CONSOLIDATED

ANNUAL ACTIVITY
REPORT 2017
 PDF ISBN 978-92-9499-032-7 ISSN 2599-588X doi:10.2805/278448 TM-BA-18-001-EN-N
Print ISBN 978-92-9499-031-0 ISSN 2599-5871 doi:10.2805/902056 TM-BA-18-001-EN-C
Site ISBN ISSN 2599-588X doi:10.2805/504067 TM-BA-18-001-EN-Q

© European Food Safety Authority, 2018

Key words: [...]

Reproduction is authorised provided the source is acknowledged.

For any use or reproduction of photos or other material that is not under the EFSA copyright,
permission must be sought directly from the copyright holders.

Credits: Shutterstock
CONSOLIDATED
ANNUAL ACTIVITY REPORT 2017
Table of Contents
FOREWORD5
INTRODUCTION7
LIST OF ACRONYMS  8
PERFORMANCE AT A GLANCE 10

SECTION I — WORK PROGRAMME ACHIEVEMENTS 14

1. Prioritise public and stakeholder engagement in the
process of scientific assessment 14
2. Widen EFSA’s evidence base and optimise access
to its data 27
3. Build the EU’s scientific assessment capacity and
knowledge community 33
4. Prepare for future risk assessment challenges 9
5. Create an environment and culture that reflects EFSA’s values 46

SECTION II – MANAGEMENT OF RESOURCES 58

1. Budget and financial management 8

SECTION III — ASSURANCE 62

1. Assessment of audit results 62
2. Management assurance | 10 assurance pillars 63

DECLARATION OF ASSURANCE 67
MANAGEMENT BOARD ASSESSMENT 68

ANNEX I. RESOURCE ALLOCATION PER STRATEGIC OBJECTIVE  70

1. Financial resources per strategic objective 70
2. Human resources per strategic objective 71

ANNEX II. FINANCIAL RESOURCES 77

ANNEX III. STATUS OF PROJECTS 87
ANNEX IV. QUESTIONS CLOSED 2017 91
ANNEX V. HUMAN RESOURCES 95
ANNEX VI. NEGOTIATED PROCEDURES AND TIME TO GRANT  99
4
 5

Foreword
EFSA’s annual report for 2017 documents We also shared more scientific data than
a year of impressive work and ever before through our Data Warehouse.
achievement. Behind the facts and figures Users of the EFSA website explored
stand countless people and organisations visualisations of data in areas such as food
across the length and breadth of Europe consumption, zoonoses, antimicrobial
whose dedication and effort contributed resistance, and pesticide residues.
to another year to be proud of. So I would
like to thank all those who helped to EFSA continued to reach out
support and advance EFSA’s mission to internationally, sending delegations
protect public health in Europe: external to a number of countries in Europe
experts, institutional partners, Member and beyond. These interactions led
States, stakeholders and staff. to a doubling of the number of guest
scientists coming to EFSA and 36 joint
Collaboration is at the heart of everything projects addressing common priorities
EFSA does, and in 2017 we renewed our and emerging risks such as African swine
commitment to stakeholder partnerships fever.
with the roll-out of the new approach
to stakeholder engagement. I was In conclusion, 2017 was a year of scientific
delighted to attend the first meeting of excellence, collaboration and openness.
the Stakeholder Forum, in the company The Management Board will continue to
of more than 50 registered stakeholders. support EFSA as it applies its core values to
I am sure that this and the other dedicated address the complex issues of food safety
stakeholder groups will flourish in the in the 21st century.
years to come.
Jaana Husu-Kallio,
Last summer the Management Board Chair of the EFSA Management Board
adopted a new Independence Policy,
establishing a clear framework for the
way in which EFSA manages the interests
of its scientific experts and others with
whom it works. The new policy builds on
EFSA’s experience of managing interests
over the last 15 years as well as on input
received from stakeholders, the European
Parliament and the general public. We are
confident that it strikes the appropriate
balance between attracting the best
experts while protecting EFSA against
undue influence.

EFSA’s efforts to increase transparency

continued in 2017 with 11 open plenary
meetings of its scientific panels – open
for the first time to “virtual” observers via
a new webcasting service. This innovation
means we can reach out to more people
while at the same time reducing the
carbon footprint and costs of our panel
meetings.
6
 7

Introduction
This report is the result of the first year of the second joint interagency antimicrobial
implementation of the EFSA Strategy 2020, consumption and resistance analysis report
which translates the key priorities into 5 and a set of indicators to help Member States
strategic objectives that are guiding EFSA to to assess their progress in reducing the use of
face new challenges and opportunities and antimicrobials. The efforts of our experts and
drives our day-to-day work programme. the collaboration with EMA and ECDC were
crucial to the developments in this field.
What you will find in the next pages is not
only an annual account of deliverables and We also made major advances in the
outputs, but a reporting of the progress made development of methodologies that will
towards the achievement of key objectives in improve the quality and robustness of EFSA’s
a result-oriented-approach, i.e. via annual and risk assessments. Chief among these were
multi-annual key performance indicators, as the Scientific Committee’s key guidance
presented in our Programming Document documents on weight of evidence, biological
2017-2019. In doing this, we analysed: (i) relevance, and uncertainty.
the intermediate impact indicators, that
measure the achievement of the strategic In 2017 electronic submission and
objectives in the long term across all activities; administrative workflows were piloted for
(ii) the outcome indicators, measuring the some applications and for the management
contribution of several activities towards of digital dossiers. EFSA started piloting a pre-
achieving partially a strategic objective in submission administrative check for small and
the mid-term; (iii) the output indicators that medium-size enterprises (SMEs) in the areas of
are the annual work programme indicators feed additives and novel foods.
directly linked to the outputs of specific At the beginning of July the EU Network of
activities in a strategic area. Agencies (EUAN) came together at EFSA’s
Our scientists addressed an impressive headquarters to discuss common strategic
quantity of work – more than 750 questions initiatives. In particular, they looked into
were delivered over the year. It is thanks to more efficient ways of working together
their commitment and energy that EFSA is to provide greater value for European
able to record in these pages another year of citizens. The meeting, also attended
relevant achievements. by representatives from the European
Commission and Parliament, was hosted by
It is not possible to do justice to the whole EFSA as Chair of the EUAN from March 2017
breadth of the work carried out in 2017, but until March 2018 comprising 45 Agencies
I would like to mention some representative and Joint Undertakings.
stand-out moments showcasing our daily
commitment to achieve our goals. On top of these and many other activities,
interactions continued with the Member
EFSA organised a symposium on bees States, DG SANTE and the European
that brought together a number of key Parliament. The annual exchange of
stakeholders resulting in the setup of views with the ENVI Committee saw the
a discussion group under the auspices of participation of EFSA senior management
our Stakeholder Engagement Approach to and scientific staff at various meetings on
lay the foundations for an inclusive EU Bee AMR, novel foods, processed oils, bee health,
Partnership. Equally successful was the first acrylamide, glyphosate, independence policy,
European research conference on Xylella GMOs and environmental risk assessment, EU
fastidiosa attended by 300 participants from Agencies value, data standardisation.
all over the world and followed by another
1,200 via live web streaming. A special I am pleased to share this report with you
video shot in Puglia, southern Italy, by so that you can discover for yourself how in
our multimedia team also helped to raise 2017 EFSA executed its mission to protect
awareness of this vital plant health issue. The European consumers.
fight against antimicrobial resistance (AMR) Bernhard Url,
stayed centre stage with the production of Executive Director
the report on the antimicrobial resistance,
 8

List of acronyms
AFSCO Advisory Forum and Scientific Cooperation Unit
AHAW Panel EFSA Panel on Animal Health and Welfare
ALPHA EFSA Animal and Plant Health Unit
AMU EFSA Assessment and Methodological Support Unit
AMR Antimicrobial resistance
ANS Panel EFSA Panel on Food Additives and Nutrient Sources Added to Food
APDESK EFSA Applications Desk Unit
BAU Business as usual
BIOCONTAM EFSA Biological Hazards and Contaminants Unit
BIOHAZ Panel EFSA Panel on Biological Hazards
BPA Bisphenol A
BUS Business Services Department
CBC EFSA Corporate Business Control Team
EFSA Panel on Food Contact Materials, Enzymes, Flavourings and
CEF Panel
Processing Aids
CEN Communications Experts Network
COMMS EFSA Communications and External Relations Department
CONTAM Panel EFSA Panel on Contaminants in the Food Chain
CORSER EFSA Corporate Services Unit
CRM Customer Relation Management Project
DATA EFSA Evidence Management Unit
DEV Development projects
DG SANTE Directorate General for Health and Food Safety
DOI Declaration of Interest
doi digital object identifier
DTS Digital Transformation Services
EC European Commission
ECDC European Centre for Disease Prevention and Control
ECHA European Chemicals Agency
EEA European Environment Agency
EFSA European Food Safety Authority
EKE Expert Knowledge Elicitation
EMA European Medicines Agency
EMAS Eco-Management Audit Scheme certification
ENP European Neighbourhood Policy
EU European Union
EUAN EU Agencies Network
FEED EFSA Feed Unit
EFSA Panel on Additives and Products or Substances Used in Animal
FEEDAP Panel
Feed
 9

FIN EFSA Finance Unit

FIP EFSA Food Ingredients and Packaging Unit
FTE Full-Time staff Equivalent
GMO Genetically Modified Organism / EFSA GMO Unit
GMO Panel EFSA Panel on Genetically Modified Organisms
GPS Global Performance Services Unit
HUCAP EFSA Human Capital Unit
IAS Internal Audit Service of the European Commission
IPCHeM Information Platform for Chemical Monitoring
IPPC International Plant Protection Convention
JRC Joint Research Centre
JRC-IPSC JRC Institute for the Protection and Security of the Citizen
LA EFSA Legal and Regulatory Affairs Unit
MB EFSA Management Board
MD programme Managers’ development programme
MP Methodologies Programme
MRL Maximum Residue Level
MS Member States
NDA Panel EFSA Panel on Dietetic Products, Nutrition and Allergies
NUTRI EFSA Nutrition Unit
OECD Organisation for Economic Co-operation and Development
OHSAS Occupational Health and Safety Assessment Series
Open ScAIE Open Scientific Advanced Information and Evidence Hub
PII Process improvement initiatives
PLH Panel EFSA Panel on Plant Health
PPR Panel EFSA Panel on Plant Protection Products and Their Residues
PRAS Pesticides
PROMETHEUS Promoting Methods for Evidence Use in Scientific Assessments project
RA risk assessment
RASA EFSA Risk Assessment and Scientific Assistance Department
RAW Risk Assessment Workflow
REGPRO Regulated products area
REPRO EFSA Scientific Evaluation of Regulated Products Department
RISKCOM EFSA Risk Communication Unit
ROA Rapid Outbreak Assessment
SC EFSA Scientific Committee
SCER EFSA Scientific Committee and Emerging Risks Unit
SDWH Scientific Data Warehouse project
SEA Stakeholder Engagement Approach
SSD2 Standard Sample Description project
TDI Tolerable Daily Intake
TERA Transparency and Engagement in Risk Assessment project
 10

Performance at a glance
The report is structured in three sections: (i) Work programme achievements; (ii)
Management of resources; and (iii) Assurance.

It provides information on those indicators already defined in 2016 together with a number
of new indicators that were pending and whose definition was foreseen in 2017. Figure 1
shows that, out of a total of 125 indicators, 60 were under definition in 2017. During the year,
39 indicators were defined (of which 7 were modified and 4 deleted). For the remaining
indicators, representing 17% of the total number of indicators, it was not possible to establish
a baseline in 2017 due to technical reasons; they will be defined in 2018. The holistic view of
the organisation’s performance will be completed next year.

Figure 1. Progress of the definition of EFSA performance indicators in 2017

20

18
2
16

14 4
1
6
12
3
10
5
4 2
8
1
3
6 2
10 2 10
1
4 8
1 7 7 1 7
2 6
3 5 5 5
2
3 3 3
2
1
0
Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output

SO1 SO2 SO3 SO4 SO5

Measured in 2017 Defined in 2017 TBD in 2018

Overall, EFSA’s performance in 2017 was satisfactory, as only 9 indicators presented moderate
deviation and 2 indicators relevant deviation, out of a total of 65 measured in 2017. These
moderate and relevant deviations, such as the moderate deviation in addressing the MRL
backlog, and some relevant delays in projects aiming at enhancing EFSA’s ability to anticipate
and respond to risks, are indicative of a growing mismatch between increasing demands and
shrinking resources. This needs to be taken into consideration together with the increased
demand foreseen in the coming years in novel food assessments, pesticides, rapid outbreak
assessments and plant pest categorisations. Further pressure will thus be exerted on EFSA’s
resources, as outlined in the EFSA Programming Document 2018-2020.

Scientific production exceeded the plan set at the beginning of the year. EFSA closed
779 questions through scientific opinions, technical reports and supporting publications,
of which 575 questions were closed with scientific opinions. Figures 3-4 give an overview
of EFSA’s performance in 2017 per strategic objective at the level of output, outcome and
intermediary impact indicators.
 11

Figure 2. Overall EFSA performance in 2017

21
17% 26
21%

39 28
31% 22%

2 9
2% 7%

Over-achieved Achieved Moderate deviation Relevant deviation Defined in 2017 TBD in 2018

Under strategic objective 1, towards increasing engagement and satisfaction in EFSA’s risk
assessment activities, the production of scientific outputs exceeded expectations, for both
general risk assessment and regulated products.

In the area of general risk assessment, timeliness was on target and EFSA exceeded the 2017
target of 114 closed questions by about 50%, with a total of 174 questions addressed through
scientific outputs and technical reports. This is mainly due to the completion of activities
related to animal health categorisation and the early completion of priority 1 plant pest
opinions. For regulated products, the production of scientific outputs and technical reports
exceeded the target by 13%; 458 questions were closed against an annual target of 408 for this
type of output. The most significant over-execution was in the areas of food flavourings and
food additives re-evaluation. This is mainly because of questions being grouped under a single
output. In pesticides, the specific target was not achieved, more specifically in the MRL Article
10 work (51 questions closed against 84 planned). The indicator monitoring reduction of the
Article 12 backlog reached 84% of the yearly target, but, as agreed with DG SANTE, it will be
absorbed at the beginning of 2018. The overall backlog reduction plan is not affected.

Overall, the timeliness for regulated products stands at 87%, excluding backlog. This is below
the 90% target, yet higher than the results achieved in previous years. Timeliness in 2017 was
below target in the areas of feed additives (74%) and pesticides (82%), mainly as a result of
limited resource availability; the other areas in regulated products delivered on time.

In the area of communication timeliness, a moderate deviation from the target is observed for
the indicator ‘Proportion of scientific outputs delivered within 28 working days of adoption (%)’.
An efficiency initiative is ongoing and expected to improve the performance in early 2018.

EFSA exceeded targets for its outcome KPIs in the area of enhancing outreach and
communication, with the number of social media followers and traffic on the EFSA web
content exceeding targets set for the year. However, the indicator on ‘Impact of media
coverage’ closed the year below target, with negative coverage related to glyphosate from
the second quarter onwards. It is worth mentioning that, in the first quarter of 2017, this
indicator had registered a better-than-expected result.

In terms of development activities, the majority of projects aiming at increasing engagement

of stakeholders in scientific activities and enhancing the outreach of communication on EFSA’s
scientific work are on track. Work done through the MATRIX project, aiming at improving
efficiency and making the documentation relevant to EFSA scientific outputs fully available to
its stakeholders, concluded with some delays and major lessons learned in the areas of dossier
versioning, case management, workflow improvements, and software integration.
 12

Under strategic objective 2, towards widening and opening EFSA’s evidence base, all
targets were met for the production of scientific outputs and data collection indicators
regarding design, implementation or enhancement to operational data. Wider and open
data coverage was ensured with the finalisation of the EFSA scientific data warehouse, which
provides public access at different levels of aggregation to EFSA’s chemical and biological
monitoring data, food consumption data as well as its chemical hazards (OpenFoodTox) and
botanicals databases. The ‘data DoI’ project, aiming at ensuring that datasets used in EFSA
risk assessments are citable by assigning digital object identifiers (DoIs) and meta data, is on
track. In the context of increased standardisation and interoperability of data, the EU Menu
project on food consumption data and the FOODEX2 project on food classification and
description system are on track.

In strategic objective 3, building the EU’s scientific assessment capacity and fostering the EU
risk assessment community, the target of the output indicator on Member State cooperation
activities through networks, workshops and events was met. Moreover, the target was
exceeded for the number of international cooperation activities, as well as for activities on
building the risk assessment agenda in the EU and fostering cooperation with international
partners, with the launch of two international liaison groups in the areas of chemical risk
assessment and risk communication. The expertise management programme (EMP) is on track
with the finalisation of a comprehensive catalogue encompassing all technical competencies
(scientific and non-scientific) and fully compliant with the European Commission
methodology. With an average of 77 job profiles, this competency library will enable a state
of the art workforce planning process, supporting an optimal allocation and development
of competencies. In the context of the ‘Increased common expertise pool coverage and
availability’ index, which was partially measured this year, the target of “total number of
applicants for panel renewal” was not reached, although considerable efforts were made. In the
same context, the first European food safety risk assessment fellowship programme (EU-FORA)
was successfully launched in September, with 15 fellows selected from 11 Member States.

Under strategic objective 4, towards strengthening preparedness for future risk assessment
challenges, the target for production of scientific outputs was exceeded. The relevant ongoing
projects aiming at fostering the use of new approaches and enhancing the ability to anticipate
and respond to risks are on track, with the exception of the project on the cumulative
risk assessment of pesticides, which experienced some delay. Activities on methodology
development are also on track, together with activities supporting the implementation of
guidance already provided by EFSA, e.g. uncertainty assessment. However, a number of
strategic initiatives linked to the development of additional capabilities, in both preparedness
and methodology development, such as environmental risk assessment, have been postponed
in view of the anticipated pressure on EFSA’s resources.

Activities related to strategic objective 5 are focused on the creation of an environment

and culture that reflects EFSA’s values. In that context, an Accountability Framework with
four pillars ensuring sound operational performance and overall compliance was set up
in 2017. The first pillar, the Decision-Making Framework (DMF), was finalised clarifying
roles, responsibilities and governance structures. The second pillar, EFSA’s results‑based
management approach, was enhanced with the full alignment of planning and reporting
activities and tools to the EFSA Strategy 2020 and the definition of supporting key
performance indicators (KPIs) allowing for easier monitoring of performance at all levels.
The third pillar of quality and continuous improvement was strengthened with the further
development of EFSA’s process management capability, which included significant progress
on process standardisation and change management – showcased with the confirmation of
EFSA’s ISO 9001:2015 Quality certification following the first surveillance audit, with no recorded
non-conformities. In the same context, EFSA obtained OHSAS 18001:2007 certification,
stressing compliance with Occupational Health and Safety Assessment Series programmes
(OSHAS), and was included in the European Eco-Management Audit Scheme register (EMAS).
Compliance, transparency and effective management through provision of integrated
assurance mechanisms, the fourth pillar of the Accountability Framework, is ensured with the
definition of 10 assurance pillars, which is specifically reported in the Assurance section of
this Annual Activity Report and in the performance reports submitted to EFSA’s Management
Board during the year. In this context, the compliance index is overall within the annual target
while the financial impact of non-compliance is far below the limit.
 13

EFSA’s efforts to improve performance are complemented by the benefits expected from
projects aiming at efficient talent management under the expertise management programme
(EMP), which shows a moderate deviation in time. In the same direction, projects under the
information management programme (IMP), particularly the digital collaboration project
–which aims to improve knowledge and expertise sharing among EFSA’s networks of staff,
institutional partners, experts and stakeholders – and the new world of work project – the aim
of which is to equip EFSA with state of the art digital and physical collaboration infrastructure –
started in 2017 with some moderate deviations due to risk of delays.

Excellent financial performance was observed at year-end, with best ever indicators in
terms of commitment and payment rates. Compliance with EFSA’s independence rules is
on track (processing of annual and specific declarations of interest), while EFSA’s revised
independence policy was adopted by the Management Board. The achievement of EFSA’s
strategic objectives is supported by a world-class IT service – metrics on service delivery and
end-user satisfaction exceeded targets (respectively at 89% and 94%), while the proportion
of meetings carried out by teleconferencing exceeded the annual target of 20%. Further
improvements linked to enhancement of project ownership and change management are
expected in 2018. Staff engagement improved, with a 78% engagement index (vs. 76% in
2015), an overall favourable rate of 66% (vs. 63% in 2015) and a response rate of 80% (vs. 64%
in 2015), providing reassuring measurement of EFSAs people engagement.

The overarching indicators on the achievement of targets against all KPIs showed relevant
deviations for the output and intermediate impact indicators (82% vs 100% and 71% vs 80%
respectively) and a slight exceedance of the target (92% vs 90%) for the outcome indicators.
The result confirms EFSA’s satisfactory performance but also the ambitious targets set for the
output indicator, demonstrating EFSA’s capacity to focus on achieving key results even when
challenged by resource bottlenecks to deliver on planned annual outputs.

Figure 3. Summary of 2017 performance by SO and type of indicator

12

10
2
8
5 1
2
1 1
6 2
1
1 5
4 2
5
6
5 1 5 5
2 4 2
2 2 2
1 1 1
0
Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output Int. Impact Outcome Output

SO1 SO2 SO3 SO4 SO5

Over-achieved Achieved Moderate deviation Relevant deviation

„„ Legend

Status Symbol Thresholds

Over-Achieved ] Actual/Target more than 105%

Achieved ] Actual/Target between 95% and 105%
Moderate deviation ] Actual/Target between 75% and 95%
Relevant deviation ] Actual/Target less than 75%
N/A ] Data not available for this period
 14

Section I — Work programme

achievements
1. Prioritise public and stakeholder engagement in the
process of scientific assessment
In the area of provision and communication of scientific advice for general risk assessment
priorities and regulated products, the year 2017 was rich with achievements, the details
of which are outlined in Annex IV. The Authority’s scientific advice supports the decision-
making process of the risk managers at the European Commission and in the Member
States in the areas of general risk assessment for food and feed, plant health, animal health
and welfare. EFSA’s mandate covers the risk assessment for regulated products and refers
to the scientific safety assessment of such products before their authorisation in the EU
market. These are substances in food and feed, food contact materials, pesticides, genetically
modified organisms, food-related processes and processing aids and the evaluation of
the scientific substantiation of nutrition and health claims made for these products and
processes.

The opinions and reports reflect the efforts to improve risk managers satisfaction and
prioritise stakeholders’ engagement in the scientific assessment processes. EFSA’s activities
aim at improving the involvement from stakeholders to ensure a common understanding
of the risk assessment process, to guarantee access for EFSA and stakeholders to all available
data and information, to promote transparency and ultimately assist the risk managers with
fit-for-purpose, timely and independent scientific advice. In 2017 EFSA closed a total of 174
questions in the area of general risk assessment, and 458 questions in the area of regulated
products, through scientific outputs and technical reports.

1.1. General risk assessment

Animal health and welfare

„„ Vector-borne diseases — story maps

In 2017 EFSA launched 36 interactive story maps providing innovative, user-friendly and
visually stimulating information on vector-borne diseases from their geographical spread,
to the risk of introduction in the EU, to prevention and control measures. The story maps
are part of a scientific opinion that supports risk managers to prioritise control measures.
The interactive web pages encourage public and stakeholder engagement by providing
a graphic and illustrative means of reviewing information about various animal diseases.
 15

They represent an additional effort to optimise access to data and provide a baseline for
a future assessment of an animal disease threat.

„„ Animal health law

EFSA produced 30 scientific opinions related to transmissible diseases in terrestrial and
aquatic animals, including assessment and categorisation of these diseases according to
the rules set out by the Animal Health Law (AHL) of Regulation (EU) 2016/429. The criteria
in the regulation constitute benchmarks for listing, categorising and determining disease
prevention and control rules applicable to the various listed diseases. These opinions provide
added value in the preparation of future policies on animal disease.

„„ Animal welfare
An example of EFSA’s efforts to engage with its stakeholders and to widen its evidence
base is represented by the work related to a request submitted by Denmark, Germany, the
Netherlands and Sweden to assess issues surrounding the slaughter of pregnant farmed
animals in Europe. It was concluded that livestock foetuses could experience negative effects
with 90-100 % likelihood. Regarding methods to stun and kill livestock foetuses at slaughter,
several scenarios and respective actions explain probable and less probable situations
regarding foetal ability for conscious perception. There is limited information on this topic
and EFSA’s scientific opinion, which is based on the experts’ judgement, offers insights that
can be used by risk managers across the EU.

