mb 14 03 13 item 5 doc 4 Draft Multiannual Plan 2014-2016 ... · mb 14 03 13 item 5 doc 4 – Draft Multiannual Plan 2014-2016 EXECUTIVE OFFICE Management Board ... EFSA over-arching

mb 14 03 13 item 5 doc 4 – Draft Multiannual Plan 2014-2016

EXECUTIVE OFFICE

Management Board 14 March 2013

Parma

Meeting : Management Board, Public Session

Subject : Draft Multiannual Plan 2014-2016

Document number: mb 14 03 13 item 5 doc 4

Document for : Information

X Discussion

X Possible adoption


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COVER NOTE

Since its establishment the European Food Safety Authority (EFSA) has developed a range of strategic and policy documents with the objective of providing a transparent agreed basis and framework for the prioritisation of activities, setting goals, and direction. EFSA over-arching Strategic Plan 2009 – 2013 currently provides the overall strategic framework for EFSA‟s activities. Two other documents serve to roll out the strategic objectives identified in the Strategic Plan for EFSA‟s core activities: the Communications Strategy and the Science Strategy describing how EFSA will deliver the main outputs of its mandate.

The Management Board has recently set out strategic directions for the organisation, following an external evaluation on EFSA‟s activities carried out in 2011-2012. The Board has issues a series of recommendations to direct the development of EFSA in the coming years towards becoming a more sustainable, efficient and trusted organisation.

To date, EFSA has translated the strategic input into operational work programmes on a yearly basis with the production of Annual Management Plans, budgets and establishment plans, as required by EU financial rules.

In order to enhance the planning process, it is necessary to develop a multiannual planning exercise that facilitates a more informed process of defining priorities and of allocating resources effectively and efficiently to meet the long term objectives. Multiannual planning also enables enhanced coordination of activities with national authorities, the European Commission and other EU Agencies.

By establishing a multiannual plan of its activities, EFSA formally aligns its planning procedures with Article 25(8) of the Founding Regulation which provides for the Management Board to adopt “a revisable multiannual programme” as well as the annual work programme.

The EFSA Multiannual Plan (MAP), herewith established, covers years 2014-2016 and has a revisable 3-year rolling format. The MAP provides a consolidated overview of expected workload, key initiatives and resource allocation. It illustrates in concrete terms how the various key objectives from the strategic framework documents are being rolled out, giving an overview of trends in workload, budget and human resources applied to the key activity areas over the 3-year period.

The MAP is based on a general assumption of budget austerity. A moderate increase in budget and staff is anticipated in the plan to face new tasks that EFSA predicts to have to carry out as a consequence of new EU legislation (namely in the area of novel foods) and in view of the provision of further support to Panels in the risk assessment process. However, since the political discussion on the EU Multiannual Financial Framework 2014-2020 is not yet concluded, these assumptions may need to be updated at a later stage.

The MAP is the result of an extensive preparatory work involving discussions within EFSA and also with the Advisory Forum, Scientific Committee and Stakeholder Platform. Further consultations will be undertaken in 2013 with a view to preparing next year‟s release. Planning capacities within EFSA are being enhanced trough several initiatives aiming at improving data, tools and methods. This will enable the further refinement of the MAP in the coming years to improve quality and accuracy of assumptions and data and also to better integrate the strategic, multiannual and annual planning dimensions

In particular, EFSA will, as of next year, prepare the revised MAP in parallel with the annual planning and budgetary cycle. Furthermore, the next version of the MAP will take into account the outcomes of the revision of EFSA‟s Strategic Plan that will be conducted in 2013.

The Management Board is kindly asked to consider and possibly adopt the attached Multiannual Plan 2014-2016.


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EFSA DRAFT MULTIANNUAL PLAN 2014-2016

TABLE OF CONTENTS

Executive summary 3

1. THE CONTEXT 5

1.1 Strategic Framework 5

1.2 Operating environment 7

1.2.1 Workload 7

1.2.2 Resources 8

2.THE WORK PLAN 2014-2016 9

2.1 Priorities 9

2.2 Key corporate initiatives 9

2.3 Operational Activities 13

2.3.1. Provision of scientific opinions and advice and risk assessment approaches 13

2.3.2 Evaluation of products, substances and claims subject to authorisation 14

2.3.3 Data collection, scientific cooperation and networking 16

2.3.4 Communications 18 3. OVERVIEW OF THE ALLOCATION OF RESOURCES 19 4. MEASURING SUCCESS: KPI FOR 2014-2016 21

Annex 1 Predicted Outputs by scientific areas Annex 2 Overview of EFSA actions to address the Management Board recommendations adopted in December 2012 Annex 3: Draft Multi Annual programme for Grants and procurement (2014-2016)

Glossary


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Draft Multiannual Plan 2014 -2016

of the European Food Safety Authority

Executive Summary

The EFSA Multiannual Plan (MAP) outlines EFSA‟s work programme over the coming three years by providing a consolidated overview of EFSA‟s main activities in accordance with the objectives, priorities and actions identified within the overall Strategic Framework. The work plan has been prepared by EFSA with input from the Commission, Member States and other key stakeholders and is a revisable document in the form of a rolling 3-year plan, which will be renewed annually in parallel with EFSA‟s annual management planning and budgetary cycle.

The MAP 2014-2016 reflects the main priorities and initiatives that EFSA intends to implement to address the recommendations adopted by the Management Board in December 2012 and the roll-out of the directions provided by EFSA‟s main strategic documents, in particular the Science Strategy 2012-2016 and Communications Strategy 2010-2013 as well as the overarching Strategic Plan 2009-2013, with the latter two up for review before the end of the year.

The working environment in which the Authority predicts it will operate in the years ahead will see incoming work remaining high, with on average 600 outputs per year, increasing complexity and continuing pressure towards more openness and transparency as well as timeliness, quality and a high level of service rendered.

Overall, during this period there will be a growing demand for risk assessments and scientific advice in such areas as animal health and welfare, pesticides, GMO, novel foods and enzymes, while outputs could diminish in other areas such as health claims (not counting the evaluation of botanicals, which is currently on hold). However, the growing demand for EFSA‟s scientific evaluations to cover such matters as environmental risk assessment, post-market monitoring, risk benefit and efficacy - coupled with the trend towards new scientific areas linked to progress in technologies, scientific understanding and risk assessment methods - will continue to put EFSA‟s resources under significant pressure. Moreover, in light of the challenges posed by the growing international trade in foodstuffs and ingredients and other global challenges to food safety, EFSA must remain positioned to respond rapidly to urgent food safety-related crises, the majority of which are likely to be trans-national in nature.

Against this context, the Management Board has recommended EFSA to take action with a view to: ensuring the long term sustainability of the organisation, increasing the trust of stakeholders and citizens, further enhancing EU risk assessment capacity, and strengthening the clarity and accessibility of EFSA‟s communication.

On this basis, EFSA has identified three key priorities for the period 2014-2016, and is planning a series of initiatives.

i) Utility and fitness for purpose. EFSA will strive to enhance the quality of its outputs and to meet customer needs. It will develop a mechanism for the systematic collection of feedback from customers (European Commission, Member States and European Parliament) and stakeholders. Furthermore, in line with the EU 2020 strategy, EFSA will continue its effort to provide food and feed operators who submit applications in regulated areas with a predictable regulatory environment, a higher level of service and enhanced interaction. In line with the Science Strategy, EFSA will also further intensify its cooperation and networking activity with national food safety authorities, international organisations, and other stakeholders with the objective of building stronger, richer data sources for risk assessment activities and promoting further harmonisation of risk assessment methods.


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ii) Optimise the use of resources. In the area of Regulated Products, EFSA – in line with its Science Strategy - plans to implement a programme to redistribute the work between experts and internal staff as of beginning 2014 by providing further support to Panels in relation to some of the routine preparatory work that is currently undertaken by Panel Working Groups. The planned re-allocation of tasks between internal and external scientific staff will call for additional resources in terms of staffing for the period ahead but is expected to bring clear benefits in terms of alleviating the overload of experts, generating efficiencies in the scientific process with knock-on benefits for commercial operators; and mitigating the perception of risk of potential conflicts of interest. EFSA is also engaging in an exercise to continuously improve its working processes. In particular, EFSA will work on increasing its efficiency in handling applications (e.g. by streamlining the “stop the clock” mechanism) and will further streamline its administrative processes. Further developing its Human Capital will remain on top of EFSA‟s priorities and important initiatives are therefore envisaged over the next years, notably on knowledge management and development, career development of staff, mapping and management of roles and competences.

iii) Build more transparency and trust. EFSA will pursue its efforts within a new Transparency initiative – a two-pronged project (transparency on data and transparency on processes) – developed in cooperation with EFSA‟s institutional partners and stakeholders. EFSA will review its Communication Strategy in 2013 with the anticipated focus on: simplicity and transparency; increasing relevance and understanding of EFSA communications; and co-operation with Member States, the international risk assessment community and liaison with its stakeholders. EFSA will also focus on proactively communicating on the role of EFSA and the independence of its risk assessment work.

EFSA will deploy the available resources in view of ensuring the implementation of these initiatives and the delivery of scientific and communication work according to the work programme. The overall level of available resources has been predicted taking into account the overall context of challenging economic perspective and tight expenditure ceilings. At the time of drafting of this document, negotiations on the EU Multiannual Financial Framework 2014-2020 are not yet concluded. Therefore, EFSA assumptions on resources for 2014-2016 might need to be adapted depending on the final decision by EU budgetary authorities.

Concerning financial resources, EFSA acknowledges a scenario in line with the Commission‟s indications (nominal budget increase of 1% per year) with additional resources planned in 2015 and 2016 to finance the execution of new tasks to be entrusted to the organisation. The latter include new evaluations of novel foods as well as increased support to panels in the area of regulated products. Regarding staff, these new tasks require 50 additional posts to be progressively deployed over the period, on top of the level foreseen in the 2013 establishment plan.

The allocation of these resources to the various activities (risk assessment, evaluation of regulated products, data collection and scientific cooperation, communication and governance and support) reflects the need to provide adequate support for the execution of the work programme in the various areas, by means of staff resources, panels and working group meetings and outsourcing via the scientific cooperation programme established for the period. In this context, the resourcing of governance and support activities will be further reduced thanks to efficiency initiatives.


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Introduction

The Multiannual Plan (MAP) for 2014-2016 outlines EFSA‟s work programme over the coming three years by providing a consolidated overview of EFSA‟s main activities in accordance with the objectives and priorities identified within the overall Strategic Framework, account taken of the operating context. It provides an overview of predicted trends in workload and of resources allocated per activity over the period.

The MAP is intended to be revisable document and takes the form of a rolling 3-year plan which will be renewed annually in parallel with EFSA‟s annual management planning and budgetary cycle.

1. THE CONTEXT

1.1 STRATEGIC FRAMEWORK

The MAP 2014-2016 reflects the main priorities and initiatives that EFSA intends to implement to address the recommendations1 adopted by the Management Board in December 2012 and the roll-out of the directions provided by EFSA‟s main strategic documents.

