CELEX: 52013PC0265
Language: en
Date: 2013-05-06
Title: 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)

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}
EN                                                                                            EN
 ---pagebreak---                                   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.
EN                                                        2                                                      EN
 ---pagebreak---    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
           COM/2010/785/Final.
   3
           'Fees or charges collected by Member States to cover the costs occasioned by official controls'.
           FCEC 2009.
EN                                                  3                                                       EN
 ---pagebreak---    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.
EN                                                  4                                                 EN
 ---pagebreak---    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.
   4
           COM (2011)803.
   5
           'Preparatory work to support the impact assessment on reviewing the rules on the financing of official
           controls'. GHK Consulting Ltd working with ADAS UK Ltd. 2011.
EN                                                      5                                                         EN
 ---pagebreak---    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
EN                                                  6                                                  EN
 ---pagebreak---    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.
EN                                                   7                                                      EN
 ---pagebreak---    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
   7
           COM (2011)803.
EN                                                  8                                                  EN
 ---pagebreak---    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.
EN                                                  9                                                  EN
 ---pagebreak---    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 II: OFFICIAL CONTROLS                                AND        OTHER         OFFICIAL
   ACTIVITIES IN MEMBER STATES
                              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
EN                                                 10                                                  EN
 ---pagebreak---    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.
EN                                                  11                                              EN
 ---pagebreak---    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;
EN                                                   12                                                EN
 ---pagebreak---    •         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.
EN                                                  13                                                EN
 ---pagebreak---    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;
EN                                                 14                                                EN
 ---pagebreak---    •         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.
EN                                                15                                               EN
 ---pagebreak---                                                            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)     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.
   (2)     The Treaty also provides that the Union is to contribute to the attainment of a high
           level of consumer protection by the measures it adopts in the context of the completion
           of the internal market.
   (3)     Union legislation provides for a set of harmonised rules to ensure that food and feed
           are safe and wholesome and that activities which might have an impact on the safety
           of the food chain or on the protection of consumers interests in relation to food and
           food information are performed in accordance with specific requirements. Union rules
           exist also to ensure a high level of human, animal and plant health and animal welfare
   8
           OJ C , , p. .
   9
           OJ C , , p. .
EN                                                  16                                             EN
 ---pagebreak---        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.
   (4) 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).
   (5) 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.
   (6) 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.
   (7) Union legislation on plant health regulates the entry, establishment and spread of pests
       of plants that do not exist, or are not widely present, in the Union. Its objective is to
       protect the health of Union crops and of public and 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.
   (8) 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.
   (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.
EN                                               17                                                EN
 ---pagebreak---         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
        foodstuffs identifies products and foodstuffs farmed and produced to exact
        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
        OJ L 165, 30.4.2004, p. 1.
   12
        OJ L 300, 14.11.2009, p. 1.
   13
        OJ L 169, 10.7.2000, p. 1.
   14
        OJ L 125, 23.5.1996, p. 10.
EN                                              18                                               EN
 ---pagebreak---    (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
 ---pagebreak---    (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
 ---pagebreak---    (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
 ---pagebreak---         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
 ---pagebreak---         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
 ---pagebreak---    (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
        OJ L 24, 30.1.1998, p. 9.
   19
        OJ L 268, 24.9.1991, p. 56.
   20
        OJ L 194, 25.7.2009, p. 11.
EN                                             24                                                 EN
 ---pagebreak---         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
EN                                               25                                                EN
 ---pagebreak---         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                                                EN
 ---pagebreak---         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 and official 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.
   (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                                                EN
 ---pagebreak---         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
 ---pagebreak---         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                                                  EN
 ---pagebreak---         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 legislation and, where non-compliance 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.
   (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, to 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.
   (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                                                EN
 ---pagebreak---         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.
   (79) 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
        OJ L 351, 21.12.1989, p. 34.
   24
        OJ L395, 30.12.1989, p. 13.
   25
        OJ L 224, 18.8.1990, p. 29.
   26
        OJ L 243, 25.8.1992 p. 27.
   27
        OJ L 13, 16.1.1997, p. 28.
   28
        OJ L 139, 30.4.2004, p. 206.
   29
        OJ L 147, 31.5.2001, p. 1.
   30
        OJ L 3, 5.1.2005, p. 1.
   31
        OJ L 70, 16.3.2005, p.1.
   32
        OJ L 189, 20.7.2007, p. 1.
   33
        OJ L 303, 18.11.2009, p.1.
   34
        OJ L 309, 24.11.2009, p. 1.
   35
        OJ L 343, 14.12.2012, p.1.
   36
        OJ L 221, 8.8.1998, p. 23.
   37
        OJ L 203, 3.8.1999 p. 53.
EN                                               31                                               EN
 ---pagebreak---         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) In order to amend the references to European standards, and Annexes II and III to this
        Regulation to take into account of legislative and 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
        OJ L 268, 18.10.2003, p. 1.
   39
        OJ L 268, 18.10.2003, p. 29.
   40
        OJ L 812, 12.7.2007, p. 19.
   41
        OJ L 10, 15.1.2009, p. 7.
   42
        OJ L 47, 18.2.2009, p. 5.
   43
        OJ L 309, 24.11.2009, p. 71.
EN                                               32                                                 EN
 ---pagebreak---    (82) In order to ensure uniform conditions for the implementation of this Regulation
        regarding the designation of European Union reference laboratories and of the
        European Union reference centres for 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.
   (83) 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
 ---pagebreak---                                           Title I
               Subject matter, scope and definitions
                                          Article 1
                                  Subject matter and scope
   1. This Regulation lays down rules for:
      (a)   the performance of official controls and other official activities performed by
            the competent authorities of the Member States;
      (b)   the financing of official controls;
      (c)   the administrative assistance and cooperation between Member States in view
            of the correct application of the rules referred to in paragraph 2;
      (d)   the performance of Commission controls in Member States and in third
            countries;
      (e)   the adoption of conditions to be met by animals and goods entering the Union
            from a third country;
      (f)   the establishment of a computerised information system to manage information
            and data in relation to official controls.
   2. This Regulation shall apply to the official controls performed 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)   laying down animal health requirements;
      (e)   aiming at preventing and minimising risks to human and animal health arising
            from animal by-products and derived products;
      (f)   laying down welfare requirements for animals;
      (g)   on protective measures against pests of plants;
      (h)   on the production, with a view to 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
 ---pagebreak---             (k)    on the use and labelling of protected designations of origin, protected
                   geographical indications and traditional specialities guaranteed.
   3.       This Regulation shall also apply to official controls performed for the verification of
            compliance with requirements laid down in the rules referred to in paragraph 2
            applicable to animals and goods:
            (a)    entering the Union from third countries;
            (b)    to be exported to third countries.
   4.       This Regulation shall not apply to official controls for the verification of compliance
            with:
            (a)    the rules laid down in Regulation (EC) No 1234/2007;
            (b)    the rules laid down in Directive 2010/63/EU of the European Parliament and of
                   the Council of 22 September 2010 on the protection of animals used for
                   scientific purposes45.
   5.       Articles 3, 4, 5, 7, 11(2) and (3), 14, 30 to 33, 36 to 41, 76, Titles III and IV, and
            Articles 129 and 136 of this 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.       'official control' means any form of control that the competent authorities perform for
            the verification of compliance with:
            (a)    this Regulation;
            (b)    the rules referred to in Article 1(2);
   2.       'other official activities' means any activity, other than an official control, which is
            performed by competent authorities in accordance with:
            (a)    this Regulation;
            (b)    the rules referred to in Article 1(2) to ensure the application of those rules;
   3.       'food law' means food law as defined in point (1) of Article 3 of Regulation (EC)
            No 178/2002;
   4.       'feed law' means the laws, regulations and administrative provisions governing feed
            in general and feed safety in particular, whether at Union or national level; it covers
            all stages of production, 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
 ---pagebreak---         (c)    where appropriate, the corresponding authorities of a third country;
   6.   'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU)
        No XXX/XXXX [Office of Publications, please insert number of the Regulation on
        animal health];
   7.   'goods' means any good subject to one or more of the rules referred to in Article 1(2),
        excluding animals;
   8.   'food' means food as defined in Article 2 of Regulation (EC) No 178/2002;
   9.   'feed' means feed as defined in point (4) of Article 3 of Regulation (EC)
        No 178/2002;
   10.  'animal by-products' means animal by-products as defined in point (1) of Article 3 of
        Regulation (EC) No 1069/2009;
   11.  'derived products' means derived products as defined in point (2) of Article 3 of
        Regulation (EC) No 1069/2009;
   12.  'pests' means pests as defined in 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];
   13.  '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];
   14.  '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];
   15.  'plant protection products' means plant protection products as referred to in Article
        2(1) of Regulation (EC) No 1107/2009;
   16.  'alien species' means a species, subspecies or lower taxon, introduced outside its
        natural past or present 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;
   17.  '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;
   18.  '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];
   19.  '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
 ---pagebreak---    20. '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];
   21. 'risk assessment' means risk assessment as defined in point (11) of Article 3 of
       Regulation (EC) No 178/2002;
   22. 'certifying officer' means:
       (a)    any official of the competent authorities authorised to sign official certificates
              by such authorities;
       (b)    where provided for by the rules referred to in Article 1(2) – any other person,
              who is authorised to sign official certificates by the competent authorities;
   23. 'official certificate' means any paper or electronic document signed by the certifying
       officer and providing assurance 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)    this Regulation;
       (b)    rules referred to in Article 1(2);
   25. '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);
   26. '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;
   27. '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)    animals or goods;
       (b)    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. '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);
   30. '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
 ---pagebreak---    32. '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)    this Regulation;
       (b)    the rules referred to in Article 1(2);
   33. 'hazard' means any agent or condition with the potential to have an adverse effect on
       human, animal or plant health, animal welfare or the environment;
   34. 'specified risk material' means tissues as defined in point (g) of Article 3(1) of
       Regulation (EC) No 999/2001;
   35. 'long journey' means a journey as defined in point (m) of Article 2 of Regulation
       (EC) No 1/2005;
   36. 'exit point' means a border control post or any other place designated by a Member
       State where animals, falling within the scope of Regulation (EC) No 1/2005, leave
       the customs territory of the Union;
   37. 'pesticide application equipment' means any apparatus as defined in point (4) of
       Article 3 of Directive 2009/128/EC;
   38. 'delegated body' means a third party, to which the competent authorities have
       delegated specific official control tasks;
   39. 'control authority for organic products' 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;
   40. '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;
   41. '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);
   42. 'targeted screening' means a form of official control involving observation of one or
       more operators or their activities;
   43. '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. 'entry into the Union' means the action of bringing animals and goods into one of the
       territories listed in Annex I;
   46. 'documentary check' means the examination of the official certificates, official
       attestations and other document(s) including documents of a commercial nature,
EN                                              38                                             EN
 ---pagebreak---         which are required to accompany the consignment as provided for by the rules
        referred to in Article 1(2), Article 54(1), or by implementing acts adopted in
        accordance with Articles 75(3), 125(4), 127(1) and 128(1);
   47.  'identity check' means a visual inspection to verify that the content and the labelling
        of a consignment, including the marks on animals, seals and means of transport,
        correspond with the information provided in the official certificates, official
        attestations and other documents accompanying it;
   48.  'physical check' means a check on animals or goods and, as appropriate, checks on
        packaging, the means of transport, 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);
   49.  '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;
   50.  '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;
   51.  'supervision by the customs authorities' means action as defined in Article 4(13) of
        Regulation (EEC) No 2913/9247;
   52.  'control by the customs authorities' means customs controls as defined in
        Article 4(14) of Regulation (EEC) No 2913/92;
   53.  'official detention' means the procedure by which the competent authorities ensure
        that animals and goods subject to official controls are not moved or tampered with
        pending a decision on their destination; it includes storage by operators under the
        control of the competent authorities;
   54.  '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;
   55.  '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;
   56.  '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
 ---pagebreak---                                           Title II
          Official controls and other official activities
                                in Member States
                                        Chapter I
                               Competent authorities
                                           Article 3
                           Designation of competent authorities
   1. For each of the areas governed by the rules 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.
   2. 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.
   3. 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.
   4. Member States shall inform the Commission and other Member States of, and of any
      changes to, the contact details of:
      (a)   the competent authorities designated in accordance with paragraph 1;
      (b)   the single authorities designated in accordance with point (b) of paragraph 2;
      (c)   the control authorities for organic products referred to in paragraph 3;
      (d)   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.
   5. 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
 ---pagebreak---    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
 ---pagebreak---    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).
   4.       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
   1.       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)    subject to independent scrutiny;
            (b)    carried out in a transparent manner.