„„ Animal disease outbreaks

During the course of the year EFSA provided assistance to the European Commission and
Member States in dealing with outbreaks of several animal diseases, in particular African
swine fever (ASF), lumpy skin disease (LSD) and avian influenza.

African swine fever, a devastating virus infection affecting domestic and wild pigs is present
in the EU. The infection was detected in Estonia, Latvia, Lithuania, Poland and Romania, with
the latest outbreak in the Czech Republic. EFSA prepared technical reports analysing the
epidemiological data and possible measures to control the outbreaks and describing the
evolving situation in the region. A workshop with stakeholders was organised to discuss
possible scientific actions to improve the prevention and control of ASF in the EU.

Lumpy skin disease is a viral infection affecting cattle which is transmitted primarily by
insects. EFSA technical reports released in this field included studies of temporal and spatial
patterns of this disease, as well as examination of risk factors related to occurrence, spread
and persistence of the virus among the cattle population. Information about vaccination
effectiveness in various Member States and neighbouring countries was provided, together
with proposals for harmonisation of data collection.

Europe experienced its largest avian influenza epidemic ever in terms of poultry holdings, and
wild birds reported positive and geographical spread. EFSA experts assessed the risk of avian
influenza entering the EU and reviewed surveillance approaches, which comprise monitoring
by Member States and the actions they take to minimise its spread. The scientific advice is
based on a thorough review of all the information on the avian influenza outbreaks that have
occurred in recent years. This was done in close cooperation with Member States affected
by this epidemic. In parallel, EFSA, ECDC, the EU Reference Laboratory on avian influenza and
authorities in the affected Member States published a report on avian influenza.
 16

Plant health and plant diseases

„„ Quantitative pest risk assessment

To support the new EU plant health regime, several pest risk assessments were adopted
applying a quantitative pest risk assessment methodology. These opinions are considered to
be pilots for testing the new EFSA PLH Panel quantitative methodology, based on assessing
changes in pest population abundance as the major driver of the impact on cultivated plants
and on the environment. Crucially, the approach is quantitative, and it captures uncertainty
through the provision, by risk assessors, of quantile estimates of the probability distributions
for the assessed variables and parameters. A strategy has been developed to communicate
the results of the risk assessment in a clear, comparable and transparent way, with the aim of
providing the requestor of the risk assessment with a useful answer to the question(s) posed to
the EFSA plant health panel including uncertainty and evaluation of risk reduction options.

„„ Plant pest categorisation

Within the framework of supporting the new EU plant health law and its secondary
legislation for the listing of EU regulated pests, EFSA has delivered 42 out of 133 step 1 plant
pest categorisation reports that are planned to be delivered in three batches throughout
2017-2020. This work is the first step of pest risks assessments and improves the preparatory
phase for future risk assessments.

„„ The risk of Citrus junos fruits for the introduction of citrus canker
In the area of plant diseases EFSA analysed two scientific papers provided by Japanese
authorities, as well as 16 additional papers identified through a systematic literature review as
it was asked to indicate whether C. junos fruit could represent a pathway for the introduction
of citrus bacterial canker into the European Union. EFSA concluded that there is sufficient
demonstration that C. junos is a host of X. citri pv. citri and X.citri pv. aurantifolii and that
therefore there is no reason to consider the C. junos fruit differently from other citrus species.

„„ E valuation of a  paper by Guarnaccia et al. (2017) on the first report of Phyllosticta

citricarpa in Europe
EFSA performed the evaluation of a paper by Guarnaccia et al. (2017) on the first report of
Phyllosticta citricarpa in Europe. The Authority reviewed the paper published in summer 2017 and
compared the findings with previous predictions on the establishment of the Citrus black spot
(CBS) fungus P. citricarpa. Preliminary surveys by national plant protection organisations (NPPOs)
have not confirmed so far the findings by Guarnaccia et al. (2017) but monitoring is still ongoing.

„„ Xylella fastidiosa
EFSA has continued the work on the global host plants database and issued a report on the
susceptibility of olive varieties to the Apulian strain of Xylella fastidiosa. The first European
research conference on Xylella fastidiosa was organised by EFSA in November 2017 in
cooperation with the two H2020 projects, the ERANET Euphresco network and the University
of the Balearic Islands. The conference was attended by 300 participants on-site and more
than 1,200 by web streaming.
 17

Antimicrobial resistance

„„ Report on antimicrobial resistance by EFSA and ECDC

Infections caused by bacteria resistant to antimicrobials lead to about 25 000 yearly deaths
in the EU. Bacteria found in humans, animals and food continue to show resistance to widely
used antimicrobials, says the latest report on antimicrobial resistance (AMR) produced by EFSA
and ECDC. The report also highlights that antimicrobial resistance levels in Europe continue to
vary by geographical region, with countries in northern and western Europe generally having
lower resistance levels than those in southern and eastern Europe. Experts recommend further
research to better understand interdependencies between antibiotics use and resistance.

„„ Link between antibiotic use and antibiotic resistance

EFSA, EMA and ECDC released the second Joint Interagency Antimicrobial Consumption
and Resistance Analysis (JIACRA) report. It presents new data on antibiotic consumption
and antibiotic resistance, and reflects on improved surveillance in the EU. There are still
important differences across the EU in the use of antibiotics in animals and humans. In
both humans and animals, positive associations between consumption of antimicrobials
and the corresponding resistance in bacteria were observed for most of the combinations
investigated. Responsible use of antimicrobials in both humans and animals should be
promoted, and reducing unnecessary use will impact the occurrence of resistance.

„„ Reduction of antimicrobial resistance and antimicrobial consumption

ECDC, EFSA and EMA jointly provided indicators to assist the Member States to assess
their progress in reducing the use of antimicrobials and antimicrobial resistance. These
indicators address the human and animal sectors and reflect antimicrobial consumption and
antimicrobial resistance in the community, hospitals and food-producing animals. They are
based on data gathered through existing monitoring networks and they follow up objectives
of the recent ‘EU One Health Action Plan against antimicrobial resistance’ (1).

Biological hazards
„„ Simpler rules proposed for small retailers
EFSA has proposed a simplified approach to food safety management in small retail
businesses such as grocery shops, butchers, and bakeries. The approach includes guidelines
on how to identify the most relevant biological, chemical and physical hazards at each stage
of the food production process, the activities or practices that make hazards more likely to
occur and appropriate control measures.

„„ Origin of isolated BSE cases

The European Commission asked EFSA to investigate the origin of isolated cases of bovine
spongiform encephalopathy (BSE) reported in the EU — although none of the 60 cases
reported since 2001 entered the food chain — and to determine their cause. EFSA experts
concluded that contaminated feed is the most likely source of infection and recommended
maintaining and strengthening the EU monitoring and reporting system, and evaluating
new scientific data that become available.

(1) https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf
 18

„„ EU summary report on the monitoring of transmissible spongiform encephalopathies (TSEs)

Transmissible spongiform encephalopathies (TSEs) are a group of diseases that affect the brain
and nervous system of humans and animals, and include bovine spongiform encephalopathy
(BSE), scrapie and chronic wasting disease (CWD). The report provides results on data collected
in 2016 by all EU Member States, Iceland, Norway and Switzerland. For the first time since the
BSE epidemic started and BSE cases have been reported, the UK did not report any BSE cases.

„„ EU summary report on trends and sources of zoonoses, zoonotic agents

According to the annual report on zoonotic diseases, the decreasing trend of salmonellosis
cases in the EU has levelled off. Cases of Salmonella Enteritidis acquired in the EU have
increased in humans by 3 % since 2014 says the report, which is compiled jointly with the
European Centre for Disease Prevention and Control. In laying hens, the prevalence increased
from 0.7 % to 1.21 % over the same period.

Contaminants in food

„„ Marine biotoxins
The CONTAM Panel assessed the risks for public health related to the presence of
tetrodotoxins (TTX) and TTX-analogues in marine bivalves and gastropods. These substances
are produced by marine bacteria and have been detected in marine bivalves and gastropods
from European waters. EFSA indicated that there is no general concern for human health due
to the consumption of marine bivalves.

„„ Pyrrolizidine alkaloids in tea, herbal infusions and food supplements

The CONTAM Panel also reviewed the risk assessment on pyrrolizidine alkaloids (PA).
Exposure to these plant toxins in food, in particular for frequent and high consumers of tea
and herbal infusions, is a possible long-term concern due to their potential carcinogenicity.
The experts identified 17 PA in food and feed that should continue to be monitored and
recommended further toxicity studies on those most commonly found in food.

Furthermore, the Panel on Contaminants in the food chain adopted a scientific opinion on
the risks for animal and public health related to the presence of deoxynivalenol, metabolites
of deoxynivalenol and masked deoxynivalenol in food and feed, and a scientific opinion
on the appropriateness of setting a group health-based guidance value for nivalenol and
its modified forms. EFSA also delivered two scientific reports on human and animal dietary
exposure to ergot alkaloids and to T-2 and HT-2 toxins.

„„ Furan and methylfurans in food — EFSA confirms health concerns

In 2017, the European Commission requested a risk assessment on furan and methylfurans in
food. EFSA concluded that exposure to furan and methylfurans in food could lead to possible
liver damage. The most exposed group of people are infants, mainly through consumption
of ready-to-eat jarred or canned foods. Exposure in other population groups is mainly from
consumption of grain-based foods and coffee, depending on age and consumer habits.

„„ Veterinary medicines, unauthorised substances and contaminants found in animals and

animal-derived food
Overall, 730 000 samples were reported in 2015 from the 28 EU Member States. The level
of non-compliance in targeted samples was 0.34 %, comparable to 0.25 %-0.37 % over
the previous 8 years, with resorcylic acid lactones, metals and mycotoxins lower than the
2014 report. The summary data reported suggest high rates of compliance overall and
demonstrate the strengths of the EU monitoring system and its contribution to consumer
protection and animal welfare.
 19

Rapid outbreak assessments

„„ Multi-country Salmonella outbreaks

EFSA, in collaboration with ECDC provided rapid outbreak assessments for Salmonella
Enteritidis in eggs and Salmonella 11:z41:e,n,z15 in sesame seeds outbreaks of various species,
supporting the risk managers in the identification of the source and in tracing activities.

„„ Histamine intoxications
The European Commission asked EFSA to investigate incidents of histamine intoxication in
EU linked to consumption of tuna and notified through the Rapid Alert System for Food and
Feed. The aim of the assessment was to verify the possible correlation upstream in the food
supply chain. As a result, correlations between incidents were detected, but a single event
that could be considered the origin of all clusters of human cases was not identified.

Nutrition

„„ Dietary reference values: vitamin K and riboflavin (vitamin B2)

In the area of dietary reference values (DRVs) EFSA delivered advice for vitamin K and for
riboflavin (2) (vitamin B2). In both cases a public consultation on the draft opinion was carried
out. Public consultations were also held for a draft scientific opinion on DRVs for sodium and
the related protocol.

„„ Infant nutrition, age of introduction of complementary food

With regard to infant nutrition, a protocol for a systematic review on health outcomes related
to the age of introduction of complementary food into an infant’s diet was published after
being subject to public consultation.

Food contact materials

„„ Bisphenol A hazard assessment protocol

The hazard assessment protocol to be used in an upcoming EFSA re-evaluation of BPA was
endorsed. In line with the ‘transparency and engagement in risk assessment’ (3) approach,
the draft protocol had undergone a public consultation and interested parties were invited
to attend to a workshop to actively participate in addressing key issues identified during
the public consultation. The protocol was revised by an ad hoc EFSA working group (WG)
composed of independent experts and experts nominated by national bodies. Feedback
from all involved parties had a significant impact on the final shape of the protocol that will
be used, in 2018, to determine whether new scientific evidence still supports the current
tolerable daily intake for BPA.

(2) Vitamin B2.

(3) The Transparency and engagement in risk assessment (TERA) project aims at increasing
transparency and public engagement to transform EFSA into an open science organisation.
 20

1.2. Regulated products evaluation

Support to applicants
In 2017, two administrative guidance documents, one on new food contact materials,
and one update on a genetically modified plant, were published. In the area of regulated
products EFSA also organised two webinars (novel foods, feed additives) and two info
sessions (novel foods, pesticides), 341 requests for information were replied to and 338
applications for regulated products were centrally registered and processed by EFSA. The
fourth roundtable with industry associations with all registered stakeholders from the group
‘Business and food industry’ was also organised. As of 1 June 2017, when an output related
to an application has been completed, applicants have the chance to complete an individual
satisfaction survey.

In support to the applicants, the MATRIX project developed and piloted electronic submission
and administrative workflows for applications submitted in the areas of PRAS, GMO and FEED
and the management of digital dossiers. Some deviations in the implementation of the IT
solutions were observed, leading to a slight delay compared to the initial schedule. As a result
a pilot phase involving external stakeholders was postponed to 2018.

EFSA launched a new support pilot initiative: the ‘pre-submission administrative check’
targeting small and medium-size enterprises (SMEs) in the areas of feed additives and novel
foods, excluding traditional food.

The ‘Update of the EFSA’s Catalogue of support initiatives during the life cycle of applications
for regulated products’ and the ‘Administrative Guidance for the processing of applications
for Regulated Products’, describing the principles used to process applications for regulated
products in EFSA were done.

„„ Food contact materials

In the area of food contact materials, the application of the opinion on uncertainties has
been piloted in a scientific opinion dealing with safety assessment of ethylene glycol
dipalmitate (EGDP) for use as a processing aid in various types of plastics, acting as
a lubricant to improve injection moulding and to improve the distribution of additives in the
polymer melt.

„„ Food enzymes
To ensure scientifically sound input data for the exposure assessment of food enzymes, EFSA
launched a call for data for additional processes: cereal-based processes, savoury snacks
processing, fat and oil processing, refined sugar production and processing, grain processing
for the production of starch, fibre and gluten.

„„ Food additives
In the area of food additives, EFSA completed assessment of one study on the
carcinogenicity of sucralose and issued one statement to refine the exposure assessment of
annatto colouring principles bixin and norbixin.

In addition, four calls for data were launched to gather relevant information for the
re‑evaluation of food additives, phosphates and sweeteners. A workshop with stakeholders
on the re-evaluation programme was held with the aim of sharing lessons learnt from the
experience and to ensure engagement from all interested parties in the future activities.
EFSA also completed an assessment of the safety of hydroxyanthracene derivatives found
in botanical extracts used as ingredients of food supplements for laxative purposes in the
context of Regulation (EC) No 1925/2006.
 21

„„ Nutrition
In the context of infant nutrition, the NDA Panel delivered a scientific opinion on safety and
suitability for use by infants of follow-on formulae with a protein content of 1.6 g/100 kcal.
The opinion supported the European Commission to prepare its position at the Codex
Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) regarding the
minimum protein content in follow up formulae.

„„ Novel foods
To prepare for a new novel foods regulation, EFSA organised the first meeting of the EFSA
Scientific Network on Novel Foods aiming at facilitating exchange of information and to
reinforce the collaboration in the area of novel foods. The Member States discussed the
methodology for searching information as well as the approach to streamline submissions of
‘dully reasoned safety objections’ related to traditional foods coming from third countries.

„„ Pesticides
EFSA carried out several activities as a follow-up of the glyphosate evaluation: an Article 12
MRL review and the associated assessment of the risk of glyphosate to animal health
and an EFSA Conclusion on the potential endocrine disrupting properties of glyphosate
were adopted. Additional activities to further clarify EFSA’s assessment of glyphosate were
performed: two statements requested from the European Commission in response to
allegations made in the so-called ‘Monsanto papers’ were produced, and a scientific review
explaining the differences between the EFSA and the IARC evaluation was published in
a top-ranking scientific journal.

In parallel, re-evaluation of the risk of three neonicotinoid insecticides to bees following

a public call for data was conducted and launched for the final consultation with the
Member States in December.

Moreover, in the area of pesticides, EFSA was requested by the European Commission to prepare
comments on the Session of the Codex Committee on Pesticide Residues (CCPR); the related
Scientific Report of EFSA was the basis for deriving the EU position for the CCPR meeting.

The 2015 Annual Monitoring Report on Pesticide Residues, which analyses data from the 28
Member States was also completed.

Furthermore, the Pesticides Steering Network finalised an action plan for improving the peer-
review process, which has been presented at the Standing Committee and is already partially
implemented.

1.3. Stakeholders’ engagement and communication

Stakeholders’ engagement
Many activities under the pilot phase of the new Stakeholder Engagement Approach (SEA)
took place, including: the first annual Stakeholder Forum and Bureau meetings, the annual
Roundtable meetings with industry and NGOs, the launch of the Communicators Lab, a pilot
initiative to enhance engagement with EFSA’s registered stakeholders. A discussion group
on bee health was organised by EFSA in support of its work towards facilitating an EU Bee
Partnership among stakeholders.
 22

Aiming at further increasing transparency and fostering engagement of the stakeholders

throughout the risk assessment process, the TERA project delivered three more of the
planned measures:

„„ Enhancing use of consultation in different steps of risk assessment process (includ-

ing pilot on draft mandates);
„„ Consultation meetings with Member States authorities introduced;
„„ Enhanced transparency on reopening of opinions process.

In addition, EFSA carried out 11 open plenary meetings of its scientific Panels and Committee
in a new webcasted format, with both physical and online observers. The overall response
has been very positive so far, emphasising that web-streaming considerably decreases the
carbon footprint and costs of the event and is an excellent example of transparency. Work is
ongoing on the deployment of the measure targeting to ‘Timely and more detailed minutes
of scientific meetings published’, while the ‘Guidelines on use of consultation across the risk
assessment process’ were approved in December 2017.

A number of opportunities for engagement with EFSA’s stakeholders have taken place in
Parma. Examples are: the 1st Stakeholder Forum with the participation of the chair of EFSA’s
Management Board (MB) and over 50 registered stakeholders, aiming at fostering public and
stakeholder involvement in the process of risk assessment. The Communicators Lab has been
launched as way of eliciting feedback from EFSA’s registered stakeholders; the setting up of
Stakeholder Mandates Working Group as a new targeted engagement modality.

Media and social media

EFSA responded to approximately 800 media requests and facilitated 106 interviews (more
than twice as many as 2016) with leading media, 20 of which with the Executive Director on
sensitive topics such as glyphosate and independence. The overall impact score for media
was 15 on a scale from – 100 to + 100, down slightly from last year due to ongoing public
debate on glyphosate. A pilot project encouraging staff to use social media to promote EFSA
activities was completed and showed positive results.

Content production and dissemination

„„ Extensive multimedia output including, first data visualisation tool for antimicrobial
resistance; video, animations and tutorials for the Bees and Xylella conferences; 2018 panel
renewal call materials; videos on novel foods, alternatives to animal testing, mycotoxins,
staff/expert recruitment, network of agencies; infographics on GMOs, cooperation, meat
safety, OpenFoodTox; news on glyphosate, endocrine disruptors, hepatitis E, nitrates/
nitrites and furans; design input to improve the quality of scientific posters.
„„ Improvements to the EFSA website: several new features, public consultations now
available in real time, catalogue of cross-cutting guidance and search improvements.

The EFSA Journal published around 550 scientific outputs. Article downloads grew to over
1.5 million. The introduction of a new homepage ‘hub’ gives greater impact and delivers
functions such as new search and navigation features and the ability to create themed issues
on any aspect of EFSA’s work — from AMR to zoonoses. The listing of the EFSA Journal on
a key global bibliographic database — the Emerging Resources Index — is an important
step in strengthening its outreach and visibility.
 23

1.4. Performance indicators

Output indicators
Indicators available to monitor performance in this area are presented in Tables 1-5 below
and a summary status report for the key projects under strategic objective 1 is presented in
Annex III. Overall the performance exceeds expectations with some deviations described
below.

The production of scientific outputs and technical reports overall exceeded the target in
the area of general risk assessment (158 questions closed through scientific outputs and
16 through technical reports for a total of 174 achieving 152 % of the annual target of 114
closed question for this type of output). The increased number of questions closed is mainly
due to the completion of activities related to animal health categorisation and the early
completion of priority 1 plant pests opinions. Two opinions in the area of contaminants and
the Transmissible spongiform encephalopathy EU scientific report (TSE EUSR) 2016 have
also been finalised before the deadline. The annual target has also been largely exceeded
for questions delivered for ‘other publications’ as several external scientific reports were not
included in the initial plan.

Timeliness is on track with one scientific report of EFSA not meeting the deadline. The delay
is due to data discrepancies identified during the finalisation of the report. In agreement
with DG SANTE an ultimate consultation with the MS was decided in order to cross-check
and analyse the raw data. No other questions in SO1 general RA were closed late in this
reporting period.

Table 1. Activity and outputs indicators for SO1 — General risk assessment

ACTIVITY — OUTPUT INDICATORS

General risk assessment
IndicaWtor Executed Target Executed Status
2016 (4) 2017 2017
Number of questions delivered for
60 114 (5) 174 ]
scientific outputs and technical reports
29
Number of questions delivered for ‘other 7
(28 external/
publications’ (6) (external reports, event 74 (external ]
1 event
reports) reports)
report)
Proportion of scientific/technical
100 % 100 % 99.4 % ]
questions adopted within deadline

The production of scientific outputs and technical reports exceeded the target in the area
of the evaluation of regulated products (392 questions closed through scientific outputs
and 66 through technical reports, against a target of 408 closed questions and therefore
achieving 113 % of the annual target). The most significant over-execution, with 132
questions closed against the 99 planned, is observed in the areas of food flavourings and
food additives re-evaluation because of grouped questions under a single output. Despite
the overall over-execution for regulated products, the target was not achieved in the

(4) Allocation to SO is not available for 2016 as this new classification is new as of 2017.
(5) Significant increase of target 2017 is due to new requests foreseen to be received for plant pest
categorisation (approximately 150 questions in 2017-2019), which have a lower complexity
compared to regular questions.
(6) According to definitions of EFSA outputs (http://www.efsa.europa.eu/en/efsajournal/
scdocdefinitions).
 24

pesticides area, especially in the MRL Article 10 (51 questions closed against 84 planned),
while the conclusions on pesticides peer review almost reached the yearly target, improving
performance by the end of the year.

The annual target has also been largely exceeded for questions delivered for ‘other
publications’ as several external scientific reports were not included in the initial plan.

Article 12 backlog reduction in PRAS is not on target as 38 questions were closed out of
45, representing 84 % of the yearly target; in agreement with DG SANTE, the remaining
questions planned to be closed in 2017 will be included in a later statement in 2018, when
the respective MRL regulations will have been voted on.

Timeliness (excluding backlog) is on target in the areas of food ingredients and packaging,
nutrition, and genetically modified foods (all exceeding the 90 % target). The target was not met
in the area of feed additives (74 %) and pesticides (82 %). Overall, the timeliness for regulated
products is below the 90 % target (86.3 % excluding backlog) but still higher than previous years.

Regarding the indicator related to the feedback of applicants on the regulated product
opinions, as the response rate for 2017 is too low to establish a meaningful baseline, EFSA is
exploring potential alternative methods/tools of measurement and mitigating actions.

Table 2. Activity and output indicators for SO1 — Regulated products

ACTIVITY — OUTPUT INDICATORS
Regulated products evaluation
Indicator Executed Target Executed Status
2016 (7) 2017 2017
Number of questions delivered for
scientific outputs and technical 373 408 458 ]
reports
Number of questions delivered 74 2 8
for ‘other publications’ (8) (external for all (external (external ]
reports, event reports) activities reports) reports)
Number of questions in backlog in
46 45 38 ]
PRAS (Article 12 only) delivered
Proportion of scientific/technical
90 % 90 % 86.3 % ]
questions adopted within deadline
Number of service catalogue
50
activities with applicants (meetings, + 10 % (55) 68 ]
per year
webinars, info sessions, etc.)
Percentage of positive feedback on
TBD in TBD
regulated product opinions from NA NA
2018 in 2018
applicants

The indicator ‘Proportion of scientific outputs delivered within 28 working days of adoption
(%)’ has improved compared to the third reporting period performance (currently 75.58 %
vs 70.15 %), but it did not reach the target. Waiting for the results of the efficiency initiative,
expected early in 2018, the Department decided to reduce the target for next year to the
more realistic 80 %.

On the other hand, the indicator ‘Total number of registered stakeholders’ will be reviewed
for 2018, after the result of the first evaluation of the implementation of the pilot under the
‘stakeholders engagement approach project’, that was presented at the Management Board
meeting in December 2017.

