COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation)
Date: 2013-05-06
Institutions: European Commission
Subjects: EU control, administrative check, animal breeding, animal health, animal welfare, consumer protection, disease prevention, food safety, genetically modified organism, health control, labelling, market approval, marketing standard, plant health control, plant propagation, production standard, veterinary inspection

EUROPEAN 
COMMISSION 

Brussels, 6.5.2013  
SWD(2013) 167 final 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT 

Accompanying the document 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on official controls and other official activities performed to ensure the application of 
food and feed law, rules on animal health and welfare, plant health, plant reproductive 
material, plant protection products and amending Regulations (EC) No 999/2001, 
1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, 
Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number 
of Regulation laying down provisions for the management of expenditure relating to the 
food chain, animal health and animal welfare, and relating to plant health and plant 
reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 
2008/120/EC and 2009/128/EC (Official controls Regulation) 

{COM(2013) 265 final} 
{SWD(2013) 166 final} 

EN 

   EN 

 
 
 
 
  
 
 
Table of contents 

INTRODUCTION 

1.  PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. EX-POST ANALYSES OF THE EU SYSTEM OF OFFICIAL CONTROLS 
1.2. DATA COLLECTION BY OR ON BEHALF OF THE COMMISSION 
1.3. CONSULTATIONS 

1.3.1. MEMBER STATES 
1.3.2. STAKEHOLDERS 
1.3.3. SUMMARY OF THE CONSULTATION OF THE INTERESTED PARTIES 

1.4. INTER-SERVICE STEERING GROUP (ISSG) 
1.5. IAB OPINION 

2.  PROBLEM DEFINITION 

2.1. BACKGROUND 

2.1.1.  THE  EU  SYSTEM  OF  OFFICIAL  CONTROLS  ALONG  THE  AGRI-FOOD 

CHAIN 

2.1.2.  THE INTERNATIONAL DIMENSION 

2.2. PROBLEM IDENTIFICATION 

2.2.1.  DESIGN OF THE OFFICIAL CONTROLS' FRAMEWORK 
2.2.2.  DIFFICULTIES  AND  INEQUITIES  IN  FINANCING  OFFICIAL  CONTROL 

ACTIVITIES 
2.3. PARTIES AFFECTED 
2.4. HOW WOULD THE PROBLEM EVOLVE, ALL THINGS BEING EQUAL? 
2.5. DOES THE EU HAVE THE RIGHT TO ACT (SUBSIDIARITY)? 

2.5.1.  RIGHT OF THE EU TO ACT (LEGAL BASIS) 
2.5.2.  NECESSITY FOR THE EU TO ACT (SUBSIDIARITY) 

3.  OBJECTIVES 

3.1. GENERAL OBJECTIVES 
3.2. SPECIFIC OBJECTIVES 

3.2.1.  OBJECTIVES  RELATED  TO  THE  DESIGN  OF  THE  OFFICIAL 

CONTROLS' FRAMEWORK 

3.2.2.  OBJECTIVES RELATED TO THE FINANCING OF OFFICIAL CONTROLS 

3.3. OPERATIONAL OBJECTIVES 
3.4. CONSISTENCY  WITH  THE  OTHER  EU  POLICIES  AND  HORIZONTAL 

OBJECTIVES 

4.  POLICIY OPTIONS 

4.1. POLICY OPTIONS INCLUDED IN THE ANALYSIS 
4.2. DISCARDED POLICY OPTIONS 

5.  ANALYSIS OF IMPACTS 

6.  COMPARING THE OPTIONS IN LIGHT OF THE OBJECTIVES 

6.1. COMPARING THE OPTIONS IN LIGHT OF THE OBJECTIVES 
6.2. COST-BENEFIT ANALYSIS 
6.3. PREFERRED OPTION 

7.  MONITORING AND EVALUATION 

ANNEXES 
ANNEX I 
ANNEX II 
ANNEX III 
ANNEX IV 
ANNEX V 

GLOSSARY 
OVERVIEW OF THE EXISTING LEGISLATIVE FRAMEWORK 
PROBLEM DEFINITION – DETAILS AND EXAMPLES 
PROCEDURE – DETAILS OF THE CONSULTATION 
PROCEDURE – SPECIFIC DATA COLLECTION ACTIVITIES 

1 

2 
2 
3 
4 
4 
4 
4 
4 
5 

6 

6 
6 

7 
8 
8 

12 
15 
16 
17 
17 
17 

18 
18 
18 

19 
19 
20 
20 

21 
21 
26 

28 

41 
41 
43 
44 

45 

47 
48 
53 
59 
63 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX IX 

ANNEX X 
ANNEX XI 

ANNEX VI 
ANNEX VII 
ANNEX VIII 

ANNEX XVI 
ANNEX XVII 
ANNEX XVIII 

ANNEX XII 
ANNEX XIII 
ANNEX XIV 
ANNEX XV 

PROCEDURE – LIST OF CONSULTED STAKEHOLDERS 
PROCEDURE – LIST OF FVO AUDITS SINCE 2007 
REVISION  OF  REGULATION  882/2004  –  SUMMARY  OF  THE  MS’ 
OPINIONS 
REVISION  OF  REGULATION  882/2004  –  SUMMARY  OF  THE 
STAKEHOLDERS’ OPINIONS 
FEES – EXECUTIVE SUMMARY OF FCEC STUDY 
FEES  –  STUDY  CARRIED  OUT  BY  GHK  TO  SUPPORT  THE  IMPACT 
ASSESSMENT AS REGARDS THE FINANCING OF OFFICIAL CONTROLS 
FEES – SUMMARY OF STAKEHOLDERS’ OPINIONS 
FEES – SUMMARY OF MS’ OPINIONS 
FEES – EVIDENCE CONCERNING PROBLEMS OF INTERPRETATION 
FEES  –  EXAMPLES  OF  STATED  LIMITED  AVAILABILITY  OF 
RESOURCES IN FVO REPORTS 
FEES – VALIDATED BASELINE SCENARIO 
FEES – SUPPORTING DATA 
LABORATORIES – MS’ CONSULTATIONS ON THE ACCREDITATION OF 
OFFICIAL LABORATORIES 
LABORATORIES  –  COSTS  RELATING  TO  THE  INTRODUCTION  OF  A 
MANDATORY  ACCREDITATION  OF  OFFICIAL  LABORATORIES 
CARRYING  OUT  PLANT  HEALTH  TESTS  AND  TO  THE  CREATION  OF 
EURLs 
DIRECTIVE  96/23/EC  –  MS’  CONSULTATIONS  ON  THE  IMPACT  OF 
DIFFERENT OPTIONS 
DIRECTIVE 96/23/EC – COSTS REDUCTIONS RELATING TO THE REPEAL 
OF THE DIRECTIVE 96/23/EC 
DIRECTIVE 96/23/EC – ADMINISTRATIVE BURDEN REDUCTION 
ANNEX XXII 
ANNEX XXIII  MAIN CHANGES TO THE EXISTING LEGISLATIVE FRAMEWORK 
ANNEX XXIV 
ANNEX XXV 
ANNEX XXVI 

SIMPLIFICATIONS GAINS 
EXEMPTIONS AND REDUCTIONS FOR MICRO-ENTERPRISES 
INVASIVE ALIEN SPECIES – ONGOING INITIATIVE 

ANNEX XIX 

ANNEX XX 

ANNEX XXI 

64 
66 
75 

79 

88 
94 

103 
110 
117 
136 

151 
179 
189 

200 

203 

228 

231 
237 
244 
247 
252 

 
 
 
Introduction 

In  order  to  afford  European  Union  (EU)  citizens  a  high  level  of  human,  animal  and  plant 
health, and guarantee the functioning of the internal market, Union legislation provides for a 
set  of  harmonised  rules  to  prevent,  eliminate  or  reduce  the  level  of  health  risk  to  humans, 
animals  and  plants,  which  may  arise  along  the  agri-food  chain.  The  risks  addressed  include 
health  risks  sensu  stricto  (risks  to  the  integrity  of  humans,  animals  and  plants  from  pests, 
diseases, microbial and chemical contaminants and other hazards) but also the preservation of 
inherent qualities required to ensure a safe start of plant production and regulated production 
methods (i.e. animal welfare, organic farming, geographical indications). 

In  particular,  the  EU  has  established  rules  governing  all  the  activities,  from  primary 
production to retail and catering, which may affect: 

- 
- 
- 
- 

the health of animals and plants, 
the safety of food and feed for EU citizens,  
the welfare of animals,  
the  quality  of  plant  reproductive  material  and  other  quality  aspects  such  as  organic 
production and geographical indications. 

In  addition,  rules  have  also  been  established  to  ensure  the  provision  of  information  to 
consumers and to guarantee fair commercial practices in agri-food chain products' trade. This 
wide  ranging  set  of  rules  is  referred  to  in  this  Impact  Assessment  (IA)  as  "agri-food  chain 
rules".  

To  ensure  agri-food  chain  rules  are  enforced  by  Member  States  (MS)  across  the  EU  in  a 
harmonised manner, a legislative framework for the organisation of official controls has been 
established. This IA considers the possible impacts of reviewing such a framework.  

Figure 1 – application of EU rules across the agri-food chain 

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1. Procedural issues and consultation of interested parties 

1.1.  Ex-post analyses of the EU system of official controls 

In July 2009 the Commission issued a report for the European Parliament and the Council1 to 
review the experience gained throughout the first years of application of Regulation (EC) No 
882/2004 (hereafter "the Regulation")2. The report showed that the new rules have introduced 
important  changes  to  the  way  competent  authorities  ("CA")  organise  and  carry  out  official 
controls, establishing a more integrated approach which ensures confidence in the agri-food 
chain  across  the  EU.  However,  given  the  increasing  integration  of  business  operators  along 
the agri-food chain, it indicated that improvements could be made to meet the Commission’s 
Smart Regulation Agenda objective of simplifying regulation. This would also address issues 
of administrative burden reduction and fostering competitiveness.  

The  report  also  indicated  that  in  order  to  rationalise  and  simplify  the  overall  legislative 
framework,  whilst  simultaneously  pursuing  the  objective  of  better  regulation,  consideration 
should  be  given  to  the  possibility  of  integrating  the  rules  currently  applicable  to  official 
controls in specific areas (e.g. residues of veterinary medicines in live animals and animal 
products3; and plant health4) into the framework of the Regulation. 
Additional  research5  carried  out  to  evaluate  the  application  of  the  Regulation  outlined  the 
existence of problems regarding the application of the rules (Articles 26 to 29) governing the 
financing  of  official  controls.  The  report  concluded  that  the  overall  objective  of  ensuring 
Member  States  allocate  adequate  financial  resources  to  official  controls  is  not  being  met 
throughout the EU. It recommended reviewing Articles 26 to 29 of the Regulation. 

The  Regulation  also  establishes  the  overall  principles  for  MS’  controls  carried  out  on  third 
country imports to the EU (import controls). In December 2010, the Commission adopted a 
report on the effectiveness and consistency of sanitary and phytosanitary controls on imports 
of  food,  feed,  animals  and  plants6.  Whilst  concluding  that  the  comprehensive  body  of 
legislation  currently  in  place  allows  the  EU  to  deal  with  emerging  risks  or  emergency 
situations without causing distortions to trade, the report also found that import controls could 
be made more coherent by reviewing and consolidating existing acts7. It concluded that this 

1 COM/2009/334/Final. 
2 Regulation (EC) No 882/2004 of 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 rules. 
3 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. 
4  Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures  against  the  introduction  into  the 
Community of organisms harmful to plants or plant products and against their spread within the Community. 
5 These conclusions were based on a 2009 study on "Fees or charges collected by Member States to cover the 
costs occasioned by official controls". The executive summary is available at Annex X.  
6 (COM (2010) 785 final); the report is published on: http://ec.europa.eu/food/animal/bips/guidelines_en.htm    
7  Article  15(5)  of  Regulation  (EC)  No  882/2004  establishing  the  framework  for  the  performance  of  import 
controls  on  feed  and  food  of  non-animal  origin;  Directives  97/78  of  18  December  1997  laying  down  the 
principles  governing  the  organisation  of  veterinary  checks  on  products  entering  the  Community  from  third 
countries,  and  91/496  of  15  July  1991  laying  down  the  principles  governing  the  organization  of  veterinary 
checks  on  animals  entering  the  Community  from  third  countries  and  amending  Directives  89/662/EEC, 
90/425/EEC  and  90/675/EEC;  Directive  2000/29  on  protective  measures  against  the  introduction  into  the 
Community of organisms harmful to plants or plant products; the latter governing, inter alia, border controls on 
plants and plant products. 

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improvement would bring benefits for MS and operators handling goods from third countries 
(importers). The review of the Regulation was considered a good opportunity to take account 
of the findings of the report and consolidate controls where possible. 

Besides the above, DG Health and Consumers (DG SANCO) has conducted further analysis 
on  the  alignment  of  EU  sectoral  legislation  on  official  controls8  with  the  overarching 
principles established in the Regulation.  

The review of the Regulation is part of a package which also includes three other major 
reviews  to  modernise  the  animal  health,  plant  health  and  plant  reproductive  material 
(hereafter 'PRM') acquis9. Its aim is therefore to modernise and integrate the system of 
official  controls  in  a  manner  that  also  consistently  accompanies  the  upgrade  of  EU 
policies in these sectors. The package is scheduled for adoption in 2012. 

All  the  information,  data  and  evidence  collected  as  part  of  the  reviews  above,  including 
evaluations  of  the  existing  regimes,  has  been  used  throughout  this  IA  to  define  problems, 
assess impacts and appraise options. 

1.2.  Data collection by or on behalf of the Commission 

•  The Food and Veterinary Office (FVO) 

The  Commission  is  responsible  for  ensuring  that  Union  legislation  is  properly  implemented 
and  enforced  by  the  competent  authorities  of  the  MS.  The  Food  and  Veterinary  Office 
(''FVO'')  is  a  Commission's  service  which  contributes  to  the  fulfilment  of  this  task,  by  in 
particular  carrying  out  audits  in  the  MS  to  verify  the  implementation  of  agri-food  chain 
legislation  and  the  functioning  of  national  control  systems,  and  to  collect  information  on 
implementation practices. 
The  findings  of  each  audit  are  set  out  in  an  audit  report10.  Information  on  the  realities  and 
difficulties of day-to-day implementation of agri-food chain legislation comes from such audit 
reports, in particular the ones assessing the functioning of national control systems along the 
agri-food chain. This IA draws on the findings of these reports and the data contained within 
them. Within a task force established by DG SANCO, feedback from national authorities and 
stakeholders gathered across all sectors (notably through the audit activities of the FVO) was 
studied to identify problems and shortcomings of the EU system of official controls. 

•  Studies on the system of financing official controls 

In  addition  to  the  2009  study  on  "Fees  or  charges  collected  by  Member  States  to  cover  the 
costs  occasioned  by  official  controls"  (see  foot  note  5),  DG  SANCO  commissioned  from 
another  external  contractor11  a  study  to  support  the  assessment  of  the  options  identified 
(2011)12.  Whilst  the  contractor  reported  that  there  was  difficulty  in  obtaining  exact  figures 
from MS to quantify the problem, the report did highlight the diverse spread of cost recovery 
within  MS  and  certain  problems  with  the  application  of  EU  rules  which  corresponded  with 
previous studies and the Commission's own findings.  

8 For an overview of the legislation on official controls co-existing with Regulation 882/2004 see figure 1 and 
Annex II.  
9 The IAs accompanying those initiatives are available at: 
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm#sanco.  
10 The FVO audits reports since 2007 are listed in Annex VII. 
11 GHK Consulting Ltd working with ADAS UK Ltd. 
12  Annex  XI  provides  for  the  executive  summary  of  the  study  carried  out  by  GHK  to  support  the  impact 
assessment on reviewing the rules on the financing of official controls. 

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•  Other data sources 

In addition to the data mentioned above, further information was collected on specific issues 
(i.e.  official  controls  in  the  Plant  Health  area  and  official  controls  on  residues  of  veterinary 
medicines) to contribute to the analysis13.  

1.3.  Consultations14 

1.3.1.  Member States 

The key issues to be addressed by the review of the system of official controls as well as the 
changes to be included in the legislative framework have been extensively discussed  within 
the  Working  Group  on  the  general  application  of  the  Regulation  set  up  within  the  Standing 
Committee on the Food Chain and Animal Health (SCFCAH)15.  

The main problems identified and the provisional options were also presented and discussed 
at meetings of the Heads of Food Safety Agencies on 29 June-1 July 2011 and on 8 December 
2011.  

Moreover,  MS  were  consulted  in  the  context  of  the  two  studies  contracted  out  by  the 
Commission in the area of the financing of official controls.  

Finally, MS have been consulted within other fora and frameworks on the following specific 
issues  relating  to  official  controls:  accreditation  of  official  laboratories,  official  controls  on 
residues  of  veterinary  medicines  in  live  animals  and  animal  products,  veterinary  border 
controls, animal health, plant health and plant reproductive material. 

1.3.2.  Stakeholders 

Stakeholders (industry association representatives and NGOs) have been consulted during the 
evaluation studies and the preparation of the IA. Two ad hoc Working groups, on the review 
of the system of official controls and the review of the rules governing the financing of such 
controls  respectively,  were  convened  under  the  Advisory  Group  on  the  Food  Chain  and 
Animal Health and Plant Health. Progress was also presented and discussed in the plenaries of 
the  aforementioned  Advisory  Group  and  on  invitation  at  meetings  of  several  industry 
representative bodies. In addition to discussions with MS, stakeholder consultation was a key 
element of the two studies contracted out to external consultants in the field of the financing 
of official controls.  

1.3.3.  Summary of consultation with interested parties 

Annexes  VIII,  IX,  XII  and  XIII  give  an  overview  of  the  positions  expressed  by  MS  and 
stakeholders  at  different  stages  of  the  review;  Annex  VI  lists  all  the  stakeholders  that  have 
been consulted during the process.   

1.4. Inter-Service Steering Group (ISSG) 

A  Commission  Inter-Service  Steering  Group  on  the  IA  for  the  review  of  the  EU  system  of 
official controls along the agri-food chain was established. The group was led by DG Health 
and  Consumers  (SANCO)  with  the  participation  of  the  following  Commission  Directorates 
General and Services: Agriculture and Rural Development, Budget, Environment, Enterprise 

13 See Annex V. 
14 Details on the consultation process are available at Annex IV. 
15 http://ec.europa.eu/food/committees/regulatory/index_en.htm.  

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and  Industry,  Research  and  Innovation,  Taxation  and  Customs  Union,  Trade,  Development 
and Cooperation, Maritime Affairs and Fisheries, Legal Service, Justice and the Secretariat-
General.  The  group  met  seven  times.  A  final  draft  was  sent  to  the  group,  whose  members 
provided comments at a last meeting on 27 January 2012 which have been incorporated into 
the IA. 

1.5. IAB opinion 

The IA report was submitted to the IA board on 29 February 2012 and was formally presented 
on  28  March  2012.  Following  this  meeting  the  board  issued  an  opinion  on  30  March  2012 
emphasising  four  main  points  as  well  as  some  presentational  issues  to  be  addressed  in  the 
final version of the report. Following re-submission on 16 May, a revised opinion was issued 
on 8 June clarifying the points to be addressed: 

1)  Improve presentation of the problem definition: 

-  section  2.2.  presents  now  in  a  clearer  and  balanced  manner  the  two  main  issues  at 
stake: the deficiencies in the design of the official controls' framework (2.2.1.), and 
the uncertainties as regards the financing of such controls (2.2.2.); evidence as well 
as examples supporting both sets of issues are inserted; 

-  a  better  distinction  has  been  drawn  between  problems,  underlying  causes  and 

consequences. 

-  More  thorough  evidence  on  the  design  of  the  official  controls  and  their  efficiency 
across  MS  has  been  introduced  by,  where  possible,  quantifying  the  costs  of 
inefficient controls to MS and operators.  Where this is not possible, due to a lack of 
relevant data caused by short-comings in the current regime, this has been identified.   

-  The problem definition is supported by clearer, referenced examples and is presented 

in table 1. 

2)  Better define objectives and strengthen the intervention logic: 

-  the objectives in section 3.2. are now explained in light of the problem definition and 
the link between objectives and key problem issues is made explicit by a new table; 

-  operational  criteria  in  section  3.3  are  reformulated  in  order  to  make  them  more 

appropriate and quantifiable; 

-  the notion of safety has been reinforced in the intervention logic (problem definition, 
objectives, options, analysis of impacts), including by explaining why it is important 
that SMEs and micro-enterprises are subject to official controls without exceptions;  

-  section 4.1. now explains how the policy options included in the analysis relate to the 

specific objectives. 

3)  Reformulate  the  options  and  include  options  that  address  SME/micro  enterprise 

issues 

-  options  to  address  micro-enterprises  issues  are  now  included  in  sections  4.1.  and  5 
(under option 1B, exempting them from fees) and in section 4.2. (reducing controls 
on them); 

-  The  text  better  explains  the  effect  of  fees  on  micro-enterprises  by  integrating  into 
section 2.2.2, additional relevant examples and findings from the referenced studies; 

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-  options  2  to  4  include  and  assess  a  mechanism  to  alleviate  the  burden  of  fees  on 
micro-enterprises while taking into account competition and sustainability concerns; 

-  the presentation of the logic flow in the assessment of impacts has been improved by 
separating  the  two  steps  of  the  assessment  and  explaining  their  sequence  (section 
4.1.); 

-  the earmarking element, presented in the original report, was eliminated from options 
2 to 4 (and is no longer analysed in detail in the report) as the same objective could 
be achieved through less prescriptive tools (transparency, accountability) (section 5, 
under option 2). 

4)  Present  a  clear  overview  of  costs  and  benefits  and  make  comparison  of  options 

more transparent 

-  a new table 4 in section 6.2. provides an overview of costs and benefits that could be 
estimated  through  the  assessment  and  which  are  referenced  in  boxes  6,  7  and  9.  It 
presents figures as both benefits and costs to MS and industry, and calculations are 
explained in footnotes.  An explaination of the table now makes it clearer to which 
sectors the costs and benefits apply under the different options. 

-  section 6.2. presents in a more transparent fashion the comparative advantages of the 
different  options,  with  regard  also  to  the  views  of  stakeholders.    The  figures  and 
results  presented  in  the  analysis  of  costs  and  benefits  are  explained,  supported  by 
verifiable evidence, and clearly referenced. 

-  With  regards  to  MS  which  already  apply  full  cost  recovery,  Box  6  in  section  5, 

presents examples of practices which are currently undertaken. 

5)  Procedure and presentation: 

-  references to MS and stakeholders' opinions are now systematically made throughout 

the report.  All examples and evidence are clearly referenced; 

-  Annex  XI  includes  the  executive  summary  of  the  GHK  study  only,  and  relevent 
findings  are  drawn  out  in  a  separate  annex  (XVII)  so  that  it  is  clear  that  the 
Commission does not endorse the study as a whole; 

-  Annexes XXVII was removed because it is not relevant for the report. 

2. Problem Definition 

2.1.  Background 

2.1.1.  The EU system of official controls along the agri-food chain 

The  responsibility  to  enforce  EU  agri-food  chain  legislation  lies  with  the  MS,  whose 
authorities  monitor  and  verify  that  the  relevant  requirements  are  effectively  implemented, 
complied  with  and  enforced  across  the  Union.  In  doing  that  they  verify  that  operators' 
activities  and  goods  placed  on  the  EU  market  (either  EU  produced  or  imported  from  third 
countries) are in compliance with the relevant EU agri-food chain standards and requirements.  

Harmonised  EU  rules  to  govern  control  activities  performed  by  MS  are  established  in  the 
Regulation  with  the  aim  of  creating  an  integrated  and  uniform  approach  to  official  controls 

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along  the  agri-food  chain.  The  Regulation  provides  for  a  general  framework  for  official 
controls  in  the  sectors  of  feed  and  food  law,  animal  health  and  animal  welfare  rules, 
laying down rules governing both the organisation and the financing of such controls. 

Despite  the  above  integrated  approach,  for  historical  reasons  controls  for  animal  health 
purposes  (both  on  domestic  and  imported  goods)  and  controls  on  residues  of  veterinary 
medicines,  remained  regulated  separately.  Moreover,  certain  sectors  pertaining  to  the  agri-
food chain were not included in the scope of the Regulation - i.e. plant health, PRM, animal 
by-products (hereafter 'ABP') - and specific sectoral regimes were developed for them.16 

Competent authorities are required to perform official controls on all business operators active 
in  the  agri-food  chain.  Given  that  the  emergence  of  food  safety  risks  does  not  necessarily 
depend on the size of an operator, the current system is based on the principle that all should 
be subject to official controls, without exception, as this is the only way to ensure a risk-based 
prioritisation of controls, an efficient use of resources and the safety of the agri-food chain.  

As regards the number of business operators concerned, figures suggest that they amount to 
approximately  25  million17.  As  highlighted  in  section  5  below,  in  a  majority  of  Member 
States, micro-enterprises18 represent more than half of the total number of business operators 
(at  least  in  the  four  industries  which  are  subject  to  the  most  intensive  official  control 
activities)19.  In  this  context,  the  significance  of  controlling  smaller  businesses,  including 
micro-enterprises,  becomes  apparent.  This  need  is  further  reinforced  by  the  fact  that, 
notwithstanding their  size,  such enterprises are equally likely to conceal  serious food  safety 
risks/concerns.  The recent E.Coli crisis, which spread across several Member States due to 
contaminated sprouted seeds, originated in a micro-enterprise. The crisis not only resulted 
in  dramatic  human  losses  with  a  death  toll  of  55  people  and  4000  cases  of  serious  human 
disease,  but  also  caused  huge  economic  damage  which,  in  the  first  two  weeks  alone, 
amounted to approximately €812 million. 

2.1.2.  The international dimension 

The  efficient  operation  of  the  EU  system  of  official  controls  is  important  for  both  EU 
exports and imports.  

The  EU  is  the  world's  largest  exporter  and  importer  of  food  and  drink  products.  In  2010 
EU27  food  and  beverages  imports  were  worth  €78  billion,  and  exports  €73  billion.  The 
EU27  imported  79.3  million  tonnes  of  food  and  live  animals  and  3.4  million  tonnes  of 
beverages in 2010, with a trade deficit of 14 million tonnes for food and live animals, but a 
surplus of 6 million tonnes for beverages20. 

The  EU's  ability  to  export  towards  third  countries  relies  on  the  reputation  of  the  high 
production standards and added value that the EU goods can prove to have compared to the 
ones produced outside Europe. This can only be achieved by a reliable and trusted official 
controls system which ensures that the EU agri-food chain safety and quality standards are 
consistently enforced and corresponding expectations from trade partners met. 

16 For a complete overview of the existing legislative framework applicable to official controls along the agri-
food chain see Annex II.  
17 See Eurostat Pocketbooks, Food: From Farm to Fork Statistics 2008 Edition European Commission 
18 Enterprises with less than 10 employees and or a turnover or balance sheet equal to or less than €2 million. 
19  Micro-enterprises  are  also  likely  to  be  represented  in  large  numbers  in  other  industries  subject  to  official 
controls. 
20 Source: Comext various years. 

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As regards imports, it is essential that all food on the EU market is safe. Controls perfomed 
by the MS CAs on goods arriving from third countries ensure that the latter offer adequate 
guarantees  that  they  meet  equivalent  safety  levels.  The  relevant  import  control  rules  must 
comply  with  the  WTO  Sanitary  and  Phytosanitary  (SPS)  Agreement,  in  particular  with  the 
provisions laid down in Annex C to the SPS Agreement.  

2.2. 

Problem identification 

MS ensure a good level of implementation of official controls across the agri-food chain, and 
progress  can  be  recorded  in  the  use  of  the  enforcement  tools  established  by  Regulation 
882/2004  (e.g.  control  planning  and  coordination,  verification  of  effectiveness,  auditing21). 
However, evidence gathered over the last five years of application (feedback from MS' CAs 
and FVO audits reports) has shown shortcomings stemming,  

(cid:190)  on  the  one  hand,  from  the  design  of  the  official  controls  framework  (notably  from  the 
incomplete  implementation  of  certain  principles/objectives  laid  down  in  Regulation 
882/2004,  and  from  the  fact  that  the  integrated  approach  to  official  controls  across  the 
agri-food chain is consolidated only partly), and  

(cid:190)  on  the  other  hand,  from  uncertainties  as  to  the  availability  of  sufficient  resources  to 

adequately finance official controls.  

2.2.1. Design of the official controls' framework 

2.2.1.1. Inconsistencies, gaps in control requirements 

Despite  the  increasingly  integrated  operation  of  activities  along  the  agri-food  chain,  the 
integration of the EU system of official controls still suffers inconsistencies and legal gaps, 
in  particular  as  regards  controls  carried  out  for  plant  health,  PRM  and  ABP  purposes. 
Controls  in  these  areas  are  in  fact  not  aligned  fully  with  the  framework  laid  down  in  the 
Regulation. On the other hand, overlapping requirements subsist also in the animal health 
area, already covered by the scope of the Regulation, because of the co-existence of sectoral 
legislation which survived the adoption of the general framework in 2004. 

i)  While  certain  differences  in  the  design  of  official  controls  are  justified  because  of  the 
peculiarities of the concerned sectors (e.g. the certification procedure in the plant health area 
differs  from  that  of  the  veterinary  area),  others  appear  to  be  arbitrary  and  result  in 
inconsistencies in those cases where the same approach would be justified across sectors (e.g. 
the  mechanism  for  delegating  plant  health  control  tasks  differs  from  that  regulated  upon  by 
the Regulation; also, laboratories performing official tasks are required to be accredited under 
ISO standards in all areas except plant health and PRM). Control authorities thus operate on 
the  basis  of  different  approaches  and  under  different  conditions  depending  on  the  specific 
agri-food chain rules they are called upon to enforce, without differences being justified.  

ii) Some of the implementation tools or mechanisms established in Regulation 882/2004 are 
not available for the performance of official controls in the plant health, PRM and ABP areas 
(e.g. transparency requirements in relation to enforcement activities do not apply to controls 
on ABP rules; in the same area, no FVO audits are foreseen; EU rules on PRM do not provide 
for  FVO  audits  on  the  functioning  of  national  control  systems,  nor  do  they  regulate  upon 

21 For the most recent overview of the operation of controls activities in the Member States (years 2008-2009) 
and of the Commission's own control activities (2008-2010), see Commission Report on the overall operation of 
official controls on food safety, animal health and animal welfare and plant health COM(2012) 122. 

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competent authorities and their duties in this sector). As a result, CAs are not provided with 
the complete set of tools meant to ensure accountability, soundness and effectiveness of their 
enforcement activities. 

iii)  Certain  requirements  or  procedures  regulated  upon  by  the  Regulation  in  a  horizontal 
manner  are  also  present  in  sectoral  legislation,  in  particular  in  pre-existing  veterinary 
legislation.  For  example,  the  mechanism  for  administrative  assistance  and  cooperation  is 
regulated upon by the Regulation and by Directives 89/66222 and 89/60823. This has resulted 
in different interpretations of similar procedures by MS who undertake different activities to 
verify compliance. 

Inconsistencies and legal gaps are due to the fact that EU legislation on official controls has in 
the  areas  of  plant  health,  PRM  and  ABP  developed  separately  from  the  general  framework 
established  by  the  Regulation,  and  overlap  in  control  requirements  derived  from  the  co-
existence,  for  animal  health  related  controls,  of  the  Regulation  with  pre-existing  sectoral 
legislation. 

Whilst  it  is  not  always  possible  to  quantify  the  cost  to  MS  CA  and  operators  of  such 
inconsistencies  and  gaps  it  stands  to  reason  that  the  inefficiencies  so  caused  will  lead  to 
official  control  enforcement  regimes  which  are  unnecessarily  costly  for  CAs  to  operate  and 
are overly burdensome on operators. 

2.2.1.2. Inconsistent implementation of risk-based approach 

Regulation 882/2004 is based on the principle that official controls should be risk-based in 
order to maximise the efficiency of control activities directed at protecting health. 

Box 1: Risk based approach to official controls 

The risk based approach to official controls 

In  a  situation  where  resources  are  finite  these  are  to  be  used  selectively  and  the  selection  should  be 
based on a series of criteria which include: the hazard and risks associated with the specific business 
activity,  or  product,  the  operator's  record  of  compliance  and  reliability,  indications  of  possible  non-
compliance.  

Failure to do so would result in resources being allocated on the basis of non-risk related criteria and 
in situations where official controls which are more relevant for the protection of public health are not 
receiving appropriate attention.  

The  analysis  focuses  on  the  areas  where  the  risk-based  approach  is  still  not  fully  used 
(controls at the border and controls on residues of veterinary medicines). 

i) EU border controls on certain goods from third countries 

To  ensure  harmonised  verification  of  compliance  with  EU  agri-food  chain  rules,  MS  are 
required  to  carry  out  official  controls  on  certain  goods  coming  from  third  countries  at  the 
external borders of the EU (EU border controls). According to the risk-based approach, also 
EU  border  controls  should  be  limited  and  proportionate  to  what  is  necessary  to  contain 
potential risks for humans, animals or plants. 

22  Directive 89/662/EEC of 11  December  1989  concerning  veterinary  checks  in  intra-Community  trade  with  a 
view to the completion of the internal market. 
23  Council  Directive  89/608/EEC  of  21  November  1989  on  mutual  assistance  between  the  administrative 
authorities of the Member States and cooperation between the latter and the Commission to ensure the correct 
application of legislation on veterinary and zootechnical matters. 

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However, the continuous and timely adjustment of the control effort at the EU border to the 
needs  dictated  by  the  actual  risk  is  hampered  by  the  rigidity  and  fragmentation  of  existing 
rules  governing  border  checks  in  the  different  areas.  E.g.  current  rules  require  MS  to  take 
samples  and  perform  physical  checks  on  100%  of  consignments  of  animals,  products  of 
animal  origin  and  plants  intended  to  be  introduced  into  the  EU.  Existing  arrangements  to 
reduce  the  frequency  of  costly  and  time  consuming  physical  checks  do  not  allow  for  the 
continuous adjustment necessary to take account of situations where the potential risk of the 
consignment spreading an animal disease or otherwise endangering public health is reduced.  

In  addition,  the  prioritarisation  of  the  controls  is  carried  out  in  a  sectoral  manner  (animal 
health, public health, plant health) and not by comparing the levels of risk of all commodities 
of relevance for the agri-food chain across sectors: in other words, prioritarisation is carried 
out within sectors and not across sectors.  
ii) Official controls on residues of veterinary medicines  
MS are required by the provisions of Directive 96/23/EC to take samples of animals and foods 
for  the  presence  of  residues  of  veterinary  medicines.  Legal  requirements  are  very  strict, 
dictating the number of samples, which animals/tissues to analyse and for which substances. 
The  result  of  such  rigidity  is  that  currently  MS  are  demanded  to  carry  out  checks  and 
laboratory  analysis  for  substances  for  which  over  the  past  years  there  has  been  little  or  no 
evidence of actual risks. 
Examples24 
Stilbenes:  
MS  are  required  to  take  samples  of  all  animals  and  animal  products  to  check  the  presence  of 
'stilbenes'. The chart below shows that no non-compliance has been detected for several years now 
but,  despite  this,  between  21000  and  24000  samples  are  analysed  each  year  across  the  EU  for 
stilbenes, their derivatives, salts and esters. 

Year  Total number of samples analysed  Number of non compliances 
2007 
2008 
2009 
2010 

                     23 411 
                     21 664 
                     21 815 
                     23 455 

0 
0 
0 
0 

Resorcylic acid lactones (including zeranol): 
Samples  taken  on  pigs  to  detect  resorcylic  acid  lactones.  More  than  6000  samples  continue  to  be 
analysed each year across the EU. 

Year  Total number of samples analysed  Number of non compliances 
2007 
2008 
2009 
2010 

                       6234 
                       5594 
                       6237 
                       6166 

0 
0 
0 
0 

The  reason  for  official  controls  not  being  aligned  to  the  risk-based  approach  in  the  areas 
above is that such controls are currently prescribed by EU rules25, pre-existing the Regulation 

24 The data presented in these examples have been collected from Member States under Directive 96/23/EC and 
stored in DG SANCO application 'Residues: Monitoring Plants and Results version 4.1.1. 
25  EU  border  controls:  Directives  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, and 91/496/EEC of 
15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the 
Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC; Directive 
2000/29 on protective measures against the introduction into the Community of organisms harmful to plants or 
plant products; the latter governing, inter alia, border controls on plants and plant products. Official controls on 
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and not repealed by it, which do not establish appropriate mechanisms to take into account the 
actual  risk  a  given  good,  business  activity  or  third  country  might  present.  In  addition,  as 
regards  the  area  of  EU  border  controls,  the  lack  of  prioritarisation  of  controls  across  all 
sectors  is  due  to  the  fact  that  existing  legislation  is  highly  fragmented,  and  different  sets  of 
rules  apply  to  different  sectors  (food  and  feed  of  non  animal  origin,  live  animals  and  their 
products, plants)26. 

This results in resources being allocated – in all MS - to controls that are not justified by the 
risk and consequently are a significant waste of public resources (time and money) that could 
be  better  used  where  risks  are  higher.  The  inefficient  use  of  resources  also  results  in 
unnecessary  burdens  on  operators  (time,  staff,  equipment  and  facilities  mobilised  to  allow 
controls).  Indeed, it is estimated that the result of the current regime for residues of veterinary 
medicines may be the lost opportunity to save between €12.4 million and €98.5 million/year 
(see Box 4 in Section 5 below). 

2.2.1.3. Administrative burden and disproportionate requirements 

Unnecessary administrative burdens are placed on MS' CAs. It is the case for the obligation 
for annual updates to MS monitoring plans of residues of veterinary medicines that these be 
transmitted  to  and  approved  by  the  Commission.  In  the  same  area,  also  redundant  are  the 
specific  reporting  obligations,  as  they  duplicate  the  general  reporting  requirement  in  the 
Regulation. These burdens result from obligations on MS laid down in Directive 96/23/EC.  

In  addition,  while  requiring  official  laboratories  to  be  accredited  in  accordance  with  EN 
ISO/IEC 1702527, the Regulation does not allow temporary arrangements for emergencies or 
cases where laboratories have to use a new method not yet included in the accreditation. 

Example: no or nearly no official laboratory in the EU was accredited according to ISO 17025 for 
the  detection  of  mineral  oil  in  sunflower  oil  or  for  the  detection  of  melamine  in  food  when 
respectively the crisis on sunflower oil from Ukraine or the one on melamine in food from China 
broke  out.  This  lack  of  ability  to  allow  temporary  arrangements  for  emergencies  could  have 
weakened  the  legitimacy  of  controls  (and  analyses)  carried  out  during  the  emergency,  and  of  any 
measure taken by MS on that basis.  

Similarly, no flexibility is foreseen for small laboratories carrying out extremely basic types 
of tests).  

Example: soon after the adoption of Regulation 882/2004 several MS brought to the attention of the 
Commission  that  accreditation  is  very  burdensome  and  disproportionate  in  the  case  of  smallest 
Trichinella laboratories, which are attached to a slaughterhouse or a game handling establishment 
and only perform a very simple type of test.  

2.2.1.4. Uneven enforcement of cooperation and transparency requirements   

The  Regulation  includes  some  important  principles  and  mechanisms  which  are  currently 
underused by MS' CAs or applied according to divergent practices among MS. 

In  particular,  it  calls  for  administrative  cooperation  i)  between  MS  for  cross-border 
enforcement action, and ii) between sanitary authorities and customs services. However, MS 

residues of veterinary medicines: 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. 
26 Ibid. 
27 A laboratory can only be accredited for the use of standardised and/or validated method. 

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are  not  making  full  use  of  this  tool  and/or  they  encounter  difficulties  in  understanding  the 
conditions for its application.  

Examples:  
- the Commission received a complaint against a MS from a business operator, alleging that the MS's 
CAs,  although  aware  of  a  violation  of  agri-food  chain  rules  perpetrated  by  the  supplier  of  the 
complainant (from a second MS), failed to contact the MS of dispatch as requested by Article 38 of 
Regulation  882/2004  to  request  their  cooperation,  and  held  the  complainant  solely  responsible  and 
liable  for  the  violation.  The  receiving  MS's  CAs  were  acting  under  the  wrong  assumption  that  the 
notification in the Rapid Alert system for food and feed (RASFF) had satisfied its obligation under 
Article 38. 

-  Another  MS  recently  sent  a  complex  interpretation  query  asking  whether  national  customs 
authorities,  in  case  of  food  and  feed,  can  trigger  the  mechanisms  foreseen  in  Articles  27/29  of 
Regulation  765/2008  (requirements  for  accreditation  and  market  surveillance  relating  to  the 
marketing  of  products)  allowing  them  to  suspend  release  of  a  product  for  free  circulation  on  the 
Union market and inform the sanitary authority any time the product seems to present a serious risk 
to health, safety. 

In  both  cases,  uncertain  interpretation  of  the  rules  has  the  potential  to  result  in  CAs  not  taking 
appropriate action (to pursue cross-border violations, to prevent the release of unsafe goods). 

Another requirement laid down in the Regulation which is open to divergent practices in MS 
is the obligation for the MS' CAs to ensure a 'high level of transparency' of control activities 
with regards to operators and the public at large.  

The  uneven  enforcement  of  the  principles  and  mechanisms  above  is  mainly  due  to  the  fact 
that  the  Regulation  foresees  no  comprehensive  guidance  on  how  cooperation  should  take 
place  (timing,  information  to  be  exchanged,  etc.)  and  what  information  should  be  made 
available  to  the  public.  In  addition,  the  Commission  is  not  empowered  to  lay  down  further 
details and uniform implementation modalities. 

Whilst it is not possible to quantify the shortcomings identified in financial terms, it is clear 
that the regime established by the legislation is not serving the public to its full potential. 

2.2.2. Difficulties and inequities in financing official control activities  

Another  area  in  which  the  objective  of  the  Regulation  is  not  fully  achieved  by  MS  is  the 
financing of official controls.  

MS  are  requested  to  ensure  that  adequate  financial  resources  are  available  for  official 
controls.  

However, information from MS and FVO audits indicates widespread difficulties in the MS to 
appropriately resource control services. Annex XV lists a number of significant cases where, 
during  the  last  4  years,  EU  inspectors  have  reported  that  the  reason  for  identified 
shortcomings  in  control  activities  or  for  unsatisfactory  or  insufficient  levels  of  controls  is 
attributed  to  the  lack  or  shortage  of  resources.  In  some  cases  the  lack  of  resources  leads  to 
under-implementation  of  control  plans  or  to  a  violation  of  established  control  requirements. 
For example  an FVO audit in a MS, to evaluate controls on residues and contaminants in live 
animals and animal  products and veterinary  medicinal  products, revealed that  the  CA could 
not  afford  to  have  samples,  which  had  been  taken  from  'suspect'  slaughterhouses,  analysed 
urgently, so as to allow detention of the carcasses pending the result of the analysis. During a 
similar audit in another MS it was revealed that the insufficient provision of staff, equipment 

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and  reagents  was  a  significant  obstacle  to  the  proper  functioning  of  the  laboratory  network 
meaning  that  the  MS's  CAs  were  not  meeting  their  legal  obligations)  .    All  cases  reported, 
point to serious difficulties faced by CAs in maintaining an appropriate level of controls (e.g. 
of veterinary checks on imported goods at the border inspection posts, of farm level controls 
on the use of veterinary medicines28).  Further examples are presented in Annex XV. 

Such difficulties are exacerbated by the ongoing economic and financial crisis and there is a 
risk that further pressure on public finances and on funds made available for official controls 
might  increasingly  adversely  affect  MS'  capacity  to  deliver  efficient  official  controls,  and 
consequently the level of protection offered by EU law. 

To  reduce  the  dependency  of  the  financing  of  controls  on  public  finances,  the  Regulation 
identifies  a  number  of  control  activities  (mainly  on  meat,  milk,  fishery  production,  and  on 
controls  carried  out  at  EU  borders)  for  which  MS  shall  collect  a  fee  from  operators 
(mandatory  fee)  to  recover  control  costs29.  For  other  control  activities,  MS  can  choose 
whether to charge a fee on operators or not. 

However,  mandatory  fees  as  currently  regulated  do  not  enable  CA  to  recover  all  their  costs 
and thus to ensure a stable influx of resources to finance the performance of controls. On the 
one  hand,  fees  are  only  collected  for  certain  controls,  whereas  on  the  other  hand,  presently 
collected fees do not necessarily enable CA to recover their costs fully (MS typically recover 
between  20% and 80% of costs with respect to controls subject to mandatory fees resulting in 
the  lost  opportunity  to  mobilise  an  estimated  €0.9bn  –  €3.4bn  per  year  across  the  MS  for 
official control activities30). 

 Limited scope of mandatory fees, lack of consistency/fairness 

Current  rules  only  require  mandatory  fees  to  be  charged  for  official  control  activities  on 
businesses handling meat, fishery products, and milk, for the approval of feed establishments 
and for most controls at the borders. With the new framework for official controls established 
by the Regulation, and the requirement that MS carry out such controls at all the stages of the 
agri-food chain, the current list of mandatory fees no longer appears justified and fair. Indeed, 
the Commission is consistently informed by those sectors currently subject to mandatory fees 
that they view the limitation of mandatory fees to particular sectors as being manifestly unfair.  
Additionally,  by  limiting  the  collection  of  mandatory  fees  to  particular  sectors,  the 
opportunity is lost to mobilise a guaranteed flow of resources of official control activities the 
amount of which can be estimated to be between €2.3bn and €37bn/year across the MS (see 
table 4 below - these figures correspond to the two extreme hypothesis of all operators being 
charged at rates currently used for the smallest and largest scale businesses). 

Box 2: Control activities covered/ not covered by mandatory fee under Regulation 882/2004 

Control activities covered by a mandatory fee: 
(cid:190)  controls on slaughter, cutting operations and cold storage of meat, production and placing on the 
market of fishery products, and milk production; 
(cid:190)  controls carried out to grant feed establishments approval; 
(cid:190)  controls carried out at a border on consignments of live animals and their products; certain food 

28  See  also  Impact  Assessment  report  on  "the  proposal  to  revise  the  EU  Plant  Health  Legislation",  which 
highlights the same difficulties in that area and indicates that full cost recovery of control costs is essential for 
the good functioning of the relevant control systems. 
29  Separate  fee  provisions  are  also  laid  down  in  Directive  2000/29,  covering  certain  aspects  of  official  plant 
health control activities. 
30 Annex XI and Table 4 of this Impact Assessment Report 

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and feed of non animal origin. 

Examples of control activities not covered by a mandatory fee: 
(cid:190)  controls  carried  out  in  production  of  food  other  than  meat,  fishery  products  and  milk;  that  is: 
eggs and egg products, honey and all foods of non animal origin. 
(cid:190)  controls carried out in distribution (including wholesale, retail and restaurants) of all food; 
(cid:190)  controls carried out in production and distribution (including wholesale and retail) of feed; 
(cid:190)  controls carried out in production and distribution of animal by-products; 
(cid:190)  controls carried out during import of products originating from third countries that need to be 
checked at the border other than those already covered by a mandatory fee (for example products 
subject to a safeguard measure). 

Failure to achieve sustainable funding in the sectors subject to mandatory fees 

Current rules are based on the principle of cost recovery where fees are mandatory. However, 
in most cases, full cost recovery is not achieved, due to the fact that, for most activities for 
which a fee is due, the current system gives the MS the choice between a cost based fee and a 
standard,  or  minimum  fee,  whose  amount  is  fixed  in  the  Regulation31:  given  the  wide 
variations of control costs across MS, such EU fees may be higher or lower than the real costs 
of the activities they are meant to remunerate32. 

Furthermore, resources obtained through fees are not required to be earmarked for the needs 
of the control authorities which collect them. This, coupled with the fact that the modalities of 
calculation  of  the  fees,  and  figures  on  the  amounts  collected through the system  and on the 
use made of such revenues, contributes to the perceived unfairness of the fees system in the 
eyes of those currently charged as was repeatedly noted in consultation with stakeholders. 

Compliance / efficiency drivers are not being used / are not working 

A number of mechanism included in Articles 26 to 29, with the aim of promoting efficiency 
of the fees system and compliance by operators fail to deliver: 

•  despite the obligation laid down in Article 27(12), many MS fail to provide the public 
and the Commission with the calculation method they use to "cost" their controls and 
establish fee levels; when they do, cost categories, and other details that would ensure 
full transparency of the costing exercise are missing. Thus, on the one hand it is not 
clear  whether  fees  do  cover  the  actual  costs  of  official  controls  (and  if  so  in  which 
areas  /  MS  /  regions)  and,  on  the  other  hand,  operators  are  not  provided  with  the 
information and  data that would allow  them  to fully appreciate  the modalities of  the 
calculation of fees and their fair implementation; 

• 

the results of the external studies demonstrate that there is a widespread perception (in 
particular  among  operators)  that  the  current system  should  (but  does  not)  effectively 
reward compliant businesses by ensuring that they bear a reduced share of the cost of 
official controls compared to non-compliant businesses.  

Acceptance of the system by business operators is undermined by the perceived unfairness of 
the system, notably by the lack of "penalising" mechanisms for the less compliant actors.  

31 Where standard / minimum fees are higher than the actual cost of the official control activities they are meant 
to remunerate, MS can apply lower fees. 
32 The EP recently received a petition from a MS veterinary department, concerned that the fees collected by that 
MS could not fully compensate costs incurred and thus finance controls. 

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Micro-enterprises 

As noted in section 2.1.1, official controls are necessarily performed in accordance with the 
same principles regardless of the size of the operator concerned, and there is no evidence to-
date  to  suggest  that  this  results  in  a  disproportionate  burden  being  placed  upon  micro-
enterprises in terms of time and staff being invested because of the controls. 

On  the  other  hand,  where  operators  are  required  to  pay  mandatory  fees  for  official  controls 
carried  out  by  competent  authorities,  stakeholders  say  that  the  impact  of  such  fees  may  be 
greater  on  micro-enterprises  by  reason  of  their  lower  turnover/throughouput,  in  particular 
where standard/minimum fees are applied instead of cost based fees. Cost based fees are in 
fact  proportional  to  the  resources  deployed  during  the  performance  of  official  controls  and 
when levied on micro-enterprises, all other things being equal, they should be comparatively 
lower than those  charged  on  larger operators.  A  risk  based  approach to the organisation of 
official  controls  means  that  costs  on  compliant  operators,  including  micro-enterprises,  are 
kept at a minimum. 

This  (the  fact  that  cost  based  fees  currently  collected  are  comparatively  lower  for 
microbusinesses)  is  part  of  reason  why  the  contractor  studies  performed  on  behalf  of  the 
Commission  show  that  there  is  currently  no  evidence  to  suggest  that  the  mandatory  fees 
charged  on  the  basis  of  Regulation  882/2004  have,  in  actual  fact,  given  rise  to  adverse  or 
disproportionate  effects  on  micro-enterprises.  This  is  supported  by  the  fact  that,  with  the 
exception of some small businesses' representatives, all stakeholders consulted (be they CAs 
or businesses) have not called for an exemption of micro-enterprises (or SME) from the fees 
system established by Regulation 882/2004. 

Notwithstanding  the  above,  the  need  to  enable  control  authorities  to  recover  costs  so  as  to 
ensure  sufficient  resources  for  official  controls  should  be  balanced  and  weighed  against  the 
need to lower the burden on very small businesses, in line with the new Commission policy 
on "Minimizing regulatory burden for SMEs – Adapting EU regulation to the needs of micro-
enterprises"33.  According  to  this  policy,  micro-enterprises  should  in  principle  be  excluded 
from regulatory burdens, unless the necessity and proportionality of their being covered can 
be demonstrated.  

2.3. Parties affected 

Rules  on  official  controls  are  primarly  addressed  to  national  control  authorities  and 
impact  on  their  activities.  Thus,  national  CAs  responsible  for  the  implementation  and 
enforcement  of  agri-food  chain  rules  are  mainly  affected  by  the  present  review34  (currently, 
there  are  over  100  000  FTE  staff  involved  in  the  delivery  of  official  controls  within  the  27 
MS). This initiative will indirectly impact on business operators within the EU (the agri-
food chain is a significant sector within the EU, generating €751 008 million of added value – 
6%  of  the  EU27’s  GDP,  and  employing  over  48  million  people)  because  of  the  time,  staff, 
equipment  and  facilities  being  mobilised  during  controls.  This  burden  is  inversely 
proportional to the efficiency and effectiveness of controls carried out by the MS CAs.  

33 COM (2011)803 
34 A detailed description of the organisation of control authorities in each MS, prepared and constantly updated 
at:  
cooperation  with 
by 
http://ec.europa.eu/food/fvo/country_profiles_en.cfm  

Commission 

each  MS 

found 

close 

can 

the 

be 

in 

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Moreover, the review of the rules applicable to the financing of official controls (with the 
possibility to shift a larger share of the cost burden from the Member State CA to business) 
will also affect business operators.  

The review will look not only at the extent to which operators participate in the financing of 
the control system but also at the mechanisms to ensure that operators (and citizens at large) 
are  provided  with  information  on  how  inspection  fees  are  established  and  used  and  at  the 
mechanism intended to reward compliance with agri-food chain rules by business operators.  

The efficient operation of the EU system of official controls is of paramount importance both 
for EU exports and imports. Businesses (both in the EU and in third countries exporting to the 
EU) will also be affected by changes aimed at improving the efficency of the control system 
as a whole, and in particular of the import controls.  

Consumers  both  in  the  EU  and  outside  the  EU,  are  not  directly  concerned  by  the  review 
although they are the ultimate beneficiaries of measures to ensure the safety and quality of the 
agri-food chain. With the increased cost of controls for operators it is possible that some of 
the additional costs will be passed on to them through the price of final products, however by 
comparison with the overall cost of food production such an increase is expected to be small 
(see Box 6 and Box 8).  

2.4. How would the problem evolve, all things being equal? 

All  identified  shortcomings  in  the  problem  definition  would  remain.  Potential  under-
enforcement  of  agri-food  chain  rules  due  to  the  suboptimal  design  of  the  legislative 
framework or to underperformances of the control system could result in a loss of confidence 
in the EU market in the long term. Inefficient use of control resources (including at the EU 
borders)  could  imply  the  perpetuation  of  avoidable  administrative  costs  and  burdens  for 
operators.  

As  for  the  sectors  pertaining  to  the  agri-food  chain  but  currently  outside  the  scope  of  this 
Regulation  (plant  health,  PRM  and  ABP),  separate  systems  would  continue  to  operate  and 
develop according to sectoral logics and priorities; here again the opportunity for efficiency 
gains would be lost while existing gaps in the available range of enforcement tools in those 
areas and differences in national practices would persist.  

As regards the financing of official controls, if the legislation is not revised the current regime 
would remain with its recognised limits and shortcomings35. None of the problems identified 
can  evolve  favourably  and  most  could  worsen  without  legislative  change.  In  particular, 
uncertainty  would  remain  as  regards  the  availability  of  sufficient  resources  to  finance 
official control activities.  

The capacity of national control systems to prevent and counter risks which might arise 
along the agri-food chain (for humans, animals and plants) would inevitably be affected 
by the said shortcomings. This would represent potential obstacles to the objective of ensuring 
that  national  control  systems  are  well  equipped  and  capable  of  anticipating/preventing  risks 
and may therefore adversely impact on the safety of the agri-food chain and its products. In 
particular, less efficient controls will increase the probability of health crises, and reduce the 
capacity  of  competent  authoritires  to  remedy  them,  which  may  in  turn  lead  to  significant 
economic  and  human  losses.  Therefore,  although  cutbacks  in  relation  to  the  financing  of 

35 DG SANCO has developed an extensive baseline scenario (see Annex XVI) against which each of the options 
has been assessed. 

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official  controls  may  seem  justified  in  the  short  term,  given  relevant  savings  and  reduced 
public expenditure, in the long term they may actually result in higher costs for citizens and 
industry where controls are unable to prevent large scale emergencies36.  

With  the  current  discriminatory  treatment  between  those  operators  which  must  be 
charged (mandatory fees) for official controls they receive and those which can be charged, 
depending on whether Member States decide to collect non-mandatory fees, failure to address 
the perceived unfairness of the financing system might also increase the reluctance of industry 
to remunerate official control activities. 

2.5. Does the EU have the right to act (subsidiarity)? 

2.5.1. Right of the EU to act (legal basis) 

The Regulation was based on Articles 37, 95 and 152(4)(b) of the EC Treaty, now Article 43, 
114 and 168(4)(b) respectively of the TFEU. 

Article 43 is implementing the Common Agricultural Policy (CAP), policy qualified by the 
Lisbon Treaty as shared competence between the EU and its MS. It is obvious, however, that 
to a very large extent all fields of agricultural activity as well as ancillary activities upstream 
and  downstream,  have  been  regulated  at  the  EU  level.  This  means  that  legislation  is 
predominantly a role for the institutions of the European Union. 

Article  114  provides  the  legal  basis  for  the  establishment  and  functioning  of  the  internal 
market  for  food  products  while  ensuring  a  high  level  of  protection  of  consumers  and  the 
approximation of provisions laid down by the law, regulation or administrative actions in this 
respect.  

Article  168(4)(b)  stipulates  that  in  order  to  meet  common  safety  concerns  'measures  in  the 
veterinary  and  phytosanitary  fields  which  have  as  their  direct  objective  the  protection  of 
public health' should be adopted by the EU.   

2.5.2. Necessity for the EU to act (subsidiarity) 

Necessity  –  The  existence  of  a  harmonised  EU  legislative  framework  to  govern  the 
organisation  and  performance  of  official  controls  along  the  agri-food  chain  is  necessary  to 
ensure  the  uniform  implementation  of  agri-food  chain  rules  across  the  EU  and  the  smooth 
functioning of the internal market. This rationale, which is still valid, underpins the existing 
rules on official controls. As the problems identified by this review are linked to the current 
design of  the  EU legislative framework,  its reform cannot be achieved by MS acting alone. 
The intervention of the European legislator is required. 

European added value test – The added value of a single, uniform set of EU rules to govern 
official  controls  lies  in  the  fact  that  it  offers  national  enforcers  (and  their  operators)  a 
framework within which CAs can rely on  enforcement activities  carried out in  another MS, 
and  on  the  reproducibility  and  scientific  and  technical  soundness  of  control  results.  It  also 
ensures that EU agri-food chain standards necessary for the functioning of the single market 
are applied uniformly and consistently in the different MS and sectors.   

36 See Impact Assessment report on "the proposal to revise the EU Plant Health Legislation" for an overview of 
the economic and environmental impacts which may result from an increase in the influx of harmful organisms 
into the EU. 

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As to the financing of controls, common EU rules ensure that CAs can count on a reliable flux 
of resources to maintain the control effort at a level justified by the risks and by enforcement 
needs (e.g. level of non-compliance). Provisions on fees in particular ensure that businesses, 
which benefit directly from efficiently performed controls, participate to the financing of the 
latter, so as to minimise the dependency of control funding on public finances. Common EU 
rules  are  necessary  also  to  prevent  discriminatory  treatment  between  operators  located  in  a 
MS where the user-pays rule (and thus fees) applies and those located in a MS where this is 
not the case. Only common EU rules can ensure a uniform approach to pursue this objective. 

EU action should not go beyond what is necessary to achieve the objectives set. The present 
exercise  has  looked  at  a  broad  range  of  options,  including  that  of  harmonising  fee  levels 
across  MS,  and  that  of  de-regulating  the  matter.  The  analysis  sought  to  design  the  most 
proportionate solution to ensure a sufficient and steady flux of dedicated resources for official 
controls,  whilst  leaving  MS  the  time  and  flexibility  necessary  to  cater  for  their  internal 
arrangements and the specificities of their business population. 

3. Objectives 

3.1. General objectives 

The  main  purpose  of  this  exercise  is  to  reinforce  the  safety  of  the  agri-food  chain  (in  its 
broadest  meaning)  by  strengthening  the  enforcement  mechanisms  of  the  relevant  EU  rules 
and enable a more efficient implementation of the harmonised framework which applies to 
food, feed, animals, seeds and plants . Thus the general objectives of this initiative broadly 
coincide with the Treaty objectives to safeguard the single market while ensuring delivery of 
a  high  level  of  health  protection.  They  also  reflect  the  Commission's  objective  of  ensuring 
proper enforcement of EU law, as this is the original objective of the Regulation on official 
controls. In particular, the following general objectives are envisaged: 

•  contribute  to  promote  the  smooth  functioning  of  internal  market  rules  applicable  to 

the agri-food chain; 

•  maintain  a  high  level  of  human,  animal  and  plant  health  protection  and  animal 
welfare  throughout  the  length  of  the  agri-food  chain  and  prevent  that  this  is 
undermined by potential non-implementation of EU legislation; 

•  ensure proper and uniform implementation of EU legislation. 

3.2. Specific objectives  

The specific objectives were set with the aim of eliminating the specific obstacles identified 
during the analysis which prevent or hamper the achievement of the general objectives in this 
area37. The specific objectives address the two sets of obstacles mentioned above, i.e. those 
resulting  from  shortcomings  in  the  design  of  the  official  controls'  framework  and  those 
resulting from the difficulties and inequities in financing of official controls. 

37 As the Treaty of Lisbon has made the Charter of Fundamental Rights of the EU legally binding, the results of 
this review shall be in full compliance with the Charter of Fundamental Rights of the EU, in particular the right 
to protection of personal data and the right to an effective remedy. 

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3.2.1. Objectives related to the design of the official controls' framework 

•  Ensure a comprehensive and consistent approach  to  official controls along the agri-food 
chain, by eliminating fragmentations and inconsistencies of the current legal framework: 
- 

the system of official controls should be consistent across all agri-food chain sectors 
avoiding differences which are not justified by the peculiarities of a given sector; 
this system should provide for all tools necessary to ensure accountability, soundness 
and  effectiveness  of  the  enforcement  activities  performed  in  all  agri-food  chain 
sectors; 
this  system  should  avoid  duplications  and  overlaps  which  result  in  divergent 
interpretations and implementation. 

- 

- 

•  Allow for a more efficient use of national control resources, by eliminating residual non 

risk based mechanisms for the allocation of control resources: 
- 

the  system  of  official  controls  should  require  MS  to  allocate,  in  all  agri-food  chain 
sectors, finite control resources on the basis of the actual risk in order to achieve the 
most efficient use of such resources. 

•  Reduce administrative burden and remove unnecessary requirements: 

-  unnecessary administrative burden, in particular on MS' CAs, should be eliminated; 
- 

the  system  should  allow  for  the  necessary  flexibility  so  that  important  requirements 
(the accreditation of official laboratories) can be derogated where appropriate. 

•  Foster closer cooperation between MS to improve official control delivery:  

- 

the  system  of  official  controls  should  enable  swift  and  effective  cooperation,  and 
synergies,  among  MS'  competent  authorities  (including  customs)  which  are  tasked 
with controls over the agri-food chain. 

• 

Improve transparency: 
-  rules on official controls should provide MS with clear guidance on how a 'high level 
of transparency' should be ensured so that the European citizens can benefit from the 
same level of transparency across the EU.  

3.2.2. Objectives related to the financing of official controls 

•  Ensure the availability of adequate resources: 

-  The  system  of  financing  of  official  controls  should  ensure  the  availability  of  the 
resources  necessary  to  maintain  an  adequate  level  of  controls  and,  consequently,  the 
level of protection offered by EU agri-food chain rules. 

•  Ensure equity and fairness in the financing of official controls 

-  The system of financing of official controls should ensure that the burden on agri-food 
chain operators is distribuited in a fair and equitable manner to avoid distortions. 

• 

Improve transparency 
-  The fees system should be transparent and allow the public and, more specifically, the 
operators  to  understand  how  the  fees  are  calculed  and  how  revenue  therefrom  is 
employed; so that transparency can act as a driver to accountability and efficiency of 
the system of financing official controls. 

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3.3. Operational objectives  

•  Establish a single, simpler legislative framework for official controls along the agri-food 

chain; 

•  all controls, including border controls, to be risk based; 
• 

increase the number of cases where cross-border enforcement cases are resolved through 
administrative assistance and cooperation; 
increase  the  number  of  formalised  instruments  between  the  CAs  and  customs  (and/or 
other) authorities for the performance of official controls; 
reduce  the  occurrence  of  unsatisfactory  enforcement  results  attributed  to  resources 
shortages. 

• 

• 

Table 1: Link between the objectives and the problems 

Problem at stake 

Specific objectives 

Inconsistencies, gaps and overlaps in control 
requirements 

Ensure a comprehensive and consistent approach 
to official controls along the agri-food chain 

Inconsistent implementation of risk based 
approach 

Allow for an efficient use of national control 
resources 

Administrative burden and disproportionate 
requirements 

Reduce administrative burden and remove 
unnecessary requirements 

Uneven enforcement of cooperation 
mechanisms  

Improve transparency 

Difficulties and inequities in financing official 
controls activities 

Foster cooperation between MS to improve official 
control delivery 
-  Ensure the availability of adequate resources 

-  Ensure equity and fairness in the financing of 

official contrls 

- 

Improve transparency of the system of 
financing of official controls 

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3.4. Consistency with other EU policies and horizontal objectives 

The  review  requires  consistency  with  the  reviews of  the  animal  health  law,  the  plant  health 
law and the PRM legislation, the four proposals being adopted by the Commission together as 
a package (along with a fifth proposal establishing a multiannual programme for EU financing 
of actions aimed at ensuring a high level of health for humans, animals and plants along the 
agri-food  chain).  The  review  is  also  intended  to  ensure  that  the  provisions  of  Regulation 
882/2004 complement in a consistent manner those applicable to official controls in the field 
of veterinary medicines, also currently under review.  

Moreover, the review preserves synergies between the current system and relevant aspects of 
agricultural  legislation  and  creates  the  possibility  for  new  ones  by  enabling  environmental 
legislation on Invasive Alien Species (IAS) to be supported in its implementation through the 
control  mechanisms  established  by  the  amended  Regulation.  In  order  to  do  so  the  present 
review will take into account the outcome of the ongoing work to develop the EU legislation 
on IAS. 

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The  review  also  seeks  to  align  the  framework  of  official  controls,  in  particular  the 
terminology used, to the modernised customs code. 

With a  view to  the  Europe 2020 strategy,  the provision of effective controls along the agri-
food  chain  is  to  ensure  safe  food  and  feed  while  fostering  competitiveness  of  business 
operators, rewarding complaint business operators and ensuring user-pays principles across all 
sectors. 

This  initiative  pursues  the  objectives  of  the  Communication  on  Smart  Regulation  in  the 
European Union. One of the aims of the review is to simplify legislative burdens in light of 
comments made by MS and food business operators on the existing regime. 

4. Policy options 

4.1. Policy options included in the analysis38 

The  analysis  of  options  available  to  address  the  problems  and  achieve  the  objectives  above 
was carried out in two stages: 

1.  first,  the  potential  impact  of  deregulating  the  matter  of  the  financing  of  official 
controls and of exempting micro-enterprises from the fees system was considered; 
2.  the  outcome  of  the  analysis  under  1  was  then  used  to  design  options  2  to  4,  which 

combine the following elements: 

(cid:190)  expand  the  scope  of  the  Regulation  to  agri-food  chain  sectors  currently  outside  its 

scope (i.e. plant health, PRM and ABP); 

(cid:190)  improve and simplify the legislative framework; 
(cid:190)  ensure full cost recovery through fees; 
(cid:190)  expand the list of control activities for which the collection of a fee from operators is 

obligatory.  

Table 2: Summary of the options included in the analysis 

Scope of 
the Regulation  

Legislative 
framework 

Cost recovery 

Scope of 
mandatory fees 

deficiencies and 
shortcomings 

partial 

partial (meat, milk, fishery, 
imports) 

Baseline 

Option 
1A 
Option 1B 

Option 2 

Option 3 

Option 4 

partial (plant 
health, PRM, 
ABP out) 
status quo 

status quo 

status quo 

status quo 

status quo 

expand to plant 
health and PRM 
expand to plant 
health and PRM 

improved 

improved 

improved 

No 
(deregulation) 
status quo 

full  

full 

full  

/ 

exemption for micro-
enterprises 
status quo 

ADD plant health and PRM 

ALL registered food and 
feed operators 

38 For a description of the elements of each option and main changes implied see Annex XXIII. 

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Base line (status quo) The integration of the system of official controls along the food agri-
chain  is  partial,  some  agri-food  chain  sectors  being  outside  the  scope  of  the  Regulation. 
Official  controls  carried  out  at  EU  external  borders  on  certain  goods  arriving  from  third 
countries,  and  official  controls  on  residues  of  veterinary  medicines  are  not  aligned  to  the 
risk based approach. This will continue to generate avoidable costs (for rigidly prescribed, 
non  risk-based  controls).  Inconsistency  and  inefficencies  in  the  deployment  of  efforts  by, 
and  in  cooperation  between,  national  authorities  will  derive  from  the  lack  of  uniform 
guidance  on  how  to  implement  administrative  cooperation  and  deliver  a  high  level  of 
transparency.  No  derogation  is  foreseen  from  the  requirement  of  accrediting  official 
laboratories.  

The  collection  of  fees  is  mandatory  for  a  limited  number  of  control  activities  (control 
activities on businesses handling meat, fishery products, and milk; for the approval of feed 
establishments;  at  EU  borders  on  certain  goods  from  third  countries).  MS  can  choose  to 
charge a standard EU fee fixed in the Regulation, which does not correspond to the actual 
cost of the control. This results in potential under-resourcing of control authorities and in 
the risk that the capacity of the EU control system as whole to prevent and contain health 
risks along the agri-food chain is undermined. 

Box 3: Financing of official controls: baseline39 

Collection of mandatory fees: Twenty-one MS (AT, BE, BG, CY, CZ, DE, DK, EE, IE, EL, FI, 
FR, HU, IT, LT, NL, PL, PT, RO, SI, SK) collect fees for all official control activities for which 
mandatory fees apply40; however, five (ES, SE, LV, MT, UK) only partly collect such fees (in other 
words,  in  these  MS,  certain  mandatory  fees  are  not  collected).  Fees  for  milk  production  controls 
and fees for residue controls are the two types of control activities for which several of these MS do 
not collect fees. Data is not available for LU. 

Twenty-two MS (AT, BE, BG, CY, CZ, DK, EE, EL, ES, FI, HU, IE, IT, LT, LV, NL, MT, PT, 
RO, SK, SI, UK) collect fees for activities for which fees are not mandatory41. On the other hand, 
two MS (FR, PL) do not collect fees for activities  beyond those which are  mandatory42, and two 
MS  (DE,  ES  i.e.  countries  with  a  decentralised  management  of  fees)  collect  such  fees  in  some 
regions but not in others. 

Full cost recovery: Eight MS (NL, IT, AT, PL, LT, LV, PT, SI) currently achieve full or almost 
full cost recovery of mandatory fees for official control activities whilst eight MS (BG, CZ, EE, ES, 
FI, SE, EL, IE) achieve a low level of recovery.  Eight MS (BE, DK, FR, HU, MT, RO, SK, UK) 
recover between 34 – 66% of the cost of official controls for which mandatory fees apply.  Levels 
of cost recovery are unknown for three MS. 

