Report from the Commission to the European Parliament and to the Council on the application of 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 welfare rules
Date: 2009-07-08
Institutions: European Commission
Subjects: accession to the European Union, animal health, animal nutrition, animal welfare, food inspection, foodstuff, foodstuffs legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 8.7.2009 
COM(2009) 334 final 

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

on the application of 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 welfare rules 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

Executive summary...................................................................................................... 3 

SCOPE OF REGULATION (EC) No 882/2004.......................................................... 4 

Sectoral legislation on official controls: residues of veterinary medicines and of 
pesticides ...................................................................................................................... 4 

2.2. 

Plant Health.................................................................................................................. 5 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

3.7. 

3.8. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

STATE OF PLAY OF IMPLEMENTATION............................................................. 6 

Commission Guidelines ............................................................................................... 6 

Multiannual National Control Plans (MANCPs) and annual reports........................... 6 

General Audits ............................................................................................................. 7 

Official controls on imported feed and food ................................................................ 7 

Article 23 on approval of pre-export checks................................................................ 9 

Better Training for Safer Food................................................................................... 10 

Community Reference Laboratories (CRLs) ............................................................. 10 

Technical updates....................................................................................................... 11 

FEES .......................................................................................................................... 12 

Context ....................................................................................................................... 12 

Scope of the evaluation .............................................................................................. 12 

Main conclusions resulting from the study ................................................................ 12 

Scenarios for change .................................................................................................. 13 

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1. 

EXECUTIVE SUMMARY 

Article 65 of Regulation (EC) No 882/2004of the European Parliament and Council of 
29 April 2004 on official controls performed to ensure the verification of compliance 
with  feed  and  food  law,  animal  health  and  welfare  rules1  (the  "Official  Controls 
Regulation", hereafter: the "OCR") requires the Commission to submit a report to the 
European  Parliament  and  Council,  in  particular  to  review  the  experience  gained  from 
the application of the Regulation. 

Such report should consider the following issues: 

"(a)  re-evaluating the scope, in relation to animal health and animal welfare; 

(b) 

ensuring  that  other  sectors  contribute  to  the  financing  of  official  controls  by 
extending the list of activities referred to in Annex IV, section A and in Annex V, 
section A, and taking into account in particular the impact of the Community feed 
and food hygiene legislation after its adoption; 

(c) 

setting updated minimum rates for fees referred to in Annex IV, section B and in 
Annex V, section B, taking into account in particular risk factors". 

As regards the scope of the Regulation, in relation to animal health and animal welfare, 
experience  gained  so  far  does  not  call  for  a review  of  the  scope  of  the  Regulation  as 
currently  defined  in  Article  1.  On  the  other  hand,  ongoing  discussions  in  view  of  the 
modernisation  and  simplification  of  two  significant  sectors  might  help  clarifying  the 
relationship between the general framework established by the Regulation and existing 
sectoral legislation. This is particularly the case as regards the ongoing review activities 
carried out as a follow up to the Animal Health Strategy (2007-2013)2, which aim, inter 
alia  at  establishing  a  single  regulatory  framework  for  animal  health  ("Animal  Health 
Law"), and those activities that will result from the forthcoming review of the existing 
Plant Health acquis (Plant Health Strategy). In addition, consideration should be given 
to the need to ensure that existing sectoral Community provisions applicable to control 
activities  in  specific  fields  (on  residues  of  veterinary  medicines  and  of  pesticides,  for 
instance)  are  consistent  with  the  principles  and  requirements  of  the  Regulation. 
Section 2 of the report deals with this issue.  

Section 3 of this report gives an account of the main actions and initiatives developed 
in implementing the Regulation, looking at the experience gained since 1 January 2006. 
Member  States  are  progressively  gaining  hands-on  experience  in  the  preparation  and 
implementation  of  their  Multi-annual  control  plans  (MANCPs),  which  are  also  being 
used  by  the  Commission  Food  and  Veterinary  Office  (FVO)  in  the  framework  of  its 
regular General Audit missions. National Annual Reports are also an important feature 
of  the  new  framework  for  official  controls  established  by  the  OCR  although  the 
experience with such reports is too limited to allow an in-depth analysis to be carried 
out at this stage or conclusion to be drawn so far.  