(7) Allocation to SO is not available for 2016 as this classification is new as of 2017.
(8) According to definitions of EFSA outputs (http://www.efsa.europa.eu/en/efsajournal/
scdocdefinitions).
 25

Table 3. Activity and outputs indicators for SO1 — Communication and engagement

ACTIVITY — OUTPUT INDICATORS

Communication and engagement
Indicator Executed Target Executed Status
2016 2017 2017
Proportion of scientific outputs
delivered within 28 working days N/A 85 % 75.58 % ]
of adoption (%)
Number of (i) media and (ii)
stakeholder enquiries addressed N/A TBD in 2017 95 % N/A
within agreed deadlines (9)
Number of public consultations
N/A TBD in 2017 20 N/A
on EFSA outputs
Percentage of positive feedback
from engagement activities carried N/A TBD in 2017 90 % N/A
out with registered stakeholders
Total number of registered
70 85 (10) 107 ]
stakeholders

Outcome indicators
The targets for all indicators at outcome level are exceeded. It is acknowledged that they
were underestimated and will be redefined; one reason is the launch of promotion actions
to increase followers. This was not taken into consideration when defining the targets in the
planning phase.

(9) 15 working days deadline is set by the Ask EFSA SOP.

(10) 102 as of 31/08/2017.
 26

Table 4. Outcome indicators for SO1

KPI Indicator Baseline Target Executed Status

2017 2017
Enhance outreach of communication
Increase followers from + 46 % + 3 % + 32 %
(41 964)
]
social media platforms (40 742) (55 223)
Social media + 30 % + 90 %
Social interactions 14 881 ]
effectiveness (19 345) (36 741)
Traffic to EFSA web 2.6 % + 2 % + 21 %
(64 759)
]
content from social media (63 464) (78 436)
Traffic to EFSA’s web content (web metrics): + 0.5 % + 6 %
2.9 m ]
number of sessions (2 986 599) (3 184 611)
Number of subscribers to online +1 % + 4.8 %
33 934 ]
subscription products (newsletter and alerts) (34 273) (35 914)
Impact visibility and discoverability
TBD in
of EFSA’s scientific outputs (access, N/A N/A N/A
2018 (11)
downloads, citations)
Increased engagement of stakeholders in scientific activities
Number of contributions
TBD in
received — total and by N/A 1 943 N/A
2017 (12)
stakeholder group
Stakeholders
Sub-
engagement
Number of relevant indicator
during public TBD
contributions used in EFSA N/A deleted as N/A
consultations in 2017 non-fit-for-
outputs (13)
and other purpose (14)
stakeholders
engagement Survey feedback from
activities SEA-registered members Results
on the effectiveness N/A N/A under N/A
of EFSA’s stakeholder elaboration
engagement activities
Full availability of documentation relevant to EFSA’s scientific outputs
Proportion of EFSA’s
Availability of
scientific outputs
documentation TBD in 2017
providing direct access N/A 0 N/A
used in EFSA’s N/A (15)
scientific outputs (links) to datasets and
metadata

Intermediate impact indicators

The currently available indicator is the ‘impact of media coverage’ that is slightly below target
and below the baseline 2016. This is due to the negative coverage related to glyphosate
which started in Q2 2017.

(11) From an overall journal citation point of view application to the citation index will take place in
2017 with metrics available in 2018.
(12) Average number of total comments received through public consultations in 2016-2017. Waiting
for stakeholder groups analysis.
(13) The sub indicator is deleted.
(14) See PD 2018-2020 Appendix C.
(15) The execution 2017 will be the baseline.
 27

Table 5. Intermediate impact indicators for SO1

KPI Baseline Target Executed Status

2017 2017
Intermediary impact: Increased satisfaction of stakeholders regarding EFSA’s scientific
outputs (for EC/MS risk managers and stakeholders) and the scientific assessment process
and communication tools and material.
2016 feedback
Satisfaction via exercise Results
feedback surveys: Risk managers (external
Annual
under N/A
positive and (EC/MS) comparison
evaluation elaboration
relative qualitative survey)
improvement
(with regard to Results
follow-up actions) Stakeholders 65 % 65 % under N/A
elaboration
2014 Apdesk
survey: index
score = 12
Applicants N/A N/A
(on a scale
from – 100 to
+ 100) (16)
To be
EFSA Journal 85 % (17) defined in 70 % N/A
User satisfaction 2017
rating of
communication To be updated
tools and Other at year end. To be Results
materials communication external provided at under N/A
products evaluation year end elaboration
survey
Impact of media coverage (EFSA’s
coverage in the media, including 18 20 13.65 ]
the favourability of articles)

2. Widen EFSA’s evidence base and optimise access to its data

Accurate and efficient data collection is essential for the integrity of the risk assessment
process. The work done closely with the Member States, the European Commission and the
international bodies to collect, analyse and summarise relevant scientific data is part of the
sustained programme of scientific data collection activities falling under strategic objective 2.
The scientific ‘Data Warehouse’, ‘Knowledge Junction’ ‘Data DOI’ projects are examples of
contributions to increase the transparency and reproducibility of EFSA’s risk assessments.

2.1. Databases and data reports

A Scientific Data Warehouse providing exploratory data visualisations for food consumption,
food composition, zoonoses, antimicrobial resistance, OpenFoodTox (18), contaminant
occurrence, pesticide residue occurrence and the compendium of botanicals was put in

(16) EFSA changed the approach in collecting feedback from applicants following comments
received on a perceived survey fatigue; however, the response rate for 2017 is too low to establish
a meaningful baseline. EFSA is investigating the reasons for the low response rate and will take
mitigating actions if needed.
(17) Outcome 2016 journal survey.
(18) Chemical hazards database.
 28

place. Information for action reports was provided to support experts working on African
swine fever, norovirus in oysters and veterinary medicinal product residues.

A ‘Knowledge Junction’ (Open SCAIE Project) curated community on the ‘Zenodo platform’
enabling the exchange of evidence and supporting materials used in food and feed safety
risk assessments, with the goal of improving transparency, reproducibility and evidence
reuse was created. In December 2017 the community contained 23 datasets, 30 coded
objects and 1 062 reports with contributions from 20 Member States.

EFSA also set up an ad hoc data collection on fipronil and other substances’ residues in eggs
and poultry meat/fat as a follow up to the identification of eggs contaminated with fipronil
on the European market in July 2017. Analytical results from some 8 321 samples of eggs
and chicken muscle/fat were submitted to EFSA and summarised in a scientific report on the
occurrence of residues of fipronil and other acaricides in chicken eggs and poultry muscle/fat.

2.2. Scientific literature

As before, continuous access to scientific literature was provided, including more than
60 000 articles and more than 3 000 documents provided by document suppliers. This
was combined with a more intense support in the development and appraisal of literature
searches for scientific assessment.

In addition, the ‘Data DoI’ project was started to define a proactive approach to data
publication from EU coordinated monitoring programmes and surveys and from the EFSA
scientific data warehouse to make EFSA data citable. Development has also started on the
use of application programming interfaces (API) to facilitate the exchange on information
between EFSA and other open data portals (e.g. IPCheM portal, EU Open data portal, OECD
eCheM portal).

2.3. Data standardisation

In order to support the food consumption data collection, within the frame of the EU MENU
project, towards more standardised food consumption data at European level, a total of seven
dietary surveys from four Member States have been completed and data delivered to EFSA.

With a view to strengthening collaboration with other organisations in the remit of

data exchange and interoperability, EFSA joined the Global Open Data for Agriculture
and Nutrition network and, together with ECHA and EMA, laid the foundation for the
establishment of a European Parliament working group on harmonisation of chemical data
with a view to increased sharing, analysis and dissemination of data.

EFSA also delivered a new tool called ‘Food Additives Intake Model 2.0’ (FAIM) that can be
used by applicants, risk assessors and risk managers to estimate chronic dietary exposure to
food additives. Exposure results are provided for different population groups such as infants,
toddlers, adults and for different countries. FAIM is based on data collected from Member
States on food consumption and stored in the EFSA Comprehensive European Food
Consumption Database.

Several training sessions to EU candidate countries were delivered by the Agency on reporting
of veterinary medicinal product residue (VMPR) data, pesticide residue data as well as zoonoses
monitoring data to EFSA. In addition, training was delivered to the Member State data
providers in view of the first Member States direct reporting to EFSA on data on TSE.

Following the completion of the standard sample description version 2 (SSD2) pilot project,
the Member States agreed, on the occasion of the first joint meeting of the pesticide
monitoring and chemical occurrence data networks, to implement the new standard using
a phased approach until 2020. The added value is that at least six European data collections
will use this common standard for data transmission to EFSA. In addition, the first joint
network meeting of the veterinary medicinal product residue and pesticides data networks
 29

took place with a view to streamlining reporting between the VMPR and pesticide residue
data domains coming from the Member States and collected by EFSA.

One main achievement towards widening the EFSA’s evidence base and increasing access
to its data has been the new library services approach where a new, user-friendly library
portal with enhanced services and a discovery tool simplifying the scientific literature data
collection was implemented.

EFSA also delivered several training sessions on FoodEx (EFSA’s food classification and description
system) to European data providers as well as to non-European and international organisations.

2.4. Information management progWramme

Information Access Management (IAM) project

In 2017, the Information Access Management (IAM) project delivered a solution for accessing
EFSA’s information by means of a central IT service BuS and by establishing a new identity
management solution to ensure proper access management, i.e. secure access control for
users and user groups. EFSA’s IT tools can now exchange data and information through
reusable mechanisms replacing existing cumbersome processes. Examples of solutions
delivered in 2017 include exchange of information between RAW, MOS, DCF (19), and the
EFSA website. In 2018, the project will support the enforcement of master data management
principles, especially for people and organisations, and the further fine-tuning and securing
of the identity management.

Within the frame of the EFSA information governance project, an EFSA information
governance framework was established to govern EFSA’s information assets.

2.5. Performance indicators

Output indicators
Indicators available to monitor performance in this area are presented in Tables 6-7 and
a summary status report for the key projects under strategic objective 2 is presented in
Annex III. Overall the performance is satisfactory and described below.

The production of questions closed through scientific outputs and technical reports meets
the target with 10 questions closed. The number of questions closed through publication of
other EFSA outputs exceeded the target.

The timeliness for scientific and technical outputs is at 90 %: one technical report adopted
after the deadline.

The ‘Number of new data collections under design’ reached the annual target with fipronil
data collection designed in response to an urgent request from the Commission. EFSA is
working on a mandate to consider feasibility options for a whole genome sequencing joint
database with ECDC.

With respect to the ‘number of new data collections under implementation’, the work is
on track with TSE-BSE finalised. The urgently requested fipronil data collection has been
implemented.

(19) Risk assessment workflow; Meeting organisation system, data collection framework.
 30

Finally the ‘number of enhancements to operational data collections’ achieved the target
with the completion of the new catalogue browser and conversion from SSD2 (20) to SSD1
and the new enhancements are now in place.

Table 6. Activity and output indicators for SO2

ACTIVITY — OUTPUT INDICATORS

Indicator Executed Target Executed Status
2016 (21) 2017 2017
Number of questions delivered for
15 10 10 ]
scientific outputs and technical reports
Number of questions delivered for ‘other 21
publications’ (external reports, event 15 15 (external ]
reports) reports)
Proportion of scientific/technical
100 % 100 % 90 % ]
questions adopted within deadline
Number of operational data collections
prepared and opened within deadline 12 (22) 13 13 ]
(total and open)
Number of new data collections under
1 (23) 2 2 ]
implementation
Number of new data collections under
2 (24) 2 2 ]
design
Number of enhancements to operational TBD
20 20 ]
data collections (25) in 2017

Outcome indicators
Regarding the data accessibility index aiming at demonstrating improved access to data,
the annual target is reached for the data collections published with no data aggregation
from EFSA. Examples are contaminants-owned data, chemical hazard, and composition data,
datasets for disease status and animal population.

On the data collections and dashboards where EFSA performs aggregation, delivery of
dashboards reached the annual target (15). FAIM template is completed and available
for external users; Pesticide residues 2015 data had to be rebuilt and published, and
Consumption EUMENU dashboard had to be rebuilt and it is finalised, but could not be
published. An additional dashboard for EFSA-owned data on chemical contaminants was
finalised and contributed to reach the target.

The outcome indicators were defined during the year and a baseline is created. Especially
for the index for the European interoperability framework for European public services/
interoperability maturity model (EIF/IMM index) a corporate information management
governance was set up in 2017 and the index will be developed in 2018.

(20) Standard Sample Description.

(21) Allocation to SO is not available for 2016 as this new classification is new as of 2017.
(22) Data collections on: chemical contaminants, veterinary, medicinal products, pesticides residues,
food consumption, additive usage, additive occurrence, molecular typing and zoonoses.
(23) TSE/BSE.
(24) At least two data collections: SSD2-Matrix, animal health and plant health.
(25) This output indicator was indicated as ‘to be defined’ in the SPD 2017-2019.
 31

Table 7. Outcome indicators for SO2

KPI Indicator Baseline Target Executed Status
2017 2017
Outcome: Improved access to data
Number of publicly
accessible data collections
1 (26) 5 5 ]
Data published with no data
accessibility aggregation from EFSA
index Number of data collection
dashboards/aggregates 11 (27) 15 15 ]
published
Outcome: Wider data coverage
Number of digital objects (evidence) 500
N/A 500 N/A
uploaded to EFSA’s open repository (in 2017)
Outcome: Increased standardisation and interoperability of data
Share of regulated product areas covered TBD
N/A 0 N/A
by structured data in 2017
To be
Increased maturity in data interoperability —
defined in N/A N/A N/A
EIF/IMM index (28)
2018
Outcome: Improved quality of data
To be
Data quality index (29) defined in N/A N/A N/A
Q2 2018

Intermediate impact indicators

All intermediate impact indicators were defined during the year and are presented in Table 8.

(26) Compendium of botanicals.

(27) Chemical contaminants (occurrence), pesticide residues, zoonoses outbreaks, animal populations,
animal diseases, prevalence, antimicrobial resistance, food consumption, botanicals, food
composition, EFSA-owned raw data dashboards.
(28) European interoperability framework for European public services/interoperability maturity
model. A corporate information management governance was set up in 2017. The index will be
developed in 2018.
(29) The three most relevant data quality dimensions for EFSA scientific data collections: e.g.
accuracy — data plausible, representative, well coded; completeness — all information required/
recommended is reported; timeliness — information is reported according to deadlines and
update according to agreed timelines.
 32

Table 8. Intermediate impact indicators for SO2

KPI Indicator Baseline Target Executed Status

2017 2017
Intermediary impact: Increased satisfaction of stakeholders regarding EFSA’s evidence
management services and fostered innovative reuse of data
TBD with
Satisfaction via feedback surveys: positive Results
external
and relative qualitative improvement N/A under N/A
evaluation
(with regard to follow-up actions) elaboration
survey
User statistics from
800 in 2017 N/A 800 N/A
the data warehouse
User statistics
from the evidence
Use and reuse of hub (Open-ScAIE/ 1 105 (30) N/A 1 105 N/A
EFSA’s accessible knowledge
data and evidence Junction)
Data/evidence
re-used by TBD in
NA N/A N/A
stakeholders via 2018
citation statistics

3. Build the EU’s scientific assessment capacity and

knowledge community
EFSA aims to set up cooperation initiatives that make the best use of expertise for scientific
assessment through a partnership between EFSA staff, scientific experts and Member State
organisations. With the aim of ensuring that the scientific work and corporate initiatives are
supported with appropriate outreach tools to engage with the relevant audience, in the area
of scientific cooperation, capacity building and expertise management, cooperation with EU
agencies and Commission activities, the achievements from the implementation of the EFSA
work programme were many.

3.1. European cooperation and networking

Cooperation with Member States continued to be developed through new partnering
grants aimed at building capacity between countries, along with ongoing discussions on
international capacity building in an Advisory Forum discussion group. The trial of a new
electronic newsletter, sharing upcoming scientific cooperation events from Member States
and EFSA, provided successful.

The Executive Director visited Austria, Bulgaria, Czech Republic, Estonia, Iceland, Italy, Malta,
Poland and Slovenia. Tangible outcomes of the visits are the doubled number of guest
scientists (22) coming to EFSA and 36 joint projects addressing common priorities and
emerging risks, such as whole genome sequencing and African swine fever.

EFSA was invited by the European Commission and EU presidencies to present the outcome
of its work (African swine fever, Xylella fastidiosa, fipronil) at various high-level ministerial
meetings Similarly, EFSA addressed CVOs and COPHs during both the Maltese and Estonian
presidencies to update on areas of interest.

(30) Number of uploaded and curated digital objects — consolidating 5-year period.
 33

Biohaz scientific networks

The networks on microbiological risk assessment (MRA) and transmissible spongiform
encephalopathies (TSE) met in October 2017 and shared risk assessment experiences. MRA
network experts discussed topics such as Listeria monocytogenes, food-borne parasites,
Yersinia spp., ESBL-producing Escherichia coli, risk assessment of the dairy supply chain.
Members of the TSE Network updated each other on recent/ongoing TSE-related activities
and discussed topics such as Chronic Wasting Disease in cervids, and TSE.

Zoonoses networks
A joint meeting of EFSA’s Zoonoses Monitoring Data Network and ECDC’s FWD Network
was held on 16-17 October 2017, and focused on the ‘One Health approach to collaborative
response to foodborne disease outbreaks in EU/EEA’. The EFSA’s Zoonoses Monitoring Data
Network held its annual meeting in October 2017 in Parma. The networks for Zoonoses
Monitoring Data — subgroups Data Reporting on Antimicrobial Resistance and on TSE-BSE
were held in November 2017 in Parma.

Article 36
Ensuring that EFSA’s Article 36 List is updated regularly, EFSA managed 154 profile
updates throughout 2017. Following 17 inclusions of newly designated organisations and
eight deletions of entries from the list, by December the list contained 360 entries from
30 countries (EU Member States, Iceland and Norway). To strengthen European networking
and cooperation amongst competent organisations and EFSA, the Article 36 project closely
collaborated with Member States to simplify procedures and establish a new IT tool. The
project will continue in 2018, integrating processes and tool, and supporting Member States
in implementing the new way of working.

3.2. International cooperation

EFSA continued to implement its international cooperation work plan through high-level
visits to Japan and China, by organising seminars with international partners and Member
States agencies and by exchanges of guest scientists from Chile, China and Japan. EFSA
launched two new international liaison groups in the areas of chemical risk assessment and
risk communication, and it developed a Memorandum of Cooperation with the Food Safety
and Standards Authority of India.

3.3. Scientific capacity building

Expertise management programme
Through its Expertise Management Programme (EMP), EFSA is pursuing its efforts to develop
a comprehensive competency-based approach to talent attraction, career management
and talent retention for staff and experts and ultimately attract the best available expertise.
During 2017 important milestones were reached with:

„„ The finalisation of a comprehensive catalogue encompassing all technical compe-

tencies (scientific and non-scientific) and fully compliant with the European Com-
mission methodology. With an average of 77 job profiles, this competency library
will enable a  state-of-the-art workforce planning process, supporting an optimal
allocation and development of competences.
„„ The call for the renewal of all scientific panels and the Scientific Committee pub-
lished in June using a new recruitment e-solution, the newly established compre-
hensive library of scientific competences and a new IT tool to process the decla-
 34

rations of interest, in alignment with the new Independence Policy. Following

a thorough evaluation procedure initiated in Q3, the final outcome of the selection
process was presented to the Management Board in March 2018. However, despite
a targeted campaign using multitenant channels enabling a 17 % increase in the
number of applications started (2 330 against 1 921 for the previous call), the Pro-
gramming Document target of 1 725 applications submitted could not be reached
(1 079 vs 1 150 from the previous call).

In preparation of next year’s activities the Programme is developing a business case for an
‘EFSA Academy’ with the objective to evaluate the efficiency gains that will be brought by
the design and setting-up of a centralised hub aiming at fostering knowledge acquisition
and exchange among EFSA staff and experts and with the European risk assessment and risk
communication community.

EU-For a Fellowship Programme

The first European food safety risk assessment fellowship programme, EU-FORA, was
successfully launched in September for 15 fellows from 11 different Member States, who
started the 12-month placement at eight hosting sites in seven Member States. Partnerships
with academia resulted, via summer schools and info sessions, in reaching out to over
300 young scientists from 42 countries. EFSA hosted 25 guest scientists from 13 different
countries worldwide.

Innovative ways for strengthening capacity

EFSA explored in a first feasibility study crowdsourcing in order to explore the vast
untapped reservoirs of scientific knowledge and technical skills that could help us to do
risk assessments and other scientific work, thereby going beyond the usually targeted
community of knowledge. For this EFSA look for up-and-coming researchers, retired
professors, skilled technicians working in other fields or passionate thinkers with innovative
ideas anywhere in the world, not just in Europe.

Thanks to recent developments in the field of artificial intelligence, cognitive technologies

extend the power of computers to tasks that were originally performed by humans.
Cognitive analytics such as machine learning and natural language processing can discover
patterns and relationships in information from millions of texts, books, online articles
and other sources (e.g. social media), comprising information that could take researchers
(humans) decades to discover, retrieve and digest. As a first step in exploring its potential
role in risk assessment, EFSA needed to better understand and pilot cognitive computing
and its role in enhancing, scaling and accelerating human expertise. This has been done
through two projects exploring the application and training in the use of machine learning
techniques and the creation of an internal EFSA Knowledge and Innovation Community (KIC)
on Automation, Machine Learning and Artificial Intelligence.

3.4. Performance indicators

Output indicators
Indicators available to monitor performance in this area are presented in tables 9-10 and
a summary status report for the key projects under strategic objective 3 is presented in
Annex III. Overall the performance exceeds expectations with cooperation activities with
Member States international partners achieving or exceeding the target. The number of
cooperation agreements with international and third country organisations is slightly below
the annual target because the signing of Memorandum of Cooperation with FSSAI-India (31)
was delayed until spring 2018.

(31) Food Safety and Standards Authority of India.

 35

The production of scientific outputs and technical reports presents a moderate deviation,
as out of four technical reports foreseen in 2017, EFSA closed only three of them. However,
the missing technical report is planned to be closed in early 2018. Regarding the two ‘other
publications’ foreseen to be delivered in 2017, these were reported under SO4. The high
number of joint activities with international partners under cooperation agreements is due
to the fact that, in the original estimate, the pre-accession activities were not included. The
international activities of EFSA have been constantly increasing and they will continue in the
coming years with the renewed programme for pre‑accession (32) (agreed at the June MB
meeting), which was kicked off in December.

Table 9. Activity and output indicators for SO3

ACTIVITY — OUTPUT INDICATORS

Indicator Executed Target Executed Status
2016 2017 2017
Number of questions delivered for
0 4 3 ]
scientific outputs and technical reports
Number of questions delivered for ‘other 2
publications’ (external reports, event 0 2 (reported N/A
reports) in SO4)
Proportion of scientific/technical
0 100 % 100 % ]
questions adopted within deadline
Number of MS cooperation activities
(network meetings, national FP events/ 73 75 75 ]
workshops)
Number of cooperation agreements
with international and third country 14 17 15 ]
organisations
Number of international cooperation
19 24 39 ]
activities (meetings, events, missions)

Outcomes indicators
Results higher than targeted were achieved for the indicators of the risk assessment agenda
take-up index (see below). Targets will be reviewed accordingly for the following years.

The remaining outcome indicators were defined during the year and therefore measurement
is not applicable for 2017.

(32) Agreed in June 2017 Management Board.

 36

Table 10. Outcomes indicators for SO333

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: Building and sharing capacity within the risk assessment community at
organisational level
Number of joint
N/A 15 21 ]
projects
Number of priority
N/A 5 12 ]
areas covered
Number Member
States in joint N/A 8 19 ]
Risk assessment
projects
agenda take-up
index Number of
partners in joint N/A 20 35 ]
projects
Number of
projects not
N/A 0 N/A N/A
funded primarily
by EFSA
Number of joint activities (staff
exchange, joint projects/workshops)
5 8 57 ]
with international partners under
cooperation agreements
Number of
research
recommendations
TBD in
taken up in MS, EU N/A Replaced N/A
2017
or international
research
programmes (33).
Research agenda
take-up index Number of
research
projects (EU and
international) TBD in
N/A 1 N/A
in which EFSA 2017
is participating
(actively or
passively)

Application rate for TBD in

Participation of N/A 2.15 N/A
EFSA’s open calls 2017
MS organisations
to EFSA’s work Number of
programme Article 36
TBD in
(science grants and organisations N/A 84 N/A
2017
procurement) applying for EFSA
grants

(33) New indicator: Number of support letters written by EFSA of research proposals supporting the
EURAA. Baseline is set to 0.
 37

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: Building and sharing capacity within the risk assessment community at
individual level
Total:
1 158
Number of applicants
applicants (total) for 10 1 725 1 079 ]
for panel renewals panels
(2013-
2015)
Eligible:
998
Number of
applicants
applicants
for 10 1 080 985 ]
(eligible) for panel
panels
renewals
(2013-
2015)
Gender
balance:
Increased common Men 55 %
expertise pool /Women
coverage and 45 %
availability index Age
Balance of distribution:
applicants (total < 40 years:
and eligible) for 23 %
TBD in
panel renewals, N/A 40-55: 49 % N/A
2017
in terms of age, > 55: 28 %
gender and Geography
geography (EU
countries)
Mid-west
Europe:
88 %
East Europe:
12 %
Elapsed ‘time to
TBD in
hire’ for working N/A N/A N/A
2018
group experts
Panel expert TBD in
Panel and WG N/A N/A N/A
impact factor 2018
quality evaluated
via the expert Working group
TBD in
impact factor expert impact N/A N/A N/A
2018
factor
 38

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: strengthened capacity using innovative ways
This indicator
captures the
extent to which
EFSA, together KPI revised
Share of outputs
with MS, achieves in 2017 and
produced using
innovative 0 NA it will be NA
new types of
approaches, replaced in
capacity
cognitive 2018
computing,
artificial
intelligence, etc.

