EN    EN  
 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 oth er official activities performed to ensure the application of 
food and feed law, rules on animal health and welfare, pl ant health, plan t reproductive 
material, plant protection products a nd 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 th e management of expend iture relating to the 
food chain, animal health and animal welfar e, 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}  
 
EN 2   EN 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 oth er 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 a nd 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 welfar e, 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. P ROBLEM DEFINITION  
Background  
The responsibility to enforce European Un ion (EU) agri-food chain legislation lies 
with Member States (MS), whose authoritie s monitor that relevant requirements are 
effectively implemented across the EU. In doing so, they veri fy that operators' 
activities and goods placed on the EU market (either EU produced or imported from 
third countries) comply with relevant ag ri-food chain standards and requirements. All 
businesses operators are subject to offici al 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-en terprises, represent more than a half of 
the total number of operators in the major ity of the MS and may conceal serious risks 
despite the reduced scale of th eir activities (as in  the case of the recent E.Coli crisis). 
Harmonised EU rules to govern control activit ies performed by MS are established in 
Regulation 882/2004 (hereafter 'the Regulat ion') with the aim of creating an 
integrated and uniform approach to offi cial controls along the agri-food chain. The 
Regulation provides a general framework for official cont rols 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 re asons controls for animal 
health purposes (both on domestic and im ported goods) and controls on residues of 
veterinary medicines, remained regulated  separately. Moreover, certain sectors 
pertaining to the agri-food chai n were not included in th e scope of the Regulation - 
i.e. plant health, plant reproductive materi al (hereafter 'PRM'), animal by-
 
EN 3   EN products (hereafter 'ABP') - and specific sectoral re gimes were developed for 
them.  
The Regulation has introduced important improvements to the way competent 
authorities (CAs) organise and carry out official cont rols along the agri-food chain 
laying the foundations for a more in tegrated and horizontal approach.  However, 
evidence gathered over the last five years (feedback from MS' CAs and stakeholders, 
and DG SANCO Food Veterinary Office (F VO) audits) has shown shortcomings 
stemming from the incomplete impl ementation/achievement of certain 
principles/objectives, and from the fact th at the integrated approach to official 
controls is consolidated only partly.  
The review of the Regulation is part of a package which also includes three other 
major reviews to modernise the anim al 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 accom panies the upgrade of EU policies in these sectors.  
Problem identification  
Although MS ensure a good level of implemen tation 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 suff icient 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 ensuri ng accountability, soundness and 
effectiveness of enforcement activitie s (see examples pp. 7-8 of the report). 
Control authorities thus ope rate on the basis of diffe rent approaches and under 
different conditions depending on the sp ecific agri-food chain rules they are 
called upon to enforce, without differences being justified.  
(2) The Regulation requires o fficial controls to be risk-based  in order to maximise 
the efficiency of control activities dir ected 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 Regulati on and not repealed by it, which do not 
establish appropriate mechan isms to take into account  the actual risk a given 
good, business activity or third country might  present. This re sults in resources 
                                                
 
1 The Impact Assessments accompanying the reviews of Animal Health and Plant Health already 
received positive opinions from th e Impact Assessment Board. The Impact Assessment accompanying 
the review of Plant reproductive material is ongoing.  
 
EN 4   EN 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 opera tors (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 update s to their veterinary residues 
monitoring plans. In the same area, al so redundant are the specific reporting 
obligations, as they duplicate the ge neral 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 labor atories to be accredited in accordance 
with EN ISO/IEC 17025, the Regul ation does not allow temporary 
arrangements for emergencies or cases where laboratories have to use a new method not yet included in the accreditati on (see examples p. 10 of the report). 
Similarly, no flexibility is foreseen for small laboratories carrying out extremely basic types of tests (s ee examples p. 10 of the report).  
(5) The Regulation includes some important principles and mechanisms which are 
currently unevenly enforced by MS’ CA s or applied according to divergent 
practices among MS. In particular, calls  for administrative cooperation i) 
between MS for cross-border enforcem ent action, and ii) between sanitary 
authorities and customs services. Howeve r, MS are not making full use of this 
tool and/or they encounter difficultie s in understanding the conditions for its 
application (see examples p. 10 of the re port). 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, informati on from MS and FVO audits indicates 
widespread difficulties  in the MS to appropriatel y 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 activi ties 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 fo r official controls might adversely 
affect MS' capacity to deliver efficient o fficial controls and,  consequently, the 
level of protection offered by EU law.  
 
