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

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

(Text with EEA relevance) 

{SWD(2013) 166 final} 
{SWD(2013) 167 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Background of the proposal 

In  order  to  afford  European  Union  (EU)  citizens  a  high  level  of  human,  animal  and  plant 
health, and guarantee the functioning of the internal market, Union legislation provides for a 
set  of  harmonised  rules  to  prevent,  eliminate  or  reduce  the  level  of  health  risk  to  humans, 
animals and plants, which may arise along the 'agri-food chain', 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 (directly 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 phytosanitary legislation, which deal with risks to animal 
health  and  plant  health  in  general,  and  rules  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,  animals  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 regulated production methods (i.e. animal welfare, 
organic farming, geographical indications, plant reproductive material). It also includes rules 
established  to  ensure  the  provision  of  information  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  the  organisation  of  official 
controls has been established through Regulation (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  application.  It  aims  to  put  in  place  a  robust,  transparent  and 
sustainable  regulatory  framework  that  is  better  'fit  for  purpose'.  The  proposal  replaces  and 
repeals  the  Regulation  and  a  number  of  sectoral  acts  and  provisions  which  will  be  made 
redundant by its adoption. 

As the proposal is part of a comprehensive package, 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  official  controls  in  a  manner  that  consistently 
accompanies the upgrade of EU policies in these sectors.  

In  order  to  rationalise  and  simplify  the  overall  legislative  framework,  whilst  simultaneously 
pursuing  the  objective  of  better  regulation,  the  proposal  integrates  the  rules  currently 
applicable  to  official  controls  in  specific  areas  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) into the framework of the Regulation. 

Based on an extensive review of the provisions of the Regulation, which highlighted a number 
of cases where the burden of organising and performing 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  accreditation  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 compliance with feed and food law, animal health and 
welfare rules. 

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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 products, those of plant and plant products, and the 
controls on food and feed for which a specific risk requires increased attention at the borders. 
The  report  adopted  by  the  Commission  in  December  20102  on  the  effectiveness  and 
consistency  of  sanitary  and  phytosanitary  controls  on  imports  of  food,  feed,  animals  and 
plants, whilst concluding that the comprehensive body of legislation currently in place allows 
the  EU  to  deal  with  emerging  risks  or  emergency  situations  without  causing  distortions  to 
trade, also found that the Union's system of import controls could be made more consistent by 
reviewing  and  consolidating  the  existing  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 efficient 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 proposal 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  performance  of  official  controls.  Current  rules 
require  that  mandatory  inspection  fees  be  charged  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  borders.  Historically,  these  were  the  areas  where 
methods  of  controls  by  MS  competent  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  controls  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 the current system. External research3 carried out in 2009 to 
evaluate  the  application  of  the  financing  mechanism  established  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  ensuring  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  certain  sectors  would 
contribute to the financing of official controls, and which would not discriminate effectively 
between  compliant  and  non-compliant  behaviour.  The  2009  report  recommended  reviewing 
Articles 26 to 29 of the Regulation. 

Throughout the consultation period stakeholders have contributed 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 
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COM/2010/785/Final. 
'Fees  or  charges  collected  by  Member  States  to  cover  the  costs  occasioned  by  official  controls'. 
FCEC 2009. 

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the Commission's priority objective of ensuring proper enforcement of EU law, which is also 
the original objective of the Regulation on official controls. 

More  specifically,  the  proposal  aims  to  modernise  and  sharpen  enforcement  tools,  and  in 
particular official controls, as laid down in the existing Regulation, 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 controls and improve transparency. 

Effective  official  controls  are  necessary  to  ensure  the  correct  enforcement  of  the  legislation 
which governs the 'agri-food chain', and thus to ensure delivery on the objectives above. 

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

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

1.3. 

Regulatory Framework 

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

Harmonised EU rules to govern official control activities performed by MS are established in 
the  Regulation  with  the  aim  of  creating  an  integrated  and  uniform  approach  to  official 
controls along the food chain. The Regulation provides for a general framework for official 
controls  in  the  sectors  of  feed  and  food  law, animal  health  and  animal  welfare  rules,  laying 
down rules governing both the organisation and the financing of such controls. 

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

This  proposal  intends  to  establish  a  unique  set  of  rules  applicable  to  official  controls  in  all 
these sectors. 

1.4. 

Consistency with other policies 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 legislative burdens in light of 
comments made by MS and food business operators on the existing regime. 

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The proposal is consistent with the reviews of the animal health, the legislation on measures 
against pests of plants, and the PRM legislation, which are adopted by the Commission at the 
same  time.  It  also  intends  to  ensure  that  the  provisions  of  the  Regulation  complement  in  a 
consistent  manner  those  applicable  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 consistently accompanies the upgrade of EU policies in 
these sectors. 

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

With  a view to  the Europe 2020  strategy,  the provision  of effective  controls  along  the  food 
chain  will  ensure  safe  food  and  feed  while  fostering  competitiveness  of  business  operators, 
rewarding compliant business operators and ensuring user-pays principles across all sectors. 
To  this  end,  the  exemption  of  micro-enterprises  from  mandatory  control  fees  fulfils  the 
Commission’s commitment to lower the burden on very small businesses, in line with its new 
policy on 'Minimizing regulatory burden for SMEs – 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 targeted and general profile 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  States  were  also  consulted  in  the  context  of 
two studies contracted out by the Commission in the 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 consulted within other fora and frameworks on the 
following  specific  issues  relating  to  official  controls:  accreditation  of  official  laboratories, 
official  controls  on  residues  of  veterinary  medicinal  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 Safety Agencies and services on 29 June - 1 July 
2011 and on 8 December 2011. 

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

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COM (2011)803. 
'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. 

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2.1.2.  Data Collection 

Audit Reports by the Food and Veterinary Office (FVO), the Commission service tasked with 
appraising  Union  controls  in  the  MS,  were  extensively  used  to  inform  the  review.  They 
provide  information  and  data  on  the  organisation  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  official  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  report  did  highlight  the  diverse  spread  of 
cost recovery within MS and certain problems with the application of EU rules. 

2.1.3. 

Summary of responses and how they have been taken into account 

All stakeholders and Member States 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  controls  and  of  other  official  activities  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  gained  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  States  and,  from  businesses'  perspective,  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 the right policy balance, 
by ensuring that the new rules do not add an unaffordable or disproportionate burden on each 
operator,  whilst  securing  stable  appropriate  revenues  for  the  competent  authorities  and  their 
control systems. 

Both  stakeholders  and  Member  States  agree  that  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  risks  associated  with  the  specific  business 
activity, or product, the operator's record of compliance and reliability, indications of possible 
non-compliance) should be kept and 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 products. The proposal does this by repealing the 
special  rules  governing  the  latter  and  by  replacing  the  currently  fragmented  framework 
applicable to official controls on different categories of products from third countries with a 
common set of rules. 

Member States and operators alike welcomed the envisaged enhancements to the transparency 
requirements laid down in the Regulation. 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 information and data on enforcement work along the 
agri-food chain. Transparency was also reported to be a concern in relation to the financing of 
official controls (the fees system), which should be transparent and allow the public, and more 
specifically,  the  operators  to  understand  how  the  fees  are  calculated  and  how  revenue 

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therefrom  is  employed.  Operators  clearly  see  transparency  as  a  driver  to  accountability  and 
efficiency of the system of official controls as a whole. 

There  was  general  agreement  amongst  industry  contributors  and  Member  States  alike  that 
steps  should  be  taken  to  improve  the  functionality  of  administrative  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  responsibility  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 financing 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 leaving it to MS to decide how to ensure the 
appropriate funding of control activities and whether to charge inspection fees or not) 
[Option 1A], or  

maintain  current  EU  rules  on  fees,  including  on  mandatory  fees,  and  exempting 
micro-enterprises6 therefrom [Option 1B]. 

Both abovementioned options would substantially alter the current framework as regards the 
financing of national control systems 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 improved by clarifying, simplifying and 
streamlining  existing  provisions  on  controls  in  the  sectors  currently  covered  by  the 
Regulation, and by ensuring full cost recovery where mandatory fees are already 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 Regulation 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 recovery is ensured where mandatory fees are already 
provided  for  in  the  existing  Regulation,  as  well  as  in  the  fields  of  plant  health,  where 
mandatory  fees  are  introduced  for  official  controls  linked  to  plant  passport  obligations  and 
PRM, where mandatory fees are introduced with regards to certification. Member States will 
have the possibility to refund fees paid by micro-enterprises. 

Option  4  –  Streamline  +  Integrate  +  broader  cost  recovery.  The  legislative  framework  is 
improved  and  streamlined,  and  plant  health,  PRM,  and  ABP  are  included  in  its  scope  as 
described  under  Option  3.  Mandatory  fees  are  extended  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  informs  the  present  proposal.  However,  the 
exemption  of  micro-enterprises  from  mandatory  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. 

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Commission’s commitment to lower the burden on very small businesses, in line with its new 
policy on 'Minimizing regulatory burden for SMEs – Adapting EU regulation to the needs of 
micro-enterprises'7. 

Therefore  the  (optional)  refund  mechanism  designed  to  alleviate  micro-enterprises  from  the 
financial burden of fees, has been replaced with 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 Treaty, now Article 43, 
114 and 168(4)(b) respectively of the TFEU. Likewise, the proposal is based on these latter 
Articles. 

The  Common  Agricultural  Policy  (CAP),  which  is  based  on  Article  43  of  the  TFEU,  is 
qualified by the Lisbon Treaty as shared competence 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 means that legislation is predominantly a role for 
the  institutions  of  the  European  Union.  Article  114  provides  the  legal  basis  for  the 
establishment and functioning of the internal market for food products while ensuring a high 
level of protection of consumers and the approximation of provisions laid down by the law, 
regulation or administrative actions in this respect. Article 168(4)(b) stipulates that in order to 
meet common safety concerns 'measures in the veterinary and phytosanitary fields which have 
as their direct objective the protection of public health' should be adopted by the EU. 

3.2. 

Subsidiarity principle 

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

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

As to the financing of controls, common EU rules ensure that CAs can count on a reliable flux 
of resources to maintain the control effort at a level justified by the risks and by enforcement 
needs  (including  the  level  of  non-compliance).  Provisions  on  fees  in  particular  ensure  that 
business  activities  monitored  through  dedicated  national  control  systems,  which  benefit 
directly from efficiently performed controls, participate 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  treatment  between  operators  located  in  a  Member 
State  where  the  user-pays  rule  (and  thus  fees)  applies  and  those  located  in  a  Member  State 

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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  options,  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 sufficient and steady flux of dedicated resources for 
official controls, whilst leaving MS the time and flexibility necessary to cater for their internal 
arrangements and the specificities of their business population. 

3.4. 

Choice of instruments 

Proposed instrument: Regulation. 

Other types of measure would not be appropriate for the following reason(s). 

The existing provisions have been demonstrated to provide an appropriate framework for MS, 
however  despite  this,  inconsistency  of  interpretation  has  arisen  as  discussed  previously.  A 
Directive  would  have  led  to  still  greater  inconsistency  leading  to  uncertainty  for  Member 
States' CAs and operators. A Regulation 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 national legislation in the Member States. 

Soft law instruments such as guidelines are considered not sufficient to tackle differences in 
the interpretation and application of the legislation. 

4. 

BUDGETARY IMPLICATION 

The proposal does not imply incurring any expenditure which is not already foreseen in the 
financial statement of the common financial framework. No  additional 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 measures against pests of plants, rules governing 
the production, with a view of placing on the market, of plant reproductive material and rules 
on animal by-products. 

Moreover,  it  will  be  clarified  that  certain  Articles  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 purpose of eliminating, containing or reducing risks 
which  may  arise  for  the  health  of  humans,  animals  or  plants,  or  for  the  welfare  of  animals. 
These  activities,  which  notably  include  various  modalities  of  surveying,  surveillance  and 
monitoring  (including  epidemiologic),  and  eradication,  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. 

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Finally, it will be clarified that the Regulation shall also apply to official controls performed 
for  the  verification  of  the  requirements  applicable  to  animals  and  goods  arriving  from  third 
countries, and to animals and goods to be exported to third countries. 

Empowerment  provisions  will  allow  the  Commission  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-food chain and of risks to health. 

TITLE 
ACTIVITIES IN MEMBER STATES 

II:  OFFICIAL  CONTROLS  AND  OTHER  OFFICIAL 

CHAPTER I: COMPETENT AUTHORITIES 

The structure of this Chapter will remain largely unaltered. The terminology will be adjusted 
to give account of the broader scope of the Regulation (both in terms of sectors and activities 
covered).  However,  some  changes  will  be  necessary  to  address  certain  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 that this right will be 
applicable in the case of official controls only and that it includes each time, a documentary 
review of the sampling, analysis, testing or diagnosis by another 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 laboratory analysis, testing and diagnosis will 
become applicable to official controls and to other official activities in all the sectors covered 
by the Regulation (e.g. to surveillance, monitoring and survey activities in the plant health and 
animal health sectors). A 5 years transitional period will thus be foreseen for the plant health 
and plant propagating material sectors. 

The rules for the choice of the method to be used by the official laboratory will be clarified 
and  extended  so  as  to  require  that  methods  meet  state-of-the-art  scientific  standards,  and 
satisfy  the  analytical,  testing  and  diagnostic  need  of  the  laboratory  concerned  and  to 
incorporate methods validated by European or national reference laboratories. In the context 
of screening, targeted screening and other official 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 laboratories' will remain a mandatory condition for the 
designation  of  official  laboratories.  In  this  regard,  it  will  be  clarified  that  the  scope  of  the 
accreditation  shall  include  all  the  methods  used  by  the  laboratory  for  analysis,  testing  or 
diagnosis  when  operating  as  an  official  laboratory  (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  the  analytical,  testing  or  diagnostic  methods 
which  are  the  most  significant  and  representative).  The  inclusion  of  plant  health  under  the 

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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  laboratory  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, where changes of the method in use require a new accreditation 
or  an  extension  of  the  scope  of  the  accreditation  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 context 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  controls  performed  on  animals  and  goods  entering  the  Union.  An 
integrated approach will increase efficiency savings and should help in prioritising controls on 
the basis of risk. As noted below the Chapter is likely to be substantially altered. 

Firstly,  provisions  largely  mirroring  the  current  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 current legislation and lay down the categories of 
animals and goods arriving from third countries that require controls at entry into the Union. 
Empowerments will allow the Commission to modify the abovementioned categories and to 
establish  a  list  detailing  which  specific  animals  and  goods  (including  their  respective  CN 
codes) should be controlled. The Commission will also 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)  will  replace  the  different  entities  currently  tasked  with  border 
control  duties.  Common  requirements  for  BCPs  shall  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 suspension 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 used 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 decisions taken. The Commission 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. 

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A  common  set  of  rules  for  controls  on  consignments  (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  authorities  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  subject  to  documentary  and  identity  checks  whilst 
physical checks will be performed at a frequency 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,  identity  and  physical  checks  should  be  performed 
and to establish reduced frequencies 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, clarifying 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. Such rules will also be applicable to official 
controls performed on animals and goods arriving from third countries which are not subject 
to specific controls 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 cooperation between the said authorities with a view to ensuring 
the timely and proper access to information, the synchronisation of relevant data sets, and the 
rapid communication of decisions taken. 

CHAPTER IV: FINANCING OF OFFICIAL CONTROLS 

The  general  principle  of  the  existing  Regulation  will  be  retained.  MS  will  continue  to  be 
required to ensure that adequate financial resources are available to provide the staff and other 
resources  necessary  to  the  competent  authorities  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  are  established  and  collected,  depending  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  food  and  feed  businesses  registered  and  or 
approved under either or both of Regulation (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  defined  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  and  animal  welfare,  plant  heath  and  plant 
reproductive material rules); 

controls  performed  in  view  of  issuing  an  official  certificate  or  to  supervise  the 
issuance of an official attestation of compliance; 

official control activities performed to verify that the conditions to obtain or maintain 
approval are met; 

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• 

• 

official control activities performed with respect to border controls (including cost of 
controls  with  regard  to  plant  health  requirements,  which  will  be  transferred  to  the 
new official controls regulation); 

official control activities performed to verify compliance with emergency measures 
adopted  by  the  Commission  in  accordance  with  so  called  'safeguard'  provisions, 
where the decision establishing the measures so requires. 

Mandatory fee levels shall be calculated so as to enable the competent authorities performing 
the  official  control  activities  to  fully  recover  costs  resulting  from  official  controls  (if  the 
competent authority for which the fees are collected also performs other activities, then only 
the fraction of the relevant cost elements which results from official control activities should 
be considered for the calculation of fees). 

A  new  provision  will  ensure  that  operators  charged  a  flat-rate  fee  will  benefit  from 
recognition  of  good  performance  by  requiring  that  the  rate  of  fee  applied  to  each  operator 
shall be adjusted to take account of the operator's record of compliance 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  level  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 additional official controls due to 
non-compliance  with  enforcement  measures  (Article  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 LABORATORIES 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 view of placing on the market, 
of  plant  reproductive  material;  animal  by-products  rules),  it  will  be  possible  for  the 
Commission  to  establish  European  Union  reference  laboratories  (EURLs)  in  those  sectors. 
The  obligations  for  Member  States  to  designate  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  reproductive  material  and  for  animal  welfare.  These 
centres will in particular provide technical expertise, conduct training courses and contribute 
to the dissemination of research findings and technical innovations. 

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TITLE IV: ADMINISTRATIVE ASSISTANCE AND COOPERATION 

The  administrative  assistance  and  cooperation  provisions  of  the  Regulation  will  be  re-
enforced and clarified so as to increase their usability and effectiveness as a tool for tackling 
cross-border non-compliances. Several changes are envisaged in this respect. 

First of all, competent authorities will be required to provide 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  bodies  will  be  clarified  and  the  need  for  administrative 
assistance/cooperation  to  be  'channelled'  through  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 establish minimum requirements for liaison bodies. 

Thirdly, the modalities for requesting administrative 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 required to coordinate administrative 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  control  plan  (MANCP)  will  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 Article 44 will provide for an empowerment for the 
Commission  to  progressively  adopt  standardised  templates  taking  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 Veterinary 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 countries 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 regards GMOs and plant protection products, to 
the environment, or where there is evidence that widespread serious non-compliance 
with Union rules might be taking place; 

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• 

the  organisation  by  the  Commission  of  training  for  the  staff  of  the  competent 
authorities in the Member States and in third countries (the current programme Better 
Training  for  Safer  Food),  and  of  programmes  for  the  exchange  of  staff  between 
Member States (new activity, to be organised 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  integrated  operation  and  update  of  all  existing  and 
future  computerised  systems  through  which  information,  data  and  documents  regarding 
official controls are exchanged among competent authorities, and with the Commission (and 
operators where appropriate). 

TITLE VII: ENFORCEMENT MEASURES 

Provisions  governing  national  enforcement  measures  will  be  applicable  to  all  the  sectors  of 
the scope of the Regulation. 

A  new  provision  dealing  specifically  with  actions  to  be  taken  in  case  of  suspicion  of  non-
compliance will be included, requiring competent authority 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-compliance  will  furthermore  be 
completed:  restriction  or  prohibition  of  movements  of  animals,  imposition  of  quarantine 
periods,  slaughter  or  killing  of  animals,  postponement  of  slaughter  of  animals,  isolation  or 
closure of establishments, closure of websites will for instance be added to the list. 

A new provision in former Article 55 (on sanctions for non-compliance) will require MS to 
ensure  that  financial  penalties  applicable  to  intentional  infringements  offset  the  economic 
advantage sought by the perpetrator of the violation. Member States will also be required to 
ensure the application of appropriate criminal and/or administrative penalties to operators who 
fail to cooperate during an official control. 

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2013/0140 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL 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 European Economic and Social Committee8, 
Having regard to the opinion of the Committee of the Regions9, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

The  Treaty  requires  a  high  level  of  human  health  protection  to  be  ensured  in  the 
definition and implementation of all Union policies and activities. The achievement of 
that  objective  should,  inter  alia,  be  pursued  via  measures  in  the  veterinary  and 
phytosanitary  fields  which  have  as  their  direct  objective  the  protection  of  human 
health. 

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. 

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 
9 

OJ C , , p. . 
OJ C , , p. . 

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along the food chain and in all those areas of activity where a key objective is the fight 
against the possible spread of animal diseases, 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', contributes to the functioning of the internal market. 

The  basic  Union  rules  with  regard  to  food  and  feed  law  are  laid  down  in 
Regulation (EC)  No  178/2002  of  the  European  Parliament  and  of  the  Council  of 
28 January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing the European Food Safety Authority and 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,  including  medicated  feedingstuffs,  food  and 
feed  hygiene,  zoonoses,  animal  by-products,  residues  of  veterinary  medicinal 
products,  contaminants,  control  and  eradication  of  animal  diseases  with  a  human 
health  impact,  food  and  feed  labelling,  plant  protection  products,  food  and  feed 
additives,  vitamins,  mineral  salts,  trace  elements  and  other  additives,  food  contact 
materials,  quality  and  compositional  requirements,  drinking  water,  ionisation,  novel 
foods and genetically modified organisms (GMOs). 

Union legislation on animal health aims to ensure high standards of human and animal 
health  in  the  Union,  the  rational  development  of  the  agriculture  and  aquaculture 
sectors and to increase productivity. That legislation is necessary to contribute to the 
completion  of  the  internal  market  in  animals  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, disease eradication, veterinary controls and notification of 
diseases, and also contributes to the safety of food and feed. 

Article 13 of the Treaty recognises that animals are sentient beings. 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  suffering.  Such  rules  are  based  on  scientific 
evidence and may indirectly improve the quality and safety of food and feed. 

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  private  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. 

Union legislation on plant reproductive material 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 and ornamental species and vines. The objective 
of those rules is to ensure the identity, health and quality of plant reproductive material 
for its users, and the productivity, diversity, health and quality of the agri-food chain 
as well as contributing to the protection of biodiversity and the environment. 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Union legislation on organic production and labelling of organic products provides a 
basis for the sustainable development of organic production and aims to contribute to 

10 

OJ L 31, 1.2.2002, p. 1. 

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the  protection  of  natural  resources,  biodiversity  and  animal  welfare,  and  the 
development of rural areas. 

(10)  Union  legislation  on  agricultural  quality  schemes  for  agricultural  products  and 
to  exact 
identifies  products  and  foodstuffs  farmed  and  produced 
foodstuffs 
specifications  whilst  encouraging  diverse  agricultural  production,  protecting  product 
names and informing consumers about the specific character of agricultural products 
and foodstuffs. 

(11)  Union agri-food chain legislation is based on the principle that operators at all stages 
of production, processing and distribution within the businesses under their control are 
responsible  for  ensuring  that  the  requirements  established  by  Union  agri-food  chain 
legislation and which are relevant to their activities are fulfilled. 

(12)  The  responsibility  to  enforce  Union  agri-food  chain  legislation  lies  with  Member 
States,  whose  competent  authorities  monitor  and  verify,  through  the  organisation  of 
official  controls,  that  relevant  Union  requirements  are  effectively  complied  with  and 
enforced. 

(13)  Regulation  (EC)  No  882/2004  of  the  European  Parliament  and  of  the  Council  of 
29 April 2004 on official controls performed to ensure the verification of compliance 
with  food  and  feed  law,  animal  health  and  animal  welfare  rules11  has  established  a 
single legislative framework for the organisation of official controls. That framework 
has  significantly  improved  the  efficiency  of  official  controls,  the  enforcement  of 
Union  agri-food  chain  legislation  and  the  level  of  protection  against  risks  to  human, 
animal and plant health and animal welfare in the Union and the level of protection of 
the environment from risks that might arise from GMOs and plant protection products. 
It has also provided a consolidated legal framework to support an integrated approach 
towards the performance of official controls along the agri-food chain. 

(14)  There are a number of provisions in Union agri-food chain legislation, the enforcement 
of  which  has  not,  or  has  only  partially,  been  governed  by  Regulation  (EC) 
No 882/2004. In particular, specific official control 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  derived  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  Council  Directive  2000/29/EC  of  8  May  2000  on 
protective measures against the introduction into the Community of organisms harmful 
to plants or plant products and against their spread within the Community13. 

(15)  Council  Directive  96/23/EC  of  29  April  1996  on  measures  to  monitor  certain 
substances  and  residues  thereof  in  live  animals  and  animal  products  and  repealing 
Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC14 
also  provides  for  a  very  detailed  set  of  rules  that  establish  among  other  things 
minimum  frequencies  of  official  controls  and  specific  enforcement  measures  to  be 
adopted in cases of non-compliance. 

11 
12 
13 
14 

OJ L 165, 30.4.2004, p. 1. 
OJ L 300, 14.11.2009, p. 1. 
OJ L 169, 10.7.2000, p. 1. 
OJ L 125, 23.5.1996, p. 10. 

EN 

18 

   EN 

                                                 
(16) 

In  order  to  rationalise  and  simplify  the  overall  legislative  framework,  whilst 
simultaneously  pursuing  the  objective  of  better  regulation,  the  rules  applicable  to 
official  controls  in  specific  areas  should  be  integrated  into  a  single  legislative 
framework  for  official controls.  For that purpose,  Regulation  (EC)  No  882/2004  and 
other acts currently governing official controls in specific areas should be repealed and 
replaced by this Regulation. 

(17)  This  Regulation  should  seek  to  establish  a  harmonised  Union  framework  for  the 
organisation  of  official  controls,  and  official  activities  other  than  official  controls, 
along the entire agri-food chain, taking into account 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  agricultural  products  (arable  crops,  wine,  olive  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  place.  This  Regulation 
should  therefore  not  apply  to  the  verification  of  compliance  with  the  provisions  of 
Council  Regulation  (EC)  No  1234/2007  of  22 October  2007  establishing  a  common 
organisation of agricultural markets and on specific provisions for certain agricultural 
products (Single CMO Regulation)15. 

(19)  Certain  definitions  currently  set  out  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 meanings in different sectors. 

(20)  Union  agri-food  chain  legislation  entrusts  the  competent  authorities  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  are  the  public  interest  activities  which  the 
competent  authorities  of  the  Member  States  must  carry  out  for  the  purpose  of 
eliminating, containing or reducing risks which may arise for human, animal or plant 
health, animal welfare, or for the environment. 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 rules which are enforced through the official 
controls. 

(21)  Competent  authorities  should  be  designated  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  authorities  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  appropriately  coordinated  communication  with 
other Member States' competent authorities and with the Commission. 

