COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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) 166 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE 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) 167 final} 

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COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE 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) 

1. 

PROBLEM DEFINITION 

Background 

The  responsibility  to  enforce  European  Union  (EU)  agri-food  chain  legislation  lies 
with Member States (MS), whose authorities monitor that relevant requirements are 
effectively  implemented  across  the  EU.  In  doing  so,  they  verify  that  operators' 
activities and goods placed on the EU market (either EU produced or imported from 
third countries) comply with relevant agri-food chain standards and requirements. All 
businesses  operators  are  subject  to  official  controls  irrespective  of  their  size, 
depending on the risk different activities can pose to the safety of the agri-food chain. 
indeed, smaller businesses, including micro-enterprises, represent more than a half of 
the total number of operators in the majority of the MS and may conceal serious risks 
despite the reduced scale of their activities (as in the case of the recent E.Coli crisis). 

Harmonised EU rules to govern control activities performed by MS are established in 
Regulation  882/2004  (hereafter  'the  Regulation')  with  the  aim  of  creating  an 
integrated  and  uniform  approach  to  official  controls  along  the  agri-food  chain.  The 
Regulation provides 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,  plant  reproductive  material  (hereafter  'PRM'),  animal  by-

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products  (hereafter  'ABP')  -  and  specific  sectoral  regimes  were  developed  for 
them.  

The  Regulation  has  introduced  important  improvements  to  the  way  competent 
authorities  (CAs)  organise  and  carry  out  official  controls  along  the  agri-food  chain 
laying  the  foundations  for  a  more  integrated  and  horizontal  approach.  However, 
evidence gathered over the last five years (feedback from MS' CAs and stakeholders, 
and  DG  SANCO  Food  Veterinary  Office  (FVO)  audits)  has  shown  shortcomings 
certain 
stemming 
principles/objectives,  and  from  the  fact  that  the  integrated  approach  to  official 
controls is consolidated only partly.  

implementation/achievement 

incomplete 

from 

the 

of 

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 PRM acquis1. 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.  

Problem identification 

Although  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 the Regulation, shortcomings have been identified stemming from on 
the  one  hand,  the  design  of  the  official  controls  framework,  on  the  other  hand, 
uncertainties as to the availability of sufficient resources to adequately finance 
official controls.  

Design of the official controls framework 

(1)  The Regulation's main aim of developing an integrated and uniform approach 
to  official  controls  is  not  fully  met:  EU  official  controls  rules  for  sectors 
outside its scope are not fully aligned to the principles and requirements set out 
in the Regulation. This has resulted in inconsistencies and legal gaps as those 
sectors  lack  important  provisions  ensuring  accountability,  soundness  and 
effectiveness  of  enforcement  activities  (see  examples  pp.  7-8  of  the  report). 
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.  

(2)  The Regulation requires official controls to be risk-based in order to maximise 
the  efficiency  of  control  activities  directed  at  protecting  health.  At  present, 
there are two areas such an approach is still not used, notably official controls 
carried out at the border on certain goods coming from third countries, and 
official controls on residues of veterinary medicines (see examples pp. 8-9 of 
the report). Main reason for this is that such controls are currently prescribed 
by EU rules, pre-existing the Regulation 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. This results in resources 

1 

The  Impact  Assessments  accompanying  the  reviews  of  Animal  Health  and  Plant  Health  already 
received positive opinions from the Impact Assessment Board. The Impact Assessment accompanying 
the review of Plant reproductive material is ongoing.  

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being allocated – in all MS - to controls that are not justified by the risk and in 
a consequent 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).  

(3)  Unnecessary  administrative  burdens  are  placed  on  MS'  CAs.  This  is 
considered  to  be  the  case  whereby  MS  are  obliged  to  transmit  to  the 
Commission  for  approval,  annual  updates  to  their  veterinary  residues 
monitoring  plans.  In  the  same  area,  also  redundant  are  the  specific  reporting 
obligations,  as  they  duplicate  the  general  reporting  requirement  in  the 
Regulation.  These  burdens  results  from  obligations  on  MS  laid  down  in 
Directive 96/23/EC.  