   2.       Competent authorities shall make available the results of the audits referred to in
            paragraph 1 to the Commission upon request.
   3.       The Commission may, by means of 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.       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.
   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)    the purpose of inspections, investigations or audits;
            (b)    the protection of commercial interests of a natural or legal person;
EN                                                  42                                              EN
 ---pagebreak---       (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)   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;
      (b)   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).
   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.
   3. 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
EN                                            43                                                 EN
 ---pagebreak---            the placing on the market or the movement of the animals or goods shall be
           performed in accordance with:
           (a)   the rules referred to in Article 1(2);
           (b)   the delegated acts adopted by the 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.      Official controls shall be performed as much as possible in a manner that minimises
           the burden on the operators.
   6.      Competent authorities shall perform official controls with the same care irrespective
           of whether the animals and goods concerned are:
           (a)   available on the Union market, whether originating in the Member State where
                 the official controls are performed or in another Member State;
           (b)   to be exported from the Union;
           (c)   entering the Union from third countries.
   7.      To the extent strictly necessary for the 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)     on animals and goods at all stages of production, processing and distribution;
   (b)     on substances, materials or objects which may influence the characteristics of
           animals and goods, at all stages of production, processing and distribution;
   (c)     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
   1.      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)   the type, number and outcome of official controls;
           (b)   the type and the number of non-compliances detected;
EN                                                 44                                             EN
 ---pagebreak---       (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.
   2. 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).
   3. 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)   the rating criteria are objective, transparent and publicly available;
      (b)   appropriate arrangements are in place to ensure the consistency and
            transparency of the rating process.
                                          Article 11
                 Documented control and control verification procedures
   1. 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.
   2. Competent authorities shall have procedures in place to verify the consistency and
      effectiveness of official controls and other official activities that they perform.
   3. Competent authorities shall:
      (a)   take corrective actions in all cases where the procedures provided for in
            paragraph 2 identify shortcomings in the consistency and effectiveness of
            official controls and 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)   a description of the purpose of the official controls;
      (b)   the control methods applied;
      (c)   the results of the official controls;
      (d)   where appropriate, action that the competent authorities require the operator
            concerned to take as a result of their official controls.
EN                                            45                                             EN
 ---pagebreak---    2. Competent authorities shall provide the operator subject to an official control with a
      copy of the report provided for in paragraph 1.
   3. 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)   regularly informed of the level of compliance;
      (b)   immediately informed of any shortcoming or non-compliance identified
            through the official controls.
                                          Article 13
                         Official controls, methods and techniques
   1. Competent authorities shall perform 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)   primary producers' installations and other businesses, including their
                  surroundings, premises, offices, equipment, installations and machinery,
                  transport and their animals and goods;
            (ii)  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;
      (c)   controls on the hygiene conditions in the operators’ premises;
      (d)   an assessment of procedures on good manufacturing practices (GMP), good
            hygiene practices (GHP), good farming practices and hazard analysis critical
            control points (HACCP);
      (e)   an examination of documents and other records which may be relevant to the
            assessment of compliance with the rules referred to in Article 1(2);
      (f)   interviews with operators and with their staff;
      (g)   a reading of values recorded by operators' measuring instruments;
      (h)   controls performed with the competent authorities' own instruments to verify
            measurements taken by operators;
      (i)   any other activity required to identify non-compliances.
EN                                            46                                             EN
 ---pagebreak---                                                  Article 14
                                         Obligations of operators
   1.        To the extent that this is necessary for the performance of official controls or of other
             official activities, operators shall, where required by the competent authorities, give
             staff of the competent authorities access to:
             (a)    their premises;
             (b)    their computerised information management systems;
             (c)    their animals and goods;
             (d)    their documents and any other relevant information.
   2.        During official controls and other official activities, operators shall assist the staff of
             the competent authorities in the accomplishment of their tasks.
   3.        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                                                  EN
 ---pagebreak---    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)    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;
       (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;
       (e)    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)    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;
       (b)    scientific and technological developments;
       (c)    consumer expectations with regard to food composition and changes in patterns
              of consumption of food;
       (d)    risks to human health and animal health associated with meat and other
              products of animal origin intended for human consumption.
   4.  Insofar as this does not prevent the 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
 ---pagebreak---             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)    the need to facilitate the application of the delegated acts in small businesses;
            (b)    the need to enable the continued use of traditional methods at any of the stages
                   of production, processing or distribution of food;
            (c)    the needs of food businesses situated in regions that are subject to special
                   geographic constraints.
                                                Article 16
     Specific rules on official 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)      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;
   (b)      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);
   (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 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                                               EN
 ---pagebreak---    (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 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);
   (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 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)    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;
            (b)    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
 ---pagebreak---    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)    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;
            (d)    the verification of animal welfare requirements at border control posts and at
                   exit points and the minimum requirements applicable to such exit points;
            (e)    specific criteria and conditions for the activation of the mechanisms of
                   administrative assistance provided for in Title IV;
            (f)    the cases and conditions where official controls to verify compliance with
                   animal welfare requirements may include the use of specific animal welfare
                   indicators based on measurable 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)      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 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
 ---pagebreak---    (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)       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 having regard,
             in addition to the criteria referred to in Article 8(1), to the risks to the health, identity,
             quality and traceability of certain categories of plant reproductive material or of
             specific genera or species;
   (c)       specific criteria and conditions for the activation of the mechanisms of administrative
             assistance provided for in Title IV;
   (d)       the cases where the competent authorities in relation to specific non-compliances are
             to take one or more of the measures 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;
EN                                                    52                                                    EN
 ---pagebreak---    (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)       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, 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;
   (c)       uniform specific requirements for inspections on pesticide application equipment and
             uniform minimum frequency of such controls;
   (d)       the cases where the competent authorities in relation to specific non-compliances are
             to take one or more of the measures referred to in Article 135(2) or additional
             measures to those provided for in that paragraph;
   (e)       the design of certification systems to assist the competent authorities in the
             inspections of pesticide application equipment;
   (f)       the collection of information, monitoring and reporting on suspected poisonings from
             plant protection products;
   (g)       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.
EN                                                    53                                             EN
 ---pagebreak---                                                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.       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.
   2.       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)   the specific responsibilities and tasks of the competent authorities, in addition
                  to those provided for in Articles 4, 8, 9, 10(1), 11 to 13, 34(1) and (2), and
                  Article 36, and in addition to Articles 25, 29, 30 and 32 for the approval and
                  supervision of delegated bodies;
            (b)   additional requirements to those referred to in Article 8(1) for risk assessment,
                  and for the establishment of the frequency of official controls, and of sampling
                  as appropriate, taking into account the risk of the occurrence of non-
                  compliance;
            (c)   the minimum frequency of official controls on operators as defined in point (d)
                  of Article 2 of Council Regulation (EC) No 834/2007, and the cases where and
                  the conditions under which certain such operators are to be exempted from
                  certain official controls;
            (d)   additional methods and 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);
            (e)   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);
            (f)   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;
            (g)   additional reporting obligations to those referred to in Articles 12 and 31 for
                  the competent authorities, the control authorities for organic products, and the
                  delegated bodies in charge of official controls;
            (h)   specific criteria and conditions for 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                                                 54                                               EN
 ---pagebreak---             (a)    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;
            (b)    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;
            (c)    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;
            (d)    specific criteria and conditions for the activation of the mechanisms of
                   administrative assistance provided for in Title IV;
            (e)    specific measures to be taken, in addition to those referred to in Article 135(2)
                   in case of non-compliance and of 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                                                   EN
 ---pagebreak---    2. Where, in the case of serious risks to human or animal health or to the environment,
      imperative grounds of urgency so require, the procedure provided for in Article 140
      shall apply to delegated acts 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
   1. 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.
   2. 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).
   3. 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.
   4. 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                                               EN
 ---pagebreak---             (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)      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;
   (b)      immediately inform the competent authorities which have delegated the specific
            official control tasks whenever the results of the official controls indicate non-
            compliance or point to the likelihood of non-compliance.
                                                 Article 29
          Obligations of the competent authorities delegating specific official control tasks
   Competent authorities that have delegated specific official control tasks to delegated bodies or
   natural persons in accordance with Article 25(1) shall:
   (a)      organise audits or inspections of such bodies or persons as necessary;
   (b)      fully or partly withdraw the delegation without delay where:
            (i)    following an audit or an inspection as provided in point (a), there is evidence
                   that such delegated bodies or natural persons are failing to properly perform the
                   official control tasks delegated to them;
            (ii)   the delegated body or the natural 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                                               EN
 ---pagebreak---              (b)    the conditions laid down in Article 26(1) are fulfilled with the exception of
                    point (b)(iv).
   2.        The competent authorities may delegate specific tasks related to other official
             activities to one or more natural persons subject to compliance with the following
             conditions:
             (a)    the rules referred to in Article 1(2) allow such delegation;
             (b)    the conditions laid down in Article 26(1) are fulfilled with the exception of
                    points (b)(ii) and (b)(iv).
                                                  Article 31
    Obligations of the delegated body and natural 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)       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;
   (b)       immediately inform the competent authorities which have delegated the specific
             tasks related to other official activities whenever the results of the other official
             activities indicate non-compliance or point to the likelihood of non-compliance.
                                                       Article 32
                Obligations of the competent authorities delegating specific 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)       organise audits or inspections of such bodies or persons as necessary;
   (b)       fully or partly withdraw the delegation without delay where:
             (i)    following an audit or an inspection as provided for in point (a), there is
                    evidence that such delegated bodies or natural persons are failing to properly
                    perform the tasks related to other official activities delegated to them;
             (ii)   the delegated bodies or natural 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                                             EN
 ---pagebreak---    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)    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,
      (b)    in the absence of the rules or protocols referred to in point (a), the relevant
             methods developed or recommended by the European Union reference
             laboratories and validated in accordance with internationally accepted scientific
             protocols; or,
      (c)    in the absence of the rules or protocols referred to in point (a) and the methods
             referred to in point (b), the methods which comply with relevant rules
             established at national level; or,
      (d)    in the absence of the rules or 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,
      (e)    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.
   3. 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.
   4. 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.
   5. Wherever possible, methods used for laboratory analyses shall be characterised by
      the appropriate criteria set out in Annex III.
   6. Samples shall be taken, handled and labelled in such a way as to guarantee their
      legal, scientific and technical validity.
   7. 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).
EN                                             59                                               EN
 ---pagebreak---                                              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.
   2.    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.
   3.    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
   1.    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.
   2.    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).
EN                                               60                                              EN
 ---pagebreak---                                           Article 36
                            Designation of official laboratories
   1. 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.
   2. 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)   the tasks that the laboratory shall carry out as official laboratory;
      (b)   the conditions under which it shall carry out those tasks;
      (c)   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)   is impartial and free from any conflict of interest as regards the exercise of its
            tasks as official laboratory;
      (d)   can deliver timely the results of the 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                                                 EN
 ---pagebreak---                  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
   1.     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.
   2.     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.
   3.     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
   1.     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.
   2.     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)    it no longer complies with the conditions provided for in Article 36(4) and (5);
          (b)    it does not comply with the obligations provided for in Article 37;
          (c)    it is underperforming at inter-laboratory comparative tests referred to in
                 Article 37(2).
                                               Article 39
    Derogations from the condition for the 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:
EN                                                 62                                              EN
 ---pagebreak---              (a)    laboratories:
                    (i)    whose sole activity is the detection of Trichinella in meat;
                    (ii)   that only use for the detection of Trichinella the methods referred to in
                           Article 6 of Commission Regulation (EC) No 2075/2005 laying down
                           specific rules on official controls for Trichinella in meat50;
                    (iii) that carry out the detection of Trichinella under the supervision of the
                           competent authorities or of an official laboratory designated in
                           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;
             (b)    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);
             (c)    laboratories which only carry out analyses, tests or diagnoses in the context of
                    other official activities, provided that they:
                    (i)    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);
                    (ii)   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.        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).
   3.        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.
EN                                                    63                                               EN
 ---pagebreak---    (a)    they operate, are assessed and accredited in accordance with the standard EN
          ISO/IEC 17025 for the use of one or more methods which are similar to and
          representative of the other methods they use;
   (b)    they make regular and significant use of the methods for which they have obtained
          the accreditation referred to in point (a).
                                              Article 41
   Temporary derogations from the condition 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)   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;
          (b)   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.     The temporary designation provided for in paragraph 1 shall not exceed a period of
          one year, and may be renewed once for a further period of one year.
   4.     The official laboratories designated in 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.
EN                                                64                                              EN
 ---pagebreak---                                              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)   the controls that have already been performed on the animals and goods
                  concerned;
            (d)   the guarantees that the competent authorities of the third country of origin has
                  given with regard to compliance of the animals and goods with the
                  requirements established by the rules 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)   the point of entry into the Union;
            (b)   a border control post;
            (c)   the point of release for free circulation in the Union;
            (d)   the warehouses and the premises of the operator responsible for the
                  consignment.