(22)  Member States should be allowed to confer upon designated competent authorities the 
responsibility for official controls in relation to Union rules, including rules regarding 
alien  species  which  may  harm  agricultural  production  or  the  environment  by  their 
invasive character, other than those falling within the scope of this Regulation. 

15 

OJ L 299, 16.11.2007, p. 1. 

EN 

19 

   EN 

                                                 
(23)  For the performance of official controls aimed at verifying the correct application of 
Union  agri-food  chain  legislation,  and  of  the  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  quality,  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  rules  and  the  rules  of  this 
Regulation.  It  is  therefore  important  that  the  staff  performing  official  controls  and 
other official activities is regularly trained on the applicable legislation, according to 
their area of competence, as well as on the obligations resulting from this Regulation. 

(25)  Operators should have a right to appeal against the decisions taken by the competent 

authorities, and be informed of such a right. 

(26)  The  competent  authorities  should  ensure  that  staff  responsible  for  official  controls 
does not disclose information acquired during the performance of such controls which 
is  covered  by  professional  secrecy.  Unless  there  is  an  overriding  interest  justifying 
disclosure,  professional  secrecy  should  include  information  which  would  undermine 
the  purpose  of  inspections,  investigations  or  audits,  the  protection  of  commercial 
interests  and  the  protection  of  court  proceedings  and  legal  advice.  However, 
professional secrecy should not prevent competent authorities from disclosing factual 
information  on  the  outcome  of  official  controls  regarding  individual  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 obligation 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  Article  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  individuals  to  the  protection  of  their  personal  data  as 
provided for in Directive 95/46/EC of the European Parliament and of the Council of 
24 October  1995  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal data and on the free movement of such data16 should not be affected by this 
Regulation. 

(27)  Competent authorities should perform official controls regularly, on all the sectors and 
in relation to all operators, activities, animals and goods governed by Union agri-food 
chain  legislation.  The  frequency  of  official  controls  should  be  established  by  the 
competent authorities having regard 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 requires that official controls be performed 
irrespective of the level of risk or expected non-compliance in view of the issuance of 
an  official  certificate  or  attestation  which  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 

20 

   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 authorities should organise and conduct official control 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  the  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 legislation, to verify the conformity of animals 
and  goods  with  requirements  established  by  the  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  perform  official  controls  at  all  stages  of 
production, processing and distribution of animals and goods concerned by such rules. 
To ensure that official controls are thoroughly conducted and effective, the competent 
authorities  should  also  have  the  power  to  perform  official  controls  at  all  stages  of 
production  and  distribution  of  goods,  substances,  materials  or  objects  which  are  not 
governed  by  agri-food  chain  rules  (for  example,  of  veterinary  medicinal  products) 
insofar as this is necessary to fully investigate possible violations of those rules and to 
identify the cause of any such violation. 

(32)  The  competent  authorities  act  in  the  interest  of  operators  and  of  the  general  public 
ensuring  that  the  high  standards  of  protection  established  by  Union  agri-food  chain 
legislation  are  consistently  preserved  and  protected  through  appropriate  enforcement 
action, and that compliance with such rules is ascertained across the entire agri-food 
chain  through  official  controls.  The  competent  authorities  should  therefore  be 
accountable  to  the  operators  and  to  the  general  public  for  the  efficiency  and 
effectiveness  of  the  official  controls  they  perform.  They  should  provide  access  to 
information concerning the organisation and performance of official controls and other 
official  activities,  and  regularly  publish  information  concerning  official  controls  and 
the results therefrom. Competent authorities should also, subject to certain conditions, 
be entitled to publish or to make available 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  official  controls  they  perform.  For  that 
purpose  they  should  act  on  the  basis  of  written  documented  procedures  and  should 
provide  detailed  information  and  instructions  to  staff  performing  official  controls. 
They  should  also  have  appropriate  procedures  and  mechanisms  in  place  to 
continuously  verify  that  their  own  action  is  effective  and  consistent,  and  take 
corrective action when shortcomings are identified. 

(34)  To  facilitate  the  identification  of  non-compliances  and  streamline  the  taking  of 
corrective action by the operator concerned, the outcome of official controls should be 

EN 

21 

   EN 

recorded in a report, a copy of which should be given to the operator. Where official 
controls  require  the  continuous  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  disproportionate.  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  compliance  and  immediately  notified  of  any 
identified shortcomings. 

(35)  Operators  should  cooperate  fully  with  competent  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  establishes  a  single  legislative  framework  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  areas,  Union  legislation  lays  down  detailed 
requirements to be complied with which require special skills and specific means for 
the performance of official controls. To avoid diverging enforcement practices which 
could  generate  uneven  protection  of  human,  animal  and  plant  health,  animal  welfare 
and, as regards GMOs and plant protection products, of the environment, disrupt the 
functioning  of  the  internal  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 through the adoption of specific official control 
rules  capable  of  catering  for  the  needs  of  controls  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 Regulation and specific criteria for triggering the 
administrative assistance mechanisms provided for in this Regulation. In other cases, 
such  additional  rules  might  become  necessary  in  order  to  provide  a  more  detailed 
framework for the performance of official controls 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 environment, indicating that in the absence 
of common specifications for the performance of official controls across the Member 
States, the controls would fail to deliver the 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 controls and of the other official activities are 
preserved.  The  delegated  body  should  in  particular  be  accredited  according  to  the 
ISO standard for the performance of inspections. 

(38)  To  ensure  the  reliability  and  consistency  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  scientific  standards,  satisfy  the 
specific analytical, testing and diagnostic need of the laboratory concerned, and offer 
sound  and  reliable  analytical,  test  and  diagnostic  results.  Clear  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  International  Organisation  for  Standardisation 
(ISO),  the  European  and  Mediterranean  Plant  Protection  Organisation  (EPPO),  the 

EN 

22 

   EN 

International Plant Protection Convention (IPPC), the World Organisation for Animal 
Health (OIE), European Union and national reference laboratories, or national rules. 

(39)  Operators whose animals or goods are subject 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-diagnosis unless any such second sampling is 
technically impossible or irrelevant. Such would be the case, in particular, where the 
prevalence  of  the  hazard  is  particularly  low  in  the  animal  or  good  or  its  distribution 
particularly  sparse  or  irregular.  The  IPPC  for  that  reason  rejects  the  use  of  counter-
samples for assessing the presence of quarantine organisms in plants or plant products. 

(40)  For the purposes of performing official controls on trade which takes place through the 
internet or other remote means, competent authorities should be able to obtain samples 
through anonymously placed orders (also known as mystery shopping) which can then 
be analysed, tested or subject to a verification 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 expertise, equipment, infrastructure and staff to carry out 
such  tasks  to  the  highest  standards.  To  ensure  sound  and  reliable  results,  those 
laboratories  should  be  accredited  for  the  use  of  these  methods  according  to  standard 
EN  ISO/IEC  17025  on  'General  requirements  for  the  competence  of  testing  and 
calibration  laboratories'.  The  accreditation  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  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/9317. 

(42)  While accreditation is the instrument of choice 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  particularly  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  where  the  analyses  or  tests  performed  only 
concern  qualitative  aspects  of  plant  reproductive  material,  and,  under  certain 
conditions, in cases where the laboratory only carries out analyses, tests or diagnoses 
in the context of other official activities and not of official controls. 

(43) 

In order to ensure flexibility and proportionality of approach, in particular for animal 
health  or  plant  health  laboratories,  provision  should  be  made  for  the  adoption  of 
derogations  aimed  at  allowing  certain  laboratories  not  to  be  accredited  for  all  the 
methods they use. Moreover, accreditation of a laboratory for all the methods it should 
use  as  official  laboratory  might  not  be  immediately  available  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  and  diagnoses  for  the  competent  authorities 
before they obtain the relevant accreditation. 

17 

OJ L 218, 13.8.2008, p. 30. 

EN 

23 

   EN 

                                                 
(44)  Official  controls  performed  on  animals  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  history  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  concerned,  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 their entry into the Union. Current Union rules 
require  the  performance  of  official  controls  at  Union  borders  to  verify  that  human 
health, animal health and animal welfare standards applicable to animals, products of 
animal origin, germinal products and animal by-products are met and that plants and 
plant  products  comply  with  phytosanitary  requirements.  Increased  controls  at  entry 
into  the  Union  are  also  performed  on  certain  other  goods  where  emerging  or  known 
risks  so  warrant.  The  specificities  of  such  controls,  currently  governed  by  the 
provisions  of  Council  Directive  97/78/EC  of  18 December  1997  laying  down  the 
principles  governing  the  organisation  of  veterinary  checks  on  products  entering  the 
Community  from  third  countries18,  Council  Directive  91/496/EEC  of  15  July  1991 
laying down the principles governing the organisation of veterinary checks on animals 
entering  the  Community  from  third  countries  and  amending  Directives  89/662/EEC, 
90/425/EEC  and  90/675/EEC19,  Council  Directive  2000/29  and  Commission 
Regulation  (EC)  No  669/2009  implementing  Regulation  (EC)  No  882/2004  of  the 
European Parliament and the Council as regards the increased level of official controls 
on  imports  of  certain  food  and  feed  of  non-animal  origin  and  amending  Decision 
2006/504/EC20, 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  resources  assigned  to  border  controls  and 
facilitate  the  enforcement  of  Union  food  chain  legislation,  a  common  integrated 
system  of  official  controls  at  border  control  posts,  replacing  the  current  fragmented 
control frameworks, should be established to handle all consignments which, given the 
risk they may carry, must be controlled 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, animal welfare or, as regards GMOs and plant 
protection  products,  to  the  environment.  This  approach  should  enable  the  competent 

18 
19 
20 

OJ L 24, 30.1.1998, p. 9. 
OJ L 268, 24.9.1991, p. 56. 
OJ L 194, 25.7.2009, p. 11. 

EN 

24 

   EN 

                                                 
authorities  to  allocate  control  resources  where  the  risk  is  highest.  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  reduced  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 collection and management systems. 

(49) 

In certain cases, and as long as high levels of human, animal and plant health, animal 
welfare  and  protection  of  the  environment  in  relation  to  GMOs  and  plant  protection 
products are guaranteed, official controls normally performed by competent authorities 
at  border  control  posts  could  be  performed  at  other  control  points  or  by  other 
authorities. 

(50)  For  the  purpose  of  organising  an  efficient  system  of  official  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 arrival 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 animals and goods entering the Union from third countries should 
be performed at border control posts designated by Member States in accordance with 
a set of minimum requirements. The designation 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 protection products, to the environment. 

(52)  To guarantee the uniform application of official control 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 protection products, to the environment. 

(53) 

In  order  to  avoid  inconsistencies  and  duplications  of  the  official  controls  effort,  to 
allow consignments which are subject to official controls at border control posts to be 
timely identified, and to guarantee that controls are performed in an efficient manner, 
the cooperation and exchange of information 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  ensure  that  adequate  financial  resources  are 
always  available  in  order  to  appropriately  staff  and  equip  the  competent  authorities 
performing  official  controls  and  other  official  activities.  Although  operators  are 
primarily  responsible  for  ensuring  that  their  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 very nature, complex and resource demanding 
and should be provided with a stable influx of resources for official controls, at a level 
appropriate to the enforcement needs at any given moment. To reduce the dependency 

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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 which 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 the costs of official controls performed in 
view  of  issuing  an  official  certificate  or  attestation,  and  costs  of  official  controls 
performed by the competent authorities at border control posts. 

(55)  Fees should cover, but not exceed, the costs 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  controls  performed  over  a 
given  period  of  time.  Where  fees  are  applied  on  the  basis  of  the  actual  cost  of 
individual  official  controls,  operators  with  a  good  record  of  compliance  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 flat 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  irrespective  of  whether  they  are  subject  to  an 
official  control  during  the  reference  period,  those  fees  should  be  calculated  so  as  to 
reward operators with a consistent good record 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 benefitting from the refund at a disadvantage 
and potentially create distortions of competition. However, in order to provide support 
to micro-enterprises, these should be exempted 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 citizens 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 cases where the placing on the market or the 
movement of certain animals or goods should be accompanied by an official certificate 
signed  by  the  certifying  officer.  It  is  appropriate  to  establish  a  common  set  of  rules 
laying  down  the  obligations  of  the  competent  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  supervision  of  the  competent  authorities  or  by  the 
competent authorities themselves. It is appropriate to lay down a minimum set of rules 
ensuring  that  also  the  issuance  of  official  attestations  is  performed  according  to 
appropriate guarantees of reliability. 

(60)  Official controls and other official activities 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 uniformity of analytical, testing and diagnostic 

EN 

26 

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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 all those areas of the food chain where there 
is  the  need  for  precise  and  reliable  analytical,  testing  and  diagnostic  results.  The 
European  Union  reference  laboratories  should  in  particular  ensure  that  national 
reference 
laboratories  are  provided  with  up-to-date 
information  on  available  methods,  organise  or  participate  actively  in  inter-laboratory 
comparative  tests  and  offer  training  courses  for  national  reference  laboratories  or 
official laboratories. 

laboratories  and  official 

(61)  For the performance of official controls and other official activities 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  legislation  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  plant  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,  ensuring  consumer  confidence  in  it,  non-
compliances with Union food chain legislation requiring enforcement action in more 
than  one  Member  State  should  be  pursued  efficiently  and  consistently.  The  Rapid 
Alert  System  for  Food  and  Feed  (RASFF)  established  by  Article  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  authorities  to  ensure  that  non-compliances  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  detected  but  also  in  the 
Member  State  where  the  non-compliance  originated.  In  particular,  administrative 
assistance  and cooperation  should enable competent 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 and all notifications should be given appropriate 
follow-up.  In  order  to  facilitate  administrative  assistance  and  cooperation,  Member 
States  should  be  required  to  designate  one  or  more  liaison  bodies  to  assist  and 
coordinate  communication  flows  between  competent  authorities  in  different  Member 
States.  In  order  to  streamline  and  simplify  cooperation  amongst  Member  States  the 
Commission  should  adopt  implementing  acts  establishing  the  specifications  of  the 
technical  tools  to  be  used,  the  procedures  for  communication  between  liaison  bodies 
and a standard format for requests for assistance, notifications 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  information  on  the  structure  and  organisation  of  its 
system  of  official  controls.  Such  MANCPs  are  the  instrument  through  which  each 

EN 

27 

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Member  State  should  ensure  that  official  controls  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  and  completeness  of  MANCPs  Member  States 
should  designate  a  single  authority  responsible  for  their  coordinated  preparation  and 
implementation. In order to promote a consistent, uniform and integrated approach to 
official  controls,  the  Commission  should  have  the  power  to  adopt  rules  concerning 
MANCPs  which  should  identify  priorities  for  official  controls,  effective  control 
procedures,  criteria  for  risk  categorisation  and  performance  indicators  for  assessing 
MANCPs. 

(66)  Member States should be required to submit an annual report to the Commission with 
information on control activities and the implementation of the MANCPs. In order to 
facilitate  the  collection  and  transmission  of  comparable  data,  the  subsequent 
compilation of such data into Union-wide statistics and the preparation of reports by 
the  Commission  on  the  operation  of  official  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 perform controls in Member States to verify the 
application  of  Union  legislation  and  the  functioning  of  national  control  systems  and 
competent  authorities.  Commission  controls  should  also  serve  to  investigate  and 
collect  information  on  enforcement  practices  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 enshrined in Article 11 of Regulation (EC) No 178/2002, which 
requires  that  food  and  feed  imported  into  the  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  against  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 rules laying down animal health requirements, 
which  allow  the  entry  of  animals  and  of  certain  products  of  animal  origin  into  the 
Union  only  from  third  countries  which  are  included  in  a  list  set  up  for  that  purpose, 
and in Union rules for the organisation of official controls on products of animal origin 
intended for human consumption, which also provide for the establishment 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  that  animals  and  goods  entering  the  Union  from  third  countries 
comply  with  all  the  requirements  laid  down  in  Union  agri-food  chain  legislation  or 
with  requirements  considered  equivalent,  in  addition  to  the  requirements  established 
by  Union  rules  on  protective  measures  against  pests  of  plants,  Union  rules  laying 
down animal health requirements, and Union rules laying down specific hygiene rules 
for food of animal origin to ensure that the requirements 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 

28 

   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 third countries or from certain third countries 
or regions thereof. 

(70)  Where,  in  specific  cases,  there  is  evidence  that  certain  animals  or  goods  originating 
from a third country, a group of third countries, or regions thereof, give rise to risks 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-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 effective and efficient official controls and other official activities, 
and ultimately the safety and health of humans, animals and plants, and the protection 
of the environment, also depends on the availability to the control authorities of well 
trained  staff  possessing  an  appropriate  knowledge  of  all  the  matters  relevant  for  the 
correct  application  of  Union  legislation.  Appropriate,  dedicated  training  should  be 
provided  by  the  Commission  to  promote  a  uniform  approach  to  official  controls  and 
other  official  activities  by  the  competent  authorities.  To  promote  the  knowledge  of 
Union  agri-food  chain  legislation  and  requirements  in  third  countries,  such  training 
should be also addressed to staff of the competent authorities in third countries. 

(72)  To promote the sharing of experience and best practices among competent authorities, 
the  Commission  should  also  be  able  to  organise,  in  cooperation  with  the  Member 
States,  programmes  for  the  exchange  of  staff  tasked  with  official  controls  or  other 
official activities. 

(73) 

It  is  important  for  the  performance  of  effective  official  controls  and  other  official 
activities  that  the  competent  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 managed by the Commission to allow such data 
and  information  to  be  handled  and  managed  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 concerning the development 
of  an  integrated  computerised  veterinary  system  and  currently  used  for  the 
management  of  data  and  information  on  animals  and  products  of  animal  origin  and 
official controls thereon21. That system should be upgraded so as to allow its use for 
all goods for which Union agri-food chain legislation establishes specific requirements 
or official control modalities. Dedicated computerised 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  for  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  insert  number,  date,  title  and,  in  a 
footnote,  the  OJ  reference  for  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 reference for the Regulation on protective measures against 

21 

OJ L 8, 14.1.2003, p. 44. 

EN 

29 

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pests of plants] a system for the notification and reporting of the presence of pests and 
the  notification  of  non-compliances.  All  such  systems  should  work  in  a  harmonious, 
consistent manner that makes use of synergies between the different systems, avoids 
duplications, simplifies their operation and makes them more efficient. 

(74)  To  support  a  more  efficient  management  of  official  controls,  a  computerised 
information  system  integrating  and  upgrading  as  necessary  all  relevant  existing 
information  systems  should  be  set  up  by  the  Commission,  allowing  for  the  use  of 
advanced communication and certification 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  other  information  systems  operated  by  public 
authorities and through which relevant data is exchanged or made available. Moreover, 
the  possibility  to  use  the  electronic  signatures  within  the  meaning  of  Directive 
1999/93/EC of the European  Parliament and the Council of 13 December 1999 on a 
Community framework for electronic signatures22 should be foreseen, in line with the 
Digital Agenda for Europe. 

(75)  The competent authorities should investigate cases where there is a suspicion of non-
compliance  with  Union  agri-food 
is 
established,  determine  its  origin  and  extent  as  well  as  the  operators'  responsibilities. 
They  should  also  take  appropriate  measures  to  ensure  that  the  operators  concerned 
remedy the situation and to prevent further non-compliance. 

legislation  and,  where  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  achieved.  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 human, animal and plant health, animal welfare 
and,  as  regards  GMOs  and  plant  protection  products, 
the  environment, 
independently of the involvement or responsibility of operators or other actors, or lead 
to  situations  of  serious  widespread  non-compliance  with  food  chain  rules.  The 
Commission should therefore be able to react to serious failures 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. 

to 

(77) 

Infringements of the rules should be subject to effective, dissuasive and proportionate 
sanctions at national level throughout the Union. For financial penalties applicable to 
intentional  infringements  to  be  sufficiently  dissuasive,  they  should  be  set  at  a  level 
which is likely to offset the economic advantage sought by the perpetrator through the 
violation. Member States should 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 certain 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 

30 

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(79) 

Commission  to  ensure  the  correct  application  of  legislation  on  veterinary  and 
zootechnical  matters23;  Council  Directive  89/662/EEC  of  11  December  1989 
concerning veterinary checks in intra-Community trade with a view to the completion 
of  the  internal  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  Decision  92/438/EEC  of  13  July  1992  on 
computerization of veterinary import procedures (Shift project), amending Directives 
90/675/EEC,  91/496/EEC,  91/628/EEC  and  Decision  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 Regulation (EC) No 854/2004 
of the European Parliament and of the Council of 29 April 2004 laying down specific 
rules for the organisation of official controls on products of animal origin intended for 
human consumption28. 

In order to ensure consistency, amendments should  also be effected to the following 
acts: Regulation (EC) No 999/2001 of the European Parliament and of the Council of 
22 May 2001 laying down rules for the prevention, 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 pesticides 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  repealing  Regulation  (EEC)  2092/9132;  Regulation  (EC) 
No 1069/2009; Council Regulation (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 and repealing Council Directives 79/117/EEC 
and 91/414/EEC34; Regulation (EU) No 1151/2012 of the 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 July 1998 concerning the protection of 
animals  kept  for  farming  purposes36;  Council  Directive  1999/74/EC  of  19  July  1999 
laying down minimum standards for the protection of laying hens37; Regulation (EC) 
No 1829/2003 of the European Parliament and of the Council of 22 September 2003 

23 
24 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 
36 
37 

OJ L 351, 21.12.1989, p. 34. 
OJ L395, 30.12.1989, p. 13. 
OJ L 224, 18.8.1990, p. 29. 
OJ L 243, 25.8.1992 p. 27. 
OJ L 13, 16.1.1997, p. 28. 
OJ L 139, 30.4.2004, p. 206. 
OJ L 147, 31.5.2001, p. 1. 
OJ L 3, 5.1.2005, p. 1. 
OJ L 70, 16.3.2005, p.1. 
OJ L 189, 20.7.2007, p. 1. 
OJ L 303, 18.11.2009, p.1. 
OJ L 309, 24.11.2009, p. 1. 
OJ L 343, 14.12.2012, p.1. 
OJ L 221, 8.8.1998, p. 23. 
OJ L 203, 3.8.1999 p. 53. 

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31 

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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  Directive  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  for  the  protection  of  pigs42;  Directive  2009/128/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 laying down provisions for 
the  management  of  expenditure  relating  to  the  food  chain,  animal  health  and  animal 
welfare,  and  relating  to  plant  health  and  plant  reproductive  material]provides  a 
framework  for  the  Union's  financing  of  actions  and  measures  across  the  agri-food 
chain in those areas under the multi-annual 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.  Regulation  (EU)  No  [.…]/2013  [Office  of 
Publications,  please  insert  number  of  the  Regulation  laying  down  provisions  for  the 
management  of  expenditure  relating  to  the  food  chain,  animal  health  and  animal 
welfare,  and  relating  to  plant  health  and  plant  reproductive  material]  should  be 
amended to take account of the changes introduced by this Regulation to Regulation 
(EC) No 882/2004. 

(81) 

to 

take 

legislative  and 

into  account  of 

In order to amend the references to European standards, and Annexes II and III to this 
Regulation 
technical  and  scientific 
developments, and to supplement this Regulation with specific rules governing official 
controls and other official activities in the areas it covers, including, inter alia, rules 
on the qualification and training of staff, on additional responsibilities and tasks of the 
competent  authorities,  on  the  cases  where  the  accreditation  of  laboratories  is  not 
required, on certain exemptions from official controls 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  requirements  and  tasks  of  European  Union 
reference  laboratories  and  centres,  on  additional  requirements  for  national  reference 
laboratories, on criteria for risk categorisation and for performance 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  power  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 particular importance that the Commission carry 
out  appropriate  consultations  during  its  preparatory  work,  including  at  expert  level. 
The  Commission,  when  preparing  and  drawing  up  delegated  acts,  should  ensure  a 
simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and to the Council. 

38 
39 
40 
41 
42 
43 

OJ L 268, 18.10.2003, p. 1. 
OJ L 268, 18.10.2003, p. 29. 
OJ L 812, 12.7.2007, p. 19. 
OJ L 10, 15.1.2009, p. 7. 
OJ L 47, 18.2.2009, p. 5. 
OJ L 309, 24.11.2009, p. 71. 

EN 

32 

   EN 

                                                 
(82) 

(83) 

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  plant  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  coordinated  assistance  and  follow-up  by  the 
Commission, implementing powers should be conferred on the Commission. 

In  order  to  ensure  uniform  conditions  for  the  implementation  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  between  operators  and  competent  authorities  and  amongst 
competent  authorities,  customs  authorities  and  other  authorities,  the  methods  of 
sampling and of laboratory analysis, test and 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  countries  or  regions  that  offer  equivalent 
guarantees  to  those  applied  in  the  Union  and  its  repeal,  training  activities  and 
exchange programmes of staff amongst Member States, implementing powers should 
be  conferred  on  the  Commission.  Those  powers  should  be  exercised  in  accordance 
with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 
16  February  2011  laying  down  the  rules  and  general  principles  concerning 
mechanisms  for  control  by  Member States  of  the  Commission's  exercise  of 
implementing powers44. 

(84)  Since the objective of this Regulation, namely to ensure a harmonised approach with 
regard  to  official  controls  and  other  official  activities  performed  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, complexity, trans-border and 
international  character,  be  better  achieved  at  Union  level,  the  Union  may  adopt 
measures, in accordance with the principle of subsidiarity 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 

33 

   EN 

                                                 
Title I 
Subject matter, scope and definitions 

1. 

This Regulation lays down rules for: 

Article 1 
Subject matter and scope 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the  performance  of official controls and other official activities performed by 
the competent authorities of the Member States; 

the financing of official controls; 

the administrative assistance and cooperation between Member States in view 
of the correct application of the rules referred to in paragraph 2; 

the  performance  of  Commission  controls  in  Member  States  and  in  third 
countries; 

the adoption of conditions to be met by animals and goods entering the Union 
from a third country; 

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 for 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 stage of production, the processing and 
distribution  of  food,  including  rules  aimed  at  guaranteeing  fair  practices  in 
trade and protecting consumer interests 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  all  stages  of  production,  processing  and 
distribution of feed and the use of feed, including rules aimed at guaranteeing 
fair practices in trade and protecting consumer interests and information; 

(d) 

(e) 

laying down animal health requirements; 

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  placing  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 sustainable use of pesticides; 

(j) 

governing organic production and labelling of organic products; 

EN 

34 

   EN 

3. 

4. 

5. 