Fee rates: Across the EU fee rates vary considerably, not necessarily in relation with variances in 
costs. For example, fees paid for controls on the slaughter of adult bovine animals can vary from 
€2.3/head in some autonomous communities in Spain, to €8.2/head in Denmark and between €10-
20/head in Sweden (against a minimum fee of €5/head in Annex IV). Even within MS the scale of 
the  variation  can  be  significant.  For  example,  in  Bavaria  (Germany)  fee  rates  for  the  slaughter 
inspection of adult bovine animals range from €9.4/head to €12.9/head depending on district. 

Should  the  status  quo  be  maintained,  the  shortcomings  identified  in  Section  2.2  would 
remain. 

39 The baseline only describes the situation in MS as regards the collection of fees for the purposes of control 
activities currently falling within Regulation 882/2004. 
40 Article 27(2) of the Regulation. 
41 Article 27(1) of the Regulation. 
42 Article 27(2) of the Regulation. 

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Options 1A and 1B 

A  preliminary  analysis  focuses    on  two  possible  changes  to  the  status  quo  which  would 
specifically aim to A) repeal Union rules on control fees (thus leaving it to MS to decide 
how  to  ensure  the  appropriate  funding  of  control  activites),  and  B)  maintain  current  EU 
rules on fees,  exempting micro-enterprises therefrom.  

The outcome of such analysis is then reflected in the design of subsequent options (2 to 4).  

Although  in  theory  both  Options  1A  and  1B  could  be  combined  with  other  elements  of 
Options  2  to  4,  they  are  presented  and  assessed  individually  given  the  significance  of  the 
changes  they  purport  to  introduce.  Both  would,  in  fact,  substantially  alter  the  current 
framework  as  regards  the  financing  of  national  control  systems  and  call  into  question 
established principles. Moreover, the combination of Options 1A and 1B with other elements 
of Options 2-4 would not result in significant trade-offs and would therefore not modify the 
cost/benefit analysis of the former to an appreciable extent.  

Option 1A - Repeal Union rules on control fees 

(Existing  mandatory  inspection  fees  are  repealed;  other  provisions  of  the  legislative 
framework remain unchanged) 

Under this Option each MS is given the possibility to determine the approach it follows as 
regards the funding of official control activities, provided that it ensures a level of resources 
which  allows  the  correct  implementation  of  control  requirements  and  the  efficient 
enforcement of EU law. It would require repeal of Articles 27-29 of the Regulation and in 
particular of the mandatory collection of fees in certain areas. 

Option 1B - Mandatory exemption of micro-enterprises from the application of fees  

(Existing  mandatory  inspection  fees  are  maintained  but  not  applied  to  micro-enterprises; 
other provisions of the legislative framework remain unchanged) 

Option  1B  was  selected  in  view  of  the  Commission's  continued  efforts  to  promote  the 
competitiveness  of  micro-enterprises,  as  highlighted  in  the  Commission  policy  on 
"Minimizing regulatory burden for SMEs – Adapting EU regulation to the needs of micro-
enterprises".  

This  Option  would  provide  for  the  mandatory  exemption  of  micro-enterprises  from  the 
application  of  mandatory  fees  and  would  require  the  breadth  of  operators  upon  which 
mandatory fees are levied to be appositely restricted.  

Option 2 – Streamline 

(The  legislative  framework  is  improved  and  streamlined,  full  cost  recovery  is  ensured 
where mandatory fees are already provided, with the possibility for MS to refund fees paid 
by micro-enterprises) 

Option 2 would aim to improve the legislative framework on official controls by clarifying, 
simplifying and streamlining existing provisions on controls in sectors currently covered by 
Regulation 882/2004, and by ensuring full cost recovery in the areas where mandatory fees 
are already provided. The main changes would be:  

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a)  repeal redundant and obsolete pre-existing legislation in the area of veterinary checks 
in intra-EU trade so that overlaps in control requirments would be eliminated and the 
system would become more consistent because less open  to divergent interpretation43; 
b)  repeal existing sectoral provisions44 in the area of border controls and establishing, in 
the Regulation, a single set of rules applicable to border controls on all goods requiring 
special attention at  the external borders of the EU because of  risks to  human,  animal, 
plant  health.  This  system  would  be  aligned  to  the  risk  based  approach  underpinnying 
Regulation 882/2004 so that the allocation of control resources would be made on this 
basis.  In  addition,  the  elimination  of  the  legislative  fragmentation  in  this  area  would 
allow MS to prioritise the controls across all sectors covered by the Regulation. 

c)  repeal  Directive  96/23/EC  applicable  to  official  controls  on  residues  of  veterinary 
medicines,  with  additional  rules  established  in  line  with  the  Regulation;  as  a 
consequence,  these  controls  would  be  governed  by  Regulation  882/2004  only  on  the 
basis of the risk. In addition, the repeal of this Directive would eliminate the obligations 
identified as administrative burden. 

d)  clarify the obligation of cooperation between sanitary authorities and customs services, 
and  include  the  possibility  of  setting  control  coordination  mechanisms  with  other 
national authorities (at borders and elsewhere) so as to take advantage of  all potential 
operational synergies at borders (including with customs and on controls on IAS).  
e)  clarify the rules applicable to the methods used by official laboratories and providing 
derogations from the obligation to accredit the laboratories in certain cases in order to 
avoid this requirement to be applied in a disproportionate manner; 
introduce new empowerments to enable the Commission to i) specify the modalities of 
the  administrative  cooperation's  mechanism  so  as  to  ensure  its  uniform  application 
across MS; ii) provide guidance on how to deliver a 'high level of transparency'; 

f) 

g)  require MS to calculate existing mandatory fees in manner which enables them to fully 
recover the costs of, and appropriately finance, official controls, and eliminate current 
obstacles to full recovery resulting from the provision of minimum fees;  
h)  improve transparency and introduce incentives for compliant businesses; 
i)  provide  MS  with  the  possibility  to  refund  fees  to  micro-enterprises  in  accordance 
with  State  Aid  rules45  (current  rules  include  the  prohibition  to  refund,  directly  or 

43 Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade 
with a view to the completion of the internal market; Council Directive 90/425/EEC of 26 June 1990 concerning 
veterinary  and  zootechnical  checks  applicable  in  intra-  Community  trade  in  certain  live  animals  and  products 
with a view to the completion of the internal market;; Council Directive 96/93/EC of 17 December 1996 on the 
certification  of  animals  and  animal  products;  Council  Directive  89/608/EEC  of  21  November  1989  on  mutual 
assistance between the administrative authorities of the Member States and cooperation between the latter and 
the Commission to ensure the correct application of legislation on veterinary and zootechnical matters. 
44  Article  15(5)  of  Regulation  (EC)  No  882/2004  establishing  the  framework  for  the  performance  of  import 
controls  on  feed  and  food  of  non-animal  origin;  Directives  97/78  of  18  December  1997  laying  down  the 
principles  governing  the  organisation  of  veterinary  checks  on  products  entering  the  Community  from  third 
countries,  and  91/496  of  15  July  1991  laying  down  the  principles  governing  the  organization  of  veterinary 
checks  on  animals  entering  the  Community  from  third  countries  and  amending  Directives  89/662/EEC, 
90/425/EEC  and  90/675/EEC;  Directive  2000/29  on  protective  measures  against  the  introduction  into  the 
Community of organisms harmful to plants or plant products; the latter governing, inter alia, border controls on 
plants and plant products. 
45 The option of requiring MS to exempt all micro-businesses from payment of mandatory fees is presented in 
Option 1B and analysed in section5 (Analysis of impacts). With regard to Plant Health, exemptions for micro-
enterprises will not apply given that most operators under these health regimes could qualify as micro-businesses 
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indirectly, fees collected for the financing of official controls; Option 2 would repeal it 
insofar as micro-enterprises could benefit from the refund). 

As  the  establishment  and  application  of  a  full  cost  recovery  system  would  require  some 
adjustments in the Member States' current systems, a transition period of 2 years would be 
provided. 

Option 3 – Streamline + Integrate 

(The legislative framework is improved and streamlined, plant health and PRM, and ABP 
are included in its scope, full cost recovery is ensured where mandatory fees are already 
provided  with the possibility for MS to refund fees paid by micro-enterprises) 

In addition to the elements of option 2, option 3 would widen the scope of the Regulation 
to  cover  sectors  of  the  agri-food  chain  acquis  that  are  currently  excluded  (plant  health 
law46, PRM legislation, ABP rules) and complete the 'integration' of agri-food chain official 
controls.  This  would  be  done  by  repealing  pre-existing  provisions  governing  official 
controls  in  the  sectors  being  integrated  into  the  Regulation47.  Appropriate  transitional 
periods would be provided for new obligations (such as the laboratories' accreditation for 
plant  health  tests).  The  inclusion  of  the  sectors  above  under  Regulation  882/2004  would 
aim  to  ensure  that,  in  principle,  competent  authorities  operate  on  the  basis  of  the  same 
approach and under the same conditions no matter the agri-food chain rules they are called 
to  enforce.  Some  adjustments  would  be  introduced  to  account  for  specificities  of  those 
sectors, in particular as regards the certification procedure and the accreditation of official 
laboratories. 

As regards the financing of official controls, the control activities covered by a mandatory 
fee  would  remain  unchanged  with  the  only  exceptions  being  in  the  field  of  plant  health, 
where  mandatory  fees  will  be  introduced  for  official  controls  linked  to  plant  passport 
obligations,  and  in  the  field  of  PRM,  where  it  is  envisaged  that  the  principle  of  full  cost 
recovery through fees would be established for certification. 

Option 4 – Streamline + Integrate + broader cost recovery 

(The legislative framework is improved and streamlined, plant health and PRM, and ABP 
are included in its scope, mandatory fees are extended to cover key areas of the agri-food 
chain with the possibility for MS to refund fees paid by micro-enterprises) 

In  addition  to  the  elements  of  option  3,  option  4  would  expand  the  list  of  mandatory 
inspection fees to all controls carried out on feed and food business for which a registration 
requirement is established in accordance with food safety and feed safety rules, i.e. on all 
activities  for  which  an  obligation  for  operators  to  be  registered  exists  in  accordance  with 
Regulation  (EC)  No  852/2004  (food  hygiene)  and/or  Regulation  (EC)  No  183/2005  (feed 
hygiene).  Although  responsibility  for  the  safety  of  food  and  feed  on  the  EU  market  lies 

(see  Impact  assessment  report  on  "the  proposal  to  revise  the  EU  Plant  Health  Legislation").  The  IA 
accompanying the proposal to review PRM acquis follows the approach presented here.  
46 At present only Articles 41-46 of Regulation 882/2004 apply to Plant health. 
47 Official controls provisions laid down in Council Directive 2000/29/EC of 8 May 2000 on protective measures 
against the introduction into the Community of organisms harmful to plants or plant products and against their 
spread within the Community; 12 Council Directives on the marketing of plant reproductive material; Regulation 
(EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules 
as  regards  animal  by-products  and  derived  products  not  intended  for  human  consumption  and  repealing 
Regulation (EC) No 1774/2002. 

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primarily with food and feed business operators, in these areas an increased control effort is 
also required from CA to ensure that food and feed business operators comply with safety 
requirements, and, ultimately, that food and feed placed on the market is safe.  

Compared to the baseline, fees would also become mandatory for the following activities: 

-  production  of  food  other  than  meat,  fishery  products  and  milk  (already  subject  to 
mandatory fees): eggs and egg products, honey and all foods of non animal origin; 

-  distribution (including wholesale, retail and restaurants) of all food; 
-  production and distribution (including wholesale and retail) of feed; 
-  production and distribution of ABP in so far as the concerned operators have to be 
registered under Regulation (EC) No 852/2004 or Regulation (EC) No 183/2005; 
import of goods from third countries that need to be checked at the border other 
than  those  already  covered  by  a  mandatory  fee  (e.g.  goods  subject  to  a  safeguard 
measure). 

- 

As  the  establishment  and  application  of  cost  based  fees  in  all  areas  would  require  some 
adjustments in the MS current systems, a transition period of 3 years would be provided. 

4.2. Discarded policy options 

• Reducing controls on micro-enterprises or SME's  

Given  the  new  Commission  policy  on  "Minimizing  regulatory  burden  for  SMEs  – 
Adapting EU  regulation  to the  needs of micro-enterprises", the possibility  of exempting 
micro-enterprises  or  SME's  from  the  performance  of  official  controls  was  considered.  
This option was discarded as it ran counter to the basic principles underlying Regulation 
882/2004 and would also not have addressed the problems identified in section 2.2.  

In particular, micro-enterprises represent a very high proportion of the business population 
subject  to  official  control  activities48  and,  given  that  food  safety  risks/concerns  arise 
regardless of the size of an operator, their exemption from official controls would lead to 
the non-compliance of numerous goods placed on the EU market with relevant EU agri-
food  chain  standards  and  requirements.  The  safety  of  the  agri-food  chain  would  be 
undermined  and  the  number  of  food  crises  would  increase.  Furthermore,  as  highlighted 
with regards to the E. Coli crisis (see section 2.1.1), the gravity of food crises stemming 
from micro-enterprises/SME's should not be underestimated.    

• Non-legislative  option  (e.g.  development  and  use  of  electronic  systems,  adoption  of 

informal guidelines at EU level etc.) 

A  general  option  based  on  the  development  of  "soft  law  instruments"  to  increase  the 
clarity of the existing legal text. The option was discarded as the non-binding nature of 
soft  law  instruments  was  considered  insufficient  to  address  the  interpretation  and 
implementation difficulties linked to The Regulation and the shortcomings of the rules 
governing inspection fees. 

Further  options  relating  exclusively  to  the  availability  of  adequate  resources  for  official 
controls were also excluded: 

48 See section 2.1.1 and the analysis of Option 1B in section 5. The proportion mentioned is even higher if SME's 
are considered alongside micro-enterprises.  

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• Imposing mandatory fees on all operators subject to official controls 

The  option  of  requiring  MS  to  apply  mandatory  fees  to  all  the  operators  subject  to 
controls  in  accordance  with  the  Regulation  was  discarded.  Instead,  the  option  of 
charging food and feed operators subject to a specific registration requirement laid down 
in  Regulation  852/2004  (food  hygiene)  or  in  Regulation  183/2005  (feed  hygiene)  was 
retained  (see  option  4).  The  discarded  all-inclusive  option  would  have  required  the 
application  of  mandatory  fees  also  on  operators  not  directly  concerned  with  the 
production  of  handling  of  food  or  feed  (e.g.  keepers  of  non  food  producing  animals, 
plant nurseries) and on operators only marginally involved in the production of food for 
commercial  purposes  (e.g.  farmers  producing  for  domestic  consumption,  or  for  the 
direct supply of small quantities to final consumers or to local retailers supplying final 
consumers). These operators do not have to be registered under EU food/feed hygiene 
rules,  and  some  of  them  would  be  subject  to  official  controls  organised  in  accordance 
with  the  Regulation  only  after  the  intended  changes  to  its  scope  (options  3  and  4). 
Considering  the  absence  of  registration  requirements  for  these  operators,  the  great 
numbers and the fragmentation of the business population potentially concerned, which 
would  further  increase  with  the  present  review,  it  would  have  been  very  difficult  to 
accurately assess the impact of this option (particularly in relation to those areas where 
Regulation (EC) No 882/2004 would become applicable only following the review). 

• Full harmonisation of fees 

An option based on full harmonisation of fees across MS (i.e. the establishment of EU 
standard fees for each type of control carried out, irrespective of the actual cost in each 
MS).  This  option  was  discarded  since  it  fails  to  achieve  the  objective  of  full  cost 
recovery  (harmonised  fees  would  in  most  cases  either  'under'  or  'over'  compensate 
costs). Furthermore, the development of EU-uniform cost models for each of the types 
of  controls  would  be  a  very  burdensome  exercise.  Monitoring  and  maintaining 
appropriate harmonised fee levels would also create a disproportionately heavy burden 
for Member States and the Commission.  

The option of adjusting harmonised fees to the cost of living in each MS was also 
excluded, as although adjusted fees could be somewhat closer to the actual costs, they 
would not be fully  accounted  by  accurate and actual costing of control  activities, and 
thus  would  not  guarantee  full  cost  recovery  or  the  absence  of  overcompensation. 
Furthermore,  they  could  only  be  obtained  through  a  complex  mechanism  for  the 
calculation of standard EU costs (and fees) for each type of control, for the update and 
application  of  the  chosen  adjustment  index,  and  appropriate  monitoring  tools  to 
constantly update the EU fees. 

• Harmonised fees for certain import controls 

During  the  consultation  phase,  some  respondents  argued  in  favour  of  a  specific,  fully 
harmonised fee (i.e. not adjusted to cost-of-living or any other index) to be applied only 
for the performance of border controls on goods arriving from third countries. The 
argument for harmonised fees for import controls is that it would create a ‘level playing 
field’  across  the  EU-27  for  such  fees  and  remove  the  potential  for  trade  distortions 
derived from importers seeking out border points with lower fees. Although several of 
those  consulted  through  the  2011  Impact  Assessment  Study  see  this  as  an  issue, 
evidence of such distortions has not been found in two successive contractor studies. 

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Section 5: Analysis of impacts 

This  IA  analyses  the  likely  social,  economic  and  environmental  impacts  –  be  they  direct  or 
indirect – of the different policy options. Each option has been assessed against the theoretical 
baseline of 'do nothing' and therefore the impacts outlined are additional to the current status 
quo.  Economic  impacts  are  assessed  through  the  following  criteria:  competitiveness, 
innovation,  sustainability,  simplification,  and  administrative  burden  reduction.  Equally 
important for the analysis are social impacts (safety in particular, but also accountability). The 
assessment of each option in terms of environmental impacts and of impacts on employment 
rates has not identified significant impacts (either negative or positive). 

To help comparisons between options the impacts have been rated (0: no impact; +, ++, +++: 
small, medium or large positive impact; -, --, ---: small, medium or large negative impact). 

Option 1A – Repeal Union rules on control fees 

The  repeal  of  the  existing  EU  framework  on  inspection  fees  is  likely  to  result  in  an 
increased  variance  of  national  approaches,  and  possible  cuts  in  resources  allocated  to 
controls. 

Sustainability - Although the impact on the level of resources actually deployed will depend 
on the policy choices that each MS will make and so cannot be fully predicted and analysed, 
the  problems  identified  in  relation  to  the  current  fees  regime,  such  as  the  failure  to  ensure 
proper cost recovery, and thus appropriate and stable resourcing of controls are unlikely to be 
solved. On the  contrary, stakeholders and MS  argue that, given the current economic crisis, 
the  problems  affecting  the  sustainability  of  controls  could  worsen  if  MS  decisions  result  in 
fewer resources being allocated to the operation of national control systems. 

Simplification - The repeal of the EU framework would result in a more complex legislative 
landscape as differences in national rules on the financing of controls are likely to increase. 
Under the current system MSs already exhibit significantly wide variance  (see tables  1-4 in 
Annex  XVII)  in  cost  recovery  levels,  bonus  malus  arrangements  and  availability  of 
information to the public. In the absence of a harmonised framework, national approaches to 
the  financing  of  official  controls  are  likely  to  vary  even  further  over  time  as  MS  make 
different policy choices.  

Competitiveness - Wider disparities amongst MSs might result in distortions of competition, if 
operators in one MS are charged for controls while competitors in another MS are not, with 
adverse impacts on the operation of the single market. 

Accountability - This option would repeal the obligation for MSs to publish and communicate 
to the Commission the method of calculation of the fees, thus leaving MS free to decide the 
level of transparency (and of accountability) of their domestic regimes.  

Safety  –  A  decrease  in  the  availability  of  resources  would  inevitably  reduce  the  resources 
available  to  CAs  to  perform  official  controls  potentially  leading  to  fewer  controls  being 
carried  out.  CA  may  have  difficulties  maintaining  an  effective  oversight  of  compliance  by 
food  business  operators  and,  ultimately,  the  safety  of  the  agri-food  chain,  especially  when 
faced with large scale crises. 

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Summary of the key impacts under Option 1A 

Criteria 

Competitiveness  

Innovation 

Sustainability 

Simplification  

Administrative Burden  

Accountability  

Safety 

Impacts 

- 

0 

- 

- 

0 

- 

- 

Based  on  the  above  analysis,  the  option  to  repeal  current  EU  rules  on  fees  as 
established in Regulation 882/2004 was not considered further.  

Option 1B – Mandatory exemption of micro-enterprises from the application of fees 

The mandatory exemption  of  micro-enterprises from the application of fees would  reduce 
the  financial  burden  on  micro-enterprises  However,  the  exemption  would  undermine  the 
objective of ensuring the sustainability of the control system, and through it the safety of the 
agri-food chain. 

Sustainability: Figure 3 gives an overview of the percentage of micro-enterprises on the total 
number  of  operators  in  the  major  industries  subject  to  official  controls  (and  to  mandatory 
fees)  under  on  Regulation  882/2004.  In  16  of  the  23  Member  States  for  which  data  is 
available, micro-enterprises represent more than half of all businesses, and in 9 such States 
(AT, BE, CY, FI, IT, NL, PL, SE, SI) the percentage of micro-enterprises rises to two thirds 
(or more) of all business operators49. 

Figure 3   Share of Micro-enterprises in total number of business operators in the four major European    
                  industries affected by official control activity (2008)* 

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

*Industry sectors include: processing and preserving of meat and production of meat products; processing and preserving of 
fish, crustaceans and molluscs; manufacture of dairy products; manufacture of prepared animal feeds. Greece and Malta are 
not included in Eurostat dataset. Data for the Czech Republic and France are not available. 

49 Also see Annex XXV. 

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In  those  MS  where  micro-enterprises  represent  an  overwhelwing  majority  of  businesses 
subject  to  fees,  exempting  them  from  the  payment  of  the  latter  will  have  a  severe  negative 
impact on the proportion of costs recovered by CA. The objective of ensuring a sustainable 
financing  of  controls  via  full  cost  recovery  would,  in  most  (if  not  all)  Member  States,  be 
undermined,  as  controls  will  still  need  to  be  carried  out  on  all  operators  at  a  frequency 
dictated by the risk.  

While  the  CAs'  loss  in  revenue  represented  by  the  exemption  could  be  compensated  by 
transfers from the general budget, this would again create a strong dependency of the control 
action  on  public  resources  and  thus  create  a  situation  –  in  particular  in  times  of  crisis  and 
budget restrictions - of financial uncertainty which can not be reconciled with the objective of 
ensuring  consistent,  efficient  and  risk  commensurate  control  activities  across  the  agri-food 
chain. 

Competitiveness - The mandatory exemption of micro-enterprises from the application of fees 
would reduce the financial burden upon them and help to encourage the development of small 
businesses, including artisanal establishments. 

However, a mandatory exemption for micro-enterprises would result in the unfair treatment of 
larger  operators  who  might  be  charged  more  to  fill  in  the  cost  recovery  'void'  left  by  the 
exemption  of  micro-enterprises.  The  impact  on  larger  businesses  would  be  particularly 
disproportionate in those Member States and those sectors with a large percentage of micro-
enterprises.   

Safety – Lower cost recovery by reason of the exemption of micro-enterprises would result in 
a  lower  revenue  income  for  competent  authorities.  Over  time,  unless  competent  authorities 
were  otherwise  subsidised,  this  may  lead  to  fewer  official  controls  and  result  in  a  higher 
probability of food products not complying with EU agri-food chain legislation. The safety of 
the  agri-food  chain  could  ultimately  be  jeopardised  and  the  risk  of  food  crises  would 
increase50.  

The  analysis  carried  out  above  is  fully  in  line  with  the  views  of  competent  authorities  and 
industry.  Throughout  the  consultation  process  both  firmly  opposed  a  mandatory  exemption 
for micro-enterprises highlighting, amongst other things, that it would have a negative impact 
on  the  sustainable  performance  of  official  controls51  and  on  competition.  Similarly, 
stakeholders did not request that data on ways to support micro-enterprises be obtained. 

Summary of the key impacts under Option 1B 

Criteria 

Competitiveness  

Innovation 

Sustainability 

Simplification  

Administrative Burden  

Accountability  

Safety 

Impacts 

0/- 

0 

-- 

0 

- 

0 

-- 

50 Given the huge economic losses and human suffering that may result from food crises (see e.g. the dioxins/E. 
Coli crises) any policy option should aim to avoid them, even when this implies imposing burdens on operators. 
51 See Annex XXV for a summary of stakeholder opinions. 

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Based  on  the  above  analysis,  it  is  considered  that  an  automatic  exemption  of  micro-
enterprises (or SME's in general) from the application of fees would, on the one hand, 
undermine  the  policy  objective  of  ensuring  the  long  term  sustainability  of  national 
control systems and, on the other hand, create potential distortions of competition. This 
conclusion  also  holds  true  in  cases  where  other  possible  changes  to  the  status  quo  are 
considered and, in particular, if mandatory fees are imposed on all registered food and 
feed operators (as per Option 4) as the proportion of micro-enterprises in the different 
areas  of  the  agri-food  chain  is  very  significant  (data  published  in  April  2012  by 
Fooddrinkeurope  shows  that  79%  of  operators  in  the  food  and  drink  industry  are 
micro-enterprises).5253 
In  the  options  considered  below,  the  exemption  of  micro-enterprises  from  the 
application of fees is therfore replaced by a mechanism which aims to respond to both 
the abovementioned shortcomings (i.e. sustainability and competition). 

Option 2 – Streamline 

Increased efficiency of the risk based use of control resources and mobilisation of dedicated 
financial  resources  reducing  pressure  on  national  finances  allow  progress  towards  the 
primary objective of maintaining efficient controls and safety of the agri-food chain. MS may 
refund fees paid by micro-enterprises, conforming to State Aid rules.  

Competitiveness  -  Option  2  would  allow  for  the  full  implementation  of  the  risk  based 
approach to official controls in sectors where MS CAs are currently not allowed to adjust their 
control  efforts  to  the  actual  risks  (i.e.  official  controls  carried  out  at  EU  border  on  certain 
goods  from  third  counties,  and  official  controls  on  residues  of  veterinary  medicines).  This 
would result in a better allocation of control resources and, thus, in a more efficient control 
system54.  

Box 4: Reduced costs for official controls on residues and other substances 

A risk based approach to controls on residues of veterinary medicines would lead to a decrease of 
the number of samples ranging from 49 753 to 394 280, thus to a decrease of costs (for CA and 
ultimately for operators through the corresponding mandatory fee) ranging from € 12.4 million to € 
98.5  million  when  considering  the  average  total  cost  per  sample  for  laboratory  analysis  (staff, 
consumables, overheads, etc.). MS in general expect the sampling capacity that will be freed to be 
used to increase the sampling of other substances/residues and/or on higher risk matrices. 

Moreover, enabling national authorities to focus their control efforts where non compliances 
and risks are higher would minimise the burden of official controls on compliant businesses 
and have, therefore, a positive impact on their competitiveness. 

However,  the  benefits  in  terms  of  increased  efficiency  and  competitiveness  would  be  only 
partial  because  plant  health,  PRM  and  ABP  are  not  included  within  the  scope  of  the 
Regulation according to option 2. In fact, the best allocation of control resources can only be 
achieved by ensuring that the risk prioritisation is carried out by MS CAs across all sectors of 
the agri-food chain, including those above. This is prevented by the current fragmentation of 
official controls legislation. 

52 http://www.fooddrinkeurope.eu/uploads/publications_documents/Final_Data__Trends_30.4.2012.pdf  
53 For plant health, see impact assessment report on "the proposal to revise the EU Plant Health Legislation" 
54 For a quantification of the costs reductios relating to the repeal of Directive 96/23/EC see Annex XXI; those 
data are also included in the table 4 (section 6.2.) providing an overview of the costs and benefits associated to 
each option.  

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Fees charged on the basis of actual costs would be (and be perceived as) fairer across the MS 
since  at  present  the  use  of  standard  fees  and  the  varying  recovery  rates  applied  across  and 
within MS means that fees recovered by some MS may be either higher or lower than the cost 
incurred  by  the  CA  performing  official  controls.  Under  the  current  regime,  where  a  MS  is 
charging  a  standard  fee  which  is  higher  than  the  actual  cost  whereas  other  MS  do  not,  or 
where a MS recovers a higher percentage of fees than other MS, the operators in the territory 
of  that  MS  will  be  at  a  competitive  disadvantage  in  relation  to  operators  in  the  other  MS. 
Option 2 will create a level playing field for all operators charged with mandatory fees. 
Importantly, the bonus malus principles which are already inherent in the current legislation 
(and which will be retained in the revised legislation), and new provisions (which will allow 
businesses currently charged a flat rate fee regardless of the level of enforcement activity to 
benefit from recognition of good performance), will ensure that costs on well-performing, low 
risk businesses are comparatively lower than those on non-compliant operators. Consultation 
results demonstrate that Industry is very keen to see this taken forward. 
The  possibility  for  MS  to  alleviate  the  impact  of  full  cost  recovery  on  micro-entreprises  by 
refunding them the mandatory fees paid, on condition that this is in conformity with State aid 
rules (i.e. does not unduly affect competition), would ensure that the benefit for the recipients 
of the refund does not result in unfair competition for other businesses and does not deprive 
CA  of  the  resources  which  are  necessary  to  perform  their  control  tasks.  The  'refund' 
mechanism means that the benefit for micro-enterprises is not to be afforded at the expenses 
of full cost recovery by CA55.  

Innovation - By allowing in certain cases the use of methods not yet included in the scope of 
the  accreditation  of  an  official  laboratory,  Option  1  would  remove  legal  obstacles  to  the 
introduction and development of new analytical methods. 

Simplification  -  The  repeal  of  pre-existing  sectoral  acts  or  provisions  would  streamline  all 
rules dealing with official controls along the agri-food chain in a single legislative framework, 
eliminating duplications and overlaps with the Regulation56.  

Simplification  gains  would  also  come  from  the  streamlining  of  border  official  controls  on 
goods from third countries. CAs, instead of using different sets of rules depending on the type 
of  goods  to  be  controlled  at  the  border,  would  refer  to  a  single  framework  governing  the 
mechanism of border controls for both live animals and their products, and food and feed of 
non  animal  origin.  In  practice,  they  will  find  the  goods  subject  to  such  controls  included  in 
one consolidated list (based as much as possible on CN codes) and will be able to designate 
single border control posts where all such goods could be checked; a single and harmonised 
entry document will be used for all concerned goods. Economic operators would benefit from 
such  simplification  as  they  will  us  the  same  set  of  procedures  and  requirements,  and  a 
harmonised entry document independently of the goods they introduce into the Union. 

Box 5: Simplification gains under option 2 

Acts or provisions to be repealed under option 2 
(cid:190)  Directive 89/662/EEC concerning veterinary checks in intra-Community trade 
(cid:190)  Directive  90/425/EEC  concerning  veterinary  and  zootechnical  checks  applicable  in  intra- 
Community  trade  in  certain  live  animals  and  products  (except  for  the  provisions  concerning 
zootechnical controls);  

55  Therefore,  the  refund  could  be  replaced  by  an  exemption  from  the  payment  of  the  fees  only  if  an  amount 
equivalent to the loss of cost recovery is transferred from the general budget to the CA. 
56 Simplification gains described in Annex XXIV. 

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(cid:190)  Directive  89/608/EEC  on  mutual  assistance  between  the  administrative  authorities  of  the 
Member  States  and  cooperation  between  the  latter  and  the  Commission  to  ensure  the  correct 
application  of  legislation  on  veterinary  and  zootechnical  matters  (except  for  the  provisions 
concerning zootechnical controls); 

(cid:190)  Directive 96/93/EC on the certification of animals and animal products; 
(cid:190)  Directive  96/23/EC  on  measures  to  monitor  certain  substances  and  residues  thereof  in  live 

animals and animal products; 

(cid:190)  Directive 97/78/EC laying down the principles governing the organisation of veterinary checks 

on products entering the Community from third countries; 

(cid:190)  Directive  91/496/EEC  laying  down  the  principles  governing  the  organization  of  veterinary 

checks on animals entering the Community from third countries. 

The  legislative  framework  for  the  financing  of  official  controls  will  become  simpler  at  EU 
level, as only cost based fees will be permitted as opposed to the current system which allows 
the  possibility  of  choosing  between  actual  costs  and  standard  fees  (see  Table  5  of  Annex 
XVII, which summarises data in the baseline scenario to illustrate the variety and combination 
of calculation methods employed across the MSs). Moreover by clarifying the list of activities 
for  which  fees  are  mandatory  and  the  cost  elements  to  factor  in  to  calculations  for  each 
control  activity,  it  is  envisaged  that  implementation  of  EU  provisions  will  become  more 
uniform and transparent.57 

Sustainability - Requiring MS to fully recover the costs of controls when mandatory fees are 
used  would  mobilise  a  steadier  flux  of  financial  resources  collected  through  such  fees,  thus 
reducing the pressure on national budgets. 

In the majority of MS, control costs are only partly recovered through fees, the recovery rate 
ranging from 20% to more than 80%, and 8 MS recovering all costs. Thus, introducing full 
cost  recovery  would  see  in  some  cases  an  additional  part  of  the  costs  of  controls  being 
transferred to, and distributed amongst, agri-food chain operators. The increase in the level of 
mandatory fees would vary depending on the current recovery rate (see Figure 4 below).  

Figure 4   Potential impact of requiring MS to achieve full cost recovery on controls for which fees are          
                 currently applied58 

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*The precise recovery rate is unknown.**Data about cost recovery rates in Finland is contradictory.  The DG SANCO baseline states that it 
is  20  per  cent,  a  previous  evaluation  (FCEC  2008)  found  that  it  was  99  per  cent  (for  large  FBOs)  and  an  independent  academic  study 
(Lepostö et al. 2010) found that it is 38 per cent for municipal control authorities.  The 2011 study has concluded that cost recovery rates are 
likely to be high for large FBOs (of which there are few) and low for small FBOs (of which there are many).   

57 Obviously in those areas in which no mandatory fees are required, variations, which are not accounted for by 
cost differences, will remain. 
58 The data used to construct this table is highly uncertain. It is intended to provide an indicative assessment of 
the distributional impact of requiring full cost recovery based on current rates of recovery.  Actual impacts will 
be influenced by a range of factors in addition to current cost recovery rates. 

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Such level is expected not to represent a substantial additional burden for operators, even in 
those  sectors  where  the  cost  of  controls  impacts  most  on  the  operators’  overall  production 
costs,  which  is  meat  inspection  (see  box  6  for  some  illustrative  simulations).59  Using  the 
figures in box 6, we can estimate that, depending on the percentage of recovery of costs by 
Member  States,  additional  fees  corresponding  to  approximately  0.2%  -  0.8%  of  the  annual 
production  value  of  a  typical  operator  would  be  charged.  In  return,  this  would  guarantee 
approximately €0.9bn – 3.4bn of new funds/year for official controls across the MS.60 

Box 6: Economic impact of full cost recovery (meat inspection) – examples from the MS 

The  examples  below  refer  to  mandatory  fees  charged  for  meat  inspection  in  3  MS  which  apply 
cost based fees (as opposed to the standard EU fee). Meat inspection is the area of the agri-food 
chain where controls are most frequent and intensive (a regular and continuous presence of official 
inspectors is required in business operator's premises during operations). Thus the impact of fees on 
production costs is significantly higher in this field than in others. 

In Belgium, meat inspections are funded via a mandatory fee ("retribution") calculated on the basis 
of a half hourly rate of €23.13  and applied following specific criteria, such as the throughput of 
individual  establishments61  (volume  and  category  of  animals).  According  to  available  data, 
retributions allow Belgium to recover approximately 37% of the total costs they incur in organising 
official controls62.  
This  allows  one  to  postulate  the  level  of  fees  in  a  full  cost  recovery  scenario.  Charges63  on 
slaughterhouses  with  a  single  slaughter  line  for  adult  bovines  currently  vary  from  approximately 
€15.8/animal,  where  hourly  throughput  does  not  exceed  4  bovine  units,  to  approximately 
€5.2/animal,  where  throughput  exceeds  50  units  per  hour.  Assuming  that  such  charges  represent 
37%  of  the  actual  cost  of  controlling  the  slaughter  line  in  each  case64,  full-cost  fees  would  vary 
between  a  maximum  of  approximately  €42.7/animal  (slow  throughput)  to  a  minimum  of 
approximately  €14.05/animal,  for  operators  with  a  fast  throughput.  In  a  representative  average 
case  ("vache  de  reforme")  with  the  price  of  a  bovine  carcass  at  approximately  €1,580  (at 
slaughterhouse, i.e. before any further processing and net of any further profit margin)65, charging 
slaughterhouses  a  full  cost  fee  would  represent  between  0.89%  (fastest  lines)  and  2.7% 

59 In certain MS the level of cost recovery for mandatory fees is unknown and may amount to 0%.  Such MS are 
not  compliant  with  existing  EU  legislation  which  requires  recovery  on  the  basis  of  actual  costs  or 
minimum/standard  fees.   While  these MS  will  inevitably  face  a  greater  burden  if  Option  2  is  adopted  and  the 
principle  of  full  cost  recovery  is  reinforced,  part  of  that  additional  cost  is  the  result  of  bringing  the  national 
practice into line with existing rules, and not the consequence of the option being considered here. 
60  Sector  production  value  €400bn/year.  No  of  enterprises  60,000  (Eurostat  2008).  Average  annual  inspection 
charge per operator at full cost recover approximately €80,000/year (Industry data). 
61 See Article 3(1) Arrête Royal du 10 Novembre 2005 relatif aux rétributions visées à l'article 5 de la loi du 9 
Décembre 2004 portant financement de l'Agence fédérale pour la Sécurité de la Chaine alimentaire. 
62 See SANCO validated baseline, Annex XVI. 
63 See Arrête Royal du 10 Novembre 2005 relatif aux rétributions, cited above. 
64 It should be noted that Option 2 does not prescribe how Member States should achieve full cost recovery. The 
latter are therefore free to choose the type and manner of cost recovery, which does not necessarily imply it will 
be spread evenly across all fees. 
65 In other words, this figure does not include further processing costs (e.g. cutting, de-boning, packaging, etc.), 
nor profit margins down the processing and distribution line. Taking such elements into account would result in 
a significant increase of the total value of meat per kilogram (at least 25% on average).  
66  Such  percentages  would  be  even  lower  if  compared  to  the  final  value  of  the  carcass  noted  in  the  footnote 
above. 
67 See SANCO validated baseline, Annex XVI. 
68 http://www.food.gov.uk/foodindustry/meat/mhservice/chargesguide. 

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(slowest) of the total value of the carcass.66 
The UK presently recovers 43% of mandatory fees67. Official controls at approved meat premises 
are currently charged on a time-basis.  The presence of an auxiliary during normal working hours is 
charged  at  £29.20  (approximately  €35)  per  hour   and  the  presence  of  an  official  veterinarian  is 
charged at £37.60 (approximately €45.50)  per hour68. Achieving full cost recovery would increase 
these rates to approximately £68 (€82) and £87 (€105) respectively.  

Data  submitted  by  the  UK  Food  Standards  Agency  suggests  that  the  overall  cost  of  delivering 
official  controls  is  €65.77m  per  year.  Full  cost  recovery  would  thus  shift  a  further  €37.49m  on 
industry  per  year.  This  additional  cost  represents  0.5%  of  the  total  value  of  the  UK  meat 
industry which is thought to be worth €7.65bn per year. 

Unlike BE and UK, Italy claims to fully recover the costs of meat inspection from fees. An hourly 
rate of €50/hour  has been used to determine minimum fees for certain operators, depending on the 
throughput  of  their  establishments.  Fees  vary  from  €5/animal   in  slaughterhouses  with  a  yearly 
throughput  of  10,000  units  to  €3/animal   in  faster  lines  (more  than  70,000  units/year).  Although 
such  fees  represent  minimum  levels  and  may  therefore  fluctuate,  the  fact  that  Italian  authorities 
claim to fully recover costs would suggest that a move to Option 2 is unlikely to have significant 
effects on business operators in Italy. 

Reduction of administrative burden - Information obligations in the area of official controls of 
residues  of  veterinary  medicinal  products  (see  Annex  XXII)  and  the  corresponding 
administrative burden will be eliminated.  

Current  rules  require  MSs  to  publish  and  communicate  to  the  Commission  fees'  calculation 
methods. Strengthening such a requirement by requesting more details on cost elements and 
calculation  assumptions  is  not  expected  to  create  substantial  additional  costs.  Analysis  has 
shown  that  once  the  move  to  full  cost  recovery  has  been  made,  reporting  information 
regarding  fees  to  the  Commission  and  the  public  is  likely  to  require  little  additional 
administrative  cost  for  most  MS,  particularly  where  such  information  is  already  provided 
through CA websites (See Figure 5 below). 

Figure 5: Transparency and reporting to the public on fees for official controls by EU Member State 

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transparency 

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transparency 

No information available / 
identified 

With  regards  to  the  requirement  within  Option  2  to  calculate  all  fees  (including  those  for 
which a standard EU fee is established by the Regulation) on the basis of costs it is expected 
that  no  substantial  additional  administrative  burdens  will  fall  upon  MS  which  already 
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calculate fees in such a manner. Additional efforts will be necessary in those MS which do not 
currently  establish  fees  on  the  basis  of  costs  incurred  as  changes  to  their  administrative 
structures  may  be  required  so  as  to  ensure  that  costs  are  reflected  in  fees  and  to 
implement/monitor  cost  recovery.  Additional  costs  are  expected  to  be  affordable  by  public 
budgets (see box 7 below for estimations provided by 2 MS). Option 2 takes account of this 
adjustment  by  giving  MS  2  years  to  ready  their  administrative  systems  to  the  new 
costing/charging model. 

Box 7 – Examples of the costs of establishing a fees regime based on actual costs for the UK and Finland 

The  UK  Food  Standards  Agency  (FSA)  has  estimated  that  collating  information  on  total 
control  resources  in  a  centralised  manner  (i.e.  for  the  country  as  a  whole)  would  require 
two days of a middle manager's time and three days of a junior manager's time.  Therefore 
the cost of reporting on the financial resources devoted to official controls would be around 
€1655  per  annum69.  Given  the  decentralised  nature  of  the  UK,  the  FSA  calculated  that  a 
more detailed reporting requirement providing figures for total resources at a sub-national 
level would require an additional 6 working days by an analyst, at a cost of €1815. 

A move to a system requiring the collection of precise data on costs, based on actual time 
spent on each operator, would have a more significant financial impact on MS. The Finnish 
Food  Safety  Authority  (EVIRA)  has  estimated  that  setting  up  such  a  system  in  Finland 
(where the operation of controls is decentralised) would cost approximately €500,000 for 
appropriate IT tools. Such an expense would be a "one off" and ongoing costs would result 
from  the  need  to  maintain  4  full  time  equivalent  staff  (FTE)70  to  collect  and  submit 
information about the resources used by CAs in the execution of official control activities.  

The possibility for Member States to refund fees to micro-enterprises is also likely to result in 
increased administrative burdens in those MS which would chose to use it. Setting up a refund 
system  implies  the  need  to  determine  the  eligibility  criteria,  to  collect  fees  from  micro-
enterprises and to re-imburse them on the basis of the aforementioned criteria. Although there 
is  currently  no  data  available,  such  a  system  would  add  to  the  costs  resulting  from  the 
management  of  a  costing/charging  system  applicable  to  all  operators  (with  no  refunds  or 
exemptions fro certain categories). 

A refund system would also be more complex and more costly than the direct exemption of 
micro-enterprises from the payment of fees, as it adds the costs of the refund mechanism to 
the basic costs of managing the aid scheme. Nonetheless, a refund system allows for full cost 
recovery  and  ensures  that  competent  authorities  have  sufficient  resources  to  guarantee  the 
effective  organisation  of  official  controls  (as  opposed  to  the  exemption  mechanisms,  which 
would deprive the CA from the fees revenue, unless appropriate compensation is granted).  

Accountability  -  Option  2  would  contribute  to  increasing  the  accountability  of  control 
activities  in  light  of  the  effect  of  the  stronger  and  certain  link  between  costs  and  fees.  This 
would be underpinned by the increased transparency of the mechanisms through which fees 
are calculated as operators would be able to see clearly what they are being charged for and 
how  these  charges  are  derived  in  light  of  costs  to  CAs.    This  improved  clarity  would  be  a 

69 This calculation is carried out on the basis of hourly rates applicable to middle and junior managers in the UK. 
See http://www.statistics.gov.uk/statbase/product.asp?vlnk=13101. 
70 Costs of an FTE within a particular MS will depend on the applicable salary levels. See Table 6, Annex XVII 
for a breakdown of hourly salary rates for the food safety agencies of several MS. 

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driver for improved efficiency of official control systems and also allow better supervision of 
implementation by the Commission. 

Furthermore,  increased  transparency  would  contribute  to  the  objective  of  ensuring  that  fees 
revenues  are  not  unduly  distracted  from  their  intended  use  (compensate  control  costs).  The 
option of requiring the establishment of a specific ring-fencing mechanism to ensure that fee 
revenues  are  recycled  back  in  to  the  CAs'  budget  would  require  legislative  changes  in  a 
number  of  MS  and  could  be  difficult  to  implement.  The  same  result,  however,  could  be 
obtained  by  ensuring  a  clear  definition  of  eligible  costs,  transparency  of  full  cost  recovery 
requirements and thus the accountability of the fees system as a whole, which would enable 
the public and operators in particular to appreciate how costs are identified and charged and 
how fees are calculated and used. During the consultation, a number of MS (IT, DE, NL, FR 
and UK) noted that a fees system that has a clear definition of eligible costs, transparency of 
reporting  and  full  cost  recovery  requirements,  would  effectively  operate  as  a  ring-fencing 
mechanism without a formal requirement to do so. 

Safety  –  Increased  efficiency  of  the  risk  based  use  of  resources  would  ensure  a  better 
enforcement of agri-food chain rules covered by the Regulation (food and feed law, including 
rules on residues of veterinary medicines71, FCM and GMOs, and animal health and welfare 
rules) and thus a higher level of protection of the safety of the agri-food chain. 

A  stable  mobilisation  of  resources  coupled  with  the  other  elements  mentioned  above  (e.g. 
accountability,  bonus  malus  etc.)  allows  progress  towards  the  primary  objective  of 
maintaining efficient controls and ensuring the continued safety of the agri-food chain. 

Summary of the key impacts under Option 2 

Criteria 

Competitiveness  

Innovation 

Sustainability 

Simplification  

Administrative Burden  

Accountability  

Safety 

Impacts 

+ 

+ 

+ + 

+ 

+ 

+ 

+ 

Option 3 – Streamline + Integrate 

As in 2; plus, a fully integrated system of controls along the agri-food chain would maximise 
efficiency of enforcement through simplification and synergy gains, facilitating the fulfilment 
of the objectives of agri-food chain legislation. 

In addition to the impacts highlighted for Option 2, the following impacts would be produced 
by expanding the scope of the Regulation to the plant health, PRM and ABP sectors.  

Competitiveness  -  As  a  consequence  of  including  the  new  areas  under  the  scope  of  the 
Regulation, MS CAs would be able to carry out the risk prioritisation taking into account all 
agri-food  chain  sectors,  better  allocate  control  resources  and  increase  the  efficiency  of  the 

71 See Section 5 of Annex XX. 

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control system as a whole. In turn, economic operators would benefit from a more focused, 
and fully risk based system of controls.  

Simplification - Option 3 would ensure a harmonised approach to official controls along the 
entire  agri-food  chain,  while  taking  into  account  the  specificities  of  every  sector  where 
necessary.  The  overall  system  would  become  more  consistent  and  reliable  as  the  same 
mechanisms and tasks would be being used by all sectors72.  

Box 8: Simplification gains under option 3 

Acts or provisions to be repealed under option 3 
(cid:190)  Acts referred to in Box 6. 
(cid:190)  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 
Community (official controls provisions to be replaced by revised Regulation 882/2004; other 
provisions to be replaced by the new Plant Health Law); 

(cid:190)  12  Council  Directives  on  the  marketing  of  plant  reproductive  material  (official  controls 
provisions to be replaced by revised Regulation 882/2004; other provisions to be replaced by 
the new plant reproductive legislation); 

(cid:190)  Regulation  (EC)  No  1069/2009  laying  down  health  rules  as  regards  animal  by-products  and 
derived products not intended for human consumption (only official controls provisions to be 
repealed by revised Regulation 882/2004). 

Safety  –  A  fully  integrated  system  of  controls  along  the  agri-food  chain  would  maximise 
efficiency  of  enforcement  through  simplification  and  synergy  gains,  thus  allowing  optimal 
fulfilment of the objectives of the agri-food chain.  

As  regards  official  laboratories,  Option  3  would  imply  a  new  obligation  for  laboratories 
carrying out plant health tests to be accredited. This would generate additional costs (for the 
initial accreditation and for the annual audits): the costs for the initial accreditation would be 
borne by the EU, the annual audits costs would be for the laboratories themselves73. A tailor-
made  simplified  set  of  requirements  and  a  transitional  period  of  5  years  are  foreseen  to 
facilitate the smooth introduction of such an obligation. Option 3 also foresees the possibility 
to  create  a  network  of  reference  laboratories  to  improve  methods  and  protocols  used.  This 
would ensure the soundness and reliability of laboratory results and would improve safety. 

Summary of the key impacts under Option 3 

Criteria 

Competitiveness  

Innovation 

Sustainability 

Simplification  

Administrative Burden  

Accountability  

Safety 

Impacts 

+ + 

+ 

+ + 

+ + 

+ 

+ + 

+ + 

Option 4 – Streamline + Integrate + Broader cost recovery 

72 Simplification gains described in Annex XXIV. 
73  For  a  quantification  of  these  costs  see  Annex  XIX;  these  data  are  also  included  in  table  4  (section  6.2.) 
providing an overview of the costs and benefits associated to each option. 

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As in 3; plus, by broadening the collection of mandatory fees to key activities of the agri-food 
chain,  this  option  would  improve  the  sustainability  of  the  control  system  as  a  whole  and 
reduce  its  overall  dependency  on  budgetary  decisions.  It  also  ensures  a  more  equitable 
approach  to  inspection  fees,  by  eliminating  the  perceived  unfairness  of  the  current  system, 
which only requires certain categories of operators to be charged. 

In addition to each of the changes identified under Option 3, operators who are registered in 
accordance with Regulation (EC) No 852/2004 and/or Regulation (EC) No 183/2005 would 
be charged fees for official control activities.  

All of the benefits applicable to Option 3 also apply to Option 4.  Moreover, by expanding the 
scope of the list of mandatory fees, this option also addresses other issues, giving rise to the 
further effects detailed below. 

Sustainability  -  Option  4,  as  compared  to  Option  3,  would  improve  mobilisation  of  CA 
resources  for  official  controls  as  a  stable  flux  of  resources  would  be  available  not  only  for 
controls on operators for which mandatory fees apply under the current regime, but also for 
other  controls  carried  out  on  operators  registered  in  accordance  with  Regulations  (EC)  No 
852/2004 and Regulation (EC) No 183/2005.   

The economic impact on each MS and on operators would depend on whether (and to what 
extent) MS charge sectors which are not subject to mandatory fees but which would become 
so  under  Option  4.  For  those  MS  that  already  collect  such  fees,  effects  are  likely  to  be 
minimal for CAs and business operators alike. On the contrary, effects are likely to be more 
significant  in  those  MS  which  do  not.  Box  9  illustrates  the  potential  impact  on  business 
operators  of  the  extension  of  mandatory  fees.74.  Data  available  from  MS  currently  charging 
such fees shows that when these are levied upon all operators subject to controls (irrespective 
of  whether  an  inspection  is  actually  carried  out  during  a  reference  period)  the  amounts  are 
modulated  according  to  the  size  or  the  throughput  of  the  business  and  represent  a  rather 
negligible  fraction  of  production  costs.  For  instance,  fees  applied  annually  irrespective  of 
whether  an  inspection  is  actually carried  out  during  the  year  may  range  from  small  (€84.5 
for  the  smallest  scale  restaurants  in  Belgium)  to  higher,  yet  still  not  significant,  sums 
(€1,500 for the largest scale industrial bakeries in Italy).  On the other hand, in MS where 
the  actual  cost  of  each  inspection  is  charged,  amounts  vary  in  relation  to  the  hourly  cost  of 
control activities (see box 9 below for examples). Evidence suggests that the increase in costs 
for  those  individual  operators  in  sectors  which  would  be  covered  by  the  extended  scope  of 
mandatory fees is likely to be of little significance for the overall production costs. 

It is impossible to quantify the precise economic impact that the extension of mandatory fees 
would  have  on  business  operators  as  this  is  closely  linked  to,  and  depends  upon,  national 
features  such  as  the  hourly  cost  and/or  intensity  of  controls  (i.e.  frequency,  length,  tools 
employed, training etc.). Nonetheless, some idea as to the scale of the impact that Option 4 
may  have  can  be  deduced  by  analysing  the  charges  applied  by  those  Member  States  which 
already charge non-mandatory fees. In particular, this can give an indication of the charges 
which may result from the expansion of the scope of mandatory fees (assuming that MS 

74 Annex XVII, Tables 7-8 present an analysis of the number of enterprises in each Member State that could be 
affected  by  an  extension  of  the  scope  of  mandatory  fees  to  cover  operators  registered  in  accordance  with 
Regulations  (EC)  No  852/2004  and  No  183/2005.  In  summary,  the  assessment  of  expanding  the  scope  of 
mandatory fees indicates that high impact will be felt in a relatively small number of countries, but where a large 
number of businesses may be affected. In the majority of MS, operators would see moderate impact from this 
extension. See also Annex XI. 

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generally devote similar levels of effort to official controls, guaranteeing equivalent levels of 
efficiency). 

It  is  also  very  important  to  note  that  in  areas  currently  not  covered  by  mandatory  fees  (e.g. 
inspections in restaurants, in establishments producing non animal foodstuffs) official controls 
are not carried out at intensities comparable with that of meat inspection; thus, costs per year 
and  per  operator  are  a  fraction  of  little  significance  of  the  costs  incurred  for  the  latter.  The 
control  frequency  in  those  areas  depends  on  the  risk,  on  the  record  of  compliance  of  the 
operator,  on  the  reliability  of  its  own  checks,  on  indications  of  possible  non  compliance.  It 
varies therefore from one sector and from one category of business to the other. However, for 
illustration purposes a typical example would be the case of a small food retailer, controlled 
on a yearly basis, by 1 inspector who spends 1.5 hours to perform the checks and 1.5 hours of 
desk work to prepare for and to report from it. Such a hypothetical control would cost, if 
charged on the basis of control time used, around €50/year  in Poland and €150/year  in a MS 
using Italy's hourly rate. Inspection visits in a restaurant would have a similar frequency but 
would take on average longer (2-3 hours if arrangements facilitate the visit) and would cost 
between 30-40% more (from €65/year in Poland up to €210/year in Italy).  On a global scale, 
this could guarantee between €2.3bn - €37bn/year of new funds for official controls across the 
Member States.75 

Box 9:  Impact on business operators of the extension of mandatory fees 
As noted above (see Box 3), in Italy Legislative Decree No. 194 of 19 November 200876 calculates 
fees for official controls across the entire food production chain (such fees include those presently 
not mandatory under Regulation 882/2004)77. Calculations are made on the basis of actual costs in 
line with the criteria set out in Annex VI of Regulation 882/200478. Moreover full cost recovery is 

75  Combined  new  fees  for  sectors  currently  subject  to  mandatory  fees  (i.e.  top  up  fees  in  meat  sector  under 
Option  2)  and  those  to  be  charged  for  the  first  time  under  Option  4.  No.  of  enterprises  25m  (Eurostat  2008). 
Typical range of fees charged under Option 4 - €85-€1500 (see Box 6). 
76 See Italian Official Journal No. 289 of 11 December 2008. 
77 Ibid, Annex A. 
78 The hourly charge for official control activities in Italy has been calculated as being €50/hour and this forms 
the  basis  for  all  subsequent  determination  of  fees.  See  Italian  Official  Journal  No.  289  of 11  December  2008, 
Annex C. 
79 See DG SANCO's validated baseline, Annex XVI. 
80  Feed  producers  are  charged  €11,984.70  where  production  is  more  than  200,000  tonnes  per  year.  See  Avis 
relative a l'indexation des montants fixes a l'arrête royal du 10 Novembre 2005 fixant les contributions visees a 
l'article 4 de la loi du 9 decembre 2004 relative au financement de l'Agence Federale pour la securite de la chaine 
alimentaire.  

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ensured . 

Amongst  the  non-mandatory  fees  currently  collected  by  Italy  is  a  yearly  charge  imposed  on 
wholesale bakeries and manufacturers producing oven baked products. Such a charge, which is 
meant    to  cover  official  control  activities,  increases  progressively  in  line  with  operators'  yearly 
production and ranges from €400/year  where production is less than 500 tonnes to a maximum of 
€1,500/year where production exceeds 1,000 tonnes . 

In  Belgium,  non-mandatory  fees  ("contributions")  are  charged  to  all  relevant  operators  at  the 
beginning  of  the  year  and  are  meant  to  cover  routine  inspections  regardless  of  whether  these 
actually  take  place  throughout  the  year.  "Contributions"  appear  to  fully  recover  costs  incurred  by 
Belgium in carrying out official controls in the relevant areas79. Depending upon the size and sector 
of establishments, "contributions" may range from approximately €20 - €12,000.80 Restaurants, for 
example, are charged as little as €87.68 when they employ 0-4 people and up to €1,719.58 when the 
employ 100 or more people. 

In  Germany,  although  charging  practices  vary  across  Länder  an  indicative  hourly  rate  for  certain 
non-animal  health  controls  (i.e.  those  to  which  the  scope  of  mandatory  fees  may  be  extended)  is 
approximately €44/hour plus transport costs81 calculated on an actual-cost basis.  

In Poland, non-mandatory fees for official controls are charged at €13 per control activity with an 
additional €4 per hour for sampling and testing. Such fees include transport costs, document control 
and verification procedures and are claimed to represent full cost recovery.82  

Competitiveness - Option 4  addresses  the  perceived unfairness of the  current  system,  which 
only  requires  certain  categories  of  operators  to  participate  in  the  financing  of  controls,  by 
ensuring  that  mandatory  fees  are  applicable  to  a  wider  array  of  operators  within  the  food 
production chain. 

Administrative  burden  -  As  with  Option  2,  Option  4  would  result  in  limited  additional 
administrative  burdens  for  CAs  to  record  the  cost  of  controls  and  calculating,  setting,  and 
collecting fees. The scale of such costs is likely to be comparable to those to be expected from 
Option 2, only marginally increased by the broader scope of the calculations. A transitional 
period of 3 years would be provided to MS to organise the new costing/charging system with 
the expanded scope. Such costs would in any event decrease over time and, eventually, only 
the  costs  of  collecting  fees  would  remain.  The  latter  would  also  gradually  decrease  as  fee 
collecting mechanisms become more streamlined and effective.  

Summary of key impacts under Option 4 

Criteria 

Competitiveness  

Innovation 

Sustainability 

Simplification  

Administrative Burden  

Accountability  

Safety 

Impacts 

+ + + 

+ 

+ + + 

+ + 

+ 

+ + 

+ +  

81 See Annex XVI. 
82 Ibid. 

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Section 6: Comparing the options 

6.1. Comparing the options in light of the objectives  

Table 3: Options compared against the objectives 

General objectives 

Option 1A 

Option 1B  Option 2 

Option 3 

Option 4 

Contribute to promote the 
smooth functioning of the 
internal market 

(--) Divergences 
among MS likely to 
increase and affect 
competition  

(0) 

(0) 

(+) Distortions due to divergent 
practices (fees) are eliminated 
(where mandatory fees apply 
currently) 

(+) More risk-based controls 
would increase the efficiency 
and capability to respond to 
risks  

(++) As in 2, plus 
streamlined rules on 
official controls 
would apply across 
all agri-food chain 
areas 
(++) Efficiency of 
controls is 
maximised and risks 
of suboptimal 
protection reduced 

(+++) As in 3, plus 
distortions linked to 
fees are eliminated 
also in the new areas 
covered by 
mandatory fees 
(++) As in 3 

(-) Possible 
reduction of controls 
and of ability to 
respond to risks 

(0) 

(-) Possible 
suboptimal 
enforcement of law 
if resources decrease 

(+) Clearer list of activities to 
be charged and list of costs; 
only cost based fees  

(++) Same 
requirements and 
tasks across all agri-
food chain sectors  

(++) As in 3 

Specific objectives 

Option 1A 

Option 1B 

Option 2 

(0) 

(0) 

(+) Consistent use of risk based 
principle  

(0) 

(0) 

(+) Full risk based approach  

Option 3 

(++) Same tasks & 
mechanisms used by 
all sectors  

Option 4 

(++) As in 3 

(++) As in 3 

(++) The inclusion 
of all agri-food chain 
areas in would allow 
cross-sectors risk 
prioritisation 

(0) Removes AB 
linked to EU fee 
rules, but MS would 
administer their own 
regimes 
(0) 

(0) 

(0) 

(-) Sufficient 
funding would 
depend on budgetary 
choices –failure to 
ensure cost recovery 
likely to worsen in 
times of crisis  

(- -) 
insufficient 
funds, as no 
fees charged 
on  micro-
enterprises 

(+) Redundant plans & reports 
eliminated  

(+) As in 2 

(+) As in 2 

(+) Rules on admin. 
cooperation can be adopted, 
synergies developed (IAS) 

(++) As cost would be 
recovered through fees, 
dependency from and pressure 
on national budgets decreases 

(++) Synergies 
possible also with 
plant health, PRM 
sectors  

(++) As in 2 

(++) As in 3 

(+++) As in 2, on a 
broader scale 

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  EN 

Maintain a high level of 
human, animal and plant 
health protection and 
animal welfare and 
prevent that this is 
undermined by potential 
non-implmentation  of 
EU legislation
Ensure proper and 
uniform implementation 
of EU legislation 

Ensure a comprehensive 
and consistent approach 
to official controls along 
the agri-food chain 

Allow for a more efficient 
use of national control 
resources 

Reduce administrative 
burden and remove 
uneccesary requirements 

Foster closer cooperation 
between MS to improve 
official control delivery 

Ensure the availability of 
adequate resources 

EN 

 
 
 
 
 
Ensure equity and 
fairness in the financing 
of official controls 

(-) No level playing 
field guaranteed as 
approaches to fee 
likely to vary  

(-) No level 
playing field 
as micro-
enterprises 
advantaged  

(+) All operators charged with 
mandatory fees would pay the 
actual cost of controls 

(+) As in 2 

(++) As in 2, plus 
all operators 
benefiting most 
from controls would 
all be charged 

Improve transparency, 
including of the system of 
financing official controls 

(0) 

(++) 'High transparency' 
requirements can be detailed; 
transparency of fee mechanism 
would increase  

(++) As in 2  

(++) As in 2 

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6.2. Costs-benefits analysis  
Table 4: Policy Options - Significant Costs / Benefits 

Option 1.A 
deregulate fees 

Option 1.B exempt 
micro-entreprises 

Option 2. Streamline 

Option 3. Streamline + integrate83 

Option 4. Streamline + integrate + broader cost 
recovery 

Cost 

Action 

€ 

Action 

Will depend on choices made by each MS on 
whether to charge or not for official controls 
(1A)  and  on  whether  to  recover  costs  of 
controls  on  micro-enterprises  from  other 
businesses  and % of the latter (1B) 

and 
Estalishing 
reporting 
operating 
regime  for  calculation 
and charging of fees 

€ 
€0.5m one off  + €2000/year 
(per MS). €13.5m one off + 
 €54,000/year 
MS)84 

(across 

EU 

Action 
Same  (as  Option  2  + 
Plant  Health  and  Plant 
Reproductive 
Materials) 

€ 
Same  

Action 

Same as Options 
2&3 

€ 

Same  

Member  
State CA 

Benefit 

charged 

Stable  funding  in  areas 
already 
i.e. 
meat  sector 
(top  up 
from  the  %  of  costs 
already 
to 
reach full cost recovery) 

charged 

Depends  on  %  recovery  of 
costs by MS. 
Approx.  €0.9bn  –3.4bn  new 
funds  per  year  across  EU 
MS85,86 

Same  

Same  

Full  cost  recovery  for 
all  OC  on  registered 
operators + 'top-up' as 
per Option 2 

Approx.  total  of  new 
fees €2.3bn –37bn/year  
across EU MS87 
+ €0.9 – 3.4bn per year 

Cost 

Will depend on choices made by each MS on 
whether to charge or not for official controls 
(1A)  and  on  whether  to  recover  costs  of 
controls  on  micro-enterprises  from  other 

Top  up  to  existing  fees 
(meat  sector)  to  reach 
full cost recovery 

Depends  on  %  recovery  of 
costs by MS. 
Approx.  €0.9bn  –3.4bn  new 
fees  (across  EU  MS)  (approx 

Same  (as  Option  2  + 
Plant  Health  and  Plant 
Reproductive 
Materials) 

Same  

costs 

for 
New 
currently 
operators 
not 
(non 
charged 
meat  sector)  +  'top-

Approx.  total  of  new 
charges 
–
37bn/year  across  EU 
MS89  +  €0.9  –  3.4bn  per 

€2.3bn 

Business 
Oper. 

83 For Option 3, costs/benefits would relate to inclusion of plant health, PRM and ABP into the scope, impacts of which have been assessed within the relevant Impact Assessments for 
these sectors and which are not included here. 
84 Based on FI / UK data. See Box 6. 
85 Sector production value €400bn/year (DG Enterprise). No. of enterprises 60,000 (Eurostat 2008). Average annual inspection charge per operator at full cost recovery approximately 
€80,000/year (Annex XI). 
86 , The majority of operators, in individual MS, are currently being charged between 30% and 80% of inspection charges, with some paying 100% (see figure 4) 
87 New fees for those sectors to be charged for the first time under option 4. Average cost to operators not currently subject to fees - €85 – 1500/yr (See Box 6). No. of operators who 
are not currently subject to fees – 25m (Eurosat 2008). 

EN 

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businesses and % of the latter (1B) 

Benefit 

Risk based approach to 
vet. med. controls 

0.2 – 0.8% of annual product. 
value in the meat sector88) 
EU-wide saving of €12.4m – 
98.5m/year (covered by fee) 

Same  

Same  

Same as Options 2&3 

Same 

up' as per Option 2 

year 

88 Based on UK industry estimates (see Box 6) 
89 See footnotes 85-87 above 

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6.3. Preferred option  

In light of the assessment above, it is considered that Option 4 (i.e. the legislative framework 
is improved and streamlined, plant health and PRM are included in its scope, and mandatory 
fees are extended to cover key areas of the agri-food chain) provides the best way to achieve 
the objectives. It offers the best approach to simplification, clarity, coherence and reduction of 
administrative burden without losing the capacity of the legislative framework to account for 
the specificities of every concerned sector.  

Insofar  as  the  financing  of  official  controls  is  concerned,  Option  4  preserves  the  long  term 
sustainability of national control systems90. The conclusion of this IA is that the rationale for 
the current system is still valid, i.e. agri-food chain business operators should bear the costs 
incurred by competent authorities when performing official controls. While they are primarily 
responsibile for preventing that unsafe products enter the agri-food chain, the system of own 
controls that they are required to establish could not deliver fully if it was not complemented 
by  a  dedicated,  complex  and  costly  system  of  official  controls  maintained  by  each  MS, 
requiring from CAs an effort which goes beyond "normal" market surveillance duties.  

In this respect, CAs assessment of the changes proposed through option 4 is overall positive 
as improvements to the control system as a whole are expected to result from the extension of 
the range of mandatory fees and from the full cost recovery rule. Industry stakeholders worry 
about  costs  of  such  changes,  while  recognising the  positive  impact  to  be  expected  from  the 
increased  transparency  and  comparability  of  systems  across  the  EU,  and  stress  the  need  to 
eliminate the unfairness of the current system of charging only some sectors for control costs.  

As  to  such  costs,  while  the  move  to  full  cost  recovery  without  expanding  the  scope  of 
mandatory  fees  (Option  2)  would  impact  essentially  on  the  sectors  already  charged  (meat 
inspection in particular), generating between €0.9bn and  €3.4bn  new revenue for CAs, with 
an impact on individual operators which remains marginal when rapported to their turnover, 
the  proposed  option  of  also  expanding  the  scope  of  mandatory  fees  to  cover  all  the  sectors 
which "use" most intensely the official control capacity of national CAs would impact on all 
such  sectors  and  generate  yearly  an  extra  revenue  estimated  to  be  beteween  €2.3bn  and 
several  times  this  figure  (up  to  €37bn/year  in  the  hypothetical  case  of  all  operators  being 
charged at rates currently applied to the largest food businesses, i.e. around €1.500).  

Furthermore, Option 4 ensures the most effective achievement of the objective of providing 
an improved legal framework for official controls across all sectors of the agri-food chain.  

Options 2 and 3 achieve the set objectives partly, only in the areas specifically covered by 
each of them, thus failing to cover the whole agri-food chain in an integrated approach, and to 
promote  synergies  and  cost  savings.  They  also  fail  to  address  the  unfairness  and 
discriminatory character of the current financing system and the resulting lack of legitimacy. 

As  to  Options  1A  and  1B,  they  cannot  ensure  the  sustainability  of  the  system  of  official 
controls due to their potential consequences on the availability of sufficient resources for the 
performance of such controls. 

The cost/benefit comparison of the different options must take into account quantifiable and 
non quantifiable elements (an approximation of the former being included in Table 4 above). 

90 This is in line with the conclusions of the abovementioned impact assessment reports on plant health and plant 
reproductive material where full cost recovery is also foreseen. 

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In  terms  of  costs,  options  2  to  4  all  imply  additional  costs  for  the  setting  up  of  a  full  cost 
recovery  system  in  those  MS  which  do  not  have  one  (one-off  cost  for  the  setting  up  of  the 
system and subsequent operating costs). The estimates available suggest that such costs will 
be  affordable  and  that  they  will  decrease  with  time  as  the  system  stabilises  and  staff  and 
organisations  familiarize  themselves  with  it.  These  options  also  alleviate  the  competent 
authority  from  the  burden  of  some  non  risk-based  controls  (and  operators  from  the 
corresponding fees). 

When it comes to the impact on operators, Option 4 ensures that costs are spread in a more 
equitable  manner  across  all  operators  which  are  responsible  for  the  safety  of  the  agri-food 
chain.  This  is  expected  to  result  in  a  positive  increase  of  the  legitimacy  of  the  financing 
system.  

Also  a  net  benefit  of  Option  4  is  the  increased  accountability  of  competent  authorities 
towards  the  operators  they  control  and  charge,  which  is  the  result,  on  the  one  hand,  of  the 
direct link between costs and charges and, on the other hand, of the increased transparency of 
the  financing  system,  which  gives  operators  direct  access  to  the  details  of  the  costing 
mechanisms. Operators will thus be able to see and scrutinise how the cost of controls (and 
the fees) are established, and thus – albeit indirectly – the efficient use of fees revenue. 

Indeed, the improved transparency of the system is instrumental in ensuring that the increased 
financial security of CAs corresponds to an increased accountability of the control system as 
such towards business operators and the public in general.  

Section 7: Monitoring and evaluation  

The review of the EU legislative framework applicable to official controls along the agri-food 
chain aims at improving the efficiency and consistency of the system, and ensuring its long 
term sustainability. It is considered that whichever option is taken forward would clarify the 
existing rules and make them easier to apply by MS CAs.  