1 
2 

OJ L 165, 30.4.2004, p. 1. 
A  new  Animal  Health  Strategy  for  the  European  Union  (2007-2013)  where  “Prevention  is  better  than 
cure”.  Communication  from  the  Commission  to  the  Council,  the  European  Parliament,  the  European 
Economic and social committee and the Committee of the Regions. COM 539 (2007) final. 

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Article 65 requires that special attention be given to the issue of fees collected for the 
financing of official controls ("inspection fees"). Section 4 of the report gives account 
of the current state of play of discussions and reflections on this rather complex issue, 
on  the  basis  of  the  results  of  a  recent  study  carried  out  for  the  Commission  by  an 
external evaluator. 

The study in question provides the Commission with a valuable insight of the current 
functioning of the fees system, identifies some shortcomings in the current legislative 
framework  applicable  to  inspection  fees  and  in  its  implementation  by  Member  States 
and  discusses  the  possible  need  to  review  some  of  the  features  of  that  framework. 
According to the study, a number of possible options for change may be considered, to 
enable Member States to ensure delivery on the objective laid down in Article 26 of the 
OCR,  according  to  which  "Member  States  shall  ensure  that  adequate  financial 
resources are available to provide the necessary staff and other resources for official 
controls".  For  which  it  suggests  possible  future  scenarios,  ranging  from  full 
harmonisation  of  the  features  of  the  fees'  system  to  increased  flexibility  for  Member 
States in the implementation of the system, whilst ensuring transparency and clarity of 
the functioning of the system across Member States. 

Further  analyses  on  the  issues  raised  by  the  study  are  needed,  including  a  public 
discussion with stakeholders on the results of the evaluation carried out, and an impact 
assessment  of  available  options  for  change.  The  Commission  intends  to  launch  such 
impact assessment in the course of 2009.  

2. 

SCOPE OF REGULATION (EC) NO 882/2004  

2.1. 

Sectoral  legislation  on  official  controls:  residues  of  veterinary  medicines  and  of 
pesticides 

Although official controls also include controls on residues of veterinary medicines and 
pesticides,  the  OCR  makes  reference  to  the  necessity  to  maintain  in  force  the  more 
specific rules existing in the area of feed and food and animal health, and stipulates in 
particular to keep in place Council Directive 96/23/EC on measures to monitor certain 
substances and residues thereof3 and Council Directive 86/362/EEC of 24 July 1986 on 
the  fixing  of  maximum  levels  for  pesticide  residues  in  and  on  cereals4,  which  was 
subsequently  repealed  by  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  origin5  and  amending  Council  Directive 
91/414/EEC.  

Directive 96/23/EC requires Member States to implement national residue control plans 
which  are  annually  submitted  to  the  Commission  together  with  the  results  of  the 
implementation  in  the  previous  year  and  the  actions  taken  as  follow-up  of  non-
complaint  results.  It  also  establishes  the  minimum  number  of  samples  that  shall  be 
analysed for each food commodity according to the national production without taking 
into  account  other  elements  which  may  impact  on  the  risk  assessment  (e.g.  rearing 

3 
4 
5 

OJ L 125, 23.5.2006, p. 10. 
OJ L 221, 7.8.1986, p. 37. 
OJ L 70, 16.3.2005, p. 1. 

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practices,  medicinal  products  authorised,  etc).  Apart  from  residues  of  veterinary 
medicines  and  pesticides,  Annex  I  and  II  to  Directive  96/23/EC  also  include 
environmental  contaminants6  among  the  group  of  substances  to  be  controlled  in  the 
framework of residue control plans.  

A  Reflection  Paper  was  published  already  in  2003  launching  a  broad  consultation 
process  on  the  technical  aspects  of  the  Directive7.  During  this  process  stakeholders 
expressed great interest in a review of this Directive and in the clarification of the line 
of demarcation between controls of veterinary medicines and contaminants in general 
in order to ensure alignment with the OCR.  

