Annual report 2009 : committed to ensuring that Europe's food is safe.
Date: 2010-08-19
Institutions: European Food Safety Authority
Subjects: European Food Safety Authority, activity report

Annual Report 2009

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Committed to ensuring that Europe’s food is safe

 
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C O N T E N T S

FOREWORDS	

Foreword by Jo Leinen 

Foreword by Androulla Vassiliou 

Message from Diána Bánáti 

Message from Catherine Geslain-Lanéelle 	

I.		

	CONSOLIDATING	EFSA’S	ROLE	IN		
THE	EU	FOOD	SAFETY	SYSTEM	

II.		 COMMITTED	TO	ENSURING	THAT	EUROPE’S	FOOD	IS	SAFE	

1.	 PROVIDING	COMPREHENSIVE	ADVICE	 
Reviewing all mandates to better address issues 
Renewing EFSA’s Scientific Committee and Panel members 
A fully operational quality review process 
Working closely with Member States 
Making the most of pan-European scientific excellence 
Calling on the best of Europe 
Integrating interagency expertise for risk managers 
Taking a multidisciplinary approach to food chain contaminants 
An integrated approach to animal health 
Developing new risk assessment methodologies for pesticides 
Pest risk assessment to maintain plant health in Europe 
Providing scientific support across EFSA 

2.	 TIMELY	HIGH-QUALITY	EVALUATIONS 
Managing applications: the case of GMOs 
Evaluating health claims 
Further improving the peer review of active substances  
in plant protection products 
Guiding and discussing with applicants: the example of feed additives 
Assessing food additives 
Evaluating and providing guidance on food contact materials and 
flavourings 

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3.	 GATHERING	EU	DATA	
What’s Europe eating? 
EFSA’s first annual pesticides residues report 
Reporting on zoonoses and food-borne outbreaks EU-wide 
Helping to spot emerging risks 

4.	 BUILDING	INTERNATIONAL	PARTNERSHIPS		

Going global 
Forging closer ties internationally 

5.	 COMMUNICATION	AND	DIALOGUE			

Cooperation on communications with Member States 
Dialogue with stakeholders 
Engaging in scientific dialogue 
Reaching out to the scientific community 
A strong partnership with EU Institutions 
Working alongside other EU agencies 
Forging closer ties with EFSA’s local community 

6.	 RESPONSIVENESS,	EFFICIENCY	AND	EFFECTIVENESS	

In case of crisis… 
From theory to practice 
Being efficient and effective 

III.		LOOKING	AHEAD	TO	2010	

IV.		ANNEXES	

Annex I 
Annex II 
Annex III 
Annex IV 

Organisational chart 
Glossary 
EFSA’s opinions and scientific documents 2009 
 Financial report 

CD-ROM	WITH	EFSA’S	SCIENTIFIC	OUTPUTS	2009

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F O R E W O R D  by Jo Lei nen

C H A I R   O F   T H E   C O M M I T T E E   O N   T H E   E N V I R O N M E N T , 
P U B L I C   H E A L T H   A N D   F O O D   S A F E T Y,   E U R O P E A N   P A R L I A M E N T

As Chairman of the Committee on the Environment, 
Public Health and Food Safety (ENVI), one of my main 
priorities  is  to  strengthen  and  to  enhance  the  high 
level of food safety in the European Union. With the 
European internal market, food can be sold freely in 
all Member States, offering a broad variety of speciali-
ties to European consumers. It is therefore imperative 
that these products are assessed by an independent 
body, establishing compliance with the high EU safe-
ty standards. 

The European Food Safety Authority (EFSA) thus plays 
an important role in the EU in not only assessing food 
and nutrition safety but also by being the watchdog 
for animal health and welfare, as well as for plant pro-
tection and plant health. 

EFSA,  although  only  being  in  existence  for  seven 
years, has become a crucial partner of the European 
Parliament  on  food  safety  and  health  issues,  and  a 
well  established  and  recognised  authority  in  these 
fields. Its work is thus not only impacting on the EU 
but also sets global standards.  

In order to establish sound food safety legislation that 
protects consumers from health risks, the Parliament 
relies on the scientific contributions and expert opin-
ions  from  EFSA.  Recent  debates  about  novel  foods, 
products  from  cloned  animals,  genetically  modified 
food and food additives demonstrate again the high 
relevance of EFSA’s work of assessing risks associated 
with  the  food  chain. The  registration  and  the  ongo-
ing  assessment  of  the  so-called  “health  claims”  has 
sparked high interest not only within the concerned 
producer community; consumers became much more 
aware  of  the  issue.  In  the  framework  of  the  health 
claims  regulation,  ESFA  is  researching  each  claim 
made  on  food  labelling,  presentation  or  marketing 
in the European Union on whether it is accurate and 
based on evidence accepted by the scientific commu-
nity. This is one of many good examples of how the 
agency is working in the interest of citizens, by ensur-
ing that producers deliver on their promises.

Europe  faces  new  challenges  related  to  climate 
change  and  sustainability.  Along  the  entire  food 
chain,  agriculture  and  food  production  are  contri-
buting to global warming. Searching for ways to cope 
with  these  challenges,  e.g.  by  improving  crop  yields 
or by making changes to animal feed to reduce meth-
ane  emissions,  new  technologies  will  be  developed. 
There, we also need to ensure that safety and health 
standards are duly taken into account. 

The work of EFSA includes a huge variety of tasks and 
has to satisfy highest quality requirements in order to 
keep consumers safe. While it is therefore a very de-
manding occupation it is at the same time very ben-
eficial  for  EU  citizens.  EFSA  has  worked  successfully 
in the past years to establish high standards of food 
safety in the European Union.  

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Jo Leinen  
Chair of the Committee on the Environment, 
Public Health and Food Safety, European Parliament

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F O R E W O R D  by Androu lla Vassiliou

E U   C O M M I S S I O N E R   F O R   H E A L T H   ( 2 0 0 8 - 2 0 0 9 )

We  at  the  European  Commission  firmly  believe  that 
the most important ingredient in food is safety.  

A series of crises in the 1990s – such as those concern-
ing BSE and dioxins – delivered a huge blow to con-
sumer confidence in the European Union and, in fact, 
worldwide. We learned our safety lesson the hard way 
and that led us to rethink our overall food safety ap-
proach. The  end  result  was  a  comprehensive  reform 
of the EU food safety system. It has been so success-
ful that it allows us today to be proud of the fact that 
the European Union enjoys one of the finest and most 
comprehensive food safety systems in the world.  

This  significant  improvement  would  have  been  im-
possible had it not been based on solid science. This is 
where the European Food Safety Authority enters the 
picture. EFSA has proven its capacity to deliver scien-
tific opinions that the Union needs to underpin its leg-
islation. To put it simply, EFSA is an essential partner in 
our efforts to ensure food safety.

Since its creation, seven years ago, it has gradually es-
tablished  itself  as  a  scientific  point  of  reference.  It  is 
today a well-respected authority and it is recognised 
for its scientific excellence. 

During  2009,  EFSA  has  successfully  responded  to  a 
high number of requests from the Commission – not 
an  easy  task  given  the  heavy  workload.  During  the 
past year we had to tackle a series of challenges and 
risks to the food chain – melamine-contaminated milk 
in China is just one such example where EFSA’s con-
tribution was actually globally acknowledged. EFSA’s 
role  in  providing  scientific  advice  speedily  has  been 
pivotal in our efforts to deal with this and other similar 
situations. 

But  EFSA  is  not  only  valuable  for  its  scientific  advice. 
Through the gathering and analysis of scientific data, 
EFSA gives us a better view of the risks related to food 
and allows us to reassess long-term issues in the light 
of scientific progress and technological development. 

As Commissioner for Health, I have worked hand-in-
hand with EFSA to achieve a solid scientific basis for 
EU policies. The European Commission is committed 
to continue walking along the path of close cooper-
ation with EFSA. After all, we share the same concerns 
and goals. 

In  short,  the  European  Commission  and  EFSA  will 
keep  doing  their  utmost  to  ensure  that  the  most 
important  food  ingredient  is  always  present  at  our 
table: we will keep doing our best to keep the food 
we eat safe. 

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Androulla Vassiliou
EU Commissioner for Health (2008-2009)

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M E S S AG E  from Di ána  Bánáti

ME SSAGE from Catherine Geslain-Lanéelle

C H A I R   O F   T H E   E F S A   M A N A G E M E N T   B O A R D

“No one can whistle a symphony. It takes a whole orchestra to play it.” 

(H.E. Luccock)

EFSA’s main aim is to give reliable and science-based 
information on all risks associated with the food chain. 
Our vision is to become globally recognised as the Eu-
ropean reference body for risk assessment in food and 
feed safety, animal health and welfare, nutrition, plant 
protection and plant health. To achieve this, in 2009 
EFSA has continued to grow in Europe and around the 
globe, reaching out further than ever before, in close 
cooperation  with  its  partners  in  the  EU  Institutions 
and Member States.

In 2009, the Management Board adopted EFSA’s inter-
national strategy, mapping the key objectives needed 
to  consolidate  existing  and  future  initiatives  with 
Member States, third countries and international or-
ganisations. We  also  encouraged  the  Authority’s  risk 
assessment capacity and expertise. In 2009, following 
the successful recruitment campaign run in 2008 until 
early 2009, we approved the nomination of 174 inde-
pendent scientific experts to re-establish the Author-
ity’s Scientific Committee and eight of its ten Panels 
for  a  fresh  three-year  term.  In  addition,  recognising 
the contribution of EFSA’s experts, we also endorsed a 
proposal to strengthen compensation for experts and 

adopted the EUR 73 million 2010 budget required to 
address EFSA’s ever-expanding scientific work, in par-
ticular in applications and data collection.

We already know EFSA’s workload is growing because 
of the requests from our partners. So, last year we star-
ted negotiations to evaluate and assess the impact of 
EFSA’s work. In 2009 one of the most important tasks 
in EFSA’s work was to scientifically substantiate health 
and nutrition-based claims to help consumers make 
informed and meaningful dietary choices. In 2010, we 
will define key indicators to measure how our advice 
is helping shape EU law and contribute to the overall 
food safety system. 

We believe in cooperation and dialogue, and we make 
great efforts each year to further reinforce and build 
on  these  networks.  This  does  not  just  apply  to  our 
partners  but  also  the  wide  variety  of  stakeholders, 
interested and involved in our work. Consequently in 
2009, we took stock and reviewed the activities of our 
Stakeholder Consultative Platform. The Management 
Board  has  initiated  discussion  and  emphasised  the 
need  to  continue  to  further  build  cooperation  with 
Member States to be more effective and efficient.

The  communication  landscape  and  EFSA  itself  have 
changed  considerably  since  the  Authority’s  commu-
nication strategy was first adopted in 2006. In recog-
nition, the Board discussed a paper outlining how to 
best review this strategy. We look forward to continu-
ing this discussion in 2010 to help refine the direction 
of EFSA’s important communications work.

I  would  like  to  extend  my  thanks,  on  behalf  of  the 
Management  Board,  to  the  Executive  Director,  Ms 
Catherine Geslain-Lanéelle, to the 1 500 experts work-
ing  in  the  Scientific  Committee  and  Panels,  and  the 
more than 400 staff at EFSA for their continued hard 
work  over  2009.  They  manage  the  increased  work-
load,  helping  to  deliver  even  more  output  for  risks 
managers across Europe. I would also like to thank my 
fellow  Board  members,  for  their  work  during  2009.  I 
look forward to continue to work together in guiding 
EFSA as it becomes increasingly recognised as an inte-
gral component of the EU’s food safety system. 

