EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 6.5.2013  
COM(2013) 265 final 
2013/0140 (COD) 
  
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 heal th, 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 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) 
(Text with EEA relevance) 
{SWD(2013) 166 final} 
{SWD(2013) 167 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
1.1. Background of the proposal 
In order to afford European Union (EU) citi zens a high level of human, animal and plant 
health, and guarantee the functioni ng of the internal market, Union legislation provides for a 
set of harmonised rules to prevent, eliminate or  reduce the level of he alth risk to humans, 
animals and plants, which may arise along the 'agri- food chain', this term being used in a very 
broad sense, to comprehend all those processes,  products and activities which relate to food, 
its production and handling, and the rules which (d irectly or indirectly, e.g. through the safety 
requirements for feed) ensure that it is safe and fit for human consumption. It also includes 
rules referred to as veterinary and phytosanitar y legislation, which deal with risks to animal 
health and plant health in general, and rule s on the identity, health and quality of plant 
reproductive material. Thus this vast acquis governs  health risks in the strict sense (risks to 
the integrity of humans, animal s and plants from pests, diseases, microbial and chemical 
contaminants and other hazards) and also the preservation of inherent qualities required to ensure a safe start of plant production and re gulated production methods (i.e. animal welfare, 
organic farming, geographical indi cations, plant reproductive materi al). It also includes rules 
established to ensure the provision of info rmation to consumers and to guarantee fair 
commercial practices in agri -food chain products' trade. 
To ensure that this extensive set of rules is enforced by the Member States (MS) across the 
EU in a harmonised manner, a legislative framework for th e organisation of official 
controls  has been established through Regula tion (EC) No 882/2004 ('the Regulation')
1. 
The proposal revises the legislation on official controls to overcome shortcomings identified 
in its wording and in its app lication. It aims to put in place a robu st, transparent and 
sustainable regulatory framework that is be tter 'fit for purpose'. The proposal replaces and 
repeals the Regulation and a num ber of sectoral acts and pr ovisions which will be made 
redundant by its adoption. 
As the proposal is part of a comprehensive p ackage, which also includes three major reviews 
to modernise the animal health, plant health and plant reproductive material aquis , it also aims 
to modernise and integrate the system of offici al controls in a manner that consistently 
accompanies the upgrade of EU po licies in these sectors.  
In order to rationalise and simplify the overall legislativ e framework, whilst simultaneously 
pursuing the objective of bette r regulation, the proposal inte grates the rules currently 
applicable to official controls in specific area s currently governed by separate sets of rules 
(e.g. controls on residues of veterinary medicinal products in live animals and animal 
products, and plant health controls) in to the framework of the Regulation. 
Based on an extensive review of the provision s of the Regulation, which highlighted a number 
of cases where the burden of organising and perfo rming official controls could be reduced by 
eliminating redundant requirements (e.g. separate reporting from official  controls on residues 
of veterinary medicinal products) or allowing a proportionate and flexible approach to some 
specific situations (e.g. not requiring full accred itation of official laboratories in case of 
emergencies), the proposal introduces such changes. 
                                                 
1 Regulation (EC) No 882/2004 of the European Parliament and Council of 29 April 2004 on official 
controls performed to ensure the verification of comp liance with feed and food law, animal health and 
welfare rules. EN 3   EN As regards official controls performed on goods arriving from third countries, the provisions 
of the Regulation currently apply together with  sectoral provisions which govern respectively 
the imports of animals and animal origin prod ucts, those of plant and plant products, and the 
controls on food and feed for which a specific ri sk requires increased attention at the borders. 
The report adopted by the Commission in December 20102 on the effectiveness and 
consistency of sanitary and phytosanitary cont rols on imports of food, feed, animals and 
plants, whilst concluding that the comprehensive body of legisla tion currently in place allows 
the EU to deal with emerging risks or emerge ncy situations without causing distortions to 
trade, also found that the Union' s system of import controls c ould be made more consistent by 
reviewing and consolidating the ex isting sectoral acts with regard to official controls. The 
report indicates that this recommendation would bring benefits for MS and operators handling 
goods from third countries, by enabling a more e fficient prioritisation of  controls and a better 
allocation of public resources employed on import  controls. The review of the Regulation was 
considered a good opportunity to take account of  the findings of the report and consolidate 
controls where possible. The pr oposal includes therefore a set of common and comprehensive 
rules applicable to controls performed on animals and goods from third countries. 
As regards the financing of official controls , the Regulation confirms the general principle 
according to which MS should allocate appropriate financial resources to official controls, and 
also the obligation for MS to collect, in certain  areas, so-called 'control fees' to recover from 
business operators the costs incurred for the pe rformance of official controls. Current rules 
require that mandatory inspection fees be char ged only for official control activities on 
businesses handling meat, fishery products, and milk and for the approval of feed 
establishments and for (most) controls at bor ders. Historically, these were the areas where 
methods of controls by MS comp etent authorities (CAs) were first harmonised at EU level; 
the legislator assumed that in those areas  operators benefiting from the added value 
represented by the assurances provided by the official cont rols should be called upon to 
compensate the costs incurred by the States because of such controls. 
The proposal maintains the system of mandatory  fees while introducing the changes necessary 
to address the shortcomings of th e current system. External research3 carried out in 2009 to 
evaluate the application of the financing mechanism estab lished by the Regulation indeed 
pointed to the existence of problems regarding the application of the relevant rules 
(Articles 26 to 29), and concluded that the overall objective of en suring that competent 
authorities are provided with adequate financial resources to perform official controls is not 
being met throughout the EU with a subsequent impact on delivery of  controls. It also pointed 
out the unfairness of a system of mandatory  fees whereby only ce rtain sectors would 
contribute to the financing of o fficial controls, and which woul d not discriminate effectively 
between compliant and non-compliant behavi our. The 2009 report recommended reviewing 
Articles 26 to 29 of the Regulation. 
Throughout the consultation period stakeholders have contribu ted fully, both to the evaluation 
studies and the preparation of the Impact Assessment (IA). 
1.2. Objectives of the proposal 
The general objectives of the revision coincide with the Treaty objectives to safeguard the 
single market while ensuring delivery of a high level of health protection. They also reflect 
                                                 
2 COM/2010/785/Final. 
3 'Fees or charges collected by Member States to cover the costs occasioned by official controls'. 
FCEC 2009. EN 4   EN the Commission's priority objective of ensuring pr oper enforcement of EU law, which is also 
the original objective of the Re gulation on official controls. 
More specifically, the proposal aims to modern ise and sharpen enforcement tools, and in 
particular official controls, as  laid down in the existing Regu lation, to simplify the legislative 
framework, make it easier to use and more efficient (for example with regard to 
administrative cooperation). As to the financing of official controls, the proposal aims to 
ensure the availability of stable and appropriate resources, ensure equity and fairness in the financing of official contro ls and improve transparency. 
Effective official controls are necessary to en sure the correct enforcem ent of the legislation 
which governs the 'agri-food chain', and thus to  ensure delivery on th e objectives above. 
The efficient operation of the EU system of offi cial controls is importa nt for both EU exports 
and imports. The EU's ability to export towards third countries relies on  the reputa tion of the 
high production standards and adde d value that the EU goods can prove to have compared to 
the ones produced outside Europe. This can onl y be achieved by reliable and trusted official 
controls which ensure that the EU agri-food chain safety  and quality standards are 
consistently enforced and corresponding e xpectations from trade partners met. 
As regards imports, it is essentia l that all food on th e EU market is safe. Controls performed 
by the MS CAs on goods arriving from third count ries offer adequate guarantees that they 
meet equivalent safety requirements. The releva nt import control rules must comply with the 
WTO Sanitary and Phytosanitary (SPS) Agreement, in particular with the provisions laid 
down in Annex C to the SPS Agreement. 
1.3. Regulatory Framework 
The responsibility to enfor ce EU agri-food chain legisla tion lies with the MS, whose 
authorities monitor and verify that the releva nt requirements are effectively applied, complied 
with and enforced across the Union. In doing th at they verify that operators' activities and 
goods placed on the EU market (either EU produ ced or imported from th ird countries) are in 
compliance with the relevant EU food  chain standards and requirements. 
Harmonised EU rules to govern o fficial control activit ies performed by MS are established in 
the Regulation with the aim of creating an in tegrated and uniform approach to official 
controls along the food chain. The Regulation provides for a ge neral 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 hist orical reasons official controls for animal 
health purposes (both on domestic and importe d goods) and official controls on residues of 
veterinary medicinal products, remained regul ated separately. More over, certain sectors 
pertaining to the food chain were not included in the scope of the Re gulation - i.e. plant 
health, plant reproductive material (PRM), anim al by-products (ABP) - and specific sectoral 
regimes were developed for them. 
This proposal intends to establis h a unique set of rules applicable to official controls in all 
these sectors. 
1.4. Consistency with other policie s and objectives of the Union 
This initiative pursues the objectives of the Communication on Smart Regulation in the 
European Union. One of the aims of the review is  to simplify legislativ e burdens in light of 
comments made by MS and food busine ss operators on the existing regime. EN 5   EN The proposal is consistent with the reviews of the animal health , the legislation on measures 
against pests of plants, and the PRM legisla tion, which are adopted by the Commission at the 
same time. It also intends to ensure that th e provisions of the Regulation complement in a 
consistent manner those applicab le to veterinary medicinal products, also currently being 
reviewed. A thorough analysis on the alignment of this EU sectoral legislation with 
overarching provisions of the Regulation was conducted so as to integrate the system of 
official controls in a manner that also consis tently accompanies the upgrade of EU policies in 
these sectors. 
The proposal also seeks to align the framewor k of official controls, in particular the 
terminology used, to the modernised customs code. 
With a view to the Europe 2020 strategy, the provision of effective controls along the food 
chain will ensure safe food and feed while fo stering competitiveness of business operators, 
rewarding compliant business operators and ensu ring user-pays principles across all sectors.  
To this end, the exemption of micro-enterpri ses from mandatory control fees fulfils the 
Commission’s commitment to lowe r the burden on very small busin esses, in line with its new 
policy on 'Minimizing regulatory burden for SM Es – Adapting EU regulation to the needs of 
micro-enterprises'4. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
2.1. Consultation process 
2.1.1. Consultation methods, main sectors targ eted and general pr ofile of respondents 
The Working Group created within the context of the Standing Committee for the Food Chain 
and Animal Health to discuss matters related to  the application of the Regulation met several 
times to discuss the on-going review. Member Stat es were also consulted in the context of 
two studies contracted out by the Commission in th e area of the financing of official controls 
(the 2009 study mentioned above, and a second in 2011 exploring further the shortcomings 
identified5). Member States have also been consulte d within other fora and frameworks on the 
following specific issues relating to  official controls: accreditat ion of official laboratories, 
official controls on residues of veterinary me dicinal products in live animals and animal 
products, veterinary border controls, animal  health, plant health and plant reproductive 
material. The main problems identified and the provisional options were  also presented and 
discussed at meetings of the Heads of Food Safe ty Agencies and servi ces on 29 June - 1 July 
2011 and on 8 December 2011. 
Stakeholders (industry association representati ves and NGOs) have been consulted during the 
evaluation studies and the preparation of the IA. Two ad hoc Working groups, on the review 
of the system of official controls and the revi ew of the rules governing the financing of such 
controls respectively, were convened under the Advisory Group on the Food Chain and 
Animal Health and Plant Health. Progress was also  presented and discussed in the plenaries of 
the aforementioned Advisory Group and on i nvitation at meetings of several industry 
representative bodies. In addition to discussi ons with MS, stakeholder consultation was an 
equally important element of the two external c ontractor studies on the financing of official 
controls. 
                                                 
4 COM (2011)803. 
5 'Preparatory work to support the impact assessment on reviewing the rules on the financing of official 
controls'. GHK Consulting Ltd working with ADAS UK Ltd. 2011. EN 6   EN 2.1.2. Data Collection 
Audit Reports by the Food and Veterinary Offi ce (FVO), the Commission service tasked with 
appraising Union controls in th e MS, were extensively used to inform the review. They 
provide information and data on the organisatio n and functioning of control systems in the 
Member States and on the application of agri -food legislation. The findings of each audit 
carried out by the FVO are set out in an audit report, which is made available to the public. 
As regards the financing of o fficial controls, the 2011 study highlighted the difficulty in 
obtaining exact figures from Member States to  quantify the overall control costs and the 
corresponding resourcing problem. However the re port did highlight the diverse spread of 
cost recovery within MS and certain probl ems with the application of EU rules. 
2.1.3. Summary of responses and how th ey have been taken into account 
All stakeholders and Member St ates welcomed the proposal to review the Regulation and the 
objective of establishing a clearer, simpler and more efficient legislative framework for the 
organisation of official contro ls and of other official activ ities along the entire agri-food 
chain, whilst taking into account the specificities  of each sector. Indeed, there was almost 
unanimous consensus that the review should take account of relevant official control rules in 
sectoral legislation and of any experience ga ined and lessons learnt since the Regulation 
entered into force.  
As regards the rules on the financing of official  controls, views varied according to the current 
practices in each Member Stat es and, from businesses' pers pective, on whether they are 
currently being charged or not through mandatory fees. 
If a general preoccupation emerged regarding the proposal to expand the list of mandatory 
fees, most respondents would agree as to the unfairness of collecting such fees only from 
certain operators and all would accept the importance of appropriately resourcing national 
control systems. The proposal was prepared with  a view to striking th e right policy balance, 
by ensuring that the new rules do not add an una ffordable or disproportio nate burden on each 
operator, whilst securing stable appropriate re venues for the competent authorities and their 
control systems. 
Both stakeholders and Member States agree th at the 'risk-based controls' principle in the 
Regulation (i.e. that where resources are finite  theses are to be used selectively and the 
selection should be based on the hazard and ri sks associated with the specific business 
activity, or product, the operator' s record of compliance and reli ability, indications of possible 
non-compliance) should be kept a nd reinforced, in particular in those areas were  current rules 
create obstacles to the efficient allocation of  control resources, namely border controls and 
controls on residues of veterinary medicinal pr oducts. The proposal does this by repealing the 
special rules governing the latter and by re placing the currently fr agmented framework 
applicable to official controls on different cat egories of products from third countries with a 
common set of rules. 
Member States and operators alike welcomed th e envisaged enhancements  to the transparency 
requirements laid down in the Regul ation. Thus, one of the specific objectives of the review is 
that the system of controls should provide MS with a clear guidance as to how they are 
expected to deliver on the obligation to ensure a 'high level of transparency' of their activities, 
so that citizens can have access to basic info rmation and data on enforcement work along the 
agri-food chain. Transparency was al so reported to be a concern in  relation to th e financing of 
official controls (the fees system), which shou ld be transparent and allow the public, and more 
specifically, the operators to understand how the fees are calculated and how revenue EN 7   EN therefrom is employed. Operators clearly see tr ansparency as a driver to accountability and 
efficiency of the system of of ficial controls as a whole. 
There was general agreement amongst industry c ontributors and Member States alike that 
steps should be taken to impr ove the functionality of admi nistrative assistance between 
Member States with a view to improving the main instrument through which cross border 
violations of food chain rules can  be investigated and pursued and application of Union rules 
made more effective. In response, the proposal  makes clear the respon sibility of Member 
States when the need for administrative assistance arises. 
2.2. Impact Assessment 
The options developed and assessed looked both at the design of the legislative framework 
and at the rules on the financi ng of national control systems. 
A preliminary analysis focused on two possible changes to the current rules on control fees, 
specifically aiming to: 
• repeal Union rules on control fees (thus leav ing it to MS to decide how to ensure the 
appropriate funding of control activities and whether to char ge inspection fees or not) 
[Option 1A], or  
• maintain current EU rules on fees, incl uding on mandatory fees, and exempting 
micro-enterprises6 therefrom [Option 1B]. 
Both abovementioned options would substantiall y alter the current framework as regards the 
financing of national control system s and were found not to be viable. 
The following options were further assessed by comparison with the status quo : 
Option 2 – Streamline.  The legislative framework is im proved by clarifying, simplifying and 
streamlining existing provisions on controls  in the sectors currently covered by the 
Regulation, and by ensuring full cost recovery wher e mandatory fees are al ready provided for, 
with the possibility for Member States to  refund fees paid by  micro-enterprises. 
Option 3 – Streamline + Integrate.  The legislative framework is improved and streamlined as 
described under Option 2, the scope of the Regulat ion is widened such that plant health and 
PRM, and animal by-products (ABP) are included (therefore completing the 'integration' of food chain official controls). Full cost recove ry is ensured where mandatory fees are already 
provided for in the existing Re gulation, as well as in the fi elds of plant health, where 
mandatory fees are introduced for official cont rols linked to plant passport obligations and 
PRM, where mandatory fees are introduced with regards to cert ification. Member States will 
have the possibility to refund f ees paid by micro-enterprises. 
Option 4 – Streamline + Inte grate + broader cost recovery.  The legislative framework is 
improved and streamlined, and plant health, PR M, and ABP are included in its scope as 
described under Option 3. Mandatory fees are ex tended to cover all controls performed on 
feed and food businesses registered and or  approved in accordance with food and feed 
hygiene Regulations as well as operators defined in plant health and PRM law. MS have the 
possibility to refund fees paid by micro-enterprises. 
Option 4 was retained and substantially in forms the present proposal. However, the 
exemption of micro-enterprises from mandato ry control fees is required to fulfil the 
                                                
 
6 Enterprises with less than 10 employees and or a turnover or balance sheet equal to or less than 
EUR 2 million. EN 8   EN Commission’s commitment to lowe r the burden on very small busin esses, in line with its new 
policy on 'Minimizing regulatory burden for SM Es – Adapting EU regulation to the needs of 
micro-enterprises'7. 
Therefore the (optional) refund mechanism desi gned to alleviate micro-enterprises from the 
financial burden of fees, has been replaced w ith a mandatory exemption of those enterprises 
from the fees. 
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
3.1. Legal basis 
The Regulation was based on Articles 37, 95 and 152(4)(b) of the EC Tr eaty, now Article 43, 
114 and 168(4)(b) respectively of the TFEU. Likewise, the propos al is based on these latter 
Articles. 
The Common Agricultural Policy (CAP), whic h is based on Article 43 of the TFEU, is 
qualified by the Lisbon Treaty as shared comp etence between the EU and its MS. However, 
the majority of agricultural activity, as well as ancillary activities upstream and downstream, 
have been regulated at the EU level. This mean s that legislation is pr edominantly a role for 
the institutions of the European Union. Ar ticle 114 provides the legal basis for the 
establishment and functioning of the internal market for food products while ensuring a high 
level of protection of consumers and the appr oximation of provisions laid down by the law, 
regulation or administrative actions  in this respect. Article 168(4 )(b) stipulates that in order to 
meet common safety concerns 'measures in the veterinary and phytosanitary fields which have 
as their direct objective the protection of public health' should be adopted by the EU. 
3.2. Subsidiarity principle 
The existence of a harmonised EU legislative framework to govern the organisation and 
performance of official controls along the f ood chain is necessary to ensure the uniform 
application of the agri-food chain rules acro ss the EU and the smooth functioning of the 
internal market. This rationale, which is stil l valid, underpins the exis ting 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 ach ieved by MS acting alone . The intervention of 
the European legislator is required. 
European added value test - The added value of  a single, uniform set of EU rules to govern 
official controls lies in the fact that it offers national enforcers (and their operators) a framework within which CAs can rely on enfor cement activities carried out in another MS, 
and on the reproducibility and scientific and tec hnical soundness of contro l results. It also 
ensures that EU agri-food chain standards necessa ry for the functioning of the single market 
are applied uniformly and consistently in the different Member States and sectors. 
As to the financing of controls, common EU rule s 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 (including the level of non-compliance). Pr ovisions on fees in part icular ensure that 
business activities monitored through dedicat ed national control systems, which benefit 
directly from efficiently performed controls, partic ipate to the financing of the latter, so as to 
minimise the dependency of control funding from public finances. Common EU rules are 
necessary also to prevent discriminatory treat ment between operators located in a Member 
State where the user-pays rule (and thus fees ) applies and those loca ted in a Member State 
                                                
 
7 COM (2011)803. EN 9   EN where this is not the case. Only common EU rules can ensure a uniform approach to pursue 
this objective. 
3.3. Proportionality principle 
EU action should not go beyond what is necessary  to achieve the objectives set. The present 
exercise has looked at a broad range of opti ons, including that of harmonising fee levels 
across Member States, and that of de-regulating  the matter. The analysis sought to design the 
most proportionate solution to ensure a sufficien t 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 specificiti es of their business population. 
3.4. Choice of instruments 
Proposed instrument: Regulation. 
Other types of measure would not be a ppropriate for the following reason(s). 
The existing provisions have been demonstrated  to provide an appropriate framework for MS, 
however despite this, inconsistency of interpre tation has arisen as discussed previously. A 
Directive would have led to still greater inco nsistency leading to un certainty for Member 
States' CAs and operators. A Regul ation provides a consistent approach for Member States to 
follow and reduces the administrative burden as operators do not need to familiarise themselves with the individual nationa l legislation in the Member States. 
Soft law instruments such as gui delines are considered not suffici ent to tackle differences in 
the interpretation and application of the legislation. 
4. BUDGETARY
 IMPLICATION 
The proposal does not imply incurring any expend iture which is not already foreseen in the 
financial statement of the common financial framework. No additiona l human resources are 
envisaged either. 
5. OPTIONAL  ELEMENTS   
TITLE I: SUBJECT MATTER, SCOPE, AND DEFINITIONS 
The scope of the Regulation will be expanded  to cover controls performed to verify 
compliance with the legislation concerning meas ures against pests of plants, rules governing 
the production, with a view of placing on the ma rket, of plant reproductive material and rules 
on animal by-products. 
Moreover, it will be clarified that certain Artic les of the Regulation also apply to official 
activities, other than official controls. These are the public interest activities entrusted to 
competent authorities of the MS for the purpos e of eliminating, containing or reducing risks 
which may arise for the health of humans, animal s or plants, or for the welfare of animals. 
These activities, which notably include vari ous modalities of surveying, surveillance and 
monitoring (including epidemiologic), and erad ication, containment, and other diseases 
control tasks, are governed by the same sectoral  rules which are enforced through the official 
controls. 
Existing definitions will be adjusted to give account of the broader scope of the Regulation in 
terms of sectors and activities covered by it. New definitions will be introduced, some by 
cross-referring to sectoral rules. EN 10   EN Finally, it will be clarified that the Regulation shall also apply to official controls performed 
for the verification of the requirements appli cable to animals and goods arriving from third 
countries, and to animals and goods to be exported to third countries. 
Empowerment provisions will allow the Comm ission to adopt delegated acts to lay down 
sector specific rules for such goods in order to take account of the specific official controls 
needs of certain areas of the agri-f ood chain and of risks to health. 
TITLE II: OFFICIAL CONTRO LS AND OTHER OFFICIAL 
ACTIVITIES IN MEMBER STATES 
CHAPTER I: COMPETENT AUTHORITIES  
The structure of this Chapter wi ll remain largely unaltered. Th e terminology will be adjusted 
to give account of the broader scope of the Regul ation (both in terms of sectors and activities 
covered). However, some changes will be ne cessary to address certa in shortcomings and 
provide the competent authorities with the most efficient tools to perform official controls and 
other official activities. 
CHAPTER II: SAMPLING , ANALYSIS , TESTING AND DIAGNOSIS . 
The existing provisions on the second expert opinion will be clarified so th at this right will be 
applicable in the case of official controls on ly and that it includes each time, a documentary 
review of the sampling, analysis , testing or diagnosis by anothe r expert and, where relevant 
and technically feasible, a sufficient number of  other samples offered to the operator for 
another expert opinion or, if this  is not possible, another analysis , test or diagnosis carried out 
on the existing sample. An empowerment will allow the Commission to adopt implementing 
rules in order to ensure  a uniform application. 
Requirements on methods of sampling and of labor atory analysis, testin g and diagnosis will 
become applicable to official controls and to ot her official activities in all the sectors covered 
by the Regulation (e.g. to surveillan ce, monitoring and survey activ ities in the plant health and 
animal health sectors). A 5 years transitional peri od will thus be foreseen for the plant health 
and plant propagating material sectors. 
The rules for the choice of the method to be us ed by the official laboratory will be clarified 
and extended so as to require that methods meet state-of-the-a rt scientific standards, and 
satisfy the analytical, testing and diagnostic need of the laborato ry concerned and to 
incorporate methods validated by European or national reference laborat ories. In the context 
of screening, targeted screening and other offici al activities and in the absence of Union rules 
on methods or performance criteria on methods, it will be furthermore possible to use any of 
the methods prescribed by the cascade. 
The accreditation according to EN ISO/IEC 17025 on 'General requirements for the 
competence of testing and calibration laboratori es' will remain a mandatory condition for the 
designation of official la boratories. In this regard, it will be clarified that the scope of the 
accreditation shall include all th e methods used by the laboratory for analysis, testing or 
diagnosis when operating as an official la boratory (with the exception of cases to be 
specifically identified by secondary legislation – for instance in the plant health sector - where 
the scope of accreditation could be limited to th e analytical, testing or diagnostic methods 
which are the most significant and representative ). The inclusion of pl ant health under the EN 11   EN scope of the Regulation will imply that official  laboratories carrying out analysis, testing or 
diagnosis in this sector will have to be accredited according to EN ISO/IEC 17025. A five 
years transitional period will be thus  foreseen for these laboratories. 
The temporary designation of an official labor atory for the use of a method required for 
laboratory analysis, testing or diagnosis not included in its scope of accreditation will be 
possible (for a period of one year renewable once) when the use of the method is newly 
required by Union legislation, wh ere changes of the method in use require a new accreditation 
or an extension of the scope of the accreditatio n already obtained by the laboratory, and in 
emergency situations or in cases of emerging risks where the sudden increase of analytical, 
testing or diagnostic needs requires the urgent use by official laboratories of a method which 
is not included in their scope of accreditation. 
Derogations from the accreditation requirement will be introduced for laboratories which only 
carry out detection of Trichinella in meat and use only the methods prescribed by Union rules, 
for laboratories performing analyses or tests on plant reproductive materials other than plant 
health analysis, testing or diagnosis, and for certain laboratories only carrying out analysis, 
testing or diagnosis in the contex t of other official activities. 
CHAPTER III:  OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE 
UNION  
Chapter V of Regulation (EC) No  882/2004 will be redrafted in order to create a common set 
of rules applicable to all c ontrols performed on animals and goods entering the Union. An 
integrated approach will increase efficiency savi ngs and should help in prioritising controls on 
the basis of risk. As noted below the Chapte r is likely to be substantially altered. 
Firstly, provisions largely mirroring the cu rrent Articles 15 and 16 of Regulation (EC) 
No 882/2004 (to be deleted) will be inserted. Some adjustments will be made to align the said 
provisions to the modernised customs code and to guarantee that sectoral specificities are 
accounted for. 
Secondly, a specific section will consolidate curre nt legislation and lay down the categories of 
animals and goods arriving from third countries th at require controls at  entry into the Union. 
Empowerments will allow the Commission to m odify the abovementioned categories and to 
establish a list detailing whic h specific animals and goods (inc luding their respective CN 
codes) should be controlled. The Commission will al so be given the power to define the cases 
and conditions under which animals and goods can be exempted from said controls. 
Border Control Posts (BCPs) w ill replace the different entities currently tasked with border 
control duties. Common requirements for BCPs sh all be established with the possibility for 
the Commission to further refine such requirements to take account of specific features related 
to the different categories of animals and goods being controlled. Harmonised rules for the 
designation, listing, withdrawal and suspen sion of BCPs will also be laid down. 
A Common Health Entry Document  (CHED) will be established and governed by rules based 
on current practices. The CHED will be us ed by operators for the mandatory prior notification 
of arrival of consignments of animals and goods and by competent authorities to record 
controls on such consignments and any decisi ons taken. The Commissi on shall be empowered 
to establish the format of the CHED, the modalities for its use,  and the minimum time 
requirements for the prior notification of consignments to Border Control Posts. EN 12   EN A common set of rules for controls on cons ignments (including those of a non-commercial 
nature) of animals and goods subject to controls  at borders will also be laid down. Controls 
will, in principle, be performed by the BCP au thorities to whom the consignment is first 
presented although the Commission will be allowed to establish exceptions to this rule in certain cases. All consignments shall be subj ect to documentary and identity checks whilst 
physical checks will be performed at a frequenc y depending on the risk posed by each specific 
animal/good or category of animals/goods. Empowerments will, inter alia, allow the Commission to detail how documentary, identit y and physical checks should be performed 
and to establish reduced frequencie s for identity and physical checks. 
Thirdly, the provisions detailing the actions to be taken in case of suspicion and in case of 
non-compliant consignments will be amended. Changes will aim to increase efficiency by 
simplifying the decision-making of BCPs, clarif ying the steps that the competent authorities 
of such BCPs should take and by ensuring that the specificities of the sectors being brought 
under the Regulation are fully taken into account. Su ch rules will also be applicable to official 
controls performed on animals and goods arriving from third countries which are not subject 
to specific contro ls at borders. 
Finally , a new provision will be introduced to require close cooperation between  competent 
authorities, customs authorities and other authorities involved in  the handling of animals and 
goods arriving from third countries. Moreover,  an empowerment will allow the Commission 
to establish the modalities of coope ration between the said authori ties with a view to ensuring 
the timely and proper access to information, the synchronisation of releva nt data sets, and the 
rapid communication of decisions taken. 
CHAPTER IV: FINANCING OF OFFICIAL CONTROLS  
The general principle of the existing Regulatio n will be retained. MS will continue to be 
required to ensure that adequate financial resour ces are available to provide the staff and other 
resources necessary to the competent authoritie s to perform official controls and the other 
activities referred to in the Regulation. 
As it is the case under the current rules, Member  States will decide at what level (local, 
regional, national) the fees ar e established and collected, de pending on the organisation of 
their competent authorities. 
Under new provisions, mandatory fees will be  collected to cover the costs occasioned by: 
• official control activities performed on f ood and feed businesses registered and or 
approved under either or both of Regul ation (EC) No 852/2004 (food hygiene) and 
Regulation (EC) No 183/2005 (feed hygiene) , on operators defined in the future 
Plant Health Regulation and on those defi ned in the future Regulation on Plant 
Reproductive Material, in order to verify compliance with Union 'agri-food chain' 
rules (feed and food law, animal health a nd animal welfare, pl ant heath and plant 
reproductive material rules); 
• controls performed in view of issuing an official certificate or to supervise the 
issuance of an official at testation of compliance; 
• official control activities performed to verify that the conditions to obtain or maintain 
approval are met; EN 13   EN • official control activities perf ormed with respect to border controls (including cost of 
controls with regard to plant health requi rements, which will be transferred to the 
new official controls regulation); 
• official control activities pe rformed to verify complian ce with emergency measures 
adopted by the Commission in accordance with so ca lled 'safeguard' provisions, 
where the decision establishing the measures so requires. 
Mandatory fee levels shall be calculated so as to enable the competen t authorities performing 
the official control activities to fully recover costs resulting from official controls (if the 
competent authority for which the fees are collec ted also performs othe r activities, then only 
the fraction of the relevant cost  elements which results from of ficial control activities should 
be considered for the calculation of fees). 
A new provision will ensure that operators charged a flat-rate f ee will benefit from 
recognition of good performance by requiring that the rate of fee app lied to each operator 
shall be adjusted to take account  of the operator's record of co mpliance as ascertained through 
official controls. As a rule, fees applied to consistently compliant operators should be lower 
than those applied to  non-compliant ones. 
Existing provisions that prohibit the refund – direct or indirect - of mandatory fees will be 
retained (unless of course the fees were unduly collected).  
Enterprises employing fewer than 10 persons and whose annual turnover or balance sheet 
does not exceed EUR 2 million (micro-businesses)  will be exempted from the payment of 
mandatory fees. 
Underpinning the provisions on the financing of official controls  will be the requirement that 
competent authorities shall ensure the highest le vel of transparency of the method and data 
used to establish fees, and of the use of resources collected through such fees. 
The current provisions with regard  to expenses arising from add itional official controls due to 
non-compliance with enforcement measures (Ar ticle 28 of the Regulation) will be made 
clearer in order to ensure effective use by Member States. 
CHAPTER V: OFFICIAL CERTIFICATION  
The definition of 'official certification' and the relevant provisions will be amended to ensure 
that the Regulation is the general framework for official certification as regards all sectors covered by the Regulation. 
TITLE III: REFERENCE LABO RATORIES AND CENTRES 
As a consequence of the extension of scope of the Regulation to new sectors (measures 
against pests of plants; rules governing the production, with a vi ew of placing on the market, 
of plant reproductive material; animal by- products rules), it will be possible for the 
Commission to establish European Union refere nce laboratories (EURLs) in those sectors. 
The obligations for Member States to designat e national reference laboratories (NRLs) for 
each EURL designated by the Commission will follow accordingly. 
It will also be possible for the Commission to designate European Union reference centres for 
the production and marketing of plant reproductiv e material and for animal welfare. These 
centres will in particular provi de technical expertise, conduct training courses and contribute 
to the dissemination of research fi ndings and technical innovations. EN 14   EN TITLE IV: ADMINISTRATIVE AS SISTANCE AND COOPERATION 
The administrative assistance and cooperation provisions of the Regul ation will be re-
enforced and clarified so as to increase their usability and effectiveness as a tool for tackling cross-border non-compliances. Several cha nges are envisaged in this respect. 
First of all, competent authori ties will be required to provid e each other with administrative 
assistance where necessary to ensure the correct  application of Union rules. The requirement 
for all communications to be in writing will also be introduced. Moreover, the Commission 
will be empowered to establish a standard format for requests for assistance and for 
communication exchanges. 
Secondly, the role of liaison bodi es will be clarified and th e need for administrative 
assistance/cooperation to be 'channelled' throu gh such bodies will be made explicit. The 
Commission will be required to publish and update  the list of liaison bodies on its website. An 
empowerment will also allow it to establ ish minimum requirements for liaison bodies. 
Thirdly, the modalities for requesting administra tive assistance and for activating cooperation 
procedures will be simplified (where necessary ) and the actions that competent authorities 
must take following requests for assistance shall be defined. 
Finally, the cases in which the Commission is re quired to coordinate ad ministrative assistance 
and cooperation, and the actions that it can take  in such circumstances, will be clarified. 
TITLE V: PLANNING  AND REPORTING 
The Multi-annual national cont rol plan (MANCP) w ill remain a document produced and 
owned by the MS which they will use to assist  the competent authorities in ensuring the 
delivery of official controls in compliance with Union law. 
A new provision requiring Member  States to designate the single competent authority 
responsible for coordinating the preparation of the MANCP and ensuring the coherence of 
such plan will be created. 
With regard to annual reports a revised Arti cle 44 will provide for an empowerment for the 
Commission to progressively a dopt standardised templates ta king duly into account, where 
appropriate, existing reporting requirements. 
TITLE VI: UNION ACTIVITIES 
This title will continue to govern a number of activities at Union level: 
• controls by the Commission's Food and Vete rinary Office (FVO) in Member States 
and in third countries; 
• the procedures (clarified and streamlined) for the establishment of requirements for 
the entry of certain categories of goods from  third countries into the Union, and of 
measures regarding certain goods form certain  specific third countri es in cases where 
there is evidence that the entry into the Union of those goods may pose a risk to 
human, animal or plant health or, as rega rds GMOs and plant pr otection products, to 
the environment, or where there is eviden ce that widespread serious non-compliance 
with Union rules might be taking place; EN 15   EN • the organisation by the Commission of tr aining for the staff of the competent 
authorities in the Member States and in th ird countries (the current programme Better 
Training for Safer Food), and of programme s for the exchange of staff between 
Member States (new activity, to be orga nised in cooperation with Member States). 
This title will also include the creation of an integrated information management system for 
official controls, which will allow the integr ated operation and update of all existing and 
future computerised systems through which information, data and documents regarding 
official controls are exchanged among competen t authorities, and with the Commission (and 
operators where appropriate). 
TITLE VII: ENFORCEMENT MEASURES 
Provisions governing national enfo rcement measures will be appli cable to all the sectors of 
the scope of the Regulation. 
A new provision dealing specifi cally with actions to be take n in case of suspicion of non-
compliance will be included, requiring competent au thority to carry out investigations in order 
to confirm or to eliminate the suspicion or doubt. 
The list of possible measures in case of established non-co mpliance will furthermore be 
completed: restriction or pr ohibition of movement s of animals, imposition of quarantine 
periods, slaughter or killing of animals, postpone ment of slaughter of animals, isolation or 
closure of establishments, closure of website s will for instance be added to the list. 
A new provision in former Artic le 55 (on sanctions for non-compliance) will require MS to 
ensure that financial penaltie s applicable to intentional in fringements offset the economic 
advantage sought by the perpetrator of the viola tion. Member States will also be required to 
ensure the application of appropr iate criminal and/or administra tive penalties to operators who 
fail to cooperate during an official control. EN 16   EN 2013/0140 (COD) 
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) 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 43(2), 114 and 168(4)(b) thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the Eu ropean Economic and Social Committee8, 
Having regard to the opinion of  the Committee of the Regions9, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) The Treaty requires a high level of human  health protection to be ensured in the 
definition and implementation of all Union pol icies and activities. The achievement of 
that objective should,  inter alia, be pursued via m easures in the veterinary and 
phytosanitary fields which have as their direct objective the protection of human 
health. 
(2) The Treaty also provides that the Union is  to contribute to the attainment of a high 
level of consumer protection by the measures  it adopts in the context of the completion 
of the internal market. 
(3) Union legislation provides for a set of harmonised rules to  ensure that food and feed 
are safe and wholesome and that activities which might have an impact on the safety 
of the food chain or on the protection of consumers interests in relation to food and 
food information are performed in accordance  with specific requirements. Union rules 
exist also to ensure a high level of human, animal and plant health and animal welfare 
                                                
 
8 OJ C , , p. . 
9 OJ C , , p. . EN 17   EN along the food chain and in all those areas of activity where a key objective is the fight 
against the possible spread of animal diseas es, in some cases transmissible to humans, 
or of pests injurious to plants or plant products, and to ensure the protection of the 
environment from risks that might arise from GMOs and plant protection products. 
Union rules also guarantee the identity and quality of plant reproductive material. The 
correct application of those rules, hereinafter collectively referred to as 'Union agri-
food chain legislation', cont ributes to the functioning of the internal market. 
(4) The basic Union rules with regard to food and feed law are laid down in 
Regulation (EC) No 178/2002 of the Europe an Parliament and of the Council of 
28 January 2002 laying down the general prin ciples and requireme nts of food law, 
establishing the European Food Safety Author ity and setting out procedures in matters 
of food safety10. In addition to those rules, more  specific food and feed law covers 
different areas such as animal nutrition, in cluding medicated feedingstuffs, food and 
feed hygiene, zoonoses, animal by-products , residues of veterinary medicinal 
products, contaminants, control and eradica tion of animal diseases with a human 
health impact, food and feed labelling, plant protection products, food and feed 
additives, vitamins, mineral salts, trace el ements and other additives, food contact 
materials, quality and com positional requirements, drinki ng water, ionisation, novel 
foods and genetically modified organisms (GMOs). 
(5) Union legislation on animal health aims to  ensure high standards of human and animal 
health in the Union, the rational developm ent of the agriculture and aquaculture 
sectors and to increase producti vity. That legislation is nece ssary to contri bute to the 
completion of the internal market in anim als and animal products  and to avoid the 
spread of infectious diseases  of Union concern. It covers areas such as intra-Union 
trade, entry into the Union, di sease eradication, veterinary controls and notification of 
diseases, and also contributes to  the safety of food and feed. 
(6) Article 13 of the Treaty recognises that an imals are sentient bei ngs. Union legislation 
on animal welfare requires animal owners, animal keepers and competent authorities to respect animal welfare requirements  guaranteeing their humane treatment and 
avoiding them unnecessary pain and sufferi ng. Such rules are based on scientific 
evidence and may indirectly improve the quality and safety of food and feed. 
(7) Union legislation on plant health regulates the entry, establishment and spread of pests 
of plants that do not exist, or  are not widely present, in the Union. Its objective is to 
protect the health of Union crops and of public and priv ate green space and forests 
while simultaneously safeguarding the Union’s biodiversity and environment and guaranteeing the quality and safety of  food and feed made from plants. 
(8) Union legislation on plant reproductive mate rial regulates the production with a view 
to placing on the market, and the placing on the market, of plant reproductive material 
of agricultural, vegetable, forest, fruit a nd ornamental species and vines. The objective 
of those rules is to ensure the identity, heal th and quality of plan t reproductive material 
for its users, and the produc tivity, diversity, health and qua lity of the agri-food chain 
as well as contribu ting to the protection of biodi versity and the environment. 
(9) Union legislation on organic production a nd labelling of organic products provides a 
basis for the sustainable development of or ganic production and aims to contribute to 
                                                