   3.       The competent authorities at border 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;
EN                                                  65                                             EN
 ---pagebreak---           (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)   always include a documentary check;
          (b)   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.     The competent authorities shall carry out the physical checks referred to in point (b)
          of paragraph 1 under appropriate conditions allowing investigations to be conducted
          properly.
   3.     Where the documentary, identity and physical checks referred to in paragraph 1 show
          that animals and goods do not comply with the rules referred to in Article 1(2),
          Articles 64(1), (3), (4) and (5), 65, 66, 67, 69(1) and (2) and 70(1) and (2) shall
          apply.
   4.     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)   establish the mechanisms necessary to ensure the traceability of the animals or
                goods referred to in point (b) of paragraph 1;
          (b)   identify the documents that must accompany the animals or goods referred to
                in paragraph 1 when samples have been taken by the competent authorities.
          Those implementing acts shall be adopted in accordance with the examination
          procedure referred to in Article 141(2).
EN                                                66                                               EN
 ---pagebreak---                                         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;
EN                                           67                                                   EN
 ---pagebreak---             (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).
   3.       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.
   4.       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.
                                                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)      goods sent as commercial or trade samples or as display items for exhibitions, which
            are not intended to be placed on the market;
   (b)      animals and goods intended for scientific purposes;
   (c)      goods on board means of transport operating internationally which are not unloaded
            and are intended for consumption by the crew and passengers;
   (d)      goods which form part of passengers personal luggage and are intended for personal
            consumption;
   (e)      small consignments of goods sent to natural persons which are not intended to be
            placed on the market;
   (f)      pet animals as defined in point (10) of Article 4(1) of Regulation (EU)
            No XXX/XXXX [Office of Publications, please insert number of the Regulation on
            animal health];
   (g)      goods which have undergone heat treatment and do not exceed quantities to be
            defined in those delegated acts;
   (h)      any other category of animals or goods for which controls at border control posts are
            not necessary given the risks they pose.
                                                Article 47
                                Official controls at border control posts
   1.       The competent authorities shall perform 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.
EN                                                  68                                               EN
 ---pagebreak---    2.  All consignments of the categories of animals and goods referred to in Article 45(1)
       shall be subject to documentary and identity checks.
   3.  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.
   4.  Physical checks to verify compliance with animal health and welfare requirements or
       with plant health requirements laid down in the rules referred to in Article 1(2) shall
       be performed by, or under the 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.
   5.  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.
   6.  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
   1.  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.
   2.  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.
   3.  Consignments shall not be split until official controls have been performed and the
       Common Health Entry Document (CHED) referred to in Article 54 has been
       finalised in accordance with Articles 54(4) and 55(1).
EN                                            69                                                 EN
 ---pagebreak---                                                 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)      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;
   (b)      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);
   (c)      the cases where and the conditions under which identity and physical checks of
            transhipped consignments and of animals arriving by air or sea and staying on the
            same means of transport for onward travel may be performed at a border control post
            other than the one of first arrival into the Union;
   (d)      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;
EN                                                  70                                              EN
 ---pagebreak---       (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. Point (b) of Article 54(2), point (a) of Article 55(2) and Articles 57, 58, 60, 61, 62(3)
      and (4), shall apply to the control points referred to in point (a) of paragraph 1.
                                         Article 52
                         Frequency of identity and physical checks
   1. The Commission shall be empowered to 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)   information collected by the Commission in accordance with
                  Article 124(1);
            (ii)  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)   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;
      (c)   the procedures for ensuring that the frequency rates of physical checks
            established in accordance with point (a) are applied in a timely and uniform
            manner.
EN                                           71                                                 EN
 ---pagebreak---    3.       The Commission shall, by means of implementing acts, lay down rules establishing:
            (a)    the frequency of physical checks for the categories of goods referred to in point
                   (d) of Article 45(1);
            (b)    the frequency of physical checks for the categories of animals and goods
                   referred to in points (e) and (f) of 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.       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.
   2.       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)   record the outcome of the official controls performed and any decisions
                         taken on that basis, including the decision to reject a consignment;
                   (ii)  communicate the information 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.
EN                                                  72                                                EN
 ---pagebreak---    4.    The competent authorities of the border control post shall finalise the CHED as soon
         as:
         (a)    all official controls required by Article 47(1) have been performed;
         (b)    the results from physical checks, where such checks are required, are available;
         (c)    a decision on the consignment has been taken in accordance with Article 53
                and recorded on the CHED.
                                              Article 55
               Use of the Common Health Entry Document by customs authorities
   1.    The placing of consignments of the 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)    the format of the CHED and the instructions for its presentation and use;
         (b)    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.
EN                                                73                                               EN
 ---pagebreak---                                           Article 57
                            Designation of border control posts
   1. 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).
   2. Member States shall notify the Commission at least three months before designating
      a border control post. That notification shall include all the information necessary for
      the Commission to verify that the proposed border control post complies with the
      minimum requirements laid down in Article 62.
   3. Within three months of receiving the 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.
   4. 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
   1. 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)   its contact details and opening hours;
      (b)   its exact location and whether it is a port, airport, rail or road entry point;
      (c)   the categories of animals and goods referred to in Article 45(1) which are
            included in the scope of its designation;
      (d)   the equipment and premises available for performing official controls on each
            of the categories of animals and goods for which it is designated;
      (e)   the volume of the animals and goods handled per calendar year for each of the
            categories of animals and goods referred to in Article 45(1) for which it is
            designated.
   2. The Commission shall, by means of 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).
EN                                            74                                               EN
 ---pagebreak---                                               Article 59
      Withdrawal of approvals for, and re-designation of, existing border control entities
   1.    The approval of border inspection posts in accordance with Article 6 of Council
         Directive 97/78/EC and Article 6 of Council Directive 91/496/EEC and the
         designation of points of 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.
   2.    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.
   2.    Member States shall inform the Commission and the other Member States of the
         withdrawal of the designation of a border control post as provided for in paragraph 1
         and of the reasons for such withdrawal.
   3.    The Commission shall be empowered to 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
   1.    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.
   2.    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.
   3.    Member States shall indicate the suspension of the designation of a border control
         post in the lists referred to in Article 58(1).
   4.    Member States shall remove the suspension provided for in paragraph 1 as soon as:
EN                                                75                                              EN
 ---pagebreak---       (a)   the competent authorities are satisfied that the risk referred to in paragraph 1 no
            longer exists;
      (b)   they have communicated to the Commission and to the other Member States
            the information on the basis of which the suspension is removed.
   5. 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
   1. Border control posts shall be located in the immediate vicinity of the point of entry
      into the Union and in a place suitably equipped to be designated by the customs
      authorities in accordance with Article 38(1) of Regulation (EEC) No 2913/92.
   2. 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.
   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)   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;
      (d)   arrangements in place to guarantee, as appropriate, access to any other
            equipment, premise and service necessary to apply the measures taken in
            accordance with Articles 63, 64 and 65 in cases of suspicion, non-compliant
            consignments or consignments presenting a risk;
      (e)   contingency arrangements to ensure the smooth operation of official controls
            and the effective application of the measures taken in accordance with
            Articles 63, 64 and 65 in cases of unforeseeable and unexpected conditions or
            events;
      (f)   the technology and equipment necessary for the efficient operation of the
            TRACES system and, as appropriate, of other computerised information
            management systems necessary for the handling and exchange of data and
            information;
      (g)   access to the services of official 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;
EN                                           76                                                 EN
 ---pagebreak---          (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
                                            Article 63
                  Suspicion of non-compliance and intensified official controls
   1.    In case of suspicion of non-compliance of consignments of the categories of animals
         and goods referred to in Article 45(1) with the rules referred to in Article 1(2), the
         competent authorities shall perform official controls in order to confirm or to
         eliminate that suspicion.
   2.    Consignments of animals and goods which 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.
   3.    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.
   4.    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.
   5.    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.
EN                                              77                                               EN
 ---pagebreak---    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).
                                          Article 64
              Measures to be taken in cases of non-compliant consignments
                          entering the Union from third countries
   1. 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.
   2. 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).
   3. 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)   re-dispatch the consignment outside the Union in accordance with Article 70(1)
            and (2); or
      (c)   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)   the Commission;
      (b)   the competent authorities of the other Member States;
      (c)   the customs authorities;
      (d)   the competent authorities of the third country of origin;
      (e)   the operator responsible for the consignment.
      That notification shall be performed via the computerised information management
      system referred to in Article 130(1).
   5. If a consignment of the categories of 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
EN                                            78                                                  EN
 ---pagebreak---             (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)      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
   (b)      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)   invalidate the official certificates and other documents accompanying
                  consignments which have been subject to measures pursuant to Article 64(3)
                  and (5) and Article 65;
            (b)   cooperate in accordance with Title IV to take any further measures necessary to
                  ensure that it is not possible to 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
EN                                                 79                                                EN
 ---pagebreak---             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)    that the consignment be destroyed or subject to any other appropriate measure;
            (b)    in the cases referred to in Article 65, that the consignment be destroyed in
                   suitable facilities located as close as possible to the border control post, taking
                   all measures necessary to protect human, animal or 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).
EN                                                   80                                                EN
 ---pagebreak---    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)    the destination has been agreed with the operator responsible for the
             consignment;
      (b)    the operator responsible for the consignment has first informed the competent
             authorities of the third country of 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.
   2. 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).
   3. 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
   1. 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. 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,
EN                                            81                                               EN
 ---pagebreak---              where there is no reason to suspect non-compliance with the rules referred to in
             Article 1(2) or fraudulent behaviour;
      (b)    the official certificates that must accompany consignments entering the Union;
      (c)    a model for such certificates;
      (d)    the competent authorities of the third country under the responsibility of which
             pre-export controls must be performed;
      (e)    where appropriate, any delegated body to which those competent authorities
             may delegate certain tasks. Such delegation may only be approved if it meets
             the criteria of Articles 25 to 32 or equivalent conditions.
   3. The approval provided for in paragraph 1 may only be granted to a third country if
      the evidence available and, where 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)    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;
      (b)    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:
      (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.
   5. 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
   1. When official controls on consignments of categories of animal and goods in respect
      of which specific pre-export controls have been approved in accordance with Article
      71(1) reveal serious and recurrent non-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
EN                                              82                                              EN
 ---pagebreak---           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)    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);
          (b)    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.
EN                                                83                                                EN
 ---pagebreak---    2.       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.
   3.       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.
   4.       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
                  invoice accompanying the consignment and on any other relevant
                  accompanying document:
                  '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.
   5.       In the case of consignments of animals and goods other than those subject to controls
            at entry into the Union as required by Article 45(1) and for which no customs
            declaration for release for free circulation has been made, customs authorities, where
            they have reason to believe that the 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
EN                                                  84                                                EN
 ---pagebreak---                    601/2004 and repealing Regulations (EC) No 1093/94 and (EC) No
                   1447/199951 from a fishing vessel flying a third country flag;
            (b)    consignments of unskinned, furred wild game;
            (c)    consignments of the categories of goods 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)    feed and food accompanying animals and intended for the feeding of those
                   animals;
            (f)    animals and goods ordered by distance selling and delivered from a third
                   country to an address in the Union, and the notification requirements necessary
                   to allow the proper 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)    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;
            (i)    goods entering the Union in bulk from a third country, irrespective of whether
                   they all originate from that third country;
            (j)    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).
   51
           OJ L 286, 29.10.2008, p. 1.
EN                                                  85                                               EN
 ---pagebreak---                                         Chapter VI
      Financing of official controls and other official activities
                                            Article 76
                                         General rules
   1.  Member States shall ensure that adequate financial resources are available to provide
       the staff and other resources necessary for the competent authorities to perform
       official controls and other official activities.
   2.  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).
   3.  This Chapter also applies in the case of delegation of specific official control tasks in
       accordance with Article 25.
   4.  Member States shall consult the operators concerned on the methods used to
       calculate the fees provided for in Article 77.
                                            Article 77
                                        Mandatory fees
   1.  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)    food business operators as defined in Article 3(3) of Regulation (EC)
                     No 178/2002 that are either registered or approved, or registered and
                     approved, in accordance with Article 6 of Regulation (EC) No 852/2004;
              (ii)   feed business operators as 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:
   52
      OJ L 35, 8.2.2005, p. 1.