To assess the success of the measures introduced, the following core progress indicators have 
been identified in line with the operational objectives of the policy action: 

Establish a single and simpler  legislative framework for official controls 

→ Indicator - Number of requests for legal interpretation received by the Commission  

→  Indicator  -  Number  of  pieces  of  EU  level  legislation  applying  to  official  controls  per 
sector/product 

→  Indicator  -  The  reported  change  in  the  declared  average  administrative  burden  on 
industry and MS 

All controls, including border controls, risk based 

→Indicator  –  Surveying  MS  on  whether  resources  freed  by  this  review  are  being  used  to 
perform controls in areas of higher risk 

Increase  the  number  of  cases  where  cross-border  enforcement  cases  are  resolved 
through administrative assistance and cooperation 

→ Indicator - Number of contacts through administrative cooperation contact points foreseen 
by Article 35 of the Regulation 

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→ Indicator - Number of complaints from economic operators pointing to MS having failed 
to coordinate investigations in case of cross border non-compliances  
Increase  the  number  of  formalised  instruments  between  the  CAs  and  customs 
authorities for the performance of official controls 
→  Indicator  -  Number  of  service  level  agreements  formalised  between  CAs  and  other 
authorities including customs 

Reduce occurrence of unsatisfactory enforcement results in FVO reports attributed to 
resources shortages 

→ Indicator – Trends in the number of FVO reports which point to a lack of resources in MS. 

The monitoring  of  the correct implementation of the  legislation on  official controls along 
the agri-food chain is ensured by the audits carried out by the FVO on the functioning of 
national systems of controls. This will provide the Commission on a regular basis with data 
and information about the indicators listed above and more generally about the fulfilment 
by MS of the objectives pursued by the legislation.  

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Annex I: Glossary  

EU: European Union 

FVO: Food and Veterinary Office 

MS: Member States 

CA: Competent authority 

EURLs: EU Reference Laboratories 

NRLs: National Reference Laboratories 

MANCP: Multi Annual National Control Plan 

CVO: Chief veterinary offices 

FCM: Food Contact Material 

PH: Plant Health 

AH: Animal Health 

AW: Animal Welfare 

PRM: Plant Reproductive Material 

ABP: Animal by-products 

FCM: Food contact material 

TRACES: TRAde Control and Expert System 

BIP: Border inspection post 

DPE: Designated point of entry 

SCFCAH: Standing Committee on the Food Chain and Animal Health  

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Annex II: Overview of the legislative framework applicable to 
official controls along the food chain 

1. Official controls to enforce feed and food law, animal health and welfare rules 

The EU system of official controls consists of a general framework established by Regulation 
882/2004  of  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  rules  and  of  a  complex  constellation  of  sectoral  acts  laying  down  official 
controls  provisions  (for  the  implementation  of  feed  and  food  law,  animal  health  and 
welfare rules). This is due to the fact that when Regulation 882/2004 was adopted a plethora 
of pre-existing acts (characterised by a sectoral approach) were kept in force.  

Regulation 882/2004 also provides for a set of rules aimed at ensuring that CAs tasked with 
control  duties  are  appropriately  resourced,  including  through  the  levying  of  inspection  fees 
from business subject to official controls. 

1.1. Regulation 882/2004 on official controls 

Regulation 882/2004 was adopted to complement a wider initiative of modernisation, recast 
and simplification of EU legislation in the areas of food and feed safety, animal health, animal 
welfare  and  in  part,  plant  health,  carried  out  between  2000  and  2004,  with  a  coherent  legal 
framework  for  official  control  activities  in  those  areas,  to  ensure  the  smooth  functioning  of 
the  Single  Market  through  the  effective  implementation  of  food  and  feed  standards  and  of 
public, animal and (only partially) plant health rules. This new legal framework has been in 
application since 1st January 2006. 

The  Regulation  applies  to  control  activities  performed  to  ensure  the  verification  of 
compliance  with  feed  and  food  law,  animal  health  and  welfare  rules  across  the  EU.  To  a 
limited  extent,  it  also  applies  to  Plant  Health  related  controls,  in  particular  as  far  as  the 
provisions on the multiannual control plans and Union audits are concerned.  

Regulation  882/2004  provides  CAs  in  the  MS  with  a  solid  and  comprehensive  set  of  rules 
which affords them the necessary powers and tools to deliver their enforcement duties in an 
efficient and reliable fashion. In particular, the Regulation includes: 

(cid:131) 

(cid:131) 

(cid:131) 

the  obligation  for  MS  to  designate  the  authorities  responsible  for  the  performance  of 
official controls in the areas covered by the Regulation; 

the  all-important  principle  according  to  which  official  controls  must  be  risk  based,  so 
that the deployment of control/enforcement resources is prioritised on the basis of the risk,  

the obligation to plan official controls through a multiannual programming instrument (the 
multiannual control plan – MANCP) and to report on their implementation and outcomes; 

(cid:131)  provisions intended to ensure that  

o  competent authorities are transparent and fully accountable with regard to the 
performance  of  their  duties  and  the  effectiveness  of  their  work;  the  outcomes  of 
official controls are sound and reliable and remain so also in case of delegation 
to other control bodies; 

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o  competent authorities possess the powers necessary to control compliance with 
the rules and to enforce them, and the powers necessary to supervise and monitor 
situations where risks for the health of humans or animals may arise; 

o  official laboratories perform to the highest standards; 

The Regulation also provides for:  

(cid:131) 

the  general  framework  and  procedures  applicable  to  official  controls  on  feed  and  food 
imported  from  third  countries  into  the  territory  of  the  Union  and  specific  rules  on  the 
establishment  of  increased  controls  at  the  point  of  entry  into  the  Union  for  certain 
products91); and  

(cid:131)  procedures for establishing import conditions (i.e. the requirements that imports into the 
Unions must satisfy in order to ensure that they do not pose a risk to human or animal or 
health) for such commodities and to the extent that those conditions are not provided for 
by other EU law. 

The  Regulation  also  lays  down  the  rules  governing  the  audits  carried  out  by  Commission 
experts  (the  Directorate  F,  Food  and  Veterinary  Office  [FVO]  of  DG  SANCO)  in  Member 
States and third countries to verify the implementation of EU law and the functioning of the 
systems of official controls in MS. 

Finally, a key section of the Regulation is Chapter VI, which provides for a set of rules aimed 
at ensuring that CAs tasked with control duties are appropriately resourced, including through 
the  levying  of  inspection  fees  from  business  subject  to  official  controls.  In  particular,  the 
Regulation provides for: 

(cid:131) 

the general principle according to which MS shall ensure that adequate financial resources 
are  available  for  official  controls  by  whatever  means  considered  appropriate,  including 
through general taxation or by establishing fees or charges; 

(cid:131)  an obligation for MS to use fees (mandatory fees) for financing control activities when it 

comes to certain sectors:  

-  controls  on  slaughter,  cutting  operations  and  cold  storage  of  meat,  production  and 

placing on the market of fishery products, and milk production; 

-  controls carried out to grand feed establishments approval; 

-  controls  carried  out  at a  border  on  consignments of live animals, products of  animal 
origin,  animal  products,  animal  by  products;  certain  food  and  feed  of  non  animal 
origin. 

(cid:131)  a set of standard fees applicable in some cases where mandatory fees are required: where 
standard  fees  exist,  they  offer  the  CAs  a  statutory  fee  in  cases  where  the  MS  has  not 
calculated the costs of the activity in question for the purposes of charging a cost based 
fee; 

(cid:131)  a set of common principles applicable to mandatory and non-mandatory fees among 

which the all-important one according to which fees are meant to cover the costs incurred 
and cannot exceed such costs; 

(cid:131) 

the obligation for MS to make public the method of calculation of fees and communicate 
it to the Commission; 

91 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 (OJ L 194, 25.7.2009, p. 1).  

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(cid:131) 

the obligation for the MS competent authorities to charge the operators for the expenses 
arising from additional official controls carried out when non compliances are detected. 

1.2. Official controls on residues of veterinary medicines in live animals and animal 
products (Directive 96/23/EC) 

Regulation 882/2004 stipulates to keep in place Council Directive 96/23/EC on measures to 
monitor certain substances and residues thereof in live animals and animal products. 

Directive 96/23/EC requires MS to implement national residues monitoring plans which are 
not  included  in  the  MANCP  and  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  mandatory  minimum  number  of  samples  that  shall  be 
analysed for each combination sub-group of substances / animal or animal product according 
to the national production without taking into account other  elements which may impact on 
the risk assessment (e.g. rearing practices, veterinary medicinal products authorised, etc). The 
requirements  for  third  countries  are  essentially  the  same  as  for  MS.  Apart  from  residues  of 
veterinary  medicines,  Annex  I  to  Directive  96/23/EC  also  includes  several  residues  of 
pesticides92  and  several  environmental  contaminants93  among  the  group  of  substances  to  be 
controlled within the framework of the national residues monitoring plans.  

1.3. Official controls on products of animal origin intended for human consumption 
Regulation  (EC)  No  854/200494  of  the  European  Parliament  and  of  the  Council  lays  down 
specific  rules  for  official  controls  on  products  of  animal  origin  intended  for  human 
consumption.  The  Regulation  addresses  specific  aspects  of  official  controls  associated  with 
such products, including meat, live bivalve molluscs, fishery products and milk. In particular, 
the  Regulation  lays  down  specific  rules  on  approval  of  establishments,  specific  official 
control activities in EU establishments and specific rules for controls of products imported to 
the EU. 

1.4. Veterinary border controls  

As mentioned above, Regulation 882/2004 sets out the general framework and the procedures 
applicable to official controls on feed and food imported from third countries into the territory 
of the Union. Moreover, it establishes a legal basis for the introduction of an increased level 

92  Regulation  (EC)  N°396/2005  on  maximum  residue  levels  of  pesticides  in  or  on  food  and  feed  of  plant  and 
animal  origin  and  amending  Council  Directive  91/414/EEC  requires  MS  to  carry  out  official  controls  on 
pesticides residues in accordance with relevant provisions of Regulation (EC) N° 882/2004 and to establish risk 
based multi-annual national control programmes. It requires also the Commission to prepare a coordinated multi-
annual  Union  control  programme  with  a  view  to  assessing  consumer  exposure  and  the  application  of  current 
legislation. 
93  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. Regulation (EEC) 315/93 and Regulation 
(EC)  N°  1881/2006  require  MS  to  carry  out  official  controls    on  contaminants  on  the  basis  of  their  own  risk 
assessment. 
94 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). 

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of official controls at the point of entry of the Union for certain feed and food of non-animal 
origin on the basis of known or emerging risk.  

Specific rules for veterinary border controls on animal origin products and on live animals, , 
are  laid  down  in  Directives  91/496/EEC95  and  97/78/EC96.  These  specify  that  veterinary 
checks have to be carried out in approved border inspection posts (BIPs) which are listed in 
Decision  2009/821/EC97  on  such  consignments  and  how  these  veterinary  checks  need  to  be 
carried  out.  Additional  details  are  laid  down  in  secondary  legislation,  such  as  the  minimum 
requirements  for  BIP  facilities  and  their  technical  equipment,  the  frequency  of  physical 
checks, the list of animals and animal origin products to be checked in BIPs and details for 
checks and follow up on specific consignments, e.g. transit and transhipment. 

1.5. Official controls in the animal health sector 

The  rules  of  Regulation  882/2004  already  apply  to  official  controls  carried  out  to  verify 
compliance  with  the  requirements  of  animal  health  rules.  However  its  wording  in  certain 
cases is more focused on food and feed products and, as a result, not always consistent when 
it comes to its applicability to animal health issues.  

In parallel, two Directives dealing with official controls carried out to verify compliance with 
animal health requirements in intra-Community trade (Directives 89/662/EEC98 and 90/42599) 
have  also  remained  in  force.  Those  rules  are  complemented  by  a  Directive  dealing  with 
official  certification  in  the  veterinary  area100,  and  a  Directive  on  mutual  cooperation  of 
competent authorities and administrative assistance between them101. 

2. Official controls in sectors not (or only partially) covered by Regulation 882/2004 

There are a number of provisions governing the food chain whose enforcement is not (or only 
partially) governed by Regulation 882/2004. 

2.1. Official controls in the animal by-products sector 

Regulation (EC) No 1069/2009 laying down health rules as regards animal by-products and 
derived products not intended for human consumption102 establishes inter alia its own system 

95 Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of 
veterinary  checks  on  animals  entering  the  Community  from  third  countries  and  amending  Directives 
89/662/EEC, 90/425/EEC and 90/675/EEC. 
96 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. 
97  Commission Decision 2009/821/EC of 28 September 2009 drawing up a list of approved border inspection 
posts,  laying  down  certain  rules  on  the  inspections  carried  out  by  Commission  veterinary  experts  and  laying 
down the veterinary units in Traces. 
98 Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra- Community trade 
with a view to the completion of the internal market. 
99 Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in 
intra- Community trade in certain live animals and products with a view to the completion of the internal market. 
100 Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products. 
101  Council  Directive  89/608/EEC  of  21  November  1989  on  mutual  assistance  between  the  administrative 
authorities of the Member States and cooperation between the latter and the Commission to ensure the correct 
application of legislation on veterinary and zootechnical matters 
102  Regulation  (EC)  No  1069/2009  of  the  European  Parliament  and  of  the  Council  of  21 October  2009  laying 
down health rules as regards animal by-products and derived products not intended for human consumption and 
repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1). 

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of official controls, excluding thus the applicability of Regulation 882/2004 except for those 
provisions explicitly recalled thereof.  

2.2 Official controls in the plant health sector plant propagating material sector 

Regulation 882/2004 does not concern, with the exception of some specific Articles (dealing 
with  the  multiannual  controls  plan  and  Union  audits  in  MS  and  third  countries),  official 
controls  in  the  field  of  plant  health.  Official  controls  in  this  area  are  governed  by  Council 
Directive 2000/29/EC103, which rules and measures concerning certification, import and intra-
EU movements of plants and plant products, with regards to eradication and containment of 
outbreaks and in relation to Union co-financing of measures taken.  

In parallel with Regulation 882/2004, it imposes inter alia obligations on the MS to carry out 
controls  to  verify  compliance  with  the  requirements  thereof  and  defines  what  legal  persons 
may be charged with official tasks in this respect. It also foresees a system of fees that may 
(plant passport) or shall (import) be levied by the MS to finance official controls. 

2.3. Official controls on plant reproductive material 

The plant reproductive material legislation is fully outside the scope of Regulation 882/2004. 
The  limited  number  of  official  controls  is  currently  regulated  by  a  set  of  12  Council 
Directives  on  the  marketing  of  plant  reproductive  material104.  These  Directives  too  impose 
obligations on the MS to carry out controls to verify compliance with the requirements thereof 
and define what legal persons may be charged with official tasks in this respect. They do not 
foresee a system of inspection fees. 

103  Council  Directive  2000/29/EC  of  8  May  2000  on  protective  measures  against  the  introduction  into  the 
Community of organisms harmful to plants or plant products and against their spread within the Community (OJ 
L 169, 10.7.2000). 
104  Council  Directive  66/401/EEC  of  14  June  1966  on  the  marketing  of  fodder  plant  seed;  Council  Directive 
66/402/EEC on the marketing of cereal seed; Council Directive 68/193/EEC of 9 April 1968 on the marketing of 
material for the vegetative propagation of the vine; Council Directive 98/56/EC of 20 July 1998 on the marketing 
of  propagating  material  of  ornamental  plants;  Council  Directive  1999/105/EC  of  22  December  1999  on  the 
marketing  of  forest  reproductive  material;  Council  Directive  2002/53/EC  of  13  June  2002  on  the  common 
catalogue  of  varieties  of  agricultural  plant  species;  Council  Directive  2002/54/EC  of  13  June  2002  on  the 
marketing  of  beet  seed;  Council  Directive  2002/55/EC  of  13  June  2002  on  the  marketing  of  vegetable  seed; 
Council  Directive  2002/56/EC  of  13  June  2002  on  the  marketing  of  seed  potatoes;  Council  Directive 
2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants; Council Directive 2008/72/EC of 
15 July 2008 on the marketing of vegetable propagating and planting material, other than seed; Council Directive 
2008/90/EC of 29 September 2008 on the marketing of fruit propagating material and fruit plants intended for 
fruit production. 

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Annex III: Details of the problem identification 

• 

Inconsistencies, gaps and overlap in control requirements 

The  EU  legislative  framework  for  official  controls  on  the  food  chain  is  an  incomplete 
patchwork. Inconsistencies and gaps have been identified. In particular,  

-  differences (e.g. the definitions of CAs and the mechanism for delegation of official tasks, 
including laboratory tasks, the logic of risk based controls, the system of border controls) 
are apparent between Regulation 882/2004 and the legislation concerning official controls 
in  the  plant  health  sector;  while  some  of  these  differences  are  justified  because  of  the 
peculiarities  of  that  sector  (i.e.  certification  procedures),  others  appear  to  be  arbitrary 
insofar  as  they  result  in  different  rules  where  the  activities  regulated  upon  call  for  the 
same set of guarantees to be applied;  

-  current  EU  rules  on  plant  reproductive  material  do  not  include  provisions  on  official 

controls; 

-  Regulation 882/2004 only partly applies to controls on animal by-products and derived 
products  not  intended  for  human  consumption  (ABP);  as  a  result,  some  important 
provisions  (e.g.  on  transparency  of  enforcement  activities,  on  accreditation  of  official 
laboratories, on FVO audits in MS) are currently not applicable to such controls.  

-  On the other hand, certain requirements and procedures laid down in Regulation 882/2004 
are also present in pre-existing sectoral legislation, either with an identical formulation or 
with  a  slightly  different  wording  which  however  does  not  change  the  substance  of  the 
provisions, calling however for different interpretations. For example, the mechanism for 
administrative  assistance  and  cooperation  are  regulated  upon  by  Regulation  882/2004, 
Directives 89/662105 and 89/608106); registration and approval requirements for operators 
are  laid  down  in  Regulation  882/2004,  and  Regulations  183/2005107,  852/2004108, 
854/2004109.  

105 Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra- Community trade with a 
view to the completion of the internal market 
106  Council  Directive  89/608/EEC  of  21  November  1989  on  mutual  assistance  between  the  administrative 
authorities of the Member States and cooperation between the latter and the Commission to ensure the correct 
application of legislation on veterinary and zootechnical matters 
107  Regulation  (EC)  No  183/2005  of  the  European  Parliament  and  of  the  Council  of  12  January  2005  laying 
down requirements for feed hygiene 
108 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene 
of foodstuffs 
109 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 

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•  Inconsistent implementation of risk-based approach resulting in insufficient / differing 

/ inefficient prioritisation of official controls  

Regulation  882/2004  requires  official  controls  to  be  risk  based,  and  MS  to  prioritise  their 
control  efforts  and  allocate  resources  giving  priority  to  situations/areas  where  the  risk  is 
higher.  Existing  harmonised  rules  in  certain  areas  prevent  however  this  principle  to  fully 
deploy its benefits in terms of more efficient use of resources and of reduction of unnecessary 
burden on business operators subjected to controls (time, staff, equipment and facilities being 
mobilised to allow controls). 

As regards import controls, MS are currently required to carry out official controls on certain 
commodities arriving from third countries at the outer borders of the EU (border controls).  

In fact, safety of goods from third countries is ensured not only through risk based controls 
carried  out  by  national  authorities  at  any  stage  of  the  food  chain,  but,  most  importantly,  by 
sanitary checks carried out at the outer borders of the EU on goods which present an intrinsic 
risk  for  human,  animal  or  plant  health.  Border  Inspection  Posts  ("BIPs")  exist  for  the 
performance  of  veterinary  checks  on  animals  and  products  of  animal  origin,  Designated 
Points  of  Entry  ("DPEs")  carry  out  border  checks  on  certain  foods  and  feed  of  non  animal 
origin,  and  entry  points  are  designated  by  each  MS  for  the  performance  of  phytosanitary 
controls110 on imported plants and plant products. 

The rationale and the underpinning principles of such controls across the range of food chain 
products (from plants to animals and animal products, to food and feed, animal by-products, 
food contact materials) are the same and they conform to the overarching principle according 
to which border controls shall be limited and proportionate to what is necessary to contain the 
potential risks for humans, animals or plants. The possibility to fully adjust the control effort 
to the level of risk is however limited by two different factors: on the one hand by the rigidity 
of  current  rules,  which  in  some  areas  do  not  allow  the  continuous  adjustment  of  the 
frequencies of physical checks as established in legislation to take into account of situations 
where the risk is reduced. On the other hand, as the different control systems at the borders 
are  operated  in  accordance  with  different  sets  of  rules  (and  by  different  authorities  in  some 
cases) depending on the sectors/products to be controlled, there is no integrated mechanisms 
to allow the prioritisation of checks by comparing the levels of risk of all the commodities of 
relevance  for  the  food  chain;  in  other  words,  risk  prioritisation  is  carried  out  within  sectors 
and not across sectors. 

This results in burdens (above) and costs (most border controls result in a fee levied on the 
business operator responsible for the consignment) not always justified by the risk posed by 
the  product  being  introduced  into  the  EU.  Similarly,  the  lack  of  integration  of  the  different 
control  structures  operating  at  the  border  also  prevents  efficiency  gains  and  savings  in 
administrative costs to be reflected in lower fees being charged on operators.  

Example 

A  number  of  Member  States  asked  the  Commission  whether  Designated  Points  of  Entry  can  be 
located within the same facilities of EU approved Border Inspection Posts.  

Under Directive 96/23/EC on official controls of residues of veterinary medicines, MS are 
required to include in their national residues monitoring plans a minimum number of samples 
for each combination of animal (or animal product) and (sub)group of substances, and to test 

110 Official controls carried out in the area of plant health. 

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for  certain  substances  and  substance  groups  also  in  cases  where  there  has  been  little  or  no 
evidence of a risk that would justify that intensity of checks. 

Examples 

Stilbenes - All animals and animal products 

Although  absolutely  no  non  compliance  has  been  detected  for  several  years  now, 
between 21000 and 24000 samples are analysed each year across the EU for stilbenes, 
their derivatives, salts and esters. 

Year 

2007 

2008 

2009 

2010 

Total number of samples 
analysed 

Number of non compliances 

23 411 

21 664 

21 815 

23 455 

0 

0 

0 

0 

Resorcylic acid lactones (including zeranol) in pigs. 

Although absolutely no non compliance has been detected for several years now, more 
than 6000 samples continue to be analysed each year across the EU. 

Year 

2007 

2008 

2009 

2010 

Total number of samples 
analysed 

Number of non compliances 

6234 

5594 

6237 

6166 

0 

0 

0 

0 

The  Directive  also  prescribes  in  a  detailed  fashion  what  enforcement  action  Member  State’ 
authorities  must  take  in  relation  to  the  different  possible  violation  of  EU  rules  (illegal 
treatment,  use  of  unauthorised  substances,  presence  of  residues  of  veterinary  medicines  at 
levels exceeding the maximum residues limits (MRLs), repeated infringements of MRLs, etc). 
No flexibility is left to CAs in view of ensuring that enforcement action is proportionate to the 
situation at hand and to their specific enforcement needs. The rigidities in the system created 
by  the  Directive  clearly  result  in  an  inefficient  allocation  of  control  resources,  unnecessary 
burdens on operators, and inefficient enforcement action. 

•  Administrative burden and disproportionate control requirements 

Rules  governing  official  controls  on  residues  of  veterinary  medicines  result  in  avoidable 
administrative  burdens  for  both  the  MS  CAs  and  the  Commission,  in  several  respects.  
Directive  96/23/EC  requires  that  annual  updates  to  MS’  monitoring  plan  of  residues  of 
veterinary  medicines  be  transmitted  to  and  approved  by  Commission.  There  is  no  such 
requirement for any of the other control planning instruments or for the MANCP as such and 
the  long  and  heavy  administrative  procedure  laid  down  in  the  Directive  of  residues  is  not 
justified 
out.  
A  similar  requirement  exists  in  relation  to  the  residues  monitoring  plans  of  third  countries 
exporting animals or animal products to the EU. While of course appropriate guarantees must 

specificity 

controls 

carried 

any 

the 

by 

be 

of 

to 

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be  provided  by  exporting  third  countries  that  their  produce  offer  a  level  of  safety  which  is 
equivalent to the one offered by EU products, less bureaucratic mechanisms can be designed 
to replace the current formal approval. 
Also  redundant  with  the  general  reporting  requirement  set  by  Regulation  882/2004  for  all 
control activities are the specific reporting obligations laid down in the Directive. 

Article  12  of  Regulation  882/2004  provides  for  the  mandatory  accreditation  of  official 
laboratories  in  accordance  with  EN  ISO/IEC  17025111.  No  flexibility  is  allowed  for  cases 
where the official laboratories might have to use a specific method which is not yet included 
in the scope of the accreditation because of an emergency or because the method is new. 

Example  

No  or  nearly  no  official  laboratory  in  the  EU  was  accredited  according  to  ISO  17025  for  the 
detection of mineral oil in sunflower oil or for the detection of melamine in food when respectively 
the crisis on sunflower oil from Ukraine or the one on melamine in food from China broke out. 

Nor there is flexibility for the very specific case of small laboratories attached to operators' 
establishments, where extremely basic tests are carried out.  

Example 

A  concrete  example  of  the  latter  situation  is  the  small  laboratories  performing  Trichinella  tests. 
Soon after the adoption of Regulation 882/2004 several Member States brought to the attention of 
the  Commission  that  accreditation  is  very  burdensome  for  very  small  Trichinella  laboratories, 
attached to slaughterhouses or game meat handling establishments which only perform that type of 
test  (the  test  is  not  complex  and  easy  to  carry  out)  and  covering  only  the  needs  of  the  one 
establishment.  Therefore,  besides  a  transitional  period  for  the  accreditation  of  all  laboratories 
granted  for  4  years,  ending  in  2009,  the  Commission  extended  such  a  transitional  period  until  31 
December 2013 for the accreditation of laboratories tasked with Trichinella testing and located in a 
slaughterhouse or a game handling establishment. 

•  Unclear rules and  insufficient implementation details 

Regulation  882/2004 
interpretation and application, and thus legal uncertainty. 

includes  some  unclear  rules,  which  may  generate  divergent 

a)  The  Regulation  lays  down  a  general  obligation  for  MS  CAs  to  ensure  a  "high  level  of 
transparency" when performing their control activities. The provisions on transparency are 
unclear  as  regards  both  the  types  of  information  to  be  disclosed  and  the  degree  of  such 
disclosure.  

b)  Doubts exist about whether all methods used by a laboratory when operating as an official 
laboratory must be included in the accreditation. Furthermore, divergent interpretation are 
reported of Article 12(3) of Regulation 882/2004, according to which the accreditation of 
testing laboratories in accordance with EN ISO/IEC 17025 may relate "to individual tests 
or  groups  of  tests"(depending  on  the  practice  followed  by  the  different  national 
accreditation bodies, the scope of accreditation can comprise one method, several methods 
or even groups of methods).  

111 A laboratory can only be accredited for the use of standardised and/or validated method 

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has 

and 

been 

develop 

validate 

methods 

positively 

The  scope  of  accreditation  according  to  EN  ISO/IEC  17025  of  a  laboratory  can  be  fixed  or 
flexible.  A  flexible  scope  accreditation  is  in  general  more  difficult  to  obtain  as  it  allows  the 
laboratory not only to carry out the methods specified in the scope of accreditation, but also to add 
methods within the defined limits to the scope on the basis that the competence of the laboratory 
to 
evaluated.
For both types of accreditation scopes, the interpretation of Article 12.3 differs greatly from one 
another.
MS 
In some Member States, a fixed scope accreditation can only cover the use of a specific method 
(to be followed very precisely by the laboratory) on a specific matrix in order to detect a specific 
substance, virus, bacteria, etc (e.g. HPLC analysis of aflatoxins in pistachios). The consequence is 
for instance that for each new use of the method (e.g. on another very similar matrix like peanuts 
or almonds), the laboratory has to undergo a new accreditation procedure. In other Member States, 
fixed scope accreditations are given for the use of a method on several similar matrices making it 
for  instance  possible  for  the  laboratory  to  use  the  method  on  another  similar  matrix  without 
procedure.
undergoing 
Also, for some accreditation bodies but not for others, a flexible scope accreditation can cover the 
use  of  all  methods  using  a  same  analytical  technique  (like  for  instance  all  methods  using  the 
ELISA technique). 

accreditation 

new 

to 

a 

c)  In some cases, identical terms are used to define different concepts; for instance, while the 
terms  'surveillance'  and  'monitoring'  indicate  in  Regulation  882/2004  specific  forms  of 
official controls to verify compliance with the law, in the animal health and plant health 
legislation, such terms refer to activities carried out by CAs but also by stakeholders, with 
the objective of detecting, eradicating or containing diseases or harmful organisms. 

d)  While the scope of Regulation 882/2004 covers the enforcement of feed and food law, and 
of animal health and animal welfare rules, the wording of many provisions is specifically 
focused on feed and food. This results in uncertainties and divergent interpretations as to 
whether such provisions apply to controls on compliance with animal health and animal 
welfare rules, or with specific legislation governing the materials and articles intended to 
come  into  contact  with  food  (FCM)112  or  the  deliberate  release  into  the  environment  of 
genetically modified organisms113. 

Example 

Recently, Sweden enquired whether the mandate of the FVO as defined in article 45 of Regulation 
882/2004  extends  to  Directive  2001/18/EC  on  the  deliberate  release  into  the  environment  of 
genetically  modified  organisms.  In  particular,  it  asked  whether  controls  of  field  trials,  including 
the authorisation process and the cultivation of the Amflora potato fall within the mandate of the 
FVO. 

•  Insufficient administrative cooperation amongst public authorities  

CAs  rarely  make  use  of  the  rules  of  Regulation  882/2004  on  administrative  cooperation, 
which require them to liaise with their counterparts in another MS to ensure that serious non-

112  Regulation  (EC)  No 1935/2004  of  the  European  Parliament  and  of  the  Council  of  27 October  2004  on 
materials  and  articles  intended  to  come  into  contact  with  food  and  repealing  Directives  80/590/EEC  and 
89/109/EEC. 
113  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the  deliberate 
release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. 

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compliances are also pursued in the MS where the violation originates. The reason for that is 
to be found in the fact that no implementing tools exist to allow the cooperation mechanisms 
to function (i.e. CAs are not provided with any rule on how to trigger cooperation requests, on 
what the request content could be and what can be expected as a result of it etc., nor on the 
technicalities of the cooperation mechanisms).  

Example 

The  Commission  received  a  complaint  against  Germany  from  a  food  business  operator.  The 
complainant indicated that Germany, although aware of the fact that a violation of food chain rules 
was also to be attributed to the supplier of the complainant located in Poland, failed to contact the 
MS  of  dispatch  (Poland)  as  requested  by  Article  38  of  Regulation  882/2004,  and  held  the 
complainant solely responsible and liable for the violation. Germany maintained instead wrongly 
that the notification in the Rapid Alert system for food and feed (RASFF) satisfied its obligation 
under Article 38. 

For  import  controls,  Regulation  882/2004  requires  customs  and  sanitary  authorities  to 
cooperate during controls they carry out on imported products. However, feedback from CAs 
indicates  that  some  important  efficiency  gains  could  be  made  if  the  operation  of  the  two 
parallel  systems  of  customs  and  sanitary  checks  on 
imported  products  could  be 
"synchronised"  better  so  as  to  eliminate  all  unnecessary  duplications  in  the  two  parallel 
processes, e.g. in the collection of pre-arrival information and in the processing of it, or in the 
processing of information necessary for the final clearance of products (also from a sanitary 
point of view) before they are released for free circulation. Such duplications are a burden and 
have  a  cost  for  all  concerned  (customs  authorities  and  sanitary  authorities  and,  inevitably, 
importers). This is again the result of the lack of detailed indications on what modalities the 
cooperation obligation laid down in Regulation 882/2004 must take for it to fully deploy its 
potential  in  terms  of  efficiency  gains  and  reduced  burden  on  operators  subject  to  import 
checks. 

Example 

France asked the Commission whether the national customs authorities, in case of food and feed, 
can trigger the mechanisms foreseen in Articles 27 to 29 of Regulation 765/2008 (on setting out the 
requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products) 
allowing them to suspend release of a product for free circulation on the Union market and inform 
the sanitary authority any time the product seems to present a serious risk to health, safety. 

Moreover,  potential  synergies  of  action  across  different  competent  authorities  are  hampered 
as no provision of Regulation 882/2004 allows the delegation of specific controls tasks to the 
sanitary  authority  present  at  border.  One  important  example  is  the  present  inability  of  the 
competent authority responsible for biodiversity rules to delegate border control tasks to the 
sanitary authority at the border to verify the presence of Invasive Alien Species (IAS), which 
would lead to important efficiency gains.114 

114 On the ongoing initiative on Invasive Alie Species, see Annex XXVI. 

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Annex IV: PROCEDURE - Details of the consultation 

1) Consultation of Member States 

•  Meetings  of  the  Working  Group  on  the  general  Application  of  Regulation  882/2004 
set  up  within  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health 
(SCFCAH) were held on: 

- 7 September 2009,  

- 3 May, 27 September 2010,  

- 1 March, 11 April, 23 May, 27 June, 7 October, 10 November and 5 December 2011.   

In addition, Member States were consulted on the following specific issues: 

(cid:131)  Financing of official controls 
The  Commission  contracted  out  to  an  external  contractor115  a  study  on  the  state  of  the 
application  of  the  rules  on  inspection  fees  imposed  by  MS  on  operators  to  finance  official 
controls  (Inspection  Fees).  In  this  context,  a  survey  of  the  Member  States'  competent 
authorities  was  carried  out  by  means  of  a  questionnaire  to  collect  both  information  on  the 
state of the implementation of the rules on the financing of official controls and views about a 
series  of  possible  options  for  addressing  existing  difficulties.  The  final  results  of  this  study 
were made available to the Commission in February 2009116 and presented at the meeting of 
the Heads of Food Safety Agencies organised by the Swedish Presidency in Stockholm on 25-
26 September 2009. The Commission started a second consultation of MS through an ad hoc 
MS experts working group which met on 7 September 2009. 

In preparation of the impact assessment (IA), a second study was contracted out to an external 
contractor117  to  assess  the  impact  of  the  options  identified  to  address  the  weaknesses  of  the 
system.  The  options  on  inspection  fees  were  discussed  with  Member  States  by  the  external 
contractor to gather evidence and data to inform a decision on the recommended option. The 
final results were made available to the Commission on 20th September 2011 and presented to 
the  Member  States  at  the  meeting  of  the  Working  Group  on  the  general  application  of 
Regulation (EC) No 882/2004 on 10th November 2011118.  

(cid:131)  Accreditation of official laboratories (Article 12 of Regulation (EC) No 882/2004) 

Accreditation of official food, feed and animal health laboratories according to Article 12 of 
Regulation (EC) No 882/2004 was discussed at two meetings of the Working Group on the 
general application of Regulation (EC) No 882/2004 (3 May and 27 September 2010) with the 
participation  of  Directorate  General  Enterprise  and  Industry  and  European  co-operation  for 

115 Food Chain Evaluation Consortium (FCEC), consisting of Civic Consulting, Agra CEAS Consulting (project 
leader), Van Dijk Management Consultants and Arcadia International. 
116 http://ec.europa.eu/food/food/controls/inspection_fees/docs/external_study_en.pdf; Annex X to this document 
provides for the executive summary of this study. 
117 GHK 
118 Annex XI to this document provides for the study carried out by GHK to support the impact assessment on 
reviewing the rules on the financing of official controls. 

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Accreditation (EA). As a follow-up to these meetings, a discussion paper119 was drafted with 
the  purpose  of  summarising  the  main  issues  identified  during  the  discussions  as  well  as  the 
corresponding suggestions for improvement from the MS. The aim of the paper was to reflect 
on  available  options  to  improve  the  enforcement  of  Article  12  of  Regulation  (EC)  No 
882/2004. This paper was sent in January 2011 to the members of the Working Group on the 
general application of Regulation (EC) No 882/2004. In June 2011, the discussion paper was 
also  sent  to  the  Chief  Veterinary  Officers  (CVOs)  in  order  to  identify  any  specific  issues 
concerning in particular animal health laboratories. These results of the discussions as well as 
the answers to the consultations received from the Member States have been presented to the 
Working  Group  on  the  general  application  of  Regulation  (EC)  No  882/2004  (meeting  on  5 
December 2011) as well as to the members of EA (meeting on 8 December 2011) and fed into 
this Impact Assessment Report. 

The  possible  introduction  of  a  mandatory  accreditation  for  plant  health  laboratories  and  the 
possibility  to  establish  EU  reference  laboratories  in  the  plant  health  sector  were  discussed 
with the chief officers for plant health (COPHs) of the Member States as well as during the 
specific task force with MS experts and the Commission on 26 May 2011 (see "Plant Health 
and Seed and plant propagating material related controls" hereafter). After these meetings, the 
COPHs and the task force members were consulted in writing on the costs of the introduction 
of a mandatory accreditation for plant laboratories. 

Similar consultations were organised during the evaluation and review of the EU regime for 
the  marketing  of  seed  &  plant  propagating  material  (Task  force  with  MS  experts  and  the 
Commission  –  see  "Plant  Health  and  Seed  and  plant  propagating  material  related  controls" 
hereafter). 

(cid:131)  Official controls on residues of veterinary medicines in live animals and animal products 

(Directive 96/23/EC) 

In  2003  the  Commission  launched  a  broad  consultation  process  to  review  the  whole 
legislation  on  residues  of  pharmacologically  active  substances  used  for  the  treatment  of 
animals  including  Directive  96/23/EC  which  was  finally  not  modified  nor  repealed  as  its 
revision was put on hold.  

At the beginning of 2011, the extensive material collected at that time was considered, insofar 
as  it  was  still  relevant,  and  a  new  consultation  of  the  MS  on  the  impacts  of  the  different 
options  available  was  carried  out.  The  objective  of  this  consultation  was  to  update  and 
complement  the  relevant  information  gathered  in  2003  with  fresher  input  and  to  collect 
additional data to be used to assess the impact of the available options. A questionnaire120 was 
addressed to the Working Group on the general application of Regulation (EC) No 882/2004, 
to  the  Chief  Veterinary  Officers  (CVOs)  of  the  MS  as  well  as  to  officials  in  the  MS  in 
particular  responsible  for  the  management  of  residues  of  veterinary  medicinal  products 
control plans in the MS (the "residues experts working group" set up within the SCFCAH). 
The  outcome  of  the  consultation121  was  then  presented  to  and  discussed  with  the  Working 
Group  on  the  general  application  of  Regulation  (EC)  No  882/2004  (meeting  on  27  June 
2011), the CVOs (meeting on 29 September 2011) and the "residues experts working group" 
(meeting on 5 September 2011). 

119 See Annex XVIII. 
120 See Annex XX. 
121 See annex XX of this document 

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(cid:131)  Veterinary border controls 

In  2007  the  Commission  launched  a  questionnaire  to  all  Member  States  to  investigate  in 
which  areas  there  are  difficulties  with  the  implementation  of  the  veterinary  checks  in  BIPs. 
All  Member  States  provided  detailed  replies  favouring  the  review  of  the  veterinary  border 
control  legislation  and  highlighting  the  need  for  more  effective  physical  checks  including  a 
risk  based  approach.  In  addition  several  problematic  areas,  such  as  implementation  of  pre-
notification,  re-enforced  physical  checks,  procedures  for  specific  consignments  such  as  for 
transit, for transhipment, channelled and rejected consignments, re-imports and approval and 
supervision  of  specific  free  and  customs  warehouses  were  raised.  These  problematic  areas 
were  discussed  in  the  Working  Group  on  veterinary  check  legislation  with  Member  States' 
representatives.  

Two Steering Group meetings were hold (27.05.2010 and 03.03.2011) to inform the members 
(including stakeholders), during which the Commission explained how the work concerning 
the  Review  of  the  import  control  legislation  started  and  how  it  is  planned  to  continue. 
Participants in the Steering Groups did raise several questions for clarification but no major 
comments in relation to the review were raised. 

In addition two task forces with a limited number of Member States representatives were held 
(25.01.2011, 23.06.2011) to discuss the review of Regulation (EC) No 882/2004 to integrate 
principles of import controls for live animals and products of animal origin and repealing and 
replacing Council Directives 91/496/EEC and 97/78/EC. The results of the discussions in the 
Taskforces  were  presented  to  the  Working  Group  for  veterinary  checks  and  the  review  of 
Regulation (EC) No 882/2004 was discussed on 02.12.2010, 11.03.2011 and 06.07.2011. 

(cid:131)  Animal Health related controls 

The Animal Health Law, including related controls aspects, was discussed at numerous Chief 
Veterinary Officers' working group meeting since early 2009. On some elements two public 
consultations also took place in 2009 and 2010 respectively and in particular at the meeting 
on  22  March  2011.  In  addition,  a  dedicated  meeting  of  the  Working  group  on  the  Animal 
Health Law, with representatives of the MS was organised on 30 May 2011 to discuss certain 
aspects relating to animal health controls.  

(cid:131)  Plant Health and plant reproductive material related controls 

Repeated consultations were organised for the review of the EU plant health regime, during 
the  evaluation  phase,  for  the  preparation  of  options  for  the  future  and  for  assessing  the 
potential impacts of certain measures. The consultations included the organisation of meetings 
and conferences as well as written consultations. 

 The relationship between the plant health regime and Regulation (EC) No 882/2004 and the 
possible full inclusion of the former in the scope of that Regulation was discussed repeatedly 
with  the  Chief  Officers  for  Plant  Health  of  the  Member  States.  On  their  request,  a  specific 
task force with MS experts and the Commission and reporting to the said Chief Officers was 
convened  on  26  May  2011  to  discuss  the  feasibility  of  the  inclusion  of  plant  health  related 
controls in the horizontal framework for official controls.  

Repeated consultations were similarly organised during the evaluation and review of the EU 
regime for the marketing of seed & plant propagating material. Also in this area, a task force 
with MS experts and the Commission was set up to discuss the feasibility of the inclusion of 

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seeds  and  propagating  material  within  the  scope  of  the  general  framework  for  official 
controls. This task force was convened on 24 May and 19 July 2011. 

2) Consultation of stakeholders  

•  Under  the  Advisory  Group  on  the  Food  Chain  and  Animal  Health  and  Plant  Health, 

two ad hoc Working Groups were established:  

- the one on the review of the inspection fees rules took place on19 October 2009,  

- the one on the review of the system of official controls took place on 19 September 
2011.  

•  The  Advisory  Group  on  the  Food  Chain  and  Animal  Health  and  Plant  Health  took 

place on: 

- 14 March 2011, 

- 14 November 2011. 

3) Inter Service Steering Group 

•  The  Commission  Inter-Service  Steering  Group  on  the  IA  for  the  review  of  the  EU 

system of official controls along the food chain met six times on: 

-  5 May 2011 (planned approach and problem analysis were discussed),  

-  24th June 2011 (collection of data and a first draft of the IA were discussed),  

-  19  July  2011  (outcome  of  the  results  of  the  consultation  on  Directive  96/23, 

problem definition, objectives and policy options),  

-  7 September 2011 (problem definition and objectives),  

-  18 October 2011 (policy options),  

-  25 November 2011 (policy options and analysis of impacts), 

-  20 December 2011 (analysis of impacts and preferred options). 

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Annex V: PROCEDURE – Specific data collection activities 

(cid:131)  Directive  96/23  on  official  controls  on  residues  of  veterinary  medicines  in  live 

animals and animal products 

Information collected in the context of the 2003-2009 evaluation in order to review the whole 
legislation  on  residues  of  pharmacologically  active  substances  used  for  the  treatment  of 
animals  (including  Directive  96/23/EC122)  has  been  considered  for  this  review  insofar  as  it 
was  still  relevant.  It  has  been  updated  and  complemented  by  information  and  data  received 
from the MS through the consultation carried out at the beginning of 2011.  

A  significant  amount  of  information  was  also  available  in  the  Commission's  "Residues 
Application",  which  records  the  number  of  samples  of  animals  or  animal  products  analysed 
for  residues  and  the  corresponding  results.  Data  on  the  cost  of  the  residues  controls  was 
collected through a questionnaire sent to the MS at the beginning 2011123.  

Data from the "Residues Application" and from the consultations carried out have been used 
in particular to assess the potential impacts of the options available124. 

(cid:131)  Plant Health 
The  general  evaluation  of  the  EU  plant  health  regime  was  carried  out  in  2009-2011125  and 
included elements of the EU regime on official controls in the Plant Health sector. 

A  data  gathering  exercise  was  also  conducted  with  regard  to  additional  burdens  to  MS 
authorities and operators that could result from 1) a possible link of plant and plant products 
imports  to  the  TRACES  system,  2)  the  cost  of  mandatory  accreditation  of  laboratories  for 
methods  related  to  plant  health  and  3)  the  cost  of  setting  up  EU  reference  laboratories  for 
plant health. 

122 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. 
123 The questionnaire and the results of this consultation are presented in Annex XX.  
124 See Annex XXI. 
125 http://ec.europa.eu/food/plant/strategy/index_en.htm  

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Annex VI126: PROCEDURE – List of consulted stakeholders 

Acronym 

AESGP 
AIPCE-CEP 

AVEC 

CEFIC 
CELCAA 

FOODDRINK 
EUROPE 
(former CIAA) 
CLITRAVI 
COCERAL 

COPA-COGECA 

EDA 
EHPM 

ESA 
ESA 
EUROCHAMBERS 

EUROCOMMERCE 

Organisation 

European Self-Medication Industry 
European Fish Processors Association 
European Federation of National Organisations of Importers and 
Exporters of Fish 
Association of Poultry Processors and Poultry Trade in the EU 
countries 
European Chemical Industry Council 
European Liaison Committee for the Agricultural and Agri-Food 
Trade 
European food and drink industry 

(recent Confederation of the food and drink industries of the EU) 

Center for the Meat Processing Industry in the European Union 
Comité du Commerce des céréales, aliments du bétail, 
oléagineux, huile d'olive, huiles et graisses et agrofournitures 
Committee of Professional Agricultural Organisations-General 
Confederation of Agricultural Cooperatives 
European Dairy Association 
European Federation of Associations of Health Product 
Manufacturers 
European Seed Association 
European Snacks Association 
European Association of Chambers of Commerce and  
Industry 
The retail, wholesale and international trade representation to the 
EU 
Eurogroup for animal welfare at European Union level 

European Association for Bioindustries 
European Feed Manufacturers' Federation 
EU Association of Specialty Feed Ingredients and their Mixtures 
European Federation for Animal Health and Sanitary Security 

EUROGROUP FOR 
ANIMALS 
EUROPABIO 
FEFAC 
FEFANA 
FESASS 
FRESHFEL EUROPE  European Fresh Produce Association 
Federation of Veterinarian of Europe 
FVE 
Trade association of hotels, restaurants and cafés in the  
HOTREC 
European 
International Federation of Organic Agriculture Movements 
European Association of craft, small and medium-sized 
enterprises 
European Livestock And Meat Trading Union 

IFOAM-EU GROUP 
UEAPME 

UECBV 

126 Stakeholders active in the fields of Plant Health and Plant reproductive material were also consulted in the 
context of the related reviews. 

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FRUCOM 

UGAL 

Representation of European Importers of Dried Fruit, Edible Nut, 
Processed Fruit & Vegetable, Processed Fishery Product, Spices, 
Honey and Similar Foodstuffs 
Breiz Europe 
Union of Groups of Independent Retailers of Europe 

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Annex VII: PROCEDURE – List of FVO audits since 2007 

GENERAL AUDITS 

CLOSING DATE

REFERENCE 

ongoing 
ongoing 
Feb 2011 
Feb 2011 
March 2011 
March 2011 
April 2011 
May 2011 
March 2010 
March 2010 
May 2010 
March 2010 
Nov 2009  
Mar 2010  
Jan 2010  
Jan2009 
Jan2010 
Apr 2009  
Feb 2009  
Nov 2008  
Jan 2008 
Apr 2009  

2011-6092 
2011-6084 
2010-8710 
2010-8730 
2010-8627 
2010-8741 
2010-8723 
2010-8713 
2010-8371 
2010-8372 
2009-8315 
2009-8378 
2009-8783  
2009-8316  
2009-8821  
2009-8774  
2010-8779  
8600-2009  
2009-8346  
2008-8724  
2007-7995  
2008-8380  

GENERAL 
AUDIT 
YEAR 
2011 
2011 
2010 
2010 
2010 
2010 
2010 
2010 
2010 
2010 
2009 
2009 
2009 
2009 
2009 
2009 
2010 
2008 
2008 
2008 
2007 
2008 

DATE OF 
PUBLICATION 

Not yet published 
Not yet published 
Not yet published  
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published  
Not yet published 
Not yet published 
Not yet published 
30/03/2011 
01/12/2010 
16/03/2011 
31/03/2011 
17/08/2011 
11/05/2010 
05/02/2010 
18/08/2010 
10/12/2008 
03/02/2011 

GENERAL FOLLOW UP MISSIONS and AUDITS 

2010 
2010 
2010 
2010 
2010 
2010 
2011 
2011 
2011 
2011 
2011 
2011 
2011 
2009 

Sep 2010 
May 2010 
May 2010 
May 2010 
Nov 2010 
Dec 2010 
March 2011 
April 2011 
Sept 2011 
Nov 2011 
Nov 2011 
Oct 2011 
Jan 2011 
Oct 2009 

2010-8373 
2010-8365 
2010-8363 
2010-8364 
2010-8375 
2010-8374 
2011-6076 
2011-6077 
2011-6085 
2011-6075 
2011-6090 
2011-6088 
2011-6074 
2009-8120 

Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 

MEMBER 
STATE 

FR 
AT 
CZ 
RO 
FR 
IT 
SE 
BG 
UK 
CY 
EL 
PT 
CY 
FI 
LV 
LT 
SI 
EE 
HU 
IE 
AT 
SK 

LV 
SK 
NL 
IE 
FI 
LT 
SI 
PT 
RO 
DE 
SE 
IT 
ES 
HU 

EN 

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HU 
CZ 
CY 
BG 
GR 
LU 

2011 
2011 
2010 
2009 
2010 
2011 

Jul 2011 
May 2011 
ongoing 
Oct 2009 
Dec 2010 
Oct 2011 

2011-6078 
2011-6079 
2010-8372 
2009-8100 
2010-8368 
2011-6083 

Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 
Not yet published 

SPECIFIC AUDITS  

MEMBER 
STATE   

SPECIFIC 
AUDIT 
YEAR 

DATES  

TITLE 

REFERENCE 

AT  

2007 

29/01 – 02/02 

AT  

AT  

2007 

05/11 – 09/11 

2007 

25/06 – 06/06 

AT  

2007 

04/06 – 11/06 

AT  

2007 

04/09 – 12/09 

AT  

2007 

22/05 – 30/05 

AT  

2007 

04/09 – 12/09 

CY 

2009 

19/01 – 28/01  

CY 

2009 

02/02 – 10/02 

CY 

2009 

02/03 – 06/03 

CY 

2009 

17/03 – 24/03  

Food, feed and seed 
consisting of or produced 
from genetically 
modified organisms 
Import controls on food 
and feed of non-animal 
origin 
Intra-Community trade in 
live animals 
Intra-Community trade in 
semen and embryos of 
domestic animals 
of the bovine species 
Official controls on feed 
and compliance with 
requirements for feed 
hygiene 
Health rules on animal 
by-products 
Plant passport system, the 
current situation of 
Erwinia amylovora 
(Burr) and the system of 
import controls for plant 
health 
Poultry meat and poultry 
meat products 
General Food Hygiene, 
bottled water, 
pesticide residues (food 
of plant origin) 
Bovine Spongiform 
Encephalopathy (BSE) 
Residues and 
contaminants and the use 
of veterinary 
medicinal products in 
food producing animals 

2007-7177 

2007-7224 

2007-7350 

2007-7370 

2007-7500 

2007-7518 

2007-7602 

2009-8064 

2009-8143 

2009-8304 

2009-8130 

EN 

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  EN 

 
 
 
 
 
CY 

CY 
CY 

CY 

2009 

18/05 – 22/05  

2009 
2009 

21/09 – 25/09  
19/10 – 23/10  

2009 

16/11 – 24/11  

FI 

2009 

23/02 - 27/02 

FI 

FI 

2009 

23/03 - 01/04 

2009 

30/03 - 03/04 

FI 

2009 

04/05 - 11/05 

FI 

2009 

02/06 - 11/06 

FI 

2009 

30/06 - 09/07  

FI 

2009 

07/09 - 18/09  

Import/transit control 
system and border 
inspection posts 
Feed hygiene 
Animal welfare 
Contingency plans for 
epizootic diseases 
Eradication programme 
for Brucella melitensis 
Evaluate the 
implementation of 
controls for animal 
welfare on farms, during 
transport and at the time 
of slaughter 
Evaluate the official 
controls systems in place 
for import controls, food 
additives and food 
contact materials 
Evaluate import/transit 
control system and border 
inspection posts 
Evaluate the control of 
residues and 
contaminants and 
the use of veterinary 
medicinal products in 
food 
producing animals 
Evaluate the food safety 
control systems in place 
governing the production 
and placing on the market 
of poultry meat and 
poultry meat products 
Evaluate the 
implementation of 
measures concerning 
official controls on feed 
legislation 
Evaluate the follow-up 
action taken by the 
Competent Authorities 
with regard to official 
controls related to the 
safety of food of animal 
origin, in particular meat, 
milk and their products 

2009-8076 

2009-8086 
2009-8244 

2009-8253 

2009-8262 

2009-8149 

2009-8081 

2009-8125 

2009-8065 

2009-8088 

2009-8229 

EN 

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  EN 

 
 
 
FI 

2009 

05/10 - 09/10 

LV 

LV 

LV 

2009 

2009 

2009 

19/01 

2/02 

9/03 

LV 

2009 

16/03 

LV 

2009 

5/05 

LV 

LV 

LV 

LV 

LT 

LT 

LT 

LT 

LT 

2009 

2009 

2009 

2009 

2009 

2009 

2009 

2009 

25/05 

15/06 

2/11 

30/11 

2/03 

16/03 

20/04 

12/05 

2009 

25/05 

LT 

2009 

9/06 

Evaluate the system of 
import controls for plant 
health and the internal 
market controls of wood 
products of relevance for 
Bursaphelenchus 
xylophilus 
Public Health (Hygiene 
Package) – red meat and 
milk 
Animal welfare 
Import / transit controls 
on live animals and 
products of 
animal origin 
Public Health (Hygiene 
Package) poultry meat 
and poultry 
meat products 
Residues and 
contaminants in live 
animals and animal 
products, veterinary 
medicinal products 
Plant Health – protected 
zones and import controls 
Animal Health – 
contingency plans and 
rabies control 
Food hygiene, additives 
and food contact 
materials 
Animal By-Products 
Import / transit controls 
and border inspection 
posts (BIPs) 
Feed and compliance 
with requirements for 
feed hygiene 
Salmonella risk in the 
table egg sector 
Plant Passport/Protected 
Zones+ Import controls 
General Food Hygiene, 
Food additives (FA) & 
Food Contact 
Materials (FCM) 
Residues and 
contaminants in live 
animals and animal 

2009-8150 

2009-8207 

2009-8271 

2009-8078 

2009-8068 

2009-8126 

2009-8166 

2009-8259 

2009-8174 

2009-8431 

2009-8079 

2009-8089 

2009-8069 

2009-8169 

2009-8159 

2009-8131 

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  EN 

EN 

 
 
 
LT 

LT 

LT 

SI 

SI 

SI 

SI 

SI 

2009 

2009 

2009 

2010 

20/07 

19/10 

23/11 

07/09-11/09 

2010 

26/01-30/01 

2010 

20/04-30/04 

2010 

04/05-08/05 

2010 

19/01-23/01 

SI 

2010 

16/06-24/06  

SI 

2010 

03/03-13/03 

SI 

2010 

05/10-13/10 

SI 

2010 

23/03-30/03 

products, veterinary 
medicinal products 
Contingency plans & 
Rabies 
Traceability and beef 
products 
Animal Welfare 
contingency plans and 
eradication programmes 
for epizootic diseases 
measures concerning 
Bovine Spongiform 
Encephalopathy (BSE) 
systems in place to 
control the Salmonella 
risk in the table egg 
sector 
Veterinary import/transit 
control system and border 
inspection posts 
control of residues and 
contaminants and the use 
of veterinary medicinal 
products in food 
producing animals 
implementation of 
controls for animal 
welfare on farms, during 
transport and at the time 
of slaughter 
follow-up action taken 
with regard to official 
controls related to the 
safety of food of animal 
origin, in particular meat, 
milk and their products 
official control systems in 
place for food hygiene, 
traceability, labelling and 
bottled water and the 
official control system in 
place for food additives 
and food contact 
materials 
import controls for plant 
health, the 
implementation of the 
protected zone for 
Erwinia amylovora and 
the internal market 

2009-8265 

2009-8234 

2009-8252 

2009-8267 

2009-8114 

2009-8071 

2009-8203 

2009-8132 

2009-8241 

2009-8223 

2009-8168 

2009-8157 

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  EN 

EN 

 
 
 
EE 

2008 

16/06-20/06 

EE 

2008 

20/05-29/05 

EE 

2008 

14/04-18/04 

EE 

2008 

15/09-19/09 

EE 

2008 

22/04-30/04 

EE 

2008 

10/03-14/03 

EE 

2008 

16/09-26/09 

HU 

2008 

19/5-29/5 

HU 

2008 

1/9-5/9 

controls of wood 
products of relevance for 
Bursaphelenchus 
xylophilus 
veterinary import/transit 
control system and border 
inspection posts 
control systems in place 
in relation to disease 
contingency plans for 
epizootic diseases (in 
particular foot and mouth 
disease and classical 
swine fever) and 
surveillance activities for 
bluetongue 
implementation of health 
rules on animal by-
products 
implementation of 
controls for animal 
welfare on farms, during 
transport and at the time 
of slaughter 
control systems in place 
governing the production 
and placing on the market 
of fishery products 
official control systems in 
place for food of non-
animal origin 
plant health controls for 
imports, the plant 
passport system and the 
protected zone for 
Erwinia amylovora 
Evaluate the food safety 
control systems in place 
governing the production 
and placing on the market 
of poultry meat and 
poultry meat products 
Evaluate the 
implementation of 
measures concerning 
official controls on feed 
and compliance with 
requirements for feed 
hygiene 

2008-7756 

2008-7785 

2008-7739 

2008-7765 

2008-7640 

2008-7842 

2008-7898 

2008-7629 

2008-7720 

EN 

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  EN 

 
 
 
HU 

2008 

13/5-23/5 

HU 

2008 

20/5-30/5 

HU 

2008 

8/9-12/9 

HU 

2008 

2/9-11/9 

HU 

2008 

15/4-25/4 

HU 

2008 

6/10-10/10 

HU 

2008 

16/6-20/6 

HU 

2008 

14/10-15/10 

IE 

2008 

04/02 – 15/02 

Carry out a specific audit 
to assess import/transit 
controls and border 
inspection posts 
Carry out a specific audit 
to evaluate the 
implementation of 
controls for animal 
welfare on farms, during 
transport and at the time 
of slaughter 
Evaluate the control of 
residues and 
contaminants in 
live animals and animal 
products, including 
controls on veterinary 
medicinal products 
Evaluate the Classical 
Swine Fever eradication 
control programme 
Carry out a specific audit 
to evaluate the follow-up 
action taken by the 
competent authorities 
with regard 
to official controls related 
to the safety of food 
(meat, milk and 
babyfood) 
Evaluate controls of 
pesticide residues in food 
of plant origin 
Assess the official control 
systems in place for food 
hygiene (within the 
meaning of Regulation 
(EC) No 852/2004), 
traceability and labeling 
Evaluate the food safety 
control systems in place 
governing the production 
and placing on the market 
of poultry meat and 
poultry meat products 
(follow up 
to mission 2008/7629) 
To evaluate the system of 
import controls for plant 
health 

2008-7754 

2008-7767 

2008-7774 

2008-7798 

2008-7817 

2008-7849 

2008-7866 

2008-8009 

2008-7891 

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  EN 

EN 

 
 
 
IE 

2008 

04/02 – 15/02 

IE 

2008 

27/02 – 07/03 

IE 

2008 

31/03 – 04/04 

IE 

2008 

07/04 – 11/04 

IE 

2008 

21/04 – 25/04 

IE 

2008 

19/05 – 23/05 

IE 

2008 

03/09 – 12/09 

IE 

2008 

07/09 – 12/09 

To evaluate the 
implementation of the 
plant passport system, the 
situation of Erwinia 
amylovora (Burr) and its 
protected zone 
and the control of 
Ralstonia solanacearum 
To evaluate the food 
safety control systems in 
place governing 
the production and 
placing on the market of 
poultry meat and 
poultry meat products 
To assess controls on 
food of non-animal origin 
To carry out a specific 
audit to evaluate the 
control of residues 
and contaminants in live 
animals and animal 
products, including 
controls on veterinary 
medicinal products 
To evaluate import/transit 
controls and border 
inspection posts 
To carry out a specific 
audit to evaluate the 
implementation of 
measures concerning 
official controls on feed 
and compliance 
with requirements for 
feed hygiene 
To evaluate the control 
systems in place 
governing the 
production and placing 
on the market of fishery 
products 
To carry out a specific 
audit to evaluate the 
implementation of 
controls for animal 
welfare on farms, during 
transport and at the 
time of slaughter. 

2008-7893 

2008-7631 

2008-7843 

2008-7780 

2008-7750 

2008-7721 

2008-7641 

2008-7768 

EN 

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  EN 

 
 
 
IE 

2008 

03/11 – 10/11 

SK 

SK 

SK 

SK 

2008 

2008 

2008 

2008 

22/10 

12/05 

22/09 

9/06 

SK 

2008 

3/11 

SK 

2008 

14/04 

SK 

SK 

SK 

2008 

16/06 

2008 

2008 

1/04 

13/10 

To evaluate the 
implementation of EU 
animal health 
requirements for intra-
community trade in 
semen and embryos 
of domestic animals of 
the bovine species, as 
part of the 
general audit in Ireland 
Public Health (Hygiene 
Package) - Meat/Milk 
Salmonella risk in the 
table egg sector 
Poultry meat and poultry 
meat products 
Food additives (FA) and 
food contact materials 
(FCM) 
Food hygiene and other 
issues related to food 
production and 
distribution3 
Residues and 
contaminants in live 
animals and animal 
products, veterinary 
medicinal products 
Feed and compliance 
with requirements for 
feed hygiene 
Import / transit controls 
and border inspections 
posts (BIPs) 
Animal Welfare 

2008-7802 

2008-7815 

2008-7634 

2008-7635 

2008-7850 

2008-7861 

2008-7776 

2008-7722 

2008-7751 

2008-7769 

EN 

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  EN 

 
 
 
 
Annex VIII: Member States' Opinions 

This Annex presents an overview of the positions taken by the Member States in reply to the 
consultations about the review of Regulation (EC) No 882/2004 held within:  

1)  the Working Group on the general application of Regulation (EC) No 882/2004; 

2)  the  Working  Group  of  Chief  Officers  for  Plant  Health  and  its  Task  Force  on  the 

inclusion of plant health in regulation  (EC) No 882/2004; 

3)  the Task Force on " Plant reproductive material" under Regulation (EC) No 882/2004  

The  Commission  has  attempted  to  correctly  summarise  and  refer  to  those  positions,  which 
however had to be re-arranged and interpreted for the purposes of this Annex. 

Scope  

1.  Issue: clarifying the scope of Regulation (EC) No 882/2004  

Member  States:  general  support.  MS  would  welcome  some  clarifications  on  the 
extent to which the Regulation applies to AW and AH sectors. Some MS stated it must 
be  clear  that  the  Regulation  does  not  apply  to  food  itself,  but  also  to  packaging  and 
food contact materials.  

2.  Specific  measures:  clarify  the  definitions  of  the  terms  "monitoring",  "survey"  and 
"surveillance" in order to align them to those included in the sectoral legislation and 
clarify to which extent Regulation (EC) No 882/2004 applies to these activities.  

Member States: general support. Many MS suggest aligning these definitions to those 
of the OIE or other international organizations. One MS claim it should be clarified if 
the "surveys" carried out in the PH sector (in its opinion a crucial part of the control 
activities  carried  in  this  sector)  are  to  be  considered  as  an  official  control  and,  thus, 
included within the scope of  Regulation (EC) No 882/2004. 

3.  Issue:  extending  the  scope  of  Regulation  (EC)  No  882/2004  to  ABP,  PH  and  Plant 

Reproductive material legislation.  

Member  States:  diverging  views.  Some  MS  (4)  are  in  favour  of  this  measure,  as  it 
would permit to build a more coherent and exhaustive framework of official controls. 
Other MS (4) opposed the proposal to extend the scope to PH and Plant reproductive 
material  legislation:  since  the  aims  and  the  functioning  of  control  activities  in  these 
sectors differ profoundly, such an extension would be a complex and possibly costly 
exercise. 

Language and terminology   

4.  Issue: Adjust the language and the terminology used throughout Regulation (EC) No 
882/2004  in  order  to  avoid  divergent  interpretations  and  take  fully  account  of  all 
sectors already covered by the Regulation as well as, in case of an extension to PH, 
Plant reproductive material and ABP sectors, will fall under its scope.  

EN 

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  EN 

 
 
 
 
 
  
 
Member  States:  general  support.  All  MS  recognise  the  need  to  reformulate  the 
language and terminology, in particular if the scope of Regulation (EC) No 882/2004 
is to be expanded. 

5.  Issue:  clarify  the  definitions  of  "official  controls",  "competent  authority",  "control 
body",  "official  certification",  "import"  provided  for  by  article  2,  in  particular  when 
inconsistencies  exist  with  the  respective  definitions  provided  for  by  AH  and  PH 
legislation. 

Member  States:  general  support.  Many  MS  proposed  to  align  these  definitions  to 
those  of  the  OIE,  IPPC,  EPPO,  ISTA  or  other  international  relevant  organizations. 
Regarding the definition of "official control" one MS suggested including, under the 
definition  of  "official  controls",  the  follow-up  activities  carried  out  in  case  of  non 
compliance  under  article  54.  Some  MS  also  stated  that  the  definition  of  "official 
certification" should be amended in order to take into account the specificities of the 
Plant reproductive material sector. 

Transparency  

6.  Issue:  amendment  to  the  provision  on  transparency  (article  7),  in  order  to  set  the 
minimum level of information to be disclosed by the Competent Authorities as well as 
the  degree  of  such  disclosure.  The  possibility  of  establishing  a  common  format  for 
providing this information was also considered. 

Member States: general support except for one MS, according to which the extension 
of this provision to the Plant Health and to the Plant reproductive material sectors (if 
included in the scope of the Regulation) would de disproportionately onerous for MS 
control  services.  Another  MS  considers  that  information  should  only  be  disclosed  in 
summary format, and that, in any case, CA should be left free to decide the format to 
adopt for the report.  

7.  Issue:  introduction  of  an  obligation  for  MS  to  make  the  MANCPs  and  the  ARs 

available to the public.  

Member  States:  one  MS  opposed  this  measure,  affirming  that  the  decision  on  the 
disclosure should pertain to MS.   

Border controls  

8.  Issue: establishing a common set of rules governing border controls in relation to all 
commodities  requiring  controls  prior  to  their  entry  into  the  EU.  A  list  of  the 
abovementioned commodities would be adopted. The type and frequency of the border 
controls, as well as their frequency, would be harmonised and risk-based.  

Member  States:  general  support.  MS  believe  this  measure  would  enhance  the 
transparency  and  efficiency  of  border  controls.  However,  two  MS  affirm  that  EU 
action should be limited to establish the general principles and requirements governing 
border  controls,  while  the  more  specific  issues  would  be  regulated  under  sectoral 
legislation. As concerns the Plant Health sector, some MS opposed the adoption of a 
risk-based approach, insisting that the rule should be 100% frequency checks. 

EN 

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  EN 

 
 
 
 
 
 
 
Information management and handling system for official controls (TRACES+)  

9.  Issue:  establishment  of  a  computerised  information  system  for  the  management  and 
exchange  of  data  and  information  concerning  official  controls.  TRACES+  should  be 
interoperable and integrated with other European and national systems.  

Member  States:    general  support  except  for  one  MS  according  to  which  the 
establishment  of  TRACES+  would  result  in  additional  administrative  burdens  and 
costs. Interface problems between national IT systems and the current TRACES were 
reported  by  MS,  which  affirmed  that  attention  is  required  on  this  point  in  the 
development of IT tools in the implementation phase. 

Official certification  

10. Issue:  clarify  and  harmonise  the  principles  governing  official  certification  and  the 
conditions  under  which  it  is  issued.  Amendment  of  the  definition  of  "official 
certification in order to include the official certification issued by operators under the 
supervision of the Competent authority. 

Member  States:  general  support.  MS  suggest  aligning  the  provisions  concerning 
official certification to the existing internationally recognised rules. Some MS affirm 
the  peculiarities  of  the  Plant  Health  and  of  the  Plant  reproductive  material  sectors 
should  be  taken  into  account  when  establishing  the  rules  governing  official 
certification.    As  regards  the  Plant  reproductive  material  sector,  MS  welcome  the 
possibility of amending the definition of "official certification", as this would allow to 
take into account the peculiarities of this sector. 

Planning and reporting  

11. Issue:  extension  of  planning  and  reporting  requirements  to  the  sectors  newly 

introduced within the scope of Regulation (EC) No 882/2004.  

Member States: MS are against this measure, in particular as regards the extension of 
planning  and  reporting  requirements  to  the  Plant  reproductive  material  sector  (note 
that  the  obligation  already  covers  the  plant  health  sector).  In  their  opinion,  this 
obligation would represent an unnecessary and excessive burden. 

12. Issue: empowerment to the EC to provide MS with standard templates for the drafting 

of the MANCPs and of the ARs.  

Member  States:  general  support  except  for  one  MS,  according  to  which  there  is  no 
need for such a template.     

13. Issue:  empowerment  to  introduce  a  minimum  level  of  controls  for  certain  illegal 

substances in the MANCPs 

Member  States:  Ms  were  sceptical  about  this  measure,  as  it  is  incoherent  with  the 
risk-based  approach  of  official  controls  and  might  lead  to  an  ineffective  use  of 
financial  resources  by  MS.  In  any  case,  MS  stated  further  discussions  on  this  point 
were needed.  

EN 

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  EN 

 
 
 
 
 
 
 
 
In addition, overviews of the positions expressed by MS in relation to specific issues can be 
found in the following Annexes: 

(cid:190)  Annex  XVIII  –  Laboratories  -  MS'  consultations  on  the  accreditation  of  official 

laboratories (discussion paper and results). 

(cid:190)  Annex  XX  –  Directive  96/23  -  MS'  consultations  on  the  available  options 

(questionnaire and results). 

(cid:190)  Annex XXI – Directive 96/23 - costs reductions relating to the repeal of the Directive. 

EN 

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Annex IX: REVISION OF REGULATION 882/2004 – Summary of 
stakeholders' opinions in 2011 

This  Annex  presents  an  overview  of  the  positions  taken  by  the  stakeholders  in  reply  to  the 
consultations,  either  at  conferences  and  consultation  meetings  or  in  writing  about  general 
issues  relating  to  the  review  of  Regulation  882/2004.  The  Commission  has  attempted  to 
accurately summarise and refer to those positions, which however had to be re-arranged for 
the purposes of this Annex127. 