3.4.3. Intermediate impact indicators

All intermediate impact indicators were under development in 2017.

Table 11. Intermediate impact indicators for SO3

KPI Baseline Target 2017 Executed Status
2017
Intermediary impact: Increased efficiency at European and international level
Increase of shared and decrease of
duplicated/overlapping services/
activities/outputs (risk assessments,
TBD in 2017 N/A replaced N/A
data, methodologies) at the
Member State and European/
international level (34)
Intermediary impact: Increased satisfaction of MS, EU, and international partners
with regard to the building and sharing of risk assessment capacity and a knowledge
community at organisational and individual level, in general and via specific tools
(e.g. grants)
Satisfaction — MS, EU,
Results
general satisfaction international, Annual
N/A under N/A
with and usefulness third country comparison
elaboration
of joint outputs organisations
— via feedback
surveys: positive and TBD from
relative qualitative Results
Individual external
improvement (with under N/A
experts N/A evaluation
regard to follow-up elaboration
survey
actions)

Number of 3-5 %
N/A N/A
page visits increase
Outreach of supporting publications
on grants and procurement (access, Number of 3-5 %
N/A N/A
downloads, citations) (35) downloads increase
Number of 3-5 %
N/A N/A
citations increase

(34) Replaced by the indicator: ‘Identification of potential incidents of duplication and divergence and
resolution of issues when identified within EU development and roll-out of a database for sharing
MS RA activities)’.
(35) Report from WILEY to be provided in Q2 each year.
 39

4. Prepare for future risk assessment challenges

Anticipating risk assessment priorities and related methodology and evidence needs ensures
that EFSA is prepared for present and new challenges in a dynamic food safety system, whilst
driving harmonisation of methodologies to improve food safety across Europe. In order
to contribute to the EFSA’s effort to be prepared for potential future challenges and crises
in food risk assessment a relevant number of guidance documents has been produced.
Continuous update and creation of standardised guidelines or methodologies to assess risks
in a consistent and harmonised manner demonstrate this effort. Involvement of stakeholders
in these processes has been an important step to ensure the relevance of EFSA’s work while
promoting transparency and trust.

4.1. Preparedness and response

EFSA’s activities on emerging risks were: (i) to carry out activities aimed at identifying
emerging risks in the remit of EFSA (public health impacts related to food and feed, animal
and plant health); (ii) to develop and improve emerging risk identification methodologies
and approaches. The EFSA Emerging Risks 2016 Activities Report (published in November
2017) summarises the activities of all groups involved in the emerging risks identification
procedure, in particular the MS Expert Network and the Stakeholders Discussion Group.
It furthermore includes the issues identified in the course of 2016 and a description of
methodologies being developed and collaboration activities carried out.

The Discussion group on emerging risks continued its activities initiated in 2010 proving to
be a successful input to the EFSA Emerging risks identification procedure. A symposium was
organised with the discussion group, FAO and WHO on ‘Identification of Emerging Risks in
Food — Different Approaches to Achieve a Common Goal’ at the International Association
for Food protection European Conference in Brussels in March 2017.

EFSA has also developed a multiannual training strategy (2017-2020) addressing EFSA
crisis preparedness needs. The proposal builds on past experience in the domain of
crisis preparedness and includes a matrix of training themes and sector involvement,
encompassing scientific and communication job functions within the EC, MSs, EFSA, other
EU agencies and international organisations. In 2017 three different table top simulation
exercises were also done, including one in the area of plant health.

Animal health preparedness

In order to foster the use of new approaches and enhance the ability to respond to risks,
EFSA continues its collaboration with key partners and stakeholders. In this context the
‘Wildlife’ project targets the geographic distribution and abundance of wild boar populations
in ASF-at-risk or affected countries. In addition, the ‘Vectornet’ project is supporting the
collection of data on vectors related to both animal and human health and was carried
out in collaboration with ECDC. A ‘one health’ approach is also established for the avian
influenza monitoring reports, where EFSA is working closely with ECDC, EURL and Member
States affected during the reporting period. Preparatory discussions took place with MS
representatives during the AHAW Network and with chief veterinary officers (CVOs) to
improve the data exchange on animal disease outbreaks and populations of susceptible
domestic animals. Another area of collaboration between EFSA and MS considers rapid risk
assessment tools where a joint webinar has been organised in order to assist risk managers
in the initial stage of a disease outbreak to prepare and respond to possible health threats
and to reduce the social and economic consequences of the threat.

Plant health preparedness

On the basis of DG SANTE mandates EFSA has started in 2017 two projects to support EU
plant health crisis preparedness: (i) a process for plant health horizon scanning by media
and literature monitoring and (ii) a project to provide Member States with plant health
surveillance datasheets and guidelines. Based on an automated scanning of media sources
 40

conducted in the JRC MediSys platform and on a manned review, articles about known, as well as
emerging plant pests are selected and a monthly newsletter is issued to support risk managers.

A cooperation grant has been awarded to the Malta national plant protection organisation for the
organisation of activities and crisis workshops with the other involved Member States. In addition,
EFSA has awarded a cooperation project for a thematic grant on airborne plant pathogen
surveillance, which includes a study on the airborne spores detection for the CBS fungus.

4.2. Guidance development

Cross-cutting guidance
EFSA’s Scientific Committee has developed guidance that provides an approach for carrying
out risk assessment of substances in food (intentionally added or not) for infants below
16 weeks. EFSA scientists developed the approach following a state-of-the-art assessment
of infant development before and after birth. Developing this guidance document has
clarified the way EFSA performs its risk assessment, ensure a common understanding of the
methodology used and in the end facilitate the acceptance of EFSA scientific panels’ outputs.

EFSA’s Scientific Committee has also developed three key methodological frameworks to
improve the robustness, quality and transparency of the scientific assessments done by
EFSA’s 10 sectoral scientific panels:

„„ Weight of evidence: a  practical three-step approach for assembling, weighing and

integrating evidence on the basis of its reliability, relevance and consistency; it con-
siders qualitative and quantitative approaches and provides simplified reporting tools.
„„ Biological relevance: a flexible framework that clarifies definitions and concepts and
sets criteria for determining the nature/magnitude of an observed effect and for
deciding if the effect seen is adverse, beneficial or neither (i.e. relevant for an assess-
ment).
„„ Uncertainty: how to assess and combine the limitations in our knowledge at the time
of the assessment and identify the data gaps that need filling (to reduce uncertainty).

The draft guidance on uncertainty has been trialled internally at EFSA over 1 year (April 2016
— April 2017). As part of the trial phase the methodology on expert knowledge elicitation
was applied by almost all EFSA panels within their case studies. A workshop in June 2017
offered the opportunity to risk assessors and risk managers to meet and exchange views and
experiences on the testing phase of the draft uncertainty guidance document. Challenges
and benefits encountered during the testing phase were presented and discussed. Further
insights from the testing phase were collected to produce recommendations for finalising
the EFSA guidance on uncertainty. As an outcome of the workshop an event report was
published.

The concise guidance on uncertainty analysis in scientific assessments was developed as

a practical, user-friendly and step-by-step guidance with simple flow charts. It includes
separate sections for the main types of assessment. The former draft Guidance on
uncertainty was revised into a supporting opinion.

The opinion provides supporting information for the concise Guidance (e.g. justify the
approach taken, introduce and explain key principles for uncertainty analysis, review a wide
range of qualitative and quantitative methods and reorganise the sections in a more
streamlined way). Both the guidance and the opinion were adopted by the Scientific
Committee in November 2017.

In December 2017, the EFSA Scientific Committee finalised an opinion clarifying some
aspects related to genotoxicity assessments for food and feed safety. The opinion improves
clarity and predictability for applicants when preparing their dossiers for evaluation by EFSA.
 41

It also helps risk assessors when carrying out assessments of genotoxicity and risk managers
when deciding on the approval or restriction of substances in the food chain.

EFSA has recognised the need to foster the understanding, uptake and use of the best risk
assessment practices developed by EFSA in particular through its guidance documents.
The training courses included four types of specialised training addressing (i) uncertainty
in EFSA’s scientific assessments, (ii) Environmental Risk Assessment, (iii) benchmark dose
modelling (BMD) and (iv) computational toxicology and modelling tools. The majority of the
attendees considered the trainings very useful for their future work.

Feed additives
The FEEDAP Panel adopted and published three guidance documents: (i) Guidance on the
assessment of the safety of feed additives for the consumer, (ii) Guidance on the identity,
characterisation and conditions of use of feed additives, (iii) Guidance on the assessment
of the safety of feed additives for the target species. They were submitted for public
consultation and outcomes were published on the website as technical reports.

The FEEDAP Panel also endorsed two guidance documents for public consultation on the
assessment of the efficacy of feed additives and on the characterisation of microorganisms
used as feed additives or as production organism.

Genetically modified organisms

Two guidance documents were adopted by the GMO Panel. The first was supplementary
guidance on allergenicity of GM plants, which addresses non-IgE-mediated adverse
immune reactions, in vitro protein digestibility and endogenous allergenicity. During
the development of this document, EFSA involved the stakeholders at different stages,
strengthening new means of engagement in its scientific process. The second ‘guidelines
on possible derogation of existing requirements for applications of GM food and feed at
low levels submitted under Regulation (EC) No 1829/2003 on GM food and feed’ indicates
scientific requirements of Annex II of Regulation (EU) 503/2013 necessary for the risk
assessment of the unintended, adventitious or technically unavoidable presence in food and
feed of low level (maximum 0.9 % per ingredient) of GM plant material intended for markets
other than the European Union.

Nutrition
The NDA Panel updated the Guidance on the scientific requirements for health claims related to
antioxidants, oxidative damage and cardiovascular health. In the area of infant nutrition, a scientific
and technical guidance for the preparation and presentation of applications for authorisation of an
infant and/or follow-on formula manufactured from protein hydrolysates was delivered.

Pesticides
In the area of pesticides, EFSA finalised a new guidance paper on dermal absorption of
plant protection products (PPPs), as well as a guidance document on the revision of the
EFSA Pesticide Residue Intake Model (PRIMo). EFSA also adopted a guidance document for
predicting environmental concentrations of active substances of plant protection products
and transformation products of these active substances in soil and developed user-friendly
software tools to facilitate use of the tiered approach in regulatory practice.

EFSA finalised the project for improving the use of epidemiological studies in the risk
assessment of pesticides with a scientific conference that took place in November.
 42

The draft joint EFSA/ECHA guidance on the assessment of endocrine disruptors in pesticides
and biocides has also been launched for public consultation.

The PPR Panel activities have also covered human health and environmental assessments:
one opinion on the follow-up of the findings of the external scientific report ‘Literature
review on epidemiological studies linking exposure to pesticides and health effects’
(University of Ioannina Medical School, 2013), and the other addressing the state of the
science on risk assessment for amphibians and reptiles have been adopted.

Biological hazards — guidance on microbiological criteria

The BIOHAZ Panel adopted in October 2017 a scientific opinion reviewing approaches
used by the Panel to address requests from risk managers to suggest the establishment of
microbiological criteria, and providing guidance on required scientific evidence, data and
methods/tools necessary to develop microbiological criteria in food, and listing tasks of risk
assessors and risk managers in the process.

4.3. Methodology and data preparedness

Cross cutting: Prometheus
EFSA implemented the Prometheus project (PROmoting METHods for Evidence Use
in Scientific assessments) to further improve its scientific processes and contribute to
the release of the strategic objectives related to evidence and methods for scientific
assessments. Through this project, the Authority defined a set of principles for the
scientific assessment process (based on its core values), a four-step approach (plan/carry
out/verify/report) to fulfil those principles (EFSA, 2015), and carried out an analysis of its
‘methodological needs’ for evidence use (e.g. methods, tools, procedures, processes) (EFSA,
2016). The project also included a trial phase for the 4-step approach in a series of case-
studies, one from each EFSA Panel. In October 2017, an EFSA workshop was held to collect
feedback on the trial phase for the Prometheus approach and provide input to the EFSA
management for the next steps in the implementation of this method in EFSA scientific
assessments. Linked to the implementation, training was provided to EFSA staff and experts
on several aspects such as expert knowledge elicitation and appraisal techniques. In
October 2017 an EFSA colloquium on evidence integration was also organised jointly with
the Evidence-Based Toxicology Collaboration at Johns Hopkins Bloomberg School of Public
Health. This is a recognised challenge in evidence-based risk assessment, for which different
methods exist ranging from approaches based on expert judgement, through structured
qualitative methods, to complex quantitative methods.

Chemical risk assessment

Within the preparedness activities EFSA published external scientific reports on generation of
occurrence data on citrinin in food; bioaccumulation and toxicity of mineral oil hydrocarbons in rats.

Microbiological risk assessment

Within the preparedness activities EFSA published external scientific reports on Listeria
monocytogenes and comparison of isolates from different compartments along the food
chain, and from humans using whole genome sequencing analysis; and assessment of
classical scrapie infectivity in sheep embryos.

EFSA run a public consultation on a draft BIOHAZ scientific opinion on Listeria

monocytogenes in ready-to-eat foods. In September 2017 EFSA held a meeting to present
the draft opinion and gather feedback from stakeholders.

In the field of preparedness EFSA also carried out activities on hepatitis E infections in EU due
to raw pork. Consumption of raw or undercooked pork meat and liver is the most common
 43

cause of hepatitis E infection in the EU. Experts from EFSA’s Panel on Biological Hazards
recommend that Member States increase awareness of public health risks associated with
raw and undercooked pork meat and advise consumers to cook pork meat thoroughly. They
also recommend the development of suitable methods for detecting hepatitis E in food.

Environmental risk assessment

Furthermore, the Bee Partnership Stakeholder Discussion Group was set up, as a follow up on

‑
the Scientific Symposium on collecting and sharing data on bee health. The Symposium was
organised together with COPA-COGECA, the European Professional Beekeepers Association
(EPBA), Bee Life (European Beekeeping Coordination) and the European Crop Protection
Association (ECPA) and was part of the 2017 European Week of Bee and Pollination
organised by the ‘Apiculture & Bee Health’. The objective of the event was to bring together
stakeholders involved in bee health, beekeepers, farmers, industry, scientists, risk assessors
and managers, citizens, and policymakers to discuss ways of (i) improving data sharing and
data management, (ii) standardising data collection-reporting-storing, and (iii) strengthening
collaboration to enable a more holistic and robust risk assessment of bee health in Europe.
In October 2017, the Norwegian Scientific Committee for Food Safety (VKM) and EFSA held
a joint symposium on ‘Risk assessment and risk management cooperation on environmental
protection goals’ in Oslo. The objectives of the symposium were to share experiences, to plan
risk assessors/risk managers cooperation for environmental risk assessment and to pilot the
method for making environmental protection goals operational.

4.4. Performance indicators

Output indicators
Indicators available to monitor performance in this area are presented in Table 12 below.
A summary status report for the key projects under strategic objective 4 is presented in
Annex III. Overall the performance exceeds expectations.

The production of scientific outputs and technical reports overall exceeded the target in
the area of preparedness and methodological development (25 questions closed through
scientific outputs and 24 through technical reports against the annual target of a total of 40
closed questions).

The publication of other EFSA outputs (22 external reports and five event reports), exceeded
the annual target of 18 in total. Timeliness remains on target.

Table 12. Activity and output indicators for SO4

ACTIVITY — OUTPUT INDICATORS

Indicator Executed Target 2017 Executed Status

2016 (36) 2017
Number of questions delivered for
Included in
scientific outputs and technical 40 49 ]
SO1
reports
27
Number of questions delivered for
Included in (22 external
‘other publications’ (external reports, 18 (37) ]
SO1 reports/
event reports)
5 event)
Proportion of scientific/technical
100 % 100 % 98 % ]
questions adopted within deadline

(36) Allocation to SO is not available for 2016 as this new classification is new as of 2017.

(37) (14 external/4 event reports).

 44

Outcome indicators
All outcome indicators were under development in 2017 and included in Table 13.

Table 13. Outcome indicators for SO4

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: Fostered use of new approaches and enhanced ability to anticipate and
respond to risks
Number of capabilities included in EFSA’s
strategy implementation plan (original
or revised) (38) having been further
TBD in
developed (moved at least one stage N/A 4 N/A
2017
from non-explored to feasibility, piloting,
guidance endorsed, training provided,
application in risk assessment) (39)
Outcome: Accessibility of EFSA methods and tools
Software
To be
Number of methods and tools readily uploads
defined in
accessible for use by external users statistics
2018 (10 % N/A N/A
(available in online repositories and on from the
increase
platforms) knowledge
each year)
junction
Outcome: Harmonisation of risk assessment methodologies
Number of
citations
of cross-
Increase in the use of cross-cutting TBD in
cutting N/A N/A
guidance documents by EFSA panels (40) 2018
guidance
in EFSA
Journal
Use of ‘compulsory’ guidance documents To be done TBD in
N/A N/A
by panels and working groups (41) in 2018 (42) 2018

(38) Defined in 2017: Plant health preparedness; Vector-borne diseases and wild animal diseases;

Trace-back, trace-forward methodologies; Anti-microbial resistance; Endocrine disruptors;
Epigenetics; Chemical mixtures/Cumulative exposure assessment; Nanotechnology; Read-
across; Human variability; Human biomonitoring; Developmental neurotoxicity testing strategy;
Food-borne viruses; Campylobacter from farm to fork; Predictive modelling for biological
risks; Microorganisms as plant protection products; Microbiological criteria; Whole genome
sequencing; Animal-based indicators for animal welfare risk assessment; Environmental RA —
Bee health; Environmental RA — landscape-based framework; Environmental RA — Spatially
explicit ecotoxicology and fate and behaviour; Risk-based food inspections tools — risk ranking
of biological and chemical hazards; Risk-based food inspections tools — development of surveys
and surveillance schemes.
(39) Update of the indicator: ‘Number and proportion of new approaches (self-tasks and internal

mandates) moving from feasibility to piloting, endorsement of guidance documents, training, and
application in risk assessments according to plan’.
(40) To be defined in the context of further developing the EFSA process architecture and specifically

the ‘methodologies management’ process.
(41) To be defined in the context of further developing the EFSA process architecture and specifically

the ‘methodologies management’ process.
(42) Compliance check on use of compulsory guidance.

 45

Intermediate impact indicators

All intermediate impact indicators were under development in 2017 and now included in
Table 14.

Table 14. Intermediate impact indicators for SO4

KPI Indicator Baseline Target 2017 Executed Status

2017
Intermediary impact: Increased effectiveness of preparedness and response
% of questions
for which data,
Preparedness with methods and TBD in 2018 N/A N/A N/A
data, methods expertise are
and expertise readily available
to address a risk
assessment % of questions
question when (regular
received and and urgent)
TBD in 2018 N/A 90 % N/A
mutually agreed delivered within
the initially
agreed timelines
Intermediary impact: Increased satisfaction of stakeholders with regard to EFSA’s
preparedness, methodologies and response
Results
Risk managers Annual
under
Satisfaction via (EU/MS) comparison
evaluation
feedback surveys:
TBD in Results
positive and Stakeholders 2019
2017(external under
relative qualitative (general) comparison N/A
evaluation evaluation
improvement
MS, EU, survey)
(with regard to Results
follow-up actions) international, Annual
under
third country Comparison
evaluation
organisations
Use of EFSA’s methodologies
TBD in Q2
and tools (access, downloads, N/A N/A N/A
2018 for 2017
citations) (43)
Number of
registered
users per
Use of EFSA’s tools (access, model in
N/A N/A N/A
downloads, citations) the R4EU
platform. To
be calculated
in 2017

5. Create an environment and culture that reflects

EFSA’s values
In order to foster a culture of openness, innovation, cooperation, independence and
scientific excellence among its experts, partners and staff, EFSA carried out initiatives to
sustain organisational performance improvements. As of January 2017, a transformation
journey started in the administration department to foster the shift from a transactional to

(43) From an overall journal citation point of view, application to the citation index will take place in
2017 with metrics available in 2018.
 46

a strategic approach. The new Business Services Department encompasses six units, with
an enhanced remit, aiming at providing effective solutions for the production of trusted
scientific advice via a strong partnering approach in the following areas:

„„ ‘Global Performance Services’, to drive and support in a  centralised manner EFSA

2020 implementation, to reinforce business intelligence and analysis capability
while promoting results-based management and budgeting as well as process
enhancement and change management capabilities.
„„ ‘Digital Transformation Services’, to prepare EFSA for future risk assessment chal-
lenges by driving digitalisation of information, products, and processes, to lift capa-
bilities in innovation and openness, and to maximise efficiency and quality by intro-
ducing shared standardised technology solutions.
„„ ‘Legal and Assurance Services’, to promote a central reference point for compliance
and legal advice, risk management and audit-related activities via a streamlined and
integrated management of internal control standards and assurance functions.
„„ ‘Human Capital Services’, to support an effective management of EFSA’s breadth of
talents (staff, experts, non-contractual contributors) via an efficient focus on compe-
tency management, strategic workforce planning, talent and performance develop-
ment, and the sound management of rights and entitlements.
„„ ‘Financial services’, to foster market intelligence and strategic sourcing of suppliers,
goods and services and to promote financial optimisation in a context of resources
scarcity.
„„ ‘Corporate services’, to standardise and streamline transactional services.

With the overall objective to develop an environment focused at improving organisational

performance and capabilities, the internal reorganisation enabled the achievement of the
following outcomes:

5.1. S etting up of an accountability framework

with four pillars ensuring sound operational
performance and overall compliance

Decision-making
With the overall ambition of strengthening governance and accountability, the EFSA
Decision-Making Framework (DMF) has been finalised and has adopted clarifying roles,
responsibilities and governance structures against the EFSA Process Architecture framework.
Within this context, EFSA initiated the exercise of reframing the governance process of the
production of its scientific outputs and is developing a paper on the Quality of Science. The
DMF will ultimately support optimisation of resources as well as foster compliance with rules
and obligations. The overarching Accountability Framework will be further elaborated, with
a subsequent policy, in a second phase in 2018.

Results-based management
To foster an environment focused on improving organisational performance and capabilities,
EFSA’s results-based management approach was enhanced with:

„„ The full alignment of planning and reporting activities and tools to EFSA Strategy
2020 (programming document, performance reports, annual activity report) and
the definition of supporting key performance indicators (KPIs) allowing for easier
monitoring of performance at all levels and regular analysis.
 47

„„ The monitoring framework was further strengthened with the development of an

EFSA’s intervention logic and with a proposal to set up an evaluation framework. This
new approach should allow systematising and standardising ex ante and ex post eval-
uations of outcomes, programmes and projects to foster sound performance analysis.
„„ EFSA’s 3rd External Evaluation was initiated in the course of 2017. The Inception
Report was adopted in December by the Management Board Steering Committee,
the desk and field research were completed and an interim report provided. The
outcomes of this exercise, including the reflections stemming from EFSA’s manage-
ment self-evaluation, will be available in 2018 providing useful insights for develop-
ing the post-2020 EFSA strategy cycle. Moreover, in the framework of the EFSA 2025
preparatory process which will be a key highlight of 2018, EFSA started developing
in 2017 an environment-scanning and scenario-planning capacity.
„„ As part of the strengthening of its analytical capability, EFSA demonstrated its fore-
casting abilities, developing a multiannual resource outlook up to 2020 and beyond.
This exercise supported a better steering of EFSA’s strategic planning while inform-
ing in a relevant manner the preparatory process of the next multiannual financial
framework post-2020. The analysis conducted highlighted in particular the detri-
mental impact of the steadily increasing share of Title I  over the total budget on
EFSA’s operational capacities, an assessment which led to managerial action.
„„ The focus on performance is also shared by the Network of European Agencies,
with EFSA playing a leading role in 2017. In this context were brought forward: (i)
actions for the strengthening of the EUAN Performance Framework with a maturity
model allowing continuous improvement, (ii) the development of a standard meth-
odology to measure the use and benefits of shared services, (iii) the integration of
the new internal control framework in agencies’ planning and monitoring activities,
(iv) proposals for further improvements of the programming document templates
(particularly the streamlining of the planning documents), (v) approaches towards
a more flexible resource allocation and management based on results. EFSA partic-
ipated in the EC inter-service working group on Budget for results in October 2017
to present the agencies’ achievements.
„„ To ensure full alignment with DG-SANTE priorities, the EFSA-EC Roadmap was
re-established. In addition, in a strengthened approach of cooperation with SANTE
a higher number and a larger scope of bilateral meetings (from operational to senior
management) were held to cover planning, resource and prioritisation issues. This
exercise allowed to showcase with concrete examples performance and resource
management achievements, and to discuss possible approaches for flexible
resource management and additional ways of funding in the future.