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Professor Diána Bánáti ,  
Chair of the EFSA Management Board

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ME S SAGE from Catherine Geslain-Lanéelle

E F S A   E X E C U T I V E   D I R E C T O R

2009  was  a  year  of  strengthened  cooperation  and  
dialogue  for  EFSA.  We  can  look  back  on  another 
successful  year  of  fruitful  collaboration  with  the 
European  Commission,  the  Member  States,  EU 
agencies 
and 
continued  constructive  dialogue  with  our  stake-
holders.  EFSA’s  commitment  to  delivering  high-
quality outputs flourished in 2009 with 636 scientific 
outputs compared with 489 the year before. 

counterparts, 

international 

and 

One  milestone  in  this  endeavour  was  in  EFSA’s 
progress  in  the  evaluation  of  products,  substances 
and  claims  subject  to  authorisation.  In  particular,  
we  evaluated  hundreds  of  health  claims,  against  
quite  tight  deadlines,  in  addition  to  the  evaluation  
of  food  additives,  GMOs,  flavourings,  pesticides  and 
feed additives. 

isms, and to clarify our position as a provider of inde-
pendent  scientific  advice.  It  proved  to  be  a  valuable 
opportunity  to  listen  and  learn,  and  to  engage  with 
scientists and stakeholders through fruitful open dis-
cussions,  in  particular  regarding  strengthened  guid-
ance for environmental risk assessment. 

We  further  worked  on  our  responsiveness  and  our 
commitment to react rapidly and efficiently to urgent 
situations. In 2009, we carried out comprehensive cri-
sis  simulation  exercises  covering  risk  assessment  in 
crisis situations and risk communications with the Eu-
ropean Commission and Member States. As in previ-
ous years, such theory was put into practice when we 
provided  urgent  responses  to  immediate  threats  to 
food safety, as in the cases of nicotine in mushrooms 
and a printing ink in breakfast cereals. 

Engaging  with  partners  and  stakeholders  continued 
to be an important element of our daily work. For ex-
ample, in 2009 we organised a conference to discuss, 
and  explain,  to  stakeholders  and  scientists  our  role 
in  assessing  the  risks  of  genetically  modified  organ-

Also in 2009, we took an important step towards real-
ising our vision to be globally recognised as the Euro-
pean reference body for food and feed risk assessment 
through  the  adoption  of  our  international  strategy. 
This new strategy will help guide developments in our 

international outreach. And already in 2009 this was 
more than just words. We had fruitful meetings with 
key  organisations  working  in  the  areas  of  food  safe-
ty, animal and plant health in the United States. The 
cooperation with Health Canada, New Zealand Food 
Safety  Authority  and  Food  Standards  Australia  New 
Zealand is now supported by an exchange of letters 
that  will  facilitate  the  scientific  cooperation  on  data 
collection and data sharing related to risk assessment. 
In  addition,  in  2009  EFSA  signed  a  Memorandum  of 
Cooperation with Japan.

Throughout  the  year,  our  achievements  would  not 
have  been  possible  without  the  dedication  and 
professionalism  of  EFSA  staff,  scientific  experts  and 
partners in both EU Institutions and Member States, 
as well as all stakeholders. Through their continuous 
commitment  and  support,  EFSA  continues  to  play 
a  crucial  role  in  protecting  food  safety  and  public 
health. 

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Catherine Geslain-Lanéelle,  
EFSA Executive Director

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I.  CONSOLIDATING EFSA’S ROLE IN THE EU FOOD SAFE T Y SYSTEM

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I .   C O N S O L I D A T I N G   E F S A ’ S   R O L E   I N   T H E   E U   F O O D   S A F E T Y   S Y S T E M

Established  in  2002  in  response  to  the  food  crises 
that  undermined  consumer  trust  in  the  way  food 
safety  was  handled  in  the  1990s,  EFSA  enters  the 
new decade ready to play its role in the field of food 
safety and risk assessment, both within the EU and 
increasingly  internationally.  EFSA  invested  in  its 
early  years  in  creating  ties  and  building  networks 
across Europe, while internally putting in place the 
processes  and  structures  that  now  underpin  its 
work. Growth over the previous years has enabled 
the  Authority  to  strengthen  its  support  for  its  risk 
management  partners  in  the  European  Commis-
sion, the European Parliament and Member States, 
who all rely on EFSA for advice to inform their deci-
sion making. 

A  growing  body  of  EU  law  involves  EFSA  in  sup-
porting the authorisation process – with respect to 
health  claims,  pesticides,  GMOs,  flavourings,  food 
and feed additives, to name but a few. In addition, 
looking to the future and planning ahead, EFSA has 
strengthened its dialogue with the Commission on 
future medium-term activities and priorities as out-
lined in mutually agreed roadmaps. 

2009  was  the  first  year  that  EFSA’s  new  Strategic 
Plan  –  looking  forward  from  2009  to  2013  –  was 
implemented. This plan aims to shape the Author-
ity over the coming years and to prepare it for the 
challenges ahead. Following the key strategic areas 
identified  in  this  plan,  EFSA  focused  on  six  objec-
tives: 

•  A comprehensive approach to risk assessments

•  Timely high-quality evaluations

•  Gathering EU data

•  Building international partnerships

•  Communication and dialogue

•  Responsiveness, efficiency and effectiveness 

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I I .   C O M M I T T E D   T O   E N S U R I N G   T H A T   E U R O P E ’ S   F O O D   I S   S A F E

1.			PROVIDING	COMPREHENSIVE	ADVICE	

One	of	EFSA’s	key	strengths	is	the	breadth	of	its	
expertise	in	risk	assessment,	operating	across	the	
food	chain,	from	field	to	plate.	The	Authority	covers	
all	areas	of	food	and	feed	safety,	animal	health	and	
welfare,	nutrition,	plant	protection	and	plant	health.	
This	allows	it	to	draw	on	a	wide	range	of	knowledge	
available	in	order	to	respond	to	the	challenges	
presented	by	the	evolving	political	environment	
and	scientific	progress,	and	to	ensure	a	safe	supply	
of	food	to	European	consumers.	This	means	that	
EFSA	can	offer	risk	managers	comprehensive	advice,	
increasingly	by	taking	a	multidisciplinary	and	
integrated	approach.	This	is	being	achieved	not	only	
by	incorporating	the	contributions	of	expertise	from	
all	around	Europe,	but	also	by	combining	forces	with	
other	EU	agencies	and	by	cooperating	closely	with	
Member	States.	EFSA	is	also	internally	building	up	a	
comprehensive	and	inclusive	approach,	reinforcing	
horizontal	structures	and	processes,	and	linking	
together	the	work	of	its	administrative	and	scientific	
units	for	maximum	effectiveness.	All	told,	in	2009,	
EFSA	delivered	636	scientific	outputs,	a	30	%	increase	
over	2008.

Reviewing	all	mandates	to	better	address	
issues

Each  week  EFSA’s  Mandates  Review  Committee 
screens  all  requests  sent  to  the  Authority.  This 
allows EFSA’s Executive Director, the Chair of the 
Scientific Committee and Heads of Directorates to 
get a top-level view of incoming requests in order 
to best address the issues and allocate the work to 
the most appropriate panel(s) and/or unit(s). It al-
lows the possible need for collaboration between 
units and communications to be considered at an 
early stage. As a result, EFSA can give as broad an 
overview as possible in its answers, ensuring that 
risk managers are fully informed. 

Renewing	EFSA’s	Scientific	Committee	and	
Panel	members

In 2009, EFSA renewed, for a new three-year term, 
members of its Scientific Committee and eight of 
its  ten  Scientific  Panels. This  was  the  second  re-
newal since the European food safety watchdog 
was established in 2002. 

To draw up a shortlist of suitable and highly quali-
fied candidates, a rigorous selection process was 
carried out. An independent external evaluation 
committee  then  reviewed  the  selection  process. 
EFSA’s Management Board altogether appointed 
174 independent experts. 

Overall,  there  was  a  7 %  increase  in  the  number 
of application requests compared to the last call 
to renew panel members in 2006. There are more 
women  in  the  new  panels  than  previously  and, 
again, there is a large spread of nationalities. 79 % 
of the existing panel members reapplied for the 
positions. Out of the 174 members proposed for 
nomination, 101 were re-appointed for a second 
or third mandate, underlining EFSA’s capacity  to 
attract and retain the scientists it relies upon.

A	fully	operational	quality	review	process

Another milestone for EFSA in 2009 was the im-
plementation of the last phase of its Internal and 
External Review (INEX) System for the Authority’s 
scientific  work.  This  entailed  appointing  inde-
pendent experts to carry out external reviews of 
EFSA’s scientific outputs. 

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The review system is now fully operational and is 
designed to give EFSA continuing feedback about 
the quality of its work. This system consists of three 
layers of reviews: a self-review of all scientific out-
puts by the unit that produced the output; an inter-
nal review of randomly sampled scientific outputs 
of each unit by senior scientists; and – since 2009 
– an external review by independent experts. The 
internal  and  external  reviews  complement  each 
other: the internal review draws on the extensive 
knowledge held across the units at EFSA while the 
external  review  benefits  from  the  expertise  and 
views of external and independent scientists. 

The external review working group of 23 experts 
was  established  through  a  call  for  expression  of 
interest in 2009 and was organised around seven 
scientific  areas.  The  external  review  resulted  in 
a  report  that  was  submitted  to  the  Authority’s  
Executive Director in December 2009. 

After  analysing  the  findings  and  recommenda-
tions of this report, EFSA will use the outcome to 
continuously improve the quality of its scientific 
outputs and the process of developing them.  

Working	closely	with	Member	States

EFSA’s Advisory Forum is a core body of the Au-
thority that plays a central role in strengthening 
EFSA’s  cooperation  with  Member  States.  It  con-
nects EFSA with the national food safety authori-
ties of all 27 EU Member States. One of the tasks 
of its members is to suggest national experts to 
participate  in  its  particular  meetings  and  EFSA 
networks  for  three  years.  These  specific  net-
works bring together experts, representing their 
Member  State  in  a  given  field.  Dedicated  scien-
tific networks exist in the areas of data collection 
(food  consumption,  chemical  occurrence)  and 
risk assessment (animal health and welfare, plant 
health, BSE). The general objectives of these sci-
entific networks is to allow participants to share 
scientific  information,  pool  resources  and  work 
towards  coordinating  work  programmes  and  to 
facilitate harmonisation of risk assessment prac-
tises  and  methodologies.  In  addition,  they  hold 
EU Regulation-based exchange of views on EFSA’s 
work on GMOs, feed additives and health claims.

An  important  example  of  this  is  the  progress, 
spearheaded by EFSA and the Advisory Forum, in 
bringing together food consumption data – who 

is eating what and at what levels – to allow more 
efficient and accurate exposure assessment at EU 
level. Such data also help set science-based pub-
lic  health  targets  related  to  diet  and  health  (see 
also p. 22, “What’s Europe eating?”).

In 2009, EFSA organised more frequent meetings 
with  Member  States’  representatives  and  thus 
facilitated the exchange of information between 
the  Authority  and  the  Member  States.  The  Ad-
visory  Forum  itself  met  five  times  in  2009,  with 
strong  participation  from  Member  States. There 
was  increased  willingness  to  share  information 
and coordinate ongoing work. 

In  addition  to  Advisory  Forum  meetings,  special-
ised  meetings  bringing  together  national  repre-
sentatives  on  specific  topics  were  also  held.  For 
example, in 2009 the second meeting of national 
plant health representatives took place. The event 
focused on data collection and emerging risks to 
plant health, and gave EFSA’s Panel on plant health 
(PLH Panel) an opportunity to present a review of 
its activities and discuss its developing role in the 
European  plant  health  system,  including  harmo-
nisation  of  pest  risk  assessment  methodologies  
(see also p. 15). 