Management Board Recommendations

Following the results of an external evaluation of EFSA carried out by an external consultant2, the Management Board acknowledged the finding of the external evaluation that EFSA is fulfilling its mandate and is operating in an independent, open and transparent manner, providing high quality scientific advice to underpin and add value to the European system of food and feed law.

In making its recommendations in December 2012, the Management Board emphasised the importance of ensuring that EFSA continues to provide risk managers at the European and national level as well as stakeholders with independent, high-quality, timely, fit-for-purpose and clear scientific advice following open and transparent processes while communicating clearly to all interested parties on its findings. The Management Board identified four key areas which it wishes to be further acted on as a matter of priority during the period 2013-2017:

1) To ensure the long-term sustainability of EFSA‟s operations by, for example, optimising the roles of experts, staff and other partners/organisations within the risk assessment process;

2) To increase trust by continuing to ensure independence and enhance transparency and openness in its scientific work;

3) To further enhance EU risk assessment capacity through strengthened cooperation with Member States, the European Commission and other EU agencies in planning EU work;

4) To strengthen the clarity and accessibility of EFSA‟s communication and seek to better understand public perception of the independence of its scientific advice.

EFSA’s Strategic documents

EFSA‟s activities are currently guided by its overarching Strategic Plan 2009-20133 along with two main specific strategies: the Science Strategy 2012-20164 , which lays out the vision of how EFSA will continue to support the European food safety system over the next five years; and the Communications Strategy 2010-20135 , which sets out the long-term communication objectives for the Authority, outlining how these will be achieved and the measures implemented to evaluate success.

The main priorities indicated by the Management Board are also identified in EFSA‟s Strategies. In particular, the need to optimise the use of EU risk assessment capacity and strengthen cooperation is a key objective of EFSA‟s Science Strategy adopted in 2012. Similarly, the need to enhance the clarity and accessibility of EFSA‟s communication and effectively communicate on its independence are reflected in EFSA‟s Communications Strategy.

1 See Recommendations from EFSA Management Board adopted on 13 December 2012, available at: http://www.efsa.europa.eu/en/keydocs/docs/mbrecommendations2012.pdf 2 Report available at http://www.efsa.europa.eu/en/keydocs/docs/efsafinalreport.pdf 3 EFSA‟s Strategic Plan 2009-2013 Adopted by EFSA Management Board on 18.12.2008 4 EFSA‟s Science Strategy 2012 - 2016– Adopted by EFSA Management Board on 15. 12. 2011 5 EFSA Communications Strategy 2010 – 2013. Adopted by EFSA Management Board on 16.12 .2010

http://www.efsa.europa.eu/en/keydocs/docs/mbrecommendations2012.pdf

http://www.efsa.europa.eu/en/keydocs/docs/efsafinalreport.pdf


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The table below provides an overview of the relations between the various goals and objectives of EFSA‟s strategic framework.

EF

SA

’s V

isio

n a

nd

Mis

sio

n

EF

SA

‟s g

oal i

s to

be

glob

ally

rec

ogni

sed

as th

e E

urop

ean

refe

ren

ce b

ody

for

risk

asse

ssm

ent

on f

ood

and

feed

saf

ety,

ani

mal

hea

lth

and

wel

fare

, nu

triti

on,

plan

t pr

otec

tion

and

plan

t he

alth

. Its

ulti

mat

e ob

ject

ive

is t

o pr

otec

t pu

blic

hea

lth a

nd s

tren

gthe

n co

nsum

er

conf

iden

ce i

n th

e E

urop

ean

foo

d su

pply

. It

aim

s to

be

an i

ndep

ende

nt,

resp

onsi

ve a

nd t

rust

ed p

artn

er f

or r

isk

man

ager

s an

d

proa

ctiv

e in

con

trib

utin

g to

the

hig

h le

vel o

f con

sum

er p

rote

ctio

n ch

osen

by

the

Eur

opea

n U

nion

. EFSA’s Strategic Plan

Strategic goals Thematic Strategies

Key Objectives

Focus on providing an integrated approach to delivering scientific advice associated with the food chain from field to plate

EF

SA

’s S

cien

ce S

trat

egy

2012

- 2

016

1. Further develop the excellence of EFSA‟s scientific advice

2. Optimise the use of EU risk assessment capacity

3. Develop and harmonise methods and approaches to assessing risks associated with the food chain

4. Strengthen the scientific evidence base for risk assessment and risk monitoring

Provide timely, high-quality evaluation of products, substances and claims subject to the regulatory authorisation process

Coordinate the collation, dissemination and analysis of data in the fields within EFSA‟s remit

Position EFSA at the forefront of risk assessment methodologies and practices in Europe and internationally

Assure the responsiveness, efficiency and effectiveness of EFSA

EF

SA

’s C

om

mu

nic

atio

ns

Str

ateg

y 20

10 -

2013

1. Simplicity and Transparency: Increase relevance and understanding of EFSA communications for key target audiences and informed lay audiences, in co-operation with Member States 2. Independence: Augment proactive communications on the independence of EFSA‟s risk assessment advice 3. Visibility and outreach: enhance outreach, in the EU and beyond, by increasing awareness and recognition of EFSA and its role and work as risk assessor 4. Coherence: further increase the coherence of risk communications across the EU and beyond 5. Dialogue: enhance dialogue with stakeholders and increase audience interactivity 6. Capacity building: strengthen EFSA‟s capacity to develop, disseminate and oversee effective risk communications 7. Internal communications

Reinforce confidence and trust in EFSA and the EU food safety system through effective risk communication and dialogue with partners and stakeholders

EFSA’s Core Values: Openness and transparency, Excellence in science, Independence, Responsiveness.


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1.2 OPERATING ENVIRONMENT

The environment in which the Authority predicts it will operate in the years ahead sees incoming work remaining high, with increasing complexity and continuing pressure towards more openness and transparency as well as timeliness, quality and a high level of service rendered.

The following assumptions have been made in relation to how workload and resources will evolve over the next three years.

1.2.1 Workload

The MAP workload forecast relies on the extensive planning jointly undertaken by EFSA and the European Commission to predict incoming work, supplemented by estimates of additional scientific activities, including self-tasking and other requests coming form Member States and the European Parliament.6

Although it is predicted that the number of scientific outputs EFSA produces will remain largely stable during the period 2014-2016 – on average around 600 outputs per year – the actual scientific workload is expected to rise due to the increased complexity and nature of the questions that have to be addressed to meet the demands and the requirements under which EFSA‟s assessments are carried out. The figures below provide an overview of the Scientific Work Programme 2014 – 2016. The detailed predicted outputs per scientific areas are provided in Annex 1.

Figure 1: Total predicted scientific outputs 2013-2016 by ABB Activity (excluding internal reports)

Figure 2: Predicted scientific workload by areas

6 The so called “Medium-term planning” exercise conducted by EFSA and the DG SANCO twice a year.

0

100

200

300

400

500

600

700

2013 2014 2015 2016

Activity 3

Activity 2

Activity 1

0

50

100

150

200

250

300

FIP FEED GMO NUTRI PRAS AHAW BIOHAZ BIOMO CONTAM DCM PLH SAS AFSCO EMRISK SCOM

2013

2014

2015

2016


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Overall during this period there will be a growing demand for risk assessments and scientific advice (number of outputs) in such areas as GMO, novel foods, enzymes and pesticides, while outputs could diminish in other areas such as health claims, unless the European Commission asks EFSA to carry out the evaluation of botanicals7.

However, the growing demands for EFSA‟s scientific evaluations to cover such matters as environmental risk assessment, post-market monitoring, risk benefit and efficacy – coupled with the trend towards new scientific areas linked to progress in technologies, scientific understanding and risk assessment methods – will continue to put EFSA‟s resources under significant pressure.

Current estimates suggest that the evaluation of regulated products will represent a growing share of EFSA‟s outputs during 2014-2016. This is borne out by the European Commission‟s work programme with the coming into force of recently launched regulatory initiatives (e.g. enzymes) and of some others that are still in their drafting stage (e.g. pesticides, novel foods).

In line with the Management Board recommendations, EFSA will endeavour to maintain the balance between the evolving demand for support in the evaluation of regulated substances and the need to continue to address generic questions in a proactive way, remain vigilant to emerging risks and ready to address urgent requests for advice in times of crisis.

In particular, in light of the challenges posed by the growing international trade in foodstuffs and ingredients and other global challenges to food safety, EFSA must remain positioned to respond rapidly to urgent food safety-related crises, the majority of which are likely to be trans-national in nature, as experience has taught us.

1.2.2 Resources

The financial programming for 2014-2016 is drawn in a context of challenging economic perspective and tight expenditure ceilings.

The overall level of available resources has been predicted taking into account the overall context of challenging economic perspective and tight expenditure ceilings. At the time of drafting of this document, negotiations on the EU Multiannual Financial Framework 2014-2020 are not yet concluded. Therefore, EFSA assumptions on resources for 2014-2016 might need to be adapted depending on the final decision by EU budgetary authorities.

Concerning financial resources, EFSA acknowledges a scenario in line with the Commission‟s indications (nominal budget increase of 1% per year) with additional resources needed in 2015 and 2016 to finance the execution of new tasks over the period. The latter include new evaluations of novel food as well as an increased support to panels in the area of regulated products.

Regarding staff, these new tasks require 50 additional posts to be progressively deployed over the period, on top of the level specified in the 2013 establishment plan. Figure 3 below provides an overview of the expected evolution in terms of Budget and Staff.

Figure 3: Overview of anticipated EFSA resources 2014-2016

7 The are currently more than 1500 outstanding questions related to the evaluation of health claims for botanicals.

481

506

531 531

78 79

84 84

40

45

50

55

60

65

70

75

80

85

90

300

350

400

450

500

550

600

650

Budget 2013 Preliminary budget 2014

Forecast 2015 Forecast 2016

Budg

et (M

. €)

Tota

l EFS

A St

aff

Budget

Staff


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2. THE WORK PLAN 2014-2016

2.1 PRIORITIES

Based on the recommendations of the Management Board and taking into account the operating environment, EFSA has identified three key priorities (“must wins”) for the period 2014-2016:

1. To strengthen utility and fitness for purpose of its work

2. To optimise the use of its resources

3. To build more transparency and trust in its work

EFSA aims to achieve these goals over the period via a number of key corporate initiatives (“must dos”) to be implemented in parallel to the delivery of its core operational work, i.e. scientific and communication outputs. The key corporate initiatives and EFSA‟s operational work for the period 2014-2016 are presented in the following two sections.

2.2 KEY CORPORATE INITIATIVES

EFSA‟s key corporate initiatives for 2014-2016 are presented in this section, grouped according to the three key priorities as identified above. A table summarizing the corporate initiatives, their link wit the Management Board recommendations and key priorities, as well as information on timelines, milestones and deliverables is provided in Annex 2.

Strengthen utility and fitness for purpose

In order to increase the utility of EFSA‟s work by providing fit-for-purpose scientific advice and communication, EFSA envisages the following corporate initiatives:

Focus on Quality and customer needs

Quality is at the core of EFSA‟s activities: building on the existing quality management systems during the years ahead, EFSA will focus in particular on developing the continuous improvement cycle by elaborating a mechanism for the systematic collection of customer/stakeholder feedback.