(4) 

In addition, while requiring official laboratories to be accredited in accordance 
with  EN  ISO/IEC  17025, 
temporary 
arrangements  for  emergencies  or  cases  where  laboratories  have  to  use  a  new 
method not yet included in the accreditation (see examples p. 10 of the report). 
Similarly,  no  flexibility  is  foreseen  for  small  laboratories  carrying  out 
extremely basic types of tests (see examples p. 10 of the report).  

the  Regulation  does  not  allow 

(5)  The Regulation includes some important principles and mechanisms which are 
currently  unevenly  enforced  by  MS’  CAs  or  applied  according  to  divergent 
practices  among  MS.  In  particular,  calls  for  administrative  cooperation  i) 
between  MS  for  cross-border  enforcement  action,  and  ii)  between  sanitary 
authorities and customs services. However, MS are not making full use of this 
tool  and/or  they  encounter  difficulties  in  understanding  the  conditions  for  its 
application  (see  examples  p.  10  of  the  report).  Another  requirement  which  is 
open  to  divergent  practices  in  MS  is  the  obligation  for  MS’  CAs  to  ensure  a 
'high  level  of  transparency'  of  control  activities  with  regards  to  operators  and 
the public at large. This 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. 

Financing of official controls 

(1)  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  (p.  132  of  the  report)  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 
level  of  controls  is  attributed  to  the  lack  or  shortage  of  resources  (see 
examples p. 11 of the report). Such difficulties are exacerbated by the on-going 
economic and financial crisis and there is a risk that further pressure on public 
finances  and  on  funds  made  available  for  official  controls  might  adversely 
affect MS' capacity to deliver efficient official controls and, consequently, the 
level of protection offered by EU law.  

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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 costs. 
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  flux  of  resources  to  finance  the 
performance of controls.  

In addition, a significant variance in the amount each MS recovers for official 
control  activities  has  resulted  in  a  perception  amongst  businesses,  across  the 
EU, that the cost of official control activities is not evenly or fairly spread out 
amongst  agri-food  chain  operators  in  the  EU.  Operators  also  complain  about 
the fact that the current system does not sufficiently reward compliant business 
behaviour (and call for a stronger bonus malus approach). 

their 

reason  of 

(2)  Where  operators  are  required  to  pay  mandatory  fees,  the  impact  of  such  fees 
may  be  greater  on  micro-enterprises  by 
lower 
turnover/throughput.  Although  there  is  currently  no  evidence  to  suggest  that 
the  mandatory  fees  charged  on  the  basis  of  the  current  framework  have,  in 
actual  fact,  given  rise  to  adverse  or  disproportionate  effects  on  micro-
enterprises,  the  need  to  enable  control  authorities  to  recover  costs  so  as  to 
ensure  sufficient  resources  for  official  controls  should  be  balanced  and 
weighted 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"2. 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. 

ANALYSIS OF SUBSIDIARITY 

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. 

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.  

2 

COM(2011) 803. 

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An efficient EU official control system is important for both EU exports and imports. 
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. 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  guarantess  that  they  meet  equivalent  safety 
levels. 

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  business  concerned  with  the  handling  of  feed/food,  which 
benefit directly from efficiently performed controls, participate towards 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. 

POLICY OBJECTIVES 

The general objectives (broadly coinciding with the Treaty objectives) are: 

1. 

contribute to promoting the smooth functioning of the internal market; 

2.  maintain a high level of human, animal and plant health protection and animal 
welfare and prevent that this is undermined by potential non-implementation of 
EU legislation; 

3. 

ensure proper and uniform implementation of EU legislation. 

The  specific  objectives  are  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 area.  

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Table 1: specific objectives and their link with 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 

k
r
o
w
e
m
a
r
f

Inconsistent 
approach 

implementation  of  risk  based 

Allow  for  an  efficient  use  of  national  control 
resources 

Administrative  burden  and  disproportionate 
requirements 

Reduce 
unnecessary requirements 

administrative  burden 

and 

remove 

Uneven  enforcement  of  cooperation  and 
transparency requirements  

Improve transparency 

controls activities 

  Difficulties  and  inequities  in  financing  official 
s
l
o
r
t
n
o
c

l
a
i
c
i
f
f
o

Foster cooperation between MS to improve official 
control delivery 

-  Ensure the availability of adequate resources 

-  Ensure equity and fairness in the financing of 

official controls 

- 

Improve 
transparency  of 
financing of official controls 

the  system  of 

'
s
l
o
r
t
n
o
c

l
a
i
c
i
f
f
o
f
o
n
g
i
s
e
D

f
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n
i
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n
a
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F

4. 

