WG  meeting  on  PPP  formulation  and  analysis  was 
organised,  which  focused  on  developing  Reference  Documents  to  provide  guidance  to 
Member States on analytical strategy and on the interpretation of analytical results.  The 
WG on enforcement of PPP legislation met twice in 2017 and once in 2018. One of these 
meetings  was  organised  as  a  workshop,  addressing  official  controls  in  large-scale 
warehouses, import controls at ports, and inspections of manufacturers of plant protection 

40  Commission Decision 2007/363/EC - OJ L 138, 30.5.2007, p. 24–49. 
41  Commission Decision 2006/677/EC - OJ L 278, 10.10.2006, p. 15–23. 
42  Report from the Commission to the European Parliament and the Council on Member State National 
Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use 
of pesticides. 

43  The Member States were required to adopt National Action Plans to implement the SUD for the first 
time  by  November  2012.  These  plans  should  contain  quantitative  objectives,  targets,  measurements 
and timetables to reduce the risks and impacts of pesticide use. These plans should be reviewed at least 
every five years.  

16 

 
                                                           
products. This provided a useful basis for Member States to improve inspection activities 
in this area. 

6.2.2.  Better Training for Safer Food (BTSF) 

BTSF  is  a  Commission  initiative  aimed  at  organising  training  for  stakeholders  in  the 
areas of EU food law, feed law, animal health and animal welfare rules, as well as plant 
health  rules,  organic  farming  and  quality  schemes.  The  outcome  of  the  Commission’s 
controls  (e.g.  audits)  helps  identify  training  needs.  The  2017  and  2018  BTSF 
programme44  contained,  workshops  on  a  range  of  topics  such  as  the  prevention  and 
control  of  antimicrobial  resistance,  on  the  preparedness  of  the  veterinary  services  for 
natural disasters and training on internal audits.  

6.3.  Enforcement  

When a Member State breaches EU law, the Commission determines appropriate actions 
on a case-by-case basis in line with its "EU law: Better results through better application” 
approach45. Such actions may range from contacts with the Member States' authorities at 
appropriate  levels  aimed  at  ensuring  the  correct  application  of  EU  law  up  to  the 
launching of EU Pilot exchanges and/or infringement proceedings in cases where there is 
a clear and sound legal basis, and where all other avenues to encourage compliance have 
been exhausted. In the food safety area, enforcement tools other than infringements also 
include the imposition of protective or safeguard measures. These can range from taking 
precautionary  measures  on  the  trade  in  and  movements  of  animals,  plants  or  food  and 
feed products to adopting safeguard measures in accordance with the relevant legislation. 

A first  line of action is a high-level  letter to  the relevant  Member State, where needed, 
followed by the pre-litigation and litigation phases of the infringement procedure46.  

During 2017-2018 one infringement cases was brought before the Court of Justice of the 
European  Union  in  the  areas  covered  by  the  OCR.  The  Commission  decided  in  May 
2018 to refer Italy to the Court of Justice of the EU over its failure to adequately prevent 
further spread of the quarantine harmful organism Xylella fastidiosa in Apulia47.  

7.  CONCLUSIONS 

The EU has a solid legislative framework to control safety hazards in the supply chain. 
Member  State  national  authorities  demonstrated  in  their  annual  reports  on  official 
controls that they continue to fulfil their important role to monitor and to verify, through 
the  organisation  of  official  controls,  that  relevant  Union  requirements  are  effectively 
complied with and enforced.  

44  See https://ec.europa.eu/chafea/food/bookshelf/reports/index_en.htm for annual reports on BTSF. 
45  See  https://ec.europa.eu/info/publications/communication-commission-eu-law-better-results-through-

better-application_en.   

46  Article 258 of the Treaty of the Functioning of the EU. 
47  https://ec.europa.eu/commission/presscorner/detail/en/IP_18_3805 

17 

 
                                                           
The  accompanying  Staff  Working  Document  provides  details  of  Commission  controls 
carried out in the Member States to verify that Union requirements on food and feed law, 
animal  health  and  welfare,  plant  health  and  plant  protection  products  are  properly 
implemented and enforced by the Member States. The results of these controls show that 
overall  Member  States  have  the  requisite  control  systems  in  place,  which  ensure 
generally acceptable levels of compliance. The Commission controls however, continue 
to  identify  deficiencies  in  official  controls  and  highlight  that  there  is  still  room  for 
improvement. 

Relaxed  attitudes  to  food  safety  always  backfire  and  when  they  do,  it  may  not  only 
threaten  public  health  but  also  affect  the  trust  of  our  citizens  as  well  as  our  trading 
partners in the EU food  system  as a whole. There cannot  be  any  complacency towards 
food safety and all planned control activities set out in Member States’  MANCPs need 
to be implemented. Nevertheless, the Annual Reports for 2017 and 2018 again highlight 
that many Member States are facing challenges to secure adequate financial resources for 
performing the necessary official controls. 

The  systematic  follow-up  of  audit  recommendations  shows  that,  in  general,  Member 
States  take  the  appropriate  corrective  measures  to  address  identified  shortcomings.  In 
addition, the Annual Reports highlight ongoing efforts by the Member States to improve 
the efficiency and effectiveness of their controls, in particular through better IT systems, 
data analysis, quality manuals and training. 

The adoption of the OCR has introduced significant changes, which will contribute to the 
improvement of official controls.  

In  order  to  ensure  coherence  of  MANCPs,  Member  States  need  to  designate  a  single 
body  tasked  with  coordinating  their  preparation  and  collecting  information  on  their 
implementation, review and update. The MANCPs shall set out strategic objectives and 
how  the  prioritisation  of  official  controls  and  allocation  of  resources  reflect  these 
priorities.  

On  transparency,  the  OCR  requires  that  the  MANCPs  shall  be  made  available  to  the 
public. In addition, there is a possibility for Member States to deliver on the requirements 
of transparency by publishing their annual report. 

The  introduction  of  a  standard  model  form  for  the  annual  reports  to  be  submitted  by 
Member  States  will  facilitate  the  collection  of  comparable  information  and  data  on 
Member  States  official  controls  across  the  EU  agri-food  chain  and  will  contribute  to  a 
smoother drafting and publication of the Commission’s Annual Report. 

Working in partnership, the Commission remains dedicated to support the Member States 
to  continuously  improve  their  official  control  systems  through  the  networks  and  the 
BTSF initiative. 

18