EN                                              86                                                EN
 ---pagebreak---             (i)   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;
            (ii)  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];
            (iii) to obtain and maintain the authorisation referred to in Article 25 of
                  Regulation (EU) No XXX/XXXX [Office of Publications, please insert
                  number of the Regulation on the production and making available on the
                  market of plant reproductive material];
      (d)   official controls performed by the competent authorities at the border control
            posts or at the control points referred to in point (a) of Article 51(1).
   2. For the purposes of paragraph 1, the official controls referred to in point (a) of that
      paragraph shall include 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.
   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;
EN                                            87                                               EN
 ---pagebreak---             (b)   the cost of facilities and equipment, including maintenance and insurance
                  costs;
            (c)   the cost of consumables, services and tools;
            (d)   the cost of training of staff referred to in point (a), with the exclusion of the
                  training necessary to obtain the 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.
                                                Article 79
                                           Calculation of fees
   1.       Fees collected in accordance with Article 77 shall be:
            (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.
   2.       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.
   3.       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.
                                                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,
EN                                                  88                                                 EN
 ---pagebreak---    so that fees applied to consistently compliant operators are lower than those applied to other
   operators.
                                               Article 81
                                           Application of fees
   1.       Operators shall receive proof of the payment of fees provided for in Article 77(1).
   2.       Fees collected in accordance with point (d) of Article 77(1) shall be paid by the
            operator responsible for the consignment or its representative.
                                               Article 82
                          Fees refunds and exemption for microenterprises
   1.       Fees provided for in Article 77 shall not directly or indirectly be refunded, unless
            unduly collected.
   2.       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.
   3.       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)   the method and data used to establish the fees provided for in Article 77(1);
            (b)   the use of resources collected through such fees;
            (c)   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)   the costs to the competent authority for which a fee is due in accordance with
                  Article 77(1), indicating the breakdown of such costs per activity referred to in
                  Article 77(1) and per cost element referred to in Article 78(1);
            (b)   the amount of the fees provided for in Article 77(1) applied to each category of
                  operators, and for each category of official controls;
            (c)   the method used to establish the fees provided for in Article 77(1), including
                  the data and estimates used for the 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).
EN                                                 89                                                 EN
 ---pagebreak---                                                    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;
   (b)       official controls performed at the request of the operator;
   (c)       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;
   (d)       official controls performed and action taken by the competent authorities in
             accordance with Articles 64 to 67, 69 and 70, and corrective action taken by a third
             party upon request by the competent authorities, in cases where the operator has
             failed to carry out corrective action 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
   1.        In accordance with rules referred to in Article 1(2), official certification shall take the
             form of:
             (a)    official certificates; or,
             (b)    official attestations.
   2.        Where the competent authorities delegate specific tasks related to the issuance of
             official certificates or 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
   1.        When the rules referred to in Article 1(2) require the issuance of an official
             certificate, the provisions of Articles 87, 88 and 89 shall apply.
   2.        Articles 87, 88 and 89 shall also apply to official certificates which are necessary for
             the purposes of exporting consignments of animals and goods to third countries.
EN                                                     90                                                  EN
 ---pagebreak---                                             Article 87
                        Signature and issuance of official certificates
   1. Official certificates shall be issued by the competent authorities.
   2. Competent authorities shall designate the certifying officers who are authorised to
      sign official certificates. 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)    facts and data relevant for the certification, knowledge of which was
             ascertained by another person authorised for that purpose by, and acting under
             the control of, the competent authorities, provided that the certifying officer
             can verify the accuracy of such facts and data;
      (c)    facts and data relevant for the 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)    enable the identification of the person who signed them;
      (e)    allow the verification of the link between the certificate and the consignment,
             lot or individual animal or good covered by the certificate.
   2. The competent authorities 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:
EN                                              91                                              EN
 ---pagebreak---             (a)    the temporary suspension of the certifying officer from its duties;
            (b)    the withdrawal of the authorisation to sign official certificates;
            (c)    any other necessary measure to prevent that the offence referred to in the first
                   sentence of this paragraph is repeated.
                                                 Article 89
                               Implementing powers for official certificates
   The Commission may, by means of implementing acts, lay down rules for the uniform
   application of Articles 87 and 88 concerning:
   (a)      model official certificates and rules for the issuance of such certificates;
   (b)      the mechanisms and the legal and technical arrangements to ensure the issuance of
            accurate and reliable official certificates and prevent risk of fraud;
   (c)      the procedures to be followed in the case of withdrawals of official certificates and
            for the production of replacement certificates;
   (d)      rules for the production of certified copies of official certificates;
   (e)      the format of documents that must accompany animals and goods after official
            controls have been performed;
   (f)      rules for the issuance of electronic certificates and for the use of electronic
            signatures.
   Those implementing acts shall be adopted in accordance with the examination procedure
   referred to in Article 141(2).
                                                 Article 90
                                           Official attestations
   1.       When the rules referred to in Article 1(2) 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;
EN                                                    92                                             EN
 ---pagebreak---           (ii)   the rules laid down in this Regulation.
   4. Competent authorities shall perform regular official controls to verify that:
      (a) the operators issuing the attestations comply with the conditions laid down in
          the rules referred to in Article 1(2);
      (b) the attestation is issued on the basis of relevant, correct and verifiable facts and
          data.
EN                                          93                                                 EN
 ---pagebreak---                                         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)   the methods of analysis, test or diagnosis employed by the official laboratories
            designated in accordance with Article 36(1);
      (b)   the results of the analyses, tests and diagnoses performed by those official
            laboratories.
   2. The designations provided for in paragraph 1 shall:
      (a)   follow a public selection process;
      (b)   be reviewed regularly.
   3. European Union 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.
EN                                           94                                                 EN
 ---pagebreak---    2. European Union reference laboratories shall be responsible, in accordance with
      annual or multiannual work programmes approved by the Commission, for the
      following tasks:
      (a)   providing national reference laboratories with details of methods of laboratory
            analysis, test or diagnosis, including reference methods;
      (b)   coordinating the application by the 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;
      (c)   coordinating practical arrangements necessary to apply new methods of
            laboratory analysis, test or diagnosis, and informing national reference
            laboratories of advances in this field;
      (d)   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)   providing information on relevant Union, national and international research
            activities to national reference laboratories;
      (g)   collaborating within the scope of their mission with laboratories in third
            countries and with the European Food Safety Authority, the European
            Medicines Agency and the European Centre for Disease Prevention and
            Control;
      (h)   assisting actively in the diagnosis of outbreaks in Member States of foodborne,
            zoonotic or animal diseases, or of 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)    reference collections of pests of plants or reference strains of pathogenic
                   agents;
            (ii)   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).
EN                                            95                                               EN
 ---pagebreak---                                                 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;
   (b)     organising comparative tests and field trials on plant reproductive material;
   (c)     conducting training courses for the benefit of staff of the competent authorities and
           of experts from third countries;
   (d)     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;
   (e)     disseminating research findings and technical innovations in the fields within the
           scope of their mission.
EN                                                  96                                                EN
 ---pagebreak---                                                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)     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;
   (b)     providing scientific and technical expertise for the development and application of
           the animal welfare indicators referred to in point (f) of Article 18(3);
   (c)     developing or coordinating the development of methods for the assessment of the
           level of welfare of animals and of methods for the improvement of the welfare of
           animals;
   (d)     carrying out scientific and technical studies on the welfare of animals used for
           commercial or scientific purposes;
   (e)     conducting training courses for the benefit of staff of the national scientific support
           networks or bodies referred to in point (a), of staff of the competent authorities and
           of experts from third countries;
EN                                                 97                                                 EN
 ---pagebreak---    (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;
       (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.
   2.  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.
   3.  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.
   4.  If the Commission controls referred to in paragraph 3 show non-compliance with the
       requirements laid down in Articles 91(3), 92, 93(3), 95(3) and 96, the Commission
       shall, after having received the 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;
EN                                            98                                                  EN
 ---pagebreak---       (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. 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.
   6. 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)   collaborate with the European Union reference laboratories, and participate in
            training courses and in inter-laboratory comparative tests organised by these
            laboratories;
      (b)   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;
EN                                           99                                              EN
 ---pagebreak---       (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.
   2. 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
   1. 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.
   2. 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.
   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.
   4. All communications between competent authorities in accordance with Articles 102
      to 105 shall be in writing.
   5. In order to streamline and simplify communication exchanges, the Commission shall,
      by means of implementing acts, establish a standard format for:
      (a)   the requests for assistance provided for in Article 102(1);
      (b)   the communication of common and 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
   1. Each Member State shall designate one or more liaison bodies responsible for the
      exchange of communications between competent authorities in accordance with
      Articles 102 to 105.
   2. The designation of liaison bodies shall not preclude direct contacts, exchange of
      information or cooperation between the staff of competent authorities in different
      Member States.
   3. 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.
EN                                          100                                              EN
 ---pagebreak---    4. Member States shall communicate to the Commission and other Member States the
      details of their liaison bodies designated in accordance with paragraph 1, and any
      subsequent modification of those details.
   5. 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.
   6. All requests for assistance pursuant to Article 102(1), and notifications and
      communications pursuant to Articles 103, 104 and 105 shall be transmitted by a
      liaison body to its correspondent in the Member State to which the request or the
      notification is addressed.
   7. The Commission shall, by means of 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
   1. 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)    acknowledge receipt of the request without delay;
      (b)    indicate within ten days from the date of receipt of the request, the time
             necessary to provide an 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.
   2. Documents may be transmitted in their original form or copies may be provided.
   3. 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)    shall at all times be able to produce written authority stating their identity and
             their official capacity;
      (b)    shall have access to the same premises and documents as the staff of the
             requested competent 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.
EN                                           101                                                EN
 ---pagebreak---                                          Article 103
                                Assistance without request
   1. When the competent authorities in a Member State become aware of a non-
      compliance, and if such non-compliance may have implications for another Member
      State, they shall notify such information to the competent authorities of that other
      Member State without being requested to do so and without delay.
   2. The competent authorities notified in accordance with paragraph 1:
      (a)   shall acknowledge receipt of the notification without delay;
      (b)   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)   acknowledge receipt of the notification;
      (b)   indicate what investigations they intend to carry out;
      (c)   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.
EN                                           102                                             EN
 ---pagebreak---    4. When official controls performed on animals or goods originating in another
      Member State show repeated cases of non-compliance with the rules referred to in
      Article 1(2), the competent authorities of the Member State of destination shall
      inform the Commission and the competent authorities of the other Member States
      without delay.
                                          Article 105
                                 Assistance by third countries
   1. When competent authorities receive information from a third country indicating non-
      compliance or a risk to human, animal or plant health, animal welfare or, as regards
      GMOs and plant protection products, to the 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.
   2. 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)    the competent authorities which have provided the information consent to such
             communication;
      (b)    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)    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,
      (b)    information available to the Commission indicates that the same, or similar,
             activities that are, or appear to be, non-compliant with the rules referred to in
             Article 1(2) might be taking place in more than one Member State; and,
      (c)    the competent authorities in the Member States concerned are unable to agree
             on appropriate action to address the non-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;
EN                                            103                                              EN
 ---pagebreak---       (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.
EN                                        104                                              EN
 ---pagebreak---                                              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)    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;
        (b)    the risk categorisation of the official controls;
        (c)    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)    the general organisation and management of official controls at national,
               regional and local level, including official controls in individual
               establishments;
        (f)    control systems applied to different sectors and coordination between the
               different services of competent 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;
EN                                               105                                               EN
 ---pagebreak---            (i)    the documented procedures provided for in Article 11(1);
           (j)    the organisation and operation of contingency plans in accordance with the
                  rules referred to Article 1(2);
           (k)    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.      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.
   2.      The multi-annual national control plan shall be updated every time it is necessary to
           adjust it to changes to the rules referred to in Article 1(2), and shall be reviewed on a
           regular basis to take account at least of the following factors:
           (a)    the emergence of new diseases, pests of plants or other risks to human, animal
                  or plant health, animal welfare or, in the case of GMOs and plant protection
                  products, to the environment;
           (b)    significant changes to the structure, management or operation of the competent
                  authorities in the Member State;
           (c)    the results of Member States' official controls;
           (d)    the results of Commission controls performed in the Member State in
                  accordance with Article 115(1);
           (e)    delegated acts adopted by the Commission in accordance with Article 110;
           (f)    scientific findings;
           (g)    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)     criteria for the risk categorisation of the operators' activities;
   (b)     priorities for official controls based on the criteria laid down in Article 8 and in the
           rules provided for in Articles 15 to 24;
   (c)     procedures to maximise the effectiveness of official controls;
   (d)     the main performance indicators to be applied by the competent authorities in
           assessing the multi-annual national control plan and its implementation.