 
10 OJ L 31, 1.2.2002, p. 1. EN 18   EN the protection of natural resources, biodiversity and animal welfare, and the 
development of rural areas. 
(10) Union legislation on agricultural quali ty schemes for agricultural products and 
foodstuffs identifies products and foods tuffs farmed and produced to exact 
specifications whilst encouraging diverse agricultural production, protecting product 
names and informing consumers about the spec ific character of ag ricultural products 
and foodstuffs. 
(11) Union agri-food chain legisla tion is based on the principle that operators at all stages 
of production, processing and distribution w ithin the businesses under their control are 
responsible for ensuring th at the requirements establis hed by Union agri-food chain 
legislation and which are relevant to their activities are fulfilled. 
(12) The responsibility to enforce Union ag ri-food chain legislation lies with Member 
States, whose competent authorities monito r and verify, through the organisation of 
official controls, that relevant Union re quirements are effectively complied with and 
enforced. 
(13) Regulation (EC) No 882/2004 of the Eur opean Parliament and of the Council of 
29 April 2004 on official controls performed to ensure the verification of compliance 
with food and feed law, animal health and animal welfare rules11 has established a 
single legislative framework for the organisati on of official controls. That framework 
has significantly improved the efficiency of  official controls, the enforcement of 
Union agri-food chain legislation and the le vel of protection agai nst risks to human, 
animal and plant health and animal welfare in the Union and the le vel of protection of 
the environment from risks that might aris e from GMOs and plan t protection products. 
It has also provided a consolid ated legal framework to suppo rt an integrated approach 
towards the performance of official controls along th e agri-food chain. 
(14) There are a number of pr ovisions in Union agri-food chai n legislation, the enforcement 
of which has not, or has only partia lly, been governed by Regulation (EC) 
No 882/2004. In particular, specific official c ontrol rules were kept in place in Union 
legislation on plant reproductive material and in Regulation (EC)  No 1069/2009 of the 
European Parliament and of the Council of 21 October 2009 laying down health rules 
as regards animal by-products and de rived products not intended for human 
consumption and repealing Regulation (EC) No 1774/200212. Plant health also largely 
falls outside the scope of Regulation (EC) No 882/2004 with certain rules on official 
controls being laid down in Counc il Directive 2000/29/EC of 8 May 2000 on 
protective measures against the introduction into the Community of organisms harmful 
to plants or plant products and agai nst their spread w ithin the Community13. 
(15) Council Directive 96/23/ EC of 29 April 1996 on measures to monitor certain 
substances and residues thereof in live an imals and animal products and repealing 
Directives 85/358/EEC a nd 86/469/EEC and Decisions  89/187/EEC and 91/664/EEC14 
also provides for a very de tailed set of rules that establish among other things 
minimum frequencies of offici al controls and specific enforcement measures to be 
adopted in cases of non-compliance. 
                                                 
11 OJ L 165, 30.4.2004, p. 1. 
12 OJ L 300, 14.11.2009, p. 1. 
13 OJ L 169, 10.7.2000, p. 1. 
14 OJ L 125, 23.5.1996, p. 10. EN 19   EN (16) In order to rationalise and simplif y the overall legislative framework, whilst 
simultaneously pursuing the obj ective of better regulation, the rules applicable to 
official controls in specific areas shoul d be integrated into  a single legislative 
framework for official controls. For th at purpose, Regulatio n (EC) No 882/2004 and 
other acts currently governing official contro ls in specific areas should be repealed and 
replaced by this Regulation. 
(17) This Regulation should seek to esta blish a harmonised Union framework for the 
organisation of official contro ls, and official activities other than official controls, 
along the entire agri-food chain, taking into acco unt the rules on official controls laid 
down in Regulation (EC) No 882/2004 and in relevant sectoral legislation, and the 
experience gained from their application. 
(18) For the verification of compliance with  the rules on the common organisation of the 
markets of agricultura l products (arable crops, wine, o live oil, fruit and vegetables, 
hops, milk and milk products, beef and veal, sheepmeat and goatmeat and honey), a well-established and specific control system  is already in plac e. This Regulation 
should therefore not apply to the verifica tion of compliance with  the provisions of 
Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common 
organisation of agricultural ma rkets and on specific  provisions for certain agricultural 
products (Single CMO Regulation)
15. 
(19) Certain definitions currently set ou t in Regulation (EC) No 882/2004 should be 
adapted to take account of the broader scope  of this Regulation, to align them with 
those set out in other Union acts, and to  clarify or, where appropriate, replace 
terminology having different mean ings in different sectors. 
(20) Union agri-food chain legislation entrusts  the competent author ities of the Member 
States with specialised tasks to be carried out for the protection of  animal health, plant 
health and animal welfare, for the protection of the environment in relation to GMOs and plant protection products, and in order to  ensure the identity and a high quality of 
plant reproductive material. Those tasks ar e the public interest activities which the 
competent authorities of the Member St ates must carry out for the purpose of 
eliminating, containing or reducing risks wh ich may arise for human, animal or plant 
health, animal welfare, or for the environm ent. Those activities, which include product 
approval, surveying, surveillance and monitoring including for epidemiologic 
purposes, and the eradication and containment of diseases, and other disease control 
tasks, are governed by the same sectoral ru les which are enforced through the official 
controls. 
(21) Competent authorities should be designa ted by the Member States in all the areas 
falling within the scope of this Regulation. While Member States are best placed to 
decide which competent authority or author ities to designate for each area, and at 
which level of the administration, they should also be required to  designate a single 
authority that in each area ensures appr opriately coordinated communication with 
other Member States' competent au thorities and with the Commission. 
(22) Member States should be allowed to c onfer upon designated comp etent authorities the 
responsibility for official controls in relati on to Union rules, incl uding rules regarding 
alien species which may harm agricultural production or the environment by their 
invasive character, other than those falli ng within the scope of this Regulation. 
                                                
 
15 OJ L 299, 16.11.2007, p. 1. EN 20   EN (23) For the performance of official controls aimed at verifying the correct application of 
Union agri-food chain legislation, and of th e other official activities entrusted to 
Member State authorities by Union agri-food chain legislation, Member States should 
designate competent authorities which act in the public interest, are appropriately 
resourced and equipped, and offer guarantees  of impartiality and professionalism. 
Competent authorities should ensure the qua lity, consistency and effectiveness of 
official controls. 
(24) The correct application and enforcement of  the rules falling within the scope of this 
Regulation requires appropriate  knowledge of both such ru les and the rules of this 
Regulation. It is therefore important that the staff performing o fficial controls and 
other official activities is regularly traine d on the applicable le gislation, according to 
their area of competence, as well as on th e obligations resulting from this Regulation. 
(25) Operators should have a right to appeal  against the decisions taken by the competent 
authorities, and be inform ed of such a right. 
(26) The competent authorities should ensure th at staff responsible for official controls 
does not disclose information acquired during the performance of such controls which 
is covered by professional secrecy. Unless th ere is an overriding interest justifying 
disclosure, professional s ecrecy should include information which would undermine 
the purpose of inspections, investigations or audits, the prot ection of commercial 
interests and the protection of court pr oceedings and legal advice. However, 
professional secrecy should not prevent comp etent authorities from disclosing factual 
information on the outcome of official cont rols regarding indivi dual operators when 
the operator concerned has been allowed to  comment upon it prior to the disclosure 
and such comments have been taken into account, or released alongside the 
information being divulged by the competent authorities. The need to respect professional secrecy is also without prejudice to the oblig ation to inform the general 
public where there are reasonable grounds to suspect that food or feed may present a 
risk for health in accordance with Ar ticle 10 of Regulation (EC) No 178/2002. 
The obligation for competent authorities to inform the general public in cases where 
there are reasonable grounds to suspect that  a food or feed may present a risk for 
human or animal health, in accordance with Article 10 of Regulation (EC) 
No 178/2002, and the right of i ndividuals to the pr otection of their personal data as 
provided for in Directive 95/46/EC of the Eu ropean Parliament and of the Council of 
24 October 1995 on the protection of individu als with regard to the processing of 
personal data and on the free movement of such data
16 should not be affected by this 
Regulation. 
(27) Competent authorities shoul d perform official controls re gularly, on all the sectors and 
in relation to all operators , activities, animal s and goods governed by Union agri-food 
chain legislation. The frequenc y of official controls sh ould be established by the 
competent authorities having rega rd to the need to adjust the control effort to the risk 
and to the level of compliance expected in  the different situations. In some cases, 
however, Union agri-food chain legislation requir es that official controls be performed 
irrespective of the level of ri sk or expected non-compliance in  view of the issuance of 
an official certificate or attestation whic h is a pre-requisite for the placing on the 
market or for the movements of animals or  goods. In such cases the frequency of the 
official controls is dictated by the certification or attestation needs. 
                                                 
16 OJ L 281, 23.11.1995, p. 31. EN 21   EN (28) To preserve the effectiveness of official controls in the verification of compliance, no 
warning should be given prior to performing controls, unless the nature of the official 
control activities requires otherwise (as is notably the case of audit activities). 
(29) Official controls should be thorough and effective and should ensure that Union 
legislation is applied correctly. Given that official controls may represent a burden for 
operators, competent authoritie s should organise and conduct  official cont rol activities 
taking their interests into account and limiting the said burden to what is necessary for 
the performance of efficient and effective official controls. 
(30) Official controls should be performed with the same level of care by the competent 
authorities of the Member State irrespective of whether the rules being enforced apply 
to activities which are only relevant on th e territory of that Member State or to 
activities which will have an impact on the compliance with Union legislation of 
animals and goods which are to be moved or  placed on the market in another Member 
State or exported outside the Union. In the latter case, competent authorities may also 
be required, in accordance with Union legisl ation, to verify the conformity of animals 
and goods with requirements established by th e third country of destination of such 
animals or goods. 
(31) To ensure that the Union agri-food chain rules are correctly enforced, the competent 
authorities should have the power to perfor m official controls at all stages of 
production, processing and distri bution of animals and goods concerned by such rules. 
To ensure that official c ontrols are thoroughly conducted an d effective, the competent 
authorities should also have th e power to perform official controls at all stages of 
production and distribution of goods, substanc es, materials or objects which are not 
governed by agri-food chain rules (for ex ample, of veterinary medicinal products) 
insofar as this is necessary to fully investig ate possible violations of those rules and to 
identify the cause of any such violation. 
(32) The competent authorities act in the inte rest of operators and of the general public 
ensuring that the high standards of protec tion established by Union agri-food chain 
legislation are consistently preserved and protected through appropriate enforcement 
action, and that compliance with such rule s is ascertained across the entire agri-food 
chain through official controls. The co mpetent authorities should therefore be 
accountable to the operators and to the general public for the efficiency and effectiveness of the official controls th ey perform. They s hould provide access to 
information concerning the organisation and pe rformance of official controls and other 
official activities, and regularly publish info rmation concerning official controls and 
the results therefrom. Compet ent authorities should also, subject to certain conditions, 
be entitled to publish or to make availabl e information about the rating of individual 
operators based on the outcome of official controls. 
(33) It is of the utmost importance that competent authorities ensure and verify the 
effectiveness and the consistency of the of ficial controls they perform. For that 
purpose they should act on the basis of wr itten documented procedures and should 
provide detailed information and instructions  to staff performing official controls. 
They should also have appropriate pro cedures and mechanisms in place to 
continuously verify that their own action is effective and consistent, and take 
corrective action when shor tcomings are identified. 
(34) To facilitate the identification of non-compliances and streamline the taking of 
corrective action by the operato r concerned, the outcome of o fficial controls should be EN 22   EN recorded in a report, a copy of which should be given to the operator. Where official 
controls require the conti nuous or regular presence of the staff of the competent 
authorities to monitor the operator's activities, a report of each individual inspection or visit to the operator would be disproportio nate. In such cases reports should be 
prepared with a frequency that enables the competent authorities and the operator to be 
regularly informed of the level of comp liance and immediatel y notified of any 
identified shortcomings. 
(35) Operators should cooperate fully with co mpetent authorities and delegated bodies to 
ensure the smooth performance of official  controls and to enable the competent 
authorities to perform other official activities. 
(36) This Regulation establis hes a single legislative framew ork for the organisation of 
official controls to verify compliance with  agri-food chain rules in all the areas that 
such rules cover. In some of those ar eas, Union legislation lays down detailed 
requirements to be complied with which requi re special skills and specific means for 
the performance of official controls. To avoid diverging enforcement practices which 
could generate uneven protec tion of human, animal and plant health, animal welfare 
and, as regards GMOs and plant protection pr oducts, of the environment, disrupt the 
functioning of the inte rnal market for animals and goods  falling within the scope of 
this Regulation and distort competition, the Commission should be able to supplement 
the rules laid down in this Regulation thr ough the adoption of specific official control 
rules capable of catering for the needs of cont rols of those areas. In particular, such 
rules should lay down specific requirements for the performance of official controls 
and minimum frequencies for such controls, specific or additional measures to those 
provided for in this Regulation that competent authorities should take in relation to non-compliances, specific responsibilities and tasks of the competent authorities in 
addition to those provided for in this Regulat ion and specific criter ia for triggering the 
administrative assistance mechanisms provide d for in this Regula tion. In other cases, 
such additional rules might become necessa ry in order to provide a more detailed 
framework for the performance of official co ntrols in relation to food and feed, where 
new information emerges about risks to human  or animal health or, in relation to 
GMOs and plant protection products to the en vironment, indicating that in the absence 
of common specifications for the performance of official controls across the Member 
States, the controls would fail to deliver th e expected level of protection against those 
risks, as provided for by Union agri-food chain legislation. 
(37) The competent authorities should be able to delegate some of their tasks to other 
bodies. Appropriate conditions should be laid  down to guarantee that the impartiality, 
quality and consistency of the official contro ls and of the other official activities are 
preserved. The delegated body should in part icular be accredited according to the 
ISO standard for the performance of inspections. 
(38) To ensure the reliability and consistenc y of official controls  and other official 
activities across the Union, the methods used for sampling and for laboratory analyses, tests and diagnoses should meet  state-of-the-art scientif ic standards, satisfy the 
specific analytical, testing and diagnostic need of the laboratory concerned, and offer 
sound and reliable analytical, test and di agnostic results. Cl ear rules should be 
established for the choice of the method to be used where more than one is available 
from different sources, such as the Inte rnational Organisation for Standardisation 
(ISO), the European and Mediterranean Pl ant Protection Organi sation (EPPO), the EN 23   EN International Plant Protection Convention (I PPC), the World Organisation for Animal 
Health (OIE), European Union and national reference laboratories, or national rules. 
(39) Operators whose animals or goods are subj ect to sampling, analysis, test or diagnosis 
in the context of official controls should have the right to apply for a second expert 
opinion which should include the taking of  a second sample for the purposes of 
counter-analysis, counter-test or counter-d iagnosis unless any such second sampling is 
technically impossible or irre levant. Such would be the ca se, in particular, where the 
prevalence of the hazard is particularly lo w in the animal or good or its distribution 
particularly sparse or irre gular. The IPPC for that reas on rejects the use of counter-
samples for assessing the pres ence of quarantine organisms in plants or plant products. 
(40) For the purposes of perf orming official controls on trad e which takes place through the 
internet or other remote means, competent au thorities should be able to obtain samples 
through anonymously placed orders (also know n as mystery shopping) which can then 
be analysed, tested or subject to a verifica tion of compliance. All steps should be taken 
by the competent authorities to preserve the rights of the operators to a second expert 
opinion. 
(41) Laboratories designated by the competent authorities to carry out analyses, tests and 
diagnoses on samples taken in the context of official controls and other official 
activities should possess the expe rtise, equipment, infrastruc ture and staff to carry out 
such tasks to the highest standards. To ensure sound and reliable results, those 
laboratories should be accredite d for the use of these methods according to standard 
EN ISO/IEC 17025 on 'General requirement s for the competence of testing and 
calibration laboratories'. The accreditati on should be delivered by a national 
accreditation body operating in accordance with  Regulation (EC) No 765/2008 of the 
European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance re lating to the marketing of products and 
repealing Regulation (EEC) No 339/93
17. 
(42) While accreditation is the instrument of c hoice to ensure state-of-the-art performance 
by official laboratories, it is also a complex and costly process, which would result in a 
disproportionate burden for the laboratory in cases where the method of laboratory 
analysis, test or diagnosis is particular ly simple to perform and does not require 
specialised procedures or equipment, as is the case for the detection of Trichinella in 
the context of the inspection, in cases wh ere the analyses or tests performed only 
concern qualitative aspects of plant re productive material, and, under certain 
conditions, in cases where the laboratory onl y carries out analyses, tests or diagnoses 
in the context of other official activ ities and not of official controls. 
(43) In order to ensure flexib ility and proportionality of approa ch, in particular for animal 
health or plant health laboratories, pr ovision should be made for the adoption of 
derogations aimed at allowing certain labora tories not to be accredited for all the 
methods they use. Moreover, accreditation of a laboratory fo r all the methods it should 
use as official laboratory mi ght not be immediately availa ble in certain cases where 
new or recently modified methods should be used, and in cases of emerging risks or in 
emergency situations. Under certain conditions , official laboratories should therefore 
be allowed to carry out analyses, tests a nd diagnoses for the competent authorities 
before they obtain th e relevant accreditation. 
                                                 
17 OJ L 218, 13.8.2008, p. 30. EN 24   EN (44) Official controls performed on animal s and goods entering the Union from third 
countries are of key importance to ensure that they comply with legislation applicable 
within the Union and, in particular, with the rules established to protect across the 
Union human, animal and plant health, animal welfare and, as regards GMOs and plant protection products, the environment. Such  official controls should take place as 
appropriate before or after the animals or goods are released for free circulation within 
the Union. The frequency of official controls  should adequately address risks to health, 
animal welfare and to the environment, that animals and goods entering the Union might pose, taking into account the histor y of compliance with the requirements 
provided for in Union agri-food chain rules,  the controls already performed on those 
animals and goods in the third country conc erned, and the guarantees given by that 
third country that animals and goods exported to the Union meet the requirements laid 
down in Union legislation. 
(45) Given the risks to human, animal or plant health, animal welfare or to the environment 
that certain animals or goods may pose, they  should be subject to specific official 
controls to be performed upon them at thei r entry into the Union. Current Union rules 
require the performance of official controls  at Union borders to  verify that human 
health, animal health and anim al welfare standards applicable to animals, products of 
animal origin, germinal produc ts and animal by-products ar e met and that plants and 
plant products comply with phytosanitary requirements. In creased controls at entry 
into the Union are also performed on certain other goods where emerging or known 
risks so warrant. The specificities of su ch controls, current ly governed by the 
provisions of Council Directive 97/78/ EC of 18 December 1997 laying down the 
principles governing the or ganisation of veterinary ch ecks on products entering the 
Community from third countries
18, Council Directive 91/496 /EEC of 15 July 1991 
laying down the principles governing the orga nisation of veterinary checks on animals 
entering the Community from third count ries and amending Directives 89/662/EEC, 
90/425/EEC and 90/675/EEC19, Council Directive 200 0/29 and Commission 
Regulation (EC) No 669/2009 implementi ng Regulation (EC) No 882/2004 of the 
European Parliament and the Council as regard s the increased level of official controls 
on imports of certain food and feed of non-animal origin and amending Decision 2006/504/EC
20, should be provided for in this Regulation. 
(46) In order to reinforce the efficiency of the Union's official control system, ensure an 
optimal allocation of official control re sources assigned to border controls and 
facilitate the enforcement of Union f ood chain legislation, a common integrated 
system of official controls at border cont rol posts, replacing th e current fragmented 
control frameworks, should be established to  handle all consignments which, given the 
risk they may carry, must be contro lled at their entry into the Union. 
(47) Official controls performed at border control posts should include documentary and 
identity checks on all consignments and physical checks performed at a frequency dependent on the risk posed by each consignment of animals or goods. 
(48) The frequency of physical checks should be  determined and modified on the basis of 
risks to human, animal or plant health, anim al welfare or, as regards GMOs and plant 
protection products, to the environment. Th is approach should enable the competent 
                                                
 
18 OJ L 24, 30.1.1998, p. 9. 
19 OJ L 268, 24.9.1991, p. 56. 
20 OJ L 194, 25.7.2009, p. 11. EN 25   EN authorities to allocate control resources wh ere the risk is highe st. The frequency of 
identity checks should also be subject to reduction or limited to the verification of a 
consignment's official seal where this is justified by a re duced risk of the 
consignments entering the Union. The risk-based approach to identity and physical checks should be pursued by making full use of available data sets and information, 
and of computerised data colle ction and management systems. 
(49) In certain cases, and as long as high levels of human, an imal and plant health, animal 
welfare and protection of the environment in relation to GMOs and plant protection 
products are guaranteed, official  controls normally perfor med by competent authorities 
at border control posts coul d be performed at other co ntrol points or by other 
authorities. 
(50) For the purpose of organisi ng an efficient system of of ficial controls, consignments 
arriving from third countries which require controls at their entry into the Union 
should be accompanied by a common health entry document (CHED), to be used for 
the prior notification of the ar rival of consignments at the border control post, and to 
record the result of official controls  performed and of decisions taken by the 
competent authorities in relation to the consignment they accompany. The same document should be used by the operator to  obtain clearance by customs authorities 
once all official controls have been performed. 
(51) Official controls on anim als and goods entering the Union from third countries should 
be performed at border control posts designa ted by Member States in accordance with 
a set of minimum requirements. The designa tion of such entities should be withdrawn 
or suspended when they no longer comply with those requirements or when their activities may pose a risk to human, animal or  plant health, animal welfare or, in the 
case of GMOs and plant protecti on products, to the environment. 
(52) To guarantee the uniform application of official contro l rules on consignments arriving 
from third countries, common rules should be established to govern the actions that the 
competent authorities and operators should take in case of suspicion of non-
compliance, and in relation to non-compliant consignments and of consignments which might pose a risk to human, animal or plant health, animal welfare or, as 
regards GMOs and plant protecti on products, to the environment. 
(53) In order to avoid inconsistencies and duplic ations of the official controls effort, to 
allow consignments which are subject to offici al controls at border control posts to be 
timely identified, and to guarantee that cont rols are performed in an efficient manner, 
the cooperation and exchange of informati on amongst competent authorities, customs 
authorities and other relevant authorities dealing with consignments arriving from 
third countries should be ensured. 
(54) Member States should be required to en sure that adequate financial resources are 
always available in order to appropriatel y staff and equip the competent authorities 
performing official controls and other official activities. Although operators are 
primarily responsible for ensuring that thei r activities are carried out in compliance 
with Union agri-food chain rules,  the system of own controls that they put in place for 
that purpose needs to be complemented by a dedicated system of official controls 
maintained by each Member State to ensure  effective market surveillance along the 
agri-food chain. Such a system is, by its ve ry nature, complex and resource demanding 
and should be provided with a st able influx of resources for o fficial controls, at a level 
appropriate to the enforcement needs at any given moment. To reduce the dependency EN 26   EN of the official control system from public  finances, competent authorities should 
collect fees to cover the costs they incur when performing official  controls on certain 
operators and for certain activities for whic h Union agri-food chain legislation requires 
registration or approval in accordance with  Union rules on the hygiene of food and 
feed or rules governing plant health and plant reproductive material. Fees should also 
be collected from operators to compensate th e costs of official controls performed in 
view of issuing an official certificate or attestation, and costs of official controls 
performed by the competent aut horities at border control posts. 
(55) Fees should cover, but not exceed, the co sts incurred by the competent authorities to 
perform official controls. Such costs should be calculated on the basis of each individual official control or on the basis of all official contro ls performed over a 
given period of time. Where fees are appl ied on the basis of the actual cost of 
individual official controls , operators with a good record of comp liance should bear 
lower overall charges than non-compliant ones,  as they should be subject to less 
frequent official controls. In  order to promote compliance with Union legislation by all 
operators irrespective of the method (based on actual costs or on a fl at rate) that each 
Member States will chose for the calculation of the fees, when these are calculated on 
the basis of overall costs incurred by the competent authorities over a given period of 
time, and charged on all operators irrespec tive of whether they are subject to an 
official control during the re ference period, those fees should be calculated so as to 
reward operators with a consistent good r ecord of compliance with Union food chain 
legislation. 
(56) The direct or indirect refund of fees collected by the competent authorities should be 
prohibited as it would put operators not bene fitting from the ref und at a disadvantage 
and potentially create distortions of competiti on. However, in order to provide support 
to micro-enterprises, these should be exempt ed from the payment of the fees collected 
in accordance with this Regulation. 
(57) The financing of official  controls through fees collected  from operators should occur 
in full transparency, so as to enable c itizens and businesses to understand the method 
and data used to establish fees and be  informed on the use of fees revenue. 
(58) Union agri-food chain rules establish the cas es where the placing on  the market or the 
movement of certain animals or goods shoul d be accompanied by an official certificate 
signed by the certifying officer. It is appropr iate to establish a common set of rules 
laying down the obligations of the compet ent authorities and the certifying officers 
with regard to the issuance of  official certificates as well  as the characteristics that 
official certificates should have  to ensure their reliability. 
(59) In other cases, the rules falling within the scope of this Regulation provide that the 
placing on the market or the movement of certain animals or goods must be 
accompanied by an official label, official mark  or other official attestation issued by 
the operators under the official supervisi on of the competent authorities or by the 
competent authorities themselves. It is appr opriate to lay down a minimum set of rules 
ensuring that also the issuance of offici al attestations is performed according to 
appropriate guarantees of reliability. 
(60) Official controls and other official activ ities should be based on analytical, testing and 
diagnostic methods that meet state-of-the-art scientific  standards and offer sound, 
reliable and comparable results across the Union. The methods used by official 
laboratories as well as the quality and unifo rmity of analytical, testing and diagnostic EN 27   EN data generated by them should therefore be  improved continuously. For that purpose, 
the Commission should be able to designate , and rely on the expert assistance of 
European Union reference laboratories in al l those areas of the food chain where there 
is the need for precise and reliable anal ytical, testing and di agnostic results. The 
European Union reference laboratories shou ld in particular ensure that national 
reference laboratories and official labo ratories are provided with up-to-date 
information on available methods, organise or  participate actively in inter-laboratory 
comparative tests and offer training cour ses for national refere nce laboratories or 
official laboratories. 
(61) For the performance of official controls  and other official ac tivities on the production 
and marketing of plant reproductive material, and in the field of animal welfare, the 
competent authorities should have access to updated, reliable and consistent technical 
data, to research findings,  new techniques and expertise necessary for the correct 
application of Union legisl ation applicable in those areas. For that purpose the 
Commission should be able to designate, and rely on the expert assistance of, 
European Union reference centres for plan t reproductive material and for animal 
welfare. 
(62) In order to pursue the objectives of this Regulation and contribute to the smooth 
functioning of the internal market, en suring consumer confidence in it, non-
compliances with Union food chain legislat ion requiring enforcement action in more 
than one Member State should be pursued efficiently and cons istently. The Rapid 
Alert System for Food and Feed (RASFF) established by Artic le 50 of Regulation 
(EC) No 178/2002 already enables competent authorities to rapidly exchange and 
disseminate information on serious direct or indirect risks to human health in relation 
to food or feed, or serious risks to human or  animal health or to the environment in 
relation to feed, for the purpose of enabling rapid measures to be taken to counter 
those risks. However, that instrument, while allowing for timely action across all 
Member States concerned to counter certain  serious risks along the food chain, cannot 
serve the purpose of enabling effective cross border assistance and cooperation 
between competent authoritie s to ensure that non-comp liances with Union agri-food 
chain legislation which have a cross-border dimension are effectively pursued not only 
in the Member State where the non-compliance is first de tected but also in the 
Member State where the non-compliance orig inated. In particular, administrative 
assistance and cooperation should enable comp etent authorities to share information, 
detect, investigate and take effective and proportionate action to pursue cross-border 
violations of agri-food chain rules. 
(63) Requests for administrative assistance a nd all notificati ons should be given appropriate 
follow-up. In order to facilitate admini strative assistance and cooperation, Member 
States should be required to designate one or more liaison bodies to assist and 
coordinate communication flow s between competent authoriti es in different Member 
States. In order to streamline and simp lify cooperation amongst Member States the 
Commission should adopt implementing acts es tablishing the specifications of the 
technical tools to be use d, the procedures for communi cation between liaison bodies 
and a standard format for requests for assistance, notifica tions and responses. 
(64) Each Member State should be required to set up and regularly update a multi-annual 
national control plan  (MANCP) covering all the areas governed by Union agri-food 
chain legislation and containing informati on on the structure and organisation of its 
system of official controls . Such MANCPs are the inst rument through which each EN 28   EN Member State should ensure that official c ontrols are performed in a risk based and 
efficient manner across their territory and across the entire agri-food chain, and in compliance with this Regulation. 
(65) In order to guarantee the coherence a nd completeness of MANCPs Member States 
should designate a single authority responsib le for their coordina ted preparation and 
implementation. In order to promote a consis tent, uniform and integrated approach to 
official controls, the Commission should have  the power to adopt  rules concerning 
MANCPs which should identify priorities fo r official controls, effective control 
procedures, criteria for risk categorisati on and performance indicators for assessing 
MANCPs. 
(66) Member States should be required to su bmit an annual report to the Commission with 
information on control activities and the im plementation of the MANCPs. In order to 
facilitate the collection and transmissi on of comparable data, the subsequent 
compilation of such data into Union-wide statistics and the prep aration of reports by 
the Commission on the operation of offi cial controls across the Union, the 
Commission should be able to adopt implementing acts in respect of establishing standard model forms for annual reports. 
(67) Commission experts should be able to perf orm controls in Member States to verify the 
application of Union legisl ation and the functioning of national control systems and 
competent authorities. Commission controls  should also serve to investigate and 
collect information on enforcement practic es or problems, emergencies and new 
developments in Member States. 
(68) Animals and goods from third countries should comply with the same requirements 
which apply to Union animals and goods, or  with requirements which are recognised 
to be at least equivalent in  relation to the objectives pursued by Union agri-food chain 
rules. This principle is en shrined in Article 11 of Regul ation (EC) No 178/2002, which 
requires that food and feed imported into th e Union must comply with the relevant 
requirements of the Union's food law or with  requirements considered to be at least 
equivalent thereto. Specific requirements to apply that principle are provided for in 
Union rules on protective measures agai nst pests of plants, which prohibit the 
introduction into the Union of certain pests which are not present (or only present to a 
limited extent) in the Union, in Union rule s laying down animal health requirements, 
which allow the entry of animals and of cer tain products of anim al origin into the 
Union only from third countries which are in cluded in a list set up for that purpose, 
and in Union rules for the organisation of offi cial controls on products of animal origin 
intended for human consumption, which also pr ovide for the establis hment of a list of 
third countries from which those products  can enter the Union. Concerning plant 
reproductive material, an equivalence system is in place whereby third countries from 
which plant reproductive material can be  imported are authorised and listed. 
(69) In order to ensure th at animals and goods entering th e Union from third countries 
comply with all the requirements laid dow n in Union agri-food chain legislation or 
with requirements considered equivalent, in  addition to the requirements established 
by Union rules on protective measures agai nst pests of plants, Union rules laying 
down animal health requirem ents, and Union rules laying down specific hygiene rules 
for food of animal origin to  ensure that the requirement s laid down in Union agri-food 
legislation in relation to  phytosanitary and veterinary  concerns are met, the 
Commission should be allowed to establish conditions for the entry of animals and EN 29   EN goods into the Union to the extent necessary to ensure that those animals and goods 
comply with all relevant requirements of Union agri-food chain legislation or 
equivalent requirements. Such conditions  should apply to animals or goods or 
categories of animals or goods from all thir d countries or from cer tain third countries 
or regions thereof. 
(70) Where, in specific cases, there is eviden ce that certain animals or goods originating 
from a third country, a group of third countries, or regions ther eof, give rise to risks to 
human, animal or plant health or, as rega rds GMOs and plant pr otection products, to 
the environment or where there is eviden ce that widespread serious non-compliance 
with Union agri-food chain legislation might  be taking place, the Commission should 
be able to adopt measures  to contain such risks. 
(71) The performance of effectiv e and efficient official controls  and other official activities, 
and ultimately the safety a nd health of humans, animals and plants, and the protection 
of the environment, also depends on the avai lability to the control authorities of well 
trained staff possessing an appropriate knowle dge of all the matters relevant for the 
correct application of Uni on legislation. Appropriate, de dicated training should be 
provided by the Commission to promote a unifo rm approach to official controls and 
other official activities by the competent au thorities. To promote the knowledge of 
Union agri-food chain legislation and require ments in third count ries, such training 
should be also addressed to staff of the competent authorities in third countries. 
(72) To promote the sharing of experience a nd best practices among competent authorities, 
the Commission should also be able to or ganise, in cooperati on with the Member 
States, programmes for the exchange of sta ff tasked with official controls or other 
official activities. 
(73) It is important for the performance of e ffective official controls and other official 
activities that the competen t authorities in the Member  States, the Commission and, 
where relevant, operators be able to exchange  data and information related to official 
controls or results therefrom rapidly and efficiently. Several information systems are 
established by Union legislation and manage d by the Commission to allow such data 
and information to be handled and mana ged through Union wide computerised and 
internet-based tools. A system dedicated to recording and tracing official control 
results is the Trade Control and Expert System (TRACES system), established by 
Commission Decision 2003/24/EC  of 30 December 2002 con cerning the development 
of an integrated computerised veterina ry system and currently used for the 
management of data and information on animals and products of animal origin and official controls thereon
21. That system should be upgraded so as to allow its use for 
all goods for which Union agri-food chain legi slation establishes sp ecific requirements 
or official control modalities. Dedicated co mputerised systems also exist for the rapid 
exchange of information between Member States and with the Commission on risks 
which might arise in the food chain or fo r animal and plant health. Article 50 of 
Regulation (EC) No 178/2002 establishes the RASFF, Article 20 of Regulation (EU) 
XXX/XXXX [ Office of Publications, please in sert number, date, title and, in a 
footnote, the OJ reference fo r the Regulation on animal health ] a system for the 
notification and reporting on the measures  on listed diseases, and Article 97 of 
Regulation (EU) XXX/XXXX [ Office of Publications, please insert number, date, title 
and, in a footnote, the OJ refe rence for the Regulation on protective measures against 
                                                 
21 OJ L 8, 14.1.2003, p. 44. EN 30   EN pests of plants ] a system for the notification and re porting of the presence of pests and 
the notification of non-compliances. All su ch systems should work in a harmonious, 
consistent manner that makes use of synerg ies between the different systems, avoids 
duplications, simplifies their operation  and makes them more efficient. 
(74) To support a more efficient management  of official contro ls, a computerised 
information system integrating and upgradin g as necessary all relevant existing 
information systems should be set up by the Commission, allowing for the use of 
advanced communication and certif ication tools, and for the most efficient use of the 
data and information related to official controls. In view of avoiding unnecessary 
duplications of information requirements, the design of such computerised system 
should take into account the need to ensure, wherever appropriate, the compatibility of 
such computerised system with othe r information systems operated by public 
authorities and through which relevant data is  exchanged or made available. Moreover, 
the possibility to use the electronic si gnatures within the meaning of Directive 
1999/93/EC of the European Parliament and the Council of 13 December 1999 on a Community framework fo r electronic signatures
22 should be foresee n, in line with the 
Digital Agenda for Europe. 
(75) The competent authorities should investig ate cases where there is a suspicion of non-
compliance with Union agri-food legisl ation and, where non -compliance is 
established, determine its origin and extent as well as the operato rs' responsibilities. 
They should also take appropriate measures  to ensure that the operators concerned 
remedy the situation and to pr event further non-compliance. 
(76) The verification of compliance with agri-food chain legislation through official 
controls is of fundamental importance to ensure that, across the Union, the objectives 
of that legislation are effectively achieve d. Failures in a Member State's control 
systems can in certain cases substantially hinder the achievement of those objectives and lead to the emergence of risks to huma n, animal and plant health, animal welfare 
and, as regards GMOs and plant prot ection products, to the environment, 
independently of the involvement or responsibil ity of operators or ot her actors, or lead 
to situations of serious widespread non-compliance with food chain rules. The 
Commission should therefore be able to react to serious fa ilures in a Member State's 
control system by adopting measures aimed at containing or eliminating those risks 
from the agri-food chain pending the necessary  action to be taken by the concerned 
Member State to make good the failure in the control system. 
(77) Infringements of the rules should be subj ect to effective, diss uasive and proportionate 
sanctions at national level th roughout the Union. For financia l penalties applicable to 
intentional infringements to be sufficiently dissuasive, they should be set at a level 
which is likely to offset the economic a dvantage sought by the pe rpetrator through the 
violation. Member States shoul d also be required to apply appropriate criminal and/or 
administrative penalties in cases where operators fail to cooperate during an official control. 
(78) This Regulation covers areas  that are already covered in ce rtain acts currently in force. 
To avoid duplications and to  establish a coherent legislative framework, the following 
acts should be repealed and replaced by the rules of this Regulation: Council Directive 
89/608/EEC of 21 November 1989 on mutual assistance between the administrative 
authorities of the Member States and cooperation between the latter and the 
                                                
 
22 OJ L 13, 19.1.2000, p. 12. EN 31   EN Commission to ensure the correct applic ation of legislation on veterinary and 
zootechnical matters23; Council Directive 89/662/ EEC of 11 December 1989 
concerning veterinary checks in intra-Commun ity trade with a view to the completion 
of the internal market24; Council Directive 90/425/EEC of 26 June 1990 concerning 
veterinary and zootechnical checks applicable in intra-Community trade in certain live 
animals and products with a view to the completion of the internal market25; Council 
Directive 91/496/EEC; Council Deci sion 92/438/EEC of 13 July 1992 on 
computerization of veterinary import proce dures (Shift project),  amending Directives 
90/675/EEC, 91/496/EEC, 91/628/EEC and D ecision 90/424/EEC, and repealing 
Decision 88/192/EEC26; Council Directive 96/23/EC; Council Directive 96/93/EC of 
17 December 1996 on the certification of animals and animal products27; Council 
Directive 97/78/EC; Regulation (EC) No 882/2004; and Regulati on (EC) No 854/2004 
of the European Parliament and of th e Council of 29 April 2004 laying down specific 
rules for the organisation of of ficial controls on products of  animal origin intended for 
human consumption28. 
(79) In order to ensure consistency, amendmen ts should also be effected to the following 
acts: Regulation (EC) No 999/2001 of the Eur opean Parliament and of the Council of 
22 May 2001 laying down rules for the preven tion, control and eradication of certain 
transmissible spongiform encephalopathies29; Council Regulation (EC) No 1/2005 of 
22 December 2004 on the protection of animals during transport and related operations 
and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) 
No 1255/9730; Regulation (EC) No 396/2005 of the European Parliament and of the 
Council of 23 February 2005 on maximum levels of pesticid es in or on food and feed 
of plant of animal origin and amending Council Directive 91/414//EEC31; Council 
Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of 
organic products and repe aling Regulation (EEC) 2092/9132; Regulation (EC) 
No 1069/2009; Council Regula tion (EC) No 1099/2009 of 24 September 2009 on the 
protection of animals at the time of killing33; Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council of 21 October 2009 concerning the placing of 
plant protection products on the market a nd repealing Council Directives 79/117/EEC 
and 91/414/EEC34; Regulation (EU) No 1151/2012 of th e European Parliament and of 
the Council of 21 November 2012 on quality  schemes for agricultural products and 
foodstuffs35; Council Directive 98/58/EC of 20 Ju ly 1998 concerning the protection of 
animals kept for farming purposes36; Council Directive 1999/74/ EC of 19 July 1999 
laying down minimum standards fo r the protection of laying hens37; Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
                                                 