EFSA will work together with customers (European Commission, Member States and the European Parliament) and stakeholders to: agree on a clear definition of EFSA‟s “products”; identify customer and stakeholder requirements; refine the quality criteria against which the feedback should be asked; and set up a new feed-back mechanism at various stages of the assessment process that can trigger improvements in the way EFSA operates.

One important benefit of this initiative is that it will allow better framing of questions with both risk managers and stakeholders, which in turn will allow better planning of EFSA‟s activities, with due consideration of political priorities and societal drivers.

In relation to Quality Management, EFSA aims to ensure a high quality of its scientific outputs which is essential for building trust in the European food safety system. By the end of 2013, EFSA shall have completed the first main module of the Quality Management System covering scientific activities before moving to other parts of EFSA‟s operations in 2014 to 2016. The system will be based on and be compatible with ISO 9001:2008 and is scheduled to cover all of EFSA‟s activities by the end of 2016.

Enhance services to applicants

In line with the EU 2020 strategy, EFSA will continue its effort to provide food and feed operators who submit applications in regulated areas with a predictable regulatory environment and a higher level of service. EFSA therefore intends to enhance its services to applicants and increase the interaction, in line with the Management Board recommendation.

In particular, EFSA will work on a system for the electronic submission of dossiers, first by conducting a feasibility study drawing from inter alia experience in similar initiatives by other EU agencies (e.g. ECHA) and, subsequently by progressively implementing the system in the area of regulated products. EFSA will also enhance its pre-submission support and meeting with applicants, with a particular focus on SMEs.

EFSA will also examine the opportunity of introducing a broader range of services to applicants covering the whole lifespan of a product from the very early phase of product development to the commercial phase during which the impacts of products are assessed (pre-market assessment) and then monitored through vigilance activities. This broad set of services, however, would only – possibly – be implemented after 2016, and require extra resources. Adequate


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consideration would need to be given in this context to the possibility that applicant industries are charged for having access to those services.8

Promote further harmonization of methods and data

In line with the Science Strategy, EFSA will intensify its cooperation and networking activity with national food safety authorities, international organisations, and other stakeholders with the objective of building stronger, richer data sources for risk assessment activities and promoting further harmonisation of risk assessment methods.

Through the so called “Data Warehouse” initiative, EFSA will promote data harmonization, data accessibility and develop an appropriate IT structure that enables the effective collection and analysis of data. The main focus will be on data relating to food consumption, chemical compounds and biological agents, antimicrobial resistance and foodborne outbreaks, and post-market and environmental monitoring. A pilot phase will be carried out in 2013, followed by phased implementation in 2014 and 2015.

EFSA will also work on the harmonization of risk assessment procedures. In particular EFSA will work internally, with Member States, across EU Agencies and with International Bodies on a review of existing EFSA guidance and develop further guidance where needed, with particular focus on areas where several panels may be active, to ensure adherence and coherence.

Work will continue working on the “Virtual Library” initiative to develop an integrated approach for scientific literature access and review. A feed and food literature repository will be available to external parties by 2014.

Furthermore EFSA will intensify its involvement in the EU Research Agenda within the framework of the EU 2020 Agenda9 and the context of Horizon 2020. In particular, EFSA will work closely with the European Commission and other EU Institutions to ensure that risk assessment needs are addressed in the definition and implementation of the research agenda.

In relation to scientific cooperation, EFSA will continue its efforts to engage in longer-tem planning of workload with the Member States through the sharing of multiannual work plan and making more use of on multi-annual/framework contracts. EFSA has developed a multiannual work programme for Grants and Procurement (see Annex 3). In particular, EFSA plans to concentrate its cooperation activities on more focussed projects, particularly towards supporting Member State organisations in their collection and transmission of occurrence data and the harmonised collection of food consumption data in the EU under the EU Menu project. In addition, EFSA will allocate increasing resources to the area of preparatory work for regulated products and post-market monitoring of approved chemical substances used in food production in relation to food safety and environmental aspects, as well as on the monitoring of contaminants. To facilitate the involvement of national food safety organisations in EFSA‟s grants and procurement programme, EFSA will provide additional guidance and training.

With regard to international cooperation, as outlined in its Science Strategy, EFSA plans to encourage a constructive and integrated sharing of data with key international organisations and will further strengthen its partnership with international organisations.

Optimise the use of resources

In a context of limited resources, efficiency and effectiveness in the use of resources will continue to be fundamental drivers of EFSA‟s operations. In order to optimise the use of resources, the following initiatives are envisaged:

Better use of scientific expertise

One of the main organisational risks EFSA faces in the coming years is the sustainability of its current operating model with its reliance on external expertise, in particular in the area of regulated products. To address the risk, EFSA plans to implement a programme to redistribute the work between experts and internal staff as of the beginning of 2014, in the areas of GMO, Food ingredients and packaging, feed additives and health claims. This will provide further support to Panels in relation to some of the routine preparatory work that is currently undertaken by Panel Working Groups for application dossiers.

8 Article 43 of the Founding Regulation foresees that EFSA may obtain part of its budget from “charges for publications, conferences, training

activities and any other similar activities provided by the Authority”. 9 Communication from the Commission. Europe 2020 A strategy for smart, sustainable and inclusive growth. COM(2010) final 3.3.2010


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Part of the tasks currently carried out by the Working Groups will be transferred to internal scientific staff: while EFSA staff will take responsibility for the bulk of the preparatory work, legal responsibility for scientific opinions will remain firmly with the Scientific Panels in line with the Founding Regulation.

The planned re-allocation of tasks between internal and external scientific experts will bring clear benefits. It will alleviate the overload of external experts with routine work and allow them to focus on the more value-added scientific work; it will reduce the burden on national scientific organizations who currently employ the external experts (e.g. circa 100 Panel experts and 400 external experts called upon in standing and ad hoc Working Groups currently contribute to the work on evaluation of regulated products); it will generate efficiencies in the scientific process with knock-on benefits for commercial operators; and it will also mitigate the perception of risk of potential conflicts of interest that is inherent with external experts who are likely to have worked with industry at some point in their careers.

This project will call for additional resources in terms of staffing for the period ahead. EFSA plans to recruit 25 new senior scientists in 2014 and 20 more in 2015 and 2016. Additional costs in 2014 will be covered via internal efficiency gains, while from 2015 onwards an additional €4.8 M will be required on an annual basis.

Increase efficiency in handling applications

With a view to coping with workload in a more efficient and effective way, EFSA is implementing a plan to address the issue of accumulated workload (particularly in the area of Pesticides, Feed and GMO) and gain flexibility in dealing with future applications. Accumulated and future workload peaks will be tackled with specific action plan involving the mapping of workload areas, the identification of competence gaps and of ways to fill then through training, outsourcing, staff deployment etc.

EFSA will also concentrate its efforts on streamlining the current workflows with particular reference to improving the stop-the-clock procedures i.e. reducing the time in which evaluation procedures remain dormant. EFSA will produce, discuss with all parties concerned and eventually implement a streamlined approach in this area, based on common guidelines in the various regulatory areas and on a harmonized use of the request for additional information to the applicants.

This initiative, together with the work on electronic submission and the joint efforts with the European Commission and the European legislators towards the harmonisation of the regulatory flows are expected to bring about greater efficiency gains during the coming years while providing a better service to both applicants and risk managers.

Continuously improve working processes

To complement ongoing work on quality management, the following important initiatives aiming at improving EFSA‟s working processes will be implemented:

The Lean Process initiative, started in 2013, will continue to drive a systematic application of a methodology to re-design working processes to better support the organization‟s mission and reduce costs to allow re-deployment of resources on core scientific tasks. This review of EFSA‟s delivery model to optimize the services and deliverables will rationalise, simplify and automate the way the organisation works to optimise the consumption of resources (time, staff and budget). This approach will integrate a risk-based evaluation that is in compliance with the legal framework of the European Institutions.

The Project and Resource Management initiative was set up in 2012 and will be implemented in a phased approach from 2013 until 2015. The initiative looks at fully integrating across the organisation a project management approach with a view to enhancing transparency and flexibility in resource allocation and prioritization of work as well as to better support strategic decision making and finally increase efficiency. Implementation will involve setting up a new governance structure and delegation mechanism in alignment with the strategic planning and programming cycle. A detailed IT implementation will be kicked off by mid 2013 and run until 2014. The training and coaching programme will start in 2013 and be completed by mid-2014.

EFSA is also developing an enhanced and harmonised Document Management System (DMS) to be applied to all documents received or created in the context of its operational, governance and administrative activities. While the year 2013 will see the implementation of new policies and procedures on retention, security classification and archiving within existing systems, the whole organisation will migrate in 2014 to a new DMS IT tool, to be customized to best serve the organisation‟s needs.

The deployment of information technology (IT) plan, which will assist the organisation in further gaining efficiencies in key areas, inter alia the above mentioned initiatives on electronic submission of application, the electronic collection and dissemination of structured data as well as an electronic document management system. The 2013 IT Strategy will support the vision that by 2016 EFSA need to be recognized as the EU Hub for scientific information on risks related to food, feed, animal health, plant health and on nutrition.


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Further develop EFSA’s Human Capital

Initiatives in the period 2014-2016 will build on the work already started and focus on: reinforcing the link between EFSA strategy and learning activities, guiding and focusing the development of EFSA managerial and leadership competences, better identifying EFSA key competences and roles to facilitate the growth of the organisation and defining a career development model to support professional evolution and attract talents.

The new Human Capital and Knowledge Management model implemented as from 2012 will continue contributing to increase EFSA‟s efficiency and performance in 2014 through four main pillars, i.e:

Knowledge Management and Development, to enhance learning activities for staff and experts through the definition of learning systems and a training catalogue;

Management Development, with the implementation of ad hoc programmes and tools aiming at bringing managers more in line with EFSA strategic decisions;

Roles, responsibilities and competences, an initiative aiming at managing competences based on a comprehensive mapping exercise

Career development, to deploy enhanced performance appraisal and career development tools for staff.

This approach to Human Capital and Knowledge Management at EFSA will be complemented by the alignment with the Recruitment and Resource Planning strategy towards a sustainable Human Capital model.

Build more transparency and trust

The transparency Initiative

Through this initiative, EFSA will further develop its policy on openness and transparency particularly in relation to the processes (from the mandate to the output) and to the data used, to ensure that basis for the opinions are shared and clearly understood, including data sources and data considered, assumptions and uncertainties.

It will be a two-pronged initiative, developed in cooperation with EFSA‟s institutional partners and stakeholders.

Concerning process transparency, two working groups are being set up with EFSA customers (Member States, European Commission and European Parliament) and stakeholders. These groups will examine and devise a system for assuring wider transparency with customers and stakeholders at the various stages of the evaluation process, through consultations, attendance to meetings and a regular review process. The customer and stakeholder feedback mechanism described above will be developed in parallel with, and as part of, these activities.

