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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.

The risks addressed include health risks sensu stricto risks to the integrity of humans, animals and plants from pests, diseases, microbial and chemical contaminants and other hazards but also the preservation of inherent qualities required to ensure a safe start of plant production and regulated production methods i.

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In particular, the EU has established rules governing all the activities, from primary production to retail and catering, which may affect:. In addition, rules have also been established to ensure the provision of information to consumers and to guarantee fair commercial practices in agri-food chain products’ trade.

This wide ranging set of rules is referred to in this Impact Assessment IA as “agri-food chain rules”. To ensure agri-food chain rules are enforced by Member States MS across the EU in a harmonised manner, a legislative framework for the organisation of official controls has been established.

This IA considers the possible impacts of reviewing such a framework. The report showed that the new rules have introduced important changes to the way competent authorities “CA” organise and carry out official controls, establishing a more integrated approach which ensures confidence in the agri-food chain across the EU. This would also address issues of administrative burden reduction and fostering competitiveness.

The report also indicated that in order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, consideration should be given to the possibility of integrating the rules currently applicable to official controls in specific areas e. Additional research[5] carried out to evaluate the application of the Regulation outlined the existence of problems regarding the application of the rules Articles 26 to 29 governing the financing of official controls.

The report concluded that the overall objective of ensuring Member States allocate adequate financial resources to official controls is not being met throughout the EU. It recommended reviewing Articles 26 decretoo 29 of the Regulation. In Decemberthe Commission adopted a report on the effectiveness and consistency of sanitary and phytosanitary controls on imports of food, feed, animals and plants[6]. 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, the report also found that import controls could be made more coherent by reviewing and consolidating existing acts[7].

Decretp concluded that this improvement would bring benefits for MS and operators handling goods from third countries importers. 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 review of the Regulation is part of a package which also includes three other major reviews to modernise the animal health, plant health and plant reproductive material hereafter ‘PRM’ acquis[9].

Its aim is therefore to modernise and integrate the system of official controls in a manner that also consistently accompanies the upgrade of EU policies in these sectors. The package is decteto for adoption in All the information, data and evidence collected as part of the reviews above, including evaluations of the existing regimes, has been used decreho this IA to define problems, assess impacts and appraise options.

The Commission is responsible for ensuring that Union legislation is properly implemented and enforced by the competent authorities of the MS. The Food and Veterinary Office ”FVO” is a Commission’s service which contributes to the fulfilment of this task, by in particular carrying out audits in the MS to verify the implementation of agri-food chain legislation and the functioning of national control systems, and to collect information on implementation practices. The findings of each audit are set out in an audit report[10].

Information on the realities and difficulties of day-to-day implementation of agri-food chain legislation comes from such audit reports, in particular the ones assessing the functioning of national control systems along the agri-food chain. This IA draws on the findings of these reports and the data contained within them.

Within deceeto task force established by DG SANCO, feedback from national authorities and stakeholders gathered across all sectors notably through the audit activities of the FVO was studied to identify problems and shortcomings of the EU system of official controls. In addition to the study on “Fees decretp charges collected by Member States 52-09 cover the costs occasioned by official controls” see foot note 5DG SANCO commissioned from another external contractor[11] a study to support the dedreto of the options identified [12].

Whilst the contractor reported that there was difficulty in obtaining exact figures from MS to quantify the problem, the report did highlight the diverse spread of cost recovery within MS and certain problems with the application of EU rules which corresponded with previous studies and the Commission’s own findings.

In addition dscreto the data mentioned above, further information was collected on specific issues i. The key issues to be addressed by the review of the system of official controls as well as the changes to be included in the legislative framework have been extensively discussed within the Working Group on the general application of the Regulation set up within the Standing Committee on the Food Chain and Animal Health SCFCAH [15]. The main problems identified and the provisional options were also presented and discussed at meetings of the Heads of Food Safety Agencies on 29 June-1 July and on 8 December Moreover, MS 52-309 consulted in the context of the two studies contracted out by the Commission in the area of the financing of official controls.


