REPORT FROM THE COMMISSION on the overall operation of official controls in the Member States on food safety,  animal health and animal welfare, and plant health
Date: 2012-03-23
Institutions: European Commission
Subjects: administrative check, animal feedingstuffs, animal welfare, food inspection, food safety, health control, plant health control, traceability, veterinary inspection

EUROPEAN COMMISSION 

Brussels, 23.3.2012 
COM(2012) 122 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
TO THE COUNCIL 

on the overall operation of official controls in the Member States on food safety,  animal 
health and animal welfare, and plant health 

 
 
 
 
  
 
TABLE OF CONTENTS 

1.  Background ................................................................................................................. 1 

2.  The EU Food Chain..................................................................................................... 2 

3.  Overview of EU food safety controls.......................................................................... 3 

3.1.  Review of annual reports of Member States ..................................................... 3 

3.2.  Results of the Commission's control activities in the Member States............. 10 

3.3.  Other sources of information on controls in the Member States..................... 21 

3.4.  Commission follow-up and enforcement ........................................................ 22 

4.  Conclusions ............................................................................................................... 24 

 
 
 
 
 
1.  Background 

Article  44 (1)  of  Regulation  (EC)  No  882/20041  (Feed  and  Food  Controls  Regulation) 
requires  Member  States  to  submit  to  the  Commission  each  year  a  report  on  the 
implementation  of  their  multi-annual  national  control  plans  established  in  compliance 
with Article 41 of that Regulation.  The reports should contain: 

(a)  details of amendments to multi-annual national control plans, to take into account 
among  other  factors,  changes  in  legislation,  new  diseases  or  risk  factors,  new 
science, the results of past controls and significant organisational changes; 

(b) 

the results of controls and audits carried out in the previous year under the national 
control plan; 

(c) 

the type and number of cases of non-compliance identified through the controls; 

(d)  actions  to  ensure  effective  implementation  of  the  national  control  plan,  including 

enforcement actions and their results.  

Article 44 (4) and (6) of the Regulation require the Commission to establish and submit 
to  the  European  Parliament  and  Council  an  annual  report  on  the  overall  operation  of 
controls in the Member States in the light of: 

(a) 

the annual reports submitted by the national authorities; 

(b)  EU audits2 and inspections carried out in the Member States; 

(c)  and any other relevant information. 

The Commission submitted its first report to the European Parliament and the Council in 
August 2010.3  The main purpose of that report was to provide a first screening of the 
data  and  information  on  official  controls  contained  in  the  first  annual  reports  from  the 
Member States. It also gave a summary of results of EU audits and inspections. It was 
discussed by Member States in the Standing Committee of the Food Chain and Animal 
Health in September 2010. The Committees on the Environment and on Agriculture and 
Rural Affairs of the European Parliament, discussed it in October 2010. 

The Commission has begun discussions with the Member States on the issues raised in 
the  first  report,  and  specifically  on  how  the  collection  and  handling  of  data  on  official 
controls can be streamlined and standardised. 

1   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 (OJ L 165, 30.4.2004, p1). 

2   Since  2010,  the  term  "inspection"  has  been  replaced  by  "audit",  to  reflect  the  broader  scope  of  FVO 

activities. "Audit" is generally used in this report, for ease of reference.  

3   COM(2010) 441 final of 25.8.2010. 

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This second report takes a somewhat different approach from the first. It aims to give an 
overview  of  EU  food  safety  controls  that  is  not  confined  to  the  latest  year  for  which 
annual reports are available from all Member States but draws on the latest information 
from all three main sources of information on controls to give as up to date an account as 
possible of how the EU control system is functioning.  

The main sources this report draws on are: (a) the annual reports from the Member States 
for 2008 and 2009, (b) the results of the Commission’s control activities over the period 
2008-2010, and (c) other relevant information on controls including: 

•    recent reports from Member States on controls in specific sectors; 

•    the  results  of  EU  rapid  alert  systems  (Rapid  Alert  System  for  Feed  and  Food  - 
RASFF,  the  Animal  Disease  Notification  System - ADNS and, the alert system for 
threats to plant health - Europhyt); 

•    discussions and decisions on controls in the Standing Committee on the Food Chain 

and Animal Health and the Standing Committee on Plant Health; 

•    a  review  of  infringement  cases  related  to  weaknesses  in  control  systems  in  the 

Member States. 

2.  The EU Food Chain 

To  understand  how  the  EU  system  of  official  controls  along  the  food  chain  (including 
those  necessary  to  ensure  plant  health,  and  animal  health  and  welfare)  operates,  it  is 
useful to first get an idea of the scale and complexity of the EU food chain.  According 
to  the  latest  data  available  from  Eurostat,  the  value  of  total  output  from  the  EU  food 
chain is around €750 billion. Total employment 
in the sector, from primary production 
through  to  retail  and  catering,  is  over  48 million.  There  are  around  14 million  primary 
agricultural producers and 3 million food business operators operating along the EU food 
chain from food manufacturing to retail and catering. These global figures give an idea 
of the scale of the food industry. It is huge, but it is also highly varied and complex.  

In primary production, for example, the average size of farm ranges from around 90 ha 
in  countries  such  as  the  Czech  Republic,  to  around  50 ha  in  countries  like  the  UK, 
France and Germany, and to less than 8 ha in other countries such as Poland, Bulgaria 
and Romania. 

There is also a great variation in the types of farming practiced across the EU; to a large 
degree  this  is  explained  by  agro-climatic  conditions,  but  also  by  longstanding 
agricultural traditions.  

In the EU, there are around 300,000 food manufacturing businesses. However, for many 
products  -  such  as  wine,  olive  oil,  eggs  and  cheese  -  processing  may  be  done  by 
agricultural  holdings  rather 
the 
manufacturing  sector  alone  would  understate  the  total  size  and  complexity  of  the  EU 
food system. Within the manufacturing sector specifically, a small number of enterprises 
operating on a global scale account for a very large share of output. In the dairy sector 
for  example,  1%  of  the  enterprises  produce  over  60%  of  total  EU  output.  Outside  of 

than  manufacturing  enterprises.  To  focus  on 

2

 
 
primary production, the largest number of food business operators is found towards the 
end  of  the  food  chain,  in  the  retailing  and  catering sectors.  There  are over one million 
food retailers in the EU, many of them small family businesses, although a small number 
of large supermarket chains dominate the sector in terms of total sales. There are almost 
1.4 million restaurants and catering establishments. 

3.  Overview of EU food safety controls 

3.1.  Review of annual reports of Member States 

The EU has developed extensive and detailed legislation designed to ensure that the food 
provided to consumers through this large and complex system of food production is safe 
and  wholesome.    The  basic  principles  of  EU  feed  and  food  law  are  laid  down  in 
Regulation  (EC)  No  178/20024.  Under  this  Regulation,  the  primary  responsibility  for 
ensuring that food is safe rests with the food businesses right along the food chain, from 
primary production to the point of final sale to the consumer.  Member States are obliged 
to monitor and verify that business operators fulfil the requirements of EU law on food 
and  feed  safety  (including  animal  health,  animal  welfare  and  plant  health).  They  are 
required to operate a system of controls for this purpose. 

Regulation  (EC)  No  882/2004  sets  out  how  these  controls  should  be  organised  and 
operated. In essence it lays down general rules for the performance of official controls to 
verify  compliance  with  EU  rules  on  the  safety  of  the  food  chain.  In  particular,  the 
Regulation imposes requirements on the Member States: when they verify: 

•  compliance by operators with the sectoral legal requirements, or  

• 

that goods to be placed on the EU market (either EU produced or imported from 
third countries) are in compliance with the standards and requirements of sectoral 
legislation.  

In addition, Member State authorities perform other official tasks under Regulation (EC) 
No 882/2004, such as those carried out to fight or eradicate animal disease agents (e.g.. 
animal  testing  for  certain  diseases  in  the  contest  of  a  programme,  an  epidemiological 
investigation following an outbreak, vaccination against animal diseases, or the killing of 
animals infected with pathogens.) 

Regulation (EC) No 882/2004 also sets out detailed rules on controls by the Commission 
services on the Member States to verify that they comply with the obligations laid down 
in  sectoral  legislation  and  in  Regulation  (EC)  No  882/2004.  Member  States  must 
establish  and  implement  multi-annual  national  control  plans  to  give  effect  to  the 
requirements of the Regulation.  These plans typically cover a three to five-year period 
and were applied for the first time from the start of 2007. Member States are required to 
submit to the Commission an annual report on the implementation of their multi-annual 
national control plans. Annual reports have been received for 2007, 2008 and 2009. 

4   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. 

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The results of the Commission’s first analysis of national reports were summarised in its 
overview report of last year, COM(2010) 441. In that report it was very difficult to draw 
conclusions for the EU as a whole due the large variability between national reports in 
both structure and content and the absence of harmonised data on controls. This is still a 
feature of the reports for 2008 and 2009 and reflects, in part, the significant differences 
between  Member  States  in  terms  of  agri-structures,  administrative  cultures  and  size. 
Nonetheless,  the  comparability  of  reports  has  improved  significantly,  as  a  result  of  a) 
Member  States  acquiring  experience  with  their  production,  and  b)  the  Commission's 
ongoing and active dialogue with the Member States to further improve the content, and 
in particular to enhance their comparability.  Since information has now been provided 
by  most  Member  States  for  a  sequence  of  three  years,  some  interesting  trends  and 
developments over time can be identified. These are summarised below.  