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EFSA Scientific Committee 

During  the  year,  EFSA  also  organised  focused 
meetings  to  maintain  a  coherent  approach  in 
specific areas, and to ensure that Member States 
and  EFSA  are  kept  abreast  of  the  latest  devel-
opments  throughout  Europe.  For  example  in 
September  2009,  the  Authority’s  scientists  or-
ganised a special meeting with nutrition experts 
from Member States to exchange views on draft 
opinions in the area of Dietary Reference Values 
(DRVs) and Food-Based Dietary Guidelines. DRVs 
indicate the amount of an individual nutrient that 
people need for good health depending on their 
age and gender. They can be used, for instance, as 
a basis for reference values in food labelling. They 
may be also be used for the assessment and plan-
ning of diets and when making nutrient recom-
mendations and developing Food-Based Dietary 
Guidelines. 

The  meeting  also  gave  EFSA  an  opportunity 
to  brief  national  experts  about  the  comments 
it  had  received  on  these  draft  opinions  during 
the  consultation  period,  to  clarify  its  scientific 
role  in  determining  DRVs  and  to  help  Member 
State  experts  translate  the  reference  values 
into  practical  food-based  guidelines  for  their 
respective populations.

Focal  Points  are  another  mechanism 
to 
strengthen  cooperation  between  and  among 
Member  States  and  EFSA.  The  Focal  Points  act 
as an interface between EFSA and national food 
safety  authorities  by  supporting  their  Advisory 
Forum  member. 
In  2009,  the  Focal  Points 
experienced  the  second  year  of  full  operation. 
Their  key  tasks  include  exchanging  scientific 
information,  supporting  activities  under  the 
Article  36  network,  as  well  as  promoting  EFSA’s 
expert  database.  For  example,  with  the  help  of 
Focal  Points,  the  Authority’s  expert  database 
received  around  2  300  applications.  In  addition, 
Focal  Points  raised  EFSA’s  scientific  visibility  in 
Member  States  by  organising  in-country  events 
and  disseminating 
information  about  EFSA 
through  Focal  Point  web  pages  and  printed 
materials. 

Encouragingly,  in  terms  of  coordination  and  co-
operation,  over  550  documents  related  to  risk 
assessment were uploaded by Member States to 
EFSA’s  Information  Exchange  Platform.  This  tool 
was  considered  by  Member  States  to  be  useful 
for  keeping  Member  States  and  EFSA  informed 
about  upcoming  and  ongoing  risk  assessments 
on food and feed safety. 

All  told,  in  2009,  efforts  to  further  strengthen 
Member  State  collaboration,  as  identified  in  the 
2008 interim review of EFSA’s strategy for coop-
eration  and  networking,  are  delivering  results 
for the mutual benefit of EFSA and national food 
safety  authorities  (see  also  p.  12, “Calling  on  the 
best of Europe”).

Making	the	most	of	pan-European	
scientific	excellence

EFSA’s  Scientific  Cooperation  projects  (ESCOs)  are 
another  effective  tool  through  which  it  pooled 
pan-European scientific resources, and strength-
ened  cooperation  and  networking  between  the 
Authority and its counterparts in Member States 
in  2009.  In  contrast  to  the  scientific  networks,  
ESCOs work on a specific topic for a fixed amount 
of  time  and  include  national  experts,  members 
of  the  Scientific  Panels  or  Scientific  Committee 
and EFSA’s scientific staff. The topics covered by 
ESCOs are of mutual interest to the Authority and 
Member States. 

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In 2009, ESCOs delivered, for example, a report on 
the analysis of risks and benefits of the fortifica-
tion of food with folic acid and advice on the EFSA 
guidance document for the safety assessment of 
botanicals  and  botanical  preparations  intended 
for  use  as  food  supplements  (see  also  p.  13).  In 
the  case  of  folic  acid,  the  ESCO  working  group 
concluded that the health benefits in relation to 
reducing the risk of neural tube defects are well 
established.  However,  available  studies  neither 
confirm  the  hypothesis  that  folic  acid  supple-
mentation  reduces  the  risk  of,  for  example,  car-
diovascular disease risk for humans, nor provide 
sufficient data to allow an assessment of the pos-
sible effect of folic acid on cancer risk. 

To test the methodology outlined in EFSA’s guid-
ance  on  how to assess  botanicals, the Authority 
initiated  an  ESCO  project  to  select  a  number  of 
plant preparations and apply the methodology in 
the assessment of their safety. This activity end-
ed  in  2009.  Through  the  harmonisation  efforts 
of  EFSA  and  due  to  the  integration  of  Member 
States’  expertise,  the  competent  bodies  of  the 
Member States now have a comprehensive guid-
ance document on botanicals at hand. 

Calling	on	the	best	of	Europe

In  addition  to  the  scientific  networks  and  coop-
eration  projects,  EFSA  also  uses  contracts  and 
grants to access Member States’ expertise. Using 
standard  EU  procurement  procedures,  contracts 
are  put  out  to  tender  e.g.  through  open  calls  or 
negotiated  procedures.  EFSA  can  also  award 
grants  to  organisations  that  have  been  nomi-
nated  by  Member  States  to  assist  the  Author-
ity  in  its  tasks,  under  Article  36  of  its  Founding 
Regulation.  These  organisations  carry  out  such 
activities  as  data  collection,  preparatory  work 
for  the  development  of  scientific  opinions  and 
other scientific and technical support. This helps 
EFSA respond more effectively and flexibly to its 
growing workload. The Article 36 network is also 
an  important  practical  tool  for  the  Authority  to 
leverage a wider spectrum of scientific excellence 
in Member States. After the list of competent or-
ganisations was enlarged and then approved by 
the EFSA Management Board in December 2008, 
in 2009 the Authority was able to access an even 
wider knowledge base than ever before (the list 
has grown from 243 organisations to 371 organi-
sations from all but one Member State). 

On grants and contracts, EFSA spent EUR 6.8 mil-
lion in 2009 compared to EUR 5.5 million in 2008. 
Of these, EUR 2.5 million were spent on Article 36 
grants (against EUR 2 million in 2008), while the 
remainder was spent on procurement contracts. 
Hence,  the  overall  amount  of  money  spent  on  
outsourced  projects  increased  by  20 %  in  2009 
and  more  than  doubled  compared  to  2007 
(EUR 2.9 million), the first operational year of the 
Article  36  list.  There  were  a  variety  of  subjects 
covered  by  the  Article  36  projects  launched  in 
2009. These included mycotoxin detoxifying feed 
additives; animal welfare guidelines on assessing 
housing  and  management  risks;  toxicology  of 
3-MCPD esters; modelling and mapping aflatox-
ins in cereals in the EU due to climate change; the 
identification  of  common  assessment  groups  of 
pesticides; genetic selection and broiler chicken 
welfare and health; a comparative EU-wide plant 
health  pest  risk  assessment  using  case  studies; 
and a pilot pan-European dietary survey. 

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Meeting of the Heads of Agencies 
at EFSA in October 2009

Given the increasing importance of contracts and 
grants to assist EFSA, the Authority launched two 
new IT support tools, a database of Article 36 organ-
isations and an extranet workspace for all members 
of the Article 36 network. It also surveyed units in 
EFSA and the organisations carrying out the work 
to evaluate the two schemes. The results showed 
that  grants  and  contracts  have  contributed  sub-
stantially  to  the  scientific  output  of  EFSA  and  in 
fostering  networking  among  organisations.  They 
are also perceived as effective and useful tools by 
both  scientific  units  and  participating  organisa-
tions. Nonetheless, in 2010 the Authority will con-
tinue to analyse the survey results to identify areas 
where the schemes could be further improved. 

Integrating	interagency	expertise	for	risk	
managers	

In addition to leveraging the wide body of knowl-
edge available within EFSA, in 2009 the Author-
ity  also  steered  and  coordinated  the  exchange 
of views and experiences within the cooperation 
network of EU agencies in order to provide more 
comprehensive and wide reaching advice to risk 
managers (see also p. 30). 

In  November  2009,  EFSA’s  Panel  on  Biological 
Hazards  (BIOHAZ  Panel)  –  in  collaboration  with 
the European Centre for Disease Prevention and 
Control (ECDC), the European Medicines Agency 
(EMA), and the European Commission’s Scientific 
Committee  on  Emerging  and  Newly  Identified 
Health Risks (SCENIHR) – published a joint scientific 
opinion  on  antimicrobial  resistance  (AMR).  The 
focus  was  on  infections  transmitted  to  humans 
from animals and food (zoonoses). The agencies 
collaborated to produce a joint opinion, building 
on  the  already  existing  data  and  documents  to 
answer  the  European  Commission’s  request  for 
advice.  The  joint  opinion  concluded  that  better 
surveillance is needed to fight the growing spread 
of antimicrobial resistance in zoonotic infections. 

The  agencies  similarly  worked  together  on  the 
joint  scientific  report  on  methicillin-resistant  Sta-
phylococcus aureus (MRSA) in livestock, pets and 
foods,  which  was  published  in  June  2009.  Fol-
lowing  concerns  about  the  increase  of  MRSA  in 
livestock and companion animals, both EMA and 
EFSA  worked  on  the  matter  in  a  self-tasking  ex-
ercise.  EFSA  subsequently  also  involved  ECDC 
to benefit from their knowledge when touching 
upon issues that related to human health. The re-
sulting umbrella document concluded that there 

is currently no evidence that eating or handling 
MRSA-contaminated  food  poses  an  increased 
health risk for humans. 

In  2009,  EFSA  also  collaborated  with  EMA  and 
European Member States on botanicals. Botanical 
preparations  are  made  from  plants,  algae,  fungi 
or  lichens  and  are  most  often  marketed  with  a 
variety  of  claims  regarding  possible  nutritional 
or health benefits. The responsibility for ensuring 
that these products are safe is given to the food 
operators  and  the  Member  States’  competent 
authorities. As some of these products are at the 
frontier  between  foods  and  medicines,  the  Au-
thority  kept  close  links  with  EMA,  and  also  with 
the  European  Commission  and  with  Member 
States, to draw on their expertise. 

This work resulted in guidance for European risk 
assessors  with  a  methodology  detailing  how 
to  assess  the  safety  of  botanicals.  EFSA  has  also 
compiled  information  on  botanicals  that  have 
been reported to contain substances of potential 
health concern; this compendium is intended to 
assist manufacturers and food safety authorities 
by highlighting possible safety issues. After EFSA’s 
Scientific  Committee  published  this  guidance 
in September 2009, EFSA organised a workshop 

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13

with  all  parties  concerned  (European  Commis-
sion, national food safety authorities, stakehold-
ers  and  industry  representatives)  to  present  the 
work  and  to  develop  a  common  understanding 
of the methodology. The added-value of this in-
clusive  approach  is  that  EFSA’s  final  output  has 
already been discussed by different relevant par-
ties, which increases its acceptance. 

Furthermore  in  May  2009,  EFSA  signed  a  Memo-
randum of Understanding with ECHA. This laid the 
basis  to  further  develop  information  exchange, 
cooperation and mutual understanding between 
both organisations, and in particular to ensure co-
herence in the risk assessment approach  for sub-
stances that may have a bearing on food safety. 

All  these  examples  show  how  EFSA  engages  in 
and  supports  the  sharing  of  scientific  expertise. 
By using such a wider knowledge base, EFSA, in 
unison with other agencies, is better positioned to 
tackle bigger issues that, in their entirety, are be-
yond its remit but that nevertheless have the po-
tential to affect food safety. As such, interagency 
cooperation can be an effective way of integrat-
ing  the  knowledge  and  the  resources  available 
within the EU’s system of agencies to contribute 
to a high level of consumer protection. 

Taking	a	multidisciplinary	approach	to	
food	chain	contaminants

An  example  of  the  broad,  multidisciplinary  and 
collaborative scientific work within EFSA was the 
Authority’s  assessment  of  marine  biotoxins  in 
2009. The European Commission had asked EFSA 
to assess the EU limits for various different types 
of regulated and non-regulated toxins, known as 
marine biotoxins, in shellfish, as well as the test-
ing methods established for EU legislation. 

