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2016 Annual Activity Report Consumers, Health, Agriculture and Food Executive Agency Ref. Ares(2017)1838453 - 06/04/2017

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  • 2016

    Annual Activity Report

    Consumers, Health, Agriculture and Food

    Executive Agency

    Ref. Ares(2017)1838453 - 06/04/2017

  • CHAFEA_aar_2016__FINAL Page 2 of 134

  • CHAFEA_aar_2016__FINAL Page 3 of 134

    Table of Contents

    CHAFEA IN BRIEF 4

    EXECUTIVE SUMMARY 8

    A) IMPLEMENTATION OF THE AGENCY'S ANNUAL WORK PROGRAMME - HIGHLIGHTS OF THE YEAR (EXECUTIVE SUMMARY OF SECTION 1) ............................................................................................................................................................................ 8 B) KEY PERFORMANCE INDICATORS (KPIS) ....................................................................................................................... 13 C) KEY CONCLUSIONS ON FINANCIAL MANAGEMENT AND INTERNAL CONTROL (EXECUTIVE SUMMARY OF SECTION 2.1) ................... 16 D) INFORMATION TO THE COMMISSIONERS ...................................................................................................................... 16

    1. IMPLEMENTATION OF THE AGENCY'S ANNUAL WORK PROGRAMME - HIGHLIGHTS OF THE YEAR 17

    1.1 PROMOTION OF AGRICULTURAL PRODUCTS .............................................................................................. 22 1.2 CONSUMER PROGRAMME .......................................................................................................................... 25 1.3 BETTER TRAINING FOR SAFER FOOD ........................................................................................................... 30 1.4 HEALTH PROGRAMME ................................................................................................................................ 17

    2. ORGANISATIONAL MANAGEMENT AND INTERNAL CONTROL 33

    2.1 FINANCIAL MANAGEMENT AND INTERNAL CONTROL ................................................................................................ 33 2.1.1 CONTROL RESULTS ........................................................................................................................................... 33 2.1.2 AUDIT OBSERVATIONS AND RECOMMENDATIONS ................................................................................................... 65 2.1.3 ASSESSMENT OF THE EFFECTIVENESS OF THE INTERNAL CONTROL SYSTEMS .................................................................. 66 2.1.4 CONCLUSIONS AS REGARDS ASSURANCE ................................................................................................................ 67 2.1.5 DECLARATION OF ASSURANCE ............................................................................................................................ 68

    DECLARATION OF ASSURANCE 69

    2.2 OTHER ORGANISATIONAL MANAGEMENT DIMENSIONS ............................................................................................ 70 2.2.1 HUMAN RESOURCE MANAGEMENT ...................................................................................................................... 70 2.2.2 INFORMATION MANAGEMENT ASPECTS ................................................................................................................ 71 2.2.3 EXTERNAL COMMUNICATION ACTIVITIES ............................................................................................................... 71

    ANNEXES (APPLICABLE TO CHAFEA) 72

    ANNEX 1: STATEMENT OF THE RESOURCES DIRECTOR .............................................................................................. 72 ANNEX 2: REPORTING – HUMAN RESOURCES, BETTER REGULATION, INFORMATION MANAGEMENT AND EXTERNAL COMMUNICATION ....................................................................................................................................................... 73 ANNEX 3: DRAFT ANNUAL ACCOUNTS AND FINANCIAL REPORTS ................................................................................ 78 ANNEX 4: MATERIALITY CRITERIA ......................................................................................................................... 79 ANNEX 5: INTERNAL CONTROL TEMPLATE(S) FOR BUDGET IMPLEMENTATION (ICTS) .................................................... 81 ANNEX 12: PERFORMANCE TABLES ...................................................................................................................... 108

  • CHAFEA_aar_2016__FINAL Page 4 of 134

    CHAFEA IN BRIEF

    The "Consumers, Health, Agriculture and Food Executive Agency" (hereinafter Chafea or the Agency) being one of the six EU Executive Agencies set up based on Council

    Regulation (EC) N° 58/2003) was set up in 2005 to execute, by delegation of the

    European Commission, the management of the EU 2nd Health Programme.

    The Agency's name reflects the regular enlargement of its scope since then. The Agency

    received its lifetime and mandate extended by the Commission in 2008 and 2013. Today, in close cooperation with the responsible Directorate-Generals (so called parent DGs) of

    the Commission, Chafea implements:

    4 programmes /initiatives for Better Health and Better Life, of about 1 billion €

    over 2014-2020 :

    Chafea mission is to efficiently manage the four programmes and successfully meet their objectives, in line with the Commission priorities and the Directorate Generals guidance,

    ultimately contributing to the positive perception of the European project.

    The Agency actively promotes the participation to the programmes; performs the daily

    The Health Programme, funding actions aiming to promote and support a European cooperation on some of the most challenging health-related issues such as: chronic and

    rare diseases, anti-microbial resistance and health technology assessment (DG SANTE and DG GROW);

    The Better Training for Safer Food initiative, well-known for promoting European

    food safety standards in the EU and worldwide, with hundreds of trainings organised

    each year for professionals actors (DG SANTE);

    The Consumer Programme, with actions targeting safer products and market surveillance, assistance to consumers on cross-border issues, education and information

    initiatives as well as providing data in support of policy (DG JUST);

    Since 2016, the Promotion of Agriculture Products, which implements actions to

    increase awareness of the merit of EU products and quality schemes, as well as their competitiveness and market share worldwide (DG AGRI).

    Programmes managed by the Agency

  • CHAFEA_aar_2016__FINAL Page 5 of 134

    management of related projects and actions in line with legal and financial procedures; monitors and reports on outcomes and disseminates the programmes results.

    Chafea ensures that the European budget funds entrusted to the Agency are allocated

    and spent in accordance to the principles of sound financial management. This applies to both the administrative budget (EUR 8.8 millions) and the budget devoted to the

    implementation of the programmes through grants and procurement (EUR 180 millions in commitment and payment appropriations in 2016).

    HEALTH PROGRAMME:

    Better care for rare disease

    patients – 24 European reference

    networks approved

    CONSUMERS PROGRAMME:

    Consumer safety – toy market

    surveyed; 1850 samples tested

    BETTER TRAINING FOR SAFER

    FOOD:

    "Closing the loop" – 7500 national

    experts from 138 countries trained

    PROMOTION OF AGRICULTURAL PRODUCTS:

    EU products promotion over the world - 33 third countries targeted

    – Biggest number ever

    KEY BUDGET-FOR-RESULTS OUTPUTS in 2016

  • CHAFEA_aar_2016__FINAL Page 6 of 134

    Daily work with hundreds funded partners working to make programmes'

    objectives concrete and real in EU and Third countries

    Chafea strategic goal:

    Increase performance in delivering programmes expected results and thus

    contribute to the Union priorities

    Manage changes: be prepared for next generation of programmes

    respecting the EP/Council/Commission expectations

    The objective is now to further develop the Agency as a centre of excellence for programme management, delivering meaningful results and as a great place to work.

    In 2016, the core line remained to keep a high level of performance both towards the

    Commission and towards the programme partners and beneficiaries while in parallel Chafea’s initiated a review of its structure and operations, in agreement with its

    stakeholders in order to better align itself with the new Commission’s objectives- such as the Budget for Results initiative- and preparations for the next generation of programmes

    and to achieve further efficiency and synergies gains.

    Agency´s life

  • CHAFEA_aar_2016__FINAL Page 7 of 134

    The agency just passed its first decade; 2016 was the right time for assessing lessons learnt and launching new challenges.

    The Agency activities are based on an Annual work programme aligned to the parent DGs

    management plans. To achieve meaningful results, the Agency works in close relationship with those DGs, and reports to a Steering Committee set-up of

    representatives from the parent DGs and the Human Resources Directorate General.

    End of 2016, Chafea signed a new Memorandum of Understanding with its parents DGs,

    to better define the sharing of responsibilities and collaboration dynamics between the concerned services.

  • CHAFEA_aar_2016__FINAL Page 8 of 134

    EXECUTIVE SUMMARY

    The Annual Activity Report is a management report of the Director of the Consumers, Health, Agriculture and Food Executive Agency to the College of Commissioners. Annual

    Activity Reports are the main instrument of management accountability within the

    Commission and constitutes the basis on which the College takes political responsibility for the decisions it takes as well as for the coordinating, executive and management

    functions it exercises, as laid down in the Treaties1.

    a) Implementation of the Agency's Annual Work

    programme - Highlights of the year (executive summary of section 1)

    In line with the Public Health annual work programme for 2016, Chafea centred its

    activity of Chafea on the following priorities:

    Actions to support Member states' efforts to address the health impact of the high

    influx of refugees, especially in the most affected EU countries.