Regulation (EC) No 396/2005 on pesticides contains a number of articles which relate 
directly  to  controls  (Articles  26-30),  aiming  at  verifying  randomly  compliance  with 
maximum  residue  levels  (MRLs)  at  Community  level,  complemented  by  targeted 
controls  at  Member  State  level.  The  Regulation  (Articles  31-32)  also  contains  annual 
reporting  requirements.  Some  differences  in  the  approach  taken  between  Regulation 
(EC)  No  396/2005  and  the  provisions  of  the  OCR  are  the  result  of  the  separate, 
simultaneous interinstitutional negotiations that led to the adoption of the two acts. 

With  the  objective  of  better  regulation  in  mind,  consideration  should  be  given  to  the 
possibility  of  integrating  through  the  necessary  legislative  changes  the  rules  currently 
applicable 
to  official  controls  on  pesticides,  contaminants  and  residues  of 
pharmacologically active substances in food into the framework of the OCR, so as to 
rationalise and simplify the overall legislative framework whilst allowing the flexibility 
necessary to ensure the integration of both sectors into Member States' MANCPs.  

2.2. 

Plant Health  

In  the  Plant  Health  sector,  Council  Directive  2000/29/EC  on  protective  measures 
against  the  introduction  into  the  Community  of  organisms  harmful  to  plants  or  plant 
products  and  against  their  spread  within  the  Community8  establishes  sectoral  control 
rules. Official controls in that area are therefore not governed by the OCR except for 
the  provisions  applicable  to  the  establishment  of,  and  annual  reporting  on,  MANCPs 
and  to  Community  inspections  within  the  Member  States  and  third  countries 
(Articles 41 to 46).  

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Council  Regulation  (EEC)  No  315/93  of  8  February  1993  laying  down  Community  procedures  for 
contaminants  in  food  defines  contaminant  as  any  substance  not  intentionally  added  to  food  which  is 
present  in  such  food  as  a  result  of  the  production  (including  operations  carried  out  in  crop  husbandry, 
animal  husbandry  and  veterinary  medicine),  manufacture,  processing,  preparation,  treatment,  packing, 
packaging, transport or holding of such food, or as a result of environmental contamination. Monitoring of 
other  contaminants  than  those  included  in  the  annexes  to  Directive  96/23/CE  is  organised  in  the 
framework of contaminants legislation. 
As result of this Regulation (EC) No 2377/90 has been amended by Regulation (EC) No xxx/2009 of the 
European Parliament and the Council laying down Community Procedures for the establishment of residue 
limits of pharmacologically active substances in foodstuffs of animal origin (COD 2007/0064). 
OJ L 169, 10.7.2000, p. 1. 

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As part of a more general exercise aimed at evaluating the existing acquis in the Plant 
Health  area9,  consideration  will  be  given  to  the  need  to  streamline  the  provisions  on 
official controls of Directive 2000/29/EC and those of the OCR. 

3. 

STATE OF PLAY OF IMPLEMENTATION 

3.1. 

Commission Guidelines 

The OCR introduces a number of new obligations for the Member States regarding the 
planning, auditing and reporting of their official control activities. The Commission in 
accordance  with  Article  43  of  the  OCR  has  drawn  up  guidelines  to  assist  Member 
States  in  meeting  these  requirements.  The  following  Commission  Decisions  were 
adopted to this end:  

– 

– 

– 

Commission  Decision  2006/677/EC  of  29  September  2006  setting  out  the 
guidelines laying down criteria for the conduct of audits under Regulation (EC) 
No 882/2004 of the European Parliament and of the Council on official controls 
to verify compliance with feed and food law, animal health and animal welfare10.  

Commission  Decision  2007/363/EC  of  21  May  2007  on  guidelines  to  assist 
Member  States  in  preparing  the  single  integrated  multi-annual  national  control 
plan  provided  for  in  Regulation  (EC)  No  882/2004  of  the  European  Parliament 
and of the Council.11 

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  of  the 
European Parliament and the Council12. 

The  Commission  organises  regularly  working  groups  to  further  develop  the 
implementation  of  the  guidelines  and  to  provide  assistance  to  the  Member  States  in 
their preparation of the MANCPs, reports and audits.  