In  performing  this  assessment  a  working  group  
of  the  Authority’s  Panel  on  contaminants  in 
the  food  chain  (CONTAM  Panel),  supported  by 
its  Data  Collection  and  Exposure  (DATEX)  and  
CONTAM  Units,  collected  data  and  calculated  
the  exposure  to  marine  biotoxins.  This  made 
it  possible  for  the  CONTAM  Panel  to  assess  the  
potential  public  health  risk  posed  by  the  pres-
ence of marine biotoxins in shellfish. 

The work not only covered the implications of the 
consumption  of  shellfish  for  human  health,  but 
also  incorporated  animal  welfare  aspects. These 
were considered by the Panel when recommend-
ing alternative chemical methods to test for the 
presence  of  these  toxins,  which  currently  is  pri-
marily done using mouse bioassays. 

In  its  summary  opinion,  EFSA  brought  together 
the conclusions of six earlier risk assessments on 
regulated marine biotoxins. Using available con-
sumption data, the EFSA experts identified 400 g 
as a realistic estimate of a large portion of shell-
fish and used this in assessing current permitted 
levels  of  the  toxins. The  CONTAM  Panel  also  as-
sessed the influence of processing on the levels 
of  marine  biotoxins  and  started  assessing  non-
regulated marine biotoxins.

An	integrated	approach	to	animal	health

Another  example  of  EFSA’s  integrated  approach 
are  the  opinions  that  were  published  on  dairy 
cow  housing  and  husbandry  systems  in  2009. 
One,  from  the  BIOHAZ  Panel,  covered  the  food 
safety  aspects  of  dairy  cow  housing  and  hus-
bandry systems, while five others, from the Panel 
on  animal  health  and  welfare  (AHAW  Panel), 
looked at the overall effects of the most relevant 
farming  systems  on  the  welfare  of  dairy  cows 
and related diseases. They assessed the potential  
impacts  of  housing,  feeding,  management  and 
genetic selection on the welfare of dairy cows. 

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Taking a comprehensive perspective on the topic, 
and  after  bringing  together  the  wealth  of  avail-
able data, the Authority’s experts first carried out 
risk  assessments  in  four  sub-areas  (metabolic 
and reproductive disorders, udder disorders, leg 
and locomotion problems, as well as behavioural 
disorders, fear and pain) before adopting the five 
scientific opinions that provide an overall assess-
ment of the whole topic area. 

EFSA  concluded  that  the  nature  of  the  farm-
ing systems and long-term genetic selection for 
higher milk yields are important factors affecting 
the  health  and  welfare  of  dairy  cows  and  gave 
recommendations on housing, feeding, manage-
ment  and  genetic  selection  practices  that  could 
improve the welfare of dairy cows.

Developing	new	risk	assessment	
methodologies	for	pesticides

Pest	risk	assessment	to	maintain	plant	
health	in	Europe

EFSA’s  work  on  cumulative  effects  of  pesti-
cides  is  part  of  the  Authority’s  broader  and  all- 
embracing approach and, altogether, represents 
a new dimension of EFSA’s risk assessments. For 
this  work,  EFSA  proposed  methodologies  to  as-
sess  the  cumulative  effects  resulting  from  con-
sumer exposure to pesticides, in particular those 
pesticides  that  have  similar  chemical  structures 
and toxic effects. 

In June 2009, the EFSA Panel on plant protection 
products  and  their  residues  (PPR  Panel)  issued 
an opinion on the applicability of the new meth-
odologies by implementing them for a group of 
pesticides  selected  on  the  basis  of  their  toxico-
logical  similarities.  The  Panel  also  identified  the 
next  steps  and  open  issues  that  need  to  be  ad-
dressed  before  cumulative  risk  assessments  can 
be  applied  routinely  for  pesticides. This  work  is, 
therefore,  part  of  EFSA’s  on-going  commitment 
to  be  at  the  forefront  of  developing  risk  assess-
ment  methodologies,  in  particular  concerning 
cumulative risk assessment following on from the 
Scientific  Colloquium  on  this  same  topic  organ-
ised in 2006. 

EU risk managers rely on pest risk assessments to 
support decision-making on phytosanitary meas-
ures. This calls for a transparent evaluation proce-
dure, based on scientific principles, to ensure an 
objective and consistent approach is used in eval-
uating assessments of the risks posed to plant life 
or plant health. Therefore, in October 2009, EFSA’s 
Panel on plant health (PLH Panel) published guid-
ance  on  the  evaluation  of  documents  prepared 
by  EU  Member  States  or  third  parties  to  justify 
requests  for  the  consideration  of  phytosanitary 
measures. 

In  developing  this  guidance  the  Panel  reviewed 
the  36  opinions  published  between  2006  and 
2008, and paid particular attention to the evalu-
ation process for 30 pest risk analysis documents 
prepared  by  France  with  regard  to  organisms 
considered  harmful  for  certain  French  overseas 
departments.  The  Panel  also  verified  that  the 
criteria used by the Panel in evaluating evidence 
to justify claims that an organism may be consid-
ered to be harmful are in line with International 
Standards for Phytosanitary Measures.

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15

The  resulting  guidance  describes  the  process, 
criteria  and  main  methodologies  recommended 
by the Panel for use in pest risk assessment and 
for evaluating pest risk management options. Ul-
timately, such guidance underpins EFSA’s role in 
harmonising assessments across Europe to better 
support risk managers.

In  the  course  of  2009,  the  Panel  also  worked 
on  guidance  aimed  at  providing  a  harmonised 
framework for assessing the risks posed to plants 
and plant products by pests, and for identifying 
and  evaluating  risk  management  options.  This 
additional  guidance  was  published  in  February 
2010.

Providing	scientific	support	across	EFSA

EFSA’s Assessment Methodology Unit (AMU) pro-
vided support to most panels in EFSA in 2009. It 
developed new approaches to help decision mak-
ing in risk assessments and also assisted various 
EFSA  panels  in  managing  data  in  their  scientific 
opinions. This  included,  for  example,  systematic 
literature  reviews  and  meta-analysis  modelling 
activities used by the CONTAM Panel in its opin-
ion on dose-related effects of cadmium. 

AMU also provided guidance on the application 
of  systematic  review  methodology  to  food  and 
feed  safety  assessments  in  support  of  decision 
making. This guidance was the basis for a work-
shop for EFSA panel experts and staff held in Feb-
ruary 2010. 

|

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2.	TIMELY	HIGH-QUALITY	EVALUATIONS

Evaluating	products,	substances	and	claims	that	
need	to	be	authorised	under	EU	law	has	steadily	
grown	to	be	a	large	part	of	EFSA’s	workload.	In	
this,	the	Authority	plays	an	important	role	in	
the	regulatory	framework	related	to	European	
food	and	feed	safety.	In	2009,	for	example,	
applications	represented	68	%	of	EFSA’s	scientific	
outputs	and	consumed	an	ever-growing	amount	
of	its	resources.	

Given the tight legal time constraints for EFSA to 
conduct these evaluations, in 2009 EFSA further 
strengthened  internal  processes  supported  by 
new IT tools to monitor and track progress of its 
scientific work. For instance, the risk assessment 
IT  workflow  tool  helps  the  Authority  monitor 
the  entire  risk  assessment  process  from  receipt 
of mandate to its eventual publication and pos-
sible communication. This helps EFSA determine 
publication  timeframes,  and  to  forecast  and 
characterise  future  workloads.  In  addition,  EFSA 
and  the  European  Commission  introduced  the 
“roadmap” in 2009 to help EFSA in the planning 
of its resource allocation and in the managing of 
its  scientific  output,  for  example  in  the  areas  of 
flavourings and pesticides. It consists of mutually 
agreed prioritisations of the workload and realis-
tic timeframes for evaluating applications, in part 
drawing on the information from EFSA’s workflow 
tool. In addition, throughout the year, to further 

facilitate  the  workflow  and  monitor  progress, 
EFSA  and  the  European  Commission  continued 
to  maintain  close  collaboration  through  regular 
dialogue  on  progress  and  prioritisation  in  many 
areas, such as pesticides, and food and feed ad-
ditives.  

Furthermore, in May 2009, EFSA´s Scientific Com-
mittee published further guidance in support of 
good risk assessment practice. The guidance fo-
cused on transparency in producing EFSA’s scien-
tific outputs. It contained general principles that 
should  be  applied  to  scientific  risk  assessments, 
such as evaluations, to ensure quality continues 
to be maintained. The principles cover the identi-
fication of data sources, criteria for including/ex-
cluding data, confidentiality of data, and assump-
tions and uncertainties. This follows the Scientific 
Committee’s  earlier  guidance  from  2006,  on  the 
procedural aspects of risk assessments.

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17

Managing	applications:	the	case	of	GMOs

Evaluating	health	claims

Under EU law, GM food or feed or derived prod-
ucts must undergo a risk assessment by EFSA to 
help risk managers decide whether or not to au-
thorise their use in the EU. To further improve EF-
SA’s support in this area, the assessment of GMO 
applications was further streamlined in 2009. As 
a result, the average time between the receipt of 
a  new  application  and  the  declaration  of  its  va-
lidity became 21 weeks. In addition, the Panel on 
genetically modified organisms (GMO Panel) has 
more than halved the time from validation of an 
application until the delivery of the first letter to 
applicants with questions or requests for further 
data (in 96 % of cases, applicants are required to 
provide further information required for the safe-
ty assessment of GMOs). Even with these requests 
for further data, new efficiency gains allowed the 
GMO  Panel  to  adopt  three  times  more  opinions 
on GMO applications in 2009 (14 opinions cover-
ing  18  applications  compared  to  four  opinions 
covering five applications in 2008). 

EFSA  is  responsible  for  verifying  the  scientific 
substantiation of submitted health claims, which 
then serve as a basis for the European Commis-
sion  and  Member  States  that  decide  on  the  au-
thorisation of the claims. 

In 2009, EFSA’s Panel on dietetic products, nutri-
tion and allergies (NDA Panel) met all legal dead-
lines  to  evaluate  the  numerous  health  claims’ 
applications it  had  received.  For  applications  on 
more specific health claims referring to the reduc-
tion of the risk of disease or to children’s develop-
ment or health, EFSA adopted 68 opinions within 
tight legal deadlines. 

Regarding  more “general  function”  health  claims, 
such as “calcium is good for your bones”, in 2009 
the  Authority  published  a  combined  list  of  the 
approximately 4 000 health claims it had received 
in 2008 from the Commission and Member States; 
it  also  published  the  literature  references  (ap-
proximately  40 000)  it  received  for  some  2 000 

claims  that  had  entered  the  scientific  evaluation 
process.  It  has  since  adopted  and  published 
in  October  2009  around  500  claims  that  were 
addressed  in  94  opinions  and,  later  in  the  year, 
adopted 400 additional health claims that are due 
to be published in 2010. 

The  new  working  sub-groups  that  were  created 
by the Authority to support evaluations of func-
tional health claims started their activities in 2009 
and  successfully  relieved  the  standing  working 
group  on  claims  and  the  actual  panel  of  impor-
tant preparatory work. 

As part of this, experts from NDA Panel also met 
health claims applicants and industry experts in 
Brussels for an exchange of views on the presen-
tation  of  applications  for  health  claim  authori-
sations  and  to  provide  additional  guidance  on 
claim applications. 

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Further	improving	the	peer	review	of	
active	substances	in	plant	protection	
products	

By  2009,  EFSA’s  Pesticide  Risk  Assessment  Peer 
Review (PRAPeR) Unit had completed its work on 
the peer review of the existing active substances 
used in pesticides. This will enable the European 
Commission  to  decide  on  the  list  of  active  sub-
stances that may be included in plant protection 
products  throughout  the  EU.  Applicants,  whose 
active substances were not included in the posi-
tive list, could then resubmit their applications for 
consideration under an accelerated procedure.    