Finally, MS have been consulted within other fora and frameworks on the following specific issues relating to official controls: 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 a key element of the two studies contracted out to external consultants in the field of the financing of official controls. The group met seven times. A final draft was sent to the group, whose members provided comments at a last meeting on 27 January which have been incorporated into the IA.

Following this meeting the board issued an opinion on 30 March emphasising four main points as well as some presentational issues to be addressed in the final version of the report.

Following re-submission on 16 May, a revised opinion was issued on 8 June clarifying the points to be addressed:. Where this is cecreto possible, due to a lack of relevant data decrefo by short-comings in the current regime, this has been identified.

It presents figures as both benefits and costs to MS and industry, and calculations are explained in footnotes. An explaination of the table now makes it clearer to which sectors decrreto costs and benefits apply under the different options.

The figures and results presented in the analysis of costs and benefits are explained, supported by verifiable evidence, and clearly referenced. All examples and evidence are clearly referenced. The responsibility to enforce EU agri-food chain decrrto lies with the 523-099, whose authorities monitor and verify that the relevant requirements are effectively implemented, complied with and enforced across the Union.

In doing that they verify that operators’ activities and goods placed on the EU vecreto either EU produced or imported from third countries are in compliance with the relevant EU agri-food chain standards and requirements. Harmonised EU rules to govern control activities performed by MS 523-90 established in the Regulation with the aim of creating an integrated and uniform approach to official controls along the agri-food chain.

The Regulation provides for a general framework for official edcreto in the sectors of feed and food law, animal recreto 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 controls for animal health purposes both on domestic and imported goods and controls on residues of veterinary medicines, remained regulated separately.

Moreover, certain sectors pertaining to the agri-food chain were not included in the scope of the Regulation – i.

Competent authorities decretto required to perform official controls on all business operators active in the agri-food chain. Given that the emergence of food safety risks does not necessarily depend on the size of an operator, the current system is based on the principle that all should be subject to official controls, without exception, as this is the only way to ensure a risk-based prioritisation of controls, an efficient use of resources and the safety of the agri-food chain.

As regards the number of business operators concerned, figures suggest that they amount to approximately 25 million[17]. As highlighted in section 5 below, in a majority of Member States, micro-enterprises[18] represent more than half of the total number of business operators at least in the four industries which 523-9 subject to the most intensive official control activities [19].

Deccreto this context, the significance of controlling smaller businesses, including micro-enterprises, becomes apparent.

Coli crisis, which spread across several Member States due to contaminated sprouted seeds, originated in a micro-enterprise. The efficient operation of the EU system of official controls is important for both EU exports and imports. The EU is the world’s largest exporter and importer of food and drink products. The EU27 imported 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 decreeto have compared to the ones produced outside Europe.

This can only be achieved by a reliable and trusted official controls system which ensures 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 decrero is safe. Controls perfomed by the MS CAs on goods arriving from third countries ensure that the latter offer adequate guarantees that they meet equivalent safety levels.

However, evidence gathered over the last five years of application feedback from MS’ CAs and FVO audits reports has shown shortcomings stemming. Despite the increasingly integrated operation of activities along the agri-food chain, the integration of the EU decreho of official controls still suffers inconsistencies and legal decrego, in particular as regards controls carried out for plant health, PRM and ABP purposes.

Controls in these areas are in fact not aligned fully with the framework laid down decdeto the Regulation. On the other hand, overlapping requirements subsist also in the animal health area, already covered by the decretto of the Regulation, because of the co-existence of sectoral legislation which survived the adoption of the general framework in Control authorities thus operate on the basis of different approaches and under different conditions depending on the specific agri-food chain rules they are called upon to enforce, without differences being justified.


As a result, Decretk are not provided with the complete set of tools meant to ensure accountability, soundness and effectiveness of their enforcement activities.