3.2.  Multiannual National Control Plans (MANCPs) and annual reports 

According  to  Articles  41  and  42  of  the  OCR,  Member  States  are  required  to  prepare 
and  implement  a  single  integrated  multi-annual  national  control  plan  (MANCP)  not 
later than 1 January 2007 and to provide the Commission with an up-to-date copy upon 
request.  

All  Member  States  have  provided  the  Commission  with  their  MANCPs  and  they  are 
being  evaluated  in  the  framework  of  the  Commission  Food  and  Veterinary  Office 
(FVO) General Audits (see chapter 3.3). 

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10 
11 
12 

The Council called on the Commission to evaluate the current plant health acquis and to consider possible 
modifications  to  it,  and  subsequently  present  a  proposal  for  a  Community  plant  health  strategy.  The 
Commission has launched the evaluation, and a study is to start by mid 2009. 
OJ L 278, 10.10.2006, p. 15. 
OJ L 138, 30.5.2007, p. 24. 
OJ L 214, 9.8.2008, p. 56. 

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According  to  Article  44,  one  year  after  starting the implementation of MANCPs, and 
subsequently  every  year,  Member  States  shall  submit  to  the  Commission  a  report 
indicating any amendment of the MANCPs, the results of controls and audits, the type 
and  number  of  cases  of  non-compliance  and  the  actions  taking  to  ensure  effective 
operation and enforcement. To date, the Commission has received the annual reports of 
26  Member  States  (Portugal  has  not  submitted  an  annual  report  because  its  first 
MANCP was not put in place until 2008 due to restructuring of its control services and 
therefore the first report will be made in the 2009 reporting cycle).  

3.3. 

General Audits 

Article  45  of  the  OCR  requires  that  Commission  experts  shall  carry  out  general  and 
specific  audits  in  Member  States  to  verify  that  official  controls  take  place  in  the 
Member  States  in  accordance  with  the  MANCPs  and  in  conformity  with  Community 
law.  

The Commission's FVO carries out the general audits of the Member States on a three-
year cycle. In 2007 general audits were conducted in Austria and the Netherlands and 
in  2008  in  further  six  Member  States  (Germany,  Estonia,  Hungary,  Ireland,  Slovakia 
and Spain). Nine Member States will be subject to a General Audit in 2009 (Belgium, 
Cyprus,  Finland,  Greece,  Latvia,  Lithuania,  Portugal,  Slovenia  and  the  United 
Kingdom). The 10 remaining Member States will be audited in 2010.  

Final  reports  following  a  General  Audit  are  being  published  and  can  be  found  at  the 
following address: http://ec.europa.eu/food/fvo/ir_search_en.cfm 

3.4. 

Official controls on imported feed and food 

Official controls to verify compliance with feed and food law and with animal welfare 
and animal health rules must be carried out on both Community-produced and imported 
food, feed and animals. The provisions laid down in Title II, Chapter V and Title VI, 
Chapter  II  of  the  OCR  create  the  general  framework  and  procedures  applicable  to 
official controls on feed and food imported from third countries into the territory of the 
Community.  

Title II, Chapter V of Regulation (EC) No 882/2004 contains uniform rules applicable 
to:  

• 

• 

• 

actions  to  be  taken  by  the  competent  authorities  following  official  controls  on 
import  of  feed  and  food,  as  for  instance,  in  case  of  suspicion  or  of  established 
non-compliance (Articles 18 to 22); 

approval  of  pre-export  checks  carried  out  by  third  countries  with  a  view  to 
reducing frequency of controls at import (Article 23); 

required cooperation between competent sanitary authorities and custom services 
for the organisation of official controls (Article 24). 

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Article  25  empowers  the  Commission,  through  the  procedure  laid  down  in  Council 
Decision  1999/468/EC  (Comitology  procedure)13,  to  adopt  the  measures  necessary  to 
ensure the uniform implementation of official controls on imported feed and food. 

