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| dossier | COM(2023)770 - Bescherming van dieren tijdens het vervoer en daarmee samenhangende activiteiten. |
|---|---|
| document | COM(2023)770  |
| datum | 7 december 2023 |
In order to ensure the effectiveness, efficiency and economy of the Commission controls, the control strategy will be oriented towards a balance of ex-ante and ex-post checks and focus on three key stages of grant/contract implementation, in accordance with the Financial Regulation:
- Selection of proposals/tenders that fit the policy objectives of the Regulation;
- Operational, monitoring and ex-ante controls that cover project implementation, public procurement, pre-financing, interim and final payments;
- Ex-post controls at the beneficiaries’ sites will also be carried out, typically on a risk-based sample of transactions due to efficiency considerations.
The Directorate General for Health and Food Safety (DG SANTE) is subject to administrative controls including budgetary control, annual reports by the European Court of Auditors and the Commission’s Internal Audit Service, the annual discharge for the execution of the EU budget and possible investigations conducted by OLAF to ensure that the resources allocated are put to proper use.
In accordance with the Commission’s Internal Control Framework64, DG SANTE has elaborated an internal control strategy which focusses on financial management and its compliance with the Financial Regulation, especially with regard to the five control objectives65 and the main principles of cost-efficient and effective controls and anti-fraud measures. The strategy is an evolving document which is regularly updated and it is adopted by DG SANTE's Management Board.
The Director in charge of Risk Management and Internal Control (RMIC) of DG SANTE is responsible for co-ordinating the drafting, updating and communication of the control strategy to all staff concerned. To this end, the Director launches each year an annual assessment of the internal control system that feeds into the Annual Activity Report of DG SANTE.
2.2.2. Information concerning the risks identified and the internal control system(s) set up to mitigate them
Risk management is fully integrated into DG SANTE’s planning and control cycle. The most important risks are identified in the annual risk assessment exercise. The focus is on the residual risk exposure taking into account all measures already taken to mitigate the risk. The exercise closes with discussions at senior management level chaired by the Director General. The so-called “critical risks” are reported to the Commissioner together with an action plan to reduce them to an acceptable level. To monitor the implementation of the action plans, a progress report is prepared and communicated to the Commissioner in the context of the mid-term report.
DG SANTE integrated risk management into its budget implementation processes. Potential risks, issues or problems are identified in each step of the financial management process.
The implementation of the new Regulation focuses on the attribution of public procurement contracts as well as a number of grants for specific activities and organisations.
The public procurement contracts will mainly be concluded in areas such as IT product development and support and studies.
The main risks are the following:
• Risk of not fully achievening the objectives of the Regulation due to insufficient uptake or quality/delays in the implementation of the selected projects or contracts;
Risk of inefficient or non-economic use of funds awarded, both for grants (complexity of funding rules) and for procurement (limited number of economic providers with the required specialist knowledge entailing insufficient possibilities to compare price offers in some sectors);
• Reputational risk for the Commission, if fraud or criminal activities are discovered; only partial assurance can be drawn from the third parties' internal control systems as contractors and beneficiaries are each operating their own control system.
The Commission put in place internal procedures that aim at covering the risks identified above. The internal procedures are in full compliance with the Financial Regulation and include anti-fraud measures and cost-benefit considerations. Within this framework, the Commission continues to explore possibilities to enhance the management and to realise efficiency gains. Main features of the control framework are the following:
Controls before and during the implementation of the projects:
• An appropriate project management system will be put in place focusing on the contributions of projects and contracts to the policy objectives, ensuring a systematic involvement of all actors, establishing a regular project management reporting complemented by on-site-visits on a case by case basis, including risk reports to senior management, as well as maintaining appropriate budgetary flexibility.
• Model grant agreements and service contracts used are developed within the Commission. They provide for a number of control provisions such as audit certificates, financial guarantees, on-site audits as well as inspections by OLAF. The rules governing the eligibility of costs are being simplified, for example, by using unit costs, lump sums, contributions not linked to costs and other possibilities offered by the Financial Regulation. This will reduce the cost of controls and put the focus on checks and controls in high risk areas.