I. Issues specifically addressed during the Working Group held on the 19/09/2011 

1. Transparency 

1.1 High level of transparency 

The  issue  of  transparency  was  addressed  by  the  majority  of  the  stakeholders  as  one  of  the 
priority of the review.  

Eurogroup provided the Commission with a detailed proposition on how to improve the level 
of  transparency  throughout  the  Regulation.  Firstly  they  underlined  that  in  Article  7  the 
meaning “a high level of transparency”, “relevant information” or “information on the control 
activities and their effectiveness” is unclear. Consequently they suggest that the text specifies 
which information the member states must make publicly available and what they need to do 
to  inform  the  public  that  this  information  is  available.  Secondly  they  suggest  that  the 
following documents are made available on the Commission website: 

-  Above  mentioned  documents,  with  links  to  each  of  the  national  reports,  plans  and 
other documents of each member state,  

- Reports including following controls on-farm and in slaughterhouses,   

-  Multi  Annual  Control  Plans  (MANCP),  of  the  Annual  reports  and  of  reports  of 
controls  conducted by third  countries administrations on food  and feed products and 
live animals to be imported, 

- Measures taken by the member States take in case of infringements to the European 
Commission (eg. the amount in case of a fine)  

The  European  Snack  Association  and  Fooddrink  strongly  believe  that  the  primary 
objective  of  the  revision  of  Regulation  (EC)  No  882/2004  is  to  ensure  a  greater  level  of 
transparency  and  clarity  at  all  levels  among  stakeholders.  Furthermore  practices  and 
interpretation  by  authorities  should  be  more  transparent  to  food  operators  throughout  the 
supply  chain.  Another  key  concern  for  them  is  transparency  in  the  listing  and  delisting 
process. They suggest creating a more transparent process regarding how decisions on testing 
frequencies  are  reached.  In  addition  ESA  affirms  that  greater  cooperation  and  information 
exchange  would  enable  food  operators  and  their  suppliers  to  more  quickly  and  directly 
respond  to  food  safety  concerns,  resolving  them  expeditiously  and  thus  would  benefit  the 

127 Stakeholders active in the fields of Plant Health and Plant reproductive material were also consulted in the 
context  of  the  related  reviews,  inter  alia  as  regards  the  inclusion  of  those  sectors  under  Regulation  882  and 
consequent implications. 

EN 

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  EN 

 
 
 
 
 
 
                                                 
 
entire food supply chain. Finally they warn that the existent lack of transparency adds to the 
fear among food operators and suppliers that it will continue to be easier to add things to the 
list  than  take  them  off,  leading  to  a  gradual  lengthening  of  the  Annex  I  list  (and  associated 
increase in costs to importers).  

UECBV is in  favour  of full  transparency between Food Business Operators and Competent 
Authorities in both directions. It is important for FBOs to know what criteria are applied when 
inspections are carried out and the reasons behind the decisions taken. Similarly, it must also 
be clear to CAs what is done at company level, in particular with regard to the framework of 
their HACCP-based systems or certification schemes. With regards transparency towards the 
public,  they  believe  the  most  important  and  relevant  information  is  whether  a  plant  is  EU 
approved.  Such  approval  ensures  that  the  FBO  is  producing  safe  food.  They  are  concerned 
that  providing  more  complex  and  detailed  information  would  lead  to  misunderstandings  by 
consumers and possible distortions of competition. 

CELCAA  emphasises  that  the  authorities  need  to  provide  a  complete  picture  of  the  risk 
involved to the public.  

•  Transparency of official controls on feed and food on non-animal origin  

The  European  Snack  Association  claims  that  there  is  a  lack  of  transparency  about  how 
foodstuffs that are subject to increased levels of control have been defined, the criteria used to 
make such decisions and also regarding the basis used for adding or deleting foodstuffs from 
the high risk list. They would welcome an explanatory note with the background for each of 
the commodities/origins included in the Annex as well as for any deletions to the list, as this 
would  enable  origins/suppliers  to  better  understand  where  any  deficiencies  exist,  and  how 
they can be addressed. Since there appears to be no formal notification of 3rd countries or of 
the commodities regarding the imposition of mandatory import controls (where commodities 
are added to the list), they request stakeholders/interested parties to be informed as early as 
possible  and  that  appropriate  transitional  arrangements  are  put  in  place  to  allow  industry  to 
ensure compliance. In addition they would consider the publication of a consolidation of the 
quarterly  reports  provided  by  the  Member  States  to  the  Commission  to  be  of  great  value  to 
stakeholders  since  it  would  not  only  help  them  to  understand  better  how  the  Annex  review 
process works but also add credibility to the actions taken. Finally they emphasise that not all 
Member  States  adhere  to  the  established  timeframe  of  15  days  for  control  and  that  given 
improvements  in  analytical  methods  and  costs  associated  with  demurrage,  a  shorter  period 
should be established when dealing with food products (especially perishable items). 

1.2. Publication of MANCP and Annual reports  

While five stakeholders claim that these documents should be made available to the public, 
one is opposed to this measure. 

The  European  Snack  Association,  Fooddrink  and  UECBV  believe  that  these  two 
documents  should  be  made  publicly  available  in  order  to  increase  transparency  and 
confidence among stakeholders. In their view Member States should also be obliged to report 
their  focus  for  the  coming  year,  where  they  are  going  to  be  doing  surveillance,  etc.  In  the 
same line of thought, they believe that Member States should be obliged to include how they 
to  bonded  warehouse  pending 
deal  with 
testing/release/reshipment,  fees,  etc.  FEFAC  is  of  the  opinion  that  the  MANCP  and  the 
Annual  reports  should  be  made  available  to  the  public,  as  this  would  help  operators  and 
national  authorities  from  other  Member  States  to  review  and  adapt  their  own  risk  analyses. 
UECBV claims that these documents should be made available on the Commission web-site. 
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to  move  goods 

retesting, 

ability 

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CELCAA  notices  that  the  publication  of  these  documents  should  be  well  reflected  and 
submitted  to  clear  criteria  in  view  of  the  damage  some  information  may  cause  to  FBOs. 
Nevertheless  CELCAA  would  welcome  to  have  access  to  information  (on  at  least  the  parts 
relevant to them) via the CIRCA system.  

1.3. Performance rating ('system of smileys') 

While  one  stakeholder  fully  supports  of  the  introduction  of  a  'smileys  system',  and  another 
one is clearly opposed to it, three believe this issue deserves more investigation.  

According to Eurogroup system of rating (smileys) could be a good way to inform the public 
of  the  level  of  compliance  found  for  specific  food  business  operators.  However  more 
information is needed on how it is applied, what level of information it represents and what is 
the perception of the public.  

UECBV  is  not  in  favour  of  performance  ratings  such  as  smileys,  since  where  such  ratings 
exist, they differ very much from one Member State to another, can be misleading and may 
not be comparable at an EU level. HORTEC also considers that Member States should remain 
free  to  implement  or  not  such  systems.  They  argue  that  the  experience  has  shown  that  the 
divergences between the countries where the system is already in place and other ones, have 
no impact on the single market.  

Fooddrink'view is that the suggested system based on ‘smileys’ or similar initiatives would 
need  further  investigation.  CELCAA  notes  that  such  a  system  has  little  relevance  for  B2B 
communication.  In  addition  caution  and  diligence  should  be  used  in  developing  such  a 
performance rating and in defining the criteria to be used. FEFAC is not opposed in principle 
to a system of performance rating. As a matter of fact, they believe performance of individual 
companies  is  an  element  to  be  taken  into  account  by  control  authorities  when  establishing 
their control plan. However, they are not in favour of a publication of this performance rating 
by individual companies. They suggest instead encouraging Member States to develop tools 
allowing to measure an overall performance level for the whole feed and food chain in order 
to provide a picture of the evolution of the overall safety status of feed and food over time. 

2. Right of second opinion (extent of the right provided in Article 12) 

The three stakeholders who expressed their views on this question claimed that the right to get 
a second opinion should be systematic.  

It  is  considered  by  CELCAA  as  one  of  the  FBOs'  basic  right.  It  would  be  useful  to  get  a 
second opinion of a neutral arbitrator when tolerance levels approach the detection level.  

FEFAC  is  of  the  opinion  that  the  possibility  for  an  operator  to  call  for  a  second  expert 
opinion should be systematic. However, they underline that the legislation should specify the 
conditions under which this second expert opinion may be requested and what should happen 
in  case  of  contradictory  opinions.  They  insist  in  particular,  on  the  fact  that  the  method  of 
analysis  to  be  used  is  an  essential  element  to  be  clarified.  Regulation  (EC)  No  882/2004 
indeed favours official EU analytical methods over standardized (ISO/CEN) methods over in-
house  methods  (cascade  approach).  However,  official  or  CEN  methods  are  tested  and 
validated  for  certain  matrixes  or  sample  types.  In  case  the  composition  of  a  sample  to  be 
tested deviates from these "standard samples", the official / standardised method may not be 
as accurate and should be in principle validated for each type of sample, which is never the 
case  in  practice.  As  a  result,  the  analytical  data  obtained  by  a  standard  routine  may  not  be 
more  correct  than  results  obtained  by  an  in-house  method  which  is  well  adapted  to  the 
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specific properties of a sample. We therefore hold the view that second expert opinion based 
on analytical results should allow using a second sample preparation / analytical method. 

UECBV is strongly in favour of such a right as the urgent need for such a system has been 
emphasized  in  different  food  crises,  including  the  latest  incident  regarding  ”ecoli  in 
cucumbers”.  However,  UECBV  is  not in favour  of a system such  as that in DK and in FR, 
where  only  one  party  is  heard  i.e.  the  Competent  Authorities.  On  the  contrary  they  are  in 
favour  of  a  referee  system,  consisting  of  members  of  different  disciplines  and  composed  of 
representatives  both  from  FBOs  and  from  CAs.  It  must  be  fair  and  balanced,  involving 
independent experts. 

The European Snack Association argues that the lack of a clear specified timeframe for the 
second opinion test (and reference test) can discourage food operators from exercising their 
rights  if  told  it  will  take  30  days  for  a  retest.  They  suggest  establishing  an  obligation  on 
inspection  authority  to  adhere  to  timelines  –  either  fees  are  not  charged  or,  at  least,  goods 
undergoing  retest  should  be  allowed  to  be  moved  (under  supervision)  to  avoid  incurring 
further charges. 

3. Import controls  

3.1. Use of improved IT tools 

CELCAA  claims  that  TRACES  should  be  expanded  to  products  of  non-animal  origin,  in 
order  to  provide  reliable  information  on  serious  risks  detected  in  relation  to  food  and  feed. 
They further suggest the Commission to look closely at the community customs code and the 
e-customs initiative.  

3.2. Documentary checks v Analytical checks (Article 16) 

FEFAC  highlights  that  EU  legislation  gives  priority  to  analytical  controls,  in  particular  for 
the control of the presence of contaminants or constituents. They underline that it may happen 
that even if a method of analysis exists, it may not always be relevant for control purposes. 
They give two examples to illustrate this: 

- control of the added amount of copper as declared on the compound feed label: copper can 
be analysed by an analytical method but this method will not be able to differentiate between 
added and native copper; therefore, the result of the analysis is likely to exceed the amount of 
added copper declared under the feed additive heading on the compound feed label. 

-  control  of  added  amounts  of  antioxidants:  the  level  of  antioxidants  in  compound  feed  is 
decreasing  overtime  as  they  are  eliminated  when  performing  their  function;  therefore,  the 
amount  of  antioxidants  to  be  determined  by  analytical  means  is  likely  to  be  below  the 
declared amount on the label. 

In  both  cases,  they  claim  that  the  only  adequate  way  to  control  that  the  declaration  on  the 
label of the added amount of copper or antioxidant is correct is documentary checks.  

They  therefore  suggest  to  introducing  a  provision  in  the  Regulation  (EC)  No  882/2004 
whereby  specific  rules  for  the  performance  of  official  controls  could  be  developed  by 
comitology, in particular as regards the relevance of documentary vs. analytical checks. 

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3.3. Points of entry and prior notification (Article 17) 

The European Snack Association stresses that not all points of entry have facility to inspect 
consignments – e.g. to unload containers, warehousing, etc… 

3.4. Special treatment (Article 20) 

The  European  Snack  Association  argues  that  in  the  absence  of  any  effective  recourse  on 
damage resulting from delays the net result is that all these costs end up with the consumer 
and  add  to  food  inflation.  Moreover  they  underline  that  the  administration  costs  for  this 
regulation  are  hidden  but  are  huge  in  terms  of  communications,  claims,  etc.  They  also 
emphasise the absurd situation whereby small sample consignments, (e.g. 200g), which some 
DPE’s insist are covered by the requirement for a CED (at a cost of £75).  

3.5. Approval of pre-export checks by third countries (Article 23) 

The  European  Snack  Association  claims  that  no  real  account  appears  to  be  taken  of 
companies who have invested in GAP, GMP, certification and which undertake origin testing 
before shipment. They state that it is possible that investments towards safeguarding imports 
into the EU would be adversely affected if Article 23 was not changed, since implementing 
such  costly  pre-export  controls  does  not  provide  any  additional  consideration  or  confidence 
among  EU  authorities.  According  to  them  it  is  crucial  that  the  Commission  specifies  that 
controls  should  be  <1%,  otherwise  it  is  left  to  Member  States  interpretation.  It  is  also 
important to ensure that documentation is clearly different from commodities coming in under 
emergency  measures  –  again,  import  authorities  do  not  easily  distinguish  between  the  two 
schemes, since the documentation is very similar (basically the same CED).  

3.6. Border Control Points 

BREIZ highlights that the EU lacks a coherent policy concerning food imports controls and 
particularly the BIPs. They underline that they are more than 300 BIPs (with comparison to 
ten  in  the  US  for  veterinary  and  phytosanitary  controls).  Consequently  they  argue  that  a 
reduction  of  the  number  of  BIPs  would  enhance  their  administrative,  financial  and  staff 
resources.  

4.  Administrative assistance and cooperation 

4.1 Assistance in the event of non-compliance (Article 38) 

The European Seed Association is in favour of the introduction of a harmonized approach to 
address non-compliance on the national as well as on EU level in respect of S&PM and PH 
legislation.  UGAL  welcomes  the  initiative  to  overhaul  the  provisions  on  administrative 
assistance so that competent authorities more systematically and effectively work together to 
enforce  food  law  against  the  Union  operators  actually  responsible  for  food  risks  and  non-
compliances.  

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4.2 Relations with third countries (Article 39) 

The  European  Snack  Association  requests  that  where  emergency  measures  are  to  be 
introduced,  there  should  be  more  formal  consultation  with  third  country  governments; 
otherwise  it  is  unclear  how  they  are  to  respond  or  work  with  their  industries  to  improve  a 
perceived deficiency in their production practices.  

4.3. Coordinated assistance and follow-up by the Commission (Article 40) 

The  European  Snack  Association's  opinion  is  that  where  issues  are  raised  to  the 
Commission, there should be a transparent way of having these issues added to the agenda of 
a Working Group meeting.  

II. Other issues  

5. General comments 

Fooddrink  underlines  the  following  shortcomings  of  the  system:  fees  are  not  posted,  it  is 
unclear when reprocessing is/is not allowed, process for selecting consignments is not clear, 
FBOs  do  not  receive  any  summary  information  regarding  the  number  of  consignments 
received, inspected, and percentage rejected. 

6. Scope of the Regulation 

While the three stakeholders who addressed this issue supported the extension of the scope of 
the regulation to include PH and S&PM, two of them underlined that the sectoral specificities 
should be carefully taken into account.   

Eurogroup  has  welcomed  the  inclusion  of  animal  welfare  legislation  in  the  scope  of  the 
official control regulation. They believe that guaranteeing the welfare of animals is essential 
to provide for a high degree of food safety.  

FEFANA  supports  the  idea  of  including  the  review  of  Regulation  No  882/2004  within  the 
context  of  an  integrated  package.  Nevertheless they  stress  that  sufficient  attention  has  to  be 
paid to the different provisions of the sectorial legislations and their combination. 

The  European  Seed  Association  is,  in  general,  in  favor  of  harmonization  and  therefore 
supports  the  idea  of  making  use  of  the  already  existing  harmonized  EU  framework  also  in 
respect  of  controls  for  the  purposes  of  S&PM  and  PH  legislation  as  long  as  it  is  consistent 
with the specificities of these sectoral legislations. In particular they support the introduction 
of harmonized EU controls over the controls carried out on national level also in the field of 
S&PM and PH legislation. Nevertheless they underline that they are in favour of leaving the 
sector specific elements in place whenever it appears appropriate (e.g. seed certification and 
delegation  of  official  tasks  under  official  supervision  to  third  parties,  including  private 
operators). 

7.  Risk-based controls (Article 3) 

All three stakeholders who addressed this issue supported the risk-based approach.  

According  to  Fooddrink  it  is  essential  that  the  future  EU  framework  for  a  control  system 
clearly defines that official controls should be carried out on a risk basis. CELCAA believes 

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official controls should be carried out based on the risk involved as well. They precise that the 
risk should be determined by clearly defined, objectively verifiable and harmonised criteria. 
The risk-based analysis should determine the nature and intensity of the controls to which the 
diverse agricultural commodities should undergo.  

The  English  National  Federation  of  Meat  &  Food  Traders  (member  of  IBC)  believes  that 
meat  inspection  should  be  greatly  reduced  in  scale.  Operator  responsibility  should  be 
enhanced and legislation should be based on a risk based approach.  

8. Competent authorities (Title II, Chapter 2) 

Eurogroup  has  highlighted  the  following  problems  relating to the infrastructure of national 
authorities: 

-  Failure  to  carry  out  or  include  the  necessary  proportion  of  animal  welfare  checks  in  the 
annual inspection programmes 

- Lack of staff or appropriately trained staff 

- Failure to put in place effective and dissuasive sanction systems to react to infringements 

They underline that standards are especially poorly enforced in the area of: 

- the protection of live animals during transport: insufficient controls at the start of journeys 
including on journey plans; 

-  production  systems  for  laying  hens:  lack  of  progress  in  the  conversion  of  barren  battery 
cages into enriched cages or alternative systems 

-  the  protection  of  pigs:  tail  docking  is  performed  routinely  and  no  foraging  material  is 
generally provided.  

CELCAA makes two observations: 

- The quality and efficiency of controls has an impact on the costs 

-  Decisions  taken  by  the  competent  authorities  may  have  great  consequences  for  the 
business operators.  

They  conclude  that  the  time  efficiency  in  performing  official  controls,  in  terms  of  staff, 
procedures and equipment as well as in delivering results by control authorities is essential. 
They stress that inefficiencies by control authorities should be avoided as far as possible as 
they create additional burden to FBOs in terms of costs and delays in discharging/delivering 
the goods.  

8.1. Delegation of tasks (Article 5)  

The European Seed Association is of the opinion that the specificities of the Seed sector are 
key to a flexible and well-functioning seed legislation and that there is a risk that these key 
elements  may  be  harmed  with  a  full  integration  of  the  S&PM  and  PH  legislations  into  the 
scope  of  the  Regulation  (EC)  No  882/2004.  In  particular,  bringing  the  seed-related  controls 
under this regulation should not have any consequences for existing and new possibilities for 
delegation  of  official  tasks  under  official  supervision  to  third  parties,  including  private 
operators. 

Bundesinnung der Fleischer (member of IBC) claims that meat inspections in slaughterhouses 
slaughtering 1,000 livestock units or less per year should be authorized to be carried out by an 

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official  meat  inspector  instead  of  an  official  veterinarian  (only  in  case  of  doubt  an  official 
veterinarian should have to be consulted). The English National Federation of Meat & Food 
Traders  (member  of  IBC)  also  stresses  that  there  is  no  need  for  extensive  veterinary 
attendance  in  the  case  of  meat  inspection.  They  argue  that  meat  inspectors  (auxiliaries)  can 
carry out post mortem inspections after slaughtering has finished if it can be proved that it is 
necessary and efficient. 

8.2. Verification procedures (Article 8) 

Eurogroup  believes  that  the  verification  procedures  are  essential  provisions  and  therefore 
guidelines should be established for their preparation. They suggest adding to Paragraph 4(d) 
a  requirement  for  the  documented  procedures  to  be  submitted  to  the  European  Commission 
for advice.  

8.3. Reports (Article 9)  

The European Snack Association and Fooddrink recommend that inspection reports should 
always  be  provided  as  one  of  the  specific  documentation  accompanying  a  consignment  the 
Authorities require. They stress that their members have reported situations where laboratory 
analyses were not provided, even when requested. In the light of two concrete examples they 
underline  the  need  for  maximum  transparency  and  best  practice  shared  between  Member 
States and more commitment on the part of the authorities to avoid unnecessary recalls. They 
suggest that a basic level of information on reports (e.g. date codes etc.) should be harmonised 
across the EU to prevent uncertainty for FBO’s who operate across different Member States.  

Eurogroup states that reports should be made available to the public. 

9. Methods of sampling and analysis (Article 11) 

The European Snack Association stresses the importance of protecting both product quality 
and  food  safety  during  this  part  of  the  inspection  procedure.  They  have  been  informed  that 
some inspection points do not have the ability to move goods to a warehouse to unload  the 
container  before  inspection  or  while  awaiting  testing  results,  leading  to  excessive 
costs/demurrage and exposure to weather. Furthermore where containers are unloaded, there 
is  frequently  a  problem  with  re-loading  the  entire  product  back  into  the  container,  leaving 
individual  pallet(s)  with  no  where  to  go.  Food  operators  have  reported  containers  being 
unloaded,  and  authorities  not  properly  reloading,  resulting  in  losses/damage  during  onward 
transit. In the light of these information they claim that not having specific areas for unloading 
can also result in the product being exposed to cross contamination/microbial contamination 
from  standing  water,  birds,  etc.  Moreover  they  underline  that  importers  have  no  realistic 
recourse to the Port companies or PHA's for any damage caused and that labs are often not all 
located at the port, resulting in delays for analysis. 

10. Official certification (Article 30) 

Eurogroup states that the kind of certification covered and its purpose needs to be clarified in 
Article 30.  

The  European  Snack  Association  emphasises  the  fact  that  lab  reports/inspection  reports 
should always be provided. 

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The European Seed Association believes it has to be noted that both the S&PM and the PH 
legislation  contain  some  very  specific  provisions  as  regards  controls  that  have  to  be  carried 
out  for  the  purposes  of  seed  certification.  Since  decades  seed  certification  under  the  EU 
S&PM legislation is carried out according to the rules as defined by ISTA, the International 
Seed  Testing  Agency.  Similarly,  seed  certified  in  third  countries  in  accordance  with  OECD 
seed  schemes  is  eligible  for  equivalence  recognition  in  the  EU.  As  these  international 
standards exist and have long been used by the seed industry the EU should continue to make 
use of them instead of creating new ones. 

10.1 Veterinary certificate 

BREIZ  underlines  that  the  veterinary  certificate  that  FBOs  receive  in  exchange  of  the  fees 
they pay (which hinders their competitivity) is not recognize by administrations whose control 
tasks  are  relating  to  other  legislations  than  those  of  sanitary  rules.  This  is  particularly 
problematic when the customs services do not recognize the certificate and refuse to allow a 
product  to  be  exported  to  third  countries.  Breiz's  opinion  is  that  it  discredits  the  entire  OC 
system in the eyes of the European and international firms.  

10.2 Third party certification 

FEFANA They believe that the revision of this Regulation should be an excellent opportunity 
to  explore  with  Member  States  and  Commission  the  role  of  third  party  certification  as  a 
support  to  the  official  control  and  to  bring  the  feed  legislation  closer  to  the  Commission 
communication on third party certification. 

11. Registration/approval of feed and food business establishments (Article 31)  

The European Seed Association is in favour of the introduction of an obligation for S&PM 
suppliers of being registered at national and/or EU level. They are of the opinion that from the 
perspective  of  controls  such  a  registration  obligation  could  be  very  helpful  in  spotting  or 
avoiding non-compliance with the legislation as well as other possible illegal activities. 

12. National enforcement measures  

12.1. Action in case of non-compliance (Article 54) 

The  European  Snack  Association  notices  that  not  all  Member  States  allow  the  practices 
provided  by  technological  improvement  in  terms  of  resorting,  reprocessing,  etc...  It  is 
important  in  their  view  to  have  a  better  understanding  of  individual  Member  State’s 
interpretation of this Article.  

12.2. Sanctions (Article 55) 

Eurogroup  argues  that  since  sanctions  play  an  important  role  in  improving  enforcement  of 
EU  rules,  they  should  be  harmonised.  They  underline  that  in  the  field  of  animal  welfare 
sanctions  are  not  always  dissuasive  and  thus  not  effective.  They  would  welcome  guidelines 
from the European Commission on what they consider to be appropriate sanctions in specific 
infringement cases.  

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Annex X: FEES – Executive summary of the study on fees or charges 
collected by the MS to cover the costs occasioned by official 
controls prepared by food chain evaluation consortium (FCEC) 

Regulation 882/2004128 (hereafter  referred to as  ‘The Regulation’)  sets out  requirements for 
the  authorities  in  EU  Member  States  that  have  responsibility  for  monitoring  and  verifying 
compliance  with,  and  enforcement  of,  feed  and food  law,  animal  health  and  animal  welfare 
rules,  i.e.  the  'Competent  Authorities'  (CAs)  responsible  for  organising  and  undertaking 
'official controls' (OCs).  

According  to  Article  65  of  the  Regulation,  three  years  after  its  entry  into  force,  the 
Commission should review the experience gained from its application, in particular in terms 
of  scope  and  the  fee-setting  mechanism,  and  whether/how  the  current  fees  regime  can  be 
improved. The data collected and results of this study, which focused on the implementation 
of  the  financing  provisions  of  the  Regulation  (Articles  26-29),  will  feed  into  a  Commission 
Report  to  the  European  Parliament  and  Council  for  a  possible  modification  of  the  current 
legislation. 

The objectives of the study are two-fold: 

a)  to  establish  a  detailed  picture  and  evaluate  the  present  situation  as  regards  the 
application  of  the  current  fees  regime,  in  particular  the  way  in  which  the  system 
operates in practice; and, 

b) to assess the advantages and disadvantages of a range of policy options (regarding the 

scope of current rules and the fee-setting mechanism).  

As such, the final aim is to provide input to the Commission’s development of proposals to 
improve the fees system in future. 

The  assessment  of  the  current  system  and  future  policy  options  take  into  account  the  wider 
objectives and principles of EU policy in this sector. As such, the study considers the overall 
objective of the Regulation to ensure a harmonised approach with regard to official controls, 
the objectives of EU food and feed law129 to ensure a high level of protection of human life 
and health and achieve the free movement in the Community of compliant feed and food, and 
the  objectives  of  the  Lisbon  Strategy  to  promote  better  regulation  and  support  industry 
competitiveness. Furthermore, the principles of proportionality, subsidiarity (Article 5 of the 
Treaty)  and  FBO  responsibility  (in  accordance  with  current  food  and  feed  law)  frame  the 
approach of this study.  

The study was carried out in the period April-November 2008 through a survey of EU27 CAs, 
in depth analysis (case studies) in six MS representing a variety of fee regimes (Germany, the 
UK, Italy, Poland, France and Slovakia), interviews with key experts and stakeholders at EU 

128  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. 
129  Regulation  (EC)  178/2002  (General  Food  law)  and  the  Hygiene  Package  (Regulations  (EC)  852/2004, 
853/2004 and 854/2004). 

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level130, and extensive literature and data review (including relevant FVO reports and national 
legislation). 

The  study  has  found  that  significant  progress  has  been  made  in  the  application  of  the 
Regulation  by  MS,  and  in  particular  the  financing  provisions  of  Articles  26-29,  since  their 
entry into force on 1 January 2007. However, the enforcement of these provisions has been 
slow and gradual, with significant delays in most MS. In some cases, full implementation is 
still pending subject to the approval of draft national legislation enacting Article 27, despite 
the fact that the deadline for its definitive entry into force was 1 January 2008. In these cases 
the  fee  system  in  place  is  largely  based  on  that  laid  down  in  previous,  repealed  legislation 
(Directive 85/73).  

Despite progress a number of important shortcomings have been identified in the current state 
of implementation of Articles 26-29, as follows: 

Competent Authorities (CAs): There are significant differences in the organisation, structure 
and staffing (number and profiles of staff) between MS, which have financial implications for 
the cost of official controls (OCs). Contrary to the Commission’s expectations, more than one 
CA  is  involved  in  most  cases,  which  may  create  lack  of  transparency  and  of  central/overall 
responsibility. In MS with decentralised management, the central CA is not always in control 
and efficient/effective coordination is not always ensured. The study findings confirm issues 
which  are  already  highlighted  in  relevant  FVO  reports.  In  several  MS  initiatives  are  under 
way  to  rationalize  veterinary  services,  such  as  the  use  of  appropriately  trained  contractual 
staff for the OCs rather than civil servants.  

Activities for which fees are collected: A distinction is made throughout the study between 
OC activities for which fee collection is ‘compulsory’ (Article 27.2, activities of Annexes IV 
and V), and those for which fee collection is optional or ‘non-compulsory’ (Article 27.1). The 
study  has  found  that,  in  the  case  of  ‘compulsory’  fees:  9  MS  collect  such  fees  only  partly; 
fees for milk production and for residue controls were found to be ‘controversial’ and often 
not collected at all; on the other hand, in some MS fees are collected for the same OCs more 
than once along the production chain (e.g. at slaughter and cutting plant even within the same 
establishment, contrary to Article 27.7). In the case of ‘non-compulsory’ fees: 19 MS collect 
fees for activities beyond those of Article 27.2, while 6 do not collect any such fees; fees are 
collected in some MS for OCs on products of non-animal origin. 

Fee  rates  used:  Regulation  882/2004  leaves  it  up  to  MS  to  define  fee  system:  either 
minimum fees as defined in Annex IV (domestic controls) and V (import controls) or fee rates 
calculated on the basis of the actual costs of OCs (‘flat rates’). In practice, a multitude of fee 
rates  apply  for  the  various  activities:  18  MS  use  a  mix  of  the  two  systems  (flat  rates  and 
minimum  rates);  the  current  situation  is  quite  complex,  not  transparent  and  confusing  for 
FBOs; the CAs appear to  have interpreted relevant  provisions  of  Article 27 rather ‘openly’. 
Furthermore, 12 MS apply fees below minimum rates, however it is not clear or sufficiently 
justified whether the conditions of Article 27.6 (controls of reduced frequency and criteria of 
para 5) are respected in these cases.  

Fee calculation: Article 27.4 stipulates that where flat rates are used, fee levels need to be set 
within the limits of the minimum fees set out in Annexes IV and V, and a maximum set by the 
actual controls costs; the fee calculation in this case must respect the criteria of Annex VI. In 
practice:  the  calculation  method  used  is  not  always  available,  or  has  not  always  been 
communicated to the Commission (contrary to requirements of Article 27.12); even when the 

130  Including  consultations  with  the  following  EU  professional  organisations:  AVEC,  CIBC/IMV/IBC, 
CLITRAVI, EDA, FEFAC, FVE, and the UECBV.  

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method  is  available,  it  is  not  always  transparent  what  type  of  costs  are  included  under  the 
various  cost  categories  and  what  reference  time  period  is  used;  in  most  cases  it  is  not  clear 
whether  the  actual  costs  included  in  the  calculation  respect  the  criteria  of  Annex  VI  (staff 
salaries; staff costs including overheads; lab analysis and sampling). 

Fee collection & use of revenue: The rationale of the system is to ensure adequate financial 
resources  to  provide  the  necessary  staff  and  other  resources  (Article  26).  In  practice:  in  the 
majority  of  MS  the  collected  revenue  is  incorporated  into  the  General  State  Budget,  either 
entirely (11 MS) on in part (7 MS); only 9 MS claim to be ‘ring fencing’ revenues specifically 
for the CAs performing the controls; 14 MS indicated they do not cover the OC costs through 
the fees, while a further 6 MS claim this is occurring in some cases (regions, activities). This 
partial cost coverage may be due to inappropriate fee setting (insufficient fee levels) as well as 
inappropriate fee collection / use of revenue. The position appears to be better in the case of 
imports controls, partly because Article 27.8 stipulates that such fees should be paid to the CA 
in charge. 

Enforcement of Article 27: Although the Regulation should be directly enforceable, Article 
27 allows some discretion to MS on the actual fee system to use and the activities for which 
OCs should be  charged beyond those of Article 27.2. The study has found that, in practice, 
there  is  significant  variation  between  MS  in  the  enforcement  of  Articles  26-29.  Underlying 
this, there is a strong perception - in some cases documented by FVO reports - of significant 
variation in the organisation and effectiveness of OCs, and that – as documented by the study 
findings  -  CAs  have  rather  liberally  interpreted  provisions  of  Articles  26-29  (this  is 
particularly  a  problem  in  some  MS  with  decentralised  management  and  lack  of  sufficient 
central control by the CCA). 

The study has therefore concluded that, as it currently stands, the system of fees for OCs does 
not fully fulfil its key objective: to provide sufficient resources for the effective and efficient 
operation of the OCs. Furthermore, the actual implementation of the system raises issues with 
regard to its contribution to the functioning of the internal market and the cost-efficiency of 
the system of OCs. 

Contribution  to  the  functioning  of  the  internal  market:  MS  broadly  agree  with  the 
rationale of Articles 26-29. However, could the heterogeneity in their application in practice 
cause distortions in competition? The study has investigated various potential distortions that 
may arise in this context. It has found that in practice: 

• Distortions at  EU  level: There  is a general concern  amongst stakeholders in  the  various 
MS that implementation of rules by national authorities put them at disadvantage vis-a-vis 
other  MS.  However,  it  is  difficult  to  substantiate  these  claims  due  to  lack  of  clarity  and 
uniformity  in  MS  approaches  which  makes  the  comparison  of  actual  fees  difficult. 
Although evidence of unjustified variations in fee levels were found between MS, there is 
no  evidence  of  significant  distortion  in  competitiveness  between  MS  caused  by  differing 
fee levels. Other key factors affecting competitiveness appear to be more significant. 

• Regional  distortions  are  a  concern  particularly  in  some  MS  with  decentralised 

management e.g. amongst the case study countries (Germany, also Italy and Spain); 

• Discrimination against the meat sector, which is seen as unfairly bearing the cost of the 

OCs, from which other sectors along the chain also benefit; 

• Discrimination against smaller or disadvantaged FBOs, which compound the difficulties 
they  face  in  the  general  economic  climate;  this  is  particularly  evident  for  those  MS  that 
have not adopted special provisions for these businesses in line with Article 27.5. 

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Cost efficiency issues have been raised with regard to:  

• Staff costs: Stakeholders argue that Regulation 882/2004 could go further than the general 
requirement  to  have  “a  sufficient  number  of suitably  qualified  and  experienced  staff”.  In 
practice, there are wide variations in the number and profile of staff involved in controls, 
and this has repercussions on salary costs; 

• Administrative costs: There is lack of transparency on what type of costs are taken into 
account,  the  formulation  of  Annex  VI  is  considered  too  broad  (in  particular  criterion  2: 
‘associated costs’), resulting in wide variation between MS and unjustifiably high costs in 
some cases; 

• Proportionate and risk based controls: important cost savings could be made in the costs 
of OCs if the guiding principles of OCs (risk basis, FBO responsibility and ‘self-control’ 
systems)  were  sufficiently  taken  into  account  by  MS  in  implementing  the  provisions  of 
Articles 26-29. 

To address the various shortcomings in the current application of the Regulation131, the study 
has  examined  the  following  key  options:  moving  from  the  current  system  towards  more 
harmonisation; moving towards more subsidiarity; and, the continuation of the status quo. A 
complementary option, which transcends the above three alternative options, is the extension 
of the financing obligation to sectors beyond those currently covered by the Regulation.  

The  key  components  of  the  financing  system  (basis  of  fee  charging;  level  of  fee  rates;  fee 
calculation  method;  fee  reductions  and  penalties;  and,  list  of  activities  covered  by  fees),  as 
identified  on  the  basis  of  the  intervention  logic  of  the  current  legislation  (Articles  26-29), 
were combined to develop a range of scenarios within the above options (Error! Reference 
source  not  found.).  The  basis  of  fee  charging  is  compulsory  for  all  MS  under  the 
harmonisation option, optional under the subsidiarity option, and a mixed approach under the 
continuation of current rules. 

The scenarios were assessed in terms of advantages and disadvantages, feasibility (whether 
and under which conditions they would work in practice), and the acceptance that they might 
have from the various groups of stakeholders. Key criteria for the assessment were the main 
goals  and  principles  of  the  Regulation,  as  well  as  the  wider  objectives  of  Community  food 
and  feed  law  and  the  Lisbon  strategy,  in  particular:  improving  the  effectiveness  and 
efficiency  of  the  official  controls;  simplification  of  the  current  system;  and  providing  the 
right incentives for FBOs to encourage compliance and discourage non-compliance. As these 
criteria may not necessarily point in the same direction, the initial assessment of the scenarios 
provided  here  aims  to  provide  a  balance  between  the  various  objectives  and  needs  of 
stakeholders.   

The  assessment  has  shown  that  neither  harmonisation  nor  subsidiarity  would  work  in  their 
most extreme expression. Although both scenarios would simplify the current system at the 
level of central management (particularly if full subsidiarity is pursued), they ultimately carry 
the risk that they may not lead to sufficient cost-recovery in some MS, and that the level of 
cost-recovery  may  vary  significantly  between  MS.  This  could  undermine  the  overall 
effectiveness  of  the  official  control  system  at  EU  level,  and/or  act  as  a  disincentive  to 
improving its efficiency.  

131  It  is  noted  that  addressing  some  of  the  current  shortcomings  identified  by  this  study  requires  action  that 
extends beyond the financing provisions of Regulation 882/2004, to the wider legislation in the area of food and 
feed safety. The discussion of solutions to such shortcomings was therefore limited to its relevance to the costs 
and the financing of the official controls. 

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An  intermediate  solution  would  clearly  provide  the  most  pragmatic  way  forward. 
Intermediate  scenarios  provide  different  degrees  of  balance  between  the  flexibility  that  the 
majority  of  MS  require,  as  an  incentive  inter  alia  to  rationalise  the  system,  with  the 
simplification  needed  at  the  level  of  central  management  (Commission,  MS  CCAs).  The 
study  has  found  that  the  rationale  for  a  flexible  approach,  which  underlies  the  current 
Regulation,  continues  to  apply  today.  The  majority  of  MS  CAs  and  stakeholders  have 
indicated  that  a  system  that  allows  MS  flexibility  to  set  the  fee  rates,  within  a  commonly 
agreed set of rules, continues to be the most favoured option. This approach is considered the 
most appropriate for the system to be able to adapt to national conditions.  

On  balance,  amongst  the  various  scenarios  that  can  be  envisaged  at  an  intermediate  level, 
those leading to more subsidiarity appear to be more attractive than those that lead to more 
harmonisation.  This  is  because  the  degree  of  flexibility  given  to  MS  diminishes,  while  the 
degree of complexity of the legislation increases.   

Moving towards more subsidiarity, if the primary aim of the legislation is to ensure that MS 
have the funds necessary to cover the costs of official controls whatever the means, scenario 
4 (maintain only the general obligation for MS to provide adequate funding, in the line of a 
modified  Article  26)  could  present  an  attractive  alternative  to  pursue  for  the  purposes  of 
simplification.  

The disadvantage  of this scenario would be that it could result in wider variations between 
MS than those created by the current system. To reduce these variations, conditions could be 
attached in the form of common principles at EU level for a more harmonised calculation of 
the fees and/or fee reductions/penalties across the EU (scenario 3). 

Although the continuation of the status quo would be an alternative intermediate solution, the 
analysis  of  current  shortcomings  under  section  Error!  Reference  source  not  found.  has 
shown that to do nothing is clearly not an acceptable or a pragmatic option. However, if the 
current  mixed  approach  of  the  Regulation  (which  represents  the  political  reality  of  the 
evolution of the system since Directive 85/73) was to be maintained, certain improvements 
could  be  introduced  as  follows:  at  a  general  level  improve  the  understanding  of  the 
Regulation; provide a rationale for setting minimum fee levels and review Annexes IV and V 
in  the  light  of  this  rationale;  reinforce  transparency  and  accountability  criteria;  refine  and 
define  certain  provisions  more  precisely  at  technical  level;  update  Articles  26-29  with  the 
progress made since the adoption of the General Food Law and the Hygiene Package. 

Whatever  the  scenario  to  be  pursued  at  an  intermediate  level,  the  study  has  identified  the 
need  for  the  definition  of  common  principles  that  can  apply  for  a  more  harmonised 
calculation of the fees and/or fee reductions/penalties across the EU. These could be general 
principles only or they could be more detailed criteria defined at a  technical level. General 
principles  would  include:  transparency  in  the  calculation  method  of  fee  setting  and  for 
calculating fee reductions/penalties, on the basis of actual costs; and, the obligation for MS to 
communicate  these  to  the  Commission  and  the  public.  Detailed  technical  criteria  would 
include  for  instance  the  calculation  method  to  be  followed  for  fee  setting  and  for  fee 
reductions/penalties, cost-recovery targets that should be sought, precise cost categories that 
should be taken into account, and even maxima/ceilings for each cost element. 

The  level  at  which  common  principles  should  be  set  needs  to  be  further  explored,  as  it  is 
crucial  in  controlling  MS  flexibility  and  mitigating  the  potential  disadvantages  of 
subsidiarity.  The  greater  the  degree  to  which  EU  legislation  moves  from  defining  common 
principles  and  general  guidelines  (as  is  currently  the  case  with  Articles  27-29)  to  more 
technical criteria, the more difficult it will be for MS to deviate from a common denominator.  

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On the other hand, this increases the complexity of the provisions and the extent of follow up 
needed at central level (Commission, MS CCAs). 

In terms of the calculation of fee reductions and penalties, in particular, the principles could 
build on the advantages and benefits of self-control systems, as introduced at EU level by the 
Hygiene  Package.  Both  MS  and  stakeholders  are  in  principle  in  favour  of  providing 
incentives to FBOs to assume greater responsibility. The study has examined the possibility 
to follow an integrated approach more consistently linking compliance and non-compliance, 
and therefore fee reductions and penalties, to the uptake of self-control systems by industry 
(through a bonus-malus system).  Such systems have already been developed in few MS (e.g. 
Belgium),  highlighting  the  advantages  of  an  integrated  approach.  The  study  has  concluded 
that,  although  the  development  of  such  systems  needs  to  be  encouraged  at  EU  level,  their 
actual design can at present only be pursued at MS level. 

Furthermore,  the  cross-cutting  theme  of  the  extension  in  scope  of  the  Regulation  was 
favourably  assessed,  in  relation  in  particular  to  the  inclusion  of  all  stages  along  the  food 
chain.  The  case  of  the  extension  of  the  system  to  stages  upstream  and  downstream  of  the 
slaughtering and meat cutting operations along the meat production chain was a case in point. 
The  study  has  concluded  that  an  extension  in  this  form  would  spread  the  costs  of  controls 
currently  pursued  only  at  a  particular  point  in  the  chain  but  for  the  benefit  of  stages 
upstream/downstream more equitably along the food chain. Again, this approach is currently 
being adopted/explored in several MS. 

This forward looking element of the project aimed to provide an initial assessment of certain 
key scenarios. The purpose was not to provide a full feasibility analysis (whether at political 
or  technical  level).  Nonetheless,  specific  recommendations  were  made  to  develop  these 
scenarios,  or  indeed  other  potential  combinations  of  their  components,  including  through 
future impact assessments. 

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Annex XI: FEES – Executive summary of the study carried out by 
GHK to support the impact assessment as regards the financing of 
official controls 

Preparatory work to support the impact 
assessment on reviewing the rules on the 
financing of official controls 

A final report to DG SANCO 

Date: 20 September 2011 

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EN 

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Executive Summary 

E.1 

This report examines the impacts of proposed changes to Regulation (EC) 882/2004 
regarding the rules on financing official controls 

This  is  the  final  report  of  a  study  to  assess  the  impacts  of  potential  revisions  to  Regulation 
(EC) 882/2004 regarding the rules on financing official controls. The report presents results of 
the  research  conducted  and  impact  analysis  on  options  proposed  by  the  Directorate-General 
for  Health  and  Consumers  (DG  SANCO)  to  change  the  current  system  in  order  to  improve 
shortcomings identified in an evaluation of the Regulation conducted in 2008.  The study was 
led by GHK Consulting Ltd working with ADAS UK Ltd.  

This  study  contributes  to  the  preparation  of  an  impact  assessment  of  proposed  revisions  to 
Regulation  882/2004/EC  regarding  the  rules  on  financing  official  controls.  The  objective  of 
the study was to provide the Commission with:  

▪  Data that substantiate the problems in the current operation of the legislation with 

respect to financing official controls; and 

▪  An assessment of the impacts of policy options identified by the Commission to 

address these problems.  

The analysis demonstrates that there are options available that, when suitably packaged and 
with careful implementation, could mobilise the resources needed to finance efficient controls 
at the same time as fostering the development of a system that is fairer, more transparent, and 
does  more  to  encourage  efficient  management  of  risk  by  both  food  business  operators  and 
competent authorities. 

E.2 

The objectives of the existing legislation are not being met  

The objective of Articles 26-29 of the Regulation is to ensure that the approach to financing 
official  controls  is  consistent  across  Member  States  (MS).    The  Regulation  describes  the 
general approach that should be taken by MS, and the principles that should be adopted by the 
relevant  authorities.  Articles  26-29  of  the  Regulation  outline  the  provisions  related  to  the 
financing of official controls. They specify that: 

▪  Member States must ensure that adequate financial resources are made available 

for official controls (Article 26); 

▪  Where inspection fees are imposed on feed and food business operators, common 
principles  must  be  observed  for  fee-setting  and  the  methods  and  data  used  for 
calculating the fees must be published or otherwise made available to the public 
(Article 27); and 

▪  When official controls reveal non-compliance with feed and food law, the extra 
costs that result from more intensive controls must be borne by the feed and food 
business operator concerned (Article 28). 

Previous analysis of the implementation of Articles 26-29 has identified four main problems 
with  the  legislation  and  its  implementation:  a  lack  of  clarity  and  uniformity,  a  lack  of 
transparency  in  the  calculation  of  costs  by  competent  authorities,  the  fact  that  in  most 
instances  fees  do  not  cover  inspection  costs,  and  a  lack  of  flexibility  in  the  current  legal 
framework.  The reforms are intended to address those issues. 

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E.2.1 

There is a lack of clarity and uniformity in the Regulation, which results in diverging 
interpretations in EU Member States 

Text of the Regulation is imprecise in places. This has resulted in differences of interpretation 
by  Member  States  and  led,  in  turn,  to  significantly  different  fee  charging  systems  in  which 
Member  States  calculate  fees  on  different  bases.  Fees  that,  according  to  EU  law,  are 
compulsory  are  not  always  collected.  The  level  of  cost  recovery  achieved  varies  widely. 
Article  3  specifies  criteria  that  Member  States  should  follow  in  the  design  of  their  official 
control fees systems. These are particularly relevant where Member States adapt their controls 
systems in light of risk factors, the degree of businesses’ past compliance and own checks, the 
presence of small businesses and issues related to the location of remote businesses.  The way 
in which these criteria are described in the legislation makes them difficult to implement. 

E.2.2  There is a lack of transparency in the calculation of costs at Member State level 

Many  Member  States  calculate  fees  in  breach  of  the  terms  set  out  in  Article  27  of  the 
Regulation. Many also fail to provide the Commission with the calculation method they use 
as  required  by  Article  27.12.  Where  the  calculation  method  has  been  made  available  it  has 
often not been transparent: the cost categories included and the Competent Authority that has 
incurred  them  are  unclear,  as  are  the  time  periods  to  which  the  costs  relate.    Furthermore, 
under Annex VI of the Regulation fees can be used to recover ‘staff salaries’, ‘staff costs’ and 
‘laboratory  analysis  and  sampling’.    But  the  wording  of  the  Annex  is  insufficiently  precise 
and  has  proven  to  be  open  to  various  interpretations  –  resulting  in  a  lack  of  consistency  of 
approach across and even within Member States. 

E.2.3  Fees do not cover inspection costs 

The general principle of financing official controls is that funding should be made available to 
Competent Authorities for control activities and that for some controls a fee must be levied. 
Where fees must be levied, these should cover the costs of carrying out the specified control 
activities.  In  the  majority  of  Member  States,  however,  the  fees  collected  do  not  cover  the 
inspection costs. Fees collected are often incorporated into a Member State’s general revenues 
(either in entirety or in part), with no restrictions or conditions regarding how they should be 
used subsequently. 

E.3 

The  Commission  has  developed  proposals  for  revision  of  the  legislation  that  are 
intended to address these problems 

The legislative revision is intended to develop a clearer, simpler and more transparent system, 
while  taking  into  account  the  principles  of  proportionality  and  subsidiarity  and  the  need  to 
avoid  disturbing  the  internal  market.      Embedded  in  the  general  objectives  are  principles  of 
proportionality,  subsidiarity  and  food  business  operator  responsibility  that  to  be  taken  into 
account by Member States when considering the scope and specification of fees. The specific 
objectives for the reforms are to ensure: 

▪  Mobilisation of resources for efficiently delivered controls: ensuring that Member 
State official bodies have adequate financial means to efficiently perform official 
controls to ensure food safety;  

▪  Simplification: providing a clearer and simpler legal framework;  

▪  Comparability: avoiding disturbance of the internal market while accounting for 

different cost structures across Member States;  

▪  Streamlining:  reducing  the  administrative  burden  on  Member  States  and 

stakeholders as far as possible; and 

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▪  Accountability:  ensuring  that  stakeholders  have  access  to  information  on  how 

resources are collected and used. 

DG  SANCO  has  identified  three  policy  options,  drawing  on  an  conducted  in  evaluation  in 
2008  and  further  evidence  collected  from  stakeholders  and  the  Food  and  Veterinary  Office. 
These options are:  

▪  Option A: Improve the current system; 

▪  Option B: Harmonise inspection fees; and 

▪  Option C: Implement full subsidiarity of inspection fees. 

Option A includes a number of distinct sub-options. In this analysis interactions between sub-
options  have  been  considered  with  a  view  to  the  development  of  a  coherent  ‘package’  of 
complementary  and  mutually  reinforcing  measures.  Options  have  been  assessed  against  a 
reference ‘do nothing’ scenario represented by the Member States’ current arrangements for 
financing official controls. 

E.4 

The analysis suggests that the problems with the Regulation would best be remedied 
by  improving  the  current  system,  rather  than  moving  to  a  model  based  on  full 
harmonisation or on full subsidiarity 

Option A – improvement of the current system – is the most promising reform option.  The 
various potential components of the option have each been assessed on their own merits, and 
the  way  in  which  they  might  best  be  ‘packaged’  also  considered.      The  paragraphs  below 
summarise that analysis. 

E.4.1  Extend the scope of mandatory fees 

This sub-option specifies an extension in the scope of the mandatory fees (i.e. increasing the 
number  of  official  controls  for  which  Member  States  are  obliged  to  collect  fees).  In  simple 
terms, it shifts the financing of controls from tax revenue to the businesses that are subject to 
controls but do not currently pay fees.  Managed appropriately and in combination with other 
sub-options,  this  sub-option  could  encourage  processes  that  improve  Competent  Authority 
efficiency  and  improve  comparability,  creating  a  level  playing  field  across  the  EU  and  the 
food  chain.  The  measure  would  result  in  new  costs  for  those  sectors  that  are  not  currently 
charged. It could also increase administrative costs to Competent Authorities in the additional 
assessment and collection of fees (though such costs could themselves be covered by fees if 
the legislation was appropriately worded). The controls for which fees are mandatory should 
be  clearly  stated.  Clearer  definitions  of  cost  should  be  considered  in  conjunction  with 
potentially extending the scope of fees.  Some of the industry which pays fees today believes 
that extension of mandatory fees across the food chain would reduce the cost of controls to 
those businesses. 

E.4.2   Require full cost recovery 

This  sub-option  would  impose  a  legal  requirement  on  Member  States  to  achieve  full  cost 
recovery of the (eligible) costs of official controls where mandatory fees apply. This is likely 
to have a positive impact on mobilisation of resources to finance controls, and therefore meets 
the primary objective that this sub-option is designed to achieve. Most Member States do not 
achieve full cost recovery at present, and a requirement would enable Member States to put 
systems  in  place  to  do  so.    It  would  shift  the  financing  burden  from  general  taxation  to  the 
food  chain,  increasing  costs  to  FBOs.  A  year-by-year  staged  increase  in  cost  recovery  rates 
(where these are currently less than 100%) would provide time for adjustment both by FBOs 
and by Competent Authorities. If businesses are being asked to pay more it is important that 
the  system  is  seen  to  be  fair,  transparent  and  efficient  therefore  this  option  would  best  be 
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combined with complementary measures on transparency, governance and clear definition of 
eligible costs.  The sub-option that gives Member States the option to provide fee exemptions 
to  micro-enterprises  would  also  enable  Member  States  to  mitigate  impacts  of  full  cost 
recovery on very small businesses where necessary.  

E.4.3  Clearly define eligible costs 

This sub-option would change Annex VI of the Regulation in order to define more clearly the 
costs  that  can  be  recovered  via  fees  linked  to  performing  official  controls.    A  precise 
definition  of  eligible  costs  is  required.    Definitions  that  leave  scope  for  differences  of 
interpretation  (e.g.  on  the  recovery  of  overheads  and  administrative  costs)  are  unlikely  to 
solve the present problems. An alternative list of eligible costs proposed by the Commission 
provides a solid basis for discussion. It would be helpful to have clear rules on recovery of 
competent authorities’ overheads and administrative costs, such as by setting a ceiling on such 
recovery that is set at a given percentage of eligible staff costs.  

E.4.4  Introduce time-based fees 

This sub-option would require that time-based fees (rather than flat fees) are used for official 
controls that require continuous or systematic presence of officials, and potentially for other 
controls too. Time-based fees can be aligned to efficient, risk-based inspection strategies.  A 
shift  from  flat  fees  to  time-based  fees  where  continuous/systematic  presence  of  officials  is 
needed can affect the distribution of payments within a sector.  Larger operations with high 
throughput  may  pay  less  under  a  time-based  fee  regime  while  small  operations  with  low 
throughputs may find that charges increase. The potential risks to FBOs of time-based fees – 
that is, of excess payments for inefficiently delivered inspections – can be mitigated by other 
sub-options on governance, transparency, clear definition of eligible costs and the option for 
micro-enterprise exemptions. The extension of time-based fees to controls where continuous 
presence is not required warrants careful consideration on a case-by-case basis. 

E.4.5   Require ring-fencing of resources 

Under this sub-option the Regulation would introduce a requirement that fee revenue be used 
exclusively to cover the costs of the official controls for which they are being charged. This 
sub-option  could  have  significant  positive  impacts  on  mobilisation  of  resources  for  official 
controls and result in improved accountability and comparability of official controls systems.  

E.4.6  Incorporate bonus-malus principles 

This  sub-option  would  introduce  new  wording  into  the  Regulation  that  supports  the 
incorporation of bonus-malus principles in the fee system for official controls such that best 
performers  are  rewarded  while  the  worst  performers  are  penalised.  Bonus-malus  principles 
are  likely  to  have  a  positive  impact  on  the  efficiency  of  official  controls  systems  by 
encouraging  risk-minimising  behaviour.  They  can  reinforce  risk-based  controls  strategies  in 
which resources are used to target establishments that pose greater risks to the food chain.  It 
may be difficult to provide specific measures within the Regulation’s text on the financing of 
official controls but Articles 26-29 should be screened to ensure that they do not inadvertently 
inhibit use of such strategies and application of bonus-malus principles. The specification of 
minimum fees in EU legislation, for instance, can inhibit the application of fee schedules that 
reward good performance with lower fees.  

E.4.7 Introduce transparency and reporting requirements 

In this sub-option the Regulation would require Member States to provide information to the 
Commission  regarding  the  financial  resources  devoted  to  official  controls  each  year,  and  to 
the public regarding fees, modes of payment and other administrative procedures. Providing 

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information  to  the  public  regarding  fees  for  official  controls  will  have  positive  impacts  on 
accountability  and  the  additional  administrative  costs  are  expected  to  be  modest.  A 
requirement to report to the Commission on resources devoted to official controls will have 
similarly  positive  impacts  on  accountability,  but  comes  with  greater  administrative  cost 
burdens to Competent Authorities, particularly in Member States with decentralised systems.  
The scale of that burden will vary depending on exactly what data or indicators are required 
and  on  whether  existing  reporting  requirements  are  rationalised  and  clarified.  Increased 
transparency  will  contribute  to  the  creation  of  a  fairer,  more  efficient  system  and  thus  has 
significant indirect positive impacts for FBOs.  

E.4.8 Provide for industry participation 

In  this  sub-option  the  Regulation  would  provide  FBOs  with  the  right  to  participate  in  the 
process of setting the structure of fee rates (though not in determining the fee levels).  More 
participatory governance arrangements should have positive impacts on accountability, giving 
industry a voice in the fee setting process. Industry participation could provide opportunities 
for  FBOs  and  Competent  Authorities  to  work  together  to  pursue  common  objectives.  Fee 
acceptance is also likely to be higher where industry can participate in the process. Enhancing 
provisions for consultation, together with improved transparency, ought to promote efficiency 
in the application of official controls and the emergence of a fairer system.  

E.4.9 Introduce exemptions and reductions for micro-enterprises 

Under  this  sub-option  the  Regulation  would  provide  reduced  fees  or  fee  exemptions  for 
micro-enterprises (or provide an option for Member States to apply such exemptions). Where 
this  sub-option  is  made  a  requirement,  it  may  reduce  cost  recovery  in  Member  States, 
particularly for those with a large number of such businesses. Respondents indicated a clear 
preference  for  having  an  option  to  provide  such  an  exemption  or  no  provision  of  such  an 
exemption,  rather  than  a  requirement  to  provide  universal  exemptions  or  reductions. 
Providing  Member  States  with  the  option  to  determine  whether  or  not  to  provide  an 
exemption or reduction would allow this decision to be made on a case-by-case basis in each 
Member  State.    This  would  also  enable  Member  States  to  make  judgements  about  how  to 
mitigate  impacts  of  other  sub-options  (e.g.  full  cost  recovery)  on  their  smallest  food 
businesses. 

E.5 

A  policy  ‘package’  built  from  the  proposed  sub-  options  under  Option  A  has  the 
potential  to  significantly  reduce  administrative  burdens,  improve  cost  recovery  and 
create  greater  efficiencies  in  the  system,  if  the  potential  for  positive  interactions 
between the sub-options is exploited 

It is clear from the consultations and analysis that the sub-components of Option A need to be 
considered  as  a  ‘package’.  The  individual  components  deal  with  different  elements  of  the 
‘system’  and  have  a  cumulative  and  collective  impact  on  the  problems  that  the  reforms  are 
intended to address. The interactions between sub-options are mostly positive but sometimes 
negative. 

The core purpose of the reforms is to ensure that the official controls are properly resourced 
but also efficiently delivered and that charges that are fair, transparent and based on principles 
common to all within the EU. Several of the core sub-options would increase payments made 
by food business operators for the financing of official controls, shifting the financial burden 
from  pressurised  public  finances  to  the  food  chain.  In  some  cases  this  represents  a  shift  in 
approach,  moving  away  from  controls  being  a  free  public  service.  If  the  scope  and  level  of 
fees for business is to increase then there needs to be counter-veiling pressures on competent 
authorities  to  discharge  their  responsibilities  efficiently,  not  least  to  reduce  the  financial 

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impact  to  FBOs.  This  can  be  done  through,  for  instance,  enhanced  transparency,  industry 
participation, a clearer definition of what costs can be included. Risk-based control strategies 
that  result  in  efficient  use  of  authorities’  resources  and  focus  effort  on  FBOs  which  pose 
greater risk will also help relieve burdens on well-run businesses. A coherent reform package 
can  thus  encourage  a  restructuring  of  the  cost  base  (where  needed)  at  the  same  time  as 
addressing fees and revenues. 

E.6 

Full harmonisation of inspection fees for official controls is unlikely to be feasible  

There  are  valid  questions  about  the  feasibility  of  full  harmonisation  of  inspection  fees  for 
official controls throughout the EU, as proposed in Option B.  Developing a cost model or set 
of  pricing  principles  for  each  official  control  that  was  seen  by  stakeholders  to  be  fair  and 
appropriate  (given  control  costs)  would  be  an  extremely  challenging  exercise.  Due  to  the 
significant  differences  in  the  organisation  of  official  controls  systems,  variation  in  cost 
factors, etc. amongst Member States it would be impossible to identify a fee level that would 
be  appropriate  for  every  country.    Harmonised  fees  would  also  be  politically  difficult  to 
implement  in  Member  States  with  highly  decentralised  decision  making  and  governance 
structures.  In  Member  States  with  decentralised  control  systems,  it  may  not  be  possible  to 
specify the fee rates under existing national legislative arrangements. There are cases where 
new national legislation would be needed. 

E6.1   Introduce unified fees for the EU-27 

In this sub-option fees for the provision of controls are determined on a unified basis for the 
EU as a whole (i.e. the same fee rates apply in each Member State). This is likely to have a 
negative impact on official controls systems across the EU-27. Full harmonisation, applying a 
unified rate across the EU-27, is likely to reduce the efficiency of the official control system. 
The distribution of impacts is affected by the level at which harmonised fees are set. If fees 
were harmonised at the level of the highest prevailing fee in Europe then aggregate payment 
by  industry  would  rise  substantially.  If  the  fees  were  harmonised  at  the  level  of  the  lowest 
prevailing  fee  then  industry  would,  on  balance,  gain  but  there  would  be  a  corresponding 
deficit  in  government  income  and  in  the  overall  cost-recovery  rate.  If  fees  were  set  in  the 
middle  of  the  current  range  then  there  would  be  ‘winners’  and  ‘losers’  on  a  state-by-state 
basis.  

E.6.2  Adjust unified fees using a cost of living index 

This sub-option is a modified version of the above, in which harmonised fees are adjusted for 
each Member State using a cost of living index. Indexation of rates according to the cost of 
living would mitigate some of the impacts of harmonisation on a unified basis but the process 
of  setting  an  appropriate  harmonised  fee  would  remain  burdensome  and  is  very  unlikely  to 
result in a schedule of fees that reflects the actual costs of inspecting individual FBOs or even 
whole  sectors  at  a  Member  State  level.  Although  the  sub-option  could  result  in  positive 
impacts  on  comparability  and  streamlining,  these  are  likely  to  be  outweighed  by  the 
significant negative impacts on efficiency and also of fairness and adherence to principles of 
cost recovery. 

E.6.3  Introduce EU harmonised fees only for certain import controls 

Under this sub-option the Regulation would require that certain import controls are subject to 
harmonised fees, particularly those controls where there is a higher degree of harmonisation 
(e.g. BIPS and DPEs). A single, uniform price would apply to any EU border point. As with 
the other sub-options for harmonised fees, harmonisation of fees for import controls is likely 
to have a negative impact on the official controls systems across the EU-27. Development of a 
cost model or set of pricing principles for import controls would be an extremely challenging 
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exercise, and due to variance in the current controls systems it would be impossible to identify 
a fee level that would be appropriate for every country.  

E.7 

Repealing  Articles  26-29  of  the  Regulation  and  moving  to  full  subsidiarity  is 
expected to increase problems associated with lack of coherence and consistency in 
the application of fees for official controls 

Option  C  considers  the  possibility  that  Member  States  are  obliged  to  allocate  ‘sufficient 
resources’  to  official  controls  but  that  each  Member  State  will  be  free  to  determine  the 
approach they follow. Option C requires repeal of Articles 26-29 in Regulation 882/2004/EC. 
This  option  is  likely  to  have  a  negative  impact  on  the  coherence  and  consistency  of  the 
financing  of  official  controls  system  in  the  EU.  It  is  likely  to  widen  disparities  between 
Member  States.    Some  Competent  Authorities  may  be  pressured  to  lower  fees  in  order  to 
maintain industry’s competitive advantage which would constrain the resources available for 
proper  delivery  of  official  controls.    Other  CAs  may  increase  fees  and/or  expand  fee 
collection for control activities in order to achieve full cost recovery. 

E.8 

Monitoring  indicators  should  be  collected  in  order  to  assess  the  effectiveness  and 
impact of the legislative revision 

In  order  to  assess  whether  the  legislative  revision  is  achieving  its  objectives,  and  whether 
there are any unexpected impacts, the European Commission will need to collect, review and 
publish  monitoring  indicators.    It  will  also  be  necessary  to  undertake  a  more  detailed 
evaluation  exercise  once  sufficient  time  has  elapsed,  in  order  to  thoroughly  review  the 
performance of the revised legislation. 

Two sets of indicators can be considered.  Macro indicators linked to strategic objectives can 
be used to track progress of the system as a whole, using aggregate data reported by Member 
States.  Alongside that a set of micro indicators  can be  used  to identify impacts on specific 
groups  of  actors  within  the  system,  particularly  food  business  operators  and  competent 
authorities.  These  impacts  could  be  identified  and  tracked  through  following  a  cohort  over 
time and/or through periodic sampling of the population of FBOs and authorities. 

Work  by  the  Commission,  previous  evaluations,  and  this  study  have  all  demonstrated  the 
challenges of mapping the situation in Member States in a context where arrangements for the 
financing  of  controls  vary  widely,  interpretation  of  the  legislation  varies  and  there  has  not 
always  been  timely  compliance  with  European  legislation.  In  Member  States,  the  central 
Competent  Authorities  themselves  often  have  limited  visibility  of  the  situation  in  different 
parts of their own countries due to the devolution of powers of control to local and regional 
authorities and limited pass-through of information back up to the centre. 

Changes in the financing of official controls could be tracked more easily if two changes are 
made.  First,  the  annual  reports  produced  by  Member  States  under  Regulation  882/2004/EC 
need to be improved in terms of their consistency, coverage and clarity. There is a case for 
reviewing the existing system of reporting under the Regulation so that the performance of the 
overall  system  can  be  monitored  more  effectively  and  efficiently  against  a  set  of  key 
indicators  without  imposing  undue  burden  on  Member  States.      Second,  adoption  of  sub-
option  A7  on  publication  of  cost  data  (and/or  the  second  component  of  sub-option  A7  on 
reporting  to  the  Commission)  would  ensure  that  information  is  made  available  to  track 
changes over time. 

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Annex XII: FEES - Summary of the opinions of stakeholders 

This  Annex  presents  an  overview  of  the  positions  taken  by  the  stakeholders  in  reply  to  the 
consultations,  either  at  conferences  and  consultation  meetings  or  in  writing  about  specific 
issues relation to the financing of official controls. Positions were summarised and compiled 
for the purposes of this Annex132. 

1. Cost recovery principle  

Stakeholders  are  in  general  (predictably)  opposed  to  charges  being  collected  for  official 
controls, and thus to the cost recovery principle.  Many would claim that official controls 
are a public service, whose costs should be borne by society at large.  

Positions  become  more  nuanced  when  questions  refer  to  what  changes  to  the  current 
system would be needed in order to ensure the sustainability of the system and its increased 
efficiency.  The  answers  suggest  that  the  position  of  full  cost  recovery  is  dependent  of  the 
range  of  costs  which  are  being  considered.  Opposition  to  full  cost  recovery  is  linked 
impact 
particularly 
disproportionately on mall scale or remote businesses.     

transport)  and  on  costs  which  would 

to  certain  costs  (e.g. 

CLITRAVI, CELCAA, UEAPME Food Forum and the National Federation of Meat and 
Food Traders (member of the IBC) claim that here should be no charges at all of official 
controls.  FEFAC  believes  that  the  principle  of  fees  is  an  obstacle  to  improve  control  cost 
efficiency. An incentive to control authorities to reduce costs can only be achieved if the costs 
are born by authorities.  Fees also raise issues of independency of control bodies. HOTREC 
considers that, as far as food hygiene inspections in restaurants are concerned, the possibility 
for national authorities to charge fees for inspections should remain optional. 

UEAPME  also  argues  that  any  full  cost  recovery  would  prejudice  small  remote  food 
businesses  (because  of  transport  costs),  thus  full  costs  recovery  is  not  acceptable  for  SME. 
Bundesinnung der Fleischer (member of IBC) states that the cost recovery principle always 
leads to higher fees, as there is no link between the work involved and the result. The English 
National  Federation  of  Meat  &  Food  Traders  argues  that  full  cost  recovery  should  be 
abandoned  as  it  is  unfair  for  operators  to  pay  travel  costs  and  overtime  etc.  (which  impact 
most on smaller operators). UECBV is not in favour of including transport costs in the fees as 
the geographical location and travelling  distances of  officials are decided by the Competent 
Authorities. If the principle of full cost recovery is retained, UECBV can accept this only in 
respect of direct costs. All indirect costs, including transport, must be borne by the CA.  

In favour of a system of shared costs 

Danish  Agriculture  Food  Council  argues  there  is  a  strong  need  for  official  control  to  be 
fully or partly publicly financed by the EU and MS. EDA also claims that part of the costs of 
inspections should be publicly funded (with FRUCOM and UGAL). AVEC claims that cost 
sharing  will  be  an  incentive  for  both  sides  to  do  the  job  as  efficiently  and  effectively  as 
possible. CIAA claims that each Member State should prove that it is charging the entire food 
chain for at least 50% of the total cost of controls (the remaining 50% can be paid by the MS). 

132 This Annex only refers to the inspection fees collected for the purpose of control activities currently covered 
by Regulation 882/2004 (feed and food law, animal health and animal welfare rules). 

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AVEC  claims  that  up  to  75%  of  the  official  inspection  costs  should  be  funded  through 
taxation in case of well performing operators. 

2. Extension of the scope of mandatory fees 

As to the question of whether the list of mandatory fees should be extended to cover sectors 
currently not charged for controls, answers depend largely on whether the respondents are 
currently  charges  a  mandatory  fee  (meat,  milk,  imports)  or  not  (other  animal  origin 
products, non-animal origin products).  

In favour  

Some stakeholders would welcome an extension of the scope of mandatory fees. In particular, 
according to AVEC mandatory fees are essential. CLITRAVI would like to see the principle 
of  mandatory  fees  extended  to  food  sectors  other  than  the  one  of  fresh  meat.  The  Danish 
Agriculture Food Council argues that a fees system covering the whole food chain (where 
e.g. retailers would also contribute to the general principle of ensuring the adequate financial 
resources for official control is needed. 

Against  

UGAL claims that the extension of mandatory fees along feed/food chain is not justified and 
would result in illegitimate costs and burdens for operators. According to them it is repugnant 
to  the  principle  of  primary  responsibility  of  food  business  operators  to  charge  producers 
whose  operations  do  not  involve  major  veterinary  risks.  Moreover,  there  is  a  risk  that  by 
extending  mandatory  fees  to  other  operators  in  the  supply  chain,  competent  authorities  will 
increase  inspections  of  large  low  risk  operators  as  a  way  to  generate  revenue.  Outside  the 
veterinary area, it is the responsibility of MS to ensure that adequate resources are provided 
via national budgetary allocations. 

3. Harmonised/Non-harmonised fee rates 

While no one argues in favour of fully harmonised fee rates, opinions are divided on what 
criteria  should  be  used  to  limit  variances  of  fee  rates  (minimum  levels,  maximum  levels, 
indexation).  