The OCR recognises the specificities of controls to be carried out on feed and food of 
animal  origin  (Article  14)  as  opposed  to  feed  and  food  of  non  animal  origin 
(Articles 15 to 17). As regards the former, the Regulation recognises the validity of the 
existing framework of harmonised import procedures established by Council Directive 
97/78/EC14 and performed by the network of Border Inspection Posts set up throughout 
the  Community  external  borders.  The  Regulation  requires  the  competent  authority 
designated in accordance  with  Directive 97/78/EC to also carry out controls to verify 
compliance with aspects of the feed of food law not covered by this Directive. 

The Commission, as part of its new Animal Health Strategy (2007 - 2013), is currently 
reviewing  its  veterinary  import  controls  to  deliver  a  better  risk  based  approach  to 
border inspections. The review will address how best to ensure the early warning and 
prompt detection of risks from animal products so that import measures can be applied 
to ensure the continued high level of protection of public and animal health within the 
EU. 

Contrary to what happens at present for feed and food of animal origin, feed and food 
of  non-animal  origin  are  not  subject  to  systematic  EU-harmonised  checks  at  the 
border  prior  to  being  imported  into  the  Community  (with  the  exception  of  those 
products for which emergency measures based on Article 53 (1) of Regulation EC No 
178/200215  are  in  place).  According  to  the  provisions  laid  down  in  Article  15  of  the 
OCR controls on imported feed and food of non-animal origin are to be carried out at 
an  appropriate  place,  including  the  point  of  entry  into  the  Community,  the  point  of 
release  for  free  circulation,  warehouses,  the  premises  of  the  importing  feed  and  food 
business operator or other points of the feed and food chain. Member States decide, on 
the  basis  of  their  assessment  of  the  risk,  the  most  appropriate  frequency  and  the 
modalities of official controls on imported products. 

A deviation from the mentioned general rules is laid down in paragraph 5 of the same 
Article 15, which stipulates that a list shall be drawn up of feed and food of non-animal 
origin that is, on the basis of known or emerging risk, to be subject to an increased level 
of official controls at the point of entry into the Community. A draft Regulation aiming 
at establishing general provisions and such list for the  first time  has been adopted on 
x.x.2009 [to be updated before release].  

The rules above are complemented by those of Title VI, Chapter I and II of the OCR 
which  establish  the  procedures  through  which  the  Commission  gathers  relevant 
information  as  regards  the  level  of  compliance  of  third  countries'  systems  with 
Community standards for feed and food (Articles 46 and 47), and decides what, if any, 

13 

14 

15 

Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the  procedures  for  the  exercise  of 
implementing powers conferred on the Commission, OJ L 184, 17.7.1999, p. 23. 
Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation 
of veterinary checks on products entering the Community from third countries, OJ L 24, 30.1.1998, p. 9. 
Regulation (EC) N° 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  requirements  and  principles  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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specific import conditions are to be imposed for feed and food to be allowed into the 
Community (Article 48). 

Relevant  information  is  also  gathered  through  FVO  missions  in  third  countries 
(Article 46)  and  through  pre-mission  questionnaires  sent  in  advance  of  said  missions, 
which  provide  in  particular  information  about  the  countries'  organisation  and 
management of sanitary controls. 

To  the  extent  that  the  conditions  and  detailed  procedures  for  import  are  not  already 
provided  for  by  Community  legislation,  (in  particular  by  Regulation  (EC)  No 
854/200416),  specific  import  conditions  may  be  laid  down  in  accordance  with 
Comitology procedure. They may include the establishment of a list of third countries 
from which specific products may be imported into the Community, the establishment 
of  models  of  certificates  accompanying  consignments  and/or  other  special  import 
conditions depending on the type of product or animal and the possible risks associated 
(Article 48). 

Rules applicable to the conclusion of equivalence agreements with third countries are 
laid  down  in  Article  49.  These  agreements  may  recognize  that  measures  that  third 
countries  apply  in  specific  areas  offer  guarantees  equivalent  to  those  applied  in  the 
Community, provided that the third countries supply objective proof in this respect. 

3.5. 

Article 23 on approval of pre-export checks  

Article  23  of  the  OCR  gives  the  possibility  to  the  Commission  to  approve,  in 
accordance with the procedure referred to in Article 62 (3) of the Regulation, specific 
pre-export checks carried out by a third country prior to exporting a given product (feed 
and food) to the Community. As a consequence of the approval of pre-export checks, 
the frequency of import controls for feed or food may be reduced. 