(k)  on  the  use  and  labelling  of  protected  designations  of  origin,  protected 

geographical indications and traditional specialities guaranteed. 

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) 

(b) 

entering the Union from third countries;  

to be exported to third countries. 

This Regulation shall not apply to official controls for the verification of compliance 
with: 

(a) 

(b) 

the rules laid down in Regulation (EC) No 1234/2007; 

the rules laid down in Directive 2010/63/EU of the European Parliament and of 
the  Council  of  22  September  2010  on  the  protection  of  animals  used  for 
scientific purposes45. 

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  Regulation  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, the following definitions shall apply: 

1. 

2. 

3. 

4. 

'official control' means any form of control that the competent authorities perform for 
the verification of compliance with: 

(a) 

(b) 

this Regulation; 

the rules referred to in Article 1(2); 

'other  official  activities'  means  any  activity,  other  than  an  official  control,  which  is 
performed by competent authorities in accordance with: 

(a) 

(b) 

this Regulation; 

the rules referred to in Article 1(2) to ensure the application of those rules; 

'food  law'  means  food  law  as  defined  in  point  (1)  of  Article  3  of  Regulation  (EC) 
No 178/2002; 

'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, processing and distribution of feed and the use of feed; 

5. 

'competent authorities' means: 

(a) 

the  central  authorities  of  a  Member  State  responsible  for  the  organisation  of 
official  controls  and  of  other  official  activities,  in  accordance  with  this 
Regulation and the rules referred 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 

35 

   EN 

                                                 
6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

(c)  where appropriate, the corresponding authorities of a third country; 

'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]; 

'goods' means any good subject to one or more of the rules referred to in Article 1(2), 
excluding animals; 

'food' means food as defined in Article 2 of Regulation (EC) No 178/2002; 

'feed'  means  feed  as  defined  in  point  (4)  of  Article  3  of  Regulation  (EC) 
No 178/2002; 

'animal by-products' means animal by-products as defined in point (1) of Article 3 of 
Regulation (EC) No 1069/2009; 

'derived  products'  means  derived  products  as  defined  in  point  (2)  of  Article  3  of 
Regulation (EC) No 1069/2009; 

'pests'  means  pests  as  defined  in  Article  1(1)  of  Regulation  (EU)  No  XXX/XXXX 
[Office  of  Publications,  please  insert  number  of  the  Regulation  on  protective 
measures against pests of plants]; 

'plants'  means  plants  as  defined  in  point  (1)  of  Article  2  of  Regulation  (EU) 
No XXX/XXXX [Office of Publications, please insert number of the Regulation on 
protective measures against pests of plants]; 

'plant reproductive material' means plant reproductive material as defined in point (2) 
of  Article 3  of  Regulation  (EU)  No  XXX/XXXX  [Office  of  Publications,  please 
insert number, date, title and, in a footnote, the OJ reference for the Regulation on 
the production and making available on the market of plant reproductive material]; 

'plant  protection  products'  means  plant  protection  products  as  referred  to  in  Article 
2(1) of Regulation (EC) No 1107/2009; 

'alien  species'  means  a  species,  subspecies  or  lower  taxon,  introduced  outside  its 
natural  past  or  present  distribution  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; 

'products of animal origin' means products of animal origin as defined 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 
origin46; 

'germinal products' means germinal products as defined in point (25) of Article 4(1) 
of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of 
the Regulation on animal health]; 

'plant  products'  means  plant  products  as  defined  in  point  (2)  of  Article  2  of 
Regulation  (EU)  No  XXX/XXXX  [Office  of  Publications,  please  insert  number  of 
the Regulation on protective measures against pests of plants]; 

46 

OJ L 139, 30.4.2004, p. 55.  

EN 

36 

   EN 

                                                 
20. 

21. 

'other objects' means other objects as defined in point (4) of Article 2 of Regulation 
(EU)  No  XXX/XXXX  [Office  of  Publications,  please  insert  number  of  the 
Regulation on protective measures against pests of plants]; 

'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  concerning  compliance  with  one  or  more 
requirements laid down in the rules referred to in Article 1(2); 

24. 

'non-compliance' means non-compliance with: 

(a) 

(b) 

this Regulation; 

rules referred to in Article 1(2); 

25. 

26. 

27. 

'official attestation' means any label, mark or other form of attestation issued by the 
operators under the supervision, through dedicated official controls, of the competent 
authorities,  or  by  the  competent  authorities  themselves,  and  providing  assurance 
concerning compliance with one or more requirements laid down in the rules referred 
to in Article 1(2); 

'operator'  means  any  natural  and  legal  person  subject  to  one  or  more  obligations 
provided for in the rules referred to in Article 1(2), except the competent authorities 
and the other bodies in charge of official controls and other official activities; 

'consignment'  means  a  number  of  animals  or  quantity  of  goods  of  the  same  type, 
class,  or  description,  covered  by  the  same  official  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) 

(b) 

animals or goods; 

activities  under  the  control  of  operators  falling  within  the  scope  of  the  rules 
referred  to  in  Article  1(2)  and  equipment,  means  of  transport,  substances  and 
materials used to perform those activities; 

(c)  places where operators perform their activities; 

29. 

30. 

'border control post' means a place, and the facilities belonging to it, designated by a 
Member State to perform the official controls provided for in Article 45(1); 

'audit'  means  a  systematic  and  independent  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  suitable  to  achieve 
objectives; 

31. 

'rating'  means  a  classification  of  operators  based  on  an  assessment  of  their 
conformity with rating criteria; 

EN 

37 

   EN 

32. 

33. 

34. 

35. 

36. 

37. 

38. 

39. 

40. 

41. 

42. 

43. 

'official  veterinarian'  means  a  veterinarian  appointed  by  the  competent  authorities 
and  appropriately  qualified  to  perform  the  official  controls  and  other  official 
activities in accordance with: 

(a) 

(b) 

this Regulation; 

the rules referred to in Article 1(2); 

'hazard' means any agent or condition with the potential to have an adverse effect on 
human, animal or plant health, animal welfare or the environment; 

'specified  risk  material'  means  tissues  as  defined  in  point  (g)  of  Article  3(1)  of 
Regulation (EC) No 999/2001; 

'long  journey'  means  a  journey  as  defined  in  point  (m)  of  Article  2  of  Regulation 
(EC) No 1/2005; 

'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; 

'pesticide  application  equipment'  means  any  apparatus  as  defined  in  point  (4)  of 
Article 3 of Directive 2009/128/EC; 

'delegated  body'  means  a  third  party,  to  which  the  competent  authorities  have 
delegated specific official control tasks; 

'control authority for organic products' means a public administrative organisation of 
a  Member  State  to  which  the  competent  authorities  have  conferred,  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; 

'control  verification  procedures'  means  the  arrangements  put  in  place  and  actions 
performed  by  the  competent  authorities  for  the  purpose  of  ensuring  that  official 
controls and other official activities are consistent and effective; 

'screening'  means  a  form  of  official  control  performed  by  conducting  a  planned 
sequence of observations or measurements with a view to obtaining an overview of 
the state of compliance with this Regulation and the rules referred to in Article 1(2); 

'targeted screening' means a form of official control involving observation of one or 
more operators or their activities; 

'control  system'  means  a  system  comprising  the  competent  authorities  and  the 
resources,  structures,  arrangements  and  procedures  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. 

46. 

'entry into the Union' means the action of bringing animals and goods into one of the 
territories listed in Annex I; 

'documentary  check'  means  the  examination  of  the  official  certificates,  official 
attestations  and  other  document(s)  including  documents  of  a  commercial  nature, 

EN 

38 

   EN 

47. 

48. 

49. 

50. 

51. 

52. 

53. 

54. 

55. 

56. 

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); 

'identity check' means a visual inspection to verify that the content and the labelling 
of  a  consignment,  including  the  marks  on  animals,  seals  and  means  of  transport, 
correspond  with  the  information  provided  in  the  official  certificates,  official 
attestations and other documents accompanying it; 

'physical check'  means a  check on animals or goods and, as appropriate, checks on 
packaging,  the  means  of  transport,  labelling  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); 

'transhipment' means the movement of goods subject to the official 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 under customs supervision to another vessel or 
aircraft in the same port or airport in preparation for onward travel; 

'transit'  means  movement  from  one  third  country  to  another  third  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; 

'supervision by the customs authorities' means action as defined  in  Article 4(13) of 
Regulation (EEC) No 2913/9247; 

'control  by  the  customs  authorities'  means  customs  controls  as  defined  in 
Article 4(14) of Regulation (EEC) No 2913/92; 

'official  detention'  means  the  procedure  by  which  the  competent  authorities  ensure 
that animals and goods subject to  official controls are not moved or tampered with 
pending  a  decision  on  their  destination;  it  includes  storage  by  operators  under  the 
control of the competent authorities; 

'additional official controls' means those controls which were not originally planned 
and which were decided on the basis of the findings of previous official controls, or 
other official activities; 

'official  certification'  means 
the  procedure  by  which  assurance  concerning 
compliance  with  one  or  more  requirements  laid  down  in  the  rules  referred  to  in 
Article 1(2) is provided by the competent authorities; 

'control plan' means a description established by the competent authorities containing 
information on the structure and organisation of the official control system, and of its 
operation and the detailed planning 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 

39 

   EN 

                                                 
Title II 
Official controls and other official activities  
in Member States 

Chapter I 
Competent authorities 

Article 3 
Designation of competent authorities 

1. 

2. 

3. 

4. 

5. 

For each of the areas governed by the rules referred to in Article 1(2), Member States 
shall  designate  the  competent  authority  or  authorities  on  which  they  confer  the 
responsibility to perform official controls and other official activities. 

Where,  for  the  same  area,  a  Member  State  confers  the  responsibility  to  perform 
official controls or other official activities 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 effective coordination between 
all  authorities  involved,  and  the  consistency  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. 

Competent  authorities  responsible  for  the  verification  of  compliance  with  the  rules 
referred to in point (j) of Article 1(2) may confer specific official control tasks to one 
or more control authorities for organic products. In such cases, they shall attribute a 
code number to each of them. 

Member States shall inform the Commission and other Member States of, and of any 
changes to, the contact details of: 

(a) 

(b) 

(c) 

(d) 

the competent authorities designated in accordance with paragraph 1; 

the single authorities designated in accordance with point (b) of paragraph 2; 

the control authorities for organic products referred to in paragraph 3; 

the delegated bodies referred to in Article 25(1). 

The information referred to in the first subparagraph shall also be made available to 
the public. 

Member States may confer to the competent authorities referred to in paragraph 1 the 
responsibility to carry out controls for the verification of compliance with, or for the 
application of, rules, including those regulating specific risks which may arise from 
the presence of alien species in the Union, other than those referred to in Article 1(2). 

EN 

40 

   EN 

6. 

The  Commission  may,  by  means  of  implementing  acts,  determine  the  means  by 
which  the  information  referred  to  in  paragraph  4  is  to  be  made  available  to  the 
public.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 141(2). 

Article 4 
General obligations of the competent authorities 

1. 

The competent authorities shall: 

(a)  have  procedures  and  arrangements  in  place  to  ensure  the  effectiveness  and 

appropriateness of official controls and other official activities; 

(b)  have arrangements in place to ensure the impartiality, quality and consistency 

of official controls and other official 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  sufficient  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 this Regulation and in the rules referred 
to in Article 1(2); 

(h)  have legal procedures in place in order to ensure that staff have access to the 
premises  of  and  documents  kept  by  operators  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  competently  and  to  perform  official  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 authorities resulting from this Regulation. 

Competent  authorities  shall  develop  and  implement  training  programmes  for  the 
purpose  of  ensuring  that  staff  performing  official  controls  and  official  activities 
receive the training referred to in points (a), (b) and (c). 

EN 

41 

   EN 

3. 

4. 

1. 

2. 

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  empowered  to  adopt  delegated  acts  in 
accordance  with  Article  139  concerning  rules  for  the  specific  qualification  and 
training  requirements  of  such  staff,  having  regard  to  the  scientific  and  technical 
knowledge necessary to perform official controls and other official activities in each 
of the areas referred to in Article 1(2). 

When, within the services of a competent authority, more than one unit is competent 
to  perform  official  controls  or  other  official  activities,  efficient  and  effective 
coordination and cooperation shall be ensured between the different units. 

Article 5 
Audits of the competent authorities 

Competent authorities shall carry out internal audits or have audits 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) 

(b) 

subject to independent scrutiny; 

carried out in a transparent manner. 

Competent  authorities  shall  make  available  the  results  of  the  audits  referred  to  in 
paragraph 1 to the Commission upon request. 

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  for  the 
conduct of the audits provided for in paragraph 1. Those implementing acts shall be 
adopted in accordance with the examination procedure referred 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  against  those  decisions  in 
accordance with national law. 

Article 7 
Confidentiality obligations of the staff of the competent authorities 

1. 

2. 

Competent authorities shall require members of their staff not to disclose information 
acquired  when  undertaking  their  duties  in  the  context  of  official  controls  and  other 
official  activities  which  by  its  nature  is  covered  by  professional  secrecy,  subject  to 
paragraph 2. 

Unless there is an overriding public interest in its disclosure, information covered by 
professional  secrecy  as  referred  to  in  paragraph  1  shall  include  information  whose 
disclosure would undermine: 

(a) 

(b) 

the purpose of inspections, investigations or audits; 

the protection of commercial interests of a natural or legal person; 

EN 

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(c) 

the protection of court proceedings and legal advice. 

3. 

Paragraphs  1  and  2  shall  not  prevent  the  competent  authorities  from  publishing  or 
making  otherwise  available  to  the  public  information  about  the  outcome  of  official 
controls  regarding  individual  operators,  provided  that  the  following  conditions  are 
met: 

(a) 

(b) 

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 publication or release; 

the  information  which  is  published  or  made  otherwise  available  to  the  public 
takes  into  account  the  comments  expressed  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 official controls on all operators regularly, on a 
risk basis and with appropriate frequency, taking account of: 

(a) 

identified risks associated with: 

(i) 

animals and goods; 

(ii) 

the activities under the control of operators; 

(iii) 

the location of the activities or operations of operators; 

(iv) 

the use of products, processes, materials or substances that may influence 
food or feed safety, animal health or animal welfare, plant health or plant 
reproductive  material  identity  and  quality,  or,  in  the  case  of  GMOs  and 
plant protection products, may adversely impact on the environment; 

(b)  operators'  past  record  as  regards  the  results  of  official  controls  performed  on 

them and their compliance with the rules referred to in Article 1(2); 

(c) 

the  reliability  and  results  of  own  controls  that  have  been  performed  by  the 
operators,  or  by  a  third  party  at  their  request,  for  the  purpose  of  ascertaining 
compliance with the rules referred to in Article 1(2); 

(d) 

any information that might indicate non-compliance with the rules referred to 
in Article 1(2). 

Competent  authorities  shall  perform  official  controls  on  a  regular  basis  and  with 
appropriate frequency to identify possible intentional violations of the rules referred 
to  in  Article  1(2),  taking  into  account,  in  addition  to  the  criteria  referred  to  in 
paragraph  1,  information  regarding  such  possible  intentional  violations  shared 
through the mechanisms of administrative assistance provided for in Title IV and any 
other information pointing to the possibility of such violations. 

Official  controls  performed  prior  to  the  placing  on  the  market  or  the  movement  of 
certain  animals  and  goods  in  view  of  the  issuance  of  the  official  certificates  or 
official attestations required by the rules referred to in Article 1(2) as a condition for 

2. 

3. 

EN 

43 

   EN 

the  placing  on  the  market  or  the  movement  of  the  animals  or  goods  shall  be 
performed in accordance with: 

(a) 

(b) 

the rules referred to in Article 1(2); 

the delegated acts adopted by the Commission in accordance with Articles 15 
to 24. 

4. 

Official controls shall be performed without prior warning, except where: 

(a)  prior notification of the operator is necessary; 

(b) 

the operator has requested such official controls. 

5. 

6. 

7. 

Official controls shall be performed as much as possible in a manner that minimises 
the burden on the operators. 

Competent authorities shall perform official controls with the same care irrespective 
of whether the animals and goods concerned are: 

(a) 

(b) 

(c) 

available on the Union market, whether originating in the Member State where 
the official controls are performed or in another Member State; 

to be exported from the Union; 

entering the Union from third countries. 

To the extent strictly necessary for the organisation of the official controls, Member 
States of destination may require operators who have animals or goods delivered to 
them from another Member State to report the arrival of such animals or goods. 

Article 9 
Persons, processes and activities subject 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) 

(b) 

(c) 

1. 

on animals and goods at all stages of production, processing and distribution; 

on  substances,  materials  or  objects  which  may  influence  the  characteristics  of 
animals and goods, at all stages of production, processing and distribution; 

on operators and the activities and operations 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 

Competent  authorities  shall  perform  official  controls  with  a  high  level  of 
transparency  and  make  available  to  the  public  relevant  information  concerning  the 
organisation and the performance of official controls. 

They  shall  also  ensure  the  regular  and  timely  publication  of  information  on  the 
following: 

(a) 

(b) 

the type, number and outcome of official controls; 

the type and the number of non-compliances detected; 

EN 

44 

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2. 

3. 

1. 

2. 

3. 

(c) 

the  cases  where  measures  were  taken  by  the  competent  authorities  in 
accordance with Article 135; 

(d) 

the cases where the penalties referred to in Article 136 were imposed. 

To ensure the uniform implementation 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 referred to in Article 141(2). 

Competent authorities shall be entitled to publish or make otherwise available to the 
public information about the rating of individual operators based on the outcome of 
official controls, provided that the following conditions are met: 

(a) 

(b) 

the rating criteria are objective, transparent and publicly available; 

appropriate  arrangements  are  in  place  to  ensure  the  consistency  and 
transparency of the rating process. 

Article 11 
Documented control and control verification procedures  

Competent authorities shall perform official 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 staff performing official 
controls. 

Competent  authorities  shall  have  procedures  in  place  to  verify  the  consistency  and 
effectiveness of official controls and other official activities that they perform. 

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 other official activities; 

(b)  update the documented procedures provided for in paragraph 1 as appropriate. 

Article 12 
Reports on official controls 

1. 

Competent  authorities  shall  draw  up  reports  on  every  official  control  that  they 
perform. 

Those reports shall contain: 

(a) 

(b) 

(c) 

a description of the purpose of the official controls; 

the control methods applied; 

the results of the official controls; 

(d)  where  appropriate,  action  that  the  competent  authorities  require  the  operator 

concerned to take as a result of their official controls. 

EN 

45 

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2. 

3. 

Competent authorities shall provide the operator subject to an official control with a 
copy of the report provided for in paragraph 1. 

Where  official  controls  require  the  continuous  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  frequency  that  enables  the 
competent authorities and the operator to be:  

(a) 

(b) 

regularly informed of the level of compliance; 

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  official  controls  using  control  methods  and 
techniques  that  shall,  as  appropriate,  include  screening,  targeted  screening, 
verification, inspections, audits, sampling, analysis, diagnosis and tests. 

2. 

Official controls shall include the following, as appropriate: 

(a) 

an examination of the control systems that operators have put in place and of 
the results obtained; 

(b) 

an inspection of: 

(i) 

(ii) 

primary  producers'  installations  and  other  businesses,  including  their 
surroundings, premises, offices, equipment, installations and  machinery, 
transport and their animals and goods; 

raw  materials,  ingredients,  processing  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  maintenance  products  and  processes,  plant  protection 

products; 

(v) 

labelling, presentation and advertising; 

controls on the hygiene conditions in the operators’ premises; 

an  assessment  of  procedures  on  good  manufacturing  practices  (GMP),  good 
hygiene  practices  (GHP),  good  farming  practices  and  hazard  analysis  critical 
control points (HACCP); 

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); 

interviews with operators and with their staff; 

a reading of values recorded by operators' measuring instruments; 

controls  performed  with  the  competent  authorities'  own  instruments  to  verify 
measurements taken by operators; 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

any other activity required to identify non-compliances. 

EN 

46 

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1. 

2. 

3. 

Article 14 
Obligations of operators 

To the extent that this is necessary for the performance of official controls or of other 
official activities, operators shall, where required by the competent authorities, give 
staff of the competent authorities access to: 

(a) 

(b) 

(c) 

(d) 

their premises; 

their computerised information management systems; 

their animals and goods; 

their documents and any other relevant information. 

During official controls and other official activities, operators shall assist the staff of 
the competent authorities in the accomplishment of their tasks. 

The operator responsible for the consignment shall: 

(a) 

cooperate  fully  with  the  competent  authorities  to  ensure  the  efficient 
performance of official controls or other official activities; 

(b)  make  available  all  information  concerning  the  consignment  on  paper  or 

electronically. 

4. 

The Commission may, by means of implementing acts, lay down rules: 

(a) 

establishing  the  modalities  for  access  by  the  competent  authorities  to  the 
computerised information management systems 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 controls and on action to be taken by the competent authorities in 
relation to the production of products of animal origin intended for human consumption 

1. 

Official controls on the production of meat shall include: 

(a) 

the verification, by or under the responsibility of an official veterinarian, of the 
health and welfare of the animals prior to the slaughter; 

(b)  official  controls,  by  or  under  the  responsibility  of  an  official  veterinarian,  in 
slaughterhouses,  cutting  plants  and  game  handling  establishments,  to  verify 
compliance with the requirements applicable to: 

(i) 

the hygiene of meat production; 

(ii) 

the presence of residues of veterinary medicinal products in products of 
animal origin intended for human consumption; 

(iii) 

the  handling  and  disposal  of  animal  by-products  and  of  specified  risk 
material; 

(iv) 

the health and welfare of the animals. 

EN 

47 

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2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  specific  rules  for  the  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  performance  of  official  controls  and 
uniform  minimum  frequency  of  such  official  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 product of animal origin and the different 
processes it undergoes; 

(c) 

(d) 

(e) 

the  cases  where  and  the  conditions  under  which  slaughterhouse  staff  may  be 
involved  in  official  controls,  and  the  design  and  application  of  tests  to  assess 
their performance; 

the  cases  where  the  competent  authorities  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; 

criteria  to  determine  when,  on  the  basis  of  a  risk  analysis,  the  official 
veterinarian is not required to be present in slaughterhouses and game handling 
establishments during the official controls referred to in paragraph 1. 

Where,  in  cases  of  risks  which  cannot  be  effectively  addressed  in  the  absence  of 
common  specifications  for  the  official  controls  or  for  the  action  to  be  taken  by  the 
competent  authorities  following  such  official  controls,  imperative  grounds  of 
urgency so require, the procedure provided for in Article 140 shall 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) 

(b) 

(c) 

(d) 

the  experience  gained  by  food  business  operators  on  the  application  of  the 
procedures  referred  to  in  Article  5  of  Regulation  (EC)  852/2004  of  the 
European Parliament and of the Council48; 

scientific and technological developments; 

consumer expectations with regard to food composition and changes in patterns 
of consumption of food; 

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  achievement  of  the  objectives  of  human  health 
and  animal  health  pursued  by  the  rules  referred  to  in  points  (a),  (c),  (d)  and  (e)  of 
Article 1(2), applicable to products of animal origin intended for human consumption 

48 

OJ L 139, 30.4.2004, p. 1. 

EN 

48 

   EN 

                                                 
and  to  animals  intended  for  the  production  of  such  products,  the  Commission  shall 
also  take  into  account  the  following  elements,  when  adopting  delegated  acts  as 
provided for in paragraph 2: 

(a) 

(b) 

(c) 

the need to facilitate the application of the delegated acts in small businesses; 

the need to enable the continued use of traditional methods at any of the stages 
of production, processing or distribution of food; 

the  needs  of  food  businesses  situated  in  regions  that  are  subject  to  special 
geographic constraints. 

Article 16 
Specific rules on official controls 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 controls performed to verify compliance with the rules referred to 
in point (a) of Article 1(2) applicable to certain substances whose use on crops or animals or 
to produce or process food or feed may result in residues of those substances in food or feed, 
and  on  action  to  be  taken  by  the  competent  authorities  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  violation  of  the  rules  referred  to  in  point  (a)  of 
Article 1(2), and lay down rules on: 

(a) 

(b) 

(c) 

uniform  specific  requirements  for  the  performance  of  official  controls  and  uniform 
minimum  frequency  of  such  official  controls,  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; 

specific  additional  criteria  and  specific  additional  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); 

the cases where the competent authorities 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. 

Article 17 
Specific rules on official controls and on action to be taken by the competent authorities in 
relation to animals, products of animal origin, germinal products, animal by-products and 
derived products 

The Commission shall be empowered to adopt delegated 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-products  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  animal  health  risks  related  to  animal  by-products  and  derived 
products, and 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; 

EN 

49 

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(b) 

(c) 

uniform specific requirements for the performance of official controls, and uniform 
minimum  frequency  of  such  official  controls,  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  controls  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); 

the cases where the competent authorities 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. 

Article 18 
Specific rules on official controls 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) 

(b) 

in  case  of  long  journeys  between  Member  States  and  with  third  countries, 
official  controls  performed  prior  to  the  loading  to  check  the  fitness  of  the 
animals for transport; 

in  case  of  long  journeys  between  Member  States  and  with  third  countries  of 
domestic  equidae  other  than  registered  equidae  and  domestic  animals  of  the 
bovine, ovine, caprine and porcine species, prior to the journey:  

(i) 

official controls on journey logs to verify that the 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 certificates 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 transported and on the 
means of transport; 

(ii)  official  controls  to  verify  that  transporters  comply  with  applicable 
international  agreements  and  have  valid  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 porcine species have been or are to 
be transported over long journeys. 

2. 

Where  the  rules  referred  to  in  point  (f)  of  Article  1(2)  require  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  control  methods  and  techniques  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 accordance with point (f) of paragraph 3. 

EN 

50 

   EN 

3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  rules  for  the  performance  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 welfare risk related to  the farming activities 
and to the transport, slaughter and killing 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  official  controls,  having  regard,  in 
addition  to  the  criteria  referred  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) 

(d) 

(e) 

(f) 

the  cases  where  the  competent  authorities  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; 

the  verification  of  animal  welfare  requirements  at  border  control  posts  and  at 
exit points and the minimum requirements applicable to such exit points; 

specific  criteria  and  conditions  for  the  activation  of  the  mechanisms  of 
administrative assistance provided for in Title IV; 

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  performance  criteria,  and  the  design  of  such 
indicators on the basis of scientific and technical evidence. 