23 OJ L 351, 21.12.1989, p. 34. 
24 OJ L395, 30.12.1989, p. 13. 
25 OJ L 224, 18.8.1990, p. 29. 
26 OJ L 243, 25.8.1992 p. 27. 
27 OJ L 13, 16.1.1997, p. 28. 
28 OJ L 139, 30.4.2004, p. 206. 
29 OJ L 147, 31.5.2001, p. 1. 
30 OJ L 3, 5.1.2005, p. 1. 
31 OJ L 70, 16.3.2005, p.1. 
32 OJ L 189, 20.7.2007, p. 1. 
33 OJ L 303, 18.11.2009, p.1. 
34 OJ L 309, 24.11.2009, p. 1. 
35 OJ L 343, 14.12.2012, p.1. 
36 OJ L 221, 8.8.1998, p. 23. 
37 OJ L 203, 3.8.1999 p. 53. EN 32   EN on genetically modified food and feed38; Regulation (EC) No 1831/2003 of the 
European Parliament and the Council of 22 September 2003 on additives for use in 
animal nutrition39; Council Directiv e 2007/43/EC of 28 June 2007 laying down 
minimum rules for the protection of chickens kept for meat production40; Council 
Directive 2008/119/EC of  18 December 2008 laying down minimum standards for the 
protection of calves41; Council Directive 2008/120/EC  of 18 December 2008 laying 
down minimum standards fo r the protection of pigs42; Directive 2009/1 28/EC of the 
European Parliament and of the Council of 21 October 2009 establishing a framework 
for the Community action to achieve the sustainable use of pesticides43 
(80) Regulation (EU) No [.…] /2013 [Office of Publications, please insert number, date, 
title and, in a footnote, the OJ reference for the Regulation layi ng 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]provides a 
framework for the Union's financing of ac tions and measures across the agri-food 
chain in those areas under the multi-annua l financial framework 2014-2020. Some of 
those acts and measures aim to improve the performance of official  controls and other 
official activities across the Union. Re gulation (EU) No [ .…]/2013 [Office of 
Publications, please in sert number of the Regulation laying down provisions for the 
management of expenditure relating to th e food chain, animal health and animal 
welfare, and relating to plant health a nd plant reproductive material] should be 
amended to take account of the changes introduced by this Regulation to Regulation 
(EC) No 882/2004. 
(81) In order to amend the references to European standards, and Annexes II and III to this 
Regulation to take into account of le gislative and techni cal and scientific 
developments, and to supplement this Regula tion with specific rules governing official 
controls and other official activi ties in the areas it covers, including, inter alia , rules 
on the qualification and tr aining of staff, on additional res ponsibilities an d tasks of the 
competent authorities, on the cases wher e the accreditation of laboratories is not 
required, on certain exemptions from official c ontrols at the borders, on the criteria to 
be used to determine the frequency of  identity and physical checks, on the 
establishment of conditions to be met by certain animals or goods entering the Union 
from third countries, on additional requi rements and tasks of European Union 
reference laboratories and centres, on additional requirements for national reference laboratories, on criteria for ri sk categorisation and for pe rformance indicators for the 
MANCPs , and on the  contingency plans for food and feed provided for in Article 
55(1) of Regulation (EC) No 178/2002, the pow er to adopt acts in accordance with 
Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of par ticular importance that the Commission carry 
out appropriate consultations during its preparat ory work, including at expert level. 
The Commission, when preparing and draw ing up delegated acts, should ensure a 
simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council. 
                                                
 
38 OJ L 268, 18.10.2003, p. 1. 
39 OJ L 268, 18.10.2003, p. 29. 
40 OJ L 812, 12.7.2007, p. 19. 
41 OJ L 10, 15.1.2009, p. 7. 
42 OJ L 47, 18.2.2009, p. 5. 
43 OJ L 309, 24.11.2009, p. 71. EN 33   EN (82) In order to ensure uniform conditions  for the implementation of this Regulation 
regarding the designation of European Union reference laboratories and of the 
European Union reference centres for plan t reproductive material and for animal 
welfare, the adoption of the programme of  the Commission controls in the Member 
States, and the performance of increased official controls in the event of violations of 
agri-food chain rules which require coor dinated assistance and follow-up by the 
Commission, implementing powers shoul d be conferred on the Commission. 
(83) In order to ensure un iform conditions for the implem entation of this Regulation, 
including, inter alia , rules and modalities in respect of audits, the format of certificates 
and other documents, the establishment of  computerised information management 
systems, the cooperation be tween operators and compet ent authorities and amongst 
competent authorities, customs authorities and other authorities, the methods of 
sampling and of laboratory analysis, test a nd diagnosis as well as their validation and 
interpretation, traceability, the listing of products or goods subject to controls as well 
the listing of countries or regions that can export certain animals and goods to the 
Union, prior notification of consignments, exchanges of information, border control 
posts, isolation and quarantine, approval of  pre-export controls performed by third 
countries, measures to contain a risk or put an end to a widespread serious non-
compliance relating to certain animals or goods  originating from a third country or a 
region thereof, the recognition of third coun tries or regions that offer equivalent 
guarantees to those applied in the Union and its repeal, training activities and 
exchange programmes of staff amongst Me mber States, implementing powers should 
be conferred on the Commission. Those pow ers should be exercised in accordance 
with Regulation (EU) No 182/2011 of the Eur opean Parliament and of the Council of 
16 February 2011 laying down the rules and general principles concerning 
mechanisms for control by Member Stat es of the Commission's exercise of 
implementing powers44. 
(84) Since the objective of th is Regulation, namely to ensure  a harmonised approach with 
regard to official controls a nd other official activities pe rformed in view of ensuring 
the application of Union agri -food chain rules, cannot be sufficiently achieved by the 
Member States and can therefore, by reason of its effect, comple xity, trans-border and 
international character, be better achiev ed at Union level, the Union may adopt 
measures, in accordance with the principle of s ubsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set 
out in that Article, this Regulation does not exceed what is necessary in order to achieve that objective, 
HAVE ADOPTED THIS REGULATION: 
                                                
 
44 OJ L 55, 28.2.2011, p. 13. EN 34   EN Title I 
Subject matter, scope and definitions 
Article 1 
Subject matter and scope 
1. This Regulation lays down rules for: 
(a) the performance of official controls a nd other official activities performed by 
the competent authorities of the Member States; 
(b) the financing of official controls; 
(c) the administrative assistance and coopera tion between Member States in view 
of the correct application of the rules referred to in paragraph 2; 
(d) the performance of Commission controls  in Member States and in third 
countries; 
(e) the adoption of conditions to be met by animals and goods entering the Union 
from a third country; 
(f) the establishment of a computerised information system to manage information 
and data in relation to official controls. 
2. This Regulation shall apply to the official  controls performed fo r the verification of 
compliance with the following rules, whether established at Union level or by the 
Member States to apply Union legislation in those areas: 
(a) governing food and food safety, at any st age of production, the processing and 
distribution of food, including rules aime d at guaranteeing fair practices in 
trade and protecting consumer interest s and information, and the manufacture 
and use of materials and articles intended to come into contact with food; 
(b) governing the deliberate release into the environment and the contained use of 
GMOs; 
(c) governing feed and feed safety, at a ll stages of production, processing and 
distribution of feed and the use of f eed, including rules aimed at guaranteeing 
fair practices in trade and protecting consumer interests and information; 
(d) laying down animal health requirements; 
(e) aiming at preventing and minimising risks to human and animal health arising 
from animal by-products and derived products; 
(f) laying down welfare requirements for animals; 
(g) on protective measures against pests of plants; 
(h) on the production, with a view to placi ng on the market, and placing on the 
market of plant reproductive material; 
(i) laying down requirements for the placing on the market and use of plant 
protection products and the sust ainable use of pesticides; 
(j) governing organic production and la belling of organic products; EN 35   EN (k) on the use and labelling of protected designations of origin, protected 
geographical indications and trad itional specialities guaranteed. 
3. This Regulation shall also apply to official  controls performed for the verification of 
compliance with requirements laid down in the rules referred to in paragraph 2 applicable to animals and goods: 
(a) entering the Union from third countries;  
(b) to be exported to third countries. 
4. This Regulation shall not apply to official  controls for the verification of compliance 
with: 
(a) the rules laid down in Regulation (EC) No 1234/2007; 
(b) the rules laid down in Directive 2010/63/EU  of the European Parliament and of 
the Council of 22 September 2010 on th e protection of animals used for 
scientific purposes
45. 
5. Articles 3, 4, 5, 7, 11(2) and (3), 14, 30 to 33, 36 to 41, 76, Titles III and IV, and 
Articles 129 and 136 of this Re gulation shall also apply to  other official activities 
performed by the competent authorities in accordance with this Regulation or with 
the rules referred to in paragraph 2 of this Article. 
Article 2 
Definitions 
For the purposes of this Regulation, th e following definitions shall apply: 
1. 'official control' means any form of contro l that the competent au thorities perform for 
the verification of compliance with: 
(a) this Regulation; 
(b) the rules referred to in Article 1(2); 
2. 'other official activities' means any activity, other than an official control, which is 
performed by competent authorities in accordance with: 
(a) this Regulation; 
(b) the rules referred to in Article 1(2) to ensure the application of those rules; 
3. 'food law' means food law as defined in point (1) of Article 3 of Regulation (EC) 
No 178/2002; 
4. 'feed law' means the laws, regulations and administrative  provisions governing feed 
in general and feed safety in particular, whether at Union or national level; it covers all stages of production, pro cessing and distribution of feed and the use of feed; 
5. 'competent authorities' means: 
(a) the central authorities of a Member St ate responsible for the organisation of 
official controls and of other official activities, in accordance with this Regulation and the rules refe rred to in Article 1(2); 
(b) any other authority to which that responsibility has been conferred; 
                                                
 
45 OJ L 276, 20.10.2010, p. 33. EN 36   EN (c) where appropriate, the correspondin g authorities of a third country; 
6. 'animals' means animals as defined in point  (1) of Article 4(1)  of Regulation (EU) 
No XXX/XXXX [ Office of Publications, please insert number of the Regulation on 
animal health ]; 
7. 'goods' means any good subject to one or more of the rules referred to in Article 1(2), 
excluding animals; 
8. 'food' means food as defined in Arti cle 2 of Regulation (EC) No 178/2002; 
9. 'feed' means feed as defined in point  (4) of Article 3 of Regulation (EC) 
No 178/2002; 
10. 'animal by-products' means animal by-products as defined in point (1) of Article 3 of 
Regulation (EC) No 1069/2009; 
11. 'derived products' means derived products as defined in point (2) of Article 3 of 
Regulation (EC) No 1069/2009; 
12. 'pests' means pests as defined in Artic le 1(1) of Regulation (EU) No XXX/XXXX 
[Office of Publications, pl ease insert number of the Regulation on protective 
measures against pests of plants]; 
13. 'plants' means plants as defined in poi nt (1) of Article 2 of Regulation (EU) 
No XXX/XXXX [Office of Publications, pl ease insert number of the Regulation on 
protective measures against pests of plants]; 
14. 'plant reproductive material' means plant re productive material as defined in point (2) 
of Article 3 of Regulat ion (EU) No XXX/XXXX [ Office of Publications, please 
insert number, date, title and, in a footnot e, the OJ reference for the Regulation on 
the production and making available on the market of plant reproductive material ]; 
15. 'plant protection products' means plant prot ection products as referred to in Article 
2(1) of Regulation (EC) No 1107/2009; 
16. 'alien species' means a species, subspecies  or lower taxon, introduced outside its 
natural past or present dist ribution and includes any part, gametes, seeds, eggs, or 
propagules of such species, as well as any hybrids, varieties or breeds, that might 
survive and subsequently reproduce; 
17. 'products of animal origin' means products of  animal origin as de fined in point 8.1 of 
Annex I to Regulation (EC) No 853/2004 of  the European Parliament and of the 
Council of 29 April 2004 laying down specific hygiene rules for food of animal origin
46; 
18. 'germinal products' means germinal products as  defined in point (25) of Article 4(1) 
of Regulation (EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on animal health ]; 
19. 'plant products' means plant products as defined in point (2) of Article 2 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on protective meas ures against pests of plants ]; 
                                                 
46 OJ L 139, 30.4.2004, p. 55.  EN 37   EN 20. 'other objects' means other objects as defi ned in point (4) of Ar ticle 2 of Regulation 
(EU) No XXX/XXXX [ Office of Publications, please insert number of the 
Regulation on protective measur es against pests of plants ]; 
21. 'risk assessment' means risk assessment as  defined in point (11) of Article 3 of 
Regulation (EC) No 178/2002; 
22. 'certifying officer' means: 
(a) any official of the competent authorities authorised to sign official certificates 
by such authorities; 
(b) where provided for by the rules referred to  in Article 1(2) – any other person, 
who is authorised to sign official certificates by the competent authorities; 
23. 'official certificate' means any paper or electronic document signed by the certifying 
officer and providing assurance concer ning compliance with one or more 
requirements laid down in the rule s referred to in Article 1(2); 
24. 'non-compliance' means non-compliance with: 
(a) this Regulation; 
(b) rules referred to in Article 1(2); 
25. 'official attestation' means any label, mark or other form  of attestati on issued by the 
operators under the supervisi on, through dedicated official controls, of the competent 
authorities, or by the competent authori ties themselves, and providing assurance 
concerning compliance with one or more requi rements laid down in the rules referred 
to in Article 1(2); 
26. 'operator' means any natura l and legal person subject to one or more obligations 
provided for in the rules referred to in Ar ticle 1(2), except the competent authorities 
and the other bodies in charge of official  controls and other official activities; 
27. 'consignment' means a number of animals or quantity of goods of the same type, 
class, or description, covered by the same offi cial certificate, official attestation or 
any other document, conveyed by the same means of transport and having the same 
origin; it may consist of one or more lots; 
28. 'inspection' means a form of official  control involving the examination of: 
(a) animals or goods; 
(b) activities under the control of operators falling within the scope of the rules 
referred to in Article 1(2) and equipmen t, means of transport, substances and 
materials used to perform those activities; 
(c) places where operators pe rform their activities; 
29. 'border control post' means a place, and th e facilities belonging to it, designated by a 
Member State to perform the official controls provided for in Article 45(1); 
30. 'audit' means a systematic and indepe ndent examination to determine whether 
activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are su itable to achieve 
objectives; 
31. 'rating' means a classification of ope rators based on an assessment of their 
conformity with rating criteria; EN 38   EN 32. 'official veterinarian' means a veterinari an appointed by the competent authorities 
and appropriately qualified to perform th e official controls and other official 
activities in accordance with: 
(a) this Regulation; 
(b) the rules referred to in Article 1(2); 
33. 'hazard' means any agent or condition with the potential to have an adverse effect on 
human, animal or plant health, an imal welfare or the environment; 
34. 'specified risk material' means tissues as  defined in point (g) of Article 3(1) of 
Regulation (EC) No 999/2001; 
35. 'long journey' means a journey as defined in point (m) of Article 2 of Regulation 
(EC) No 1/2005; 
36. 'exit point' means a border control post or  any other place designated by a Member 
State where animals, falling within the scope of Regulation (EC) No 1/2005, leave 
the customs territory of the Union; 
37. 'pesticide application equipment' means a ny apparatus as defined in point (4) of 
Article 3 of Directive 2009/128/EC; 
38. 'delegated body' means a third party, to  which the competent authorities have 
delegated specific official control tasks; 
39. 'control authority for organic products' mean s a public administrative organisation of 
a Member State to which the competent auth orities have conferre d, in whole or in 
part, their competences in relation to  the application of Regulation (EC) 
No 834/2007, including, where appropriate, the corresponding authority of a third 
country or operating in a third country; 
40. 'control verification procedures' means the arrangements put in place and actions 
performed by the competent au thorities for the purpose of ensuring that official 
controls and other official activit ies are consistent and effective; 
41. 'screening' means a form of official control performed by conducting a planned 
sequence of observations or measurements w ith a view to obtaining an overview of 
the state of compliance with this Regulation and the rules referred to in Article 1(2); 
42. 'targeted screening' means a form of offi cial control involving observation of one or 
more operators or their activities; 
43. 'control system' means a system compri sing the competent authorities and the 
resources, structures, arrangements and pr ocedures set up in a Member State to 
ensure that official controls are performed  in accordance with this Regulation and 
with the rules provided for in Articles 15 to 24; 
44. ‘equivalence’ or 'equivalent' means: 
(a) the capability of different systems or measures to meet the same objectives; 
(b) different systems or measures capable of meeting the same objectives; 
45. 'entry into the Union' means the action of  bringing animals and goods into one of the 
territories listed in Annex I; 
46. 'documentary check' means the examination of the official certificates, official 
attestations and other document(s) includ ing documents of a commercial nature, EN 39   EN which are required to accompany the consignment as provided for by the rules 
referred to in Article 1(2), Article 54( 1), or by implementing acts adopted in 
accordance with Articles 75(3), 125(4), 127(1) and 128(1); 
47. 'identity check' means a visual inspection to  verify that the content and the labelling 
of a consignment, including the marks on an imals, seals and means of transport, 
correspond with the information provided in  the official certificates, official 
attestations and other documents accompanying it; 
48. 'physical check' means a check on animals or goods and, as appropriate, checks on 
packaging, the means of transport, labe lling and temperature, the sampling for 
analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2); 
49. 'transhipment' means the movement of goods subject to the offici al controls provided 
for in Article 45(1) which arrive by sea or by air transport from a third country from 
a vessel or aircraft and are transported unde r customs supervision to another vessel or 
aircraft in the same port or airpor t in preparation for onward travel; 
50. 'transit' means movement from one third country to another th ird country passing 
under customs supervision through one of the territories listed in Annex I or from 
one of the territories listed in Annex I to another territory listed  in Annex I passing 
through the territory of a third country; 
51. 'supervision by the customs authorities' mean s action as defined in Article 4(13) of 
Regulation (EEC) No 2913/92
47; 
52. 'control by the customs authorities' means customs controls as defined in 
Article 4(14) of Regulation (EEC) No 2913/92; 
53. 'official detention' means the procedure by which the competent authorities ensure 
that animals and goods subject to official controls are not move d or tampered with 
pending a decision on their de stination; it includes st orage by operators under the 
control of the competent authorities; 
54. 'additional official controls' means those c ontrols which were not originally planned 
and which were decided on the basis of the fi ndings of previous official controls, or 
other official activities; 
55. 'official certification' means the pr ocedure by which assu rance concerning 
compliance with one or more requirements laid down in the rules referred to in 
Article 1(2) is provided by the competent authorities; 
56. 'control plan' means a descri ption established by the compet ent authorities containing 
information on the structure and organisation of  the official control system, and of its 
operation and the detailed planni ng of official controls to be  performed in each of the 
areas referred to in Article 1(2) over a period of time; 
57. 'journey log' means the document set out in points 1 to 5 of Annex II to Council 
Regulation (EC) No 1/2005. 
                                                 
47 OJ L 302, 19.10.1992, p. 1. EN 40   EN Title II 
Official controls and other official activities  
in Member States 
Chapter I 
Competent authorities 
Article 3 
Designation of competent authorities 
1. For each of the areas governed by the rules re ferred to in Article 1(2), Member States 
shall designate the competent authority or  authorities on which they confer the 
responsibility to perform official cont rols and other official activities. 
2. Where, for the same area, a Member St ate confers the respons ibility to perform 
official controls or other official activiti es on more than one competent authority, at 
national, regional or local level, or where the competent authorities designated in accordance with paragraph 1 are allowed by that designation to transfer specific 
responsibilities for official controls or other official activities to other public 
authorities, the Member State shall: 
(a) put in place procedures to  ensure efficient and eff ective coordination between 
all authorities involved, and the consis tency and effectiveness of official 
controls or other official activities across its territory; 
(b) designate a single authority responsible to coordinate the cooperation and the 
contacts with the Commission and other Member States in relation to the official controls and other official  activities performed in that area. 
3. Competent authorities responsible for the verification of compliance with the rules 
referred to in point (j) of Article 1(2) may c onfer specific official  control tasks to one 
or more control authorities for organic produc ts. In such cases, they shall attribute a 
code number to each of them. 
4. Member States shall inform the Commission and other Member States of, and of any 
changes to, the contact details of: 
(a) the competent authorities designate d in accordance with paragraph 1; 
(b) the single authorities desi gnated in accordance with poi nt (b) of paragraph 2; 
(c) the control authorities for organic pr oducts referred to in paragraph 3; 
(d) the delegated bodies referre d to in Article 25(1). 
The information referred to in the first s ubparagraph shall also be made available to 
the public. 
5. Member States may confer to the competen t authorities referred to  in paragraph 1 the 
responsibility to carry out controls for the verification of compliance with, or for the 
application of, rules, includi ng those regulating  specific risks which may arise from 
the presence of alien species in the Union, ot her than those referred to in Article 1(2). EN 41   EN 6. The Commission may, by means of implementing acts, determine the means by 
which the information referred to in paragr aph 4 is to be made available to the 
public. Those implementing acts shall be adopted in accordance with the 
examination procedure refe rred to in Article 141(2). 
Article 4 
General obligations of the competent authorities 
1. The competent authorities shall: 
(a) have procedures and arrange ments in place to ensure  the effectiveness and 
appropriateness of official controls  and other official activities; 
(b) have arrangements in place to ensure th e impartiality, quality and consistency 
of official controls and other o fficial activities at all levels; 
(c) have arrangements in place to ensure that  staff performing official controls and 
other official activities are free from any conflict of interest; 
(d) have, or have access to, an adequate laboratory capacity for analysis, testing 
and diagnosis; 
(e) have, or have access to, a suffici ent number of suitably qualified and 
experienced staff so that official controls and other official activities can be performed efficiently and effectively; 
(f) have appropriate and properly maintained  facilities and equipment to ensure 
that staff can perform official controls and other official activities efficiently 
and effectively; 
(g) have the legal powers to perform official  controls and other official activities 
and to take the action provided for in th is Regulation and in  the rules referred 
to in Article 1(2); 
(h) have legal procedures in pl ace in order to ensure that staff have access to the 
premises of and documents kept by opera tors so as to be able to accomplish 
their tasks properly; 
(i) have contingency plans in place, and be prepared to operate such plans in the 
event of an emergency, where appropriate in accordance with the rules referred 
to in Article 1(2). 
2. Staff performing official controls and other official activities shall: 
(a) receive, for their area of competence, appropriate training enabling them to 
undertake their duties compet ently and to perform offi cial controls and other 
official activities in a consistent manner; 
(b) keep up-to-date in their area of competence and receive regular additional 
training as necessary; 
(c) receive training in the subject matters set out in Chapter I of Annex II and on 
the obligations of the competent aut horities resulting from  this Regulation. 
Competent authorities shall develop a nd implement training programmes for the 
purpose of ensuring that staff performing of ficial controls and official activities 
receive the training referred to in points (a), (b) and (c). EN 42   EN 3. For the purpose of ensuring that the staff of the competent authorities referred to in 
point (e) of paragraph 1 and in paragraph 2 have the necessary qualifications, skills 
and knowledge, the Commission shall be empow ered to adopt delegated acts in 
accordance with Article 139 concerning rule s for the specific qualification and 
training requirements of such staff, havi ng regard to the scientific and technical 
knowledge necessary to perform of ficial controls and other o fficial activities in each 
of the areas referred to in Article 1(2). 
4. When, within the services of a competent authority, more than one unit is competent 
to perform official controls or other o fficial activities, efficient and effective 
coordination and cooperation shall be ensured between the different units. 
Article 5 
Audits of the competent authorities 
1. Competent authorities shall carry out intern al audits or have a udits carried out, and 
shall take appropriate measures in the light of their results, to ensure that they are 
complying with this Regulation.  
Those audits shall be: (a) subject to independent scrutiny; 
(b) carried out in a transparent manner. 
2. Competent authorities shall make available the results of the audits referred to in 
paragraph 1 to the Commission upon request. 
3. The Commission may, by means of implem enting acts, lay dow n rules for the 
conduct of the audits provided for in para graph 1. Those implem enting acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 141(2). 
Article 6 
Decisions of the competent authorities concerning natural and legal persons 
The decisions taken by the competent authorities  in accordance with Article 53, Article 64(3) 
and (5), Articles 65, Article 134(2) and Article  135(1) and (2) concerning natural or legal 
persons shall be subject to the right of appeal  of such persons agai nst those decisions in 
accordance with national law. 
Article 7 
Confidentiality obligations of the staff of the competent authorities 
1. Competent authorities shall require members of their staff not to disclose information 
acquired when undertaking their duties in th e context of official controls and other 
official activities which by its nature is covered by professional secrecy, subject to 
paragraph 2. 
2. Unless there is an overriding public interest  in its disclosure, information covered by 
professional secrecy as referred to in pa ragraph 1 shall include information whose 
disclosure would undermine: 
(a) the purpose of inspections, i nvestigations or audits; 
(b) the protection of commercial intere sts of a natural or legal person; EN 43   EN (c) the protection of court pro ceedings and legal advice. 
3. Paragraphs 1 and 2 shall no t prevent the competent authorities from publishing or 
making otherwise available to the public information about  the outcome of official 
controls regarding individua l operators, provided that  the following conditions are 
met: 
(a) the operator concerned is given the opportunity to comment on the information 
that the competent authority intends to publish or make otherwise available to 
the public, prior to the p ublication or release; 
(b) the information which is published or made otherwise available to the public 
takes into account the comments expre ssed by the operator concerned or is 
published or released together with such comments. 
Chapter II 
Official Controls 
Article 8 
General rules on official controls 
1. Competent authorities shall perform offici al controls on all ope rators regularly, on a 
risk basis and with appropri ate frequency, taking account of: 
(a) identified risks associated with: 
(i) animals and goods; (ii) the activities under th e control of operators; 
(iii) the location of the activit ies or operations of operators; 
(iv) the use of products, processes, mate rials or substances that may influence 
food or feed safety, animal health or animal welfare, plan t health or plant 
reproductive material identity and qual ity, or, in the case of GMOs and 
plant protection products, may adve rsely impact on the environment; 
(b) operators' past record as regards the re sults of official c ontrols performed on 
them and their compliance with the rules referred to in Article 1(2); 
(c) the reliability and results of own contro ls that have been performed by the 
operators, or by a third part y at their request, for th e purpose of ascertaining 
compliance with the rules re ferred to in Article 1(2); 
(d) any information that might indicate non- compliance with the rules referred to 
in Article 1(2). 
2. Competent authorities shall perform official controls on a regular basis and with 
appropriate frequency to identify possible inte ntional violations of the rules referred 
to in Article 1(2), taking into account, in  addition to the crit eria referred to in 
paragraph 1, information regarding such po ssible intentional violations shared 
through the mechanisms of administrative as sistance provided for in Title IV and any 
other information pointing to the possibility of such violations. 
3. Official controls performed prior to the placing on the market or the movement of 
certain animals and goods in view of the is suance of the official  certificates or 
official attestations required by the rules re ferred to in Article 1(2) as a condition for EN 44   EN the placing on the market or the moveme nt of the animals or goods shall be 
performed in accordance with: 
(a) the rules referred to in Article 1(2); 
(b) the delegated acts adopted by the Commi ssion in accordance with Articles 15 
to 24. 
4. Official controls shall be performe d without prior warning, except where: 
(a) prior notification of the operator is necessary; 
(b) the operator has requested such official controls. 
5. Official controls shall be performed as much as possible in a manner that minimises 
the burden on the operators. 
6. Competent authorities shall perform official  controls with the same care irrespective 
of whether the animals and goods concerned are: 
(a) available on the Union market, whether originating in the Member State where 
the official controls are performe d or in another Member State; 
(b) to be exported from the Union; 
(c) entering the Union from third countries. 
7. To the extent strictly necessary for the or ganisation of the official controls, Member 
States of destination may re quire operators who have an imals or goods delivered to 
them from another Member State to repor t the arrival of such animals or goods. 
Article 9 
Persons, processes and activities su bject to official controls 
To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), 
competent authorities shall perform official controls: 
(a) on animals and goods at all stages of production, processing and distribution; 
(b) on substances, materials or objects whic h may influence the characteristics of 
animals and goods, at all stages of pr oduction, processing and distribution; 
(c) on operators and the activities and operati ons under their control, on their premises 
and processes, on the storage, transport, and the use of goods and the keeping of 
animals. 
Article 10 
Transparency of official controls 
1. Competent authorities shall perform offi cial controls with a high level of 
transparency and make available to the pub lic relevant information concerning the 
organisation and the performa nce of official controls. 
They shall also ensure the regular a nd timely publication of information on the 
following: 
(a) the type, number and outcome of official controls; 
(b) the type and the number of  non-compliances detected; EN 45   EN (c) the cases where measures were taken by the competent authorities in 
accordance with Article 135; 
(d) the cases where the penalties referr ed to in Article 136 were imposed. 
2. To ensure the uniform implem entation of the rules provided for in paragraph 1 of this 
Article, the Commission shall, by means of  implementing acts, lay down and update 
as necessary the format in which the information referred to in that paragraph shall be published. Those implementing acts shall be adopted in accordance with the examination procedure refe rred to in Article 141(2). 
3. Competent authorities shall be  entitled to publish or make  otherwise available to the 
public information about the rating of indi vidual operators based on the outcome of 
official controls, provided that  the following conditions are met: 
(a) the rating criteria are objective, tr ansparent and publicly available; 
(b) appropriate arrangements are in plac e to ensure the consistency and 
transparency of the rating process. 
Article 11 
Documented control and contro l verification procedures  
1. Competent authorities shall perform offici al controls in accordance with documented 
procedures. 
Those procedures shall cover the subject areas for control procedures set out in 
Chapter II of Annex II and contain detailed instructions for sta ff performing official 
controls. 
2. Competent authorities shall have procedur es in place to verify the consistency and 
effectiveness of official controls and othe r official activities that they perform. 
3. Competent authorities shall: 
(a) take corrective actions in all cases where the procedures provided for in 
paragraph 2 identify shortcomings in the consistency and effectiveness of official controls and ot her official activities; 
(b) update the documented procedures provide d for in paragraph 1 as appropriate. 
Article 12 
Reports on official controls 
1. Competent authorities shall draw up repor ts on every official control that they 
perform. 
Those reports shall contain: (a) a description of the purpose of the official controls; 
(b) the control methods applied; 
(c) the results of the official controls; 
(d) where appropriate, action that the compet ent authorities requi re the operator 
concerned to take as a result of their official controls. EN 46   EN 2. Competent authorities shall provide the opera tor subject to an official control with a 
copy of the report provided for in paragraph 1. 
3. Where official controls require the con tinuous or regular presence of staff or 
representatives of the competent authorities in the operator's premises, the reports provided for in paragraph 1 shall be produced with a fr equency that enables the 
competent authorities and the operator to be:  
(a) regularly informed of the level of compliance; 
(b) immediately informed of any shortcoming or non-compliance identified 
through the official controls. 
Article 13 
Official controls, methods and techniques  
1. Competent authorities shall perform offi cial controls using control methods and 
techniques that shall, as appropriate,  include screening, targeted screening, 
verification, inspections, audits, samp ling, analysis, diagnosis and tests. 
2. Official controls shall incl ude the following, as appropriate: 
(a) an examination of the control systems th at operators have put  in place and of 
the results obtained; 
(b) an inspection of: 
(i) primary producers' installations and other businesse s, including their 
surroundings, premises, offices, equipm ent, installations  and machinery, 
transport and their animals and goods; 
(ii) raw materials, ingredients, proce ssing aids and other products used for 
the preparation and production of goods or for feeding or treating 
animals; 
(iii) semi-finished goods; (iv) cleaning and mainte nance products and processes, plant protection 
products; 
(v) labelling, presentation and advertising; 
(c) controls on the hygiene conditions in the operators’ premises; 
(d) an assessment of procedures on good manufacturing practices (GMP), good 
hygiene practices (GHP), good farming pract ices and hazard analysis critical 
control points (HACCP); 
(e) an examination of documents and other records which may be relevant to the 
assessment of compliance with the rules referred to in Article 1(2); 
(f) interviews with operators and with their staff; 
(g) a reading of values recorded by operators' measuring instruments; 
(h) controls performed with the competent au thorities' own instruments to verify 
measurements taken by operators; 
(i) any other activity required to identify non-compliances. EN 47   EN Article 14 
Obligations of operators 
1. To the extent that this is necessary for the performance of official controls or of other 
official activities, operators shall, where re quired by the competent authorities, give 
staff of the competent authorities access to: 
(a) their premises; 
(b) their computerised information management systems; 
(c) their animals and goods; 
(d) their documents and any other relevant information. 
2. During official controls and other official activities, operators shall assist the staff of 
the competent authorities in th e accomplishment of their tasks. 
3. The operator responsible for the consignment shall: 
(a) cooperate fully with the competent au thorities to ensure the efficient 
performance of official controls  or other official activities; 
(b) make available all information con cerning the consignment on paper or 
electronically. 
4. The Commission may, by means of im plementing acts, lay down rules: 
(a) establishing the modalities for access by the competent authorities to the 
computerised information management sy stems referred to in paragraph 1(b); 
(b) on the cooperation between operators and competent authorities as referred to 
in paragraph 3. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 15 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
relation to the production of products of ani mal origin intended for human consumption 
1. Official controls on the pr oduction of meat shall include: 
(a) the verification, by or under the responsibility  of an official veterinarian, of the 
health and welfare of the an imals prior to the slaughter; 
(b) official controls, by or under the responsib ility of an official veterinarian, in 
slaughterhouses, cutting pl ants and game handling es tablishments, to verify 
compliance with the requirements applicable to: 
(i) the hygiene of meat production; (ii) the presence of residues of veteri nary medicinal products in products of 
animal origin intended for human consumption;  
(iii) the handling and disposal of anim al by-products and of specified risk 
material; 
(iv) the health and welfare of the animals.  EN 48   EN 2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning specific rules for th e performance of official controls on 
products of animal origin intended for human consumption and on animals intended for the production of such products to verify  compliance with the rules referred to in 
points (a), (c), (d) and (e) of Article 1(2)  applicable to those products and animals, 
and on action to be taken by the competent authorities following official controls. 
Those delegated acts shall lay down rules on: 
(a) the specific responsibilities and tasks of the competent authorities, in addition 
to those provided for in paragraph 1 and in Articles 4, 8, 9, 10(1), 11, 12, 13, 
34(1) and (2), and 36; 
(b) uniform specific requirements for the pe rformance of official controls and 
uniform minimum frequency of such o fficial controls, having regard, in 
addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each produc t of animal origin and the different 
processes it undergoes; 
(c) the cases where and the conditions unde r which slaughterhouse staff may be 
involved in official controls, and the de sign and application of tests to assess 
their performance; 
(d) the cases where the competent aut horities in relation to specific non-
compliances are to take one or more  of the measures referred to in 
Article 135(2) or additional measures to those provided for in that paragraph; 
(e) criteria to determine when, on the basi s of a risk analysis, the official 
veterinarian is not require d to be present in slaughterhouses and game handling 
establishments during the official co ntrols referred to in paragraph 1. 
Where, in cases of risks which cannot be effectively addressed in the absence of 
common specifications for the official contro ls or for the action to be taken by the 
competent authorities following such o fficial controls, imp erative grounds of 
urgency so require, the procedure provided for in Article 140 shal l apply to delegated 
acts adopted pursuant to this paragraph. 
3. The Commission shall take into account the following when adopting delegated acts 
as provided for in paragraph 2: 
(a) the experience gained by food business operators on the a pplication of the 
procedures referred to in Article 5 of Regulation (EC) 852/2004 of the 
European Parliament and of the Council
48; 
(b) scientific and technol ogical developments; 
(c) consumer expectations with regard to food composition and changes in patterns 
of consumption of food; 
(d) risks to human health  and animal health  associated with meat and other 
products of animal origin intended for human consumption. 
4. Insofar as this does not prevent the achieve ment of the objectives of human health 
and animal health pursued by the rules referr ed to in points (a), (c), (d) and (e) of 
Article 1(2), applicable to products of an imal origin intended for human consumption 
                                                 