Against harmonised fee rates 

AVEC  argues  that  a  system  of  harmonized  fees  would  be  too  rigid  and  suggests  that  fees 
should reflect the different cost structures between MS, with a maximum fee payable by any 
individual  slaughterhouse.    Verband  Schweizer  Metzgermeister  (member  of  ICB)  remarks 
that a harmonized fee rates system will probably lead to an increase of the fees and therefore 
oppose this proposition.  

In favour of harmonised fees  

Koninklijke Nederlandse Slagersorganisatie (member of IBC) claims that it would be a good 
idea to harmonized fee rates if this leads to a reduction of the costs for small slaughterhouses. 
Another member of IBC (and FEFANA) state that harmonized fee rates would put an end to 
competitive  distortion  and  ensure  a  level-playing-field.  According  to  them  harmonisation 
does not necessarily mean that a single identical fee is applied in all MS, but rather that the 
system is consistent and does not create unfair competition.  

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In favour of minimum/maximum fees  

UECBV  argues  that  to  avoid  the  disregard  of  the  veterinary  fees  system  by  any  MS,  it  is 
necessary to fix a minimum amount for the fees. They are also in favour of a maximum fee. 
AVEC  warns  that  although  a  minimum  fee  per  animal  might  be  considered  it  should  not 
discourage an efficient and effective inspection.  

Verband  Schweizer  Metzgermeister  (member  of  IBC)  suggest  to  introduce  an  explicit  rule 
stating  that  the  authorities  can  go  below  the  minimum  fees  (eg.  by  one  third),  'to 
counterbalance unfair competition for decentralized small businesses'.  

4. Harmonised/Non-harmonised fee calculation 

Most stakeholders would agree that harmonised common criteria for the calculation of fees 
are necessary.  

In favour of a harmonized framework for fee calculation  

Most  respondents  are  in  favour  of  harmonised  calculation  criteria.  CIAA  would  favour 
further harmonisation regarding the calculation of fees since it believes that the current rules 
cause  distortion  in  competition  between  Member  States  and  sometimes  even  between 
companies  in  different  regions  of  a  Member  State.  ESA  believes  that  the  inspection  costs 
charged to importers should be calculated following a harmonized method and list of criteria, 
which  should  be  fully  transparent  and  available  for  consideration  by  industry  prior  to 
shipment. AVEC argues that the actual costs components to be included in the calculation of 
the  fee  should  be  harmonised  and  that  the  calculation  should  be  kept  simple  and  be  based 
upon the time spent by the inspector and using the average salary per hour of all inspectors 
involved. CLITRAVI supports the harmonization since in their view it would ensure the right 
mix of flexibility and fair competition. FRUCOM suggests that inspection costs charged to 
importers should be calculated following a harmonised method and list of criteria, based only 
on the direct costs. UGAL is also in favour of a harmonized framework. 

In the opinion of CELCAA criteria for calculating the fees have to be transparent and should 
be  harmonized.  FEFAC  understands  that,  for  sectors  already  subject  to  fees,  further 
harmonization  in  the  method  for  the  calculation  of  fees  might  be  needed.  Breiz  Europe 
supports  the  idea  of  a  harmonized  framework  for  fee  rates.  They  argue  that  the  current 
situation  is  extremely  complicated  and  constraining  for  the  FBOs.  Furthermore  they  claim 
that  the  national  difference  concerning  the  fee  rates  impedes  the  smooth  functioning  of  the 
single market.  

Criticisms of existent system / suggestions for improvements  

Others  expressed  criticism  with  regard  to  the  current  system.  CLITRAVI's  opinion  is  that 
fixing the fee per head of animal slaughtered is not the right approach when considering that 
the  real  cost  comes  from  the  staff  inspectors  in  slaughterhouses.  According  to  them,  this 
method  of  calculation  is  seriously  penalizing  the  largest  and  more  efficient  slaughterhouses 
which  are  bearing  exorbitant  costs.  UECBV  remarks  that  the  existing  payment  per  tonnage 
(in slaughterhouses and cutting plants) is not related to the actual costs incurred by CAs.    

VION suggests to clarify in Art. 27(4) that the costs borne encompass the actual costs but not 
the theoretical costs. The term "single fee" in Art. 27 (7) should be clarified as well. Finally in 
Annex  IV  the  definition  of  the  costs  for  staff  involved  in  the  official  controls  has  to  be 

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clarified, in particular that only the direct costs should be calculated. For example it should be 
clearer that the costs of the training of assistants should not be included. 

AVEC believes that an average of full EU rate should be calculated and that only 50% of this 
rate will be  the  reference for charging  the inspections fees. They suggest that this 50% rate 
may be adjusted per MS by an index which is based on the difference between the costs of 
living or average salary per hour in that MSs compared to the same indicators in the EU. They 
stress  that  in  this  fee  no  differentiation  should  be  made  between  the  time  spent  by  a 
veterinarian or an auxiliary. 

5. Bonus-malus system 

Stakeholders generally support the introduction of bonus-malus mechanisms.  

In favour of an integrated bonus-malus system 

CIAA  argues  that  fee  reductions/  penalties  should  be  linked  to  the  uptake  of  self-control 
systems by industry through an integrated bonus-malus system. CLITRAVI underlines that a 
bonus-malus system should be risk-based and foresee clear implementing measures in order 
to  guarantee  that  establishments  with  reliable  and  strong  self-controls  and  precautionary 
systems would have their premises visited by a gradually reduced number of inspectors and 
thus  paying  a  low  inspection  cost.  UECBV  thinks  that  the  basic  principle  of  a  future 
veterinary fee system should be a bonus-malus system open to all operators i.e. each plant has 
to  be  regarded  individually  and  has  to  be  charged  with  fees  proportionally  to  its  individual 
cost. UGAL is also in favour of this measure. 

FEFANA  suggests  increasing  the  scope  of  the  bonus-malus  system,  already  present  in  the 
current regulation, particularly taking into account the use of certification bodies and Code of 
Good  Practice  established  by  a  number  of  regulations  affecting  the  products.    CELCAA 
supports the idea of criteria of a bonus-malus system. However they underline that the criteria 
for  the  establishment  of  such  a  system  have  to  be  well  reflected  and  clearly  defined  in  the 
Regulation. FEFAC emphasizes that bonus-malus systems should be established at national 
level  in  order  to  encourage  companies  in  further  investing  in  effective  certified  feed  safety 
systems. 

Against a harmonised bonus-malus system 

Two  stakeholders  do  not  hold  this  measure  for  necessary.  Danish  Agriculture  &  Food 
Council's view is that it should not be a matter for the EU to set up a penalty system towards 
individual citizens in MS. It may nevertheless be considered to launch community guidelines 
supporting  a  common  approach.  AVEC  claims  that  if  fees  are  directly  related  to  the  time 
spent  on  inspections  (as  they  suggest)  the  reward  or  penalty  is  already  incorporated  for 
operators  who  contribute  to  a  higher  efficiency  of  the  inspection  services,  will  be  charged 
less. A bonus-malus system is therefore not needed.  

FEFANA claims that the costs of controls should be based on a specific control strategy and 
plan,  and  thus  on  a  risk  assessment  (example  of  increased  control  at  the  border  for  certain 
products). Furthermore they emphasize that there should be a strong connection between the 
established control plans and the determination of the fee. This would be a good incentive for 
operators to source from safer manufacturing site and processes, in order to avoid that their 
products are subject to increased control. 

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6.  Costs to be covered by the fees 

Stakeholders criticise the wording of the list of cost elements in Annex VI, as it allows CA 
to "overprice" controls. Some stakeholders have views on which costs should be covered by 
the MS and which ones by FBOs, most take issue with administrative/overhead costs.   

Critics of the current system / suggestions to improve  

UEAPME stresses that there is under the current system no common interpretation of what 
might be considered as the costs of inspections and what might be seen as extras. FRUCOM 
underlines the fact that the lack of infrastructure should not create extra-costs for importers as 
it  is  currently  done.  For  example  in  ports  where  there  is  a  shortage  of  space  to  store 
containers, the related costs are charged to importers as part of the inspection fees although it 
is not in line with Art. 16(3) of Regulation 882/2004. UGAL argues that a list of the activities 
to be covered by fess should be established in order to create a harmonized framework.  

Costs to be covered by the MSs  

FRUCOM  claims  that  the  extra  costs  as  well  as  the  random/routine  controls  have  to  be 
covered  by  the  budget  of  the  MS.  They  assert  as  well  that  indirect  costs  should  be  bornby 
CAs.  UEAPME  argues  that  visits  to  enforce  general  food  hygiene  regulations,  to  approve 
premises  to  be  used  for  the  processing  of  products  of  animal  origin  should  not  carry  any 
charge on the FBOs. UECBV states that overhead costs (indirect costs) have to be borne by 
CAs. VION specifies with regards to Annex VI that the salaries of the staff involved should 
not include the working breaks and the times for changing clothes. 

Costs to be covered by the FBOs  

FRUCOM suggests that the costs of reinforced controls at the specific levels set in the EU 
legislation be covered by importers. Danish Agriculture & Food Council stresses that a fees 
system must cover the actual costs but not the additional ones. It is important to them that fees 
collected  for  the  purpose  of  official  controls  shall  not  be  higher  than  the  costs  born  by  the 
responsible competent authorities. EDA claims that the fees that FBOs pay should cover the 
real costs only, as it would consequently encourage CAs to operate in an efficient manner and 
to demonstrate that their overheads are reasonable.  

7. Transparency to the Commission and the FBOs 

Stakeholders  are  largely  in  favour  of  increased  transparency  of  the  methods  and 
assumptions used by CA when costing the controls and establishing fees.  

Criticisms of the current system 

Danish  Agriculture  &  Food  Council  complains  about  the  fact  that  although  according  to 
Regulation 882/2004 MSs must provide information to the Commission on the application of 
the Regulation, e.g. the method of calculation of fees, this is not done.  

In favour of a more transparent system 

Some stakeholders made suggestions on how to improve the transparency. FRUCOM argues 
that  MSs  should  be  required  to  report  to  the  Commission  and  explain  in  detail  the  method 
applied  for  calculating  and  charging  inspection  fees  on  operators.  UEBCV  claims  that  the 
detailed  calculation  of  the  fees,  showing  how  each  parameter  is  taken  into  account  for  the 
calculation of the fee of each FBO, must be available for the FBO concerned. VION shares 
the view that MSs shall make the detailed method of calculation regularly public to the FBOs. 
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EN 

  EN 

 
 
 
 
 
They specify that the report shall include the actual times worked by the veterinarians and the 
assistants,  a  description  of  the  kind  of  work,  and  the  details  of  the  additional  costs.  ESA 
claims that Member States should be required to post the costs they charge.  

8. The Principle of Thriftiness  

Many stakeholders worry that revenues collected through fees would not be used efficiently 
by CAs. 

Suggestion of new dispositions to be introduced in Regulation 882/2204 

Two  stakeholders  underlined  the  importance  of  the  principle  of  thriftiness  and  suggested 
referring  to  it  in  the  new  Regulation.  UEBV  underlined  that  a  clear  stipulation  should  be 
established  in  Regulation  882/2004  which  specifies  that  the  administration  must  strictly 
follow  the  economic  principles  of  thriftiness  while  fulfilling  inspection  tasks  pursuant  to 
Regulation 854/2004. VION suggests that a new paragraph should be added to Art. 27(13) in 
order to oblige the authorities to follow the principle of thriftiness, especially concerning the 
costs of the staff involved to employ not more persons than needed and not more expensive 
staff than needed as defined in the regulation 854/2004. 

UECBV underlines that since the main cost of the ante and post mortem inspection consists 
of salaries it has to be ruled how many persons-hours are needed for the corresponding tasks. 
They add that the approach must be risk-based proportionately to the individual plant-risk for 
food safety. 

9. Ringfencing 

FRUCOM states that inspection fees collected by the Competent Authorities from operators 
should be allocated to a specific budget and not to the general budget.  

10. Time-based calculation of fees 

Views are divided and vary depending on the area considered. Consequences of time based 
fees are difficult to anticipate. 

Views on the merits and consequences of time-based fees 

AVEC argues that the fees should be calculated on a time basis to encourage and reward the 
establishments that adopt best practice and reduce the hygiene risks and therefore the official 
time  that  needs  to  be  spent  in  the  establishment.  UECBV  remarks  that  combined  with 
minimum  inspection  times  and  maximum  inspection  figures  it  leads  to  disproportionate 
incomes of the veterinarian personal to the prejudice of the industry. They believe the risk of 
such a system, is that more time is spent in the establishments than needed.  

In favour of time-based calculation of fees 

AVEC thinks the EU should establish a rate per hour that might be charged and in this way 
harmonize the system. UECBV is in favour of a time-based fee in cutting plants, where the 
presence of CA officials is not permanent and a fee of 2€ per tonne is most commonly applied 
amongst  the  Member  States,  independently  of  the  presence  of  the  official  authorities.  It  is 
important to link the fee with the effective work of the official authorities. 

Other position 

EN 

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CELCAA  underlines  that  time  based  fee  may  be  difficult  to  apply  for  certain  kinds  of 
businesses.  They  believe  that  their  feasibility  and  impact  on  businesses  has  to  be  carefully 
evaluated sector-by-sector. They clarify that if this becomes the favored approach it would be 
essential to ensure that in the counterpart competent authorities commit to perform as efficient 
and timely controls as possible.  

11. Small establishments 

Views  are  divided.  No  respondents  supports  the  automatic  exemption  of  small  businesses 
from the payment of fees. Larger scale operators are of the view that smaller ones already 
benefit  from  the  current  system,  by  paying  less  than  actual  costs  would  require,  at  the 
expenses of larger competitors. 

In favour of a system that favours small establishments  

Two  stakeholders  argued  that  the  new  Regulation  should  include  a  system  protecting  small 
establishments from paying to high fees. AVEC claims that there is a need for having at least 
a maximum fee per animal or tonnage to avoid small establishments will have no chance at all 
to  survive  due  to  disproportionate  share  of  inspections  fees  in  the  total  costs.  CLITRAVI 
states that as a consequence of the different fees according to the size of slaughterhouses, big 
establishments  usually  pay  lower  fees  per  animal.  If  an  equal  amount  were  to  be  imposed 
regardless of the throughput, this would imply that big slaughterhouses would subsidize the 
official controls for small establishments. 

Koninklijke  Nederlandse  Slagersorganisatie  (member  of  the  IBC)  argues  that  special  rules 
regarding fees should apply to small slaughterhouses.  

In favour of a system that does not taken into account the size of the establishment 

Two  stakeholders  underlined  that  the  current  system  already favoured  small  establishments. 
FRUCOM  suggested  that  large  importers  should  be  controlled  in  the  same  proportion  as 
smaller  companies  so  as  to  better  spread  the  potentiality  of  finding  a  problem  and  to  better 
share  the  total  costs  of  inspection  fees.  VION  argued  that  MS  tend  to  calculate  fees  on  the 
total costs of  the authorities and not with  the total costs at the individual plant. As a result, 
while small FBOs do not have to pay for all the costs they caused, bigger FBOs have to. In 
addition they claim that Art. 27 (5) (b) might be confusing and should be clarified. 

VION  suggested  clarifying  Art  27  (5)  (b),  in  particular,  that  the  subsidizing  of  businesses 
with a low throughput has to be done by the national authorities and not with the fees of the 
businesses with a high throughput. 

EN 

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Annex XIII: FEES – Summary of MS' opinions 

Introduction 

MS  were  consulted  in  the  context  of  a  first  study  contracted  out  by  the  Commission  to  an 
external  contractor133  on  the  state  of  the  application  of  the  rules  of  Regulation  882/2004 
governing the financing of official controls (2009)134; and during a second study carried out in 
the  same  field  by  another  external  contractor135  to  support  the  assessment  of  the  options 
identified (2011)136137. 

In  addition  to  the  two  contractor  studies  referred  to  above,  however,  the  key  issues  were 
discussed within the Working Group on the general application of Regulation 882/2004138 set 
up  within  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health  (SCFCAH)139. 
These  discussions  are  summarised  below  (Sections  1  and  2).    Moreover  the  main  problems 
identified and provisional options were also presented and discussed at meetings of the Heads 
of Food Safety Agencies on 29 June-1 July 2011 and on 8 December 2011.  Discussions are 
summarised here at Sections 3 and 4. 

It should be stressed that views expressed at these fora do not necessarily represent the agreed 
positions of the MSs but are in fact an opportunity to discuss the issues at hand with national 
experts from the different MS.  

Nonetheless,  the  points  raised  in  discussion  at  these  meetings  were  given  careful 
consideration when developing the Impact Assessment. 

NB: The numbering of options which the MS were consulted on does not correspond to the 
ones  used  in  this  Impact  Assessment.  Option  1  (Full  subsidiarity)  is  in  Option  1  of  the  IA; 
Option 2 (Improvement of the financing of official controls through fees) is in Options 2 and 
3. Option 3 (Extend the scope of mandatory fees) is in Option 4 of the IA; Option 4 (Fully 
harmonise  inspection  fees  for  official  controls)  was  discarded  and  is  not  included  in  the 
analysis carried out in the IA. 

133 Food Chain Evaluation Consortium (FCEC), consisting of Civic Consulting, Agra CEAS Consulting (project 
leader), Van Dijk Management Consultants and Arcadia International. 
134 http://ec.europa.eu/food/food/controls/inspection_fees/docs/external_study_en.pdf; Annex II provides for the 
executive summary of this study. 
135 GHK 
136 Annex III provides for the study carried out by GHK to support the impact assessment on reviewing the rules 
on the financing of official controls. 
137 This Annex only refers to the inspection fees collected for the purpose of control activities currently covered 
by Regulation 882/2004 (feed and food law, animal health and animal welfare rules). 
138 At it's meetings of 10 November and 5 December 2011. 
139 http://ec.europa.eu/food/committees/regulatory/index_en.htm  

EN 

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1.  SUMMARY OF THE COMMENTS MADE ON INSPECTION FEES DURING THE 
MS WORKING GROUP MEETING, BRUSSELS,  10 NOVEMBER 2011. 

The Commission presented the Contractor Study (Annex XI of this Impact Assessment). 

Option 1 - Full subsidiarity (deregulation) 

DE, IE, FR, LV against full subsidiarity but all stressed the need for room for MS flexibility. 

Option 2 – Improvement of the financing of official controls through fees  

2. i) - Eliminate minimum / standard fees 

UK,  FI  supported  option  noting  the  minimum  fees  hinder  recovery  of  actual  costs  if  lower 
than min. fee. 

SE, NL, IE, DE, LV, against this option. Preferred maintaining minimum fees whilst making 
it more effective.  For example: 

- indexing the minimum fees to the costs of living 

- calculating on a time-basis 

- calculating them as a percentage of the costs charged for carrying out official controls, 

2. ii) - clarify the list of activities for which fees are mandatory 

SE  and  FI  supported.    FI  suggested  that  two  approaches.  (i)  fees  charged  "product  by 
product", (ii) horizontal (activity-based) approach (e.g. residues control for all sectors except 
the meat sector). In this case, the amount of fees should be defined according to the kind of 
control activity. 

2.iii) - Clarify list of eligible costs  

- NL, FR, PT, supported but wished for broad interpretation., 

2. (iv) - Ring fence fees revenue  

No comments in support of or against this issue. 

2. (v) - Micro-enterprises 

NL, CY, PT, LXsupported. However, they pointed out the necessity to agree on a definition 
of micro-enterprises in order to avoid distortions of competition within the single market. 

FI  argued  that  this  measure  could  lead  to  enterprises  splitting  their  activities  into  micro 
enterprises  in  order  to  benefit  from  the  exemption.  As  a  consequence  they  preferred  a  risk-
based approach to a size-based one.  

2. (vi) - Introduce transparency and reporting requirements  

SE,  LT,  FR,  DE  against  this  option,  (supported  transparency  per  se,  but  believed  it  would 
increase the administrative burden. 

2.(vii) – Incorporate bonus-malus principles 

NL, BE, UK, FI, SE supported in principle and NL referred back to discussions on standard 
fees, agreeing that they hindered bonus malus. MS also noted that in most cases it would be 

EN 

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sufficient to apply a risk-based system, taking into account the past record of compliance (or 
non-compliance) of the operator.  

FR cautioned against increased administrative burdens.  

NL noted that this system was used by there CAs and expanded further, saying that fees were 
calculated not company by company bur rather by sector. If the sector performed well, fees 
went  down,  whereas  if  the  sector  performed  badly,  fees  went  up.    In  this  way,  "good" 
operators from the sector would automatically pressure "bad" ones.  They felt, therefore, that 
in this way bonus-malus principles were used.  They noted too that Article 28 still applied to 
individual underperforming operators. 

Option 3 – Extend the scope of mandatory fees  

Those against (SE, IE, DK), argued that: 

- it is too extreme an option, since it would include the primary producers and the retail area 
(risk of distortion of competition in these sectors is the main concern of the stakeholders),  

-  based  on  previous  experience,  one  DK  noted  that  it  would  create  administrative  problems 
and high administrative costs, 

-  will  make  food  more  expensive  for  the  consumers  (to  be  avoided  in  the  context  of  the 
financial crisis) 

Those in favour (FI, FR, LV) pointed out that: 

- in some cases they already collected fees across the whole food production chain, 

-  supermarkets  and  canteens,  with  high  food  safety  risks,  they  should  also  be  subject  to 
mandatory fees,  

-  one  FR  proposed  expanding  mandatory  fees  further  than  the  proposed  option,  to  finance 
control activities on the primary producers in the animal health sector.  

Option 4 – Fully harmonise inspection fees for official controls 

NL against any extreme option (1 or 4). Favour intermediate solution (option 2 or 3). 

LV supported harmonised fees for border controls. 

EN 

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2.  SUMMARY OF THE COMMENTS MADE ON INSPECTION FEES DURING THE 
MS WORKING GROUP MEETING, BRUSSELS,  5 DECEMBER 2011. 

Option  Supported by: 

Opposed by: 

1 

LV, but with harmonisation in the areas of 

IT 

•  A defined maximum fee 

•  Clarification of eligible costs 

•  Expenses arising from additional official controls 

•  Recognition  of  operator  own-checks  with  regard  to 

bonus malus 

DE, FR, SE, IE 

UK, NL, IT, PT, DK 

DE, LV 

2 

3 

4A 

4B 

Additional Comments 

Expanding scope 

LV, FR, IE 

Direct support from IT, UK, NL.  Opposition from FR. 

Concerns regarding high admin burden from FR, DK, IE. However, UK suggested that it 
can be cost effective. 

Eligible Costs 

NL, FI, DK, UK, FR, SE wish for wide interpretation. 

NL prefers subsidiarity with regard to indirect costs. 

Ring Fencing 

No direct support. 

IE, DE, FI and SE opposed, but 

IT, DE, NL, FR, UK in support of 'ring fencing principles'. 

Bonus Malus 

Supported by UK, IT, FR, SE, NL, LV, IE, DK. 
LV, FR  - strong role for 3rd party accreditation. 

SE - should apply at the company level on a case by case basis. 

EN 

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Concern regarding wider review 

LV – PH / AH needs to be addressed specifically. 

PL – Bringing in 12 pieces of legislation will cause problems. 

Harmonisation of Import Fees 

NL - current minimum fees sufficient. 

Minimum Fees 

No support for EU-wide minimum fees, but flexible mechanisms suggested by NL (all direct 
costs to be collected) and IE (a minimum % of total cost). 

EN 

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3. SUMMARY OF THE COMMENTS MADE ON INSPECTION FEES DURING THE 
HEADS OF AGENCIES MEETING (ROTTERDAM, JUNE 30TH – JULY 1ST 2011)  

The  Heads  of  Agencies  considered  it  necessary  to  have  a  flexible  framework  in  the  882  to 
enable the introduction of fees in the entire food supply chain. Flexibility is needed because of 
the differences in traditions regarding fees in the different member states. 

The HoA suggested to explicitly mention the option of bonus malus in the 882. Experience in 
member  states  which  have  such  a  system  shows  that  it  contributes  to  a  safer  food  chain.  A 
clarification in the 882 would enable the introduction of this in the member states.  

When  considering  the  introduction  of  bonus  malus  systems  it  is  advised  to  have  a  good 
discussion  with  the  sectors  involved,  beforehand.  The  objective  has  to  be  to  make  the  food 
chain safer and to stimulate the FBO’s to act in conformity with the law. In this respect is it of 
importance  that  the  system  is  transparent  in  terms  of  the  fee  calculation  and  the  way  the 
system is applied. The agencies should be able to report to the sector that it contributes to a 
safer  food  system  with  less  costs  for  the  “good”  FBO’s  and  higher  costs  for  the  “bad” 
operators.  

It  helps  also  when  the  fees  collected  are  used  for  improving  food  safety,  not  just  as  a 
contribution (tax) to the state budget or a municipality budget.  

The HoA suggested the bonus part could be a reduced frequency of inspections or a lower fee. 
The  malus  part  could  be  just  to  let  them  pay  for  the  additional  and  a  full  fee  until  there  is 
compliance. At a certain stage other instruments as penalties and other enforcement measures 
are necessary. 

EN 

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4. SUMMARY OF THE COMMENTS MADE DURING THE HEADS OF AGENCIES 
MEETING (LODTZ, 8 DECEMBER 2011)  

COM gave a presentation of the state of play of the Review of Regulation (EC) No 882/2004, 
in particular as regards the fees chapter. Tour de table: 

HoA 

Comment 

Preferred option 

CZ  Asked how standard fees would be replaced under the new 

Option 2 

system  

HU  Support for  extending scope of mandatory fees -FBO should 

Option 3 

share costs, risk map has changed, resources for 
contingencies / emergency  should be made available   

IE 

Fees = taxes, FBO look at overall cost (including fees/taxes) 
and see no difference 

Option 1(?) 

UK  OK to expanding the scope of mandatory fees, insist on 

Option 3 

bonus malus, on flexibility and subsidiarity in 
implementation, no to exemption for small businesses, ok to 
deletion of minimum fees, support for cost recovery 
principles but MS should be free to determine how to 
recover money. 

FI  Asks whether there is a clear link between suggested 

changes and food safety 

PL  Apart from border checks, other fees should not be 

harmonised; yes to reduced fees for microbusiness, yes to 
bonus malus, doubts that any option will reach consensus   

NL  Fees review should consider that FBO are responsible for 
safety and therefore pay for checks – suggestion: link fees 
with custom duties? 

(?) + 

Option 4 B 

Option 3 

IT  Agrees with L. Miko (fees necessary to maintain food 

Option 3 + 

safety) 

Important to ring fence resources  

DK  Agrees with NL and UK  

Cost of living (?) 

Option 3 

BE  Minimum levels of controls should not be dependent on fees, 

Option 2 or 3 

ok to transparency   

SW  Ok to bonus malus 

Option 2 or 3 

EN 

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Annex XIV - Evidence concerning problems of interpretation/implementation of the rules governing the 
financing of official controls140 

Provision 
concerned/ 
Sources 
Regulation 
(EC) No 
882/2204 

Annex VI 
(list of 
eligible costs) 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

1) Author: International Butchers' Confederation        
Question: Are the UK's competent authorities 
allowed to include a pension deficit in their 
calculation of inspection fees?                                       
2) Author: Farmers' Union of Wales                            
Question: Is the UK's Food Standard Agency's 
inclusion of their pension deficit in the calculation 
of transferable costs legal under EC 882/2004?  

140 This Annex only refers to the inspection fees collected for the purpose of control activities currently covered by Regulation 882/2004 (feed and food law, animal health and 
animal welfare rules). 

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Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

Article 27  

EN 

2008/4966, 4967, 4968 and 4969 
Complainant: law firm Keul & Farber 
Complaint:  
The Länder Northrhine-Westphalia (Case 
2008/4966),  Schleswig-Holstein – Kreis Steinfurt 
(Case 2008/4967) and Baden-Württemberg – 
Landratsamt Waldshut-Tiengen(2008/4968) are 
said to have violated Article 27 (2) to Regulation 
(EC) No 882/2004, by not having charged some of 
the fees for activities covered by Article 27 (2)  in 
conjunction with Annex IV Part A and Annex V 
Part A , e.g. milk, imported fishery products, 
poultry, rabbit meat, import and transit of live 
animals. 

In Case 2008/4967, Article 27 (10) is said to be 
violated because separate control fees are charged 
for the meat-cutting division of the complainant. 

In Case 2008/4968, Article 27 (12) is said to be 
violated because the authorities claim that they 
were under no obligation to make a detailed 
calculation method available to the complainant.  

In Case 2008/4969 (Rhineland-Palatinate – 
Eifelkreis Bitburg-Prüm) there are travel 
supplements and percentage-wise increases of the 
basic rate, which are particularly disadvantageous 
for small establishments. 

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ECJ Judgements 

Infringement cases 

Provision 
concerned/ 
Sources 
Annex IV, 
Section A 
(list of 
activities for 
which a fee 
shall be 
collected) 

Article 27(3) 
in relation 
with 27(4) 

Requests for interpretation addressed to the 
COM by MS 

Author: French Ministry of Agriculture and 
Fisheries                                                   Question: 
Are pet food establishments included among feed 
establishments for which point 2, Section A, Annex 
IV of Regulation (EC) No 882/2004 requires the 
collection of a fee for their approval?  

Author: UK, Imports Border Controls                         
Question:                                           
Could the Commission exlpain the apparent 
contradiction between Article 27.3 of Regulation 
(EC) No 882/2004 (where it is stated that inspection 
fees shall not be lower than the minimum set out in 
the Regulation) and Article 27.4 of the same 
Regulation (where it is stated that inspection fees 
should not be higher than the costs borne by the 
Competent Authorities)? 

EN 

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Provision 
concerned/ 
Sources 

Article 27 (4) 

Requests for interpretation addressed to the 
COM by MS 

Author: RA'e Dr Fuchs und Renger                             
Questions:                                                               a) 
According to the legal interpretation by Germany's 
highest administrative court (the Federal 
Administrative Court), under the previous Directive 
85/73/EEC as amended by Directive 96/43/EC, 
collection of fees other than the flat-rate fees fixed 
in Annex A, Chapter I, Nos 1 and 2a was possible, 
according to either No 4a or No 4b. However, the 
competent authority had to opt for one of the two 
alternatives. Can this interpretation also be applied 
to the wording of Article 27.4.b? If so, is a 
combination of both alternatives within an 
authority's area of competence possible?                      
b) If the Competent Authority opts to collect a flat-
rate fee, can it then calculate fees on the basis of the 
costs borne over a given period of time as a result of 
all the controls carried out pursuant to paragraphs 
1or 2, taking into account only the types of costs 
referred to in Annex VI?                                        
c) If the Competent Authority opts for minimum 
fees in accordance with Annexes IV and V of 
Regulation (EC) No 882/2004, is the fixing of fees 
by the Competent Authority in compliance with the 
provisions of Article 27 of Regulation (EC) No 
882/2004?                                               
d) Is the Competent Authority obliged to fix at least 
the minimum fees referred to there for all the 
activities listed in Annexes IV and V (official 

l )

EN 

ECJ Judgements 

Infringement cases 

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Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

C-523/09   7 July 2011 
Maag Piimattööstus AS v Veterinaar- ja 
Toiduamet  (reference for preliminary 
ruling)                                                
Question: Must Article 27(4)(a) of 
Regulation [No 882/2004] be interpreted 
as not prohibiting the demanding of a fee 
from an operator at the minimum rate laid 
down in Part B of Annex IV to that 
regulation for the activities listed in Part A 
of Annex IV to the regulation, even if the 
costs borne by the responsible competent 
authorities in connection with the items 
listed in Annex VI to that regulation are 
lower than the abovementioned minimum 
rates? 

Article 27(4) 
(a) 

Article 
27(4)(b) 

Author: Counsellor for Agricultural Affairs, 
Permanent Representation of Estonia to the EU 
Question: When a Member State implements 
Regulation (EC) No 882/2004 in such a way that the 
fees collected for the official controls are fixed at 
the minimum rates provided in Annex IV Section B 
[Article 27 part 4(b)], is that Member State required 
to take into consideration the actual costs borne by 
the competent authorities in order to make sure that 
the fees are not higher than the costs?" 

EN 

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ECJ Judgements 

Infringement cases 

Provision 
concerned/ 
Sources 

Article 27(7) 

Article 
27(12) 

Requests for interpretation addressed to the 
COM by MS 

Author: Association of Independant Meat Suppliers   
Question: What is your view on the way Article 
27.7 of Regulation (EC) No 882/2004  has been 
implemented in the UK (who charges two fees for 
establishments carrying out both slaughter and 
cutting)? 

1) Author: Studio Giffoni sprl/bvba Customs 
Consultancy                                           Question: 
Article 27 paragraph 12) says that "Member States 
shall make public the method of calculation of fees 
and communicate it to the Commission".Is it 
possible to receive the complete list of fees or 
charges related to official controls in the 
Communityapplied by each Member States?     

2) Author: International Butchers' Confederation        
Question: What charges are levied in the different 
i
M b S

?

f

i

3) Author: Belgian federal Agency for the Safety of 
the Food Chain                                                              
Question: How is the method of calculation of fees 
to be made public? is it sufficient for the person in 
question to be informed in a meeting, and for the 
information to be set out in the minutes?  

EN 

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concerned/ 
Sources 

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COM by MS 

ECJ Judgements 

Infringement cases 

Annex IV , 
Section A 

EN 

C-523/09   7 July 2011  
Maag Piimattööstus AS v Veterinaar- ja 
Toiduamet                                               
(reference for preliminary ruling)                  
Question: Is a Member State entitled, on 
the conditions mentioned in the previous 
question [see Article 27(4)(a)], to establish 
fees for the activities listed in Part A of 
Annex IV to [Regulation No 882/2004] 
that are lower than the minimum amounts 
laid down in Part B of Annex IV to that 
regulation, if the costs borne by the 
responsible competent authorities in 
connection with the items listed in Annex 
VI to that regulation are lower than the 
above mentioned minimum rates, without 
the conditions laid down in Article 27(6) 
of that regulation being satisfied?’ 

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EN 

 
 
 
 
   
 
 
 
  
  
Provision 
concerned/ 
Sources 

Annex IV, 
Section B 

Requests for interpretation addressed to the 
COM by MS 

Author: Belgian Federal Agency for the Safety of 
the Food Chain     
Question: Why are no minimum tariffs laid down 
for all official controls, e.g.: controls on imported 
feed and food of non-animal origin; 
registration/recognition of feed and food companies, 
export of feed and food?  

Annex IV, 
Section B,   
Chapter I 

Annex IV, 
Section B,   
Chapter II 

Author: Belgian Federal Agency for the Safety of 
the Food Chain                           
Question: Do the fees for inspections during 
slaughter include the fees for sampling, residue 
analysis and BSE analysis (in cattle)? 

Author: Law firm Tuengerthal & Liebenau                 
Question: What is the opinion of the Commission 
on their own interpretation of the legislation: the 
collection of fees for controls in cutting plants 
pursuant to Annex IV, Chapter II leads to fees that 
are not reflecting the actual costs that the authority 
has to bear? 

EN 

ECJ Judgements 

Infringement cases 

2007/4703 
Complainant: Keul & Farber 
Complaint: The veterinary fees charged by the 
District of Bergstraße, Hessen are higher than the 
minimum fees set out in Annex IV, Part 
B, to Regulation (EC) No 882/2004 on official 
controls. 

2007/4755 
Complainant: Keul & Farber 
Complain: The veterinary fees charged by the 
District of Steinburg, Schleswig-Holstein, are 
higher than the minimum fees set out in 
Annex IV, Part B, to Regulation (EC) No 
882/2004 without there being a proper 
implementing act.  

Page 126/253 

EN 

 
 
 
 
   
 
 
 
  
 
  
  
  
  
Requests for interpretation addressed to the 
COM by MS 

Author: Ministry of Foreign Affairs of Latvia             
Question: Regulation 882, Annex IV, Section B, 
Chapter IV milk production – what exactly is meant 
– raw milk production in the holdings or milk 
processing in dairies? 
1) Author: Belgian Federal Agency for Safety of 
the Food Chain                                 
Question: What is the difference between 'first 
placing on the market of fishery and aquaculture 
products' and 'first sale in fish market' ?   

2) Author: Veterinary Directorate General       
Questions:                                                              a) 
What is the difference between "first placing on the 
market of fishery" and "first sale in fish market"?        
b) The correct implementation of Regulation 
882/2204 implies the rupture with the repealed 
Directive procedures and determines the charge of 
first placing on the market to the primary producer?    
c) If so to whom should be charged the first sale in 
fish market: to the auction all operator or to the first 
purchaser?  

Author: Belgian Federal Agency for Safety of the 
Food Chain                                     
Questions:                                                              a) 
What exactly does "associated costs" mean?                
b) To what extend can overheads be charged? For 
example can electricity and heating costs be partly 
through-charged by the Personnel Department?         

Provision 
concerned/ 
Sources 

Annex IV , 
Section B,   
Chapter IV 

Annex IV, 
Section B,   
Chapter V 

Annex VI, 
point 2 

EN 

ECJ Judgements 

Infringement cases 

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Sources 

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COM by MS 

ECJ Judgements 

Infringement cases 

Directive 
85/73/CEE 
as amended 
by Directive 
96/43/CEE 

EN 

C-270/07  19 March 2009                                    
Commission of the European Communities v 
Federal Republic of Germany  
(failure to fulfil obligation)   
Request: The applicant requested the Court to 
declare that, by failing to adapt to the Community 
provisions Paragraph 4 of the law implementing 
the legislation on the health inspection of meat and 
poultrymeat in the Land Schleswig-Holstein, the 
Federal Republic of Germany has failed or 
continues to fail to fulfil its obligations under 
Articles 1 and 5(3) and (4) of Council Directive 
85/73/EEC and under Article 27(2), (4) and (10) of 
Regulation (EC) No 882/2004 

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Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

C284/00 and C-288/00   30 May 2002          
C-284/00 Stratmann GmbH und CO.KG 
and Landrätin des Kreises Wesel                   
C-288/00 Fleischversorgung Neuss GmbH 
und Co. KG and Landrat des Kreioses 
Neuss                             
(references for a preliminary ruling)              
Questions:                                                      
a) Does the standard fee applicable under 
Council Directive 85/73/EEC for the 
inspection of fresh meat intended for the 
domestic market, in accordance with 
Council Directive 64/433/EEC, also cover 
the costs of carrying out examinations of 
fresh pigmeat for trichinae?         
b) Does the standard fee applicable under 
Council Directive 85/73/EEC, in 
conjunction with Council Decision 
88/408/EEC, for the inspection of fresh 
meat intended for the domestic market, 
also cover the costs of carrying out a 
bacteriological examination required in an 
individual case? 

2006/4749 
Complainant: Keul & Farber 
Complaint: The Land Schleswig-Holstein did not 
transpose Directive 85/73, Decision 88/408 and 
Directive 93/118. The relevant law of 
12.1.1998, which provides for veterinary fees 
which cover the costs, including for bacteriological 
and trichinae examinations had retroactive effect. 

2006/4750 and 4773 
Complainant: Keul & Farber 
Complaint: The Land Niedersachsen did not 
transpose Decision 88/408 and Directive 93/118. 
Directive 85/73 as amended by Directive 
96/43 has not been transposed completely and 
accurately. An amendment of 23.01.2003 still 
maintains specific fees for bacteriological and 
trichinae examinations by way of an increase of 
the general examination fee. 

EN 

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concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

2006/4751 
Complainant: Keul & Farber 
Complaint:The Land Brandenburg did not 
transpose Directive 85/73 as amended by Directive 
93/118 and transposed Directive 85/73 as 
amended by Directive 96/43 incompletely and 
incorrectly. It charges fees in excess of the 
Community flat rate and adds 
specific fees for bacteriological and trichinae 
examinations, which is in contradiction with the 
Directive as interpreted by the Court in Cases C-
284/00 and C-288/00 - Stratmann.  

2006/4761 
Complainant: Keul & Farber 
Complaint: The Land Nordrhein-Westfalen 
transposed Directive 85/73 as amended by 
Directive 96/43 belatedly, incompletely and with 
retroactive effect and increased the Community 
flat rate. In a regulation of 18.9.2000 it provides 
for specific fees in addition to 
the general examination fee in contradiction with 
the Directive as interpreted by the Court in Cases 
C-284/00 and C-288/00.  

Page 130/253 

EN 

EN 

 
 
 
 
   
 
 
 
  
  
  
 
Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

2006/4762 
Complainant: Keul & Farber 
Complaint: A local authority in Sachsen-Anhalt 
has requested fees which the complainant 
considers to be in contradiction with the ECJ 
judgements in C-284/00 and C-288/00 - Stratmann 
since the inclusion of specific fees is considered to 
be contrary to the principles of a uniform fee and 
transparency. 

2006/4763 
Complainant: Keul & Farber 
Complaint: The Land Niedersachsen did not 
transpose Decision 88/408 and Directive 93/118. 
Directive 85/73 as amended by Directive 
96/43 has not been transposed completely and 
acurately. An amendment of 23.01.2003 still 
maintains specific fees for 
bacteriological and trichinae examinations by way 
of an increase of the general examination fee. 

2006/4764 and 4766 
Complainant: Keul & Farber 
Complaint: In Hessen a regulation adds fees for 
trichinae examinations to the general veterinary 
examination fee, which is said to be 
incompatible with Directive 85/73 and the 
Stratmann case law (Cases C-284/00 and C-
288/00). 

Page 131/253 

EN 

EN 

 
 
 
 
   
 
 
 
  
  
  
 
 
Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

2006/4767 
Complainant: Keul & farber 
Complain: A local authority in Sachsen-Anhalt 
has requested fees which the complainant 
considers to be in contradiction with the ECJ 
judgements in C-284/00 and C-288/00 - Stratmann 
since the inclusion of specific fees is considered to 
be contrary to the 
principles of a uniform fee and transparency. In 
addition the complainant criticises the retroactive 
application of derogations in Directive 85/73/EEC 
in Sachsen-Anhalt. 

2006/4778 
Complainant: Keul & Farber 
Complaint: The competent local authority in 
Rheinland-Pfalz charges veterinary fees which 
include fees for bacteriological and trichinae 
examinations. These fees are higher than the flat 
rate provided for in Directive 85/73 and the 
complainant considers them to be incompatible the 
Directive as interpreted by the Court in Cases C-
284/00 and C-288/00 - Stratmann. 

2006/4843 and 4915 
Complainant: Keul & Farber 
Complaint: In Bavaria the Directive was 
transposed and applied at local level (Landkreise). 
Additional fees were charged, e.g. for 
examinations for trichinae. 

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EN 

EN 

 
 
 
 
   
 
 
 
  
  
  
 
 
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concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

C-374/97   9 September 1999  
Anton Feyer and Landkreis Rottal-Inn, 
Intervener: Landesanwaltschaft Bayern  
(reference for prelimanry ruling)                   
Question: Is the authorisation given to 
Member States under Article 2(3) of 
Council Directive 85/73/EEC as amended 
by Directive 93/118/EC to collect an 
amount exceeding the Community fees 
dependent on the total fee collected in the 
Member State as a whole and the actual 
figure for inspection costs incurred in the 
Member State as a whole or is it sufficient, 
when the Member State has delegated 
authorisation to collect the fees to the local 
authorities, that the total fee collected by 
the local authority is not greater than the 
actual figure for inspection costs incurred 
by that authority? 

Page 133/253 

EN 

Article 2(3) 

EN 

 
 
 
 
   
 
 
 
  
  
Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

C-374/97   9 September 1999  
Anton Feyer and Landkreis Rottal-Inn,  
Intervener: Landesanwaltschaft Bayern  
(reference for prelimanry ruling)                   
Questions:                                                     
a) Can an individual oppose the collection 
of fees higher than the standard amounts 
listed in point 1 of the annex relating to 
Article 2(1) of Council Directive 
85/73/EEC as amended by Council 
Directive 93/118/EC where the Member 
State has not transposed Directive 
93/118/EC into national law within the 
prescribed period?  
b) Can a Member State collect fees higher 
than the standard amounts in reliance on 
point 4(b) of the annex relating to Article 
2(1) of Council Directive 85/73/EEC as 
amended by Directive 93/118/EC provided 
that the fees levied do not exceed the 
actual costs, no further conditions being 
imposed?  

Page 134/253 

EN 

Annex 
relating to 
Article 2(1) 

EN 

 
 
 
 
   
 
 
 
  
  
Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

C-309/07 19 March 2009  
Baumann GmbH v Land Hessen                   
(reference for a preliminary ruling)               
Questions:                                                      
a) Is a national legislature, when availing 
itself of the power laid down in Article 
5(3) of [Directive 85/73] and in point 4(a) 
of Chapter I of Annex A thereto to 
increase the standard amounts of fees for 
individual establishment and in point 4(b) 
to collect a fee which covers actual costs, 
strictly bound by the fee structure laid 
down in points 1 and 2(a) of Chapter I of 
Annex A or may it make a distinction, 
when setting the amounts of scales of fees, 
between inspections of slaughtering units 
in large establishments and other 
inspections and, in addition, also within 
those two groups adjust the rate of fees on 
a diminishing scale according to the 
number of animals slaughtered within the 
animal types, provided only that that 
reflects the actual costs? 
b) On the basis of the abovementioned 
provisions, may a national legislature 
collect, in respect of slaughtering carried 
out outside normal slaughtering hours at 
the request of the owner, an additional fee 
on a percentage basis on top of the fee 
collected for slaughtering inspections in 

Page 135/253 

EN 

Article 5(3) 
and Chapter I 
of Annex A 

EN 

 
 
 
 
   
 
 
 
  
  
  
  
  
Provision 
concerned/ 
Sources 

Requests for interpretation addressed to the 
COM by MS 

ECJ Judgements 

Infringement cases 

normal slaughtering hours when that 
increase reflects the additional actual 
costs, or must those costs be contained in 
the standard (increased) fee for all persons 
subject to a fee? 
C-430/07   25 June 2009  
Exportslachterij J. Gosschlak & Zoon B v 
Minister van Landbouw, Natuur en 
Voedselkwaliteit  
(reference for a preliminary ruling)               
Question: Must the second subparagraph 
of Article 5(4) of Directive 85/73/EEC be 
interpreted as meaning that this Directive 
does not preclude the Member State from 
charging a fee on account of the costs of 
the BSE tests which were carried out? If 
so, what requirements must be met by a 
fee for the BSE tests which were carried 
out?’ 

2006/4747 and 4830 
Complainant: Keul & Farber 
Complaint: Incorrect transposition/application in 
Baden-Württemberg of Directive 85/73 as 
amended by Directive 93/118 and 96/43. 
Although the relevant provision provided for an 
increase of the EC flat rate based on the 
particularities of the establishment, 
additional fees for bacteriological and trichinae 
examination were charged. The Directive was re-
transposed retroactively. 

Page 136/253 

EN 

Article 5(4), 
second 
subparagraph 

Annex A, 
Chaper 1,No 
4(b) 

EN 

 
 
 
 
   
 
 
 
  
  
  
  
Provision 
concerned/ 
Sources 

Directive 
96/23/EC 

Requests for interpretation addressed to the 
COM by MS 

Author: Fuchs und Renger                                   
Question: According to which criteria must the 
competent authority take account of the costs of 
testing for residues (Directive 96/23/EC): 
- when fixing flat-rate fees? 
- when fixing minimum fees? 

Annex A, 
Chaper 1,No 
2(a) 

EN 

ECJ Judgements 

Infringement cases 

2006/4746, 4774, 4781, 4809, 4963 and 5034 
Complainant: Keul & Farber 
Complaint:  
The Land Nordrhein-Westfalen transposed 
Directive 85/73 as amended by Directive 96/43 
belatedly, incompletely and with 
retroactive effect and increased the Community 
flat rate. In a regulation of 18.9.2000 it provides 
for specific fees in addition to 
the general examination fee in contradiction with 
the Directive as interpreted by the Court in Cases 
C-284/00 and C-288/00 - Stratmann. 

2006/4703  
Complainant: law firm Keul & Farber 
Complaint:  Germany (and in particular the city of 
Koblenz) is violating Directive 85/73/EEC, as 
amended by Directive 96/43/EC, which provides, 
in Annex A Chapter 1 No 2(a), that the hygiene 
controls and inspections 
connected with meat cutting establishments must 
be covered a standard fee of € 3/tonne of meat. 
Derogation from the standard 
fee is only allowed under certain conditions. 
The City of Koblenz (Rhineland-Palatinate) has 
disregarded these conditions by adopting a blanket 
scale of fees on the basis of which an increased 
flat-rate fee of € 30.91 is being charged. 

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Annex XV: FEES - Examples of stated limited availability of resources as reported in FVO reports 

MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

2008-7781 SA (residues and 
contaminants in live animals and 
animal products, including veterinary 
medicinal products) 

"In the autonomous community visited there had been no 
controls on private veterinary practitioners.  The competent 
authority explained that this was due to the need to prioritise 
resources. Controls on retailers were deemed to be of greater 
importance." 

Lack of financial resources  

ES 

HU 

DK 

2008-7774 SA (residues and 
contaminants in live animals and 
animal products, including veterinary 
medicinal products) 
2010-8440 SA (residues and 
contaminants and the use of veterinary 
medicinal products in food producing 
animals) 

SE 

2010-8438 SA (residues and 
contaminants and the use of veterinary 
medicinal products in food producing 
animals) 

EN 

"The discrepancy between planned arrangements and the 
factual number of controls is due to budgetary reductions"   

Lack of financial resources  

"At one of the RVFA offices delays in follow-up 
investigations were ascribed to a lack of staff, particularly 
during holiday periods, and due to subsequent priority 
setting."  

"According to the two County Administrative Boards visited, 
limited staff resources had led to strict prioritisation of 
official controls. [...] A lack of staff and a re-organisation of 
the District Veterinary Organisation by the Board of 
Agriculture had led to under-sampling for the NRCP (on-farm 
samples) in 2009. [...] Participation in training was 
sometimes restricted due to lack of staff and resources." 

Lack of staff 

Lack of financial resources, staff and training  

Page 138/253 

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MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

BU 

2010-8436 SA (residues and 
contaminants and the use of veterinary 
medicinal products in food producing 
animals) 

RO 

2010-8441 SA (residues and 
contaminants and the use of veterinary 
medicinal products in food producing 
animals) 

"At regional level, appropriate and properly maintained 
facilities and equipment were available to staff in charge of 
controls. However, this was not the case in the laboratory 
where (laboratory management) claims of inadequate 
funding have resulted in a situation whereby the competent 
authority is not complying with Articles 4 (2) c of Regulation 
(EC) No 882/2004 and can not meet its obligations under 
Article 15 of Council Directive 96/23/EC." 

 "As a result of substantial budgetary constraints, there is 
currently insufficient laboratory capacity or capability to 
enable the analyses of the number of samples and substances 
included in the NRCP"; "So far in 2010, the IHVPH has 
received 15% of its annual budget and has announced that as a 
result, analyses of a range of substances can no longer be 
performed";"although the laboratories visited had sufficient 
analytical equipment, the Director of one laboratory stated that 
substantial refurbishment was necessary [...]"; "Officials 
met in the counties visited had been provided with relevant 
training during 2008 but little or none in 2009 owing to 
budgetary issues". "Little relevant training has been 
provided and the resulting lack of awareness of certain 
requirements, combined with the effects of on-going 
budgetary problems and limited ability to oblige farmers and 
FBOs to undergo sampling, prevents the effective 
implementation of the official control system for residues and 
the NRCP in particular." 

Lack of resources results in lack of appropriate 
facilities and equipment 

Lack of financial resources resulting in insufficient 
laboratory capability; inappropriate equipment, no/little 
training. 

EN 

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MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

RO  

2010-8479 SA (controls on feed 
legislation) 

"Training concerning feedingstuffs for 2009 and 2010 has 
been cancelled due to financial reasons"                                    

Lack of financial resources resulting in a lack of 
training  

BU 

2010-8478 SA (controls on feed 
legislation) 

SK 

2010-8807 SA (health rules on animal 
by-products (ABP)) 

"In the regions visited, the audit team noted that neither NVS 
feed inspectors nor municipality inspectors met were 
supplied with the equipment necessary to take samples of 
feed";                                 "Representatives of NVS at central 
and regional level acknowledged that NVS feed inspectors in 
the 28 regions and municipality veterinarians had not 
received training prior to their appointment [...] NVS 
representatives met informed the audit that, at present, there 
is no training programme related to feed issues neither for 
regional NVS inspectors nor for municipality veterinarians".  

"the officials from the RVFAs and the DVFAs visited as well 
as the inspectors responsible for official controls met in the 
processing plants visited, stated that they had not received 
training on HACCP based procedures nor on their 
assessment. According to the SVFASR representatives met, 
training in this respect was planned for end of 2010 but 
due to financial limitations has been postponed to 2011." 

Lack of equipment and training 

Lack of financial resources results in a lack of training. 

SK 

2008-7776  SA (residues and 
contaminants in live animals and 
animal products, veterinary medicinal 
products) 

"The SVFA stated that due to budgetary limitations, 'suspect' 
samples are taken and submitted to the laboratory as ordinary 
'targeted' NRCP samples which means that the carcasses are 
not detained in the slaughterhouse as required by Article 24 of 
Council Directive 96/23/EC." 

Lack of financial resources  

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

GR 

2008-7793 MR (animal health - 
bovine brucellosis and tuberculosis, 
ovine & caprine brucellosis) 

LT 

2009-8131 SA (residues and 
contaminants and the use of veterinary 
medicinal products in food producing 
animals) 

"In the Prefectures visited the number of veterinarians 
employed was very low compared with the posts in the 
organisation chart (e.g. in one Prefecture 21 out of 76, in 
another one 3 out of 11). Due to the lack of veterinary staff, 
in one Prefecture visited one LVS (Local veterinary station) 
was not in operation and in another one, only 6 LVSs out of 9 
were actually in operation. In another Prefecture visited, the 
activities of the local level were performed by the official of 
the Prefectural level. [...] No specific technical training has 
been organized at Central level for new or existing staff since 
2003 and no training has been planned at central or 
Prefectural level for 2008 on issues related to the 
programmes." 

"In 2008, the ratio between samples taken for Group A 
analyses in bovines on farms and in the slaughterhouses was 
40:60 and not 50:50 as planned and required under Council 
Directive 96/23/EC. The NRCP coordinator explained that 
this discrepancy was spotted after the second quarter of the 
sampling year. However, due to the number of samples 
already taken, it was impossible to rectify the situation 
without additional financial resources - which were not 
available." 

Lack of staff and training  

Lack of financial resources 

MT 

2009-8278 MR (Public Health - Food 
Hygiene) 

"The CA stated that certain laboratory analyses were not 
carried out due to a shortage of staff in the laboratory." 

Lack of staff 

MT 

2010-8590 SA (Food hygiene, food 
contact materials and food additives) 

"Staffing levels in the PHL are insufficient [...]. Inspectors 
have not been adequately trained in FCM and FA [...]." 

Lack of staff and appropriate training 

EN 

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MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

MT 

2010-8558 SA (import/transit control 
system and border inspection posts) 

NL 

2009-8095 MR (controls on feed 
legislation)  

"BIP infrastructure is generally in accordance with 
requirements except in Luqa airport BIP where significant 
shortcomings in maintenance and operational hygiene 
were noted[...]. The attribution of staff resources especially 
official veterinarians for BIPs is not satisfactory. This leads 
to certain veterinary controls being carried out by improperly 
qualified staff, as a result veterinary checks are not carried out 
appropriately. [...] Training is provided for BIP matters, and a 
plan is in place for 2010. However, some of the shortcomings 
noted regarding veterinary checks and veterinary decision 
indicate that the training provided is not satisfactory." 

"Training arrangements were mainly satisfactory except in the 
areas of import controls and inspections at primary production 
of feed, for which the official met had not received the 
appropriate training required by Art. 6 of Regulation (EC) 
No 882/2004. The resources dedicated by AID and VWA to 
the implementation of official controls on feed were 
insufficient to meet the objectives of their respective control 
programmes. Resources were also inadequate in order to 
provide a timely follow-up on corrective actions imposed and 
to undertake all necessary legal proceedings." 

No properly mantained facilities and equipment; lack 
of staff and appropriate training 

Lack of human and financial resources; lack of 
appropriate training 

EN 

Page 142/253 

EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

"The CA indicated that due to a long-term staff shortage at 
the Animal Health Directorate (AHD) it has not been possible 
to set up a centrally approved sampling programme for BIPs. 
[...] The lack of staff at central level is central to problems in 
the provision of training, updating and development of 
necessary manuals and the implementation of a verification 
system. This has also contributed to the lack of a system to 
ensure ongoing training needs are identified and met.[...] For 
Customs training is insufficient, in those entry points where 
they are responsible for checks on accompanied pet animals, 
to ensure correct execution of controls. (as evidenced by a 
lack ofawareness of the requirements by officials 
encountered)." 

"Various competent authorities stated that they had not 
access to a sufficient number of suitably qualified and 
experienced staff as required by Article 4 of Regulation (EC) 
No 882/2004. 
Subsequently auditing and control tasks were not consistently 
completed [.. ] No specific training on FA was provided to 
the official inspectors in the last two years at any level.[..] 
Some theoretical training related to post mortem inspection 
has been provided to slaughterhouse staff also by official 
veterinarian in charge of slaughterhouse. However overall 
training duration was less than 30 hours for the course led 
by the official veterinarian. There was no evidence of 
training provided to the newcomers." 

Lack of staff and training  

Lack of staff and training  

GR 

2009-8077 SA (import/transit control 
system and border inspection posts) 

FI 

2009-8316 GA  

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

MT 

2010-8458 SA (poultry meat and the 
systems in place to control the 
Salmonella risk in poultry)  

GR 

2009-8333 MR (health rules on animal 
by-products (ABP)) 

"There is insufficient number of staff to complete the 
assigned tasks in poultry meat producing establishments.[...] 
Scheduled frequency of inspections in poultry establishments 
is based on risk assessment however due to the lack of human 
resources the planned schedule set in 2009 is currently not 
being met." 

"Significant staff shortages remain in the CA with 
responsibilities for the ABP chain which might affect the 
implementation of the official controls required by Art. 26 of 
Regulation (EC) No 1774/2002. As such, the relevant 
recommendation made following report 2007-7611 has not 
been addressed and the requirements of Art. 4(2) of 
Regulation (EC) No 882/2004 ave not been fulfilled."  

Lack of staff 

Lack of staff and training  

FR  

2007-7185 MR  (import controls - 
food of non-animal origin) 

"In the DDCCRF of Marseille, the human resources 
available for the control of imported foodstuffs were not 
sufficient, which could compromise the frequency of 
sampling established in Commission Decision 2006/504/EC."  

Lack of staff 

IT  

2009-8233 MR (public health - baby 
food) 

"The LSV and the SIAN are using the same risk classification 
but the frequency of the visits is not the same. In one 
establishment visited (under the joint supervision of the LVS 
and the SIAN) which was classified as high risk, the LVS 
carry out monthly inspections whereas the SIAN officers visit 
once a year. In one other establishment visited, also classified 
as high risk, the LVS performs 8 inspections per year and the 
SIAN only 3. The CA stated that this is because of limited 
human resources in the SIAN." 

Lack of staff 

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

UK  

2009-8299 SA (Plant Health - import 
controls; Bursaphelenchus xylophilus; 
and Anoplophora chinensis) 

"Mainly because of lack of human resources, the frequency 
of documentary checks, physical identity checks and plant 
health checks falls far short of meeting EU requirements for 
import controls, and the mission team considers that these 
shortcomings result in a significant risk of introduction and 
spread of harmful organisms into the Community. 
Furthermore having no or reduced frequency checks outside 
the framework of the EC legislation could result in redirection 
of trade in favour of UK points of entry." 

Lack of staff 

DE 

2010-8567 MR (import/transit control 
system applied in the border 
inspection post of Bremerhaven) 

"According to the head of BIP the failure to enter all relevant 
data in TRACES was due to lack of staff" 

Lack of staff  

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

"According to the information provided to the AT during the 
mission 910 jobs were lost this year for budgetary reasons. 
[...] At central level, it appeared during the mission that due 
the numerous responsibilities applied to a limited number of 
staff, some planned activities cannot be always ensured. [...] at 
central level where staff is accommodated in premises with 
limited working area per person and where many people have 
to share the same room. In another county once the official 
samples are taken and sealed by the OVs, it is the 
responsibility of the FBOs to deliver them to the laboratory 
due to limited availability of means of transport for the official 
sampletaker.[...] Since 2009, the training frequency has 
decreased (one training session every two months took place 
in 2008 while in 2009 only one training session took place). 
[...] The efficiency of the implementation of the official 
control system is diminished by insufficient staffing at 
central level, insufficient training of inspecting staff at 
county level and insufficient availability of means of 
transport identified in some counties. 

"The CCA stated that there has not been considerable progress 
in the re-evaluation of approved establishments due to a 
limited number of staff available for this task and due to 
financial problems concerning travel expenses. In addition the 
CCA informed the FVO team that they had a salary cut of 
25% in 2010. [...] According to the CCA a shortage of 
financial resources has had an impact on training 
organised in 2010. Recommendation 2 has not been 
satisfactorily addressed and inadequate training for OVs in 
certain areas was noted by the FVO team."  

Lack of financial resources resulting in staff shortages, 
lack of appropriate training and equipment  

Lack of financial resources resulting in lack of staff 
and training 

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EN 

RO  2010-8528 SA (Fishery products) 

RO 

2010-8512 SA (public health - food 
hygiene) 

EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

BU 

2010-8513 SA (public health - food 
hygiene) 

RO 

2008-8003 MR (Control of residues 
and contaminants in live animals and 
animal products, including controls on 
veterinary medicinal products) 

GR 

2011-8840 MR (Poultry meat and 
poultry meat products) 

GR 

2011-8810 MR (Health rules on 
animal by-products (ABP)) 

"The NVS informed the FVO team that the GDCVA prepare 
an audit plan each year. In 2010 ten audits were planned to ten 
different RVS, however the CA stated that only six of these 
audits had been carried out due to budgetary constraints." 
"Significant delays in allocation of the budget allied with the 
fact that the national residue control plan is not yet financed 
by fees pursuant to Article 27 and Annex IV Section B to 
Regulation (EC) No 882/2004, have contributed to the marked 
delay in the implementation of the 2008 plan which is not in 
line with point 2.1. of Annex to 16 Commission Decision 
98/179/EC. Budgetary constraints and late implementation 
of the plan collectively undermine the effectiveness of the 
residues control system." 
"The number of controls performed varied between regions. In 
one region visited the set target was achieved. In a second 
region, due to budgetary constraints, only approximately 
20% of foreseen checks were performed. As a result some 
establishments were never controlled in 2010. The audit team 
was informed that for 2011 this specific region will be in 
the same situation." 

"At two prefectures out of the 11 visited by the audit team, 
evidence was shown that a risk based plan was set up, 
however; the inspectors met by the audit team declared that 
they were not able to execute this plan due to lack of 
resources." 

Lack of financial resources 

Lack of financial resources 

Lack of financial resources 

Lack of financial resources 

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

GR 

2010-8609 MR (Protected zones, 
harmful organisms and controls for 
Rhynchophorus ferrugineus) 

RO 

2010-8560 SA (Import/transit control 
system and border inspection posts) 

UK  

2009-8092 SA (Official controls on 
feed legislation)  

"Greece has organised an official action programme aiming to 
seek confirmation that the relevant harmful organisms are not 
endemic or established in the protected zones in 2009. The 
action programme is generally based on appropriate planning 
and methodology. However, a number of Prefectures were 
omitted from the survey plan because of a lack of 
resources." 

"All BIPs in Romania are approved for HC and NHC and they 
are also listed as Designated Points of Entry under Regulation 
(EC) No. 669/2009. The BIP facilities are shared for controls 
of POAO and products of non-animal origin. At the BIPs 
visited no formal system for minimising the risk of cross-
contamination was in place. The effectiveness of the existing 
measures,however, cannot be ensured due to the lack of 
resources for cleaning and disinfection of the shared 
facilities." 

One of the LAs responsible for official controls on imported 
feed at one seaport visited (England) had no documented 
procedure in place for the implementation of such controls. 
According to a representative from this LA, documentary 
checks were not performed and physical checks (sampling) 
were very limited due to a lack of resources [..]. As a 
result, few samples were taken and they were tested for 
melamine and genetically modified organisms only." 

Lack of financial resources 

Lack of financial resources 

Lack of resources   

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

RO 

2010-8460 SA (Salmonella National 
Control Programme in particular 
poultry populations)  

FI 

2009-8065  SA (poultry meat and 
poultry meat products) 

PL 

2010-8602 SA (Plant Health - potatos 
and the general system of surveillance 
for harmful organisms) 

PT 

2010-8611 MR (Pinewood Nematode) 

BU  

2010-8552 SA (Import/transit control 
system and border inspection posts) 

"A shortage of financial resources has had an impact on 
sampling levels in 2009 and training organised in 2009/2010. 
As of today, the CA has the necessary legal powers needed for 
the SNCP implementation. While some training has been 
organised relevant to SNCP, in some cases this has been 
insufficient/ineffective." 
"Sampling plans were not always fully mplemented; in one 
MFCA visited the plan for first half of 2008 was not 
implemented at all and no official samples were taken.As a 
reason the MFCA indicated lack of financial resources." 

"The mission team noted that in one of the local offices 
visited, the chief inspector reported that there was too few 
staff  to carry out the minimum level of planned checks, in 
particular, that in 2009, it had not been possible to carry out 
the mandatory annual documentary check at premises 
registered in accordance with Directive 92/90/EC." 

Trucks sealed with private seals are not controlled and due to 
a lack of resources there is no system in place to control that 
trucks intercepted with non-compliant material follow the 
instructions of GNR.  

"No internal or external audits subject to independent 
scrutiny and transparency have been done in the framework of 
Regulation (EC) No 882/2004. According to the CA this was 
due to lack of resources. No concrete plans were in place for 
implementation of such audits for BIPs. [...] The lack of 
supervision for the biggest BIP in Bulgaria cannot ensure that 
official controls are carried out correctly." 

Lack of financial resources affecting controls and 
training 

lack of financial resources 

Lack of staff 

Lack of financial resources 

Lack of financial resources 

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

SE 

2010-8501 SA (Public Health - Food 
Hygiene) 

SE 

2007-7433 MR (Import controls for 
plant health) 

SE 

2010-8606 SA (plant health import 
controls) 

"The NFA stated that there is not yet a uniform training 
system in place across the different CAs in Sweden to ensure 
the competence of officials carrying out official controls. […] 
the basis for future training has been established through the 
completion of the "skills in food control" project but so far no 
funding for the implementation of the project has been 
secured." 

"Most of the shortcomings are related to limited human 
resources. Not all regulated articles are checked, and some 
checks are carried out after customs clearance.[...] The 
competent authorities in Sweden are recommended to ensure 
that: 
(1) There are adequate staff available to enable plant health 
checks to be carried out [..]" 
"Understaffing is the major limiting factor for carrying out 
plant health controls. This affects for example import controls, 
where not all checks are carried out, where it is required by 
EU legislation. […] despite the increase in the number of ID 
inspectors, there still appears to be a shortage of staff and 
inspectors are charged with a wide range of tasks in other food 
and feed safety areas. Thus, recommendation 1 of the 2007 
mission report has not been fully addressed." 

Lack of financial resources resulting in lack of training  

Lack of staff 

Lack of staff 

EN 

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EN 

 
 
 
 
   
 
 
 
MS 

FVO Audit Reference 

Instances where MS have stated that they could not carry 
out controls because of a lack of resources 

Problem raised by the MS 

"The CCA indicated that the reduction in staff did not 
significantly affect the performance in the field. However:◦ 
One DVO visited lacked supervisory staff: it had no district 
superintending veterinary officer (SVI) (not replaced), and 
had been for the last two years without Higher Executive 
Officer (HEO, in charge of administrative and staff matters). 
Poor supervision and enforcement was observed in this DVO.◦ 
Significant delays in notifying IUT movements were 
explained by the staff in charge (at the DVO level) as due to 
the limitation of human resources.[...] Impact of the 
reduction of staff, and consequently the field presence of the 
CA in charge of the TB eradication programme, is mitigated 
by the automation of tasks and the reorganisation of official 
controls on a risk basis. However, the level of implementation 
of official controls is insufficiently verified to ensure their 
effectiveness throughout the country. This verification is all 
the more necessary in the execution of the TB eradication plan 
[...]." 

"[...] the insufficient provision of staff, equipment and 
reagents commensurate with designated tasks remains a 
significant obstacle to the proper functioning of the laboratory 
network 
and the Greek competent authorities have therefore not met 
their obligations under Article 4(2)(a), 4(2)(c) and 4(4) of 
Regulation (EC) No 882/2004." 

Lack of staff 

Lack of staff and equipment 

IE 

2010-8408 MR (Animal health - 
bovine tuberculosis) 

GR 

2011-8901 MR (Monitoring of 
residues and contaminants in live 
animals and animal products, 
including controls on veterinary 
medicinal products) 

EN 

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EN 

 
 
 
 
   
 
 
 
Annex XVI FEES - Validated baseline scenario141 

Issue to be 
considered 

Belgium 

Italy 

UK 

Belgium's system is based on the  the idea 
that costs for official controls need to be 
shared between FBOs and MS. So FBOs 
only contribute to part of the costs and the 
rest is financed with the general budget (at 
the moment around 40%FBOs-60%MS). 
There are 2 types of fees: 
- retributions: these are the areas covered by 
mandatory fees and an hourly rate between 
40 and 60 eur is applicable (depending on 
the qualifications of the inspectors) unless 
the application of throughput charges is 
higher than that (these charges are similar to 
the mandatory fees in 882/2004). 
- contributions: paid by all FBOs at the 
beginning of the year depending on size and 
sectors. They cover routine inspections 
throughout the year regardless if inspections 
take place for a specific FBO. 
Out of office hours activities have, in certain 
cases, a surcharge. 

With the new legislation of 2008 (Legislative 
Decree 194/2008) Italy intends to use the fees 
to cover 100% of the costs related to official 
controls along the food chain but with the 
exclusion of retail, ABP, primary production, 
feed. 
There are 2 types of fees: 
- mandatory fees under Reg. 882/2004 are 
calculated on a throughput/quantity basis 
(similar to Annex IV and V) - fees are 
provided also for import of food of non-animal 
origin 
- fees for all the other FBOs are calculated as a 
flat rate contribution paid at the beginning of 
the year depending on size/category (from 400 
to 1500 eur /year) 

Fees as a tool of 
financing official 
controls 

UK mainly collect the mandatory fees. 
From 9/2009 a time-based fee has been 
introduced in the meat slaughterhouses and 
cutting plants  
The fee to the establishments varies depending 
on their size, as the percentage of cost recovery 
was originally based on previous charges that 
hinged on livestock and throughput units. 
The aim is to reach 100% coverage of costs in 
a few years. 
Fees are not applied in the dairy sector. 
According to UK the fact that they did not 
apply those fees prior to Reg. 882/2004 
exempts them from this obligation.                      
There are differing levels of fees being applied 
on the fish sector as it is acknowledged that the 
actual administrative burden of running the fee 
system in some establishments is greater than 
the fees  collected                                             
An exercise to improve efficiency of the 
inspection services in the meat sector is on 
going and has led to a decrease of costs. 
However fees are growing at the moment 
because: 
- UK aim at increasing cost coverage towards 

141 This Annex only refers to the inspection fees collected for the purpose of control activities currently covered by Regulation 882/2004 (feed and food law, animal health and 
animal welfare rules). 