Concerning data transparency, two other working groups are being set up with EFSA customers and stakeholders, to examine and define modalities for how best and to what extent data used in risk assessments can be made available to the broader scientific community and interested parties, due respect being paid to confidentiality rules and property rights.

Enforce and review independence policy

EFSA has already implemented effective procedures and processes to deal with independence. This has been recognized both by the external evaluators10 and by the ECA. In the coming years, EFSA will therefore concentrate its efforts on ensuring proper enforcement of its Independence policy11 and implementing rules. At the end of 2013, EFSA will launch a review of its implementing rules on declaration of interests to examine if further adaptations are needed

New Communications Strategy

EFSA will review its Communications Strategy in 2013: it is anticipated that the direction of the existing strategy will hold true and be built on with the key focus on: simplicity and transparency; increasing relevance and understanding of EFSA communications; and co-operation with Member States, the international risk assessment community and liaison with its stakeholders. EFSA will also focus on proactively communicating on the role of EFSA and the independence of its risk assessment work.

10 The report form the External Evaluator indicates that “EFSA has already implemented effective procedures to deal with independence and their additional reinforcement is not recommended, not to introduce additional burdens to experts‟ participation to EFSA‟s activities”( page 14 of the final report available at: http://www.efsa.europa.eu/en/keydocs/docs/efsafinalreport.pdf ). 11 MB 15 12 11 – Policy on independence and scientific decision making process


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2. 3 OPERATIONAL ACTIVITIES EFSA‟s operational activities over the period 2014-2016 are classified and described in line with the Activity Based Budgeting nomenclature i.e. scientific activities, communication and governance and support.

2.3.1. Provision of scientific opinions and advice and risk assessment approaches (Activity 1)

Overall Trends

Planning activities will continue to be built to better predict work load and allocate priorities ensuring that EFSA‟s work on generic questions linked to health and the identification of emerging risks continue to be an important element of EFSA‟s programming. A pilot project on risk ranking was launched in 2012 and to try and develop an evidence base for the comparison of health benefits and health risks of chemical, microbiological and nutritional substances in food. The results of this work will be carefully considered and may lead in 2014 to the development of specific tools for guidance on prioritisation of EFSA‟s scientific work.

Over the 2014 – 2016 period, the Scientific Committee and Scientific Panels will continue to explore new concepts and scientific progress in risk assessment so as to ensure EFSA remains at the forefront of risk assessment methods. In line with the implementation of the Science Strategy, the role of the Scientific Committee in the provision of guidance on new and harmonised risk assessment approaches shall be pivotal and its involvement in the handling of complex multi-sectoral issues is expected to be enhanced. In its multi-sectoral activities EFSA will look to other European agencies to initiate joint work where a scientific question encompasses areas of relevance to another EU agency.

In line with the roll out of the Science Strategy, with the support of the Scientific Committee, EFSA will further work on developing transparent ways of working and in particular in relation to data collection and other preparatory work, to document in a transparent manner how evidence is weighed, data gaps are considered and what assumptions are made to address them, dealing with underlying uncertainties and their potential impact on the decisions made.

Trends across scientific areas

An increase in the number of requests for opinions in the area of animal health is foreseen, also in the context of the new animal health law (under preparation) and specific community legislation for the control of animal diseases. The work in the animal welfare area continues to support the implementation of the recently adopted EU Animal Welfare Strategy 2012-2015, such as in the area of animal welfare indicators for farm animal species, continuing the work started in 2011 and 2012, and in the field of welfare related to animal transport.

The BIOHAZ Panel will continue to work on opinions on the public health risk posed by pathogens on food of non-animal origin and on foodborne zoonoses in food of animal origin. Furthermore, it will continue to provide the annual update of the qualified presumption of safety (QPS) list, and continue to work on transmissible spongiform encephalopathies (TSEs) and bovine spongiform encephalopathies (BSEs).

EFSA is also expected to receive new requests between 2013 and 2015 for further work in the area of pharmacologically active substances (Regulation (EC) No 470/2009, Art 19) in addition to activities for assessing the risk of mycotoxins, metals and processing contaminants, which will be important areas of work for the CONTAM Panel.

The PLH Panel will continue to conduct pest risk assessments and the identification and evaluation of options to reduce the level of risk for harmful organisms of plants and plant products listed in Annex IIAII of Council Directive 2000/29/EC. An increase in requests over the period 2014-2016 is expected to update the annexes of current Directive 2000/29/EC before moving to the new legislation.

With regards to Nutrition, EFSA will continue to work on dietary reference values for micronutrients up to 2015 – a key part of establishing food-based dietary guidelines in the Member States. In 2013, EFSA will have access to a detailed nutrient composition database that together with food consumption information will facilitate this work. New mandates given to EFSA in 2013 on the provision of general advice related to dietetic products, such as foods for infants and young children, very low calorie diets and sports foods will impact on the workload of the NDA Panel in 2014.

In the area of Feed additives, EFSA will prepare and update guidance documents to applicants12 on specific issues

related to the assessment and will work on scientific opinions concerning generic issues under its remit.

As a consequence of the recent definition of implementing measures for article 8 of Regulation 1925/2006 and in view of the Member States activities in this field it can be expected that the ANS Panel will receive increased requests on other substances with nutritional or physiological effects.

12 Regulation (EC) No 1831/2003


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The CEF Panel might have to work on a guideline to assess the safety of non plastic food contact materials (e.g. coating paper and boards, adhesives, printing inks and rubbers) as for several thousands of these substances no harmonised assessment methods are available in Europe.

The risk assessment work of the Panels will be supported by the SAS, BIOMO and DCM units. The SAS unit will provide practical modelling support following good statistical and epidemiological practices and will continue to work on the development and harmonisation of risk assessment methods. The BIOMO unit will provide data for microbiological risk assessments and assist in data analyses. The DCM Unit will assess dietary exposure to hazardous compounds using occurrence data in food and feed and food consumption information stored at an individual level in the Comprehensive European Food Consumption Database.

EFSA will further intensify its cooperation with the ECDC (European Centre for Disease Prevention and Control) in the areas of animal/human interface, rapid foodborne outbreak assessment, and molecular typing.

In line with EFSA‟s crisis preparedness procedures, the units that carry out generic risk assessments will continue to respond with priority to urgent requests for scientific advice, as required. Consideration will be given to developing further methods for the rapid assessment of risks in an emergency situation including new tiered approach methodologies. The approach that has been piloted for the early identification of emerging risks will be implemented through the Scientific Committee in order to enhance EFSA‟s capacity to anticipate new issues. In addition, further attention will be given to considering multiple hazard exposure, the impact of chemical mixtures taking into account the results of the critical review of the human risk assessment of chemical mixtures and the work of already undertaken within EFSA and in international bodies13. Approaches and data gaps for addressing the multifactorial impacts leading to a decline in bee health will be addressed.

2.3.2 Evaluation of products, substances and claims subject to authorisation (Activity 2)

Overall Trends

The trend in the demand for the evaluation of regulated products will continue to result in a substantial proportion of EFSA‟s resources (approx 40%) being committed to this activity between 2014-2016. In line with the objectives of the Science Strategy 2012-2016, EFSA will further focus on developing methodologies and strategic approaches to define priorities and better estimate resources refining and consolidating the medium - long term planning with the European Commission, the Member States and the European Parliament. In the meantime, aligned to the recommendations of EFSA‟s Management Board, strategic initiatives will be taken towards enhancing sustainability of the current operating model of providing scientific advice by increasing timeliness and consistency of the scientific outputs, minimising the overreliance on external expertise and ensuring that the scientific advice is – and is perceived to be – independent of any undue influence.

A key objective during 2014 - 2016 and beyond is to gain efficiency through more consistent regulatory workflows. Given the higher proportion of resources used in the evaluation of regulated products compared to other areas and the fact that this area is driven by provisions contained in regulations, EFSA will continue to place substantial emphasis on identifying areas with immediate need for improvements in the regulatory workflows concerning scientific evaluation of regulated products. Compared with other agencies undertaking risk assessments and in particular the evaluation of regulated products, EFSA currently operates on the basis of approximately 34 different directives and regulations which define some 39 different workflows on the basis of which reviews have to be carried out. Given the diversity of the different models significant effort will be needed to identify how to build greater harmonisation.

In the long term EFSA will work with risk managers to design optimal regulatory models, applicable across the various regulatory areas that may be used as a reference for future discussions with the legislators (the Commission, MS, EP) in the context of new legislative initiatives with the overall objective of building simpler, efficient and transparent workflows. Internal work already completed on the mapping and assessment of existing regulatory workflows may be broadened during 2013 - 2014 to benchmark against other EU Agencies and identify best practices.

Notwithstanding legislative peculiarities in different sectoral legislation, the use of the stop-the-clock mechanism needs will be both clarified and harmonised. In line with this, work has been initiated aiming to define agreed, indicative and harmonised timelines as well as harmonised procedures across the Scientific Panels for the submission of supplementary/additional information, when EFSA requests such information.

13 EMRISK internal mandate Scientific report on international frameworks dealing with human risk assessment of chemical mixtures.


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Better mapping of staff competences, will enable strategic re-allocation of staff, in line with current resources and the Medium Term Plan as agreed with the European Commission. This will be complemented by prioritisation of outsourcing needs, aiming to increase efficiency in dealing with accumulated and future workload in the area of regulated products.

EFSA will consider how to better harmonise the procedures used for data submission with guidance on test protocols, including quality standards that need to be adhered to. The Scientific Panels have already identified current and future needs for guidance document revisions and these will be reviewed and prioritised so that a multi-annual plan of guidance document development can be put in place. In line with the implementation of the Science Strategy (2012-2016), this will look at building within guidance documents test strategies, data requirements and methodological approaches on how to assess chemical and biological risks. The trend to develop recommendations for further improvements and harmonisation, a key component in ensuring scientific excellence will continue.

Over the longer term EFSA will seek further improvements in efficiency through the planning and building of the work of the Applications Desk Unit (APDESK) established in 2011 which will further centralise and process the initial administrative steps of all applications. During 2014 - 2016 the APDESK Unit will also focus on both enhancing dialogue and the quality of the service provided to applicants, Member States and any other stakeholders, as well as building short and long term strategic approach for increasing interactions with small and medium enterprises (SMEs) with the development of an EFSA SME office, APDESK webform, info session on applications, survey on stakeholders needs followed by a yearly satisfaction surveys on the services provided by APDESK.

The feasibility study into the electronic submission of dossiers to be carried out during 2012-2013 will provide further insights into the development of an electronic unified platform for applications. In addition, IT tools for harmonisation of workflow control and tracking interactions with applicants are under development.

EFSA will further increase the cooperation with sister European Agencies for strategic agenda-setting, collaboration and identification of areas of mutual interest within the regulated products area eg. in the handling of scientific questions of common interest. The establishment of enhanced dialogue on emerging situations where urgent cooperation would be necessary will be a part of these joint efforts to increase coherence of the scientific opinions.