Data collection and analysis 

One feature common to most reports is an increasing effort to improve the gathering and 
collection of data on the number and type of controls completed and on their results. In 
the  drive  for  efficiency  and  effectiveness,  good  up-to-date  data  is  essential  to  assess 
performance and to identify priorities for future control activities. While many new and 
ongoing initiatives in this direction are referred to in the annual reports, there appears to 
be  limited  sharing  of  know-how  and  experience  across  different  control  authorities 
within or between Member States.  In its annual report last year, the Commission stated 
its  intention  to  examine,  in  cooperation  with  the  Member  States,  how  the  potential  for 
the  electronic  transmission  and  analysis  of  data  can  be  exploited  to  achieve 
simplification  and  standardisation  at  EU  level.  Work  has  now  started  on  this,  and  this 
may  in  turn  assist  Member  States  in  the  development  of  their  own  information 
management systems.  

Overall statements of performance 

The  Commission's  guidelines  on  the  structure  and  content  of  reports  request  each 
national authority to give an overall statement on the performance of its control system 
each  year.    These  statements  differ  in  quality.  In  most  reports  they  are  limited  to  a 
general  statement  that  controls  were  carried  out  in  accordance  with  planned 
arrangements, that overall standards of food safety, animal health and welfare and plant 
health  are  satisfactory,  and,  where  non-compliances  have  been  identified,  they  are 
normally of a minor nature. However, some reports provide a more comprehensive and 
substantiated  assessment  based  on  a  set  of  indicators  of  performance.  In  some  cases 
these indicators are confined to the number and type of controls carried out and whether 
they  are  in  line  with  initial  plans.  In  others  (France,  Finland,  Sweden  and  the  Slovak 
Republic)  the  indicators  go  further  and  aim  to  measure  performance  against  the 
incidence of specific animal diseases or food borne illnesses. In France there is also an 
attempt to track the cost of controls in a number of specific areas. 

Progress in the implementation of multi-annual national control plans 

The requirement on Member States to introduce integrated multi-annual national control 
plans covering all control activities across the whole food chain from farm to fork was a 
major  challenge.  National  control  systems  in  most  countries  are  highly  complex,  often 

4

 
 
 
with many different organisations involved in various aspects of control activity in food 
and feed, animal health, animal welfare and plant health. In most Member States, these 
different organisations would have had little experience in the past of working together 
to draw up integrated control plans. Moreover, the operational responsibility for carrying 
out  controls  is  devolved  to  regional  and  local  authorities  in  most  Member  States. 
Ensuring that their activities are fully integrated within the national plans in a consistent 
and  coherent  manner  required  national  authorities  to  reinforce  mechanisms  for 
consultation  and  communication  with  their  regional  and  local  authorities.  The  annual 
reports on the implementation of the plans indicate that considerable progress has been 
made in setting up the structures and procedures for integrating the control plans of all 
the  actors  at  national,  regional  and  local  level.  The  main  challenge  now  for  most 
authorities  is  to  develop  information  and  communication  systems  that  can  provide 
accurate data on the controls carried out and on their results, so that performance under 
the multi-annual national control plans can be accurately assessed over time, and control 
objectives and targets adjusted according to risk-based priorities.  

Registration of food business operators 

Effective  traceability  of  food,  from  original  source  to  final  destination,  is  a  central 
principle  of  the  EU  food  safety  control  system.  The  key  building  blocks  of  the  system 
are  a  comprehensive  registration  of  all  operators,  an  effective  system  of  animal 
identification,  and  traceability of feed and food. There has been significant progress in 
the registration of food businesses. However, in the feed area, the registration of smaller 
feed  establishments  is  still  incomplete.  As  regards  traceability  of  animals,  some 
shortcomings are apparent in the identification of cattle and pigs and in particular, in the 
systems for sheep, goats and horses. 

Risk assessment and prioritisation 

Regulation  (EC)  No  882/2004  specifically  requires  national  authorities  to  have  an 
explicit  risk  assessment  and  control  prioritisation  system.  As  the  pressure  builds  on 
resources  in  the  years  ahead,  this  aspect  of  multi-annual  national  control  plans  and 
related annual reports needs to be given higher priority. Some Member State reports give 
a good description of the systems of risk categorisation of food businesses and how their 
controls  are  organised  according  to  this  risk  categorisation.  The  Netherlands,  Finland 
and  Slovenia  are  particularly  advanced  in  this  area.  In  a  number  of  Member  States, 
however,  better  risk  categorisation  of  food  and  feed  business  operators  is  identified  by 
national authorities as an important area needing improvement. In recent years the Food 
and  Veterinary  Office  (FVO)  of  the  Directorate  General  for  Health  and  Consumers, 
through its audits, has been placing increased emphasis on the need for Member States to 
ensure  that  official  controls  in  all  sectors  are  carried  out  regularly  on  a  risk  basis  and 
with appropriate frequency. 

The intensity and scope of controls 

Overall, the reports indicate that there is a high level of control intensity throughout the 
EU. However, the frequency of inspections varies greatly according to the nature of the 
businesses.  For  example  in  sectors  regarded  as  high  risk,  such  as  meat  and  milk 
production, controls are much more frequent.  

5

 
 
 
Controls  in  the  areas  of  feed  and  animal  by-products  are  less  intensive  than  for  food. 
Major changes in EU law over the past decade regarding feed and animal by-products, in 
particular  the  need  to  have  all  feed  and  animal  by-product  businesses  registered,  have 
imposed a heavy workload on businesses and on control authorities. It is acknowledged 
in  most  reports  that  there  is  scope  for  improvements  and  for  further  intensification  of 
controls based on risk prioritisation in these sectors. 

Controls  in  the  area  of  animal  health  focus  on  verification  of  compliance  with 
requirements  concerning  animal  identification  and  testing  for  animal  diseases  such  as 
brucellosis, tuberculosis, classical swine fever and BSE. In addition, Member States are 
required to have contingency plans in place to deal with major food and feed safety and 
animal health crises. 

Coordination between national, regional and local authorities 

In  many  Member  States,  the  operational  responsibility  for  conducting  official  controls 
rests primarily with regional and local authorities. This is notable in member states with 
devolved  competences,  such  as  Germany,  Spain,  Italy,  Greece,  the  UK,  Sweden  and 
Finland, where regional and local authorities may have a strong degree of autonomy. The 
challenge  these  Member  States  face  is  how  to  ensure  a  sufficiently  robust  system  of 
accountability  through  which  regional  and  local  authorities  can  provide  a  proper  and 
consistent  account  of  their  control  activities  to  their  national  authorities,  and  through 
them, to the EU level. 

There  is  also  the  related  issue  of  overlapping  responsibilities  and  control  activities 
between  different  authorities.  This  is  a  long-standing  issue  in  a  number  of  Member 
States.  In  Greece,  Portugal  and  Romania,  for  example,  their  own  internal  audit 
authorities  cite  overlapping  responsibilities  and  operational  activities  as  a  significant 
problem. These Member States are also among those that point to inadequate resources 
as one of the reasons why targets for the number of controls cannot be met. In general, 
Member  States  with  clearly  defined  responsibilities  and  management  structures,  which 
demonstrate accountability at all levels, appear to operate most effectively. 

National audit systems 

Regulation  (EC)  No  882/2004  requires  Member  States  to  carry  out  internal  audits,  or 
have  external  audits  carried  out,  to  ensure  that  their  control  systems  are  achieving  the 
objectives of the Regulation. It also specifies that these audits be subject to independent 
scrutiny and carried out in a transparent manner. 

Almost all Member States have a system of audits in place, although in most cases they 
cover only a limited range of specific control areas within the overall system. The results 
of these audits are presented in the annual reports, but often in very summary form. The 
main  weaknesses  identified  in  these  internal  audits  and  the  remedial  actions  taken,  are 
generally  not  reported  on  in  detail.  There  are,  however,  some  notable  exceptions.  For 
example,  Finland  and  the  Czech  Republic  report  on  the  results  of  their  audits  and  the 
areas of weakness identified.  

In addition, there is limited information in the annual reports on the provisions in place 
to give effect to the requirements for audit reports to be subject to independent scrutiny. 

6

 
 
The  reliability,  or  otherwise,  of  Member  States'  own  audit  systems  in  delivering 
necessary improvements in controls will increasingly become a risk criterion taken into 
account in planning future FVO audits. 

Resources 

According  to  data  provided  by  national  authorities,  it  is  estimated  that  over  100,000 
people  are  employed  directly  or  indirectly  at  national,  regional  and  local  level  in  the 
carrying out of controls in food and feed safety, animal health, animal welfare and plant 
health. This is a very substantial resource but, in comparing targets for controls with the 
actual  outturn,  some  national  authorities  are  pointing  to  staff  shortages  as  one  of  the 
underlying  reasons  why  control  targets  are  not  met.  Some  Member  States,  such  as  the 
Netherlands,  are  quite  explicit  in  stating  that  their  control  systems  and  operations  are 
being  adjusted  to  take  account  of  the  reality  of  staff  reductions  and  rationalisation  in 
recent years. Risk assessment and prioritisation of controls, are essential elements in this 
adjustment. 