Article 19 
Specific rules on official controls and action to be taken by the competent authorities in 
relation to plant health 

The Commission shall be empowered to adopt delegated 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 shall take account of plant health risks associated 
with plants, plant products and other objects in relation to specific pests of plants or operators 
and lay down rules on: 

(a) 

(b) 

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; 

uniform  specific  requirements  for  the  performance  of  official  controls  on  the 
introduction into and movement in the Union of particular plants, 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  controls  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 and other objects of  a  particular  origin or 
provenance; 

EN 

51 

   EN 

(c) 

uniform  frequencies  of  official  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,  please  insert  number  of 
the  Regulation  on  protective  measures  against  pests  of  plants]  having  regard,  in 
addition  to  the  criteria  referred  to  in  article  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,  please  insert  number  of 
the  Regulation  on  protective  measures  against  pests  of  plants]  for  the  plants,  plant 
products and other objects they produce; 

(d) 

the cases where the competent authorities 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. 

Article 20 
Specific rules on official controls 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  reproductive  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  competent  authorities  following  such  official 
controls. Those delegated acts shall lay down rules on: 

(a) 

(b) 

(c) 

(d) 

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; 

uniform specific requirements for the performance 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; 

specific criteria and conditions for the activation of the mechanisms of administrative 
assistance provided for in Title IV; 

the cases where the competent authorities 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. 

Article 21 
Specific rules on official controls and action to be taken by the competent authorities in 
relation to GMOs and genetically modified food and feed 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning rules for the performance 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  taken  by  the  competent  authorities  following  such 
official controls. Those delegated acts shall take into account the need to ensure a minimum 
level of official controls to prevent practices in violation with those rules, and 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; 

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(b) 

uniform  specific  requirements  for  the  performance  of  official  controls  and  uniform 
minimum frequency of such official controls on: 

(i) 

the presence on the market of GMOs and of genetically modified food and feed 
which  have  not  been  authorised  in  accordance  with  Directive  2001/18/EC  of 
the European Parliament and the Council of 12 March 2001 on the deliberate 
release  into  the  environment  of  genetically  modified  organisms  and  repealing 
Council Directive 90/220/EEC49 or Regulation (EC) No 1829/2003; 

(ii) 

the  cultivation  of  GMOs  and  the  correct  application  of  the  monitoring  plan 
referred  to  in  point  (e)  of  Article  13(2)  of  Directive  2001/18/EC  and  in 
Articles 5(5) and 17(5) of Regulation (EC) 1829/2003; 

(iii) 

the contained use of genetically modified microorganisms; 

(c) 

the cases where the competent authorities 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. 

Article 22 
Specific rules on official controls and on action to be taken by the competent authorities in 
relation to plant protection products 

The Commission shall be empowered to adopt delegated 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 shall lay down rules on: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

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; 

uniform  specific  requirements  for  the  performance  of  official  controls  and  uniform 
minimum  frequency  of  such  official  controls,  concerning  the  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 illegal trade of such products; 

uniform specific requirements for inspections on pesticide application equipment and 
uniform minimum frequency of such controls; 

the cases where the competent authorities 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; 

the  design  of  certification  systems  to  assist  the  competent  authorities  in  the 
inspections of pesticide application equipment; 

the collection of information, monitoring and reporting on suspected poisonings from 
plant protection products; 

the  collection  of  information,  and  the  monitoring  of  and  reporting  on  counterfeited 
plant protection products and illegal trade of plant protection products. 

49 

OJ L 106, 17.4.2001, p. 1. 

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Article 23 
Specific rules on official controls 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. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts,  in  accordance  with 
Article  139  concerning  rules  for  the  performance  of  official  controls  to  verify 
compliance  with  the  rules  referred  to  in  points  (j)  and  (k)  of  Article  1(2)  and  on 
action to be taken by the competent authorities following such official controls. 

In  relation  to  the  rules  referred  to  in  point  (j)  of  Article 1(2),  the  delegated  acts 
referred to in paragraph 1 shall lay down rules on: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

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; 

additional requirements to those referred to in Article 8(1) for risk assessment, 
and for the establishment of the frequency of official controls, and of sampling 
as  appropriate,  taking  into  account  the  risk  of  the  occurrence  of  non-
compliance; 

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; 

additional  methods  and  techniques  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  the  traceability  of  organic  products  at  all 
stages  of  the  production,  preparation  and  distribution,  and  at  providing 
assurances  as  to  compliance  with  the  rules  referred  to  in  point  (j)  of 
Article 1(2); 

additional  criteria  to  those  referred  to  in  the  second  subparagraph  of 
Article 135(1) and in Article 30(1) of Regulation (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); 

additional  requirements  to  those  provided  for  in  point  (f)  of  Article  4(1)  in 
relation to the facilities 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; 

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  the  activation  of  the  mechanisms  of 
administrative assistance provided for in Title IV. 

3. 

In  relation  to  the  rules  referred  to  in  point  (k)  of  Article  1(2),  the  delegated  acts 
referred to in paragraph 1 shall lay down rules on: 

EN 

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(a) 

(b) 

(c) 

(d) 

(e) 

additional  requirements,  methods  and  techniques  to  those  referred  to  Articles 
11  and  13  for  official  controls  performed  to  verify  compliance  with  product 
specifications and labelling requirements; 

additional  methods  and  techniques  to  those  referred  in  Article  13  for  the 
performance of official controls aimed at ensuring the traceability 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 distribution, and at providing assurances 
as to compliance with those rules; 

specific additional criteria and specific additional 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 provided for in Article 112; 

specific  criteria  and  conditions  for  the  activation  of  the  mechanisms  of 
administrative assistance provided for in Title IV; 

specific measures to be taken, in addition to those referred to in Article 135(2) 
in case of non-compliance and of serious or recurrent non-compliance. 

4. 

Where appropriate, the delegated acts referred to in paragraphs 2 and 3 shall derogate 
from the provisions of this Regulation referred to in those paragraphs. 

Article 24 
Specific rules on official controls 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  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  specific  rules  on  official  controls  performed  on  certain 
categories of food or feed to verify compliance with the rules referred 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 human or animal health or, in relation to 
GMOs and plant protection products to the environment, or any such risks emerging 
from new patterns of production or consumption 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  performance  of  official  controls  and 
uniform  minimum  frequency  of  such  official  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 category of food and feed and the different 
processes it undergoes; 

(c) 

the  cases  where  the  competent  authorities  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 

55 

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2. 

1. 

2. 

3. 

4. 

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 adopted pursuant to paragraph 1. 

Chapter III 
Delegation of specific tasks of the competent authorities 

Article 25 
Delegation by the competent authorities of specific official control tasks 

Competent  authorities  may  delegate  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. 

Competent  authorities  shall  not  delegate  the  decision  concerning  the  measures 
provided for in point (b) of Article 135(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 compliance with the rules referred to in point (j) 
of Article 1(2). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  establishing  specific  official  control  tasks  that  may  not  be  delegated  in 
order to preserve the independence or the core functions of the competent authorities. 

Where  competent  authorities  delegate  specific  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 attribute a code number to each delegated body 
and designate authorities responsible for their approval and supervision. 

Article 26 
Conditions for delegating specific official control tasks to delegated bodies 

1. 

The  delegation  of  specific  control  tasks  to  a  delegated  body  referred  to  in 
Article 25(1) shall be in writing and shall comply with the following conditions: 

(a) 

the delegation contains a precise description of: 

(i) 

the specific official control tasks 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  infrastructure  required  to  perform  the 
specific official control tasks delegated to it; 

(ii)  has a sufficient number of suitably qualified and experienced staff; 

(iii) 

is impartial and free from any conflict of interest as regards the exercise 
of the specific official control tasks delegated to it; 

(iv)  works and is accredited in accordance 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 

56 

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(c) 

there  are  arrangements  in  place  ensuring  efficient  and  effective  coordination 
between the delegating competent authorities and the delegated body. 

Article 27 
Conditions for delegating specific official control tasks to natural persons 

Competent  authorities  may  delegate  specific  official  control  tasks  to  one  or  more  natural 
persons where the rules provided for in Articles 15 to 24 so allow. Such delegation shall be in 
writing.  

Article 26(1) shall apply to the delegation of specific official control tasks to natural persons, 
with the exception of points (b)(ii) and (b)(iv). 

Article 28 
Obligations of the delegated 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) 

(b) 

communicate the results of the official controls performed by them to the competent 
authorities which have delegated the specific official control tasks on a regular basis 
and whenever those competent authorities so request; 

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 official control tasks to delegated bodies or 
natural persons in accordance with Article 25(1) shall: 

(a) 

(b) 

organise audits or inspections of such bodies or persons as necessary; 

fully or partly withdraw the delegation without delay where: 

(i) 

(ii) 

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; 

the  delegated  body  or  the  natural  person  fails  to  take  appropriate  and  timely 
action to remedy the shortcomings identified 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 

57 

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(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) 

(b) 

the rules referred to in Article 1(2) allow such delegation; 

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 person 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) 

(b) 

communicate  the  results  of  the  other  official  activities  performed  by  it  to  the 
competent authorities which have delegated the specific tasks related to other official 
activities on a regular basis and whenever the competent authorities so request; 

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 tasks 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) 

(b) 

organise audits or inspections of such bodies or persons as necessary; 

fully or partly withdraw the delegation without delay where: 

(i) 

(ii) 

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; 

the  delegated  bodies  or  natural  persons  fail  to  take  appropriate  and  timely 
action to remedy the shortcomings identified 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  laboratory  analyses,  tests  and  diagnoses  during 
official  controls  and  other  official  activities  shall  comply  with  Union  rules 
establishing those methods or the performance criteria for those methods. 

EN 

58 

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2. 

In the absence of the Union rules referred to in paragraph 1, official laboratories shall 
use state-of-the-art methods for their specific analytical, testing and diagnostic needs, 
taking into account: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  most  recent  available  methods  complying  with  relevant  internationally 
recognised rules or protocols, including those that the European Committee for 
Standardisation (CEN) has accepted; or, 

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, 

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, 

in  the  absence  of  the  rules  or  protocols  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 recommended by national reference laboratories 
and validated in accordance with internationally accepted scientific protocols; 
or, 

in  the  absence  of  the  rules  or  protocols  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 relevant methods validated in accordance 
with internationally accepted scientific protocols. 

In the context of screening, targeted screening and 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. 

Where  laboratory  analyses,  tests  or  diagnoses  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 validation of an appropriate 
method in accordance with internationally accepted scientific protocols. 

Wherever  possible,  methods  used  for  laboratory  analyses  shall  be  characterised  by 
the appropriate criteria set out in Annex III. 

Samples  shall  be  taken,  handled  and  labelled  in  such  a  way  as  to  guarantee  their 
legal, scientific and technical validity. 

The Commission may, by means of implementing acts, lay down rules for: 

(a) 

the  methods  to  be  used  for  sampling  and  for  laboratory  analyses,  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). 

3. 

4. 

5. 

6. 

7. 

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Article 34 
Second expert opinion 

1. 

The  competent  authorities  shall  ensure  that  operators,  whose  animals  or  goods  are 
subject  to  sampling,  analysis,  test  or  diagnosis  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 diagnosis by another expert; 

(b)  where  relevant  and  technically  feasible,  having  regard  in  particular  to  the 
prevalence  and  distribution  of  the  hazard  in  the  animals  or  goods,  to  the 
perishability  of  the  samples  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. 

The  application  by  the  operator  for  a  second  expert  opinion  in  accordance  with 
paragraph  1  shall  not  affect  the  obligation  of  competent  authorities  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  referred  to  in  Article  1(2)  and  with  this 
Regulation. 

The Commission may, by means of implementing 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  the  examination  procedure  referred  to  in 
Article 141(2). 

Article 35 
Sampling of animals and goods offered for sale by means of distance communication 

In  the  case  of  animals  and  goods  offered  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. 

Competent authorities shall take all steps to ensure that the operators from whom the 
samples are ordered in accordance with paragraph 1: 

(a) 

are  informed  that  such  samples  are  being  taken  in  the  context  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 paragraph 1 are analysed or tested, are entitled 
to  exercise  the  right  to  apply  for  a  second  expert  opinion  provided  for  in 
Article 34(1). 

2. 

3. 

1. 

2. 

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Article 36 
Designation of official laboratories  

1. 

2. 

The  competent  authorities  shall  designate  official  laboratories  to  carry  out  the 
laboratory analyses, tests and diagnoses on samples taken during official controls and 
other  official  activities,  in  the  Member  State  in  whose  territory  those  competent 
authorities operate or in another Member State. 

Competent  authorities  may  designate  as  official  laboratory  a  laboratory  located  in 
another Member State subject to compliance 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 inspections to the competent authorities of the 
Member State where the laboratory 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) 

(b) 

(c) 

the tasks that the laboratory shall carry out as official laboratory; 

the conditions under which it shall carry out those tasks; 

the  arrangements  necessary  to  ensure  efficient  and  effective  coordination  and 
collaboration between the laboratory and the competent authorities. 

4. 

The  competent  authorities  may  only  designate  as  official  laboratory  a  laboratory 
which: 

(a)  has the expertise, equipment and infrastructure required to carry out analyses or 

tests or diagnoses on samples; 

(b)  has a sufficient number of suitably qualified, trained and experienced staff; 

(c) 

(d) 

is impartial and free from any conflict of interest as regards the exercise of its 
tasks as official laboratory; 

can deliver timely the results of the analysis, test or diagnosis carried out on the 
samples taken during official controls and other official activities; 

(e)  operates  in  accordance  with  the  standard  EN ISO/IEC  17025  on  'General 
requirements for the competence of testing and calibration laboratories' and is 
assessed  and  accredited  in  accordance  with  that  standard  by  a  national 
accreditation body operating in accordance with Regulation (EC) No 765/2008. 

5. 

The scope of the assessment and accreditation of an official laboratory referred to in 
point (e) of paragraph 4: 

(a) 

shall include all the methods of laboratory 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 laboratory 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 methods in addition to those methods, on 

EN 

61 

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the basis of the laboratory's own validations 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,  infrastructure  and  staff  necessary  to  perform  new  or 
particularly  uncommon  laboratory  analyses,  tests  or  diagnoses,  the  competent 
authorities may request a laboratory or diagnostic centre which does not comply with 
one  or  more  of  the  requirements  of  paragraphs  3  and  4  of  this  Article  to  carry  out 
those analyses, tests and diagnoses. 

Article 37 
Obligations of official laboratories 

Official  laboratories  shall  immediately  inform  the  competent  authorities  where  the 
results  of  an  analysis,  test  or  diagnosis  carried  out  on  samples  indicate  non-
compliance or point to the likelihood of non-compliance by an operator. 

Upon  request  by  the  European  Union  reference  laboratory  or  national  reference 
laboratory,  official  laboratories  shall  take  part  in  inter-laboratory  comparative  tests 
organised for the analyses, tests or diagnoses they perform as official laboratories. 

Official laboratories shall  make  available  to  the  public the  list  of  methods  used  for 
analyses,  tests  or  diagnoses  performed  in  the  context  of  official  controls  and  other 
official activities. 

Article 38 
Audits and inspections of official laboratories 

The  competent  authorities  shall  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. 

The competent authorities shall immediately withdraw the designation 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) 

(b) 

(c) 

it no longer complies with the conditions provided for in Article 36(4) and (5); 

it does not comply with the obligations provided for in Article 37; 

it  is  underperforming  at  inter-laboratory  comparative  tests  referred  to  in 
Article 37(2). 

1. 

2. 

3. 

1. 

2. 

Article 39 
Derogations from the condition for the mandatory 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 irrespective of whether they fulfil the condition 
provided for in that point: 

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(a) 

laboratories: 

(i)  whose sole activity is the detection of Trichinella in meat; 

(ii) 

(iii) 

that  only  use  for  the  detection  of Trichinella  the  methods  referred  to  in 
Article  6  of  Commission  Regulation  (EC)  No  2075/2005  laying  down 
specific rules on official controls for Trichinella in meat50; 

that  carry  out  the  detection  of  Trichinella  under  the  supervision  of  the 
in 
competent  authorities  or  of  an  official 
accordance with Article 36(1), and assessed 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; 

laboratory  designated 

(b) 

(c) 

laboratories carrying out analyses or tests to verify compliance with the rules 
on plant reproductive material referred to in point (h) of Article 1(2); 

laboratories which only carry out analyses, tests or diagnoses in the context of 
other official activities, provided that they: 

(i) 

(ii) 

only use the methods of laboratory analysis, test and diagnosis referred to 
in Article 33(1) and points (a), (b) and (c) of Article 33(2); 

carry  out  the  analyses,  tests  or  diagnoses  under  the  supervision  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  assurance  system  in  place  to  ensure  sound  and  reliable 
results from the methods for laboratory analysis, test and diagnosis used. 

2. 

3. 

Where  the  methods  used  by  the  laboratories  referred  to  in  point  (c)  of  paragraph  1 
require  confirmation  of  the  result  of  the  laboratory  analysis,  test  or  diagnosis,  the 
confirmatory laboratory analysis, test or diagnosis shall be carried out by an official 
laboratory which complies with the requirements of point (e) of Article 36(4). 

The  official  laboratories  designated  in  accordance  with  points  (a)  and  (c)  of 
paragraph 1 shall be located in the Member States in whose territory the competent 
authorities which have designated them are located. 

Article 40 
Powers to adopt derogations from the condition 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  conditions  under  which,  competent  authorities  may 
designate as official laboratories in accordance with Article 36(1) laboratories which do not 
fulfil the conditions referred 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. 

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(a) 

(b) 

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; 

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 for 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  official  laboratory  as  official  laboratory  in 
accordance with Article 36(1) for the use of a method of laboratory 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 accreditation obtained by the official laboratory; or, 

(c) 

in cases where the need for the use of the method results from an emergency 
situation or an emerging risk to human, animal or plant health, animal welfare 
or, as regards GMOs and plant protection products, to the environment. 

2. 

The  temporary  designation  referred  to  in  paragraph  1  shall  be  subject  to  the 
following conditions: 

(a) 

(b) 

the official laboratory is already accredited 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; 

a quality assurance system is in place in the official laboratory 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  carried  out  under  the  supervision  of  the 
competent authorities or the national reference laboratory for that method. 

3. 

4. 

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. 

The  official  laboratories  designated  in  accordance  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. 

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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 subject to specific official controls at borders 

1. 

The  competent  authorities  shall  perform  official  controls  regularly  on  animals  and 
goods entering the Union to ascertain compliance 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 appropriate frequency, taking into account: 

(a) 

the risks to human, animal or plant health, animal welfare or, as regards GMOs 
and  plant  protection  products,  to  the  environment,  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 and establishment of origin; 

(ii)  of the exporter; 

(iii)  of the operator responsible for the consignment; 

(c) 

(d) 

the  controls  that  have  already  been  performed  on  the  animals  and  goods 
concerned; 

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  referred  to  in  Article  1(2)  or  with 
requirements recognised to be at least equivalent thereto. 

2. 

The official controls provided for in paragraph 1 shall be performed at an appropriate 
place within the customs territory of the Union, including: 

(a) 

(b) 

(c) 

(d) 

the point of entry into the Union; 

a border control post; 

the point of release for free circulation in the Union; 

the  warehouses  and  the  premises  of  the  operator  responsible  for  the 
consignment. 

3. 

The competent authorities at border control 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  may  pose  a  risk  to  human,  animal  or  plant 
health,  animal  welfare  or,  as  regards  GMOs  and  plant  protection  products,  to  the 
environment: 

(a)  means of transport, including where empty; 

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(b)  packaging. 

4. 

The  competent  authorities  may  also  perform  official  controls  on  goods  that  are 
placed  under  one  of  the  customs  procedures  defined  in  points  (a)  to  (g)  of 
Article 4(16) of Council Regulation (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 referred to in Article 42(1) shall: 

(a) 

(b) 

always include a documentary check; 

include identity and physical checks depending on the risk to human, animal or 
plant  health,  animal  welfare  or,  as  regards  GMOs  and  plant  protection 
products, to the environment. 

2. 

3. 

4. 

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. 

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)  and  (2)  and  70(1)  and  (2)  shall 
apply. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  the  cases  where  and  the  conditions  under  which  competent 
authorities  may  request  operators  to  notify  the  arrival  of  certain  goods  entering  the 
Union. 

Article 44 
Samples taken on animals and goods not subject to specific official controls at borders 

1. 

Where samples on animals and goods are taken, 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 means of implementing acts: 

(a) 

(b) 

establish the mechanisms necessary to ensure the traceability of the animals or 
goods referred to in point (b) of paragraph 1; 

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). 

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SECTION II 
OFFICIAL CONTROLS AT BORDER CONTROL POSTS ON  
ANIMALS AND GOODS 

Article 45 
Animals and goods subject to official controls 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, germinal 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  certain  third  countries  for  which  the  Commission  has 
decided, by means of implementing acts provided for in point (b) of paragraph 
2,  that  a  measure  requiring  a  temporary  increase  of  official  controls  at  their 
entry into the Union is necessary 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  the  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,  please  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  rules  referred  to  in  Article  1(2),  which 
require that compliance with those conditions or measures be ascertained at the 
entry of the animals or goods into the Union. 

2. 

The Commission shall, by means of implementing acts: 

(a) 

establish  lists  detailing  the  animals  and  goods  belonging  to  the  categories 
referred to in points (a) and (b) of paragraph 1, indicating their codes from the 
Combined Nomenclature; 

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(b) 

establish the list of goods belonging to the category referred to in point (d) of 
paragraph  1,  indicating  their  codes  from  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). 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning amendments of the categories of consignments 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. 

Unless  otherwise  provided  by  the  acts  establishing  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. 

3. 

4. 

Article 46 
Animals and goods exempted from official controls at border control posts 

The Commission shall be empowered to adopt delegated 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 exempted from the provisions of Article 45: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

1. 

goods sent as commercial or trade samples or as display items for exhibitions, which 
are not intended to be placed on the market; 

animals and goods intended for scientific purposes; 

goods on board means of transport operating internationally which are not unloaded 
and are intended for consumption by the crew and passengers; 

goods which form part of passengers personal luggage and are intended for personal 
consumption; 

small  consignments  of  goods  sent  to  natural  persons  which  are  not  intended  to  be 
placed on the market; 

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]; 

goods  which  have  undergone  heat  treatment  and  do  not  exceed  quantities  to  be 
defined in those delegated acts; 

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  

The competent authorities shall perform official 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. 

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2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

All consignments of the categories of animals and goods referred to in Article 45(1) 
shall be subject to documentary and identity checks. 

Physical checks shall be performed on consignments of the categories of animals and 
goods referred to in Article 45(1) at a frequency 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. 

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  supervision  of,  staff  possessing  appropriate 
qualifications  in  veterinary  or  phytosanitary  matters  respectively,  designated  by  the 
competent authorities for that purpose. 

Where such checks are performed on animals they shall be carried out by an official 
veterinarian or under his supervision. 

The  competent  authorities  at  border  control  posts  shall  systematically  perform 
official  controls  on  consignments  of  animals  being  transported  and  on  means  of 
transport to verify compliance with the animal welfare requirements laid down in the 
rules  referred  to  in  Article  1(2).  Arrangements  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. 

The  Commission  may,  by  means  of  implementing  acts  establish  the  modalities  of 
presentation of consignments of the categories 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  consignment,  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 accompanying consignments and split consignments 

The  original  official  certificates  or  documents,  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 authorities of the border control post. 

The  competent  authorities  of  the  border  control  post  shall  issue  the  operator 
responsible for the consignment with an authenticated paper 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. 

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). 

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Article 49 
Specific rules for official controls at border control posts 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning rules to establish: 

(a) 

(b) 

(c) 

(d) 

the cases where and the conditions under which the competent authorities of a border 
control  post  may  authorise  the  onward  transportation  of  consignments  of  the 
categories  of  animals  and  goods  referred  to  in  Article  45(1)  to  the  place  of  final 
destination  pending  the  availability  of  the  results  of  physical  checks,  where  such 
checks are required; 

the  time  limits  and  modalities  for  carrying  out  documentary,  identity  and  physical 
checks on transhipped consignments of the categories of goods referred to in Article 
45(1); 

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 first arrival into the Union; 

the  cases  where  and  the  conditions  under  which  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  performed  at  border  control  posts  on  such 
consignments,  including  the  cases  and  conditions  for  their  storage  in  specially 
approved free or customs warehouses. 

Article 50 
Details of documentary, identity and physical checks 

For  the  purposes  of  ensuring  the  uniform  implementation  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 ensure 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  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  rules  establishing  the  cases  where  and  the  conditions  under 
which: 

(a) 

identity and physical checks on consignments 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  control  posts  provided  that  those  control 
points  comply  with  the  requirements  provided  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  post  of  first  arrival  may  be  performed  at 
another border control post in a different Member State;  

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(c) 

specific control tasks relating to the following may be attributed by competent 
authorities to customs authorities or other public authorities: 

(i) 

consignments referred to in Article 63(2); 

(ii)  passengers personal luggage; 

(iii)  goods ordered by distance selling. 

2. 

1. 

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  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning rules establishing 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  consignments  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  adopt  delegated  acts  in  accordance  with 
Article 139 concerning rules establishing: 

(a) 

the  criteria  and  the  procedures  for  determining  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 Article 45(1) and to 
adjust them to the level of risk associated with those categories, having regard 
to: 

(i) 

(ii) 

information  collected  by 
Article 124(1); 

the  Commission 

in  accordance  with 

the outcome of controls performed 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) 

(c) 

the conditions under which Member States may increase the frequency rates of 
physical checks established in accordance with point (a) so as to take account 
of local risk factors; 

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. 

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3. 

The Commission shall, by means of implementing acts, lay down rules establishing: 

(a) 

(b) 

the frequency of physical checks for the categories of goods referred to in point 
(d) of Article 45(1); 

the  frequency  of  physical  checks  for  the  categories  of  animals  and  goods 
referred  to in  points (e)  and (f) of Article 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. 

2. 

A  decision  shall  be  taken  by  the  competent  authorities  on  each  consignment  of  the 
categories  of  animals  and  goods  referred  to  in  Article  45(1)  following  the 
performance  of  official  controls,  indicating  whether  the  consignment  is  in 
compliance  with  the  rules  referred  to  in  Article  1(2)  and,  where  relevant,  the 
applicable customs procedure. 

Decisions taken following a physical check to verify compliance with animal health 
and  welfare  requirements  or  with  plant  health  requirements  shall  be  taken  by  staff 
possessing  appropriate  qualifications 
in  veterinary  or  phytosanitary  matters 
respectively, and designated by the competent authorities for that purpose. 