EN 

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EN 

 
 
 
 
   
 
 
 
 
                                                 
Issue to be 
considered 

Belgium 

Italy 

UK 

2005: 42% of total costs 
2006: 46% of total costs 
2007: 39% of total costs 
2008: 38% of total costs 
2009: 37% of total costs 

Costs covered with 
fees 

Non-mandatory fees 

Covered by the contributions paid by all 
participants to the food chain at the 
beginning of the year. 

Activities covered 

The whole food chain (also primary 
production). 
Also activities carried out on FBOs request 
are subject to fees (e.g. export certificates) - 
a combination of cost per certificate and 
hourly rates. 
In general authorisation/registration requests 
are not covered by fees even if they require 
an inspection on the spot. However the 
authorisation of some establishments 
(agrement) is subject to a fee. 

100% 
- the weak pound. 
Annex VI is the reference including social 
security costs and overheads.                                
In the slaughterhouse and cutting plant sector 
the following level of cost recovery was 
achieved 
2007:41% 
2008:43%                                                              
2009:44%                                                              

Only specific areas: approval of irradiation 
facilities, pesticide residues programme (fee on 
chemical industry), sampling and testing of 
raw cow milk in England and Wales 
Only mandatory areas under Reg. 882/2004 
(with the exclusion of dairy sector and the few 
exceptions mentioned above) 

2005: 50% estimate 
2006: 50% estimate 
2007: 50% estimate 
From 2009 fees are to be applied with an 
automatic 20% increase, then after the end of 
the year the actual cost is calculated and the 
automatic increase/decrease is re-calculated to 
reach 100% cost coverage.  
A 0.5% increase is meant to cover costs related 
to the implementation of MANCP and ring 
fenced for this purpose to the Ministry of 
Health. 
Covered by the flat rates contributions paid by 
FBOs at the beginning of the year + fees on 
import of food of non animal origin. 

The food chain with exclusion of retail, ABP, 
feed and primary production. 
Authorisation of establishments (also feed) is 
subject to a flat rate fee. 
Export certification is subject to hourly rate of 
50 eur. 
Out of office hours activities have a surcharge 
(30%).                                                                   
Italy is considering the possibility to extend 
fees also to the transhipment part of import.  

EN 

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EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 

Belgium 

Italy 

UK 

For retributions, the hourly rates/throughput 
fees are determined by legislation. 
For contributions a declaration is made 
every year (also electronically) and yearly 
fees depend on size and sector (from 50eur 
up to 11,000). 

All fees are calculated on the basis of Annex 
VI of Reg. 882/2004 (including social 
contributions) and reviewed at least every 2 
years to ensure coverage of 100% of costs. 
For administrative costs a reference is made to 
them being "linked to the controls carried out". 

Calculation method 

Small/disadvantaged 
FBOs 

Some small establishments and businesses 
are exempted from payment or payment 
reduced. 

All information is available on line and 
regularly updated. www.afsca.be 

Transparency 

Some flexibility is mentioned in the basic law 
with a reference to paragraphs 5 and 6 of Art. 
27 Reg. 882/2004 but that cannot derogate 
100% cost recovery. Unclear if specific rules 
are needed. 
Basic law is published on the official journal. 
Then information are prepared and published 
by local competent authorities. No centralized 
information. 
The basic law prescribe regular information to 
the Commission on: 
- calculation method 
- figures on use of income from fees. 

EN 

Fees are calculated on the basis of annex VI of 
Reg. 882/2004 including social contributions 
and overheads. In the meat slaughterhouses 
and cutting plant establishments fees are 
calculated as a percentage of actual costs, the 
percentage being paid will differ depending on 
the size of the business, therefore it takes into 
account livestock and throughput units. In the 
case of the percentage that is being charged 
being lower than the EU minima, charges will 
then be increased to meet EU minima. In the 
fish sector guidance provided to Local 
Authorities explains a calculation method that 
is based on relevant 882/2004 annex.  
A discount is calculated on the time-based fee 
as the percentage to be paid decreases as 
throughtput and livestock units decrease.             
Guidance on "Cold inspection" have been 
developed to maximize CA efficiency 
All information is available on line and 
regularly updated. 
www.food.gov.uk 

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EN 

 
 
 
 
   
 
 
 
Belgium 

Italy 

UK 

Issue to be 
considered 

Mechanisms to 
increase efficiency 

A bonus-malus system is in place. If haccp 
system of the FBO is certified by accredited 
bodies recognized by AFSCA, then the 
yearly contributions is reduced by 50%. If 
not, a malus of 20%(2009), 60% (2010) and 
100% (from 2011)  is applied. 
For poultry slaughterhouses where FBOs are 
involved in controls the fees are reduced. 

Application of mandatory fees can take into 
consideration previous record of conformity, 
risk category and efficient own checks but 
cannot derogate to 100% cost recovery. 
With an agreement State/Regions it is possible 
to detemine time-based fees for 
slaughterhouses on the basis of minimum 
inspection times to be respected by the CA 
(e.g. 4 minutes per cattle). 

See above. For the mandatory fees a specific 
system is not in place apart from an increase 
in the fees in case animals with unclear 
identification (slaughterhouse) 

See above 

Reward/penalize 
systems 

/ 

Fees for several 
controls at the same 
place 

Operators charged  The FBOs 

Ring-fenced for AFSCA activities 

Ring-fence 

EN 

The principle included in Art. 27.7 of Reg. 
882/2004 is repeated in the basic legislation 
clarifying that the single fee to be applied is 
based on the recovery of actual costs. 
The FBOs 
95% of the income from fees on domestic 
activities is ring fenced for the local CA and 
laboratories. 5% is for regional and central 
authorities to cover costs related to 
implementation of MANCP. 
20% of the income from fees on imported 
products is ring fenced for the CA. 80% goes 
to the general budget.   

CA and FBOs sign Business Agreements 
where the presence of the CA is agreed. In 
case of disagreements a mechanism is in place 
to solve them. If the CA loses the case and 
they believe an increased presence of the CA is 
all the same needed, they pay for it. FBOs can 
propose changes to the way of production in 
order to decrease the need for CA presence. 
This system has ensured that the pressure to 
ensure efficient and effective delivery of OCs 
has been shared with FBOs. 
The UK was to further develop a fee system 
that clearly takes into account FBO 
compliance levels when setting the fee system. 
Unclearness within the UK as to the legal 
meaning and scope of articles 27 and 28 has 
previously hampered developments on that 
front. 
No specific rules. In general fees take into 
consideration the proximity of slaughterhouses 
and cutting plants which is to be considered in 
line with Art. 27.7 of Reg. 882/2004. 
the FBOs 
In part. Controls carried out by Food standards 
agency operations in slaughterhouses and meat 
cutting plants are ring fenced (collected and 
used within the agency).                         The 
rest of the sectors when monies are collected 
this is done through Local Authorities and kept 
within the authority. 

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EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 

Art. 28 - non-routine 
checks 

Belgium 

Italy 

UK 

Inspections which reveal non-compliances 
are not charged per se. However the costs 
related to sampling and analysis and further 
enforcement actions (destruction, treatment, 
etc. ) are paid by the FBOs.  

Controls under Article 28 (and on the basis of 
EU emergency measures) are charged to the 
operators with an hourly rate of 50eur + costs 
of analysis (rate calculated on the basis of 
Annex VI Reg. 882/2004). 

Information sources 

AFSCA website 
Questionnaire submitted in 2008 (fees 
study) 

Legislative Decree 194/2008 
Case study in the 2008 fees study 
Web sites of a few local authorities 

UK has a very restrictive understanding of Art. 
28 which leads to its application only in 
extreme cases of non compliances which lead 
to a risk for consumers. So, in general, 
additional controls are not charged to FBOs 
even if they reveal non-compliances as it was 
felt at a UK level that art. 28 was not drafted to 
that effect, and that it was unclear whether art. 
27 applied instead. 
FSA web site 
Case study in 2008 fees study 
Questionnaire submitted in 2008 (fees study) 
Information received from UK CA after 
working group with MSs 

EN 

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EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

EN 

France  

Poland 

Germany 

Fees are under the responsibility of each 
Lander and therefore systems vary greatly. 
In general they only cover mandatory fees but 
a significant number of Landers cover also 
non mandatory fees in the areas of food safety 
and animal health. Also approval of plants is 
mentioned among non mandatory fees. 

Poland collects all the mandatory fees under 
Reg. 882/2004 at the minimum levels 
indicated (some differences are due to the 
exchange rate). 
In the veterinary area some non-mandatory 
fees are set (feed, certification, ABP, etc.). 
In 2009 Regulation of the Minister of Health 
656/2009 introduced fees for all official 
controls performed on FBOs dealing with 
food (and not included in the veterinary 
sector). 
In this way fees cover the whole food chain 
(apart from primary production) 

2008: CA claims 100% cost coverage (no 
data) 

No data 

France only collect mandatory fees. 
Fees are based on cost recovery. For import 
on the basis of the costs calculated the year 
before (BIP by BIP) and then adjusted for the 
next year to cover 100% costs. For domestic 
production following rules similar to the 
national rules on VAT. Rates are slightly 
below minimum fees in Reg. 882/2004. 
From June 2010 a fee has been introduced for 
the authorisation of animal feed producers. 
From 1 January 2010, fees for controls on 
slaughtering and aquaculture production now 
include also costs related to the control of 
residues of veterinary medicines (before they 
were separately charged). In the fish and 
aquaculture sectors a process of alligning the 
mandatory fees to the requirements of 
Regulation 882/2004 is on-going. 
2005: For import: 3.8 million costs - 3.7 
million recovered 
2006: For import: 4.1 million costs - 4.4 
million recovered 
2008: For import : 4,16 million costs - 4,21 
million recovered 
For domestic production: 70% estimate (80 
million euro costs, 56 million recovered) => 
45 % estimate (125 million euro costs, 55 
millions recovered) 
For import: around 100% (but in general 
rental costs are not included here and paid 
by operators directly. This accounts for 
about 20% of total costs) 

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EN 

 
 
 
 
   
 
 
 
France  

Poland 

Germany 

Issue to be 
considered 

Non-mandatory fees 

No. Fees for export certification and 
authorisation of plants are being considered 
inside and outside of the EU 
A fee for animal by-products  during 
slaughter is collected on national basis (part 
fee part subsidy). 

Activities covered 

Only mandatory areas under Reg. 882/2004 
(with some exceptions) 

For import the following elements are 
considered:rental costs for BIPs if not 
already paid by operators, equipment, 
training, cleaning, travelling expenses, 
salaries of staff directly involved in controls, 
sampling. 
For domestic production salaries of staff 
directly involved, training, property charges, 
operational costs including sampling. 

Calculation method 

Small/disadvantaged 
FBOs 

Transparency 

No specific rules but the way fees are 
applied seems not to create particular 
problems to them. 
Legislation is published in the OJ. 
Notes de service are sent to the CA. 
Relevant ministries publish information 

EN 

In the veterinary area. They refer mainly to 
certification (export, health), feed (domestic), 
ABP, emergency slaughter outside plant, 
genetic materials, markets, animal quarantine.
Outside the veterinary area, Regulation 
656/2009 introduces a fee for official controls 
on food other than veterinary area.  
The whole food chain (apart from primary 
production) but with specific systems for 
veterinary and non veterinary areas. 
In the veterinary area: fees include the costs 
for salaries of personnel involved in controls, 
administrative costs related to controls, 
training of inspectors, sampling and testing. 
Minimum fees are used for areas covered as 
mandatory by Reg. 882/2004. Specific fees 
for veterinary non mandatory fees 

Outside the veterinary area: fees include 
transport costs, document control, sampling 
and testing, verification procedures. 
Flat rate of 45 PLN (13 EUR) is charged per 
control + 15 PLN (4 EUR) per hour + 
sampling + testing (specific rates). Specific 
rates are also set for import. 
No specific rules. 

Charged in some Landers. 

Mainly veterinary area but in some Landers 
also food safety in general (whole food chain). 

In general a mix between minimum fees and 
cost based fees is used. Costs are calculated 
but then the minimum fee acts as a lower limit 
(apart from Bavaria). In some Landers fees are 
calculated for each establishment. In some 
Landers also maximum ceilings are included. 
The costs recorded the previous year are the 
basis for the fees in the following one. 
For some fees (e.g. authorisation of plants) a 
hourly fee is set (with min and max) at 44 
eur/hour + travel 

No specific rules 

Legislation is published in the OJ. 

Legislation published in the OJ 

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EN 

 
 
 
 
   
 
 
 
 
Issue to be 
considered 

France  

Poland 

Germany 

(Agriculture, Customs) 

No specific rules. 

No specific rules. 

Mechanisms to 
increase efficiency 

Reward/penalize 
systems 

Fees for several 
controls at the same 
place 
Operators charged 

Ring-fence 

A bonus malus system is being considered. 
Slaughterhouses are classified in 4 
categories depending on level of 
compliance. The first 2 categories would 
have a bonus, the others a malus. 
No specific rules 

No specific rules. 

No specific rules. 

No specific rules 

The FBOs 
Fees for import are ring fenced but not for 
domestic production. All fees are reversed to 
the general budget. A direct budget line is 
against national tax legislation. 

The FBOs 
Fees go to the general budget. 
Fees for veterinary controls are ring-fenced 
for the CA when contractors are used. 

Art. 28 - non-routine 
checks 

No specific rules 

No specific rules. 

EN 

No specific system in place. 
A system of categorization of meat 
establishments according to risk is being tried 
in some Landers in order to modulate 
frequency of inspections to the related risk 
category. 
Industry is asking for consultation on the 
setting of fees in order to increase efficiency 
and risk based approach. Salaries are one of 
the biggest cost but industry is not involved in 
their setting (only CA and trade unions) 
No specific rules 

The FBOs 
In general fees are collected to be directly 
used to finance the official controls (they are 
in fact mainly based on full cost recovery). 
In those Landers where fees go to the general 
budget in any case they are earmarked for the 
CA. 
No specific rules 

Page 159/253 

EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 

Information sources 

France  

Poland 

Germany 

Case study in 2008 fees study 
Questionnaire submitted in 2008 (fees 
study) 
Information received from France after an 
FVO inspection 
Notification from France under Art. 27.12 

Case study in 2008 fees study 
Questionnaire submitted in 2008 (fees study) 
Notification from Poland under Art. 27.12 

Case study in 2008 fees study 
Questionnaire submitted in 2008 (fees study) 
Notification from Germany under Art. 27.12 

EN 

Page 160/253 

EN 

 
 
 
 
   
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

Non-mandatory fees 

Activities covered 

Slovakia 

Estonia 

Latvia 

Fees included in Annexes IV and V are 
collected at the minimum rates.  
Non mandatory fees are also collected for 
import of food of non-animal origin,  
veterinary controls of animals, hatching eggs, 
germinal products and animal by products 
(also with reference to export).  These fees 
are collected as time-based fees. 

2005: 52% 
2006: 55% 
2007: 51% 
Non mandatory fees are also collected for 
import of food of non-animal origin,  
veterinary controls of animals, hatching eggs, 
germinal products and animal by products 
(also with reference to export).  These fees 
are collected as time-based fees. 
mandatory fees, import of food of non-animal 
origin, veterinary controls of animals, 
hatching eggs, germinal products and animal 
by products (also with reference to export). 

Fees included in Annexes IV and V are 
collected at the minimum rates. 
Outside these sectors: 
- food sector: FBOs are charged using a time 
based fee 
- feed sector: rates are calculated quarterly on 
the basis of quantities produced/exported 
- veterinary sector other than Annexes IV and 
V: a time based fee is used. 
2005: 31% 
2006: 28% 
2007: 20% 
The whole food and feed chain is covered but 
fees are calculated in different ways according 
to sector. 

Fees cover all mandatory fees (but not milk) 
and some minor activities outside these 
sectors.  
Specific rules and calculation method apply fo 
fees in the residues area (Dir. 96/23). 
The other sectors are either covered with the 
minimum fee or a flat rate based on actual 
costs (depending on the activity) 

100% (according to the CA) 

Fees cover issuing of health certificates and 
permits. Fees cover also import of food contact 
materials and feed of non-animal origin 

The whole food and feed chain. 

Only mandatory fees and minor activities 
outside them. 

EN 

Page 161/253 

EN 

 
 
 
 
   
 
 
 
 
Issue to be 
considered 

Slovakia 

Estonia 

Latvia 

Minimum fees for the mandatory ones. 
For import controls on food of non animal 
origin,  veterinary controls of animals, 
hatching eggs, germinal products and animal 
by products (also with reference to export) a 
time based fee (hourly) is calculated on the 
basis of the items included in Annex VI of 
the Regulation. 

Calculation method 

Small/disadvantaged 
FBOs 

Transparency 

Mechanisms to 
increase efficiency 
Reward/penalize 
systems 

No specific rules (CA feel that different rules 
would put some business categories at 
disadvantage compared to others - there is 
also the need to maintain a minimum level of 
income for official controls). 
Relevant legislation is published in the 
official journal. 
No specific rules. 

No specific rules. 

EN 

Fees under Annex IV and V are collected at 
the minimum rates. 
Feed sector: fees depend on quantity and 
quality of feed. 
Other veterinary fees and food sector: hourly 
fee calculated on the basis of average 
remuneration of a supervisory official + 
average administrative and economic costs 
relating to carrying out the inspection. The 
remuneration refers to an official working for 
the local CA or at BIPs - the average refers to 
remuneration in the previous year. 
The administrative and economic costs are the 
average cost per official with reference to the 
items listed in point 2 of Annex VI to the 
Regulation and related to the inspection 
activities. 
Every year the hourly fee is updated taking 
into consideration the costs of the year before. 
Fully considered in the food sector and partly 
considered in the veterinary area with the use 
of a time based fee outside Annexes IV and V.

Covering the costs mentioned in Annex VI 
(administrative costs are included adding 10% 
to the direct costs) 

No information 

Legislation published in the OJ. 

No information 

No specific rules. 

No specific rules. 

No information 

No information 

Page 162/253 

EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 
Fees for several 
controls at the same 
place 

Operators charged 

Ring-fence 

Art. 28 - non-routine 
checks 

Information sources 

EN 

Slovakia 

Estonia 

Latvia 

CA apply only one fee in slaughterhouses 
with annexed cutting plants. 

FBOs 
In the milk sector only dairy farms (not 
processors) are charged. 
Fees go to the general budget and only in part 
it goes back to the competent authorities 

Specific legislation for additional official 
controls needed after detection of non 
compliance. FBOs are charged using a time 
based fee (hourly) identical to the one 
foreseen for import of food of non-animal 
origin and veterinary controls of animals, 
hatching eggs, germinal products and animal 
by products (also with reference to export). 
Costs related to sampling needed in relation 
to the detected non compliance are also 
included. 
Case study in 2008 fees study 
Questionnaire submitted in 2008 (fees study) 
Notification from Slovakia under Art. 27.12 

No specific rules. 

No information 

FBOs 

Fees (except for feed control) are used 
directly to finance official controls. Fees for 
feed control go to the general budget. 
FBOs are charged using a time based fee, in 
case of laboratory investigations the costs of 
these are added. 

FBOs 

Yes, fully. 

In the residues area, if non compliance is 
detected the costs of the controls carried out 
are charged to the operators. 

Estonia notification under Art. 27.12 

Questionnaire submitted in 2008 (fees study) 

Page 163/253 

EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

Non-mandatory fees 

Activities covered 

Calculation method 

Small/disadvantaged 
FBOs 

Transparency 

Mechanisms to 
increase efficiency 
Reward/penalize 
systems 
Fees for several 
controls at the same 
place 
Operators charged 

Ring-fence 

EN 

Lithuania 

Bulgaria 

Cyprus 

Fees cover all mandatory fees and some 
minor activities outside these sectors. 
Flat rate fees are calculated on the basis of 
actual costs. 
100% (according to the CA) 

Fees cover issuing of specific certificates 

Fees cover all mandatory fees and some minor 
activities outside these sectors. 
Flat rate fees are calculated on the basis of 
actual costs. 
2005: no data 
2006: 25% 
2007: 29% 
Fees cover animal welfare controls and import 
of feed of non animal origin,  

Only mandatory fees and minor activities 
outside them. 
Covering the costs included in Annex VI 
(including social security of inspectors). 
Fees are calculated on the basis of actual 
costs and can go below minimum fees if 
costs are lower. 
No information 

Only mandatory fees and minor activities 
outside them. 
Covering the costs included in Annex VI 
(including social security of inspectors). 
Fees are calculated on the basis of actual costs 
using average costs and a specific hourly fee 
per inspector (10 BGN) 
No information. 

Basic law (Resolution) and annual updates 
are published in the official journal 
No information 

No information 

No information 

No information. 

No information. 

No information. 

No information. 

Fees cover all mandatory fees and some minor 
activities outside these sectors. 
Minimum fees are followed apart from cutting 
plants where an hourly rate is used. 
No data (CA state that fees do not cover costs 
but no data are available) 

Fees cover export certificates and import of 
products of animal origin outside Regulation 
882/2004. 
Only mandatory fees and minor activities 
outside them. 
Minimum fees for all mandatory sectors apart 
from cutting plants where an hourly fee is used 
(calculated on the basis of the salaries of 
inspectors) 

No information 

No information 

No information 

No information 

No information 

FBOs 
Fees go to the general budget and only in 
part it goes back to the competent 

FBOs 
Fees go to the general budget and only in part 
it goes back to the competent authorities 

FBOs 
Fees go to the general budget and only in part it 
goes back to the competent authorities 

Page 164/253 

EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 

Art. 28 - non-routine 
checks 

Information sources 

Lithuania 

Bulgaria 

Cyprus 

authorities 
No information 

Questionnaire submitted in 2008 (fees 
study) 

No information. 

No information 

Questionnaire submitted in 2008 (fees study) 

Questionnaire submitted in 2008 (fees study) 

EN 

Page 165/253 

EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Czech Republic 

Denmark 

Finland 

Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Fees cover all mandatory fees and some 
minor activities outside these sectors. 
Minimum fees are followed for activities 
within the EU and flat rates, on the basis of 
actual costs, for import. 

Fees cover all mandatory fees and some other 
activities outside these sectors. 
Flat rates are used and calculated on the basis 
of actual costs. Minimum fees are used for 
small abattoirs 

Costs covered with 
fees 

2005: 36% 
2006: 33% 
2007: 28% 

Non-mandatory fees 

Activities covered 

Calculation method 

Fees cover issuing certificates and approval 
and registration of establishments and 
laboratories 

Only mandatory fees and minor activities 
outside them. 
Minimum fees for domestic activities. 
For import, flat rates are calculated on the 
basis of actual costs according to the items 
of Annex VI 

Small/disadvantaged 
FBOs 

No information 

Transparency 

No information 

Mechanisms to 

No information 

EN 

CA state full cost coverage with the exception 
of small abattoirs where only 35% of costs is 
recovered (this subsidy is calculated in around 
10 million DKK a year) 
Fees cover food and feed of non animal origin, 
food additives, ABP, food contact materials, 
animal welfare during transport, approval and 
registration of establishments 
Mandatory fees and some activities outside 
them. 
Flat rates are calculated on the basis of actual 
costs. Small abattoirs are charged minimum 
fees. 
A time based fee is calculated plus a starting 
fee for each control which covers associated 
costs). 
Feed establishments pay also an annual fee. 
Analysis are charged at cost. 
For residues a quantity based fee is calculated. 
Small abattoirs are charged only minimum fees 
and the extra costs are paid with the state 
budget. 
No information 

No information 

Fees cover all mandatory fees and some other 
activities outside these sectors. 
Flat rates are used and calculated on the basis 
of actual costs. Minimum fees can be used for 
smaller establishments under the responsibility 
of municipalities. 
2005: around 100% (20% for small plants) 
2006: around 100% (20% for small plants) 
2007: around 100% (20% for small plants) 

Fees cover all feed controls and approval of 
establishments 

Mandatory fees and some activities outside 
them. 
Flat rates are calculated with a time based fee. 
Smaller establishments are under the 
responsibility of municipalities and they can be 
charged on the basis of costs or at minimum 
fees depending on the municipality. 

Smaller establishments in municipalities can be 
charged minimum fees instead of at cost. 

Relevant legislation is published in the official 
journal and on the EVIRA wesite 
No information 

Page 166/253 

EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 
increase efficiency 
Reward/penalize 
systems 
Fees for several 
controls at the same 
place 
Operators charged 

Ring-fence 

Czech Republic 

Denmark 

Finland 

No information 

No information 

No information 

No information 

No information 

No information 

FBOs 
Fees go to the general budget and only in 
part it goes back to the competent authorities 

FBOs 
Fees are used direclty to finance official 
controls. 

FBOs 
Fees are used directly to finance official 
controls in case of controls under the 
responsibility of municipalities. Otherwise it 
goes to the general budget and only in part it 
goes back to the competent authorities. 
No information 

Art. 28 - non-routine 
checks 

Information sources 

Outside the veterinary sector, when 
inspections detect a non compliance, the 
cost of the analysis that detected the non 
compliance is charged to the FBOs 
Questionnaire submitted in 2008 (fees 
study) 

No information 

Questionnaire submitted in 2008 (fees study) 

Questionnaire submitted in 2008 (fees study) 

EN 

Page 167/253 

EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

Non-mandatory fees 

EN 

Ireland 

Greece 

Spain 

Ireland collect mandatory and some non-
mandatory fees. Minimum fees are followed 
for imports of animal origin. For meat,  a 
system of standard unit charges (which may 
or may not recover the full cost of the 
service). In the dairy sector a flat-rate system 
applies, based on the quantity of milk 
purchased on a monthly basis. The level of 
Inspection fee currently applying for imports 
of products of animal origin exceeds the 
minimum level requirements under 
Regulation (EC) No. 882/2004. The National 
Standards Authority of Ireland (NSAI) 
provide official food control services in 
premises requiring recognition for the 
extraction of natural mineral water. A fees is 
charged by the NSAI to cover the costs of 
audit and on site activites.                                  
2005: Meat: 48% Milk: 90% Animal Feed: 
82%   
2006: Meat: 38% Milk: 90% Animal Feed: 
80% 
2007: Meat: 42% Milk: 90% Animal Feed: 
76% Imports of animal origin: 27% 2009 
Meat: 40% Milk: 90% (approx) Imports of 
animal origin no change, Mineral Water 
Establishments  50-70%  
Yes for meat cold stores supervised by 
DAFF.  The NSAI fees for premises 
requiring recognition for the extraction of 
natural mineral water.  

Fees cover all mandatory fees and some minor 
activities outside these sectors, with the 
exception of the costs for the approval of 
feedingstuffs' establishments that is covered by 
annual fees. Flat rates are used and calculated 
on the basis of actual costs. 

Fees are under the responsibility of each 
Autonomous Community, not all control 
activities are covered by rules or specific 
provisions on fees collection under Reg. 
882/2004. For imports of differents products 
the fees are under responsability of the Central 
Competente Authority and they are different 
of the indicated in  the Reg.882/2004.In this 
moment,it is preparing a new rule on 
reinforced controls in the products of non 
animal origin (Reg 669/2009) and a new fee 
should be created.  

Fees do not cover costs. No data available (for 
the years before 2008 fees were not collected). 

In general the fees do not cover the costs. 

Fees cover all type of inspections in 
feedingstuffs. 

Charged in some Autonomous 
Communities.Also la Agencia Española de 
Seguridad Alimentaria y Nutrición (AESAN) 
has some fees on  several dietetic foods in 
relation with the evaluation and registration. 

Page 168/253 

EN 

 
 
 
 
   
 
 
 
Ireland 

Greece 

Spain 

Mandatory fees and other minor activities 
outside them. 

Flat rates are calculated on the basis of actual 
costs, according to the criteria of Annex VI of 
Regulation 882/2004. 

Not all control activities are covered by rules 
or specific provisions on fees collection under 
Reg. 882/2004.In imports they cover the 
imports of food of animal origin. 
In principle, minimum fees are applied. In the 
dairy sector, flat-rates and minimum rates are 
both used.In imports the calculation of fees is 
based on the type of product and the weight 
and it is calculateted by telematique way.  

Issue to be 
considered 

Activities covered 

Calculation method 

Small/disadvantaged 
FBOs 

Transparency 

Mandatory areas under Reg. 882/2004 and 
non mandatory fees charged for official 
controls in coldstores (See Appendix from 
Ireland for further information on rates) 
On what concerns meat these fees are either a 
fee per animal slaughtered, a fee per tonne of 
product going through cutting plants and 
independent cold stores or an hourly charge 
for time spent supervising product in 
processing plants, integrated cold stores and 
for overtime on meat inspection work. In the 
dairy sector a flat rate system is followed, 
fees are collected according to quantity of 
milk produced and cost of services on a 
monthly basis. 
Some small establishments are exempted 
from payment or payment reduced 

Relevant legislation is accessible on the 
website www.fsai.ie and 
www.irishstatutebook.ie 

The budget for the cost of controls has been 
planned and it was allocated according to the 
amounts that each establishment produced and 
disposed. 
No information 

There are no exemptions for the small 
establisments. 

Basic laws and annual updates are published 
on the official journals of the State (imports 
and fees of AESAN) and the Autonomous 
Communities.For the imports is also in the 
web page of Ministerio de Sanidad y Politica 
Social.Also some Autonomous Communities 
and AESAN have developped informatic 
applications in their web pages. 
Industry is asking for consultation on the 
setting of fees when a basic law or an update is 
preparing. 

Page 169/253 

EN 

Mechanisms to 
increase efficiency 

A working group has been established to 
review and evaluate the fees charged by the 
Department of Agriculture, Fisheries and 
Food for the provision of official controls 

No information 

EN 

 
 
 
 
   
 
 
 
Ireland 

Greece 

Spain 

Issue to be 
considered 

Reward/penalize 
systems 

Fees for several 
controls at the same 
place 

Operators charged 

Ring-fence 

Art. 28 - non-routine 
checks 

and inspection services in the meat and dairy 
hygiene sector as required under EU 
legislation 

Not applied 

No information 

Not applied 

No information 

FBOs of approved meat and milk 
etsbalishments and importers of food of 
animal origin (for imports of non animal 
origin see details in Annex)  
Fees go to the general budget and only a 
percentage is used to cover the costs of the 
controls carried out. 

Not applied 

FBOs 

Fees go to the general budget of the Ministry 
of Rural Develpoment and Food and only a 
percentage is used to cover the costs of the 
contros carried out. 
No information 

Information sources 

Questionnaire submitted in 2008 (fees study);   
notification from Ireland under art. 27.12. 

Questionnaire submitted in 2008 (fees study) 

EN 

Application of mandatory fees can take into 
consideration previous record of conformity, 
risk category , efficient own checks and other 
items (not working at night ,administrative 
support) but cannot derogate to 100% cost 
recovery. 
There is not a general rule.In some case is 
charged a single fee (the highest).In other 
cases there is an acumulation of the fees.    
FBOs included importers or responsibles for 
the consignements. 

Fees go to the general budget and only in part 
it goes back to the competent authorities. 

In the most part of the cases when there are 
detections of non compliance the additional 
official controls are charged FBOs (operators 
responsible for the non compliance or 
importers or FBO responsible for the 
consignements). 
Questionnaire submitted in 2008 (fees 
study).Consult to competent authorities(june 
2010). 

Page 170/253 

EN 

 
 
 
 
   
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

Non-mandatory fees 

Activities covered 

Calculation method 

EN 

Luxembourg 

Hungary 

Malta 

Fees cover all mandatory activites and some 
other activites outside them. Flat rates are used 
and calculated on the basis of actual costs, in 
the case of import control a fee below the 
minimum rate is applied. 

2005: around 60% 
2006: around 60% 
2007: around 60% 
Fees cover inspection of herds; certification 
and control of animals and animal products 
transport; control of animal exhibition, 
competition; tuberculine testing and sampling. 
Mandatory fees and some activities outside 
them. 

Flat rates are calculated on the basis of the 
actual costs. In the case of import control, a 
fee below the minimum rate is being applied. 

Fees are collected according to the Fees for 
Abattoir and Veterinary Service Regulations 
(LN 68/1986) (SL 35.10). Implementing 
legislation covers only red meat inspection fees. 
However, fees charged by Border Inspection 
Posts are collected according to Annex V of 
Regulation 882/2004, under a minimum rate 
system.  SL 35.10 is currently under review to 
render collection of fees for red meat inspection 
in line with minimum rates of Annex IV of 
Council Regulation (EC) 882/2004 and 
introduce new fees for other areas that are not 
covered by Council Regulation (EC) 882/2004 
or SL 35.10  
2005: 36.5 % 
2006: 36.9 % 
2007: 39.4 % 
No, implementing legislation is required. 

The present implementing legislation directly 
covers only red meat inspection fees. However, 
fees charged by Border Inspection Posts are in 
line with Annex V since July 2007. 
Fees under Annex V of Regulation 882/2004 
are collected at minimum rates. Cost of salaries 
of staff involved in official controls are 
included. 

Page 171/253 

EN 

 
 
 
 
   
 
 
 
  
 
 
 
 
Issue to be 
considered 

Small/disadvantaged 
FBOs 

Transparency 

Mechanisms to 
increase efficiency 

Reward/penalize 
systems 

Fees for several 
controls at the same 
place 

Operators charged 

Ring-fence 

EN 

Luxembourg 

Hungary 

Malta 

No information 

No information 

No information 

No information 

No information 

FBOs 

Fees are used directly to finance official 

Malta's largest FBOs are to be considerd small 
enterprises as per definition of SMEs.  The 
greater majority of Maltese FBOs are 
microenterprises with highly reduced activity 
and personnel. 
Collection of funds by the Agriculture and 
Fisheries Regulation Department for official 
controls and meat inspection are all recorded in 
a general direct accounting system (DAS) under 
the revenue vote.  An electronic receipt is issued 
for each payment.  The system falls under the 
Public Service Auditing system and is audited 
as part of the normal audits that take place from 
time to time. 
We have combined various controls to be 
carried out during inspections.  This saves 
sending numerous teams of veterinarians and 
officers to the same establishments or farms to 
carry out inspections for different 
issues/purposes. 
No mechanism exists for reward systems but an 
administrative fine procedure exists in the 
parent Act (CAP 437) for breaches of 
regulations falling under this Act. 
The system of compunding fees is not adopted 
at present. 

FBOs are charged.  Red meat slaughtering 
establishments are run by the state and therefore 
only internal paper transactions are considered. 
Fees go to the general budget and only in part 

Page 172/253 

EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
Issue to be 
considered 

Art. 28 - non-routine 
checks 

Information sources 

Luxembourg 

Hungary 

Malta 

controls. 

No information 

Questionnaire submitted in 2008 (fees study) 

return back to the competent authorities 

At present there is no extra collection of fees for 
enforcement work arising out of additional 
official controls for non-compliance.  
Questionnaire submitted in 2008 (fees study) 
(Updated 30.06.10) 

EN 

Page 173/253 

EN 

 
 
 
 
   
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Costs covered with 
fees 

Non-mandatory fees 

EN 

Netherlands 

Austria 

Portugal 

Fees cover mandatory areas and some 
activites outside them. For imports 
minimum fees are followed, for other 
activites under Annex IV of Reg.882/2004, 
meat and official controls on residues a flat-
rate system is used. In fee calculation the 
principles of direct benefit and 
cost/effectiveness are considered. For milk 
the fee is below the minimum rate because 
the actual costs of these official controls are 
below the minimum fee. 
2005: 75 % 
2006: 86 % 
2007: 81 %                                                       
2008/2009: 90% (est.) 

Fees cover all official controls and analyses 
in FBO's (meat and feed). There are also 
fees for registration of other foodoperators, 
approval an maintenance of approvals for 
dairy and milk products and eggs and egg 
products. 

Fees cover all mandatory fees and some minor 
activites outside them. Flat rates are used and 
calculated on the basis of actual costs. The 
fees for border checks are calculated on a 
minimum rate basis. For small establishments, 
fee setting is under responsibility of the 
different Landers. 

Fees cover all mandatory fees and some other 
activities. Minimum fees are applied, with the 
exception of plant approval and inspection on 
HACCP, where a flat-rate is adopted. The 
plant health fees, are the minimal fees 
according the EU regulation. 

CA state that fees entirely cover costs, with 
the exception of border checks (no data 
available). At the Swiss border, lower fees are 
charged in accordance with an agreement 
between the Ec and Switzerland. 
Fees cover hygiene checks in establishments 
that are subject to approval in accordance with 
Regulation (EC) No 853/2004 (processing; 
milk; eggs; fish). 

No data (CA state that fees do not cover costs 
but no data are available) 

Fees cover certification, slaughter, rabies 
vaccination, medicines and veterinary products 
approval and licensing.   other fees cover 
oficial checks in establishments that are subject 
to approval in accordance with Regulation 
(EC) No 853/2004 (processing; milk; eggs; 
fish), and subject to control under Regulation 
(EC) no 1774/2002 and import from third 
countries (BIP, minimum annex V).; 
considering vaccines it is in place a fee, due to 
lab control, before release to market/users. On 
the import control of foodstuffs of non-animal 
origin and within the scope of audits to verify 
the traceability and HACCP requirements, 
operators support the cost of the analysis. 

Page 174/253 

EN 

 
 
 
 
   
 
 
 
Netherlands 

Austria 

Portugal 

Mandatory fees and some minor activities 
outside them. 

Mandatory fees and some activities outside 
them. 

Issue to be 
considered 

Activities covered 

Calculation method 

Mandatory fees and some activities outside 
them. In general fees are applied for all all 
official veterinary controls and analyses in 
approved FBO's and border inspection 
posts. 
Minimum fees apply for import activities. In 
the areas under Annex IV of Reg.882/2004, 
for meat products and official controls on 
residues a flat-rate system is followed. In 
fee calculation the following principles are 
taken into consideration: direct benefit, a 
direct link is needed between the benefit of 
the control activites for the FBOs and the 
fee to be paid for such activity; the 
cost/effectiveness, fees have to cover 
integral costs, but never being higher than 
the costs to be covered in a (group of) 
sector(s) or activities. Most fees have an 
hourly rate. 

Fees are charged on a flat rate basis taking into 
account the duration, the position of the person 
performing the activity, the type of activity 
and resources used, and the type of 
establishment, distinctions being made on the 
basis of throughput. The fees for border 
checks are calculated, under a minimum rate 
system, on the basis of Annex V to Regulation 
(EC) 882/2004. 

Small/disadvantaged 
FBOs 

Transparency 

There are reduced fees for AM and PM 
inspections in very small slaughteries taking 
into consideration their low throughput. 
Legislation and fees are published in OJ. 
This information an further information on 
calculation method is available on line 
(www.vwa.nl)  

In the case small establishments, Landers are 
responsible for fee seeting. 

No information 

EN 

Minimum fees are applied as defined in 
Regulation 882/2004. Minimum fees apply 
even if they can clash with other criteria set by 
the Regulation (e.g. fees cannot be higher than 
costs). For plant approval, plant inspection and 
HACCP (under the Regulation (EC) No 
853/2004) a flat-rate system on the basis of the 
actual costs is adopted. On the import control 
of foodstuffs of non-animal origin a standard 
value for issuing certificates are applied to all 
operators. In addition, if the commodity is 
randomly selected for analytical control the 
full costs of laboratory analyses are billed 
directly to the operator 
Within the scope of audits to verify the 
traceability and HACCP requirements, 
operators support only the cost of the analysis 
if sampling is done. 
 Some small establishments (local micro-
economies) outside from Annex IV of Reg 
(CE) n.º 882/2004 have reduced fees. 
No information 

Page 175/253 

EN 

 
 
 
 
   
 
 
 
Issue to be 
considered 

Mechanisms to 
increase efficiency 

Reward/penalize 
systems 

Fees for several 
controls at the same 
place 

Operators charged 

Ring-fence 

Art. 28 - non-routine 
checks 

Information sources 

EN 

Netherlands 

Austria 

Portugal 

> call fee and time based fee (fee by quarter 
of an hour): the better the FBO functions, 
shorter and fewer official controls are 
needed which reduce the costs for FBO's. > 
set of rules for requests for official controls 
by FBO's  > surcharges for i) requests for 
controls outside regular working hours  i) 
overtime (on top of original requested time)  
If possible official controls are risk-based 
which in combination to the time based fees 
leads to less or more charges to FBOs  
Just one call fee for the same official; the 
total time for each offical is charged 
according to the applicable fee for the 
specific control 
FBOs, BIPs, cattle dealers, citizens who 
need a veterinary certificate 
Fees are directly and only used to finance 
control activities. 

All FBOs, BIPs and cattle traders - 
including retail - are charged for additional 
official controls according to art. 28 of Reg. 
882/2004. 
Questionnaire submitted in 2008 (fees 
study); questionnaire submitted in 2010 

No information 

No information 

No information 

No information 

No information 

No information 

FBOs 

FBOs 

Fees are used directly to finance official 
controls. In the case of Border Checks they are 
incorporated into the State's General Budget. 
No information 

Fees are used directly to finance official 
controls. 

No information 

Questionnaire submitted in 2008 (fees study) 

Questionnaire submitted in 2008 (fees study) 
Decreto-Lei nº 154/2005 (plant health 
inspection);Decreto-Lei n.º 178/2008 e Portaria 
n.º 1450/2009 (controls according  Reg.(CE) 
n.º 853/2004; n.º 183/2005 e n.º1774/2002) 

Page 176/253 

EN 

 
 
 
 
   
 
 
 
 
Romania 

Slovenia 

Sweden 

Issue to be 
considered 

Fees as a tool of 
financing official 
controls 

Fees cover all mandatory fees and some 
other activites outside them. Minimum fees 
are used on a time-basis that takes into 
account the salaries and the training cvosts 
for the personnel. For official controls on 
residues, FBOs dealing with products of non 
animal origin  and some general activites a 
flat-rate is applied. 

Fees cover all mandatory fees and some 
control activites outside them. Minimum fees 
are followed, except for official controls on 
residues and all non-mandatory activities, 
where  a flat-rate system based on the actual 
costs is used. 

Fees entirely cover costs for FBOs 
processing products of animal origin, but not 
for FBOs that process, stores and trades 
products of non animal orgin.                           
2006: 60% 
2007: 50% 

Costs covered with 
fees 

100% (According to the CA) 

Non-mandatory fees 

Fees cover businnesses of products of non 
animal origin  

Fees cover animal feed (control of approved 
establishments) and official control not 
covered by Annex IV of Regulation 882/2004 

EN 

Food: Full cost recovery (Meat in 2010 approx 
95% cost recovery). General national system 
where FBO's pay an annual fee for official 
controls. Annual fees are based on annual 
control time, which in its turn is calculated  by 
using av model for risk classification of FBO's, 
taking into account type and size of the FBO's 
activities, the risks involved and the FBO's past 
record. For slaughterhouses and GHE (and, to a 
certain extent, cutting plants) a different system 
applies, with annual fees calculated by 
estimating control hours per year multiplied by 
hourly rates based on actual costs for control 
performed by official veterinarians and official 
auxiliaries.                          
Food: Generally speaking, the aim of the fees 
system is full cost recovery for all official 
controls. The fees charged must be sufficient to 
finance the official control deemed necessary, 
and fees may not be used to finance other 
activities. Administrative costs, training, 
overheads, development of OC are included in 
the hourly rate. Slaughter upp to 200 tonnes per 
year is partly subsidised (approx. total of 9 
million SEK in subsidies 2010). 
Fees cover all official controls on food 
(including imports), pesticides and residues, 
and the import of feed of non animal origin and 
animal by-products.Animal welfare in 
slaughterhouses is included. 

Page 177/253 

EN 

 
 
 
 
   
 
 
 
 
Issue to be 
considered 

Activities covered 

Calculation method 

Small/disadvantaged 
FBOs 

Transparency 

EN 

Romania 

Slovenia 

Sweden 

Mandatory areas and some activities outside 
them (animal feed for control of approved 
establishments, official controls not covered 
by Annex IV of Regulation 882/2004 - to be 
further described). 
Minimum fees for the mandatory sectors, 
including total costs under Annex VI to 
regulation 882/2004 and, in case of live 
animals in I/C trade, also the costs covered by 
Regulation 1857/2006. For what concerns 
official controls on residues (Directive 96/23) 
and all activites covered by non-mandatory 
fees a flat-rate system is adopted. 

Food: The whole food chain, except primary 
producers. 

Food: Fees are calculated on the basis of Annex 
VI of Reg. 882/2004. Flat rates are used, they 
are based on an hourly rate including travel 
costs and out-of-office hours costs. Overheads, 
training, administrative costs are included.   
Minimum levels in EU-legislation are obeyed. 

Mandatory fees and some other activities 
outside them. 

Minimum fees are applied on a time-basis 
system that considers the total cost/hour for 
the control activites making the sum 
between the salaries of the involved 
personnel/hour and the costs for personnel 
training/hour.  For what concerns official 
controls on residues, processing, storage and 
trading businnesses of products of non 
animal origin and some other general 
activites (cold stores, repackaging units, en-
gross market) flat-rates are applied. 
In the amount of time calculation, the 
production volume and the sector of activity 
are also taken into account. 

No information 

No information 

No information 

Food: Annual fees for control take into account 
the size of the FBO's activities. Reduced fees 
apply for small slaughterhouses, based on 
applicable minimum fees according to 
Regulation 882/2004 
Laws and regulations on fees are published 
officially. Guidelines on risk classification have 
been published by the NFA. Detailed 
information on the calculating of fees is 
published on the NFA's homepage. Detailed 
info on calculation of control hours regarding 
slaughter houses and GHE is published on the 
NFA´s homepage.FBO's and other 
organisations receive proposals for new fee 
rules or fee levels and are given opportunity to 

Page 178/253 

EN 

 
 
 
 
   
 
 
 
Romania 

Slovenia 

Sweden 

No information 

No information 

Issue to be 
considered 

Mechanisms to 
increase efficiency 

Reward/penalize 
systems 

No information 

No information 

No information 

No information 

Fees for several 
controls at the same 
place 

Operators charged 

Ring-fence 

FBOs 
Fees are used directly to finance official 
controls. 

FBOs 
Fees go to the general budget and only in part 
it goes back to the competent authorities. 

No information 

No information 

Art. 28 - non-routine 
checks 

comment the proposals.  

Food: Risk-based approach to fees means that 
the risks in the FBO's activities are reflected in 
annual control time. System also takes into 
account the FBO's past record, where 
compliance or non-compliance can lead to a 
reduction or an increase in the annual control 
time and annual fees. 
See above. FBO's past record affects the annual 
fee paid. 
Food: Separate fees may apply for export 
authorisation, control of imported foodstuffs 
and of residues.              Authorization covering 
several activities, i.e. Slaughterhouse with 
annexed cutting plant and/or production plant, 
will be charged one fee calculated on volumes 
placed on market from each separate activity, 
provided each activity can be considered 
separate from the other activities.  
Food: FBOs 
Local and central authorities use fees directly to 
finance their official controls. Fees may not be 
used to finance other activities. 
Food: Article 28 is applied in all cases where 
non-compliance leads to extra control. An 
hourly rate applies. Costs for all types of 
control are covered. 

Information sources 

Questionnaire submitted in 2008 (fees 
study) 

Questionnaire submitted in 2008 (fees study)  Questionnaire submitted in 2008 (fees study) 

EN 

Page 179/253 

EN 

 
 
 
 
   
 
 
 
Annex XVII: FEES – Supporting data 

(*)This Annex only refers to the inspection fees collected for the purpose of control activities 
currently  covered  by  Regulation  882/2004  (feed  and  food  law,  animal  health  and  animal 
welfare rules). 

Table 1 Full cost recovery across EU Member States 

Member 
state 

Percentage of costs 
recovered 

Percentage of costs 
not recovered 

Impact of reaching 
100% recovery 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

ES 

FI 

FR 

GR 

HU 

IE 

IT 

LT 

LU 

LV 

MT 

NL 

PT 
PL142 

RO 

SE 

100% 

37% (2009) 

27% (2007) 

0% 

63% 

73% 

No impact 

Medium 

High 

No information 

Unknown  

Unknown impact 

28% (2007) 

72% 

High 

No information 

Unknown  

Unknown impact 

35% (small abattoirs) 

20% (2007) 

65% 

80% 

Costs not covered 

Unknown  

20% (small FBOs) 

45% - 70% (domestic) 

Costs not covered 

60% (2007) 

40% meat 
90% milk 
76% imports (2009) 

100% (2009) 

100% 

80% 

30% - 55% 

Unknown  

40% 

67% 
(average) 

0% 

0% 

Medium 

High 

High 

High 

Medium 

High 

Medium 

High 

No impact 

No impact 

No information 

Unknown  

Unknown impact 

100% 

39% (2007) 

81% (2007) 

100% 

100% 

50% non-animal origin 
(2007)  

0% 

61% 

19% 

0% 

100%  

50% 

Costs not covered 

Unknown  

No impact 

Medium 

Low 

No impact 

No impact 

Medium 

High 

142 The baseline data provided by DG SANCO indicate that Poland achieves full cost recovery; interviews with 
the Polish CA for this study, however, suggest that there is little data on cost recovery and that cost recovery is 
thought to be insufficient. 

EN 

Page 180/253 

  EN 

 
 
 
 
                                                 
Member 
state 

Percentage of costs 
recovered 

Percentage of costs 
not recovered 

Impact of reaching 
100% recovery 

SI 

SK 

UK 

100% 

51% (2007) 

43% (2008) 

0% 

49% 

57% 

No impact 

Medium 

Medium 

DG SANCO baseline 

including  social  security  costs  and  overheads.                        

is 

Annex  VI 

the  reference 

CA claims 100% but has no data to support claim 

Notes on the baseline data presented in Table 1 
United Kingdom: 
▪ 
In  the  slaughterhouse  and  cutting  plant  sector  the  following  level  of  cost  recovery  was 
achieved 
Poland:  
▪ 
The  baseline  data  provided  by  DG  SANCO  indicate  that  Poland  achieves  full  cost 
recovery;  interviews  with  the  Polish  CA  for  this  study,  however,  suggest  that  there  is  little 
data on cost recovery and that the available data indicate that cost recovery is insufficient. 
Portugal: 
▪ 
Lithuania 
▪ 
Greece 
▪ 
collected). 
Austria 
▪ 
the EU and Switzerland. 
Sweden 
▪ 
Generally  speaking,  the  aim  of  the  fees  system  is  full  cost  recovery  for  all  official 
controls. The fees charged must be sufficient to finance the official control deemed necessary, 
and fees may not be used to finance other activities. Administrative costs, training, overheads, 
development of OC are included in the hourly rate. Slaughter upp to 200 tonnes per year is 
partly subsidised (approx. total of 9 million SEK in subsidies 2010). 

At the Swiss border, lower fees are charged in accordance with an agreement between 

Fees  do  not  cover  costs.  No  data  available  (for  the  years  before  2008  fees  were  not 

CA claims 100% 

EN 

Page 181/253 

  EN 

 
 
 
 
Table 2 Ring-fencing of resources for official control activity in EU Member States 

MS  All resources 
ring-fenced 

Percentage 0f 
resources ring-fenced 
(if less than 100%) 

Resources ring-
fenced, with 
some exceptions

Resources to 
general budget 

No 
information 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

ES 

FI 

FR 

GR 

HU 

IE 

IT 

LT 

LU 

LV 

MT 

NL 

PT 

PL 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

Border 
inspection fees 

95% local CA and 
laboratories 
5% regional and central 
CAs 
20% import fees 

For AFSCA 
activities 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

Feed control 

Controls by 
municipal 
authorities 

Imports 

(cid:31) 

Other controls 

Domestic 
production 

95% domestic fee 
income for local CA and 
laboratories 
5% regional and central 
CAs 
20% import fees 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

(cid:31) 

Veterinary 
controls when 
contractors used 

EN 

(cid:31) 

Page 182/253 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MS  All resources 
ring-fenced 

Percentage 0f 
resources ring-fenced 
(if less than 100%) 

Resources ring-
fenced, with 
some exceptions

Resources to 
general budget 

No 
information 

(cid:31) 

(cid:31) 

RO 

SE 

SI 

SK 

UK 

DG SANCO baseline 

100% FSA controls for 
slaughterhouses and 
cutting plant controls. 
Other  controls are 
performed by local 
authorities and revenue 
remains at this level. 

(cid:31) 

(cid:31) 

Controls carried out by Food standards agency operations in slaughterhouses and meat 

 The  rest  of  the  sectors  when  monies  are  collected  this  is  done  through  Local 

Notes on baseline data for ring-fencing in EU MS:  
United Kingom: 
▪ 
cutting plants are ring fenced (collected and used within the agency).                         
▪ 
Authorities and kept within the authority. 
Germany: 
▪ 
In general fees are collected to be directly used to finance the official controls  (they 
are in fact mainly based on full cost recovery).  In those Landers where fees go to the general 
budget in any case they are earmarked for the CA. 
Sweden: 
• 
Fees may not be used to finance other activities. 

Local  and  central  authorities  use  fees  directly  to  finance  their  official  controls. 

EN 

Page 183/253 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 3 Member State bonus-malus arrangements for official controls fees 

Member 
State 

BE 

FR 

DE 

IT 

MT 

NL 

SP 

SE 

Description 

Annual contributions are reduced by 50% if the Hazard Analysis Critical Control Point 
system of the FBO is certified by accredited bodies (recognised by AFSCA).  If such an 
accredited system is not in place then FBOs must pay an additional 20% (2009), 60% 
(2010) and 100% (2011). Poultry slaughterhouses where FBOs are involved in controls 
have reduced fees. Animals in slaughterhouses that are not clearly identified are subject 
to a higher fee. 

Slaughterhouses are classified in 4 categories depending on their level of compliance.  
FBOs in the two categories with good compliance receive a reward, while FBOs in the 
two categories with poor compliance receive a punishment.  The reward / punishment 
system is specified in the case study analysis Error! Reference source not found.. 

Some Landers have trialled a system of categorising meat establishments according to 
risk.  The frequency of inspections is changed to reflect the risk posed by the FBO. 

The application of mandatory fees may take into consideration the FBO’s previous 
record of conformity, risk category and the efficiency of their own checks. 

No mechanism exists to reward FBOs.  However there is a procedure to levy fines for 
breaches of some elements of the Regulation. 

There is a fee per inspection visit and a time-based fee charged per quarter of an hour.  
FBOs that have better organised operations and require less CA time have lower cost. 
Where possible official controls are risk-based. There are surcharges for requests for 
controls outside regular working hours, and CA overtime that is incurred over the time 
originally requested by the FBO. 

The application of mandatory fees may take account of an FBO’s previous record of 
conformity, its risk category, the efficiency of its own checks, and other items such as 
the level of administrative support required, or if inspections occur at unsocial hours. 

FBO’s deemed to have a higher risk incur longer and / or more frequent inspections, and 
thus have higher inspection costs.  The level of risk posed by an FBO is determined by 
the FBO’s past record; compliance or non-compliance can lead to a reduction or an 
increase in the annual control time and annual fees. 

UK 

FBOs and CAs agree to the amount of time a CA will spend during inspections.  FBOs 
can propose changes to the production process to decrease the need for CA presence. 

Source: DG SANCO baseline 

EN 

Page 184/253 

  EN 

 
 
 
 
Table 4  Transparency and reporting to the public on fees for official controls by EU Member State 

E
B

E
I

K
U

S
E

L
F

L
N

E
S

E
D

E
E

R
F

T
I

T
L

L
P

K
S

T
M

T
A

G
B

Y
C

Z
C

K
D

R
G

U
H

U
L

V
L

T
P

O
R

I
S

All information 
available online 

Legislation published 
in the official journal 

Information recorded 
but not available / 
published 

No information 
available / identified 

DG SANCO baseline 

(cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31) 

(cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31) 

(cid:31) 

High transparency 

Medium transparency 

Low transparency 

No information available / identified 

(cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31)  (cid:31) 

EN 

Page 185/253 

EN 

 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 5  Fee rates used for official controls across the EU-27 

Member 
State 

Flat rates 
only 

Minimum 
rates only 

Flat + 
min rates 

Reduction below 
minimum rates 

Flat rates on throughput
or time basis 

AT 

BE 

BG 

CY 

CZ 

DE 

DK 

EE 

ES 

FI 

FR 

GR 

HU 

IE 

IT 

LT 

LU* 

LV 

MT 

NL 

PT 

PL 

RO 

SE 

SI 

SK 

UK 

TOTAL 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

7 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

1 

17 

5 

Source: DG SANCO Baseline data (2010)  

*Luxembourg – no data available 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

(cid:51) 

17 

EN 

Page 186/253 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 6  Data for the Standard Cost Model obtained through the survey indicate  high variation 
in FTE rates across MS (between €3.31/hour and €64.74/hour) 

MS 

CA 

Q1 

Response 

Q2 

Q3 

BE  Federal Agency for the 

€64.74 / hr 

Staff time: 836 
hours 
External costs: 0 

Staff time: 836 
hours 
External costs: 0 

Safety of the Food Chain 
(FASFC) 

BG  Bulgarian Food Safety 

Agency 

ES 

SG Sanidad Exterior 
(MSPSI); SG Acuerdos 
Sanitarios y Control en 
Frontera (MARM) 

FI 

Finnish Food Safety 
Authority (Evira) 

€1.86 / employee / 
hr 

€20.42 / hr 

n/a 

n/a 

€42 / hr 

Staff time: 4 FTE 
External costs: 
€500,000 

FR  Direction générale de 

€29.50 / hr  

n/a 

l’alimentation (DGAI) – 
Ministère chargé de 
l’agriculture  

LT  State Food and Veterinary 

€3.31 / hr 

n/a 

Service of Republic of 
Lithuania 

UK  Food Standards Agency 

(FSA) 

Grade 7: €55.44 / hr 
Senior Executive 
Officer: €42.07 / hr 

Staff time: 5-6 
FTE 

Source: Survey of CAs conducted as part of GHK Impact Assessment study. 

n/a 

n/a 

n/a 

n/a 

n/a 

n/a 

EN 

Page 187/253 

  EN 

 
 
 
 
 
Table 7  Potential impact of extending the scope of mandatory fees to include enterprises related 
to Regulations 852 /2004 and 183/2005, excluding primary holdings* 

K
U

S
E

Y
C

E
S

T
P

E
B

T
A

E
I

G
B

U
L

T
I

e
D

L
N

K
D

U
H

L
S

O
R

L
P

I
F

V
L

K
S

E
E

T
L

Z
C

R
F

R
G

T
M

High 
impact 

Medium 
impact 

Low 
impact 

No data 
available 

(cid:57)  (cid:57) 

  (cid:57)  (cid:57)  (cid:57) (cid:57)  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57)  

  (cid:57) (cid:57) (cid:57) (cid:57) (cid:57)  (cid:57)  (cid:57)  (cid:57) 

  (cid:57) (cid:57) (cid:57) (cid:57)

High impact 
(>20% enterprises) 

Medium impact 
(10% - 19% 
enterprises) 

Low impact 
(0% - 9% 
enterprises) 

Eurostat 2008 

*Total  number  of  enterprises  in  the  following  sectors:  Processing  and  preserving  of  fruit  and  vegetables; 
Manufacture of vegetable and animal oils and fats; Manufacture of grain mill products, starches and starch 
products;  Manufacture  of  prepared  animal  feeds;  Manufacture  of  beverages;  Wholesale  of  agricultural  raw 
materials  and  live  animals;  Wholesale  of  food,  beverages  and  tobacco;  Retail  sale  of  food,  beverages  and 
tobacco  in  specialised  stores;  Restaurants  and  mobile  food  service  activities;  Event  catering  and  other  food 
service activities; and, Beverage serving activities. 

Table 8  Potential impact of extending the scope of mandatory fees to include primary holdings 
(excluding other potentially relevant enterprises) related to Regulations 852 /2004 and 183/2005* 

O
R

T
L

G
B

V
L

L
P

K
S

L
S

U
H

Y
C

E
I

T
P

T
A

E
E

T
I

S
E

E
S

E
S

K
U

I
F

R
F

K
D

L
N

E
B

U
L

Z
C

R
G

T
M

High 
impact 

Medium 
impact 

Low 
impact 

No data 
available 

(cid:57)  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57) 

  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57)  

  (cid:57)  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57)  

  (cid:57) (cid:57)

High impact 
(>67% enterprises) 

Medium impact 
(33% - 66% 
enterprises) 

Low impact 
(0% - 33% 
enterprises) 

Eurostat 2008 

*Primary holdings include: All holdings with arable land; All holdings growing permanent crops; All 
holdings rearing livestock; and, All holdings rearing other livestock.   

EN 

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  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 9  Potential impact of extending the scope of mandatory fees to include enterprises and 
primary holdings related to Regulations 852/2004 and 183/2005* 

O
R

T
L

G
B

L
P

V
L

K
S

L
S

U
H

Y
C

E
I

K
U

T
P

T
A

S
E

E
S

T
I

E
E

I
F

K
D

E
D

E
B

R
F

L
N

U
L

Z
C

R
G

T
M

High 
impact 

Medium 
impact 

Low 
impact 

No data 
available 

(cid:57)  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57)  (cid:57)  (cid:57)  (cid:57)  (cid:57)  

  (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) (cid:57) 

  (cid:57)  (cid:57)  (cid:57)  (cid:57) (cid:57)  

  (cid:57) (cid:57)

High impact 
(>67% enterprises) 

Medium impact 
(33% - 66% 
enterprises) 

Low impact 
(0% - 33% 
enterprises) 

Eurostat 2008 

*Total  number  of  enterprises  in  the  following  sectors:  Processing  and  preserving  of  fruit  and 
vegetables; Manufacture of vegetable and animal oils and fats; Manufacture of grain mill products, 
starches  and  starch  products;  Manufacture  of  prepared  animal  feeds;  Manufacture  of  beverages; 
Wholesale of agricultural raw materials and live animals; Wholesale of food, beverages and tobacco; 
Retail sale of food, beverages and tobacco in specialised stores; Restaurants and mobile food service 
activities; Event catering and other food service activities; and, Beverage serving activities.  Primary 
holdings include: All holdings with arable land; All holdings growing permanent crops; All holdings 
rearing livestock; and, All holdings rearing other livestock.  

EN 

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Annex XVIII: LABORATORIES – Consultations on current issues 
related to the accreditation of official laboratories and possible 
options for improvement – Discussion paper and results of the 
consultations 

A. Discussion paper sent to the Chief Veterinary Officers (CVOs) and to the Regulation 
(EC) No 882/2004 competent authorities on current issues related to the accreditation of 
official laboratories and possible options for improvement 

Background 

Article 12 of Regulation (EC) No 882/2004 establishes that competent authorities may only 
designate laboratories that are accredited in accordance with certain European standards listed 
in  the  Regulation  (EN  ISO/IEC  17025  applicable  to  laboratories  and  EN  ISO/IEC  17011 
applicable to Accreditation Bodies). 

The  transitional  period  (Commission  Regulation  (EC)  No  2076/2005)  is  over  (1  January 
2010)  and  no  derogation  is  applicable  with  the  only  exception  of  Trichinella  laboratories 
attached  to  slaughterhouses  or  game  handling  establishments  (transitional  period  extended 
until end of 2013, Article 6 of Commission Regulation (EC) No 1162/2009). 

Results of laboratory analysis are a key element in the framework of official controls carried 
out in order to verify compliance with EU legislation and to ensure that food is safe. Many 
decisions are based on the results of those analyses, including remedial action in case of non 
compliance.  The  results  of  laboratory  tests  must  therefore  be  as  sound  and  as  reliable  as 
possible.  It  is  thus  necessary  that  the  analyses  are  carried  out  according  to  agreed  validated 
methods and standards which can be endorsed by all stakeholders across the food chain within 
the EU and by our trade partners.  

The  lack  of  accreditation  of  some  laboratories  is  a  recurrent  finding  of  the  Food  and 
Veterinary  Office  (FVO)  missions,  in  particular  for  certain  sectors  and  with  differences 
between MS (some being more advanced than others).  

Accreditation was discussed at the first working group on Regulation 882/2004 in May 2010, 
where DG ENTR presented the EU common framework for accreditation143, in particular the 
role of national accreditation bodies and the co-ordinating role of the European co-operation 
for  Accreditation  (EA).  A  representative  from  EA  was  invited  at  the  2nd  meeting  of  the 
working  group  on  27th  September  2010,  and  her  presentation  was  followed  by  discussions 
with the Member States (MS). 

The purpose of this  paper is to summarise the main points identified during the  discussions 
and  the  suggestions  from  the  MS  with  the  aim  to  reflect  on  available  options  to 
improve/facilitate the enforcement of this important requirement. 

143  
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and repealing 
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30–47) 

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1.  Existing legislation  

Accreditation  Bodies  (ABs)  use  legislation,  reference  methods  laid  down  in  legislation  and 
official documents as benchmark for the accreditation.  

1.1. Introduction  of  new  legal  requirements  including  new  analytical  techniques 
Accreditation  standard  EN  ISO/IEC  17025  requires  the  laboratory  to  use  validated 
methods:  the  laboratory  "shall  validate  non-standardised  methods,  laboratory 
designed/developed methods, standardised methods used outside their intended range 
and amplifications of standardised methods to confirm that the methods are fit for the 
intended  use"  (cf.  requirement  5.4.5.2).  Validation  is  the  confirmation  that  the 
particular requirements for a specific intended use of the method are fulfilled (cf. EN 
ISO/IEC  17025  requirement  5.4.5.1).In  fact,  without  proper  validation,  it  cannot  be 
proved  that  the  method  is  fit  for  the  intended  use,  produces  comparable  results  and 
can  be  used  when  making  decisions.  This  accreditation  requirement  is  not  always 
easy in particular with new analytical techniques. 

⇒  Are general rules on how to legislate about the introduction of new analytical methods 
necessary? Should it be considered when drafting new legislation or when introducing 
new methodological requirements that the laboratories might need some time for the 
validation of the methods? 

1.2. Not "up-to-date" legislation. 

Reference methods laid down in the legislation might be out of date or no standards are 
available but nevertheless they are still in the legislation. 

⇒  This point was raised at the meeting. Any concrete example(s)? 

2.  Flexible scope/fixed scope 

Historically, accreditation has generally been based on so called fixed scopes of accreditation. 
The fixed scope provides for a certain degree of flexibility as limited extensions to the scope 
can be done at any time throughout the assessment cycle. 

In 2008 EA has also published its requirements for the accreditation of flexible scopes. They 
allow  not  only  to  carry  out  the  methods  in  use,  but  also  to  add  methods  within  the  defined 
limits  to  the  scope  of  accreditation  on  the  basis  that  the  competence  of  the  laboratory  to 
develop and validate methods has been positively evaluated. 

EA  has  carried  out  some  surveys  and  has  confirmed  that  most  ABs  offer  accreditation  on 
flexible scopes. Those ABs who don't yet are in the process of developing the service. 

However, the choice of a flexible scope would not necessarily result in a reduced cost. In fact, 
this accreditation is more demanding both initially and on-going. The flexible scope should be 
considered depending on the case. It is in general more suitable for activities where changes 
are frequent.  

⇒  Could guidance from EA on differences, pros and cons, etc. of flexible scope accreditation 
and fixed scope accreditation help each laboratory in order for it to take the best decision 
as regards to its specific situation? 

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3.  Emergency situations 

Under  emergency  situations,  for  example  during  a  food  crisis  (melamine,  Sudan  red,  etc.), 
there  is  a  need  for  having  reliable  results  under  time  pressure  by  an  accredited  laboratory 
using a validated method because results given by: 

- a non validated method cannot be used when making decisions, 

- a non-accredited laboratory can be legally challenged. 

⇒  Does  the  flexible  scope  offer  a  solution?  Should  this  be  mentioned  in  the  EA  guidance 

mentioned in 2.? 

⇒  If not, what other options are available?  

4.  Scope of the accreditation 

ABs have diverging interpretations of Article 12.3 of Regulation (EC) No 882/2004 
according to which "the accreditation and assessment of testing laboratories (in 
accordance with EN ISO/IEC 17025) may relate to individual tests or groups of tests". 

⇒  Should  a  clearer  definition  of  what  is  covered  by  accreditations  related  to  "groups  of 
tests"  be  discussed  in  the  framework  of  EA  on  the  basis  of  examples  of  differences 
provided to better understand the issue? (e.g. HPLC analysis of aflatoxins in pistachios: 
in some MS the scope of accreditation covers "foodstuffs" and in other MS laboratories 
need  to  be  accredited  for  every  different  matrix).  Should  this  be  mentioned  in  the  EA 
guidance mentioned in 2.? 

5.  New laboratories or new staff 

For new official laboratories, accreditation is as well a requirement to start operating. 
However they might not have proven the necessary experience to the AB. This problem can 
also be applicable to new staff who need proper training and time to be considered 
sufficiently competent. 

⇒  Concerning new personnel, EN ISO/IEC 17025 allows new personnel under condition of 
their  appropriate  supervision  and  training  (5.2.1  "The  laboratory  management  shall 
ensure  the  competency  of  all  who  operate  specific  equipment,  who  perform  tests  and/or 
calibrations,  evaluate  results  and  sign  test  reports  and  calibration  certificates.  When 
using staff which is undergoing training, appropriate supervision shall be provided"). 

⇒  Concerning new laboratories, is there a need to regulate the pre-accreditation phase so 
as  to  allow  new  laboratories  to  operate  (as  official  laboratories)  prior  to  their  formal 
accreditation? Which legal consequences would a pre-accreditation phase have?  

6.  Proficiency tests 

Participation  at  proficiency  tests  (PTs)  is  used  as  external  quality  control  to  prove  that  the 
laboratory  is  indeed  capable  of  producing  valid  results.  ISO  17025  recommends  the 
participation at PTs ("5.9 The laboratory shall ensure the quality of results by monitoring test 
and/or  calibration  results.  This  monitoring  shall  be  planned  and  reviewed  and  may  include, 
but  not  limited  to  the  …  participation  in  inter-laboratory  comparison  or  proficiency  testing 

EN 

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programmes") and the results of the participation are considered by the ABs as an important 
source of information.  
However, in some areas, like residues of veterinary medicines144 and pesticides145, legislation 
provides  compulsory  participation  at  PTs  for  official  control  laboratories.  This  apparently 
results in a heavier burden for laboratories with a large scope of accreditation. 

Also, there can be areas for which there are no PTs schemes yet. 

⇒  Are there divergent interpretations of EN ISO/IEC 17025 requirement 5.9 made by ABs ? 

The  problems  raised  seem  more  to  be  linked  with  the  legal  requirement  of  mandatory 
participation at PTs than with the EN ISO/IEC 17025 accreditation. 

⇒  Concerning  residues  of  pesticides,  could  a  common  (e.g.  together  with  EU  Reference 
Laboratories)  and  precise  understanding  of  the  implementation  of  Article  28.3  of 
Regulation  (CE)  No  396/2008  ("All  laboratories  analysing  samples  for  the  official 
controls  on  pesticides  residues  shall  participate  in  the  Community  proficiency  tests  for 
pesticides residues organised by the Commission") be of any help? 