EN                                                 106                                               EN
 ---pagebreak---                                                 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)      the organisation and the implementation of coordinated control plans of limited
            duration in one of the areas governed by the rules referred to in Article 1(2);
   (b)      the organisation, on an ad hoc basis, of 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)    any amendments made to its multi-annual national control plan to take account
                   of the factors referred to in Article 109(2);
            (b)    the results of official controls performed in the previous year under its multi-
                   annual national control plan;
            (c)    the type and number of cases of non-compliance with the rules referred to in
                   Article 1(2) detected in the previous year by 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)    the annual reports submitted by the Member States in accordance with
                   Article 112;
            (b)    the results of Commission controls performed in accordance with Article
                   115(1);
EN                                                  107                                               EN
 ---pagebreak---       (c)   any other relevant information.
   2. 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
   1. For the application of the general plan for crisis management provided for in
      Article 55(1) of Regulation (EC) No 178/2002, Member States shall draw up
      operational contingency plans for food and 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:
      (a)   the competent authorities to be involved;
      (b)   the powers and responsibilities of the authorities referred to in point (a);
      (c)   channels and procedures for sharing information between competent authorities
            and other parties concerned as appropriate.
   3. Member States shall review their contingency plans for food and feed regularly to
      take into account changes in the organisation of the competent authorities and
      experience gained from implementing the plan and simulation exercises.
   4. The Commission shall be empowered to 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.
EN                                           108                                              EN
 ---pagebreak---                                          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 to emergency situations, emerging problems or new
                   developments in the Member States.
   2. The controls provided for in paragraph 1 shall be organised in cooperation with the
      competent authorities of the Member States and be performed on a regular basis.
   3. 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.
   4. 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)   send to the Member State where those controls were performed a copy of the
            draft report provided for in point (a) for its comments;
      (c)   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).
EN                                            109                                              EN
 ---pagebreak---    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)    take appropriate follow-up measures to remedy any specific or systemic
          shortcomings identified by the controls performed by the Commission experts in
          accordance to Article 115(1);
   (b)    give all necessary assistance and provide all documentation and other technical
          support that Commission experts request to enable them to perform controls
          efficiently and effectively;
   (c)    ensure that Commission experts have access to all premises or parts of premises,
          animals and goods, and to information, 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;
EN                                               110                                                  EN
 ---pagebreak---            (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)    the legislation of the third country;
           (b)    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;
           (c)    the training of staff in the performance of official controls;
           (d)    the resources including analytical, testing and diagnostic facilities available to
                  competent authorities;
           (e)    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)    the extent and operation of official controls performed on animals, plants and
                  their products arriving from other third countries;
           (h)    the assurances which the third country can give regarding compliance with, or
                  equivalence to, the requirements laid down in the rules referred to in
                  Article 1(2).
   3.      In order to facilitate the efficiency and 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.
   4.      The Commission may appoint experts from Member States to assist its own experts
           during the controls provided for in paragraph 1.
                                                Article 120
                         Frequency of Commission controls in third countries
   The frequency of Commission controls in third countries shall be determined on the basis of:
   (a)     a risk assessment of the animal and goods exported to the Union from them;
   (b)     the rules referred to in Article 1(2);
   (c)     the volume and nature of animals and goods entering the Union from the third
           country concerned;
   (d)     the results of controls already performed by the Commission experts or by other
           inspection bodies;
   (e)     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;
EN                                                  111                                              EN
 ---pagebreak---    (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)       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;
   (i)       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;
EN                                                   112                                           EN
 ---pagebreak---         (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)    any sanitary or phytosanitary regulations adopted or proposed within their
               territory;
        (b)    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.
EN                                              113                                           EN
 ---pagebreak---                                               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)    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;
          (b)    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;
          (c)    the requirement that consignments of certain animals and goods be
                 accompanied by an official certificate, an official attestation, or by any other
                 evidence that the consignments comply with the relevant requirements referred
                 to in paragraph 1 or with requirements recognised to be at least equivalent;
          (d)    the obligation to provide the evidence referred to in point (c) in accordance
                 with a specific format;
          (e)    any other requirement necessary to ensure that certain animals and goods offer
                 a level of protection of health and, as regards GMOs and plant protection
                 products, of the environment, equivalent to that ensured by the requirements
                 referred to in paragraph 1.
   3.     Where, in case of risks arising from 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.
   4.     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).
                                              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.
EN                                                114                                                EN
 ---pagebreak---    2. 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).
   3. The Commission shall decide on the request referred to in paragraph 2 taking into
      account, as appropriate:
      (a)   the third country's legislation in the sector concerned;
      (b)   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;
      (c)   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;
      (d)   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)    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);
            (ii)   a list of the establishments referred to in point (i) is drawn up and kept up
                   to date;
            (iii) the list of establishments referred to in point (i) and its updated versions
                   are communicated to the Commission without delay;
            (iv) 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
EN                                            115                                                EN
 ---pagebreak---       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)    the prohibition of entry into the Union of the animals and goods referred to in
             paragraph 1 originating or dispatched from the concerned third countries or
             regions thereof;
      (b)    the requirement that the animals 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;
      (c)    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;
      (d)    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)    the information collected in accordance with Article 124;
      (b)    any other information that the third countries concerned have provided;
      (c)    where necessary, the results of 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
EN                                            116                                               EN
 ---pagebreak---       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)   the nature and content of the official certificates or attestations that must
            accompany the animals or goods;
      (b)   specific requirements applicable to the entry into the Union of the animals or
            goods and the official controls to be performed at entry into the Union;
      (c)   where necessary, procedures for 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. 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.
   2. 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)   this Regulation and the rules referred to in Article 1(2);
      (b)   control methods and techniques relevant for the official controls and for the
            other official activities of the competent authorities;
      (c)   production, processing and marketing methods and techniques.
EN                                            117                                              EN
 ---pagebreak---    3. 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.
   4. 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).
   5. 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.
   6. 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)
   1. The Commission shall set up and manage a computerised information management
      system for the integrated operation of the mechanisms and tools through which data,
      information and documents concerning official controls are managed and handled
      ('the IMSOC').
   2. The IMSOC shall:
      (a)    integrate fully and provide the necessary updates to the TRACES system as
             established by Decision 2003/24/EC;
      (b)    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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 ---pagebreak---                                              Article 131
                               General functionalities of the IMSOC
   The IMSOC shall:
   (a)    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;
   (b)    provide a mechanism for the exchange of data and information in accordance with
          the provisions of Title IV;
   (c)    provide a tool to collect and manage the reports on official controls provided by the
          Member States to the Commission;
   (d)    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
   1.     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.
   2.     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.
   3.     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:
EN                                               119                                            EN
 ---pagebreak---            (a)   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;
           (b)   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)     the technical specifications and the specific rules for the functioning of the IMSOC
           and of its components;
   (b)     contingency arrangements to be applied in case of unavailability of any of the
           functionalities of the IMSOC;
   (c)     the cases where and the conditions under which concerned third countries and
           international organisations may be granted partial access to the functionalities of the
           IMSOC and the modalities of such access;
   (d)     the cases where and the conditions under which exemptions from the use of the
           TRACES system can be granted to occasional users;
   (e)     the rules concerning an electronic system under which electronic certificates issued
           by the competent authorities of third countries shall be accepted by the competent
           authorities.
EN                                              120                                                EN
 ---pagebreak---                                         Title VII
                               Enforcement action
                                        Chapter I
           Action by the competent authorities and penalties
                                          Article 134
      General obligations of the competent authorities as regards enforcement action
   1.  When acting in accordance with this Chapter, the competent authorities shall give
       priority to action to be taken to eliminate or contain risks to human, animal and plant
       health, animal welfare and, as regards GMOs and plant protection products, to the
       environment.
   2.  In case of suspicion of non-compliance, the competent authorities shall perform an
       investigation in order to confirm or to eliminate that suspicion.
   3.  Where necessary for its purposes, the investigation referred to in paragraph 2 shall
       include:
       (a)   the performance of intensified official controls on animals, goods and operators
             for an appropriate period;
       (b)   the official detention of animals and goods and of any unauthorised substances
             or products as appropriate.
                                          Article 135
            Investigations and measures in 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;
EN                                            121                                              EN
 ---pagebreak---       (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)   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;
      (j)   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.
   4. All expenditure incurred pursuant to this Article shall be borne by the responsible
      operators.
                                         Article 136
                                          Penalties
   1. Member States shall lay down the rules on penalties applicable to infringements of
      the provisions of this 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.
   2. 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.
   3. Member States shall ensure in particular that penalties are provided for in the
      following cases:
EN                                           122                                                 EN
 ---pagebreak---       (a)   where operators fail to cooperate during official controls or other official
            activities;
      (b)   false or misleading official certification;
      (c)   fraudulent production or use of official certificates, 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. 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)   the prohibition to make available on the market or to transport, move or
            otherwise handle certain animals or goods concerned by the failure in the
            official control system;
      (b)   special conditions for the activities, animals or goods referred to in point (a);
      (c)   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).
   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.
   3. 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).
EN                                            123                                             EN
 ---pagebreak---                                      Title VIII
                             Common provisions
                                       Chapter I
                             Procedural provisions
                                        Article 138
              Amendment of Annexes and references to European standards
   1. The Commission shall be empowered to 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.
   2. 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
   1. The power to adopt delegated acts is conferred on the Commission subject to the
      conditions laid down in this Article.
   2. The delegation of power referred to in Articles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21,
      22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2),
      60(3), 62(2), 69(3), 75(1) and (2), 97(2), 98(6), 99(2), 101(3), 106(3), 110, 111,
      114(4) and 125(1), the third subparagraph of Article 132(1), 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.
   3. The delegation of powers referred to in Articles 4(3), 15(2), 16, 17, 18(3), 19, 20, 21,
      22, 23(1), 24(1), 25(3), 26(2), 40, 43(4), 45(3), 46, 49, 51(1), 52(1) and (2), 56(2),
      60(3), 62(2), 69(3), 75(1) and (2), 97(2), 98(6), 99(2), 101(3), 106(3), 110, 111,
      114(4) and 125(1), the third 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.
   4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
      the European Parliament and to the Council.
   5. A delegated act adopted pursuant to 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
EN                                          124                                                 EN
 ---pagebreak---       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
   1. 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.
   2. Either the European Parliament or the Council may object to a delegated act in
      accordance with the procedure referred to in Article 139(5). In such a case, the
      Commission shall repeal the act without delay following the notification of the
      decision to object by the European Parliament or by the Council.
                                         Article 141
                                         Committee
   1. The Commission shall be assisted by the Standing Committee on Plants, Animals,
      Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That
      Committee is a Committee in the meaning of Regulation (EU) No 182/2011.
   2. 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.
   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].
EN                                           125                                              EN
 ---pagebreak---    2.       Regulation (EC) No 854/2004 and Directives 89/662/EEC, 90/425/EEC,
            91/496/EEC, 96/23/EC and 97/78/EC are repealed as from [Office of Publications,
            please insert date of entry into force of this Regulation + 3 years].
   3.       References to the repealed acts shall be construed as references to this Regulation
            and shall be read in accordance with the correlation table in Annex IV.
                                               Article 143
       Transitional measures related to the repeals of Directives 91/496/EEC and 97/78/EC
   1.       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.
   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
   1.       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.
   2.       Article 29(1) and (2) of Directive 96/23/EC shall continue to apply until the date to
            be determined in the delegated act adopted in accordance with paragraph 3.
   3.       The Commission shall be empowered to adopt delegated acts in accordance to
            Article 139 concerning the date on which 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.';
EN                                                 126                                                  EN
 ---pagebreak---    (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)      point (a) of paragraph 3 is deleted;
   (d)      Article 7 is deleted.
                                              Article 146
                                 Amendments to Directive 1999/74/EC
   Directive 1999/74/EC is amended as follows:
   (a)      Article 8 is amended as follows:
            (i)   paragraph 1 is deleted;
            (ii)  paragraph 2 is replaced by the following:
                  'Member States shall submit to the Commission by 30 June each year an annual
                  report for the previous year on the inspections carried out by the competent
                  authority to check compliance with the requirements of this Directive. The
                  report shall be accompanied by an analysis of the most serious findings of non–
                  compliances and a national action plan to prevent or decrease their occurrence
                  for the forthcoming years. The 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)      Articles 19 and 21 are deleted;
   (b)      In Annex X, Chapters A and B are deleted.
                                              Article 148
                            Amendments to Regulation (EC) No 1829/2003
   Regulation (EC) No 1829/2003 is amended as follows:
   (a)      Article 32 is amended as follows:
            (i)   the first and second subparagraphs are deleted
EN                                                127                                              EN
 ---pagebreak---            (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;
EN                                                 128                                             EN
 ---pagebreak---    (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.       Articles 26, 27(1) and 30 of Regulation (EC) No 396/2005 shall continue to apply
            until the date to be determined in the delegated act adopted in accordance with
            paragraph 3.