48 OJ L 139, 30.4.2004, p. 1. EN 49   EN and to animals intended fo r the production of such products, the Commission shall 
also take into account the following el ements, when adopting delegated acts as 
provided for in paragraph 2: 
(a) the need to facilitate the application of  the delegated acts in small businesses; 
(b) the need to enable the con tinued use of traditional met hods at any of the stages 
of production, processing or  distribution of food; 
(c) the needs of food businesses situated in  regions that are subject to special 
geographic constraints. 
Article 16 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
relation to the residues of certain  substances in food and feed  
The Commission shall be empowered to adopt delegated acts in accordance with Article 139  
concerning rules on official cont rols performed to verify compliance with the rules referred to 
in point (a) of Article 1(2) appl icable to certain substances w hose use on crops or animals or 
to produce  or process food or feed may result in resi dues of those substances in food or feed , 
and on action to be taken by the competent au thorities following official controls. Those 
delegated acts shall take account of  the need to ensure a minimum level of official controls to 
prevent the use of those substances in violati on of the rules referred  to in point (a) of 
Article 1(2), and lay down rules on: 
(a) uniform specific requirements for the perfor mance of official controls and uniform 
minimum frequency of such official cont rols, having regard, in addition to the 
criteria referred to in Article 8(1), to the specific hazards and risks related to non-
authorised substances and to the non-authorised use of authorised substances; 
(b) specific additional criteria and specific addi tional content to those provided for in 
Article 108, for the preparat ion of the relevant parts of the multi-annual national 
control plan provided fo r in Article 107(1); 
(c) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph. 
Article 17 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
relation to animals, products of animal or igin, germinal products , animal by-products and 
derived products 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning rules for the performance of official  controls on animals, on products of animal 
origin, on germinal products, on animal by-pr oducts and on derived products to verify 
compliance with the Union rules referred to in points (d) and (e) of Article 1(2) and on action to be taken by the competent authorities following  official controls. Those delegated acts shall 
take account of animal health risks  related to animals, products of  animal origin and germinal 
products, and of human and anim al health risks re lated to animal by-products and derived 
products, and lay down rules on: 
(a) the specific responsibilities and tasks of th e competent authorities, in addition to 
those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36; EN 50   EN (b) uniform specific requirements for the perfor mance of official controls, and uniform 
minimum frequency of such official cont rols, having regard, in addition to the 
criteria referred to in Article 8(1), to the need to address specific hazards and risks to 
animal health by means of official contro ls performed to verify compliance with 
disease prevention and control measures laid down in accordance with the rules 
referred to in point (d) of Article 1(2); 
(c) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph. 
Article 18 
Specific rules on official contro ls and action to be taken by the competent authorities in 
relation to the welfare requirements for animals 
1. Official controls to verify compliance with the rules laying down welfare 
requirements for animals in case of their transport shall include: 
(a) in case of long journeys between Member  States and with third countries, 
official controls performed prior to th e loading to check the fitness of the 
animals for transport; 
(b) in case of long journeys between Member  States and with third countries of 
domestic equidae other th an registered equidae and domestic animals of the 
bovine, ovine, caprine and porcine sp ecies, prior to the journey:  
(i) official controls on jour ney logs to verify that th e journey log is realistic 
and indicates compliance with Regulation (EC) No 1/2005; 
(ii) official controls to verify that the transporter indicated in the journey log 
has a valid transporter authorisation,  certificate of approval for the means 
of transport for long journeys and ce rtificates of competence for drivers 
and attendants;  
(c) at border control posts provided for in  Article 57(1) and at exit points: 
(i) official controls on the fitness of  the animals being tr ansported and on the 
means of transport; 
(ii) official controls to verify that  transporters comply with applicable 
international agreements and have va lid transporter authorisations and 
certificates of competence for drivers and attendants; 
(iii) official controls to verify whether domestic equidae and domestic 
animals of bovine, ovine, caprine and por cine species have been or are to 
be transported over long journeys. 
2. Where the rules referred to in point (f) of Article 1(2) requi re that certain non-
quantifiable standards of animal welfare be  met, or where those rules require the 
adoption of certain practices adherence to  which cannot be effectively verified 
through the sole use of the official cont rol methods and techni ques referred to in 
Article 13, official controls performed to  verify compliance with those rules may 
include the use of specific indicators of animal welfare, in the cases and under the 
conditions that shall be adopted in acco rdance with point (f) of paragraph 3. EN 51   EN 3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rules for the perfor mance of official controls to verify 
compliance with Union rules referred to in point (f) of Article 1(2). Those delegated 
acts shall take into account the animal welf are risk related to the farming activities 
and to the transport, slaughter and killi ng of animals, and shall lay down rules on: 
(a) the specific responsibilities and tasks of the competent authorities, in addition 
to those provided for in paragraph 1 and Articles 4, 8, 9, 10(1), 11, 12, 13, 
34(1) and (2), and 36; 
(b) uniform specific requirements for the performance of official controls, and 
uniform minimum frequency of such o fficial controls, having regard, in 
addition to the criteria refe rred to in Article 8(1), to the risk associated with 
different animal species and means of transport, and the need to prevent non-
compliant practices and to limit the suffering of animals; 
(c) the cases where the competent aut horities in relation to specific non-
compliances are to take one or more  of the measures referred to in 
Article 135(2) or additional measures to those provided for in that paragraph; 
(d) the verification of animal welfare requi rements at border control posts and at 
exit points and the minimum requirements applicable to such exit points; 
(e) specific criteria and conditions for th e activation of the mechanisms of 
administrative assistance provided for in Title IV; 
(f) the cases and conditions where official controls to verify compliance with 
animal welfare requirements may include the use of specific  animal welfare 
indicators based on measurable perform ance criteria, and the design of such 
indicators on the basis of scie ntific and technical evidence. 
Article 19 
Specific rules on official contro ls and action to be taken by the competent authorities in 
relation to plant health 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning rules for the performance of official  controls on plants, plant products and other 
objects in order to verify compliance with Union rules referred to in point (g) of Article 1(2) applicable to such goods and on action to be taken by the competent authorities following 
such official controls. Those delegated acts shal l take account of plant he alth risks associated 
with plants, plant products and ot her objects in relation to  specific pests of plants or operators 
and lay down rules on: 
(a) the specific responsibilities and tasks of th e competent authorities, in addition to 
those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36; 
(b) uniform specific requirements for the pe rformance of offici al controls on the 
introduction into and movement in the Uni on of particular plan ts, plant products and 
other objects subject to the rules referred to  in point (g) of Article 1(2) and uniform 
minimum frequencies of such official c ontrols having regard, in addition to the 
criteria referred to in Article 8(1), to the specific hazards and risks to plant health in 
relation to specific plants, plant products a nd other objects of a particular origin or 
provenance; EN 52   EN (c) uniform frequencies of offi cial controls performed by competent authorities on 
operators authorised to issue plant passports in accordance with Article 79(1) of Regulation (EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on protective measures against pests of plants ] having regard, in 
addition to the criteria referred to in arti cle 8(1), to whether those operators have 
implemented a phytosanitary risk management  plan as referred to  in Article 86 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on protective meas ures against pests of plants ] for the plants, plant 
products and other obje cts they produce; 
(d) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph. 
Article 20 
Specific rules on official contro ls and action to be taken by the competent authorities in 
relation to plant reproductive material 
The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning rules for the performance of official  controls on plant repr oductive material in 
order to verify compliance with the rules referred to in point (h) of Article 1(2) applicable to 
such goods and on action to be taken by the co mpetent authorities following such official 
controls. Those delegated act s shall lay down rules on: 
(a) the specific responsibilities and tasks of th e competent authorities, in addition to 
those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36; 
(b) uniform specific requirements for the perfor mance of official controls having regard, 
in addition to the criteria referred to in Article  8(1), to the risks to the health, identity, 
quality and traceability of certain categories of plant reproductive material or of 
specific genera or species; 
(c) specific criteria and conditions for the activ ation of the mechanisms of administrative 
assistance provided for in Title IV; 
(d) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph. 
Article 21 
Specific rules on official contro ls and action to be taken by the competent authorities in 
relation to GMOs and genetica lly modified food and feed 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning rules for the performa nce of official controls on GMOs and genetically modified 
food and feed performed to verify compliance with  the rules referred to in points (a), (b) and 
(c) of Article 1(2) and on action to be take n by the competent authorities following such 
official controls. Those delegate d acts shall take into account the need to ensure a minimum 
level of official controls to pr event practices in violation with those rules, and lay down rules 
on: 
(a) 
the specific responsibilities and tasks of th e competent authorities, in addition to 
those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1)  and (2) and 36; EN 53   EN (b) uniform specific requirements for the perfor mance of official controls and uniform 
minimum frequency of such  official controls on: 
(i) the presence on the market of GMOs a nd of genetically modified food and feed 
which have not been authorised in accordance with Directive 2001/18/EC of 
the European Parliament and the Counc il of 12 March 2001 on the deliberate 
release into the environment of genetic ally modified organisms and repealing 
Council Directive 90/220/EEC49 or Regulation (EC) No 1829/2003; 
(ii) the cultivation of GMOs and the corre ct application of the monitoring plan 
referred to in point (e) of Article 13(2) of Dir ective 2001/18/EC and in 
Articles 5(5) and 17(5) of  Regulation (EC) 1829/2003; 
(iii) the contained use of genetic ally modified microorganisms; 
(c) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph. 
Article 22 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
relation to plant protection products 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning rules for the performance of official controls to verify compliance with the rules 
referred to in Article 1(2)(i). 
Those delegated acts shall take into account the risks that plant protection products may 
represent for human health, animal health or the environment, and sh all lay down rules on: 
(a) the specific responsibilities and tasks of th e competent authorities, in addition to 
those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 36; 
(b) uniform specific requirements for the perfor mance of official controls and uniform 
minimum frequency of such official cont rols, concerning th e manufacture, placing 
on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products, having regard, in addition to the criteria referred to in 
Article 8(1), to the need to ensure the safe and sustainable use of plant protection products and to combat illeg al trade of such products; 
(c) uniform specific requirements for inspecti ons on pesticide app lication equipment and 
uniform minimum frequency of such controls; 
(d) the cases where the competent authorities in  relation to specific non-compliances are 
to take one or more of the measures re ferred to in Article 135(2) or additional 
measures to those provided for in that paragraph; 
(e) the design of certification systems to a ssist the competent authorities in the 
inspections of pesticid e application equipment; 
(f) the collection of information, monitoring a nd reporting on suspected poisonings from 
plant protection products; 
(g) the collection of information, and the m onitoring of and reporting on counterfeited 
plant protection products and illegal trade of plant protection products. 
                                                
 
49 OJ L 106, 17.4.2001, p. 1. EN 54   EN Article 23 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
relation to organic products and to protected designations of origin, protected geographical 
indications and traditional  specialties guaranteed 
1. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 139 concerning rules for the perfor mance of official controls to verify 
compliance with the rules referred to in po ints (j) and (k) of Article 1(2) and on 
action to be taken by the competent author ities following such official controls. 
2. In relation to the rules referred to in poi nt (j) of Article 1(2), the delegated acts 
referred to in paragraph 1 shall lay down rules on: 
(a) the specific responsibilities and tasks of the competent authorities, in addition 
to those provided for in Articles 4, 8, 9, 10(1), 11 to 13, 34(1) and (2), and Article 36, and in addition to Articles 25, 29, 30 and 32 for the approval and 
supervision of delegated bodies; 
(b) additional requirements to those referred to  in Article 8(1) for risk assessment, 
and for the establishment of the frequenc y of official controls, and of sampling 
as appropriate, taking into account the risk of the occurrence of non-compliance; 
(c) the minimum frequency of official controls  on operators as defined in point (d) 
of Article 2 of Council Regulation (EC) No 834/2007 , and the cases where and 
the conditions under which certain such operators are to be exempted from 
certain official controls; 
(d) additional methods and techni ques for official controls to those referred to in 
Articles 13 and 33(1) to (5) and specific requirements  for the performance of 
official controls aimed at ensuring th e traceability of orga nic products at all 
stages of the production, preparation and distribution, and at providing 
assurances as to compliance with th e rules referred to in point (j) of 
Article 1(2); 
(e) additional criteria to those referred  to in the second subparagraph of 
Article 135(1) and in  Article 30(1) of Regulatio n (EC) No 834/2007, relating to 
the measures to be taken in case of the occurrence of non-compliance, and additional measures to those provided for in Article 135(2); 
(f) additional requirements to those provided for in point (f) of Article 4(1) in 
relation to the facili ties and equipment necessary to carry out official controls 
and additional conditions and obligations to those referred to  in Articles 25 to 
30 and 32 for the delegation of  official control tasks; 
(g) additional reporting obligations to those referred to in Articles 12 and 31 for 
the competent authorities, the control authorities for organic products, and the 
delegated bodies in charge  of official controls; 
(h) specific criteria and conditions for th e activation of the mechanisms of 
administrative assistance provided for in Title IV. 
3. In relation to the rules referred to in poi nt (k) of Article 1( 2), the delegated acts 
referred to in paragraph 1 shall lay down rules on: EN 55   EN (a) additional requirements, methods and tec hniques to those referred to Articles 
11 and 13 for official controls performed to verify compliance with product specifications and labelling requirements; 
(b) additional methods and techniques to those referred in Article 13 for the 
performance of official controls aimed at ensuring the trace ability of products 
falling within the scope of the rules referred to in point (k) of Article 1(2) at all 
stages of production, preparation and di stribution, and at providing assurances 
as to compliance with those rules; 
(c) specific additional criteria and specific a dditional content to those provided for 
in Article 108, for the preparation of the relevant parts of the multi-annual 
national control plan provided for in Article 107(1), and specific additional content of the report prov ided for in Article 112; 
(d) specific criteria and conditions for th e activation of the mechanisms of 
administrative assistance provided for in Title IV; 
(e) specific measures to be taken, in addition to those referred to in Article 135(2) 
in case of non-compliance and of se rious or recurrent non-compliance. 
4. Where appropriate, the delegated acts referred to in pa ragraphs 2 and 3 shall derogate 
from the provisions of this Regulatio n referred to in those paragraphs. 
Article 24 
Specific rules on official contro ls and on action to be taken by  the competent authorities in 
cases of newly identified risks in relation to food and feed 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning speci fic rules on official cont rols performed on certain 
categories of food or feed to verify complia nce with the rules refe rred to in points (a) 
to (e) of Article 1(2) and on action to be taken by the competent authorities following 
such official controls. Those delegated acts shall address newly identified risks 
which may be posed through food or feed to hu man or animal health  or, in relation to 
GMOs and plant protection products to the en vironment, or any su ch risks emerging 
from new patterns of production or consump tion of food or feed, or which cannot be 
effectively addressed in the absence of  common specifications for the official 
controls and for the action to be taken by the competent authorities following such 
official controls, and shall lay down rules on: 
(a) the specific responsibilities and tasks of the competent authorities, in addition 
to those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13, 34(1) and (2), and 
36; 
(b) uniform specific requirements for the pe rformance of official controls and 
uniform minimum frequency of such o fficial controls, having regard, in 
addition to the criteria referred to in Article 8(1), to the specific hazards and risks which exist in relation to each categ ory of food and feed and the different 
processes it undergoes; 
(c) the cases where the competent aut horities in relation to specific non-
compliances are to take one or more  of the measures referred to in 
Article 135(2) or additional measures to  those provided for in that paragraph. EN 56   EN 2. Where, in the case of serious risks to human or animal health or to the environment, 
imperative grounds of urgency so require, the procedure provided for in Article 140 shall apply to delegated acts a dopted pursuant to paragraph 1. 
Chapter III 
Delegation of specific tasks of the competent authorities 
Article 25 
Delegation by the competen t authorities of specific official control tasks 
1. Competent authorities may de legate specific official control tasks to one or more 
delegated bodies or natural persons in accordance with the conditions provided for in Articles 26 and 27 respectively. 
2. Competent authorities shall not delega te the decision concerning the measures 
provided for in point (b) of Article 13 5(1) and in Article 135 (2) and (3). 
The first subparagraph shall not apply to the measures to be taken in accordance with 
Article 135 or with the rules provided for in point (e) of Article 23(2) following 
official controls performed to verify complia nce with the rules refe rred to in point (j) 
of Article 1(2). 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 establishing specific official c ontrol tasks that may not be delegated in 
order to preserve the independence or the co re functions of the competent authorities. 
4. Where competent authorities delegate sp ecific official control tasks for the 
verification of compliance with the rules referred to in point (j) of Article 1(2) to one or more delegated bodies, they shall attrib ute a code number to each delegated body 
and designate authorities responsible  for their approval and supervision. 
Article 26 
Conditions for delegating specific offici al control tasks to delegated bodies 
1. The delegation of specific control ta sks to a delegated body referred to in 
Article 25(1) shall be in writing and sh all comply with the following conditions: 
(a) the delegation contains a precise description of: 
(i) the specific official control task s that the delegated body may perform; 
(ii) the conditions under which it may perform them; 
(b) the delegated body: 
(i) has the expertise, equipment and in frastructure required to perform the 
specific official control tasks delegated to it; 
(ii) has a sufficient number of suitabl y qualified and experienced staff; 
(iii) is impartial and free from any confli ct of interest as regards the exercise 
of the specific official control tasks delegated to it; 
(iv) works and is accredited in accord ance with standard EN ISO/IEC 17020  
'Requirements for the operation of various types of bodies performing 
inspection' or another standard if more  relevant to the delegated tasks in 
question; EN 57   EN (c) there are arrangements in place ensuri ng efficient and effe ctive coordination 
between the delegating competent authorities and the delegated body. 
Article 27 
Conditions for delegating specific offici al control tasks to natural persons 
Competent authorities may delegate specific offi cial control tasks to one or more natural 
persons where the rules provided fo r in Articles 15 to 24 so allow.  Such delegation shall be in 
writing.  
Article 26(1) shall apply to the delegation of spec ific official control tasks to natural persons, 
with the exception of poi nts (b)(ii) and (b)(iv). 
Article 28 
Obligations of the delega ted body and natural person 
 to which specific official control tasks are delegated 
Delegated bodies or natural persons to whom  specific official control tasks have been 
delegated in accordance with  Article 25(1) shall: 
(a) communicate the results of the official cont rols performed by them to the competent 
authorities which have delega ted the specific official control tasks on a regular basis 
and whenever those competent authorities so request; 
(b) immediately inform the competent authorities which have delegated the specific 
official control tasks whenever the results  of the official controls indicate non-
compliance or point to the likelihood of non-compliance. 
Article 29 
Obligations of the competent authorities delegating specific official control tasks 
Competent authorities that have delegated specific offi cial control tasks to  delegated bodies or 
natural persons in accordance with Article 25(1) shall: 
(a) organise audits or inspections of such bodies or persons as necessary; 
(b) fully or partly withdraw the delegation without delay where: 
(i) following an audit or an inspection as provided in point (a), there is evidence 
that such delegated bodies or natural persons are failing to properly perform the official control tasks delegated to them; 
(ii) the delegated body or the natural pers on fails to take appropriate and timely 
action to remedy the shortcomings iden tified during the audits and inspections 
provided for in point (a). 
Article 30 
Conditions for delegating specific tasks related to other official activities 
1. The competent authorities may delegate specific tasks related to other official 
activities to one or more delegated bodies  subject to compliance with the following 
conditions: 
(a) the rules referred to in Article 1(2)  do not prohibit such delegation; EN 58   EN (b) the conditions laid down in Article 26(1) are fulfilled with the exception of 
point (b)(iv). 
2. The competent authorities may delegate specific tasks related to other official 
activities to one or more natural persons subject to compliance with the following 
conditions: 
(a) the rules referred to in Article 1(2) allow such delegation; 
(b) the conditions laid down in Article 26(1) are fulfilled with the exception of 
points (b)(ii) and (b)(iv). 
Article 31 
Obligations of the delegated body and natural pe rson to which specific tasks related to other 
official activities are delegated 
The delegated body or the natural person to whom  specific tasks related to other official 
activities have been delegated in accordance with Article 30 shall: 
(a) communicate the results of the other offi cial activities performed by it to the 
competent authorities which have delegated th e specific tasks related to other official 
activities on a regular basis and whenever  the competent authorities so request; 
(b) immediately inform the competent authorities which have delegated the specific 
tasks related to other official activities whenever the results of the other official 
activities indicate non-compliance or point  to the likelihood of non-compliance. 
Article 32 
Obligations of the competent authorities delegating specific task s related to other 
official activities 
Competent authorities that have delegated specific tasks related to other official activities to 
delegated bodies or natural persons in accordance with Article 30 shall: 
(a) organise audits or inspections of such bodies or persons as necessary; 
(b) fully or partly withdraw the delegation without delay where: 
(i) following an audit or an inspection as  provided for in point (a), there is 
evidence that such delegated bodies or natural persons are failing to properly 
perform the tasks related to other official activities delegated to them; 
(ii) the delegated bodies or natural pers ons fail to take appropriate and timely 
action to remedy the shortcomings iden tified during the audits and inspections 
provided for in point (a). 
Chapter IV 
Sampling, analyses, tests and diagnoses 
Article 33 
Methods used for sampling, analyses, tests and diagnoses 
1. Methods used for sampling and for laborat ory analyses, tests and diagnoses during 
official controls and other official ac tivities shall comply with Union rules 
establishing those methods or the pe rformance criteria for those methods. EN 59   EN 2. In the absence of the Union rules referred to in paragraph 1, official laboratories shall 
use state-of-the-art methods for their specifi c analytical, testing and diagnostic needs, 
taking into account: 
(a) the most recent available methods comp lying with relevant  internationally 
recognised rules or protocols, including those that the European Committee for 
Standardisation (CEN) has accepted; or, 
(b) in the absence of the rules or protocols referred to in point (a), the relevant 
methods developed or recommended by the European Union reference 
laboratories and validated in accordance with internationally accepted scientific 
protocols; or, 
(c) in the absence of the rules or protocols referred to in  point (a) and the methods 
referred to in point (b), the methods  which comply with relevant rules 
established at national level; or, 
(d) in the absence of the rules or protocol s referred to in point  (a), the methods 
referred to in point (b) and the national rules referred to in point (c), the relevant methods developed or recomme nded by national refere nce laboratories 
and validated in accordance with intern ationally accepted scientific protocols; 
or, 
(e) in the absence of the rules or protocol s referred to in point  (a), the methods 
referred to in point (b), the national rules referred to in point (c) and the 
methods referred to in point (d), the re levant methods validated in accordance 
with internationally accepted  scientific protocols. 
3. In the context of screening, targeted screening an d of other official activities, any of 
the methods referred to in paragraph 2 may be used in the absence of Union rules 
referred to in paragraph 1. 
4. Where laboratory analyses, tests or diagnos es are urgently needed and none of the 
methods referred to in paragraphs 1 and 2 exists, the relevant national reference 
laboratory or, if no such national reference laboratory exists, any other laboratory 
designated in accordance with Article 36( 1) may use methods other than those 
referred to in paragraphs 1 and 2 of this Article until the validati on of an appropriate 
method in accordance with internationa lly accepted scientific protocols. 
5. Wherever possible, methods used for labor atory analyses shall be characterised by 
the appropriate criteria set out in Annex III. 
6. Samples shall be taken, handled and labell ed in such a way as to guarantee their 
legal, scientific and technical validity. 
7. The Commission may, by means of impl ementing acts, lay down rules for: 
(a) the methods to be used for sampling and for laboratory an alyses, tests and 
diagnoses; 
(b) performance criteria, analysis, test or diagnosis parameters, measurement 
uncertainty and procedures for the validation of those methods; 
(c) the interpretation of analytical, testing and diagnostic results. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). EN 60   EN Article 34 
Second expert opinion 
1. The competent authorities shall ensure that operators, whose animals or goods are 
subject to sampling, analysis, test or diagnos is in the context of official controls, 
have the right to apply for a second expert opinion. 
Such right: (a) shall always entitle the operator to request a documentary review of the 
sampling, analysis, test or di agnosis by another expert; 
(b) where relevant and technically feasible, having regard in particular to the 
prevalence and distribution of the haza rd in the animal s or goods, to the 
perishability of the samp les or the goods and to the amount of available 
substrate, shall entitle the operator to request: 
(i) that a sufficient number of other samples be taken for a second expert 
opinion; or, 
(ii) where it is not possible to take a sufficient number of samples as referred 
to in point (i), that an independent second analysis, test or diagnosis on 
the sample be carried out. 
2. The application by the operator for a second expert opinion in accordance with 
paragraph 1 shall not affect the obligation of competent au thorities to take prompt 
action to eliminate or contain the risks to  human, animal and plant health, or for 
animal welfare or, as regards GMOs and plant protection products, for the 
environment, in accordance with the rules refe rred to in Article 1(2) and with this 
Regulation. 
3. The Commission may, by means of implemen ting acts, lay down procedures for the 
uniform application of the rules provided for in paragraph 1 and for the presentation 
and handling of applications for a second expert opinion. Those implementing acts shall be adopted in accordance with th e examination procedure referred to in 
Article 141(2). 
Article 35 
Sampling of animals and goods offered for sale by means of distance communication 
1. In the case of animals and goods o ffered for sale by means of distance 
communication, samples ordered from operators by the competent authorities without identifying themselves may be used for the purposes of an official control. 
2. Competent authorities shall take all steps to  ensure that the operators from whom the 
samples are ordered in acco rdance with paragraph 1: 
(a) are informed that such samples are bei ng taken in the contex t of an official 
control and, where appropriate, analysed  or tested for the purposes of such 
official control; and, 
(b) where the samples referred to in paragra ph 1 are analysed or tested, are entitled 
to exercise the right to apply for a second expert opinion provided for in 
Article 34(1). EN 61   EN Article 36 
Designation of offici al laboratories  
1. The competent authorities shall designate  official laboratories to carry out the 
laboratory analyses, tests and diagnoses on samples taken du ring official controls and 
other official activities, in the Member State in whose territory those competent 
authorities operate or in another Member State. 
2. Competent authorities may designate as o fficial laboratory a laboratory located in 
another Member State subject to co mpliance with the following conditions: 
(a) appropriate arrangements are in place under which they are enabled to perform 
the audits and inspections referred to in Article 38(1) or delegate the performance of such audits and inspectio ns to the competent authorities of the 
Member State where the la boratory is located;  
(b) that laboratory is already designated as an official laboratory by the competent 
authorities of the Member State on whose territory it is located. 
3. The designation shall be in writing and shall include a detailed description of: 
(a) the tasks that the laboratory shall carry out as official laboratory; 
(b) the conditions under which it sh all carry out those tasks; 
(c) the arrangements necessary to ensure e fficient and effective coordination and 
collaboration between the laborator y and the competent authorities. 
4. The competent authorities may only designa te as official la boratory a laboratory 
which: 
(a) has the expertise, equipment and infrastru cture required to carry out analyses or 
tests or diagnoses on samples; 
(b) has a sufficient number of suitably qua lified, trained and experienced staff; 
(c) is impartial and free from any conflict of interest as regards the exercise of its 
tasks as official laboratory; 
(d) can deliver timely the results of the analys is, test or diagnosi s carried out on the 
samples taken during official contro ls and other official activities; 
(e) operates in accordance with the standard EN ISO/IEC 17025 on 'General 
requirements for the competence of testi ng and calibration laboratories' and is 
assessed and accredited in accordance w ith that standard by a national 
accreditation body operating in accordance with Regulation (EC) No 765/2008. 
5. The scope of the assessment and accreditati on of an official labor atory referred to in 
point (e) of paragraph 4: 
(a) shall include all the methods of laborato ry analysis, test or  diagnosis required 
to be used by the laboratory for analyses , tests or diagnoses when it operates as 
an official laboratory; 
(b) may comprise one or more methods of la boratory analysis, test or diagnosis or 
groups of methods; 
(c) may be defined in a flexible manner, so  as to allow the accreditation scope to 
include modified versions of the methods used by the official laboratory when 
the accreditation was granted or new met hods in addition to those methods, on EN 62   EN the basis of the laboratory's own validat ions without a specific assessment by 
the national accreditation body prior to the use of those modified or new methods. 
Where no official laboratory designated in the Union in accordance with paragraph 1 
has the expertise, equipment, infrastructu re and staff necessary to perform new or 
particularly uncommon laboratory analys es, tests or diagnoses, the competent 
authorities may request a laboratory or di agnostic centre which does not comply with 
one or more of the requirements of paragr aphs 3 and 4 of this Article to carry out 
those analyses, tests and diagnoses. 
Article 37 
Obligations of official laboratories 
1. Official laboratories shall immediately inform the competent authorities where the 
results of an analysis, test or diagnos is carried out on samples indicate non-
compliance or point to the likelihoo d of non-compliance by an operator. 
2. Upon request by the European Union refe rence laboratory or national reference 
laboratory, official laboratori es shall take part in inte r-laboratory comparative tests 
organised for the analyses, tests or diagnoses  they perform as official laboratories. 
3. Official laboratories shall make available to the public the list of methods used for 
analyses, tests or diagnoses performed in th e context of official controls and other 
official activities. 
Article 38 
Audits and inspections of official laboratories 
1. The competent authorities sh all organise audits or inspections of the official 
laboratories they have designated in  accordance with Article 36(1): 
(a) on a regular basis; 
(b) any time they consider that an audit or inspection is necessary. 
2. The competent authorities shall immediatel y withdraw the designa tion of an official 
laboratory, either completely or for certain tasks, where it fails to take appropriate 
and timely remedial action following the results  of an audit or an inspection provided 
for in paragraph 1 which disclose any of the following: 
(a) it no longer complies with the conditions provided for in Article 36(4) and (5); 
(b) it does not comply with the obliga tions provided for in Article 37; 
(c) it is underperforming at inter-laboratory  comparative tests referred to in 
Article 37(2). 
Article 39 
Derogations from the condition for the mandat ory assessment and accreditation for certain 
official laboratories 
1. By derogation from point (e) of Article 36(4), competent authorities may designate 
the following as official laboratories irre spective of whether th ey fulfil the condition 
provided for in that point: EN 63   EN (a) laboratories: 
(i) whose sole activity is the detection of Trichinella  in meat; 
(ii) that only use for the detection of Trichinella  the methods referred to in 
Article 6 of Commission Regulat ion (EC) No 2075/2005 laying down 
specific rules on official controls for  Trichinella  in meat50; 
(iii) that carry out the detection of Trichinella  under the supe rvision of the 
competent authorities or of an o fficial laboratory designated in 
accordance with Article 36(1), and a ssessed and accredited in accordance 
with the standard EN ISO/IEC 17025 on ‘General requirements for the 
competence of testing and calibration laboratories’ for the use of the methods referred to in point (a)(ii) of this paragraph; 
(b) laboratories carrying out analyses or test s to verify compliance with the rules 
on plant reproductive material referred to in point (h) of Article 1(2); 
(c) laboratories which only carry out analyses, tests or dia gnoses in the context of 
other official activitie s, provided that they: 
(i) only use the methods of laboratory an alysis, test and diagnosis referred to 
in Article 33(1) and points (a),  (b) and (c) of Article 33(2); 
(ii) carry out the analyses, tests or diagnoses under the s upervision of the 
competent authorities or of the national reference laboratories for the 
methods they use;  
(iii) participate regularly in the inter- laboratory comparative tests organised 
by the national reference laboratories for the methods they use; 
(iv) have a quality assura nce system in place to ensure sound and reliable 
results from the methods for laborator y analysis, test and diagnosis used. 
2. Where the methods used by the laboratories referred to in point (c) of paragraph 1 
require confirmation of the re sult of the laboratory analys is, test or diagnosis, the 
confirmatory laboratory analysis, test or di agnosis shall be carried out by an official 
laboratory which complies with the require ments of point (e) of Article 36(4). 
3. The official laboratories designated in  accordance with points (a) and (c) of 
paragraph 1 shall be located in the Member States in w hose territory the competent 
authorities which have designated them are located. 
Article 40 
Powers to adopt derogations from the c ondition for the mandatory assessment and 
accreditation of all the methods  of laboratory analysis, test  and diagnosis used by official 
laboratories 
The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning the cases where, and the conditio ns under which, competent authorities may 
designate as official laboratories in accordan ce with Article 36(1) laboratories which do not 
fulfil the conditions re ferred to in point (e) of Article 36(4) in relation to all the methods they 
use, provided that such laboratories comply with the following conditions: 
                                                