⇒  Concerning residues of  veterinary medicines: 

1.  Should any legal modification be envisaged during the review of Directive 96/23/EC 
and its implementing Decision (EC) No 396/2008 (Annex : "laboratories must prove 
their competence by regularly and successfully participating in adequate proficiency 
testing  schemes  recognised  or  organised  by  the  national  or  community  reference 
laboratories"); 

2.  Could  a  common  (e.g.  together  with  EU  Reference  Laboratories)  and  precise 
understanding of the implementation of this requirement of the Annex be of any help? 

7.  Rapid tests 

Rapid  tests  are  by  definition  easy  to  use  and  don't  require  high  expertise  or  sophisticated 
equipment. They provide results within a very short time, allowing testing of a high number 
of  samples  in  a  speedy  manner;  therefore  they  are  very  useful  for  controls  purposes.  Rapid 
tests  aim  at  having  low  percentage  of  false  negatives.  However,  these  interesting 
characteristics make their performance difficult to accredit as they are not as accurate as other 
more sophisticated methods.  

In  some  cases  if  the  result  obtained  after  a  rapid  test  is  positive,  it  needs  confirmation  by 
confirmatory  methods  and  usually  the  scope  of  the  accreditation  covers  the  performance  of 
both  tests.  If  they  are  not  used  as  screening  i.e.  if  they  have  a  meaning  by  themselves  (e.g. 
microbiological tests for E. coli in water or Salmonella in meat), their performance can also 
be accredited independently. 

⇒  A  discussion  within  EA  on  what  are  the  difficulties  for  the  ABs  to  accredit  the 
performance  of  rapid  tests  could  be  organised.  Are  these  difficulties  linked  to  a  lack  of 
clear validation requirements for rapid tests? Would therefore guidance on the validation 
of rapid tests by the EURLs help? 

144 Commission Decision 98/179/EC. 
145 Regulation (EC) No 396/2008 

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B. Results of the consultations carried out 

Following input from the Member States and discussions have been taken into account in this 
part: 

-  meetings  of  the  Working  Group  on  the  general  application  of  Regulation  (EC)  No 

882/2004 held in May and September 2010, 

-   answers from Regulation (EC) No 882/2004 competent authorities to the discussion paper 

presented in part A of this annex, 

-  meeting  of  the  Working  Group  on  the  general  application  of  Regulation  (EC)  No 

882/2004 held in May 2011, 

- 

answers from the Chief Veterinary Officers (CVOs) to the discussion paper presented in 
part A of this annex,  

-   meetings in 2011 of the Working Group of Chief Officers for Plant Health (COPHs) and 

of its Task Force on the inclusion of plant health in Regulation (EC) No 882/2004, 

-   meetings  in  2011  of  the  Task  Force  on  "  Plant  reproductive  material"  under  Regulation 

(EC) No 882/2004. 

Twelve issues have been identified during these consultations and discussions. Each issue as 
well  as  the  main  comments  from  the  Member  States  on  it  and  the  corresponding  favourite 
option(s) are described hereafter. 

1. Article 12.3 of Regulation (EC) No 882/2004  

Issue 1:  

Article  12.3  of  Regulation  (EC)  No  882/2004  according  to  which  the  accreditation  of 
laboratories  in  accordance  with  ISO  17025  “may  relate  to  individual  tests  or  groups  of 
tests” is unclear.  

Main comments from the MS and corresponding options: 

The sentence needs to be clarified. 

« Groups  of  tests »  refers  in  particular  to  flexible  scope  accreditation.  EA  Guide  –  2/15  on 
accreditation of flexible scopes needs to be clarified. 

(cid:170)  Option:  clarification  of  Article  12  of  Regulation  (EC)  No  882/2004:  unless  otherwise 
specified, the scope of accreditation shall include all methods used by the laboratory as 
official laboratory. 

(cid:170)  Option: clarification of EA Guide – 2/15 on accreditation of flexible scopes. 

2. Use of a method recently required in legislation 

Issue 2:  

The  use  of  a  method  is  a  recent/new  requirement  in  Union  legislation  and  requires  the 
validation  of  the  new  method  and  (in  general)  a  new  accreditation  or  an  extension  of 
accreditation of the laboratory. 

EN 

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General comments from MS and corresponding option:  

Time is needed for the validation of the method and the accreditation of the laboratory. The 
use  of  a  validated  but  « not  (yet)  accredited »  method  by  an  already  ISO  17025  accredited 
official laboratory should be possible. 

(cid:170)  Option: in this case, possibility for the CA to temporarily designate the laboratory under 
specific  conditions  (alternative  guarantees):  the  laboratory  is  already  accredited 
according  to  ISO  17025  (i.e.  a  solid  quality  assurance  system  is  already  in  place)  to 
ensure  sound  and  reliable  results;  analysis/diagnosis  are  carried  out  under  the 
supervision  of  the  CA  or  the  national  reference  laboratory  (NRL);  the  temporary 
designation  shall  not  exceed  one  year  renewable  once  –  Modification  of  Article  12  of 
Regulation (EC) N° 882/2004. 

3. Changes of a method already in use 

Issue 3:  

Changes  of  a  method  already  in  use  require  a  new  accreditation  or  an  extension  of  the 
accreditation already obtained by the laboratory. 

General comments from MS and corresponding option:  

Time  is  needed  for  the  validation  of  the  method  and  the  (extension  of)  accreditation  of  the 
laboratory.  The  use  of  a  validated  but  « not  (yet)  accredited »  method  by  an  already  ISO 
17025 accredited laboratory should be possible. 

(cid:170)  Option: in this case, possibility for the CA to temporarily designate the laboratory under 
specific  conditions  (alternative  guarantees):  the  laboratory  is  already  accredited 
according  to  ISO  17025  (i.e.  a  solid  quality  assurance  system  is  already  in  place)  to 
ensure  sound  and  reliable  results;  analysis/diagnosis  are  carried  out  under  the 
supervision  of  the  CA  or  the  national  reference  laboratory  (NRL);  the  temporary 
designation  shall  not  exceed  one  year  renewable  once  –  Modification  of  Article  12  of 
Regulation (EC) N° 882/2004. 

4. Emergency situations and emerging risks 

Issue 4:  

Emergency  situations  or  cases  of  emerging  risks  where  a  sudden  increase  of  analytical 
needs requires the use by official laboratories of a non standardised or non validated method 
or a standardised method which is not included in their scope of accreditation 

General comment from MS and corresponding option:  

The swift and efficient management of the situation/risk is the priority. The use of a validated 
but « not (yet) accredited » method by an already ISO 17025 accredited laboratory should be 
possible. 

(cid:170)  Option: in this case, possibility for the CA to temporarily designate the laboratory under 
specific  conditions  (alternative  guarantees):  the  laboratory  is  already  accredited 
according  to  ISO  17025  (i.e.  a  solid  quality  assurance  system  is  already  in  place)  to 
ensure  sound  and  reliable  results;  analysis/diagnosis  are  carried  out  under  the 
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supervision  of  the  CA  or  the  national  reference  laboratory  (NRL);  the  temporary 
designation  shall  not  exceed  one  year  renewable  once  –  Modification  of  Article  12  of 
Regulation (EC) N° 882/2004. 

5. Small sized Trichinella laboratories 

Issue 5:  

Small  sized  Trichinella  laboratories  attached  to  slaughterhouses  or  game  handling 
establishments have important difficulties to be accredited according to ISO 17025. 

General comment from MS and corresponding option:  

The  requirement  for  these  laboratories  carrying  out  extremely  basic  tests,  to  be  accredited 
according to ISO 17025 is disproportionate and not adapted. 

(cid:170)  Option: modification of Article 12 of Regulation (EC) No 882/2004: possibility for the 
competent authority to permanently derogate small sized laboratories attached to food 
business operators’ (FBOs) premises  

•  exclusively  carrying  out  specific  basic  tests  prescribed  in  Union  legislation  on  a 

limited number of samples pertaining to the FBOs’ process, 

•  using standardised/validated methods, 

•  having a quality assurance system in place, 

•  and operating under the supervision of an official laboratory accredited according to 

ISO 17025 or of the competent authority. 

6. Accreditation of plant health and plant reproductive material laboratories  

Issue 6:  

Currently official laboratories operating under the Plant Health and/or the Plant Reproductive 
Material regimes are not obliged to be accredited according to ISO 17025. There is a need to 
improve reliability, soundness and uniformity of their results. Weaknesses and problems 
as  regards  the  performance  of  official  Plant  Health  or  Plant  Reproductive  Material 
laboratories have often been identified during FVO audits. 

General comments from MS:  

Worldwide, there is a strong trend towards accreditation of laboratories. The move towards 
accreditation has to be supported under certain conditions. Many official Plant Health or 
Plant Reproductive Material laboratories are already accredited.  

(cid:170)  Option:  modification  of  Article  12  of  Regulation  (EC)  No  882/2004:  extension  of  the 

mandatory accreditation:  

• 

to  laboratories  under  the  Plant  Health  and  the  Plant  Reproductive  Material  regimes 
carrying out plant (or seeds) health tests,  

•  after a transitional period, 

•  with the possibility to: 

EN 

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(cid:170)  determine exemptions to Article 12.3 taking into account the characteristics of 
the different sectors (e.g. accreditation at least for a single diagnostic protocol or 
a single protocol per taxonomic discipline), 

(cid:170)  permanently derogate universities and research centres, 

(cid:170)  temporarily  designate  laboratories  (like  foreseen  for  food/feed  and  animal 

health laboratories – see issues 2, 3 and 4) 

7. Accreditation of animal health laboratories 

Main comments from MS and corresponding option:  

Accreditation is globally not a problem. Accreditation may however be difficult: 

-  

- 

for  methods  used  in  diagnosis  of  viral  diseases  because  of  the  important  resources 
needed  for  documentation  and  validation  of  the  methods  (solution:  accreditation  for 
types of methods or  techniques?), 

for  methods  used  in  the  diagnosis  of  parasitic  diseases  because  of  the  multitude  of 
parasitic diseases and the broad spectrum of diagnostic tests. 

(cid:170)  Option:  modification  of  Article  12  of  Regulation  (EC)  No  882/2004:  possibility  to 
determine  exemptions  to  Article  12.3  taking  into  account  the  characteristics  of  the 
different sectors. 

8. Participation in proficiency tests (PTs) or comparative tests (CTs) 

Issue 8:  

ISO 17025 recommends the participation in PTs/CTs:  “5.9 The laboratory shall ensure the 
quality  of  results  by  monitoring  test  and/or  calibration  results.  This  monitoring  shall  be 
planned  and  reviewed  and  may  include,  but  not  limited  to  the  …  participation  in  inter-
laboratory comparison or proficiency testing programmes”. 

In  some  areas,  like  residues  of  veterinary  medicines  and  residues  of  pesticides,  EU 
legislation provides for the mandatory participation in PTS/CTs. 

Interpretations of ISO 17025 on this point differ from one Member State to another. Different 
mandatory  minimum  frequencies  of  participation  in  PTs/CTs  furthermore  exist  accross  the 
EU.  Finally,  a  lack  of  participation  of  laboratories  in  PTs/CTs  and  a  lack  of  PTs/CTs 
organised are sometimes reported.  

Main comments from the MS and corresponding option:  

The frequent/regular participation in PTs/CTs relevant to the scope of accreditation of the 
laboratory  and  the  satisfactory  performance  at  these  PTs/CTs  are  absolutely  necessary/ 
mandatory. 

The participation in PTs/CTs has to be verified during the assessment of the laboratory by the 
accreditation  body.  The  lack  of  participation  in  PTs/CTs  is  sometimes/rarely  due  to  high 
costs, more often to the unavailability of PTs/CTs. 

To ensure a higher level of participation at PTs/CTs, the participation at PTs organised by the 
EU reference laboratories (EURLs) should be made possible for routine laboratories, as well 
as  the  possibility  to  participate  at  PTs/CTs  organised  by  national  reference  laboratories 
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EN 

  EN 

 
 
 
 
 
 
(NRLs) from other MS. Less limited/narrow scopes of accreditation according to ISO 17025  
and "a more horizontal" organisation of PTs/CTs should also be considered. 

(cid:170)  Option:  modification  of  Article  12  of  Regulation  (EC)  No  882/2004:  mandatory 
participation of laboratories in PTs/CTs organised in their scope of accreditation by the 
EURL or the NRL on request by either of them. 

9. Validation of methods 

Issue 9:  

According  to  ISO  17025,  the  laboratory  has  to  use  standardised  methods  or  validated 
methods: 

-  Requirement 5.4.5.1: « Validation is the confirmation by examination and the provision of 
effective  evidence  that  the  particular  requirements  for  a  specific  intended  use  are 
fulfilled ». 

-   Requirement 5.4.5.2: « The laboratory shall validate non-standardised methods, laboratory 
designed/ developed methods, standardised methods used outside their intended range and 
amplifications of standardised methods to confirm that the methods are fit for the intended 
use“. 

Which methods can be given equivalent status to « standardised methods »? 

Main comments from MS and corresponding option:  

Methods  validated  by  EURLs/NRLs  should  be  given  equivalent  status  to  « standardised 
methods »: 

-   validated methods by EURLs: all EU accreditation bodies should deliver the accreditation 
for  their  use  within  the  intended  scope  without  requesting  a  supplementary  internal 
validation by the laboratory (only a verification by the laboratory would be necessary); 

-  validated methods by the NRL in a MS: the national accreditation body of this MS should 
deliver  the  accreditation  for  their  use  within  the  intended  scope  without  requesting  a 
supplementary internal validation by the laboratory in the MS (only a verification by the 
laboratory would be necessary). 

(cid:170)  Option: modification of Article 11 of Regulation (EC) No 882/2004: methods validated 
by  EURLs/NRLs  are  given  equivalent  status  to  « standardised  methods »  and  are 
incorporated accordingly in the cascade of methods of Article 11.1 of Regulation (EC) No 
882/2004. 

10. Specific mandatory methods in legislation  

Issue 10:  

There  is  a  global  lack  of  flexibility  of  the  system  (e.g.  in  case  of  changes  of  the  method, 
emergency situations) due to too specific mandatory methods in EU legislation. 

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Proposal from several MS:  

Mandatory  method  performance  criteria  should  be  preferred  when  establishing  legislation 
(instead  of  mandatory  specific  methods)  to  ease/fasten  the  introduction  and  the  use  of  the 
latest and most appropriate method. 

11. Flexible scope / fixed scope accreditation 

Issue 11:  

There  are  very  different/diverging  requirements  in  particular  for  flexible  scope 
accreditation (but also for fixed scope accreditation) from one national accreditation body 
to another. 

Main comments from MS and corresponding option: 

The  EA  Guide  –  2/15  on  accreditation  of  flexible  scopes  is  too  general.  A  harmonised 
interpretation of the accreditation of flexible scopes is absolutely needed across the EU. If not, 
huge differences in levels of difficulty, time needed and costs for laboratories will continue to 
exist. 

The  accreditation  of  flexible  scopes  is  useful  in  particular  when  no  specific  assessment  by 
accreditation body prior to the addition of the matrix/analyte/method to the scope is requested 
(e.g. in case of emergency situations and emerging risks). 

Some examples of diverging interpretations between accreditation bodies are: 

- 

- 

In some Member States, a fixed scope accreditation can only cover the use of a specific 
method (to be followed very precisely by the laboratory) on a specific matrix in order to 
detect  a  specific  substance,  virus,  bacteria,  etc.  The  consequence  is  for  instance  that  for 
each  new  use  of  the  method  (e.g.  on  another  very  similar  matrix),  the  laboratory  has  to 
have a new accreditation. In other Member States, fixed scope accreditations are given for 
broader  combinations  method/analyte/matrix  making  it  for  instance  possible  for  the 
laboratory  to  use  the  method  on  another  similar  matrix  without  undergoing  a  new 
accreditation procedure. 

In  some  Member  States,  the  use  of  a  slightly  newer  version  of  a  method  (on  the  same 
matrix in order to detect the same substance, virus, bacteria, etc) by an official laboratory 
being already accredited according to ISO 17025 for the use of the slightly older version 
is only possible when the laboratory has a flexible scope accreditation for the use the older 
version  of  the  method.  In  other  Member  States,  the  use  of  the  slightly  newer  version  is 
possible for laboratories having only a fixed scope accreditation for the use of the older 
version of the method. 

-  When  a  new  method  is  already  covered  by  the  flexible  scope  accreditation  of  the 
laboratory, then in some MS the accreditation body includes it automatically in the scope 
of  accreditation  without  carrying  out  a  specific  assessment  of  the  laboratory.  In  other 
Member States, the accreditation body first carries out a specific accreditation assessment. 

-  For some accreditation bodies but not for others, a flexible scope accreditation can cover 

the use of all methods using a same analytical technique (e.g. ELISA, LC-MS/MS). 

(cid:170)  Option:  additional  EA  guidance  on  pros  and  cons  of  flexible  and  fixed  scopes,  with 
examples,  on  what  a  flexible  scope  could  cover  and  corresponding  precise 
requirements, on degrees of flexibility of flexible scopes, on flexible scope accreditation 
assessments by Abs 

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12. New laboratories/new personal 

Issue 12: New laboratories have first to be accredited according to ISO 17025 before being 
able to be designated by the competent authority.  The possibility to use new staff in already 
accredited laboratories is very difficult. 

Main comments from MS and corresponding option:  

The designation, by the competent authority, of the laboratory before its formal accreditation 
is risky (because the laboratory is not yet accredited for the use of any method), difficult and 
not necessary. It shouldn't be allowed. 

ISO  17025  allows  already  touse  new  personal  under  the  condition  of  their  appropriate 
supervision and training. 

(cid:170)  Option: no action. 

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Annex XIX: LABORATORIES – Costs relating to the introduction of a 
mandatory accreditation of official laboratories carrying out plant 
health tests and to the creation of EU reference laboratories 

1.  Cost  relating  to  the  introduction  of  a  mandatory  accreditation  of  laboratories 
carrying out plant health tests 

The  inclusion  of  plant  health  and  plant  reproductive  material  regimes  in  the  scope  of 
Regulation (EC) N° 882/2004 would legally create the obligation for laboratories carrying out 
plant health tests to be accredited according to EN ISO/IEC 17025. Some flexibility would be 
foreseen as regards the scope of accreditation (laboratories would at least be accredited for a 
single  diagnostic  protocol  or  a  single  diagnostic  protocol  per  taxonomic  discipline)  and  the 
transitional  period  (five  years).  The  costs  for  the  initial  accreditation  (valid  for  four  years) 
would  be  borne  by  the  EU,  the  following  accreditation  costs  (following  accreditations  are 
each  time  valid  for  five  years)  would  be  for  the  laboratories  themselves  and  should  be 
included  in  the  cost-recovery  based  fees  to  the  extent  that  a  laboratory  carries  out  official 
diagnoses. 

Financial impact: accreditation according to EN ISO/IEC 17025 requires laboratories to set 
up a quality assurance system, including the appointment of a quality assurance officer (this 
may be an additional task for a staff member who is not actively involved in the diagnoses). 
Quality assurance should be good practice for any modern laboratory and the associated costs 
should therefore not be taken into account as additional. The transitional period of five years 
should normally be sufficient.  

The additional costs relate to the formal accreditation itself, which depends on the size of the 
laboratory  and  the  price  level  in  the  MS.  Based  on  a  survey  of  MS  laboratories146  and 
information  available  from  different  accreditation  bodies,  the  average  costs  of  the 
accreditation  according  to  EN  ISO/IEC  17025  are  assumed  to  be  €3,000  per  laboratory  per 
year. 

1.1. Official laboratories performing plant health tests under the EU plant health regime 

In some MS, the laboratories have already been accredited or largely so. In others, this is not 
yet  the  case.  The  number  of  laboratories  per  MS  presumably  ranges  between  one  (for 
centralised MS)147 and 26 (for MS with regional laboratories). In this study, it is assumed that 
20 MS still have laboratories which need to apply for accreditation that this would concern on 
average six laboratories148 per MS. 

Based on these assumptions, the accreditation costs would be: 

- for the Commission: 20 x 6 x € 3,000 x 4 years = € 1,44 million (total costs) 

- for the MS: 20 x 6 x  €3,000 = €360,000 per year 

146 Replies were received from AT, BE, CZ, DE, DK, ES, FR, IE, LV, NL, MT, PL, SE, SI, SK.  
147 One MS does not have any such laboratory at all but has contracted out all analyses to other MS. 
148 This is the average number of relevant laboratories in the 15 MS that replied to the consultation. 

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1.2.  Official  laboratories  performing  plant  health  tests  under  the  EU  plant  reproductive 
material regime 

Official laboratories under the EU plant reproductive materials regime would only be required 
to be accredited according to EN ISO/IEC 17025 when they carry out plant health (i.e. seed 
health) tests.   

Specialised seed testing laboratories as well as laboratories charged with the testing of: 

- seed potatoes,  

-  wine  and  fruit  plant  propagating  material,  vegetable  young  plants,  forest  reproductive 
material and propagating material of ornamental plants 

would be concerned. 

1.2.1. Official seed testing laboratories 

According to the information available (in particular data from the International Seed Testing 
Association  (ISTA)  and  information  available  on  the  websites  of  the  laboratories),  it  is 
assumed that approximately 35 official seed testing laboratories in the EU carrying out plant 
health (i.e. seed health) tests are not yet accredited according to EN ISO/IEC 17025149. 

Based on these assumptions, the accreditation costs would be: 

- for the Commission: 35 x € 3,000 x 4 years = € 420,000 (total costs), 

- for the MS: 35 x  €3,000 = €105,000 per year. 

1.2.2. Official laboratories testing seed potatoes 

Laboratories  charged  under  the  plant  reproductive  material  regime  with  testing  of  seed 
potatoes (i.e., small potato tubers for planting) would in general not incur additional costs as, 
in principle, they also carry out the plant health tests  under the EU plant  health regime and 
any supplementary accreditation costs are covered above under that regime.  

1.2.3. Official laboratories testing wine and fruit plant propagating material, vegetable young 
plants, forest reproductive material and propagating material of ornamental plants 

The number of laboratories concerned not yet accredited according to EN ISO/IEC 17025 is 
estimated to be 70.  

Based on these assumptions, the accreditation costs would be: 

- for the Commission: 70 x € 3,000 x 4 years = € 840,000 (total costs), 

- for the MS: 70 x  €3,000 = €210,000 per year. 

In total: 

-  the  total  costs  for  the  Commission  (financing  of  the  initial  accreditations  valid  for  four 
years) would be: 1,440,000+ 420,000 + 840,000= €2,700,000 

149  Most  of  these  laboratories  are  accredited  according  to  and  by  ISTA  which  does  not  comply  with  the 
requirements  for  national  accreditation  bodies  and  the  operation  of  accreditation  of  Regulation  (EC)  N° 
765/2008  of  the  European  Parliament  and  of  the  Council  of  9  July  2008  setting  out  requirements  for 
accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 
339/93. 

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-  the  yearly  costs  for  the  MS  for  the  accreditation  according  to  EN  ISO/IEC  17025  of 
official laboratories carrying out plant health tests would amount to 360,000 + 105,000 + 
210,000 = €675,000  

2. Cost relating to the creation of EU Reference Laboratories (EURLs) for plant health 
diagnosis 

The  inclusion  of  plant  health  and  plant  reproductive  material  regimes  in  the  scope  of 
Regulation  (EC)  N°  882/2004  would  legally  create  the  possibility  to  set  up  EURLs  in  the 
these areas and support these financially from the EU budget.  

Financial impact: it is estimated that in due course EURLs would be set up for circa ten to 
twelve priority pests. At present, the EU supports 44 EU Reference Laboratories in the food, 
feed and animal health areas covered by Regulation (EC) N° 882/2004 for a total annual sum 
of €14.2 millions (figure for 2010/2011); the average EU support thus amounts to €323,000. 
This  implies  that  the  annual  costs  for  EURLs  in  the  plant  health  and  plant  reproductive 
material  areas  would  be  €3.2  millions  to  €3.9  millions  (based  on  this  our  assumption  is  €4 
millions). 

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Annex XX: DIRECTIVE 96/23/EC - Consultation of the competent 
authorities in the MS on the impacts of the different options 
regarding the revision of Directive 96/23/EC – Questionnaire and 
results of the consultations 

The questionnaire addressed to the Member States is made of parts 1, 2, 3 and 4 hereafter. 
Part 5 presents the results of the consultations carried out. 

1. About the consultation 

1.1. Background of the consultation 

Pharmacologically  active  substances  administered  to  animals  both  intentionally  and  non-
intentionally, may result in the presence of residues in the food obtained from such animals. 
Whereas  animals  need  to  be  treated  for  animal  health  and  welfare  reasons,  the  intake  of 
residues in the food can be harmful to the consumers. 

The adoption of Directive 96/23/EC aimed at increasing consumer protection by establishing 
harmonised rules for the controls to be carried out by Member States on residues of veterinary 
medicines in live animals and foodstuffs of animal origin produced in the EU and imported. 
The first objective of this Directive was the fight against the illegal use of growth promoters 
in livestock. The second was to ensure that consumers are exposed neither to harmful residues 
of  veterinary  medicinal  products  and  pesticides,  nor  to  contaminants,  at  levels  above  those 
established by the legislation. 

 In 2003, the Commission launched a broad consultation process to review the legislation on 
residues of pharmacologically active substances used for the treatment of animals (Reflection 
Paper on residues in foodstuffs of animal origin)150. The main purpose of the exercise was to 
eliminate  inconsistencies  between  different  legal  instruments  and  to  replace  them  with  a 
single act. 

Indeed, at that time, the following legislative acts were in force: 

1.  Regulation  (EC)  No  2377/90151  laying  down  Community  procedures  for  the 
establishment  of  maximum  residues  limits  (MRLs)  of  pharmacologically  active 
substances in foodstuffs of animal origin ("MRLs regulation"),  

2.  Council Directive 96/22/EC152 concerning the prohibition on the use in stockfarming 
of  certain  substances  having  a  hormonal  or  thyrostatic  action  and  of  beta-agonists 
(ban on the use of hormones for growth promotion - "Hormone Directive"), 

3.  Council  Directive  96/23/EC153  on  measures  to  monitor  certain  substances  and 
residues thereof in live animals and animal products ("Residue Control Directive"). 

Member  States  (MS),  Third  Countries  (TC)  and  stakeholders  provided  substantive 
encouraging feedback during the abovementioned process154 and Regulation (EC) No 2377/90 

150 Reflection Paper on residues in foodstuffs of animal origin 
151 OJ L 224, 18.8.1990, p. 1. 
152 OJ L 125, 23.5.1996, p. 3 
153 OJ L 125, 23.05.1996, p. 10 
154 Comments to the Reflection paper-29.6.2004 

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as  well  as  Directive  96/22/EC  were  amended.  Indeed  some  of  the  issues  identified  by  the 
consultation process were addressed through the adoption of the following acts:  

1.  Regulation  (EC)  No  470/2009155  laying  down  Community  procedures  for  the 
establishment of residue limits of pharmacologically active substances in foodstuffs of 
animal origin 

The  aim  of  this  new  Regulation  is  to  limit  the  exposure  of  consumers  to 
pharmacologically active substances and at the same time to enhance the availability 
of veterinary medicinal products in the European Union (EU).  

2.  Directive  2008/97/EC156  amending  Council  Directive  96/22/EC  concerning  the 
prohibition  on  the  use  in  stockfarming  of  certain  substances  having  a  hormonal  or 
thyrostatic action and of beta-agonists  

This  act  introduced  two  main  modifications  of  Directive  96/22/EC:  the  limitation  of 
the scope of Directive to food-producing animals only and the total prohibition of the 
use of 17 beta-oestradiol in food producing animals. 

Directive 96/23/EC was not revised. 
In 2004, with the adoption of Regulation (EC) No 882/2004157 on official controls performed 
to ensure the verification of the compliance with feed and food law, animal health and animal 
welfare  rules,  a  general  framework  for  the  performance  of  official  controls  along  the  food 
chain was established. The "Official Controls Regulation" created an integrated approach to 
official  controls  in  all  areas  related  to  the  food  chain.  Considering  that  during  the 
abovementioned  exercise  of  review  of  the  rules  on  veterinary  medicines  was  ongoing, 
controls  on  residues  covered  by  Directive  96/23/EC  were  excluded  from  the  scope  of 
Regulation (EC) No 882/2004. 

In  July  2009,  the  Commission  transmitted  a  Report  to  the  European  Parliament  and  the 
Council  on  the  implementation  of  Regulation  (EC)  No  882/2004  since  1st  January  2006, 
reporting  on  the  first  years'  experience  of  enforcement  and  pointing  at  some  necessary 
reviews  to  be  considered.  The  Report  indicated  the  need  to  consider  the  possibility  of 
integrating the rules currently applicable to official controls on pesticides, contaminants and 
residues  of  pharmacologically  active  substances  in  food  into  the  framework  of  Regulation 
(EC) No 882/2004, so as to rationalise and simplify the overall legislative framework whilst 
allowing  the  Member  States  to  integrate  controls  on  residues  in  food  in  their  multi-annual 
control  plans  (MANCPs).  This  would  also  allow  a  more  consistent  approach  on  controls  of 
residues of veterinary medicines in food produced or imported to the EU. 

1.2. Purpose of the consultation 

This consultation is part of the exercise aiming to review Directive 96/23/EC. A roadmap for 
the exercise is published at: 

http://ec.europa.eu/governance/impact/planned_ia/docs/418_sanco_rev_dir_substances_anima
ls_en.pdf. 

In  order  to  align  the  legislative  framework  applicable  to  official  controls  on  residues  of 
veterinary  medicinal  products  with  the  more  modern  principles  established  in  Regulation 

155 OJ L 152, 16.6.2009, p. 11 
156 OJ L 318, 28.11.2008, p. 9 
157 OJ L 165, 30.04.2004, p. 1 

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(EC)  No  178/2002158  as  well  as  with  the  provisions  of  Regulation  (EC)  No  882/2004  and, 
notably,  with  the  need  to  plan  and  carry  out  control  activities  on  the  basis  of  risks,  the 
extensive  material  collected  in  the  framework  of  the  evaluation  started  in  2003  will  be 
considered, insofar as it is still relevant after the adoption of Regulation (EC) No 470/2009, 
and complemented with fresher input and additional feedback from MS and stakeholders to 
specifically  address  the  issues  related  to  the  alignment  of  the  veterinary  medicines'  residues 
controls with the requirements of Regulation (EC) No 882/2004. 

Therefore the purpose of this consultation is twofold: 

1.  to  update  (relevant)  information  gathered  during  the  consultations  carried  out  in 

the past, 

2.  to collect additional data to be used to assess the impact of the options available: 
MS  are  requested  to  provide  as  detailed  information  as  possible  to  allow  the 
evaluation of the impacts of the different options proposed. 

The  information  collected  through  this  questionnaire  will  be  used  to  assess  the  potential 
impacts of the main options possible to reach the objective stated, consideration being given 
also to possible synergies and trade-offs. 

1.3. Who is consulted and how to submit contributions 

This  questionnaire  is  addressed  to  the  Competent  Authorities  (CA)  of  the  Member  States 
(MS) responsible for the management of official controls in the food, feed and animal health 
sectors  (members  of  the  "Working  group  on  the  general  application  of  Regulation  (EC)  No 
882/2004"),  to  the  Chief  Veterinary  Officers  (CVOs)  of  the  Member  States  as  well  as  to 
officials  in  the  MS  in  particular  responsible  for  the  management  of  residues  of  veterinary 
medicinal  products  control  plans  in  the  Member  States  (members  of  the  "Residue  expert 
working group"). The questionnaire can be shared with other departments concerned.  

For  the  purpose  of  consolidating  the  responses,  only  one  contribution  per  Member  State 
should  be 
at 
sent 
alexander.rogge@ec.europa.eu . 

to  Alexander  Rogge 

the  Commission  per 

email 

to 

An  acknowledgement  of  receipt  will  be  issued  for  each  contribution  received  within  five 
working days. 

1.4. Timetable  

All contributions should be submitted to the Commission by the 1st April 2011 latest (the ones 
received before this deadline being of course warmly welcomed). 

1.5. Next steps  

All contributions will be carefully analysed. A summary of the outcome of the  consultation 
will  be  published  on  the  website  of  the  European  Commission  and  also  sent  directly  to  all 
contributors. The results of the consultation will be used for the impact assessment report on 
the revision of the Directive 96/23/EC. 

158  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of  28  January  2002  laying 
down the general principles and requirements of food law, establishing the European Food Safety Authority and 
laying down procedures in matters of food safety – OJ L 31, 01.02.2002, p. 1 

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2. Problem definition and objective 

Directive  96/23/EC  brought  about  a  significant  degree  of  harmonisation  of  controls  on 
residues of veterinary medicinal products and contaminants in the MS. The act provides for a 
minimum number of samples to be taken for each type of live animal or product per group or 
sub-group of substances according to the animal production as listed in the Annexes.  

While  harmonisation  clearly  has  the  advantage  of  ensuring  a  uniform  approach  to 
enforcement  actions  performed  to  fight  against  the  use  of  illegal  substances  and  to  control 
compliance  with  levels  of  residues  of  authorised  veterinary  medicinal  products,  the  lack  of 
flexibility,  which  is  the  consequence  of  the  detailed  and  over  prescriptive  nature  of  the 
Directive, may result in a reduced efficiency of the controls carried out. In fact, this rigidity: 

• 

limits the possibility to establish control priorities and to allocate controls resources on the 
basis of risks (other than the size of the animal production), 

•  does only permit very limited risk based changes to frequencies and methods of controls. 

The general objective of the current exercise is therefore to assess the possibility of aligning 
the rules applicable to official controls on residues of veterinary medicines to the principles 
and  rules  on  which  the  system  of  official  controls  is  based  following  the  adoption  of 
Regulation  (EC)  No  882/2004,  so  as  to  rationalise  and  simplify  the  overall  legislative 
framework  and  to  allow  MS  more  flexibility  necessary to ensure the  integration of residues 
controls into their MANCPs.  

More specifically the objective announced above would require the following to be achieved:  

•  simplify existing rules and eliminate overlaps which may result from the implementation 
of  Directive  No  96/23/EC  and  other  legislation,  in  particular,  on  contaminants  (Council 
Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for 
contaminants  in  food  and  Commission  Regulation  (EC)  No  1881/2006  of  19  December 
2006 setting maximum levels for certain contaminants in foodstuffs) and plant protection 
products (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); 

•  ensure  that  official  controls  on  residues  of  veterinary  medicinal  products  are  carried  out 
with a frequency established on the basis of risk and taking into account past records of 
compliance, any indication of non-compliance and reliability of own checks; 

• 

• 

• 

if  necessary,  ensure  a  minimum  level  of  control  of  certain  substances  whose  illegal  or 
non-compliant  use  would  represent  a  particularly  serious  health  risk  (e.g.  growth 
promoters or antibiotics); 

reduce the burden resulting from redundant or unnecessary procedures, in particular those 
laid  down  in  Directive  96/23/EC  for  the  approval  of  the  control  plans,  and  eliminate 
overlapping requirements on the MS; 

in  line  with  EU's  international  obligations  under  WTO  SPS  Agreement,  increase 
transparency  vis-à-vis  Third  Countries  by  simplifying  import  requirements  and  making 
them  clearer  (increased  transparency  facilitating  also  EU's  exports  due  to  a  better 
understanding of Third Countries of EU's control system(s)). 

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3. Data needs  

A  significant  amount  of  information  is  already  available  in  the  Residues  Application  in 
particular  in  terms  of  number  of  samples  analysed  and  results  of  analysis.  However,  the 
Commission  is  lacking  important  data  on  the  cost  of  the  residues  controls  which  is 
indispensable to evaluate the impacts of the different options proposed. 

Therefore, the following data would be necessary: 

• 

total annual cost of implementing the national residue control plan  (NRCP) referred to in 
Chapter II of Directive 96/23/EC including all expenses: staff, laboratories, consumables, 
overheads, etc., 

•  average total cost per sample, including all expenses, 

•  average cost per sample for laboratory analysis only, 

Data on number of samples and on results of analysis will be taken from submissions to the 
Residues  Application.  Please  provide  the  following  data  only  if  figures  differ  from  those 
recorded  in  the  Residues  Application,  stating  the  reasons  for  this  difference  (e.g.  additional 
control system in place): 

•  number of samples taken for residue controls per year under Directive 96/23/EC (please 

provide the average figure per year for the last two years), 

•  number of non-compliant samples. 

4. Key issues  

4.1. Key issue 1- List of substances in Annex I 

Annex I of Directive 96/23/EC provides for two groups of substances to be investigated: 

(cid:190)  Group  A  "substances  having  anabolic  effect  and  unauthorised  substances"  whose  use  is 

partly or entirely explicitly prohibited in food producing animals,  

(cid:190)  Group B "veterinary drugs and contaminants": 

•  B1  and  B2  substances  that  may  be  authorised  for  use  in  veterinary  medicinal 

products for food producing animals,  

•  B3  "other  substances  and  environmental  contaminants" 

(organochlorine 
compounds, organophosphorus compounds, chemical elements, mycotoxins, dyes 
and "others").  

Minimum sampling levels depending on type of animals (bovine, porcine, ovine, caprine and 
equine animals, poultry) or animal products (aquaculture products, milk, eggs, honey, rabbit 
meat,  meat  of  wild  and  farmed  game)  are  required  for  the  groups  and  sub-groups  of 
substances.  

Specific  enforcement  measures  to  be  taken  in  case  of  non-compliance  depend  on  the 
classification of the substance: non-compliance with Group A substances is reckoned as more 
severe than exceeding MRLs for an authorised substance of Sub-Group B1 or B2.  

Finally,  unlike  substances  of  Groups  A,  B1  and  B2,  the  presence  of  the  substances  and 
contaminants referred to in Sub-Group B3 (e.g. cadmium, lead, mercury, PCBs and dioxins, 
aflatoxin B1, ochratoxin A) is in general not due to intentional use. 

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4.1.1. Contaminants 

Issue 

According to Article 2 of Regulation (EC) No 315/93 laying down Community procedures for 
contaminants  in  food,  foodstuffs  shall  not  be  placed  on  the  market  when  they  contain  a 
contaminant  exceeding  a  maximum  level  set  in  the  relevant  legislation.  Commission 
Regulation (EC) No 1881/2006 sets the maximum levels for certain contaminants listed in its 
Annex:  nitrate,  mycotoxins,  metals 
tin),  3-
monochloropropane-1,2-diol  (3-MCPD),  dioxins  and  PCBs,  and  Polycyclic  Aromatic 
Hydrocarbons (PAHs), in food of animal origin (e.g. milk, eggs, fish, meat of bovine animals, 
sheep, pig and poultry). Unlike Directive 96/23/EC, the Regulation does not provide for the 
mandatory  establishment  and  approval  of  a  control  plan,  nor  for  a  minimum  number  of 
samples to be planned and analysed each year: Member States carry out control activities on 
the basis of their own risk assessment. 

(lead,  cadmium,  mercury, 

inorganic 

Article 9 of Commission Regulation (EC) No 1881/2006 furthermore requires Member States 
to report to the Commission findings from official controls on most of the mycotoxins, as well 
as  on  dioxins,  PCBs,  acrylamide  and  furan,  whereas  according  to  Article  8  of  Directive 
96/23/EC,  MS  have  to  forward  annually  to  the  Commission  the  results  of  their  monitoring 
plans comprising all substances listed in its Annex.   

Finally,  methods  for  sampling  and  analysis  for  contaminants  are  laid  down  in  different 
specific  legislation  and  the  approaches  for  the  validation  of  analytical  methods  and  the 
establishment  of  measurement  uncertainty  differ  between  both  (on  one  hand,  Commission 
Regulations  (EC)  No  333/2007  (lead,  cadmium,  mercury, 
tin,  3-MCPD, 
benzo(a)pyrene), No 1882/2006 (nitrates), No 401/2006 (mycotoxins), No 1883/2006 (dioxins 
and  dioxins-like  PCBs)  and,  on  the  other  hand,  Commission  Decision  2002/657/EC 
implementing Directive 96/23/EC). 

inorganic 

Against this background, several Member States suggested in their answers to the Reflection 
Paper, contaminants to be taken out of the scope of this Directive 96/23/EC and the intensity 
of official controls to be based on each Member State's risk assessment.   

Number of samples and results: 

In 2009, 45 014 samples were analysed in the EU under Directive 96/23/EC for substances in 
group B3 of which 487 samples were found to be non-compliant (1.08 %).  

The  highest  percentage  of  non-compliant  samples  in  almost  all  species  was  found  for 
chemical  elements  (B3c)  (2.25 %).  Cadmium,  lead  and  mercury  were  the  most  frequently 
reported  elements.  Instances  of  non-compliance  for  organochlorine  compounds  (B3a)  and 
organophosphorus compounds (B3b) were much lower: 0.19 % and 0.04 %, respectively. For 
mycotoxins (B3d), nine non-compliant samples for ochratoxin A in pigs, one for aflatoxin B1 
in sheep and goats, and five for aflatoxin M1 in milk were reported. Dyes (B3e) were reported 
in aquaculture (1.6 %). Substances found were malachite green and leuco-malachite-green159. 

There is no overview of the number of samples analysed for control of contaminants in food 
of animal origin in the EU under the contaminants legislation. 

159 EFSA Report for 2009 on the results from the monitoring of veterinary medicinal product residues and other 
substances in live animals and animal products 

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Questions (1) 

Evaluation  of  potential  impacts  of  repealing  the  requirements  on  official  controls  on 
contaminants  currently  laid  down  in  Directive  96/23/EC  (so  that  Regulation  (EC)  No 
882/2004 and the existing specific EU contaminants legislation would only apply) 

1.  Do you agree with the description of the issue?  

Yes 

No 

Comments 

2.  Socio economic impacts 

2.1. 

2.2. 

How  many  samples  are  taken  for  Subgroup  B3  per  year  in  your  Member  State? 
(please  provide  data  if  different  from  the  information  submitted  to  the  Residues 
Application and exclude pesticide residues as they are treated in 4.1.2 hereafter) 

Do  you  consider  that  the  number  of  samples  taken  to  test  for  the  presence  of 
contaminants would have been globally lower in your country, had you been allowed 
to establish the frequency of sampling only on the basis of risk assessments?  

If yes,  

  If not, 

(cid:131)  would you be able to give an indication of the impact of the reduction (in 
%, both in relation to the number of samples and to the overall costs)?   

(cid:131)  would you expect the sampling capacity that would be freed to be used to 

increase sampling on other substances? 

(cid:131)  would  you  expect  an  increase  of  the  number  of  samples  taken  for 

contaminants? 

or 

(cid:131)  would you expect the level to remain more or less the same?  

3.  Public Health impacts 

Would an exclusively risk based system of controls for contaminants (and thus the repeal of 
the  requirements  on  official  controls  on  contaminants  currently  laid  down  in  Directive 
96/23/EC) improve consumer protection? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments: 

4.  Administrative burden impacts 

What would be the effect on administrative burden on national Competent Authorities if the 
requirements on official controls on contaminants currently laid down in Directive 96/23/EC 
were  repealed  so  that  Regulation  (EC)  No  882/2004  and  the  existing  specific  EU 
contaminants legislation would only apply? 

Administrative burden would increase. Please substantiate your answer. 

Administrative burden would decrease. Please substantiate your answer. 

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Administrative burden would not change. Please substantiate your answer. 

Other comments: 

5.  Other impacts 

Please indicate any other impact that you consider relevant. 

4.1.2. Pesticide residues 

Issue 

Directive  96/23/EC  determines  minimum  sampling  levels  to  be  respected  in  the  national 
monitoring  plans  depending  on  type  of  animals  or  products  for  the  following  subgroups  of 
pesticides:  

–  carbamates and pyrethroids (B2c), 

–  organochlorine compounds (B3a), 

–  organophosphorus compounds (B3b), 

–  others (B3f). 

Following  the  entry  into  application  of  Regulation  (EC)  No  396/2005  on  maximum  residue 
levels (MRLs) of pesticides in or on food and feed of plant and animal origin, Member States 
are required to carry out official controls on pesticide residues in accordance with the relevant 
provisions of Regulations (EC) N° 178/2002 and 882/2004. Annex I of Regulation (EC) No 
396/2005 establishes a list of 315 products (animal products included) to which MRLs apply. 
Article 29 requires the Commission to prepare a coordinated multi-annual Community control 
programme  with  a  view  to  assessing  consumer  exposure  and  the  application  of  current 
legislation  and  Article  30  requires  Members  States  to  establish  risk  based  multi-annual 
national control programmes.  

Thus, in each MS several plans or programmes for testing pesticide residues in food and feed 
are currently in place: 

1. 

2.  

the EU coordinated programme under Regulation (EC) No 396/2005: the lots sampled 
are  chosen  without  any  particular  suspicion  towards  a  specific  operator  and/or 
consignment  and  the  results  obtained  are  considered  as  an  indicator  of  MRL 
compliance  in  food  placed  on  the  market  and  of  consumer  exposure  (statistical 
approach); 

the  risk  based  national  controls  programmes  under  Regulation  (EC)  No  396/2005 
based  on  past  records  and  focused  on  food  and  feed  with  higher  probability  for  non 
compliance; 

3.  

the control plan under Directive 96/23/EC with its targeted approach. 

Each year, the two programmes and the plan as well as the results thereof are communicated 
to the Commission. 

The  evident  overlap  of  the  two  sets  of  rules  also  implies  that  methods  of  analysis  and 
corresponding  validation  requirements  can  differ  for  the  same  substance  and  matrix 
depending  on  which  rules  are  applied:  whereas  laboratories  carrying  out  analysis  under 
Directive 96/23/EC follow Commission Decision 2002/657, laboratories carrying out analysis 
under  Regulation  (EC)  No  396/2005  apply  the  "Method  Validation  and  Quality  Control 
Procedures for Pesticide Residues (Doc. SANCO/2007/3131), 31 October 2007". 

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One important difference results from the different rationale of the two sets of rules: whereas 
each  year,  carbamates,  pyrethroids,  organochlorine  compounds  and  organophosphorus 
compounds  are  analysed  in  the  live  animals  and  the  products  mentioned  in  the  Annex  of 
Directive  96/23/EC,  the  product-pesticide  combinations  selected  in  the  EU  coordinated  and 
national control programmes under Regulation (EC) No 396/2005 may vary from one year to 
another, depending on risk prioritisation. 

Number of samples and results: 

According to the European Food Safety Authority (EFSA) report for 2009 on the results from 
the monitoring of veterinary medicinal product residues and other substances in live animals 
and animal products, 32 796 targeted samples were taken for groups B3a, B3b and B2c under 
Directive 96/23/EC in animals and products of animal origin. Instances of non-compliance for 
organochlorine compounds (B3a) and organophosphorus compounds (B3b) were 0.19 % and 
0.04 %, respectively. 

EFSA  publishes  also  annual  reports  on  the  EU  coordinated  programme  and  the  national 
control  programmes  of  pesticides  residues  according  to  Article  32  of  Regulation  (CE)  No 
396/2005. The last report presented the results of the analyses in food commodities sampled 
during  2008  in  the  27  EU  Member  States  as  well  as  in  Norway  and  Iceland  (two  EFTA 
(European Free Trade Association) states). More than 70 000 samples of nearly 200 different 
types of food were analysed. 96.5% of the samples complied with the MRLs of pesticides. 

11 610 samples of nine different commodities (of plant origin only) were taken in the 2008 
EU coordinated programme where the overall MRL exceedance rate was 2.3%. The 70 143 
samples analysed in the context of the national control programmes in 2008 included 67 887 
surveillance  samples  and  2  256  enforcement  samples  (N.B.:  these  figures  do  also  comprise 
the  number  of  samples  taken  for  the  EU  coordinated  programme).  The  majority  of  samples 
taken  originated  from  the  European  reporting  countries  (77%),  while  20%  of  the  samples 
were  taken  from  imported  consignments  or  lots.  For  3  %  of  the  samples  the  origin  was  not 
reported. 

Data on controls in food of animal origin will only be available in the 2009 report. 

Questions (2) 

Evaluation  of  potential  impacts  of  repealing  the  requirements  on  official  controls  on 
pesticides B3a, B3b, B3f and B2c currently laid down in Directive 96/23/EC (other than 
authorised veterinary medicines) (so that Regulation (EC) No 882/2004 and the existing 
specific EU pesticides legislation would only apply) 

1.  Do you agree with the description of the issue?  

Yes 

No 

Comments 

2.  Socio economic impacts. 

2.1. 

2.2. 

How many samples are taken for the analysis of pesticides residues under Directive 
96/23/EC per year? (please provide data if different from the information submitted 
to the Residues Application) 

Do you consider that the number of samples taken to test pesticides residues would 
have  been  globally  lower  in  your  country,  had  you  been  allowed  to  establish  the 
frequency of sampling only on the basis of risk assessments?  

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If yes,  

(cid:131)  would you be able to give an indication of the impact of the reduction (in 
%  points,  both  in  relation  to  the  number  of  samples  and  to  the  overall 
costs)?   

(cid:131)  would you expect the sampling capacity that would be freed to be used to 

increase sampling on other substances? 

If not, 

(cid:131)  would you expect an increase of the number of samples taken for pesticides 

residues?  

or 

(cid:131)  would you expect the level to remain more or less the same?  

3.  Public Health impacts 

Would an exclusively risk based system of national controls for pesticides residues (and thus 
the  repeal  of  the  requirements  on  official  controls  on  pesticides  currently  laid  down  in 
Directive  96/23/EC)  improve  consumer  protection?  (Please  do  not  consider  the  EU 
coordinated programme in your answer) 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments: 

4.  Administrative burden impacts 

What would be the effect on administrative burden on national Competent Authorities if the 
requirements  on  official  controls  on  pesticides  currently  laid  down  in  Directive  96/23/EC 
were repealed so that Regulation (EC) No 882/2004 and the existing specific EU pesticides 
legislation would only apply?  

Administrative burden would increase. Please substantiate your answer. 

Administrative burden would decrease. Please substantiate your answer. 

Administrative burden would not change. Please substantiate your answer. 

Other comments: 

5.  Other impacts 

Please indicate any other impact that you consider relevant. 

4.2. Key issue 2 - National residues monitoring plans 

Issue 

Council  Directive  96/23/EC  requires  Member  States  to  submit  annual  national  residues 
monitoring plans to the Commission respecting the minimum number of samples per type of 
animal or product and (sub)group of substances combinations laid down in Annex IV of the 
Directive as well as in the Decision 97/747/EC.  

As the number of samples is linked to the individual Member States’ animal production in the 
preceding  years,  this  can  result  in  very  small  numbers  of  samples  being  taken  in  those  MS 
where  there  is  limited  production  of  certain  species  and  the  relevance  of  taking  one  or  two 

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samples is questionable. On the other hand, in countries with larger animal productions, the 
numbers of samples specified  by the Directive are much greater than if a statistically based 
sampling approach (e.g. the one advocated by the Codex Alimentarius160) is followed.    

Furthermore  the  current  rigid  framework  of  Directive  96/23/EC  militates  against  the 
application  of  a  risk-based  approach  as  laid  down  in  Article  3  of  Regulation  (EC)  No 
882/2004 which states that official controls shall be carried out regularly, on a risk basis, with 
appropriate frequency and taking into account identified risks, past records, reliability of own 
checks  and  any  indication  of  non-compliance  (risk  approach).    Whilst  some  degree  of  risk-
based approach is possible under the current Directive (for example MS are free to prioritise 
certain  substances  within  specific  substance  groups  and  the  minimum  sample  numbers 
specified  in  the  Directive  can  be  exceeded),  the  fact  remains  that  MS  are  forced  to  test  for 
certain  substances  and  substance  groups  where  there  has  been  little  evidence  of  a  residues 
problem for many years (e.g. Group A1 – stilbenes).   

Moreover,  the  approval  of  the  national  monitoring  plans  involves  a  long  and  heavy 
administrative  procedure  including  notification,  formal  examination  and  approval  by  the 
Commission  to  be  carried  out  every  year  and  no  clear  indication  is  given  of  the  possible 
consequences of not approving a national plan.  

Against  this  background,  MS  expressed  during  the  consultations  their  view  that  the 
requirements for the national monitoring plans under Directive 96/23/EC were not providing 
satisfactory  results  in  relation  to  the  resources  invested.  They  suggested  that  (part  of)  the 
samples should be selected in accordance to the principles in Regulation (EC) No 882/2004 
(i.e. on a risk basis) while considering the opportunity to give some priority to the detection of 
the use of prohibited substances presenting a serious health risk for consumers. 

Number of samples and results: 

A  total  of  445 968  targeted  samples  and  38 119  suspect  samples  were  reported  under  the 
Directive  96/23/EC  in  2009.  There  were  1 342  non-compliant  samples  (0.30 %)  out  of  the 
total targeted samples. From the total of collected targeted samples, 40.9 % were analysed for 
substances  having  anabolic  effect  and  prohibited  substances  (group  A)  and  63.1 %  for 
veterinary drugs and contaminants (group B).  

Questions (3) 

Evaluation of potential impacts of: 

Option 1: repealing the current prescriptive harmonisation of the modalities for control 
planning laid down in Directive 96/23/EC and allowing Member States to plan controls 
according to their own risk assessments and to integrate these controls in their MANCP; 

Option 2: option 1 combined with EU harmonised uniform control modalities for certain 
substances or groups of substances and/or certain combinations animal(s) or product(s) 
and substance(s) established in case of specific "intrinsic" risks (e.g. growth promoters) 
or other risks that would justify the introduction of minimum control frequencies at EU 
level under certain conditions and for certain combinations animal(s) or product(s) and 
substance(s). 

Please do not consider contaminants (treated in 4.1.1.)  and  pesticides residues (treated in 
4.1.2.) when answering to the following questions. 

160 http://www.codexalimentarius.net/download/standards/11252/CXG_071e.pdf 

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1.  Do you agree with the description of the issue? 

Yes 

No 

Comments 

2.  Socio economic impacts 

2.1. 

Do  you  consider  that  the  number  of  samples  taken  would  have  been  lower  in 
your  country,  had  you  been  allowed  to  plan  controls  only  on  the  basis  of  your 
risk assessments (as in option 1)? 

(a)  If yes: 

(i)  would  you  be  able  to  give  an  indication  of  the  impact  of  the 
reduction  (in  %  points,  both  in  relation  to  the  number  of  samples 
and to the overall costs)? 

(ii) would  you  expect  the  sampling  capacity  that  will  be  freed  to  be 
used  to  increase  sampling  on  other  substances  or  for  a  monitoring 
programme to assess consumer exposure? 

(b) If not: 

(i)  would you expect an increase of the number of samples taken? 

or 

(ii) would you expect the level to remain more or less the same? 

2.2.  Would  you  be  able  to  estimate  any  impact  of  EU  harmonised  uniform  control 
modalities for certain (groups) substances and/or certain combinations animal(s) 
or product(s) and substance(s) (as in option 2) on the number of samples taken in 
your country? 

Yes. Please substantiate your answer. 

No,  I'm  not  able  to  estimate  any  difference  between  options  1  and  2.  Please 
substantiate your answer 

Other comments: 

3.  Public Health impacts 

3.1.  Would a system of controls exclusively based on your own risk assessments (as 

in option 1) improve consumer protection? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

3.2.  Would  you  be  able  to  estimate  any  impact  of  EU  harmonised  uniform  control 
modalities for certain (groups) substances and/or certain combinations animal(s) 
or product(s) and substance(s) (as in option 2) in regard to consumer protection? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

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4.  Administrative burden impacts 

Option 1 and option 2 would require the MS to draft the national residues control programmes 
according to its own risk assessments but they would no longer require each MS to submit its 
national control plan and its results for specific approval (each MS would include its plan in 
the MANCP).  

4.1. 

What  would  be  the  effect  of  option  1  on  the  administrative  burden  for  the 
national Competent Authority? 

Administrative burden would be increased. Please substantiate your answer. 

Administrative burden would be decreased. Please substantiate your answer. 

Administrative burden would not change. Please substantiate your answer. 

Other comments: 

4.2. 

Would you be able to estimate any impact of EU harmonised uniform control 
modalities  for  certain  (groups)  substances  and/or  certain  combinations 
animal(s)  or  product(s)  /  substance(s)  (as  in  option  2)  on  the  administrative 
burden of  the Competent Authority? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

5.  Other impacts 

Please indicate any other impact that you consider relevant. 

4.3. Key issue 3 - Requirements for Third Countries on residues controls/imports  

Issue 

Article  29  of  Directive  96/23/EC  requires  that  Third  Countries  (TCs)  provide  "guarantees" 
that  have  an  "effect  at  least  equivalent"  to  the  measures  that  are  to  be  implemented  by 
Member  States  (MS)  according  to  the  Directive.  In  particular,  TCs  have  to  submit  on  an 
annual  basis  a  residues  monitoring  plan,  the  requirements  being  very  prescriptive  and 
essentially  the  same  as  for  the  Member  States'  plans  (minimum  sampling  frequencies,  etc.), 
and to provide details on their control system. According to this article, TCs with an approved 
residues  monitoring  plan  appear  on  a  list  from  which  MS  are  authorised  to  import 
(Commission Decision 2004/432/EC). 

During the consultation, a simpler and more transparent framework as well as the definition 
of  criteria  to  assess  the  effective  equivalence  of  monitoring  plans  and  control  systems  were 
requested and to a certain extent, this has been delivered already with the publication of the 
Commission's  Third  Country  residues  web  page  in  which  the  provision  of  guarantees 
equivalent to those provided for by Directive 96/23/EC are described161. 

In 2004, the entry into force of Regulation (EC) No. 882/2004 has created a more horizontal 
approach to the establishment of import requirements. In particular: 

161 http://ec.europa.eu/comm/food/food/chemicalsafety/residues/third_countries_en.htm 

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1.  

2.  

3.  

Article  47  of  the  Regulation  requires  TCs  to  provide  accurate  and  up-to-date 
information on the general organisation and the management of their sanitary control 
systems,  sanitary  regulations,  control  and  inspection  procedures,  risk  assessment 
procedures  and  the  factors  taken  into  consideration,  results  of  their  controls,  their 
follow  up  to  the  recommendations  made  pursuant  to  FVO  missions,  changes  of  the 
structure and functioning of the relevant control systems, etc.; 

Article 48 gives the possibility to lay down if necessary specific import conditions and 
detailed procedures which may include the establishment of a list of Third Countries 
from  which  specific  products  may  be  imported  and  the  definition  of  specific  import 
conditions  depending  on  the  type  of  animal  or  product  and  the  possible  risks 
associated therewith. 

Article  46  requires  FVO  controls  to  be  carried  out  in  TCs  in  order  to  verify,  on  the 
basis  of  the  information  referred  to  in  Article  47,  the  compliance  or  equivalence  of 
TCs legislation and systems with EU feed and food law and animal health legislation.  

These  controls  shall  have  particular  regard  to  the  legislation  of  the  TC,  the 
organisation  of  the  its  competent  authorities,  their  supervision,  powers  and 
independence, the training of their staff, their resources including diagnostic facilities, 
the  existence  and  operation  of  documented  and  adequate  control  procedures  and 
systems  as  well  as  the  assurances  which  the  Third  Country  can  give  regarding 
compliance with, or equivalence to, EU requirements. 

Approximately 80 countries are listed in Commission Decision 2004/432/EC for animals and 
food  from  animal  origin  for  which  a  residues  monitoring  plan  has  been  submitted  and 
positively  assessed  by  the  Commission.  FVO  missions  are  furthermore  carried  out  to  check 
the effective implementation of the plans.  

Questions (4) 

Evaluation of potential impacts of: 

Option  1:  repealing  the  current  prescriptive  modalities  for  TCs'  residues  monitoring 
plans in Directive 96/23/EC and replacing them by a set of minimum specific guarantees 
as  regards  equivalence  or  compliance  of  the  control  system  and  programme  of 
veterinary  medicines'  residues  of  the  TC  (legislation,  authorisation,  control  of 
production  and  use  of  veterinary  medicines,  identification  of  prohibited  substances, 
control programme for testing residues in animals and food from animal origin) which 
shall  be  provided  by  the  Third  Country  in  order  for  it  to  be  inscribed  in  the  list 
established  under  Article  48  of  Regulation  (EC)  No  882/2004  and  which  shall  be 
controlled  during  FVO  missions  at  frequencies  determined  in  accordance  with 
prescriptions of Article 46 of Regulation (EC) No 882/2004; 

Option 2: option 1 combined with mandatory minimum control frequencies in the TC's 
control  programme  for  certain  substances  or  groups  of  substances  whose  illegal  use 
would  represent  a  particularly  serious  violation  and/or  health  risk  for  the  consumers 
(e.g.  growth  promoters  or  certain  antibiotics)  and  which  require  a  specific  approach 
(special import conditions). 

EN 

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Impacts: 

1.  Do you agree with the description of the issue?  

Yes 

No 

Comments 

2.  Socio economic impacts 

2.1.  

Would you be able to estimate any socio-economic impact of option 1 on your 
national Competent Authority (human resources, controls, etc.)? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

2.2. 

Comparing  option  1  with  option  2,  would  you  be  able  to  estimate  any 
difference in the socio-economic impact on your national Competent Authority 
(human resources, controls, etc.)? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments: 

3.  Public health impacts 

3.1.  

  Would option 1 improve consumer protection? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

3.2. 

Comparing option 1 with option 2, would you be able to estimate any impact 
of  mandatory  minimum  control  frequencies  in  the  TCs'  control  programmes 
(for  certain  substances  or  groups  of  substances  whose  illegal  use  would 
represent a particularly serious violation and/or health risk for the consumers) 
on consumer protection? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments 

4.  Administrative burden 

4.1. 

What  would  be  the  effect  of  option  1  on  the  administrative  burden  for  your 
national Competent Authority? 

Administrative burden would be increased. Please substantiate your answer. 

Administrative burden would be decreased. Please substantiate your answer. 

Administrative burden would not change. Please substantiate your answer. 

Other comments: 

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4.2. 

Comparing option 1 with option 2, would you be able to estimate any impact 
of  mandatory  minimum  control  frequencies  in  the  TCs'  control  programmes 
(for  certain  substances  or  groups  of  substances  whose  illegal  use  would 
represent a particularly serious violation and/or health risk for the consumers) 
on the administrative burden of your Competent Authority? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments. 

5.  Other impacts 

Please indicate any other impact that you consider relevant. 

4.4. Key issue 4 - Enforcement measures 

Articles 13, 16, 17 and 18 as well as Articles 22, 23, 24 and 25 of Directive 96/23/EC provide 
very  precise  and  specific  enforcement  measures  to  be  taken  by  Member  States  in  case  of 
illegal  treatment,  use  of  unauthorised  substances  or  presence  of  their  residues,  levels 
exceeding  the  maximum  limit  for  residues,  repeated  infringements  of  MRLs,  etc.  (e.g. 
immediate  slaughter  of  all  animals  in  case  of  confirmation  of  illegal  treatment).  The  very 
detailed  and  over  prescriptive  nature  of  the  Directive  may  result  in  some  confusion  for  the 
Competent  Authorities  and  their  enforcement  officers  as  well  as  in  a  reduced  flexibility  as 
regards of the possible enforcement actions in a given situation.  

Regulation (EC) No 882/2004 has a more flexible and rationalised approach: Article 54 of the 
Regulation  requires  that  actions  taken  by  the  Competent  Authority  shall  ensure  that  the 
operator remedies the situation and that they take account of the nature of the non-compliance 
as well as the operator's past record with regard to the non compliance. It furthermore lists the 
possible measures without linking them rigidly to specific non-compliances:  

• 

• 

imposition of sanitation procedures or any other action deemed necessary to ensure the 
safety of feed or food or compliance with law; 

restriction or prohibition of the placing on the market, import or export of feed, food 
or animals; 

•  monitoring and, if necessary, ordering the recall, withdrawal and/or destruction of feed 

or food; 

•  authorisation  to  use  feed  or  food  for  purposes  other  than  those  for  which  they  were 

originally intended; 

•  suspension  of  operation  or  closure  of  all  or  part  of  the  business  concerned  for  an 

appropriate period of time; 

•  suspension or withdrawal of the establishment's approval; 

•  any other measure the competent authority deems appropriate (for instance slaughter 

of animals). 

Article 54 finally requires that all expenditure incurred shall be borne by the responsible feed 
and food business operator. 

The alignment of the rules applicable for residues of veterinary medicines controls with the 
ones  of  Regulation  (EC)  No  882/2004  would  thus  allow  specific  case  by  case  adapted 

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measures  remedying  the  situation  without  preventing  Competent  Authorities  to  take,  if 
needed, the same enforcement measure than the one they would have taken under Directive 
96/23/EC.  

Questions (5) 

Evaluation of potential impacts of repealing the requirements on enforcement measures 
currently laid down in Directive 96/23/EC (Articles 13, 16, 17, 18, 22, 23, 24 and 25) so 
that Article 54 of Regulation (EC) No 882/2004 would only apply 

1.  Do you agree with the description of the issue?  

Yes 

No 

Comments 

2.  Socio economic impacts 

2.1.   Do  you  consider  that,  in  general,  you  would  have  taken  the  same  enforcement 
measures,  had  current  provisions  in  Article  54  of  Regulation  (EC)  No  882/2004 
been applicable? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments. 

2.2.  Do  you  consider  that  your  enforcement  actions  would  have  been  better  targeted 
and/or  adapted,  had  current  provisions  in  Article  54  of  Regulation  (EC)  No 
882/2004 been applicable? 

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other comments. 

3.  Public Health impacts 

Would  the repeal  of the rigid  requirements on enforcement  measures  currently  laid 
down in Directive 96/23/EC and the application of current provisions in Article 54 of 
Regulation (EC) No 882/2004 improve consumer protection?  

Yes. Please substantiate your answer. 

No. Please substantiate your answer. 

Other answer: 

4.  Administrative burden impacts 

What would be the effect on administrative burden on national Competent Authorities 
in  case  of  repeal  of  the  rigid  requirements  on  enforcement  measures  currently  laid 
down in Directive 96/23/EC and the application of current provisions in Article 54 of 
Regulation (EC) No 882/2004? 

Administrative burden would increase. Please substantiate your answer. 

Administrative burden would decrease. Please substantiate your answer. 

Administrative burden would not change. Please substantiate your answer. 

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Other comments: 

5.  Other impacts 

Please indicate any other impact that you consider relevant. 

5. Results of the consultation 

All 27 Member States (MS) and Norway answered to the questionnaire.  

5.1. Overlaps resulting from the implementation of Directive 96/23/EC and the 
specific EU contaminants legislation (Regulations (EC) N° 315/93 and N° 
1881/2006) 

The  option  considered  was  to  repeal  the  requirements  on  official  controls  on 
contaminants  currently  laid  down  in  Directive  96/23/EC  so  that  Regulation  (EC)  No 
882/2004 and the existing specific EU contaminants legislation would only apply. 

26  MS  agreed  with  the  description  of  the  issue  (1  disagreed).  No  MS  was  opposed  to  the 
option.  

General comments from the MS 

Some  MS  underlined  the  specific  case  of  dyes  (malachite  green  and  leucomalachite  green 
used for the illegal treatment of farmed fish) which should be considered separately.  

Others called for the inclusion in EU legislation of an EU coordinated programme for at least 
some priority environmental contaminants which should be reviewed regularly or annually. 

Several  MS  stressed  the  need  to  ensure  future  the  financing  of  official  controls  on 
contaminants through fees paid by industry and some were of the opinion that private controls 
carried out by food business operators (FBOs) should be more taken into account. 

Some  MS  focussed  on  the  possible  consequences  of  this  option  on  EU  exports:  export 
possibilities  would  have  to  be  re-negotiated  with  each  third  country  (TC)  and  new  specific 
requests from TCs (e.g. analyses of consignments) could be possible. 

Member States' perception of the potential impacts of the option 

1. Socio-economic impacts  

The  majority  of  the  MS  (18)  considered  that  the  number  of  samples  taken  to  test  for  the 
presence of contaminants would have been globally lower in their country, if the frequency 
of  sampling  was  only  on  the  basis  of  risk  assessments.  7  MS  mentioned  reductions  of  the 
number of samples (globally or for one or several group(s) of substances) between – 10 % and 
– 60 %.  

The majority of these MS (11/18) expected the sampling capacity that would be freed to be 
used  to  increase  the  sampling  of  other  substances  and/or  on  other  matrices  (in  general  if 
justified by risk assessments). Several MS noticed however that any increase of the number of 
samples is difficult in the current situation of public deficits and scarce public budgets. 

6  MS  felt  that  the  number  of  samples  would  remain  unchanged  (they  would  be  distributed 
differently) and 3 MS didn't or couldn't answer. 

EN 

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2. Public health impacts 

For the majority of MS (17), an exclusively risk based system of controls for contaminants 
would  improve  consumer  protection  (sampling  better  focussed  and  more  efficient,  better 
allocation  of  resources,  local  specificities  better  taken  into  account).  Some  MS  proposed  a 
rolling  program  based  on  risk  assessments  with  more  or  less  intensive  samplings  from  one 
year to another.   

2 MS felt that the level of consumer protection would remain the same (because of very few 
samples concerned). All other MS having answered explained that an exclusively risk based 
system would not or not necessarily improve consumer protection unless it comprises also a 
monitoring programme of low risk or low occurrence substances in order to observe medium 
and long term trends, to keep track of consumer exposure and to identify incidents. 

3. Administrative burden impacts on national competent authorities 

The majority of Member States (15) answered that the burden would decrease (10) after 
perhaps an initial increase (due to the reduced number of samples and an optimum allocation 
of resources, the repeal of the annual submission and approval by the Commission, as well as 
of  the  double  reporting)  or  that  it would  not  change  globally  (5).  9  MS  estimated  that  the 
burden would increase at least initially (because of risk assessments to be carried out, plans to 
be reviewed on a regular basis/every year). 3 MS didn't or couldn't answer. 

5.2. Overlaps resulting from the implementation of Directive 96/23/EC and the 
specific EU pesticides residues legislation (Regulation (EC) N°396/2005) 

The option considered was to repeal the requirements on official controls on pesticides 
B3a, B3b, B3f and B2c currently laid down in Directive 96/23/EC (other than authorised 
veterinary medicines) so that Regulation (EC) No 882/2004 and the existing specific EU 
pesticides legislation would only apply. 

26  MS  agreed  with  the  description  of  the  issue  (1  disagreed).  No  MS  was  opposed  to  the 
option.  

General comments from the MS 

6  MS  underlined  that  some  group  B2c  pesticides  were  pharmacologically  active  substances 
for  which  a  MRL  was  set  up  in  accordance  with  Regulation  (EC)  No  470/2009  and  which 
were used as VMPs (ecto-parasitics). These pesticides should be treated as VMPs. 

Several MS  were of the opinion that  a broader monitoring of pesticides residues in animals 
and their products was needed in order to observe medium and long term trends, to keep track 
of consumer exposure and to identify incidents and requested that animals and food of animal 
origin should be better represented in the current EU coordinated (monitoring) programme on 
pesticides residues.  

Some MS proposed that requirements concerning methods of analysis should also be aligned. 

Several MS stressed the need to ensure the future financing of official controls on pesticides 
residues through fees paid by industry. 