   3.       The Commission shall be empowered to adopt delegated acts in accordance to
            Article 139 concerning the date on which Articles 26, 27(1) and 30 referred to in
            paragraph 2 shall no longer apply. That date 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. …';
EN                                                 129                                                  EN
 ---pagebreak---    (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.
EN                                             130                                              EN
 ---pagebreak---    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                                               EN
 ---pagebreak---    (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                                                  EN
 ---pagebreak---                                                 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.       Paragraph 1, the second subparagraph of paragraph 2 and paragraphs 3, 4 and 6 of
            Article 8 and Annex II of Directive 2009/128/EC shall continue to apply until the
            date to be determined in the delegated act to be adopted in accordance with
            paragraph 3.
   3.       The Commission shall be empowered to adopt delegated acts in accordance to
            Article 139 concerning the date on which 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                                                  133                                          EN
 ---pagebreak---                   '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)   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]*;
                        (b)   the European Union reference centres for plant reproductive
                              material referred to in Article 93 of that Regulation;
                        (c)   the European Union reference centres for animal welfare referred
                              to in Article 95 of that Regulation.
                        _________________
                        * OJ L …, …, p. …';
            (iii) in paragraph 2, point (a) is replaced by the following:
                  '(a)  costs of personnel, regardless its 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                                                EN
 ---pagebreak---    (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
   1.  This Regulation shall enter into force on the twentieth day following that of its
       publication in the Official Journal of the European Union.
       Unless otherwise provided for in paragraphs 2 to 5, it shall apply from [Office of
       Publications, please insert date of entry into force of this Regulation + 1 year].
   2.  In the area covered by the rules referred to in point (g) of Article 1(2), this
       Regulation, shall apply from [Office of Publications, please insert date of application
       of the Regulation on protective measures against pests of plants], with the following
       exceptions:
       (a)   Articles 91 and 92 and 97, 98 and 99 shall apply in accordance with paragraph
             1;
       (b)   Article 33(1), (2), (3) and (4), point (e) of Article 36(4) and Article 36(5) shall
             apply from [Office of Publications, please insert date of entry into force of this
             Regulation + 5 years].
   3.  In the area covered by the rules referred to in point (h) of Article 1(2), this
       Regulation, shall apply from [Office of 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].
   4.  Articles 15(1), 18(1), 45 to 62 and 76 to 84, point (b) of Article 150, point (b)(i) of
       Article 152, point (b)(i) of Article 154, point (b)(i) of Article 155 and point (b) of
       Article 156 shall apply from [Office of Publications, please insert date of entry into
       force this Regulation + 3 years].
   5.  Article 161 shall apply from [Office of Publications, please insert date of entry into
       force of this Regulation].
EN                                            135                                                EN
 ---pagebreak---    This Regulation shall be binding in its entirety and directly applicable in all Member States.
   Done at Brussels,
   For the European Parliament                   For the Council
   The President                                 The President
EN                                                136                                             EN
 ---pagebreak---                                                 ANNEX I
                TERRITORIES REFERRED TO IN POINT 45 OF ARTICLE 2
   1.       The territory of the Kingdom of Belgium
   2.       The territory of the Republic of Bulgaria
   3.       The territory of the Czech Republic
   4.       The territory of the Kingdom of Denmark with the exception of the Faroe Islands and
            Greenland
   5.       The territory of the Federal Republic of Germany
   6.       The territory of the Republic of Estonia
   7.       The territory of Ireland
   8.       The territory of the Hellenic Republic
   9.       The territory of the Kingdom of Spain with the exception of Ceuta and Melilla
   10.      The territory of the French Republic
   11.      The territory of the Italian Republic
   12.      The territory of the Republic of Cyprus
   13.      The territory of the Republic of Latvia
   14.      The territory of the Republic of Lithuania
   15.      The territory of the Grand Duchy of Luxembourg
   16.      The territory of Hungary
   17.      The territory of the Republic of Malta
   18.      The territory of the Kingdom of the Netherlands in Europe
   19.      The territory of the Republic of Austria
   20.      The territory of the Republic of Poland
   21.      The territory of the Portuguese Republic
   22.      The territory of Romania
   23.      The territory of the Republic of Slovenia
   24.      The territory of the Slovak Republic
   25.      The territory of the Republic of Finland
   26.      The territory of the Kingdom of Sweden
   27.      The territory of the United Kingdom of Great Britain and Northern Ireland
   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                                                 137                                                  EN
 ---pagebreak---                                              ANNEX II
             TRAINING OF STAFF OF THE COMPETENT AUTHORITIES
   CHAPTER I: SUBJECT      MATTER FOR THE TRAINING OF STAFF PERFORMING OFFICIAL
   CONTROLS AND OTHER OFFICIAL ACTIVITIES
   1.    Different control methods and techniques, such as, inspection, verification,
         screening, targeted screening, sampling, and laboratory analysis, diagnosis and
         testing
   2.    Control procedures
   3.    The rules referred to in Article 1(2)
   4.    Assessment of non-compliance with the rules referred to in Article 1(2)
   5.    The hazards in the production, processing and distribution of animals and goods
   6.    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.
   7.    The evaluation of the application of HACCP procedures and of good agricultural
         practices
   8.    Management systems such as quality assurance programmes that the operators
         manage and their assessment in so far as these are relevant for the requirements set
         out in the rules referred to in Article 1(2)
   9.    Official certification systems
   10.   Contingency arrangements for emergencies, including communication between
         Member States and the Commission
   11.   Legal proceedings and implications of official controls
   12.   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
   13.   Control procedures and requirements for entry into the Union of animals and goods
         arriving from third countries.
   14.   Any other area necessary to ensure that official controls are performed in accordance
         with this Regulation.
   CHAPTER II: SUBJECT AREAS FOR CONTROL PROCEDURES
   1.    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
   2.    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
   3.    A statement on the objectives to be achieved
   4.    Tasks, responsibilities and duties of staff
EN                                               138                                             EN
 ---pagebreak---    5.  Sampling procedures, control methods and techniques, including laboratory analysis,
       test and diagnosis, interpretation of results and consequent decisions
   6.  Screening and targeted screening programmes
   7.  Mutual assistance in the event that official controls require more than one Member
       State to take action
   8.  Action to be taken following official controls
   9.  Cooperation with other services and departments that may have relevant
       responsibilities or with operators
   10. Verification of the appropriateness of methods of sampling and of laboratory
       analysis, test and diagnosis
   11. Any other activity or information required for the effective functioning of the official
       controls.
EN                                            139                                               EN
 ---pagebreak---                                         ANNEX III
              CHARACTERISATION OF METHODS OF ANALYSIS
   1. Methods of analysis and measurement results should be characterised by the
      following criteria:
      (a)   accuracy (trueness and precision);
      (b)   applicability (matrix and concentration range);
      (c)   limit of detection;
      (d)   limit of quantification;
      (e)   precision;
      (f)   repeatability;
      (g)   reproducibility;
      (h)   recovery;
      (i)   selectivity;
      (j)   sensitivity;
      (k)   linearity;
      (l)   measurement uncertainty;
      (m) other criteria that may be selected as required.
   2. The precision values referred to in 1(e) 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.
   3. Methods of analysis which are applicable uniformly to various groups of
      commodities should be given preference over methods which apply only to
      individual commodities.
   4. 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.
   5. 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
 ---pagebreak---                                             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)
   Article 1(1) second subparagraph               Article 1(2)
   Article 1(2)                                   Article 1(4)
   Article 1(3)                                   -
   Article 1(4)                                   -
   Article 2                                      Article 2
   Article 3(1)                                   Article 8(1)
   Article 3(2)                                   Article 8(4)
   Article 3(3)                                   Article 9
   Article 3(4)                                   Article 8(6)
   Article 3(5)                                   Article 8(6)
   Article 3(6)                                   Article 8(7)
   Article 3(7)                                   -
   Article 4(1)                                   Article 3(1)
   Article 4(2)                                   Article 4(1)(a), (c), (d), (e), (f), (g) and (i)
   Article 4(3)                                   Article 3(2)
   Article 4(4)                                   Article 4(1)(b)
   Article 4(5)                                   Article 4(4)
   Article 4(6)                                   Article 5(1)
   Article 4(7)                                   Article 5(3)
   Article 5(1) first subparagraph                Article 25(1)
   Article 5(1) second subparagraph               Article 25(3)
   Article 5(1) third subparagraph                Article 25(2) first subparagraph
   Article 5(2)(a), (b), (c) and (f)              Article 26(1)
   Article 5(2)(d)                                -
   Article 5(2)(e)                                Article 28
   Article 5(3)                                   Article 29
   Article 5(4)                                   -
   Article 6                                      Article 4(2) and (3)
   Article 7(1), first subparagraph               Article 10(1), first subparagraph
   Article 7(1), second subparagraph, point (a)   Article 10(1), second subparagraph
   Article 7(1), second subparagraph, point (b)   -
   Article 7(2), first sentence                   Article 7(1)
   Article 7(2), second sentence                  -
EN                                              141                                                EN
 ---pagebreak---    Article 7(2), third sentence    -
   Article 7(3)                    Article 7(2), and (3)
   Article 8(1)                    Article 11(1)
   Article 8(2)                    Article 4(1)(h)
   Article 8(3)(a)                 Article 11(2)
   Article 8(3)(b)                 Article 11(3)
   Article 8(4)                    -
   Article 9(1)                    Article 12(1) first subparagraph
   Article 9(2)                    Article 12(1) second subparagraph
   Article 9(3)                    Article 11(2)
   Article 10                      Article 13
   Article 11(1)                   Article 33(1) and (2)
   Article 11(2)                   -
   Article 11(3)                   Article 33(5)
   Article 11(4)                   Article 33(7)
   Article 11(5)                   Article 34(1) first subparagraph and (2)
   Article 11(6)                   Article 34(1)(b)(i)
   Article 11(7)                   Article 33(6)
   Article 12(1)                   Article 36(1)
   Article 12(2)                   Article 36(4)(e)
   Article 12(3)                   Article 36(5)(c)
   Article 12(4)                   Article 38(2)
   Article 13                      Article 114
   Article 14(1)                   -
   Article 14(2)                   Article 43(3)
   Article 14(3)                   -
   Article 15(1)                   Article 42(1) first sentence
   Article 15(2)                   Article 42(2) and (4)
   Article 15(3)                   Article 42(2) and (4)
   Article 15(4)                   -
   Article 15(5)                   Article 45(1)(d), 45(2)(b) and 52(3), first
                                   sentence
   Article 16(1)                   Article 43(1)
   Article 16(2)                   Article 42(1) second sentence
   Article 16(3) first sentence    Article 43(2)
   Article 16(3) second sentence   Article 33(6)
   Article 17(1) first indent      Article 57(1)
   Article 17(1) second indent     Article 54(1),(2)(a), (3) and Article 56(1)
EN                               142                                           EN
 ---pagebreak---    Article 17(2)      -
   Article 18         Article 63(1), (2) and (3)
   Article 19(1)      Article 64(1) and (3)
   Article 19(2)a     Article 65
   Article 19(2)b     Article 64(5)
   Article 19(3)      Article 64(4)
   Article 19(4)      Article 6
   Article 20         Article 69
   Article 21(1)      Article 70(1)
   Article 21(2)      Article 67
   Article 21(3)      Article 64(1)
   Article 21(4)      Article 64(4)
   Article 22         Article 84(d)
   Article 23(1)      Article 71(1)
   Article 23(2)      Article 71(2) and 72
   Article 23(3)      Article 71(3)
   Article 23(4)      Article 71(2)
   Article 23(5)      Article 71(4)(a)
   Article 23(6)      Article 71(2)(c) and (4)(b)
   Article 23(7)      Article 72
   Article 23(8)      Article 72
   Article 24(1)      Article 73(1)
   Article 24(2)      Article 55
   Article 24(3)      Article 44
   Article 24(4)      Article 74
   Article 25(1)      -
   Article 25(2)(a)   -
   Article 25(2)(b)   Article 75(1)(c)
   Article 25(2)(c)   Article 75(1)(f)
   Article 25(2)(d)   Article 46(c) and (d), and 75(1)(e) and (k)
   Article 25(2)(e)   -
   Article 25(2)(f)   Article 68
   Article 25(2)(g)   Article 75(1)(h)
   Article 25(2)(h)   Article 44(2)(b)
   Article 26         Article 76(1)
   Article 27(1)      Article 76(2)
   Article 27(2)      Article 77
   Article 27(3)      -
EN                  143                                           EN
 ---pagebreak---    Article 27(4)                    Article 79(1)