    In late 2015 and the beginning 2016 Chafea awarded five grants totalling more than 6 million euros, to channel EU financial support to countries and organisations that could

    most efficiently help EU Member States in dealing with this major crisis. These grants had a limited duration of one year, in line with the objective to provide immediate relief and

    assistance in the process of reception of a very significant number of refugees and other migrants.

    The Agency, together with the DG SANTE and other Commission services, put in place a strong coordination mechanism, to ensure optimal use of EU funding and maximize

    synergies from the different co-funded actions. One year later, the results of these

    actions, further detailed later in the report, have demonstrated the capacity of the health programme to have a direct impact improving the capacity of the receiving countries to

    better address the health challenges of the high influx of refugees and migrants.

    Actions to support the setup of the first European Reference Networks (ERNs) 2 , in the framework of the cross border care directive.

    Supporting consistent implementation of EU legislation across the EU and thus

    contributing to the achievements of the legislation's aim and objectives is one of the areas where the health programme can yield significant EU added value. As concerns the

    cross border care directive, one key aspect was the assessment of ERNs with regards to

    predefined quality criteria. The Agency ensured the timely assessment of the candidate networks and the healthcare providers composing them by accreditation bodies, leading

    to their approval by the Board of Member States in December 2016. Chafea also launched a call for proposals for Framework Partnership Agreements and related Specific

    1 Article 17(1) of the Treaty on European Union.

    2 European Reference Networks (ERNs) are virtual networks involving healthcare providers across Europe. They aim to tackle complex or rare diseases and conditions that require highly specialised treatment and

    concentrated knowledge and resources. The process and criteria for establishing an ERN and for selecting its

    members are set in EU legislation. The first ERNs were launched in March 2017, involving more than 900

    highly-specialised healthcare units from over 300 hospitals in 26 Member States.

    https://ec.europa.eu/health/rare_diseases/european_reference_networks/erf_enhttps://ec.europa.eu/health/rare_diseases/european_reference_networks/erf_enhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDFhttps://ec.europa.eu/health/ern/implementation/call_en

  • CHAFEA_aar_2016__FINAL Page 9 of 134

    Grant Agreements, to provide financial support to the approved networks for the next five years, 2017-2021.

    Actions to support to the strengthening of EU collaboration in the area of Health

    Technology Assessment (HTA).

    The rationale for European collaboration in this area is improving the current situation

    where national HTA systems, using differing procedures, methodologies and capacities often duplicate each other efforts and produce outcomes diverging across the EU, which

    leads to uncertainty for both industry and patients. Therefore the aim of the Joint Action is to transit to a single or joint assessment, which can then serve several Member States.

    2016 marked the launch of two important initiatives in this area: (a). The launch of an important study for the impact assessment of a legislative proposal in the area of HTA

    collaboration in the EU; and (b). The launch of the 3rd Joint Action engaging almost all of the HTA bodies, with a very significant financial envelope of 12 million euros of Union

    contribution. The former will provide DG SANTE with the necessary data for the baseline

    scenario and the options proposed in the impact assessment process. The latter will further reinforce the current level of common work, validating the common tools and

    methodologies; it will ease the way to more uptake of EU work at national level and strengthened cooperation in the future, feeding into the option which will be selected

    within the legislative initiative.

    Actions in support of developing country knowledge and strengthening the health

    dimension of public policies

    A key initiative in 2016 AWP was the collaborative effort between DG SANTE, the OECD

    and the WHO-European Observatory on Health Systems and Policies to put in place the

    first annual report of the so-called "State of Health in the EU" cycle.

    With the financial support of the programme and under the stewardship of Chafea, it

    became possible to tap into the unique know-how of these organisations and to put in place a system of mutual learning among EU Member States in support of effective,

    accessible and resilient health systems.

    The support by Chafea of the above, as well as other priority areas (alcohol, chronic

    disease, cancer, tobacco control and AMR) translated into the following outputs:

    Health Programme 2014 - 2020

    2016 Chafea Work Programme

    Proposals

    submitted

    Ineligible

    proposals

    Proposals to

    be co-funded

    Actions

    Grants for projects (including the Calls for the ERNs)

    62 0 22

    Grants for the functioning of NGO or

    networks 13 0 13

    Direct Grants-International

    Organizations

    13 (7 from AWP 2015

    & 6 from AWP 2016) 0 13

    Joint actions (MS) 9 (4 from AWP 2015

    & 5 from AWP 2016) 0 9

    TOTAL 110 3 57

    http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdfhttp://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdfhttps://ec.europa.eu/health/state/glance_en

  • CHAFEA_aar_2016__FINAL Page 10 of 134

    Procurement:

    In 2016 Chafea launched 24 procurement procedures (22 from the AWP 2016 and 2

    pending from the AWP 2015), i.e. 92 % of procedures foreseen. The Agency also signed 19 service contracts (9 from the AWP 2016 and 10 from the AWP 2015).

    For Promotion of Agricultural Products the year 2016 became the first year of

    implementation of the reformed policy. In this context, first two calls for grant proposals were published in February 2016 announcing 11 different priority topics, such as e.g.

    highlighting specific features of agricultural methods in the Union and the characteristics of EU agri-food products, increasing the awareness of Union sustainable agriculture and

    role of the agri-food sector for climate action and the environment, etc.

    With a total of 226 proposals, both calls were over-subscribed which ensured a good level

    of competition among proposals.

    60 simple (mono-beneficiary) programmes with total EU co-financing of EUR 94 232 114 and 6 multi-beneficiary project proposals with total EU co-financing of EUR 16 827 217

    were awarded. The programmes target 33 third countries, the biggest number ever since the beginning of the promotion policy, and benefit a large number of product sectors with

    the emphasis on products under EU quality schemes, from the outermost regions and from organic production, but also specific elements for sectors hit by market difficulties,

    such as dairy, porc, beef. Moreover, almost 50% of all adopted simple programmes were submitted by applicants who never participated in the promotion regime in the past. This

    confirms the opening brought about by the reform of the promotion policy.

    Phasing-in of technical support services as well as organisation of events and campaigns in third countries also started and will be intensified during the coming years.

    From the organisational point of view, the unit in charge of promotion of agricultural products was phased-in. Considerable effort was put into design of internal procedures.

    The Consumer protection remains high on the Commission's agenda given its

    important contribution to the Commission's policy priorities. A single market that serves the consumers well is an essential part of these priorities, as well an important element

    to stimulating Europe's economic growth. Constant developments in the area of digital

    technology are fundamentally changing the way consumers interact and shop on-line. The aim pursued by the Commission is therefore to create a Digital Single Market, where

    the free movement of goods, persons, services and capital is ensured — and where citizens and businesses can seamlessly and fairly access online goods and services:

    whatever their nationality, and wherever they live.

    With a view to contribute to this objective, during 2016, the Agency contracted various

    services aimed at analysing different aspects relevant to the development of the digital single market. Namely, a study on the on-line market segmentation through personalized

    pricing/ offers in the European Union was launched. The study should look into the

    benefits of personalised pricing/offers for sellers and consumers, as well any detriment experienced by consumers (e.g. being charged higher prices) and into how consumers

    perceive ‘personalised pricing’/offers and the impact it has on their purchasing decisions.

    A second study on the transparency of Online Platforms was contracted. The study will

    assess whether consumers have more trust in platforms overall and make better

    http://ec.europa.eu/growth/single-market/digital/index_en.htm

  • CHAFEA_aar_2016__FINAL Page 11 of 134

    decisions where there is a higher level of transparency. This study will contribute to the broad-based evidence reviewed by the Commission in the context of the regulatory

    Fitness Check of EU Consumer and Marketing Law. The ultimate study findings could

    inform targeted legislative or enforcement initiatives, non-legislative policy initiatives, and/or self-regulatory efforts by online platforms.

    In the context of the Consumer annual work programme 2016 the Agency implemented the following procedures

    Call for proposals

    Consumer Programme 2014-2020

    2016 Work Programme

    Proposals

    submitted

    Ineligible

    proposals

    Proposals

    recommender for co-funding

    Calls for proposals for projects

    Joint actions in the field of product safety 1 0 1

    Grants for the functioning of Consumer

    Organisations at EU level

    1 0 1

    Grant for the functioning of the European

    Consumer Centres

    30 0 30

    Payment of Special Indemnities for the Exchange of Officials in the areas of General

    product safety Directive and Consumer protection Cooperation

    92 0 92

    TOTAL 124 0 124

    Procurement procedures covering subjects mentioned in the respective work programmes were implemented by the Agency for all tenders for which the parent DGs

    provided input with regards to the definition of the requested service.

    The Better training for safer food Initiative is organizing multiple trainings for Member State officials dealing with the control of the food production.