POLICY OPTIONS 

The analysis of options available was carried out in two stages: 

(1) 

(2) 

first, the potential impact of two possible changes to the status quo, specifically 
aiming  at  deregulating  the  matter  of  the  financing  of  official  controls  (option 
1A) and of exempting micro-enterprises from the fees system (option 1B) were 
considered3; 

the  outcome  of  the  analysis  under  1  was  then  used  to  design  options  2  to  4, 
which combine the following elements: i) expand the scope of the Regulation 
to  food  chain  sectors  currently  outside  its  scope  (i.e.  plant  health,  PRM  and 
ABP), ii) improve and simplify the legislative framework, iii) ensure full cost 
recovery  through  fees,  iv)  expand  the  list  of  control  activities  for  which  the 
collection of a fee from operators is obligatory. 

Baseline: the integration of the system of official controls along the agri-food 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  inefficiencies  in  the 

3 

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  thereof.  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  Options  2-4  to  an  appreciable 
extent. 

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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. 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,  and  in  the  risk  that  the  capacity  of  the  control  system  to  prevent  and 
contain health risks along the agri-food chain is undermined. 

Option  1A  –  Repeal  Union  rules  on  control  fees:  each  MS  would  decide  on  the 
approach it follows as regards the funding of official control activities, provided that 
it ensures an  appropriate level of resources for controls. 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: 
this  option,  selected  in  view  of  the  Commission's  continued  efforts  to  promote  the 
competitiveness  of  micro-enterprises,  would  require  the  breadth  of  operators  upon 
which  mandatory  fees  are  levied  to  be  appositely  restricted  to  exclude  micro-
enterprises. 

Option  2  –  Streamline:  improve  the  legal  framework  by  streamlining  the  rules 
applicable to controls carried out at the EU external borders on certain goods from 
third countries and to controls on residues of veterinary medicines, aligning them 
to  the  risk-based  approach.  The  possibility  of  setting  control  coordination 
mechanisms with other national authorities (at borders and elsewhere) so as to use all 
potential  operational  synergies  would  be  introduced.  Provisions  on  official 
laboratories  would  be  simplified  providing  derogations  were  appropriate. 
Redundant/obsolete pre-existing legislation would be repealed so that overlaps and 
administrative  burdens  would  be  removed.  The  Commission  would  be 
empowered  to  specify,  by  delegated/implementing  acts,  the  modalities  of  certain 
requirements  for  which  more  detailed  rules  are  needed  (e.g.  administrative 
cooperation and transparency). 

Where already required, mandatory fees would be maintained and current obstacles 
to full cost recovery (e.g. EU harmonised standard fees) would be eliminated. The 
possibility  for  MS  to  exempt  micro-enterprises  would  be  provided.  A  transitional 
period  of  2  years  would  be  provided  for  the  application  of  a  full  cost  recovery 
system.  

Option 3 – Streamline + Integrate: additional to Option 2, Option 3 would widen the 
scope of the Regulation to cover sectors currently excluded (plant health, PRM and 
ABP) and complete the 'integration' of official controls. As regards the financing of 
official  controls,  official  controls  linked  to  plant  passport  obligations,  and  to  the 

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certification in the field of PRM would be added to the list of activities covered by 
mandatory fees4.  

Option 4 – Streamline + Integrate + Broader cost recovery: additional  to  Option 3, 
Option 4 would expand the list of mandatory inspection fees to all controls carried 
out by feed and food business for which a registration requirement is established in 
accordance with food and feed safety rules. A transition period of 3 years would be 
provided for the application of a full cost recovery system with the expanded scope. 