   Article 27(5)                    -
   Article 27(6)                    -
   Article 27(7)                    -
   Article 27(8)                    Article 81(2)
   Article 27(9)                    Article 82(1)
   Article 27(10)                   -
   Article 27(11)                   Article 81(1)
   Article 27(12) first sentence    Article 83
   Article 27(12) second sentence   -
   Article 28                       Article 84
   Article 29                       -
   Article 30(1) point (a)          Article 86
   Article 30(1) point (b)          Article 89point (a)
   Article 30(1), point (c)         Article 87(2)
   Article 30(1) point (d)          Article 89 points (b) and (f)
   Article 30(1) point (e)          Article 89 point (c)
   Article 30(1) point (f)          Article 89 point (d)
   Article 30(1) point (g)          Article 89 point (e)
   Article 30(2)(a)                 Article 88(1)(e)
   Article 30(2)(b)                 Article 88(1)(c)
   Article 30(3)                    -
   Article 31                       -
   Article 32(1)(a)                 Article 92(2)(a)
   Article 32(1)(b)                 Article 92(2)(b)
   Article 32(1)(c)                 Article 92(2)(c)
   Article 32(1)(d)                 Article 92(2)(d)
   Article 32(1)(e)                 Article 92(2)(e)
   Article 32(1)(f)                 Article 92(2)(g)
   Article 32(2)(a)                 Article 92(2)(a), (b) and (c)
   Article 32(2)(b)                 Article 92(2)(h)
   Article 32(2)(c)                 Article 92(2)(d)
   Article 32(2)(d)                 Article 92(2)(g)
   Article 32(2)(e)                 Article 92(2)(d)
   Article 32(3)                    Article 91(3)(a)
   Article 32(4)(a)                 Article 91(3)(c)
   Article 32(4)(b)                 Article 91(3)(d)
   Article 32(4)(c)                 Article 91(3)(d)
EN                                144                             EN
 ---pagebreak---    Article 32(4)(d)                         Article 7
   Article 32(4)(e)                         Article 91(3)(e)
   Article 32(4)(f)                         Article 92(2)(j)(iii)
   Article 32(4)(g)                         Article 91(3)(e)
   Article 32(4)(h)                         Article 91(3)(f)
   Article 32(5)                            Article 97(1)
   Article 32(6)                            Article 97(2)
   Article 32(7)                            -
   Article 32(8) first sentence             Article 97(3)
   Article 32(8) second sentence            Article 97(4)
   Article 32(9)                            -
   Article 33(1)                            Article 98(1)
   Article 33(2)                            Article 99(1)
   Article 33(3)                            Article 98(2)
   Article 33(4)                            Article 98(4)
   Article 33(5)                            Article 98(5)
   Article 33(6)                            Article 99(2)
   Article 33(7)                            -
   Article 34(1)                            Article 100(1)
   Article 34(2)                            Article 100(1) and (2)
   Article 34(3)                            Article 100(3)
   Article 35(1)                            Article 101(1)
   Article 35(2)                            Article 101(4)
   Article 35(3)                            Article 101(2)
   Article 35(4)                            -
   Article 36(1)                            Article 102(1)(c)
   Article 36(2) first sentence             -
   Article 36(2) second sentence            Article 102(2)
   Article 36(3) first subparagraph         Article 102(3) first sentence
   Article 36(3) second subparagraph        -
   Article 36(3) third subparagraph, first  Article 102(3)(c)
   sentence
   Article 36(3) third subparagraph, second Article 102(3)(b)
   sentence
   Article 36(4)                            Article 102(3)(a)
   Article 37(1)                            Article 103(1)
   Article 37(2)                            Article 103(2)
   Article 38(1)                            Article 104(1)
   Article 38(2)                            Article 104(2)(c)
EN                                        145                             EN
 ---pagebreak---    Article 38(3)                            Article 104(3)
   Article 39(1)                            Article 105(1)
   Article 39(2)                            Article 105(2)
   Article 40(1)                            Article 106(1)
   Article 40(2)                            -
   Article 40(3)                            Article 106(2)
   Article 40(4)                            -
   Article 41                               Article 107(1)
   Article 42(1)(a)                         -
   Article 42(1)(b)                         Article 109(2)
   Article 42(1)(c)                         Article 109(3)
   Article 42(2)                            Article 108(2)
   Article 42(3)                            Article 109(2)
   Article 43(1) first sentence             Article 110, first subparagraph
   Article 43(1) second sentence            Article 110, second subparagraph
   Article 43(1)(a)                         -
   Article 43(1)(b)                         Article 110(a) and (b)
   Article 43(1)(c)                         Article 110(b) and (c)
   Article 43(1)(d) to (j)                  -
   Article 43(1)(k)                         Article 110(d)
   Article 43(2)                            -
   Article 44(1)                            Article 112(1)
   Article 44(2)                            -
   Article 44(3)                            Article 112(1)
   Article 44(4), first subparagraph, first Article 113(1)
   sentence
   Article 44(4) first subparagraph, second Article 113(2)
   sentence
   Article 44(5)                            -
   Article 44(6)                            Article 113(1)
   Article 45(1)                            Article 115(1)(2) and (4)
   Article 45(2)                            -
   Article 45(3)                            Article 116
   Article 45(4)                            Article 117
   Article 45(5)                            Article 118
   Article 45(6)                            -
   Article 46(1) first sentence             Article 119(1)
   Article 46(1) second sentence            Article 119(4)
EN                                        146                                EN
 ---pagebreak---    Article 46(1) third sentence              Article 119(2)
   Article 46(2)                             Article 119(3)
   Article 46(3)                             Article 120
   Article 46(4)                             -
   Article 46(5)                             -
   Article 46(6)                             Article 121
   Article 46(7)                             Article 122
   Article 47(1)                             Article 124(1)(a) to (e)
   Article 47(2)                             Article 124(2)
   Article 47(3)                             Article 124(1)(f) and (g)
   Article 47(4)                             -
   Article 47(5)                             -
   Article 48(1)                             Article 125(1)
   Article 48(2)                             Article 125(2)
   Article 48(3)                             Article 126(1) and (2)
   Article 48(4)                             Article 126(3)
   Article 48(5) first sentence              Article 126(3)(f)
   Article 48(5) second and third sentence   -
   Article 49                                Article 128
   Article 50                                -
   Article 51(1)                             Article 129(1) and (2)
   Article 51(2)                             Article 129(3)
   Article 51(3)                             -
   Article 52                                Article 123
   Article 53                                Article 111
   Article 54(1)                             Article 135(1)
   Article 54(2)                             Article 135(2)
   Article 54(3)                             Article 135(3)
   Article 54(4)                             Article 103(1)
   Article 54(5)                             Article 84(1) (a) and(c) and Article 135(4)
   Article 55(1)                             Article 136(1)
   Article 55(2)                             Article 136(1)
   Article 56(1)                             Article 137(1)
   Article 56(2)(a)                          -
   Article 56(2)(b)                          Article 137(2)
   Articles 57 to 61                         -
   Article 62                                Article 141
   Article 63(1)                             -
EN                                         147                                           EN
 ---pagebreak---    Article 63(2)                      Article 23
   Article 64 first subparagraph      Article 138(1)
   Article 64 point (1)               Article 138(1)
   Article 64 point (2)               Article 138(2)
   Article 65                         -
   Article 66                         -
   Article 67
   Annex I                            Annex I
   Annex II                           Annex II
   Annex III                          Annex III
   Annex IV                           -
   Annex V                            -
   Annex VI                           Article 78 and 79(2)
   Annex VII                          -
   Annex VIII                         -
   2.        Directive 96/23/EC
                 Directive 96/23/EC                  This Regulation
   Article 1                          -
   Article 2(a)                       Article 16
   Article 2(b)                       -
   Article 2(c)                       Article 16
   Article 2(d)                       Article 2(5)
   Article 2(e)                       Article 16
   Article 2(f)                       Article 36(1)
   Article 2(g)                       -
   Article 2(h)                       Article 16
   Article 2(i)                       -
   Article 3                          Articles 8(1) and (2), 16, 107(1) and 111
   Article 4(1)                       Article 3(1)
   Article 4(2)                       Articles 3(2)(a), 107(2) and 112
   Article 4(3)                       -
   Article 5                          Articles 109(2) and (3), 112(1)(a) and
                                      108(2)
   Article 6                          Articles 16(a) and (b)
   Article 7                          Article 108(2)
   Article 8(1)                       -
   Article 8(2)                       -
EN                                  148                                         EN
 ---pagebreak---    Article 8(3), (4) and (5)                       Articles 10, 112 and 113
   Article 9(A)                                    -
   Article 9(B)                                    -
   Article 10                                      Article 14
   Article 11(1) and (2)                           Articles 8(2) and 9
   Article 11(3)                                   Articles 16(c), 134 and 135
   Article 12 first paragraph                      Article 8(4)
   Article 12 second paragraph                     Article 14
   Article 13                                      Articles 16(c), 134 and 135
   Article 14(1)                                   Articles 98 and 99
   Article 14(2)                                   Article 91
   Article 15(1) first subparagraph                Article 16(a) and (b)
   Article 15(1) second subparagraph               Article 33(7)
   Article 15(1) third subparagraph                -
   Article 15(2) first subparagraph                Article 33(7)
   Article 15(2) second subparagraph               Article 34(3)
   Article 15(3) first, second and           third Articles 16(c) and 135
   subparagraphs
   Article 15(3) forth subparagraph                Title II Chapter V Section III
   Article 16(1)                                   Articles 103(1), 106(1) and 135
   Article 16(2) and (3)                           Articles 16(c) and 135
   Article 17                                      Articles 16(c) and 135
   Article 18                                      Articles 16(c) and 135
   Article 19                                      Article 135(4)
   Article 20(1)                                   Title IV
   Article 20(2) first subparagraph                Article 104(1) and (2)
   Article 20(2) second subparagraph               Article 104(3)
   Article 20(2) third and forth subparagraphs     Article 106(1)(d)
   Article 20(2) fifth and sixth subparagraphs     Article 106(2)
   Article 21                                      Articles 115, 116 and 118
   Article 22                                      Article 134
   Article 23                                      Articles 16(c) and 135
   Article 24(1) and (2)                           Articles 15(2)(d), 16(c), 134 and 135
   Article 24(3)                                   Articles 15(2)(d), 16(c) and 135
   Article 25                                      Articles 16(c) and 135(2)
   Article 26                                      Article 6
   Article 27                                      Article 136
   Article 28                                      Article 136
EN                                               149                                     EN
 ---pagebreak---    Article 29(1) and (2)                         Articles 124, 125, 126 and 128
   Article 29(3)                                 Title II Chapter V Section II
   Article 29(4)                                 Article 112(1)
   Article 30(1) and (2)                         Title II Chapter V Section III
   Article 30(3)                                 Article 128(3)
   Article 31                                    Title II Chapter VI
   Article 33                                    Article 141
   Article 34                                    Article 16(a) and (b)
   Article 35                                    -
   Article 36                                    -
   Article 37                                    -
   Article 38                                    -
   Article 39                                    -
   Annex I                                       Article 16(a) and (b)
   Annex II                                      Article 16(a) and (b)
   Annex III                                     Article 16(a) and (b)
   Annex IV                                      Article 16(a) and (b)
   3.        Directives 89/662/EEC and 90/425/EEC
                Directive 89/662/EEC                            This Regulation
   Article 1                                     -
   Article 2(1), (2) and (3)                     -
   Article 2(4)                                  Article 2(5)
   Article 2(5)                                  Article 2(32)
   Article 3(1) first and second subparagraphs   -
   Article 3(1) third 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 8(1), 9, 134 and 135
   Article 4(1) first indent                     Article 8(6)(a)
   Article 4(1) second indent                    -
   Article 4(2)                                  Article 136
   Article 5(1)(a) first subparagraph            Article 8
   Article 5(1)(a) second subparagraph           Article 134(2) and (3)
   Article 5(1)(b)                               -
   Article 5(2)                                  -
EN                                             150                                      EN
 ---pagebreak---    Article 5(3)(a), (b) and (d)   -
   Article 5(3)(c)                Article 8(7)
   Article 5(4) and (5)           -
   Article 6(1)                   Article 47
   Article 6(2)                   -
   Article 7(1)                   Title IV and Article 135
   Article 7(2)                   -
   Article 8(1)                   Title IV
   Article 8(2)                   Articles 6 and 135(3)
   Article 8(3)                   Article 135(4)
   Article 9                      -
   Article 10                     Article 3(1)
   Article 11                     Articles 9, 13 and 14
   Article 12                     -
   Article 13                     -
   Article 14                     -
   Article 15                     -
   Article 16(1)                  Article 112(1)
   Article 16(2)                  -