    Better understanding of complex food legislation is contributing to its better implementation. Trainings where EU legislation defining food production is clearly

    explained and its further implementation secured through thorough understanding allows small and medium-sized EU local food businesses to better and easier access the single

    market and to open new market possibilities for their products.

    In 2016, the Agency managed 45 different trainings subject (food hygiene at first

    production level, pesticide application equipment control, animal welfare – to name a

    view) related to the different type of the food production and controls over the food production or its transport. In this training framework 180 training events with the

    average duration of 4 days, covering most of the food production aspects were offered to almost 7500 participants from EU Member-States.

    In addition to these training events offered throughout the year, the Agency organised

  • CHAFEA_aar_2016__FINAL Page 12 of 134

    specialised trainings on emerging diseases like African swine fever or Lumpy skin disease. The knowledge of how to combat these diseases bearing serious economic

    threats was transferred to all Eastern countries bordering EU which allowed them to

    obtain latest scientific data and up-to-date information on a particular disease spreading modalities.

    Also special trainings for EU Member-State-officials was organised where specific emphasis was put on audit in different areas of plant health and plant production.

    In the framework of the BTSF annual work programme 2016 the Agency implemented procedures comprising both launch of to the second phase of existing contracts and

    launch of the new calls for tenders.

    The Agency issued 6 Newsletters informing the general public about the latest

    developments.

    Taking-over 10 developed e-learning modules into the Commission e-environment the

    Agency was preparing for running the e-learning modules by its own after September

    2017.

    Flexibility and responsiveness

    Reacting to the emerging diseases, the Agency procured seven trainings in Eastern countries of the EU. Moreover, the Agency and opened a call for the organisation of 6

    special trainings on audit principles.

    The Agency as well launched requests for service for organizing a BTSF World conference

    which is planned to be held in the middle of 2017 and a second round of trainings for 2017.

  • CHAFEA_aar_2016__FINAL Page 13 of 134

    b) Key Performance Indicators (KPIs)

    The key performance indicators deriving from regulatory provisions e.g. the efficiency

    indicators required by the Financial Regulations: time-to-pay (Art 92.1 FR), time-

    to-inform and time-to-grant (Art 128.2 FR), provide information on core aspects of the Agency’s operation. The KPI are included in the Agency's Annual Work Programme of

    2016.

    b)1. Level of Budget Implementation (commitment and payment

    appropriations)

    More than 99% of the credits received by the Agency via transfer from its parent DG

    were committed; Over 97% of the available payment appropriations were disbursed through 1214 payment transactions carried out in relation to the programmes delegated

    to the Agency.

    0

    10

    20

    30

    40

    50

    60

    HEALTH (PHP) CONSUMERS (CP) BTSF AGRI

    50,00

    16,25 15,37

    18,48

    49,71

    16,12 15,37 18,48

    42,40

    18,63 17,04

    2,71

    42,40

    18,61 17,04

    2,67

    Mill

    ion

    s

    Operational Commitments & Payments Consumption

    Commitments credits Commitments consumed Payments credits Payments consumed

    0,0

    50,0

    100,0

    150,0

    Commitments… Payments…

    Mill

    ion

    s €

    Chafea Total Commitment & Payments Consumption

    Credits

    Consumed

  • CHAFEA_aar_2016__FINAL Page 14 of 134

    b)2. Time to inform

    The Agency is bound to inform applicants on the results of their proposals’ evaluation

    within six months from the closure (expiry of deadline for submitting proposals) of the respective call for proposals; The Agency’s performance was 93 days (47, 74 and 157

    days for the Consumer, Health programme and promotion of Agricultural products respectively); it represents a duration within the deadline set by the EU Financial

    Regulation.

    b)3. Time to grant

    Time to grant refers to the number of days that elapses between final date set for submission of complete proposals and the signature of the legal commitment (a grant

    agreement) by the Authorising officer. In 2016, Chafea observed the shortest of all options (3 months) for time to grant set by the Financial Regulation (FR) and calculated

    from the date of informing to the date of the grant signature.

    2.5 - inform

    1.6 - inform

    5.2 - inform

    2.9 - grant

    2.0 - grant

    2.6 - grant

    0 1 2 3 4 5 6 7 8 9

    PHP

    CP

    AGRI

    Number of months

    Time inform & grant

    7,9

    3,6

    5,4

  • CHAFEA_aar_2016__FINAL Page 15 of 134

    b)4. Time to pay

    Over the reporting period the Agency executed 1.214 payment transactions. The average

    number of days needed for the execution of payments was 17 days regarding payments with 30 days deadline, 27 days regarding payments with 45 days deadline 31 days

    regarding payments with 60 days deadline and 65 days regarding payments with 90 days deadline. 102 (8.40%) out of the 1.214 payments executed were late however the

    number of delayed days was not considerable and resulted in relatively low materiality (16.5 € per payment at the average). Measures were agreed to improve the situation in

    the coming year.

    b)5. Residual error rate (ex-post controls)

    The main objective of ex post control is the detection and correction of undue payments

    made by the Agency that may result from errors, irregularities or fraud that would

    remain undetected at the stage of the controls that precede each payment (ex-ante controls). Results following the implementation of ex-post audits support the calculation

    of the so called ‘residual error rate’; in its turn, the calculation of the residual error rate aims at concluding whether the assessment of the quantitative materiality criterion

    related to the legality and regularity of the Agency’s underlying transactions should lead to a reservation. Currently the threshold is set at 2%, calculated for each of the

    programmes delegated to Chafea.

    The Agency follows a multiannual approach to the calculation of its residual error rate

    0

    10

    20

    30

    40

    50

    60

    70

    Average daysDeadline 30

    Average daysDeadline 45

    Average daysDeadline 60

    Average daysDeadline 90

    15

    24

    39

    64

    20

    37

    34

    65

    13

    20 21 19

    Day

    s

    Average of time to pay (grants & procurement conracts)

    PHP

    CP

    BTSF

    AGRI

    Calculation against payments deadlines of 30, 45, 60 and 90 days

  • CHAFEA_aar_2016__FINAL Page 16 of 134

    and the net amount at risk. The cumulative residual error rate was calculated as being below the 2% materiality threshold; in specific, the percentage of the residual error rates

    were 1,37% and about 0% for the Health programme and the Consumer programme

    respectively. Ex-port controls did not apply either to the grants under promotion of Agricultural products where the first grants were awarded in 2016, or to BTSF where only

    procurement contracts were concluded.

    c) Key conclusions on Financial management and

    Internal control (executive summary of section 2.1)

    In accordance with the governance statement of the European Commission, the staff of the Consumers, Health, Agriculture and Food Executive Agency conduct its operations in

    compliance with the applicable laws and regulations, working in an open and transparent

    manner and meeting the expected high level of professional and ethical standards.

    The Commission has adopted a set of internal control standards, based on international

    good practice, aimed to ensure the achievement of policy and operational objectives. The financial regulation requires that the organisational structure and the internal control

    systems used for the implementation of the budget are set up in accordance with these standards. The Agency has assessed the internal control systems during the reporting

    year and has concluded that the internal control standards are implemented and function as intended. Please refer to AAR section 2.1.3 for further details.

    In addition, the Agency has systematically examined the available control results and

    indicators, as well as the observations and recommendations issued by internal auditors and the European Court of Auditors. These elements have been assessed to determine

    their impact on the management's assurance as regards the achievement of control objectives. Please refer to Section 2.1 for further details.

    In conclusion, management has reasonable assurance that, overall, suitable controls are in place and working as intended; risks are being appropriately monitored and mitigated;

    and necessary improvements and reinforcements are being implemented. The Director, in her capacity as Authorising Officer by Delegation has signed the Declaration of

    Assurance.

    d) Information to the Commissioners

    The main elements of this report and assurance declaration have been brought to the attention of the Agency's Steering Committee and to the parent DGs Directors General,

    who have taken these into consideration in his(her) reporting to Commissioner Vytenis Andriukaitis, responsible for the Health and Food Safety portfolio, to Commissioner Vera

    Jourová , responsible for Justice, Consumers and Gender equality portfolio, Commissioner Phil Hogan, responsible for the Agriculture and Rural Development

    portfolio and Commissioner Elzibieta Bienkowska, responsible for the Internal Market,

    Industry, Entrepreneurship and Small and Medium Enterprises s portfolio.

  • CHAFEA_aar_2016__FINAL Page 17 of 134

    1. IMPLEMENTATION OF THE AGENCY'S ANNUAL WORK PROGRAMME - HIGHLIGHTS OF THE YEAR

    This Section provides information on the key results and progress towards the achievements of general and specific objectives set in the Parent DGs Management Plan 2016 and to contribute to the parent DGs policy achievements and generate Union added value.