In  response  to  the  expected  high  workload  in 
2009/2010  and  the  challenging  timelines  as-
sociated  with  resubmissions,  EFSA  began  to  ex-
tensively review its procedures and, in close col-
laboration with Member States and the European 
Commission, further streamlined its peer review 
approach.  Whilst  active  substances  continue 
to  be  subject  to  a  full  risk  assessment  and  peer 
review,  the  scientific  expert  consultation  is  now 
conducted in a more focused way, concentrating 
particularly on more important or difficult issues.

As a result of these new procedures, in 2009 EFSA 
was  able  to  peer  review  and  deliver  its  conclu-
sions  on  the  first  group  of  nine  resubmitted  ac-
tive  substances,  as  well  as  progressing  the  peer 
review  for  a  further  42  resubmitted  substances. 
Alongside  this  work,  EFSA  delivered  its  conclu-
sions on a further 19 active substances, including 
9 new active substances, and peer reviewed the 
first  group  of  existing  active  substances  on  the 
positive list due for renewal. 

Close  communication  with  the  European  Com-
mission was also crucial in the Authority’s review 
of Maximum Residue Levels (MRLs) for pesticide 
residues in or on food or feed. MRLs are the upper 
legal  levels  of  pesticide  residue  concentrations 
in or on food or feed, based on good agricultural 
practice and the lowest consumer exposure nec-
essary to protect vulnerable consumers. 2009 was 
the first full year in which the corresponding regu-
lation on MRLs was applicable and in which EFSA 
(and not the Member States) was responsible for 
the consumer risk assessment in the MRL setting 
process. The Authority issued in 2009 76 opinions 
on 300 MRLs for 53 active substances. In this case, 
dialogue  with  the  European  Commission  also 

helped in priority setting and in focusing EFSA’s 
work  on  substances  that  are  critical  with  regard 
to consumer safety and for which a full review of 
the MRLs established in the European legislation 
is planned.

Finally,  in  the  area  of  plant  protection  products, 
the  Pesticide  Steering  Committee  was  created 
to  establish  collaboration  with  the  competent 
authorities in the Member States, with the Euro-
pean  Commission  and  its  Joint  Research  Centre 
(JRC), as well as with other EU agencies. In 2009, 
this group met five times and the committee con-
sidered ways to make the process even more effi-
cient in the face of an ever-growing workload and 
an evolving regulatory environment. 

Guiding	and	discussing	with	applicants:	
the	example	of	feed	additives	

To help applicants, over the course of 2009, EFSA 
developed  guidance  so  that  they  could  better 
prepare  for  submitting  dossiers.  Improving  un-
derstanding  of  the  process  and  the  information 
required helps speed up the process and results 
in better quality applications. 

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For  example,  EFSA  has  prepared  guidance  in 
2009 for the re-evaluations of existing feed addi-
tives  that  had  been  previously  registered.  EFSA, 
and in particular the Panel on additives and prod-
ucts or substances used in animal feed (FEEDAP 
Panel),  will  be  re-evaluating  these  products  in 
the  coming  years.  Therefore,  the  Authority  not 
only updated the administrative guidance docu-
ment for applicants, including for the first time a 
“completeness  checklist”  for  applicants  but  also 
finalised  the  technical  guidance  document  for 
sensory  additives.  With  the  latter  document,  in 
2009  the  Authority  completed  the  set  of  tech-
nical  guidance  documents  in  the  area  of  feed 
additives.  These  are  chiefly  aimed  at  operators 
involved in feed production, as well as stakehold-
ers and other bodies concerned with feed safety. 
They also explain the Panel’s approach to scien-
tific risk assessment of feed additives. In addition, 
the Authority provided more support for the ap-
plicants  and  conducted  technical  hearings  with 
specific applicants and/or industry associations. 

Assessing	food	additives	

For  food  additives  the  Authority  benefited  from 
having  established  two  new  panels  to  take  up 
the  work  previously  carried  out  by  only  one 
panel.  The  workload  was  divided  among  two 
panels, the Panel on food additives and nutrient 
sources added to food (ANS Panel) and the Panel 
on  food  contact  materials,  enzymes,  flavourings 
and  processing  aids  (CEF  Panel),  set  up  in  2008. 
This  new  organisation  of  the  work  helped  EFSA 
to meet the deadline – in 2009 – of the evaluation 
programme of nutrient sources used in food sup-
plements.  This  was  an  important  achievement 
supporting the European Commission in drawing 
up a positive list of such nutrient sources by the 
end of 2009, as required by legislation. 

In completing this first comprehensive assessment 
of  nutritional  substances  proposed  to  be  used 
in  food  supplements  in  the  EU,  EFSA  examined 
533  applications  in  total,  covering  344  different 
substances;  186  applications  were  withdrawn  at 
various stages during the evaluation process, and 
EFSA  received  insufficient  scientific  evidence  to 
assess around half of the remaining applications. 

Possible  safety  concerns  were  identified  in  rela-
tion to 39 applications. With this assessment, the 
Authority  helped  ensure  that  food  supplements 
sold in the EU are not only safe but also effective in 
providing the body with the nutrients contained in 
the supplement. In addition, the provision of bet-
ter  information  for  the  applicants  –  such  as  the 
establishment  of  data  requirements  for  food  ad-
ditive applications – accelerated EFSA’s processes. 
The European Commission will consider the data 
requirements listed by EFSA when finalising legis-
lative  measures  concerning  applications  submit-
ted  for  the  evaluation  and  authorisation  of  food 
additives.  Then  in  2010,  the  ANS  Panel  will  start 
preparing a separate guidance document to indi-
cate the scientific aspects to be considered when 
preparing applications for food additives. 

In  preparation  for  the  re-evaluation  of  all  per-
mitted food additives, three public calls for data 
were made in November 2009, mainly directed at 
producers of additives, food companies, national 
authorities, or other involved parties. The objec-
tive  was  to  close  information  gaps  that  could  
otherwise  prevent  the  Panel  from  properly  
assessing the safety of the additives in question.  

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The  ANS  Panel  was  also  able  to  finalise  the  re-
evaluation of the six colours used in the so-called 
“Southampton  Study”  (Mc  Cann  et  al.,  2008), 
which the European Commission had asked EFSA 
to  consider  a  priority.  Prior  to  the  Authority’s 
evaluation,  a  study  conducted  at  the  University 
of  Southampton  had  suggested  a  link  between 
mixtures of six food colours and the preservative 
sodium  benzoate,  and  hyperactivity  in  children. 
In November 2009, the Panel concluded that the 
evidence currently available did not substantiate 
a  causal  link  between  any  of  the  six  individual 
colours  and  possible  behavioural  effects.  How-
ever, for specific reasons related to the potential 
adverse effects of each colour, the Panel has re-
duced the Acceptable Daily Intake (ADI) of three 
of the colours (E 104, E 110 and E 124). 

Evaluating	and	providing	guidance	on	
food	contact	materials	and	flavourings	

EFSA has carried out an evaluation of about 2 600 
flavouring  substances  that  had  been  registered 
by  the  European  Commission  as  existing  prod-
ucts. The Authority was largely able to complete 
this task in 2009, with only a few individual issues 
remaining that require further coordination with 
other agencies, such as EMA. In addition, the Au-
thority has outsourced the collection of the data 
and the preparation of summaries for the work-
ing groups and panels.

In 2009, EFSA also launched a public consultation 
on a draft guidance document on food flavourings 
that specifies which data industry should submit 
for the safety evaluation of new flavourings. This 
document reflects the experience gained by EFSA 
during the evaluation of the flavourings that are 
already on the market. 

Furthermore,  the  Authority  also  published 
guidelines  on  “active”  and  “intelligent”  sub-
stances in materials in contact with food. Active 
food-contact  materials  absorb  or  release  sub-
stances  to  preserve  or  improve  the  condition 
of  packaged  food  or  extend  its  shelf  life,  while 
intelligent  food-contact  materials  monitor  the 
condition of packaged food or the surrounding 
environment  and  provide  information  on  the 
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freshness of the food. 

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3.	GATHERING	EU	DATA	

The	quality	of	the	risk	assessment	done	by	
EFSA	depends	not	only	on	the	integration	
of	the	full	range	of	expertise	available.	It	
also	depends	on	the	quality,	consistency,	
topicality	and	completeness	of	the	data	that	
are	used	in	the	scientific	analyses,	monitoring	
of	risks	and	deliberations	on	the	risks	being	
assessed.	Therefore,	the	Authority	also	has	an	
important	role	in	data	collection,	coordination	
and	harmonisation	across	Europe.	In	this	role,	
EFSA	works	in	particular	with	Member	States	
to	gather,	share	and	analyse	data	at	the	EU	
level.	For	this,	it	can	rely	on	a	solid	and	efficient	
network	spanning	the	individual	countries	
and	responsible	authorities.	The	Authority’s	
work	in	this	field	includes	the	monitoring	of	
pesticide	and	veterinary	drug	residues,	chemical	
contaminants,	zoonoses	and	emerging	risks,	
as	well	as	the	compilation	of	European	food	
consumption	data,	on	the	one	hand,	and	the	use	
of	the	two	data	streams	to	calculate	exposure,	on	
the	other.	Collecting	such	data	also	allows	EFSA	
to	rapidly	respond	to	urgent	requests	for	advice	
with	a	robust	evidence	base,	so	that	potential	
risks	can	be	quickly	assessed,	enabling	risk	
managers	to	act	rapidly,	if	needed.

What’s	Europe	eating?

A  common  component  of  any  exposure  assess-
ment is information on food consumption. EFSA’s 
collection of food consumption data started with 
the development of the “Concise European Food 
Consumption Database”, led by its Data Collection 
and Exposure (DATEX) Unit. This step provided a 
first overview of food consumption in Europe. 

To  be  able  to  refine  exposure  assessments,  the 
Authority,  in  conjunction  with  Member  States, 
embarked  on  the  collection  of  detailed  data  for 
a  comprehensive  food  consumption  database, 
which was finalised by the end of 2009. This com-
prehensive database represents a major step for-
ward  for  exposure  assessment,  as  the  quality  of 
available  data  on  food  consumption  can  have  a 
major impact on the outcome of related risk as-
sessments.  This  new  comprehensive  database 
represents the best food consumption data avail-
able at the EU level; it also marks a consolidation 
of  the  relationship  between  the  Authority  and 
Member States as these now share their data. 

EFSA  is  currently  in  the  process  of  extending  its 
European food consumption database. However, 
Member  States  use  different  methods  to  collect 
food consumption data, which makes it difficult to 

carry out EU-wide analyses or country-to-country 
comparisons. In close cooperation with Member 
States, EFSA is therefore supporting further har-
monisation of data collection on food consump-
tion  across  Europe.  Such  data  consistency  will 
improve  the  accuracy  and  reliability  of  EU  wide 
exposure estimates and, consequently, of the risk 
assessments carried out by EFSA’s panels and by 
other risk assessors and scientific experts across 
Europe.  In  December  2009,  the  Authority’s  food 
consumption and exposure working group pub-
lished the general principles for the collection of 
national  food  consumption  data  with  a  view  to 
support harmonisation for data collection. 

Other food consumption and exposure data are 
also collected by Member States and sent to EFSA 
to  support  the  Authority’s  monitoring  activities 
and the production of the annual data collection 
reports on contaminants exposure. In 2009, two 
target  contaminants  were  covered  by  these  re-
ports, acrylamide in May and furans in June. Acry-
lamide  can  be  formed  in  foods  rich  in  carbohy-
drate during food processing at temperatures of 
120 °C or higher. The compound has been shown 
to  be  genotoxic  and  carcinogenic  in  laboratory 
animals. Furan can also form in foods during heat 
treatment  and  is  known  to  occur,  for  example, 

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in  coffee  and  jarred  food,  including  baby  food 
containing meat. This contaminant has also been 
shown to be carcinogenic in animal studies. 