Training 

The national reports give a detailed account of the training programmes organised each 
year for control staff and for food business operators. Overall, the training effort is very 
substantial.  It  focuses  on  three  main  priorities.  First,  the  hygiene  package  Regulations 
introduced  in  2006  required  an  increased  focus  on  good  hygiene  practice  and  the 
application of HACCP5 principles by all food business operators. Considerable work has 
been done over recent years to familiarise food business operators and control staff at all 
levels  with  the  requirements  of  the  new  Regulations.  Second,  developments  in  science 
and  technology,  especially  in  relatively  new  areas  of  food  and  feed  production  (e.g. 
novel  foods,  GMO,  food  contact  materials,  food  and  feed  additives)  require  constant 
updating  of  know-how  by  staff.  Third,  increased  focus  on  animal  feed  and  animal  by-
products  controls  has  called  for  a  special  effort  to  familiarise  businesses  and  control 
officials with the new requirements of EU law in these sectors.  

Training  at  national  level  is  supported  and  complemented  by  training  organised  by  the 
Commission under the Better Training for Safer Food programme which started in 2006 
and is provided for under Article 51 of Regulation (EC) No 882/2004.  This programme, 
covering  a  wide  range  of  topics,  aims  to  make  official  controls  more  effective  in 
ensuring  that  operators  at  all  levels  respect  EU  legislation  safeguarding  public,  animal 
and plant health, and animal welfare. This in turn contributes to providing safer food and 
feed,  advancing  animal  and  plant  health  standards,  and  raising  levels  of  consumer  and 
animal protection. 

The results of Commission control activities, such as in the area of General Hygiene as 
described in Part 3.2 of this report, confirm that further training is necessary in certain 
areas. 

5   Hazard Analysis and Critical Control Points. 

7

 
 
 
 
                                                 
Laboratories 

All Member States must designate laboratories to carry out the analysis of samples taken 
during  official  controls.  These  laboratories  are  obliged  to  operate,  and  be  assessed  and 
accredited,  according  to  defined  EU  or  international  standards  to  ensure  uniform  and 
high standards. There is a large network of official laboratories across the EU. Many of 
these operate at national level, but regional and local authorities may also designate their 
own  official  laboratories,  in  particular  in  Member  States  with  autonomous  regions  or 
local  authorities.  This  can  lead  to  a  considerable  proliferation  of  official  laboratories. 
The  process  of  accreditation  is  complex  and  often  relatively  expensive,  especially  for 
smaller regional or local laboratories. As a result, some Member Sates continue to report 
delays in reaching full accreditation of all their official laboratories involved in testing in 
the  context  of  official  controls.  In  2010,  the  Commission  initiated  discussions  with 
Member States on accreditation requirements.  

FVO  audits  confirm  that  the  level  of  compliance  of  laboratories  with  EU  law  varies 
between  sectors.  For  example  in  relation  to  fish  and  fishery  products,  in  general, 
laboratories  performing  analyses  in  the  context  of  official  controls,  seem  to  be  well 
equipped and able to carry out the analyses required; most are accredited. The situation 
is different, for instance, in relation to laboratories operating under Salmonella national 
control  plans.  FVO  audits  also  report  laboratory  shortcomings  in  relation  to  pesticides 
controls in some Member States. 

Outcome of official controls and monitoring 

a) Main areas of non-compliance 

In  food  production,  there  are  two  main  recurring  themes  in  Member  States'  reports  on 
non-compliance  in  food  production:  hygiene  controls  in  establishments;  and  labelling. 
The  requirements  of  the  hygiene  package  Regulations  took  effect  from  2006.  The 
national reports on controls for 2007 recorded widespread deficiencies in the application 
of these Regulations, probably due, in part, to the fact that they had only come into force 
the  previous  year.  Steady  progress  in  this  area  is  recorded  in  2008  and  2009  but  most 
reports point to continuing problems for small operators in the retail and catering end of 
the  food  chain.  The  main  weaknesses  include:  outdated  buildings  and  equipment; 
absence or weak systems of own-checks by businesses; poor application of HACCP; and 
inadequate record-keeping. Some authorities point to problems in the retail and catering 
sectors  caused  by  high  staff  turnover,  especially  of  seasonal  workers,  thus  making  it 
difficult  to  have  staff  well  trained  on  good  hygiene  practices.  On  labelling,  the  main 
difficulty seems to arise from the complexity of requirements arising from different areas 
of legislation (e.g. additives, nutrition, place of origin, etc). 

On  feed,  the  main  non-compliances  relate  to:  delays  in  the  registration  of  business 
operators; inadequate application of HACCP principles; hygiene in feed manufacturers; 
and contraventions of the rules on additives in feed.  

On  animal  health,  the  main  weaknesses  reported  relate  to  animal  identification  and 
movement controls.  

In relation to animal welfare on farms, many of the weaknesses found were attributed to lack of 
knowledge of farmers, particularly smaller farmers. Some Member States recorded a reduction in 

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the  level  of  non-compliances  on  farms  following  the  provision  of  training  and  information  to 
farmers. 

Outcome of official controls and monitoring 

b) Overall trends in food borne illness 

Salmonella and Campylobacter are the two main causes of food borne illness in the EU. 
EFSA’s  analysis  of  the  zoonoses  reports  of  each  Member  State  confirms  a  decreasing 
trend  in  the  European  Union  of  salmonellosis  cases  in  humans.  In  total  108,614 
confirmed human cases were reported in 2009 (data published in 2011) and in particular, 
human cases caused by S. Enteritidis decreased markedly. The EFSA report points to the 
application of Salmonella control programmes in MS as a cause for this reduction. 

The  annual  reports  of  Member  States  on  controls  indicate  that  sampling  and  testing  of 
samples for these two microbiological hazards account for a very large share of sampling 
and testing related to food production in the Member States.     

National enforcement measures 

Regulation  (EC)  No  882/2004  lays  down  that  competent  authorities  shall  ensure  that 
business  operators  take  remedial  action  when  non-compliance  is  identified.  It  also 
requires Member  States  to have clearly  defined rules on the sanctions applicable when 
EU  law  is  infringed.  The  sanctions  must  be  effective,  proportionate  and  dissuasive. 
Almost  all  reports  give  a  brief  summary  of  the  actions  taken  to  deal  with  non-
compliances.  The  most  common  actions  are  warning  notices,  fines,  temporary  or,  in 
serious  cases,  permanent  business  closures,  and,  in  rare  cases,  criminal  proceedings  in 
the case of fraud and serious breaches of legal requirements. In general, information on 
the  systems  of  sanctions  and  how  they  are  operated  is  limited  and  the  level  of  detail 
varies  from  one  Member  State  to  another.  In  the  absence  of  more  specific  and 
harmonised data in annual reports, it is not possible to judge how consistent the overall 
system of enforcement is across the Member States. In certain Member States, such as 
the Czech Republic, there is a trend towards moving from court based procedures to less 
onerous  and  more  effective  administrative  procedures  for  certain  less  serious  non-
compliances.   

Official controls following the emergence of specific health threats - food, animals and 
plants 

In  recent  years,  the  main  health  emergencies arising within the EU  in the  area of  food 
and  feed  safety  had  their  origin  in  the  manufacturing  of  feed.  In  2008  high  levels  of 
dioxin  contamination  were  detected  in  pig  meat  in  Ireland.  The  problem  was  traced  to 
problems in the feed manufacturing process arising from the use of highly contaminated 
waste  oils  in  the  drying  process.  In  2010,  dioxin  contamination  was  discovered  in 
products originating in Germany. This was traced to fats, specifically for industrial use 
only, being added to animal feed. The Commission is in the process of adopting specific 
measures to deal with this particular risk. 

In the animal health area, Member States have had to focus additional control efforts on 
Bluetongue,  and  avian  influenza.  The  recent  outbreak  of  Foot  and  Mouth  Disease  in 
Bulgaria underlines the importance of continued vigilance, but also demonstrates that the 

9

 
 
EU  control  measures  are,  when  properly  applied,  effective  in  preventing  the  spread  of 
the disease. 

In the area of plant health, the containment of the pinewood nematode threat in Portugal 
and  the  implementation  of  measures  aimed  at  eradicating  the  outbreak  in  Spain,  have 
been  assigned  a  high  priority.    Similarly,  the  rapid  spread  of  the  red  palm  weevil  in 
Mediterranean countries and repeated outbreaks of Asian and citrus long horned beetles, 
required strengthened control and containment action by Member States.  The measures 
at EU level and the control efforts made by the Member States concerned are described 
in section 3.2 of this report.  

Interesting developments as possible examples of good practice 

Classification  of  establishments  and  publication  of  the  results  (Denmark,  the  Czech 
Republic,  UK,  and  Belgium):  The  requirement  that  all  food  business  operators  be 
registered,  combined  with  the  publication  of  inspection  results  of  these  businesses  by 
official authorities, makes it easier to offer consumers a useful indication of compliance 
standards  in  restaurants  and  shops.  A  number  of  examples  are  already  available,  the 
oldest  one  being 
(http://www.findsmiley.dk/en-
US/Forside.htm). Similar ideas are being pursued in the UK and Belgium. 