    1.1 HEALTH PROGRAMME

    In the past year, the Agency further advanced in managing the implementation of the EU 3rd Health Programme, where new results were achieved in order to "complement,

    support and add value to the policies of the Member States, improve the health of the Union citizens and reduce health inequalities…" (3rd Health Programme, Art 2).

    The four Specific objectives (SO) of the 3rd Health Programme support the implementation of the priorities of the European Commission and the objectives of the

    parent DG SANTE transposed into Chafea working objectives. This part of the Report describes the progress towards objectives of the 3rd Health Programme delegated to

    Chafea. Annex 12 specifies the correlations between the DG SANTE objectives and

    objectives of the 3rd Health Programme in 2016.

    EU co-funding under this objective primarily supports exchange of good practices to

    achieve synergies between EU Member states, in sharing approaches, actions and policies. The 3rd Health progamme mobilized the following instruments to contribute to

    this objective:

    Joint action on Reducing Alcohol Related Harm (RAHRA)

    Bringing together 60 partners across 29 EU member states, including organisations such as the EMCDDA, WHO, Pompidou Group and OECD , by 2016 this Joint Action has:

    conducted a common Standardised European Alcohol Survey; built-up an integrated European common database (HARMES – Harmonising Alcohol Related Measures in

    Europe); produced a compendium of best-practices.

    Joint Action on Improving Quality in HIV Prevention (Quality Action)

    This Joint Action involves 45 partners from 26 Member States and aims at improving the

    quality of the response to HIV and AIDS in Europe, by integrating evidence-based quality improvement (including quality assurance) practices into HIV prevention across Europe.

    Specific objective: Promote health, prevent diseases, foster, healthy lifestyle

    http://eur-lex.europa.eu/legal-content/EN/TXT/;jsessionid=5Qj3TvyCyBqbhfLZzzBttjDGh3gyXkQWYrjhrt36mChMJJlp02XX!2060916514?uri=uriserv:OJ.L_.2014.086.01.0001.01.ENGhttp://www.rarha.eu/Pages/default.aspxhttp://www.emcdda.europa.eu/http://www.coe.int/t/dg3/pompidou/http://www.rarha.eu/Resources/Deliverables/Lists/Work%20Package%204/Attachments/6/RAHRA_InfoSheet_WP4_02_FINAL.pdfhttp://www.rarha.eu/Resources/Deliverables/Pages/details.aspx?itemId=10&lista=Work%20Package%206&bkUrl=/Resources/Deliverables/http://www.qualityaction.eu/

  • CHAFEA_aar_2016__FINAL Page 18 of 134

    By 2016, the Joint Action developed practical tools and materials, such as Five practical quality improvement tools, the ‘Charter for Quality in HIV Prevention’, a Policy Kit. A

    large network of experts, created by this innovative partnership have trained over 400

    quality improvement trainers and facilitators from 25 EU countries; succeeded in mainstreaming quality into HIV prevention.

    Joint Action Addressing Chronic Diseases and Healthy Ageing across the Life Cycle (CHRODIS)

    Working in this Joint Action, over 60

    partners from 25 EU countries successfully

    address challenge of chronic diseases

    focusing on health promotion and primary

    prevention. In 2016, the Joint Action

    showed the flowing deliverables: the

    CHRODIS platform created by the action is

    a unique collection of validated good

    practices. National Plans on Diabetes

    address all key dimensions, such as

    addressing high-risk population groups;

    secondary prevention and health promotion

    measures; capacity building and training of

    healthcare professionals, stakeholders and

    patients; and care delivery coordination

    and innovation. A comprehensive multi-

    morbidity Care Model responds to needs for

    care coordination and support for the self-

    management of patients.

    Tobacco service contracts

    Several service contracts were launched from 2013 to 2016 in order to assist the

    European Commission to fulfil its legal obligations under the new Tobacco Product

    Directive. In 2016, three service contracts were finalised and five studies were published:

    EU common reporting format for data on tobacco and related products' ingredients;

    assessment of risks associated with e-cigarettes; mapping of methods to decide upon

    flavour other than tobacco; Overview on evidence of toxicity, addictiveness and

    attractiveness of tobacco and related products ingredients; proposals for warning

    messages on tobacco packages; as well as, study on citizens' exposure to tobacco and e-

    cigarette marketing.

    These studies provide the Commission and the Member States with a strong evidence-

    base in support of the legislation implementation.

    http://www.qualityaction.eu/choosetool.phphttp://www.qualityaction.eu/choosetool.phphttp://staging.qualityaction.eu/wordpress/wp-content/uploads/2014/01/QACT_PolicyKit_Charter.pdfhttp://staging.qualityaction.eu/wordpress/wp-content/uploads/2014/01/QACT_PolicyKit_03.pdfhttp://chrodis.eu/http://chrodis.eu/our-work/07-type-2-diabetes/wp07-activities/http://chrodis.eu/our-work/06-multimorbidity/wp06-activities/multimorbiditycaremodel/http://chrodis.eu/our-work/06-multimorbidity/wp06-activities/multimorbiditycaremodel/http://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/reportingformat_dataingredients_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/potentialrisks_specs_refillableecigarettes.pdfhttps://ec.europa.eu/health/sites/health/files/tobacco/docs/hetoc_frep_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/specifications_warning_tobaccopackages_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/specifications_warning_tobaccopackages_en.pdfhttp://ec.europa.eu/health/sites/health/files/tobacco/docs/citizensexposure_tobaccomarketing_en.pdf

  • CHAFEA_aar_2016__FINAL Page 19 of 134

    To adapt to changing circumstances and to react to unforeseen events, in response to

    the refugee crisis, in summer of 2015 a call "Support Member States under particular migratory pressure in their response to health related challenges" was conducted in

    October-November 2015. In 2016, high value deliverables were produced by each project co-funded through the mentioned call:

    Development and piloting of a training strategy targeting health workers (health

    managers, health practitioners and administrative staff) i for a better understanding

    of the refugees’ health needs.

    Development of a model and a protocol for rapid assessment of mental health

    and psychosocial needs of refugees and psychosocial care;

    Development of “training of trainers” programmes and e-learning course to

    enhance capacity building of front-line staff dealing with migrant care;

    Implementation of mobile surveillance & response health units and general

    health needs assessments to ensure health services to newly arrived migrants;

    Establishment of multidisciplinary teams in Hotspots and migrant’s Centres, to

    sustain healthcare provision to migrants;

    Development and piloting of a syndromic surveillance protocol for monitoring

    potential disease outbreaks at migrant reception/detention centres;

    Performance of a survey of vaccinations offered to newly arrived;

    Implementation of the Personal Health Record of migrants at the moment of their

    arrival.

    Action to support the strengthening of EU collaboration in the area of Health

    Technology Assessment (HTA) with the objective to create a sustainable

    mechanism for the long-term EU-wide cooperation on HTA. Two important initiatives

    in this area were launched in 2016: a key study for the impact assessment of a

    legislative proposal in the area of HTA cooperation in EU; and the 3rd Joint Action

    engaging almost all EU Member States, Norway and Iceland.

    Actions in support of developing country knowledge and strengthening the health

    dimension of public policies, to establish the first annual cycle of the "State of Health

    in the EU" through joint effort of DG SANTE, OECD and WHO. In 2016, the Health at

    Specific objective: Protect citizens from serious cross border health threats

    Specific objective: Support public health capacity building, contribute to innovative, efficient and sustainable health systems

    http://ec.europa.eu/smart-regulation/roadmaps/docs/2016_sante_144_health_technology_assessments_en.pdfhttps://ec.europa.eu/health/state/glance_enhttps://ec.europa.eu/health/state/glance_enhttp://www.oecd.org/health/health-at-a-glance-europe-23056088.htm

  • CHAFEA_aar_2016__FINAL Page 20 of 134

    a Glance: Europe 2016 flagship report was launched with the aim to provide

    comparisons of indicators and to highlight the needs.

    Joint Action on European Health Workforce Planning and Forecasting

    The Joint Action brings together 28 associated partners from 18 countries, other

    collaborating partners, And has as its main focus helping countries plan process and prepare the future. At its current stage, the Joint Action conducted three pilot projects

    which received a full-scale follow-up in the piloting countries. The Joint Action also carried out research on driving future skills and competences of health workforce in EU

    out to the year 2035.

    Activation of Stratification Strategies and Results of the interventions on frail

    patients of Healthcare Services (ASSEHS)

    Launched in 2013, by now the action has produced: risk stratification tools that help identify and maintain on the

    health services radar complex-frail and high-risk patients and act as enablers for appropriate prevention;

    a white paper on the deployment of stratification methods.

    Benchmark comprehensive cancer care (BENCH-CAN)

    The BENCH-CAN project is designed to provide a free-at-use benchmarking tool on

    comprehensive cancer care and to yield best practice examples in a way that contributes to improving the quality of interdisciplinary patient treatment across the EU. The project

    consortium is led by OECI (Organisation of the European cancer institutes).