Table 2: Summary of the options included in the analysis 

Scope of 
the Regulation  

Legislative 
framework 

Cost recovery 

Scope of 
mandatory fees 

Baseline 

partial (plant 
health, PRM, ABP 
out) 

deficiencies and 
shortcomings 

partial 

partial (meat, milk, fishery, 
imports) 

Option 1A 

status quo 

status quo 

No 
(deregulation) 

/ 

Option 1B 

status quo 

status quo 

status quo 

Option 2 

Option 3 

Option 4 

status quo 

expand to plant 
health and PRM 

expand to plant 
health and PRM 

improved 

improved 

improved 

full  

full 

full  

exemption for micro-
enterprises 

status quo 

ADD plant health and PRM 

ALL registered food and feed 
operators 

5. 

ASSESSMENT OF IMPACTS 

The  IA  analyses  the  likely  social,  economic  and  environmental  impacts  –  be  they 
direct or indirect – of 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). 

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  in  possible  cuts  in  resources 
allocated to controls. 

Although the impact on the level of resources actually deployed would depend on the 
policy  choices  that  each  MS  would  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 the dependency of controls performance 

4 

This  would  be  done  to  account  for  the  preferred  option  selected  in  the  context  of  the  Impact 
Assessments accompanying the review of the Plant Health and PRM regimes. 

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on budgetary policies, are unlikely to be solved. Given the current economic crisis it 
is  possible  that  problems  could  worsen  if  MS  decisions  result  in  a  decrease  of 
resources made available for the operation of national control systems. This would in 
turn  result  in  increased  difficulties  by  CAs  in  maintaining  an  effective  oversight  of 
compliance with safety requirements along the agri-food chain and in preventing and 
resolving large scale crises. 

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. This 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 single market. 

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

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

In 16 of the 23 MS 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 
operators.  Where  micro-enterprises  represent  an  overwhelming  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  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 from public resources and thus create a situation – in particular in 
times  of  crisis  and  budget  restrictions  -  of  financial  uncertainty  which  cannot  be 
reconciled with the objective of ensuring consistent, efficient and risk commensurate 
control  activities  across  the  agri-food  chain.  Lower  revenue  income  for  competent 
authorities  would  result  in  fewer  controls,  a  higher  probability  of  non  compliance 
with  EU  agri-food  chain  legislation,  and  the  safety  of  the  agri-food  chain  being 
jeopardised by an increased risk of food crises.  

On the other hand, should the loss of revenue be compensated by higher fees charged 
on  larger  businesses,  the  mandatory  exemption  of  micro-enterprises  from  the  fees 
would result in the unfair treatment of larger operators and in possible distortions of 
competition.  

Based  on  the  above  analysis,  fully  supported  by  CAs  and  industry  representatives 
consulted,  it  is  considered  that  an  automatic  exemption  of  micro-enterprises  (or 
SME's  in  general)  from  the  application  of  fees  has  the  potential  to  undermine  the 
objective  of  ensuring  the  sustainability  of  national  control  systems  and  to  create 

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distortions of competition5. Therefore, in the options below, the exemption of micro-
enterprises from the application of fees is replaced by a mechanism which responds 
to such shortcomings. 

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 partly or fully exempt from fees micro-enterprises, conforming 
to State Aid rules.  

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 borders 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  system.  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. In fact, the best allocation of control resources can only be achieved 
by ensuring that the risk prioritisation is carried out by CAs across all sectors of the 
agri-food  chain, 
the  current 
fragmentation of official controls legislation. 

those  above.  This 

is  prevented  by 

including 

As  regards  the  financing  of  official  controls,  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, which would vary depending 
on  the  current  recovery  rate,  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  (using  the 
figures in box 6, p. 31 , we can estimate that, depending on the current 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); 

5 

The conclusion also holds true in cases where mandatory fees are imposed on all registered food and 
feed operators (Option 4) as the proportion of micro-enterprises in the different areas of the agri-food 
chain is always very significant (data published in April 2012 by Fooddrinkeurope shows that 79% of 
operators in the food and drink industry are micro-enterprises). 

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in return, this would guarantee approximately €0.9bn – 3.4bn of new funds/year for 
official controls across the MS6. 