Quality and continuous improvement

To improve organisational performance and capabilities, robust management functions
strengthening process performance and quality were further enhanced:

„„ In its journey towards continuous improvement, EFSA finalised the mapping of its 27
macro-processes and made further progress in the characterisation of its sub-pro-
cesses. The enhanced EFSA Process Architecture (EPA II) should be finalised in the
first semester of 2018. This important achievement will allow leveraging of perfor-
mance management, to identify and streamline processes, and to further gain in
efficiency with the ultimate goal to increase the customer and end-user satisfaction.
„„ EFSA widened its 2017 customer feedback survey to cover the whole spectrum
of its activities and stakeholders. Results indicate a  high level of satisfaction from
all stakeholders across the five strategic objectives. A point for attention would be
a slight decrease in DGSANTE satisfaction (from 95 % to 90 % between 2016 and
2017) with regard to the delivery of opinions. This concern will be addressed by
a specific action in 2018 to ensure a closer alignment between risk managers needs
and EFSA’s staff and experts.
 48

„„ In September 2017 EFSA received confirmation of its ISO 9001:2015 Quality certifica-

tion. No non-conformities were spotted, and evidence of effective top management
leadership and commitment was highlighted together with significant progress as
regards process standardisation and change management. Recommendations for
future improvements were mainly in the area of further simplification and integra-
tion of management systems, to be included in future quality plans.
„„ EFSA is moving towards establishing a world-class environment, obtaining in 2017
the OHSAS 18001:2007 certification stressing compliance with Occupational Health
and Safety Assessment Series programmes (OSHAS), and its successful enrolment
into the European Eco-Management Audit Scheme register (EMAS).

 ompliance, transparency and effective management through

C
provision of integrated assurance mechanisms
To improve organisational governance, accountability and compliance for an efficient and
effective delivery of its strategic objective, the following actions were performed:

„„ As part of the review of the 2011 Independence Policy, a public consultation was
launched in Q1 which received more than 300 comments from 209 interested par-
ties (NGOs, industry, researchers, national competent authorities). On 21 June 2017,
EFSA’s Management Board adopted a new Policy on Independence which strikes
a new balance between ensuring the impartiality of the professionals involved in
EFSA’s work and the need to attract experts. It does so inter alia by addressing the
requests of the European Parliament to include a comprehensive set of ‘cooling off’
periods, by reinforcing the transparency measures linked to independence-related
operations and by confirming key aspects of the system in place, such as a multi-lay-
ered scrutiny of declarations of interest submitted by relevant individuals.
„„ In October 2017, EFSA adopted new rules on competing interest management,
which will replace those issued in 2014, detail how EFSA will implement the Policy
in practice and provide guidance to scientific experts and others on how to declare
relevant interests and how they will be assessed by EFSA to prevent conflicts.
„„ The rules also outline the enforcement measures EFSA will take in case the rules
are breached and how transparency will be ensured throughout the process. On
20 October 2017, the Executive Director signed off the new decision on competing
interest management, implementing the high level vision set out in EFSA Strategy
2020 and in the Independence Policy. The new rules clarify the applicable procedures,
standards and criteria to prevent conflicts of interest and to manage other compet-
ing interests, enhance the enforcement tools available to the Authority, and increase
the transparency levels applied in the context of independence-related operations.
„„ Within the centralised interest management function, EFSA invested in guidance
and dedicated training for staff and experts to ensure coherent application of rules.
Internal communication and sharing of best practices were enhanced with the cre-
ation of a one-stop shop intranet portal. In the context of the Talent Management
Project under the Expertise Management Programme, a  new technological solu-
tion based on Appian software was adopted with the aim of improving the perfor-
mances of the DoI tool and assure its long-term sustainability.
„„ Accountability and compliance with a regulatory framework ensuring the legality
of EFSA’s operations were confirmed with the continuous legal and regulatory ser-
vices, the advisory role on data protection, the management of pre-litigations and
PAD obligations (244 requests processed in 2017) and of six court cases were pro-
cessed. The achievements of the centralised interest management function (with
2  196 ADOIs of experts processed) and the implementation of EFSA’s anti-fraud
strategy are also to be noted.
„„ As part of the Implementing Rules on Article  110 of the Staff Regulations, deci-
sions on prevention of psychological and sexual harassment, promotion of officials
 49

and reclassification of temporary agents and contract agents were developed and
adopted by EFSA’s Management Board on 21 June 2017.
„„ Within the EFSA Accountability Framework, the management of EFSA’s assurance
functions has been further specified with the definition of 10 assurance pillars,
which are specifically reported against an annual assurance report and in the pro-
gress reports submitted to Management Board approval three times a year. Further
details on the 10 assurance pillars, encompassing also internal control standards and
risk management are reported in the assurance section of this report (Section III).
„„ Efficient management of treasury, inventory and accounts was confirmed by the
Court of Auditors, and EFSA received an unqualified opinion on its 2016 provisional
accounts, stating their reliability and compliance with financial and accounting rules.
„„ The 2015 Budget Discharge was issued by the European Parliament with no major
issues, as should be the case for the 2016 exercise.
„„ Excellent financial performance was observed at year-end, with best-ever indicators
in terms of commitment and payment rates, as reflected in the budget and financial
management section of this report (Section II).

5.2. E fficient talent management and development

supporting a culture of performance and
accountability
„„ To foster expert attraction and to enable strategic workforce planning for experts and
staff, specific efforts were deployed through the Expertise Management Programme
(EMP) as described under the subsequent section in SO3.
„„ The effective management of the establishment plan/contract agent envelope as well
as the timeliness of recruitment procedures led to an occupancy rate of 97.5 % (against
the target 95.5 %). Seven temporary posts were suppressed in line with EC requirements.
„„ To promote EFSA’s branding and the visibility of career opportunities, all EFSA’s vacan-
cies were efficiently disseminated via EPSO, LinkedIn and Research Gate, and additional
channels such as Euroscience Jobs, Nature Jobs or Academic positions, enabling the
registration of 48 600 subscribers for EFSA jobs and over 29 000 followers on LinkedIn as
of December 2017. A new traineeship call has also been launched and concluded with
around 2 000 applications received.
„„ In terms of talent development, EFSA aligned its Learning & Development Strategy to
EFSA 2020 objectives and continued investing in learning with 207 internal sessions
organised at year-end vs 156 in 2016. Overall, 3  050 staff, experts and trainees were
trained in 2017 vs 1 785 in 2016.
„„ Dedicated efforts were made to strengthen leadership and managerial competences
with a tailor-made management development programme focusing this year on the
dimensions of collaboration and management of ambiguity and complexity and the
establishment of a managerial pipeline. A lead expert profile in scientific areas was also
established, marking an important step in developing a career path for non-managerial
scientific staff.
„„ The 2017 Staff Engagement Survey conducted in November displayed excellent results
with a 78 % engagement index (vs 76 % in 2015), an overall favourable rate of 66 % (vs
63 % in 2015) and a response rate of 80 % (vs 64 % in 2015). The highest-scoring ques-
tions suggest that staff perceive themselves very favourably and positively when asked
to self-reflect on their effort and commitment. The lowest ones pertain to the percep-
tion vis-à-vis organisational changes and the objectivity and transparency of the deci-
sion-making process. The results reveal that all dimensions but three (accountability, resil-
ience and adaptability) have increased compared to 2015, with the highest improvement
in the leadership dimension, followed by diversity, respect and communication. Despite
positive movements, leadership and communication still represent areas where
additional improvements could be made.
 50

5.3. W
 orld-class environment enabling the
achievement of EFSA’s strategic capabilities
„„ A world-class IT to enable the achievement of EFSA’s strategic objectives was ascer-
tained according to metrics on service delivery and end-user satisfaction (respec-
tively 89 % and 94 %) which exceeded target. Service owners’ satisfaction at 65 %
was also above target while the middle management satisfaction remained below
the target of 80 % due mainly to project satisfaction. Further improvements linked to
enhancement of project ownership and change management is expected for 2018.
„„ In the area of corporate services, further initiatives to streamline transactional pro-
cesses were achieved with the completion of the staff missions centralisation pro-
cess in June and the development of a new travel model for EFSA experts to be
concluded during 2018.
„„ Enhanced physical security measures were implemented and achieved in the
course of 2017. The entrance of the underground parking spaces, being recognised
as the last weak area of the EFSA premises, was secured.
„„ Complementing the social media project, the digital collaboration project will
improve the exchange of knowledge and expertise within EFSA’s networks of staff,
institutional partners, experts and stakeholders. This will be achieved across physi-
cal and organisational boundaries by maximising the adoption of social web tools
and collaboration practices. The project also aims to streamline the circulation of
information and increase the visibility and transparency of ongoing activities and
decisions. In 2017, the project was kicked off, the platform has been set up and four
pilot activities have been launched to validate and confirm the expected benefits.

5.4. EFSA as Chair of the EU Agencies Network (EUAN)

in 2017
As of March 2017, and for 1 year, EFSA has chaired the Network of EU Agencies, coordinating
key activities and achievements that are listed below.

„„ EFSA prepared and conducted the Network Plenary meeting, held in EFSA in July
2017 and attended by high-level representatives from EU institutions, and also
extensively worked on the preparation of the second meeting that will take place
in Brussels in February 2018. The main topics discussed in the July meeting were (i)
the challenges faced by the Union and their possible impact on the EU agencies,
with particular focus on the resources; (ii) the agencies input in legislative and finan-
cial processes (general financial regulation issues, multiannual financial framework,
budget, discharge, Staff Regulation Implementing Rules); (iii) the sharing of capabili-
ties in HR management and various initiatives related to sharing services among the
EU agencies, promoting their work and disseminating best practices.
„„ The Authority provided strategic input to the EU institutions via ‘high-level meet-
ings’ such as the Inter-institutional Working Group on Agencies, hearings, events,
meetings with the European Commission services and meetings at the European
Parliament and Council. The messages conveyed during such meetings particularly
focused on: (i) debating the validity of the rigid/global approaches recently applied
to control agencies staff; (ii) sponsoring a  new performance-based approach for
the agencies management of resources; (iii) promoting the recourse to additional
sources of funding.
„„ The establishment of the EUAN Shared Support Office in Brussels that is a useful way
to facilitate internal and external efficiencies for the EU agencies and EU institutions.
The office will open in March 2018 and will support the chairing agency to coordi-
nate the future activities.
„„ The handover to the upcoming Chairmanships by Frontex and ECDC will start on
1 March and 1 September 2018.
 51

Highlights from EUAN-Sub-network/thematic work

„„ The new EU Agencies Procurement Officers Sub-network (NAPO) was established to
promote joint procurements with the objective of generating efficiencies and econ-
omies of scale for the EU agencies, thus saving EU taxpayers’ money. This potential
has already been assessed with four joint calls generating an estimated benefit of
EUR 10.6 million.
„„ The Performance Development Sub-network (PDN) has developed: (i) a  maturity
model within the EUAN performance development framework; (ii) a methodology
to measure the global benefit of the EUAN shared services; (iii) a revised template of
the programming document; and (iv) an update of the KPIs catalogue.
„„ The EUAN coordination has further promoted sharing of services between the Net-
work members and the European Commission. An inter-agencies job advertise-
ment board, collecting vacancy notices from the Network, has been created and the
roadmap to implement the Commission HR tool ‘SYSPER’ in 26 agencies (including
EFSA) has been agreed.
„„ A dedicated working group (chaired by EFSA) has coordinated agencies’ input on
the revision of the financial framework regulation (FFR). The areas for revision have
been grouped in seven blocks and the Network of Agencies position on carry-overs,
Single Programming Document (SPD) and Consolidated Annual Activity Report
(CAAR) has been gathered.
„„ A working group led by EFSA and including the EU agencies ACER, EASA, ECHA,
eu‑LISA, ERA, ESMA and Eurofound drafted the document ‘EU Agencies’ funding, look-
ing forward’ aimed at contributing to the preparation of the multiannual financial
framework (2020-2026) proposal by the Commission (currently underway) and the
specialised committees at EP and Council.

5.5. Institutional relations

As part of EFSA’s institutional engagement plan for 2017, EFSA continued its regular
meetings with DG Health and Food Safety senior management (May and November, in
Brussels and Parma respectively). The Executive Director met the DG SANTE Director-General
and Members of Commissioner Andriukaitis’s Cabinet during the year.

Interactions with the European Parliament increased notably during 2017, with the first-time
hearing of the Executive Director in front of the AGRI Committee, the annual exchange of
views with the ENVI Committee, participation of EFSA senior management and scientific
staff at various meetings invited by the EP (AMR, novel foods, processed oils, bee health,
acrylamide, glyphosate, independence policy, GMOs and environmental risk assessment, EU
agencies value, data standardisation). President of the European Parliament, Antonio Tajani,
a delegation of the ENVI Committee, a delegation of Socialist and Democrat (S&D) MEPS
from the ENVI and AGRI Committees visited EFSA during the last quarter of the year. With the
support of the EP Intergroup on Apiculture, EFSA organised a 2-day scientific symposium on
bee health during the European Bee Week in June.

5.6. Information management programme

Information governance
In 2017, a corporate Information Governance Framework was established. The monitoring
of the maturity level of information management at EFSA is now embedded in the newly
established EFSA Decision Making Framework. Information Management — as a process
— is one pillar of the newly established Assurance Council, against which reporting will be
made on a biannual basis.
 52

Correspondence and record management

A new correspondence management workflow fully embedded in EFSA’s Document and
Record Management tool (i.e. DMS) was delivered. A new policy was drafted which will be
piloted and approved in 2018 together with retention and archiving rules for both paper and
electronic records.

New World of Work

A project aiming at radically changing the way EFSA staff and experts work and collaborate
has been kicked off in Q4. Via new IT services and devices, new collaborative spaces and
evolution of meeting rooms, this initiative promotes personal and group productivity while
ensuring location-independent participation.

5.7. Performance indicators

Outputs indicators
Indicators available to monitor performance in this area are presented in Tables 15-17 below
and a summary status report for the key projects under strategic objective 5 is presented in
Annex III. Overall the performance exceeds expectations with some deviations described
below.

While the compliance to independence policy indicator on approved annual DOIs is on

track, a deviation from the target is observed for the approved specific DOIs (99.8 %) due
to a non-compliance. Additional control procedures are in place (veracity and compliance
check) to guarantee a continuous surveillance on the compliance to the independence
policy.

No deviations are observed regarding the financial performance, which is analysed in detail
in section 2 of this report.

A world-class IT to enable the achievement of EFSA’s strategic objectives is ascertained

according to metrics on service delivery and end-user satisfaction (respectively 89 % and
94 %) which exceeded target in 2017. Further efforts in enhancement of project ownership
are needed to improve the indicator on ‘transformation performance’ (linked to development
project execution).
 53

Table 15. Activity and output indicators for SO5

ACTIVITY — OUTPUT INDICATORS

Indicator Executed Target Executed Status
2016 2017 2017
Proportion of experts with approved annual
100 % 100 % 100 % ]
DOI (aDOI) before first meeting invitation
Proportion of experts with approved
specific DOIs (sDOI) before participation in 100 % 100 % 99.8 % ]
an EFSA meeting
Proportion of original budget committed/ 94.1 %
105 % (44) 100 % ]
paid at year end — differentiated 94.7 %
Proportion of original budget committed/ 100 %/ 100.9 %/
n/a (45) ]
paid at year end — non-differentiated 90 % 91.9 %
Proportion of original science grants and
105 %/ 103.6 %/
procurement budget committed/paid at 100 % ]
105 % 104.9 %
year end
Carry-forward of payments to following
11.8 % 10 % 8.9 % ]
year (46)
Service delivery index (47) 73 % 77 % 89 % ]
Transformation performance index
63 % 78 % 64 % ]
(development project execution index) (48)

Outcome indicators
In the area of activities related to people management and culture development, the ‘Staff
engagement’ indicator is on target, providing reassuring measurement of EFSA’s people
engagement and willingness to work in the EFSA environment. In the same direction also
the feedback received through the survey foreseen in the following indicator “management
and leadership index”, which is on target together with the average occupancy rate for the
reporting period January-December 2017, at 97.5 %.

The compliance index is overall within the annual target while the respective financial
impact of the non-compliance is far below the limit.

Regarding the enabling work environment and the use of innovative collaboration methods
supported by world-class IT tools the proportion of tele-meetings over total meetings
exceeded the annual target of 20 %.

(44) Programming document 2017-2019 figures are draft; figures reported in this document are final.
(45) Performance indicator not available in 2016; global commitment and payment execution
(differentiated non-differentiated credits) were 100.0 % and 89.7 % respectively.
(46) Non-differentiated credits.
(47) IT services are measured in this index (perfect services: % of services which consistently achieve or
overachieve their targeted SLAs).
(48) Based on selected projects.
 54

Table 16. Outcome indicators for SO5

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: People and culture
Staff Total favourable/ 63 % (2015) > 62 % 66 %
engagement (%) 78 %
]
engagement 76 % (2015) > 75 %
index via Organisational
feedback awareness/ TBD TBD 75 % N/A
survey (based commitment
on bi-annual Deleted due
survey — Intention to to overlaps
inter-agency 45 (2013) 45/50 N/A
stay (%) with other
framework) indicators
Management (a) 71 %
feedback survey (b) 53 %
(a) Line (a) 69 % (a) 70 % (c) Deleted
management (b) 46 % (b) 55 % due to ]
(b) Leadership (c) 60 % (c) 70 % overlaps
(c) Overall with other
satisfaction indicators
Occupancy
rate (%)
95 % > 95.5 97.5 ]
Statutory staff
year average
TBD in 2018
via:
Management (a) Feedback
and leadership of participants
index in Manager’s
development
(MD)
programme
Competence
2017
management N/A N/A N/A
(b) EFSA’s
maturity level
compliance
with
European
skills/
competences
and
occupations
2017
 55

KPI Indicator Baseline Target Executed Status

2017 2017
Outcome: Compliance
Number of
exception 90 < 90 71 ]
requests
Number of
non-compliant < 25 < 25 19 ]
events
Compliance Exception
index (to laws, requests EUR 150 K
< EUR 150 000 EUR 114 198 ]
regulations, financial (2015)
decisions, impact
standards, Percentage of
policies and compliance
TBC in Q1
procedures with internal 80 (2015) 85 N/A
2018
applicable to control
EFSA) standards (ICS)
Number
of ‘critical’,
‘significant’ or
‘very important’ 0;4 (2016) 0;< 5 2 ]
findings (ECA,
IAS, audit
adviser) (49)
Outcome: Enabling work environment
% of tele-meetings
Innovative collaboration (experts and networks)
methods supported by over total meetings 15/85 20 % 20.3 % ]
world-class IT tools (50) (tele-meetings +
physical meetings) (51)
Outcome: Capabilities
Level of maturity
Performance-based based on the
Between
management maturity EUAN performance TBD N/A N/A
stages 2 and 3;
level framework maturity
model
Level of maturity
World-class IT maturity Established in
based on the PEMM N/A 1.7 N/A
level (PEMM model) (52) 2018: 1.7
model

Intermediate indicators
The long-term impact of EFSA’s continuous effort to put in practise EFSA’s values, and to
ensure delivery of strategic objectives 1-4 by optimising available resources is measured by
two indicators: sound operational performance indicator and the efficiency indicator.

Efficiency is partially defined. The indicator measured for the year 2017 ‘improved ratio of
effort (FTE) spent in operational vs support activities’ (Table 17) is on track.

(49) Outcome will be part of the 2017 assurance report.

(50) The sub-indicator ‘Physical meetings (staff )’ is deleted.
(51) Update of the indicator: ‘Ratio of physical meetings vs tele-meetings (experts and networks)’.
(52) It was decided to opt for the PEMM instead of the COBIT model as the most appropriate for EFSA
and as it can be applied eventually also to other processes.
 56

Table 17. Intermediate impact indicators for SO5535455565758

KPI Indicator Baseline Target Executed Status

2017 2017
Intermediary impact: Sound operational performance
Proportion of KPIs of
the programming
TBD in
Proportion documents reaching 80 % 71 % ]
2017
of KPIs of the target — intermediate
programming impact (53)
documents Proportion of KPIs of
(intermediate the programming TBD in
90 % 100 % ]
impact; documents reaching 2017
outcome; target — outcome (54)
output) Proportion of KPIs of
reaching target the programming TBD in
100 % 73.5 % ]
documents reaching 2017
target — output (55)
Accounts are closed (56) Yes Yes Yes ]
Discharge is granted ( ) 57
Yes Yes Yes ]
Clean discharge Observations are
achieved followed up within
100 % 100 % 100 % ]
the prescribed
deadlines (58)
Intermediary impact: Efficiency
Improved ratio of effort (FTE) spent in 2016:
> 75:25 73.4:26.6 ]
operational vs support activities 73.5:26.5
Mature processes:
improved index (ratio of TBD in
N/A N/A N/A
output and/or quality/ 2018
satisfaction vs input)
Efficiency Process maturity index:
TBD in
index in EFSA’s % of standardised vs N/A N/A N/A
2018
activities total processes
Projects improved
index delivery on TBD in
N/A 76.8 % N/A
budget, on time, in 2017
scope or better)

(53) Indicator takes into account only those intermediary impact KPIs that are already fully defined.
(54) Indicator takes into account only those outcome KPIs that are already fully defined.
(55) Indicator takes into account only those output KPIs that are already fully defined.
(56) Touch and go. On-track banking services.
(57) Achievement relative to 2015 data.
(58) Successful exercise — very positive outcome from the European Parliament.
57
 58

Section II – Management
of resources
1. Budget and financial management

1.1. Budget and financial management

In 2017, EFSA achieved 99.98 % of commitment execution, continuing the trend of the
last years reaching almost 100 % execution. The payment execution (92.31 %) was the best
execution achieved so far by EFSA. It reduced the non-differentiated credits carry forward to
8.9 %, 1.1 % below the maximum rate set in EFSA’s corporate targets.

Financial resources
Out of a total of EUR 79.22 million of commitment appropriations, EUR 79.21 million
(99.98 %) have been utilised for budgetary commitments. Interests generated in the bank
account (EUR 21 545.31) became a part of EFSA general budget and were allocated to
the building acquisition. A grant agreement for an amount of EUR 0.32 million has been
signed between EFSA and DG Neighbourhood and Enlargement Negotiations for the
implementation of cooperation activities with pre-accession countries. In addition, a grant
contract of EUR 0.02 million has been signed with the Food and Agriculture Organisation
funding cooperation project in the field of risk assessment of genetically modified organisms,
becoming part of EFSA’s revenue.

The main expenditure drivers were staff cost (EUR 41.97 million), scientific cooperation
(EUR 9.83 million), information technology (EUR 8.12 million) and scientific meetings
(EUR 8.05 million).

Out of a total of EUR 80.45 million of payment appropriations, EUR 74.26 million or 92.31 %

were paid. Out of this amount EUR 41.40 million were paid for staff cost, followed by
scientific cooperation (EUR 11.28 million) and scientific meetings (EUR 7.86 million).

Out of a total of 91 debit notes issued in 2017, 88 were recovered for an amount of
EUR 81.1 million. This amount includes the EU budget contribution (EUR 80.4 million). Four
debit notes remained open at the end of the year for a total amount of EUR 0.03 million. One
of these, for a sum of EUR 0.02 million, was issued in previous years and is in litigation at the
Court.

Details on budget execution can be found in Annex 2.

 59

Budget transfers
Increase in salary cost was the main driver of transfers in Title I. Missing budgetary resources
for EUR 0.59 million have been covered within the title from training cost, reducing the
occupancy rate of visiting experts, missions and translations.