‘smiley’  scheme 

the  Danish 

 Self-reporting  of  remedial  actions  by  business  operators  (Netherlands):  As  part  of  the 
effort  to  improve  efficiency  of  control  services  and  to  lighten  the  burden  of  control 
activities  on  food  business  operators,  the  Netherlands  has  introduced  an  electronic 
system of self-reporting by food business operators. Using this system, a food business 
operator  can  report  to  the  control  authority,  through  a  web-based  reporting  tool,  on 
actions taken in response to recommendations arising from previous control visits. In the 
case of more routine non-compliances, these reports are generally accepted without the 
need for follow-up visits by the authorities, although occasional spot checks are done on 
random basis.  

Quality  management  systems  (Belgium,  the  Czech  Republic,  Germany,  Lithuania  and 
Slovenia):  A  number  of  Member  States  have  introduced  quality  management  systems 
(QMS)  within  their  control  services  and  have  had  them  accredited  to  international 
standards. For example, in the Czech Republic, the quality management systems of most 
control bodies are audited by external bodies against the ISO 9001 standard. They regard 
these  systems  as  important  instruments  for  improving  the  overall  effectiveness  and 
efficiency  of  controls,  and  ongoing  independent  performance  reviews  encourage 
continuous  improvement.    In  Germany,  a  special  Länder  Working  Group  on  Quality 
Management has developed a harmonised framework for the preparation of QMS in each 
of the 16 Länder. 
3.2.  Results of the Commission's control activities in the Member States 

Regulation  (EC)  No  882/2004  requires  the  Commission  to  carry  out  controls  in  the 
Member States to verify that, overall, official controls take place in accordance with the 
respective multi-annual national control plans and in accordance with EU law.  

To meet the Commission’s obligations, the FVO undertakes, each year, a programme of 
audits  and  inspections  to  verify  compliance with feed  and food  law, animal health and 
welfare and plant health legislation, and to verify that official controls in these areas are 

10

 
 
carried out in line with EU law.  This programme is published on the Commission’s web 
site at the beginning of each year.  

The  findings  of  each  audit  are  set  out  in  a  report  addressed  to  the  relevant  national 
authority,  together  with  conclusions  and  recommendations  to  address  identified 
shortcomings.  How  recommendations  are  dealt  with  is  set  out  in  section  3.4  of  this 
report. 

Information  from  FVO  audits  may  trigger  the  adoption  of  emergency  or  safeguard 
measures by the Commission (in the form of Commission Decisions) in case of a serious 
threat to food safety, animal or plant health, or where risks cannot be contained by action 
taken  by  the  affected  Member  States  alone.  These  legal  instruments  may  impose  
additional  controls,  but  also  measures  to  prevent  trade  in,  or  imports  of,  feed,  food, 
animals, and plants or any of their products, depending on the situation.  

Information  from  FVO  audits  may  also  be  used,  where  relevant,  as  evidence  of 
violations of EU law, in the context of infringement proceedings (see section 3.4). 

Through the publication of the audit reports and the Member State action plans, as well 
as regularly updated country profiles, the Commission provides stakeholders and citizens 
with a factual account of how control authorities in each Member State deliver on their 
duty to ensure the correct implementation of the EU law.  

In recent years the FVO has carried out around 250 audits each year, covering the whole 
food chain as well as animal health and welfare and plant health.  

Audits in the food safety area make up the main part of the programme. Over the period 
under review, at least 70% of all audits were concerned with food safety with some of 
these  also  covering  related  aspects  of  animal  health.  Around  12%  of  audits  related 
specifically  to  animal  health  only.  Animal  welfare  and  plant  health  accounted  for  the 
balance, with roughly 8% of audits focused on each of these areas each year.  

FVO  reports  provide  meaningful  information  on  how  Member  States'  control  systems 
have been performing in the areas covered by its audits during the reporting period. The 
following section sets out the issues of interest covered by the programme over the past 
three years in the Member States on food safety, animal health, animal welfare and plant 
health.  It  provides  also  a  brief  summary  of  the  main  findings  and  conclusions  arising 
from the different series of audits.  

The  reports  of  FVO  audits,  as  well  as  competent  authority  responses  to  FVO  report 
recommendations, can be found at: http://ec.europa.eu/food/fvo/index_en.cfm 

Food Safety 

Official controls on milk and meat production 

During  the  period  under  review,  the  FVO  carried  out  a  series  of  audits  on  hygiene 
controls  related  to  red  meat  and  milk  production  in  almost  all  Member  States.  These 
confirmed that all Member States have introduced robust control systems largely in line 
with the provisions of Regulation (EC) No 882/2004 and that the necessary upgrading of 
meat/milk  producing  and  processing  establishments  to  EU  standards  in  the  context  of 

11

 
 
accession, has largely been successfully completed in the ten Member States that joined 
the  EU  in  2004.  The  food  business  operators  have  made  the  transition  to  the 
requirements  of  the  hygiene  package  Regulations.  Where  deficiencies  were  seen,  they 
could usually be attributed to individual failures of control staff, which usually points to 
a weak system of supervision. The other main reason for persisting deficiencies is related 
to poor enforcement of legislation by control authorities. 

Moreover the series identified a tendency, primarily in some of the ‘old’ Member States, 
not to comply strictly with current meat inspection requirements, for example, regarding: 
(a)  the  use  of  technical  staff  instead  of  official  veterinarians  to  carry  out  ante-mortem 
inspection, and (b) the absence of official veterinarians at slaughter, especially in smaller 
slaughterhouses, with post-mortem inspection carried out at a later stage.  

Official controls on baby food 

Audits were carried out in 11 Member States and in Switzerland to evaluate controls on 
the  production  of  baby  food.  No  major  shortcomings  with  regard  to  the  systems  of 
hygiene  control  and  traceability  were  found  at  food  businesses  operating  in  the  sector. 
However, HACCP programmes in these businesses were generally not designed to take 
into account the specific risks associated with baby foods. Shortcomings were also noted 
in relation to composition and labelling requirements, as well as own-checks of residues 
of pesticides and contaminants. 

Official  controls  on  infant  formulae  and  baby  food  were  not  always  satisfactory  in 
relation  to  ingredients,  compositional  criteria  and  nutritional  substances,  labelling,  as 
well  as  pesticide  residues.  These  shortcomings  in  official  controls  were  frequently 
connected to limited training of official staff in relation to specific requirements of the 
legislation,  inadequately  designed  sampling  and  testing  programmes  and  limited 
capacities  for  pesticide  residue  analyses.    As  is  the  case  with  other  sectors,  the 
shortcomings  identified  are  being  systematically  addressed  through  various  follow-up 
activities. 

Transitional arrangements for compliance with the ‘Hygiene Package’ Regulations 

Under  the  hygiene  package  Regulations  that  apply  since  2006,  food  businesses,  whose 
approvals  were  then  restricted  to  supplying  their  domestic  markets,  were  allowed  a 
transitional period until the end of 2009 to meet the full requirements of the Regulations. 
The businesses were typically small capacity establishments processing limited volumes 
of food of animal origin. By the end of the transitional period, these establishments had 
either  to  adjust  the  scope  of  their  activities  or  to  comply  with  hygiene  requirements, 
although the Regulations allow for flexibility in relation to certain provisions. 

Six  Member  States  were  recently  visited  to  review  progress  in  this  area.  It  was  found 
that,  where  national  authorities  had  introduced  flexibility  arrangements  in  accordance 
with  EU  Regulations,  this  provided  solutions  for  many  of  the  small  food  business 
operators,  in  particular  in  the  red  meat  and  milk  sectors.  In  Member  States  with  less 
flexible arrangements, non-compliance was more prevalent. However, because Member 
States do not fully respect the requirement to notify national flexibility arrangements to 
the Commission, full verification at EU level of compliance with these arrangements is 
not possible.  

12

 
 
Traceability of beef and beef products 

A series of audits on traceability of beef and beef products is due to be completed by the 
end  of  2011.  In  comparison  with  the  situation  in  2002,  when  the  last  review  was 
undertaken,  controls  of  traceability  of  beef  and  beef  products  and  mandatory  labelling 
have  improved  in  the  Member  States  visited.  In  relation  to  the  traceability  of  live 
animals, there were some shortcomings, mainly related to the management of databases, 
controls on holdings, and notification of movements by livestock markets or dealers.   

Official controls on fish and fishery products 

Audits  were  carried  out  in  nine  Member  States  to  assess  compliance  with  EU 
requirements on fish.  Overall it was found that comprehensive official control systems 
for fishery products were in place in all the countries visited, including registration and 
approval of establishments and fishing vessels. In some countries significant variations 
in  the  implementation  of  official  controls  were  found  between  different  regions.  In 
general, laboratories performing official analyses were well equipped and able to carry 
out the necessary analyses. Most laboratories were accredited. 

While  the  overall  systems  were  well  designed  and  managed,  three  specific  areas  of 
weakness were identified in relation to controls over: (a) primary production sites, such 
as fishing vessels and fish farms; (b) some factory and freezer vessels; and (c) specific 
parameters related to fishery products, such as organoleptic checks, freshness indicators, 
histamine, parasites and microbiological checks.  