By eliminating  the use of  EU standard fees and requiring all fees to be cost-based, 
Option 2 would create a level playing field for all operators charged with mandatory 
fees.  New  provisions  will  ensure  that  the  financing  mechanism  of  controls  can  be 
used by MS to reward well-performing, low risk businesses, also when flat rate fees 
are applied to all operators, irrespective of whether they are actually inspected during 
the reference period (by charging them with a lower rate fee than the one applied on 
non compliant operators). 

The  requirement  to  calculate  all  fees  on  the  basis  of  costs  is  expected  to  generate 
limited  additional  administrative  burdens  upon  those  MS  which  do  not  currently 
establish  fees  on  the  basis  of  costs  incurred  as  changes  to  their  administrative 
procedures may be required. Although the majority of MS derives at least part of the 
mandatory  fees  from  actual  costs,  a  fully  cost-based  system  might  require  existing 
costing  systems  to  be  adjusted.  Additional  costs  are  expected  to  be  affordable  by 
public budgets (according to estimations provided by 2 MS they would range from 
a  few  thousand  €  /year   in  FTE  time  spent  to  collect  and  compile  data  for  the 
calculation,  to  higher  figures  (€0.5m  one-off)   if  a  dedicated  IT  tool  capable  of 
recording time and resources spent on each inspection is set up, see box 6 on p. 31 of 
the report). Option 2 takes account of this adjustment needs by giving MS 2 years to 
ready their administrative systems to the new costing/charging model. 

Option  2  would  increase  the  accountability  of  control  activities  by  establishing  a 
stronger  link  between  costs  and  fees  through  the  increased  transparency  of  the  fee 
mechanisms (operators would be able to see clearly for what they are being charged 
and how charges are derived in light of costs to CAs). This improved clarity would 
be a driver for improved efficiency of official control systems and also allow better 
supervision  of 
increased 
transparency would contribute to the objective of ensuring that fees revenues are not 
unduly distracted from their intended use (compensate control costs).  

the  Commission.  Furthermore, 

implementation  by 

The  possibility  for  MS  to  alleviate  the  impact  of  full  cost  recovery  on  micro-
enterprises  by  exempting  them,  fully  or  in  part,  the  fees  paid,  on  condition  that  an 
equal sum is transferred from the general budget to the CA does not deprive CA of 
the resources which are necessary to perform their control tasks. 

Option 3 – Streamline + Integrate  

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.  MS  may  partly  or  fully 
exempt from fees micro-enterprises, provided that the MS transfers an equal sum to 
the CA from the general budget.  

In  addition  to  the  impacts  highlighted  for  Option  2,  by  expanding  the  scope  of  the 
Regulation  to  the  plant  health,  PRM  and  ABP  areas,  Option  3  would  ensure  a 

6 

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). 

EN 

12 

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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 used by all sectors. 

The  initial  costs  from  the  new  accreditation  obligation  for  plant  health  laboratories 
will be borne by the EU (see Annex XIX, p. 194) and a transitional period of 5 years 
is foreseen to facilitate the smooth introduction of the new obligation. 

Option 4 – Streamline + Integrate + Broader cost recovery 

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. 
MS  may  partly  or  fully  exempt  from  fees  micro-enterprises  provided  that  the  MS 
transfers an equal sum to the CA from the general budget. 

The traditional limitation of mandatory fees to (essentially) the meat and milk sectors 
and  border  checks  on  animal  origin  products  has  become  increasingly  difficult  to 
justify, and a source of perceived unfairness among operators being charged. Indeed, 
with the Regulation, and the requirement for CA to assess risks, and plan and carry 
out  controls  across  the  entire  agri-food  chain,  the  rationale  of  only  charging  those 
sectors  is  lost.  Option  4  ensures  that  mandatory  fees  also  apply  to  key  areas  of  the 
agri-food  chain,  where  food  and  feed  operators  benefit  directly  from  efficiently 
performed official controls, as the latter help them deliver safe food and feed on the 
market.  Exporting  the  cost  recovery  requirement  to  all  control  activities  directed  at 
ensuring the safety of food and feed ensures that the positive impacts of Option 2 in 
terms of increased sustainability of controls work on a broader scale.  