    Currently differences in EU health systems performance as flagged through prevalence,

    mortality and survival rates are not sustainable on the long term, especially with regards to the constant increase in new cancer patients. There is clearly room for improvement

    and benchmarking tools, which are ready for use and freely available is a very significant resource provided by the EU Health Programme, both to healthcare providers, as well as

    to Member States’ public health authorities.

    A free-at-use benchmarking tool on

    comprehensive cancer was produced by the project. It brings together practices and

    knowledge in comprehensive cancer care. The uptake of the results of this project will be

    integrated in the on-going Joint Action on cancer care (lead by the National Institute of

    Public Health of Slovenia).

    http://www.oecd.org/health/health-at-a-glance-europe-23056088.htmhttp://assehs.eu/https://ec.europa.eu/eip/ageing/repository/population-risk-stratification-deployment-stratification-methods-basque-country_enhttps://ec.europa.eu/eip/ageing/repository/population-risk-stratification-deployment-stratification-methods-basque-country_enhttp://assehs.eu/upload/docpublicos/white-paper-assehs-european-project.pdfhttp://www.oeci.eu/benchcan/Default.aspxhttp://www.oeci.eu/Benchcan/Doc/general/Resources/BenchCan_Manual_2016_FINAL.pdf

  • CHAFEA_aar_2016__FINAL Page 21 of 134

    Under this objective, in 2016, - Chafea supported the Commission by managing the call

    for networks European Reference Networks and ensuring the assessment of all candidate networks. The success of these Agency's activities became evident through the interest in

    the call resulted in active participation and through the fact that many networks had participated in the preceding EU health programme which shows a long-lasting impact of

    these programmes.

    Within 2016 Chafea completed the selection of the Independent Assessment Bodies and

    contracted assessment of the 24 ERNs The result of the assessment was a final Network assessment report endorsed by the Board of the Member States. Consequently, 24

    networks of health provides have become formally approved European Reference Networks in the sense of the legislation. This also makes the approved ERNs eligible for

    public funding under targeted mechanisms.

    Within the same year Chafea launched a call for proposals for funding the coordination costs of the approved networks, with the first contracts expected to be signed in early

    2017.

    Anti-Microbial Resistance. Direct grant agreement with the European

    Observatory on Health Systems and Policies

    Following the conclusions of the Dutch Presidency, Chafea awarded, in 2016, a direct

    grant agreement to the European Observatory on Health Systems and Policies with the objective to identify best practices of containing anti-microbial resistance. In this way,

    after a longer break, action in the area started, triggered by the Dutch Presidency Conference. The outputs are planned for the following periods.

    Joint action Facilitating Exchange of Organs Donated In EU Member States

    (FOEDUS)

    The Joint Action FOEDUS aimed to contribute to organ exchange in Europe by

    complementing Member states’ policies in this field, by raising awareness on the possible barriers, and by supporting EU-wide consensus on key tools for increased exchange of

    A Ministerial Conference on

    Antibiotic Resistance, co-funded by the 3rd Health Programme, was

    held early 2016 in the framework of the Dutch EU Presidency. The

    Conference. brought together 225

    participants from all EU member states, Norway and Switzerland,

    the WHO, the FAO and the European Commission and became

    a starting point for many countries to working on a ‘One Health’

    approach addressing both human and animal health.

    Specific objective: Facilitate access to better and safer healthcare for

    union citizens

    http://www.foedus-ja.eu/http://www.foedus-ja.eu/

  • CHAFEA_aar_2016__FINAL Page 22 of 134

    organs. A key output of the action is the common IT platform or “portal” www.foedus-eoeo.eu.

    INFORMATION AND DISSEMINATION

    Chafea continued supporting dissemination of Health programme implementation results,

    using platforms of national, EU-wide, or international events. The Agency's pop-up stand

    and dissemination material were present in more than 15 events of national or EU

    dimension. The following major events can be highlighted:

    A two day Conference on Migrants and Health, in May 2016, organized in

    close cooperation with DG SANTE, Portugese Directorate General of Health,

    International Organization for Migration and the COST ADAPT expert network.

    This conference brought together 165 participants, mainly policy makers and

    experts from 25 EU countries.

    Four workshops in the framework of the existing conferences: High level

    Conference on Global health security, 16th International conference on Integrated

    care, 19th European Health Forum Gastein, Demographics and Diversity in

    Europe, and 9th European Public Health conference (EUPHA2016) All for health

    and Health for All.

    The Cluster Meeting Nutrition and Physical Activity, brought together 90

    participants, including journalists, policy makers, health and education authorities,

    community and experts, representatives of World Health Organization and European

    Commission. 40 presentations were given during 8 sessions.

    1.2 PROMOTION OF AGRICULTURAL PRODUCTS

    2016 marked the first year of implementation of

    the reformed policy for promotion of agricultural products. The general objective of the policy is

    to enhance the competitiveness of the Union agricultural sector. Based on a strategy established at European level, it aims to help sector professionals' break into

    international markets and make consumers more aware of the efforts made by European

    2016 marked the first year of

    implementation of the reformed policy for promotion

    of agricultural products.

    Specific objective: Enhance the competitiveness of the Union

    agricultural sector

    http://www.foedus-eoeo.eu/http://www.foedus-eoeo.eu/http://ec.europa.eu/chafea/health/migrants-presentations_en.html

  • CHAFEA_aar_2016__FINAL Page 23 of 134

    farmers to provide quality products.

    Information provision and promotion measures can take the form of information and

    promotion programmes, and the measures on the initiative of the Commission.

    Information and promotion programmes consist of operations implemented by organisations which submit their proposals. They can take form of "simple" programmes

    where all beneficiaries come from the same member state, or "multi" programmes where beneficiaries come from different member states or are EU level organisations. The whole

    lifecycle of “multi” programmes is managed by Chafea while simple programmes are submitted to and evaluated by Chafea, and managed by the competent national

    authorities under shared management.

    In the context of the policy implementation measures, Chafea published, in February 2016, two calls for grants proposals – one for “simple” and one for “multi” proposals.

    In relation to the calls, Chafea focused in particular on facilitating the transition to the

    new rules for applicant organisations. The need for such facilitation was caused by the changes brought by the reform of the policy and changed management mode both

    representing a challenge for the applicant organisations. Therefore, Chafea provided

    guidance documents and organised a Helpdesk. A survey conducted immediately after the submission deadline shows that the quality of guidance documents, the online

    submission tool as well as the support offered by the helpdesk was assessed as very good or excellent by a large majority of respondents.

    As promotion of agricultural products is a new activity for the Agency, in parallel to

    publication of the calls it was necessary to prepare a set of internal procedures related to evaluation of proposals and management of grants, as well as to adapt Horizon-2020 IT

    tools to support those processes. These tasks were successfully carried out. Further work on the consolidated procedures is planned.

    At the end of the submission period, 199 “simple” and 27 “multi” proposals were submitted. The calls were oversubscribed, as can be seen in Table below.

    Statistics on submitted proposals and their requested grant

    As a result of the calls 60 simple (i.e. implemented by single beneficiaries) programmes

    with total EU co-financing of EUR 94,2 million and 6 multi (implemented by consortia of several beneficiaries) proposals with total EU co-financing of EUR 16,8 million were

    awarded.

    Call Number of proposals Requested grant Available budget Requested/available

    Simple 199 307,535,353 93,650,000 328%

    Multi 27 116,102,232 14,300,000 812%

    The programmes target 33 third countries, the biggest number ever

    Almost 50% of all adopted simple programmes were submitted by applicants who

    were newcomers to the EU promotion policy

  • CHAFEA_aar_2016__FINAL Page 24 of 134

    Following the call for “multi” programmes, Chafea signed its first ”multi” grant

    agreements in December 2016. The 6 promotional campaigns are targeting both the

    internal market and third countries and support the following product sectors: organic, fresh fruit and vegetables, ornamental horticulture, wine, olive oil, logo for outermost

    regions.

    In 2016, Chafea supported Measures taken on the initiative of the Commission, by

    corresponding procurement and management of the implementation of the resulting contracts including event management, under supervision of DG Agriculture and Rural

    Development.

    Measures on the initiative of the Commission take form of high-level missions,

    participation in trade fairs by means of stands, or operations aimed at enhancing the image of Union products. Moreover, the reformed promotion regime foresees the

    establishment of technical support services, in particular with a view to encouraging

    awareness of different markets, maintaining a dynamic professional network around information and promotion policy and improving knowledge of Union rules concerning

    programme development and implementation.