 
50 OJ L 338, 22.12.2005, p. 60. EN 64   EN (a) they operate, are assessed and accredited  in accordance with the standard EN 
ISO/IEC 17025 for the use of one or more  methods which are similar to and 
representative of the other methods they use; 
(b) they make regular and significant use of the methods for which they have obtained 
the accreditation referred to in point (a). 
Article 41 
Temporary derogations from the condition fo r the mandatory assessment and accreditation of 
official laboratories 
1. By derogation from point (a) of Article  36(5), the competent authorities may 
temporarily designate an existing offici al laboratory as offi cial laboratory in 
accordance with Article 36(1) fo r the use of a method of labo ratory analysis, test or 
diagnosis for which it has not obtained the accreditation referred to in point (e) of 
Article 36(4): 
(a) when the use of that method is newly required by Union rules; or, 
(b) when changes to a method in use require  a new accreditation or an extension of 
the scope of the accredi tation obtained by the offi cial laboratory; or, 
(c) in cases where the need for the use of the met hod results from an emergency 
situation or an emerging risk to human, animal or plant health, animal welfare 
or, as regards GMOs and plant protec tion products, to the environment. 
2. The temporary designation referred to in paragraph 1 shall be subject to the 
following conditions: 
(a) the official laboratory is already accred ited in accordance with the standard EN 
ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation; 
(b) a quality assurance system is in place in the official laborato ry to ensure sound 
and reliable results from the use of the method which is not included within the 
scope of the existing accreditation; 
(c) the analyses, tests or diagnoses are car ried out under the supervision of the 
competent authorities or the national reference laboratory for that method. 
3. The temporary designation provided for in paragraph 1 shall not exceed a period of 
one year, and may be renewed once for a further period of one year. 
4. The official laboratories designated in acco rdance with paragraph 1 of this Article 
shall be located in the Member States in  whose territory the competent authorities 
which have designated them are located. EN 65   EN Chapter V 
Official controls on animals and goods entering the Union 
SECTION I 
ANIMALS AND GOODS NOT SUBJECT TO SPECIFIC  
OFFICIAL CONTROLS AT BORDERS  
Article 42 
Official controls on animals and goods not subjec t to specific official  controls at borders 
1. The competent authorities shall perform of ficial controls regularly on animals and 
goods entering the Union to ascertain complian ce with the rules referred to in Article 
1(2). 
On animals and goods to which Article 45 does not apply, those official controls 
shall be performed with appropria te frequency, taking into account: 
(a) the risks to human, animal or plant heal th, animal welfare or, as regards GMOs 
and plant protection products, to the envi ronment, associated with different 
types of animals and goods; 
(b) the history of compliance with the requirements established by the rules 
referred to in Article 1(2) applicable  to the animals or goods concerned: 
(i) of the third country a nd establishment of origin; 
(ii) of the exporter; (iii) of the operator responsible for the consignment; 
(c) the controls that have already be en performed on the animals and goods 
concerned; 
(d) the guarantees that the competent authorities of the third country of origin has 
given with regard to compliance of the animals and goods with the 
requirements established by the rules refe rred to in Article 1(2) or with 
requirements recognised to be at least equivalent thereto. 
2. The official controls provided for in para graph 1 shall be performed at an appropriate 
place within the customs territory of the Union, including: 
(a) the point of entry into the Union; 
(b) a border control post; 
(c) the point of release for free circulation in the Union; 
(d) the warehouses and the premises of  the operator responsible for the 
consignment. 
3. The competent authorities at border contro l posts and other points of entry into the 
Union shall perform official controls on the following whenever they have reason to 
believe that their entry into the Union ma y pose a risk to human, animal or plant 
health, animal welfare or, as regards GM Os and plant protectio n products, to the 
environment: 
(a) means of transport, including where empty; EN 66   EN (b) packaging. 
4. The competent authorities may also perf orm official controls on goods that are 
placed under one of the customs procedur es defined in points (a) to (g) of 
Article 4(16) of Council Re gulation (EEC) No 2913/92. 
Article 43 
Types of official controls on animals and goods not subject to  
specific official controls at borders 
1. The official controls referre d to in Article 42(1) shall: 
(a) always include a documentary check; 
(b) include identity and physical checks depe nding on the risk to human, animal or 
plant health, animal welfare or, as  regards GMOs and plant protection 
products, to the environment. 
2. The competent authorities shall carry out the physical checks referred to in point (b) 
of paragraph 1 under appropriate conditions allowing investigations to be conducted 
properly. 
3. Where the documentary, identity and physical checks referred to in paragraph 1 show 
that animals and goods do not comply with the rules referred to in Article 1(2), Articles 64(1), (3), (4) and (5), 65, 66, 67, 69(1) an d (2) and 70(1) and (2) shall 
apply. 
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the cases where an d the conditions unde r which competent 
authorities may request opera tors to notify the arrival of certain goods entering the 
Union. 
Article 44 
Samples taken on animals and goods not subject to specific official co ntrols at borders 
1. Where samples on animals and goods are ta ken, the competent authorities shall: 
(a) inform the customs authorities and the operators concerned; 
(b) decide whether or not the animals or goods can be released before the results of 
the analysis, test or diagnosis carried out on the samples are available, provided that the traceability of the animals or goods is ensured. 
2. The Commission shall, by m eans of implementing acts: 
(a) establish the mechanisms necessary to en sure the traceability of the animals or 
goods referred to in poin t (b) of paragraph 1; 
(b) identify the documents that must accompany the animals or goods referred to 
in paragraph 1 when samples have been taken by the competent authorities. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). EN 67   EN SECTION II  
OFFICIAL CONTROLS AT BORDER CONTROL POSTS ON  
ANIMALS AND GOODS  
Article 45 
Animals and goods subject to official c ontrols at border control posts  
1. To ascertain compliance with the rules referred to in Article 1(2), the competent 
authorities shall perform official controls, at  the border control post of first arrival to 
the Union, on each consignment of the following categories of animals and goods entering the Union from third countries: 
(a) animals; 
(b) products of animal origin, germin al products and animal by-products; 
(c) plants, plant products, and other objects and materials capable of harbouring or 
spreading pests of plants as referred to in the lists established pursuant to Articles 68(1) and 69(1) of Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert number of  the Regulation on protective measures 
against pests of plants ]; 
(d) goods originating from certa in third countries for which the Commission has 
decided, by means of implementing acts prov ided for in point (b) of paragraph 
2, that a measure requiring a temporary incr ease of official controls at their 
entry into the Union is n ecessary due to a known or emerging risk or because 
there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2)  might be taking place; 
(e) animals and goods which are subject to an  emergency measure provided for in 
acts adopted in accordance with Article  53 of Regulation (EC) No 178/2002, 
Article 249 of Regulation (EU) No XXX/XXXX [ Office of Publications, 
please insert number of th e Regulation on animal health ], or Articles 27(1), 
29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) 
No XXX/XXXX [ Office of Publications, plea se insert number of the 
Regulation on protective measures against pests of plants ] requiring 
consignments of those animals or goods , identified by means of their codes 
from the Combined Nomenclature, to be subject to official controls at their 
entry into the Union; 
(f) animals and goods in relation to whose entry into the Union conditions or 
measures have been established by acts adopted in accordance with Articles 125 or 127 respectively, or with the rule s referred to in Article 1(2), which 
require that compliance with those conditi ons or measures be ascertained at the 
entry of the animals or goods into the Union. 
2. The Commission shall, by m eans of implementing acts: 
(a) establish lists detailing the animals and goods belonging to the categories 
referred to in points (a) and (b) of para graph 1, indicating their codes from the 
Combined Nomenclature; EN 68   EN (b) establish the list of goods be longing to the category re ferred to in point (d) of 
paragraph 1, indicating their codes fr om the Combined Nomenclature, and 
update it as necessary in relation to the risks referred to in that point. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning amendmen ts of the categories of co nsignments referred to in 
paragraph 1, to include other products which may give rise to risks to human, animal 
or plant health or, as regards GMOs and plant protection products, to the 
environment. 
4. Unless otherwise provided by the acts es tablishing the measures or conditions 
referred to in points (d), (e) and (f) of paragraph 1, this Article shall also apply to 
consignments of the categories of animals and goods referred to in points (a), (b) and (c) of paragraph 1 when they are of a non-commercial nature. 
Article 46 
Animals and goods exempted from official controls at border control posts 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139, 
concerning rules establishing the cases where and the conditions under which the following 
categories of animals and goods are exempt ed from the provisions of Article 45: 
(a) goods sent as commercial or trade samples or as display items for exhibitions, which 
are not intended to be placed on the market; 
(b) animals and goods intended for scientific purposes; 
(c) goods on board means of transport operati ng internationally which are not unloaded 
and are intended for consumpti on by the crew and passengers; 
(d) goods which form part of passengers pers onal luggage and are intended for personal 
consumption; 
(e) small consignments of goods sent to natu ral persons which are not intended to be 
placed on the market; 
(f) pet animals as defined in point (10) of Article 4(1) of Regulation (EU) 
No XXX/XXXX [ Office of Publications, please insert number of the Regulation on 
animal health ]; 
(g) goods which have undergone heat treatmen t and do not exceed quantities to be 
defined in those delegated acts; 
(h) any other category of animals or goods for which controls at border control posts are 
not necessary given the risks they pose. 
Article 47 
Official controls at border control posts  
1. The competent authorities shall perform offi cial controls on the consignments of the 
categories of animals and goods referred to  in Article 45(1) upon arrival of the 
consignment at the border control post. Those official controls shall include 
documentary, identity and physical checks. EN 69   EN 2. All consignments of the categories of an imals and goods referred to in Article 45(1) 
shall be subject to documentary and identity checks. 
3. Physical checks shall be performed on c onsignments of the categories of animals and 
goods referred to in Article 45(1) at a fr equency dependent on the risk posed by each 
animal, good or category of animals or goods to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, to the environment. 
4. Physical checks to verify compliance with animal health and welfare requirements or 
with plant health requirements laid down in  the rules referred to in Article 1(2) shall 
be performed by, or under the supervis ion of, staff possessing appropriate 
qualifications in veterinary or phytosanitary matters resp ectively, designated by the 
competent authorities for that purpose. 
Where such checks are performed on animals th ey shall be carried out by an official 
veterinarian or under his supervision. 
5. The competent authorities at border c ontrol posts shall systematically perform 
official controls on consignments of an imals being transported and on means of 
transport to verify compliance with the an imal welfare requirements laid down in the 
rules referred to in Article 1(2). Arrangeme nts shall be put in place by competent 
authorities to give priority to official controls on animals being transported and to 
reduce delays on such controls. 
6. The Commission may, by means of implem enting acts establish the modalities of 
presentation of consignments of the cate gories of goods referred to in Article 45(1), 
the sub-entities which can constitute an individual consignment and the maximum number of such sub-entities in each cons ignment, taking into account the need to 
guarantee the rapid and efficient handling of the consignments and the official 
controls to be performed by the competent authorities. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 48 
Certificates and documents accompanyi ng consignments and split consignments 
1. The original official certificates or docum ents, or electronic equivalents, which are 
required by the rules referred to in Article 1(2) to accompany consignments of the categories of animals and goods referred in Article 45(1) shall be  presented to, and 
kept by, the competent authoritie s of the border control post. 
2. The competent authorities of the borde r control post shall issue the operator 
responsible for the consignmen t with an authenticated pape r or electronic copy of the 
official certificates or documents referred to  in paragraph 1 or, if the consignment is 
split, with individually authenticated paper or electronic copies of such certificates or 
documents. 
3. Consignments shall not be split until official controls have been performed and the 
Common Health Entry Document (CHED) referred to in Article 54 has been 
finalised in accordance with Articles 54(4) and 55(1). EN 70   EN Article 49 
Specific rules for official cont rols at border control posts 
The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning rules to establish: 
(a) the cases where and the conditions under wh ich the competent authorities of a border 
control post may authorise the onward tr ansportation of consignments of the 
categories of animals and goods referred to in Article 45(1) to the place of final 
destination pending the availa bility of the results of physical checks, where such 
checks are required; 
(b) the time limits and modalities for carrying out documentary, iden tity and physical 
checks on transhipped consignments of the categories of goods referred to in Article 
45(1); 
(c) the cases where and the conditions under which identity and physical checks of 
transhipped consignments and of animals arriving by air or sea and staying on the 
same means of transport for onward travel may be performed at a border control post 
other than the one of firs t arrival into the Union; 
(d) the cases where and the conditions under whic h the transit of consignments of the 
categories of animals and goods referred to in Article 45(1) may be authorised and 
the specific official controls to be pe rformed at border c ontrol posts on such 
consignments, including the cases and c onditions for their st orage in specially 
approved free or customs warehouses. 
Article 50 
Details of documentary, identity and physical checks 
For the purposes of ensuring the uniform im plementation of the rules laid down in 
Articles 47, 48 and 49, the Commission shall by means of implementing acts, lay down the 
details of the operations to be carried out during and after the documentary, identity and 
physical checks referred to in those rules to ensu re the efficient performance of those official 
controls. Those implementing acts shall be adopted in accordance with the examination 
procedure referred to  in Article 141(2). 
Article 51 
Official controls not performed at border control posts of first arrival 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rule s establishing the cases wh ere and the conditions under 
which: 
(a) identity and physical checks on consignm ents of the categories of animals and 
goods referred to in Article 45(1) may be performed by competent authorities 
at control points other than border c ontrol posts provided that those control 
points comply with the requirements provi ded for in Article 62(3) and in the 
implementing acts adopted in accordance with Article 62(4); 
(b) physical checks on consignments which have undergone documentary and 
identity checks at a border control pos t of first arrival may be performed at 
another border control post in  a different Member State;  EN 71   EN (c) specific control tasks relating to the fo llowing may be attributed by competent 
authorities to customs authori ties or other pub lic authorities: 
(i) consignments referred to in Article 63(2); (ii) passengers personal luggage; (iii) goods ordered by distance selling. 
2. Point (b) of Article 54(2), point (a) of Article 55(2) and Articles 57, 58, 60, 61, 62(3) 
and (4), shall apply to the control points referred to in  point (a) of paragraph 1. 
Article 52 
Frequency of identity and physical checks  
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rules es tablishing the categories of animals and goods and the 
conditions under which, by derogation from  Article 47(2) and account taken of the 
reduced risk, identity checks on consignmen ts of animals and goods referred to in 
Article 45(1) shall be: 
(a) performed at a reduced frequency; 
(b) limited to the verification of a consignment's official seal, where any such seal 
is present. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rules establishing: 
(a) the criteria and the procedures for de termining and modifying the frequency 
rates of physical checks to be performed on consignments of the categories of 
animals and goods referred to in points (a ), (b) and (c) of Ar ticle 45(1) and to 
adjust them to the level of risk associ ated with those categories, having regard 
to: 
(i) information collected by the Commission in accordance with 
Article 124(1); 
(ii) the outcome of controls performe d by Commission experts in accordance 
with Article 115(1); 
(iii) operators' past record as regards compliance with the rules referred to in 
Article 1(2); 
(iv) data and information collected via the information management system 
referred to in Article 130; 
(v) available scientific assessments; and, (vi) any other information regarding the risk associated to the categories of 
animals and goods. 
(b) the conditions under which Member States may increase the frequency rates of 
physical checks established in accordance w ith point (a) so as  to take account 
of local risk factors; 
(c) the procedures for ensuring that the frequency rates of physical checks 
established in accordance with point (a ) are applied in a timely and uniform 
manner. EN 72   EN 3. The Commission shall, by means of implem enting acts, lay down rules establishing: 
(a) the frequency of physical checks for the categories of goods re ferred to in point 
(d) of Article 45(1); 
(b) the frequency of physical checks for the categories of animals and goods 
referred to in points (e) and (f) of Articl e 45(1) as long as this is not already 
provided for in the acts  referred to therein. 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to  in Article 141(2). 
Article 53 
Decisions on consignments  
1. A decision shall be taken by the competen t authorities on each consignment of the 
categories of animals and goods referre d to in Article 45(1) following the 
performance of official controls, indi cating whether the consignment is in 
compliance with the rules referred to in  Article 1(2) and, where relevant, the 
applicable customs procedure. 
2. Decisions taken following a phys ical check to verify comp liance with animal health 
and welfare requirements or with plant he alth requirements shall be taken by staff 
possessing appropriate qualifications in  veterinary or phyt osanitary matters 
respectively, and designated by the comp etent authorities for that purpose. 
Decisions on consignments of animals shall be taken by an offici al veterinarian or 
under his supervision. 
Article 54 
Use of the Common Health Entry Document by the operator and by th e competent authorities 
1. For each consignment of the categorie s of animals and goods referred to in 
Article 45(1) the operator responsible for the consignment shall complete a CHED, providing the information necessary for the immediate and complete identification of the consignment and its destination. 
2. The CHED shall be used: 
(a) by the operators responsible for consignm ents of the categories of animals and 
goods referred to in Article 45(1) in or der to give prior notification to the 
competent authorities of the border co ntrol post of the arrival of those 
consignments; 
(b) by the competent authorities of the border control post, in order to: 
(i) record the outcome of the official  controls performed and any decisions 
taken on that basis, including the decision to reject a consignment; 
(ii) communicate the information re ferred to in point  (i) through the 
TRACES system. 
3. Operators shall give prior notification in accordance with point (a) of paragraph 2 by 
completing and submitting the relevant part of the CHED into the TRACES system 
for transmission to the competent authoritie s of the border contro l post prior to the 
physical arrival of the co nsignment into the Union. EN 73   EN 4. The competent authorities of the border c ontrol post shall finalise the CHED as soon 
as: 
(a) all official controls required by Ar ticle 47(1) have been performed; 
(b) the results from physical checks, where su ch checks are required, are available; 
(c) a decision on the consignment has been taken in accordance with Article 53 
and recorded on the CHED. 
Article 55 
Use of the Common Health Entry Document by customs authorities 
1. The placing of consignments of the cate gories of animals and goods referred to in 
Article 45(1) under supervision or contro l by the customs authorities, including the 
entry or handling in free zones or cust oms warehouses, shall be subject to the 
presentation by the operator to the custom au thorities of the CHED, or its electronic 
equivalent, duly finalised in the TRACES system by the competent authorities of the 
border control post. 
2. Customs authorities shall: 
(a) not allow the placing of the consignment under a customs procedure different 
from the one indicated by the competent authorities of the border control post; 
(b) only allow the release for free circulat ion of a consignment upon presentation 
of a duly finalised CHED which conf irms that the consignment is in 
compliance with the rules re ferred to in Article 1(2). 
3. Where a customs declaration is made for a consignment of the categories of animals 
or goods referred to in Article 45(1) and the CHED is not presented, the customs 
authorities shall detain the consignmen t and immediately notify the competent 
authorities of the border control post. The competent authorities shall take the necessary measures in acco rdance with Article 64(5). 
Article 56 
Format, time requirements and sp ecific rules for the use of  the Common Health Entry 
Document 
1. The Commission shall, by means of implem enting acts, lay down rules establishing: 
(a) the format of the CHED and the instru ctions for its presentation and use; 
(b) the minimum time requirements for prio r notification of consignments by 
operators as provided for in point (a) of  Article 54(2) in order to enable the 
competent authorities of the border control post to perform official controls in a 
timely and effective manner. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rule s establishing the cases wh ere and the conditions under 
which the CHED must accompany consignments of the categories of animals and goods referred to in Article 45(1)  to the place of destination. EN 74   EN Article 57 
Designation of border control posts 
1. Member States shall designate border co ntrol posts for the purpose of performing 
official controls on one or more of the cat egories of animals and goods referred to in 
Article 45(1). 
2. Member States shall notify the Commission at least three months before designating 
a border control post. That notification shall include all the information necessary for the Commission to verify that the proposed  border control post complies with the 
minimum requirements laid down in Article 62. 
3. Within three months of receiving the notif ication referred to in paragraph 2, the 
Commission shall inform the Member State: 
(a) whether the designation of the proposed border contro l post is dependent upon 
the favourable outcome of a control performed by Commission experts in 
accordance with Article 115 in  order to verify compliance with the minimum 
requirements laid down in Article 62; 
(b) of the date of such a control. 
4. The Member State shall delay designa ting the border control post until the 
favourable outcome of the control has b een communicated to it by the Commission. 
Article 58 
Listing of border control posts 
1. Each Member State shall make available on  the Internet up-to-date lists of border 
control posts on its territory, providing th e following information for each border 
control post: 
(a) its contact details and opening hours; 
(b) its exact location and whether it is a port,  airport, rail or road entry point; 
(c) the categories of animals and goods refe rred to in Article 45(1) which are 
included in the scope of its designation; 
(d) the equipment and premises available for performing official controls on each 
of the categories of animals and goods for which it is designated; 
(e) the volume of the animals and goods handled per calendar year for each of the 
categories of animals and goods referred to in Article 45(1 ) for which it is 
designated. 
2. The Commission shall, by means of im plementing acts, establish the format, 
categories, abbreviations for designations  and other information to be used by 
Member States in the lists of border control posts. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). EN 75   EN Article 59 
Withdrawal of approvals for,  and re-designation of, existi ng border control entities 
1. The approval of border inspection posts in accordance with Article 6 of Council 
Directive 97/78/EC and Article 6 of  Council Directive 91/496/EEC and the 
designation of points of entr y in accordance with Arti cle 5 of Regulation (EC) 
No 669/2009 and with Article 13(c)(4) of  Council Directive 2000/29/EC shall be 
withdrawn. 
2. Member States may re-designate border inspection posts, designated points of entry 
and points of entry referred to in paragra ph 1 as border control posts in accordance 
with Article 57(1) provided that the mini mum requirements referred to in Article 62 
are complied with. 
3. Article 57(2) and (3) shall not apply to th e re-designation referre d to in paragraph 2. 
Article 60 
Withdrawal of the designati on of border control posts 
1. Where border control posts cease to comply  with the requirements referred to in 
Article 62, the Member States shall: 
(a) withdraw the designation pr ovided for in Article 57(1)  for all or for certain 
categories of animals and goods for which the designation was made; 
(b) remove them from the lists referred to in Article 58(1), for the categories of 
animals and goods for which the designation is withdrawn. 
2. Member States shall inform the Commission and the other Member States of the 
withdrawal of the designation of a border control post as provided for in paragraph 1 
and of the reasons for such withdrawal. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 139 concerning the cases where, a nd the procedures by wh ich, border control 
posts whose designation has only been partia lly withdrawn in accordance with point 
(a) of paragraph 1 may be re-designated by derogation from the provisions of Article 
57. 
Article 61 
Suspension of the designati on of border control posts 
1. A Member State shall immediately suspe nd the designation of a border control post 
and order its activities to be stopped, for a ll or for certain categories of animals and 
goods for which the designation was made, in  cases where such activities may result 
in a risk to human, animal or plant healt h, animal welfare or, as regards GMOs and 
plant protection products, to the environment. 
2. Member States shall immediately info rm the Commission and the other Member 
States of any suspension of the designati on of a border control post and the reasons 
for such a suspension. 
3. Member States shall indicate the suspen sion of the designation of a border control 
post in the lists referred  to in Article 58(1). 
4. Member States shall remove the suspensi on provided for in paragraph 1 as soon as: EN 76   EN (a) the competent authorities are satisfied that the risk referred to in paragraph 1 no 
longer exists; 
(b) they have communicated to the Commissi on and to the other Member States 
the information on the basis of which the suspension is removed. 
5. The Commission may, by means of implementi ng acts, establish procedures for the 
exchanges of information and communicati ons referred to in paragraph 2 and in 
point (b) of paragraph 4. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 62 
Minimum requirements for border control posts 
1. Border control posts shall be located in the immediate vicinity of the point of entry 
into the Union and in a place suitably equipped to be designated by the customs authorities in accordance with Articl e 38(1) of Regulation (EEC) No 2913/92. 
2. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 139 concerning the cases where and conditions under which a border control post can be situated at a certain distance fr om the point of entry into the Union given 
specific geographical constraints. 
3. Border control posts shall have: 
(a) a sufficient number of suitably qualified staff; 
(b) premises appropriate for the nature a nd volume of the categories of animals 
and goods handled; 
(c) equipment and premises to allow the perf ormance of official controls for each 
of the categories of animals and goods for which the border control post has been designated; 
(d) arrangements in place to guarantee, as appropriate, access to any other 
equipment, premise and service necessary to apply the measures taken in accordance with Articles 63, 64 and 65 in  cases of suspicion, non-compliant 
consignments or consignments presenting a risk; 
(e) contingency arrangements to ensure the smooth operation of official controls 
and the effective application of the measures taken in accordance with Articles 63, 64 and 65 in cases of unfor eseeable and unexpected conditions or 
events; 
(f) the technology and equipment necessary for the efficient operation of the 
TRACES system and, as appropriate,  of other computerised information 
management systems necessary for the handling and exchange of data and 
information; 
(g) access to the services of official labor atories capable of providing analytical, 
testing and diagnostic results within a ppropriate deadlines and equipped with 
the information technology tools necessary  to ensure the introduction of the 
results of analyses, tests or diagnoses carried out into the TRACES system as 
appropriate; EN 77   EN (h) appropriate arrangements for the proper handling of different categories of 
animals and goods and to prevent ri sks which may result from cross-
contamination; 
(i) arrangements to comply with relevant bi osecurity standards in  order to prevent 
the spread of diseases into the Union. 
4. The Commission may, by means of implementing acts, detail the requirements laid 
down in paragraph 3 to take into account sp ecific features and logistic needs related 
to the performance of official controls and to the application of the measures taken in 
accordance with Article 64(3) and (5) and Article 65 in relation to the different categories of animals and goods referred to in Article 45(1). 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
SECTION III  
ACTION IN CASE OF SUSPICION OF NON -COMPLIANCE AND OF NON -COMPLIANCE 
OF ANIMALS AND GOODS  
FROM THIRD COUNTRIES  
Article 63  
Suspicion of non-compliance and intensified official controls 
1. In case of suspicion of non-compliance of consignments of the categories of animals 
and goods referred to in Article 45(1) with the rules referred to in Article 1(2), the 
competent authorities shall perform official  controls in order to confirm or to 
eliminate that suspicion. 
2. Consignments of animals and goods which ar e not declared by opera tors to consist of 
the categories of animals and goods referred to  in Article 45(1), shall be subject to 
official controls by the competent authori ties where there is reason to believe that 
such categories of animals or goods are present in the consignment. 
3. The competent authorities shall place the consignments referred to in paragraphs 1 
and 2 under official detention until they obta in the results of the official controls 
provided for in those paragraphs. 
Where appropriate, those consignments shall be isolated or quar antined and animals 
shall be sheltered, fed, watered and trea ted pending the results of the official 
controls. 
4. Where the competent authorities have reas ons to suspect fraudul ent behaviour by an 
operator or official controls give grounds to believe that the rules referred to in 
Article 1(2) have been seriously or re peatedly infringed, they shall, where 
appropriate, and in addition to the measures  provided for in Article 64(3), intensify 
official controls on consignments with the same origin or use as appropriate. 
5. The competent authorities shall notify the Commission and the Member States 
through the TRACES system of their deci sion to perform intensified official 
controls, as provided for in paragra ph 4, indicating the purported fraudulent 
behaviour or serious or repeated infringement. EN 78   EN 6. The Commission shall, by means of implem enting acts, establish procedures for the 
coordinated performance by competent authoriti es of the intensified official controls 
referred to in paragraphs 4 and 5. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 64  
Measures to be taken in cases of non-compliant consignments  
entering the Union from third countries 
1. The competent authorities shall place unde r official detention any consignment of 
animals or goods entering the Union from third countries which does not comply with the rules referred to in Article 1(2)  and refuse entry into the Union to it. 
As appropriate, any such consignment shall be isolated or quarantined and animals 
belonging to it shall be kept  and treated under appropr iate conditions pending any 
further decision. 
2. The Commission shall, by means of impl ementing acts, lay down the modalities for 
the isolation and quarantine provided for in the second subparagraph of paragraph 1. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
3. Having, where possible, heard the operato r responsible for the consignment, the 
competent authorities shall, without  delay, order that the operator: 
(a) destroy the consignment in compliance, where appropriate, with the rules 
referred to in Article 1(2); or 
(b) re-dispatch the consignment outside the Union in accordance with Article 70(1) 
and (2); or 
(c) subject the consignment to special treat ment in accordance with Article 69(1) 
and (2) or to any other measure necessary  to ensure compliance with the rules 
referred to in Article 1(2), and, where a ppropriate, destines the consignment for 
purposes other than those for whic h it was originally intended. 
4. The competent authorities shall immediatel y notify any decision to refuse entry of a 
consignment as provided for in paragra ph 1 and any order issued pursuant to 
paragraphs 3 and 5 and Article 65 to: 
(a) the Commission; 
(b) the competent authorities of  the other Member States; 
(c) the customs authorities; 
(d) the competent authorities of the third country of origin; 
(e) the operator responsible for the consignment. 
That notification shall be performed via the computerised information management 
system referred to in Article 130(1). 
5. If a consignment of the categories of anim als or goods referred to in Article 45(1) is 
not presented for the official co ntrols referred to in that Ar ticle, or is not presented in 
accordance with the requirements  laid down in Articles 48(1)  and (3), 54(1), (2) and EN 79   EN (3), or with the rules adopt ed pursuant to Articles 46,  47(6), 49, 51(1 ) and 56, the 
competent authorities shall order that it  be retained or re called, and placed under 
official detention without delay. 
Paragraphs 1, 3 and 4 of this Articl e shall apply to such consignments. 
Article 65  
Measures to be taken on animals or goods ente ring the Union from third countries presenting 
a risk 
Where official controls indicate  that a consignment of animal s or goods presents a risk to 
human, animal or plant health, animal welfar e or, as regards GMOs and plant protection 
products, to the environment, such consignment shall be isolated or quarantined and animals 
belonging to it shall be kept  and treated under appropriate conditions  pending any further 
decision. 
The competent authorities shall retain the cons ignment in question under official detention 
and shall, without delay: 
(a) order that the operator destroy the consi gnment in compliance, where appropriate, 
with the rules referred to in Article 1(2), ta king all the measures necessary to protect 
human, animal or plant health, animal  welfare or the environment; or  
(b) subject the consignment to special treatme nt in accordance with Article 69(1) and 
(2). 
Article 66  
Follow up of decisions taken in relation to non-compliant consignments entering the Union 
from third countries 
1. The competent authorities shall: 
(a) invalidate the official certificates  and other documents accompanying 
consignments which have been subject to measures pursuant to Article 64(3) 
and (5) and Article 65; 
(b) cooperate in accordance with Title IV to take any further measures necessary to 
ensure that it is not possible to rein troduce consignments into the Union which 
have been refused entry in accordance with Article 64(1). 
2. The competent authorities in the Member State where the offici al controls were 
performed shall supervise the applicati on of the measures ordered pursuant to 
Article 64(3) and (5) and Article 65 to ensure  that the consignment does not give rise 
to adverse effects on human, animal or plant health, animal welfare, or the 
environment, during or pending the application of those measures. 
Where appropriate, such application shall be  completed under the supervision of the 
competent authorities of another Member State. 
Article 67  
Failure by the operator to apply the measur es ordered by the competent authorities 
1. The operator shall carry out all the measur es ordered by the competent authorities in 
accordance with Article 64 (3) and (5) and 65 without delay and, at the latest, within EN 80   EN 60 days from the day on which the compet ent authorities notified the operator of 
their decision in accordance with Article 64(4). 
2. If, after the expiry of the 60-day period no action has been taken by the operator, the 
competent authorities shall order: 
(a) that the consignment be destroyed or s ubject to any other appropriate measure; 
(b) in the cases referred to in  Article 65, that the consignment be destroyed in 
suitable facilities located as  close as possible to the border control post, taking 
all measures necessary to protect human, animal or pl ant health, animal welfare 
or the environment. 
3. The competent authorities may extend the peri od referred to in paragraphs 1 and 2 of 
this Article for the time necessary to obtai n the results of the second expert opinion 
referred to in Article 34, provided that th is is without advers e effects to human, 
animal and plant health, animal welfare and, as regards GMOs and plant protection 
products, to the environment.  
Article 68  
Consistency of applicatio n of Articles 64 and 65 
The Commission shall, by means of implementing acts, lay down rules to ensure consistency 
across all border control posts refe rred to in Article 57(1) and control points referred to in in 
point (a) of Article 51(1) of d ecisions and measures taken and orders issued by the competent 
authorities pursuant to Articles 64 and 65, in the form of instructions to be followed by the 
competent authorities when responding to co mmon or recurring situations of non-compliance 
or risk. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 141(2). 
Article 69  
Special treatment of consignments 
1. The special treatment of consignments prov ided for in point (c) of Article 64(3) and 
point (b) of Article 65 may, as appropriate, include: 
(a) treatment or processing, including d econtamination, where appropriate, but 
excluding dilution, so that the consignm ent complies with the requirements of 
the rules referred to in Artic le 1(2), or with the requi rements of a third country 
of re-dispatch; 
(b) treatment in any other manner suitable fo r safe animal or human consumption 
or for purposes other than animal or human consumption. 
2. The special treatment provided  for in paragraph 1 shall: 
(a) be carried out effectively and ensure th e elimination of an y risk to human, 
animal or plant health, animal welf are or, as regards GMOs and plant 
protection products, to the environment; 
(b) be documented and carried out under the c ontrol of the compet ent authorities; 
(c) comply with the requirements laid down in the rules referred to in Article 1(2). EN 81   EN 3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the requirements and the conditions in accordance with which the special treatment provided for in paragraph 1 shall take place. 
In the absence of rules adopt ed by delegated act, such sp ecial treatment shall take 
place in accordance with national rules. 
Article 70  
Re-dispatch of consignments 
1. The competent authorities shall allow the re-dispatch of consignments subject to 
compliance with the following conditions: 
(a) the destination has been agreed with the operator responsible for the 
consignment; 
(b) the operator responsible for the consignment has first informed the competent 
authorities of the third country of orig in or third country of destination, if 
different, of the reasons and circumstances for the refusal of the entry into the Union of the consignment of animals or goods concerned; 
(c) where the third country of destination is  not the third country of origin, the 
competent authorities of the third count ry of destination have notified the 
competent authorities of the Member State that they are prepared to accept the 
consignment; 
(d) in the case of consignments of animals the re-dispatch is in compliance with 
animal welfare requirements. 
2. The conditions of points (b) and (c) of pa ragraph 1 shall not a pply to consignments 
of the categories of goods referred to in point (c) of Article 45(1). 
3. The Commission shall, by means of implem enting acts, specify the procedures for 
the information exchanges and notifications referred to in paragraph 1. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 71  
Approval of pre-export controls  performed by third countries 
1. The Commission may, by means of implemen ting acts, approve specific pre-export 
controls that a third country carries out on consignments of animals and goods prior 
to export to the Union with a view to verifying that the exported consignments 
satisfy the requirements of the rules referr ed to in Article 1( 2). The approval shall 
only apply to consignments originating in  the third country concerned and may be 
granted for one or more categories of animals or goods. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
2. The approval provided for in paragraph 1 shall specify: 
(a) the maximum frequency of official cont rols to be performed by the competent 
authorities of Member States at the en try of the consignments into the Union, EN 82   EN where there is no reason to suspect non-co mpliance with the rules referred to in 
Article 1(2) or fr audulent behaviour; 
(b) the official certificates that must acco mpany consignments entering the Union; 
(c) a model for such certificates; 
(d) the competent authorities of the third c ountry under the responsibility of which 
pre-export controls must be performed; 
(e) where appropriate, any delegated body to  which those competent authorities 
may delegate certain tasks. Such delegation may only be approved if it meets 
the criteria of Articles 25 to  32 or equivalent conditions . 
3. The approval provided for in paragraph 1 may only be granted to  a third country if 
the evidence available and, where appropr iate, a Commission control performed in 
accordance with Article 119, demonstrate that th e system of official controls in that 
third country can ensure that: 
(a) the consignments of the animals or goods exported to the Union meet the 
requirements of the rules referred to in Ar ticle 1(2), or equiva lent requirements; 
(b) the controls performed in the third country prior to dispatch to the Union are 
sufficiently effective to replace or re duce the frequency of the documentary, 
identity and physical checks laid down in  the rules referred to  in Article 1(2). 
4. The competent authorities or a delega ted body specified in the approval shall: 
(a) be responsible for cont acts with the Union; 
(b) ensure that the official certificates re ferred to in point (b) of paragraph 2 
accompany each consignment controlled. 
5. The Commission shall by means of implemen ting acts establish detailed rules and 
criteria for approving pre-export controls performed by third countries in accordance 
with paragraph 1. Those implementing acts shall be adopted in accordance with the 
examination procedure refe rred to in Article 141(2). 
Article 72 
Non-compliance with, and withdrawal of, the approval of pre-export controls  
performed by third countries 
1. When official controls on consignments of  categories of animal and goods in respect 
of which specific pre-export controls have  been approved in accordance with Article 
71(1) reveal serious and recurrent non-comp liances with the rules referred to in 
Article 1(2), Member States shall immediately: 
(a) notify the Commission and the other Memb er States and operators concerned 
via the TRACES system in addition to seeking administrative assistance in 
accordance with the procedures  established in Title IV; 
(b) increase the number of official contro ls on consignments from the relevant 
third country and, where necessary to allow a proper analytical examination of the situation, detain a reasonable numb er of samples under appropriate storage 
conditions. 
2. The Commission may, by means of impl ementing acts, withdraw the approval 
provided for in Articl e 71(1) where, following the official controls referred to in EN 83   EN paragraph 1, it appears that the requirements laid down in Article 71(3) and (4) are 
no longer being met. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to in Article 141 (2). 
Article 73 
Cooperation amongst authorities in relation to co nsignments entering the Union from third 
countries 
1. Competent authorities, customs authoritie s and other authorities of the Member 
States shall cooperate closel y to ensure that the offi cial controls performed on 
consignments of animals and goods enteri ng the Union are performed in accordance 
with the requirements of this Regulation. 
For that purpose, competent authorities, customs authorities and other authorities 
shall: 
(a) guarantee reciprocal access to inform ation which is relevant for the 
organisation and conduct of their respectiv e activities in rela tion to animals and 
goods entering the Union; 
(b) ensure the timely excha nge of such informati on, including via electronic 
means. 
2. The Commission shall, by means of impl ementing acts, adopt uniform rules on the 
cooperation arrangements that competent au thorities, customs authorities and other 
authorities referred to in paragraph 1 ar e required to put in place to ensure: 
(a) access by competent authorities to the in formation necessary for the immediate 
and complete identification of the consignments of animals and goods entering the Union that are subject to official  controls at a bor der control post in 
accordance with Article 45(1); 
(b) the reciprocal update, through exchanges of information or synchronisation of 
relevant data sets, of information gath ered by competent au thorities, customs 
authorities and other authorities on consignments of animals and goods 
entering the Union; 
(c) the swift communication of decisions take n by such authorities on the basis of 
the information referred to in points (a) and (b). 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 74 
Cooperation amongst authorities in relation to cons ignments not subject to specific controls 
at borders  
1. In the case of consignments of animals and goods other than those subject to controls 
at entry into the Union as required by Article 45(1) and for which a customs 
declaration for release for free circulation has been made in accordance with Articles 
4(17) and 59 to 83 of Regulation (EC) No 2913/92, paragraphs 2, 3, and 4 shall 
apply. EN 84   EN 2. Customs authorities shall suspend release fo r free circulation when they have reason 
to believe that the consignment may present a risk to human, animal or plant health, 
animal welfare or, as regards GMOs and plant protection products, to the environment and immediately notify the comp etent authorities of such suspension.  
3. A consignment whose release for free circ ulation has been susp ended pursuant to 
paragraph 2 shall be released if, within three working days of the suspension of 
release, the competent author ities have not requested customs authorities to continue 
the suspension or have informed customs authorities that no risk is present.  
4. Where the competent authorities consider that a risk to huma n, animal or plant 
health, animal welfare or, as regards GM Os and plant protectio n products, to the 
environment, is present:  
(a) they shall instruct the customs authorit ies not to release the consignment for 
free circulation and to include the fo llowing statement on the commercial 
invoice accompanying the consi gnment and on any other relevant 
accompanying document: 
'Product presents a risk — release fo r free circulation not authorised — 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ]'; 
(b) no other customs procedure shall be permitted without the consent of the 
competent authorities;  
(c) Articles 64(1), (3), (4) and (5), 65, 66, 67, 69(1) and (2 ) and 70(1) and (2) shall 
apply. 
5. In the case of consignments of animals and goods other than those subject to controls 
at entry into the Union as required by Article 45(1) and for which no customs 
declaration for release for free circulation has been made, customs authorities, where 
they have reason to believe that the consi gnment may present a risk to human, animal 
or plant health, animal welfare or, as re gards GMOs and plant protection products, to 
the environment, shall transmit all relevant information to the customs authorities in 
the Member States of final destination. 
Article 75 
Rules for specific official contro ls and for measures to be ta ken following the performance of 
such controls 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning rules for the performan ce of specific official controls and for 
the adoption of measures in cases of non-co mpliance, to account fo r the specificities 
of the following categories of animals and goods or their tran sport modalities and 
means: 
(a) consignments of fresh fishery products directly landed in ports designated by 
Member States in accordance with Artic le 5(1) of Council Regulation (EC) 
No 1005/2008 of 29 September 2008 estab lishing a Community system to 
prevent, deter and eliminate illegal, unreported and unregulated fishing, amending Regulations (EEC) 2847/93, (EC) No 1936/2001 and (EC) No EN 85   EN 601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No 
1447/199951 from a fishing vessel flying a third country flag; 
(b) consignments of unskinned, furred wild game; 
(c) consignments of the categories of goods refe rred to in point (b ) of Article 45(1) 
which are delivered, with or without st orage in a specially approved free or 
customs warehouse, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers; 
(d) wood packaging material; 
(e) feed and food accompanying animals and intended for the feeding of those 
animals; 
(f) animals and goods ordered by distance selling and delivered from a third 
country to an address in the Union, and the notification requirements necessary to allow the proper performa nce of official controls; 
(g) plant products which, on account of their subsequent destination, may give rise 
to the risk of spreading infectious  or contagious animal diseases; 
(h) consignments of the categories of animals and goods referred to in points (a), 
(b) and (c) of Article 45(1) origina ting from, and returning to, the Union 
following a refusal of en try by a third country; 
(i) goods entering the Union in bulk from a th ird country, irrespective of whether 
they all originate from that third country; 
(j) consignments of goods referred to in Artic le 45(1) coming from the territory of 
Croatia and transiting through the territory of Bosnia and Herzegovina at Neum 
(‘Neum corridor’) before re-entering the te rritory of Croatia via the points of 
entry at Klek or Zaton Doli; 
(k) animals and goods exempted from the pr ovisions of Article 45 in accordance 
with Article 46. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the conditions for monitoring th e transport and arrival of 
consignments of certain animals and goods, fr om the border control post of arrival to 
the establishment at the place of destination in the Union or the border control post of exit. 
3. The Commission may, by means of implem enting acts, lay down rules concerning: 
(a) model official certificates and rules for the issuance of such certificates; 
(b) the format of documents that must accompany the categories of animals or 
goods referred to in paragraph 1. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 141(2). 
                                                
 
51 OJ L 286, 29.10.2008, p. 1. EN 86   EN Chapter VI 
Financing of official controls and other official activities 
Article 76 
General rules 
1. Member States shall ensure that adequate financial resources are available to provide 
the staff and other resources necessary fo r the competent authorities to perform 
official controls and other official activities. 
2. In addition to the fees collected in acco rdance with Article 77, Member States may 
collect fees to cover costs occasioned by offici al controls other than those referred to 
in Article 77(1) and (2). 
3. This Chapter also applies in the case of de legation of specific official control tasks in 
accordance with Article 25. 
4. Member States shall cons ult the operators concerned on the methods used to 
calculate the fees provi ded for in Article 77. 
Article 77 
Mandatory fees 
1. For the purpose of ensuring that competen t authorities are provided with adequate 
resources for the performance of official controls, the competent authorities shall 
collect fees to recover the co sts they incur in relation to: 
(a) official controls performed to verify th at the following operators comply with 
the rules referred to in Article 1(2): 
(i) food business operators as defined in Article 3(3) of Regulation (EC) 
No 178/2002 that are either registered  or approved, or registered and 
approved, in accordance with Article 6 of Regulation (EC) No 852/2004; 
(ii) feed business operators as define d in Article 3(6) of Regulation (EC) 
No 178/2002 registered or approved in accordance with Articles 9 and 10 
of Regulation (EC) No 183/2005 of the European Parliament and of the 
Council laying down requirements for feed hygiene52; 
(iii) professional operators as defined in  point (7) of Article 2 of Regulation 
(EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on protective meas ures against pests of plants ]; 
(iv) professional operators as defined in  point (6) of Article 3 of Regulation 
(EU) No XXX/XXXX [ Office of Publications, pl ease insert number of 
the Regulation on the production and making available on the market of 
plant reproductive material ]; 
(b) the official controls performed in view of  the issuance of official certificates or 
to supervise the issuance of  official attestations; 
(c) official controls performed to ve rify that the conditions are met: 
                                                 