The economic impact on each MS and on operators would depend on whether (and 
to what extent) MS charge already sectors which are not subject to mandatory fees. 
Data  available  from  MS  which  do  so,  suggests  that  amounts  vary  according  to  the 
size/  throughput  of  the  business  and  represent  a  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/year for smallest 
scale  restaurants  in  Belgium)  to  higher,  yet  still  not  significant,  sums 
(€1,500/year for largest scale i ndustrial bakeries in Italy).  

In MS where the actual cost of each inspection is charged, amounts vary in relation 
to the hourly cost of control activities. Official control frequency depends on the risk, 
on the operators' record of compliance, on the reliability of their own checks, etc. and 
varies  depending  on  the  sector  and  on  the  category  of  business.  For  illustration 
purposes  a  typical  example  would  be  the  case  of  a  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,  charged on the  basis of control time used, around  €50/year  in Poland, 
€150/year   in  Italy.  Inspections  in  a  restaurant  would  have  a  similar  frequency  but 
would take longer and would cost between 30-40% more (€65/year in Poland, up to 
this  could  guarantee  between  €2.3bn  –  and 
€210/year  in  Italy).  On  a  global  scale, 

EN 

13 

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several  times  this  figure  (up  to  €37  billi on  in  the  hypothetical  case  of  all  operators 
being  charged  at  rates  currently  applied  to  the  largest  food  businesses,  i.e.  around 
€1,500) 7. 

As with Option 2, Option 4 would result in limited additional administrative burdens 
for  CAs  to  establish  a  fees  collecting  system,  the  scale  of  which  is  likely  to  be 
comparable  to  those  of  Option  2,  marginally  increased  by  the  broader  scope  of  the 
calculations. Such costs would decrease over time as the fees collecting mechanisms 
become  streamlined  and  more  effective.  A  transitional  period  of  3  years  would  be 
provided to MS.  

7 

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 above). 

EN 

14 

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6. 

COMPARISON OF OPTIONS  

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 

and 

plant 

Maintain  a  high  level  of  human, 
animal 
health 
protection  and  animal  welfare 
and 
is 
undermined  by  potential  non-
implementation of EU legislation 

prevent 

that 

this 

Ensure  proper 
and  uniform 
implementation of EU legislation 

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

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

(-) Possible 
suboptimal 
enforcement of law if 
resources decrease 

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

Allow for a more efficient use of 
national control resources 

(0) 

(0) 

Reduce  administrative  burden 
unnecessary 
and 
requirements 

remove 

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

(0) 

(0) 

(0) 

(0) 

(0) 

(0) 

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

(++)  As  in  2,  plus 
streamlined  rules  on 
official controls would 
apply  across  all  agri-
food chain areas 

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

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

(++)  Efficiency  of 
controls  is  maximised 
and 
of 
risks 
suboptimal  protection 
reduced 

(++) As in 3 

(+)  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  

(+)  Consistent  use  of 
risk based principle  

(+) Full risk based 
approach  

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

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

(++) As in 3 

(++) As in 3 

(++) As in 3 

(+) Redundant plans & 
reports eliminated  

(+) As in 2 

(+) As in 2 

closer 

Foster 
cooperation 
between  MS  to  improve  official 
control delivery 

(0) 

(0) 

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

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

(++) As in 3 

Ensure 
adequate resources 

the 

availability 

of 

depend 

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

likely 

in 

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

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

(++) As in 2 

(+++)  As 
broader scale 

in  2,  on  a 

Ensure  equity  and  fairness  in  the 
financing of official controls 

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

to 

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

operators 
(+)  All 
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) 

(++) As in 2  

(++) As in 2 

'High 

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

EN 

15 

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Option 1.A 
deregulate 
fees 

Action 

Option 1.B 
exempt 
micro-
entreprises 
€ 

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 
the 
businesses  and  %  of 
latter(1B) 

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) 

Cost 

Benefit 

Member 
State 
CA 

Cost 

Business 
Oper. 