In Title II, the transfer of resources was mainly directed to building acquisition

(EUR 0.24 million), absorbing, in addition to bank interests of EUR 0.02 million, also
EUR 0.08 million remaining in Title I at the end of the year.

In Title III, the appropriations have been transferred mainly from (i) multiannual IT
projects (EUR 0.97 million) and (ii) risk communication (EUR 0.31 million) into operational
development and control (EUR 0.65 million), IT systems (EUR 0.48 million) and scientific
cooperation (EUR 0.34 million).

1.2. Human resources management

On 31 December 2017, 447 of the available 463 posts were occupied (including officials,
temporary agents, contract agents and seconded national experts).

With specific reference to statutory staff (officials, temporary agents and contract agents), the
posts occupied on 31 December were 434 of the available 448 (96.9 %) while the January-
December average occupancy rate was 97.5 % vs the yearly target of > 95.5 % (on average,
about 436.8 of the available 448 posts were occupied). A total of 28 statutory staff members
were recruited with start date in 2017 of which 14 were temporary agents and 14 contract
agents.

Seven temporary agent posts were suppressed, in line with European Commission
requirements.

Table 18. Human resource overview

Human resources 2016 2017 2017

Budget budget reported
request request period
Temporary agents and officials executives,
230 227 208
managers and officers (AD)
Temporary agents and officials assistant functions
100 96 103
(AST)
Total 330 323 311
Contract agents officer functions (CA FGIV) 75 90 94
Contract agents assistant functions (CA FG I, II, III) 50 35 29
TOTAL 125 125 123
Seconded national experts 15 15 13
TOTAL STAFF ALL CATEGORIES 470 463 447

FTEs and budget indicators

In terms of resources, a moderate deviation in the human resources invested per year is
observed in the activities related to strategic objective 1. The budget reduction, around 10 %,
is mainly due to a lower share of allocated staff and infrastructure costs.

The resources invested in strategic objective 2 and 4 are in line with the initial plan; FTEs
allocated to strategic objective 3 are slightly higher than initially planned due to extra
effort spent on international cooperation, on the organisation of the third EFSA scientific
conference that will take place in 2018 and in the renewal of the scientific panels.
 60

With regard to strategic objective 5 the absolute value of resources is higher than the initial
plan. This is mainly due to the activities related to the Network of Agencies chairmanship, the
centralisation of some activities such as the mission organisation under the BuS department
and an increase of resources invested in development projects like Digital collaboration,
External Talent Pool and Attraction Package, Strategic Competencies Analysis, all aiming at
improving the operational efficiency of the core processes.

The budget of strategic objective 5 is increased compared to the initial plan due to the
bigger share of staff and infrastructure costs allocated.

Table 19. Input indicators for SO1 (FTEs and Budget as full cost of all Titles)
Input Indicators
Resources invested per year Target 2017 Executed 2017
Total SO1 FTEs 198 194
Budget (M, €) 32.63 29,12
Scientific general risk assessment
FTEs 43 47
Input sub-indicator
Budget (M, €) 8.70 9.29
Scientific regulated products evaluation
FTEs 122 116
Input sub-indicator
Budget (M, €) 18.71 16.03
Communication and engagement
FTEs 32 31
Input sub-indicator
Budget (M, €) 5.22 3.80

Table 20. Input indicators for SO2 (FTEs and Budget as full cost of all Titles)
Input Indicators
Resources invested per year Target 2017 Executed 2017
Total SO2 FTEs 24 23
Budget (M, €) 4.64 4.95

Table 21. Input indicators for SO3 (FTEs and Budget as full cost of all Titles)
Input Indicators
Resources invested per year Target 2017 Executed 2017
Total SO3 FTEs 37 32
Budget (M, €) 8.67 8.75

Table 22. Input indicators for SO3 (FTEs and Budget as full cost of all Titles)
Input Indicators
Resources invested per year Target 2017 Executed 2017
Total SO4 FTEs 35 35
Budget (M, €) 8.77 8.58

Table 23. Input indicators for SO5 (FTEs and Budget as full cost of all Titles)
Input Indicator
Resources invested per year Target 2017 Executed 2017
Total SO5 FTEs 162 172
Budget (M, €) 24.50 27.81
61
 62

Section III — Assurance

1. Assessment of audit results
The European Court of Auditors conducted its annual audit of the Authority’s 2016 accounts,
and adopted its report on 17 October 2017. In the report, ECA expressed the following
opinions:

„„ Opinion on the reliability of the accounts

In the Court’s opinion, the Authority’s annual accounts present fairly, in all material
respects, its financial position as of 31 December 2016 and the results of its opera-
tions and its cash flows for the year then ended, in accordance with the provisions
of its financial regulation and the accounting rules adopted by the Commission’s
accounting officer.
„„ Opinion on the legality and regularity of the transactions underlying the accounts
In the Court’s opinion, the transactions underlying the annual accounts for the year
ended 31 December 2016 are legal and regular in all material respects.

Internal Audit Service (IAS)

The work of the IAS is based on a Strategic Internal Audit plan that originates from an in-
depth risk assessment. The purpose of the exercise is to review all processes to constitute
risk-based plans and determine the priorities of the internal audit activity. In 2017 the IAS
performed the risk assessment, whereby the IT Business Continuity process and, more in
particular, the IT Disaster Recovery sub-process was identified as the only process where
controls needed to be further improved. The related action plan for the Business Continuity
Project will be fully implemented by mid-2018. The Strategic Internal Audit 2018-2020 was
presented to the EFSA Audit Committee in December 2017.

The final report on Evaluation of Regulated Products: ‘Assessment’ Phase in Pesticides

Authorisation was received on 13 June 2017. The objective of the audit was to assess the
adequacy, efficiency and effectiveness of the internal control system with regard to the
process leading to the assessment and delivery of conclusions/opinions in the pesticides
field, including the production of the Annual Report on Pesticides Residue in the EU.

The auditors concluded that the audited process is generally capable of delivering the
scientific outputs in the pesticides field in accordance with the applicable legislation. Two
very important observations were identified on the Internal Rules on Declarations of Interest
and the Preparation of the Annual Report on Pesticides Residues in the EU.
 63

2. Management assurance | 10 assurance pillars

Within the EFSA Accountability Framework, the governance for EFSA’s assurance is organised
and integrated into the following 10 assurance pillars to provide a holistic and integrated
view on the activities and outcomes of assurance in EFSA.

„„ Audit management; follow-up of audit recommendations and action plans (2.1)

„„ Financial reporting; budget implementation, accounts and discharge (2.2)
„„ Internal control (2.3)
„„ Risk management and anti-fraud strategy (2.4)
„„ Legality and regularity compliance (2.5)
„„ Information management (2.6)
„„ Evaluation (2.7)
„„ Quality certification(2.8)
„„ Security and business continuity (2.9)
„„ Health and safety (2.10)

2.1. A
 udit management; follow-up of
recommendations and action plans
At the end of 2017, with the full implementation of the action plans for seven very important
recommendations, no critical and three very important audit recommendations stemming
from audits carried out in 2016 and 2017 were still open. They concerned the following
audit observations from the 2017 IAS audit report on Evaluation of Regulated Products:
‘Assessment’ Phase in Pesticides Authorisation on the review of the Internal Rules on
Declaration of Conflict of Interest and the improvement on the preparation of the Annual
Report on Pesticides Residues; all of them within the agreed timelines with IAS and one audit
observation on the disclosure and transparency of the scientific decision-making process
from the 2016 IAC Audit Report on the Role of the Expert in the Scientific Decision-Making
process; planned for full implementation in March 2018.

2.2. F inancial reporting, budget implementation,

accounts and discharge
On 27 April 2017, the European Parliament (EP) granted to EFSA the Discharge in respect
of the implementation of the budget for the financial year 2015. This is the final approval
of the budget implementation and the closure of the accounts for 2015. Regarding the
observations made by the European Parliament in the Discharge 2015 with respect to some
aspects of EFSA’s financial and administrative management, EFSA has informed the European
Parliament that the majority of the 2015 recommendations have been implemented, and the
remaining are in the process of being completed.

2.3. Internal control

The revised EFSA Internal Control Framework, based on the equivalent Internal Control
Management System laid down by the European Commission, was adopted by EFSA’s
Management Board in December 2017. The Internal Control Framework consists of five
internal control components and 17 principles based on the COSO Internal Control
Integrated Framework. During the course of 2017 the internal control monitoring criteria
of EFSA were defined and internal control indicators were set and included in the EFSA
 64

programming documents to ensure an adequate assessment of the presence and

functioning of all internal control principles. The assessment performed for the reported
year concluded that, overall, all internal control components were present and functioning.
Measures will be taken to further improve (i) the risk assessment component at processes
level with the completion of the EFSA Process Architecture (EPA) and the alignment of
process, project and programme methodology with risk management; (ii) the control
activities component with full implementation of the Disaster Recovery Plan for the Business
Continuity Project.

2.4. Risk management and anti-fraud strategy

The design of the risk management process was revised to further align and integrate
the risk management methodology used in EFSA at process, project, programme and
corporate level. All risks will be classified according to the COSO risk typology to facilitate the
identification of the risks and to help ensure that all risks are covered and therefore providing
a consistent basis for analysis across EFSA. A shared risk register template and a corporate risk
and control matrix were developed to harmonise the identification, analysis and monitoring
of critical and cross-cutting risks. The full benefits of this revised risk management process
design will materialise in terms of further improvement and harmonisation of methodology,
tools, and monitoring in 2018.

EFSA developed its Anti-Fraud Strategy, following an internal risk assessment carried out
in accordance with the European Anti-Fraud Office methodology and guidance. EFSA fully
implemented the action plan included in the Anti-Fraud Strategy. During the reporting year,
EFSA did not have to transmit or follow up on any suspicions of fraud cases to OLAF.

2.5. Legality and regularity compliance

In accordance with the Internal Control Principle 12, EFSA has implemented a process for
the management and control of exceptions, including the identification of corrective and/or
preventive actions related to non-conformities. To ensure traceability, the deviations from all
applicable rules and regulations are documented in an exception request, which is registered
in a dedicated exceptions register. At year end there were 90 recorded deviations, nearly
79 % of the recorded deviations concerned exception requests approved ex ante, whereas
21 % concerned non-conformities noted ex post. The financial value of the deviations
amounted to EUR 114 198. Neither the number nor the amount or nature of the recorded
deviations is a matter of concern for the organisation.

Conflict of interest and veracity checks

In the reference year, EFSA continued performing compliance and veracity checks on
a random sample of the assessment and validation processes of declarations of interests (DoI)
submitted by experts participating in the Scientific Committee, scientific panels, working
group meetings and peer review meetings. The two compliance checks revealed that, for 28
out of the 30 cases selected, the procedure for the screening of Annual Declarations of Interest
(ADoI), Specific Declarations of Interest (SDoI) and Oral Declarations of Interest was in line
with the applicable rules. In one case, an expert failed to declare a past employment activity
that ended in the 5 years preceding the day of submission of the ADoI. As a result, the expert
submitted an updated ADoI, which was screened by EFSA as not leading to the identification
of a conflict of interest. For the second case, one expert SDoI and ODoI was found to be
missing from the records. A non-conformity was recorded for the non-compliance, and
awareness of the concerned staff members was increased to reduce the risk that the same
omission is repeated in the future. The veracity check demonstrated that the ADoIs of 25 out
of 30 experts were in line with EFSA’s DoI Rules, while in five cases, omissions were identified.
Four of the concerned experts submitted an updated ADoI including the missing information.
In the resulting screening of the update DoIs, EFSA concluded that the omissions were of
 65

a minor nature and not resulting into a conflict of interest. Failure by an expert to comply
with the request resulted in the expert being prevented from participating in meetings of the
scientific group until such update is provided and the ADoI is validated by EFSA.

2.6. Information management

Information security
EFSA is actively committed to safeguarding the confidentiality, integrity and availability
of all information that it manages, to ensure that regulatory, operational and contractual
requirements are fulfilled. In 2017, EFSA introduced a centralised access management tool,
improved protection against malware, provided training on cloud security considerations
and started the roll-out of a mandatory training on information security to all staff.

Data protection
The General Data Protection Regulation (EU) 2016/679 (GDPR) will become applicable to
all EU Member States from May 2018. Rules and principles on personal data protection
applicable to EU institutions including EFSA shall be aligned with the GDPR. The Commission
proposal for the new data protection regulation for the EU institutions was presented on 10
January 2017 and is still in the legislative process. The new data protection regulation brings
some novelties and the realisation of data protection principles. Personal data processing
will be subject to higher standards of compliance. In 2017, the EFSA Data Protection
Officer performed a compliance check of several ‘off-the-shelf’ cloud computing solutions
envisaged in the context of specific EFSA projects. The compliance check usually happens
ex ante, applying a risk-based approach and resulting in the adjustment or amendment of
standard terms and conditions applied by cloud service providers before signature and/or
privacy configurations of the tool. Contributions from a data protection point of view in the
preparation and drafting of various EFSA policies and projects were provided. Awareness-
raising sessions on the new data protection legal framework were initiated in 2017 and
will continue in 2018. In November 2017, the European Data Protection Supervisor (EDPS)
performed an inspection at EFSA focusing on anti-harassment informal procedures, video-
surveillance and data subjects’ rights. The conclusions of this EDPA inspection will be made
available in 2018.

2.7. Evaluation
Evaluations refer to a wide range of activities assessing EFSA’s performance in reaching
its policy, operational and financial objectives. They include activities that focus on the
reporting on specific aspects of the performance of the organisation, its programmes and
projects.

At programme level no development programmes closed and no programme evaluations

were done. The activities of the Project Coordination Office were regularly executed over
the year granting ex ante evaluation of all EFSA projects in line with the internal procedures.
With regard to the ex post evaluation of projects, they are self-assessed through retrospective
evaluation questionnaires covering the minimum evaluation criteria (59).

At the end of 2017, the ex post evaluation of the STEP 2018 project has been outsourced
and the results will be available in June 2018. Out of the total 13 closed projects, 12
retrospective self assessments were completed highlighting that the evaluation criteria set
on effectiveness, efficiency, relevance, coherence and added value were met.

As mentioned in Section I, the EFSA external evaluation was initiated in 2017. The results of
the external evaluation of EFSA will become available in 2018 and will provide insights and
learning to further improve also in the evaluation context.

(59) Efficiency, efficacy, coherence, relevance and added value.

 66

2.8. Quality certification

In November 2016, EFSA obtained the ISO 9001:2015 certification of the Quality
Management System attesting EFSA’s ability to consistently produce services that meet
EFSA’s customers’ requirements and foster a culture of continuous improvement. In 2017,
EFSA further improved document control and harmonisation, traceability of internal unit
documents against Quality Management System document structure, development of
the EFSA Process Architecture, dissemination of risk-based thinking and broadening of the
concept of non-conformity.

The 2017 ISO 9001:2015 surveillance audit confirmed the certification of Quality

Management System. The ISO audit report concluded that EFSA’s QMS is robust and fit for
purpose. The following improvement actions will be addressed in 2018: Reviewing the ISO
Internal Audit programme by providing references to the individual clauses of the standard
that are addressed, streamline the design of new working instructions, consider reviewing
the administrative guidance for applicants and to systematically monitor the outcome of
improvement actions.

2.9. Security and business continuity

EFSA’s approach on security is established upon the concept that the external and internal
environments of the Agency are designed and managed to create conditions that shall
reduce the risk of harm against its staff, its tangible and intangible assets.

EFSA’s Business Continuity is to maintain the continuity of its activity, systems, facilities
and processes and where these are disrupted by an event to enable it to return to ‘normal’
operations as soon as possible, taking fully into account the impact of any delay on the
EFSA’s quality of service, reputation and budget. EFSA’s business continuity plan is based on
a business impact analysis and used by trained staff to ensure that EFSA is able to continue
working to the extent possible in case of a major disruption. EFSA completed a new Business
Impact Analysis and the Disaster Recovery systems replicated in the remote site will be
tested and implemented by mid-2018.

2.10. Health and safety

EFSA is committed to establish and continuously promote a sound management system
that aims at ensuring a healthy and safe work environment and a sustainable business.
The first part of the programme was concluded in 2017 with the establishment of an
Eco-Management System compliant with the main international standards in the field of
environmental protection allowing EFSA to achieve the ISO 14001:2004 certification and
the EMAS registration. Further to the external certification audit performed end-2017 EFSA
has officially received the BS-OHSAS 18001:2007 certification attesting the compliance of
its Health and Safety Management System with the international standard and with the
regulation in the field of health and safety at work.
 67

Declaration of assurance
I, the undersigned, Executive Director of the European Food Safety Authority,

In my capacity as authorising officer,

Declare that the information contained in this report gives a true and fair view.

State that I have reasonable assurance that the resources assigned to the activities described
in this report have been used for their intended purpose and in accordance with the
principles of sound financial management, and that the control procedures put in place
give the necessary guarantees concerning the legality and regularity of the underlying
transactions.

This reasonable assurance is based on my own judgement and on the information at

my disposal such as the Assurance report, the work of the Internal Audit Service and the
lessons learnt from the reports of the Court of Auditors for the years prior to the year of
this declaration, and the reasonable assurance provided by the EFSA Accounting Officer
regarding the reliability of the 2017 EFSA Provisional Accounts.

Confirm that I am not aware of anything not reported here that could harm the interests of
the Agency.

Parma, 9 March 2018

Bernhard Url
 68

Management
Board assessment
The Management Board,

„„ having regard to Regulation (EC) No 178/2002 of the European Parliament and of

the Council of 28 January 2002
„„ having regard to the Financial Regulation applicable to the budget of the Euro-
pean Food Safety Authority and in particular Article 47 thereof,
„„ having regard to the EFSA Strategy 2020 adopted by the Management Board in
March 2016,
„„ having regard to the 2017-2019 Programming Document of the Authority adopted
by the Management Board in December 2016,

1. Welcomes a second year of implementation of the Strategy.

2. Appreciates the important efforts made to improve risk managers satisfaction with fit
for purpose, timely and independent scientific advice and communication activities while
maximising the use of the limited resources.

3. Acknowledges the initiatives carried out to prioritise stakeholder’s engagement in the

scientific assessment processes and guarantee access to data and information to promote
transparency.

4. Acknowledges the achievements to support the applicants in the area of regulated

products evaluation and all the guidance documents produced.

5. Notes the very good productivity of the Authority in the finalization of 779 scientific
questions.

6. Welcomes all the initiatives in the field of antimicrobial resistance, such as, to quote
one among many: the second Joint Interagency Antimicrobial Consumption and Resistance
Analysis report released in close collaboration with EMA and ECDC.

7. Welcomes the assistance provided by EFSA to the Commission and Member States in
dealing with animal diseases outbreaks such as the African swine fever, lumpy skin disease
and avian influenza.

8. Notes the difficulties in the attempt to absorb the MRL backlog and in reaching the
targets in the Pesticides and feed additives areas and calls for a focused and flexible
resource management to address these priority areas, as well as other that may face similar
bottlenecks in the future.

9. Appreciates the efforts made towards preparedness, particularly the progress made in the
area of plant health, and takes note of the resource challenges which lead in the application
 69

of negative priorities in this area potentially slowing down EFSA’s achievement of strategic
targets.

10. Appreciates and calls for a further strengthening of the cooperation and networking
initiatives carried out by the Authority to foster and make the best use in a shared manner
of available EU-wide expertise and to ensure that the scientific work is supported by the
appropriate outreach tools to engage with the relevant audience.

11. Welcomes the transformation journey of the resources and support department towards
business services that shifted from a transactional to a strategic approach in order to foster
a culture of openness, innovation, cooperation, independence and scientific excellence
among its experts, staff and partners and to ensure organisational performance.

12. Notes the excellent compliance, highlighting the adoption and application of the
new Independence Policy and its implementing decisions and appreciates the budget
management outcome with 100% of resources consumed and all the initiatives aimed at
achieving budget and human resources efficiency and fully supports the Agency’s calls for
the provision of the necessary resources to fulfil its mandate.
 70

Annex I. Resource allocation

per strategic objective
1. Financial resources per strategic objective
Table 24. Budget allocations per strategic objective (% of the total EFSA budget)
EFSA’S strategic objective Executed Budget Executed
2016 2017 2017
M€ % M€ % M€
SO1 Prioritise public and stakeholder
engagement in the process of 32.20 41% 32.63 29.12 37%
scientific assessment
SO2 Widen EFSA’s evidence base and
4.83 6% 4.64 4.95 6%
optimise access to its data
SO3 Build the EU’s risk assessment
6.50 8% 8.67 8.75 11%
capacity and knowledge community
SO4 Prepare for future risk assessment
11.60 15% 8.77 8.58 11%
challenges
SO5 Create an environment and
24.35 31% 24.50 27.81 35%
culture that reflects EFSA’s values
Of which operations 9.02 11% 9.74 9.85 12%
Of which support 15.33 19% 14.76 17.96 23%
Total EFSA 79.49 100% 79.20 79.21 100%
 71

2. Human resources per strategic objective

Table 25. FTE allocations per strategic objective
EFSA’S strategic objective Executed plan 2017 ACTUAL 2017
2016
FTE(60)/ fte(61)/ % FTEs %
posts posts
SO1 Prioritise public and
stakeholder engagement in the 200/202 198/201 43% 194 42%
process of scientific assessment
SO2 Widen EFSA’s evidence base
19/19 24/24 5% 23 5%
and optimise access to its data
SO3 Build the EU’s risk assessment
capacity and knowledge 31/32 37/37 8% 32 7%
community
SO4 Prepare for future risk
35/36 35/36 8% 35 8%
assessment challenges
SO5 Create an environment and
179/181 162/165 36% 172 38%
culture that reflects EFSA’s values
Of which operations 57/58 50/51 11% 51 11%
Of which support 122/123 112/114 25% 121 27%
Total EFSA 464/470 456/463 100% 456 100%
 72

Annex II. Financial resources

Table 26. Expenditures (60)

TITLE Commitment Payment Executed Executed

appropriations appropriations Commitment Payment
Title I - Staff expenditure 42.06 42.06 41.97 41.40
Title II - Infrastructure and
8.58 8.58 8.69 7.36
operating expenditure
Title III - Operational
28.56 29.79 28.55 25.50
expenditure

TOTAL EXPENDITURE 79.22 80.45 79.21 74.26

60
C1 credits.
Table 27. budget execution per budget line

Budget line Description Initial Current Executed % Current Payment Executed %

Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
1100 Basic salary 22,422,185.00 22,719,751.15 22,719,751.15 100.00% 22,719,751.15 22,719,751.15 100.00%

1101 Family allowance 2,907,000.00 2,987,348.08 2,987,348.08 100.00% 2,987,348.08 2,987,348.08 100.00%
Transfer and expatriation
1102 2,397,000.00 2,454,597.11 2,454,597.11 100.00% 2,454,597.11 2,454,597.11 100.00%
allowance
1103 Secretarial allowance 13,000.00 11,907.39 11,907.39 100.00% 11,907.39 11,907.39 100.00%

1113 Stagiaires 818,000.00 766,085.80 766,085.80 100.00% 766,085.80 766,085.80 100.00%

1115 Contract staff 6,290,000.00 6,572,174.74 6,572,174.74 100.00% 6,572,174.74 6,572,174.74 100.00%

1130 Insurance against sickness 786,000.00 811,415.71 811,415.71 100.00% 811,415.71 811,415.71 100.00%
Insurance against accidents
1131 116,000.00 91,063.16 91,063.16 100.00% 91,063.16 91,063.16 100.00%
and occupational disease
Unemployment insurance for
1132 290,000.00 300,862.13 300,862.13 100.00% 300,862.13 300,862.13 100.00%
tempory staff
Establishment or maintenance
1133 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
of pension rights for TA
1140 Birth and death allowance 3,000.00 2,181.41 2,181.41 100.00% 2,181.41 2,181.41 100.00%
Annual leave travelling
1141 280,000.00 269,427.59 269,427.59 100.00% 269,427.59 269,427.59 100.00%
expenses
1147 Call on duties 70,000.00 52,571.32 52,571.32 100.00% 52,571.32 52,571.32 100.00%
Other allowances and
1149 20,000.00 0.00 0.00 0.00% 0.00 0.00 0.00%
repayments
Translation centre
1171 Luxembourg (administrative 120,000.00 40,500.00 40,500.00 100.00% 40,500.00 37,290.25 92.07%
maters)
Payment for administrative
1172 assistance from the 250,000.00 250,105.63 250,105.63 100.00% 250,105.63 250,105.63 100.00%
Community institutions