52 OJ L 35, 8.2.2005, p. 1. EN 87   EN (i) to obtain and maintain the appr oval provided for in Article 6 of 
Regulation (EC) No 852/2004 or in Ar ticles 9 and 10 of Regulation (EC) 
No 183/2005; 
(ii) to obtain and maintain the author isation referred to in Articles 84, 92 and 
93 of Regulation (EU)  No XXX/XXXX [ Office of Publications, please 
insert number of the Regulation on pr otective measures against pests of 
plants ]; 
(iii) to obtain and maintain the authorisation referred to in Article 25 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of the Regulation on the production and making available on the 
market of plant reproductive material ]; 
(d) official controls performed by the comp etent authorities at  the border control 
posts or at the control points referre d to in point (a) of Article 51(1). 
2. For the purposes of paragraph 1, the official controls referred to in point (a) of that 
paragraph shall include offi cial controls performed to  verify compliance with 
measures adopted by the Commission in accordance with Article 137 of this 
Regulation, Article 53 of Re gulation (EC) No 178/2002, Articles 27(1), 29(1), 40(2), 
41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert number of th e Regulation on protective measures against 
pests of plants ], Articles 41 and 144 of Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert number of the Regulation on the production and making 
available on the market of  plant reproductive material ] and Part VI of Regulation 
(EU) No XXX/XXXX [ Office of Publications, please insert number of the 
Regulation on animal health ], unless the decision establishing the measures requires 
otherwise. 
3. For the purposes of paragraph 1: 
(a) the official controls referred to in poin t (a) of that paragraph shall not include 
official controls performed to verify compliance with temporary restrictions, 
requirements or other di sease control measures adopted by the competent 
authorities in accordance with Articl es 55(1), 56, 61, 62, 64, 65, 68(1) and 69, 
and rules adopted pursuant to Articles 55(2), 63, 67 and 68(2) of Regulation 
(EU) No XXX/XXXX [ Office of Publications, plea se insert number of the 
Regulation on animal health ] and Article 16 of Regulation (EU) 
No XXX/XXXX [ Office of Publications, plea se insert number of the 
Regulation on protective measur es against pests of plants ]; 
(b) the official controls referred to in poin t (a) and (b) of that paragraph shall not 
include official controls performed to verify compliance with the rules referred 
to in Article 1(2)(j) and (k). 
Article 78 
Costs 
1. The competent authorities shall collect fees in accordance with Article 77 to recover 
the following costs: 
(a) the salaries of the staff, including support staff, invol ved in the performance of 
official controls, their social secu rity, pension and insurance costs; EN 88   EN (b) the cost of facilities and equipment,  including maintenance and insurance 
costs; 
(c) the cost of consumables, services and tools; 
(d) the cost of training of staff referred to in point (a), with the exclusion of the 
training necessary to obtain the qualifi cation necessary to be employed by the 
competent authorities; 
(e) the cost of travel of the staff referred to in point (a), and associated subsistence 
costs; 
(f) the cost of sampling and of laborat ory analysis, testing and diagnosis. 
2. If the competent authorities collecting fees in accordance with Article 77 also 
perform other activities, only the fraction of the cost elements referred to in 
paragraph 1 of this Article which results fr om the official controls referred to in 
Article 77(1) shall be considered for the calculation of the fees. 
Article 79 
Calculation of fees 
1. Fees collected in accordan ce with Article 77 shall be: 
(a) established at a flat-rate on the basis of the overall co sts of official controls 
borne by the competent authorities over a given period of time, and applied to 
all operators irrespective of whether a ny official control is performed during 
the reference period in relation to each  operator charged; in establishing the 
level of the fees to be charged on each sector, activity and category of operators, the competent authorities sha ll take into consideration the impact 
that the type and the size of the activity  concerned and the relevant risk factors 
have on the distribution of the overall costs of those official controls; or, 
(b) calculated on the basis of the actual cost s of each individual official control, 
and applied to the ope rators subject to such offici al control; such fee shall not 
exceed the actual costs of the official control performed and may be partly or 
entirely expressed as a function of th e time employed by the staff of the 
competent authorities to perf orm the official controls. 
2. Travel costs as referred to in point (e) of Arti cle 78(1) shall be considered for the 
calculation of the fees referred to in Article 77(1) in a manner that does not 
discriminate between operators on the basis of  the distance of their premises from the 
location of the competent authorities. 
3. Where fees are calculated in accordance with point (a) of pa ragraph 1, the fees 
collected by competent author ities in accordance with Arti cle 77 shall not exceed the 
overall costs incurred for the official co ntrols performed over the period of time 
referred to in point (a) of paragraph 1. 
Article 80 
Reduction of fees for consis tently compliant operators 
Where fees are established in accordance with point (a) of Article 79(1), th e rate of the fee to 
be applied to each operator shall be determined  taking into account the operators' record of 
compliance with the rules referred to in Articl e 1(2) as ascertained th rough official controls, EN 89   EN so that fees applied to consistently compliant operators are lower than those applied to other 
operators. 
Article 81 
Application of fees 
1. Operators shall receive proof  of the payment of fees provided for in Article 77(1). 
2. Fees collected in accordance with point (d ) of Article 77(1) shall be paid by the 
operator responsible for the cons ignment or its representative. 
Article 82 
Fees refunds and exemption for microenterprises 
1. Fees provided for in Article 77 shall not di rectly or indirectly be refunded, unless 
unduly collected. 
2. Enterprises employing fewer than 10 pers ons and whose annual tu rnover or annual 
balance sheet total does not exceed EUR 2 million shall be exempted from the payment of the fees prov ided for in Article 77. 
3. The costs referred to in Articles 77, 78 and 79 shall not include t hose incurred for the 
performance of official c ontrols on the enterprises re ferred to in paragraph 2. 
Article 83 
Transparency 
1. The competent authorities shall ensure the highest level of transparency of: 
(a) the method and data used to establish the fees provided for in Article 77(1); 
(b) the use of resources coll ected through such fees; 
(c) the arrangements in place to ensure an e fficient and thrifty use of the resources 
collected through such fees. 
2. Each competent authority shall make available to the public the following 
information for each reference period: 
(a) the costs to the competent authority for which a fee is due in accordance with 
Article 77(1), indicating the breakdown of such costs per activity referred to in 
Article 77(1) and per cost element referred to in Article 78(1); 
(b) the amount of the fees provided for in Arti cle 77(1) applied to each category of 
operators, and for each category of official controls; 
(c) the method used to establish the fees provided for in Article 77(1), including 
the data and estimates used for the establis hment of the flat rate fees referred to 
in point (a) of Article 79(1); 
(d) where point (a) of Article 79(1) applies, the method used to adjust the level of 
the fees in accordance with Article 80; 
(e) the overall amount of fees co rresponding to the exempti on referred to in Article 
82(2). EN 90   EN Article 84 
Expenses arising from additional official controls and from  
enforcement measures 
Competent authorities shall charge  fees to cover the additional costs they have incurred as a 
result of: 
(a) additional official controls: 
(i) which have become necessary follow ing the detection of a non- compliance 
during an official control performed in accordance with this Regulation; 
(ii) performed to assess the extent and the impact of the non-compliance or to 
verify that the non-compliance has been remedied; 
(b) official controls performed at the request of the operator; 
(c) corrective action taken by the competent auth orities, or by a thir d party upon request 
by the competent authorities, where an ope rator has failed to carry out corrective 
action ordered by the competent authorities in accordance with Article 135 to remedy 
the non-compliance; 
(d) official controls performed and action taken by the competent authorities in 
accordance with Articles 64 to 67, 69 and 70, and corrective action taken by a third 
party upon request by the competent authorities, in cases where the operator has 
failed to carry out corrective action or dered by the competent authorities in 
accordance with Articles 64(3) and (5), 65 and 67.   
Chapter VII 
Official certification 
Article 85 
General requirements concerning official certification 
1. In accordance with rules referred  to in Article 1(2), official  certification shall take the 
form of: 
(a) official certificates; or, 
(b) official attestations. 
2. Where the competent authorities delegate specific tasks related to the issuance of 
official certificates or offici al attestations, or to the offi cial supervision referred to in 
Article 90(1) such delegation shall comply  with the provisions of Articles 25 to 32. 
Article 86 
Official certificates 
1. When the rules referred to in Article 1(2) require the issuance of an official 
certificate, the provisions of Articles 87, 88 and 89 shall apply. 
2. Articles 87, 88 and 89 shall also apply to o fficial certificates wh ich are necessary for 
the purposes of exporting consignments of  animals and goods to third countries. EN 91   EN Article 87 
Signature and issuance of official certificates 
1. Official certificates shall be issued by the competent authorities. 
2. Competent authorities shall designate the certifying officers who are authorised to 
sign official certificates. Ce rtifying officers shall: 
(a) be free from conflict of interest in relation to what is being certified and act 
impartially; 
(b) receive appropriate training on the rules with which compliance is certified by 
the official certificate as well as on the provisions of this Chapter. 
3. Official certificates shall be signed by the certifying o fficer and issued on one of the 
following grounds: 
(a) direct knowledge by the certif ying officer of facts a nd data relevant for the 
certification, obtained through: 
(i) an official control; or (ii) the acquisition of another official  certificate issued by the competent 
authorities; 
(b) facts and data relevant for the certification, knowledge of which was 
ascertained by another person authorised for that purpose by, and acting under 
the control of, the competent authorities,  provided that the certifying officer 
can verify the accuracy of such facts and data; 
(c) facts and data relevant for the certif ication which were obtained from the 
operators’ own-control systems, comple mented and confirme d by results from 
regular official cont rols, where the certifying officer  is thus satisfied that the 
conditions for issuing the offi cial certificate are met. 
4. Official certificates shall be signed by the certifying o fficer and issued only on the 
basis of point (a) of paragraph 3 when rule s referred to in Arti cle 1(2) so require. 
Article 88 
Guarantees of reliability fo r official certificates  
1. Official certificates shall: 
(a) not be signed by the certifying officer where they are blank or incomplete; 
(b) be drawn up in one of the official la nguages of the institu tions of the Union 
that is understood by the certifying officer  and, where relevant, in one of the 
official languages of the Me mber State of destination; 
(c) be authentic and accurate; 
(d) enable the identification of the person who signed them; 
(e) allow the verification of the link between the certificate and the consignment, 
lot or individual animal or good covered by the certificate. 
2. The competent authorities sh all take all measures necessa ry to prevent and penalise 
the issuance of false or misleading offici al certificates or th e abuse of official 
certificates. Such measures sh all include where appropriate: EN 92   EN (a) the temporary suspension of the certifying officer from its duties; 
(b) the withdrawal of the authorisati on to sign official certificates; 
(c) any other necessary measure to prevent that the offence referred to in the first 
sentence of this paragraph is repeated. 
Article 89 
Implementing powers for o fficial certificates  
The Commission may, by means of implementi ng acts, lay down rule s for the uniform 
application of Articles 87 and 88 concerning: 
(a) model official certificates and rules for the issuance of such certificates; 
(b) the mechanisms and the legal and technical arrangements to ensure the issuance of 
accurate and reliable offi cial certificates and prevent risk of fraud; 
(c) the procedures to be followed in the case of  withdrawals of offici al certificates and 
for the production of replacement certificates; 
(d) rules for the production of certified co pies of official certificates; 
(e) the format of documents that must accompany animals and goods after official 
controls have been performed; 
(f) rules for the issuance of electronic certificates and for the use of electronic 
signatures. 
Those implementing acts shall be adopted in  accordance with the examination procedure 
referred to in Article 141(2). 
Article 90 
Official attestations  
1. When the rules referred to in Article 1(2) re quire the issuance of official attestations 
by the operators under the offici al supervision of the compet ent authorities, or by the 
competent authorities themselves, paragraphs  2, 3 and 4 of this Article shall apply. 
2. Official attestations shall: 
(a) be authentic and accurate; 
(b) be drawn up in one of the official lan guages of the institutions of the Union; 
(c) where they relate to a consignment or a lot, allow the veri fication of the link 
between the official attestation and that consignment or lot. 
3. Competent authorities shall ensure that the staff performing official controls to 
supervise the certification procedure or, wher e the official attestations are issued by 
the competent authorities, the staff invol ved in the issuance of those official 
attestations: 
(a) are impartial and free from any conflict of interest in relation to what is being 
certified by the official attestations; 
(b) receive appropriate training on: 
(i) the rules with which compliance is certified by the official attestations; EN 93   EN (ii) the rules laid down in this Regulation. 
4. Competent authorities sha ll perform regular official controls to verify that: 
(a) the operators issuing the attestations comp ly with the conditions laid down in 
the rules referred to in Article 1(2); 
(b) the attestation is issued on the basis of relevant, correct and verifiable facts and 
data. EN 94   EN Title III 
Reference laboratories and centres 
Article 91 
Designation of European Union reference laboratories 
1. The Commission may, by means of implem enting acts, designate European Union 
reference laboratories in the areas governed by the rules referred to in Article 1(2) 
where the effectiveness of official contro ls also depends on the quality, uniformity 
and reliability of: 
(a) the methods of analysis, test or diagnos is employed by the official laboratories 
designated in accordance with Article 36(1); 
(b) the results of the analyses, tests and diagnoses performed by those official 
laboratories. 
2. The designations provided for in paragraph 1 shall: 
(a) follow a public selection process; 
(b) be reviewed regularly. 
3. European Union refere nce laboratories shall: 
(a) operate in accordance with the sta ndard EN ISO/IEC 17025 on ‘General 
requirements for the competence of testi ng and calibration labor atories’ and be 
assessed and accredited in accordance w ith that standard by a national 
accreditation body, operating in accordan ce with Regulation (EC) No 
765/2008; 
(b) be impartial and free of conflict of intere sts as regards the exercise of its tasks 
as European Union reference laboratories; 
(c) have suitably qualified staff with adequa te training in analytical, testing and 
diagnostic techniques applied in their area of compet ence, and support staff as 
appropriate; 
(d) possess or have access to the infrastruc ture, equipment and products necessary 
to carry out the tasks assigned to them; 
(e) ensure that their staff have good know ledge of internatio nal standards and 
practices and that the latest developmen ts in research at national, Union and 
international level are taken into account in their work; 
(f) be equipped to perform their ta sks in emergency situations; 
(g) where relevant, be equipped to comply with relevant bios ecurity standards. 
Article 92 
Responsibilities and tasks of Europe an Union reference laboratories 
1. European Union reference laboratories shall contribute to the improvement and 
harmonisation of methods of analysis, test  or diagnosis to be used by official 
laboratories designated in accordance with Ar ticle 36(1) and of the analytical, testing 
and diagnostic data generated by them. EN 95   EN 2. European Union reference laboratories shall be responsible, in accordance with 
annual or multiannual work programmes  approved by the Commission, for the 
following tasks: 
(a) providing national reference laboratories with details of methods of laboratory 
analysis, test or diagnosis, including reference methods; 
(b) coordinating the application by the na tional reference laboratories and, if 
necessary, by other official laboratories of the methods re ferred to in point (a), 
in particular, by organising regular inte r-laboratory comparative testing and by 
ensuring appropriate follow-up of such  comparative testing in accordance, 
where available, with intern ationally accepted protocols; 
(c) coordinating practical arrangements necessary to apply new methods of 
laboratory analysis, test or diagnos is, and informing national reference 
laboratories of advances in this field; 
(d) conducting training courses fo r the benefit of staff from national reference 
laboratories and, if needed, from other o fficial laboratories,  as well as of 
experts from third countries; 
(e) providing scientific and technical assi stance to the Commission within the 
scope of their mission; 
(f) providing information on relevant Uni on, national and international research 
activities to national reference laboratories; 
(g) collaborating within the scope of their mission with laboratories in third 
countries and with the European F ood Safety Authority, the European 
Medicines Agency and the European Centre for Disease Prevention and 
Control; 
(h) assisting actively in the diagnosis of outbreaks in Member States of foodborne, 
zoonotic or animal diseases, or of pest s of plants, by carrying out confirmatory 
diagnosis, characterisation and taxonomi c or epizootic studies on pathogen 
isolates or pest specimens; 
(i) coordinating or performing tests for the ve rification of the quality of reagents 
used for the diagnosis of animal , zoonotic or foodborne diseases; 
(j) where relevant for their area of comp etence, establishing and maintaining: 
(i) reference collections of  pests of plants or refe rence strains of pathogenic 
agents; 
(ii) reference collections of materials intended to come into contact with food 
used to calibrate analytical equipm ent and provide samples thereof to 
national reference laboratories; 
(iii) up-to-date lists of available refe rence substances and reagents and of 
manufacturers and suppliers of such substances and reagents. 
3. European Union reference laboratories shal l publish the list of th e national reference 
laboratories designated by the Member St ates in accordance with Article 98(1). EN 96   EN Article 93 
Designation of European Union reference centres for plant reproductive material 
1. The Commission may, by means of implem enting acts, designate European Union 
reference centres that shall support the activities of the Commission, the Member States and the European Plant Variety Agen cy (EPVA) in relation to the application 
of the rules referred to in point (h) of Article 1(2). 
2. The designations provided for in paragraph 1 shall: 
(a) follow a public selection process; 
(b) be reviewed regularly. 
3. European Union reference centres for plant reproductive material shall: 
(a) possess a high level of scientific and t echnical expertise in inspection, sampling 
and testing of plant reproductive material; 
(b) have suitably qualified staff with adequate  training in the areas referred to in 
point (a) and support staff as appropriate; 
(c) possess or have access to the infrastr ucture, the equipmen t and the products 
necessary to carry out the tasks assigned to them; 
(d) ensure that their staff have good know ledge of internatio nal standards and 
practices in the areas referred to in point (a) and that the latest developments in 
research at national, Union and international level in those areas are taken into 
account in their work. 
Article 94 
Responsibilities and tasks European Union refere nce centres for plant reproductive material 
The European Union reference centres designate d in accordance with Article 93(1) shall be 
responsible, in accordance with annual or multiannual work programmes approved by the Commission for the following tasks: 
(a) providing scientific and tec hnical expertise, within th e scope of their mission, on: 
(i) field inspection, sampling and testing pe rformed for the cert ification of plant 
reproductive material; 
(ii) post-certification tests of plant reproductive material; (iii) tests on standard material cate gories of plant reproductive material; 
(b) organising comparative test s and field trials on plant reproductive material; 
(c) conducting training courses for the benefit of staff of th e competent authorities and 
of experts from third countries; 
(d) contributing to the development of certificat ion and post-certifica tion test protocols 
for plant reproductive material , and of performance indicator s for the certification of 
plant reproductive material; 
(e) disseminating research findings  and technical innovations in  the fields within the 
scope of their mission. EN 97   EN Article 95 
Designation of European Union reference centres for animal welfare 
1. The Commission may, by means of implem enting acts, designate European Union 
reference centres that sha ll support the activities of the Commission and of the 
Member States in relation to the applicati on of the rules referred to in point (f) of 
Article 1(2). 
2. The designations provided for in paragraph 1 shall: 
(a) follow a public selection process; 
(b) be reviewed regularly. 
3. European Union reference centres for animal welfare shall: 
(a) possess a high level of scientific and technical expertise in human-animal 
relationship, animal behaviour, animal physiology, animal health and nutrition 
related to animal welfare, and animal welfare aspects related to the commercial 
and scientific use of animals; 
(b) have suitably qualified staff with adequate  training in the areas referred to in 
point (a) and in ethical issues rela ted to animals and support staff as 
appropriate; 
(c) possess or have access to the infrastr ucture, the equipment and products 
necessary to carry out the tasks assigned to them; 
(d) ensure that their staff have good know ledge of internatio nal standards and 
practices in the areas referred to in point (a) and that the latest developments in 
research at national, Union and international level in those areas are taken into account in their work. 
Article 96 
Responsibilities and tasks of European Un ion reference centres for animal welfare 
The European Union reference centres designate d in accordance with Article 95(1) shall be 
responsible, in accordance with annual or multiannual work programmes approved by the Commission for the following tasks: 
(a) providing scientific and techni cal expertise within the scope of their mission to the 
national scientific support networks or  bodies provided for in Article 20 of 
Regulation (EC) No 1099/2009; 
(b) providing scientific and tec hnical expertise for the deve lopment and application of 
the animal welfare indicators referred to in point (f) of Article 18(3); 
(c) developing or coordinating the development of methods for the assessment of the 
level of welfare of animals and of methods  for the improvement of the welfare of 
animals; 
(d) carrying out scientific  and technical studies on the welfare of animals used for 
commercial or scientific purposes; 
(e) conducting training courses for the benefit of  staff of the national scientific support 
networks or bodies referred to in point (a), of staff of the competent authorities and 
of experts from third countries; EN 98   EN (f) disseminating research findings and tec hnical innovations and collaborating with 
Union research bodies in the fields  within the scope  of their mission. 
Article 97  
Obligations of the Commission 
1. The Commission shall publish and upda te, whenever necessary, the list of: 
(a) European Union reference laborato ries provided for in Article 91; 
(b) European Union reference centres for pl ant reproductive material provided for 
in Article 93; 
(c) European Union reference centres for animal welfare provided for in 
Article 95. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the establishment of requirements, responsibilities and tasks 
for the European Union reference laboratorie s, the European Union reference centres 
for plant reproductive material and the Eur opean Union reference centres for animal 
welfare in addition to thos e laid down in Articles 91(3), 92, 93(3), 95(3) and 96. 
3. European Union reference laboratories  and European Unio n reference centres  shall 
be subject to Commission cont rols to verify compliance with the requirements of 
Articles 91(3), 92, 93(3), 95(3) and 96. 
4. If the Commission controls referred to in paragraph 3 show non-compliance with the 
requirements laid down in Articles 91(3) , 92, 93(3), 95(3) and 96, the Commission 
shall, after having received the comment s of the European Union reference 
laboratory or European Union reference centre: 
(a) withdraw the designatio n of that laboratory or centre; or, 
(b) take any other appropriate measure. 
Article 98  
Designation of national reference laboratories 
1. Member States shall designate one or more  national reference laboratories for each 
European Union reference laboratory designated in accordance with Article 91(1). 
A Member State may designate a laboratory situated in anot her Member State or in a 
third country that is a Contracting Part y to the European Fr ee Trade Association 
(EFTA). 
A single laboratory may be designated as a national reference laboratory for more 
than one Member State. 
2. The requirements provided for in point (e) of Article 36(4), Articles 36(5), 38 and 
41(1), points (a) and (b) of Article 41(2) and Article 41(3) shall apply to national 
reference laboratories. 
3. National reference laboratories shall: 
(a) be impartial and free of conflict of intere sts as regards the exercise of its tasks 
as national reference laboratories; EN 99   EN (b) have suitably qualified staff with adequa te training in analytical, testing and 
diagnostic techniques in their area of competen ce, and support staff as 
appropriate; 
(c) possess or have access to the infrastructure equipment and products needed to 
carry out the tasks assigned to them; 
(d) ensure that their staff have good know ledge of internatio nal standards and 
practices and that the latest developmen ts in research at national, Union and 
international level are taken into account in their work; 
(e) be equipped to perform their ta sks in emergency situations; 
(f) where relevant, be equipped to comply with biosecurity standards. 
4. Member States shall: 
(a) communicate the name and address of each national reference laboratory to the 
Commission, the relevant European Un ion reference laboratory and other 
Member States; and, 
(b) make that information available to the public; 
(c) update that information whenever necessary. 
5. Member States that have more than one national reference laboratory for a European 
Union reference laboratory shall ensure that  such laboratories work closely together, 
so as to ensure efficient coordination be tween them, with other national laboratories 
and with the European Un ion reference laboratory. 
6. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the establishment of requirements for national reference 
laboratories in addition to those laid down in paragraphs 2 and 3. 
Article 99  
Responsibilities and tasks of na tional referen ce laboratories 
1. National reference laboratories sha ll, in their area of competence: 
(a) collaborate with the European Union refe rence laboratories, and participate in 
training courses and in in ter-laboratory comparative tests organised by these 
laboratories; 
(b) coordinate the activities of official la boratories designated in accordance with 
Article 36(1) with a view of harm onising and improving the methods of 
laboratory analysis, test or  diagnosis and their use; 
(c) where appropriate, organise inter-labora tory comparative tests between official 
laboratories, ensure an appropriate fo llow-up of such tests and inform the 
competent authorities of the results of such tests and follow-up; 
(d) ensure the dissemination to the competent authorities and official laboratories 
of information that the European Union reference laboratory supplies; 
(e) provide within the scope of their mission scientific and technical assistance to 
the competent authorities for the implem entation of coordinated control plans 
adopted in accordance with Article 111; EN 100   EN (f) where relevant, establish and maintain up-to-date lists of available reference 
substances and reagents and of manufact urers and suppliers of  such substances 
and reagents. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the establishment of  responsibilities and tasks for national 
reference laboratories in addition to those provided in paragraph 1. 
Title IV 
Administrative assistance and cooperation 
Article 100 
General rules 
1. The competent authorities in the Member States concerned shall provide each other 
with administrative assistan ce in accordance with Articl es 102 to 105, in order to 
ensure the correct application of the rules referred to in Article 1(2) in cases which have relevance in more than one Member State. 
2. Administrative assistance  shall include, where approp riate, participation by the 
competent authorities of a Member State in  on-the-spot official  controls that the 
competent authorities of another Member State perform. 
3. The provisions of this Title sh all not prejudice national rules: 
(a) applicable to the release of documents that are the object of, or related to, 
judicial proceedings; 
(b) aimed at the protection of natural or  legal persons' commercial interests. 
4. All communications between competent au thorities in accordance with Articles 102 
to 105 shall be in writing. 
5. In order to streamline and simplify comm unication exchanges, th e Commission shall, 
by means of implementing acts, establish a standard format for: 
(a) the requests for assistance provided for in Article 102(1); 
(b) the communication of common and recu rrent notifications and responses. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 101  
Liaison bodies 
1. Each Member State shall designate one or more liaison bodies responsible for the 
exchange of communications between competent authorities in accordance with Articles 102 to 105. 
2. The designation of liaison bodies shall not preclude direct contacts, exchange of 
information or cooperation between the sta ff of competent authorities in different 
Member States. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 139 concerning the establishmen t of minimum requirements that liaison 
bodies designated in accordance with pa ragraph 1 are required to comply with. EN 101   EN 4. Member States shall communicate to the Commission and other Member States the 
details of their liaison bodies designated  in accordance with paragraph 1, and any 
subsequent modificatio n of those details. 
5. The Commission shall publish and update the list of liaison bodi es communicated to 
it by the Member States in accordance with paragraph 4 on its website. 
6. All requests for assistance pursuant to  Article 102(1), and notifications and 
communications pursuant to Articles 103, 104 and 105 shall be transmitted by a liaison body to its correspondent  in the Member State to which the request or the 
notification is addressed. 
7. The Commission shall, by means of implem enting acts, establish the specifications 
of the technical tools and the procedures  for communication be tween liaison bodies 
designated in accordance with paragraph 1. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 102  
Assistance on request 
1. Where the competent authorities in a Member State consider that, for the 
performance of official controls or for th e effective follow-up to such controls in 
their territory, they require data or information from the competent authorities of 
another Member State, they shall issue a motivated request for administrative assistance to the competent authorities of that Member State. The requested competent authorities shall: 
(a) acknowledge receipt of the request without delay; 
(b) indicate within ten days from the date of receipt of the request, the time 
necessary to provide an info rmed response to the request; 
(c) perform official controls or investiga tions necessary to provide the requesting 
competent authorities without delay with all necessary information and documents to enable them to take informed decisions and verify compliance with Union rules with in their jurisdiction. 
2. Documents may be transmitted in their original form or copies may be provided. 3. By agreement between the requesting co mpetent authorities and the requested 
competent authorities, staff designated by the former may be present during the 
official controls and investigations referre d to in point (c) of paragraph 1 performed 
by the requested competent authorities. 
In such cases the staff of the requesting competent authorities: (a) shall at all times be able to produce writt en authority stating their identity and 
their official capacity; 
(b) shall have access to the same premises and documents as the staff of the 
requested competent author ities, through their intermediary, and for the sole 
purpose of the administrative enquiry being carried out; 
(c) may not, on their own initiative, exercise  the powers of enquiry conferred on 
officials of the requested competent authorities. EN 102   EN Article 103  
Assistance without request 
1. When the competent authorities in a Member State become aware of a non-
compliance, and if such non-compliance may have implications for another Member State, they shall notify such information to  the competent authorities of that other 
Member State without being requested to do so  and without delay. 
2. The competent authorities notified in accordance with paragraph 1: 
(a) shall acknowledge receipt of th e notification without delay; 
(b) shall indicate within ten days from th e date of receipt of the notification: 
(i) what investigations th ey intend to carry out; or, 
(ii) the reasons why they consider th at no investigations are necessary; 
(c) where investigations referred to in poi nt (b) are considered necessary, they 
shall investigate the matter and inform the notifying competent authorities without delay of the results and, where appropriate, of any measures taken. 
Article 104  
Assistance in the event of non-compliance  
1. Where, during official controls performe d on animals or goods originating in another 
Member State, the competent authorities es tablish that such an imals or goods do not 
comply with the rules referred to in Article 1( 2) in such a way as to create a risk to 
human, animal or plant health, animal welfare or, as regards GMOs and plant 
protection products, to the envi ronment, or to constitute a serious infringement of 
those rules, they shall, without delay, notif y the competent authorities of the Member 
State of dispatch and of any other concerned Member State in order to enable them to 
undertake appropriate  investigations. 
2. The notified competent author ities shall without delay: 
(a) acknowledge receipt of  the notification; 
(b) indicate what investigations  they intend to carry out; 
(c) investigate the matter, take all necessa ry measures and inform the notifying 
competent authorities of the nature of th e investigations and official controls 
performed, of the decisions taken and of the reasons for such decisions. 
3. If the notifying competent aut horities have reason to believe that the investigations 
performed or the measures taken by th e notified competent authorities do not 
adequately address the non-compliance esta blished, they shall request the notified 
competent authorities to complement the official controls performed or the measures taken. In such cases: 
(a) the competent authorities from the two Member States shall seek an agreed 
approach with the aim of appropriately addre ssing the non-compliance, 
including through joint official contro ls and investigations performed in 
accordance with Article 102(3); 
(b) they shall inform the Commission without  delay where they are not able to 
agree on appropriate measures. EN 103   EN 4. When official controls performed on animals or goods originating in another 
Member State show repeated  cases of non-compliance with  the rules referred to in 
Article 1(2), the competent authorities of  the Member State of destination shall 
inform the Commission and the competent au thorities of the other Member States 
without delay. 
Article 105 
Assistance by third countries  
1. When competent authorities receive information from a third country indicating non-
compliance or a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, to the en vironment, they shall, without delay: 
(a) notify such information to the compet ent authorities in other concerned 
Member States; 
(b) communicate such information to the Commission where it is or may be 
relevant at Union level. 
2. Information obtained through official cont rols and investigations performed in 
accordance with this Regulation may be comm unicated to the third country referred 
to in paragraph 1, provided that: 
(a) the competent authorities which have pr ovided the information consent to such 
communication; 
(b) the third country has undert aken to provide the assist ance necessary to gather 
evidence of practices that are or appear  to be non-compliant with Union rules 
or that pose a risk to humans, anim als or plants or the environment; 
(c) relevant Union and national rules appli cable to the communication of personal 
data to third countries are complied with. 
Article 106  
Coordinated assistance and follow-up by the Commission 
1. The Commission shall coordinate without delay the measures and actions undertaken 
by competent authorities in accordance with this Title where: 
(a) information available to the Commission repor ts activities that are, or appear to 
be, non-compliant with the ru les referred to in Article 1(2), and such activities 
have, or might have, ramifications in  more than one Member State; or, 
(b) information available to the Commission indicates that the same, or similar, 
activities that are, or appear to be, non-compliant with the rules referred to in 
Article 1(2) might be taking place in  more than one Member State; and, 
(c) the competent authorities in the Member  States concerned are unable to agree 
on appropriate action to address the non-co mpliance with the rules referred to 
in Article 1(2). 
2. In the cases referred to in paragraph 1 the Commission may: 
(a) in collaboration with the Member State concerned, send an inspection team to 
perform an on-the-spot official control; EN 104   EN (b) request, by means of implementing acts, th at the competent authorities in the 
Member State of dispatch and, where appropriate, in other Member States 
concerned, appropriately intensify offici al controls and report to it on the 
measures taken by them; 
(c) take any other appropriate measure in accordance with the rules referred to in 
Article 1(2). 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 to establish rules for the rapi d exchange of information in the cases 
referred to in paragraph 1. EN 105   EN Title V 
Planning and reporting 
Article 107  
Multi-annual national co ntrol plans (MANCP) and singl e authority for the MANCP 
1. Member States shall ensure that offici al controls governed by this Regulation are 
performed by the competent authorities on the basis of a multi-annual national 
control plan, the preparation and impleme ntation of which are coordinated across 
their territory. 
2. Member States shall designate a single authority responsible for: 
(a) the coordination of the preparation of th e plan referred to in paragraph 1 across 
all competent authorities responsib le for the official controls; 
(b) ensuring that such plan is coherent and consistently implemented. 
Article 108  
Content of the multi-annual  national control plans 
1. Multi-annual national control plans shall be prepared so as to ensure that: 
(a) official controls are planned in all the ar eas governed by the ru les referred to in 
Article 1(2) and in accordance with the cr iteria laid down in Article 8 and in 
the rules provided for in Articles 15 to 24; 
(b) there is efficient prioritisation of offici al controls and efficient allocation of 
control resources. 
2. Multi-annual national control plans shall co ntain general information on the structure 
and organisation of the systems of official  control in the Member State concerned, 
and shall contain at least information on the following: 
(a) the strategic objectives of the multi-a nnual national control plan and on how 
the prioritisation of official controls and allocation of resources reflect these 
objectives; 
(b) the risk categorisation of  the official controls; 
(c) the designation of competent authorities a nd their tasks at central, regional and 
local level, and on resources av ailable to those authorities; 
(d) where appropriate, the delegation of tasks to delegated bodies; 
(e) the general organisation and management  of official controls at national, 
regional and local level, including official controls in individual 
establishments; 
(f) control systems applied to different sectors and coordination between the 
different services of competent authoritie s responsible for official controls in 
those sectors; 
(g) procedures and arrangements in place to ensure compliance with the 
obligations of the competent author ities provided for in Article 4(1); 
(h) the training of staff of the competent authorities; EN 106   EN (i) the documented procedures provided for in Article 11(1); 
(j) the organisation and operation of con tingency plans in accordance with the 
rules referred to Article 1(2); 
(k) the organisation of cooperation and mu tual assistance between competent 
authorities in the Member States. 
Article 109  
Preparation and implementation of multi-annual control plans  
1. Member States shall ensure that the mu lti-annual national control plan provided for 
in Article 107(1) is made available to the public, with the exceptio n of those parts of 
the plan the disclosure of  which could undermine the effectiveness of official 
controls. 
2. The multi-annual national control plan shall be updated every time it is necessary to 
adjust it to changes to the rules referred to  in Article 1(2), and shall be reviewed on a 
regular basis to take account at least of the following factors: 
(a) the emergence of new diseases, pests of plants or other risks to human, animal 
or plant health, animal we lfare or, in the case of GMOs and plant protection 
products, to the environment; 
(b) significant changes to the structure, ma nagement or operation of the competent 
authorities in the Member State; 
(c) the results of Member States' official controls; 
(d) the results of Commission  controls performed in  the Member State in 
accordance with Article 115(1); 
(e) delegated acts adopted by the Commi ssion in accordance with Article 110; 
(f) scientific findings; 
(g) the outcome of official c ontrols performed by the comp etent authorities of third 
country in a Member State. 
3. Member States shall provide the Commissi on with an up-to-date  version of their 
multi-annual national control plan on request. 
Article 110 
Delegated powers for multi- annual national control plans 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning the multi-annual national contro l plans provided for in Article 107(1). 
Those delegated acts shall lay down rules on: (a) criteria for the risk categorisation of the operators' activities; 
(b) priorities for official controls based on the criteria laid down in Article 8 and in the 
rules provided for in Articles 15 to 24; 
(c) procedures to maximise the eff ectiveness of official controls; 
(d) the main performance indicators to be applied by the competent authorities in 
assessing the multi-annual national control plan and its implementation. EN 107   EN Article 111  
Coordinated control plans and information and data collection 
With a view to conducting Union wide targeted assessment of the state of application of the 
rules referred to in Article 1(2) or establishi ng the prevalence of certain hazards across the 
Union, the Commission shall be empowered to adopt delegated acts in accordance with 
Article 139 concerning: 
(a) the organisation and the implementation of  coordinated control plans of limited 
duration in one of the areas governed by the rules referred to in Article 1(2); 
(b) the organisation, on an ad hoc basis, of th e collection of data and information in 
relation to the application of a specific set of  the rules referred to in Article 1(2) or 
regarding the prevalence of certain hazards. 
Article 112  
Annual reports by the Member States 
1. By 30th June every year, each Member State shall submit to the Commission a report 
setting out: 
(a) any amendments made to its multi-annual national control plan to take account 
of the factors referred to in Article 109(2); 
(b) the results of official controls perfor med in the previous year under its multi-
annual national control plan; 
(c) the type and number of cases of non-compliance with the rules referred to in 
Article 1(2) detected in  the previous year by th e competent authorities; 
(d) measures taken to ensure the effectiv e operation of its mu lti-annual national 
control plan, including enforcement acti on and the results of such measures. 
2. In order to ensure the uniform presenta tion of the annual reports provided for in 
paragraph 1, the Commission shall, by mean s of implementing acts, adopt and update 
as necessary standard model forms for th e submission of the information and data 
referred to in paragraph 1. 
Those implementing acts shall, whenever po ssible, allow the use of the standard 
model forms adopted by the Commission fo r the submission of other reports on 
official controls that the competent au thorities are required to submit to the 
Commission in accordance with the rules referred to in Article 1(2). 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Article 113  
Annual reports by the Commission 
1. The Commission shall make available to th e public an annual report on the operation 
of official controls in the Me mber States, taking into account: 
(a) the annual reports submitted by the Member States in accordance with 
Article 112; 
(b) the results of Commission controls performed in accordance with Article 
115(1); EN 108   EN (c) any other relevant information. 
2. The annual report provided for in para graph 1 may, where appropriate, include 
recommendations on possible improvements to  official control systems in Member 
States and specific official controls in certain areas. 
Article 114  
Contingency plans for food and feed  
1. For the application of the general plan  for crisis management provided for in 
Article 55(1) of Regulation (EC) No  178/2002, Member States shall draw up 
operational contingency plans for food and f eed setting out measures to be applied 
without delay when food or feed is found to  pose a serious risk to human or animal 
health either directly or  through the environment. 
2. The contingency plans for food and feed pr ovided for in paragraph 1 shall specify: 
(a) the competent authorities to be involved; 
(b) the powers and responsibilitie s of the authorities refe rred to in point (a); 
(c) channels and procedures for sharing information between competent authorities 
and other parties concerned as appropriate. 
3. Member States shall review  their contingency plans for food and feed regularly to 
take into account changes in the organisation of the competent authorities and 
experience gained from implementing the plan and simulation exercises. 
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning: 
(a) rules for the establishment of the conti ngency plans provided for in paragraph 1 
to the extent necessary to ensure the consistent and efficient use of the general plan for crisis management provided fo r in Article 55(1) of Regulation (EC) 
No 178/2002; 
(b) the role of stakeholders in the es tablishment and operation of those 
contingency plans. EN 109   EN Title VI 
Union activities 
Chapter I 
Commission controls 
Article 115  
Commission controls in  Member States  
1. Commission experts shall perform c ontrols in each Member State to: 
(a) verify the application of the rules referre d to in Article 1(2)  and those provided 
for in this Regulation; 
(b) verify the functioning of national c ontrol systems and of the competent 
authorities which operate them; 
(c) investigate and collect information: 
(i) on official controls and enforcement practices; 
(ii) on important or recurring problems with the application or enforcement 
of the rules referred to in Article 1(2); 
(iii) in relation to emergency situ ations, emerging problems or new 
developments in the Member States. 
2. The controls provided for in paragraph 1 shall be organised in  cooperation with the 
competent authorities of the Member Stat es and be performed on a regular basis. 
3. The controls provided for in paragraph 1 may include on the s pot verifications. The 
Commission experts may acco mpany the staff of the competent authorities 
performing official controls. 
4. Experts from the Member States may assist the Commission experts. National 
experts accompanying Commissi on experts shall be given th e same rights of access 
as the Commission experts. 
Article 116 
Reports by the Commission on controls by its experts in Member States 
1. The Commission shall: 
(a) prepare a draft report on the findings of controls performed in accordance with 
Article 115(1); 
(b) send to the Member State where those c ontrols were performed a copy of the 
draft report provided for in point (a) for its comments; 
(c) take the comments of the Member State re ferred to in point (b) into account in 
preparing the final report  on the findings of the c ontrols performed by its 
experts in the Member States as  provided for in Article 115(1); 
(d) make publicly available the final repor t referred to in point (c) and the 
comments of the Member State referred to in point (b). EN 110   EN 2. Where appropriate, the Comm ission may recommend in its final reports provided for 
in paragraph 1 corrective or preventive action to be taken by the Member States to address the specific or systemic shortc omings identified by its experts during 
controls performed in accordance with Article 115(1). 
Article 117 
Programme of the Commission controls in Member States 
1. The Commission shall, by m eans of implementing acts: 
(a) establish an annual or multiannual control programme for the controls to be 
performed by its experts in the Member States as provided for in Article 
115(1); 
(b) by the end of each year, communicate to the Member States the annual control 
programme or any update to the multiannual control programme for the following year. 
2. The Commission may, by means of implem enting acts, amend its control programme 
to take account of developments in the ar eas governed by the rules referred to in 
Article 1(2). Any such amendment shall be communicated to the Member States. 
Article 118 
Obligations of the Member States  as regards Commission controls 
Member States shall: 
(a) take appropriate follow-up measures to  remedy any specific or systemic 
shortcomings identified by the controls  performed by the Commission experts in 
accordance to Article 115(1); 
(b) give all necessary assistance and provide  all documentation and other technical 
support that Commission experts request to  enable them to perform controls 
efficiently and effectively; 
(c) ensure that Commission experts have access to all premises or parts of premises, 
animals and goods, and to information, includ ing computing systems, relevant for the 
execution of their duties. 
Article 119  
Commission controls in third countries  
1. Commission experts may perform contro ls in third countries in order to: 
(a) verify the compliance or equivalence of third-country legislation and systems, 
including official certification and the issu ance of official ce rtificates, official 
labels, official marks and other official attestations, with th e requirements laid 
down in the rules referred to in Article 1(2); 
(b) verify the capacity of the third count ry control system to ensure that 
consignments of animals and goods e xported to the Union comply with 
relevant requirements established by the ru les referred to in Article 1(2) or with 
requirements recognised to be at  least equivalent thereto; EN 111   EN (c) collect information and data to elucidat e the causes of r ecurring or emerging 
problems in relation to exports of an imals and goods from a third country. 
2. The controls provided for in paragrap h 1 shall have particular regard to: 
(a) the legislation of the third country; 
(b) the organisation of the third country's competent authorities, their powers and 
independence, the supervision to which th ey are subject and the authority they 
have to enforce the applicable legislation effectively; 
(c) the training of staff in the perf ormance of official controls; 
(d) the resources including analytical, testing and diagnostic facilities available to 
competent authorities; 
(e) the existence and operation of documen ted control procedures and control 
systems based on priorities; 
(f) where applicable, the situation regard ing animal health, zoonoses and plant 
health, and procedures for notifying the Commission and relevant international 
bodies of outbreaks of animal di seases and pests of plants; 
(g) the extent and operation of official controls performed  on animals, plants and 
their products arriving from other third countries; 
(h) the assurances which the third country can give regarding compliance with, or 
equivalence to, the requirements laid  down in the rules referred to in 
Article 1(2). 
3. In order to facilitate the efficiency and e ffectiveness of the controls provided for in 
paragraph 1, the Commission may, prior to pe rforming such controls, request that the 
third country concerned provide: 
(a) the information referred to in Article 124(1); 
(b) where appropriate, the written records on the official cont rols it performs. 
4. The Commission may appoint experts from Me mber States to assi st its own experts 
during the controls provided for in paragraph 1. 
Article 120  
Frequency of Commission controls in third countries 
The frequency of Commission controls in third countries shall be determined on the basis of: 
(a) a risk assessment of the animal and goods exported to the Union from them; 
(b) the rules referred to in Article 1(2); 
(c) the volume and nature of animals and goods entering the Union from the third 
country concerned; 
(d) the results of controls al ready performed by the Commission experts or by other 
inspection bodies; 
(e) the results of official controls on anim als and goods entering the Union from the 
third country and of any other official cont rols that competent authorities of Member 
States have performed; 
(f) information received from the European Food Safety Authority or similar bodies; EN 112   EN (g) information received from interna tionally recognised bodies such as: 
(i) the World Health Organisation; (ii) the Codex Alimentarius Commission; (iii) the World Organisation for Animal Health; (iv) European and Mediterranean  Plant Protection Organisation; 
(v) the secretariat of the Internat ional Plant Protection Convention; 
(vi) Organisation for Economic Co-operation and Development; (vii) United Nations Economic Commission for Europe; (viii) the secretariat of the Cartagena Protocol on Biosafety to the Convention on 
Biological Biodiversity; 
(h) evidence of emerging disease situations or other circumst ances that might result in 
animals and goods entering the Union from a third country presenting health or environmental risks; 
(i) the need to investigate or  respond to emergency situ ations in individual third 
countries. 
Article 121  
Reports by the Commission on controls by its experts in third countries 
The Commission shall report on the findings of each control performed in accordance with 
Articles 119 and 120. 
Its report shall, where appropr iate, contain recommendations. 
The Commission shall make its reports publicly available. 
Article 122  
Programme of the Commission controls in third countries 
The Commission shall communicate its programme of  controls in third countries to Member 
States in advance and report on the results. The Commission may amen d that programme to 
take account of developments in the areas govern ed by the rules referred  to in Article 1(2). 
Any such amendment shall be communicated to the Member States. 
Article 123  
Third-country controls in Member States  
1. Member States shall inform the Commission of: 
(a) planned controls in their territory by the competent authorities of third 
countries; 
(b) the intended schedule and sc ope of such controls. 
2. Commission experts may participate in the co ntrols referred to in  paragraph 1, at the 
request of either of the following: 
(a) the competent authorities of Member St ates where those controls are being 
performed; EN 113   EN (b) the competent authorities of the thir d country performing those controls. 
The participation by Commission experts a nd the final schedule and scope of the 
controls referred to in paragraph 1 shall be organised in close cooperation between 
the Commission and the competent authorit ies of the Member State where those 
controls are being performed. 
3. The participation by Commission experts in the controls referred to in paragraph 1 
shall serve in particular to: 
(a) provide advice on the rules refe rred to in Article 1(2); 
(b) provide information and data available at Union level that may be useful for 
the control performed by the competen t authorities of the third country; 
(c) ensure uniformity with regard to controls performed by the competent 
authorities of third countries. 
Chapter II 
Conditions for the entry into th e Union of animals and goods 
Article 124  
Information on third countries' control systems 
1. The Commission shall request third count ries intending to export animals and goods 
to the Union to provide the following accurate and up-to-date information on the general organisation and management of sa nitary and phytosanitary control systems 
in their territory: 
(a) any sanitary or phytosanitary regulati ons adopted or proposed within their 
territory; 
(b) risk-assessment procedures and factor s taken into consideration for the 
assessment of risks and for the determination of the appropriate level of sanitary or phytos anitary protection; 
(c) any control and inspection procedures and mechanisms, including, where 
relevant, on animals or goods arrivi ng from other third countries; 
(d) official certification mechanisms; 
(e) where appropriate, any measures take n following recommendations provided 
for in the second paragraph of Article 121; 
(f) where relevant, results of  official controls perf ormed on animals and goods 
intended to be exported to the Union; 
(g) where relevant, information on changes made to the structure and functioning 
of control systems adopted to meet  Union sanitary or phytosanitary 
requirements or recommendations provided for in the second paragraph of 
Article 121. 
2. The request for information referred to in  paragraph 1 shall be proportionate, taking 
account of the nature of the animals and goods to be export ed to the Union and of the 
specific situation and struct ure of the third country. EN 114   EN Article 125  
Establishment of additional conditions for entry into the Union of animals and goods 
1. The Commission shall be empowered to a dopt delegated acts, in accordance with 
Article 139 concerning the conditions to be respected by animals and goods entering the Union from third countries where these ar e necessary to ensure that the animals 
and goods comply with the relevant require ments established by the rules referred to 
in Article 1(2), with the excep tion of points (d), (e), (g) a nd (h) of Article 1(2) and of 
Article 6 of Regulation (EC) No 853/2004, or with requirements recognised to be at 
least equivalent. 
2. The conditions referred to in paragraph 1 shall identify animals and goods by 
referring to their codes from the Combined Nomenclature and may include: 
(a) the requirement that certai n animals and goods shall only enter the Union from 
a third country or region of a third co untry which appears on a list drawn up by 
the Commission for that purpose; 
(b) the requirement that consignments of certain animals and goods from third 
countries be dispatched from and obtaine d or prepared in establishments which 
comply with the relevant requirements referred to in paragraph 1 or with 
requirements recognised to be at least equivalent; 
(c) the requirement that consignments of certain animals and goods be 
accompanied by an official certificate, an  official attestation, or by any other 
evidence that the consignments comply w ith the relevant requirements referred 
to in paragraph 1 or with requirements recognised to be at least equivalent; 
(d) the obligation to provide the evidence refe rred to in point (c) in accordance 
with a specific format; 
(e) any other requirement necessary to ensure  that certain animals and goods offer 
a level of protection of health and, as regards GMOs and plant protection 
products, of the environment, equivalent to that ensured by the requirements 
referred to in paragraph 1. 
3. Where, in case of risks arising from an imals and goods entering the Union from third 
countries to human health, animal health or, as regards GMOs and plant protection 
products, to the environment, imperative grounds of urgency so require, the procedure provided for in Article 140 shall apply to delegated acts adopted pursuant 
to paragraph 1. 
4. The Commission may, by means of implemen ting acts, lay down rules concerning 
the format and type of official certificates , official attestations or evidence required 
in accordance with the rules provided for in point (c) of paragraph (2). 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to  in Article 141(2). 
Article 126  
Inclusion in the list of third countri es referred to in  Article 125(2)(a) 
1. The inclusion of a third country or region ther eof in the list referre d to in point (a) of 
Article 125(2) shall be made in accordance w ith paragraphs 2 and 3 of this Article. EN 115   EN 2. The Commission shall approve, by mean s of implementing acts, the request 
transmitted to it for that purpose by the third country concerned, accompanied by 
appropriate evidence and guarantees that th e concerned animals and goods from that 
third country comply with the relevant requi rements referred to in Article 125(1) or 
with requirements equivalent thereto. Thos e implementing acts sh all be adopted and 
updated in accordance with th e examination procedure refe rred to in Article 141(2). 
3. The Commission shall decide on the request  referred to in paragraph 2 taking into 
account, as appropriate: 
(a) the third country's legislati on in the sector concerned; 
(b) the structure and organisation of the comp etent authorities of the third country 
and its control services, th e powers available to them, the guarantees that can 
be provided with regard to the application and enforcem ent of the legislation of 
the third country applicable to the sect or concerned, and the reliability of the 
official certification procedures; 
(c) the performance by the competent authori ties of the third co untry of adequate 
official controls and other activities to assess the presence of hazards for 
human, animal or plant health, for animal welfare or for the environment in relation to GMOs and pl ant protection products; 
(d) the regularity and rapidity of informa tion supplied by the third country on the 
presence of hazards for human, animal or  plant health, for animal welfare or 
for the environment in relation to GMOs and plant protection products; 
(e) the guarantees given by a third country that: 
(i) conditions applied to the establishm ents from which animals or goods are 
exported to the Union comply with re quirements that are equivalent to 
those referred to in Article 125(1); 
(ii) a list of the establishments referred to in point (i) is drawn up and kept up 
to date; 
(iii) the list of establishments referred  to in point (i) a nd its updated versions 
are communicated to the Commission without delay; 
(iv) the establishments referred to in point (i) are the subj ect of regular and 
effective controls by the competent authorities of the third country; 
(f) any other information or data on the capab ility of the third country to ensure 
that only animals or goods which offer the same or an equivalent level of 
protection as that afforded by the releva nt requirements referred to in Article 
125(1) enter the Union. 
Article 127  
Establishment of special measures re garding the entry into the Union of  
certain animals and goods 
1. Where, in cases other than those refe rred to in Article 53 of Regulation (EC) 
No 178/2002, Article 249 of Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert number of the Regulation on animal health ] and in 
Articles 27(1), 29(1), 40(2), 41(2), 47(1), 49(2) and 50(2) of Regulation (EU) No 
XXX/XXXX [ Office of Publications, please in sert number of the Regulation on EN 116   EN protective measures against pests of plants ], there is evidence that the entry into the 
Union of certain animals or goods origina ting from a third country, a region thereof 
or a group of third countries, may pose a risk to human, animal or plant health or, as 
regards GMOs and plant protection products, to the environment, or where there is 
evidence that widespread serious non-complianc e with the rules referred to in Article 
1(2) might be taking place, the Commission shall adopt, by means of implementing acts, the measures necessary to contain such  risk or put an end to the identified non-
compliance. Those implementing acts shal l be adopted in a ccordance with the 
examination procedure refe rred to in Article 141(2). 
2. The measures referred to in paragraph 1 shall identify animals and goods by referring 