EN 5   EN To reduce the dependency of the financi ng of controls on public finances, the 
Regulation identifies a nu mber of control activiti es (mainly on meat, milk, 
fishery production, and on c ontrols 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 enab le 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 th e amount each MS recovers for official 
control activities has re sulted in a perception amongs t businesses, across the 
EU, that the cost of official control activ ities 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). 
(2) Where operators are required to pay manda tory fees, the impact of such fees 
may be greater on micro-enterprises  by reason of their lower 
turnover/throughput. Although th ere is currently no evidence to suggest that 
the mandatory fees charged on the basi s 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 offici al controls should be balanced and 
weighted against the need to lower the bur den 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 pr inciple be excluded from regulatory 
burdens, unless the necessity and proportiona lity of their being covered can be 
demonstrated.  
2. A NALYSIS OF SUBSIDIARITY  
The existence of a harmonised EU legisla tive 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 ch ain 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 th e problems identified by this review are 
linked to the current design of the EU legislative fram ework, 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 activitie s 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 consisten tly in the different MS and sectors.  
                                                
 
2 COM(2011) 803. 
 
EN 6   EN An efficient EU official cont rol system is important for both EU exports and imports. 
The EU's ability to export towards third countri es relies on the re putation 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 achieve d by a reliable and 
trusted official controls system which ensu res that the EU agri-food chain safety and 
quality standards are consistently enfor ced 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 guara ntess 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 concer ned 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 de pendency of control funding on public finances. 
Common EU rules are necessary also to pr event discriminatory treatment between 
operators located in a MS where the user-p ays rule (and thus f ees) 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 necess ary to achieve the objectives set. The 
present exercise has looked at a broa d 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 so lution 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 inte rnal arrangements and the specificities of 
their business population.  
3. P
OLICY OBJECTIVES  
The general  objectives (broadly coinciding wi th 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 under mined by potential non-implementation of 
EU legislation; 
3. ensure proper and uniform im plementation of EU legislation. 
The specific  objectives are set with the aim of eliminating the specific obstacles 
identified during the analysis which prev ent or hamper the achievement of the 
general objectives in this area.  
 
EN 7   EN 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 
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 
Improve transparency Design of official controls' 
framework Uneven enforcement of cooperation and 
transparency requirements  
Foster cooperation between MS to improve official 
control delivery Financing of 
official controls Difficulties and inequities in financing official 
controls activities - Ensure the availability of adequate resources 
- Ensure equity and fairness in the financing of 
official controls 
- Improve transparency  of the system of 
financing of official controls  
4. P OLICY OPTIONS  
The analysis of options availabl e was carried out in two stages:  
(1) first, the potential impact of two possi ble changes to the status quo, specifically 
aiming at deregulating the matter of the fi nancing of official controls (option 
1A) and of exempting micro- enterprises from the fees system (option 1B) were 
considered3; 
(2) 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 lis t of control activities for which the 
collection of a fee from operators is obligatory. 
Baseline:
 the integration of the system of of ficial controls al ong the agri-food chain 
is partial, some agri-food chain sectors be ing outside the scope of the Regulation. 
Official controls carried out at EU exte rnal borders on certai n goods arriving from 
third countries, and official controls on residues of veterinary medicines are not 
aligned to the risk based appr oach. This will continue to generate avoidable costs (for 
rigidly prescribed, non risk-bas ed 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 give n the significance of the ch anges 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 es tablished 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/b enefit analysis of Options 2-4 to an appreciable 
extent. 
 
EN 8   EN deployment of efforts by, and in cooperation between, national authorities will derive 
from the lack of uniform guidance on how to implement admini strative 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 lim ited 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 c ontrol. This result s 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 activ ities, provided that 
it ensures an appropriate level of res ources for controls. It would require repeal  of 
Articles 27-29  of the Regulation and in particular of the mandatory co llection of fees 
in certain areas.  
Option 1B – Mandatory exemption of micro-en terprises from the a pplication 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 w ould 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-enterprise s would be provided. A transitional 
period of 2 years  would be provided for the appli cation 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 ex cluded (plant health, PRM and 
ABP) and complete the 'integration' of offi cial controls. As rega rds the financing of 
official controls, offici al controls linked to plant passport  obligations, and to the 
 
EN 9   EN 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 exemption for micro-
enterprises 
Option 2 status quo improved full  status quo 
Option 3 expand to plant 
health and PRM improved full ADD plant health and PRM 
Option 4 expand to plant 
health and PRM improved full  ALL registered food and feed 
operators 
5. A SSESSMENT 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. Ec onomic 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 leve l 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. 
 