The approval of third country pre-export checks may be granted on condition that 

– 

– 

a  Community  audit  has  shown  that  feed  or  food  exported  to  the  Community 
meets the Community requirements or equivalent requirements 

the pre-export checks carried out in the third country are sufficiently effective and 
efficient as to replace or allow to reduce the documentary, identity and physical 
checks carried out on the basis of Community legislation.  

In  other  words,  approved  pre-export  checks  guarantee  that  controls  are  carried  out  in 
conformity with the relevant requirements laid down in Community law.  

The  approval  of  pre-exports  checks  on  the  basis  of  Article  23  of  the  OCR  does  not 
affect the right of the Member States' competent authority to carry out official controls 
on imported feed and food. Nevertheless, the existence of an approved scheme of pre-
export  checks  shall  be  considered  by  Member  States'  competent  authorities  when 

16 

Regulation  (EC)  No  854/2004  of  the  European  Parliament  and  of  the  Council  of  29  April  2004  laying 
down  specific  rules  for  the  organisation  of  official  controls  on  products  of  animal  origin  intended  for 
human  consumption  - OJ  L  139,  30.4.2004,  p.  206  corrected  and  re-published  in  OJ  L  226,  25.6.2004, 
p. 83. 

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deciding  the  frequency  of  physical  checks  to  be  carried  out  on  food  and  feed.  Such 
frequency is determined on the basis of the risks associated with the different types of 
feed  and  food,  the  guarantees  offered  by  the  exporting  third  country,  the  controls 
carried out by the feed or food business operator importing the product, the history of 
compliance  with  the  requirements  for  the  product  concerned  of  the  third  country  and 
the  establishment  of  origin  and  of  the  food  and  feed  business  operators  importing  or 
exporting the product. 

Commission  Decision  2008/47/EC  of  20  December  2007  approving  the  pre-export 
checks  carried  out  by  the  United  States  of  America  on  peanuts  and  derived  products 
thereof as regards the presence of aflatoxins17 is the only Commission Decision to grant 
the approval of such a scheme so far. 

3.6. 

Better Training for Safer Food 

Article 51 of the OCR empowers the Commission to organise training for both the staff 
of the competent authorities of Member States and of third countries dealing with food 
and feed law, animal health, animal welfare and plant health rules. In accordance with 
this article, the Commission launched the Better Training for Safer Food initiative, now 
in its third year of activity. The second year's results were published in the initiative's 
annual report: 
http://ec.europa.eu/food/training_strategy/annual_report2007/index_en.htm. 

At  the  end  of  2008,  approximately  7  500  participants  had  benefited  directly  from  the 
training provided within the initiative, of which 52% came from Member States, 13% 
from  Candidate  Countries,  Potential  Candidate  Countries,  European  Free  Trade 
Association  countries  and  European  Neighbourhood  Policy  countries  and  35%  from 
other  third  countries.  Participation  levels  are  set  to  increase  in  the  coming  years,  to 
reach an average of 6 000 participants per year. 

In September 2006, the Commission adopted a Communication to the Council and the 
European  Parliament  on  Better  Training  for  Safer  Food18,  in  which  the  scope  and 
purpose  of  the  initiative  and  its  strategy  for  future  development  are  outlined.  In 
accordance with the conclusions of the Communication and the results of a cost-benefit 
analysis carried out by an independent consultant, the Commission decided to delegate 
implementation  tasks  of  the  programme  to  the  "Executive  Agency  for  Health  and 
Consumers"19.  

3.7. 

Community Reference Laboratories (CRLs) 

Annex  VII  to  the  OCR  established  the  consolidated  list  of  Community  reference 
laboratories  (CRLs)  for  feed  and  food  and  animal  health,  which  includes  laboratories 
previously  designated  by  various  sectoral  acts  and  new  CRLs  in  areas  not  already 

17 
18 

19 

OJ L 11, 15.1.2008, p. 12. 
COM (2006) 519, 20.09.2006, available online at: 
http://ec.europa.eu/food/training/communication_final_report_en.pdf  
Commission  Decision  2008/544/EC  of  20  June  2008  amending  Decision  2004/858/EC  in  order  to 
transform  the  "Executive  Agency  for  the  Public  Health  Programme"  into  the  "Executive  Agency  for 
Health and Consumers", OJ L 173, 3.7.2008, p. 27. 