Ad hoc reports on the occurrence of specific con-
taminants  were  also  requested  by  the  European 
Commission, e.g. for dioxins in food and feed. EFSA 
received contaminant data in food and feed prod-
ucts from Member States and other interested par-
ties, and issued a draft report in 2009 for discussion 
with Member States and the Commission. 

EFSA’s	first	Annual	Pesticide	Residues	
Report

Another  responsibility  that  has  been  handed 
over  to  EFSA  from  the  European  Commission  is 
the publication of the Annual Report on Pesticide 
Resi dues  in  food,  which  is  based  on  the  legal 
framework of the new MRL legislation applicable 
since  September  2008  and  for  which  Member 
States  have  to  provide  the  data.  In  July  2009, 
EFSA’s  Pesticide  Risk  Assessment  Peer  Review 
(PRAPeR) Unit published the first of these reports, 
providing  an  overview  of  the  pesticide  residues 
found  in  food  samples  marketed  in  Europe 
in  2007,  but  also  providing  a  risk  assessment 

of  the  consumer  exposure  to  the  residues.  In 
total,  more  than  74  000  samples  of  nearly  350 
different types of food were analysed; 4 % of the 
samples exceeded the legal MRLs. The consumer 
exposure  assessment  identified  some  critical 
results.  Based  on  these  findings,  EFSA  derived 
recommendations  to  be  considered  for  future 
control activities. 

States, 

improve 
To  help  draft  the  report,  and  to 
collaboration  with  Member 
the 
Authority  established  a  networking  group. 
The  group  consists  of  nominated  experts  from 
Member  States  and  a  European  Commission 
representative.  This  group  discusses  all  issues 
related  to  the  monitoring  report,  in  particular 
the necessary improvements required regarding 
the  format  of  the  data  and  the  level  of  details 
reported  to  EFSA.  Consequently,  in  2009,  the 
Authority  developed  a  data  model  for  the 
reporting  of  results  and  successfully  carried  out 
a  comprehensive  pilot  project.  After  the  formal 
adoption,  the  data  model  will  be  implemented 
for  collecting  data  from  the  2009  monitoring 
results. The new format will allow EFSA to perform 
a more accurate consumer exposure assessment.  

Reporting	on	zoonoses	and	food-borne	
outbreaks	EU-wide

As in previous years, EFSA’s Zoonoses Data Collec-
tion (“Zoonoses”) Unit issued in 2009 the Commu-
nity Summary Report on Zoonoses and Food-borne 
Outbreaks. This  report  series  is  prepared  in  close 
collaboration  with  ECDC,  which  provides  and 
analyses  the  data  from  the  disease  cases  in  hu-
mans, and with the Task Force on Zoonoses Data 
Collection. This pan-European network of national 
representatives  and  international  organisations 
assists  EFSA  by  gathering  and  sharing  informa-
tion  on  zoonoses  in  their  respective  countries. 
These community summary reports are used both 
by  risk  managers  and  assessors,  as  well  as  other 
stakeholders  across  the  EU.  In  particular,  the  risk 
managers  at  EU  level  use  the  reports  when  con-
sidering the need for further EU control measures 
and  when  monitoring  the  impact  of  existing  EU 
measures. 

A N N U A L   R E P O R T   2 0 0 9

23

The major findings of the latest report, published 
in January 2010, are that in 2008 campylobacte-
riosis and salmonellosis continued to be the most 
frequently reported zoonotic diseases in humans, 
although  salmonellosis  cases  decreased  signifi-
cantly for the fifth consecutive year. An important 
decline in the occurrence of Salmonella in laying 
hens  was  observed  in  2008  due  to  control  pro-
grammes  implemented  by  Member  States.  This 
could  be  the  reason  for  a  corresponding  fall  in 
human Salmonella infections, typically related to 
the consumption of eggs that was also observed 
during the same year. 

Other  2009  highlights  were  EFSA’s  reports  on 
analyses of the EU-wide baseline surveys of two 
zoonotic  bacteria,  Salmonella  and,  methicillin-
resistant Staphylococcus aureus (MRSA) in breed-
ing pigs. Both of these bacteria were commonly 
found from breeding pig holdings in many Mem-
ber States. The results of these surveys will help 
risk managers when setting Salmonella reduction 
targets for breeding pigs and when considering 
the need to control and monitor MRSA in pigs in 
view of protecting public health. 

To  harmonise  zoonoses-related  data  collection 
across  the  EU  and  to  improve  their  analysis,  in 
2009 EFSA published two reports with specifica-
tions  for  harmonised  surveys  of  the  food-borne 
pathogens, verotoxigenic E. coli and Yersinia, as a 
guide  to  Member  States. The  Authority  also  ap-
plied improved statistical methods for analysing 
the trends in zoonotic agents over the years, and 
even better data validation by using, for the first 
time, a new data management system. 

Helping	to	spot	emerging	risks

In  2009,  EFSA’s  Emerging  Risks  (EMRISK)  Unit 
developed  new  tools  for  efficiently  monitor-
ing  and  analysing  data  to  identify  new  or  re- 
emerging  hazards,  in  particular  from  the  Rapid 
Alert  System  for  Food  and  Feed  (RASFF).  This 
database, maintained by the European Commis-
sion, includes detailed information on food safety 
events  notified  by  the  members  of  the  RASFF-
network. 

Another  important  source  of  data  for  the  iden-
tification of emerging risks is the media. EMRISK 

assessed the usefulness for this task of a media-
monitoring  tool  developed  by  the  European 
Commission’s Joint Research Centre. These tools, 
together with monitoring of trade data provide a 
first step in the implementation of EFSA’s strategy 
for addressing emerging risks. 

One  specific  topic  being  addressed  by  the 
Authority’s EMRISK Unit is the impact of climate 
change  on  aflatoxins  (carcinogenic  chemicals 
produced  by  certain  moulds,  particularly 
prevalent  in  hot  and  humid  climates,  which  
grow  on  cereals)  in  cereals.  Based  on  different 
climate change scenarios, the aim of this project, 
which  started  in  2009,  is  to  gather  and  analyse 
data  on  aflatoxin  production  to  build  predictive 
models,  define  scenarios  and  create  maps  high-
future  contamination 
lighting  areas  where 
of  cereal  crops  may  occur.  While  this  is  a  very 
prospective  project  that  looks  decades  ahead, 
a  more  immediate  benefit  of  this  work  is  the 
development  of  methodologies  and  tools  for 
anticipating the emergence of new risks in food 
and feed. 

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Visit of Japanese delegation 
to EFSA in December 2009

4.	BUILDING	INTERNATIONAL	PARTNERSHIPS	

Crops,	animals,	and	food	and	feed	products	are	
transported	around	the	world	in	an	increasingly	
global	world	–	as	are	the	associated	risks.	Therefore,	
being	involved	internationally	–	in	support	of	EU	
policy	–	is	paramount	for	EFSA’s	ability	to	keep	
Europe’s	food	supply	safe	and	to	protect	consumers.	
To	this	end,	EFSA	seeks	to	build	partnerships	with	
food	safety	agencies	in	countries	outside	the	EU	
and	with	international	organisations	in	order	to	
ensure	access	to	the	larger	pool	of	international	
scientific	data	and	information.	This	will	allow	the	
Authority	to	continue	to	provide	a	strong	basis	
for	risk	assessment	and	identify	emerging	risks,	
to	take	part	in	risk	assessment	internationally,	to	
support	international	harmonisation	efforts	on	data	
collection	and	risk	assessment,	and	to	promote	
coherence	in	risk	communications.	In	addition,	
the	Authority	is	also	building	awareness	of	its	
activities	internationally	to	build	its	reputation	as	an	
organisation	that	is	globally	recognised	and	trusted	
as	the	European	reference	body	for	risk	assessment.

Going	global

EFSA adopted its “strategic approach” to its inter-
national activities in January 2009. As a first step, 
the authority took stock of the multiplicity of ex-
isting formal and informal collaborations, and in-
ternational contacts at individual levels. Then, to 
prioritise regions and organisations where closer 
collaboration  and  an  alignment  of  positions  are 
of  relevance  for  EFSA,  the  Authority  identified 
priority partners and target countries for the de-
velopment of longer-term relationships. The ob-
jective of these relationships is to strengthen the 
Authority’s  capacity  to  perform  risk  assessment 
based on shared perceptions of the risks and to 
better  communicate  them  internationally.  For 
EFSA,  strengthening  its  position  in  the  interna-
tional arena is also necessary given the fact that 
food-related risks are increasingly global: interna-
tional food trade is ever-increasing and, through 
the  global  food  chain,  risks  can  easily  appear  in 
products from far-away countries. 

The  Authority  supports  the  international  ex-
change  of  data  and  risk  assessments.  It  contrib-
utes  to  the  development  and  harmonisation  of 
methodologies and promotes a common under-
standing of the underlying principles. EFSA seeks 
to  contribute  to  and  guide  international  best 
practices  –  with  the  ultimate  aim  of  becoming 
globally  recognised  as  the  European  reference 
body  for  assessing  the  risks  related  to  the  food 
chain. 

Forging	closer	ties	internationally	

In 2009, EFSA prepared and began implementing 
its  international  strategy  –  prioritising  its  actions 
on  supporting  EU  policy  –  and  already  set  new 
important  milestones  for  its  international  activi-
ties. Foremost among these achievements was the 
formalisation  of  relationships  with  the  Japanese 
risk assessor, the Food Safety Commission (FSC) of 
Japan, through signing in December a Memoran-
dum of Cooperation on the collection and sharing 

A N N U A L   R E P O R T   2 0 0 9

25

Visit of Chinese delegation to EFSA in January 2009

of data required for the assessment of current and 
emerging risks. Likewise, EFSA committed to work 
together and exchange data with the competent 
authority  of  New  Zealand  through  an  exchange  
of  letters;  similar  activities  were  advanced  with 
Canada and Australia. In addition, EFSA provided 
scientific  support  for  the  European  Commission 
delegation to Codex Alimentarius (a joint FAO/WHO 
body which develops international food standards, 
guidelines,  etc.)  and  contributed,  in  particular,  to 
the EU position on ractopamine, a growth promoter 
used in animal feed.

Early  in  2009,  a  delegation  from  Chinese  public 
health  authorities  visited  EFSA.  Other  interna-
tional  high-level  visits  to  EFSA  in  2009  included 
the  visit  of  a  delegation  of  the WHO  to  present 
their work programme in the area of food safety 
and  to  discuss  scientific  issues,  such  as  animal 
health  and  welfare,  pesticides,  zoonoses,  nutri-
tion,  food  additives,  contaminants,  and  general 
principles  of  risk  assessment  and  risk  communi-
cations. A common theme underlying all the in-
ternational visits was the identification of future 
cooperation  activities  and  harmonisation  steps. 
EFSA  delegations  have  also  visited  international 
partners;  For  example  in  July  2009  a  delegation 
visited US Federal institutions.

Finally, in 2009 EFSA initiated a series of initiatives 
under  the  EU’s  pre-accession  programme  for 
candidate and potential candidate countries, i.e. 
Turkey, Croatia and the former Yugoslav Republic 
of Macedonia plus Albania, Bosnia-Herzegovina, 
Kosovo,  Montenegro  and  Serbia.  The  objective 
of this programme is to help national food safety 
authorities in these countries in their own risk as-
sessments and risk communications. In particular, 
the programme aims to help them prepare for fu-
ture  participation  in  EFSA  networks;  to  develop 
communication  and  information  exchange  sys-
tems; to transfer knowledge of areas covered by 
EFSA; and to support the beneficiary countries in 
their risk communication activities.