Trends across scientific areas

In relation with Regulation 1331/2008 and 562/2012 an increase in the workload is anticipated in the area of food enzymes which will be addressed by the CEF Panel14 due to the high number of applications. In addition the CEF Panel will continue its high workload on Food Contact Materials and Flavourings (Additional data on genotoxicity). The ANS Panel will continue to focus on the re-evaluation of the authorised food additives15, while also assessing new applications for food additives16, nutrient sources17 and some other substances added to food for nutritional or physiological purposes.

In the area of GMOs in food and feed, and for cultivation18 the GMO Panel will continue to receive a constant number of applications per year, albeit with increased complexity due to novel traits and methodologies. The GMO Panel will further assist the European Commission in the area of post market environmental monitoring19 and in translating Panel recommendations into legal requirements. Guidance on various aspects of food and feed risk assessment of GM Plants such as allergenicity and renewal of existing products will be reviewed and updated, and strategies for risk assessment in the absence of a suitable non-GM comparator will be elaborated

In the area of nutrition, the NDA Panel20 during this period will continue to evaluate health claims on food21, with opinions developed in relation to Article 14 and 13.5 claims and to work on the development of further or revised guidance for applicants. Safety assessment of novel foods will continue, together with the development of guidance for applicants in the context of the new Novel Foods Regulation. In particular, this new regulation, when it is coming into force, foresees a centralized risk assessment to be carried out by EFSA, without an initial assessment by the Member States as under current rules. It is foreseen amongst other that all novel food applications are to undergo a centralised risk assessment by EFSA and that a simplified notification procedure for traditional foods from third countries with the involvement of EFSA is established in order to allow easier market access for these types of products. Without taking into account the already increasing number of novel food applications, the transfer from a partially decentralised to a fully centralised procedure alone will result in an increase in workload for EFSA in this area by 50%. It is also expected that EFSA will receive per year around 10 notifications for traditional foods from third countries with a high peak to be expected immediately after the

14 Regulation (EC) 1332/2008 over 1000 enzymes are anticipated over this period 15 Regulation (EU) No 257/2010 and Regulation (EU) No 1129/2011 16 Regulation (EC) No 1333/2008 17 Regulation (EC) No 1925/2006 18 Regulation (EC) No 1829/2003 and Directive 2001/18/EC 19 Regulation (EC) No 1831/2003 20 Not including the more than 1500 botanical claims which are on hold 21 Regulation (EC) No 1924/2006, Art. 13.1


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date of application of the Regulation.22 These new tasks will require additional staff (5 scientific officers) and related budgetary resources (€ 1.27 million per year).

In the area of feed additives and products, it is foreseen that the majority of the work of the FEEDAP Panel will be on applications under Regulation (EC) No. 1831/2003. It is expected that until 2015, the re-evaluation of feed additives under Article 10 will continue. Additional questions on new additives or new uses and supplementary dossiers following inconclusive opinions are expected, following the trend of previous years. In addition to that, from 2014 EFSA shall receive applications under Article 14 for the renewal of feed additives. It is also expected that in the coming years the FEEDAP Panel will undertake the assessment of applications on feed for particular nutritional purposes23.

In the Pesticides area, the work performed during 2013 on the renewal of active substance approvals24 will continue during 2014 and 2015. New work on the consumer risk assessment for biocides which require the setting of MRLs may be initiated in 2013 and is expected to increase during 2014 and 2015. There will be a high workload during 2014 - 2016 in the area of reasoned opinions on proposals for new or the amendments of existing maximum residue levels (MRLs) for applications under Regulation (EC) No 396/2005 and an increasing workload under Article 12 of this Regulation also related to the review of MRLs.

Most of the activities of the PPR Panel from 2013 to 2016 will consist in supporting the development of risk assessment methodologies and guidance, in particular in the area of environmental risk assessment. The Panel will also deliver important opinions on the evaluation of cumulative risks of pesticides.

It is envisaged that several opinions will be adopted by the BIOHAZ Panel on animal by-products25 and on the efficacy and development of antimicrobial resistance of substances for the surface decontamination of foods of animal origin26.

The evaluation of regulated products and claims will be supported by the SAS and DCM units. In particular, SAS will provide statistical reviews of dossiers submitted to EFSA and prioritise the development of guidance for statistical reporting and templates for reviewing studies. DCM will support the Panels in evaluating exposure calculations submitted by industry in support of applications and will focus on the continuing harmonisation of existing exposure methodologies used by the various Panels. 2.3.3 Data collection, scientific cooperation and networking (Activity 3)

Cooperation activities, data collection, and networking are essential elements supporting robust science. In addition to the invaluable contributions of experts from the Member States to EFSA‟s Scientific Committee, Panels and working groups, (approximately half of whom work for national food safety bodies), EFSA will continue to build its cooperation and networking. EFSA will also increase cooperation with European agencies and other European level bodies (e.g. EC scientific committees, JRC, DG RTD) and international bodies with the objective of building stronger richer data sources for risk assessment activities, sharing best practices, avoiding unnecessary duplication and building harmonisation. Similarly there will be further emphasis on building relationships with other European (ECDC, ECHA, EMA) and international agencies to strengthen data collection and sharing, enabling EFSA to build more accurate pictures of the challenges posed by complex multi-sectoral issues, increased international trade, climate change risks posed by migration. Attention will be given to strengthening the platform of scientific cooperation not only for data and scientific information exchange at pan European or international level, but also to better support applicants with new test strategies and risk assessment methodological approaches based on the latest developments of science from all sources.

EFSA, the Advisory Forum and the Focal Points will develop further medium and longer term joint planning so as to build a clearer overview of needs with a more strategic vision multi-annual investment programme to be developed. To assist both EFSA and Member States, it will be possible to more effectively prioritise and deploy resources within the contracts and grants programme on areas with particularly heavy workloads such as the evaluation of regulated products. In line with its longer term strategic and operational planning, scientific cooperation investment can be better targeted while ensuring that it is brought in line with the medium planning of risk assessment work agreed with the European Commission. Annex 3 provides an overview of the anticipated work programme for grants and procurement.

Taking into account the experience gained in the past, and in line with the multi-annual planning initiatives under development in cooperation with the Member States and the European Commission, EFSA will make particular efforts to establish longer-term framework contracts with Member State competent organisations. To this extent, a number of

22 This is expected to be driven by botanicals used in traditional Chinese and Ayurvedic medicine which currently cannot enter the market because of their Novel Food status. 23 Regulation (EC) No. 767/2009 24 Regulation (EU) No 1141/2010 - Art. 16, and Regulation(EU) No 844/2012 – Art. 13 25 Regulation (EC) No 1069/2009 26 Regulation (EC) No 853/2004


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additional framework contracts are foreseen to be launched in 2013 and to be used in the following four years, covering all relevant areas where EFSA has recurrent needs for support, including preparatory work aiming at reducing accumulated work and processing current applications more efficiently. EFSA will continue to implement simplifications to its grants scheme, in line with the new legal provisions in force, in order to increase their attractiveness to the Member State organisations and maximise its use. In addition, EFSA is currently exploring with the Member States and the European Commission, under the auspices of its Advisory Forum, the set up of grants targeted to applied research projects that would in the medium term have a leveraging effect and considerable impact (e.g. capacity building) in addressing food safety issues under the remit of EFSA.

Over the period, it will also be possible to identify areas of mutual interest with the Member States and also with the other EU Agencies where joint initiatives can be envisaged, including enabling better planning of the Article 36 investment work. Furthermore, the cooperation through the existing Scientific Networks in specific scientific fields, including animal health and welfare, GMOs, BSE-TSE, zoonoses, microbiological risk assessment, emerging risks, pesticides, harmonisation of risk assessment methodologies, plant health, nanotechnologies, chemical occurrence and exposure data, will be enhanced and built on.

The key project launched on harmonising human food consumption data collection (EUMenu) will continue to be central to EFSA work and there will be a steady shift from the pilot phase to the actual implementation. Further work is anticipated in relation to risk monitoring to enhance these data particularly in relation to exposure assessment. The food classification system released in 2010-2011 will be progressively integrated into EFSA‟s activities and made available to Member States. Planning and collection of harmonised occurrence and food consumption data will be promoted and supported by DCM, including the post-market monitoring of food additives. Emphasis will be placed on developing the post-market monitoring of chemical and biological agents within the context of human health and environmental impacts, particularly in relation to prioritised regulated products.

In this context, EFSA has prioritised for the period 2014 – 2016 the further development of IT tools (Data Warehouse) allowing the effective collection, analysis, distribution and reporting of data on food consumption, nutrients in food, on occurrence of chemical compounds and biological agents, anti-microbial resistance and food borne outbreaks. Harmonisation of data collection procedures will be undertaken to enable greater compatibility and comparability of data collected with the Member States. EFSA intends to develop an integrated system to support food vigilance. In line with its Science Strategy, EFSA will therefore further engage to strengthen data sharing and data access agreements with other key national, European agencies (e.g. ECDC, EFSA, EMA) and international organisations (e.g. FAO, WHO, OECD). Within this context, EFSA is also exploring the idea of linking the Data Warehouse (including post-market monitoring data) to external databases. This would provide EU citizens with a user-friendly query to obtain a holistic risk/benefit overview of their food, allow consumers to make informed decisions about the food they eat. Scientific researchers would have access to data infrastructures to develop world class science, and the food industry, especially SMEs, would benefit from data access to support innovation to bring safe and healthy food solutions to the market. This initiative will require significant extra resources and could only be possibly implemented after 2016, unless additional resources become available.

On a longer term perspective, EFSA intends to integrate and supplement all these initiatives and develop a comprehensive food vigilance system, involving data monitoring at both pre-marketing and post marketing stage. This should allow for assessment of whether the exposure envisaged at the time of marketing authorisation matches the true exposure when marketed. Expected benefit from this initiative are significant, in particular an harmonised database would further support the evidence based risk assessment and contribute to the risk ranking exercise to allow focussing on real risks.

Ongoing during this period will be the production of the Annual Report on Pesticide Residues, zoonoses, foodborne outbreaks and antimicrobial resistance. The monitoring data on pesticide residues will be essential for the implementation of cumulative risk assessment which will be another priority in 2014 to 2016. The activities on data collection of zoonoses, antimicrobial resistance and food borne outbreaks and occurrence and consumption data will continue to be highly relevant activities with a strong reliance on cooperation activities with the Member States and other EU Agencies (eg ECDC and EMA) and a new and revised reporting specifications for EU Member States is foreseen to be issued in 2013-2014. The BIOMO and BIOHAZ units will for instance collaborate with ECDC in collecting data on molecular typing data from foodborne pathogens in food and animals. The BIOMO unit will also contribute to the joint reports from ECDC, EMA and EFSA on antimicrobial resistance and consumption in humans and animals.

Work is also anticipated to further develop and harmonise risk assessment methods, including in the areas of modelling, statistics and epidemiological practices. Over 2014-2016 the Scientific Assessment Support (SAS) Unit in EFSA will


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increasingly focus on providing statistical reviews of dossiers submitted to EFSA in relation to regulated products while still maintaining support to the other Panels. Through the review of existing guidance it will work further to build comprehensive support for statistical reporting and templates. It is anticipated that the Scientific Panels will in particular require support in evaluating exposure calculations submitted by industry in their applications for regulatory products. Focus will be given to harmonising existing exposure methodologies used by the various Scientific Panels.