73

61
C1 credits only
Budget line Description Initial Current Executed % Current Payment Executed %
Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
1175 Interim services 1,014,000.00 943,901.61 943,901.61 100.00% 943,901.61 860,243.33 91.14%

1176 Consultancy 240,000.00 177,771.25 177,771.25 100.00% 177,771.25 56,930.37 32.02%

1177 Other services 245,000.00 282,530.00 282,530.00 100.00% 282,530.00 198,100.00 70.12%
Miscellaneous expenditure on
1180 100,000.00 98,689.50 98,689.50 100.00% 98,689.50 79,439.50 80.49%
recruitment
Travel expenses (including for
1181 10,000.00 9,353.34 9,353.34 100.00% 9,353.34 9,353.34 100.00%
members of the family)
Installation, resettlement and
1182 190,000.00 172,689.30 172,689.30 100.00% 172,689.30 172,689.30 100.00%
transfer allowances
1183 Removal expenses 120,000.00 119,887.06 119,887.06 100.00% 119,887.06 92,892.45 77.48%
Temporary daily subsistence
1184 60,000.00 40,610.96 40,610.96 100.00% 40,610.96 40,610.96 100.00%
allowance
1190 WEIGHTINGS 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%

Chapter 11 Staff in active employment 38,761,185.00 39,175,424.24 39,175,424.24 100.00% 39,175,424.24 38,837,040.72 99.14%

1300 Mission and travel expenses 261,000.00 161,500.00 161,500.00 100.00% 161,500.00 160,527.99 99.40%

1301 Shuttles for missions and duty 100,000.00 93,300.00 93,300.00 100.00% 93,300.00 85,792.87 91.95%

Chapter 13 Missions and duty travel 361,000.00 254,800.00 254,800.00 100.00% 254,800.00 246,320.86 96.67%
Restaurants, meals and
1400 64,000.00 43,780.00 43,780.00 100.00% 43,780.00 39,330.75 89.84%
canteens
1410 Medical service 255,000.00 227,568.07 227,568.07 100.00% 227,568.07 170,195.61 74.79%
Further training, language
1420 584,000.00 403,636.69 403,636.69 100.00% 403,636.69 263,511.13 65.28%
courses and retraining for staff
Chapter 14 Sociomedical infrastructure 903,000.00 674,984.76 674,984.76 100.00% 674,984.76 473,037.49 70.08%
Visiting experts, National
1520 719,000.00 601,364.68 601,364.68 100.00% 601,364.68 586,498.79 97.53%
Experts on Detachment
Authority officials temporarily
1521 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
assigned

74
Budget line Description Initial Current Executed % Current Payment Executed %
Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
Exchange of officials and
Chapter 15 719,000.00 601,364.68 601,364.68 100.00% 601,364.68 586,498.79 97.53%
experts
1600 Special assistance grants 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%

1610 Social contacts between staff 50,000.00 34,819.06 34,819.06 100.00% 34,819.06 28,019.06 80.47%

1620 Other interventions 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
Early childhood centres and
1630 1,250,000.00 1,225,451.32 1,225,451.32 100.00% 1,225,451.32 1,225,451.32 100.00%
other crèches
Complementary aid for the
1640 10,000.00 4,474.42 4,474.42 100.00% 4,474.42 4,474.42 100.00%
handicapped
Chapter 16 Social welfare 1,310,000.00 1,264,744.80 1,264,744.80 100.00% 1,264,744.80 1,257,944.80 99.46%
Reception and entertainment
1700 5,000.00 2,478.72 2,478.72 100.00% 2,478.72 2,478.72 100.00%
expenses
Reception and entertainment
Chapter 17 5,000.00 2,478.72 2,478.72 100.00% 2,478.72 2,478.72 100.00%
expenses
Title 1 STAFF 42,059,185.00 41,973,797.20 41,973,797.20 100.00% 41,973,797.20 41,403,321.38 98.64%

2000 Rent 45,000.00 38,690.00 38,690.00 100.00% 38,690.00 38,690.00 100.00%

2001 Acquisition 1,802,000.00 2,058,712.35 2,058,712.35 100.00% 2,058,712.35 2,058,712.35 100.00%

2010 Insurance 38,000.00 30,996.56 30,996.56 100.00% 30,996.56 29,996.56 96.77%

Water, gas, electricity and
2020 525,000.00 485,160.16 485,160.16 100.00% 485,160.16 423,362.06 87.26%
heating
2030 Maintenance 347,000.00 334,610.79 334,610.79 100.00% 334,610.79 253,305.70 75.70%

2031 Cleaning 275,000.00 274,999.30 274,999.30 100.00% 274,999.30 220,413.34 80.15%

Refurbishment of premises/
2040 94,000.00 76,388.47 76,388.47 100.00% 76,388.47 17,871.28 23.40%
Fitting out
Security and surveillance of
2050 791,000.00 754,889.25 754,889.25 100.00% 754,889.25 582,655.12 77.18%
buildings
preliminary to construction,
2080 acquisition or rental of 215,000.00 166,680.00 166,680.00 100.00% 166,680.00 106,500.00 63.89%
immovable property

75
Budget line Description Initial Current Executed % Current Payment Executed %
Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
Other expenditure on
2090 782,500.00 735,950.82 735,950.82 100.00% 735,950.82 677,457.50 92.05%
buildings
Investments in immovable
Chapter 20 property, rental of buildings 4,914,500.00 4,957,077.70 4,957,077.70 100.00% 4,957,077.70 4,408,963.91 88.94%
and associated cost
Purchase/ Maintenance of
2100 404,000.00 483,490.61 483,373.02 99.98% 483,490.61 258,891.42 53.55%
equipment
Purchase / maintenance of
2101 649,000.00 786,679.73 786,679.73 100.00% 786,679.73 703,285.83 89.40%
software
2103 Software development 1,015,000.00 979,625.00 979,625.00 100.00% 979,625.00 853,659.07 87.14%

2104 User Support 746,000.00 827,247.24 827,247.24 100.00% 827,247.24 717,513.91 86.74%
Expenditure on data
Chapter 21 2,814,000.00 3,077,042.58 3,076,924.99 100.00% 3,077,042.58 2,533,350.23 82.33%
processing
Technical equipment and
2200 80,000.00 80,000.00 80,000.00 100.00% 80,000.00 56,955.84 71.19%
installations
Hire or leasing of technical
2201 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
equipment and installations
Maintenance and repair of
2202 technical equipment and 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
installations
2210 Purchase of furniture 20,000.00 14,174.19 14,174.19 100.00% 14,174.19 10,374.39 73.19%
Movable property and
Chapter 22 100,000.00 94,174.19 94,174.19 100.00% 94,174.19 67,330.23 71.50%
associated costs
2300 Stationery and office supplies 66,000.00 46,499.92 46,499.92 100.00% 46,499.92 45,749.92 98.39%

2320 Bank charges 1,000.00 500.00 500.00 100.00% 500.00 478.00 95.60%

2330 Legal expenses 185,000.00 120,950.00 120,950.00 100.00% 120,950.00 62,450.00 51.63%

2340 Damages 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%

2350 Miscellaneous insurance 11,000.00 5,816.70 5,816.70 100.00% 5,816.70 4,413.20 75.87%
Removals and associated
2353 0.00 0.00 0.00 0.00% 0.00 0.00 0.00%
handling

76
Budget line Description Initial Current Executed % Current Payment Executed %
Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
2390 Publications 12,000.00 1,450.00 1,450.00 100.00% 1,450.00 0.00 0.00%
Current administrative
Chapter 23 275,000.00 175,216.62 175,216.62 100.00% 175,216.62 113,091.12 64.54%
expenditure
2400 Postal charges 35,500.00 25,170.00 25,170.00 100.00% 25,170.00 14,916.38 59.26%
Telecommunications
2410 201,000.00 165,483.11 165,483.11 100.00% 165,483.11 63,450.79 38.34%
subscriptions and charges
Purchase and installation of
2411 128,000.00 112,374.11 112,374.11 100.00% 112,374.11 106,984.84 95.20%
equipment
Postal charges and
Chapter 24 364,500.00 303,027.22 303,027.22 100.00% 303,027.22 185,352.01 61.17%
communications
2500 Management Board meetings 110,000.00 78,394.80 78,219.80 99.78% 78,394.80 55,199.66 70.41%

Chapter 25 Governance expenditure 110,000.00 78,394.80 78,219.80 99.78% 78,394.80 55,199.66 70.41%
BUILDING, EQUIPMENT
AND MISCELLANEOUS
Title 2 8,578,000.00 8,684,933.11 8,684,640.52 100.00% 8,684,933.11 7,363,287.16 84.78%
OPERATING EXPENDITURE
LINKED TO THE AUTHORITY
3020  REPRO Experts meetings 4,118,000.00  4,394,632.92 4,391,632.92 99.93% 4,394,632.92  4,273,933.98  97.25%
Scientific Evaluation of
Chapter 30 4,118,000.00 4,394,632.92 4,391,632.92 99.93% 4,394,632.92 4,273,933.98 97.25%
regulated products
3120  RASA Experts meetings 3,695,000.00  3,573,854.75  3,573,854.75  100.00%  3,573,854.75 3,496,650.15  97.84% 

3130 Crisis support 9,000.00 0.00 0.00 0% 0.00 0.00 0%

Risk assessment and scientific
Chapter 31 3,704,000.00 3,573,854.75 3,573,854.75 100.00% 3,573,854.75 3,496,650.15 97.84%
assistance
3210  EFSA Grants & Procurement 9,490,000.00  9,831,507.13  9,831,506.70  100.00%  11,287,254.13 11,284,108.44 99.97%
Scientific Cooperation
3220 68,000.00 86,304.86 86,304.86 100.00% 86,304.86 86,304.86 100.00%
meetings
Chapter 32 EFSA Scientific Cooperation 9,558,000.00 9,917,811.99 9,917,811.56 100.00% 11,373,558.99 11,370,413.30 100.00%

COMMS                

77
 Budget line Description Initial Current Executed % Current Payment Executed %
Commitment Commitment Committment Committment Appropriation Payment Paid
Appropriation Appropriation
Risk communications activities
3410 1,089,000.00 779,165.78 777,119.78 99.74% 779,165.78 510,701.76 65.54%
& materials
3420 External relations 310,000.00 192,305.49 192,303.49 100.00% 192,305.49 187,352.29 97.42%

Chapter 34 Communications 1,399,000.00 971,471.27 969,423.27 99.79% 971,471.27 698,054.05 71.86%

OPERATIONAL SUPPORT

3500 Operational IT Systems 3,975,000.00 4,458,476.33 4,458,475.83 100.00% 4,458,476.33 1,890,767.32 42.41%
Multiannual operational IT
3501 1,202,000.00 226,467.00 226,467.00 100.00% 0.00 0.00 0.00%
projects
Translation, Interpretation
3511 Linguistic proofreading and 200,000.00 241,000.00 241,000.00 100.00% 241,000.00 194,714.96 80.79%
editing
3512 Library 534,000.00 547,906.08 547,906.08 100.00% 547,906.08 455,612.99 83.16%
Mission of staff related to
3513 950,000.00 792,200.00 792,200.00 100.00% 792,200.00 770,534.96 97.27%
operational duties
3514 Shuttles 1,025,000.00 1,008,000.00 998,000.00 99.01% 1,008,000.00 928,053.36 92.07%

3520 Conferences & Outreach 1,100,000.00 987,049.92 986,905.52 99.99% 987,049.92 854,720.11 86.59%
Operational Development &
3530 760,000.00 1,406,179.74 1,406,085.00 99.99% 1,406,179.74 530,651.25 37.74%
Control
3540 Quality management 40,000.00 39,950.00 39,950.00 100.00% 39,950.00 33,500.00 83.85%

Chapter 35 Horizontal operations 9,786,000.00 9,707,229.07 9,696,989.43 99.89% 9,480,762.07 5,658,554.95 59.68%
OPERATING EXPENDITURE
Title 3 28,565,000.00 28,565,000.00 28,549,711.93 99.95% 29,794,280.00 25,497,606.43 85.57%
LINKED TO AUTHORITY
GRAND
EFSA 79,202,185.00 79,223,730.31 79,208,149.65 99.98% 80,453,010.31 74,264,214.97 92.31%
TOTAL

„„ Carry forward
The non-differentiated appropriations carried forward to 2017 were utilised at 96.4% (€7.91 out of 8.20 million).
The under-execution comes mainly from unused carry forward of training and interims services (Title I), building cost and telecom charges (Title II) and scientific meetings, IT systems

78
and events (Title III).
Appropriations carried forward from 2017 to 2018 amount to € 6.17 million and are € 2.03 million lower than previous year.
 79

Table 28. Carry forward

Title Carry forward Amount paid % used Carry forward
2016 2017
Personnel 893,080 810,502 90.8% 576,992
Infrastructure 2,244,470 2,184,416 97.3% 1,321,353
Operations 5,059,788 4,911,408 97.1% 4,278,240
Total 8,197,338 7,906,327 96.4% 6,176,585

Table 29. Budget Transfers 2017

Title Budget headings Commitment and payment appropriation 2017
transfers from year start Initial Transfers Final
1 STAFF
11 STAFF IN ACTIVE EMPLOYMENT
110 Staff in active employment
1100 Basic salary 22,422,185.00 297,566.15 22,719,751.15
1101 Family allowance 2,907,000.00 80,348.08 2,987,348.08
Transfer and expatriation
1102 2,397,000.00 57,597.11 2,454,597.11
allowance
1103 Secretarial allowance 13,000.00 -1,092.61 11,907.39
tot. of 110 27,739,185.00 434,418.73 28,173,603.73
111 Other staff
1113 Stagiaires 818,000.00 -51,914.20 766,085.80
1115 Contract staff 6,290,000.00 282,174.74 6,572,174.74
tot. of 111 7,108,000.00 230,260.54 7,338,260.54
Employer's social security
113
contributions
1130 Insurance against sickness 786,000.00 25,415.71 811,415.71
Insurance against accidents
1131 116,000.00 -24,936.84 91,063.16
and occupational disease
Unemployment insurance for
1132 290,000.00 10,862.13 300,862.13
temporary staff
Establishment or
1133 maintenance of pension 0.00 0.00 0.00
rights for temporary staff
tot. of 113 1,192,000.00 11,341.00 1,203,341.00
Miscellaneous allowances
114
and grants
1140 Birth and death allowance 3,000.00 -818.59 2,181.41
Annual leave travelling
1141 280,000.00 -10,572.41 269,427.59
expenses
1147 Call on duties 70,000.00 -17,428.68 52,571.32
Other allowances and
1149 20,000.00 -20,000.00 0.00
repayments
tot. of 114 373,000.00 -48,819.68 324,180.32
117 Supplementary services
1171 Translation and interpretation 120,000.00 -79,500.00 40,500.00
Payment for administrative
1172 assistance from the 250,000.00 105.63 250,105.63
Community institutions
 80

Title Budget headings Commitment and payment appropriation 2017

transfers from year start Initial Transfers Final
1175 Interim services 1,014,000.00 -70,098.39 943,901.61
1176 Consultancy 240,000.00 -62,228.75 177,771.25
1177 Other services 245,000.00 37,530.00 282,530.00
tot. of 117 1,869,000.00 -174,191.51 1,694,808.49
118 Recruitment costs and expenses on entering and leaving the service
Miscellaneous expenditure
1180 100,000.00 -1,310.50 98,689.50
on recruitment
Travel expenses (including for
1181 10,000.00 -646.66 9,353.34
members of the family)
Installation, resettlement and
1182 190,000.00 -17,310.70 172,689.30
transfer allowances
1183 Removal expenses 120,000.00 -112.94 119,887.06
Temporary daily subsistence
1184 60,000.00 -19,389.04 40,610.96
allowance
tot. of 118 480,000.00 -38,769.84 441,230.16
119 Salary weightings
1190 Salary weightings 0.00 0.00 0.00
tot. of 119 0.00 0.00 0.00
tot. of 11 38,761,185.00 414,239.24 39,175,424.24
13 MISSIONS AND DUTY TRAVEL
130 Mission and travel expenses
1300 Mission and travel expenses 261,000.00 -99,500.00 161,500.00
1301 Shuttles for missions and duty 100,000.00 -6,700.00 93,300.00
tot. of 130 361,000.00 -106,200.00 254,800.00
tot. of 13 361,000.00 -106,200.00 254,800.00
14 SOCIOMEDICAL INFRASTRUCTURE
140 Restaurants, meals and canteens
Restaurants, meals and
1400 64,000.00 -20,220.00 43,780.00
canteens
tot. of 140 64,000.00 -20,220.00 43,780.00
141 Medical service
1410 Medical service 255,000.00 -27,431.93 227,568.07
tot. of 141 255,000.00 -27,431.93 227,568.07
 81

Title Budget headings Commitment and payment appropriation 2017

transfers from year start Initial Transfers Final
142 Further training, language courses and retraining for staff
Further training, language
1420 courses and retraining for 584,000.00 -180,363.31 403,636.69
staff
tot. of 142 584,000.00 -180,363.31 403,636.69
tot. of 14 903,000.00 -228,015.24 674,984.76
15 EXCHANGE OF OFFICIALS AND EXPERTS
152 Exchange of officials and experts
Visiting experts, National
1520 719,000.00 -117,635.32 601,364.68
Experts on Detachement
Authority officials temporarily
assigned to national civil
1521 services, to international 0.00 0.00 0.00
organisations or to public or
private institutions
tot. of 152 719,000.00 -117,635.32 601,364.68
tot. of 15 719,000.00 -117,635.32 601,364.68
16 SOCIAL WELFARE
160 Special assistance grants
1600 Special assistance grants 0.00 0.00 0.00
tot. of 160 0.00 0.00 0.00
161 Social contacts between staff
1610 Social contacts between staff 50,000.00 -15,180.94 34,819.06
tot. of 161 50,000.00 -15,180.94 34,819.06
162 Other interventions
1620 Other interventions 0.00 0.00 0.00
tot. of 162 0.00 0.00 0.00
163 Early childhood centres and other creches
Early childhood centres,
1630 other creches and EU school 1,250,000.00 -24,548.68 1,225,451.32
contribution
tot. of 163 1,250,000.00 -24,548.68 1,225,451.32
164 Complementary aid for the handicapped
Complementary aid for the
1640 10,000.00 -5,525.58 4,474.42
handicapped
tot. of 164 10,000.00 -5,525.58 4,474.42
tot. of 16 1,310,000.00 -45,255.20 1,264,744.80
17 RECEPTION AND ENTERTAINMENT EXPENSES
170 Reception and entertainment expenses
Reception and entertainment
1700 5,000.00 -2,521.28 2,478.72
expenses
tot. of 170 5,000.00 -2,521.28 2,478.72
tot. of 17 5,000.00 -2,521.28 2,478.72
tot. of 1 42,059,185.00 -85,387.80 41,973,797.20
 82

Title Budget headings Commitment and payment appropriation 2017

transfers from year start Initial Transfers Final
BUILDINGS, EQUIPMENT AND MISCELLANEOUS OPERATING EXPENDITURE
2
LINKED TO THE AUTHORITY
INVESTMENTS IN IMMOVABLE PROPERTY, RENTAL OF BUILDING AND ASSOCIATED
20
COSTS
200 Building
2000 Rent 45,000.00 -6,310.00 38,690.00
2001 Acquisition ( )
64
1,802,000.00 235,167.04 2,058,712.35
tot. of 200 1,847,000.00 228,857.04 2,097,402.35
201 Insurance
2010 Insurance 38,000.00 -7,003.44 30,996.56
tot. of 201 38,000.00 -7,003.44 30,996.56
202 Water, gas, electricity and heating
Water, gas, electricity and
2020 525,000.00 -39,839.84 485,160.16
heating
tot. of 202 525,000.00 -39,839.84 485,160.16
203 Cleaning and maintenance
2030 Maintenance 347,000.00 -12,389.21 334,610.79
2031 Cleaning 275,000.00 -0.70 274,999.30
tot. of 203 622,000.00 -12,389.91 609,610.09
204 Refurbishment of premises/Fitting out
Refurbishment of premises/
2040 94,000.00 -17,611.53 76,388.47
Fitting out
tot. of 204 94,000.00 -17,611.53 76,388.47
205 Security and surveillance of buidings
Security and surveillance of
2050 791,000.00 -36,110.75 754,889.25
buidings
tot. of 205 791,000.00 -36,110.75 754,889.25
Preliminary expenditure relating to construction, acquisition or rental of
208
immovable property
Preliminary to construction,
2080 acquisition or rental of 215,000.00 -48,320.00 166,680.00
immovable property
tot. of 208 215,000.00 -48,320.00 166,680.00
Other expenditure on
209
buildings
Other expenditure on
2090 782,500.00 -46,549.18 735,950.82
buildings
tot. of 209 782,500.00 -46,549.18 735,950.82
tot. of 20 4,914,500.00 21,032.39 4,957,077.70
21 EXPENDITURE ON DATA PROCESSING
210 Purchase and maintenance of IT for administration and non operational
Purchase/ maintenance of IT
2100 404,000.00 79,490.61 483,490.61
equipment

(64) Amended June 2017

 83

Title Budget headings Commitment and payment appropriation 2017

transfers from year start Initial Transfers Final
Purchase / maintenance of
2101 649,000.00 137,679.73 786,679.73
software
2103 Software development 1,015,000.00 -35,375.00 979,625.00
2104 User Support 746,000.00 81,247.24 827,247.24
tot. of 210 2,814,000.00 263,042.58 3,077,042.58
tot. of 21 2,814,000.00 263,042.58 3,077,042.58
22 MOVABLE PROPERTY AND ASSOCIATED COSTS
220 Technical equipment and installations
Technical equipment and
2200 80,000.00 0.00 80,000.00
installations
Hire or leasing of technical
2201 0.00 0.00 0.00
equipment and installations
Maintenance and repair of
2202 technical equipment and 0.00 0.00 0.00
installations
tot. of 220 80,000.00 0.00 80,000.00
221 Furniture
2210 Purchase of furniture 20,000.00 -5,825.81 14,174.19
2211 Hire of furniture 0.00 0.00 0.00
Maintenance and repair of
2212 0.00 0.00 0.00
furniture
tot. of 221 20,000.00 -5,825.81 14,174.19
tot. of 22 100,000.00 -5,825.81 94,174.19
23 CURRENT ADMINISTRATIVE EXPENDITURE
230 Stationery and office supplies
2300 Stationery and office supplies 66,000.00 -19,500.08 46,499.92
tot. of 230 66,000.00 -19,500.08 46,499.92
232 Financial charges
2320 Bank charges 1,000.00 -500.00 500.00
2321 Other financial charges 0.00 0.00 0.00
tot. of 232 1,000.00 -500.00 500.00
233 Legal expenses
2330 Legal expenses 185,000.00 -64,050.00 120,950.00
tot. of 233 185,000.00 -64,050.00 120,950.00
234 Damages
2340 Damages 0.00 0.00 0.00
tot. of 234 0.00 0.00 0.00
235 Other operating expenditure
2350 Miscellaneous insurance 11,000.00 -5,183.30 5,816.70
Removals and associated
2353 0.00 0.00 0.00
handling
tot. of 235 11,000.00 -5,183.30 5,816.70
239 Publications
2390 Publications 12,000.00 -10,550.00 1,450.00
tot. of 239 12,000.00 -10,550.00 1,450.00
tot. of 23 275,000.00 -99,783.38 175,216.62
 84