Decisions  on  consignments  of  animals  shall  be  taken  by  an  official  veterinarian  or 
under his supervision. 

Article 54 
Use of the Common Health Entry Document by the operator and by the competent authorities 

1. 

For  each  consignment  of  the  categories  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 consignments of the categories of animals and 
goods  referred  to  in  Article  45(1)  in  order  to  give  prior  notification  to  the 
competent  authorities  of  the  border  control  post  of  the  arrival  of  those 
consignments; 

(b)  by the competent authorities of the border control post, in order to: 

(i) 

(ii) 

record the outcome of the official controls performed and any decisions 
taken on that basis, including the decision to reject a consignment; 

communicate  the  information  referred  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 authorities of the border control post prior to the 
physical arrival of the consignment into the Union. 

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4. 

The competent authorities of the border control post shall finalise the CHED as soon 
as: 

(a) 

(b) 

(c) 

all official controls required by Article 47(1) have been performed; 

the results from physical checks, where such checks are required, are available; 

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  categories  of  animals  and  goods  referred  to  in 
Article 45(1) under supervision or control by the customs authorities, including the 
entry  or  handling  in  free  zones  or  customs  warehouses,  shall  be  subject  to  the 
presentation by the operator to the custom authorities 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 circulation of a consignment upon presentation 
of  a  duly  finalised  CHED  which  confirms  that  the  consignment  is  in 
compliance with the rules referred 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  consignment  and  immediately  notify  the  competent 
authorities  of  the  border  control  post.  The  competent  authorities  shall  take  the 
necessary measures in accordance with Article 64(5). 

Article 56 
Format, time requirements and specific rules for the use of the Common Health Entry 
Document 

1. 

The Commission shall, by means of implementing acts, lay down rules establishing: 

(a) 

(b) 

the format of the CHED and the instructions for its presentation and use; 

the  minimum  time  requirements  for  prior  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  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  rules  establishing  the  cases  where  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. 

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1. 

2. 

3. 

4. 

1. 

Article 57 
Designation of border control posts 

Member  States  shall  designate  border  control  posts  for  the  purpose  of  performing 
official controls on one or more of the categories of animals and goods referred to in 
Article 45(1). 

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. 

Within  three  months  of  receiving  the  notification  referred  to  in  paragraph  2,  the 
Commission shall inform the Member State: 

(a)  whether the designation of the proposed border control 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. 

The  Member  State  shall  delay  designating  the  border  control  post  until  the 
favourable outcome of the control has been communicated to it by the Commission. 

Article 58 
Listing of border control posts 

Each  Member  State  shall  make  available  on  the  Internet  up-to-date  lists  of  border 
control  posts  on  its  territory,  providing  the  following  information  for  each  border 
control post: 

(a) 

(b) 

(c) 

(d) 

(e) 

its contact details and opening hours; 

its exact location and whether it is a port, airport, rail or road entry point; 

the  categories  of  animals  and  goods  referred  to  in  Article  45(1)  which  are 
included in the scope of its designation; 

the equipment and premises available for performing official controls on each 
of the categories of animals and goods for which it is designated; 

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  implementing  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). 

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Article 59 
Withdrawal of approvals for, and re-designation of, existing border control entities 

1. 

2. 

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  entry  in  accordance  with  Article  5  of  Regulation  (EC) 
No 669/2009  and  with  Article  13(c)(4)  of  Council  Directive  2000/29/EC  shall  be 
withdrawn. 

Member States may re-designate border inspection posts, designated points of entry 
and points of entry referred to in paragraph 1 as border control posts in accordance 
with Article 57(1) provided that the minimum requirements referred to in Article 62 
are complied with. 

3. 

Article 57(2) and (3) shall not apply to the re-designation referred to in paragraph 2. 

Article 60 
Withdrawal of the designation 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  provided  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. 

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. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning the cases where, and the procedures by which, border control 
posts whose designation has only been partially 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 designation of border control posts 

A Member State shall immediately suspend the designation of a border control post 
and order its activities to be stopped, for all 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 health, animal welfare or, as regards GMOs and 
plant protection products, to the environment. 

Member  States  shall  immediately  inform  the  Commission  and  the  other  Member 
States of any suspension of the designation of a border control post and the reasons 
for such a suspension. 

Member  States  shall  indicate  the  suspension  of  the  designation  of  a  border  control 
post in the lists referred to in Article 58(1). 

Member States shall remove the suspension provided for in paragraph 1 as soon as: 

2. 

3. 

1. 

2. 

3. 

4. 

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(a) 

(b) 

the competent authorities are satisfied that the risk referred to in paragraph 1 no 
longer exists; 

they  have  communicated  to  the  Commission  and  to  the  other  Member  States 
the information on the basis of which the suspension is removed. 

The Commission may, by means of implementing acts, establish procedures for the 
exchanges  of  information  and  communications  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 

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 Article 38(1) of Regulation (EEC) No 2913/92. 

The  Commission  shall  be  empowered  to  adopt  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 from the point of entry into the Union given 
specific geographical constraints. 

5. 

1. 

2. 

3. 

Border control posts shall have: 

(a) 

a sufficient number of suitably qualified staff; 

(b)  premises  appropriate  for  the  nature  and  volume  of  the  categories  of  animals 

and goods handled; 

(c) 

(d) 

(e) 

(f) 

(g) 

equipment and premises to allow the performance of official controls for each 
of  the  categories  of  animals  and  goods  for  which  the  border  control  post  has 
been designated; 

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; 

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 unforeseeable and unexpected conditions or 
events; 

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; 

access  to  the  services  of  official  laboratories  capable  of  providing  analytical, 
testing  and  diagnostic  results  within  appropriate  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; 

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(h) 

appropriate  arrangements  for  the  proper  handling  of  different  categories  of 
animals  and  goods  and  to  prevent  risks  which  may  result  from  cross-
contamination; 

(i) 

arrangements to comply with relevant biosecurity 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 specific 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 

1. 

2. 

3. 

4. 

5. 

Article 63  
Suspicion of non-compliance and intensified official controls 

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. 

Consignments of animals and goods which are not declared by operators to consist of 
the categories of animals and goods referred to in Article 45(1), shall be subject to 
official  controls  by  the  competent  authorities  where  there  is  reason  to  believe  that 
such categories of animals or goods are present in the consignment. 

The  competent  authorities  shall  place  the  consignments  referred  to  in  paragraphs  1 
and  2  under  official  detention  until  they  obtain  the  results  of  the  official  controls 
provided for in those paragraphs. 

Where appropriate, those consignments shall be isolated or quarantined and animals 
shall  be  sheltered,  fed,  watered  and  treated  pending  the  results  of  the  official 
controls. 

Where the competent authorities have reasons to suspect fraudulent behaviour by an 
operator  or  official  controls  give  grounds  to  believe  that  the  rules  referred  to  in 
Article  1(2)  have  been  seriously  or  repeatedly  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. 

The  competent  authorities  shall  notify  the  Commission  and  the  Member  States 
through  the  TRACES  system  of  their  decision  to  perform  intensified  official 
controls,  as  provided  for  in  paragraph  4,  indicating  the  purported  fraudulent 
behaviour or serious or repeated infringement. 

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6. 

The Commission shall, by means of implementing acts, establish procedures for the 
coordinated performance by competent authorities 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). 

1. 

2. 

3. 

Article 64  
Measures to be taken in cases of non-compliant consignments  
entering the Union from third countries 

The  competent  authorities  shall  place  under  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  appropriate  conditions  pending  any 
further decision. 

The Commission shall, by means of implementing 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). 

Having,  where  possible,  heard  the  operator  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) 

(c) 

re-dispatch the consignment outside the Union in accordance with Article 70(1) 
and (2); or 

subject the consignment to special treatment 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 appropriate, destines the consignment for 
purposes other than those for which it was originally intended. 

4. 

The competent authorities shall immediately notify any decision to refuse entry of a 
consignment  as  provided  for  in  paragraph  1  and  any  order  issued  pursuant  to 
paragraphs 3 and 5 and Article 65 to: 

(a) 

(b) 

(c) 

(d) 

(e) 

the Commission; 

the competent authorities of the other Member States; 

the customs authorities; 

the competent authorities of the third country of origin; 

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 animals or goods referred to in Article 45(1) is 
not presented for the official controls referred to in that Article, or is not presented in 
accordance with the requirements laid down in Articles 48(1) and (3), 54(1), (2) and 

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(3),  or  with  the  rules  adopted  pursuant  to  Articles  46,  47(6),  49,  51(1)  and  56,  the 
competent  authorities  shall  order  that  it  be  retained  or  recalled,  and  placed  under 
official detention without delay. 

Paragraphs 1, 3 and 4 of this Article shall apply to such consignments. 

Article 65  
Measures to be taken on animals or goods entering the Union from third countries presenting 
a risk 

Where  official  controls  indicate  that  a  consignment  of  animals  or  goods  presents  a  risk  to 
human,  animal  or  plant  health,  animal  welfare  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  consignment  in  question  under  official  detention 
and shall, without delay: 

(a) 

(b) 

order  that  the  operator  destroy  the  consignment  in  compliance,  where  appropriate, 
with the rules referred to in Article 1(2), taking all the measures necessary to protect 
human, animal or plant health, animal welfare or the environment; or  

subject  the  consignment  to  special  treatment  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) 

(b) 

the  official  certificates  and  other  documents  accompanying 
invalidate 
consignments  which  have  been  subject  to  measures  pursuant  to  Article  64(3) 
and (5) and Article 65; 

cooperate in accordance with Title IV to take any further measures necessary to 
ensure that it is not possible to reintroduce 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  official  controls  were 
performed  shall  supervise  the  application  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 measures ordered by the competent authorities 

1. 

The operator shall carry out all the measures ordered by the competent authorities in 
accordance with Article 64 (3) and (5) and 65 without delay and, at the latest, within 

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60  days  from  the  day  on  which  the  competent  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) 

(b) 

that the consignment be destroyed or subject to any other appropriate measure; 

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 plant health, animal welfare 
or the environment. 

3. 

The competent authorities may extend the period referred to in paragraphs 1 and 2 of 
this Article for the time necessary to obtain the results of the second expert opinion 
referred  to  in  Article  34,  provided  that  this  is  without  adverse  effects  to  human, 
animal and plant health, animal welfare and, as regards GMOs and plant protection 
products, to the environment.  

Article 68  
Consistency of application of Articles 64 and 65 

The Commission shall, by means of implementing acts, lay down rules to ensure consistency 
across all border control posts referred to in Article 57(1) and control points referred to in in 
point (a) of Article 51(1) of decisions 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 common 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 provided for in point (c) of Article 64(3) and 
point (b) of Article 65 may, as appropriate, include: 

(a) 

treatment  or  processing,  including  decontamination,  where  appropriate,  but 
excluding dilution, so that the consignment complies with the requirements of 
the rules referred to in Article 1(2), or with the requirements of a third country 
of re-dispatch; 

(b) 

treatment in any other manner suitable for 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  the  elimination  of  any  risk  to  human, 
animal  or  plant  health,  animal  welfare  or,  as  regards  GMOs  and  plant 
protection products, to the environment; 

(b)  be documented and carried out under the control of the competent authorities; 

(c) 

comply with the requirements laid down in the rules referred to in Article 1(2). 

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3. 

The  Commission  shall  be  empowered  to  adopt  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  adopted  by  delegated  act,  such  special  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) 

(b) 

the  destination  has  been  agreed  with  the  operator  responsible  for  the 
consignment; 

the operator responsible for the consignment has first informed the competent 
authorities  of  the  third  country  of  origin  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  country  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. 

The conditions of points (b) and (c) of paragraph 1 shall not apply to consignments 
of the categories of goods referred to in point (c) of Article 45(1). 

The  Commission  shall,  by  means  of  implementing  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 

The Commission may, by means of implementing 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  referred  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. 

3. 

1. 

2. 

The approval provided for in paragraph 1 shall specify: 

(a) 

the maximum frequency of official controls to be performed by the competent 
authorities of Member States at the entry of the consignments into the Union, 

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where there is no reason to suspect non-compliance with the rules referred to in 
Article 1(2) or fraudulent behaviour; 

the official certificates that must accompany consignments entering the Union; 

a model for such certificates; 

the competent authorities of the third country under the responsibility of which 
pre-export controls must be performed; 

(b) 

(c) 

(d) 

(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  appropriate,  a  Commission  control  performed  in 
accordance with Article 119, demonstrate that the system of official controls in that 
third country can ensure that: 

(a) 

(b) 

the  consignments  of  the  animals  or  goods  exported  to  the  Union  meet  the 
requirements of the rules referred to in Article 1(2), or equivalent requirements; 

the  controls  performed  in the third country prior  to dispatch  to the Union are 
sufficiently  effective  to  replace  or  reduce  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 delegated body specified in the approval shall: 

5. 

1. 

(a)  be responsible for contacts with the Union; 

(b) 

ensure  that  the  official  certificates  referred  to  in  point  (b)  of  paragraph  2 
accompany each consignment controlled. 

The  Commission  shall  by  means  of  implementing  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 referred to in Article 141(2). 

Article 72 
Non-compliance with, and withdrawal of, the approval of pre-export controls  
performed by third countries 

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-compliances  with  the  rules  referred  to  in 
Article 1(2), Member States shall immediately: 

(a)  notify the Commission and the other Member 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  controls  on  consignments  from  the  relevant 
third country and, where necessary to allow a proper analytical examination of 
the situation, detain a reasonable number of samples under appropriate storage 
conditions. 

2. 

The  Commission  may,  by  means  of  implementing  acts,  withdraw  the  approval 
provided  for  in  Article  71(1)  where,  following  the  official  controls  referred  to  in 

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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 consignments entering the Union from third 
countries 

1. 

Competent  authorities,  customs  authorities  and  other  authorities  of  the  Member 
States  shall  cooperate  closely  to  ensure  that  the  official  controls  performed  on 
consignments of animals and goods entering 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  information  which  is  relevant  for  the 
organisation and conduct of their respective activities in relation to animals and 
goods entering the Union; 

(b) 

ensure  the  timely  exchange  of  such  information,  including  via  electronic 
means. 

2. 

The Commission shall, by means of implementing acts, adopt uniform rules on the 
cooperation  arrangements  that  competent  authorities,  customs  authorities  and  other 
authorities referred to in paragraph 1 are required to put in place to ensure: 

(a) 

(b) 

access by competent authorities to the information 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  border  control  post  in 
accordance with Article 45(1); 

the reciprocal update, through exchanges of information or synchronisation of 
relevant  data  sets,  of  information  gathered  by  competent  authorities,  customs 
authorities  and  other  authorities  on  consignments  of  animals  and  goods 
entering the Union; 

(c) 

the swift communication of decisions taken 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 consignments 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. 

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2. 

3. 

4. 

5. 

Customs authorities shall suspend release for 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 competent authorities of such suspension.  

A  consignment  whose  release  for  free  circulation  has  been  suspended  pursuant  to 
paragraph  2  shall  be  released  if,  within  three  working  days  of  the  suspension  of 
release, the competent authorities have not requested customs authorities to continue 
the suspension or have informed customs authorities that no risk is present.  

Where  the  competent  authorities  consider  that  a  risk  to  human,  animal  or  plant 
health,  animal  welfare  or,  as  regards  GMOs  and  plant  protection  products,  to  the 
environment, is present:  

(a) 

they  shall  instruct  the  customs  authorities  not  to  release  the  consignment  for 
free  circulation  and  to  include  the  following  statement  on  the  commercial 
relevant 
invoice  accompanying 
accompanying document: 

the  consignment  and  on  any  other 

'Product  presents  a  risk  —  release  for  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. 

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 consignment may present a risk to human, animal 
or plant health, animal welfare or, as regards 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 controls and for measures to be taken following the performance of 
such controls 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning rules for the performance of specific official controls and for 
the adoption of measures in cases of non-compliance, to account for the specificities 
of  the  following  categories  of  animals  and  goods  or  their  transport  modalities  and 
means: 

(a) 

consignments  of  fresh  fishery  products  directly  landed  in  ports  designated  by 
Member  States  in  accordance  with  Article  5(1)  of  Council  Regulation  (EC) 
No 1005/2008  of  29  September  2008  establishing  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 

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601/2004  and  repealing  Regulations  (EC)  No  1093/94  and  (EC)  No 
1447/199951 from a fishing vessel flying a third country flag; 

(b) 

(c) 

consignments of unskinned, furred wild game; 

consignments of the categories of goods referred to in point (b) of Article 45(1) 
which  are  delivered,  with  or  without  storage  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) 

(f) 

feed  and  food  accompanying  animals  and  intended  for  the  feeding  of  those 
animals; 

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 performance 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) 

(i) 

(j) 

consignments of the categories of animals and goods referred to in points (a), 
(b)  and  (c)  of  Article  45(1)  originating  from,  and  returning  to,  the  Union 
following a refusal of entry by a third country; 

goods entering the Union in bulk from a third country, irrespective of whether 
they all originate from that third country; 

consignments of goods referred to in Article 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  territory  of  Croatia  via  the  points  of 
entry at Klek or Zaton Doli; 

(k) 

animals and goods exempted from the provisions of Article 45 in accordance 
with Article 46. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  the  conditions  for  monitoring  the  transport  and  arrival  of 
consignments of certain animals and goods, from 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 implementing 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). 

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1. 

2. 

3. 

4. 

1. 

Chapter VI 
Financing of official controls and other official activities 

Article 76 
General rules 

Member States shall ensure that adequate financial resources are available to provide 
the  staff  and  other  resources  necessary  for  the  competent  authorities  to  perform 
official controls and other official activities. 

In addition to the fees collected in accordance with Article 77, Member States may 
collect fees to cover costs occasioned by official controls other than those referred to 
in Article 77(1) and (2). 

This Chapter also applies in the case of delegation of specific official control tasks in 
accordance with Article 25. 

Member  States  shall  consult  the  operators  concerned  on  the  methods  used  to 
calculate the fees provided for in Article 77. 

Article 77 
Mandatory fees 

For  the  purpose  of  ensuring  that  competent  authorities  are  provided  with  adequate 
resources  for  the  performance  of  official  controls,  the  competent  authorities  shall 
collect fees to recover the costs they incur in relation to: 

(a)  official controls performed to verify that the following operators comply with 

the rules referred to in Article 1(2): 

(i) 

(ii) 

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; 

feed  business  operators  as  defined  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,  please  insert  number  of 
the Regulation on protective measures against pests of plants]; 

(iv)  professional operators as defined in point (6) of Article 3 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]; 

(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 verify that the conditions are met: 

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(i) 

(ii) 

(iii) 

to  obtain  and  maintain  the  approval  provided  for  in  Article  6  of 
Regulation (EC) No 852/2004 or in Articles 9 and 10 of Regulation (EC) 
No 183/2005; 

to obtain and maintain the authorisation referred to in Articles 84, 92 and 
93  of  Regulation  (EU)  No  XXX/XXXX  [Office  of  Publications,  please 
insert number of the Regulation on protective measures against pests of 
plants]; 

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  competent  authorities  at  the  border  control 

posts or at the control points referred to in point (a) of Article 51(1). 

For the purposes of paragraph 1, the official controls referred to in point (a) of that 
paragraph  shall  include  official  controls  performed  to  verify  compliance  with 
measures  adopted  by  the  Commission  in  accordance  with  Article  137  of  this 
Regulation, Article 53 of Regulation (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 the 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. 

2. 

3. 

For the purposes of paragraph 1: 

(a) 

the official controls referred to in point (a) of that paragraph shall not include 
official  controls  performed  to  verify  compliance  with  temporary  restrictions, 
requirements  or  other  disease  control  measures  adopted  by  the  competent 
authorities in accordance with Articles 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,  please  insert  number  of  the 
Regulation  on  animal  health]  and  Article  16  of  Regulation 
(EU) 
No XXX/XXXX  [Office  of  Publications,  please  insert  number  of  the 
Regulation on protective measures against pests of plants]; 

(b) 

the official controls referred to in point (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, involved in the performance of 
official controls, their social security, pension and insurance costs; 

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(b) 

(c) 

(d) 

the  cost  of  facilities  and  equipment,  including  maintenance  and  insurance 
costs; 

the cost of consumables, services and tools; 

the  cost  of  training  of  staff  referred  to  in  point  (a),  with  the  exclusion  of  the 
training necessary to obtain the qualification 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 laboratory 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  from  the  official  controls  referred  to  in 
Article 77(1) shall be considered for the calculation of the fees. 

1. 

Fees collected in accordance with Article 77 shall be: 

Article 79 
Calculation of fees 

(a) 

established  at  a  flat-rate  on  the  basis  of  the  overall  costs  of  official  controls 
borne by the competent authorities over a given period of time, and applied to 
all  operators  irrespective  of  whether  any  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  shall  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  costs  of  each  individual  official  control, 
and applied to the operators subject to such official 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  the  time  employed  by  the  staff  of  the 
competent authorities to perform the official controls. 

Travel  costs  as  referred  to  in  point  (e)  of  Article  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. 

Where  fees  are  calculated  in  accordance  with  point  (a)  of  paragraph  1,  the  fees 
collected by competent authorities in accordance with Article 77 shall not exceed the 
overall  costs  incurred  for  the  official  controls  performed  over  the  period  of  time 
referred to in point (a) of paragraph 1. 

2. 

3. 

Article 80 
Reduction of fees for consistently compliant operators 

Where fees are established in accordance with point (a) of Article 79(1), the 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 Article 1(2) as ascertained through official controls, 

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so that fees applied to consistently compliant operators are lower than those applied to other 
operators. 

Article 81 
Application of fees 

1. 

2. 

1. 

2. 

3. 

Operators shall receive proof of the payment of fees provided for in Article 77(1). 

Fees  collected  in  accordance  with  point  (d)  of  Article  77(1)  shall  be  paid  by  the 
operator responsible for the consignment or its representative. 

Article 82 
Fees refunds and exemption for microenterprises 

Fees  provided  for  in  Article  77  shall  not  directly  or  indirectly  be  refunded,  unless 
unduly collected. 

Enterprises  employing  fewer  than  10  persons  and  whose  annual  turnover  or  annual 
balance  sheet  total  does  not  exceed  EUR  2  million  shall  be  exempted  from  the 
payment of the fees provided for in Article 77. 

The costs referred to in Articles 77, 78 and 79 shall not include those incurred for the 
performance of official controls on the enterprises referred to in paragraph 2. 

Article 83 
Transparency 

1. 

The competent authorities shall ensure the highest level of transparency of: 

(a) 

(b) 

(c) 

the method and data used to establish the fees provided for in Article 77(1); 

the use of resources collected through such fees; 

the arrangements in place to ensure an efficient 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) 

(b) 

(c) 

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); 

the amount of the fees provided for in Article 77(1) applied to each category of 
operators, and for each category of official controls; 

the  method  used  to  establish  the  fees  provided  for  in  Article  77(1),  including 
the data and estimates used for the establishment 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 corresponding to the exemption referred to in Article 
82(2). 

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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  following  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; 

official controls performed at the request of the operator; 

corrective action taken by the competent authorities, or by a third party upon request 
by  the  competent  authorities,  where  an  operator  has  failed  to  carry  out  corrective 
action ordered by the competent authorities in accordance with Article 135 to remedy 
the non-compliance; 

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  ordered  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 

In accordance with rules referred to in Article 1(2), official certification shall take the 
form of: 

(a)  official certificates; or, 

(b)  official attestations. 

Where  the  competent  authorities  delegate  specific  tasks  related  to  the  issuance  of 
official certificates or official attestations, or to the official supervision referred to in 
Article 90(1) such delegation shall comply with the provisions of Articles 25 to 32. 

Article 86 
Official certificates 

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. 

Articles 87, 88 and 89 shall also apply to official certificates which are necessary for 
the purposes of exporting consignments of animals and goods to third countries. 

(b) 

(c) 

(d) 

1. 

2. 

1. 

2. 

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Article 87 
Signature and issuance of official certificates 

1. 

2. 

Official certificates shall be issued by the competent authorities. 

Competent  authorities  shall  designate  the  certifying  officers  who  are  authorised  to 
sign official certificates. Certifying 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 officer and issued on one of the 
following grounds: 

(a)  direct  knowledge  by  the  certifying  officer  of  facts  and  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) 

(c) 

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; 

facts  and  data  relevant  for  the  certification  which  were  obtained  from  the 
operators’ own-control systems, complemented and confirmed by results from 
regular  official  controls,  where  the  certifying  officer  is  thus  satisfied  that  the 
conditions for issuing the official certificate are met. 

4. 

Official certificates  shall  be  signed  by  the  certifying  officer  and  issued  only  on  the 
basis of point (a) of paragraph 3 when rules referred to in Article 1(2) so require. 

Article 88 
Guarantees of reliability for 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  languages  of  the  institutions  of  the  Union 
that  is  understood  by  the  certifying  officer  and,  where  relevant,  in  one  of  the 
official languages of the Member State of destination; 

(c)  be authentic and accurate; 

(d) 

(e) 

enable the identification of the person who signed them; 

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 shall take all measures necessary to prevent and penalise 
the  issuance  of  false  or  misleading  official  certificates  or  the  abuse  of  official 
certificates. Such measures shall include where appropriate: 

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(a) 

(b) 

(c) 

the temporary suspension of the certifying officer from its duties; 

the withdrawal of the authorisation to sign official certificates; 

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 official certificates  

The  Commission  may,  by  means  of  implementing  acts,  lay  down  rules  for  the  uniform 
application of Articles 87 and 88 concerning: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

model official certificates and rules for the issuance of such certificates; 

the mechanisms and  the legal and technical arrangements to ensure the issuance of 
accurate and reliable official certificates and prevent risk of fraud; 

the procedures to be followed in the case of withdrawals of official certificates and 
for the production of replacement certificates; 

rules for the production of certified copies of official certificates; 

the  format  of  documents  that  must  accompany  animals  and  goods  after  official 
controls have been performed; 

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) require the issuance of official attestations 
by the operators under the official supervision of the competent 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 languages of the institutions of the Union; 

(c)  where  they  relate  to  a  consignment  or a  lot,  allow  the  verification  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, where the official attestations are issued by 
the  competent  authorities,  the  staff  involved  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; 

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(ii) 

the rules laid down in this Regulation. 

4. 

Competent authorities shall perform regular official controls to verify that: 

(a) 

(b) 

the operators issuing the attestations comply with the conditions laid down in 
the rules referred to in Article 1(2); 

the attestation is issued on the basis of relevant, correct and verifiable facts and 
data. 

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Title III 
Reference laboratories and centres 

Article 91 
Designation of European Union reference laboratories 

1. 