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covered.  Since  July  2005,  the  Commission  has  launched  three  calls  for  the  selection 
and designation of new CRLs.  

This has allowed the addition to the list in Annex VII of the following new CRLs:  

– 

– 

– 

New  CRLs  in  the  sectors  of:  foot-and-mouth  disease,  Brucellosis,  Listeria 
monocytogenes,  Coagulase  positive  Staphylococci,  Escherichia  coli  including 
Verotoxigenic  E.coli 
in  particular 
Trichinella, Echinococcus, Anisakis), antimicrobial resistance, animal proteins in 
feedingstuffs, pesticides residues, mycotoxins in food and feed, dioxins and PCBs 
and Polycyclic Aromatic Hydrocarbons (PAHs)20. 

(VTEC),  Campylobacter,  parasites 

( 

CRL for equine diseases other than African horse sickness21. 

CRLs  for  crustacean  diseases,  rabies  and  bovine  tuberculosis,  laying  down 
additional  responsibilities  and  tasks  for  the  CRL  for  rabies  and  bovine 
tuberculosis22  

3.8. 

Technical updates  

EN ISO/IEC 17020 standard replaces EN 45004 

According to Article 5 of the OCR the competent authority may delegate specific tasks 
related  to  official  controls  to  one  or  more  control  bodies  in  accordance  with  certain 
requirements.  These  control  bodies  must  work  and  be  accredited  in  accordance  with 
European  Standards,  in  particular  with  the  EN  standard  on  «General  criteria  for  the 
operation  of  various  types  of  bodies  performing  inspection».  The  previous  EN  45004 
standards  has  been  replaced  by  EN  ISO/IEC  17020.  The  OCR  should  therefore  be 
amended  accordingly.  The  Commission  is  currently  preparing  and  amendment,  to  be 
adopted by comitology procedure, of the OCR to reflect the changes to ISO standards.  

EN ISO/IEC 17011 standard replaces EN 45002 and EN 45003 

According  to  Article  12  (1-2)  of  the  OCR,  the  competent  authority  designates 
laboratories  that  may  carry  out  the  analysis  of  samples  taken  during  official  controls 
and  these  laboratories  had  to  be  accredited  in  accordance  with  certain  European 
Standards. The previous EN 45002 on  "General criteria for the assessment of testing 
laboratories"  and  EC  45003  on  "Calibration  and  testing  laboratory  accreditation 
system – General requirements for operation and recognition» have been replaced by 
the  same  EN  ISO/IEC  17011  on  "General  requirements  for  accreditation  bodies 
accrediting  conformity  assessment  bodies",  and  the  OCR  has  been  amended 
accordingly23.  

20 
21 
22 
23 

Commission Regulation (EC) No 776/2006 of 23 May 2006, OJ L 136, 24.5.2006, p. 3. 
Commission Regulation (EC) No 180/2008 of 28 February 2008, OJ L 56, 29.2.2008, p. 4. 
Commission Regulation (EC) No 737/2008 of 28 July 2008, OJ L 201, 30.7.2008, p. 29. 
Commission Regulation (EC) No 1029/2008 of 20 October 2008 amending Regulation (EC) No 882/2004 
of  the  European  Parliament  and  of  the  Council  to  update  a  reference  to  certain  European  standards, 
OJ L 278, 21.10. 2008, p. 6. 

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4. 

FEES 

4.1. 

Context 

Article  65  of  the  OCR  requires  the  present  Report  to  address  special  attention  to  the 
issue of fees collected for the financing of official controls ("inspection fees"). 

In  order  to  be  able  to  report  on  this  complex  issue,  the  Commission  called  for  an 
external evaluation aimed at providing a better understanding of the functioning of the 
inspections fees systems as currently implemented by the Member States on the basis 
of the relevant provisions of the OCR (Articles 26 to 29).  