Title Budget headings Commitment and payment appropriation 2017

transfers from year start Initial Transfers Final
POSTAL CHARGES AND
24 24
TELECOMMUNICATIONS
240 Postal charges
2400 Postal charges 35,500.00 -10,330.00 25,170.00
tot. of 240 35,500.00 -10,330.00 25,170.00
241 Telecommunications
Telecommunications
2410 201,000.00 -35,516.89 165,483.11
subscriptions and charges
Purchase and installation of
2411 128,000.00 -15,625.89 112,374.11
equipment
tot. of 241 329,000.00 -51,142.78 277,857.22
tot. of 24 364,500.00 -61,472.78 303,027.22
25 GOVERNANCE EXPENDITURE
250 Governance expenditure
2500 Management Board meetings 110,000.00 -31,605.20 78,394.80
tot. of 250 110,000.00 -31,605.20 78,394.80
tot. of 25 110,000.00 -31,605.20 78,394.80
tot. of 2 8,578,000.00 85,387.80 8,684,933.11
 Title Budget Headings B 2017 Commitment appropriations B 2017 Payments appropriations
Chapter Transfers from year starts
Article Initial Transfers Final Initial Transfers Final
Item
3 OPERATING EXPENDITURE LINKED TO THE AUTHORITY
30 SCIENTIFIC EVALUATION of REGULATED PRODUCTS
302 REPRO Experts meetings
3020 REPRO Experts meetings 4,118,000.00 276,632.92 4,394,632.92 4,118,000.00 276,632.92 4,394,632.92
tot. of 302 4,118,000.00 276,632.92 4,394,632.92 4,118,000.00 276,632.92 4,394,632.92
tot. of 30 4,118,000.00 276,632.92 4,394,632.92 4,118,000.00 276,632.92 4,394,632.92
31 RISK ASSESSMENT & SCIENTIFIC ASSISTANCE
312 RASA Experts meetings
3120 RASA Experts meetings 3,695,000.00 -121,145.25 3,573,854.75 3,695,000.00 -121,145.25 3,573,854.75
tot. of 312 3,695,000.00 -121,145.25 3,573,854.75 3,695,000.00 -121,145.25 3,573,854.75
313 Crisis support
3130 Crisis support 9,000.00 -9,000.00 0.00 9,000.00 -9,000.00 0.00
tot. of 313 9,000.00 -9,000.00 0.00 9,000.00 -9,000.00 0.00
tot. of 31 3,704,000.00 -130,145.25 3,573,854.75 3,704,000.00 -130,145.25 3,573,854.75
32 EFSA SCIENTIFIC COOPERATION
321 EFSA Grants & Procurement
3210 EFSA Grants & Procurement 9,490,000.00 341,507.13 9,831,507.13 10,754,280.00 532,974.13 11,287,254.13
tot. of 321 9,490,000.00 341,507.13 9,831,507.13 10,754,280.00 532,974.13 11,287,254.13
322 Scientific cooperation meetings
3220 Scientific cooperation meetings 68,000.00 18,304.86 86,304.86 68,000.00 18,304.86 86,304.86
tot. of 343 68,000.00 18,304.86 86,304.86 68,000.00 18,304.86 86,304.86
323 Pre-accession and ENP Programmes*
3230 Pre-accession programme 0.00 0.00 0.00 0.00 0.00 0.00
ENP (European Neighbourhood
3231 0.00 0.00 0.00 0.00 0.00 0.00
programme)
tot. of 323 0.00 0.00 0.00 0.00 0.00 0.00
Collaboration with other
324
organisations*
3240 Collaboration with FAO 0.00 0.00 0.00 0.00 0.00 0.00
tot. of 3324 0.00 0.00 0.00 0.00 0.00 0.00

85
tot. of 32 9,558,000.00 359,811.99 9,917,811.99 10,822,280.00 551,278.99 11,373,558.99
34 COMMUNICATIONS
341 Risk Communication
3410 Risk Communication 1,089,000.00 -309,834.22 779,165.78 1,089,000.00 -309,834.22 779,165.78
tot. of 341 1,089,000.00 -309,834.22 779,165.78 1,089,000.00 -309,834.22 779,165.78
342 External relations
3420 External relations 310,000.00 -117,694.51 192,305.49 310,000.00 -117,694.51 192,305.49
tot. of 342 310,000.00 -117,694.51 192,305.49 310,000.00 -117,694.51 192,305.49
35 HORIZONTAL OPERATIONS
350 Operational IT Systems
3500 Operational IT Systems 3,975,000.00 483,476.33 4,458,476.33 3,975,000.00 483,476.33 4,458,476.33
3501 Multiannual IT Projects 1,202,000.00 -975,533.00 226,467.00 1,167,000.00 -1,167,000.00 0.00
tot. of 350 5,177,000.00 -492,056.67 4,684,943.33 5,142,000.00 -683,523.67 4,458,476.33
351 Operational support
Translation, Interpretation, Linguistic
3511 200,000.00 41,000.00 241,000.00 200,000.00 41,000.00 241,000.00
Proofreading and Editing
3512 Library 534,000.00 13,906.08 547,906.08 534,000.00 13,906.08 547,906.08
Mission of staff related to operational
3513 950,000.00 -157,800.00 792,200.00 950,000.00 -157,800.00 792,200.00
duties
Shuttles for experts and staff related
3514 1,025,000.00 -17,000.00 1,008,000.00 1,025,000.00 -17,000.00 1,008,000.00
to operational duties
tot. of 351 2,709,000.00 -119,893.92 2,589,106.08 2,709,000.00 -119,893.92 2,589,106.08
352 Conferences & Outreach
3520 Conferences and Outreach 1,100,000.00 -112,950.08 987,049.92 1,100,000.00 -112,950.08 987,049.92
tot. of 352 1,100,000.00 -112,950.08 987,049.92 1,100,000.00 -112,950.08 987,049.92
353 Operational development & Control
3530 Operational Development & Control 760,000.00 646,179.74 1,406,179.74 760,000.00 646,179.74 1,406,179.74
tot. of 353 760,000.00 646,179.74 1,406,179.74 760,000.00 646,179.74 1,406,179.74
354 Quality Management
3540 Quality Management 40,000.00 -50.00 39,950.00 40,000.00 -50.00 39,950.00
tot. of 354 40,000.00 -50.00 39,950.00 40,000.00 -50.00 39,950.00
tot. of 35 9,786,000.00 -78,770.93 9,707,229.07 9,751,000.00 -270,237.93 9,480,762.07
tot. of 3 28,565,000.00 0.00 28,565,000.00 29,794,280.00 0.00 29,794,280.00

86
Annex III. Status of projects
Table 30. Projects and Process improvement initiatives under SO1 – Status report
Intermediary Impact Expected result – Outcome Project Overall Status
Customer oriented approach for applications for Regulated Products Closed
increased engagement of stakeholders in TERA ]
Increased satisfaction of stakeholders
regarding EFSA’s scientific outputs (for scientific activities Stakeholder Engagement Approach (SEA) ]
EC/MS risk managers and stakeholders) Reputation Management (including Barometer) ]
and the scientific assessment process and
full availability of documentation relevant
communication tools and materials Matrix ]
to EFSA scientific outputs
enhanced outreach of communication Social Media 2020 strategy ]

Table 31. Projects and Process improvement initiatives under SO2 – Status report

Intermediary impact Expected result - outcome Project Overall Status

Increased satisfaction of stakeholders regarding EFSA’s evidence management services Information Management Programme ]
and fostered innovative re-use of data Information governance project ]
Developing a system for assigning digital object identifiers (dois)
]
project
Improved access to data
Scientific Data Warehouse (DWH) Closed
Open ScAIE project ]
Wider data coverage Molecular typing project Closed
Increased satisfaction of stakeholders Introduction of a framework for Information Access Management ]
regarding EFSA’s evidence management
services and fostered innovative re-use of EU MENU project ]
data FOODEX2 project ]
Increased standardisation and
interoperability of data IPCHEM project Closed
]
SSD2 pilot project in closing
phase
Improved quality of data Data collection services project ]
87
Table 32. Projects and Process improvement initiatives under SO3 – Status report
Intermediary impact Expected result - Outcome Project Overall Status
Expertise Management Programme ]
EU-FORA ]
Increased efficiency at European and Building and sharing capacity within
international level EFSA Pre-accession Programme ]
the risk assessment community at
organisational level Innovative approach for Article 36 networking and
Increased satisfaction of MS, EU and international ]
management of the list
partners with regard to the building and sharing
of risk assessment capacity and a knowledge ]
Machine Learning techniques applied in risk assessment
community at organisational and individual level, in closing
Strengthened capacity using innovative related to food safety
in general and via specific tools (e.g. grants) phase
ways
Envisioning
Crowdsourcing
phase

88
Table 33. Projects and Process improvement initiatives under SO4 – Status report
Intermediary impact Expected result - outcome Project Overall Status
Wildlife project ]
Vectornet project ]
Define new activity on urgent response for plant health issues ]
]
Tracing methodology
in closing phase
Preparatory work for future advice / Integrating new approaches in chemical risk assessment ]
Cumulative Risk Assessment of Pesticides - part II ]
Data collection on historical control data Not started yet
Coordinated framework for the development of environmental risk assessment across the
various EFSA units and panels: Pilot Projects with MSs on 4 areas (pesticides soil, pesticides Not started yet
aquatic, plant health, multi-stressors)
Bee health ]
Guidance on submissions for evaluation of nutrients or of other ingredients proposed for use
]
in the manufacture of foods
Fostered use of new Guidance documents for health claims ]
approaches and enhanced ]
Increased effectiveness of ability to anticipate and Use of protein hydrolysates in formulae
in closing phase
preparedness and response respond to risks Aquatic RA Guidance: Opinion on TK/TD and simple food chain effects modelling for RA ]
Increased effectiveness of Fostered use of new
preparedness and response approaches and enhanced ]
EFSA guidance on Dermal Absorption
ability to anticipate and in closing phase
respond to risks Epidemiological studies Closed
Hazard assessment of Endocrine Disruptors ]
PECs in Soil ]
QSAR Dermal absorption ]
Repair action of the FOCUS surface water scenarios ]
Guidance for the identification of biological relevance of adverse / positive health effects from
Closed
experimental animal and human studies
Update of the guidance of the Scientific Committee on the use of the benchmark dose
Closed
approach in risk assessment
Risk Assessment of Substances Present in Food Intended for Infants Closed
Guidance on the use of the Weight of Evidence Approach in Scientific Assessments Closed
Review of the published non-dietary exposure data to pesticides for residents and bystanders ]
and for environmental RA. in closing phase
Terrestrial RA Guidance. Non-target terrestrial plants and Amphibians and reptile Guidance ]
Testing strategies for evaluation of developmental neurotoxicity ]

89
 Intermediary impact Expected result - outcome Project Overall Status
Set up of a plan for the further development and use of animal-based indications for animal
Not started yet
welfare risk assessment
Harmonisation of risk Expert knowledge elicitation (EKE) ]
Increased satisfaction of assessment methodologies Scientific Committee Guidance Document Review framework (Guidance review) ]
stakeholders with regard Harmonise EFSA environmental risk assessment (ERA) schemes Not started yet
to EFSA's preparedness,
methodologies and response Evidence use in risk assessment: Prometheus ]
Risk Assessment tools for the safety of global food and feed supply chains (FPA with BfR) ]
Accessibility of EFSA methods
R4EU ]
and tools
Knowledge junction (through Open ScAIE) Closed

Table 34. Projects and Process improvement initiatives under SO5 – Status report
Intermediate impact Expected result - Outcome Project Overall Status
External evaluation ]
EU Agencies' Network (EUAN) ]
People and culture Talent Management ]
Centralisation of competing interest management Closed
Independence policy ]
Compliance Business continuity ]
OHSAS 18000 certification ]
Sound operational performance Correspondence & records management ]

Efficiency Organisational development: mission centralisation and travel

]
logistics outsourcing
Enabling work environment
New World of Work ]
COMMS Digital Collaboration ]
Performance and results management approach ]
EMAS certification registration. ISO 14001 certification and
]
Capabilities certification achievement
Chartering
Businesses DWH (B.I.K.E. project)
phase

90
Annex IV. Questions closed 2017
Table 35. Questions closed 2017
REPRO RASA

BIOCONTAM

TOTAL
APDESK

ALPHA
Questions per strategic objective and type of EFSA output

NUTRI

DATA
PRAS
FEED

GMO

SCER
AMU
FIP
SO1 – Prioritise public and stakeholder engagement in the process of scientific assessment

SO1 – EFSA scientific outputs – general risk assessment 0 1 0 0 3 0 130 0 21 3 0 158

Of which:                        

– Opinion of the Scientific Committee / Scientific Panel    1     2   120   14     137

– Guidance of the Scientific Committee / Scientific Panel                       0

– Statement of the Scientific Committee / Scientific Panel             1   2     3

– Scientific report of EFSA             8   5 3   16

– Guidance of EFSA                       0

– Statement of EFSA         1   1         2

SO1 – Technical reports – general risk assessment         4   6   6     16

SO1 – Other publications (external scientific reports/event reports) – General risk
0 0 0 0 2 0 19 0 8 0 0 29
assessment
Other publications - External Scientific Report         2   18   8     28

Other publications - Event Report             1         1

SO1 – Sub total – general risk assessment 0 1 0 0 9 0 155 0 35 3 0 203

SO1 – EFSA scientific outputs – evaluation of regulated products 0 54 128 18 25 166 0 0 1 0 0 392

91
 REPRO RASA

BIOCONTAM

TOTAL
APDESK

ALPHA
Questions per strategic objective and type of EFSA output

NUTRI

DATA
PRAS
FEED

GMO

SCER
AMU
FIP
Of which:                        

Conclusion on pesticides peer review           37           37

– Opinion of the Scientific Committee / Scientific Panel   54 125 13 22       1     215

– Guidance of the Scientific Committee / Scientific Panel       1               1

– Statement of the Scientific Committee / Scientific Panel     1 2 3             6

– Reasoned opinion           74           74

– Scientific report of EFSA           38           38

– Guidance of EFSA           2           2

– Statement of EFSA     2 2   15           19

SO1 – Technical reports – evaluation of regulated products 1 2 3 18 1 41           66

SO1 – Other publications (external scientific reports/event reports) – evaluation
0 1 1 5 1 0 0 0 0 0 0 8
of regulated products
Other publications - External Scientific Report   1 1 5 1             8

Other publications - Event Report                       0

SO1 – Sub total – evaluation of regulated products 1 57 132 41 27 207 0 0 1 0 0 466

SO1 – Total 1 58 132 41 36 207 155 0 36 3 0 669

SO2 – Widen EFSA’s evidence base and optimise access to its data

SO2 – EFSA scientific outputs                       0

SO2 – Technical reports                   10   10

92
 REPRO RASA

BIOCONTAM

TOTAL
APDESK

ALPHA
Questions per strategic objective and type of EFSA output

NUTRI

DATA
PRAS
FEED

GMO

SCER
AMU
FIP
SO2 – Other publications (external scientific reports/event reports) 0 0 0 0 0 0 0 0 0 19 2 21

Other publications - External Scientific Report                   19 2 21

Other publications - Event Report                       0

SO2 – Total 0 0 0 0 0 0 0 0 0 29 2 31

SO3 – Build the EU’s scientific assessment capacity and knowledge community

SO3 – EFSA scientific outputs                       0

SO3 –Technical reports       1         2     3

SO3 – Other publications (external scientific reports/event reports) 0 0 0 0 0 0 0 0 0 0 0 0

Other publications - External Scientific Report                       0

Other publications - Event Report                       0

SO3 – Total 0 0 0 1 0 0 0 0 2 0 0 3

SO4 – Prepare for future risk assessment challenges

SO4 – EFSA scientific outputs 0 3 0 1 3 5 0 0 6 0 7 25

Of which:                        

Opinion of the Scientific Committee / Scientific Panel         1 2     4   3 10

Scientific report of EFSA           1           1

Statement of the Scientific Committee / Scientific Panel                 2     2

Guidance of the Scientific Committee / Scientific Panel   3   1 2           4 10

93
Guidance of EFSA           2           2
 REPRO RASA

BIOCONTAM

TOTAL
APDESK

ALPHA
Questions per strategic objective and type of EFSA output

NUTRI

DATA
PRAS
FEED

GMO

SCER
AMU
FIP
SO4 – Technical reports   3   1 3 7     1   9 24

SO4 – Other publications (external scientific reports/event reports) 0 0 0 0 0 6 3 5 6 0 7 27

Other publications - External Scientific Report           5 3 5 5   4 22

Other publications - Event Report           1     1   3 5

SO4 – Total 0 6 0 2 6 18 3 5 13 0 23 76

Total questions 1 64 132 44 42 225 158 5 51 32 25 779

94
Annex V. Human resources
Figure 4. Organisational chart (31/12/17)

95
Table 36. Establishment plan 2017

2017
Function group and grade Authorised under the EU Budget Filled as of 31/12/2017
Permanent posts Temporary posts Permanent posts Temporary posts
AD 16 - - - -
AD 15 - 1 - -
AD 14 - 2 - 1
AD 13 - 2 - 0
AD 12 1 16 - 6
AD 11 - 11 - 6
AD 10 1 17 - 13
AD 9 1 42 - 25
AD 8 - 54 - 57
AD 7 1 56 5 49
AD 6 1 15 - 35
AD 5 - 6 - 11
AD TOTAL 5 222 5 203
AST 11 - - - -
AST 10 - - - -
AST 9 - - - -
AST 8 - 3 - -
AST 7 - 4 - 2
AST 6 - 9 - 3
AST 5 - 30 - 16
AST 4 - 23 - 36
AST 3 - 25 - 22
AST 2 - 2 - 21
AST 1 - - - 3
AST TOTAL - 96 - 103

96
 2017
Function group and grade Authorised under the EU Budget Filled as of 31/12/2017
Permanent posts Temporary posts Permanent posts Temporary posts
AST/SC 6 - - - -
AST/SC 5 - - - -
AST/SC 4 - - - -
AST/SC 3 - - - -
AST/SC 2 - - - -
AST/SC 1 - - - -
AST/SC TOTAL - - - -
TOTAL 5 318 5 306
GRAND TOTAL 323 311

97
 98

Table 37. Results of the benchmarking exercise in accordance with provision of Art. 29 (3)
Framework Financial Regulation and Methodology for Agencies Job Screening(a)

Job type (sub)category Year 2016 Year 2017

Administrative support and Coordination 21.4% 20.8%
Administrative support 19.7% 18.8%
Coordination 1.7% 2.0%
Operational 71.6% 72.6%
Top Level Operational Coordination 3.7% 2.6%
Programme Management and Implementation 54.9% 56.6%
Evaluation & Impact Assessment 0.0% 0.0%
General operational 13.1% 13.3%
Neutral 7.0% 6.6%
Finance/Control 6.4% 6.1%
Linguistics 0.5% 0.6%
TOTAL 100% 100%
 99

Annex VI. Negotiated

procedures and time to grant
Table 38. 2017 negotiated procedure
2017 Exceptional Negotiated Procedures under Article 134 (1) a to f art 53 RAP
No. Procedure Contractor name Subject of contract Contract
type amount
Participation of Pre-
Ministry of Food accession countries
1 Neg Art 134 1b Agriculture and in the framework of 16,200.00 €
Livestock the Instrument of Pre-
Accession Programme II
Purchase of Springer's
2 Neg Art 134 1b Springer 30,000.00 €
e-books collection
Bionumerics Service for
Management & Analysis
of whole genome
3 Neg Art 134 1b Applied Maths sequencing data from 20,000.00 €
listeria monocytogenes,
salmonella & escherichia
coli isolates
Purchase of access to ISI
THOMSON Web of Science platform
4 Neg Art 134 1e 84,859.65 €
REUTERS with sub-databases by
Thomson Reuters Scientific
Annual Subscription to EU
5 Neg Art 134 1b Bartlett Media Ltd 20,000.00 €
Food Policy
COMMS/2017/PO05 -
6 Neg Art 134 1b Politico sprl Subscription to Politico Pro 19,763.00 €
Agri and Food 2017/2018
not applicable
Professional network
7 Neg Art 134 1b LinkedIn Ireland (interagency
services
call)
Convezione per i servizi di
8 Neg Art 134 1b GARR 226,467.00 €
Connettività alla rete GARR
Legal assistance for
Kapellmann und the defence of EFSA in
9 Neg Art 134 1i 25,000.00 €
Partner a proceeding before the
General Court of the EU
legal assistance for
Kapellmann the defence of EFSA in
10 Neg Art 134 1i und Partner proceedings before the 34,000.00 €
Rechtsanwaelte General Court of the
European Union
Table 39. Time to grant
Procedure Title Procedure reference Deadline for Signature of Grant Committed Art 128 2 Art 128 2
applications award decision Agreement amount a (E-D) b (F-E)
signature date
15/09/2017 25/10/2017 22/11/2017 57,840.90 € 40 28
Partnering projects: Grants to
stimulate joint projects among 2 or 15/09/2017 25/10/2017 22/11/2017 99,700.00 € 40 28
more Member States to exchange 15/09/2017 25/10/2017 22/11/2017 46,416.15 € 40 28
knowledge and expertise, in support 15/09/2017 25/10/2017 04/12/2017 81,463.20 € 40 40
of the EU risk assessment agenda
GP/EFSA/AFSCO/2017/01 15/09/2017 25/10/2017 04/12/2017 99,766.24 € 40 40
priorities. Such projects shall maximise
return of existing risk assessment 15/09/2017 25/10/2017 30/11/2017 100,000.00 € 40 36
capacity in Member States, in order to 15/09/2017 25/10/2017 04/12/2017 82,254.84 € 40 40
strengthen Europe’s capacity in food 15/09/2017 25/10/2017 22/11/2017 100,000.00 € 40 28
safety risk assessment.
15/09/2017 25/10/2017 22/11/2017 98,663.51 € 40 28
24/02/2017 30/05/2017 11/06/2017 27,799.20 € 95 12
24/02/2017 30/05/2017 11/06/2017 27,799.20 € 95 12
24/02/2017 30/05/2017 11/06/2017 27,799.20 € 95 12
24/02/2017 30/05/2017 06/06/2017 28,085.20 € 95 7
24/02/2017 30/05/2017 20/07/2017 33,919.60 € 95 51
24/02/2017 30/05/2017 11/07/2017 33,919.60 € 95 42
24/02/2017 30/05/2017 11/06/2017 27,799.20 € 95 12
Fellowship Programme - grant call for
GP/EFSA/AFSCO/2016/02 24/02/2017 30/05/2017 14/06/2017 30,745.00 € 95 15
fellow hosting sites
24/02/2017 30/05/2017 14/06/2017 30,745.00 € 95 15
24/02/2017 30/05/2017 14/06/2017 30,745.00 € 95 15
24/02/2017 30/05/2017 05/06/2017 33,919.60 € 95 6
24/02/2017 30/05/2017 08/06/2017 34,663.20 € 95 9
24/02/2017 30/05/2017 08/06/2017 24,882.00 € 95 9
24/02/2017 30/05/2017 27/06/2017 24,882.00 € 95 28
24/02/2017 30/05/2017 12/07/2017 35,521.20 € 95 43
Thematic grant GP/EFSA/AFSCO/2017/04 25/10/2017 06/12/2017 15/12/2017 314,503.29 € 42 9
Collection of data and information in
Balearic Islands on biology of vectors
GP/EFSA/ALPHA/2017/01 11/09/2017 26/10/2017 16/11/2017 200,000.00 € 45 21
and potential vectors of Xylella
fastidiosa

100
 Procedure Title Procedure reference Deadline for Signature of Grant Committed Art 128 2 Art 128 2
applications award decision Agreement amount a (E-D) b (F-E)
signature date
29/09/2017 20/11/2017 27/11/2017 NA 52 7
29/09/2017 20/11/2017 21/11/2017 NA 52 1
29/09/2017 20/11/2017 27/11/2017 NA 52 7
29/09/2017 20/11/2017 22/11/2017 NA 52 2
Entrusting support tasks in the area of GP/EFSA/ALPHA/2017/02 29/09/2017 20/11/2017 01/12/2017 NA 52 11
Plant Health (FPA) FPA 29/09/2017 20/11/2017 27/11/2017 NA 52 7
29/09/2017 20/11/2017 27/11/2017 NA 52 7
29/09/2017 20/11/2017 22/11/2017 NA 52 2
29/09/2017 20/11/2017 22/11/2017 NA 52 2
29/09/2017 20/11/2017 22/11/2017 NA 52 2
Tasking Grant for WGS : GP/EFSA/
02/10/2017 23/10/2017 06/12/2017 100,000.00 € 21 44
Biofinformatician BIOCONTAM/2017/01
Thematic grant GP/EFSA/AFSCO/2017/03 25/10/2017 24/11/2017 30/11/2017 375,000.00 € 30 6
Framework Partnership Agreement: 13/10/2017 24/11/2017 01/12/2017 NA 42 7
Tasking grant Preparation of 13/10/2017 24/11/2017 04/12/2017 NA 42 10
Authority’s conclusions and
13/10/2017 24/11/2017 24/11/2017 NA 42 0
reasoned opinions (Framework grant
FPA/GP/EFSA/ 13/10/2017 24/11/2017 30/11/2017 NA 42 6
agreements with organisations in
PRAS/2017/02
the article 36 list and designated as
Member State competent Authorities
13/10/2017 24/11/2017 04/12/2017 NA 42 10
under article 75 of Regulation (EC) No
1107/2009
Thematic grant methods and systems GA/EFSA/
06/11/2016 18/11/2016 09/02/2017 368,301.12 € 12 83
for the identification of emerging risks AFSCO/2016/01-LOT 1
AVERAGE 61 19

101
 TM-BA-18-001-EN-N

Via Carlo Magno 1A Tel. +39 0521 036 111

43126 Parma Fax +39 0521 036 110
ITALY www.efsa.europa.eu