Official controls on poultry 

There were 12 audits of Member State control systems for poultry meat and poultry meat 
products.  Generally  the  overall  level  of  compliance  was  good.  The  entire  poultry 
production  chain  was  covered,  although  in  some  cases  the  number  of  controls  at  farm 
level  was  limited.  The  main  areas  identified  for  improvement  were  in  relation  to:  the 
application  of  specific  hygiene  requirements,  such  as  the  sampling  frequency  of 
carcasses  and  the  implementation  of  HACCP  plans  in  establishments;  and  non-
notification  to  the  Commission  of  national  legislation  allowing  flexibility  for  small 
capacity  slaughterhouses.  The 
the  situation  on  flexibility 
arrangements in the red meat and milk sectors described earlier in this report. 

latter  point  mirrors 

Salmonella control plans 

Seven audits of Salmonella national control plans in the poultry sector were carried out. 
In  all  Member  States  visited,  control  plans  had  been  introduced,  but  in  some  cases 
implementation had been delayed for certain categories.  In all Member States, the plans 
for  monitoring  and  official  sampling  for  Salmonella  in  different  poultry  categories  did 
not  fully  comply  with  EU  legislation,  largely  due  to  deficiencies  in  sampling,  actions 
taken following positive test results, and laboratories. 

Import controls for food of non-animal origin 

On  the  implementation  of  Commission  Decisions  relating  to  mycotoxin  and  Sudan  dye 
adulteration,  official  controls  have  improved  significantly,  in  particular  for  sampling, 

13

 
 
 
  
sample preparation and dealing with non-compliant consignments. However, weaknesses 
were found in: commodities where the frequency of controls is subject to risk assessment 
by  Member  States;  Rapid  Alert  notifications;  laboratories;  and  reporting  of  analytical 
results.  

More recently, FVO audits in Member States have been paying particular attention to the 
implementation  of  Regulation  (EC)  No  669/2009  on  official  controls  on  imports  of 
certain  feed  and  food  of  non-animal  origin6.  The  first  results  indicate  that,  overall, 
Member States have implemented the key obligations of the Regulation, in particular by 
creating  Designated  Points  of  Entry  (DPEs)  for  documentary,  identity  and  physical 
checks.  Areas  requiring  further  development  include:  improved  networking  between 
competent  authorities;  and  the  facilitation  of  onward  transportation  of  consignments 
between different Member States while results of physical checks are pending. 

Pesticide residues 

The  FVO  carried  out  10  audits  on  controls  of  pesticide  residues  in  the  Member  States. 
The  results  indicate  that  responsibilities  for  competent  authorities  are  clearly  identified 
and overall pesticide residue control programmes were being implemented satisfactorily, 
and were risk-based. 

However  official  controls  in  several  Member  States  suffer  from  a  lack  of  laboratory 
equipment  capable  of  performing  effective  analyses  within  the  broad  analytical  scope 
required by EU legislation. Recommendations for corrective action have been addressed 
to these Member States and are being actively followed up. 

FVO audits noted that, while own-controls are a general requirement under EU food law,   
food  business  operators  (notably  the  large  retail  chains)  have  implemented  particularly 
comprehensive auto-control systems targeted at pesticide residues. They also noted that 
these systems, which operate in parallel with official controls, had not been subject to an 
assessment  by  competent  authorities.  Therefore,  and  in  line  with  Regulation  (EC)  No 
882/2004, FVO recommended that Member States evaluate the reliability of these own-
control systems, and take account of the results in establishing the frequency of official 
controls (the Regulation specifically requires Member States' official controls shall take 
account of the reliability of own-checks carried out by FBO).   

Official controls on the application of Regulation (EC) 852/2004 ("General Hygiene") 

Twenty two audits took place to Member States to assess the official control systems in 
place  to  verify  compliance  with:  food  hygiene  rules  established  under  Regulation  (EC) 
No 852/2004; traceability and labelling provisions; and rules applicable to the placing on 
the  market  of  bottled  water.  Official  controls  were  in  place  in  all  the  Member  States 
visited  and  the  inspections  observed  by  FVO  audit  teams  confirmed  that  national 
inspectors were confident in assessing hygiene requirements. However, in relation to the 
assessment  of  HACCP  by  competent  authorities,  weaknesses  were  encountered  in  most 

6   Commission  Regulation  (EC)  No  669/2009  of  24  July  2009  implementing  Regulation  (EC)  No  882/2004  of  the  European 
Parliament  and  of  the  Council  as  regards  the  increased  level of official controls on imports of certain feed and food of non-
animal origin and amending Decision 2006/504/EC. 

14

 
 
                                                 
Member States, with a corresponding low level of implementation of HACCP principles 
by food business operators themselves.  A lack of training was also observed. 

Official controls on food additives 

Sixteen  audits  were  carried  out  to  assess  the  official  control  systems  in  place  for  food 
additives  in  certain  Member  States.  The  results  showed  that  well  established  legal 
frameworks  and  organisational  structures  were  in  place  for  official  controls  in  all  the 
Member  States  visited,  including  good  laboratory  networks.  There  is  generally  a 
sufficient number of control staff, although the level of qualifications and training could 
be improved. Control procedures are generally well documented, the risk-based approach 
in controls is broadly followed, and measures are undertaken in cases of non-compliance. 
However,  some  deficiencies  were  identified  in  controls  on  the  purity  and  labelling  of 
food  additives.  In  general,  there  is  no  control  at  the  point  of  import,  except  for  the 
unauthorised  colours  explicitly  referred  to  in  EU  legislation.  EU  legislation  on 
monitoring the consumption and use of food additives was not implemented in a number 
of Member States.  This is being actively addressed through the follow-up process. 

Official controls on materials intended to come into contact with food 

A  series  of  sixteen  audits  was  undertaken  to  assess  official  controls  on  food  contact 
materials  (FCM).  While legal frameworks are established for official controls on FCM, 
implementation  has  only  started  recently  in  a  number  of  Member  States  and  further 
efforts are needed to develop the control systems, including specific control guidelines, 
laboratory  upgrading,  and  sector-specific  training.  The  designation  of  competent 
authorities  for  official  controls  is  often  unclear,  resulting  in  the  lack,  or  overlap,  of 
controls. As the registration of FCM operators is not mandatory under EU law, there is no 
guarantee  that  they  are  covered  by  official  controls.  There  were,  generally,  well 
established  risk-based  controls  at  FCM  manufacturing  level,  but  further  efforts  are 
needed on controls at FCM user level, such as on food processors. Competent authority 
staff  often  had  been  insufficiently  trained  on  specific  issues  related  to  FCM,  such  as 
traceability  systems,  good  manufacturing  practice,  and  assessing  the  declaration  of 
compliance. 

Official controls on genetically modified organisms (GMO) 

FVO audits focused on official controls carried out to verify compliance with traceability 
and labelling requirements related to the placing on the market of GMO food, feed and 
seed,  and  on  the  performance  of  specific  controls  required  under  emergency  decisions 
aimed  at  preventing  the  import  of  non-authorised  GMO.  While  controls  are  in  general 
carried out according to EU requirements, some shortcomings were noted in relation to: 
import  controls  of  Chinese  rice;  laboratory  accreditation;  and  insufficient  sampling  for 
laboratory analysis. 

Animal Health 

Animal disease eradication programmes: task force activities 

In addition to FVO activities on disease eradication, as described below, a task force for 
monitoring  EU  co-financed  disease  eradication  programmes  was  created  in  2000,  with 
the  objective  of  increasing  the  effectiveness  of  these  programmes.    For  some  diseases, 

15

 
 
such  as  bovine  tuberculosis,  brucellosis,  rabies  and  classical  swine  fever,  specific 
subgroups  have  been  created  to  provide  technical  support  to  Member  States  and  to 
monitor implementation. 

Bovine tuberculosis and brucellosis eradication 

The eradication of bovine tuberculosis and brucellosis in cattle, sheep and goats is a high 
priority in Member States not officially free from these diseases. The FVO carried out 10 
audits  of  tuberculosis  and/or  brucellosis  eradication  programmes.  In  general  the 
programmes, approved and co-financed by the EU, were well implemented. Nonetheless, 
in  some  of  the  Member  States  visited,  shortcomings  (in  some  cases  serious)  were 
detected  in  respect  of  movement  restrictions,  testing  and  sampling  frequencies,  and/or 
the performance of epidemiological investigations.   

As  a  result  of  FVO  and  task  force  activities,  the  Commission  is  paying  particular 
attention  to  ensuring  that  shortcomings  in  these  Member  States  are  addressed  through 
enhanced design, implementation and monitoring of eradication programmes.  

Rabies 

Due to the implementation of the EU-funded rabies eradication programmes, significant 
progress in the eradication of rabies has been reported in the course of FVO audits to the 
Baltic  Member  States.    However,  in  some  Member  States,  the  implementation  of 
vaccination programmes showed deficiencies. The results of FVO audits indicate that the 
incidence of rabies in domestic and wild animals is still of concern. 