This has resulted in different interpretations of similar procedures by MS who undertake different activities to verify compliance. Inconsistencies and legal gaps are due to the fact that EU legislation on official controls has in the areas of plant health, PRM and ABP developed separately from the general framework established by the Regulation, and overlap in control requirements derived from the co-existence, for animal health related controls, of the Regulation with pre-existing sectoral legislation.

Whilst it is 5523-09 always possible to quantify the cost to MS CA and operators of such inconsistencies and gaps it stands to reason that the inefficiencies so caused will lead to official control enforcement regimes which are unnecessarily costly for CAs to operate and are overly burdensome on operators. In a situation where resources are finite these are to be used selectively and the selection should be based on a series of criteria which include: Failure to do so would result in resources being allocated on the basis of non-risk related criteria and in situations where official controls which are more relevant for the protection of public health 5223-09 not receiving appropriate attention.

The analysis focuses on the areas where the risk-based approach is still not fully used controls at the border and controls on residues of veterinary medicines. To ensure harmonised verification of compliance with EU agri-food chain rules, MS are required to carry out official controls on certain goods coming from third countries at the external decerto of the EU EU border controls.

According to the risk-based approach, also EU border controls should be limited and proportionate to what is necessary to contain potential risks for humans, animals or plants.

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However, the continuous and timely adjustment of the control effort at the EU border to the needs dictated by the actual risk is hampered by the rigidity and fragmentation of existing rules governing border checks in the different areas.

Existing arrangements to reduce the frequency of costly and time consuming physical checks do not allow for the continuous adjustment necessary to take account of situations where the potential risk of the consignment spreading an animal disease or otherwise endangering public health is reduced. In addition, the prioritarisation of the controls is carried out in a sectoral manner animal health, public health, plant health and not by comparing the levels of risk of all commodities of relevance for the agri-food chain across sectors: The result of such rigidity is that currently MS are demanded to carry out checks and laboratory analysis for substances for which over the past years there has been little or no evidence of actual risks.

MS are required to take samples of all animals and animal products to check the presence of ‘stilbenes’. The chart below shows that no non-compliance has been detected for several years now but, despite this, between and samples are analysed each year across the EU for stilbenes, their derivatives, salts and esters.

Samples taken on pigs to detect resorcylic acid lactones. More than samples continue to be analysed each year across the EU. The reason for official controls not being aligned to the risk-based approach in the areas above is that such controls are currently prescribed by EU rules[25], pre-existing the Regulation and not repealed by it, which do not establish appropriate mechanisms to take into account the actual risk a given good, business activity or third country might present.

In addition, as regards the area of EU border controls, the lack of prioritarisation of controls across all sectors is due to the fact that existing legislation is highly fragmented, and different sets of rules apply to different sectors food and feed of non animal origin, live animals and their products, plants [26].

This results in resources being allocated — in all MS – to controls that are not justified by the risk and consequently are a significant waste of public resources time and money that could be better used where risks are higher.

The inefficient use of resources also results in unnecessary burdens on operators time, staff, equipment and facilities mobilised to allow controls. Unnecessary administrative burdens are placed on MS’ CAs. It is the case for the obligation for annual updates to MS monitoring plans of residues of veterinary medicines that these be transmitted to and 5230-9 by the Commission. In the same area, also redundant are the specific reporting obligations, as they duplicate the general reporting requirement in the Regulation.

This lack of ability to allow temporary arrangements for emergencies could have weakened the legitimacy of controls and analyses carried out during the emergency, and of any measure taken by MS on that basis. Similarly, no flexibility is foreseen for small laboratories carrying out extremely basic types of tests.

The Regulation includes some important principles and mechanisms which are currently underused by MS’ CAs or decreot according to divergent practices among MS. In particular, it calls for administrative cooperation i between MS for cross-border enforcement action, and ii between sanitary authorities and customs services.