    The building of technical support services started during 2016 and will contribute to

    efforts to facilitate the participation of stakeholders in the reformed information and promotion policy. A dedicated portal was developed and will be put online in the first

    weeks of 2017. Moreover, market reports for three South-East Asian markets were delivered in 2016, and will be presented via a webinar offered on the future web portal.

    With respect to organisation of events and campaigns in third countries, one business

    delegation visit to three South-East Asian countries (Vietnam, Singapore and Indonesia) was organised in October 2016. Preparations were launched for organisation of the high

    level visit to Canada taking place in spring 2017. The latter will be coupled with participation at the SIAL (Salon International de l'Alimentation) Toronto trade fair where

    the EU will be presented with a dedicated pavilion as “region of the year”.

  • CHAFEA_aar_2016__FINAL Page 25 of 134

    1.3 CONSUMER PROGRAMME

    The 2014-2020 Consumer Programme supports the Europe-2020 targets of growth and

    competitiveness. It integrates the specific Europe-2020 priorities on the digital agenda for Europe in order to ensure that digitalisation actually leads to increased consumer

    welfare, sustainable growth, social inclusion and smart regulation.

    In 2016, CHAFEA further contributed to the achievement of these objectives through the

    implementation of the actions whose management was delegated to it by the Commission on the basis of the provisions of the Commission decision implementing the

    Consumer Programme 2014-2020.

    Support to European Consumer Centres

    In this framework, the Agency organised the procedure for the award of grants supporting the European Consumer Centres to assist consumers who wanted to take

    advantage of the Single market when travelling to other EU countries or making online cross border purchases.

    Joint Actions enhancing safety of consumer products

    During 2016, to improve consumer product safety in Europe, the Agency launched and

    managed the procedure for the award of grants for joint actions by the Member States linked to product safety.

    Exchange of enforcement officials

    To support monitoring and enforcement activities, the Agency funded the exchanges of enforcement officials. These exchanges give the opportunity to participants to share

    experience and knowledge on the practical implementation of Directive 2001/95 EC (General Product Safety) and Regulation 2006/2004 (Consumer Protection Cooperation).

    Strengthening the European consumer movement

    In order to ensure that consumer's interests are represented at EU level, the Agency co-

    funded the activities of the Bureau Européen des Unions de Consommateurs (with its headquarter in Brussels, Belgium), who represents consumer organisations in all Member

    States, as well as European Economic Area countries and countries that are applicants for EU membership

    During 2016, the Agency followed up the implementation of various consumer education

    Europe-2020 targets of growth and competitiveness

  • CHAFEA_aar_2016__FINAL Page 26 of 134

    activities. In particular, it monitored the running of the projects linked to capacity building to consumer organisations (consumer champion)3 and the development and

    maintenance of the teacher's interactive on-line platform on consumers education

    (consumer classroom)4.

    Market monitoring

    Moreover the Agency launched several public procurement procedures in order to gather

    and provide to the parent DG relevant and timely consumer evidence to inform key policy actions. Namely, the following services were contracted: a market monitoring survey

    for an EU wide representative survey of consumers in over 50 consumer markets, behavioural economic studies on transparency in online platforms and on circular

    economy and market studies on personalised pricing and on the real estate market. The results will be available in 2017.

    To achieve an equal level of consumer protection across the EU and take action against

    dangerous products on the market place, the Agency provides financial support to joint enforcement actions, allowing market surveillance authorities

    and customs to pool resources and expertise. The joint actions provide a platform to further improve the Member

    States' exchange of information on dangerous products and

    sharing of experience with procedures for carrying our market surveillance in general and for specific products.

    Joint market surveillance activities on toys have been

    developed on an annual basis as from 2014. This activity is focusing its attention

    on risks associated with acoustic toys. 16 surveillance authorities are participating in

    this product activity. Samples were tested

    from various categories such as toy mobile phones, rattles, squeeze toys, cap-firing toys to percussion, wind toys

    and other types of acoustic toys.

    Various types of toys intended for children of age under 3 years were

    3 The project aims at providing, free of charge, training, resources and networking opportunities addressed to

    consumer professionals. Its global objective is to offer capacity building activities aimed at strengthening

    the effectiveness of consumer organisations (including other actors and stakeholders in consumer policy

    such as: ECCs, EU Member States' ministries responsible for consumer policy). It also intends to promote

    exchange of practices between Consumer Professionals. http://www.consumerchampion.eu/

    4 The Consumer classroom is a community website for teachers bringing together an extensive library of consumer education resources from across the EU, along with interactive and collaborative tools to help

    prepare and share lessons with students and other teachers. https://www.consumerclassroom.eu/

    Unsafe products

    have no place on

    the EU market

    Toys:

    Over 1850 models inspected

    over 604 samples tested

    Specific Objective: Safety - to consolidate and enhance product

    safety through effective market surveillance throughout the Union

    cific Objective: Safety

    http://www.consumerchampion.eu/https://www.consumerclassroom.eu/

  • CHAFEA_aar_2016__FINAL Page 27 of 134

    chosen for sampling and testing.

    During the reporting period, over 1.850 different models of toys were inspected, out of

    which 604 samples were sent for testing. Testing mainly focused on the mechanical and

    physical properties of the toy, A number of samples were tested for chemical requirements.

    Once the risk level is determined, market surveillance authorities take action / measures to remedy any unsafe

    situations within their respective part of the Single Market.

    More information to be found in the following website:

    http://www.prosafe.org/

    In 2016, the Agency continued managing the implementation of surveys on consumer related issues. The purpose is to provide the underlying data and the related analysis to

    feed into the editions of the Consumer Scoreboard. In order to do this, the following is surveyed:

    Consumers’ and retailers’ attitudes towards cross-

    border trade and consumer protection Performance of the most important consumer markets

    from the point of view of consumers.

    Consumer trust in the market is essential for good and sustainable business-to-consumer relations.

    Identify and remove

    non-compliant products

    Evidence base for

    consumer policy

    Specific Objective: Consumer information and education and support

    organisations - to improve consumers' education, information and awareness of their rights, to

    develop the evidence base for consumer policy and to provide support to consumer organisations

    including taking into account the specific needs of vulnerable consumers

    http://www.prosafe.org/

  • CHAFEA_aar_2016__FINAL Page 28 of 134

    In 2016, the Agency contracted a study on legal and commercial guarantees market, which examined to what extent sellers are aware of, and comply with, the requirements

    of relevant EU and national legislation.

    The study showed: (a) consumers' good understanding of the legal guarantee

    coverage; (b) 50% consumers' considering that sellers inform about legal guarantees; (c)

    50% consumers' agreeing that sellers' information on legal guarantees is clear and transparent.

    The key findings of the study have been used to support EU policy in the area of online and other distance sales of goods.5 Furthermore, its key findings are currently supporting

    the REFIT exercise that is being carried out on the legal and commercial guarantees Directive 6.

    Children are exposed to a number of

    problematic marketing practices in on-line games, mobile applications and social media

    sites. To better understand the scope and effects of online marketing on children, the

    Agency, contracted a study on Europe online marketing targeting children. In 2016 the outcomes of the study were delivered.

    By flagging and documenting problematic marketing practices to which children are exposed online, the study provides evidence for:

    revision of the UCPD Guidance

    on-going review of EU consumer and marketing law enforcement activities in the area.

    BEUC (Bureau Européen des Unions de Consommateurs) is an independent non-profit

    consumer organisation. Its mission is promote, defend and represent the interests of EU

    consumers in the EU Institutions. BEUC

    operations are co-funded by the Agency in the form of an operating grant. BEUC's areas of activity cover all topics relevant to consumers, such as energy, telecommunication,

    travelling and transport, digital market and innovative trade patterns, health, environment and food safety, etc.

    In 2016, the European Commission proposed measures to tackle geo-blocking in e-commerce in the digital single market. This proposal take on board BEUC’s key appeal to

    5 Proposal for a Directive of the European Commission and European Council on certain aspects concerning

    contracts for the online and other distance sales of goods:

    http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015PC0635&from=EN 6 Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the

    sale of consumer goods and associated guarantees.

    Study on consumers' of the legal guarantee coverage

    Impact of online marketing on

    children's behaviour. Study of online marketing targeting

    children

    Support to consumer organisations: Removing

    obstacles to digital single market

    http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015PC0635&from=EN

  • CHAFEA_aar_2016__FINAL Page 29 of 134

    0

    20

    40

    60

    80

    100

    2009 2010 2011 2012 2013 2014 2015 2016

    Total

    CPC

    GPSD

    allow consumers enjoy the benefits of the EU digital single market.

    The exchange of officials gives opportunity to share experience and knowledge on the practical

    implementation of the General Product Safety and Consumer Protection Cooperation.

    In 2016, the Agency received the highest number of applications since the special

    indemnities are in place. A total of 92

    applications were processed in 2016, while in 2015 the number of exchanges was 86.