Benefit 

Option 2. Streamline 

Option 3. 
Streamline + 
integrate8 

Option 4. Streamline 
+ integrate + broader 
cost recovery 

for 

Action 
Establishing 
and 
operating 
reporting 
regime 
calculation 
and 
charging  of 
fees 
Stable 
funding 
areas 
already 
charged  i.e. 
meat  sector 
(top  up  to 
the  %  of 
costs 
already 
charged  to 
reach 
full 
cost 
recovery) 

in 

to 

Top  up 
existing 
fees 
sector) 
reach 
cost 
recovery 

(meat 
to 
full 

Risk  based 
approach  to 
vet.  med. 
controls 

one 

€ 
€0.5m 
off 
+ 
€ 2000/year 
(per MS)  

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

€ 
Action 
Same   Same  as 

€ 
Same  

Options 
2&3 

Same  

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

of 

Approx. 
total 
new fees 
€ 2.3bn  –
37bn/year 
across  EU 
MS11 
+ 
€0.9-
3.4bn  per 
year 

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

Same   New 

costs  for 
operators 
currently 
not 
charged 
(non 
meat 
sector)  + 
'top-up' 
as 
per 
Option 2 

of 

Approx. 
total 
new 
charges 
€2.3bn-
37bn/year 
across  EU 
MS 
+ 
€0.9-
3.4bn  per 
yeat 

Same  

Same   Same  as 

Same  

Options 
2&3 

Depends  on 
% 
recovery 
of  costs  by 
MS. 
Approx. 
€ 0.9bn 
3.4bn 
funds 
year 
EU MS9,10 

–
new 
per 
across 

Depends  on 
% 
recovery 
of  costs  by 
MS. 
Approx. 
–
€ 0.9bn 
new 
3.4bn 
fees  (Across 
EU 
MS) 
(approx 0.2 – 
0.8% 
of 
annual 
product. 
value  in  the 
meat 
sector12) 
EU-wide 
saving 
€ 12.4m 
98.5m/year 
(covered  by 
fee) 

of 
– 

8 

9 

10 

11 

12 

For  Option  3,  costs/benefits  are  related  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 which 
are not included here. 
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 of IA). 
The majority of operators in individual Member States are currently being charged between 30% and 
80% of inspection charges, with some paying 100%. 
New fees for those sectors to be charged for the first time under Option 4. These figures correspond to 
the two extreme hypotheses of all operators being charged at rates currently used for the smallest and 
largest scale businesses. No. of operators who are not currently subject to fees – 25m (Eurostat 2008). 
Based on UK industry estimates. 

EN 

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Preferred option 

It  is  considered  that Option  4  provides  the  best  way  to  achieve  the  objectives  (see 
summary  in  the  table  above).  In  fact,  although  the  full  integration  of  all  agri-food 
chain sectors into a single legislative framework implies limited associated costs, it 
offers  the  best  approach  to  simplification,  clarity,  coherence  and  reduction  of 
administrative burden. As to the financing of controls, Option 4 preserves the long 
term  sustainability  of  national  control  systems  by  reducing  their  dependency  on 
public finances and reducing the risk that the ongoing economic and financial crisis 
impact  on  the  level  of  control  resources  available.  The  limited  additional  costs  for 
operators  are  compensated  by  more  efficient  controls,  mechanisms  to  reward 
compliance, and increased accountability of control services. 

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 will 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: 

Operational objectives 

Indicators 

Establish  a  single  and  simpler  legislative  framework  for 
official controls 

-  Number of requests for legal interpretation received by 

the Commission  

-  Number  of  pieces  of  EU  level  legislation  applying  to 

official controls per sector/product 

- 

reported  change 

The 
administrative burden on industry and MS 

in 

the  declared  average 

All controls, including border controls, risk based 

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

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

-  Number of contacts through administrative cooperation 

contact points foreseen by Article 35 of the Regulation 

-  Number  of  complaints  from  economic  operators 
pointing 
coordinate 
investigations in case of cross border non-compliances  

to  MS  having 

failed 

to 

Increase  the  number  of  formalised  instruments  between 
the  CAs  and  customs  authorities  for  the  performance  of 
official controls 

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 

Trends in the number of FVO reports which point to a lack 
of resources in MS 

EN 

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