• All staff sign up to the code of good administrative behaviour. Staff who are involved in the selection procedure or in the management of the grant agreements/contracts (also) sign a declaration of absence of a conflict of interest. Staff is regularly trained and uses networks to exchange best practices.
• Technical implementation of a project is checked at regular intervals at the desk on the basis of technical progress reports of the contractors and beneficiaries; in addition contractors'/beneficiaries' meetings and on-site-visits are foreseen on a case by case basis.
Controls at the end of the project: Ex-post audits are performed on a sample of transactions to verify on-the-spot the eligibility of cost claims. The aim of these controls is to prevent, detect and correct material errors related to the legality and regularity of financial transactions. With a view to achieving a high control impact, the selection of beneficiaries to be audited may combine a risk based selection with a random sampling. Attention to operational aspects will be paid whenever possible during the on-site audit.
2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure)
The Commission’s and DG SANTE’s internal control strategies take into consideration the main cost drivers, and the efforts already taken over several years to reduce the cost of controls, without compromising the effectiveness of controls. The existing control systems proved to be able to prevent and/or to detect errors and/or irregularities, and in case of errors or irregularities, to correct them.
2.3. Measures to prevent fraud and irregularities
Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy.
Article 325 of the Treaty on the functioning of the European Union (TFEU) requires the EU and its Member States to combat fraud and any other illegal activities that may affect the EU’s financial interests. According to Article 317 of the TFEU and Article 36 of the Financial Regulation66, the EU Commission implements the EU budget, in compliance with sound financial management principles, applying effective and efficient internal control67, which includes preventing, detecting, correcting, and following up on fraud and irregularities.
As for its activities in direct management, the Commission shall take appropriate measures ensuring that the financial interests of the European Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by effective checks and, if irregularities are detected, by the recovery of the amounts wrongly paid and, where appropriate, by effective, proportional and deterrent penalties. To this effect, the Commission adopted an anti-fraud strategy, latest update of April 2019 (COM(2019) 196) with the revised Action Plan of July 2023 (COM(2023) 405). DGs and executive agencies have developed and implemented their own anti-fraud strategies on the basis of the methodology provided by OLAF. In general, these are updated every three years and their implementation is monitored and reported to the management on a regular basis.
For budget implementation under direct management, the Commission also implements a series of measures such as:
- decisions, agreements and contracts resulting from the implementation of the Regulation will expressly entitle the Commission, including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and inspections and to recover amounts unduly paid and, where appropriate, impose administrative sanctions;
- during the evaluation phase of a call for proposals/tender, the applicants and tenderers are checked against the published exclusion criteria based on declarations and the Early Detection and Exclusion System (EDES);
- the rules governing the eligibility of costs will be simplified in accordance with the provisions of the Financial Regulation;
- regular training and awareness raising on issues related to fraud and irregularities is given to all staff involved in contract management as well as to auditors and controllers who verify the beneficiaries' declarations on the spot.
The assurance building process of the Authorising Officer by Delegation (AOD) is based on the capacity of the control systems in place to detect significant and/or repetitive deficiencies. The control systems are composed of different elements: supervision and verification of operations, ex-ante verifications, ex-post controls, and audits of the Internal Audit Service and the European Court of Auditors, as well as the health and food audits performed by DG SANTE in EU Member States and third countries. All actors involved play an essential role in fraud prevention and detection.
3. ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE
3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
- Existing budget lines
In order of multiannual financial framework headings and budget lines.