    Evolution of exchange numbers of CPC & GPSD officials since 2009

    Support enforcement of

    consumer rights by strengthening cooperation

    between national enforcement bodies and supporting consumers

    with advice

    Specific Objective: Enforcement - to support enforcement of

    consumer rights by strengthening cooperation

    between national enforcement bodies and supporting consumers with advice

  • CHAFEA_aar_2016__FINAL Page 30 of 134

    1.4 BETTER TRAINING FOR SAFER FOOD

    BTSF is a training initiative aimed at protecting human, animal and plant health. It covers food and feed

    law, animal health and welfare, and plant health rules, and is designed for public officials. Their task is to ensure

    food safety for EU citizens, uniform application of EU legislation. BTSF also encourages countries outside EU to share the EU standards.

    Most BTSF programs take place for control staff from EU

    Member-States, candidate and potential candidate countries,

    European Free Trade Association and European Neighbourhood Policy countries. Training programs in non-EU countries cover

    any sanitary and/or phytosanitary subject anywhere in the world. To maximize the program’s impact, participants must be in a position to

    subsequently train colleagues in their own administrations.

    80% Member States Candidate countries

    EFTA/EEA

    0.5% Candidate countries

    9.5% EFTA

    2% ENP (European Neighbourhood

    Policy)

    8% Other non-EU countries

    As regards initiatives supporting monitoring and enforcement activities, the Agency

    funded the exchanges of enforcement officials. The exchanges give the opportunity to participants to share experience and knowledge on the practical implementation of

    Directive 2001/95 EC (General Product Safety) and Regulation 2006/2004 (Consumer

    Protection Cooperation).

    The Agency managed 45 different trainings subjects related to the different types of the

    food production and controls of the food production or its transport, offering 180 training events, where each lasts on average 4 days to almost 7500 EU Member-State

    participants in the 2016 and covering with this most of the aspects in food production.

    Training as a key

    Coverage: EU’s overall

    target

  • CHAFEA_aar_2016__FINAL Page 31 of 134

    Conceived as a Commission initiative aimed at organising a Community (EU) training strategy in the areas of food law, feed law, animal health and animal welfare rules, as

    well as plant health rules 7 the Better Training for Safer Food in implemented through

    annual decisions taken by the Commission on financing of a number of topics that fall into the scope of the general Commission priority:

    BTSF programme has a leading role in spreading awareness of EU legislation

    and
in ensuring harmonized controls

    BTSF TRAININGS

    In 2016, the Agency organized trainings for prudent use of

    of antimicrobials in veterinary medicine. BTSF is an excellent tool for assisting Member States in the battle

    against Antimicrobial resistance. It provides training on how to implement and monitor all aspects of the

    problem. The BTSF program ensures flexibility, rapid responses to training needs.

    In addition to the standard training, offered throughout the year, the Agency organized in 2016 specialized trainings on emerging diseases like African swine fever and Lumpy

    skin disease, Avian influenza. Knowledge was transposed to all Eastern bordering EU countries allowing them to get

    latest scientific data and up-to-date information on the spreading of a disease, with domestic animals and wildlife.

    Veterinary specialists from EU and neighboring countries meet regularly to share modern

    diagnostics and new legislation, take part in simulation exercises on emergencies. BTSF offers multiple opportunities to secure these.

    In 2016, the Agency organized special trainings for EU Member state officials, with emphasizes on how to perform audit in different areas of plant health and plant

    production, to ensure that Member States are aware and prepared to take action. The training tackles pest risk

    assessment, and surveillance and outbreak management

    for agricultural and forest pests. A recent workshop about new and emerging risks to plant health, and surveillance,

    brought together representatives from Member States, the European Food Safety Authority and the European and Mediterranean Plant Protection Organization to discuss

    7 Article 51 of Regulation (EC) No 882/2004 Regulation (EC) No 882/2004

    ANTIMICROBIAL

    RESISTANCE

    EMERGING DISEASES

    SPECIAL TRAININGS

    Promoting awareness, Job Creation and Growth

    http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0882-20130701&qid=1397561052810&from=EN

  • CHAFEA_aar_2016__FINAL Page 32 of 134

    the outcomes of fact finding missions, preventive measures based on the best available science and information on surveillance, control and eradication techniques.

    E –LEARNING

    The development of e-learning modules and the completion of the e-learning pilot project progressed further during the year, with the launch of three new English-language e-

    learning modules: HACCP (Hazard Analysis and Critical Control Point); the EU plant quarantine regime for imports; and food hygiene and controls on fishery products and

    LBMs (Live bivalve molluscs). French- and German-language modules on animal welfare at slaughter and killing for disease control, food contact materials, RASFF (Rapid Alert

    System for Food and Feed) and HACCP are available. 57 e-learning editions were launched in 2016 with over 6 000 participants. Two e-learning modules were added in

    2016 (Prevention, control and eradication of TSE (Transmissible spongiform

    encephalopathies); and Animal welfare at slaughter and killing for disease control for poultry) with English, French, German, Spanish and Portuguese versions for each of the

    10 developed modules.

  • CHAFEA_aar_2016__FINAL Page 33 of 134

    2. ORGANISATIONAL MANAGEMENT AND INTERNAL CONTROL

    This section answers to the question how the achievements described in the previous

    section were delivered by the Agency. This section is divided in two subsections.

    The first subsection reports the control results and all other relevant information that

    support management's assurance on the achievement of the financial management and internal control objectives. It includes any additional information necessary to establish

    that the available evidence is reliable, complete and comprehensive; appropriately covering all activities, programmes and management modes relevant for the Agency.

    The second subsection deals with the other components of organisational management: human resources, information management and external communication.

    2.1 Financial management and internal control

    Assurance is an objective examination of evidence for the purpose of providing an

    assessment of the effectiveness of risk management, control and governance processes.

    This examination is carried out by management, who monitors the functioning of the

    internal control systems on a continuous basis, and by internal and external auditors. Its results are documented and reported to the Director.

    This section reports the control results and other relevant elements that support management's assurance. It is structured into (1) Control results, (2) Audit observations

    and recommendations, (3) Effectiveness of the internal control system, and resulting in

    (4) Conclusions as regards assurance.

    2.1.1 Control results

    This section reports and assesses the elements identified by management that support

    the assurance on the achievement of the internal control objectives8. The DG's assurance building and materiality criteria are outlined in the AAR Annex 4. Annex 5 outlines the

    main risks together with the control processes aimed to mitigate them and the indicators used to measure the performance of the control systems.

    When managing the delegated activities the Agency applies internal control to ensure

    that the budget is implemented in compliance with effective and efficient internal control and in accordance with the relevant rules. The control process is applicable at all levels

    and designed to provide reasonable assurance of achieving the following objectives: effectiveness, efficiency and economy of operations; reliability of reporting; (c)

    safeguarding of assets and information; (d) prevention, detection, correction and follow‑

    up of fraud and irregularities; (e) adequate management of the risks relating to the

    legality and regularity of the underlying transactions, taking into account the multiannual

    8 Effectiveness, efficiency and economy of operations; reliability of reporting; safeguarding of assets

    and information; prevention, detection, correction and follow-up of fraud and irregularities; and adequate management of the risks relating to the legality and regularity of the underlying transactions, taking into account the multiannual character of programmes as well as the nature of the payments (FR Art 32).

  • CHAFEA_aar_2016__FINAL Page 34 of 134

    character of programmes as well as the nature of the payments concerned.

    The internal control includes: (a) segregation of tasks; (b) risk management and control

    including control at recipient level; (c) avoidance of conflicts of interests; (d) adequate

    audit trails and data integrity in data systems; (e) monitoring of performance and for

    follow‑up of identified internal control weaknesses and exceptions; (f) periodic

    assessment of the internal control system. (ref. FR Art 32).

    Being an executive agency Chafea implements financial appropriations through the direct management mode provided (ref FR Art 58). At the same time, while implementing the

    Promotion of agricultural products policy, Chafea is responsible for the preparatory stage (call initiation and publication, evaluation of proposals, grant preparation and award) of

    grant management in shared mode.