The  evaluation  (“the  study”)  was  carried  out  by  a  contractor  in  the  period  April-
November  2008  through  a  survey  addressed  to  competent  authorities  in  all  Member 
States, an in-depth analysis (case studies) in relation to six Member States representing 
a  variety  of  fee  regimes,  interviews  with  key  experts  and  stakeholders  at  EU  level, 
extensive  analysis  of  existing  literature  and  data  review  (including  relevant  FVO 
reports and national legislation). 

The  results  of  the  study  were  finalised  and  made  available  to  the  Commission  in 
February 2009. 

4.2. 

Scope of the evaluation  

The objectives of the study were two-fold: 

(a) 

(b) 

to  evaluate  the  present  situation  as  regards  the  application  of  the  existing 
provisions on fees, in particular the way in which the system operates in practice; 

to  assess  the  advantages  and  disadvantages  of  a  range  of  policy  options 
(regarding the scope of current rules and the fee-setting mechanism). 

The  evaluators  were  also  asked  to  identify  the  main  strengths  and  weaknesses  of  the 
current system, as well as key problems and shortcomings that should be addressed in 
the future. They looked in particular at how Articles 26 to 29 of the OCR are currently 
implemented and how the fee system, as it is currently applied, contributes to achieving 
the objectives of the OCR.  

4.3.  Main conclusions resulting from the study 

The study established that there is a significant degree of variation in the enforcement 
of the financing provisions of the OCR by the Member States and a significant lack of 
clarity and transparency of the various national fee systems as currently implemented. 
As a result, direct comparison of actual fee levels across the EU (and between sectors) 
is extremely difficult. 

The study results also suggest that, due to the very broad definition of cost categories in 
Annex VI to the Regulation and to the reported lack of transparency of the calculation 
methods,  it is quite unclear whether cost-based fees truly reflect actual costs incurred 
by  the  competent  authorities  of  the  Member  States  for  the  performance  of  the 
inspections for which the fees are collected. 

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In  more  general  terms,  the  study  investigated  whether  the  main  objective  of  the 
inspection  fees  system  as  in  place  at  the  moment  has  been  reached,  i.e.  ensuring  that 
Member  States  have  sufficient  financial  resources  to  carry  out  the  official  controls 
(Article 26 of the Regulation). The study suggests that this main objective has largely 
not been fulfilled at present for the EU as a whole. 

4.4. 

Scenarios for change 

On the basis of the findings reported, the study assesses advantages and disadvantages 
of a range of policy options and compares possible alternatives to the current rules. 

As working hypothesis, the study considers the two following extreme scenarios: 

– 

– 

"full subsidiarity", which would imply the repeal of most of the constraints laid 
down in the existing legal framework, as regards in particular the calculation of 
the  fees  and  the  scope  of  the  mandatory  fees;  Member  States  would  be  free  to 
decide on the best way to finance their official control services; 

"full harmonisation", with fees fixed at the same level across the whole European 
Union and for all the sectors concerned (identified by Community legislation). 

The study then assesses advantages and disadvantages of intermediate scenarios, which 
result  from  the  addition  of  mitigating  elements  to  the  two  most  radical  options.  The 
analysis  is  carried  out  in  particular  considering  how  the  main  components  of  a 
legislative framework on inspection fees would be characterised on a scale from "full 
subsidiarity" to "full harmonisation". Such main components are in particular: 

• 

• 

• 

• 

• 

mandatory/non-mandatory nature of the fee 

harmonised/non-harmonised level of fee rates 

harmonised/non-harmonised fee calculation method 

harmonised /non-harmonised fee reductions and penalties for non-compliances 

list of activities covered by fees (scope of the system). 

Consideration is also given to the possibility of maintaining the system as it stands but 
with some improvements to address, as far as possible, the reported shortcomings. 

The  Commission  will  now  carry  out  an  Impact  Assessment  to  evaluate  the  options 
available and the need to prepare a legislative proposal. This will include a consultation 
of stakeholders and other interested parties. 

Full details of the study results on fees are published at the following address: [to be 
completed]. 

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