   Article 16(3)                  Article 112(2)
   Article 17                     Article 141
   Article 18                     Article 141
   Article 19                     -
   Article 20                     -
   Article 22                     -
   Article 23                     -
   Annex A                        -
   Annex B                        -
EN                              151                        EN
 ---pagebreak---                 Directive 90/425/EEC                            This Regulation
   Article 1                                     -
   Article 2(1) to (5)                           -
   Article 2(6)                                  Article 2(5)
   Article 2(7)                                  Article 2(32)
   Article 3(1) and (2)                          -
   Article 3(3)                                  Articles 8, 134(2) and (3) and 135
   Article 3(4)                                  -
   Article 4(1)                                  Article 8
   Article 4(2)                                  -
   Article 4(3)                                  Article 136
   Article 5(1)(a) first subparagraph            Article 8
   Article 5(1)(a) second 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)
   Article    5(2)(a)        second    and third
                                                 -
   subparagraphs
   Article 5(2)b                                 -
   Article 5(3)                                  -
   Article 6                                     -
   Article 7(1)                                  Article 47
   Article 7(2)                                  -
   Article 8(1)                                  Title IV and Article 135
   Article 8(2)                                  -
   Article 9(1)                                  Title IV
   Article 9(2)                                  Articles 6 and 135(3)
   Article 9(3)                                  Article 135(4)
   Article 9(4)                                  -
   Article 10                                    -
   Article 11                                    Article 3(1)
   Article 12                                    -
   Article 13                                    Articles 9, 13 and 14
   Article 14                                    -
   Article 15                                    -
EN                                             152                                  EN
 ---pagebreak---    Article 16                                   -
   Article 17                                   Article 141
   Article 18                                   Article 141
   Article 19                                   Article 141
   Article 20                                   Articles 130, 131, 132 and 133
   Article 21                                   -
   Article 22(1)                                Article 112(1)
   Article 22(2)                                -
   Article 22(3)                                Article 112(2)
   Article 23                                   -
   Article 24                                   -
   Article 26                                   -
   Article 27                                   -
   Annex A                                      -
   Annex B                                      -
   Annex C                                      -
   4.        Directives 97/78/EC and 91/496/EEC
                 Directive 97/78/EC                            This Regulation
   Article 1                                    -
   Article 2                                    Article 2
   Article 2(2)(a)                              Article 2(17)
   Article 2(2)(b)                              Article 2(46)
   Article 2(2)(c)                              Article 2(47)
   Article 2(2)(d)                              Article 2(48)
   Article 2(2)(e)                              -
   Article 2(2)(f)                              Article 2(27)
   Article 2(2)(g)                              Article 2(29)
   Article 2(2)(h)                              -
   Article 2(2)(i)                              -
   Article 2(2)(j)                              -
   Article 2(2(k)                               Article 2(5)
   Article 3(1) and (2)                         Article 45(1)
   Article 3(3)                                 Article 14 and 54(1), (2)(a) and (3)
   Article 3(4)                                 Article 55
   Article 3(5)                                 Article 45(2) and (3) and Article 56
   Article 4(1)                                 Article 47(4)
EN                                            153                                    EN
 ---pagebreak---    Article 4(2)                       -
   Article 4(3) and (4)               Article 47(1), (2) and (3) and Article 50
   Article 4(5)                       Article 50
   Article 5(1)                       Article 54(2)(b) and(4)
   Article 5(2)                       Article 56(2)
   Article 5(3)                       Article 48(2) and (3)
   Article 5(4)                       Article 56
   Article 6(1)(a), first paragraph   Article 62(1)
   Article 6(1)(a) second paragraph   Article 62(2)
   Article 6(1)(b)                    -
   Article 6(2)                       Article 57 and 60
   Article 6(3)                       Article 61
   Article 6(4)                       Article 58(1) and 61(3)
   Article 6(5)                       -
   Article 6(6)                       Article 58(2), 60(3), 61(5), 62(2), 62(4)
   Article 7(1)                       Article 48(1)
   Article 7(2)                       Article 47(1), (2) and (3) and Article 50
   Article 7(3)                       Article 55
   Article 7(4)                       Article 48(2), 53 and 54(4)
   Article 7(5)                       -
   Article 7(6)                       Article 50 and 56
   Article 8(1)                       -
   Article 8(2)                       Article 75(1)(b)
   Article 8(3),(4), (5), (6), (7)    Article 75(2)
   Article 9                          Article 49(b) and (c)
   Article 10(1), (2), (4)            Article 52(2)
   Article 10(3)                      -
   Article 11                         Article 49(d)
   Article 12                         Articles 46(h) and 75(1)(k)
   Article 13                         Article 75(1)(c)
   Article 14                         -
   Article 15                         Article 75(1)(h)
   Article 16(1)(a)                   Article 46(d)
   Article 16(1)(b)                   Article 46(e)
   Article 16(1)(c)                   Article 46(c)
   Article 16(1)(d)                   Article 46(g)
   Article 16(1)(e)                   Article 46(a)
EN                                  154                                         EN
 ---pagebreak---    Article 16(1)(f)                 Article 46(b)
   Article 16(2)                    -
   Article 16(3)                    -
   Article 16(4)                    Article 75(1)(c) and (f)
   Article 17(1)                    Article 64(5)
   Article 17(2)                    Article 64(1), (2) and (3)
   Article 17(2)(a)                 Article 64(3)(b), 67 and Article 70
   Article 17(2)(a) first indent    -
   Article 17(2)(a) second indent   Article 66(1)(a)
   Article 17(2)(b)                 Article 67
   Article 17(3)                    Article 63(4), (5) and (6)
   Article 17(4)                    -
   Article 17(5)                    Articles 64(3), 67, 84(1)(d)
   Article 17(6)                    -
   Article 17(7)                    Article 63(6), 68 and 70(3)
   Article 18                       Article 62(2)
   Article 19(1)                    Article 75(1)(g)
   Article 19(2)                    Article 75(1)(a)
   Article 19(3)                    Article 62(3)(a) and 62(4)
   Article 20(1)                    Article 63
   Article 20(2)                    -
   Article 22(1)                    -
   Article 22(2)                    Article 65
   Article 22(3)                    -
   Article 22(4)                    -
   Article 22(5)                    -
   Article 22(6)                    -
   Article 22(7)                    -
   Article 24                       Article 63(4), (5) and (6)
   Article 24(3)                    Articles 71 and 128
   Article 25(1)                    Articles 100-106
   Article 25(2)                    Article 6
   Article 25(3)                    -
   Article 26                       Article 129(5) and (6)
   Article 27                       Article 4(2) and (3) and 129(1) and (6)
   Article 28                       -
   Article 29                       -
EN                                155                                       EN
 ---pagebreak---    Article 30                          -
   Article 31                          -
   Article 32                          -
   Article 33                          -
   Article 34                          -
   Article 35                          -
   Article 36                          -
   Annex I                             Annex I
   Annex II                            Article 62
   Annex III                           Article 50
                Directive 91/496/EEC                  This Regulation
   Article 1                           -
   Article 2(1)                        -
   Article 2(2)a                       Article 2(46)
   Article 2(2)b                       Article 2(47)
   Article 2(2)c                       Article 2(48)
   Article 2(2)d                       -
   Article 2(2)e                       Article 2(27)
   Article 2(2)f                       Article 2(29)
   Article 3(1)(a)                     Articles 54(1) and (2)(a), 56(1)(b)
   Article 3(1)(b)                     Article 45(1), 64(2)
   Article 3(1)(c)(i)                  Articles 54(2)(b), 54(4), and 55
   Article 3(1)(c)(ii)                 Article 77(1)(d)
   Article 3(1)(d)                     Article 55
   Article 3(2)                        -
   Article 4(1)                        Articles 47(1), 47(2) and 50
   Article 4(2)                        Articles 47(1), 47(3), 47(4) and 50
   Article 4(3)                        Article 49c
   Article 4(4)                        Article 77(1)(d)
   Article 4(5)                        Article 4(2) and (3), 49(c) and 50
   Article 5                           Articles 53, 54(2)(b), 54(4), 55, 56(1)(a),
                                       and 64(1).
   Article 6(1)                        -
   Article 6(2)(a)                     Article 62(1) and (2)
   Article 6(2)(b)                     Article 62(1)
   Article 6(2)(c)                     Article 57
EN                                   156                                           EN
 ---pagebreak---    Article 6(2)(d)              Article 62(3)(a) and (4)
   Article 6(3)                 Article 58
   Article 6(3)(a)              Article 58(1)(b)
   Article 6(3)(b)              Article 58(1)(c)
   Article 6(3)(c)              Articles 57(2) and 62(3)
   Article 6(3)(d)              Article 58(1)(d)
   Article 6(3)(e)              Articles 57(2) and 62(3)
   Article 6(3)(f)              Articles 57(2) and 62(3)
   Article 6(3)(g)              Article 58(1)(e)
   Article 6(4)                 Article 57 and 58(1)
   Article 6(5)                 Article 58(2)
   Article 7(1) first indent    Article 48(2)
   Article 7(1) second indent   Articles 54(2))(b), 54(4) and 56
   Article 7(1) third indent    Article 48(1)
   Article 7(2)                 Article 56
   Article 7(3)                 -
   Article 8                    Article 51(1)(b)
   Article 9                    Article 49(d)
   Article 10                   Article 64(2)
   Article 11(1)                Article 63
   Article 11(2)                -
   Article 12 (1)               Articles 64, 66 and 67
   Article 12(2)                Articles 64(3), 67, 84(1)(d)
   Article 12(3)                Articles 68, 69(3) and 70(3)
   Article 12(4)                -
   Article 12(5)                -
   Article 13                   Article 62(2)
   Article 14                   -
   Article 15                   Article 77(1)(d)
   Article 16                   Articles 52
   Article 17                   Article 6
   Article 17a                  -
   Article 18(1)                -
   Article 18(2)                Article 65
   Article 18(3)                -
   Article 18(4)                -
   Article 18(5)                -
EN                            157                                EN
 ---pagebreak---    Article 18(6)                      -
   Article 18(7)                      -
   Article 18(8)                      -
   Article 19                         Article 115 and 116
   Article 20                         Articles 100-106
   Article 21                         Article 129 (5) and (6)
   Article 22                         -
   Article 23                         -
   Article 24                         -
   Article 25                         -
   Article 26                         -
   Article 27                         -
   Article 28                         -
   Article 29                         -
   Article 30                         -
   Article 31                         -
   Annex A                            Article 62
   Annex B                            Article 64(2)
   5.        Directive 96/93/EC
                 Directive 96/93/EC                  This Regulation
   Article 1                          -
   Article 2(1)                       Article 2(22)
   Article 2(2)                       Article 2
   Article 3(1)                       Article 87(2)(b)
   Article 3(2)                       Article 87(3)(a) and (b)
   Article 3(3)                       Article 88(1)(a)
   Article 3(4)                       Article 87(3)(b)
   Article 3(5)                       Article 89
   Article 4(1)                       Articles 87(2)(a) and 88(2)
   Article 4(2)                       Article 88(1)(b)
   Article 4(3)                       Article 88(1)(d)
   Article 5                          Article 88(2)
   Article 6                          Article 128
   Article 7                          Article 141
   Article 8                          -
   Article 9                          -
EN                                  158                              EN
 ---pagebreak---    Article 10                           -
   6.        Directive 89/608/EEC
                Directive 89/608/EEC                   This Regulation
   Article 1                           -
   Article 2                           -
   Article 3                           Title IV
   Article 4                           Title IV
   Article 5                           Title IV
   Article 6                           Title IV
   Article 7                           Title IV
   Article 8                           Title IV
   Article 9                           Title IV
   Article 10                          Article 7 and Title IV
   Article 11                          -
   Article 12                          Title IV
   Article 13                          -
   Article 14                          -
   Article 15                          Article 7 and Title IV
   Article 16                          -
   Article 17                          -
   Article 18                          -
   Article 19                          -
   Article 20                          -
   7.        Decision 92/438/EEC
                Decision 92/438/EEC                    This Regulation
   Article 1                            Articles 130 to 133
   Article 2                            -
   Article 3                            Articles 130 to 133
   Article 4                            Articles 130 to 133
   Article 5                            Articles 130 to 133
   Article 6                            Article 62(3)(f)
   Article 7                            -
EN                                   159                               EN
 ---pagebreak---    Article 8    -
   Article 9    -
   Article 10   -
   Article 11   -
   Article 12   -
   Article 13   -
   Article 14   -
   Article 15   -
   Annex I      Articles 130 to 133
   Annex II     Articles 130 to 133
   Annex III    Articles 130 to 133
EN            160                   EN