    Budget coverage

    Under 2016 annual work programmes Chafea managed the following budget appropriations:

    OPERATIONAL BUDGET

    Programme Commitments Payments

    Credits

    (million EUR)

    Implemented

    (million EUR)

    Credits

    (million EUR)

    Implemented

    (million EUR)

    HEALTH (PHP) 50,00 49,71 42,40 42,40

    CONSUMERS

    (CP)

    16,25 16,12 18,63 18,61

    BTSF 15,37 15,37 17,04 17,04

    AGRI 18,48 18,48 2,71 2,67

    TOTAL 100,10 99,68 80,79 80,72

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    OPERATING (ADMINISTRATIVE) BUDGET

    Credits (million EUR) Implemented (million EUR)

    8,79 8,67

    TOTAL CHAFEA BUDGET

    Commitments Payments

    Credits (million

    EUR)

    Implemented

    (million EUR)

    Credits (million

    EUR)

    Implemented

    (million EUR)

    108,89 108,35 80,79 80,72

    8,789,446.00, 99%

    119,446.00, 1%

    Administrative Budget Consumption

    Commitments credits Commitments consumed

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    As an autonomous EU body, the Agency has its own operating (=administrative) budget

    in a form of an annual subsidy from the EU. In 2016, it amounted to EUR 8,8 million. The

    budget covers the running costs of the Agency including staff expenditure, office related costs, IT services, as well as a number of programme support activities such as

    payments to external experts assisting the evaluation of the proposals and of certain deliverables under Health programme, and organisation of communication and

    dissemination activities. The Director of the Agency is the Authorising Officer with regards to the implementation of the Agency's operating budget.

    In 2016, the Agency prepared, launched and managed calls for proposals aimed at implementation of Health, Consumer and Agricultural product promotion Programs: 6 (2

    AGRI + 3 PHP + 1 CP) open calls for grant proposals were launched, 4 (2 CP + 2 PHP invited calls for submission of proposals targeted at beneficiaries who were parties to

    Framework partnership agreements. 7 PHP invitations to conclude Grant Agreement were

    launched, respectively with competent authorities of Member States (Joint Actions) or with International Organisations, 1 invitation to submit applications for special

    indemnities (exchange of officials).

    During the same time, the Agency conducted 24 (9 BTSF, 24 PHP, 9 CP) public

    procurement procedures for the provision of intellectual services to Health, Consumers, BTSF programmes. Procured were mainly studies related to the policy making of the

    Agency's parent DG and the provision of training courses on audits for the employees of

    national authorities of the EU Member States dealing with food controls9.

    The Agency’s control strategy ensures that all commitments and payment authorisations

    are ex-ante verified in regard to both their procedural, legal and financial aspects. 100% of the Agency’s transactions are ex-ante verified before the signature of a related

    commitment or the authorisation of a payment towards a beneficiary or service provider.

    The Agency performs ex-post controls for a limited amount covering its payment transactions that are, in principle, performed after the implementation of actions co-

    financed under grant agreements.

    9 For more detailed information regarding the scope of those procurement procedures please refer to Part

    I of the present document

    0,0

    20,0

    40,0

    60,0

    80,0

    100,0

    120,0

    Commitments99,51 %

    Payments99,93 %

    Mill

    ion

    s €

    Chafea Commitment & Payments

    Consumption

    Credits

    Consumed

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    Coverage of the Internal Control Objectives and their related main indicators

    Control effectiveness as regards legality and regularity

    Chafea has set up internal control processes aimed to ensure the adequate management

    of the risks relating to the legality and regularity of the underlying transactions, taking into account the multiannual character of programmes as well as the nature of the

    payments concerned.

    As set with the materiality criteria referred to in Annex 4 of this report the control

    objective is considered to be achieved if (a) the residual error rate does not exceed 2% of the annual payment authorisations per ABB (Activity Based Budging) activity; (b) no

    significant internal control weaknesses were reported/detected; (c) no significant and/or repetitive errors occurred; (d) no critical issues pertaining to the Agency’s control

    systems audited were reported by the Internal Audit Service, the Court of Auditors or

    OLAF (provided that the audit coverage of the year was satisfactory); and that (e) no other event that resulted in a reputational detriment occurred.

    The implementation of the objective " Effective and reliable internal control system giving the necessary guarantees concerning the legality and the regularity of the underlying

    transactions" is measured by the following indicators:

    - Estimated residual error rate, measured on yearly basis and ant the end of the

    programing period (2020) versus the baseline of 2014 while the target value does (not) exceed 2%, both annual and cumulative by the end of the programme implementation.

    - Estimated overall amount at risk for the year for the entire budget under the DGs

    responsibility

    - Estimated future corrections.

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    Objective 1 (mandatory): Effective and reliable internal control system giving the necessary guarantees concerning the legality and the regularity of the underlying

    transactions

    Indicator 1 (mandatory): Estimated residual error rate10 Source of data: Chafea calculation of residual error rate per programme managed- ex post control strategy

    Baseline (2014 AAR) Target Below the materiality criteria (2%)

    Health Programme: 1.94%

    Consumer Programme: 1.18% Better Training for Safer Food (BTSF): 0% (estimation)

    Agricultural Promotion Programme: start of programme implementation - no data available

    Health Programme: 1.39%;

    Consumers programme: 0,48 %; AGRI: N/A BTSF: N/A

    Indicator 2 (mandatory): Estimated overall amount at risk at closure for the year for the

    entire budget under the Agency's responsibility Source of data: Annual Activity Report/per ABB

    Baseline (2014) Target Below the materiality criteria (< 2% of payments)

    Health Programme: EUR 574.200 Consumer Programme: EUR 100.596

    BTSF: N/A

    Health Programme: ~ EUR 310.000 Consumer Programme: ~ EUR 50.000

    BTSF: N/A AGRI: N/A

    Indicator 3 (mandatory): Estimated future corrections

    Source of data: aggregated data on corrective capacity since 2010, provided by DG BUDG annually, in aggregated report

    Baseline (2014 AAR) Target (none)

    EUR 1.574.867 (2,3% over payments of the period)

    EUR 2.880.634 (3,6% over payments of the period 2010-2016)

    The Agency has carried out the activities underpinning the fulfilment of the objective:

    - Assessment of the effectiveness of its internal control and risk management system

    aimed at eliminating the weaknesses and risks in order to increase the efficiency and

    effectiveness of the Agency's performance;

    - The Agency follows the evolution of Commission’s guidance on application of internal

    control standards adapting its underlying procedures accordingly;

    - The Agency implements the action plan agreed with IAS following the latter’s audit

    on grant management in Chafea.

    The Agency continued integrating with corporate tools (e.g. e-grant management

    implemented by the new Promotion of Agricultural Products Unit (AGRI), e-procurement management); and migration to paperless workflows.

    Grant management under direct management mode (art. 58 of the Financial Regulation)

    10 For the definition, see the first annex to the AAR instructions 2016 "Key definitions for determining amounts

    at risk" at https://myintracomm.ec.testa.eu/budgweb/EN/rep/aar/Pages/guidance.aspx.

    https://myintracomm.ec.testa.eu/budgweb/EN/rep/aar/Pages/guidance.aspx

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    Overall, the actions receiving co-financing under the programmes and policy under implementation have a duration between one and three years. The actions are

    implemented by public and academic organisations, NGO's, networks, private entities.

    The beneficiaries are located in different countries participating to the programmes (EU, EEA, EFTA, accession countries …). Applications are evaluated on the basis of pre-

    announced selection and award criteria that are specified in the annual Commission implementing decision serving as a legal basis for the ensuing budgetary commitment

    and authorisations. Based on applicable regulatory provisions and internal control standards, the Agency has developed and established a system of procedures to ensure

    that the best proposals are chosen in a competent, objective, impartial and transparent manner. The Agency’s operates in close collaboration with parent DG (DG SANTE, JUST,

    AGRI and GROW).

    The grants awarded under the Third Health Programme, the Second Consumer

    Programme and within the Promotion of Agricultural products, take the form of

    reimbursement of a specified proportion of eligible costs that were actually incurred by the beneficiary; the cost reimbursement is subject to a preliminary budget estimate that

    is submitted with the proposal and annexed to the grant agreement after budgetary adjustments that are likely to incurred following the proposals’ evaluation. The

    calculation and verification of eligible costs bears a relatively high risk of errors minding that beneficiaries differ in their legal status, are located in a wide range of States where

    different legal orders apply and operate on the basis of their own internal control system (e.g. with regards to accounting practices, documentation of working inputs/outputs etc).

    Indicators measuring effectiveness as regards legality and regularity of grant

    management:

    The key control indicators give the picture of the effective management of procedures

    relating to the award of grants11 as well as the estimate of possible future risk related to the payment management based on the results of the ex-post controls over earlier

    transactions by respective programme:

    Stages of Internal Control Procedure 2014 2015 2016

    A. Programming and planning

    % of calls successfully concluded (to the number of calls foreseen in the

    annual work programme)

    PHP:

    100%

    PHP: 100%

    PHP: 100%

    CP:

    100%

    CP: 75%

    CP: 100%

    AGRI: 100%

    Number of proposals received PHP: 130 PHP: 91 PHP: 90

    CP: 63 CP: 35 CP: 32

    AGRI: 226

    11 PHP stands for Public Health Programme, CP stands for Consumer Programme; no grants are awarded under

    the BTSF Initiative

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    % of Budget