EN 10   EN on budgetary policies, are unlikely to be solv ed. 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-ente rprises, would undermine the objective 
of ensuring the sustainability of the cont rol system, and through it the safety of the 
agri-food chain. 
In 16 of the 23 MS for which data is availa ble, micro-enterprises represent more than 
half of all businesses, and in 9 such Stat es (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 repr esent 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 cont rols 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 represente d 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 t hus 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, effi cient and risk commensurate 
control activities across the agri-food chai n. Lower revenue income for competent 
authorities would result in fewer contro ls, a higher probabili ty of non compliance 
with EU agri-food chain legislation, and the safety of the agri-food chain being 
jeopardised by an increase d risk of food crises.  
On the other hand, should the loss of reve nue be compensated by higher fees charged 
on larger businesses, the mandatory exemp tion of micro-enterpri ses from the fees 
would result in the unfair treatment of larg er operators and in po ssible distortions of 
competition.  
Based on the above analysis, fully supporte d by CAs and industr y representatives 
consulted, it is considered that an auto matic 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 sy stems and to create 
 
EN 11   EN distortions of competition5. Therefore, in the options be low, 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 us e of control resources and mobilisation of 
dedicated financial resources reducing pre ssure 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. offi cial controls carried out at EU borders on 
certain goods from third counties, and offi cial controls on residues of veterinary 
medicines). This would result in a better al location 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 acro ss all sectors of the 
agri-food chain, including those above. This is prevented by the current fragmentation of official  controls legislation. 
As regards the financin g 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 su ch fees, thus reducing the pressure on 
national budgets. 
In the majority of MS, control costs ar e only partly recovered through fees, the 
recovery rate ranging from 20% to more th an 80%, and 8 MS recovering all costs. 
Thus, introducing full cost reco very would see in some cases  an additional part of the 
costs of controls being transferred t o, and distributed amongst, agri-food chain 
operators. The increase in the level of ma ndatory 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 th at, depending on the cu rrent percentage of 
recovery of costs by Member States, add itional 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). 
 
EN 12   EN in return, this would guarantee approx imately €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-pe rforming, low risk businesses, also when flat rate fees 
are applied to all operators, ir respective 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 e xpected to generate 
limited additional administrative burden s 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 major ity 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 provi ded 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 thr ough the increased transp arency of the fee 
mechanisms (operators would be able to se e clearly for what they are being charged 
and how charges are derived in light of co sts to CAs). This improved clarity would 
be a driver for improved efficiency of offi cial control systems and also allow better 
supervision of implementation by the Commission. Furthermore, increased 
transparency would contribute to the objectiv e of ensuring that fees revenues are not 
unduly distracted from their intended use (compensate control costs).  
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 genera l 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 c hain would maximise 
efficiency of enforcement through simp lification and synergy gains, facilitating the 
fulfilment of the objectives of agri-food c hain legislation. MS may partly or fully 
exempt from fees micro-enterprises, provid ed 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 a nd 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 13   EN harmonised approach to official contro ls along the entire agri-food chain, while 
taking into account the specificities of ev ery sector where necessary. The overall 
system would become more consistent a nd reliable as the same mechanisms and 
tasks would be used by all sectors. 
The initial costs from the new accreditati on 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 sm ooth introduction of the new obligation. 
Option 4 – Streamline + Integr ate + Broader cost recovery  
By broadening the collection of mandatory f ees 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 el iminating the perceived unfairness of the 
current system, which only requires certain categories of operator s 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 unfair ness among operators being charged. Indeed, 
with the Regulation, and the re quirement for CA to assess risks, and plan and carry 
out controls across the enti re agri-food chain, the rationale of only charging those 
sectors is lost. Option 4 ensures that mandato ry fees also apply to key areas of the 
agri-food chain, where food and feed operato rs benefit directly from efficiently 
performed official controls, as the latter he lp them deliver safe food and feed on the 
market. Exporting the cost recovery requireme nt to all control activities directed at 
ensuring the safety of food and feed ensure s that the positive im pacts 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, sugge sts that amounts vary according to the 
size/ throughput of the business and represent a negligible fraction of production 
costs.  For instance, fees applied annually ir respective 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 charge d, amounts vary in relation 
to the hourly cost of control activities. O fficial 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 sect or 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 
€210/year in Italy). On a global scale, this could guarantee between €2.3bn – and 
 
EN 14   EN several times this figure (up to €37 billi on in the hypothetical cas e of all operators 
being charged at rates curren tly 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 syst em, the scale of which is likely to be 
comparable to those of Option 2, margina lly increased by the broader scope of the 
calculations. Such costs would decrease ove r time as the fees co llecting mechanisms 
become streamlined and more effective. A transitional period of 3 years would be provided to MS.  
                                                