To further implement evidence-based risk assessment, EFSA will over this period provide methodological and hands-on support for systematic literature reviews including training for experts and staff. EFSA has prioritised for the years 2014-2016 the development of IT tools (Virtual Library) to assist with the retrieval and processing of scientific information for the risk assessment activities of EFSA.

Finally, EFSA will build training initiatives with Member States‟ experts and a programme of short term secondments for national experts will be put in place during 2014- 2016 in order to develop the capacity for risk assessment and data collection further in Member States.

2.3.4 Communication Activities (Activity 4)

The key strategic priorities laid down in EFSA‟s Communications Strategy 2010-2013, provide a framework for the development of communications initiatives over the planning period 2014-2016. It should be noted however, that in the course of 2013, a thorough review of the current Communications Strategy will be undertaken and activities may be modified in light of relevant findings. Nevertheless, the overall trends at this time can be defined as follows based upon the recommendations from EFSA‟s Management Board based on the 2012 External Evaluation:

- Strengthen the clarity of EFSA‟s communications, improve accessibility and usability of the information in its portfolio of communication tools focusing particularly on the Authority‟s website and other online communications tools;

- Increase efforts to understand and meet target audience needs and expectations regarding EFSA‟s work. The Authority should also seek to better understand public perception regarding the independence of EFSA‟s scientific advice;

- Augment proactive communications to stakeholders with the aim of increasing trust by enhancing transparency and openness and visibility. Outreach should be enhanced in the EU and beyond by increasing awareness, understanding and recognition of EFSA and its role as risk assessor supporting the decision making process.

In support of these priorities, EFSA will continue to strengthen its capacity to develop, disseminate and oversee effective and efficient risk communications. The re-organised structure of EFSA‟s Communications Directorate has strengthened focus on core, strategic communications work supported by an increased proportion of knowledge workers. In line with the Human Capital Strategy, the Communications Directorate will continue to build and develop its capacity to deliver against strategy.

The plan proposed for 2014-2016 outlines a series of initiatives and tools to effectively implement the thematic approach recommended to increase overall understanding of EFSA and its work within the EU food safety system. EFSA will pursue the development of integrated communications plans – in co-operation with other internal stakeholders (science, stakeholder and institutional relations).

Increasing the outreach and understanding of EFSA‟s activities will remain both a challenge and a key priority during the 2014 – 2016. EFSA will continue to improve its website and online services (information architecture, usability and functionality) to facilitate access to information and will provide overall communications support to initiatives put in place by the Authority to increase the transparency of its work and working processes (e.g. access to data submitted by applicants). Additionally, the Authority will proactively monitor and utilise as appropriate social media in order to reach out to new users and build visibility for EFSA‟s work amongst interested communities.

Building appreciation and recognition of EFSA‟s policy and procedures concerning the independence and transparency of its scientific decision-making processes will remain a key priority over the planning period. In doing so, EFSA will seek to reach out to and engage with third parties who can help to raise awareness and explain the practices put in place by EFSA to ensure the impartiality of its scientific advice. Furthermore target audience research will be pursued to measure trust, effectiveness of communications as well as the commissioning of a third Eurobarometer survey, planned for 2015 to gauge consumer perceptions to risks in the food chain.

EFSA will aim to further develop its outreach in the Member States through enhanced co-operation with the Advisory Forum working Group on Communications and mobilisation of Focal Point networks in both on- and offline


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communications activities. Promoting risk communications expertise will include joint projects such as the annual update of the risk communications guidelines, glossary of food safety terms and the joint organisation of speaking platform opportunities at key events including regular participation of EFSA and Member State experts.

Throughout the planned period, EFSA will implement an integrated Internal Communications plan addressing needs of staff as well as external experts.

3. OVERVIEW OF THE ALLOCATION OF RESOURCES

As mentioned in section 1.2.2, EFSA acknowledges a scenario in line with the Commission‟s indications (nominal budget increase of 1% per year) with additional resources needed in 2015 and 2016 to finance the execution of the following new tasks over the period:

1. The provision of enhanced support to Panels by EFSA Staff on scientific assessment in the regulated products area which will require 45 additional experienced scientific experts to be recruited over the period 2014-2015. For 2014 EFSA proposes to absorb the costs required to achieve this objective within the budget indicated by the European Commission, and the investments for the recruitment of the 25 additional scientific staff (approximately €3.5 M in 2014) will be compensated by efficiency gains and savings in other areas (mostly by reducing the travel and financial compensation costs in experts working groups).

2. The additional workload linked to the implementation of the Novel Food Regulation which as of 2015 is expected to require 5 additional staff and an increased budget of around €1.3 million annually.

The budget and establishment plan anticipated to carry out the present work programme are outlined in the two tables below, based on these assumptions. Budget by expenditure title is adjusted by the need to finance the recruitment of new staff. In 2014, the recruitment will be financed internally, hence the shifting of resources from Title 3 to Title 1. In 2015 and 2016, the predicted overall budget increases are reflected in Title 1.

Table 1: Expected Budget Evolution by Title of expenditure 2013-2016

Table 2: Expected Establishment plan 2013-2016

Human Resources 2013 2014 2015 2016

Establishment plan posts: AD 231 262 287 287

Establishment plan posts: AST 120 114 114 114

Total Establishment plan posts 351 376 401 401

Contract Agents 110 110 110 110

Seconded National Experts 20 20 20 20

Total staff 481 506 531 531

Budget 2013

M.€ %

2014 M.€ %

2015 M.€ %

2016 M.€ %

Title 1 - Personnel 39.81 43.42 46.94 46.94

Title 2 – Infrastructure 8.92 9.13 9.50 9.50

Title 3 – Operations 29.32 26.33 27.76 27.76

Total Budget 78.05 78.88 84.20 84.20


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The Tables below illustrate the allocation of budget and staff by ABB activity27. The planned allocation of resources in 2014, 2015 and 2016 reflects the need to execute the predicted workload through adequate deployment of staff, the financing of panels and working group meetings, scientific cooperation - including grant and procurement activities according to the work plan (see Annex 3) - and communication activities.

The budget allocation is geared towards EFSA‟s workload evolution and its key initiatives as described in section 2.2 and in particular:

- Continue to deliver in a timely fashion the different types of high quality outputs required by its mission and by the different vertical legislations governing food safety in the EU.

- Pursue the investment in the evaluation of Regulated products (Activity 2) and progressively provide further support to the Panels as well as progressively bringing the support service to be provided by EFSA to a level comparable to other EU agencies dealing with the evaluation of regulated products,

- Support the scientific cooperation programme with Member States, which is planned to decrease from EUR 10.5 million in 2013 to EUR 9.07 million in 2014, to return to a level of EUR 10 million in 2015 and 2016 to support the work in the Regulated Product area and data collection,

- Reduce governance and support activities thanks to efficiency initiatives.

Table 3: Expected Budget Allocation by Activity28

EFSA’s Activities Budget 2013

Preliminary budget 2014

Forecast 2015 Forecast 2016

M EUR % M EUR % M EUR % M EUR %

Provision of scientific advice and risk assessment approaches (Activity 1)

13 17% 14 18% 14 17% 14 17%

Evaluation of regulated products (Activity 2) 20 28% 21 27% 26 31% 27 32%

Data collection, scientific cooperation and networking (Activity 3) 28 26% 26 33% 26 31% 26 31%

Communication and dialogue (Activity 4) 6 8% 5 6% 5 6% 5 6%

Total Operational Activities 67 86% 66 84% 71 85% 72 86%

Governance and Support 11 14% 13 16% 13 15% 12 14%

Total EFSA 78 100% 79 100% 84 100% 84 100%

Table 4: Expected staff allocation based on the medium term planning in Full Time Equivalents (FTE)28

EFSA’s Activities Budget 2013

Preliminary budget 2014

Forecast 2015 Forecast

2016

FTE % FTE % FTE % FTE %

Provision of scientific advice and risk assessment approaches (Activity 1) 81 17% 77 15% 78 15% 79 15%

Evaluation of regulated products (Activity 2) 137 28% 168 33% 193 36% 196 37%

Data collection, scientific cooperation and networking (Activity 3) 126 26% 129 25% 130 24% 131 25%

Communication and dialogue (Activity 4) 40 8% 40 8% 40 8% 40 8%

Total Operational Activities 384 80% 413 82% 441 83% 446 84%

Governance and Support 97 20% 93 18% 90 17% 85 16%

Total EFSA 481 100% 506 100% 531 100% 531 100%

27

Every year, more detailed figures on the resources allocated to the various activities will be provided in the document setting forward the activity of

EFSA in the year to come, i.e. EFSA‟s Annual Management Plan. 28

Rounding of values may lead to some discrepancies.


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4. MEASURING SUCCESS: KPIs FOR 2014-2016

In order to monitor the implementation and measuring success of EFSA‟s multiannual work-plan, the following KPIs have been identified. Table 5: Multi-annual Key Performance Indicators

Objective Indicator Base line 2013

Target 2016

EFSA‟s scientific work meets customers‟ expectation

% of output considered “fit-for-purpose” by risk managers

tbd

+10%

Industry applicants are satisfied with the services provided by EFSA

% of applicants declaring overall satisfaction (source applicants survey)

tbd

+10%

Timeliness of scientific advice Proportion of scientific outputs adopted within deadline

80%

90%

EFSA‟s work is recognized internationally

Number of citations in international scientific literature

tbd +10%

EFSA provides timely and relevant scientific support during crisis

% of cases for which a Timely and relevant opinion was provided and communication follow up

100% 100%

Increase staff on operational activities, enhanced staff profile

Ratio of knowledge workers29 /support workers Ratio of staff in operation/support activities

0.66

0.80

0.70

0.85

Ensure attractiveness of EFSA as a place of work

Internal staff satisfaction survey External Experts satisfaction surveys

tbd

tbd

+10%

+10%

Increased confidence and trust in EFSA‟s work

Consumers‟ trust in national and European food safety agencies

(Eurobarometer)

Favourability 30on independence (%) neutral + positive

64%31

65%

+5%

70%

These indicators integrate and complement32 the indicators already collected and monitored in the framework of the Annual Planning and Monitoring cycle. EFSA will in the context of the review of the Multi Annual Plan measure and report on the progress made towards the targets.