to their codes from the Combined Nomenclature and may include: 
(a) the prohibition of entry into the Union of the animals and goods referred to in 
paragraph 1 originating or dispatched from the concerned third countries or 
regions thereof; 
(b) the requirement that the animals a nd goods referred to in paragraph 1 
originating or dispatched from certain third countries or regions thereof be 
subject, prior to dispatch, to specific treatment or controls; 
(c) the requirement that the animals a nd goods referred to in paragraph 1 
originating or dispatched from certain third countries or regions thereof be 
subject, upon entry into the Union, to specific treatment or controls; 
(d) the requirement that consignments of the animals and goods referred to in 
paragraph 1 originating or dispatched fr om certain third co untries or regions 
thereof, be accompanied by an official cert ificate, an official  attestation, or by 
any other evidence that the consi gnment complies with requirements 
established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent; 
(e) the requirement that the evidence referred to in point (d) be provided in 
accordance with a specific format; 
(f) other measures necessary to contain the risk. 
3. When adopting the measures referred to in paragraph 2, account shall be taken of: 
(a) the information collected in accordance with Article 124; 
(b) any other information that the third countries concerned have provided; 
(c) where necessary, the results of Co mmission controls provided for in 
Article 119(1). 
4. On duly justified imperative grounds of urgency relating to  human health and animal 
health or, as regards GMOs and plant pr otection products, to the protection of the 
environment, the Commission shall adopt immediately applicable implementing acts 
in accordance with the procedur e referred to in Article 141(3). 
Article 128  
Equivalence 
1. In the areas governed by the rules referred to  in Article 1(2), with the exclusion of 
points (d), (e), (g) and (h) of Article  1(2), the Commissi on may, by means of EN 117   EN implementing acts, recognise that measures applied in a third country, or regions 
thereof, are equivalent to the requirements  laid down in those rules, on the basis of: 
(a) a thorough examination of information a nd data provided by the third country 
concerned pursuant to Article 124(1); 
(b) where appropriate, the satisfactory out come of a control performed in 
accordance with Article 119(1); 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
2. The implementing acts referred to in paragraph 1 shall set out the modalities 
governing the entry of animals and goods in to the Union from the third country 
concerned, or regions thereof, and may include: 
(a) the nature and content of the official ce rtificates or attestations that must 
accompany the animals or goods; 
(b) specific requirements applicable to the entry into the Union of the animals or 
goods and the official controls to be performed at entry into the Union; 
(c) where necessary, procedures for drawi ng up and amending lists  of regions or 
establishments in the third country concerned from which the entry of animals and goods into the Union is permitted. 
3. The Commission shall, by means of impl ementing acts, repeal without delay the 
implementing acts provided for in paragra ph 1 where any of the conditions for the 
recognition of equivalence cease to be fulfilled. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Chapter III 
Training of staff of the competent authorities 
Article 129 
Training and exchange of staff of the competent authorities 
1. The Commission may organise training ac tivities for the staff of the competent 
authorities and, where appropriate, for staff of  other authorities of  the Member States 
involved in investigations of possible viola tions of the provisions of this Regulation 
and of the rules referre d to in Article 1(2). 
The Commission may organise those activities in cooperation with Member States. 
2. The training activities referred to in paragr aph 1 shall facilitate the development of a 
harmonised approach to official controls and other official activities in Member 
States. They shall include, as appropriate, training on: 
(a) this Regulation and the rules referred to in Article 1(2); 
(b) control methods and techniques relevant for the official controls and for the 
other official activities of the competent authorities; 
(c) production, processing and marke ting methods and techniques. EN 118   EN 3. The training activities referred to in paragraph 1 may be open to staff of the 
competent authorities of th ird countries and may be or ganised outside the Union.  
4. Competent authorities shall ensure that the knowledge acquired  through the training 
activities referred to in paragraph 1 is di sseminated as necessary and appropriately 
used in the staff training activities re ferred to in Article 4(2) and (3).  
Training activities aimed at disseminatin g such knowledge shall be included in the 
training programmes referred to in Article 4(2).  
5. The Commission may organise in coopera tion with the Member States programmes 
for the exchange of staff of the competent authorities performing o fficial controls or 
other official activities between  two or more Member States. 
Such exchange may take place through the temporary secondment of staff of the 
competent authorities from one Member State to the other or through the exchange of such staff between the rele vant competent authorities.  
6. The Commission shall, by means of im plementing acts, lay down rules for the 
organisation of the training activities re ferred to in paragraph 1 and of the 
programmes referred to in paragraph 5. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
Chapter IV 
Information mana gement systems 
Article 130  
Information management system fo r official controls (IMSOC) 
1. The Commission shall set up and manage a computerised information management 
system for the integrated operation of the mechanisms and tools through which data, 
information and documents concerning offi cial controls are managed and handled 
('the IMSOC'). 
2. The IMSOC shall: 
(a) integrate fully and provide the necessa ry updates to the TRACES system as 
established by Decision 2003/24/EC; 
(b) integrate fully and provide the necessa ry updates to existing computerised 
systems managed by the Commission and us ed for the rapid exchange of data, 
information and documents in relation to risks to human, animal health and welfare, and plant health, as estab lished by Article 50 of Regulation (EC) 
No 178/2002, Article 20 of Regulation (EU) XXX/XXXX [ Office of 
Publications, please insert number of the Regulation on animal health ] and 
Article 97 of Regula tion (EU) XXX/XXXX [ Office of Publications, please 
insert number of the Regulation on pr otective measures against pests of 
plants ]; 
(c) provide appropriate linkages between the TRACES system and the systems 
referred to in point (b) to allow, as n ecessary, the efficient exchange and update 
of data between those systems and be tween the TRACES system and those 
systems. EN 119   EN Article 131 
General functionalities of the IMSOC 
The IMSOC shall: 
(a) allow for the computerised handling a nd exchange of information, data and 
documents necessary for the performance of  official controls, resulting from the 
performance of official controls or the r ecording of the performance or outcome of 
official controls in all cas es where the rules referred to  in Article 1(2) and the 
delegated acts provided for in Articles 15 to 24 provi de for the exchange among 
competent authorities, betw een the competent authori ties and the Commission, and 
where appropriate with other authorities an d the operators, of such information, data 
and documents; 
(b) provide a mechanism for the exchange of data and information in accordance with 
the provisions of Title IV; 
(c) provide a tool to collect a nd manage the reports on offici al controls provided by the 
Member States to the Commission; 
(d) allow for the production, handling and transm ission, including in electronic form, of 
the journey log referred to in Article 5(4) of Regulation (EC) No 1/2005, of the 
records obtained by the navigation system re ferred to in Article 6(9) of Regulation 
(EC) No 1/2005, of official certificates and of the common health entry document 
referred to in Article 54 of this Regulation. 
Article 132 
Use of the IMSOC in case of animals and goods  subject to specific official controls 
1. In case of animals or goods whose move ments within the Union or placing on the 
market are subject to specific requirements  or procedures established by the rules 
referred to in Article 1(2), the IMSOC sha ll enable the competent authorities at the 
place of dispatch and other competent author ities responsible for performing official 
controls on those animals or  goods to exchange in real  time data, information and 
documents concerning animals or goods be ing moved from one Member State to 
another and on official  controls performed. 
The first subparagraph shall not apply to goods subject to  the rules referred to in 
Article 1(2)(g) and (h). 
However, the Commission shall be empowered  to adopt delegated acts in accordance 
with Article 139 concerning when and to wh at extent the first subparagraph shall 
apply to the goods referred to  in the second subparagraph. 
2. In case of exported animals and goods for wh ich Union rules apply in relation to the 
issuance of the export certifi cate, the IMSOC shall enable  the competent authorities 
of the place of dispatch a nd other competent authorities responsible for performing 
official controls to exchange in real  time data, information and documents 
concerning such animals and goods and the result of controls performed on those animals and goods. 
3. In case of animals or goods subject to the official controls refe rred to in Title II, 
Chapter V, Sections I and II, the IMSOC shall: EN 120   EN (a) enable the competent authorities at the border control posts and other 
competent authorities responsible for pe rforming official c ontrols on those 
animals or goods to excha nge in real time data, information and documents 
concerning those animals and goods a nd on controls performed on those 
animals or goods; 
(b) enable the competent authorities at the border control posts to share and 
exchange relevant data, information a nd documents with customs authorities 
and other authorities responsible for performing controls on animals or goods 
entering the Union from third countries, and with operators involved in entry 
procedures, in accordance with the rule s adopted pursuant to Articles 14(4) and 
73(2) and with other relevant Union rules; 
(c) support and operate the procedures referred to in point (a) of Article 52(2) and 
in Article 63(6). 
Article 133  
Empowerment for the adoption of rule s for the functioning of the IMSOC 
The Commission shall be empowered to adopt de legated acts in accordance with Article 139 
concerning the establishment of: 
(a) the technical specifications  and the specific rules for the functioning of the IMSOC 
and of its components; 
(b) contingency arrangements to be applied in  case of unavailability of any of the 
functionalities of the IMSOC; 
(c) the cases where and the conditions under which concerned third countries and 
international organisations may be granted pa rtial access to the functionalities of the 
IMSOC and the modalities of such access; 
(d) the cases where and the conditions under wh ich exemptions from the use of the 
TRACES system can be granted to occasional users; 
(e) the rules concerning an  electronic system under which electronic certificates issued 
by the competent authorities of third countries shall be  accepted by the competent 
authorities. EN 121   EN Title VII 
Enforcement action 
Chapter I 
Action by the competent authorities and penalties 
Article 134  
General obligations of the competent aut horities as regards enforcement action 
1. When acting in accordance with this Chapter, the competent authorities shall give 
priority to action to be taken to eliminate or contain risks to human, animal and plant health, animal welfare and, as regards GM Os and plant protection products, to the 
environment. 
2. In case of suspicion of non-compliance, th e competent authorities shall perform an 
investigation in order to confirm or to eliminate that suspicion. 
3. Where necessary for its purposes, the inves tigation referred to in  paragraph 2 shall 
include: 
(a) the performance of intensified official controls on animals,  goods and operators 
for an appropriate period; 
(b) the official detention of animals and goods and of any unauthorised substances 
or products as appropriate. 
Article 135 
Investigations and measures in ca se of established non-compliance 
1. Where the non-compliance is established, the competent authorities shall: 
(a) perform any further investigation necessary to determine the origin and extent 
of the non-compliance and to establish the operator's responsibilities; 
(b) take appropriate measures to ensure that the operator remedies the non-
compliance and prevents fu rther occurrences of it. 
When deciding which measures to take, th e competent authorities shall take account 
of the nature of the non-co mpliance and the operator's past record with regard to 
compliance. 
2. When acting in accordance with paragrap h 1, competent authorities shall, as 
appropriate: 
(a) order or perform treatments on animals; 
(b) order the unloading, tr ansfer to another means of tr ansport, holding and care of 
animals, quarantine periods, the postpone ment of the slaughter of animals; 
(c) order treatments on goods, the alteration of labels or corrective information to 
be provided to consumers; 
(d) restrict or prohibit the placing on the ma rket, the movement, the entry into the 
Union or the export of animals and goods, prohibit their return to the Member State of dispatch or order their retu rn to the Member State of dispatch; EN 122   EN (e) order that the operator in creases the frequency of  own controls; 
(f) order that certain activities of the operato r concerned be subject to increased or 
systematic official controls;  
(g) order the recall, withdrawal, removal and destruction of goods, authorising, 
where appropriate, the use of the goods for purposes other than those for which 
they were originally intended; 
(h) order the isolation or closure, for an appr opriate period of time, of all or part of 
the business of the operator concerned, or  its establishments, holdings or other 
premises; 
(i) order the cessation for an appropriate pe riod of time of all or part of the 
activities of the operator c oncerned and, where relevant, of the Internet sites it 
operates or employs; 
(j) order the suspension or withdr awal of the approval of the establishment, plant, 
holding or means of transport concer ned, or of the au thorisation of a 
transporter; 
(k) order the slaughter or killing of anim als provided that this is the most 
appropriate measure to safeguard human h ealth and animal health and welfare; 
(l) take any other measure the competent au thorities deem appropriate to ensure 
compliance with the rules re ferred to in Article 1(2). 
3. The competent authorities shall provide th e operator concerned, or  its representative, 
with: 
(a) written notification of their decision c oncerning the action or measure to be 
taken in accordance with paragraphs 1 a nd 2, together with the reasons for that 
decision; and, 
(b) information on rights of appeal against such decisions and on the applicable 
procedure and time limits. 
4. All expenditure incu rred pursuant to this  Article shall be borne by the responsible 
operators. 
Article 136  
Penalties 
1. Member States shall lay down the rules on penalties applicable to infringements of 
the provisions of this Regulat ion and take all measures nece ssary to ensure that they 
are applied. The penalties provided for must be effective, proportionate and 
dissuasive. Member States shall notify those provisions to the Commission by the 
date referred to in the second subparagraph of Article 162(1) and shall notify it without delay of any subsequent amendment affecting them. 
2. Member States shall ensure that financ ial penalties applicable to intentional 
violations of the provisions of this Re gulation and of the ru les referred to in 
Article 1(2) at least offset the econo mic advantage sought through the violation. 
3. Member States shall ensure in particul ar that penalties are provided for in the 
following cases: EN 123   EN (a) where operators fail to cooperate during official controls or other official 
activities; 
(b) false or misleading official certification; 
(c) fraudulent production or use of  official certificates, o fficial labels, official 
marks and other official attestations. 
Chapter II 
Union enforcement measures 
Article 137 
Serious failure in a Member  State's control system  
1. Where the Commission has evidence of a se rious failure in a Member State's control 
systems and such failure may constitute a possible and widespread risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection 
products, to the environment, or result in a widespread infringement of the rules 
referred to in Article 1(2), it shall, by m eans of implementing acts, adopt one or more 
of the following measures, to be applied un til the failure in the control system is 
eliminated: 
(a) the prohibition to make available on the market or to transport, move or 
otherwise handle certain animals or goods  concerned by the failure in the 
official control system; 
(b) special conditions for the activities, anim als or goods referred to in point (a); 
(c) the suspension of the operation of offici al controls in border control posts or 
other control points concerne d by the failure in the official control system or 
the withdrawal of such border cont rol posts or other control points; 
(d) other appropriate temporary measures necessary to contain that risk until the 
failure in the control system is eliminated. 
Those implementing acts shall be adopted  in accordance with  the examination 
procedure referred to  in Article 141(2). 
2. The measures referred to in paragraph 1 sh all be adopted only af ter the Member State 
concerned has failed to correct the situa tion upon request and within the time limit 
set by the Commission. 
3. On duly justified imperative grounds of urgency relating to  human and animal health 
or, as regards GMOs and plant protec tion products, to the protection of the 
environment, the Commission shall adopt immediately applicable implementing acts 
in accordance with the procedur e referred to in Article 141(3). EN 124   EN Title VIII 
Common provisions 
Chapter I 
Procedural provisions 
Article 138  
Amendment of Annexes and references to European standards 
1. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning amendmen ts to Annexes II and III to  this Regulation, in order 
to take into account changes to the rules refe rred to in Article 1( 2), technical progress 
and scientific developments. 
2. In order to keep the references to the Eu ropean standards referre d to in poi nt (b)(iv) 
of Article 26(1), point (e) of Article 36(4)  and point (a) of Article 91(3) up-to-date, 
the Commission shall be empowered to  adopt delegated acts amending those 
references in the event that CEN amends them. 
Article 139  
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The delegation of power referred to in  Articles 4(3), 15(2) , 16, 17, 18(3), 19, 20, 21, 
22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2), 
60(3), 62(2), 69(3), 75(1) and (2), 97( 2), 98(6), 99(2), 101(3), 106(3), 110, 111, 
114(4) and 125(1), the third subparagraph of  Article 132(1), Ar ticles 133, 138(1) and 
(2), 143(2), 144(3), 151(3), 153(3)  and 159(3) shall be conferred for an indeterminate 
period of time from the date of en try into force of this Regulation. 
3. The delegation of powers referred to in Articles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21, 
22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2), 
60(3), 62(2), 69(3), 75(1) and (2), 97( 2), 98(6), 99(2), 101(3), 106(3), 110, 111, 
114(4) and 125(1), the third subparagra ph of Article 132(1), Articles 133, 138(1) 
and (2), 143(2), 144(3), 151(3), 153(3) and 159(3) may be revoked at any time by the 
European Parliament or by the Council. A decision of revocation shall put an end to 
the delegation of the power specified in th at decision. It shall take effect the day 
following the publication of the decision in the Official Journal of the European 
Union  or at a later date specified therein. It shall not affect the validity of any 
delegated acts al ready in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 
5. A delegated act adopted pursuant to Ar ticles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21, 
22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2), 
60(3), 62(2), 69(3), 75(1) and (2), 97( 2), 98(6), 99(2), 101(3), 106(3), 110, 111, 
114(4) and 125(1), the third subparagraph of  Article 132(1), Ar ticles 133, 138(1) and 
(2), 143(2), 144(3), 151(3), 153(3) and 159( 3) shall enter into  force only if no EN 125   EN objection has been expressed either by th e European Parliament or the Council 
within a period of two months of notificati on of that act to the European Parliament 
and the Council or if, before the expiry of  that period, the European Parliament and 
the Council have both informed the Commi ssion that they will not object. That 
period shall be extended by two months at th e initiative of the European Parliament 
or the Council. 
Article 140 
Urgency procedure 
1. Delegated acts adopted under this Article shall enter into force without delay and 
shall apply as long as no objection is expr essed in accordance with paragraph 2. The 
notification of a delegated ac t to the European Parliame nt and to the Council shall 
state the reasons for the use of the urgency procedure. 
2. Either the European Parliament or the Council may object to a delegated act in 
accordance with the procedure referred to in Article 139(5). In such a case, the 
Commission shall repeal th e act without delay followi ng the notification of the 
decision to object by the European  Parliament or by the Council. 
Article 141  
Committee 
1. The Commission shall be assisted by the Standing Committee on Plants, Animals, 
Food and Feed established by Article 58 (1) of Regulation (EC) No 178/2002. That 
Committee is a Committee in the mean ing of Regulation (EU) No 182/2011. 
2. Where reference is made to this pa ragraph, Article 5 of Regulation (EU) 
No 182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult when, within the time-limit for delivery 
of the opinion, the chair of the committee so decides or a simple majority of 
committee members so request. 
3. Where reference is made to this pa ragraph, Article 8 of Regulation (EU) 
No 182/2011, in conjunction with Ar ticle 5 thereof, shall apply. 
Chapter II 
Transitional and final provisions 
Article 142  
Repeals 
1. Regulation (EC) No 882/2004, Directives 89/608/EEC and 96/93/EC and Decision 
92/438/EEC are repealed as from [ Office of Publications, plea se insert date of entry 
into force of this Regulation + 1 year] . 
However, Articles 14 to 17 and 26 to 29 of Regulation (E C) No 882/2004 shall 
continue to apply until [Office of Publications, please insert date of entry into force 
of this Regulation + 3 years] . EN 126   EN 2. Regulation (EC) No 854/2004 and Directives 89/662/EEC, 90/425/EEC, 
91/496/EEC, 96/23/EC and 97/78/EC are repealed as from [Office of Publications, 
please insert date of entry into force of this Regulation + 3 years] . 
3. References to the repealed acts shall be construed as references to this Regulation 
and shall be read in accordance with the correlation table in Annex IV. 
Article 143 
Transitional measures related to the repe als of Directives 91/496/EEC and 97/78/EC 
1. The relevant provisions of Directiv es 91/496/EEC and 97/78/EC which govern 
matters referred to in Articles 45(2), 46, point s (b), (c) and (d) of Article 49, 51(1)(a), 
52(1) and (2), 56(1)(a) of this Regulation shall continue to apply until the date to be determined in the delegated act adopted in accordance with paragraph 2. 
2. The Commission shall be empowered to adopt delegated acts in accordance to 
Article 139 concerning the date on which th e provisions referred to in paragraph 1 
shall no longer apply. That date shall be the date of the application of the 
corresponding rules to be established pursu ant to the delegated or implementing acts 
provided for in Articles 45(2), 46, points (b),  (c) and (d) of Artic le 49, 51(1)(a), 52(1) 
and (2), 56(1)(a) of this Regulation. 
Article 144 
Transitional measures related to th e repeal of Directive 96/23/EC 
1. Competent authorities shall continue to pe rform the official co ntrols necessary to 
detect the presence of the substances a nd groups of residues listed in Annex I to 
Directive 96/23/EC, in accordance to Anne x II, III and IV to th is Directive until the 
date to be determined in the delegated act adopted in accordance with paragraph 3. 
2. Article 29(1) and (2) of Directive 96/23/EC shall continue to apply until the date to 
be determined in the delegated act a dopted in accordance with paragraph 3. 
3. The Commission shall be empowered to adopt delegated acts in accordance to 
Article 139 concerning the date on which the competent authorities shall cease to 
perform official controls in accordance with the provisions referred to in paragraph 1, 
and on which Article 29(1) and (2) of Direc tive 96/23/EC shall no  longer apply. That 
date shall be the date of the application of the corresponding rule s to be established 
pursuant to the delegated or implementing ac ts provided for in Article 16 and 111 of 
this Regulation. 
Article 145 
Amendments to Directive 98/58/EC 
Directive 98/58/EC is amended as follows: 
(a) Article 2 is amended as follows: 
(i) point 3 is deleted; (ii) the following second subparagraph is added: 
'The definition of 'competent authorities' laid down in point (5) of Article 2 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ] shall also apply.'; EN 127   EN (b) Article 6 is amended as follows: 
(i) paragraph 1 is deleted;  
(ii) paragraph 2 is replaced by the following: 
'2. Member States shall submit to the Commission by 30 June each year an 
annual report for the previous year on  the inspections car ried out by the 
competent authority to check complia nce with the requirements of this 
Directive. The report shall be accomp anied by an analysis of the most 
serious findings of non–compliances and a national action plan to prevent 
or decrease their occurrence for the forthcoming years. The Commission 
shall submit summaries of those reports to the Member States.'; 
(c) point (a) of paragraph 3 is deleted;  
(d) Article 7 is deleted. 
Article 146  
Amendments to Directive 1999/74/EC 
Directive 1999/74/EC is amended as follows: 
(a) Article 8 is amended as follows: 
(i) paragraph 1 is deleted;  (ii) paragraph 2 is replaced by the following: 
'Member States shall submit to the Commission by 30 June each year an annual 
report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis  of the most serious findings of non–
compliances and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commi ssion shall submit summaries of these 
reports to the Member States.'; 
(iii) point (a) of para graph 3 is deleted; 
(b) Article 9 is deleted. 
Article 147 
Amendments to Council Regulation (EC) No 999/2001 
Regulation (EC) No 999/2001 is amended as follows: 
(a) Articles 19 and 21 are deleted; 
(b) In Annex X, Chapters A and B are deleted. 
Article 148 
Amendments to Regulation (EC) No 1829/2003 
Regulation (EC) No 1829/2003 is amended as follows: 
(a) Article 32 is amended as follows: 
(i) the first and second s ubparagraphs are deleted EN 128   EN (ii) the third subparagraph is replaced by the following: 
'Applicants for authorisation of gene tically modified food and feed shall 
contribute to supporting the co sts of the tasks of the European Union reference 
laboratory and the national reference laboratories designated in accordance 
with Articles 91(1) and 98(1) of  Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert  number of this Regulation ] for that area.' 
(iii) in the fifth subparagraph the words 'and the annex' shall be deleted. (iv) in the sixth subparagraph the words ' and adapting the Annex' shall be deleted. 
(b) the Annex is deleted. 
Article 149 
Amendments to Regulation (EC) No 1831/2003 
Regulation (EC) No 1831/2003 is amended as follows: 
(a) in Article 7, paragraph 3(f) is replaced by the following 
'a written statement that three samples of the feed additive have been sent by the 
applicant directly to the European Union re ference laboratory referred to in Article 
21.' 
(b) Article 21 is amended as follows: 
(i) the first, third and forth paragraphs are deleted; 
(ii) paragraph 2 is replaced by the following: 
'Applicants for the authorisation of addi tives shall contribute to supporting the 
cost of the tasks of the European Uni on reference laboratory and the national 
reference laboratories designated in accord ance with Articles 91(1) and 98(1) 
of Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ] for that area.' 
(c) Annex II is deleted. 
Article 150  
Amendments to Regulation (EC) No 1/2005 
Regulation (EC) No 1/2005  is amended as follows: 
(a) Article 2 is amended as follows: 
(i) points (d), (f), (i) and (p) are deleted; (ii) the following second subparagraph is added: 
'The definitions of 'competent author ities', 'border control post', 'official 
veterinarian' and 'exit point' laid down in points (5), (29), (32), and (36) of 
Article 2 of Regulati on (EU) No XXX/XXXX [ Office of Publications, please 
insert number of this Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; 
(b) Articles 14, 15, 16, 21, 22(2), 23, 24 and 26 are deleted; EN 129   EN (c) Article 27 is amended as follows: 
(i) paragraph 1 is deleted; (ii) paragraph 2 is replaced by the following: 
'2. Member States shall submit to the Commission by 30 June each year an 
annual report for the previous year  on the inspections  carried by the 
competent authority to verify complia nce with the requi rements of this 
Regulation. The report shall be accompan ied by an analysis of the major 
deficiencies detected and an action plan to address them.'; 
(d) Article 28 is deleted. 
Article 151  
Amendments to Regulation (EC) No 396/2005 and related transitional measures 
1. Regulation (EC) No 396/2005 is amended as follows: 
(a) Articles 26, 27, 28(1) and (2 ) and 30 are deleted; 
(b) the introductory phrase of Article 31 (1) is replaced by the following: 
'1. Member States shall submit the following information concerning the 
previous calendar year to the Comm ission, the Authority and the other 
Member States by 30 June each year:'; 
2. Articles 26, 27(1) and 30 of Regulation (EC) No 396/2005 shall continue to apply 
until the date to be determined in the delegated act adopted in accordance with 
paragraph 3. 
3. The Commission shall be empowered to adopt delegated acts in accordance to 
Article 139 concerning the date on which Articles 26, 27(1) and 30 referred to in 
paragraph 2 shall no longer apply. That date sh all be the date of the application of the 
corresponding rules to be established pursuan t to the delegated acts provided for in 
Article 16 of this Regulation. 
Article 152 
Amendments to Directive 2007/43/EC 
Directive 2007/43/EC is amended as follows: 
(a) Article 2 is amended as follows: 
(i) in paragraph 1, points (c) and (d) are deleted;  
(ii) the following paragraph 3 is added: 
'3. The definitions of 'competent authorit ies' and of 'official veterinarian' laid 
down in points (5) and (32) of  Article 2 of Regulation (EU) 
No XXX/XXXX [ Office of Publications, please  insert number of this 
Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; EN 130   EN (b) Article 7 is amended as follows: 
(i) paragraph 1 is deleted; (ii) paragraph 2 is replaced by the following: 
'Member States shall submit to the Commission by 30 June each year an annual 
report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis  of the most serious findings of non–
compliances and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commi ssion shall submit summaries of those 
reports to the Member States.'. 
Article 153 
Amendments to Regulation (EC) No 834/2007 and related transitional measures 
1. Regulation (EC) No 834/2007 is amended as follows: 
(a) Article 2 is amended as follows: 
(i) point (n) is replaced by the following: 
'(n) 'competent authorities' means competent authorities as defined in 
point (5) of Article  2 of Regulation (E U) No XXX/XXXX [ Office 
of Publications, please inse rt number of this Regulation ]*. 
_________________ 
* OJ L …, …, p. …'; 
(ii) point (o) is deleted; (iii) point (p) is replaced by the following: 
'(p) 'control body' means a delegated body as defined in point (38) of 
Article 2 of Regulati on (EU) No XXX/XXXX [ Office of 
Publications, please insert  number of this Regulation ]’; 
(b) in point (a) of Article 24(1), 'Article 27(10)' is replaced by 'Articles 3(3) and 
25(4) of Regulation (EU) No XXX/XXXX [ Office of Publications, please 
insert number of this Regulation ]'; 
(c) Article 27 is amended as follows: 
(i) paragraph 1 is replaced by the following: 
'Official controls to verify compliance with this Regulation shall be 
performed in accordance with Regulation (EC) No 882/2004'; 
(ii) paragraphs 2 to 14 are deleted; 
(d) in Article 29(1), 'Article 27(4)' is re placed by 'Articles 3(3) and 25(4) of 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ]'; 
(e) in Article 30, paragraph 2 is deleted.  
2. Articles 27 and 30(2) of Regulation (EC)  No 834/2007 shall continue to apply until 
the date to be determined in the delegated act to be adopted in accordance with paragraph 3. EN 131   EN 3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 139 concerning the date on which th e provisions referred to in paragraph 2 
shall no longer apply . That date shall be the date of the application of the 
corresponding rules to be established pursuan t to the delegated acts provided for in 
Article 23(2) of this Regulation. 
Article 154  
Amendments to Directive 2008/119/EC 
Directive 2008/119/EC is amended as follows: 
(a) Article 2 is amended as follows: 
(i) point 2 is deleted;  
(ii) the following second subparagraph is added: 
'The definition of 'competent authorities' laid down in point (5) of Article 2 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; 
(b) Article 7 is amended as follows: 
(i) paragraphs 1 and 2 are deleted; 
(ii) paragraph 3 is replaced by the following: 
'3. Member States shall submit to the Commission by 30 June each year an 
annual report for the previous year on  the inspections carried out by the 
competent authority to check complia nce with the requirements of this 
Directive. The report shall be accomp anied by an analysis of the most 
serious findings of non–compliances and a national action plan to prevent 
or decrease their occurrence for the forthcoming years. The Commission 
shall submit summaries of those reports to the Member States.'; 
(c) Article 9 is deleted. 
Article 155  
Amendments to Directive 2008/120/EC 
Directive 2008/120/EC is amended as follows: 
(a) Article 2 is amended as follows: 
(i) point 10 is deleted;  
(ii) the following second subparagraph is added: 
'The definition of 'competent authorities' laid down in point (5) of Article 2 of 
Regulation (EU) No XXX/XXXX [ Office of Publications, please insert 
number of this Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; EN 132   EN (b) Article 8 is amended as follows: 
(i) paragraphs 1 and 2 are deleted; (ii) paragraph 3 is replaced by the following: 
'Member States shall submit to the Commission by 30 June each year an annual 
report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis  of the most serious findings of non–
compliances and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commi ssion shall submit summaries of those 
reports to the Member States.'; 
(c) Article 10 is deleted. 
Article 156  
Amendments to Regulation (EC) No 1099/2009 
Regulation (EC) No 1099/2009 is amended as follows: 
(a) Article 2 is amended as follows: 
(i) point (q) is deleted; (ii) the following second subparagraph is added: 
'In addition to the definitions referred to  in the first subparagraph, the definition 
of 'competent authorities' laid down in point (5) of Ar ticle 2 of Regulation (EU) 
No XXX/XXXX [ Office of Publications, plea se insert number of this 
Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; 
(b) Article 22 is deleted. 
Article 157 
Amendments to Regulation (EC) No 1069/2009 
Regulation (EC) No 1069/2009 is amended as follows: 
(a) Article 3 is amended as follows: 
(i) points 10 and 15 are deleted ; 
(ii) the following second subparagraph is added: 
'The definition of 'compete nt authorities' and 'transit' laid down in points (5) 
and (50) of Article 2 of Regulation (EU) No XXX/XXXX [ Office of 
Publications, please insert  number of this Regulation ]* shall also apply. 
_________________ * OJ L …, …, p. …'; 
(b) Articles 45, 49 and 50 are deleted. EN 133   EN Article 158 
Amendments to Regulation (EC) No 1107/2009 
Article 68 of Regulation (EC) No 1107/2009 is amended as follows: 
(a) the first paragraph is replaced by the following: 
'Member States shall finalise and submit to the Commission by 30 June each year a 
report on the scope and the results of the of ficial controls performed in order to 
verify compliance with this Regulation.'; 
(b) the second and third paragraphs are deleted. 
Article 159  
Amendments to Directive 2009/128/EC and related transitional measures 
1. Directive 2009/128/EC is amended as follows: 
(a) in Article 8, paragraph 1, the sec ond subparagraph of paragraph 2 and 
paragraphs 3, 4, 6 and 7 are deleted; 
(b) Annex II is deleted. 
2. Paragraph 1, the second subparagraph of paragraph 2 and paragraphs 3, 4 and 6 of 
Article 8 and Annex II of Directive 2009/128/ EC shall continue to apply until the 
date to be determined in the delegated act to be adopted in accordance with paragraph 3. 
3. The Commission shall be empowered to adopt delegated acts in accordance to 
Article 139 concerning the date on which th e provisions referred to in paragraph 2 
shall no longer apply. That date shall be the date of the application of the 
corresponding rules to be established pursuan t to the delegated acts provided for in 
Article 22 of this Regulation. 
Article 160 
Amendments to Regulation (EU) No 1151/2012 
Regulation (EU) No 1151/2012 is amended as follows: 
(a) Article 36 is amended as follows: 
(i) the heading is replaced by the follo wing: 'Content of official controls'; 
(ii) paragraphs 1 and 2 are deleted; (iii) in paragraph 3, the introductory  phrase is replaced  by the following: 
'3. official controls performed in accordance with Regulation (EU) No 
XXX/XXXX [ Office of Publications, please  insert number of this 
Regulation ]* shall cover: 
_________________ * OJ L …, …, p. …';  
(b) Article 37 is amended as follows: 
(i) in paragraph 1, the first subpara graph is replaced by the following:  EN 134   EN '1. In respect of protected designati ons of origin, prot ected geographical 
indications and traditional specialities  guaranteed that designate products 
originating within the Union, verifi cation of compliance with the product 
specification, before placing the pro duct on the market, shall be carried 
out by: 
(a) the competent authorities designated in accordance with Article 3 
of Regulation (EU) No XXX/XXXX  [Office of Publications, 
please insert number of this Regulation ]; or, 
(b) delegated bodies within the mean ing of point 38 of Article 2 of 
Regulation (EU) No XXX/XXXX  [Office of Publications, please 
insert number of this Regulation ].'; 
(ii) in paragraph 3, the firs t subparagraph is deleted; 
(iii) in paragraph 4, the words 'paragraphs  1 and 2' are repl aced by the words: 
'paragraph 2'; 
(c) Articles 38 and 39 are deleted. 
Article 161 
Amendments to Regulation (EU) No [….]/2013  
Regulation (EU) No [.…]/2013 [ Office of Publications, plea se insert number of the 
Regulation laying down provisions for the manage ment of expenditure relating to the food 
chain, animal health and animal welfare, and rela ting to plant health and plant reproductive 
material ] is amended as follows: 
(a) Article 29 is amended as follows: 
(i) the heading is replaced by the following: 
'European Union reference la boratories and centres'; 
(ii) paragraph 1 is replaced by the following:  
'1. To cover the costs they incur to implement the work programmes 
approved by the Commission, grants may be awarded to: 
(a) the European Union reference laborato ries referred to in Article 91 
of Regulation (EU) No XXX/XXXX [ Office of Publications, 
please insert number of this Regulation ]*; 
(b) the European Union reference centres for plant reproductive 
material referred to in Artic le 93 of that Regulation; 
(c) the European Union reference centres for animal welfare referred 
to in Article 95 of that Regulation. 
_________________ * OJ L …, …, p. …'; 
(iii) in paragraph 2, point (a) is replaced by the following: 
'(a) costs of personnel, regardless its st atus, directly involved in activities of 
the laboratories or centres which ar e carried out in their capacity of 
Union reference labora tory or centre;'; EN 135   EN (b) the following Article 29a is added: 
'Article 29a 
Accreditation of national referen ce laboratories for plant health 
1. Grants may be awarded to the national reference laboratories referred to in 
Article 98 of Regulatio n (EU) No XXX/XXXX [ Office of Publications, please 
insert number of this Regulation ] for costs incurred for obtaining accreditation 
according to the standard EN ISO/IEC 17025 for the use of methods of laboratory analysis, test a nd diagnosis to verify co mpliance with the rules on 
protective measures against pests of plants. 
2. Grants may be awarded to a single  national reference laboratory in each 
Member State for each European Union re ference laboratory for plant health, 
up to three years after the designati on of that European Union reference 
laboratory.'. 
Article 162  
Entry into force and application 
1. This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of  the European Union . 
Unless otherwise provided for in para graphs 2 to 5, it shall apply from [Office of 
Publications, please insert date of entry into force of this Regulation + 1 year].  
2. In the area covered by the rules referred  to in point (g) of Article 1(2), this 
Regulation, shall apply from [ Office of Publications, please  insert date of application 
of the Regulation on protective measures against pests of plants ], with the following 
exceptions: 
(a) Articles 91 and 92 and 97, 98 and 99 shall apply in accordance with paragraph 
1; 
(b) Article 33(1), (2), (3) and (4), point (e) of Article 36(4) and Article 36(5) shall 
apply from [Office of Publications, please insert date of entry into force of this 
Regulation + 5 years].  
3. In the area covered by the rules referred  to in point (h) of Article 1(2), this 
Regulation, shall apply from [Office of Publi cations, please insert date of application 
of the Regulation on the pr oduction and making available on the market of plant 
reproductive material], with  the following exceptions: 
(a) Articles 93, 94 and 97 shall apply in  accordance with paragraph 1; 
(b) Article 33(1), (2) (3) an d (4) shall apply from [Office of Publications, please 
insert date of entry into force of this Regulation + 5 years].  
4. Articles 15(1), 18(1), 45 to 62 and 76 to 84, point (b) of Article 150, point (b)(i) of 
Article 152, point (b)( i) of Article 154, point  (b)(i) of Article 155 and point (b) of 
Article 156 shall apply from [Office of Publications, please insert date of entry into 
force this Regulation + 3 years] . 
5. Article 161 shall apply from [O ffice of Publications, please insert date of entry into 
force of this Regulation
]. EN 136   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President EN 137   EN ANNEX I  
TERRITORIES REFERRED TO IN POINT 45 OF ARTICLE 2  
1. The territory of th e Kingdom of Belgium 
2. The territory of the Republic of Bulgaria 
3. The territory of the Czech Republic 4. The territory of the Kingdom of Denmark w ith the exception of the Faroe Islands and 
Greenland 
5. The territory of the Fe deral Republic of Germany 
6. The territory of the Republic of Estonia 7. The territory of Ireland 8. The territory of the Hellenic Republic 
9. The territory of the Kingdom of Spain with the exception of Ceuta and Melilla 
10. The territory of the French Republic 11. The territory of the Italian Republic 
12. The territory of th e Republic of Cyprus 
13. The territory of the Republic of Latvia 14. The territory of the Republic of Lithuania 15. The territory of the Gr and Duchy of Luxembourg 
16. The territory of Hungary 
17. The territory of the Republic of Malta 18. The territory of the Kingdom of  the Netherlands in Europe 
19. The territory of the Republic of Austria 20. The territory of the Republic of Poland 21. The territory of the Portuguese Republic 22. The territory of Romania 23. The territory of th e Republic of Slovenia 
24. The territory of the Slovak Republic 25. The territory of th e Republic of Finland 
26. The territory of the Kingdom of Sweden 27. The territory of the Un ited Kingdom of Great Britai n and Northern Ireland 
For the purpose of the official controls perfor med by the competent authorities to verify the 
compliance with the rules referred to in point (g ) of Article 1(2) and ot her official activities 
carried out in relation to point (g) of Article 1(2) , references to third countries shall be read as 
references to third countries and to the terr itories listed in Annex I of Regulation (EU) 
No XXX/XXXX [ Office of Publications, please insert  number of the Regulation on protective 
measures against pests of plants ], and references to the Union territory shall be read as 
references to the Union territory without  the territories listed in that Annex. EN 138   EN ANNEX II  
TRAINING OF STAFF OF THE COMPETENT AUTHORITIES  
CHAPTER I: SUBJECT MATTER FOR THE TRAINING OF STAFF PERFORMING OFFICIAL 
CONTROLS AND OTHER OFFICIAL ACTIVITIES  
1. Different control methods and techniques, such as, inspection, verification, 
screening, targeted screening, sampling, and laboratory analysis, diagnosis and 
testing 
2. Control procedures 3. The rules referred to in Article 1(2) 4. Assessment of non-compliance with the rules referred to in Article 1(2) 
5. The hazards in the production, processi ng and distribution of animals and goods 
6. The different stages of production, proces sing and distribution, and the possible risks 
to human health, and where appropriate to the health of animals and plants, to the 
welfare of animals, to the environment, and to the identity and quality of plant 
reproductive material. 
7. The evaluation of the app lication of HACCP procedur es and of good agricultural 
practices  
8. Management systems such as quality assurance programmes that the operators 
manage and their assessment in so far as these are relevant for the requirements set 
out in the rules referre d to in Article 1(2) 
9. Official certification systems 10. Contingency arrangements for emerge ncies, including communication between 
Member States and the Commission 
11. Legal proceedings and implicat ions of official controls 
12. Examination of written, documentary material and other records, including those 
related to inter-laboratory comparative te sting, accreditation and risk assessment, 
which may be relevant to the assessment of  compliance with the rules referred to in 
Article 1(2); this may include fi nancial and commercial aspects  
13. Control procedures and requirements for entry into the Union of animals and goods 
arriving from third countries. 
14. Any other area necessary to ensure that o fficial controls are performed in accordance 
with this Regulation. 
C
HAPTER II: SUBJECT AREAS FOR CONTROL PROCEDURES  
1. The organisation of the competent author ities and the relations hip between central 
competent authorities and authorities to wh ich they have confe rred tasks to perform 
official controls or ot her official activities 
2. The relationship between competent aut horities and delegated bodies or natural 
persons to which they have delegated task s related to official  controls or other 
official activities 
3. A statement on the objectives to be achieved 4. Tasks, responsibilities and duties of staff EN 139   EN 5. Sampling procedures, control methods and techniques, including laboratory analysis, 
test and diagnosis, interp retation of results and consequent decisions  
6. Screening and targeted  screening programmes 
7. Mutual assistance in the event that offici al controls require more than one Member 
State to take action 
8. Action to be taken following official controls 9. Cooperation with other services and departments that may have relevant 
responsibilities or with operators 
10. Verification of the appropriateness of  methods of sampling and of laboratory 
analysis, test and diagnosis 
11. Any other activity or information required fo r the effective functioning of the official 
controls. EN 140   EN ANNEX III  
CHARACTERISATION OF METHODS OF ANALYSIS  
1. Methods of analysis and measurement results should be characterised by the 
following criteria: 
(a) accuracy (trueness and precision); 
(b) applicability (matrix and concentration range); 
(c) limit of detection; 
(d) limit of quantification; 
(e) precision; 
(f) repeatability; 
(g) reproducibility; 
(h) recovery; 
(i) selectivity; 
(j) sensitivity; 
(k) linearity; 
(l) measurement uncertainty; 
(m) other criteria that may be selected as required. 
2. The precision values referred to in 1(e) sh all either be obtained from a collaborative 
trial which has been conducted in accordance with an internationally recognised 
protocol on collaborative trials (e.g. IS O 5725 'Accuracy (trueness and precision) of 
measurement methods and results') or, wh ere performance criteria for analytical 
methods have been established, be based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95 % confiden ce intervals as defined by ISO 5725 
'Accuracy (trueness and precision) of measur ement methods and results'). The results 
from the collaborative trial shall be published or freely available. 
3. Methods of analysis which are appli cable uniformly to various groups of 
commodities should be given preference over methods which apply only to 
individual commodities. 
4. In situations where methods of analys is can only be validated within a single 
laboratory, then they should be validated in accordance with in ternationally accepted 
scientific protocols or gui delines, or where performa nce criteria for analytical 
methods have been established, be based on criteria compliance tests. 
5. Methods of analysis adopted under this Re gulation should be edit ed in the standard 
layout for methods of analysis recommended by the ISO. EN 141   EN ANNEX IV  
CORRELATION TABLE REFERR ED TO IN ARTICLE 142(3)  
1. Regulation (EC) No 882/2004 
Regulation (EC) No 882/2004 This Regulation 
Article 1(1) first subpa ragraph Article 1(1) 
Article 1(1) second subp aragraph Article 1(2) 
Article 1(2) Article 1(4) 
Article 1(3) - 
Article 1(4) - 
Article 2 Article 2 
Article 3(1) Article 8(1) 
Article 3(2) Article 8(4) 
Article 3(3) Article 9 
Article 3(4) Article 8(6) 
Article 3(5) Article 8(6) 
Article 3(6) Article 8(7) 
Article 3(7) - 
Article 4(1) Article 3(1) 
Article 4(2) Article 4(1)(a), (c), (d), (e), (f), (g) and (i) 
Article 4(3) Article 3(2) 
Article 4(4) Article 4(1)(b) 
Article 4(5) Article 4(4) 
Article 4(6) Article 5(1) 
Article 4(7) Article 5(3) 
Article 5(1) first subpa ragraph Article 25(1) 
Article 5(1) second subp aragraph Article 25(3) 
Article 5(1) third subparagraph Article 25(2) first subparagraph 
Article 5(2)(a), (b), (c) and (f) Article 26(1) 
Article 5(2)(d) - 
Article 5(2)(e) Article 28 
Article 5(3) Article 29 
Article 5(4) - 
Article 6 Article 4(2) and (3) 
Article 7(1), first subparagraph Article 10(1), first subparagraph 
Article 7(1), second subparagraph, point (a) Article 10(1), second subparagraph  
Article 7(1), second subparagraph, point (b) - 
Article 7(2), first sentence Article 7(1) 
Article 7(2), second sentence - EN 142   EN Article 7(2), third sentence - 
Article 7(3) Article 7(2), and (3) 
Article 8(1) Article 11(1)  
Article 8(2) Article 4(1)(h) 
Article 8(3)(a) Article 11(2) 
Article 8(3)(b) Article 11(3)  
Article 8(4) - 
Article 9(1) Article 12(1) first subparagraph 
Article 9(2) Article 12(1) second subparagraph 
Article 9(3) Article 11(2) 
Article 10 Article 13 
Article 11(1) Article 33(1) and (2) 
Article 11(2) - 
Article 11(3) Article 33(5) 
Article 11(4) Article 33(7) 
Article 11(5) Article 34(1) first subparagraph and (2) 
Article 11(6) Article 34(1)(b)(i) 
Article 11(7) Article 33(6) 
Article 12(1) Article 36(1) 
Article 12(2) Article 36(4)(e) 
Article 12(3) Article 36(5)(c) 
Article 12(4) Article 38(2) 
Article 13 Article 114 
Article 14(1) - 
Article 14(2) Article 43(3) 
Article 14(3) - 
Article 15(1) Article 42(1) first sentence 
Article 15(2) Article 42(2) and (4)  
Article 15(3) Article 42(2) and (4) 
Article 15(4) - 
Article 15(5) Article 45(1)(d ), 45(2)(b) and 52(3), first 
sentence 
Article 16(1) Article 43(1) 
Article 16(2) Article 42(1) second sentence 
Article 16(3) first sentence Article 43(2) 
Article 16(3) second sentence Article 33(6) 
Article 17(1) first i ndent Article 57(1) 
Article 17(1) second indent Article 54(1),(2)(a), (3) and Article 56(1) EN 143   EN Article 17(2) - 
Article 18 Article 63(1), (2) and (3) 
Article 19(1) Article 64(1) and (3) 
Article 19(2)a Article 65 
Article 19(2)b Article 64(5) 
Article 19(3) Article 64(4) 
Article 19(4) Article 6 
Article 20 Article 69 
Article 21(1) Article 70(1) 
Article 21(2) Article 67 
Article 21(3) Article 64(1) 
Article 21(4) Article 64(4) 
Article 22 Article 84(d)  
Article 23(1) Article 71(1) 
Article 23(2) Article 71(2) and 72 
Article 23(3) Article 71(3) 
Article 23(4) Article 71(2) 
Article 23(5) Article 71(4)(a) 
Article 23(6) Article 71(2)(c) and (4)(b) 
Article 23(7) Article 72 
Article 23(8) Article 72 
Article 24(1) Article 73(1) 
Article 24(2) Article 55 
Article 24(3) Article 44 
Article 24(4) Article 74 
Article 25(1) - 
Article 25(2)(a) - 
Article 25(2)(b) Article 75(1)(c) 
Article 25(2)(c) Article 75(1)(f) 
Article 25(2)(d) Article 46(c) and (d), and 75(1)(e) and (k) 
Article 25(2)(e) - 
Article 25(2)(f) Article 68 
Article 25(2)(g) Article 75(1)(h) 
Article 25(2)(h) Article 44(2)(b) 
Article 26 Article 76(1) 
Article 27(1) Article 76(2) 
Article 27(2) Article 77 
Article 27(3) - EN 144   EN Article 27(4) Article 79(1) 
Article 27(5) - 
Article 27(6) - 
Article 27(7) - 
Article 27(8) Article 81(2) 
Article 27(9) Article 82(1) 
Article 27(10) - 
Article 27(11) Article 81(1) 
Article 27(12) first sentence Article 83 
Article 27(12) second sentence - 
Article 28 Article 84 
Article 29 - 
Article 30(1) point (a) Article 86 
Article 30(1) point (b) Article 89point (a) 
Article 30(1), point (c) Article 87(2) 
Article 30(1) point (d) Artic le 89 points (b) and (f) 
Article 30(1) point (e) Article 89 point (c) 
Article 30(1) point (f ) Article 89 point (d) 
Article 30(1) point (g) Article 89 point (e) 
Article 30(2)(a) Article 88(1)(e) 
Article 30(2)(b) Article 88(1)(c) 
Article 30(3) - 
Article 31 - 
Article 32(1)(a) Article 92(2)(a) 
Article 32(1)(b) Article 92(2)(b) 
Article 32(1)(c) Article 92(2)(c) 
Article 32(1)(d) Article 92(2)(d) 
Article 32(1)(e) Article 92(2)(e) 
Article 32(1)(f) Article 92(2)(g) 
Article 32(2)(a) Article 92(2)(a), (b) and (c) 
Article 32(2)(b) Article 92(2)(h) 
Article 32(2)(c) Article 92(2)(d) 
Article 32(2)(d) Article 92(2)(g) 
Article 32(2)(e) Article 92(2)(d) 
Article 32(3) Article 91(3)(a) 
Article 32(4)(a) Article 91(3)(c) 
Article 32(4)(b) Article 91(3)(d) 
Article 32(4)(c) Article 91(3)(d) EN 145   EN Article 32(4)(d) Article 7 
Article 32(4)(e) Article 91(3)(e) 
Article 32(4)(f) Article 92(2)(j)(iii) 
Article 32(4)(g) Article 91(3)(e) 
Article 32(4)(h) Article 91(3)(f) 
Article 32(5) Article 97(1) 
Article 32(6) Article 97(2) 
Article 32(7) - 
Article 32(8) first sentence Article 97(3) 
Article 32(8) second sentence Article 97(4) 
Article 32(9) - 
Article 33(1) Article 98(1) 
Article 33(2) Article 99(1) 
Article 33(3) Article 98(2) 
Article 33(4) Article 98(4) 
Article 33(5) Article 98(5) 
Article 33(6) Article 99(2) 
Article 33(7) - 
Article 34(1) Article 100(1) 
Article 34(2) Article 100(1) and (2) 
Article 34(3) Article 100(3) 
Article 35(1) Article 101(1) 
Article 35(2) Article 101(4) 
Article 35(3) Article 101(2) 
Article 35(4) - 
Article 36(1) Article 102(1)(c) 
Article 36(2) first sentence - 
Article 36(2) second sentence Article 102(2) 
Article 36(3) first subparagra ph Article 102(3) first sentence 
Article 36(3) second subparagraph - 
Article 36(3) third subparagraph, first 
sentence Article 102(3)(c) 
Article 36(3) third subparagraph, second 
sentence Article 102(3)(b) 
Article 36(4) Article 102(3)(a) 
Article 37(1) Article 103(1) 
Article 37(2) Article 103(2) 
Article 38(1) Article 104(1) 
Article 38(2) Article 104(2)(c) EN 146   EN Article 38(3) Article 104(3) 
Article 39(1) Article 105(1) 
Article 39(2) Article 105(2) 
Article 40(1) Article 106(1) 
Article 40(2) - 
Article 40(3) Article 106(2) 
Article 40(4) - 
Article 41 Article 107(1) 
Article 42(1)(a) - 
Article 42(1)(b) Article 109(2) 
Article 42(1)(c) Article 109(3) 
Article 42(2) Article 108(2) 
Article 42(3) Article 109(2) 
Article 43(1) first sentence Article 110, first subparagraph 
Article 43(1) second sentence Article 110, second subparagraph 
Article 43(1)(a) - 
Article 43(1)(b) Artic le 110(a) and (b) 
Article 43(1)(c) Artic le 110(b) and (c) 
Article 43(1)(d) to (j) - 
Article 43(1)(k) Article 110(d) 
Article 43(2) - 
Article 44(1) Article 112(1) 
Article 44(2) - 
Article 44(3) Article 112(1) 
Article 44(4), first subparagraph, first 
sentence Article 113(1) 
Article 44(4) first subparagraph, second 
sentence Article 113(2) 
Article 44(5) - 
Article 44(6) Article 113(1) 
Article 45(1)  Article 115(1)(2) and (4) 
Article 45(2) - 
Article 45(3) Article 116 
Article 45(4) Article 117 
Article 45(5) Article 118 
Article 45(6) - 
Article 46(1) first sentence Article 119(1) 
Article 46(1) second sentence Article 119(4) EN 147   EN Article 46(1) third sentence Article 119(2) 
Article 46(2) Article 119(3) 
Article 46(3) Article 120 
Article 46(4) - 
Article 46(5) - 
Article 46(6) Article 121 
Article 46(7) Article 122 
Article 47(1) Article 124(1)(a) to (e) 
Article 47(2) Article 124(2) 
Article 47(3) Article 124(1)(f) and (g) 
Article 47(4) - 
Article 47(5) - 
Article 48(1) Article 125(1) 
Article 48(2) Article 125(2) 
Article 48(3) Article 126(1) and (2) 
Article 48(4) Article 126(3) 
Article 48(5) first se ntence Article 126(3)(f) 
Article 48(5) second and third sentence - 
Article 49 Article 128 
Article 50 - 
Article 51(1) Article 129(1) and (2) 
Article 51(2) Article 129(3) 
Article 51(3) - 
Article 52 Article 123 
Article 53 Article 111 
Article 54(1) Article 135(1) 
Article 54(2) Article 135(2) 
Article 54(3) Article 135(3) 
Article 54(4) Article 103(1) 
Article 54(5) Article 84(1) (a ) and(c) and Article 135(4) 
Article 55(1) Article 136(1) 
Article 55(2) Article 136(1) 
Article 56(1) Article 137(1) 
Article 56(2)(a) - 
Article 56(2)(b) Article 137(2) 
Articles 57 to 61 - 
Article 62 Article 141 
Article 63(1) - EN 148   EN Article 63(2) Article 23 
Article 64 first subparagraph Article 138(1) 
Article 64 point (1) Article 138(1) 
Article 64 point (2) Article 138(2) 
Article 65 - 
Article 66 - 
Article 67  
Annex I Annex I 
Annex II Annex II 
Annex III Annex III 
Annex IV - 
Annex V - 
Annex VI Article 78 and 79(2) 
Annex VII - 
Annex VIII - 
2. Directive 96/23/EC 
Directive 96/23/EC This Regulation 
Article 1 - 
Article 2(a) Article 16 
Article 2(b) - 
Article 2(c) Article 16 
Article 2(d) Article 2(5) 
Article 2(e) Article 16 
Article 2(f) Article 36(1) 
Article 2(g) - 
Article 2(h) Article 16 
Article 2(i) - 
Article 3 Articles 8(1) a nd (2), 16, 107(1) and 111 
Article 4(1) Article 3(1) 
Article 4(2) Articles 3(2)(a), 107(2) and 112 
Article 4(3) - 
Article 5 
 Articles 109(2) and (3), 112(1)(a) and 
108(2) 
Article 6 Articles 16(a) and (b) 
Article 7 Article 108(2) 
Article 8(1) - 
Article 8(2) - EN 149   EN Article 8(3), (4) and (5) Articles 10, 112 and 113 
Article 9(A) - 
Article 9(B) - 
Article 10 Article 14 
Article 11(1) and (2) Articles 8(2) and 9 
Article 11(3) Articles 16(c), 134 and 135 
Article 12 first para graph Article 8(4) 
Article 12 second paragraph Article 14 
Article 13 Articles 16(c), 134 and 135 
Article 14(1) Articles 98 and 99 
Article 14(2) Article 91 
Article 15(1) first subparagraph Article 16(a) and (b) 
Article 15(1) second subparagraph Article 33(7) 
Article 15(1) third subparagraph - 
Article 15(2) first subparagraph Article 33(7) 
Article 15(2) second subparagraph Article 34(3) 
Article 15(3) first, second and third 
subparagraphs Articles 16(c) and 135 
Article 15(3) forth subparagraph Title II Chapter V Section III 
Article 16(1) Articles 103(1), 106(1) and 135 
Article 16(2) and (3) Articles 16(c) and 135 
Article 17 Articles 16(c) and 135 
Article 18  Articles 16(c) and 135 
Article 19 Article 135(4) 
Article 20(1) Title IV 
Article 20(2) first subparag raph Article 104(1) and (2) 
Article 20(2) second subparagraph Article 104(3) 
Article 20(2) third and forth subparagraphs Article 106(1)(d) 
Article 20(2) fifth and sixth subparagraphs Article 106(2) 
Article 21 Articles 115, 116 and 118 
Article 22 Article 134 
Article 23 Articles 16(c) and 135 
Article 24(1) and (2) Article s 15(2)(d), 16(c), 134 and 135 
Article 24(3) Articles 15(2)(d), 16(c) and 135 
Article 25 Articles 16(c) and 135(2) 
Article 26 Article 6 
Article 27 Article 136 
Article 28 Article 136 EN 150   EN Article 29(1) and (2) Articles 124, 125, 126 and 128 
Article 29(3) Title II Chapter V Section II 
Article 29(4) Article 112(1) 
Article 30(1) and (2) Title II Chapter V Section III 
Article 30(3) Article 128(3) 
Article 31 Title II Chapter VI 
Article 33 Article 141 
Article 34 Article 16(a) and (b) 
Article 35 - 
Article 36 - 
Article 37 - 
Article 38 - 
Article 39 - 
Annex I Article 16(a) and (b) 
Annex II Article 16(a) and (b) 
Annex III Article 16(a) and (b) 
Annex IV Article 16(a) and (b) 
3. Directives 89/662/EEC and 90/425/EEC 
Directive 89/662/EEC This Regulation 
Article 1 - 
Article 2(1), (2) and (3) - 
Article 2(4) Article 2(5) 
Article 2(5) Article 2(32) 
Article 3(1) first and second subparagraphs - 
Article 3(1) third subp aragraph Article 8(1) 
Article 3(1) forth subparagraph Artic le 134(2) and (3) and Article 135 
Article 3(2) - 
Article 3(3)  - 
Article 4(1) first sentence  Article 8(1), 9, 134 and 135 
Article 4(1) first indent Article 8(6)(a) 
Article 4(1) second indent - 
Article 4(2) Article 136 
Article 5(1)(a) first subparagraph Article 8 
Article 5(1)(a) second subpara graph Article 134(2) and (3) 
Article 5(1)(b) - 
Article 5(2) - EN 151   EN Article 5(3)(a), (b) and (d) - 
Article 5(3)(c) Article 8(7) 
Article 5(4) and (5) - 
Article 6(1) Article 47 
Article 6(2) - 
Article 7(1) Title IV and Article 135 
Article 7(2) - 
Article 8(1) Title IV 
Article 8(2) Articles 6 and 135(3) 
Article 8(3) Article 135(4) 
Article 9 - 
Article 10 Article 3(1) 
Article 11 Articles 9, 13 and 14 
Article 12 - 
Article 13 - 
Article 14 - 
Article 15 - 
Article 16(1) Article 112(1) 
Article 16(2) - 
Article 16(3) Article 112(2) 
Article 17 Article 141 
Article 18 Article 141 
Article 19 - 
Article 20 - 
Article 22 - 
Article 23 - 
Annex A - 
Annex B - EN 152   EN  
Directive 90/425/EEC This Regulation 
Article 1 - 
Article 2(1) to (5) - 
Article 2(6) Article 2(5) 
Article 2(7) Article 2(32) 
Article 3(1) and (2) - 
Article 3(3) Articles 8, 134(2) and (3) and 135 
Article 3(4) - 
Article 4(1) Article 8 
Article 4(2) - 
Article 4(3) Article 136 
Article 5(1)(a) first subparagraph Article 8 
Article 5(1)(a) second subpara graph Article 134(2) an (3) 
Article 5(1)b(i) first subparagraph - 
Article 5(1)(b)(i) second subparagraph Article 8 
Article 5(1)(b)(ii), (iii) and (iv) - 
Article 5(2)(a) first s ubparagraph Article 8(7) 
Article 5(2)(a) second and third 
subparagraphs - 
Article 5(2)b - 
Article 5(3) - 
Article 6 - 
Article 7(1) Article 47 
Article 7(2) - 
Article 8(1) Title IV and Article 135 
Article 8(2) - 
Article 9(1) Title IV 
Article 9(2) Articles 6 and 135(3) 
Article 9(3) Article 135(4) 
Article 9(4) - 
Article 10 - 
Article 11 Article 3(1) 
Article 12 - 
Article 13 Articles 9, 13 and 14 
Article 14 - 
Article 15 - EN 153   EN Article 16 - 
Article 17 Article 141 
Article 18 Article 141 
Article 19 Article 141 
Article 20 Articles 130, 131, 132 and 133 
Article 21 - 
Article 22(1) Article 112(1) 
Article 22(2) - 
Article 22(3) Article 112(2) 
Article 23 - 
Article 24 - 
Article 26 - 
Article 27 - 
Annex A - 
Annex B - 
Annex C - 
4. Directives 97/78/EC and 91/496/EEC 
Directive 97/78/EC This Regulation 
Article 1 - 
Article 2 Article 2 
Article 2(2)(a) Article 2(17) 
Article 2(2)(b) Article 2(46)  
Article 2(2)(c) Article 2(47) 
Article 2(2)(d) Article 2(48) 
Article 2(2)(e) - 
Article 2(2)(f) Article 2(27) 
Article 2(2)(g) Article 2(29) 
Article 2(2)(h) - 
Article 2(2)(i) - 
Article 2(2)(j) - 
Article 2(2(k) Article 2(5) 
Article 3(1) and (2) Article 45(1) 
Article 3(3) Article 14 a nd 54(1), (2)(a) and (3) 
Article 3(4) Article 55 
Article 3(5) Article 45(2)  and (3) and Article 56 
Article 4(1) Article 47(4) EN 154   EN Article 4(2) -  
Article 4(3) and (4) Article 47( 1), (2) and (3) and Article 50 
Article 4(5) Article 50 
Article 5(1) Article 54(2)(b) and(4) 
Article 5(2) Article 56(2) 
Article 5(3) Article 48(2) and (3) 
Article 5(4) Article 56 
Article 6(1)(a), first paragraph Article 62(1) 
Article 6(1)(a) second paragraph Article 62(2) 
Article 6(1)(b) - 
Article 6(2) Article 57 and 60 
Article 6(3) Article 61 
Article 6(4) Article 58(1) and 61(3) 
Article 6(5) - 
Article 6(6) Article 58(2), 60(3), 61(5), 62(2), 62(4) 
Article 7(1) Article 48(1) 
Article 7(2) Article 47(1), (2) and (3) and Article 50 
Article 7(3) Article 55 
Article 7(4) Article 48(2), 53 and 54(4) 
Article 7(5)  - 
Article 7(6) Article 50 and 56 
Article 8(1) - 
Article 8(2) Article 75(1)(b) 
Article 8(3),(4), (5), (6), (7) Article 75(2) 
Article 9 Article 49(b) and (c) 
Article 10(1), (2), (4) Article 52(2) 
Article 10(3) - 
Article 11 Article 49(d) 
Article 12 Articles 46(h) and 75(1)(k) 
Article 13 Article 75(1)(c) 
Article 14 -  
Article 15 Article 75(1)(h) 
Article 16(1)(a) Article 46(d) 
Article 16(1)(b) Article 46(e) 
Article 16(1)(c) Article 46(c) 
Article 16(1)(d) Article 46(g) 
Article 16(1)(e) Article 46(a) EN 155   EN Article 16(1)(f) Article 46(b) 
Article 16(2) - 
Article 16(3) - 
Article 16(4) Article  75(1)(c) and (f) 
Article 17(1) Article 64(5) 
Article 17(2) Article 64(1), (2) and (3) 
Article 17(2)(a) Article 64( 3)(b), 67 and Article 70 
Article 17(2)(a) first indent - 
Article 17(2)(a) second i ndent Article 66(1)(a) 
Article 17(2)(b) Article 67 
Article 17(3) Article 63(4), (5) and (6) 
Article 17(4) - 
Article 17(5) Articles 64(3), 67, 84(1)(d) 
Article 17(6) - 
Article 17(7) Article 63(6), 68 and 70(3) 
Article 18 Article 62(2) 
Article 19(1) Article 75(1)(g) 
Article 19(2) Article 75(1)(a) 
Article 19(3) Article  62(3)(a) and 62(4) 
Article 20(1) Article 63 
Article 20(2) - 
Article 22(1) - 
Article 22(2) Article 65 
Article 22(3) - 
Article 22(4) - 
Article 22(5) - 
Article 22(6) - 
Article 22(7) - 
Article 24 Article 63(4), (5) and (6) 
Article 24(3) Articles 71 and 128 
Article 25(1) Articles 100-106 
Article 25(2) Article 6 
Article 25(3) - 
Article 26 Article 129(5) and (6) 
Article 27 Article 4(2) a nd (3) and 129(1) and (6) 
Article 28 - 
Article 29 - EN 156   EN Article 30 - 
Article 31 - 
Article 32 - 
Article 33 - 
Article 34 - 
Article 35 - 
Article 36 - 
Annex I Annex I 
Annex II Article 62 
Annex III Article 50 
 