 
7 Combined new fees for sectors curren tly 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 15   EN 6. C OMPARISON 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 (--) Divergences 
among MS likely to 
increase and affect competition  (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  
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 (-) Possible reduction 
of controls and of 
ability to respond to 
risks (0) (+) More risk-based 
controls would 
increase the efficiency 
and capability to respond to risks  (++) Efficiency of 
controls is maximised 
and risks of 
suboptimal protection reduced (++) As in 3 
Ensure proper and uniform 
implementation of EU legislation (-) Possible 
suboptimal 
enforcement of law if 
resources decrease (0) (+) 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 
Ensure a comprehensive and 
consistent approach to official 
controls along the agri-food chain (0) (0) (+) Consistent use of 
risk based principle   (++) Same tasks & 
mechanisms used by 
all sectors   (++) As in 3  
Allow for a more efficient use of 
national control resources (0) (0) (+) Full risk based 
approach   (++) The inclusion of 
all agri-food chain 
areas in would allow cross-sectors risk prioritisation (++) As in 3  
Reduce administrative burden 
and remove unnecessary 
requirements (0) Removes AB 
linked to EU fee rules, 
but MS would 
administer their own 
regimes  (0) (+) Redundant plans & 
reports eliminated   (+) As in 2 (+) As in 2  
Foster closer cooperation 
between MS to improve official 
control delivery (0) (0) (+) Rules on admin. 
cooperation can be 
adopted, synergies developed (IAS)  (++) Synergies 
possible also with 
plant health, PRM sectors   (++) As in 3  
Ensure the availability of 
adequate resources (-) 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  (++) As cost would be 
recovered through 
fees, dependency from 
and pressure on 
national budgets  
decreases  (++) As in 2  (+++) As in 2, on a 
broader scale  
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  
 
 
EN 16   EN   Option 1.A 
deregulate 
fees Option 1.B 
exempt 
micro-
entreprises Option 2. Streamline Option 3. 
Streamline + 
integrate8 Option 4. Streamline 
+ integrate + broader 
cost recovery 
  Action € Action € Action € Action € 
Cost Establishing 
and 
operating 
reporting 
regime for 
calculation 
and 
charging of 
fees €0.5m one 
off 
+ 
€2000/year  
(per MS)  Same (as 
Option 2 + 
Plant Health 
and Plant 
Reproductive 
Materials) Same  Same as 
Options 
2&3 Same  
Member 
State 
CA 
Benefit 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) 
Stable 
funding in 
areas 
already 
charged i.e. 
meat sector 
(top up to 
the % of 
costs 
already 
charged to 
reach full 
cost 
recovery)  Depends on 
% recovery 
of costs by 
MS. 
Approx. 
€0.9bn –
3.4bn  new 
funds per 
year across 
EU MS9,10 Same  Same  Full cost 
recovery 
for all 
OC on 
registered 
operators 
+ as 'top-
up' as per 
Option 2 Approx. 
total of 
new fees 
€2.3bn –
37bn/year  
across EU 
MS11 + 
€0.9-
3.4bn per 
year 
 
Cost 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 0.2 – 
0.8% of 
annual 
product. 
value in the 
meat 
sector12) 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 Approx. 
total of 
new 
charges 
€2.3bn-
37bn/year 
across EU 
MS + 
€0.9-
3.4bn per 
yeat Business 
Oper. 
Benefit 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) 
Risk based 
approach to 
vet. med. 
controls EU-wide 
saving of 
€12.4m – 
98.5m/year  
(covered by 
fee) Same  Same  Same as 
Options 
2&3 Same  
                                                 
8 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. 
9 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). 
10 The majority of operators in individual Member States are currently being charged between 30% and 
80% of inspection charges, with some paying 100%. 
11 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 op erators who are not curre ntly subject to fees – 25m (Eurostat 2008). 
12 Based on UK industry estimates. 
 
EN 17   EN 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 fram ework implies limited associated costs, it 
offers the best approach to simplific ation, clarity, coherence and reduction of 
administrative burden. As to the financing of controls, Option 4  preserves the long 
term sustainability of national contro l 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. M
ONITORING AND EVALUATION  
The review of the EU legislative framework applicable to official controls along the 
agri-food chain aims at improving the effici ency and consistency of the system, and 
ensuring its long term sustaina bility. It is considered th at 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 introduce d, 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 lega l interpretation received by 
the Commission  
- Number of pieces of EU level legislation applying to 
official controls per sector/product 
- The reported change in the declared average 
administrative burden on industry and MS 
All controls, including border controls, risk based 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 - Number of contacts through administrative cooperation 
contact points foreseen by Article 35 of the Regulation 
- Number of complaints from economic operators 
pointing to MS having failed to coordinate investigations in case of cr oss border non-compliances  
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 authoriti es 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