Submitted for adoption in Parma on 14 March 2013

For EFSA‟s Management Board

Sue Davies Chair of the Management Board

29 Defined as staff at AD and FG4 grades and seconded national experts. 30 Percentage of articles reporting on EFSA in a neutral/positive way (from EFSA media coverage) 31 Maintaining same indicator as in the Eurobarometer 2010, see http://www.efsa.europa.eu/en/factsheet/docs/sreporten.pdf (page 7 and 20) 32 This would also address the concerns expressed by the IAS (See IAS Final Audit Report on Operational Planning and Budgeting in the European Food Safety Authority (November 2011). that there is a limited integration between the various objectives/indicators in EFSA.

http://www.efsa.europa.eu/en/factsheet/docs/sreporten.pdf

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ANNEX 1 PREDICTED OUTPUTS BY SCIENTIFIC AREAS

Science Panel/Unit

OUTPUT TYPE Subject Reference to Legislative

Framework

EFSA PREDICTED OUTPUTS

2014 2015 2016

AN

S/F

IP

Sc. Panel Opinion Additives - Food additives re-evaluation Regulation (EC) No 257/2010 , 1129/2011 11 13 15

EFSA Statement Additives - Food additives exposure assessment

Regulation (EC) No 257/2010 , 1129/2011 4 1 1

Sc. Panel Opinion Food additives - new applications Regulation (EC) No 1333/2008 1 1 1

Sc. Panel Opinion Vitamins and minerals and other substances (Other substances: Botanical)

Regulation (EC) No 1925/2006 1 1 1

Sc. Panel Opinion Vitamins and minerals and other substances (Other substances: Botanical)


TOTAL 19 17 19

CE

F/F

IP

EFSA Guidance Guidance for NON-Plastic Food Contact Material

0 1 0

Sc. Panel Opinion

Food flavourings: Re-evaluation of FGE.19 and footnote 10 substances (Regulation 1565/2000 Art 3) [Flavouring substances in the Union list with reference to Annex 1, Part 1 of Reg (EC) 1334/2008and 1565/2000]

Regulation (EC) 873/2012 17 16 12

Sc. Panel Opinion

Food flavourings: New flavourings (Regulation 1331/2008 Art 3) & Smoke flavourings (Regulation 2065/2003 Art 8) [New substances (not in the register). Application received after Nov 2008]

Regulation (EC) 1334/2008 2 2 2

Sc. Panel Opinion

Food enzymes - Scientific opinions for applications in the preparation and presentation of applications (Regulation 1332/2008) New application for enzymes

Regulation (EC) 1332/2008 Art. 17 8 25 30

Sc. Panel Opinion Food contact materials. Non-Plastic food contact materials substances (Regulation 1935/2004 Art 9)

Regulation (EC) No 1935/2004 Art. 9 1 1 1

Sc. Panel Opinion

Food contact materials: Plastic food contact materials substances (Regulation 10/2011) Monomers and additives to be used in plastics materials and articles intended to come into contact with foodstuffs.

Commission Regulation 10/2011 7 7 7

Sc. Panel Opinion

Recycled plastic materials and articles intended to come into contact with foods: -NEW- Recycling of FCM: existing and new processes (Regulation 282/2008 Art 5)

Commission Regulation (EC) No 282/2008

7 7 10

Sc. Panel Opinion

Recycling of FCM: existing and new processes (Regulation 282/2008 Art 5) Plastic recycling processes - Already in place in MSs


10 0 0

Sc. Panel Opinion Active and intelligent materials and articles (Regulation 450/2009 Art 8)


5 5 5

Sc. Panel Opinion Other EFSA outputs (self tasks, etc): Anticipated need for generic requests (Art. 29)

Bisphenol A 1 0 0

TOTAL 58 64 67

FE

ED

AP

/FE

ED

Sc. Panel Opinion Feed Additives: re-evaluation of existing additives

Regulation (EC) No 1831/2003 Art. 10 (paragraphs 2 and/or 7)

35 20 20

Sc. Panel Opinion Feed Additives: new additives, new uses or modification of existing authorisation

Regulation (EC) No 1831/2003 Art. 4 and Art. 13 28 25 30


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Science Panel/Unit


Framework


2014 2015 2016

Sc. Panel Opinion Feed Additives: renewal of authorisations

Regulation (EC) No 1831/2003 Art. 14 2 5 10

Sc. Panel Opinion

Placing on the market and use of feed:restriction and prohibition, particular nutritional purposes and substantiation of claims

Regulation (EC) No 767/2009 Art. 6, Art.10 and Art. 13

1 5 5

Sc. Panel Opinion New applications: risk assessment of feed produced from genetically modified organisms


Sc. Panel Opinion Generic questions/questions following inconclusive opinion/Self task

Regulation 178/2002 Art. 29 1 2 2

Sc.Panel Guidance Development and update technical guidance documents

Regulation 178/2002 Art. 29 1 1 1

TOTAL 70 63 71

GM

O

Sc.Panel Guidance Development and update guidance documents

Regulation (EC) No 178/2002 3 1

Sc. Panel Opinion GM food and feed (1st evaluation and re-evaluation)

Regulation (EC) No 1829/2003 Art. 3-6, 15-18

9 9 9

Sc. Panel Opinion Unforeseen EC requests related to applications (such as safeguard clauses)

5 5 5

Sc. Panel Opinion Post marketing Environmental monitoring - PMEM monitoring reports

2 2 2

TOTAL 19 17 16

ND

A/N

UT

RIT

ION

Sc.Panel Guidance Development and update of guidance

Sc. Panel Opinion Nutrition and health claims on food -applications

Regulation (EC) No 1924/2006 Art. 13.5 - Art. 14 (a) (b), Art 19

25 25 25

Tech. Report

Request for scientific assistance on comments received on adopted and published health claims opinions pursuant to Article 16(6) of Regulation (EC) nr. 1924/2006

Regulation (EC) No 1924/2006 Art. 13.5 - Art. 14 (a) (b)

5 6 6

Sc. Panel Opinion Dietary reference values 6 6

Tech. Report Public consultation on dietary reference value opinions for certain micronutrients

6 6

Sc. Panel Opinion

Other requests related to nutrition issues: Anticipated need for advice on general aspects related to nutrition, dietetic foods and health

2 1 1

Sc. Panel Opinion Novel food and ingredients Regulation (EC) No 258/97 Art. 7(1) 10 10 10

Sc. Panel Opinion Dietetic products: infant formulae and follow-on formula

Commission Directive 2006/141/EC 1 1 1

Sc. Panel Opinion Allergy Directive 2000/13/EC (as from 13 Dec 2014 will be repealed by Regulation (EU) No. 1169/2011)

1 1 0

Sc. Panel Opinion Allergy Directive 2000/13/EC (as from 13 Dec 2014 will be repealed by Regulation (EU) No. 1169/2011)

0 1 0

Event Report Meeting with Stakeholders on health claims

1

Tech. Report

Technical assistance for contribution to the evaluation report on the application of the Nutrition and Health claims Regulation

1 1

TOTAL 58 58 43


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Science Panel/Unit


Framework


2014 2015 2016

PP

R/P

esti

cid

es

Sc. Panel Opinion Scientific opinions Regulations (EC) 396/2005 and 1107/2009

4 1 2

EFSA Guidance Guidance development Regulations (EC) 396/2005 and 1107/2009

3 2 1

Conclusion on Pesticide Peer Rev.

Conclusions on new active substances under Regulation 188/2011

Regulation 188/2011 - Art. 8 1


Conclusions on new active substances under Regulation 1107/2009

Regulation (EC) No 1107/2009- Art. 12 10 10 10


Opinion on basic substances Regulation (EC) No 1107/2009 - Art. 23 5 5 5


Conclusions on renewal annex I inclusion (AIR II and III)

Regulation (EU) No 1141/2010 - Art. 16, and Regulation (EU) No 844/2012 - Art. 13

25 18 48


Peer review of confirmatory or other data for substances included already in Annex I

No legal provision for EFSA to deal with these data , but SANCO can mandate EFSA.

6 6 6

Reasoned Op. Reasoned opinions on setting new/amending existing MRLs

Regulation (EC) No 396/2005 - Art. 9-11 90 90 90

Reasoned Op. Reasoned opinions for the MRL review Regulation (EC) No 396/2005 - Art. 12(1) and Art. 12(2)

80 80 80

Reasoned Op.

Reasoned opinions following the assessment of MRLs for substances of concern, in the context of 120 days emergency authorisations or other urgent requests

Regulation (EC) No 396/2005 - Art. 43

8 8 8

EFSA Sc. Report Annual Reports on Pesticide Residues Regulation (EC) No 396/2005 - Art. 31 1 1 1


Review of approval following emergence of adverse data

Regulation (EC) No 1107/2009 - Art. 21 5 5 5

TOTAL 238 226 256

Sc. Panel Opinion Risk Assessment animal health Animal Health Law (under preparation)

and specific Community legislation for the control animal diseases

7 6 6

Sc. Panel Opinion Risk Assessment animal welfare

Community Action Plan on the Protection and Welfare of Animals 2006-2010, future Animal Welfare Law,and specific Community legislation

5 5 5

Event Report Technical meetings Art 36 - Scientific co-operation - Animal Diseases

3 1 1

Tech. Report AHAW Network meetings (Technical report)

Art 36 - Scientific co-operation - Animal Diseases

1 1 1

TOTAL 16 13 13

Sc. Panel Opinion Animal-by-products not intended for food consumption

Regulation (EC) No 1069/2003 Art7(3) &20

2 2 2

Sc. Panel Opinion General questions on BSE/TSE ( e.g. mandates related to the TSE road map)

Regulation 999/2001 4 2 2

Sc. Panel Opinion Food hygiene (food of animal and non-animal origin)

5 2 2

Sc. Panel Opinion Foodborne zoonoses and microbiological criteria, including QPS and AMR

5 3 4

Sc. Panel Opinion AMT/decontamination dossiers 2 2 2

Event Report Technical hearings Art 31 – Scientific and technical assistance - Food Hygiene

2 1 1

Tech. Report Member State collaboration with microbiological risk assessment (MRA)

2 1 1


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Science Panel/Unit


Framework


2014 2015 2016

and TSE networks

TOTAL 22 13 14

BIO

LOG

ICA

L M

ON

ITO

RIN

G

EFSA Sc. Report Annual community summary report on trend and sources of antimicrobial resistance

Directive 2003/99/EC Art. 9(2) 1 1 1

EFSA Sc. Report Annual community summary report on zoonoses and food-borne outbreaks in EU

Directive 2003/99/EC Art. 9(2) 1 1 1

EFSA Sc. Report Analyses of EU-wide baseline survey (Report A and B)

Directive 2003/99/EC Art. 9(3) 2 2 2

EFSA Sc. Report Technical specification and harmonisation guidance

Commission mandate from 2004; Directive 2003/99/EC

4 3 3

Tech. Report Reporting manuals supporting EU summary reports (Technical report)

2 2 2

Tech. Report Reporting applications supporting EU summary reports (Technical report)

3 4 4

Tech. Report Coordination of networks of Zoonoses data collection (Technical report)

1 1 1

Int. Report Assistance to EFSA Panels 7

Tech. Report Molecular typing data collection 1

TOTAL 22 12 12

CO

NT

AM

INA

NT

S

Guidance development

Sc. Panel Opinion Pharmacologically active substances Regulation (EC) No 470/2009, Art. 19 1 1 1

Sc. Panel Opinion Opinions on contaminants in food 3 5 4

Sc. Panel Opinion Opinions on contaminants in feed 1 0 1

Sc. Panel Opinion Opinions on contaminants in food and feed

5 4 4

TOTAL 10 10 10

Tech. Report

Scientific and technical data collection reports for the Commission + Ad hoc urgent advice and scientific assistance to the EC (continued mandate)

1 1 1

EFSA Sc. Report

Scientific and technical data collection reports for the Commission + Ad hoc and urgent advice and scientific assistance to the EC (continued mandate)

1 1 1

Int. Report Systematic and harmonised approach for collecting food consumption data in EU Member States (EU Menu project)

1 1 1

Int. Report Data collection and data analysis for chemical contaminants and residues (continued mandate)

1 2 2

Int. Report Support for generic opinions 5 4 4

Int. Report Support for the evaluation of products, substances and claims

2 2 2

Int. Report Network meetings - harmonisation of exposure assessment methodology vis. food consumption

1 1 1


26 | P a g e

Science Panel/Unit


Framework


2014 2015 2016

Int. Report Network meetings - harmonisation of exposure assessment methodology vis. chemical occurrence

1 1 1

TOTAL 13 13 13

PLA

NT

HE

ALT

H

Sc. Panel Opinion

Peer review of pest risk assessment (PRAs) and other justification documents prepared by Third Parties (e.g. EU MSs, third Countries etc.)