| Heading of multiannual financial framework | Budget line | Type of expenditure | Contribution | |||
| Number | Diff./Non-diff.68 | from EFTA countries69 | from candidate countries and potential candidates70 | fromother third countries | other assigned revenue | |
| 03.02.06 - Contributing to a high level of health and welfare for humans, animals and plants | Diff | NO | NO | NO | NO |
3.2. Estimated financial impact of the proposal on appropriations
3.2.1. Summary of estimated impact on operational appropriations
- The proposal/initiative does not require the use of operational appropriations
- The proposal/initiative requires the use of operational appropriations, as explained below:
EUR million (to three decimal places)
| Heading of multiannual financial framework | Number 1 | Single Market, Innovation and Digital |
| DG SANTE | Year 2024 | Year 2025 | Year 2026 | Year 2027 et seqq | TOTAL | ||
| □ Operational appropriations | |||||||
| 03.02 06 Contributing to a high level of health and welfare for humans, animals and plants | Commitments | (1a) | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | (1b) | 0,050 | 0,245 | 0,490 | 1,615 | 2,400 | |
| Appropriations of an administrative nature financed from the envelope of specific programmes | |||||||
| Budget line | (3) | 0 | 0 | 0 | 0 | 0 | |
| TOTAL appropriations for DG SANTE | Commitments | =1a+3 | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | =1b +3 | 0,050 | 0,245 | 0,490 | 1,615 | 2,400 |
| □ TOTAL operational appropriations | Commitments | -4 | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | -5 | 0,050 | 0,245 | 0,490 | 1,615 | 2,400 | |
| □ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes | -6 | ||||||
| TOTAL appropriations under HEADING 1 of the multiannual financial framework | Commitments | =4+ 6 | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | =5+ 6 | 0,050 | 0,850 | 0,490 | 1,615 | 2,400 |
| TOTAL operational appropriations (all operational headings) | Commitments | (4) | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | (5) | 0,050 | 0,245 | 0,490 | 1,615 | 2,400 | |
| TOTAL appropriations of an administrative nature financed from the envelope for specific programmes (all operational headings) | (6) | ||||||
| TOTAL appropriations under HEADINGS 1 to 6 of the multiannual financial framework (Reference amount) | Commitments | =4+ 6 | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
| Payments | =5+ 6 | 0,050 | 0,245 | 0,490 | 1,615 | 2,400 |
| Heading of multiannual financial framework | 7 | ‘Administrative expenditure’ |
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex V to the internal rules) which is uploaded to DECIDE for interservice consultation purposes.
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 et seqq | TOTAL | |||
| DG SANTE | |||||||
| □ Human resources | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 | ||
| □ Other administrative expenditure | 0,000 | 0,000 | 0,000 | 0,000 | 0,000 | ||
| TOTAL DG SANTE | Appropriations | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 |
| TOTAL appropriations under HEADING 7 of the multiannual financial framework | (Total commitments = Total payments) | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 |
EUR million (to three decimal places)
| Year 2024 | Year 2025 | Year 2026 | Year 2027 et seqq | TOTAL | |||
| TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework | Commitments | 0,849 | 1,460 | 1,980 | 1,752 | 6,040 | |
| Payments | 0,649 | 0,855 | 1,670 | 2,867 | 6,040 |
3.2.2. Estimated output funded with operational appropriations
Commitment appropriations in EUR million (to three decimal places)
| Indicate objectives and outputs | Year | Year | Year | Year | TOTAL | |||||||
| 2024 | 2025 | 2026 | 2027 et seqq | |||||||||
| | OUTPUTS | |||||||||||
| Type[1] | Average cost | No | Cost | No | Cost | No | Cost | No | Cost | Total No | Total cost | |
| SPECIFIC OBJECTIVE No 2 | ||||||||||||
| - Output | Study on modalities for the use of new technologies and digitalization to facilitate the implementation and enforcement of rules on animal welfare during transport. | 0,250 | 0,250 | |||||||||
| - Output | Development of the system in TRACES | 0,800 | 0,600 | 1,400 | ||||||||
| - Output | Maintenance of TRACES | 0,050 | 0,200 | 0,200 | 0,450 | |||||||
| - Output | Development of digital app | 0,300 | 0,300 | |||||||||
| Subtotal for specific objective No2 | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 | |||||||
| Totals | 0,250 | 0,850 | 0,800 | 0,500 | 2,400 |
3.2.3. Summary of estimated impact on administrative appropriations
- The proposal/initiative does not require the use of appropriations of an administrative nature
- The proposal/initiative requires the use of appropriations of an administrative nature, as explained below:
EUR million (to three decimal places)
| Year | Year | Year | Year | TOTAL | |
| 2024 | 2025 | 2026 | 2027 et seqq | ||
| HEADING 7 | |||||
| of the multiannual financial framework | |||||
| Human resources 71 | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 |
| Other administrative expenditure | 0 | 0,000 | 0,000 | 0,000 | 0 |
| Subtotal HEADING 7 | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 |
| of the multiannual financial framework | |||||
| Outside HEADING 7[2] | |||||
| of the multiannual financial framework | |||||
| Human resources | |||||
| Other expenditure | |||||
| of an administrative nature | |||||
| Subtotal | |||||
| outside HEADING 7 | |||||
| of the multiannual financial framework | |||||
| TOTAL | 0,599 | 0,610 | 1,180 | 1,252 | 3,640 |
The appropriations required for human resources and other expenditure of an administrative nature will be partially met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
3.2.3.1. Estimated requirements of human resources
- The proposal/initiative does not require the use of human resources.