The  Commission  may,  by  means  of  implementing  acts,  designate  European  Union 
reference  laboratories  in  the  areas  governed  by  the  rules  referred  to  in  Article  1(2) 
where  the  effectiveness  of  official  controls  also  depends  on  the  quality,  uniformity 
and reliability of: 

(a) 

(b) 

the methods of analysis, test or diagnosis employed by the official laboratories 
designated in accordance with Article 36(1); 

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 reference laboratories shall: 

(a)  operate  in  accordance  with  the  standard  EN  ISO/IEC  17025  on  ‘General 
requirements for the competence of testing and calibration laboratories’ and be 
assessed  and  accredited  in  accordance  with  that  standard  by  a  national 
accreditation  body,  operating  in  accordance  with  Regulation  (EC)  No 
765/2008; 

(b)  be impartial and free of conflict of interests as regards the exercise of its tasks 

as European Union reference laboratories; 

(c)  have  suitably  qualified  staff  with  adequate  training  in  analytical,  testing  and 
diagnostic techniques applied in their area of competence, and support staff as 
appropriate; 

(d)  possess or have access to the infrastructure, equipment and products necessary 

to carry out the tasks assigned to them; 

(e) 

ensure  that  their  staff  have  good  knowledge  of  international  standards  and 
practices  and  that  the  latest  developments  in  research  at  national,  Union  and 
international level are taken into account in their work; 

(f) 

be equipped to perform their tasks in emergency situations; 

(g)  where relevant, be equipped to comply with relevant biosecurity standards. 

Article 92 
Responsibilities and tasks of European 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 Article 36(1) and of the analytical, testing 
and diagnostic data generated by them. 

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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) 

(c) 

(d) 

coordinating  the  application  by  the  national  reference  laboratories  and,  if 
necessary, by other official laboratories of the methods referred to in point (a), 
in particular, by organising regular inter-laboratory comparative testing and by 
ensuring  appropriate  follow-up  of  such  comparative  testing  in  accordance, 
where available, with internationally accepted protocols; 

coordinating  practical  arrangements  necessary  to  apply  new  methods  of 
laboratory  analysis,  test  or  diagnosis,  and  informing  national  reference 
laboratories of advances in this field; 

conducting  training  courses  for  the  benefit  of  staff  from  national  reference 
laboratories  and,  if  needed,  from  other  official  laboratories,  as  well  as  of 
experts from third countries; 

(e)  providing  scientific  and  technical  assistance  to  the  Commission  within  the 

scope of their mission; 

(f) 

(g) 

(h) 

providing  information  on  relevant  Union,  national  and  international  research 
activities to national reference laboratories; 

collaborating  within  the  scope  of  their  mission  with  laboratories  in  third 
countries  and  with  the  European  Food  Safety  Authority,  the  European 
Medicines  Agency  and  the  European  Centre  for  Disease  Prevention  and 
Control; 

assisting actively in the diagnosis of outbreaks in Member States of foodborne, 
zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory 
diagnosis,  characterisation  and  taxonomic  or  epizootic  studies  on  pathogen 
isolates or pest specimens; 

(i) 

coordinating or performing tests for the verification of the quality of reagents 
used for the diagnosis of animal, zoonotic or foodborne diseases; 

(j)  where relevant for their area of competence, establishing and maintaining: 

(i) 

(ii) 

reference collections of pests of plants or reference strains of pathogenic 
agents; 

reference collections of materials intended to come into contact with food 
used  to  calibrate  analytical  equipment  and  provide  samples  thereof  to 
national reference laboratories; 

(iii)  up-to-date  lists  of  available  reference  substances  and  reagents  and  of 

manufacturers and suppliers of such substances and reagents. 

3. 

European Union reference laboratories shall publish the list of the national reference 
laboratories designated by the Member States in accordance with Article 98(1). 

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Article 93 
Designation of European Union reference centres for plant reproductive material 

1. 

The  Commission  may,  by  means  of  implementing  acts,  designate  European  Union 
reference  centres  that  shall  support  the  activities  of  the  Commission,  the  Member 
States and the European Plant Variety Agency (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 technical 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  infrastructure,  the  equipment  and  the  products 

necessary to carry out the tasks assigned to them; 

(d) 

ensure  that  their  staff  have  good  knowledge  of  international  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 reference centres for plant reproductive material 

The  European  Union  reference  centres  designated  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 technical expertise, within the scope of their mission, on: 

(i) 

field  inspection,  sampling  and  testing  performed  for  the  certification  of  plant 
reproductive material; 

(ii)  post-certification tests of plant reproductive material; 

(iii) 

tests on standard material categories of plant reproductive material; 

organising comparative tests and field trials on plant reproductive material; 

conducting training courses for the benefit of staff of the competent authorities and 
of experts from third countries; 

contributing  to  the  development  of  certification and post-certification test protocols 
for plant reproductive material, and of performance indicators for the certification of 
plant reproductive material; 

disseminating  research  findings  and  technical  innovations  in  the  fields  within  the 
scope of their mission. 

(b) 

(c) 

(d) 

(e) 

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Article 95 
Designation of European Union reference centres for animal welfare 

1. 

The  Commission  may,  by  means  of  implementing  acts,  designate  European  Union 
reference  centres  that  shall  support  the  activities  of  the  Commission  and  of  the 
Member  States  in  relation  to  the  application  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  related  to  animals  and  support  staff  as 
appropriate; 

(c)  possess  or  have  access  to  the  infrastructure,  the  equipment  and  products 

necessary to carry out the tasks assigned to them; 

(d) 

ensure  that  their  staff  have  good  knowledge  of  international  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 Union reference centres for animal welfare 

The  European  Union  reference  centres  designated  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) 

(b) 

(c) 

(d) 

(e) 

providing scientific  and  technical 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; 

providing  scientific  and  technical  expertise  for  the  development  and  application  of 
the animal welfare indicators referred to in point (f) of Article 18(3); 

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; 

carrying  out  scientific  and  technical  studies  on  the  welfare  of  animals  used  for 
commercial or scientific purposes; 

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; 

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(f) 

disseminating  research  findings  and  technical  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 update, whenever necessary, the list of: 

(a)  European Union reference laboratories provided for in Article 91; 

2. 

3. 

4. 

(b)  European Union reference centres for plant reproductive material provided for 

in Article 93; 

(c)  European  Union  reference  centres  for  animal  welfare  provided  for  in 

Article 95. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning the establishment of requirements, responsibilities and tasks 
for the European Union reference laboratories, the European Union reference centres 
for plant reproductive material and the European Union reference centres for animal 
welfare in addition to those laid down in Articles 91(3), 92, 93(3), 95(3) and 96. 

European  Union  reference  laboratories  and  European  Union  reference  centres  shall 
be  subject  to  Commission  controls  to  verify  compliance  with  the  requirements  of 
Articles 91(3), 92, 93(3), 95(3) and 96. 

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  comments  of  the  European  Union  reference 
laboratory or European Union reference centre: 

(a)  withdraw the designation 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 another Member State or in a 
third  country  that  is  a  Contracting  Party  to  the  European  Free  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 interests as regards the exercise of its tasks 

as national reference laboratories; 

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(b)  have  suitably  qualified  staff  with  adequate  training  in  analytical,  testing  and 
diagnostic  techniques  in  their  area  of  competence,  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  knowledge  of  international  standards  and 
practices  and  that  the  latest  developments  in  research  at  national,  Union  and 
international level are taken into account in their work; 

(e)  be equipped to perform their tasks 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  Union  reference  laboratory  and  other 
Member States; and, 

(b)  make that information available to the public; 

(c)  update that information whenever necessary. 

5. 

6. 

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 between them, with other national laboratories 
and with the European Union reference laboratory. 

The  Commission  shall  be  empowered  to  adopt  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 national reference laboratories 

1. 

National reference laboratories shall, in their area of competence: 

(a) 

(b) 

collaborate with the European Union reference laboratories, and participate in 
training  courses  and  in  inter-laboratory  comparative  tests  organised  by  these 
laboratories; 

coordinate the activities of official laboratories designated in accordance with 
Article  36(1)  with  a  view  of  harmonising  and  improving  the  methods  of 
laboratory analysis, test or diagnosis and their use; 

(c)  where appropriate, organise inter-laboratory comparative tests between official 
laboratories,  ensure  an  appropriate  follow-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  implementation of coordinated control plans 
adopted in accordance with Article 111; 

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(f)  where  relevant,  establish  and  maintain  up-to-date  lists  of  available  reference 
substances and reagents and of manufacturers and suppliers of such substances 
and reagents. 

The  Commission  shall  be  empowered  to  adopt  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 

The competent authorities in the Member States concerned shall provide each other 
with  administrative  assistance  in  accordance  with  Articles  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. 

Administrative  assistance  shall  include,  where  appropriate,  participation  by  the 
competent  authorities  of  a  Member  State  in  on-the-spot  official  controls  that  the 
competent authorities of another Member State perform. 

2. 

1. 

2. 

3. 

The provisions of this Title shall 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. 

All communications between competent authorities in accordance with Articles 102 
to 105 shall be in writing. 

In order to streamline and simplify communication exchanges, the Commission shall, 
by means of implementing acts, establish a standard format for: 

(a) 

(b) 

the requests for assistance provided for in Article 102(1); 

the communication of common and recurrent 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 

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. 

The  designation  of  liaison  bodies  shall  not  preclude  direct  contacts,  exchange  of 
information  or  cooperation  between  the  staff  of  competent  authorities  in  different 
Member States. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  the  establishment  of  minimum  requirements  that  liaison 
bodies designated in accordance with paragraph 1 are required to comply with. 

4. 

5. 

1. 

2. 

3. 

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4. 

5. 

6. 

7. 

1. 

2. 

3. 

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 modification of those details. 

The Commission shall publish and update the list of liaison bodies communicated to 
it by the Member States in accordance with paragraph 4 on its website. 

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. 

The  Commission  shall,  by  means  of  implementing  acts,  establish  the  specifications 
of the technical tools and the procedures for communication between 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 

Where  the  competent  authorities  in  a  Member  State  consider  that,  for  the 
performance  of  official  controls  or  for  the  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) 

(b) 

acknowledge receipt of the request without delay; 

indicate  within  ten  days  from  the  date  of  receipt  of  the  request,  the  time 
necessary to provide an informed response to the request; 

(c)  perform official controls or investigations 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 within their jurisdiction. 

Documents may be transmitted in their original form or copies may be provided. 

By  agreement  between  the  requesting  competent  authorities  and  the  requested 
competent  authorities,  staff  designated  by  the  former  may  be  present  during  the 
official controls and investigations referred to in point (c) of paragraph 1 performed 
by the requested competent authorities. 

In such cases the staff of the requesting competent authorities: 

(a) 

(b) 

shall at all times be able to produce written authority stating their identity and 
their official capacity; 

shall  have  access  to  the  same  premises  and  documents  as  the  staff  of  the 
requested  competent  authorities,  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. 

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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) 

(b) 

shall acknowledge receipt of the notification without delay; 

shall indicate within ten days from the date of receipt of the notification: 

(i)  what investigations they intend to carry out; or, 

(ii) 

the reasons why they consider that no investigations are necessary; 

(c)  where  investigations  referred  to  in  point  (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 performed on animals or goods originating in another 
Member State, the competent authorities establish that such animals 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  environment,  or  to  constitute  a  serious  infringement  of 
those rules, they shall, without delay, notify 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 authorities shall without delay: 

(a) 

(b) 

(c) 

acknowledge receipt of the notification; 

indicate what investigations they intend to carry out; 

investigate  the  matter,  take  all  necessary  measures  and  inform  the  notifying 
competent  authorities  of  the  nature  of  the  investigations  and  official  controls 
performed, of the decisions taken and of the reasons for such decisions. 

3. 

If  the  notifying  competent  authorities  have  reason  to  believe  that  the  investigations 
performed  or  the  measures  taken  by  the  notified  competent  authorities  do  not 
adequately  address  the  non-compliance  established,  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  addressing  the  non-compliance, 
including  through  joint  official  controls  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. 

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4. 

1. 

2. 

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  authorities  of  the  other  Member  States 
without delay. 

Article 105 
Assistance by third countries  

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 environment, they shall, without delay: 

(a)  notify  such  information  to  the  competent  authorities  in  other  concerned 

Member States; 

(b) 

communicate  such  information  to  the  Commission  where  it  is  or  may  be 
relevant at Union level. 

Information  obtained  through  official  controls  and  investigations  performed  in 
accordance with this Regulation may be communicated to the third country referred 
to in paragraph 1, provided that: 

(a) 

(b) 

the competent authorities which have provided the information consent to such 
communication; 

the third country has undertaken to provide the assistance necessary to gather 
evidence of practices that are or appear to be non-compliant with Union rules 
or that pose a risk to humans, animals or plants or the environment; 

(c) 

relevant Union and national rules applicable 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) 

(b) 

(c) 

information available to the Commission reports activities that are, or appear to 
be, non-compliant with the rules referred to in Article 1(2), and such activities 
have, or might have, ramifications in more than one Member State; or, 

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, 

the competent authorities in the Member States concerned are unable to agree 
on appropriate action to address the non-compliance 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; 

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(b) 

request,  by  means  of  implementing  acts,  that  the  competent  authorities  in  the 
Member  State  of  dispatch  and,  where  appropriate,  in  other  Member  States 
concerned,  appropriately  intensify  official  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  adopt  delegated  acts  in  accordance  with 
Article  139  to  establish  rules  for  the  rapid  exchange  of  information  in  the  cases 
referred to in paragraph 1. 

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Title V 
Planning and reporting 

Article 107  
Multi-annual national control plans (MANCP) and single authority for the MANCP 

1. 

Member  States  shall  ensure  that  official  controls  governed  by  this  Regulation  are 
performed  by  the  competent  authorities  on  the  basis  of  a  multi-annual  national 
control  plan,  the  preparation  and  implementation  of  which  are  coordinated  across 
their territory. 

2. 

Member States shall designate a single authority responsible for: 

(a) 

the coordination of the preparation of the plan referred to in paragraph 1 across 
all competent authorities responsible 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 areas governed by the rules referred to in 
Article 1(2) and in  accordance with the criteria laid down in Article 8 and in 
the rules provided for in Articles 15 to 24; 

(b) 

there  is  efficient  prioritisation  of  official  controls  and  efficient  allocation  of 
control resources. 

2. 

Multi-annual national control plans shall contain 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) 

(b) 

(c) 

the  strategic  objectives  of  the  multi-annual  national  control  plan  and  on  how 
the  prioritisation  of  official  controls  and  allocation  of  resources  reflect  these 
objectives; 

the risk categorisation of the official controls; 

the designation of competent authorities and their tasks at central, regional and 
local level, and on resources available to those authorities; 

(d)  where appropriate, the delegation of tasks to delegated bodies; 

(e) 

(f) 

the  general  organisation  and  management  of  official  controls  at  national, 
individual 
regional  and 
establishments; 

including  official  controls 

level, 

local 

in 

control  systems  applied  to  different  sectors  and  coordination  between  the 
different  services  of  competent  authorities  responsible  for  official  controls  in 
those sectors; 

(g)  procedures  and  arrangements  in  place  to  ensure  compliance  with  the 

obligations of the competent authorities provided for in Article 4(1); 

(h) 

the training of staff of the competent authorities; 

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(i) 

(j) 

(k) 

the documented procedures provided for in Article 11(1); 

the  organisation  and  operation  of  contingency  plans  in  accordance  with  the 
rules referred to Article 1(2); 

the  organisation  of  cooperation  and  mutual  assistance  between  competent 
authorities in the Member States. 

Article 109  
Preparation and implementation of multi-annual control plans  

1. 

2. 

Member States shall ensure that the multi-annual national control plan provided for 
in Article 107(1) is made available to the public, with the exception of those parts of 
the  plan  the  disclosure  of  which  could  undermine  the  effectiveness  of  official 
controls. 

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) 

(b) 

(c) 

(d) 

the emergence of new diseases, pests of plants or other risks to human, animal 
or  plant  health,  animal  welfare  or,  in  the  case  of  GMOs  and  plant  protection 
products, to the environment; 

significant changes to the structure, management or operation of the competent 
authorities in the Member State; 

the results of Member States' official controls; 

the  results  of  Commission  controls  performed  in  the  Member  State  in 
accordance with Article 115(1); 

(e)  delegated acts adopted by the Commission in accordance with Article 110; 

(f) 

(g) 

scientific findings; 

the outcome of official controls performed by the competent authorities of third 
country in a Member State. 

3. 

Member  States  shall  provide  the  Commission  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 delegated acts in accordance with Article 139 
concerning the multi-annual national control plans provided for in Article 107(1). 

Those delegated acts shall lay down rules on: 

(a) 

(b) 

(c) 

(d) 

criteria for the risk categorisation of the operators' activities; 

priorities for official controls based on the criteria laid down in Article 8 and in the 
rules provided for in Articles 15 to 24; 

procedures to maximise the effectiveness of official controls; 

the  main  performance  indicators  to  be  applied  by  the  competent  authorities  in 
assessing the multi-annual national control plan and its implementation. 

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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  establishing  the  prevalence  of  certain  hazards  across  the 
Union,  the  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning: 

(a) 

(b) 

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); 

the  organisation,  on  an  ad  hoc  basis,  of  the  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) 

(b) 

(c) 

any amendments made to its multi-annual national control plan to take account 
of the factors referred to in Article 109(2); 

the results of official controls performed in the previous year under its multi-
annual national control plan; 

the  type  and  number  of  cases  of  non-compliance  with  the  rules  referred  to  in 
Article 1(2) detected in the previous year by the competent authorities; 

(d)  measures  taken  to  ensure  the  effective  operation  of  its  multi-annual  national 
control plan, including enforcement action and the results of such measures. 

2. 

In  order  to  ensure  the  uniform  presentation  of  the  annual  reports  provided  for  in 
paragraph 1, the Commission shall, by means of implementing acts, adopt and update 
as  necessary  standard  model  forms  for  the  submission  of  the  information  and  data 
referred to in paragraph 1. 

Those  implementing  acts  shall,  whenever  possible,  allow  the  use  of  the  standard 
model  forms  adopted  by  the  Commission  for  the  submission  of  other  reports  on 
official  controls  that  the  competent  authorities  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 the public an annual report on the operation 
of official controls in the Member States, taking into account: 

(a) 

(b) 

the  annual  reports  submitted  by  the  Member  States  in  accordance  with 
Article 112; 

the  results  of  Commission  controls  performed  in  accordance  with  Article 
115(1); 

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2. 

1. 

(c) 

any other relevant information. 

The  annual  report  provided  for  in  paragraph  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  

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  feed  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 provided for in paragraph 1 shall specify: 

3. 

4. 

(a) 

(b) 

(c) 

the competent authorities to be involved; 

the powers and responsibilities of the authorities referred to in point (a); 

channels and procedures for sharing information between competent authorities 
and other parties concerned as appropriate. 

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. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning: 

(a) 

rules for the establishment of the contingency 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  for  in  Article  55(1)  of  Regulation  (EC) 
No 178/2002; 

(b) 

the  role  of  stakeholders  in  the  establishment  and  operation  of  those 
contingency plans. 

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Title VI 
Union activities 

Chapter I 
Commission controls 

Article 115  
Commission controls in Member States  

1. 

Commission experts shall perform controls in each Member State to: 

(a)  verify the application of the rules referred to in Article 1(2) and those provided 

for in this Regulation; 

(b)  verify  the  functioning  of  national  control  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 
developments in the Member States. 

to  emergency  situations,  emerging  problems  or  new 

2. 

3. 

4. 

The controls provided for in paragraph 1 shall be organised in cooperation with the 
competent authorities of the Member States and be performed on a regular basis. 

The controls provided for in paragraph 1 may include on the spot verifications. The 
Commission  experts  may  accompany  the  staff  of  the  competent  authorities 
performing official controls. 

Experts  from  the  Member  States  may  assist  the  Commission  experts.  National 
experts accompanying Commission experts shall be given the 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) 

(c) 

send to the Member State where those controls were performed a copy of the 
draft report provided for in point (a) for its comments; 

take the comments of the Member State referred to in point (b) into account in 
preparing  the  final  report  on  the  findings  of  the  controls  performed  by  its 
experts in the Member States as provided for in Article 115(1); 

(d)  make  publicly  available  the  final  report  referred  to  in  point  (c)  and  the 

comments of the Member State referred to in point (b). 

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2. 

Where appropriate, the Commission 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  shortcomings  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 means 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 implementing acts, amend its control programme 
to  take  account  of  developments  in  the  areas  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) 

(b) 

(c) 

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); 

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; 

ensure  that  Commission  experts  have  access  to  all  premises  or  parts  of  premises, 
animals and goods, and to information, including computing systems, relevant for the 
execution of their duties. 

Article 119  
Commission controls in third countries  

1. 

Commission experts may perform controls in third countries in order to: 

(a)  verify the compliance or equivalence of third-country legislation and systems, 
including official certification and the issuance of official certificates, official 
labels, official marks and other official attestations, with the requirements laid 
down in the rules referred to in Article 1(2); 

(b)  verify  the  capacity  of  the  third  country  control  system  to  ensure  that 
consignments  of  animals  and  goods  exported  to  the  Union  comply  with 
relevant requirements established by the rules referred to in Article 1(2) or with 
requirements recognised to be at least equivalent thereto; 

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(c) 

collect  information  and  data  to  elucidate  the  causes  of  recurring  or  emerging 
problems in relation to exports of animals and goods from a third country. 

2. 

The controls provided for in paragraph 1 shall have particular regard to: 

(a) 

(b) 

(c) 

(d) 

(e) 

the legislation of the third country; 

the organisation of the third country's competent authorities, their powers and 
independence, the supervision to which they are subject and the authority they 
have to enforce the applicable legislation effectively; 

the training of staff in the performance of official controls; 

the resources including analytical, testing and diagnostic facilities available to 
competent authorities; 

the  existence  and  operation  of  documented  control  procedures  and  control 
systems based on priorities; 

(f)  where  applicable,  the  situation  regarding  animal  health,  zoonoses  and  plant 
health, and procedures for notifying the Commission and relevant international 
bodies of outbreaks of animal diseases and pests of plants; 

(g) 

(h) 

the extent and operation of official controls performed on animals, plants and 
their products arriving from other third countries; 

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). 

In order to facilitate the efficiency and effectiveness of the controls provided for in 
paragraph 1, the Commission may, prior to performing 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 controls it performs. 

The Commission may appoint experts from Member States to assist its own experts 
during the controls provided for in paragraph 1. 

3. 

4. 

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) 

(b) 

(c) 

(d) 

(e) 

a risk assessment of the animal and goods exported to the Union from them; 

the rules referred to in Article 1(2); 

the  volume  and  nature  of  animals  and  goods  entering  the  Union  from  the  third 
country concerned; 

the  results  of  controls  already  performed  by  the  Commission  experts  or  by  other 
inspection bodies; 

the  results  of  official  controls  on  animals  and  goods  entering  the  Union  from  the 
third country and of any other official controls that competent authorities of Member 
States have performed; 

(f) 

information received from the European Food Safety Authority or similar bodies; 

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(g) 

information received from internationally 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 International 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) 

(i) 

evidence  of  emerging  disease  situations  or  other  circumstances  that  might  result  in 
animals  and  goods  entering  the  Union  from  a  third  country  presenting  health  or 
environmental risks; 

the  need  to  investigate  or  respond  to  emergency  situations  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 appropriate, 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 amend that programme to 
take  account  of  developments  in  the  areas  governed  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 scope of such controls. 

2. 

Commission experts may participate in the controls referred to in paragraph 1, at the 
request of either of the following: 

(a) 

the  competent  authorities  of  Member  States  where  those  controls  are  being 
performed; 

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(b) 

the competent authorities of the third country performing those controls. 

The  participation  by  Commission  experts  and  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  authorities  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 referred to in Article 1(2); 

(b)  provide  information  and  data  available  at  Union  level  that  may  be  useful  for 
the control performed by the competent 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 the Union of animals and goods 

Article 124  
Information on third countries' control systems 

1. 

The Commission shall request third countries 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 sanitary and phytosanitary control systems 
in their territory: 

(a) 

(b) 

any  sanitary  or  phytosanitary  regulations  adopted  or  proposed  within  their 
territory; 

risk-assessment  procedures  and  factors  taken  into  consideration  for  the 
assessment  of  risks  and  for  the  determination  of  the  appropriate  level  of 
sanitary or phytosanitary protection; 

(c) 

any  control  and  inspection  procedures  and  mechanisms,  including,  where 
relevant, on animals or goods arriving from other third countries; 

(d)  official certification mechanisms; 

(e)  where  appropriate,  any  measures  taken  following  recommendations  provided 

for in the second paragraph of Article 121; 

(f)  where  relevant,  results  of  official  controls  performed  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 exported to the Union and of the 
specific situation and structure of the third country. 

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Article 125  
Establishment of additional conditions for entry into the Union of animals and goods 

1. 

The  Commission  shall  be  empowered  to  adopt  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 are necessary to ensure that the animals 
and goods comply with the relevant requirements established by the rules referred to 
in Article 1(2), with the exception of points (d), (e), (g) and (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) 

(b) 

(c) 

(d) 

(e) 

the requirement that certain animals and goods shall only enter the Union from 
a third country or region of a third country which appears on a list drawn up by 
the Commission for that purpose; 

the  requirement  that  consignments  of  certain  animals  and  goods  from  third 
countries be dispatched from and obtained or prepared in establishments which 
comply  with  the  relevant  requirements  referred  to  in  paragraph  1  or  with 
requirements recognised to be at least equivalent; 

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 with the relevant requirements referred 
to in paragraph 1 or with requirements recognised to be at least equivalent; 

the  obligation  to  provide  the  evidence  referred  to  in  point  (c)  in  accordance 
with a specific format; 

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. 

Where, in case of risks arising from animals 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. 

The  Commission  may,  by  means  of  implementing  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). 

3. 

4. 

Article 126  
Inclusion in the list of third countries referred to in Article 125(2)(a) 

1. 

The inclusion of a third country or region thereof in the list referred to in point (a) of 
Article 125(2) shall be made in accordance with paragraphs 2 and 3 of this Article. 

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2. 

3. 

The  Commission  shall  approve,  by  means  of  implementing  acts,  the  request 
transmitted  to  it  for  that  purpose  by  the  third  country  concerned,  accompanied  by 
appropriate evidence and guarantees that the concerned animals and goods from that 
third country comply with the relevant requirements referred to in Article 125(1) or 
with requirements equivalent thereto. Those implementing acts shall be adopted and 
updated in accordance with the examination procedure referred to in Article 141(2). 