To  do  this  EFSA  arranges  training  seminars  and 
study tours for experts nominated by the respec-
tive programme coordinator in each country; four 
seminars were held in 2009. In the context of this 
programme,  the  candidate  and  potential  candi-
date  countries  are  also  invited  to  participate  as 
observers at EFSA meetings with Member States. 
As a result, these countries become increasingly 
involved  in  the  work  of  EFSA,  an  outcome  that 
supports international harmonisation efforts.  

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5.	COMMUNICATION	AND	DIALOGUE

EFSA	aims	to	reinforce	public	confidence	and	
trust	in	the	EU	food	safety	system	through	its	
communications	and	dialogue	with	partners	
and	stakeholders.	It	also	remains	committed	
to	ensuring	transparency	throughout	its	work,	
ensuring	visibility	and	accessibility	for	its	
scientific	outputs,	as	well	as	raising	awareness	
and	understanding	of	how	EFSA	works.

EFSA  strives  to  promote  coherence  between  its 
own risk communications and that of its partners 
in  the  EU  food  safety  system  and  beyond. This  is 
a critical goal alongside maintaining the simplicity 
and  accessibility  of  its  communications,  and  fur-
ther increasing the visibility and the understanding 
of its scientific work. To achieve this, and to better 
reach national audiences in their own languages, 
in 2009 EFSA also started implementing a multilin-
gual  approach  to  its  own  communications,  mak-
ing key corporate publications and strategy docu-
ments available in all 23 EU official languages. 

In  2009,  the  Authority  embarked  on  research 
amongst its key target audiences, acknowledging 
the need to measure the impact of its communi-
cations  and  general  awareness  about  EFSA.  Fol-
lowing  a  qualitative  approach,  EFSA  conducted 
interviews with decision makers and stakeholders 

in politics, science and the food chain at national, 
European and international levels. The results of 
this work will support the Authority in the review 
of its communication strategy, which it began in 
2009. This will also enable the Authority to further 
refine  its  EFSA  brand  guide  which  summarises 
what  EFSA  wants  to  stand  for  and  which  aims 
to guide communication outputs in delivering a 
consistent and coherent image of the Authority. 

In 2009, EFSA has considerably increased its out-
reach. For instance, it significantly enhanced the 
usability  and  accessibility  of  its  website  attract-
ing more than 2.4 million web visits, subscribers 
to the “EFSA Highlights” newsletter increased by 
over  20 %,  media  relationships  were  strength-
ened, online news expanded by nearly 30 % and 
publications more than doubled. 

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27

The Advisory Forum Working Group  
on Communication

Cooperation	on	communications	with	
Member	States

The  Advisory  Forum  Communications  Working 
Group 
(AFCWG)  continues  to  be  the  key 
vehicle  for  strengthening  the  coherence  of 
communications activities between the national 
authorities  and  EFSA,  and  for  sharing  and 
promoting  best  practice.  In  2009,  the  AFCWG 
developed  an  overall  approach  and  outline  for 
risk  communications  guidelines  to  help  support 
coherence in risk communications across the EU 
that will be finalised in 2010. 

EFSA  supported  Member  States  in  the  organi-
sation  of  joint  events,  by  publishing  targeted 
newsletters to reach stakeholders nationally and 
stronger collaboration through the AFCWG. Joint 
events were also organised by EFSA and the cor-
responding Member State during 2009 in Austria, 
Greece  and  Slovenia.  These  events  addressed  a 
variety of topics that included strengthening ca-
pacity in food safety, cooperation between EFSA 
and  Member  States,  and  the  links  between  sci-
ence  and  policy  with  regard  to  food  safety  and 
nutrition.

Dialogue	with	stakeholders

In 2009, EFSA renewed its stakeholder consulta-
tive  platform,  readopting  24  EU-wide  organisa-
tions  working in areas related to the food chain 
for  one  year.  This  platform  meets  three  times  a 
year to assist EFSA in the development of its over-
all  relations  and  policy  with  stakeholders.  The 
platform  is  an  important  channel  for  encourag-
ing  dialogue  and  engagement  of  stakeholders, 
and  for  fostering  good  relationships  with  stake-
holders. 

This  renewal  of  the  platform  represents  an  im-
portant consolidation of the Authority’s contacts 
with its stakeholders and underlines its commit-
ment to open and transparent dialogue.  

In  2009,  EFSA  held  three  plenary  meetings 
instead  of  two  as  in  previous  years.  At  these 
meetings,  stakeholders  discussed  horizontal 
strategic  documents  and  submitted  advice 
and  comments  on  EFSA’s  management  plan,  its 
annual  report  and  its  communication  strategy. 
Core  EFSA  processes  are  also  discussed  within 
the  platform  –  for  instance,  in  2009  there  was 
a  working  group  on  EFSA’s  approach  to  public 
consultations on scientific outputs. 

As  well  as  increasing  the  number  of  plenary 
meetings,  EFSA  also  increased  the  frequency  of 
the platform’s technical meetings in 2009. These 
meetings  focus  more  on  scientific  topics  and 
covered, for example, animal welfare, pesticides, 
nanotechnologies  and  novel  food.  In  addition, 
the Authority also fosters bilateral contacts with 
its stakeholders. In 2009, EFSA welcomed a BEUC 
delegation,  led  by  its  new  President,  on  a  visit 
to  its  headquarters.  It  enabled  EFSA  to  explain 
how  the  Authority  protects  consumers  through 
its work on risk assessment, as well as discuss its 
work  on  scientific  cooperation  and  communica-
tions. 

Another stakeholder event in 2009 was a meeting 
with environmental NGOs that EFSA organised in 
Parma  at  which  representatives  from  the  Euro-
pean  Commission’s  Health  and  Consumers  DG 
(DG  SANCO)  and  DG  Environment  participated 
as  observers.  This  meeting  was  an  opportunity 
for  the  Authority  to  present  its  work  in  the  area 
of  GMO  risk  assessment  and  to  exchange  views 
with  stakeholders.  It  led  to  a  better  mutual  un-
derstanding of arguments and points of view be-
tween experts of the GMO Panel and members of 

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I I .   C O M M I T T E D   T O   E N S U R I N G   T H A T   E U R O P E ’ S   F O O D   I S   S A F E

environmental NGOs. In the area of health claims, 
EFSA also  met in June 2009 with stakeholders and 
Member States to explain EFSA’s work in this area 
and how it evaluates claims, as well as to present 
the  various  relevant  guidance  documents  it  has 
produced. 

Engaging	in	scientific	dialogue

Excellence  in  science  remains  a  core  value  for 
EFSA. An important element of maintaining excel-
lence is engaging in dialogue, to listen and learn, 
and to share information. In doing so, EFSA also 
seeks to raise awareness and understanding of its 
work. For example, in September 2009, EFSA held 
a  high-level  conference  to  present  its  work  and 
to exchange views on GMO risk assessments for 
human and animal health, and the environment. 
GMOs provide a good example in which the Au-
thority  provides  sound  scientific  advice  and  sci-
ence-based  information,  facilitates  an  exchange 
of  views,  promotes  mutual  understanding  and 
learning,  and  communicates  its  risk  assessment 
work, openly and transparently. 

For the first time in Europe, this two-day confer-
ence in Brussels brought together risk managers 
and risk assessors from Member States, as well as 
representatives from stakeholders – including in-
dustry, consumer and environmental groups – to 
discuss the status and future challenges of risk as-
sessment of GMOs. On the side of the European 
Commission,  the  importance  of  this  event  was 
acknowledged  through  speeches  given  by  the 
Directors-General of DG SANCO and DG Environ-
ment, who gave the opening and closing speech-
es, respectively. In all, around 150 participants at-
tended this conference, which was well received.  

Among the scientific events organised by EFSA in 
2009, its Scientific Colloquium on Novel Foods is 
a good example. About twice a year, EFSA organ-
ises such technical conferences to offer scientists 
the possibility to exchange their points of views 
and to foster and promote new ideas. At the time 
of this event, the novel foods regulation was un-
der revision, with the new regulation foreseeing 
centralised  risk  assessment  by  EFSA.  Therefore, 
the  Authority  convened  the  Colloquium  to  dis-

cuss the scientific information and data require-
ments  needed  for  applications  for  authorisation 
of novel foods and novel food ingredients in the 
European Union. In this way, EFSA obtained early 
on  valuable  input  from  all  stakeholders  for  the 
related guidance document on the safety assess-
ment of novel foods that will be drafted in 2010. 
Approximately 100 international experts in safe-
ty  assessment  and  regulatory  affairs,  as  well  as 
food manufacturers and others involved in novel 
foods, attended the colloquium, coming from 25 
countries within the EU and overseas. 

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29

Reaching	out	to	the	scientific	community

A	strong	partnership	with	EU	Institutions

EFSA science also reached a significant milestone 
in 2009, with the launch of a new, dedicated web 
area on the Authority’s corporate website for the 
EFSA  Journal.  The  goal  of  this  further  develop-
ment  of  the  EFSA  Journal  was  to  increase  the 
visibility of the Authority’s scientific work interna-
tionally and to acknowledge the work of the sci-
entific experts in its panels and working groups. 

The “new look” EFSA Journal now makes it easier 
for readers to browse and search EFSA scientific 
outputs. Readers can also easily subscribe to re-
ceive the latest issues of the Journal and can sim-
ply  view  articles  using  online  news  syndication 
services, such as RSS. In addition, the Journal aims 
to meet scholarly publishing standards and com-
ply with requirements of bibliographic databases 
relevant  for  EFSA’s  work.  After  the  EFSA  Journal 
web area is fully implemented EFSA will apply to 
bibliographic  databases  for  indexation  of  EFSA 
Journal  articles,  further  raising  the  scientific  vis-
ibility of the Authority’s work.    

The visit of the then European Commissioner for 
Health,  Androulla  Vassiliou,  to  EFSA  in  October 
2009, was one notable example of the strong and 
increasing  partnership  between  the  Authority 
and the Institutions. In an address to staff, Com-
missioner  Vassiliou  cited  EFSA’s  robust  scientific 
advice as key to helping EU decision makers cre-
ate  a  regulatory  framework  securing  one  of  the 
highest  levels  of  food  safety  in  the  world.  The 
Commissioner  specifically  referred  to  improved 
planning and establishment of priorities as a re-
sult  of  the  close  working  relationship  between 
the Authority and the Commission – for example, 
agreeing  on “roadmaps”  in  the  areas  of  applica-
tions.

The  Commissioner’s  two-day  agenda  included 
several sessions to discuss recent EFSA activities 
in  the  fields  of  cloning,  nanotechnology,  GMOs 
and nutrition, as well as a session addressing cur-
rent and future activities in data collection. While 
commending the existing system of partnership 
between the Authority and the Commission, the 
Commissioner  commented  on  “even  closer  co-

operation” between EFSA and other institutions, 
particularly on issues including new technologies 
and GMOs. The Commissioner also identified the 
quality  of  EFSA’s  scientific  advice,  which  under-
pins EU legislation, as being the “cornerstone” of 
the Authority’s success.

In  October,  EFSA  Executive  Director  Catherine 
Geslain-Lanéelle  addressed  the  European  Parlia-
ment’s  Committee  on  the  Environment,  Public 
Health  and  Food  Safety  (ENVI  Committee)  in 
Brussels. The Executive Director emphasised the 
importance  of  consultation  with  the  Parliament 
on EFSA’s activities and priorities.

Working	alongside	other	EU	agencies	

For  EFSA,  another  important  dimension  of  2009 
was the Authority’s role as coordinator of the net-
work of EU agencies. The purpose of this network 
is to provide a forum for discussion and coopera-
tion  between  the  agencies  at  institutional  level. 
It allows agencies to share experiences, develop 
common  best  practices,  organise  joint  training 
and  promote  the  overall  image  and  visibility  of 
EU agencies. 