- The proposal/initiative requires the use of human resources, as explained below:
Estimate to be expressed in full time equivalent units
| Year 2024 | Year 2025 | Year 2026 | Year 2027 et seqq | ||||
| □ Establishment plan posts (officials and temporary staff) | |||||||
| 20 01 02 01 (Headquarters and Commission’s Representation Offices) | 3,5 | 3,5 | 6,5 | 6,5 | |||
| 20 01 02 03 (Delegations) | |||||||
| 01 01 01 01 (Indirect research) | |||||||
| 01 01 01 11 (Direct research) | |||||||
| Other budget lines (specify) | |||||||
| □ External staff (in Full Time Equivalent unit: FTE)72 | |||||||
| 20 02 01 (AC, END, INT from the ‘global envelope’) | |||||||
| 20 02 03 (AC, AL, END, INT and JPD in the delegations) | |||||||
| XX 01 xx yy zz 73 | - at Headquarters | ||||||
| - in Delegations | |||||||
| 01 01 01 02 (AC, END, INT - Indirect research) | |||||||
| 01 01 01 12 (AC, END, INT - Direct research) | |||||||
| Other budget lines (specify) | |||||||
| TOTAL | 3,5 | 3,5 | 6,5 | 6,5 |
The human resources required will be partially met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out:
| Officials and temporary staff | AD will perform all the tasks that involve relationship with Member States, reference centres, stakeholders as well as any preparation of legislation. |
| External staff |
3.2.4. Compatibility with the current multiannual financial framework
The proposal/initiative:
- can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).
EUR 2,400 million of operational expenses under budget line 03.02.06 in years 2024 to 2027 will be covered by internal redeployment within the budget line.
- requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
Explain what is required, specifying the headings and budget lines concerned, the corresponding amounts, and the instruments proposed to be used.
- requires a revision of the MFF.
Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts.
3.2.5. Third-party contributions
The proposal/initiative:
- does not provide for co-financing by third parties
- provides for the co-financing by third parties estimated below:
Appropriations in EUR million (to three decimal places)
| Year N74 | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | Total | |||
| Specify the co-financing body | ||||||||
| TOTAL appropriations co-financed |
3.3. Estimated impact on revenue
- The proposal/initiative has no financial impact on revenue.
- The proposal/initiative has the following financial impact:
- on own resources
- on other revenue
- please indicate, if the revenue is assigned to expenditure lines ◻
EUR million (to three decimal places)
| Budget revenue line: | Appropriations available for the current financial year | Impact of the proposal/initiative75 | ||||||
| Year N | Year N+1 | Year N+2 | Year N+3 | Enter as many years as necessary to show the duration of the impact (see point 1.6) | ||||
| Article …………. |
For assigned revenue, specify the budget expenditure line(s) affected.
[…]
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
[…]
1Communication from the Commission “A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system”, COM(2020)381 final.
2European Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Commission work programme 2023, A Union standing firm and united, COM(2022) 548 final
3Council 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 1255/97 OJ L3 5.1.2005, p. 1–44
4European Commission, Commission Staff Working Document, Fitness Check of the EU Animal Welfare Legislation, SWD(2022)328 final
5SWD(2021) 77 final
6Council of the EU, Council Conclusions on an EU-wide animal welfare label, 15 December 2020 (Ref 14047/20); Council of the EU, Council conclusions on animal welfare during maritime long distances transport to third countries, 28 June 2021 (Ref 10235/21).