The  Commission  shall  decide  on  the  request  referred  to  in  paragraph  2  taking  into 
account, as appropriate: 

(a) 

(b) 

(c) 

(d) 

the third country's legislation in the sector concerned; 

the structure and organisation of the competent authorities of the third country 
and its control services, the powers available to them, the guarantees that can 
be provided with regard to the application and enforcement of the legislation of 
the  third  country  applicable  to  the  sector  concerned,  and  the  reliability  of  the 
official certification procedures; 

the performance by the competent authorities of the third country 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 plant protection products; 

the regularity and rapidity of information 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) 

(ii) 

(iii) 

(iv) 

conditions applied to the establishments from which animals or goods are 
exported  to  the  Union  comply  with  requirements  that  are  equivalent  to 
those referred to in Article 125(1); 

a list of the establishments referred to in point (i) is drawn up and kept up 
to date; 

the list of establishments referred to in point (i) and its updated versions 
are communicated to the Commission without delay; 

the establishments referred to in point (i) are the subject of regular and 
effective controls by the competent authorities of the third country; 

(f) 

any  other  information  or  data  on  the  capability  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  relevant  requirements  referred  to  in  Article 
125(1) enter the Union. 

Article 127  
Establishment of special measures regarding the entry into the Union of  
certain animals and goods 

1. 

Where,  in  cases  other  than  those  referred  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  insert  number  of  the  Regulation  on 

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protective measures against pests of plants], there is evidence that the entry into the 
Union of certain animals or goods originating 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-compliance 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  shall  be  adopted  in  accordance  with  the 
examination procedure referred 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) 

(b) 

(c) 

(d) 

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; 

the  requirement  that  the  animals  and  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; 

the  requirement  that  the  animals  and  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; 

the  requirement  that  consignments  of  the  animals  and  goods  referred  to  in 
paragraph  1  originating  or  dispatched  from  certain  third  countries  or  regions 
thereof, be accompanied by an official certificate, an official attestation, or by 
any  other  evidence  that  the  consignment  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) 

(b) 

the information collected in accordance with Article 124; 

any other information that the third countries concerned have provided; 

(c)  where  necessary,  the  results  of  Commission  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  protection  products,  to  the  protection  of  the 
environment, the Commission shall adopt immediately applicable implementing acts 
in accordance with the procedure 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  Commission  may,  by  means  of 

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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 and data provided by the third country 
concerned pursuant to Article 124(1); 

(b)  where  appropriate,  the  satisfactory  outcome  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  into  the  Union  from  the  third  country 
concerned, or regions thereof, and may include: 

(a) 

(b) 

the  nature  and  content  of  the  official  certificates  or  attestations  that  must 
accompany the animals or goods; 

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  drawing  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  implementing  acts,  repeal  without  delay  the 
implementing  acts  provided  for  in  paragraph  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. 

2. 

The  Commission  may  organise  training  activities  for  the  staff  of  the  competent 
authorities and, where appropriate, for staff of other authorities of the Member States 
involved in investigations of possible violations of the provisions of this Regulation 
and of the rules referred to in Article 1(2). 

The Commission may organise those activities in cooperation with Member States. 

The training activities referred to in paragraph 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) 

(b) 

this Regulation and the rules referred to in Article 1(2); 

control  methods  and  techniques  relevant  for  the  official  controls  and  for  the 
other official activities of the competent authorities; 

(c)  production, processing and marketing methods and techniques. 

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3. 

4. 

5. 

6. 

1. 

The  training  activities  referred  to  in  paragraph  1  may  be  open  to  staff  of  the 
competent authorities of third countries and may be organised outside the Union.  

Competent authorities shall ensure that the knowledge acquired through the training 
activities  referred  to  in  paragraph  1  is  disseminated  as  necessary  and  appropriately 
used in the staff training activities referred to in Article 4(2) and (3).  

Training  activities  aimed  at  disseminating  such  knowledge  shall  be  included  in  the 
training programmes referred to in Article 4(2). 

The Commission may organise in cooperation with the Member States programmes 
for the exchange of staff of the competent authorities performing official 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 relevant competent authorities. 

The  Commission  shall,  by  means  of  implementing  acts,  lay  down  rules  for  the 
organisation  of  the  training  activities  referred  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 management systems 

Article 130  
Information management system for official controls (IMSOC) 

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  official  controls  are  managed  and  handled 
('the IMSOC'). 

2. 

The IMSOC shall: 

(a) 

(b) 

integrate  fully  and  provide  the  necessary  updates  to  the  TRACES  system  as 
established by Decision 2003/24/EC; 

integrate  fully  and  provide  the  necessary  updates  to  existing  computerised 
systems managed by the Commission and used for the rapid exchange of data, 
information  and  documents  in  relation  to  risks  to  human,  animal  health  and 
welfare,  and  plant  health,  as  established  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  Regulation  (EU)  XXX/XXXX  [Office  of  Publications,  please 
insert  number  of  the  Regulation  on  protective  measures  against  pests  of 
plants]; 

(c)  provide  appropriate  linkages  between  the  TRACES  system  and  the  systems 
referred to in point (b) to allow, as necessary, the efficient exchange and update 
of  data  between  those  systems  and  between  the  TRACES  system  and  those 
systems. 

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Article 131 
General functionalities of the IMSOC 

The IMSOC shall: 

(a) 

(b) 

(c) 

(d) 

1. 

2. 

3. 

allow  for  the  computerised  handling  and  exchange  of  information,  data  and 
documents  necessary  for  the  performance  of  official  controls,  resulting  from  the 
performance of official controls or the recording of the performance or outcome of 
official  controls  in  all  cases  where  the  rules  referred  to  in  Article  1(2)  and  the 
delegated  acts  provided  for  in  Articles  15  to  24  provide  for  the  exchange  among 
competent  authorities,  between  the  competent  authorities  and  the  Commission,  and 
where appropriate with other authorities and the operators, of such information, data 
and documents; 

provide  a  mechanism  for  the  exchange  of  data  and  information  in  accordance  with 
the provisions of Title IV; 

provide a tool to collect and manage the reports on official controls provided by the 
Member States to the Commission; 

allow for the production, handling and transmission, 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  referred  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 

In  case  of  animals  or  goods  whose  movements  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 shall enable the competent authorities at the 
place of dispatch and other competent authorities responsible for performing official 
controls  on  those  animals  or  goods  to  exchange  in  real  time  data,  information  and 
documents  concerning  animals  or  goods  being  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  what  extent  the  first  subparagraph  shall 
apply to the goods referred to in the second subparagraph. 

In case of exported animals and goods for which Union rules apply in relation to the 
issuance of the export certificate, the IMSOC shall enable the competent authorities 
of the place of  dispatch and 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. 

In  case  of  animals  or  goods  subject  to  the  official  controls  referred  to  in  Title  II, 
Chapter V, Sections I and II, the IMSOC shall: 

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(a) 

(b) 

enable  the  competent  authorities  at  the  border  control  posts  and  other 
competent  authorities  responsible  for  performing  official  controls  on  those 
animals  or  goods  to  exchange  in  real  time  data,  information  and  documents 
concerning  those  animals  and  goods  and  on  controls  performed  on  those 
animals or goods; 

enable  the  competent  authorities  at  the  border  control  posts  to  share  and 
exchange  relevant  data,  information  and  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 rules 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 rules for the functioning of the IMSOC 

The Commission shall be empowered to adopt delegated acts in accordance with Article 139 
concerning the establishment of: 

(a) 

(b) 

(c) 

(d) 

(e) 

the technical specifications and the specific rules for the functioning of the IMSOC 
and of its components; 

contingency  arrangements  to  be  applied  in  case  of  unavailability  of  any  of  the 
functionalities of the IMSOC; 

the  cases  where  and  the  conditions  under  which  concerned  third  countries  and 
international organisations may be granted partial access to the functionalities of the 
IMSOC and the modalities of such access; 

the  cases  where  and  the  conditions  under  which  exemptions  from  the  use  of  the 
TRACES system can be granted to occasional users; 

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. 

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Title VII 
Enforcement action 

Chapter I 
Action by the competent authorities and penalties 

1. 

2. 

3. 

Article 134  
General obligations of the competent authorities as regards enforcement action 

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  GMOs  and  plant  protection  products,  to  the 
environment. 

In  case  of  suspicion  of  non-compliance,  the  competent  authorities  shall  perform  an 
investigation in order to confirm or to eliminate that suspicion. 

Where  necessary  for  its  purposes,  the  investigation  referred  to  in  paragraph  2  shall 
include: 

(a) 

(b) 

the performance of intensified official controls on animals, goods and operators 
for an appropriate period; 

the official detention of animals and goods and of any unauthorised substances 
or products as appropriate. 

Article 135 
Investigations and measures in case 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 further occurrences of it. 

When deciding which measures to take, the competent authorities shall take account 
of  the  nature  of  the  non-compliance  and  the  operator's  past  record  with  regard  to 
compliance. 

2. 

When  acting  in  accordance  with  paragraph  1,  competent  authorities  shall,  as 
appropriate: 

(a)  order or perform treatments on animals; 

(b)  order the unloading, transfer to another means of transport, holding and care of 
animals, quarantine periods, the postponement 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 market, 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 return to the Member State of dispatch; 

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(e)  order that the operator increases the frequency of own controls; 

(f) 

order that certain activities of the operator 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 appropriate period of time, of all or part of 
the business of the operator concerned, or its establishments, holdings or other 
premises; 

(i) 

(j) 

order  the  cessation  for  an  appropriate  period  of  time  of  all  or  part  of  the 
activities of the operator concerned and, where relevant, of the Internet sites it 
operates or employs; 

order the suspension or withdrawal of the approval of the establishment, plant, 
holding  or  means  of  transport  concerned,  or  of  the  authorisation  of  a 
transporter; 

(k)  order  the  slaughter  or  killing  of  animals  provided  that  this  is  the  most 
appropriate measure to safeguard human health and animal health and welfare; 

(l) 

take  any  other  measure  the  competent  authorities  deem  appropriate  to  ensure 
compliance with the rules referred to in Article 1(2). 

3. 

The competent authorities shall provide the operator concerned, or its representative, 
with: 

(a)  written  notification  of  their  decision  concerning  the  action  or  measure  to  be 
taken in accordance with paragraphs 1 and 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. 

All  expenditure  incurred  pursuant  to  this  Article  shall  be  borne  by  the  responsible 
operators. 

Article 136  
Penalties 

Member States shall lay down the rules on penalties applicable to infringements of 
the provisions of this Regulation and take all measures necessary 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. 

Member  States  shall  ensure  that  financial  penalties  applicable  to  intentional 
violations  of  the  provisions  of  this  Regulation  and  of  the  rules  referred  to  in 
Article 1(2) at least offset the economic advantage sought through the violation. 

Member  States  shall  ensure  in  particular  that  penalties  are  provided  for  in  the 
following cases: 

4. 

1. 

2. 

3. 

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(a)  where  operators  fail  to  cooperate  during  official  controls  or  other  official 

(b) 

(c) 

activities; 

false or misleading official certification; 

fraudulent  production  or  use  of  official  certificates,  official  labels,  official 
marks and other official attestations. 

Chapter II 
Union enforcement measures 

Article 137 
Serious failure in a Member State's control system  

1. 

2. 

3. 

Where the Commission has evidence of a serious 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 means of implementing acts, adopt one or more 
of  the  following  measures,  to  be  applied  until  the  failure  in  the  control  system  is 
eliminated: 

(a) 

(b) 

(c) 

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; 

special conditions for the activities, animals or goods referred to in point (a); 

the  suspension  of  the  operation  of  official  controls  in  border  control  posts  or 
other  control  points  concerned  by  the  failure  in  the  official  control  system  or 
the withdrawal of such border control 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). 

The measures referred to in paragraph 1 shall be adopted only after the Member State 
concerned has failed to correct the situation upon request and within the time limit 
set by the Commission. 

On duly justified imperative grounds of urgency relating to human and animal health 
or,  as  regards  GMOs  and  plant  protection  products,  to  the  protection  of  the 
environment, the Commission shall adopt immediately applicable implementing acts 
in accordance with the procedure referred to in Article 141(3). 

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Title VIII 
Common provisions 

Chapter I 
Procedural provisions 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

Article 138  
Amendment of Annexes and references to European standards 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 139 concerning amendments to Annexes II and III to this Regulation, in order 
to take into account changes to the rules referred to in Article 1(2), technical progress 
and scientific developments. 

In order to keep the references to the European standards referred to in point (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 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

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), Articles 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 entry into force of this Regulation. 

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  subparagraph  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  that  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 already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council. 

A  delegated  act  adopted  pursuant  to  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), Articles 133, 138(1) and 
(2),  143(2),  144(3),  151(3),  153(3)  and  159(3)  shall  enter  into  force  only  if  no 

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objection  has  been  expressed  either  by  the  European  Parliament  or  the  Council 
within a period of two months of notification 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  Commission  that  they  will  not  object.  That 
period shall be extended by two months at the initiative of the European Parliament 
or the Council. 

Article 140 
Urgency procedure 

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure. 

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  the  act  without  delay  following  the  notification  of  the 
decision to object by the European Parliament or by the Council. 

Article 141  
Committee 

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 meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU) 
No 182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result 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. 

1. 

2. 

1. 

2. 

3. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU) 
No 182/2011, in conjunction with Article 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, please insert date of entry 
into force of this Regulation + 1 year]. 

However,  Articles  14  to  17  and  26  to  29  of  Regulation  (EC)  No  882/2004  shall 
continue to apply until [Office of Publications, please insert date of entry into force 
of this Regulation + 3 years]. 

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2. 

3. 

1. 

2. 

1. 

2. 

3. 

(EC)  No  854/2004  and  Directives  89/662/EEC,  90/425/EEC, 
Regulation 
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]. 

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 repeals of Directives 91/496/EEC and 97/78/EC 

The  relevant  provisions  of  Directives  91/496/EEC  and  97/78/EC  which  govern 
matters referred to in Articles 45(2), 46, points (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. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  to 
Article  139  concerning  the  date  on  which  the  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 pursuant to the delegated or implementing acts 
provided for in Articles 45(2), 46, points (b), (c) and (d) of Article 49, 51(1)(a), 52(1) 
and (2), 56(1)(a) of this Regulation. 

Article 144 
Transitional measures related to the repeal of Directive 96/23/EC 

Competent  authorities  shall  continue  to  perform  the  official  controls  necessary  to 
detect  the  presence  of  the  substances  and  groups  of  residues  listed  in  Annex  I  to 
Directive 96/23/EC, in accordance to Annex II, III and IV to this Directive until the 
date to be determined in the delegated act adopted in accordance with paragraph 3. 

Article 29(1) and (2) of Directive 96/23/EC shall continue to apply until the date to 
be determined in the delegated act adopted in accordance with paragraph 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 Directive 96/23/EC shall no longer apply. That 
date shall be the date of the application of the corresponding rules to be established 
pursuant to the delegated or implementing acts 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.'; 

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(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 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 Commission 
shall submit summaries of those reports to the Member States.'; 

(c) 

(d) 

point (a) of paragraph 3 is deleted;  

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  Commission  shall  submit  summaries  of  these 
reports to the Member States.'; 

(iii)  point (a) of paragraph 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) 

(b) 

Articles 19 and 21 are deleted; 

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 subparagraphs are deleted 

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(ii) 

the third subparagraph is replaced by the following: 

'Applicants  for  authorisation  of  genetically  modified  food  and  feed  shall 
contribute to supporting the costs 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  reference  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 additives shall contribute to supporting the 
cost 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.' 

(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  authorities',  'border  control  post',  'official 
veterinarian'  and  'exit  point'  laid  down  in  points  (5),  (29),  (32),  and  (36)  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 14, 15, 16, 21, 22(2), 23, 24 and 26 are deleted; 

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(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  compliance  with  the  requirements  of  this 
Regulation. The report shall be accompanied 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  Commission,  the  Authority  and  the  other 
Member States by 30 June each year:'; 

2. 

3. 

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. 

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 shall be the date of the application of the 
corresponding rules to be established pursuant 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 authorities' 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. …'; 

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(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  Commission  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 (EU) No XXX/XXXX [Office 
of Publications, please insert 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  Regulation  (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  replaced  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. 

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3. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  139  concerning  the  date  on  which  the  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 pursuant 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  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 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 

131 

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(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  Commission  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 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 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  'competent  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 

132 

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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  official  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  second  subparagraph  of  paragraph 2  and 
paragraphs 3, 4, 6 and 7 are deleted; 

(b)  Annex II is deleted. 

2. 

3. 

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. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  to 
Article  139  concerning  the  date  on  which  the  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 pursuant 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 following: '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 subparagraph is replaced by the following:  

EN 

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'1. 

In  respect  of  protected  designations  of  origin,  protected  geographical 
indications and traditional specialities guaranteed that designate products 
originating within the Union, verification of compliance with the product 
specification,  before  placing  the  product  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  meaning  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 first subparagraph is deleted; 

(iii) 

in  paragraph  4,  the  words  'paragraphs  1  and  2'  are  replaced  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,  please  insert  number  of  the 
Regulation  laying  down  provisions  for  the  management  of  expenditure  relating  to  the  food 
chain, animal health and animal welfare, and relating to plant health and plant reproductive 
material] is amended as follows: 

(a) 

Article 29 is amended as follows: 

(i) 

the heading is replaced by the following: 

'European Union reference laboratories 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) 

(b) 

(c) 

the European Union reference laboratories referred to in Article 91 
of  Regulation  (EU)  No  XXX/XXXX  [Office  of  Publications, 
please insert number of this Regulation]*; 

the  European  Union  reference  centres  for  plant  reproductive 
material referred to in Article 93 of that Regulation; 

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 status, directly involved in activities of 
the  laboratories  or  centres  which  are  carried  out  in  their  capacity  of 
Union reference laboratory or centre;'; 

EN 

134 

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(b) 

the following Article 29a is added: 

'Article 29a 
Accreditation of national reference laboratories for plant health 

1.  Grants  may  be  awarded  to  the  national  reference  laboratories  referred  to  in 
Article 98 of Regulation (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  and  diagnosis  to  verify  compliance  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 reference laboratory for plant health, 
up  to  three  years  after  the  designation  of  that  European  Union  reference 
laboratory.'. 

Article 162  
Entry into force and application 

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  paragraphs  2  to  5,  it  shall  apply  from  [Office  of 
Publications, please insert date of entry into force of this Regulation + 1 year]. 

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]. 

In  the  area  covered  by  the  rules  referred  to  in  point  (h)  of  Article  1(2),  this 
Regulation, shall apply from [Office of Publications, please insert date of application 
of  the  Regulation  on  the  production  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)  and  (4)  shall  apply  from  [Office  of  Publications,  please 

insert date of entry into force of this Regulation + 5 years]. 

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]. 

Article 161 shall apply from [Office of Publications, please insert date of entry into 
force of this Regulation]. 

1. 

2. 

3. 

4. 

5. 

EN 

135 

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This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

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ANNEX I 
TERRITORIES REFERRED TO IN POINT 45 OF ARTICLE 2 

The territory of the Kingdom of Belgium 

The territory of the Republic of Bulgaria 

The territory of the Czech Republic 

The territory of the Kingdom of Denmark with the exception of the Faroe Islands and 
Greenland 

The territory of the Federal Republic of Germany 

The territory of the Republic of Estonia 

The territory of Ireland 

The territory of the Hellenic Republic 

The territory of the Kingdom of Spain with the exception of Ceuta and Melilla 

The territory of the French Republic 

The territory of the Italian Republic 

The territory of the Republic of Cyprus 

The territory of the Republic of Latvia 

The territory of the Republic of Lithuania 

The territory of the Grand Duchy of Luxembourg 

The territory of Hungary 

The territory of the Republic of Malta 

The territory of the Kingdom of the Netherlands in Europe 

The territory of the Republic of Austria 

The territory of the Republic of Poland 

The territory of the Portuguese Republic 

The territory of Romania 

The territory of the Republic of Slovenia 

The territory of the Slovak Republic 

The territory of the Republic of Finland 

The territory of the Kingdom of Sweden 

The territory of the United Kingdom of Great Britain and Northern Ireland 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

22. 

23. 

24. 

25. 

26. 

27. 

For the purpose of the official controls performed by the competent authorities to verify the 
compliance with the rules referred to in point (g) of Article 1(2) and other 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  territories  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 

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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. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

Different  control  methods  and  techniques,  such  as,  inspection,  verification, 
screening,  targeted  screening,  sampling,  and  laboratory  analysis,  diagnosis  and 
testing 

Control procedures 

The rules referred to in Article 1(2) 

Assessment of non-compliance with the rules referred to in Article 1(2) 

The hazards in the production, processing and distribution of animals and goods 

The different stages of production, processing 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. 

The  evaluation  of  the  application  of  HACCP  procedures  and  of  good  agricultural 
practices  

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 referred to in Article 1(2) 

Official certification systems 

Contingency  arrangements  for  emergencies,  including  communication  between 
Member States and the Commission 

Legal proceedings and implications of official controls 

Examination  of  written,  documentary  material  and  other  records,  including  those 
related  to  inter-laboratory  comparative  testing,  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 financial and commercial aspects  

Control procedures and requirements for entry into the Union of animals and goods 
arriving from third countries. 

Any other area necessary to ensure that official controls are performed in accordance 
with this Regulation. 

CHAPTER II: SUBJECT AREAS FOR CONTROL PROCEDURES 

1. 

2. 

3. 

4. 

The  organisation  of  the  competent  authorities  and  the  relationship  between  central 
competent authorities and authorities to which they have conferred tasks to perform 
official controls or other official activities 

The  relationship  between  competent  authorities  and  delegated  bodies  or  natural 
persons  to  which  they  have  delegated  tasks  related  to  official  controls  or  other 
official activities 

A statement on the objectives to be achieved 

Tasks, responsibilities and duties of staff 

EN 

138 

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5. 

6. 

7. 

8. 

9. 

10. 

11. 

Sampling procedures, control methods and techniques, including laboratory analysis, 
test and diagnosis, interpretation of results and consequent decisions  

Screening and targeted screening programmes 

Mutual assistance in the event that official controls require more than one Member 
State to take action 

Action to be taken following official controls 

Cooperation  with  other  services  and  departments 
responsibilities or with operators 

that  may  have  relevant 

Verification  of  the  appropriateness  of  methods  of  sampling  and  of  laboratory 
analysis, test and diagnosis 

Any other activity or information required for the effective functioning of the official 
controls. 

EN 

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ANNEX III 
CHARACTERISATION OF METHODS OF ANALYSIS 

1. 

Methods  of  analysis  and  measurement  results  should  be  characterised  by  the 
following criteria: 

(a) 

(b) 

(c) 

(d) 

accuracy (trueness and precision); 

applicability (matrix and concentration range); 

limit of detection; 

limit of quantification; 

(e)  precision; 

(f) 

(g) 

(h) 

(i) 

(j) 

repeatability; 

reproducibility; 

recovery; 

selectivity; 

sensitivity; 

(k) 

linearity; 

(l)  measurement uncertainty; 

(m)  other criteria that may be selected as required. 

2. 

3. 

4. 

5. 

The precision values referred to in 1(e) shall either be obtained from a collaborative 
trial  which  has  been  conducted  in  accordance  with  an  internationally  recognised 
protocol on collaborative trials (e.g. ISO 5725 'Accuracy (trueness and precision) of 
measurement  methods  and  results')  or,  where  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  %  confidence  intervals  as  defined  by  ISO 5725 
'Accuracy (trueness and precision) of measurement methods and results'). The results 
from the collaborative trial shall be published or freely available. 

Methods  of  analysis  which  are  applicable  uniformly  to  various  groups  of 
commodities  should  be  given  preference  over  methods  which  apply  only  to 
individual commodities. 

In  situations  where  methods  of  analysis  can  only  be  validated  within  a  single 
laboratory, then they should be validated in accordance with internationally accepted 
scientific  protocols  or  guidelines,  or  where  performance  criteria  for  analytical 
methods have been established, be based on criteria compliance tests. 

Methods of analysis adopted under this Regulation should be edited in the standard 
layout for methods of analysis recommended by the ISO. 

EN 

140 

   EN 

ANNEX IV 
CORRELATION TABLE REFERRED TO IN ARTICLE 142(3) 

1. 