EN 

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Member States' perception of the potential impacts of the option 

1. Socio-economic impacts  

The  majority  of  the  MS  (17)  considered  that  the  number  of  samples  taken  to  test  for  the 
presence  of  pesticides  residues  would  have  been  globally  lower  in  their  country,  if  the 
frequency of sampling was only determined on the basis of risk assessments. More than half 
of them (9/17) expected the sampling capacity that would be freed to be used to increase the 
sampling  of  other  substances  and/or  on  other  matrices  (in  general  if  justified  by  risk 
assessments) or to use more efficient and expensive methods. 7 MS mentioned reductions of 
the  number  of  samples  between  –  2  %  and  –  100  %  depending  on  the  type  of  animals  or 
animal  products  and  the  substance  or  group  of  substances.  Only  6  MS  estimated  that  the 
number of samples would remain more or less unchanged (different distribution of samples or 
very few samples concerned) and 4 didn't or couldn't answer. 

2. Public health impacts 

For  the  majority  of  MS  (16),  an  exclusively  risk  based  system  of  national  controls  for 
pesticides residues would improve consumer protection (sampling better focussed and more 
efficient, better allocation of resources, local specificities better taken into account). Some MS 
proposed a rolling program based on risk assessments with more or less intensive samplings 
from one year to another.   

3 MS felt that the level of consumer protection would remain the same (inter alia because of 
very few samples concerned). All other MS having expressed an opinion (4) answered that an 
exclusively  risk  based  system  would  not  or  not  necessarily  improve  consumer  protection 
unless  it  comprises  also  a  monitoring  programme  of  low  risk/low  occurrence  substances  in 
order to observe medium/long term trends, to keep track of consumer exposure and to identify 
incidents. 

3. Administrative burden impacts on national competent authorities 

The  majority  of  Member  States  (15)  answered  that  the  burden  would  decrease  (9)  after 
perhaps  an  initial  increase  (because  of  less  samples,  no  annual  submission  and  approval  by 
the Commission, no double reporting, etc.) or that it would not change (6). 7 MS estimated 
that the burden would increase at least initially (because of risk assessments to be carried out, 
plans to be reviewed on a regular basis/every year). 5 MS didn't or couldn't answer. 

5.3. Enforcement measures 

The  option  considered  was  to  repeal  the  requirements  on  enforcement  measures 
currently laid down in Directive 96/23/EC (Articles 13, 16, 17, 18, 22, 23, 24 and 25) so 
that Article 54 of Regulation (EC) No 882/2004 would only apply. 

25 MS agreed with the description of the issue (2 disagreed).  

General comments from the MS 

Some MS were of the opinion that Article 54 would be sufficient while others were opposed 
to the option and requested the current measures to be kept.  

Several  MS  differentiated  between  minor  and  major  infringements:  in  their  opinion,  Article 
54  seemed  sufficient  for  group  B  substances  and  simple  cases  of  exceeded  MRLs,  where 

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more flexibility was necessary, whereas for group A substances (non authorised substances, 
growth  promoters),  stronger  and  more  uniform  enforcement  measures  more  adapted  to 
animals (than those in Article 54) were needed because of the use of illegal substances being 
related  to  (organised)  criminal  activities.  Others  thought  that,  if  enforcement  measures  in 
Directive 96/23/EC were to be deleted then measures not explicitly covered by Article 54 of 
Regulation  882/2004  should  be  "transferred"  to  the  Regulation  (this  concerned  in  particular 
movement restrictions on livestock and destruction of livestock)  

Finally,  some  MS  underlined  that  enforcement  measures  would  probably  be  more 
questioned/contested by concerned FBOs. 

Member States' perception of the potential impacts of the option 

1. Socio-economic impacts  

1.1 The majority of the MS (14) considered that, in general, they wouldn't have taken the 
same  enforcement  measures,  had  current  provisions  in  Article  54  of  Regulation  (EC)  No 
882/2004 been applicable. The reasons were following: 

-  

-  

- 

-  

a more flexible individual case by case approach as well as better targeted and easier 
measures were needed, 

in  some  cases  concerning  non  authorised  substances  or  growth  promoters,  measures 
would  have  been  less  drastic  and  in  others  more  and/or  profounder  investigations 
would have been necessary, 

in cases of first non conformity concerning an authorised substance, measures would 
have  been  essentially  administrative  and  the  focus  would  be  more  on  repeated 
offenders, 

if  several  different  measures  were  possible,  the  national  approach  would  be  to  start 
with less harmful measure. 

10 MS estimated that they would have taken more or less the same enforcement measures. 3 
MS didn't or couldn't answer. 

1.2.  The  majority  of  the  MS  (16)  considered  that  their  enforcement  actions  would  have 
been  better  targeted  and/or  adapted,  had  current  provisions  in  Article  54  of  Regulation 
(EC)  No  882/2004  been  applicable.  The  reasons  were  globally  the  same  as  those  described 
under point 1.1. For 1 MS, they would have been the same. 

7 MS only answered that their enforcement actions would not have been better targeted and/or 
adapted. 3 didn't or couldn't answer. 

2. Public health impacts 

For  a  majority  of  MS  (17),  the  repeal  of  the  rigid  requirements  on  enforcement  measures 
currently laid down in Directive 96/23/EC and the application of current provisions in Article 
54  of  Regulation  (EC)  No  882/2004  would  per  se  not  improve  consumer  protection  (the 
reason often specified being that the repeal would have no significant impact on consumer 
protection).  9  MS  were  of  the  opinion  that  it  would  improve  consumer  protection.  1  MS 
didn't answer. 

EN 

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3. Administrative burden impacts on national competent authorities 

The majority of the MS (17) estimated that the burden would not change (14) (because of 
the few cases concerned, the fact that enforcement measures would remain similar, the better 
allocation of time and resources) or that it would decrease (2).  

6 MS were however of the opinion that the burden would increase (mainly because of a more 
complicated  decision  process  and  an  increased  number  of  measures  contested  by  the 
concerned FBOs). 4 MS didn't or couldn't answer. 

5.4. National residues monitoring plans 

The options considered were: 

Option  1:  repeal  the  current  prescriptive  harmonisation  of  the  modalities  for  control 
planning  laid  down  in  Directive  96/23/EC  and  allow  MS  to  plan  controls  according  to 
their own risk assessments and to integrate these controls in their multi-annual control 
plan (MANCP) 

Option 2: option 1 combined with EU harmonised uniform control modalities for certain 
substances or groups of substances and/or certain combinations animal(s) or product(s) 
and substance(s) established in case of specific "intrinsic" risks (e.g. growth promoters) 
or other risks that would justify the introduction of minimum control frequencies at EU 
level under certain conditions and for certain combinations animal(s) or product(s) and 
substance(s) 

24 MS agreed with the description of the issue (2 disagreed). Option 2 was supported by most 
of the MS. 

General comments from the MS 

Option 1 was in general not supported by the MS (the main reason mentioned was the risk of 
a non harmonised approach between the MS with potential impacts on the internal market and 
on bilateral agreements with TCs). 

Option 2 was supported by most of the MS (18). A lot of MS indeed underlined the need 
for a mandatory (if possible EU coordinated) monitoring plan of at least group A substances 
(non  authorised  substances  and  growth  promoters)  and  antibiotics  (justified  by  the  growing 
antimicrobial  resistance)  as  well  as  dyes,  in  order  to  assess  consumer  exposure  to  their 
residues, to generate sufficient data for the risk assessments, to establish common guarantees 
for EU exports towards TCs and to maintain the preventive effect of such a monitoring. Most 
MS  mentioned  that  this  plan  should  be  revised  regularly  and  some  that  it  could  comprise 
minimum numbers of samples in accordance with Codex alimentarius rules (significantly less 
samples  than  currently).  A  lot  of  MS  underlined  that  this  EU  coordinated  monitoring  plan 
should  be  complemented  by  national  plans  based  on  MS'  own  risk  assessments.  Some  MS 
mentioned the proposal made during the previous consultation on this issue: 60 % of samples 
for the EU coordinated plan and 40 % for the national plan.  

Some MS requested common principles or guidelines or procedures for the elaboration of the 
plans  based  on  risk  assessments,  others  proposed  a  common  set  of  criteria  or  the  use  of 
internationally recognised criteria for the risk assessments to ensure a harmonised approach. 

Finally, several MS underlined also: 

-  

the need to ensure the financing of at least a part of the controls trough fees paid by 
FBOs, 

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-  

- 

-  

the importance of the data on the distribution and use of VMPs (seen as essential for 
the risk assessments by some MS), 

the  possibility  to  extend  the  range  of  substances  analysed  through  the  use  of  multi-
residue methods,  

the possibility to carry out rolling programmes based on risk assessments with more or 
less intensive samplings from one year to another. 

Member States' perception of the potential impacts of the options 

1. Socio-economic impacts  

1.1.  The  majority  of  MS  (15)  considered  that  the  number  of  samples  taken  would  have 
been lower in their country, had they been allowed to plan controls only on the basis of their 
risk assessments (as in option 1). For several MS, the current number of mandatory samples 
was  indeed  excessive  and  very  few  non  compliant  samples  for  group  A  substances  were 
detected. 13 MS expected the sampling capacity that would be freed to be used to increase the 
sampling  of  other  substances  and/or  on  other  matrices  (in  general  if  this  was  justified  by 
corresponding  risk  assessments)  or  to  use  more  efficient  and  expensive  methods.  7  MS 
mentioned reductions of the number of samples between – 10 % and – 75 % depending on the 
type of animals or animal products and the substance or group of substances. 

4  MS  estimated  the  number  of  samples  would  be  more  or  less  unchanged  (the  distribution 
only of the samples would be different), 1 MS that the number would not decrease and 7 MS 
didn't or couldn't answer.  

1.2. 12 MS were able to estimate an impact of EU harmonised uniform control modalities for 
certain  (groups)  substances  and/or  certain  combinations  animal(s)  or  product(s)  and 
substance(s)  (as  in  option  2)  on  the  number  of  samples  taken  in  their  country.  They  mostly 
mentioned a decrease  of  the number  of  samples  compared to  the current system which 
wouldn't be as significant as for option 1.  

2. Public health impacts 

2.1.  For  a  majority  of  MS  (15),  a  system  of  controls  exclusively  based  on  their  own  risk 
assessments (as in  option  1) would improve consumer protection (as the sampling would 
be  better  targeted/focussed,  local  specificities  taken  into  account  and  resources  better 
allocated). 1 MS estimated that the level of consumer protection would remain unchanged.  

7  MS  however  were  of  the  opinion  that  it  would  not  or  not  necessarily  improve  consumer 
protection (inter alia because a real monitoring of group A substances and antibiotics would 
not be guaranteed). 4 MS didn't or couldn't answer. 

2.2. Most of the MS (21) were able to estimate an impact of EU harmonised uniform control 
modalities for certain (groups) substances and/or certain combinations animal(s) or product(s) 
and substance(s) (as in option 2) in regard to consumer protection. Nearly all of them thought 
that option 2 would have the most favourable impact on consumer protection. 

3. Administrative burden impacts on national competent authorities 

3.1.  10  MS  estimated  that  option  1  would  increase  the  burden  at  least  at  the  beginning 
(because  of  the  establishment  of  new  plans  based  on  own  risk  assessments  and  the  regular 
review  of  them)  and  6  MS  answered  that  the  burden  would  not  change  (after  an  initial 
increase  for  some  of  them).  5  MS  were  of  the  opinion  that  the  burden  would  decrease 
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(because  of  less  samples  to  be  taken,  the  better  allocation  of  resources,  the  absence  of  the 
annual submission and approval of plans, etc.) and 6 MS didn't or couldn't answer. 

3.2. Only 12 MS were able to estimate the impact of option 2 on the administrative burden of 
their  CA.  Views  were  rather  varied  however  most  of  the  MS  thought  the  burden  would 
increase at the beginning and then decrease. 

5.5. Requirements for third countries (TCs) from which products may be imported  

The options considered were: 

Option  1:  to  repeal  the  current  prescriptive  modalities  for  TCs'  residues  monitoring 
plans in Directive 96/23/EC and replace them by a set of minimum specific guarantees as 
regards equivalence or compliance of the control system and programme of veterinary 
medicines' residues of the TC (legislation, authorisation, control of production and use 
of veterinary medicines, identification of prohibited substances, control programme for 
testing residues in animals and food from animal origin) which shall be provided by the 
third  country  in  order  for  it  to  be  inscribed  in  the  list  established  under  Article  48  of 
Regulation (EC) No 882/2004 and which shall be controlled during missions of the Food 
and  Veterinary  Office  (FVO)  at  frequencies  determined 
in  accordance  with 
prescriptions of Article 46 of Regulation (EC) No 882/2004 

Option  2:  option  1  combined  with  mandatory  minimum  control  frequencies  in  TCs' 
control  programmes  for  certain  substances  or  groups  of  substances  whose  illegal  use 
would  represent  a  particularly  serious  violation  and/or  health  risk  for  the  consumers 
(e.g.  growth  promoters  or  certain  antibiotics)  and  which  require  a  specific  approach 
(special import conditions). 

22 MS agreed with the description of the issue (3 disagreed).  

General comments from the MS 

MS often insisted on the necessary equivalence of the system for MS with the system for 
TCs.  

Several  MS  expressed  their  clear  preference  for  option  2  which  should  include  mandatory 
minimum  control  frequencies  at  least  for  unauthorised  substances  (even  more  if  these  are 
authorised in the TC) and growth promoters as well as antibiotics. Other MS underlined that 
the submission of plans by TCs and their approval by the Commission should globally be kept 
(some adjustments were proposed). 

Some MS were also of the opinion that: 

- 

-  

- 

residue control plans of TCs should be based on risk assessments,  

common principles or guidelines or procedures for the elaboration of the plans based 
on risk assessments should be established to ensure a harmonised approach by MS and 
TCs, 

a  harmonised  approach  for  the  controls  and  analyses  of  imports  in  the  EU  was  also 
needed. 

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Member States' perception of the potential impacts of the options 

1. Socio-economic impacts  

1.1 17 MS were able to estimate a socio-economic impact of option 1 on their national CA 
(human  resources,  controls,  etc.).  For  7  MS  of  them,  it  shouldn't  have  a  significant  impact. 
The 10 other MS however estimated that option 1 may result in an increase of the controls at 
EU boarders (as well as in an increase of re-exports and alerts for some MS). 

1.2 Comparing option 1 with option 2, 18 MS were able to estimate a difference in the socio-
economic  impact  on  their  national  CA.  For  6  of  them,  there  was  no  significant  difference 
between  option  1  and  2.  7  MS  answered  that  the  increase  of  controls  on  imports  would  be 
higher  in  option  1  than  in  option  2.  3  MS  finally  estimated  that  controls  on  imports  would 
increase only if certain conditions are not fulfilled by the TC. 

2. Public health impacts 

2.1. 13 MS considered that option 1 would not improve consumer protection whereas 6 MS 
were of the opinion that it would. 8 MS didn't or couldn’t answer. 

2.2. Comparing option 1 with option 2, 20 MS were able to estimate an impact of mandatory 
minimum  control  frequencies  in  the  TCs'  control  programmes  on  consumer  protection.  For 
the majority of these MS (18), option 2 would result in a higher consumer protection. For 
1 MS, both options would increase consumer protection and for 1 MS both options were not 
sufficiently strong as regards consumer protection. 

3. Administrative burden impacts on national competent authorities 

3.1. 13 MS estimated that option 1 would increase the administrative burden for their national 
competent authority (mainly because of increased controls of imports at boarders/in MS). On 
the  contrary  10  MS  were  of  the  opinion  that  the  burden  would  not  change.  4  MS  didn't  or 
couldn't answer.  

3.2. Comparing option 1 with option 2, 18 MS were able to estimate an impact of mandatory 
minimum control frequencies in the TCs' control programmes on the administrative burden of 
their  competent  authority.  For  8  of  them,  there  would  be  no  significant  difference  between 
options  1  and  2.  7  other  MS  estimated  that  the  burden  would  be  lower  in  case  of  option  2 
(because of less controls and less non conformities detected). 

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Annex XXI: DIRECTIVE 96/23/EC - Costs reductions relating to the 
repeal of Directive 96/23/EC on controls of certain substances 
(veterinary medicinal products (VMPs), contaminants, residues of 
pesticides) and residues thereof in live animals and animal 
products 

In the MS' replies to the consultation162, the average cost per sample for laboratory analysis 
only ranged: 

-  

from €41 to €265 when considering all 17 MS having transmitted exploitable data,  

from  €120  to  €210  when  considering  12  out  of  the  17  MS  having  transmitted 

-  
exploitable data. 

In this study, it is thus assumed that the EU average cost per sample for laboratory analysis 
only is €165. 

Furthermore, in their answers, the average total cost per sample including all expenses (staff, 
laboratories, consumables, overheads, etc.) ranged: 

-  

from €62 to €436 when considering all 18 MS having transmitted exploitable data,  

from  €150  to  €350  when  considering  16  out  of  the  18  MS  having  transmitted 

-  
exploitable data. 

In  this  study,  it  is  thus  assumed  that  the  EU  average  total  cost  per  sample  for  laboratory 
analysis is €250. 

Changes under consideration:  

(a) 

Deletion  of  the  overlaps  resulting  from  the  implementation  of  Directive 
96/23/EC  and  the  specific  EU  contaminants  legislation  (Regulations  (EC) 
N°315/93 and N° 1881/2006) i.e. repeal of the requirements on official controls 
on contaminants currently laid down in Directive 96/23/EC so that Regulation 
(EC) No 882/2004 and the existing specific EU contaminants legislation would 
only apply (sampling only based on risk assessments) 

Financial impact:  

Based on the results of the consultation of the Member States (MS), the decrease of 
the number of samples taken to test for the presence of contaminants is assumed to 
range between – 10 % and – 60 %.  As in 2009 45 014 samples were analysed under 
Directive  96/23/EC  for  contaminants  (i.e.  for  sub-groups  B3a    organochlorine 
compounds  including  PcBs,  B3b  organohosphorus  compounds,  B3c  chemical 
elements, B3d mycotoxins, B3e dyes and B3f "others" of Annex I of the Directive), 
the  decrease  would  range  from  4  501  to  27  008  samples.  Based  on  these 
assumptions, the decrease in costs would range: 

-  

from €743 000 to €4 456 000 when considering the average cost per sample for 
laboratory analysis only, 

162  
Revision of Directive 96/23/EC on measures to monitor certain substances and residues thereof in live 
animals and animal products: consultation of the competent authorities in the Member States on the impacts of 
the different options 08/02/2011 

EN 

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-  

from  €1  125  000  to    €6  752  000  when considering the average total cost per 
sample for laboratory analysis 

(b) 

Deletion  of  the  overlaps  resulting  from  the  implementation  of  Directive 
96/23/EC  and  the  specific  EU  pesticide  residues  legislation  (Regulation  (EC) 
N°396/2005)  i.e.  repeal  of  the  requirements  on  official  controls  on  residues  of 
pesticides currently laid down in Directive 96/23/EC so that Regulation (EC) No 
882/2004  and  the  existing  specific  EU  pesticides  legislation  would  only  apply 
(national sampling only based on risk assessments). 

Financial impact:  

Based  on  the  results  of  the  consultation  of  the  MS,  the  decrease  of  the  number  of 
samples taken to test for the presence of  residues of pesticides is assumed to range 
between  –  2  %  and  –  100  %.    As  in  2009  32  796  samples  were  analysed  under 
Directive  96/23/EC  for  residues  of  pesticides  (i.e.  for  sub-groups  B2c  carbamates 
and  pyrethroids,  B3a  organochlorine  compounds,  B3b  organophosphorus 
compounds and B3f "others" of Annex I of the Directive), the decrease would range 
from  655  to  32  796  samples.  Based  on  these  assumptions,  the  decrease  in  costs 
would range: 

-  

-  

from €108 000 to €5 411 000 when considering the average cost per sample for 
laboratory analysis only, 

from  €164  000  to    €8  199  000  when  considering  the  average  total  cost  per 
sample for laboratory analysis 

(c) 

Repeal  the  current  prescriptive  harmonisation  of  the  modalities  for  control 
planning  laid  down  in  Directive  96/23/EC  (mandatory  minimum  numbers  of 
samples)  and    MS'  controls  (and  sampling)  according  to  their  own  risk 
assessments  

Financial impact:  

Based  on  the  results  of  the  consultation  of  the  MS,  the  decrease  of  the  number  of 
samples taken is assumed to range between – 10 % and – 75 %. As in 2009 a total of 
445 968 samples were analysed under Directive 96/23/EC, the decrease would range 
from 44 597 to 334 476 samples. Based on these assumptions, the decrease in costs 
would range: 

-  

-  

from €7 358 000 to €55 188 000 when considering the average cost per sample 
for laboratory analysis only, 

from €11 149 000 to €83 619 000 when considering the average total cost per 
sample for laboratory analysis. 

(d) 

Repeal  the  current  prescriptive  harmonisation  of  the  modalities  for  control 
planning  laid  down  in  Directive  96/23/EC  (mandatory  minimum  number  of 
samples), MS' controls (and samplings) according to their own risk assessments 
and  definition  of  EU  harmonised  uniform  control  modalities  for  certain 
substances  or  groups  of  substances  and/or  certain  combinations  animal(s)  or 
product(s) and substance(s) established in case of specific "intrinsic" risks (e.g. 

EN 

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growth  promoters)  or  other  risks  that  would  justify  the  introduction  of 
minimum  control  frequencies  (or  minimum  number  of  samples)  at  EU  level 
under certain conditions and for certain combinations animal(s) or product(s) 
and substance(s) 

According the answers of the MS to the consultation, the decrease of the number of samples 
taken compared to the current regime would be lower than the ones estimated under (c), as a 
consequence that the decrease in costs would be lower too. 

EN 

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Annex XXII: Directive 96/23/EC – Administrative burden reduction in relation to the repeal of the Directive 

Art. no. 

Description of the 
Information Obligation 
(mainly juridical) 

Target 
group(s) / 
segments 

Total nbr 
of entities 
concerned 

Frequency 
per year 

Additional information on administrative cost 
imposed on public authorities by these 
information obligations 

Directive 
96/23/EC 

5 (1) 

8 (2) 

EN 

By 31 March at the latest 
of the year of the update, 
Member States shall 
submit to the Commission 
any update of plans 
setting out the national 
measures to be 
implemented previously 
approved on the basis of 
the experience of the 
previous years.  
Annual amendments to 
the initial plans 
communicated by the 
Member States shall be 
forwarded by the 
Commission to the other 
Member States once the 
Commission has 
established their 
conformity with this 
Directive.  

Member 
States 

27 

Once a year 

Commission 

1 

Once a year 

ACTIVITIES: Coordination and drafting of the 
changes to the previous plan, changes of the data in 
the application (addition of substances, methods, 
limits, levels, number of analyses, etc), uploading 
the data.  
STAFF REQUIERED: 3 legislators, senior 
officials, managers 
TIME SPENT: 20,000 minutes per MS; 540,000 
minutes for the 27 MS  
COST: € 10,430 per MS; € 281,610 for the 27 MS 

ACTIVITIES: a) Evaluation of the plan, b) 
Submission to the MS 
STAFF REQUIERED: several legislators, senior 
officials, managers     
TIME SPENT: 28 500 minutes 
COST: € 14,863  

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EN 

 
 
 
 
   
 
 
 
 
 
 
  
  
  
 
  
  
  
  
8 (2) 

8 (2) 

If their are no comments 
from Member States (in 
10 working days), the 
amendments to the plans 
should be deemed to be 
approved. The 
Commission shall inform 
the Member States of 
such approval 
immediately.  

Where there are 
comments from Member 
States or where the 
Commission deems the 
update not to be in 
conformity or to be 
insufficient, the 
Commission shall submit 
the updated plans to the 
Standing Veterinary 
Committee, which must 
act under the regulatory 
procedure referred to in 
Article 33 (3).  

Commission 
and MS 

28 

Once a year 

Commission 

1 

Once a year 

MS 
ACTIVITY: Drafting of comments  
STAFF REQUIERED: 1 legislator, senior official, 
manager     
TIME SPENT: 700 minutes per MS; 18 900 for the 
27 MS 
COST: € 365 per MS; € 9,860 for the 27 MS 
COMMISSION 
ACTIVITY: Information of the MS 
STAFF REQUIERED: 1 legislator, senior official, 
manager 
TIME SPENT: 60 minutes  
COST: € 31 

ACTIVITY: Submission of the updated plans to the 
Standing Veterinary Committee 
STAFF REQUIERED: 1 legislator, senior official, 
manager  
TIME SPENT: 900 minutes 
COST: € 469 

EN 

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8 (3) 

8 (3) 

Every six month, Member 
States shall inform the 
Commission and the other 
Member States of the 
implementation of plans 
approved or of the 
development of the 
situation.  

By not later than 31 
March each year, Member 
States shall forward to the 
Commission the results of 
their residue and 
substances detection plans 
and of their control 
measures.  

Member 
States 

27 

Every six 
month 

Member 
States 

27 

Once a year 

ACTIVITY: Creation of data, reportSTAFF 
REQUIERED: 1 academic legislator, senior 
official, managerTIME SPENT: 10,000 minutes per 
MS; 270,000 minutes for the 27 MSCOST: € 5,215 
per MS;  € 140,800 for the 27 MSACTIVITY: 
Transmission to the CommissionSTAFF 
REQUIERED: 1 technician, associate 
professionalTIME SPENT: 120 minutes per MS; 
3,240 minutes for the 27 MSCOST: € 37 per MS; € 
997 for the 27 MS 

ACTIVITY: Creation of data, report 
STAFF REQUIERED: 2 legislators, senior 
officials, managers 
TIME SPENT: 10,000 minutes per MS; 270,000 
minutes for the 27 MS 
COST: € 5,215 per MS;  € 140,800 for the 27 MS 

ACTIVITY: Transmission to the Commission 
STAFF REQUIERED: 1 technician, associate 
professional 
TIME SPENT: 120 minutes per MS; 3,240 minutes 
for the 27 MS 
COST: € 37 per MS; € 997 for the 27 MS 

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EN 

EN 

 
 
 
 
   
 
 
 
  
  
 
8 (3) 

8 (3) 

Member States shall make 
public the outcome of the 
implementation of the 
plans.  

Member 
States 

27 

Once a year 

The Commission shall 
inform Member States, 
within the Standing 
Veterinary Committee, of 
developments in the 
situation in the various 
regions of the 
Community.  

Commission 

1 

Once a year 

ACTIVITY: Creation of data, report 
STAFF REQUIERED: 1 legislator, senior official, 
manager 
TIME SPENT: 3 300 minutes per MS; 89,100 
minutes for the 27 MS 
COST: € 1,720 per MS;  € 46,466 for the 27 MS 

ACTIVITY: Transmission to the Commission 
STAFF REQUIERED: 1 technician, associate 
professional 
TIME SPENT: 120 minutes per MS; 3240 minutes 
for the 27 MS 
COST: € 37 per MS; € 997 for the 27 MS 

ACTIVITY: Information of the MS 
STAFF REQUIERED: legislators, senior officials, 
managers 
TIME SPENT:1 300 minutes 
COST: € 678  

EN 

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EN 

 
 
 
 
   
 
 
 
  
 
  
8 (4) 

8 (5) 

Each year, or whenever it 
deems it necessary on 
public health grounds, the 
Commission shall report 
to Member States within 
the Standing Veterinary 
Committee on the 
outcome of the checks 
and surveys.  

The Commission shall 
send the European 
Parliament and the 
Council a communication 
each year on the results of 
the action taken at 
regional, national or 
Community level, bearing 
in mind the report and 
Member States' comments 
on it.   

COMMISSION: € 
23,759  
27 MS: €  635,175   
per MS: € 23,525 

Commission 

1 

Once  a year 

ACTIVITY: Report to the MSSTAFF 
REQUIERED: 2 legislators, senior officials, 
managerTIME SPENT: 1 300 minutes COST: € 
678 

Commission 
and MS 

28 

Once  a year 

MS 
ACTIVITY: Drafting of comments  
STAFF REQUIERED: 1 legislator, senior officials, 
manager 
TIME SPENT: 900 minutes per MS; 24 300 for the 
27 MS 
COST: € 469 per MS; € 12,673 for the 27 MS 

EC 
ACTIVITY: Preparation and sending of the report  
STAFF REQUIERED: 1 legislator, senior officials, 
manager 
TIME SPENT: 13 500 minutes  
COST: € 7,040  

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EN 

TOTAL 
COST     
(per year)  

EN 

 
 
 
 
   
 
 
 
  
  
 
  
  
 
  
  
Remarks  

1) Source of the "Additional information" column: 
- MS: informal consultation of the Austrian  and UK competent authorities.  
- EC: phone calls to the different EC officials involved in the process.  

2) Method of calculation of the "COST": based on the Calculator of Administrative Costs (AC) & Administrative Burdens (AB) on Public Authorities 
- types of obligation and main actions taken into account 
- cost calculation based on the employee type and the corresponding employee tariff  

3) The employee tariff are based on standardised ESTAT data. They cover both wages and non-wage labour costs for 9 different types of activities and for all 27 
Member States.  
They reflect 2006 prices and include a standard proportion of so-called overheads costs (i.e. 25%) linked with individual employees and borne by businesses but not 
included in their salaries (fixed administration costs such as premises, telephone, heating, electricity and IT equipment). 

EN 

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Annex XXIII: Main changes to the existing legislative framework 
under the options included in the analysis 

This  Annex  gives  an  overview  of  the  main  changes  to  the  existing  legislative  framework 
implied by each of the options included in the analysis of this IA.  

As regards the legislative technique, while the changes under Option 1 will be introduced by 
a  Regulation  amending  Regulation  882/2004,  under  Options  2  to  4,  the  changes  would  be 
introduced  either  through  a  legislative  act  amending  Regulation  882/2004  and  repealing 
relevant sectoral legislation or by an act which repeals and replaces Regulation 882/2004 and 
repeal relevant sectoral legislation. 

Option 1A – Repeal Union rules on control fees 

(Existing  mandatory  inspection  fees  are  repealed  (other  provisions  of  the  legislative 
framework remain unchanged) 

The  provisions  of  Articles  27-29  of  Regulation  882/2004,  which  prescribe  the  scope  and 
level of mandatory fees for official controls, will be repealed leaving only the requirement 
on MS that they ensure a level of resources necessary to allow the correct implementation 
of control requirements and efficient enforcement of EU law, currently laid down in Article 
26 of the Regulation. 

Option 1B - Mandatory exemption of micro-enterprises from the application of fees  

(Existing  mandatory  inspection  fees  are  maintained  but  not  applied  to  micro-enterprises; 
other provisions of the legislative framework remain unchanged) 

This  Option  would  provide  for  the  mandatory  exemption  of  micro-enterprises  from  the 
application  of  mandatory  fees  and  would  require  the  breadth  of  operators  upon  which 
mandatory  fees  are  levied  to  be  appositely  restricted.  For  the  rest,  Option  1B  would 
maintain the current framework as it stands now.  

Option 2 – Streamline 

(The  legislative  framework  is  improved  and  streamlined,  full  cost  recovery  is  ensured 
where mandatory fees are already provided) 

Scope  

(a)  a  new  provision  will  be  introduced  to  explicitly  cover  official  activities  performed  by 
the  competent  authority  not  directly  linked  to  ensuring  compliance  by  operators  (e.g. 
surveillance  and  monitoring  of  sanitary  status,  surveying  in  view  of  planning  control 
activities);  

(b)  the  definitions  of  'surveillance',  'monitoring'  and  'survey'  currently  laid  down  in 
Regulation 882/2004 will be aligned with those included in the sectoral legislation; 

Language and terminology 

The  language  and  terminology  used  throughout  the  Regulation  will  be  amended  to  fully 
account for all sectors included under its scope, including animal health and animal welfare 

EN 

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legislation, and specific food legislation such as the rules governing food contact material, 
and the ones governing the release in the environment of genetically modified organisms. 

Methods of sampling and analysis 

The cascade of methods currently in Article 11 of Regulation 882/2004 will be structured 
more clearly. It will also be clarified that business operators have the right to apply for a 
supplementary expert opinion which can take several forms, inter alia, where technically 
possible and relevant, the one of a second sampling (adjustments for sectoral specificities 
in the animal health areas will be provided). 

Official laboratories 

(a)  The  provisions  currently  laid  down  in  Article  12  of  Regulation  882/2004  will  be 
clarified to clearly state that all the methods used for analysis or diagnosis by a laboratory 
when operating as an official laboratory shall be included in the scope of accreditation of 
this laboratory; and that the scope of accreditation can comprise one or several methods. 

(b) The possibility of temporary designations by the competent authority of laboratories not 
yet having the required method in their scope of accreditation will be introduced for following 
cases: 

- 

the use of the method is a recent requirement in Union legislation, 

-  changes of the method in use require a new accreditation or an extension of the scope of 

the accreditation of the laboratory, 

-  an emergency situation occurs and the sudden increase of analytical or diagnostic needs 
requires the urgent use of a validated or standardised method by official laboratories, 

-  an emerging risk requires the performance of analysis or diagnosis by official laboratories 

for which no standardised nor validated method exists (e.g. emerging risks). 

(c)  An  empowerment  for  the  Commission  to  grant  permanent  derogations  to  the  mandatory 
accreditation  according  to  EN  ISO  17025  for  small  sized  laboratories  attached  to  business 
operator's premises will be introduced. 

(d)  In  order  to  take  into  account  specific  characteristics  of  the  animal  health  sector,  an 
empowerment  for  the  definition  of  exemptions  to  the  general  rule  that  all  the  methods  or 
protocols  used  for  analysis  or  diagnosis  by  an  official  laboratory  shall  be  included  in  the 
scope of accreditation, will be created. 

Official controls for animal health purposes 

(a) Repeal of Directives 89/662, 90/425, 96/93, 89/609. 

(b) Account in the Regulation for certain specificities of this sector that is: 

- 

- 

the delegation of official control tasks to individuals (i.e. approved veterinarians); 

the  obligation  for  the  MS  competent  authorities  to  ensure  that  animals  and  animal 
products  and  products  of  animal  origin  intended  for  dispatch  to  another  Member  State, 
and for which official certification is required by Animal Health Law, are controlled at the 
place of origin prior to dispatch to another Member State. 

Border controls on goods from third countries  

(a)  Repeal  Directives  97/78/EC  and  91/496/EEC  and  Article  15(5)  of  Regulation  (EC)  No 
882/2004. 

(b)  Establish  a  new  set  of  rules  to  govern  a  single  system  of  border  controls  capable  of 

EN 

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  EN 

 
 
 
handling live animals and their products, food and feed of non animal origin and other goods 
of relevance for the food chain (e.g. food contact materials). Such rules will be the result of 
streamlining  existing  legislation.  The  single  and  streamlined  system  of  border  controls  will 
consist of the following elements (for which detailed uniform implementation modalities will 
be provided by the Commission through the use of implementing/delegated powers): 

- 

- 

- 

the categories of goods that require controls prior to their entry into the EU are explicitly 
listed,  with  an  empowerment  to  determine  the  specific  goods  which  need  to  undergo 
border import controls (CN codes will be indicated as far as possible); 

the type and frequency of border controls are harmonised and based on risk criteria. The 
mechanism  for  the  continuous  adjustment  of  control  rates  are,  on  the  basis  of  risk 
assessments, rates applied to specific commodities is established by delegated acts.  

the current Border Inspection Posts and Designated Points of Entry are replaced by border 
posts  potentially  capable  of  carrying  out  controls  on  all  commodities.  Such  entities  are 
subject to a single set of rules and requirements to ensure consistency of practices; 

-  similarly,  the  various  health  entry  documents  currently  enshrined  in  legislation  (e.g. 
Common Veterinary Entry Document, Common Entry Document) are replaced by a single 
harmonised model for all commodities (with necessary adjustments).  

(c) Introduction of provisions to strengthen and specify the modalities of cooperation between 
competent  sanitary  authorities  designated  under  Regulation  882,  customs  services  and  other 
relevant  authorities.  The  objectives  and  minimum  requirements  of  such  cooperation  will  be 
established:  e.g.  type  of  information  to  be  shared  between  sanitary  and  customs  authorities, 
timing and modalities of it, possibility to delegate certain tasks etc, in view of optimising the 
synchronisation  of  parallel  processes  on  the  same  goods  and  maximising  efficiency  gains. 
Similarly,  the  possibility  of  delegating  certain  tasks  to  non  sanitary  authorities  will  be 
introduced  (e.g.  controls  on  passengers'  luggage163),  and  vice  versa  the  possibility  that 
controls on non food chain issues be delegated to staff of the sanitary authorities present at the 
borders (e.g. border controls for the presence of invasive alien species).  

(d) Introduction of a provision for the competent authorities designated under Regulation 882 
to be tasked by national authorities responsible for Invasive Alien Species (IAS) with carrying 
out border controls to verify the presence of IAS in the interest of efficiency, coherence and 
transparency with the border control system. 

(e) Empowerments to adopt delegated / implementing acts to address technicalities of specific 
sectors are foreseen 

Information management and handling system for official controls (TRACES+) 

An  empowerment  to  upgrade  the  IT  tools  at  the  disposal  of  the  Commission  and  Member 
States  would  also  appear  necessary  under  this  option  in  order  to  guarantee  full  efficiency 
gains.  In  particular,  TRACES  would  need  to  be  geared  to  deal  with  all  commodities, 
including plants and plant products, and would be modified to  deal  with all import controls 
and documents, including the said harmonised entry document. Moreover, the interoperability 
and integration of TRACES with other Commission and Member State IT tools would need to 
be  developed  so  as  to  ensure  a  proper  and  rapid  exchange  of  information  at  defined  levels 
with  other  competent  authorities.  Finally,  in relation  to  TRACES  itself,  a  legal  basis  would 
need to be foreseen for full electronic certification including the use of e-signatures so as to 
guarantee more efficient and safe import procedures. 

163  Currently,  the  possibility  for  sanitary  authorities  to  delegate  controls  on  passengers'  luggage  to  customs 
services exists only in the animal health area.  

EN 

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Official certification 

Streamline  the  requirements  currently  laid  down  in  Article  30  of  Regulation  882/2004  with 
those of Directive 96/93 and repeal the latter.  

Empowerments  

In  addition  to  the  empowerments  mentioned  in  other  sections,  the  review  will  seek  to 
introduce  appropriate  delegated  or  implementing  powers  for  the  Commission  in  those  cases 
where the absence of uniform modalities for the application of the Regulation's provision is a 
potential source of under enforcement. Examples are:   

(a)  Empowerments  for  the  adoption  of  delegated/implementing  acts  establishing  minimum 
requirements  and  mechanisms  for  cooperation  amongst  liaison  bodies  for  the  purpose  of 
improving the administrative assistance and cooperation amongst MS. 

(b) Empowerment to introduce template for annual reports 

(c)  Empowerments  to  adopt  delegated/implementing  acts  to  provide  for  uniform  minimum 
requirements of the transparency provisions. 

Official controls on residues of veterinary medicines  

Repeal Directive 96/23/EC so that: 

-  for  environmental  contaminants,  only  Regulation  (EC)  N°  882/2004  and  the  existing 
specific EU contaminants legislation would apply (sampling and testing of environmental 
contaminants only based on risk assessments), 

-  for residues of pesticides, only Regulation (EC) N° 882/2004 and the existing specific EU 
residues  of  pesticides  legislation  would  apply  (only the  risk  based  national  control 
programmes as well as the EU coordinated control programme under Regulation (EC) N° 
396/2005 would exist), 

-  for  residues  of  veterinary  medicines,  only  Regulation  (EC)  N°  882/2004 as  well  as 
eventual implementing/delegated acts imposing minimum levels of mandatory controls in 
the MANCPs in cases where the nature of the risks involved requires a uniform minimum 
frequencies of controls across the EU would apply,  

-  only specific import conditions determined under the common regime of Regulation (EC) 
No 882/2004 would apply (third countries would have to provide information and data on 
legislation, control plans for testing residues of veterinary medicines providing guarantees 
at least equivalent to the ones provided by the minimum uniform frequencies of controls 
in the EU, etc.), 

-  only Article 54 of Regulation (EC) N° 882/2004 on enforcement measures would apply. 

Financing of official controls 

The  list  of  mandatory  fees  currently  laid  down  in  Regulation  882/2004  will  remain 
unchanged. Some changes will be introduced to improve the legislative framework. 

(a) - Cost recovery 

The following requirements will be introduced  

1.  where  fees  are  mandatory  Member  States  shall  establish  fees  on  the  basis  of  costs 

incurred for the control activities; 

2.  fees  shall  be  established  at  a  level  such  that  they  enable  CA  to  fully  recover  their 

costs; 

EN 

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3.  where fees are levied on all operators irrespective of whether the operator receives an 
inspection  during  the  reference  period,  Member  States  shall  set  up  a  system  that, 
taking into account the record of compliance of each operator, establishes higher fee 
rates for less compliant businesses;  

4.  the Annexes IV and V to Regulation 882/2004, which currently set standard/minimum 

fees will be repealed. 

(b) - Clearer costing 

1.  Control activities which an operator should be charged for will be specifically listed as 

follows: 

-  controls on slaughter, cutting operations and cold storage of meat, production and 

placing on the market of fishery products, and milk production; 

-  controls carried out to grant feed establishments approval; 

-  controls  carried  out  at  a  border  on  consignments  of  live  animals  and  their 

products,; certain food and feed of non animal origin 

2.  The  list  of  elements  to  be  included  in  the  calculation  of  overall  costs  will  be  better 

defined. 

(c) Transparency 

The  requirements  on  MS  to  inform  operators  and  the  public  of  how  control  costs  are 
established and fees calculated will be re-enforced by specifying the elements of information 
to be made publicly available. Such element shall include in particular: 

•  Overall cost of official control activity 

•  Breakdown per cost element (direct and indirect) 

•  Level of fee applied on operator 

•  Reference period used for calculation of costs (e.g. in case of flat rate) 

(d) Micro-enterprises  
MS  will  be  provided  with  the  possibility  to  (partly  or  totally)  exempt  micro-enterprises164 
from the payment of fees, provided that the exemption does not result in an equivalent cut in 
the  resources  necessary  to  CA  for  the  performance  of  official  controls.  In  other  words,  the 
exemption shall be compensated by the allocation to CA of additional resources equivalent to 
the difference between the cost of controls and the fees collected165. 

(e)  A  transition  period  of  2  years  will  be  provided  for  the  smooth  introduction  of  the  all 
provisions governing the financing of official controls.  

164 Enterprises with less than 10 employees and a turnover or balance sheet total equal or less than €2 million. 
165 The option of requiring MS to exempt all micro-businesses from payment of mandatory fees was discarded. 
See section 4.2. (Discarded policy options). With regard to Plant Health, exemptions for micro-enterprises will 
not apply given that most operators under these health regimes could qualify as micro-businesses; the new plant 
health  legislation  will  foresee  specific  exemptions  from  plant  passporting  obligations  for  small  companies 
operating exclusively on the local market (see Impact assessment report on "the proposal to revise the EU Plant 
Health  Legislation"). With  regards  to plant  reproductive material,  whether or not  exempting  micro-business  is 
still under consideration in the context of the ongoing IA.  

EN 

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Option 3 – Streamline + Integrate 

(The  legislative  framework  is  improved  and  streamlined,  plant  health  and  plant 
reproductive material, and animal by-products are included in its scope, full cost recovery 
is ensured where mandatory fees are already provided) 

In addition to changes described under option 2, option 3 would imply the following changes. 

Scope  

(a)  the  provision  designing  the  scope  of  the  Regulation  will  fully  include  plant  health  law, 
plant  reproductive  material  and  legislation  governing  animal  by-products;  as  a  consequence 
all provisions of the Regulation, streamlined and amended following option 2, will apply to 
official  controls  (including  border  controls  and  communication  with  customs)  and  other 
official  activities  not  directly  linked  to  ensuring  compliance  as  regards  these  sectors  unless 
otherwise provided. 

(b) following the repeal of Directive 2000/29 and the 12 PRM marketing Directives, the new 
Regulations on plant health and plant reproductive material will no longer include horizontal 
issues covered under Regulation 882/2004  

(c)  repeal  of  official  controls  provisions  laid  down  in  Regulation  1069/2009  (animal  by-
products Regulation) 

Language and terminology 

The  language  and  terminology  used  throughout  the  Regulation  will  be  amended  to  fully 
account for the new sectors included under its scope. 

Official laboratories carrying out plant health tests  

(a) determine tailor-made obligations for the accreditation of official laboratories carrying out 
plant  health  tests  (accreditation  only  for  limited  numbers  of  pests  representative  for  pest 
groups); 

(b) provide for a five years transitional period to allow smooth introduction of the obligation 
to accredit official laboratories in charge plant health tests; 

(c) provide for a permanent derogation for universities and research centres in the plant health 
and plant reproductive material sectors; 

(d) introduce the possibility to establish a system of EU and national reference laboratories. 

Official certification 

(a) amend the definition of 'official certification' to include the official certification issued by 
operators under the supervision of the competent authority; 

(b)  amend  Article  30  of  Regulation  (EC)  No  882/2004  to  foresee  the  possibility  for  the 
operators to issue the certification under the supervision of the competent authority, without 
prejudice of more specific legislation; 

(c)  specificities  of  certification  will  be  provided  in  the  sectoral  Regulations  on  plant  health 
and plant reproductive material.  

Financing of official controls 

The list of mandatory fees will remain as under Option 2 with the only exceptions being in the 
field of plant health, where mandatory fees will be introduced for official controls linked to 

EN 

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plant  passport  obligations166,  and  in  the  field  of  plant  propagating  material,  where  the 
principle  of  full  cost  recovery  through  fees  will  be  established  for  certification  and 
registration of varieties.167 

Option 4 – Streamline + Integrate + Broader cost recovery 

(The legislative framework is improved and streamlined, plant health and plant reproductive 
material, and animal by-products are included in its scope, and mandatory fees are extended 
to cover key areas of the food chain)  

In addition to the elements of option 3, option 4 would imply the following changes. 

(a) the list of mandatory fees will be expanded so as to also cover official controls carried out 
on activities for which an obligation for operators to be registered exists in accordance with 
Regulation  (EC)  No  852/2004  on  the  hygiene  of  foodstuffs  and/or  Regulation  (EC)  No 
183/2005 laying down requirements for feed hygiene. In addition, a fee will be required for 
all border controls on goods from third countries carried out to ascertain compliance with EU 
food chain requirements. 

This  option  would  imply  that,  in  addition  to  the  list  of  mandatory  fees  under  Option  3, 
Member  States  should  ensure  that  a  fee  is  collected  to  cover  the  costs  generated  by  official 
controls in the following cases: 

•  production  of  food  other  than  meat,  fishery  products  and  milk  -  these  being  already 
included; that is: eggs and egg products, honey and all foods of non animal origin. 

•  distribution (including wholesale, retail and restaurants) of all food; 

•  production and distribution (including wholesale and retail) of feed; 

•  production  and  distribution  of  ABP  in  so  far  as  the  concerned  operators  have  to  be 

registered under Regulation (EC) No 852/2004 or Regulation (EC) No 183/2005; 

• 

import  of  products  originating  from  third  countries  that  need  to  be  checked  at  the 
border other than those already covered by a mandatory fee (for example products subject 
to a safeguard measure). 

(b)  A  transition  period  of  3  years  will  be  provided  for  the  smooth  introduction  of  all 
provisions governing the financing of official controls. 

166 See Impact Assessment report on the proposal to revise the EU Plant Health Legislation. 
167  See  Impact  Assessment  report  on  the  placing on  the  market  and  production, with  a  view  to  placing  on  the 
market, of plant reproductive material 

EN 

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Annex XXIV- Simplification gains 

Title 

Description 

Option 1 

Expected impact 

1.   Council Directive 89/662/EEC of 11 December 
1989  concerning  veterinary  checks  in  intra-
Community trade with a view to the completion 
of the internal market 

2.  Council Directive 90/425/EEC of 26 June 1990 
concerning  veterinary  and  zootechnical  checks 
applicable in intra- Community trade in certain 
live  animals  and  products  with  a  view  to  the 
completion of the internal market 

3.   Council  Directive  96/93/EC  of  17  December 
1996 on the certification of animals and animal 
products 

This Directive deals with official controls carried out to verify 
compliance with animal health requirements in intra- EU trade, 
with a view to the completion of the internal market.  

Repealed because it overlaps with Regulation 
882/2004  

the  application  of 

for 
legislation  will  be 

the 
repealed 
they  overlap  with  Regulation 

Provisions 
veterinary 
because 
882/2004. 
Provisions regarding the zootechnical aspects 
will remain untouched.  

Repealed  and  streamlined  with  the  pertinent 
provisions of Regulation 882/2004  

This  Directive  lays  down  rules  relating  to  veterinary  and 
zootechnical checks to be applied to live animals and products 
of  animal  origin  for  intra-Community  trade.  This  legislation 
abolishes  veterinary  and  zootechnical  checks  at  the  Union's 
internal borders and reinforces those carried out at the point of 
origin, during transit and at the place of destination. 

This  Directive  defines  the  prescriptions  to  be  respected  when 
drafting, submitting and executing national residue monitoring 
plans for live animals and products of animal origin as well as 
specific  enforcement  measures  in  case  of  non  compliances  by 
food  businness  operators,  the  requirements  for  third  countries 
being  essentially  the  same  as  for  Member  States.  A  principal 
objective of Council Directive 96/23/EC is to detect illegal use 
of  substances  in  animal  production  as  well  as  detecting  the 
misuse of authorised veterinary medicinal products. Apart from 
residues  of  veterinary  medicines,  the  Directive  covers  also 
several  residues  of  pesticides  and  several  environmental 
contaminants  among  the  group  of  substances  to  be  controlled 
within the framework of the national residues monitoring plans. 

EN 

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Title 

4.  Council Directive 89/608/EEC of 21 November 
1989  on  mutual  assistance  between 
the 
administrative authorities of the Member States 
and  cooperation  between  the  latter  and  the 
Commission to ensure the correct application of 
legislation  on  veterinary  and  zootechnical 
matters 

Description 
This  Directive  establishes  the  modalities  according  to  which 
Member  States  provide  each  other  with  mutual  assistance  to 
ensure  that  veterinary  and  zootechnical  laws  are  properly 
applied. 

Expected impact 
for 
legislation  will  be 

the 
repealed 
they  overlap  with  Regulation 

the  application  of 

Provisions 
veterinary 
because 
882/2004. 
Provisions 
the 
aspects will remain untouched.  

concerning 

zootechnical 

5.  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 

This  Directive  defines  the  prescriptions  to  be  respected  when 
drafting  and  executing  national  residue  monitoring  plans  for 
live  animals  and  products  of  animal  origin.  A  principal 
objective of Council Directive 96/23/EC is to detect illegal use 
of  substances  in  animal  production  as  well  as  detecting  the 
misuse of authorised veterinary medicinal products.  

Repealed.  Certain  provisions  will  be 
streamlined into Regulation 882/2004.  

6.   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 

This  Directive  sets  out  the  legal  framework  governing  the 
checks to be carried out on products of animal origin from third 
countries at border inspection posts.  

Repealed and replaced by the new chapter on 
import controls of Regulation 882/2004.  

the  principles  governing 

7.   Council Directive 91/496/EEC of 15 July 1991 
laying  down 
the 
organization  of  veterinary  checks  on  animals 
entering  the  Community  from  third  countries 
and 
89/662/EEC, 
90/425/EEC and 90/675/EEC. 

amending  Directives 

The Directive defines the arrangements for the external border 
checks and for the internal movement of live animals from third 
countries.  

Repealed  and  replaced  by  the  chapter  on 
import  conditions  in  Regulation  (EC)  No 
882/2004. 
Delegated / Implementing acts 

EN 

Option 2 

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EN 

 
 
 
 
   
 
 
 
  
 
Title 

8.   Council  Directive  2000/29/EC  of  8  May  2000 
on protective measures against the introduction 
into  the  Community  of  organisms  harmful  to 
plants or plant products and against their spread 
within the Community 

Description 
This Directive lays down measures designed to protect Member 
States  against  the  introduction  of  organisms  harmful  to  plants 
and plant products from other Member States or third countries. 
This  Directive  also  lays  down  measures  designed  to  protect 
Member States against the spread of harmful organisms within 
the European Union 

Expected impact 
Repealed. Regulation 882/2004 will apply for 
the aspects related to official controls. For the 
rest the new Plant Health Law will apply 

9. 

12  Directives  on 
reproductive material 

the  marketing  of  plant 

10.   Regulation (EC) No 1069/2009 of the European 
Parliament  and  of  the  Council  of  21  October 
2009 laying down health rules as regards animal 
by-products  and  derived  products  not  intended 
for 
repealing 
Regulation  (EC)  No  1774/2002  (Animal  by-
products Regulation) 

consumption 

human 

and 

The purpose of the legislation is to safeguard public and human 
health by providing enforceable controls for the safe disposal of 
animal by-products. 

Repealed because redundant  
General principles in Regulation 882/2004 

EN 

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EN 

 
 
 
 
   
 
 
 
  
  
  
Annex XXV: Exemptions and reductions for micro-enterprises 

Regulation  882/2004  requires  MS  to  account  for  the  interests  of  low-throughput  businesses 
when setting fees, as it can be expected that these establishments may be disproportionately 
affected  by  the  charging  of  fees,  by  comparison  with  larger  establishments.    During  the 
consultation  process  for  the  2011  external  study  of  inspection  fees,  the  issue  of  whether 
sufficient consideration is currently given to the needs of SMEs was raised, and in particular, 
to the needs of micro-enterprises168. 

Summary of stakeholder opinions 

Through  the  2011  study,  stakeholders  (CAs  and  industry)  were  asked  to  consider  the 
advantages  and  disadvantages  of  including  fee  exemptions  or  reductions  in  the  revised 
legislation, impacts on the different stakeholder groups, and whether the Regulation should 
provide a universal exemption for micro-enterprises under EU law or provide the option 
for MS to implement reductions or exemptions as they choose. 

For  the  purpose  of  the  2011  external  study  supporting  the  impact  assessment169,  the  definition  of 
"micro-enterprise"  applied  is  that  set  out  in  Commission  Recommendation  2003/361/EC170.    This 
states that a micro-enterprise is a business which has fewer than 10 employees and has: 

•  An annual turnover of not more than €2 million; and / or 

•  A balance sheet of not more than €2 million. 

CA  and  industry  respondents  were  clearly  in  favour  of  the  option  to  have  an  exemption  or 
reduction,  or  to  have  no  special  terms  for  micro-enterprises,  rather  than  to  introduce  a 
universal exemption or reduction. 

CAs and industry recognised that such an amendment would reduce the financial burden on 
micro-enterprises and help to encourage development of small businesses.  Indeed exemptions 
are currently provided to micro-enterprises in 11 Member States (five Member States do not 
offer  such  reductions  or  exemptions  and  information  is  not  available  for  the  remaining  11 
Member States171). 

Industry noted that provisions to reduce the burden on micro-enterprises would be important 
if  Regulation  882/2004  was  to  be  amended  to  achieve  full  cost  recovery  (for  example  by 
better defining the activities subject to mandatory fees and the removal of minimum fees), and 
particularly  in  light  of  the  possibility  to  expand  the  scope  of  mandatory  fees  to  sectors  not 
currently covered, whereby micro-enterprises in a number of sectors would be required to pay 
fees for the first time. 

On  the  other  hand,  several  industry  respondents  expressed  concern  that  fee  exemptions  or 
reductions for micro-enterprises were unfair on those enterprises not subject to exemptions.  It 
was suggested that an effective risk-based system might automatically reduce the costs for the 
best-performing micro-enterprises. 

Both  CAs  and  industry  commented  that  a  universal  exemption  /  reduction  for  micro-
enterprises  would  have  a  negative  impact  or,  at  best,  no  impact  at  all  on  the  sustainable 

168 Annex X 
169 Annex XI 
170 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:124:0036:0041:en:PDF 
171 DG SANCO baseline and Eurostat 2008 

EN 

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performance  of  official  controls.    In  particular,  CAs  voiced  their  concerns  that  a  universal 
exemption / reduction would be likely to have a negative impact on resource mobilisation in 
situations where less fee revenue is collected but the number of controls remains the same, for 
example  in  MS  with  a  large  quota  of  micro-enterprises.  CAs  felt  that  the  fees  charged  to 
micro-enterprises, if at a reduced rate, may not cover the cost of collection. 

These  views,  expressed  by  stakeholders,  are  consistent  with,  and  confirm  the  overall 
conclusion  drawn  in  the  Impact  Assessment  that  it  would  not  be  appropriate  to  introduce  a 
universal  requirement  for  MS  to  exempt  all  micro-businesses  from  payment  of  mandatory 
fees as: (i) stakeholders (businesses and MSs) have opposed a rigidly established mandatory 
exemption (ii) such an exemption would have a disproportionate impact on competition and 
on cost recovery in MS with a large quota of micro-businesses. 

Measure of the impact of a universal exemption / reduction for micro-enterprises 

As highlighted by CAs during consultation (see above) a universal exemption / reduction for 
micro-enterprises would have a disproportionate impact on cost recovery in MS with a large 
quota of micro-businesses. 

Figure 1 demonstrates the number of SMEs as a percentage of the total number of enterprises 
in the major industries affected by official control activities and it can be seen from Figure 2 
(and  broken  down  by  industry  in  Table  2)  that  the  large  majority  of  these  are  micro-
enterprises.    Indeed,  for  16  of  the  23  Member  States  for  which  data  are  available,  micro-
enterprises  represent  more  than  half  of  all  FBOs  in  the  four  major  industries  affected  by 
official controls (for 9 of the 23172, this figure rises to two thirds or more of all enterprises).  
Table 2 demonstrates that the strongest disruption to effective cost recovery would occur for 
official  control  in  the  dairy  products  industry  where  72%  of  all  operators  are  micro-
enterprises.  In Slovakia, only 13% of relevant enterprises are micro-enterprises and potential 
impact  might  be  expected  to  be  smaller,  whereas  in  Sweden,  the  figure  rises  to  80%  and 
potential impact would be expected to be much larger. 

Figure 1. Share of SMEs in total number of enterprises in the four major European industries 
affected by official control activity (2008)* 

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

SMEs

172 AT, BE, CY, FI, IT, NL, PL, SE, SI 

EN 

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  EN 

 
 
 
 
 
 
                                                 
Figure 2 
European industries affected by official control activity (2008)* 

Share  of  Micro-enterprises  in  total  number  of  enterprises  in  the  four  major 

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

*Industry sectors include: processing and preserving of meat and production of meat products; processing and preserving of 
fish, crustaceans and molluscs; manufacture of dairy products; manufacture of prepared animal feeds. Greece and Malta are 
not included in Eurostat dataset. Data for the Czech Republic and France are not available. 

EN 

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Table 2 - Share of micro-enterprises in total number of enterprises in EU MS by sub-sectors 
(2008) 

Processing and 
preserving of meat 
and production of 
meat products 

Processing and 
preserving of fish, 
crustaceans and 
molluscs 

Manufacture of dairy 
products 

Manufacture of 
prepared animal feeds 

Total 

Total  Micro  Share  Total  Micro  Share Total  Micro Share Total  Micro  Share  Total  Micro Share

1,092 

823 

475 

71 

1,467* 

147 

53 

763 

571 

201 

46 

: 

89 

20 

204 

142 

70% 

69% 

42% 

65% 

: 

61% 

38% 

70% 

6 

56 

31 

: 

: 

119 

59 

2 

: 

8 

: 

: 

55 

23 

147 

129 

10,410
* 

: 

: 

496* 

11,044 

6,558 

59% 

233 

: 

: 

11 

15 

33% 

: 

26% 

: 

: 

46% 

39% 

88% 

: 

: 

85% 

22% 

158 

442 

273 

147 

146 

75 

31 

52 

1,457 

401 

100 

59 

117 

373 

125 

127 

: 

49 

11 

29 

: 

74% 

84% 

46% 

86% 

: 

65% 

35% 

56% 

: 

207 

52% 

53 

20 

53% 

34% 

56 

149 

106 

38 

: 

67 

13 

77 

: 

420 

196 

58 

25 

76 

47 

28 

: 

39 

9 

55 

: 

263 

119 

22 

45% 

1,312 

907 

69% 

51% 

1,470 

1,020 

69% 

44% 

74% 

885 

256 

381 

201 

43% 

79% 

: 

1,613 

: 

: 

58% 

69% 

71% 

408 

156 

480 

232 

57% 

63 

40% 

355 

74% 

: 

12,363 

: 

: 

63% 

12,098 

7,028 

58% 

61% 

38% 

901 

318 

517 

57% 

83 

26% 

592 

133 

334 

56% 

26 

20% 

3,559 

2,495 

70% 

128 

176 

27 

62 

69 

14 

48% 

39% 

52% 

491 

325 

66% 

3,283 

2,134 

65% 

633 

909 

72 

382 

532 

17 

60% 

59% 

24% 

163 

110 

67% 

4,153 

2,771 

67% 

13 

68 

442 

108 

66 

0 

115 

410 

211 

41 

8 

5 

689 

214 

343 

494 

367 

545 

74% 

53% 

UK 

1,035 

277 

63% 

3,295 

2,469 

75% 

579 

365 

63% 

7,875 

5,606 

71% 

36 

37 

0 

64 

280 

112 

25 

3 

2 

356 

180 

189 

33% 

56% 

0% 

56% 

68% 

53% 

61% 

38% 

40% 

42 

69 

5 

258 

718 

439 

633 

38 

87 

15 

46 

1 

206 

467 

345 

413 

3 

77 

36% 

67% 

20% 

80% 

65% 

79% 

65% 

8% 

89% 

52% 

1,462 

1,168 

80% 

84% 

55% 

127 

543 

108 

357 

85% 

66% 

16 

25 

0 

182 

461 

128 

128 

60 

16 

837 

100 

426 

8 

10 

0 

96 

50% 

40% 

0% 

294 

336 

32 

121 

162 

15 

41% 

48% 

47% 

53% 

1,046 

691 

66% 

343 

74% 

4,872 

3,224 

66% 

52 

88 

: 

9 

: 

41% 

1,411 

891 

63% 

69% 

1,711 

1,058 

62% 

: 

56% 

178 

271 

23 

13% 

198 

73% 

: 

7,141 

4,295 

60% 

91 

91% 

935 

746 

80% 

263 

62% 

2,347 

1,354 

58% 

AT 

BE 

BG 

CY 

CZ 

DK 

EE 

FI 

FR 

DE 

HU 

IE 

IT 

LV 

LT 

LU 

NL 

PL 

PT 

RO 

SK 

SI 

ES 

SE 

Total 

29,757
** 

18,573 

62% 

3,095*
** 

1,804 

58% 

9,454*
* 

6,786 

72% 

3,241 

2,008 

62% 

60,709  29.171 

48% 

Source: Eurostat.  *2007 figure  ** Sum does not include CZ and FR.  *** Sum does not include BE, FR, DE 
GR and MT are not included in Eurostat dataset 
Figures in Total column includes all available data 

Despite  the  large  share  of  total  enterprises  attributed  to  micro-enterprises  within  the  sectors 
most  affected  by  official  control  activities,  their  share  of  the  total  turn-over  within  their 
respective  MS  is,  by  comparison,  low.    Table  3  illustrates  that  in  all  but  one  MS  (Cyprus) 
share of total turn-over attributed to micro-enterprises is less than 10% (and for 17 MS it is 
5%  or  less).    This  re-enforces  the  fact  that  a  very  low  turn-over  of  individual  micro-
Page 251/253 

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enterprises by comparison with larger operators in these sectors, makes the relative impact of 
fees for official controls disproportionately greater. 

Table 3 Share of micro-enterprises' sectoral turnover in total sectoral turnover in EU MS (2008) 
(absolute figures in millions of euros) 
Processing and 
preserving of meat and 
production of meat 
products 

Processing and 
preserving of fish, 
crustaceans and 
molluscs 

Manufacture of 
prepared animal feeds 

Manufacture of dairy 
products 

Total* 

Total  Micro  Share 

Total  Micro  Share  Total  Micro  Share 

Total  Micro  Share 

Total  Micro 

3,276 

5,267 

897 

325 

: 

5,374 

246 

2,499 

244 

454 

33 

26 

: 

76 

10 

49 

Sha
re 

7% 

9% 

4% 

8% 

: 

32 

482 

30 

: 

: 

1% 

1,761 

4% 

2% 

124 

160 

35,750 

3,597 

10% 

3,140 

39,522 

1,720 

4% 

2,533 

: 

0 

1 

: 

: 

51 

15 

33 

: 

: 

1 

: 

: 

2% 

: 

: 

3% 

12% 

20% 

: 

: 

2,394 

4,241 

372 

234 

: 

0 

383 

0 

61 

153 

: 

27 

: 

: 

: 

: 

3% 

4% 

: 

11% 

: 

: 

: 

: 

900 

: 

3,259 

297 

147 

136 

: 

2,973 

67 

439 

6 

68 

: 

59 

4 

36 

26,780 

2,907 

11% 

11,978 

812 

27,593 

69 

11 

32 

8,882 

158 

926 

1,082 

47 

53 

: 

9% 

4% 

6,602 

13,248 

1,445 

305 

904 

40 

5% 

7% 

3% 

50% 

695 

121 

17% 

: 

2% 

7% 

8% 

7% 

2% 

5% 

5% 

: 

: 

10,109 

185 

820 

3,098 

30 

117 

77,648 

7,316 

78,529 

1,946 

4,680 

9,287 

168 

129 

2,645 

4,275 

109 

31 

4% 

1% 

3 

32% 

1,106 

373 

14 

4% 

3,556 

19,153 

1,251 

7% 

2,114 

309 

15% 

17,423 

1,589 

375 

615 

116 

8,248 

11,800 

2,199 

2,481 

703 

670 

9 

9 

4 

267 

487 

94 

63 

16 

30 

2% 

1% 

3% 

3% 

218 

232 

0 

: 

3 

5 

0 

: 

1% 

2% 

: 

: 

4% 

1,442 

52 

4% 

4% 

1,093 

3% 

2% 

5% 

68 

56 

15 

: 

2 

1 

: 

: 

3% 

2% 

: 

349 

856 

0 

9,642 

6,064 

1,703 

1,053 

585 

316 

2 

1 

: 

95 

96 

58 

33 

: 

6 

19,637 

1,414 

7% 

4,160 

178 

4% 

10,659 

817 

3,502 

16,624 

218 

276 

6% 

: 

2% 

2,981 

89 

64 

: 

2% 

2,752 

9,609 

53 

144 

0% 

1% 

1% 

9% 

1% 

0% 

: 

1% 

2% 

3% 

3% 

: 

2% 

8% 

2% 

1% 

6,000 

579 

10% 

44,691 

3,728 

51 

339 

0 

7,219 

2,947 

: 

233 

233 

98 

9,852 

: 

: 

0 

222 

117 

98 

2 

: 

: 

: 

: 

: 

: 

3% 

4% 

: 

1% 

: 

: 

: 

993 

2,042 

116 

25,109 

22,253 

4,995 

3,834 

1,576 

1,099 

13 

14 

4 

584 

752 

249 

101 

17 

36 

44,308 

2,408 

698 

77 

11% 

6,951 

5,880 

247 

4% 

35,092 

438 

731 

: 

2% 

4% 

4% 

9% 

2% 

4% 

1% 

8% 

1% 

1% 

3% 

2% 

3% 

5% 

3% 

1% 

3% 

5% 

6% 

2% 

AT 

BE 

BG 

CY 

CZ 

DK 

EE 

FI 

FR 

DE 

HU 

IE 

IT 

LV 

LT 

LU 

NL 

PL 

PT 

RO 

SK 

SI 

ES 

SE 

UK 

Total 

186,197 

10,484 

6% 

13,722 

729 

5% 

126,913 

6,151 

5% 

52,865 

2,784 

5% 

399,220 

20,335 

5% 

*Figures in Total column includes all available data 

EN 

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Annex XXVI: The development of an EU dedicated legislative 
instrument to tackle Invasive Alien Species – potential synergies 
with the revision of the rules on border control 

Invasive  alien  species  (IAS)  are  animals  and  plants  that  are  introduced  accidentally  or 
deliberately outside of their natural past or present distribution. They represent a serious threat 
to  biodiversity  in  Europe,  as  well  as  to  plant  health  (e.g.  agricultural weeds),  to  animal  and 
human  health  (e.g.  disease  transmitting  insects,  allergenic  weeds,  poisonous  species)  and  to 
the  economy  (e.g.  blocking  drainage  systems),  causing  millions  of  euro  worth  of  damage 
every year.  
The  Commission  published  a  Communication173  "Towards  an  EU  Strategy  on  Invasive 
Species" in December 2008 and noted that there is currently no comprehensive instrument at 
EU level to tackle IAS, except for some aspects of the problem which are addressed by the 
plant and animal health regimes.  
As announced in its EU 2020 biodiversity strategy174, the European Commission is currently 
developing a dedicated legislative instrument to tackle outstanding challenges relating to IAS 
prevention,  early  detection  and  rapid  response  and  containment  and  management,  beside 
seeking to streamline biodiversity concerns into the existing legal instruments of the animal 
and  plant  health  regimes.  The  dedicated  instrument  on  IAS  is  expected  to  close  the  policy 
gaps, not yet addressed by the EU animal and plant health regimes, including a mechanism to 
control the import of listed IAS.  

Possible synergies between Regulation 882 and the forthcoming IAS legal instrument 

In the interest of efficiency and clarity, border controls on the import of listed IAS could be 
performed  at  the  same  entry  points  designated  for  other  EU  official  border  controls  as 
established  by  Regulation  882,  carried  out  to  apply  the  plant  and  animal  health  legislation. 
This would avoid creating a parallel system of border controls but would take advantage of a 
well functioning system with limited extra investment, mainly limited to extra staff resources 
and training, as well as increased collaboration with the designated competent authorities. 

A  provision  in  Regulation  882  could  allow  that  the  competent  authorities  designated  by 
Regulation  882  can  be  tasked  by  the  IAS  relevant  competent  authorities  to  carry  out  the 
necessary border controls to verify the presence of IAS. This is expected to create efficiency 
gains as well as avoiding the creation of a confusing legal framework for importers, through 
the  establishment  of  a  parallel  system  of  border  controls.  The  impacts  and  benefits  of  such 
possibility will be fully described and analysed in the Impact Assessment accompanying the 
legislative proposal on IAS. 

Consultations and finding  

Within  the  framework  of  the  work  on  the  forthcoming  proposal  for  a  dedicated  legislative 
instrument  on  IAS,  an  intensive  consultation  exercise  was  held  between  2010  and  2011.  A 
crucial element of discussion was how to prevent the entry of new IAS into the territory of the 

173 http://ec.europa.eu/environment/nature/invasivealien/docs/1_EN_ACT_part1_v6.pdf  
174http://ec.europa.eu/environment/nature/biodiversity/comm2006/pdf/2020/1_EN_ACT_part1_v7%5b1%5d.pdf  
Page 253/253 

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EU: it was generally recognised that prevention is a much more cost-effective way of dealing 
with IAS, rather than reacting to established species or after the onset of an invasion.  

Border  controls  done  according  to  harmonised  EU  rules  were  strongly  supported  as  an 
appropriate means to avoid new invasions. There were calls to streamline as much as possible 
the border control with existing EU instruments in order to on the one hand ensure an efficient 
and cost effective use of resources and on the other hand to avoid creating an overly complex 
system  by  creating  a  parallel  system  of  controls.  The  need  to  create  synergies  with  existing 
and  well-functioning  systems  was  often  stressed.  This  lends  support  to  the  mechanism 
whereby border controls on IAS could be delegated to the competent authorities established 
by Regulation 882, with a view to increasing efficiency and maintaining the system of border 
control as simple and streamlined as possible.  

EN 

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