Classical swine fever 

Due  to  the  increased  application  of  bio-safety  measures  and  improved  vaccination 
campaigns for wild boars in the context of an EU funded eradication programme, only 
sporadic  outbreaks  of  Classical  swine  fever  (CSF)  in  domestic  pigs  have  occurred  in 
recent  years  in  the  EU.  These  were  well  contained by the Member States by  means of 
enforcement of the relevant EU legislation and contingency plans (see below). In spite of 
these improvements, CSF persists in the wild boar population in some regions in a few 
Member  States in  central and southeast Europe, thus posing a risk of reintroduction of 
the virus into the domestic pig population. The FVO monitors the disease situation and 
the authorities are assisted, inter alia through the activities of the task force, particularly 
in Bulgaria and Romania, in tackling the disease in the special circumstances prevailing 
in each of those Member States. 

Contingency plans 

Member  States  have  a  legal  requirement  to  develop  contingency  plans  in  order  to  be 
prepared  for  possible  outbreaks  on  their  territory  of  major  epizootic  diseases,  such  as 
Foot and Mouth Disease, and Classical Swine Fever. The FVO conducted audits of these 
contingency  plans  in  eight  Member  States.  These  audits  concluded  that  competent 
authorities have generally demonstrated their ability to respond promptly to notifications 
of  suspect  epizootic  diseases  and  to  take  measures  required.  Recommendations  were 
made to further improve some aspects, such as the state of preparedness of laboratories, 
local arrangements, and regular reviews and updates of the plans. 

16

 
 
Official controls on Foot and Mouth Disease (FMD) laboratories  

There is a legal requirement for the Commission to inspect EU laboratories that handle 
live  foot-and-mouth  disease  virus,  because  of  the  risks  to  animal  health  of  the  virus 
escaping  from  a  controlled  environment.  There  are  16  National  diagnostic  laboratories 
and  three  laboratories  authorised  to  handle  the  virus  for  vaccine  production.  In  recent 
years,  eight  laboratories  were  inspected,  with  mixed  results.  Serious  problems  were 
found in three laboratories, which could have presented a risk of escape of the virus. In 
two of these the problems, involving waste disposal systems, were resolved quickly, but 
in  the  third,  the  level  of  biosecurity  was  inadequate  and  approval  to  handle  live  FMD 
virus was withdrawn. Given the risks involved and the significant resources necessary to 
oversee  the  operation  of  these  laboratories  at  both  Member  State  and  EU  level,  these 
findings confirm that FMD laboratories should only be approved in those Member States 
that are in a position to guarantee compliance with Article 65 of Directive 2003/85/EC, 
and in particular to ensure the necessary resources for that purpose.  

BSE 

On BSE, there has been a sharp fall in the incidence of the disease, and this has allowed 
a substantial raising of the age for testing.  The frequency of FVO audits in this area has 
been correspondingly reduced.  

Bluetongue 

Following  the  availability  of  vaccines  against  the  bluetongue  serotype  8,  FVO  audits 
were  conducted  in  four  Member  States  to  evaluate  the  implementation  of  co-financed 
emergency  vaccination  against  bluetongue.  Although  some  shortcomings  were 
identified, mainly regarding the exclusion from vaccination of specific sub-populations 
such  as  fattening  cattle  and  replacement  lambs,  the  vaccination  campaigns  were,  in 
general, carried out as required by the approved programmes. 

Animal Welfare 

The  FVO  carried  out  39  audits  of  animal  welfare  controls  covering  welfare  on-farm, 
during transport and at slaughter. This intensive programme, which covered all Member 
States, threw up important findings in three main areas. 

FVO audits have been monitoring progress by Member States on the phasing out of un-
enriched  cages  for  laying  hens  by  the  deadline  of  1 January 2012.  There  are  concerns 
that  a  substantial  number  of  producers  in  several  Member  States  will  fail  to  meet  the 
deadline. The Commission is working with experts in the Member States with the aim of 
accelerating the phasing out process and achieving compliance during 2011. 

On  the  welfare  of  pigs,  Member  States  are  at  various  stages  in  preparation  for  the 
deadline  of  1  January  2013  for  the  obligatory  group  housing  of  pregnant  sows.  FVO 
monitoring  of  progress  on  this  issue  indicates  that  in  the  majority  of  Member  States, 
significant  efforts  will  be  needed  to  meet the  deadline.    Not  enough  progress  has  been 
made  in  regard  to  more  long-standing  requirements  such  as  the  need  to  use  other 
environmental  or  management  practices  instead  of  tail-docking  piglets,  with  the 
exception of Sweden and Finland, where there is already a ban on tail-docking. 

17

 
 
Regarding  transport,  although  only  a  small  number  of  Member  States  were  well 
organised in 2007 to meet the requirements for approval of means of transport, there has 
been steady progress in getting better levels of compliance in recent years. Notably, the 
new  requirement,  for  the  installation  of  temperature  monitoring  equipment  and  a 
warning device, has generally been successfully implemented. However, in a majority of 
Member  States  the  process  of  vehicle  approval  has  not  adequately  addressed  certain 
requirements in relation to watering devices and satellite navigation systems. 

Plant Health 

Import control of regulated articles 

Eleven  audits  have  been  carried  out  on  Member  State  import  control  systems  for  plant 
health,  as  part  of  an  audit  series  of  the  revised  EU  plant  health  import  regime  applied 
since 2005. Significant improvements were noted in control systems. However, there are 
points, which still need to be addressed, especially with regards to controls at places other 
than points of entry. Problems were noted in relation to regulated goods in transit, since it 
was not possible to identify all such goods at the first point of entry. As a result, some 
goods were thus not subjected to the necessary plant health controls. Resource allocations 
and deficiencies in infrastructure are at the root of such shortcomings in some Member 
States.  

Harmful organism outbreaks 

Twenty three audits covered a range of harmful organisms. As far as the most important 
pests  are  concerned,  the  Pinewood  nematode  (Bursaphelenchus  xylophilus)  occurs  in 
Portugal  and  an  outbreak  appeared  in  Spain.  A  series  of  legislative  adaptations  and 
Commission  enforcement  initiatives  aimed  at  strengthening  controls,  including  several 
FVO audits, has contributed to keeping the pest from spreading to the rest of the EU. In 
the case of the red palm weevil, (Rhynchophorus ferrugineus), FVO audits showed that 
Member  States  have  been  struggling  to  control  this  pest.  Its  biology  makes  early 
detection  and  control  difficult,  and  there  have  been  substantial  problems  with 
implementing the required eradication measures in private gardens and cities where the 
host plants (palms) are typically located. Red palm weevil is now widespread in many of 
the areas in the EU where palms are grown.  

The  Chinese  Longhorn  Beetle  and  the  Asian  Longhorn  beetles  (Anoplophora  spp.)  are 
pests of a wide range of woody plants.  FVO audits have shown that in practice, Member 
States  do  not  systematically  apply  the  measures  necessary  for  timely  eradication. 
Nevertheless,  with  the  exception  of  a  large  outbreak  in  Northern  Italy,  outbreaks  have 
generally been at least contained in small areas and some have been eradicated.  

Internal plant health controls 

Sixteen audits were carried out on internal plant health controls, including protected zone 
maintenance,  implementation  of  the  plant  passport  system  and  controls  in  the  potato 
sector.  Most  of  the  audits  confirmed  proper  controls  in  the  protected  zones,  but  there 
were  cases  where  Member  States  were  requested  to  improve  controls  substantially  in 
order  to  avoid  withdrawal  of  protected  zone  status.  The  plant  passport  audits  showed 
mixed  results.  They  indicated  that  numerous  non-compliances  identified  during  the 
previous audit series had not been addressed. The results also showed that with adequate 

18

 
 
prioritisation  of  tasks  and  allocation  of  resources,  a  proper  control  system  can  be 
established. Progress was recorded in most audits in the potato sector. 

Animal feed and animal by-products (ABP) 

Thirty nine audits have been undertaken in this area by the FVO. The main conclusions 
arising from these audits are set out below. 

While  the  approval  process  is  complete  in  all  Member  States  for  the  larger  feed 
establishments  requiring  approval,  the  registration  of  smaller  establishments  was  still 
very incomplete.  EU legislation requires registration of all operators active at any of the 
stages of production, processing, storage, transport or distribution of feed.  

There  were  frequent  flaws  in  the  design  and  implementation  of  HACCP-based 
procedures, coupled with a lack of expertise within the competent authorities on how to 
assess them. 

On import controls,  a risk-based approach was lacking in many cases, and there was a 
low frequency of physical checks for some commodities.   

There  is  a  potential  risk  that  processed  animal  protein,  contained  in  organic  fertilisers 
and soil improvers might find its way into feed.  FVO audits have identified the need to 
strengthen official controls on organic fertilisers and soil improvers, which were largely 
satisfactory  at  production  plants,  but  weak  in  the  rest  of  the  marketing  and  use  chain. 
The next round of FVO audits is placing particular emphasis on controls on this part of 
the feed chain. 

There  has  been  significant  improvement  in  the  use  of  ABP  commercial  documents,  as 
well  as  in  their  accuracy  and  reliability.  The  same  applies  to  the  collection,  transport, 
identification and disposal of ABP which, aside from the retail sector, are largely in line 
with the relevant requirements.  