Regulation (EC) No 882/2004 

Regulation (EC) No 882/2004 

This Regulation 

Article 1(1) first subparagraph 
Article 1(1) second subparagraph 
Article 1(2) 
Article 1(3) 
Article 1(4) 

Article 2 

Article 3(1) 
Article 3(2) 
Article 3(3) 
Article 3(4) 
Article 3(5) 
Article 3(6) 
Article 3(7) 

Article 4(1) 
Article 4(2) 
Article 4(3) 
Article 4(4) 
Article 4(5) 
Article 4(6) 
Article 4(7) 

Article 5(1) first subparagraph 
Article 5(1) second subparagraph 
Article 5(1) third subparagraph 
Article 5(2)(a), (b), (c) and (f) 
Article 5(2)(d) 
Article 5(2)(e) 
Article 5(3) 
Article 5(4) 

Article 6 

Article 1(1) 
Article 1(2) 
Article 1(4) 
- 
- 

Article 2 

Article 8(1) 
Article 8(4) 
Article 9 
Article 8(6) 
Article 8(6) 
Article 8(7) 
- 

Article 3(1) 
Article 4(1)(a), (c), (d), (e), (f), (g) and (i) 
Article 3(2) 
Article 4(1)(b) 
Article 4(4) 
Article 5(1) 
Article 5(3) 

Article 25(1) 
Article 25(3) 
Article 25(2) first subparagraph 
Article 26(1) 
- 
Article 28 
Article 29 
- 

Article 4(2) and (3) 

Article 7(1), first subparagraph 
Article 7(1), second subparagraph, point (a) 
Article 7(1), second subparagraph, point (b) 
Article 7(2), first sentence 
Article 7(2), second sentence 

Article 10(1), first subparagraph 
Article 10(1), second subparagraph  
- 
Article 7(1) 
- 

EN 

141 

   EN 

Article 7(2), third sentence 
Article 7(3) 

Article 8(1) 
Article 8(2) 
Article 8(3)(a) 
Article 8(3)(b) 
Article 8(4) 

Article 9(1) 
Article 9(2) 
Article 9(3) 

Article 10 

Article 11(1) 
Article 11(2) 
Article 11(3) 
Article 11(4) 
Article 11(5) 
Article 11(6) 
Article 11(7) 

Article 12(1) 
Article 12(2) 
Article 12(3) 
Article 12(4) 

Article 13 

Article 14(1) 
Article 14(2) 
Article 14(3) 

Article 15(1) 
Article 15(2) 
Article 15(3) 
Article 15(4) 
Article 15(5) 

Article 16(1) 
Article 16(2) 
Article 16(3) first sentence 
Article 16(3) second sentence 

Article 17(1) first indent 
Article 17(1) second indent 

- 
Article 7(2), and (3) 

Article 11(1)  
Article 4(1)(h) 
Article 11(2) 
Article 11(3)  
- 

Article 12(1) first subparagraph 
Article 12(1) second subparagraph 
Article 11(2) 

Article 13 

Article 33(1) and (2) 
- 
Article 33(5) 
Article 33(7) 
Article 34(1) first subparagraph and (2) 
Article 34(1)(b)(i) 
Article 33(6) 

Article 36(1) 
Article 36(4)(e) 
Article 36(5)(c) 
Article 38(2) 

Article 114 

- 
Article 43(3) 
- 

Article 42(1) first sentence 
Article 42(2) and (4)  
Article 42(2) and (4) 
- 
Article  45(1)(d),  45(2)(b)  and  52(3),  first 
sentence 

Article 43(1) 
Article 42(1) second sentence 
Article 43(2) 
Article 33(6) 

Article 57(1) 
Article 54(1),(2)(a), (3) and Article 56(1) 

EN 

142 

   EN 

Article 17(2) 

Article 18 

Article 19(1) 
Article 19(2)a 
Article 19(2)b 
Article 19(3) 
Article 19(4) 

Article 20 

Article 21(1) 
Article 21(2) 
Article 21(3) 
Article 21(4) 

Article 22 

Article 23(1) 
Article 23(2) 
Article 23(3) 
Article 23(4) 
Article 23(5) 
Article 23(6) 
Article 23(7) 
Article 23(8) 

Article 24(1) 
Article 24(2) 
Article 24(3) 
Article 24(4) 

Article 25(1) 
Article 25(2)(a) 
Article 25(2)(b) 
Article 25(2)(c) 
Article 25(2)(d) 
Article 25(2)(e) 
Article 25(2)(f) 
Article 25(2)(g) 
Article 25(2)(h) 

Article 26 

Article 27(1) 
Article 27(2) 
Article 27(3) 

EN 

- 

Article 63(1), (2) and (3) 

Article 64(1) and (3) 
Article 65 
Article 64(5) 
Article 64(4) 
Article 6 

Article 69 

Article 70(1) 
Article 67 
Article 64(1) 
Article 64(4) 

Article 84(d)  

Article 71(1) 
Article 71(2) and 72 
Article 71(3) 
Article 71(2) 
Article 71(4)(a) 
Article 71(2)(c) and (4)(b) 
Article 72 
Article 72 

Article 73(1) 
Article 55 
Article 44 
Article 74 

- 
- 
Article 75(1)(c) 
Article 75(1)(f) 
Article 46(c) and (d), and 75(1)(e) and (k) 
- 
Article 68 
Article 75(1)(h) 
Article 44(2)(b) 

Article 76(1) 

Article 76(2) 
Article 77 
- 

143 

   EN 

Article 27(4) 
Article 27(5) 
Article 27(6) 
Article 27(7) 
Article 27(8) 
Article 27(9) 
Article 27(10) 
Article 27(11) 
Article 27(12) first sentence 
Article 27(12) second sentence 

Article 28 

Article 29 

Article 30(1) point (a) 
Article 30(1) point (b) 
Article 30(1), point (c) 
Article 30(1) point (d) 
Article 30(1) point (e) 
Article 30(1) point (f) 
Article 30(1) point (g) 
Article 30(2)(a) 
Article 30(2)(b) 
Article 30(3) 

Article 31 

Article 32(1)(a) 
Article 32(1)(b) 
Article 32(1)(c) 
Article 32(1)(d) 
Article 32(1)(e) 
Article 32(1)(f) 
Article 32(2)(a) 
Article 32(2)(b) 
Article 32(2)(c) 
Article 32(2)(d) 
Article 32(2)(e) 
Article 32(3) 
Article 32(4)(a) 
Article 32(4)(b) 
Article 32(4)(c) 

Article 79(1) 
- 
- 
- 
Article 81(2) 
Article 82(1) 
- 
Article 81(1) 
Article 83 
- 

Article 84 

- 

Article 86 
Article 89point (a) 
Article 87(2) 
Article 89 points (b) and (f) 
Article 89 point (c) 
Article 89 point (d) 
Article 89 point (e) 
Article 88(1)(e) 
Article 88(1)(c) 
- 

- 

Article 92(2)(a) 
Article 92(2)(b) 
Article 92(2)(c) 
Article 92(2)(d) 
Article 92(2)(e) 
Article 92(2)(g) 
Article 92(2)(a), (b) and (c) 
Article 92(2)(h) 
Article 92(2)(d) 
Article 92(2)(g) 
Article 92(2)(d) 
Article 91(3)(a) 
Article 91(3)(c) 
Article 91(3)(d) 
Article 91(3)(d) 

EN 

144 

   EN 

Article 32(4)(d) 
Article 32(4)(e) 
Article 32(4)(f) 
Article 32(4)(g) 
Article 32(4)(h) 
Article 32(5) 
Article 32(6) 
Article 32(7) 
Article 32(8) first sentence 
Article 32(8) second sentence 
Article 32(9) 

Article 33(1) 
Article 33(2) 
Article 33(3) 
Article 33(4) 
Article 33(5) 
Article 33(6) 
Article 33(7) 

Article 34(1) 
Article 34(2) 
Article 34(3) 

Article 35(1) 
Article 35(2) 
Article 35(3) 
Article 35(4) 

Article 36(1) 
Article 36(2) first sentence 
Article 36(2) second sentence 
Article 36(3) first subparagraph 
Article 36(3) second subparagraph 
Article  36(3) 
sentence 
Article  36(3)  third  subparagraph,  second 
sentence 
Article 36(4) 

subparagraph, 

third 

first 

Article 37(1) 
Article 37(2) 

Article 38(1) 
Article 38(2) 

Article 7 
Article 91(3)(e) 
Article 92(2)(j)(iii) 
Article 91(3)(e) 
Article 91(3)(f) 
Article 97(1) 
Article 97(2) 
- 
Article 97(3) 
Article 97(4) 
- 

Article 98(1) 
Article 99(1) 
Article 98(2) 
Article 98(4) 
Article 98(5) 
Article 99(2) 
- 

Article 100(1) 
Article 100(1) and (2) 
Article 100(3) 

Article 101(1) 
Article 101(4) 
Article 101(2) 
- 

Article 102(1)(c) 
- 
Article 102(2) 
Article 102(3) first sentence 
- 
Article 102(3)(c) 

Article 102(3)(b) 

Article 102(3)(a) 

Article 103(1) 
Article 103(2) 

Article 104(1) 
Article 104(2)(c) 

EN 

145 

   EN 

Article 38(3) 

Article 39(1) 
Article 39(2) 

Article 40(1) 
Article 40(2) 
Article 40(3) 
Article 40(4) 

Article 41 

Article 42(1)(a) 
Article 42(1)(b) 
Article 42(1)(c) 
Article 42(2) 
Article 42(3) 

Article 104(3) 

Article 105(1) 
Article 105(2) 

Article 106(1) 
- 
Article 106(2) 
- 

Article 107(1) 

- 
Article 109(2) 
Article 109(3) 
Article 108(2) 
Article 109(2) 

Article 43(1) first sentence 
Article 43(1) second sentence 
Article 43(1)(a) 
Article 43(1)(b) 
Article 43(1)(c) 
Article 43(1)(d) to (j) 
Article 43(1)(k) 
Article 43(2) 

Article 110, first subparagraph 
Article 110, second subparagraph 
- 
Article 110(a) and (b) 
Article 110(b) and (c) 
- 
Article 110(d) 
- 

Article 44(1) 
Article 44(2) 
Article 44(3) 
Article  44(4), 
sentence 
Article  44(4)  first  subparagraph,  second 
sentence 

subparagraph, 

first 

first 

Article 44(5) 
Article 44(6) 

Article 45(1)  
Article 45(2) 
Article 45(3) 
Article 45(4) 
Article 45(5) 
Article 45(6) 

Article 46(1) first sentence 
Article 46(1) second sentence 

Article 112(1) 
- 
Article 112(1) 
Article 113(1) 

Article 113(2) 

- 
Article 113(1) 

Article 115(1)(2) and (4) 
- 
Article 116 
Article 117 
Article 118 
- 

Article 119(1) 
Article 119(4) 

EN 

146 

   EN 

Article 46(1) third sentence 
Article 46(2) 
Article 46(3) 
Article 46(4) 
Article 46(5) 
Article 46(6) 
Article 46(7) 

Article 47(1) 
Article 47(2) 
Article 47(3) 
Article 47(4) 
Article 47(5) 

Article 48(1) 
Article 48(2) 
Article 48(3) 
Article 48(4) 
Article 48(5) first sentence 
Article 48(5) second and third sentence 

Article 49 

Article 50 

Article 51(1) 
Article 51(2) 
Article 51(3) 

Article 52 

Article 53 

Article 54(1) 
Article 54(2) 
Article 54(3) 
Article 54(4) 
Article 54(5) 
Article 55(1) 
Article 55(2) 

Article 56(1) 
Article 56(2)(a) 
Article 56(2)(b) 

Articles 57 to 61 

Article 62 

Article 63(1) 

Article 119(2) 
Article 119(3) 
Article 120 
- 
- 
Article 121 
Article 122 

Article 124(1)(a) to (e) 
Article 124(2) 
Article 124(1)(f) and (g) 
- 
- 

Article 125(1) 
Article 125(2) 
Article 126(1) and (2) 
Article 126(3) 
Article 126(3)(f) 
- 

Article 128 

- 

Article 129(1) and (2) 
Article 129(3) 
- 

Article 123 

Article 111 

Article 135(1) 
Article 135(2) 
Article 135(3) 
Article 103(1) 
Article 84(1) (a) and(c) and Article 135(4) 
Article 136(1) 
Article 136(1) 

Article 137(1) 
- 
Article 137(2) 

- 

Article 141 

- 

EN 

147 

   EN 

Article 63(2) 

Article 64 first subparagraph 
Article 64 point (1) 
Article 64 point (2) 

Article 65 

Article 66 

Article 67 

Annex I 
Annex II 
Annex III 
Annex IV 
Annex V 
Annex VI 
Annex VII 
Annex VIII 

Article 23 

Article 138(1) 
Article 138(1) 
Article 138(2) 

- 

- 

Annex I 
Annex II 
Annex III 
- 
- 
Article 78 and 79(2) 
- 
- 

2. 

Directive 96/23/EC 

Directive 96/23/EC 

This Regulation 

Article 1 

Article 2(a) 
Article 2(b) 
Article 2(c) 
Article 2(d) 
Article 2(e) 
Article 2(f) 
Article 2(g) 
Article 2(h) 
Article 2(i) 

Article 3 

Article 4(1) 
Article 4(2) 
Article 4(3) 

Article 5 

Article 6 

Article 7 

Article 8(1) 
Article 8(2) 

EN 

- 

Article 16 
- 
Article 16 
Article 2(5) 
Article 16 
Article 36(1) 
- 
Article 16 
- 

Articles 8(1) and (2), 16, 107(1) and 111 

Article 3(1) 
Articles 3(2)(a), 107(2) and 112 
- 

Articles  109(2)  and  (3),  112(1)(a)  and 
108(2) 

Articles 16(a) and (b) 

Article 108(2) 

- 
- 

148 

   EN 

 
 
Article 8(3), (4) and (5) 

Articles 10, 112 and 113 

Article 9(A) 
Article 9(B) 

Article 10 

Article 11(1) and (2) 
Article 11(3) 

Article 12 first paragraph 
Article 12 second paragraph 

Article 13 

Article 14(1) 
Article 14(2) 

Article 15(1) first subparagraph 
Article 15(1) second subparagraph 
Article 15(1) third subparagraph 
Article 15(2) first subparagraph 
Article 15(2) second subparagraph 
Article  15(3) 
subparagraphs 
Article 15(3) forth subparagraph 

first, 

second  and 

- 
- 

Article 14 

Articles 8(2) and 9 
Articles 16(c), 134 and 135 

Article 8(4) 
Article 14 

Articles 16(c), 134 and 135 

Articles 98 and 99 
Article 91 

Article 16(a) and (b) 
Article 33(7) 
- 
Article 33(7) 
Article 34(3) 
Articles 16(c) and 135 

third 

Article 16(1) 
Article 16(2) and (3) 

Article 17 

Article 18  

Article 19 

Article 20(1) 
Article 20(2) first subparagraph 
Article 20(2) second subparagraph 
Article 20(2) third and forth subparagraphs 
Article 20(2) fifth and sixth subparagraphs 

Article 21 

Article 22 

Article 23 

Article 24(1) and (2) 
Article 24(3) 

Article 25 

Article 26 

Article 27 

Article 28 

EN 

Title II Chapter V Section III 

Articles 103(1), 106(1) and 135 
Articles 16(c) and 135 

Articles 16(c) and 135 

Articles 16(c) and 135 

Article 135(4) 

Title IV 
Article 104(1) and (2) 
Article 104(3) 
Article 106(1)(d) 
Article 106(2) 

Articles 115, 116 and 118 

Article 134 

Articles 16(c) and 135 

Articles 15(2)(d), 16(c), 134 and 135 
Articles 15(2)(d), 16(c) and 135 

Articles 16(c) and 135(2) 

Article 6 

Article 136 

Article 136 

149 

   EN 

Article 29(1) and (2) 
Article 29(3) 
Article 29(4) 

Article 30(1) and (2) 
Article 30(3) 

Article 31 

Article 33 

Article 34 

Article 35 

Article 36 

Article 37 

Article 38 

Article 39 

Annex I 
Annex II 
Annex III 
Annex IV 

Articles 124, 125, 126 and 128 
Title II Chapter V Section II 
Article 112(1) 

Title II Chapter V Section III 
Article 128(3) 

Title II Chapter VI 

Article 141 

Article 16(a) and (b) 

- 

- 

- 

- 

- 

Article 16(a) and (b) 
Article 16(a) and (b) 
Article 16(a) and (b) 
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 subparagraph 

Article 8(1) 

Article 3(1) forth subparagraph 

Article 134(2) and (3) and Article 135 

Article 3(2) 

Article 3(3)  

Article 4(1) first sentence 

Article 4(1) first indent 

Article 4(1) second indent 

Article 4(2) 

Article 5(1)(a) first subparagraph 

- 

- 

Article 8(1), 9, 134 and 135 

Article 8(6)(a) 

- 

Article 136 

Article 8 

Article 5(1)(a) second subparagraph 

Article 134(2) and (3) 

Article 5(1)(b) 

Article 5(2) 

EN 

- 

- 

150 

   EN 

Article 5(3)(a), (b) and (d) 

Article 5(3)(c) 

Article 5(4) and (5) 

Article 6(1) 

Article 6(2) 

Article 7(1) 

Article 7(2) 

Article 8(1) 

Article 8(2) 

Article 8(3) 

Article 9 

Article 10 
Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16(1) 

Article 16(2) 
Article 16(3) 

Article 17 

Article 18 

Article 19 

Article 20 

Article 22 

Article 23 

Annex A 

Annex B 

- 

Article 8(7) 

- 

Article 47 

- 

Title IV and Article 135 

- 

Title IV 

Articles 6 and 135(3) 

Article 135(4) 

- 

Article 3(1) 
Articles 9, 13 and 14 

- 

- 

- 

- 

Article 112(1) 

- 
Article 112(2) 

Article 141 

Article 141 

- 

- 

- 

- 

- 

- 

EN 

151 

   EN 

Directive 90/425/EEC 

This Regulation 

Article 1 

Article 2(1) to (5) 

Article 2(6) 

Article 2(7) 

Article 3(1) and (2) 

Article 3(3) 

Article 3(4) 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 5(1)(a) first subparagraph 

- 

- 

Article 2(5) 

Article 2(32) 

- 

Articles 8, 134(2) and (3) and 135 

- 

Article 8 

- 

Article 136 

Article 8 

Article 5(1)(a) second subparagraph 

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 subparagraph 

Article 8(7) 

second 

and 

third 

Article 
subparagraphs 

5(2)(a) 

Article 5(2)b 

Article 5(3) 

Article 6 

Article 7(1) 

Article 7(2) 

Article 8(1) 

Article 8(2) 

Article 9(1) 

Article 9(2) 

Article 9(3) 

Article 9(4) 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

EN 

- 

- 

- 

- 

Article 47 

- 

Title IV and Article 135 

- 

Title IV 

Articles 6 and 135(3) 

Article 135(4) 

- 

- 

Article 3(1) 

- 

Articles 9, 13 and 14 

- 

- 

152 

   EN 

 
Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22(1) 

Article 22(2) 

Article 22(3) 
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 

Article 1 

Article 2 

Article 2(2)(a) 

Article 2(2)(b) 

Article 2(2)(c) 

Article 2(2)(d) 

Article 2(2)(e) 

Article 2(2)(f) 

Article 2(2)(g) 

Article 2(2)(h) 

Article 2(2)(i) 

Article 2(2)(j) 

Article 2(2(k) 

Article 3(1) and (2) 

Article 3(3) 

Article 3(4) 

Article 3(5) 

Article 4(1) 

- 

Article 141 

Article 141 

Article 141 

Articles 130, 131, 132 and 133 

- 

Article 112(1) 

- 

Article 112(2) 
- 

This Regulation 

- 

- 

- 

- 

- 

- 

- 

Article 2 

Article 2(17) 

Article 2(46)  

Article 2(47) 

Article 2(48) 

- 

Article 2(27) 

Article 2(29) 

- 

- 

- 

Article 2(5) 

Article 45(1) 

Article 14 and 54(1), (2)(a) and (3) 

Article 55 

Article 45(2) and (3) and Article 56 

Article 47(4) 

EN 

153 

   EN 

Article 4(2) 

Article 4(3) and (4) 

Article 4(5) 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 5(4) 

Article 6(1)(a), first paragraph 

Article 6(1)(a) second paragraph 

Article 6(1)(b) 

Article 6(2) 

Article 6(3) 

Article 6(4) 

Article 6(5) 

Article 6(6) 

Article 7(1) 

Article 7(2) 

Article 7(3) 

Article 7(4) 

Article 7(5)  

Article 7(6) 

Article 8(1) 

Article 8(2) 
Article 8(3),(4), (5), (6), (7) 

Article 9 

Article 10(1), (2), (4) 
Article 10(3) 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16(1)(a) 

Article 16(1)(b) 

Article 16(1)(c) 

Article 16(1)(d) 

Article 16(1)(e) 

-  

Article 47(1), (2) and (3) and Article 50 

Article 50 

Article 54(2)(b) and(4) 

Article 56(2) 

Article 48(2) and (3) 

Article 56 

Article 62(1) 

Article 62(2) 

- 

Article 57 and 60 

Article 61 

Article 58(1) and 61(3) 

- 

Article 58(2), 60(3), 61(5), 62(2), 62(4) 

Article 48(1) 

Article 47(1), (2) and (3) and Article 50 

Article 55 

Article 48(2), 53 and 54(4) 

- 

Article 50 and 56 

- 

Article 75(1)(b) 
Article 75(2) 

Article 49(b) and (c) 

Article 52(2) 
- 

Article 49(d) 

Articles 46(h) and 75(1)(k) 

Article 75(1)(c) 

-  

Article 75(1)(h) 

Article 46(d) 

Article 46(e) 

Article 46(c) 

Article 46(g) 

Article 46(a) 

EN 

154 

   EN 

Article 16(1)(f) 

Article 16(2) 

Article 16(3) 

Article 16(4) 

Article 17(1) 

Article 17(2) 

Article 17(2)(a) 

Article 17(2)(a) first indent 

Article 17(2)(a) second indent 

Article 17(2)(b) 

Article 17(3) 

Article 17(4) 

Article 17(5) 

Article 17(6) 

Article 17(7) 

Article 18 

Article 19(1) 

Article 19(2) 

Article 19(3) 

Article 20(1) 

Article 20(2) 

Article 22(1) 

Article 22(2) 

Article 22(3) 

Article 22(4) 

Article 22(5) 

Article 22(6) 

Article 22(7) 

Article 24 

Article 24(3) 

Article 25(1) 
Article 25(2) 
Article 25(3) 

Article 26 

Article 27 

Article 28 

Article 29 

EN 

Article 46(b) 

- 

- 

Article 75(1)(c) and (f) 

Article 64(5) 

Article 64(1), (2) and (3) 

Article 64(3)(b), 67 and Article 70 

- 

Article 66(1)(a) 

Article 67 

Article 63(4), (5) and (6) 

- 

Articles 64(3), 67, 84(1)(d) 

- 

Article 63(6), 68 and 70(3) 

Article 62(2) 

Article 75(1)(g) 

Article 75(1)(a) 

Article 62(3)(a) and 62(4) 

Article 63 

- 

- 

Article 65 

- 

- 

- 

- 

- 

Article 63(4), (5) and (6) 

Articles 71 and 128 

Articles 100-106 
Article 6 
- 

Article 129(5) and (6) 

Article 4(2) and (3) and 129(1) and (6) 

- 

- 

155 

   EN 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

Annex I 

Annex II 

Annex III 

- 

- 

- 

- 

- 

- 

- 

Annex I 

Article 62 

Article 50 

Directive 91/496/EEC 

This Regulation 

Article 1 

Article 2(1) 

Article 2(2)a 

Article 2(2)b 

Article 2(2)c 

Article 2(2)d 

Article 2(2)e 

Article 2(2)f 

Article 3(1)(a) 

Article 3(1)(b) 

Article 3(1)(c)(i) 

Article 3(1)(c)(ii) 

Article 3(1)(d) 

Article 3(2) 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 4(5) 

Article 5 

Article 6(1) 

Article 6(2)(a) 

Article 6(2)(b) 

Article 6(2)(c) 

- 

- 

Article 2(46) 

Article 2(47) 

Article 2(48) 

- 

Article 2(27) 

Article 2(29) 

Articles 54(1) and (2)(a), 56(1)(b) 

Article 45(1), 64(2) 

Articles 54(2)(b), 54(4), and 55 

Article 77(1)(d) 

Article 55 

- 

Articles 47(1), 47(2) and 50 

Articles 47(1), 47(3), 47(4) and 50 

Article 49c 

Article 77(1)(d) 

Article 4(2) and (3), 49(c) and 50 

Articles  53,  54(2)(b),  54(4),  55,  56(1)(a), 
and 64(1). 

- 

Article 62(1) and (2) 

Article 62(1) 

Article 57 

EN 

156 

   EN 

 
Article 6(2)(d) 

Article 6(3) 

Article 6(3)(a) 

Article 6(3)(b) 

Article 6(3)(c) 

Article 6(3)(d) 

Article 6(3)(e) 

Article 6(3)(f) 

Article 6(3)(g) 

Article 6(4) 

Article 6(5) 

Article 7(1) first indent 

Article 7(1) second indent 

Article 7(1) third indent 

Article 7(2) 
Article 7(3) 

Article 8 

Article 9 

Article 10 

Article 11(1) 

Article 11(2) 

Article 12 (1) 

Article 12(2) 

Article 12(3) 

Article 12(4) 

Article 12(5) 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 17a 

Article 18(1) 

Article 18(2) 

Article 18(3) 

Article 18(4) 

Article 18(5) 

EN 

Article 62(3)(a) and (4) 

Article 58 

Article 58(1)(b) 

Article 58(1)(c) 

Articles 57(2) and 62(3) 

Article 58(1)(d) 

Articles 57(2) and 62(3) 

Articles 57(2) and 62(3) 

Article 58(1)(e) 

Article 57 and 58(1) 

Article 58(2) 

Article 48(2) 

Articles 54(2))(b), 54(4) and 56 

Article 48(1) 

Article 56 
- 

Article 51(1)(b) 

Article 49(d) 

Article 64(2) 

Article 63 

- 

Articles 64, 66 and 67 

Articles 64(3), 67, 84(1)(d) 

Articles 68, 69(3) and 70(3) 

- 

- 

Article 62(2) 

- 

Article 77(1)(d) 

Articles 52 

Article 6 

- 

- 

Article 65 

- 

- 

- 

157 

   EN 

Article 18(6) 

Article 18(7) 

Article 18(8) 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 25 

Article 26 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Annex A 

Annex B 

- 

- 

- 

Article 115 and 116 

Articles 100-106 

Article 129 (5) and (6) 

- 

- 

- 

- 

- 

- 

-  

- 

- 

- 

Article 62 

Article 64(2) 

5. 

Directive 96/93/EC 

Directive 96/93/EC 

This Regulation 

Article 1 

Article 2(1) 
Article 2(2) 

Article 3(1) 
Article 3(2) 
Article 3(3) 
Article 3(4) 
Article 3(5) 

Article 4(1) 
Article 4(2) 
Article 4(3) 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

EN 

- 

Article 2(22) 
Article 2 

Article 87(2)(b) 
Article 87(3)(a) and (b) 
Article 88(1)(a) 
Article 87(3)(b) 
Article 89 

Articles 87(2)(a) and 88(2)  
Article 88(1)(b) 
Article 88(1)(d) 

Article 88(2) 

Article 128 

Article 141 

- 

- 

158 

   EN 

Article 10 

6. 

Directive 89/608/EEC 

Directive 89/608/EEC 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16  

Article 17 

Article 18 

Article 19 

Article 20 

This Regulation 

- 

- 

- 

Title IV 

Title IV 

Title IV 

Title IV 

Title IV 

Title IV 

Title IV 

Article 7 and Title IV 

- 

Title IV 

- 

- 

Article 7 and Title IV 

- 

- 

- 

- 

- 

7. 

Decision 92/438/EEC 

Decision 92/438/EEC 

This Regulation 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

EN 

Articles 130 to 133 

- 

Articles 130 to 133 

Articles 130 to 133 

Articles 130 to 133 

Article 62(3)(f) 

- 

159 

   EN 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Annex I 

Annex II 

Annex III 

- 

- 

- 

- 

- 

- 

- 

- 

Articles 130 to 133 

Articles 130 to 133 

Articles 130 to 133 

EN 

160 

   EN