Directive 91/496/EEC This Regulation 
Article 1 - 
Article 2(1) - 
Article 2(2)a Article 2(46) 
Article 2(2)b Article 2(47) 
Article 2(2)c Article 2(48) 
Article 2(2)d - 
Article 2(2)e Article 2(27) 
Article 2(2)f Article 2(29) 
Article 3(1)(a) Articles 54( 1) and (2)(a), 56(1)(b) 
Article 3(1)(b) Article 45(1), 64(2) 
Article 3(1)(c)(i) Articles 54(2)(b), 54(4), and 55 
Article 3(1)(c)(ii) Article 77(1)(d) 
Article 3(1)(d) Article 55 
Article 3(2) - 
Article 4(1) Articles 47(1), 47(2) and 50 
Article 4(2) Articles 47(1), 47(3), 47(4) and 50 
Article 4(3) Article 49c 
Article 4(4) Article 77(1)(d) 
Article 4(5) Article 4(2)  and (3), 49(c) and 50 
Article 5 Articles 53, 54(2 )(b), 54(4), 55, 56(1)(a), 
and 64(1). 
Article 6(1) - 
Article 6(2)(a) Article 62(1) and (2) 
Article 6(2)(b) Article 62(1) 
Article 6(2)(c) Article 57 EN 157   EN Article 6(2)(d) Article 62(3)(a) and (4) 
Article 6(3) Article 58 
Article 6(3)(a) Article 58(1)(b) 
Article 6(3)(b) Article 58(1)(c) 
Article 6(3)(c) Articles 57(2) and 62(3) 
Article 6(3)(d) Article 58(1)(d) 
Article 6(3)(e) Articles 57(2) and 62(3) 
Article 6(3)(f) Articles 57(2) and 62(3) 
Article 6(3)(g) Article 58(1)(e) 
Article 6(4) Article 57 and 58(1) 
Article 6(5) Article 58(2) 
Article 7(1) first indent Article 48(2) 
Article 7(1) second indent Ar ticles 54(2))(b), 54(4) and 56 
Article 7(1) third indent Article 48(1) 
Article 7(2) Article 56 
Article 7(3) - 
Article 8 Article 51(1)(b) 
Article 9 Article 49(d) 
Article 10 Article 64(2) 
Article 11(1) Article 63 
Article 11(2) - 
Article 12 (1) Articles 64, 66 and 67 
Article 12(2) Articles 64(3), 67, 84(1)(d) 
Article 12(3) Articles 68, 69(3) and 70(3) 
Article 12(4) - 
Article 12(5) - 
Article 13 Article 62(2) 
Article 14 - 
Article 15 Article 77(1)(d) 
Article 16 Articles 52 
Article 17 Article 6 
Article 17a - 
Article 18(1) - 
Article 18(2) Article 65 
Article 18(3) - 
Article 18(4) - 
Article 18(5) - EN 158   EN Article 18(6) - 
Article 18(7) - 
Article 18(8) - 
Article 19 Article 115 and 116 
Article 20 Articles 100-106 
Article 21 Article 129 (5) and (6) 
Article 22 - 
Article 23 - 
Article 24 - 
Article 25 - 
Article 26 - 
Article 27 - 
Article 28 -  
Article 29 - 
Article 30 - 
Article 31 - 
Annex A Article 62 
Annex B Article 64(2) 
5. Directive 96/93/EC 
Directive 96/93/EC This Regulation 
Article 1 - 
Article 2(1) Article 2(22) 
Article 2(2) Article 2 
Article 3(1) Article 87(2)(b) 
Article 3(2) Article 87(3)(a) and (b) 
Article 3(3) Article 88(1)(a) 
Article 3(4) Article 87(3)(b) 
Article 3(5) Article 89 
Article 4(1) Articles 87(2)(a) and 88(2)  
Article 4(2) Article 88(1)(b) 
Article 4(3) Article 88(1)(d) 
Article 5 Article 88(2) 
Article 6 Article 128 
Article 7 Article 141 
Article 8 - 
Article 9 - EN 159   EN Article 10 - 
6. Directive 89/608/EEC 
Directive 89/608/EEC This Regulation 
Article 1 - 
Article 2 - 
Article 3 Title IV 
Article 4 Title IV 
Article 5 Title IV 
Article 6 Title IV 
Article 7 Title IV 
Article 8 Title IV 
Article 9 Title IV 
Article 10 Article 7 and Title IV 
Article 11 - 
Article 12 Title IV 
Article 13 - 
Article 14 - 
Article 15 Article 7 and Title IV 
Article 16  - 
Article 17 - 
Article 18 - 
Article 19 - 
Article 20 - 
7. Decision 92/438/EEC 
Decision 92/438/EEC This Regulation 
Article 1 Articles 130 to 133 
Article 2 - 
Article 3 Articles 130 to 133 
Article 4 Articles 130 to 133 
Article 5 Articles 130 to 133 
Article 6 Article 62(3)(f) 
Article 7 - EN 160   EN Article 8 - 
Article 9 - 
Article 10 - 
Article 11 - 
Article 12 - 
Article 13 - 
Article 14 - 
Article 15 - 
Annex I Articles 130 to 133 
Annex II Articles 130 to 133 
Annex III Articles 130 to 133