Directive 2000/29/EC 1 4 4

Sc. Panel Opinion

Pest risk assessment for the EU territory (including: full pest risk assessments as with Monilinia fructicola, solanaceous pospiviroids or potato cyst nematodes: specifica assessments, as for the risk of pine wood nematode spread through host plants; risk assessment of regulated plant pests present within the EU but under control, for review of Annex II Part A section 2 of Directive 2000/29/EC)

Directive 2000/29/EC 9 7 8

Sc. Panel Opinion

Scientifc opinions on Phytosanitary risk of soil and growing media, and on Pest categorisation of EU pests for free trade agreement

2

Sc.Panel Guidance Guidance documents of the Panel Directive 2000/29/EC 0 2 0

Tech. Report Member state collaboration with PLH Network (Technical report)

1 1 1

TOTAL 13 14 13

Sci

entif

ic A

sses

smen

t Sup

port

s

Int. Report Support for generic opinions 4 4 4

EFSA Sc. Report Support for generic opinions 1 1 1

Int. Report Support for the evaluation of products, substances and claims

8 12 12

Int. Report Extensive literature searches and systematic review support

4 4 4

EFSA Sc. Report Harmonisation of risk assessment methods

3 1 0

Tech. Report Harmonisation of risk assessment methods

0 1 1

EFSA Guidance Harmonisation of risk assessment methods

1 1 2

Tech. Report Harmonisation of Risk Assessment Methods - Public Consultation on Statistical Guidance

1 0 0

EFSA Guidance Guidelines for expert knowledge elicitation in food and feed safety risk assessment

1 0 0

TOTAL 23 25 25

AD

VIS

OR

Y F

OR

UM

&

SC

IEN

TIF

IC

CO

OP

ER

AT

ION

Technical Report

Information Exchange Platform 1 1 1

Technical Report Article 36 network Commission Regulation (EC) No 2230/2004

1 1 1

Technical Report EFSA Journal 1 1 1

Technical Report Expert database 1 1 1


27 | P a g e

Science Panel/Unit


Framework


2014 2015 2016

Technical Report Focal Point network 1 1 1 TOTAL 5 5 5

EM

ER

GIN

G R

ISK

S

Tech. Report

Scientific support to food and feed safety urgent requests

2 2 2

Ext. Sc. Report 1 1 1

EFSA Statement 1 0 1

Ext. Sc. Report

Identification and screening of emerging risks

2 2 2

Tech. Report 3 1 1

Tech. Report 2 2 2

Ext. Sc. Report Development of hazard database 0 1 0

Event Report Scientific Colloquia 2 2 2

TOTAL 13 11 11

SC

IEN

TIF

IC C

OM

MIT

TE

E

Opinion of the SC/SP

Uncertainties in RA 1 0 0


Exposure Assessment 0 1 0


Anticipated requests for the SC to be further defined

0 3 6


Endocrine Disruptors 1 1 0


Environmental RA 1 1 0


Guidance Review 1 1 0


Opinion on Nano 0 0 1


Cloning, Nano 1 2 2

External Scientific Report

Training of Experts and senior Staff 0 1 1

Technical Report Nanonetwork 1 0 0

Technical Report Harmonisation Network

1 1 0


Risk ranking 1 0 0


Compendium Data Collection 1 0 0


TTC 1 0 0

Scientific Report of EFSA

Compendium 1 0 1

Technical Report Public Consultation Report 0 1 1

TOTAL 11 12 12

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ANNEX 2: Overview of EFSA’s action to address the Management Board recommendations adopted in December 2012

MB

Rec

.

EFSA‟s actions

Timeframe and Milestones

En

sure

lon

g-t

erm

su

stai

nab

ility

of

EF

SA

’s o

per

atio

ns

Focus on quality and customer needs Discussion with Risk Managers and Stakeholders in 2013 Feedback mechanism in place as of 2014

Enhance services to applicants Starting 2013: feasibility study on electronic submission

Electronic submission implemented by 2014

Feasibility analysis on provision of broader range of services by 2016

Better use of scientific expertise (provide further support to Panel Working Groups)

Starting 2014 with GMO/FIP 2015 (FEED, NUTRI)

Increase efficiency in handling applications - including guidelines and harmonised use of stop the clock mechanism

Coping with accumulated and future workload: Action plan by June 2013 , implementation end 2013 Preparatory work on guidelines for the stop the clock and harmonisation of timelines concluded by end 2013, implementation as of 2014

Continuous improvement working processes:

-Lean process initiative 2013: establish „Leaning‟ circles to identify bottom up processes and tools perceived as least efficient; implement changes through pilot area and then deploy to the entire organization 2014 and onwards: regular report and monitoring on initiatives and performance

-Full project management approach (Project and Resource Management initiative)

Preparatory phase finalised by 2013; progressive implementation kicked off by mid 2013; full roll out in 2014

Training and coaching programme will start in 2013 and be completed by mid-2014

-Human Capital (knowledge management/development, competence career development)

2013: New Learning catalogue and calendar 2014: Implementation of a Learning Management System bringing together experts and staff 2014/2015: Implementation of management programs and tools 2014: Action programme to foster and certify competences 2015: Rolling update of the Competency mapping

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MB

Rec

.

EFSA‟s actions

Timeframe and Milestones

En

sure

lon

g-t

erm

sust

ain

abili

ty o

f

EF

SA

’s o

per

atio

ns - Deployment of IT plan New IT Strategy finalised in 2013 and implemented

as of 2014 IT investment Plan implementation ongoing

-Document management system, Full implementation of DMS policy and procedures in 2013; Migration to new IT DMS tool in 2014

En

han

ce E

U R

isk

asse

ssm

ent

cap

acit

y

Promote further harmonisation of methods and data:

Literature review/Virtual library Repository completed in 2013 Availability to external parties enabled in 2014

Data Warehouse –DWH initiative (further data services depending on resources)

DWH pilot concluded by December 2013: Tuning and Publishing of DWH Pilot by February 2014 DWH partial implementation by December 2014 DWH full implementation by December 2015

More effective outsourcing, including training for FSO, sharing multi annual planning and increasing use of framework contracts

Multi Annual plan for Grants and procurement prepared and discussed at Advisory Forum; new framework contracts launched in 2013, implementation as of 2014

Closer involvement in research Agenda 2013: Discussion at Advisory Forum, internal consultation within EFSA and Consultation with Standing WG on emerging risks; implementation as of 2014

Incr

eas

e tr

ust

Transparency initiative - process - data

Kick off 2013 (Meeting NGOs, EFSA and DG DANCO in January 2013; during 2013: Set up discussion SHP group and stakeholder conference; Implementation as of 2014

En

han

ce E

FS

A

Co

mm

un

icat

ion

Enforce and Review Independence Policy Dedicated project team and assessment by half of 2013, ongoing enforcing and monitoring (see the transparency initiative) Possible review in 2014

Review and implement new Communication strategy

Review by 2013

Implementation 2014-2016

mb 14 03 13 item 5 doc 4 – Draft Multiannual Plan 2014-2016 – Annex III

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ANNEX 3 Table 1. Estimated scientific cooperation programme 2014-2016

mb 14 03 13 item 5 doc 4 – Draft Multiannual Plan 2014-2016 – Glossary

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Glossary AF – Advisory Forum AFWGC – Advisory Forum Working Group on Communications AFSCO – Advisory Forum and Scientific Cooperation Unit AGRC – Advisory Group on Risk Communication AHAW Panel – Panel on Animal Health and Welfare ANS – Panel on Food Additives and Nutrient Sources Added to Food APDESK – Applications Desk Unit BIOHAZ Panel – Panel on Biological Hazards BIOMO – Biological Monitoring Unit BSE – Bovine Spongiform Encephalopathy BTSF – Better Training for Safer Food CEF – Panel on Contact Materials, Enzymes, Flavourings and Processing Aids CoA – Court of Auditors CONTAM Panel – Panel on Contaminants in the Food Chain CRL – Community Reference Laboratory DCM – Dietary & Chemical Monitoring Unit DG ENV – Directorate General Environment DG RDT – Directorate General Research and Technical Development DG SANCO – Directorate General for Health and Consumers DOI – Declaration of Interest ECDC – European Centre for Disease Prevention and Control ECHA – European Chemical Agency EDPS – European Data Protection Supervisor EEA – European Environment Agency EMA – European Medicines Agency EMRISK – Emerging Risks Unit END – Seconded National Expert ENP – European Neighbourhood Policy ENVI – The European Parliament Committee for Environment, Public Health and Food Safety ESCO – EFSA Scientific Cooperation projects FAO – Food and Agriculture Organization FDA – Food and Drug Administration (US) FEED – EFSA Feed Unit FEEDAP Panel – Panel on Additives and Products or Substances Used in Animal Feed FGE – Flavouring Group Evaluation FIP – Food Ingredients & Packaging Unit GD – Guidance Document GMO Panel – Panel on Genetically Modified Organisms IAS – Internal Audit Service of the European Commission INEX – Self, Internal and External Quality Review programme JECFA – Joint FAO/WHO Expert Committee on Food Additives JRC – Joint Research Centre of the European Commission MRL – Maximum residue level MS – EU Member States NDA Panel – Panel on Dietetic Products, Nutrition and Allergies NGO – Non-Governmental Organisation NUTRI – EFSA Nutrition Unit OIE – Office International des Epizooties OECD – Organisation for Economic Cooperation and Development OJ – Official Journal PEST – Pesticides Unit PLH Panel – Panel on Plant Health PPR Panel – Panel on Plant Protection Products and Their Residues PRAS – EFSA Pesticides Unit QMRA – Quantitative Microbiological Risk Assessment

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QPS – Qualified Presumption of Safety SAS – Scientific Assessment Support Unit SC – Scientific Committee SCOM – Scientific Committee Unit SOP – Standard Operating Procedure TSE – Transmissible Spongiform Encephalopathy

Documents

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