Import controls on food of animal origin and animals 

There have been 30 FVO audits on import and transit controls. All Member States have 
comprehensive official systems for import controls in place and in the main, they work 
properly. 

In  particular,  the  development  and  implementation  of  a  common  computerised  system 
for  imports  in  TRACES  has  facilitated  and  simplified  many  procedures  for  border 
inspection  posts  and  improved  the  communication  between  Member  States  related  to 
import and transit. It has also facilitated an overview of the pattern of imports into the 
EU. However, the fact that some of the main importing Member States do not yet fully 
use TRACES remains a weakness. 

The audits identified a number of issues to be addressed: 

The  current  rules  regarding  controls  on  transhipments  of  consignments,  originating  in 
one third country en route to another, are complex and difficult to enforce, in particular 
in  relation  to  notification  to  the  relevant  border  inspections  posts,  and  follow-up  and 
verification of exit within the required time limits.  While these difficulties apply in all 

19

 
 
ports,  they  are  most  common  in  the  larger  ports  where  the  majority  of  such 
transhipments  take  place.    Pending  a  reassessment  of  the  current  rules,  some 
amendments  have  been  made  to  the  applicable  time  limits,  and  guidelines  have  been 
issued to render the rules both more effective and easier to enforce.  

There is great variability in the monitoring plans for imported consignments in Member 
States.  The  monitoring  strategy,  the  levels  of  sampling  and  the  range  of  products  and 
origins tested differ widely.  

Competent authorities do not systematically use enforcement measures and sanctions to 
improve  compliance  in  areas  such  as  the  notification  of  consignments  before  their 
physical arrival, and the correct completion of official documentation. 

Residues of veterinary medicines and contaminants 

The FVO has conducted 20 audits on residues of veterinary medicines and contaminants 
in the Member States. The main conclusions from these are set down below. 

initial  accreditation  criteria  have  been  fulfilled, 

The  analysing  laboratories  in  most  Member  States  are  now  accredited  to  ISO 
17025:2005 but there is a great variation as to the number of residue methods included in 
the scope of accreditation. The conditions and procedures for such method accreditation 
depend on the policy of the national accreditation bodies. If they accept "flexible scope", 
laboratory  can  add 
after 
substance/matrix/species combinations to an already accredited method, without seeking 
the  approval  of  the  accreditation  body  each  time.  If  the  national  accreditation  bodies 
require  each  such  additional  method  to  be  submitted  for  approval,  which  usually  takes 
place in connection with the annual audits, the procedure is much slower and often more 
costly for laboratories. 

the 

Commission  Decision  2002/657/EC  provides  official  residue  laboratories  with  binding 
instructions  on  the  validation  of  residue  methods.  Although  time-consuming  and 
somewhat  complicated,  this  has  harmonised  the  approach  to  validation  in  Member 
States, increased the reliability of results and provided guidance for residue laboratories 
in third countries. 

Horses treated with certain medicines need to be safely excluded from the food chain for 
six  months  (for  certain  medicines)  or  for  life. This is done in Section IX  of the equine 
passport,  which  every  horse  in  the  EU  should  have  from  about  six  months  of  age. 
Although  the  deadline  for  registration  of  all  horses  has  passed,  implementation  is  still 
ongoing in several Member States. In most Member States equine passports are required 
and checked at slaughter but very few, if any, Member States have carried out controls 
on the link between certain treatments and the entries in Section IX of the passport. 

Food  chain  information  (FCI)  at  slaughter  is  being  provided  for  all  species  in  most 
Member States. However, the interpretation of the legislation varies considerably. Some 
Member States require owners/keepers to declare on the FCI all treatments given to an 
animal  during  its  lifetime.  Others  only  require  a  declaration  that  the  animals  are  not 
slaughtered before the end of a withdrawal period for a medication. 

20

 
 
 
3.3.  Other sources of information on controls in the Member States 

Sector-specific reporting 

Provisions  in  EU  legislation  on  different  aspects  of  food  safety,  animal  health  and 
welfare  and  plant  health  require  Member  States  to  submit  regular  reports  on  certain 
specific  requirements.  On  the  basis  of  these  national  reports,  the  Commission  in  turn 
produces  a  number  of  sectoral  reports,  which  provide  an  account  of  the  state  of 
implementation  of  certain  aspects  of  EU  legislation  applicable  to  the  food  chain, 
including  in  some  cases  specific  data  on  official  controls  and  of  results  thereof  in  the 
areas concerned.  

Among the most relevant such reports, are those on: monitoring and testing of ruminants 
for  the  presence  of  Transmissible  Spongiform  Encephalopathy  (TSEs);  trends  and 
sources  of  zoonoses;  zoonotic  agents  and  food-borne  outbreaks  in  the  European  Union 
(mandated to EFSA); notifiable diseases of bovine animals and swine (in the context of 
the intra-EU trade); annual EU-wide pesticide residues monitoring report; and reports on 
animal disease eradication task force meetings. 

A  table,  listing  the  main  Commission  reports  published  in  the  past  year  and  their 
websites, is included in the Annex to this Report.  

Rapid alert systems and other reporting tools  

The  existing  rapid  alert  systems  for  food  and  feed  safety  (RASFF),  animal  disease 
outbreaks (ADNS) and plant disease outbreaks (Europhyt) represent important tools for 
managing  the  rapid  response  to  emergencies  and  emerging  risks  and  a  source  of 
information on the pattern of hazards and diseases as they develop along the food chain. 
The  data  they  provide  may  be  an  important  indicator  of  compliance  shortcomings  in 
relation  to  established  safety  standards.  Detailed  results  from  these  food  safety  and 
animal disease alert systems are summarised each year in annual reports on RASFF and 
ADNS published on the Commission's web site: 
http://ec.europa.eu/food/food/rapidalert/index_en.htm 
http://ec.europa.eu/food/animal/diseases/adns/index_en.htm .  

For  Europhyt,  the  notification  tool  for  interceptions  of  consignments  for  plant  health 
reasons,  the  Commission  is  in  the  process  of  launching  a  website  with  monthly 
interception reports. 

TRACES,  the  system  which  allows  the  exchange  of  information  between  the 
Commission  and  the  Member  States  on  controls  carried  out  on  animals  and  animal 
products  (on  domestic  products  and  imports  from  third  countries)  is  another  important 
source of data, not only on volume of movements of the commodities covered, but also 
out: 
on 
http://ec.europa.eu/food/animal/diseases/traces/index_en.htm.  

veterinary 

controls 

official 

carried 

Reporting at SCOFCAH meetings 

Reports  on  the  operation  of  controls  are  also  presented  by  Member  States  regularly  at 
meetings of the Standing Committee of the Food Chain and Animal Health. These may 

21

 
 
 
be  either  routine  reports  on  the  incidence  and  control  of  food  borne  illness,  animal 
diseases  or  plant  diseases;  or  they  may  be  related  to  recent  outbreaks  and  emergency 
actions taken in response. They represent another important source of information for the 
Commission to assess how controls are operating in the Member States. In recent years, 
the  Commission  has  adopted  the  practice  of  publishing  these  presentations  on  the 
Commission’s website along with the minutes of the respective meetings. 

Also, in some areas, the Commission prepares a compilation of such reports as received 
from  the  Member  States  and  makes  them  available  through  the  proceedings  of  the 
Standing Committee (available at the following web site: 
http://ec.europa.eu/food/committees/regulatory/index_en.htm). 

3.4. 

Commission follow-up and enforcement 

Sustained  attention  to  and  co-ordination  of  enforcement  action  remains  a  priority  in  all 
areas covered by this report. The recommendations contained in FVO audit reports are an 
important input to this. They are systematically followed up, through a range of activities. 

Member State competent authorities are requested to present an "action plan" describing 
how  they  have  addressed  or  intend  to  address  the  recommendations.  In  turn,  the 
Commission evaluates the action plan and systematically monitors the implementation of 
all these actions through a number of follow-up activities including:  (a) general follow-
up audits during which the FVO and Member State authorities meet to review progress 
made  on  all  recommendations  made  to  that  Member  State;  (b)  on-the-spot  follow-up 
audits on specific issues, or requests for written reports on specific issues; and (c) high-
level bilateral meetings in the event of over-arching, or persistent problems.  

Another  source  of  information  which  may  point  to  non-compliance  or  enforcement 
problems are complaints from  members of the public or NGOs, and the Commission is 
careful to ensure that these are pursued with the Member States concerned as well, with a 
view to achieving a positive outcome.  

In terms of other tools, and during the course of 2009-2010, the Commission found the 
EU Pilot Project, which has been operating in 15 volunteer Member States since April 
2008 with the aim of providing quicker and fuller answers to questions arising from the 
application of EU laws, to be a useful tool as it has enhanced communication between 
the  Commission  and  Member  States,  and  contributed  to  the  resolution  of  enforcement 
problems, without the need to resort to formal infringement proceedings. .  

However,  there  where  competent  authorities  fail  to  take  to  take  satisfactory  corrective 
action to address persistent problems, and where the mechanisms described above do not 
lead  to  a  satisfactory  resolution  or  insufficient  progress,  the  Commission  may  have  to 
launch infringement proceedings, to achieve compliance by the Member State.   