7Council conclusions on animal welfare - an integral part of sustainable animal production – Council Conclusions (16 December 2019)
8European Parliament resolution of 20 October 2021 on a farm to fork strategy for a fair, healthy and environmentally-friendly food system (2020/2260(INI)
9European Parliament recommendation of 20 January 2022 to the Council and the Commission following the investigation of alleged contraventions and maladministration in the application of Union law in relation to the protection of animals during transport within and outside the Union (2021/2736(RSP))
10Animal welfare in the EU: closing the gap between ambitious goals and practical implementation, European, Court of Auditors, 2018.
11Transport of live animals in the EU: challenges and opportunities, European Court of Auditors, 2023
12Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 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 and plant protection products (Official Controls Regulation), OJ L 95, 7.4.2017, p. 1–142.
13Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health, OJ L 84, 31.3.2016, p. 1.
14Regulation (EC) No 561/2006 of the European Parliament and of the Council of 15 March 2006 on the harmonisation of certain social legislation relating to road transport, OJ L 102, 11.4.2006, p. 1.
15Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276 20.10.2010, p. 33.
16EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, K. et al., ‘Transmission of antimicrobial resistance (AMR) during animal transport’, EFSA Journal, Vol. 20, Issue 10 (e07586), Wiley, 2022, pp. 1-93. 10.2903/j.efsa.2022.7586
17Regulation (EC) No 561/2006 of the European Parliament and of the Council of 15 March 2006 on the harmonisation of certain social legislation relating to road transport, OJ L 102, 11.4.2006, p. 1
18
Available on the European Commission Have Your Say platform : https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12950-Animal-welfare-revision-of-EU-legislation_en
19Available on the European Commission Have Your Say platform : https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12950-Animal-welfare-revision-of-EU-legislation/public-consultation_en
20EU Animal welfare today & tomorrow, an opportunity for stakeholders to validate the preliminary findings of the Fitness Check of the current EU animal welfare legislation. https://commission.europa.eu/events/eu-animal-welfare-today-tomorrow-2021-12-09_en
21World Animal Health Organisation, Animal welfare standards during transport
22European Commission, Directorate-General for Health and Food Safety, Study supporting the Impact Assessment accompanying the revision of the EU legislation on the welfare of animals during transport, Publications Office of the European Union, 2023, section 5.2.1., doi: 10.2875/110728. (Transport study).
23European Commission, Directorate-General for Health and Food Safety, Modelling of policy options to support the Impact Assessment accompanying the revision of the EU legislation on the welfare of animals during transport, 2023, doi: 10.2875/061480
24European Commission, Directorate-General for Health and Food Safety, Study on shifting from transport of unweaned male dairy calves over long distance to local rearing and fattening: final report, Publications Office of the European Union, 2022
25European Commission, Directorate-General for Health and Food Safety, Study on economic models to prevent the transport of unfit end-of-career dairy cows: final report, Publications Office of the European Union, 2022
26European Court of Auditors, Review 03/2023 “Transport of live animals in the EU: challenges and opportunities”. https://www.eca.europa.eu/Lists/ECADocuments/RV-2023-03/RV-2023-03_EN.pdf
27The measure of maximum 9h journey times for animals for slaughter is in line with EU rules on social rights of drivers, which foresee maximum 9h when there is only one driver. The measure for animals transported for other purposes also allows alignment with the EU legislation on social rights of drivers, in the case where there are two drivers. Indeed, for two drivers, the EU legislation on social rights of drivers provides for a maximum 19h of drive. Since journey times in this proposal includes loading and unloading the animals (and estimating 1h of time for loading the animals and 1h for unloading), this corresponds to the maximum journey time of 21h.
28Audits can be consulted at: https://ec.europa.eu/food/audits-analysis/audit-report
29https://food.ec.europa.eu/horizontal-topics/official-controls-and-enforcement/legislation-official
controls/better-training-safer-food_en
30OJ C , , p. .
31OJ C , , p. .
32Council 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 1255/97 OJ L 3, 5.1.2005, p. 1–44.
33Commission Staff Working Document ‘Fitness Check of the EU Animal Welfare legislation’, SWD(2022) 328 final, 4.10.2022
34European Convention for the Protection of Animals during International Transport, Council of Europe, Chişinau, 6.XI.2003, European Treaty Series-No. 193.
35EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) Scientific Opinion on the welfare of small ruminants during transport. EFSA Journal 2022; 20(9):7404, 101 pp
36EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) Scientific Opinion on the welfare of equidae during transport. EFSA Journal 2022; 20(9):7444, 113 pp.
37EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) Scientific Opinion on the welfare of small ruminants during transport. EFSA Journal 2022; 20(9):7404, 101 pp.
38EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) Scientific Opinion on the welfare of pigs during transport. EFSA Journal 2022; 20(9):7445, 108 pp.
39EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) Scientific Opinion on the welfare of domestic birds and rabbits transported in containers. EFSA Journal 2022; 20(9):7441, 188 pp.
40Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation), C/2019/7005, OJ L 261, 14.10.2019, p. 37–96.
41Judgment of 23 April 2015, Zuchtvieh-Export GmbH, C-424/13, ECLI:EU:C:2015:259, paragraph 56
42 WOAH Terrestrial Animal Health Code, 2023, Terrestrial Code Online Access - WOAH - World Organisation for Animal Health.
43Judgement of 3 December 2015,
44Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
45https://www.parismou.org/
46Directive 2009/16/EC of the European Parliament and of the Council of 23 April 2009 on port State control (recast) (Text with EEA relevance) OJ L 131, 28.5.2009, p. 57–100.
47Commission Implementing Regulation (EU) 2023/372 of 17 February 2023 laying down rules on the recording, storing and sharing of written records of official controls performed on livestock vessels, on contingency plans for livestock vessels in the event of emergencies, on the approval of livestock vessels and on minimum requirements applicable to exit points. OJ L 51, 20.2.2023, p. 32–39.
48Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation); OJ L 119, 4.5.2016, p. 1–88.
49Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC; OJ L 295, 21.11.2018, p. 39–98.
50Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) C/2019/7005, OJ L 261, 14.10.2019, p. 37–96.
51Regulation (EC) No 561/2006 of the European Parliament and of the Council of 15 March 2006 on the harmonisation of certain social legislation relating to road transport and amending Council Regulations (EEC) No 3821/85 and (EC) No 2135/98 and repealing Council Regulation (EEC) No 3820/85,OJ L 102, 11.4.2006, p. 1–14.
52Regulation (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 339/93, OJ L 218, 13.8.2008, p. 30–47
53Council Regulation (EC) No 1255/97 of 25 June 1997 concerning Community criteria for staging points and amending the route plan referred to in the Annex to Directive 91/628/EEC, OJ L 174, 2.7.1997, p. 1–6.
54Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 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 and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) OJ L 95, 7.4.2017, p. 1–142
55Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making, OJ L 123, 12.5.2016, p. 1–14
56Regulation (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 powers, OJ L 55, 28.2.2011, p. 13–18.
57Council Decision (EU) 2015/451 of 6 March 2015 concerning the accession of the European Union to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), OJ L 75, 19.3.2015, p. 1–3.
58Council Directive 1999/22/EC of 29 March 1999 relating to the keeping of wild animals in zoos, OJ L 94, 9.4.1999, p. 24–26.
59Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33–79.
60Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves, OJ L 10, 15.1.2009, p. 7.
61Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs, OJ L 47, 18.2.2009, p. 5.
62As referred to in Article 58(2)(a) or (b) of the Financial Regulation.
63Details of budget implementation methods and references to the Financial Regulation may be found on the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-implementation/Pages/implementation-methods.aspx
64C(2017) 2373 of 19/04/2017
65According to the COSO model adopted by the Commission Internal Control Framework in its latest version: C(2017) 2373 of 19/04/2017 3 Communication to the Commission on the revision of the Internal Control Framework (C(2017) 2373 of 19/04/2017) which replaces the Internal Control Standards laid down in SEC(2001)2037 and revised by SEC(2007)1341.
66Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012, O.J. L 193, 30.7.2018, 1.
67Communication to the Commission on the Revision of the Internal Control Framework C(2017)2373 adopted on 19/04/2017 (Principle 8, Characteristic 8.2).
68Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.
69EFTA: European Free Trade Association.
70Candidate countries and, where applicable, potential candidates from the Western Balkans.
71
72AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; JPD= Junior Professionals in Delegations.
73Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).
74Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.
75As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.
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