Explanatory Memorandum to COM(2013)265 - Official controls to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products - Main contents
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| dossier | COM(2013)265 - Official controls to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant ... |
|---|---|
| source | COM(2013)265  |
| date | 06-05-2013 |
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.
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 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.
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.
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 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.
Contents
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 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 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.
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 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.
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.
- 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;
- 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.
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
- 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;
- 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.