This occurred in three cases against Greece because it persistently failed to comply with a 
range of important components of EU food safety legislation. The Court delivered three 
judgments condemning Greece for failures in the application of EU law.  Specifically: 

- FVO audits found long-standing, fundamental and systemic shortcomings in the official 
controls  carried  out  by  Greece  which  were  mainly  attributable  to  a  shortage  of  human 

22

 
 
 
resources  in  the  Greek  veterinary  services.  As  a  result,  both  the  central  administration 
and the decentralised authorities, failed to carry out official controls in an effective and 
substantial way.  The Court concluded that the results of the efforts made by the Greek 
authorities to solve these problems were unsatisfactory7.  

- the Court also concluded that Greece had failed to correctly apply key provisions of EU 
law  on  animal  by-products  not  intended  for  human  consumption8  and  on  protection  of 
animals during transport and in slaughterhouses9. 

In addition, the Commission issued reasoned opinions in 2010 against Italy and Spain. 

- In the case of Italy, FVO audits found that the ability of the Italian authorities to meet 
their obligations under EU plant health legislation was impeded by a lack of staff. As a 
result  Italy  failed  in  many  instances  to  comply  with  notification  requirements.  In 
addition, the problem identified by the FVO resulted in a chronic failure on behalf of the 
Italian authorities to ensure a close, rapid, immediate and effective co-operation with the 
Commission.  

- In the case of Spain, FVO audits found that Spain was not correctly applying EU animal 
welfare  requirements  in  relation  to:  authorisation  of  transporters;  approval  of  means  of 
transport; control of journey logs; checks on fitness of animals for transport; inspections; 
and penalties. 

More information on infringements is available in the annual reports on monitoring the 
application 
Commission's  website: 
http://ec.europa.eu/eu_law/infringements/infringements_annual_report_en.htm 

published 

law 

EU 

the 

on 

of 

4.  Conclusions 

On  the  whole,  Member  States  ensure  a  good  level  of  implementation  of  official  controls 
across the food chain, and respect for food safety, plant and animal health, and animal welfare 
issues. While there is scope for improvement, there has been progress in the efficient use of 
control  instruments  and  resources,  and  in  planning,  implementation,  and  co-ordination  of 
controls across all sectors. 

Official controls, and legislative instruments to optimise their effectiveness, are key features 
of the EU food chain. They allow competent authorities to perform controls on a risk basis, 

7  

8  

9  

Judgment of the Court of Justice of 23.4.2009 in case C-331/07. 

Judgment of the Court of Justice of 17.12.2009 in case C-248/08. 

Judgment of the Court of Justice of 10.9.2009 in case C-416/07. 

23

 
 
 
                                                 
 
and  to  identify  shortcomings  and  address  them  in  a  timely  manner.  They  also  provide 
competent authorities with a meaningful overview of the food safety and health situations. 

Member  State  reports  provide  reassurance  that  national  competent  authorities  take  their  role 
seriously and with increasing levels of competence, as confirmed by reports from audits carried 
out by Commission experts.  

On-the-spot specific audits by the Commission, as well as general follow-up audits covering 
all  sectors,  are  of  particular  importance  in  identifying  weaknesses  to  be  addressed,  and  in 
ensuring that corrective actions are taken. 

These Commission audit reports, complementing Member State control activities, provide a 
robust system for assessing the effectiveness of Member State control systems.  

In  order  to  give  reasonable  assurances  of  compliance  with  EU  legislation,  the  Commission, 
whenever  necessary,  takes  the  appropriate  measures  to  achieve  improvements  in  official 
control and audit systems in the Member States. 

_______________________ 

24

 
 
 
 
ANNEX 

LIST OF PUBLISHED COMMISSION SECTORIAL REPORTS ON THE IMPLEMENTATION OF EU LEGISLATION ON FOOD 

SAFETY, ANIMAL HEALTH, ANIMAL WELFARE AND PLANT HEALTH 

Report 

Legal basis 

Publication 

on 

the 
Annual  Report 
monitoring  and  testing  of 
ruminants  for  the  presence 
of  transmissible  spongiform 
encephalopathy (TSE) in the 
EU 

Article  6  (4)  of  Regulation  (EC)  No  999/2001  of  the  European 
Parliament  and  of  the  Council  of  22  May  2001  laying  down 
rules  for  the  prevention,  control  and  eradication  of  certain 
transmissible spongiform encephalopathies 

http://ec.europa.eu/food/food/biosafety/tse_bse/monit
oring_annual_reports_en.htm 

and 

sources 

The EU Summary Report on 
trends 
of 
zoonoses,  zoonotic  agents 
and food-borne  outbreaks in 
the European Union 

The  Rapid  Alert  System  for 
Food  and  Feed  (RASFF) 
annual report 

Article  9  (2)  of  Directive  2003/99/EC  of  the  European 
Parliament  and  of  the  Council  of  17  November  2003  on  the 
monitoring of zoonoses and zoonotic agents, amending Council 
Decision  90/424/EEC  and 
repealing  Council  Directive 
92/117/EEC 

(Mandated  to  EFSA,  elaborated  by  EFSA  in  cooperation  with 
ECDC) 

Article  50  of  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 
laying  down 
the  European  Food  Safety  Authority  and 
procedures in matters of food safety 

25

http://www.efsa.europa.eu/en/efsajournal/doc/2090.pdf 

http://ec.europa.eu/food/food/rapidalert/rasff_publicati
ons_en.htm 

 
 
 
 
 
 
 
 
 
Report 

Legal basis 

Publication 

Annual  EU-wide  Pesticide 
Residues Monitoring Report 

Article  32  of  Regulation  (EC)  No  396/2005  of  the  European 
Parliament and of the Council of 23 February 2005 on maximum 
residue  levels  of  pesticides  in  or  on  food  and  feed  of  plant  and 
animal origin and amending Council Directive 91/414/EEC 

http://ec.europa.eu/food/fvo/specialreports/pesticides_i
ndex_en.htm 

(Mandated to EFSA) 

Annual 
irradiation 

report  on 

food 

Article 7(3) of Directive 1999/2/EC of the European Parliament 
and of the Council of 22 February 1999 on the approximation of 
the  laws  of  the  Member  States  concerning  foods  and  food 
ingredients treated with ionising radiation 

on 

Commission  Staff  Working 
the 
Paper 
Implementation    of  National 
Residue Monitoring Plans in 
the Member States 

Article  8  of  Council  Directive  96/23/EC  of  29  April  1996  on 
measures  to  monitor  certain  substances  and  residues  thereof  in 
live  animals  and  animal  products  and  repealing  Directives 
85/358/EEC  and  86/469/EEC  and  Decisions  89/187/EEC  and 
91/664/EEC 

http://www.efsa.europa.eu/en/efsajournal/pub/1646.ht
http://ec.europa.eu/food/food/biosafety/irradiation/inde
x_en.htm 

http://ec.europa.eu/food/food/chemicalsafety/residues/c
ontrol_en.htm 

26

 
 
 
 
 
Report 

Legal basis 

Publication 

Commission  annual  reports 
on  surveillance  of  avian 
influenza in poultry and wild 
birds, by Member States 

Article  19.1  of  Commission  Decision  2006/875/EC  and  article 
9.1  of  Commission  Decision  2006/876/EC 
approving 
programmes  for  the  eradication  and  monitoring  of  animal 
diseases  of  certain  TSEs  and  for  the  prevention  of  zoonoses 
presented  by  the  Member  States  and  by  Bulgaria  and  Romania 
for the year 2007. 

http://ec.europa.eu/food/animal/diseases/controlmeasur
es/avian/eu_resp_surveillance_en.htm 

The Task Force was created in 2000 as an action foreseen in the 
Commission White Paper on Food Safety. 

http://ec.europa.eu/food/animal/diseases/eradication/tas
kforce_en.htm 

experts 

Reports  of  the  meetings  of 
sub-groups 
the 
(Bovine  brucellosis,  sheep& 
goats 
bovine 
brucellosis, 
tuberculosis  and  rabies)  of 
the  Task  Force  (TF)  for 
monitoring 
disease 
eradication  in  the  Member 
States. 

27

 
 
 
Report 

Legal basis 

Publication 

Art.  7  (1)  of  Commission  Regulation  (EC)  No.  206/2009/EC 
(repealing  Art.  5  (1)  of  Commission  Regulation  (EC)  No. 
745/2004)  on  the  introduction  into    the    EU  of  personal 
consignments of products of animal origin 

http://ec.europa.eu/food/animal/animalproducts/person
al_imports/sum_personal_imports_2005_2007_final.pd
f 

summary 

Annual 
  of 
submissions  from  Member 
States concerning imports of 
products    of    animal  origin 
for      personal  consumption, 
relevant 
summarising 
the 
information 
measures  taken  to advertise 
and  enforce  the  rules      laid 
down    in    the  Regulation, 
and on the results thereof 

the 

on 

Animal  welfare:  transport 
Regulation 

Article  27(2)  of  Council  Regulation  (EC)  No  1/2005  on  the 
protection of animals during transport and related operations and 
amending  Directives  64/432/EEC  and  93/119/EC  and 
Regulation (EC) No 1255/97 

http://ec.europa.eu/food/animal/welfare/transpor 

t/inspections_reports_reg_1_2005_en.htm 

28