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I I .   C O M M I T T E D   T O   E N S U R I N G   T H A T   E U R O P E ’ S   F O O D   I S   S A F E

A  working  group  between  EU  institutions  was 
created  to  draw  lessons  from  the  deployment 
of  EU  regulatory  agencies  and  to  consider  how 
agencies can best contribute in the context of the 
renewed  institutional  framework  created  by  the 
Lisbon Treaty. 

In  parallel,  the  European  Commission  began  a 
horizontal  evaluation  of  the  agencies’  system. 
This  was  discussed  within  the  network  and  led 
to reflections upon the future of the agencies, i.e. 
the development of a shared common vision for 
the  agencies  in  terms  of  governance,  effective-
ness, management, and their relationships within 
the EU system. 

For  example,  in  light  of  this  evaluation,  a  com-
munication plan was developed to underline the 
overall role and contribution of agencies to the EU 
system. This led, for instance, to the development 
of  an  interagency  promotional  brochure.  In  ad-
dition, at their October 2009 meeting, the Heads 
of  Agencies  adopted  the  Internal  Audit  Services 
(IAS)  Charter  which  formalises  the  relations  be-

tween  EU  agencies  and  the  IAS  with  respect  to 
internal  audit  activities.  The  Heads  of  Agencies 
also endorsed the IAS Mutual Expectations Paper 
which outlines the working procedures between 
the IAS and EU agencies.    

example 

concrete 

inter-agency 
of 
One 
is  the  EU  Agencies  Heads  of 
cooperation 
Information  Network,  
Communication  and 
in  2009.  One  of 
which  EFSA  also  chaired 
this  network’s  2009  milestones 
included  a 
meeting  with  the  former  EU  Communications 
Commissioner,  Margot  Wallström,  on  the  agen-
cies,  work  in  communications.  In  addition,  the 
Authority  created  and  distributed  a  contact 
list  covering  web  staff  in  all  agencies,  before 
carrying  out  a  benchmark  survey  among  them 
to  determine  common  topics  about  which  they 
need  to  learn.  Based  on  this  information,  EFSA 
then  organised  a  tailored  training  workshop 
for  EU  agencies’  web  staff,  which  also  provided 
networking  opportunities  and  a 
for 
professional  discussions  and  exchanges.  The 
workshop had 57 participants and, according to 
feedback, was a great success. 

forum 

Forging	closer	ties	with	EFSA’s	local	
community

For  EFSA,  one  particular  aspect  of  local  and  re-
gional outreach is communication with the com-
munity  in  which  the  Authority  is  located  and 
where its staff lives. It is important that the public 
in  Parma,  as  well  as  local  and  regional  decision 
makers,  understand  EFSA’s  work.  Consequently, 
each year EFSA tries to improve its local standing 
through  specific  events.  In  2009,  the  Authority 
organised a “Festa dell’Europa” – in collaboration 
with  regional  and  local  authorities  –  to  com-
memorate  Schuman  Day.  The  objective  was  to 
cultivate local understanding of EFSA and to pro-
mote awareness of the election of the European 
Parliament and, more generally, of the European 
project.  

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EFSA’s	ever-growing	output	confirms	the	
Authority’s	accomplishments	in	effectively	
designing	its	management	systems	and	
infrastructures,	in	streamlining	its	processes	
optimally,	in	allocating	its	resources	productively	
and	in	dealing	with	constraints	successfully.

6.	RESPONSIVENESS,	EFFICIENCY	AND	EFFECTIVENESS

As  in  earlier  years,  the  Authority  also  showed  in 
2009 that it can indeed react swiftly in response 
to urgent food safety threats. Learning its lessons 
from such incidents and carrying out crisis simu-
lation  exercises  helps  EFSA  to  remain  prepared 
and alert. EFSA’s effectiveness and efficiency were 
not only  confirmed by its handling of urgent is-
sues but by also its continuous and ever growing 
output. 

manage  a  crisis  successfully.  These  simulations 
were also used to test EFSA’s emergency manual 
that had been updated in early 2009. Overall, the 
simulations were a valuable exercise for Author-
ity staff to learn and test the procedures and in-
frastructure, as well as to feel more comfortable 
when a real situation arises. 

From	theory	to	practice

In	case	of	crisis…	

The crisis simulations in 2009, which comprised of 
two separate exercises, were part of a systemic ap-
proach to be ready and prepared for urgent food 
safety  threats. The  objective  of  the  first  exercise 
was to test EFSA’s internal processes, to hone its 
capacity to provide rapid risk assessment and to 
support the publication of advice with adequate 
communications  measures. The  second  exercise 
tested the Authority’s ability to communicate and 
collaborate  with  the  European  Commission  and 
Member States in an emergency. 

Together  these  two  simulations  covered  all  op-
erations and the full course of action that the Au-
thority has to complete – to be as fast as possible 
while delivering high quality results – in order to 

In addition to simulated crises, EFSA had to deal 
with real life scenarios, in particular the need to 
provide  urgent  scientific  advice  regarding  the 
presence  of  nicotine  in  wild  mushrooms  and  of 
packaging ink in breakfast cereals. 

In February 2009, a laboratory in Germany found 
high  levels  of  4-methylbenzophenone  (a  sub-
stance used in printing inks for food packaging) 
in  breakfast  cereals.  As  a  result  EFSA  received  a 
request for rapid advice from the European Com-
mission.  In  a  first  assessment,  and  building  on 
data from Member States, the Authority conclud-
ed that short-term consumption of contaminated 
breakfast cereals should not pose a risk to most 
people, but that more data would be needed to 
carry out a full risk assessment if the contamina-
tion  of  food  through  4-methylbenzophenone 

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were  to  continue.  Following  this  incident,  EFSA 
continued  to  look  into  this  matter,  and  gave 
further  advice  building  on  the  rapid  response 
provided  earlier.  The  Authority  also  established 
a  working  group  for  non-plastic  food-contact  
materials  and  compiled  a  list  of  contacts  of  ex-
perts for scientific support.   

Also in Germany in 2009, nicotine was detected 
in samples of boletus mushrooms. Again, the Eu-
ropean  Commission  contacted  EFSA  to  request 
an opinion on whether the nicotine represented 
a safety concern. The request was received on 27 
April and the deadline for the statement was set 
ten days later, on 7 May. The Authority concluded 
that the residues found indeed represented a po-
tential  consumer health risk. Based on the EFSA 
statement, the European Commission and Mem-
ber States established guidelines ensuring a high 
level  of  consumer  protection  in  the  EU.  In  par-
ticular, a monitoring programme and temporary 
guideline  values  for  residues  in  fresh  and  dried 
mushrooms were established.  

For  both  these  urgent  cases,  the  Authority  was 
able to turn the advice around quickly and avoid 
the generation of undue public concern. 

Being	efficient	and	effective	

EFSA’s  scientific  workload  also  continued  to 
grow  in  2009,  with  the  number  of  mandates 
for  scientific  advice,  mainly  from  the  European 
Commission, increasing from around 285 in 2008 
to  317  in  2009.  Correspondingly,  the  scientific 
outputs  also  increased  significantly:  a  total  of 
636  in  2009  compared  with  489  in  2008,  an 
increase  of  30 %.  In  particular,  efficiency  gains 
coupled  with  the  increase  in  resources  devoted 
to  the  units  dealing  with  applications  (ANS, 
CEF,  FEEDAP,  GMO,  NDA  and  PRAPeR  Units) 
in  recent  years  have  been  accompanied  by  a 
significant  increase  in  their  productivity,  from 
165  adopted  opinions  in  2008  to  435  in  2009. 
Furthermore,  to  support  panels  and  to  increase 
their  throughput  further,  more  activities  were 
outsourced  through  contracts  and  grants  (see 
also  p.  12,  “Calling  on  the  best  of  Europe”),  and 
the  number  of  external  experts  assisting  the 
panels in working groups increased. In addition, 
the  Authority  continued  to  raise  awareness  of 
EFSA  scientific  work  through  proactive  media 
relations: 34 % of EFSA’s opinions were supported 
by media activities in 2009; through publications 
in all EU languages, 19 events across Europe, and 
continual  improvements  to  the  EFSA  website  to 
further enhance its usability and accessibility.   

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I I I .   L O O K I N G   A H E A D   T O   2 0 1 0

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I I I .   L O O K I N G   A H E A D   T O   2 0 1 0

In 2009, the European Food Safety Authority con-
tinued to be tightly woven into the fabric of the 
EU food safety system and was increasingly visi-
ble internationally. In 2010, EFSA aims to continue 
to build on these achievements by boosting risk 
assessment capacity in Europe, strengthening the 
effectiveness of its communications and consoli-
dating its attractiveness for staff and experts.

In 2010, EFSA will continue to see its workload in-
crease,  particularly  in  the  area  of  authorisations. 
As it continues to streamline its workflows, EFSA 
productivity  will  lead  to  an  anticipated  output 
of  around  900  scientific  outputs.  Boosting  risk 
assessment  capacity  in  Europe  means  sharing 
EFSA’s work programmes with national agencies 
at an early stage to facilitate their medium-term 
planning  and  the  setting  of  priorities  in  tandem 
with the Commission.  

Another  important  project  for  the  Authority  in 
2010 is to continue to build its data collection ac-
tivities across the EU. The aim will be to further im-
prove consistency of data across Member States 
so  that  data  becomes  more  comparable.  An  ex-
ample of this is the “EU Menu” project –  “What’s on 
the Menu in Europe?” – aiming to harmonise data 
collection on food consumption across Europe. 

Putting all this work in perspective, EFSA will re-
lease its first Science Strategy in 2010. 

Strong EFSA cooperation will continue with Mem-
ber  States,  stakeholders  and  other  actors  in  the 
food  chain  to  ensure  that  consumer  protection 
and health policy are supported by the most ro-
bust  scientific  evidence  available  and  that  EFSA 
remains influential in the development of risk as-
sessment methodologies in Europe and beyond. 
To  this  end, EFSA will continue to implement its 
strategic approach to international activities.

With  a  newly-designated  European  Commission 
and  the  European  Parliament,  EFSA  will  forge 
even  stronger  links  with  EU  Institutions.  A  fun-
damental  goal  of  the  Authority  remains  the  re-
inforcement of confidence and trust in EFSA and 
the  EU  food  safety  system  through  effective  risk 
communication and through dialogue with part-
ners and stakeholders. 

EFSA will also review its communications strategy, 
first adopted in 2006, to take account of changes 
in the communications landscape, as well as the 
growth  and  evolution  of  the  organisation.  The 
overall approach aims to continue the close work-
ing relationships with national food safety agen-
cies  and  stakeholder  networks  while  further  im-

proving the simplicity of its communications and 
further  expanding  public  outreach.  The  revised 
communications  strategy  will  be  submitted  for 
public consultation and is expected to be submit-
ted to the Management Board for final validation 
by the end of 2010. 

In 2010, EFSA will also continue to strengthen re-
lations with stakeholders. For this, it will develop a 
rolling work plan that will be constantly updated. 
This plan will provide an overview of all activities 
and events organised for and with its stakeholders. 
Examples include: even more technical meetings 
with stakeholders in 2010; a new working group 
to propose ways to further engage and reinforce 
stakeholders’  involvement  in  EFSA’s  activities,  in 
addition  to  participating  in  public  consultations 
and EFSA’s scientific events; and the formation of 
consultative groups. 

In  conclusion,  EFSA  will  further  build  on  the 
progress  made  in  recent  years  to  address  the 
ever-growing  workload  while  further  engaging 
with partners and stakeholders at national, Euro-
pean and international levels. This will ensure that 
EFSA  continues  to  be  ready  and  able  to  play  its 
part in protecting food safety and public health in 
Europe.  

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A N N E X   I   –   O R G A N I S A T I O N A L   C H A R T

36

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A N N E X   I   -   O R G A N I S A T I O N A L   C H A R T

SCIENTIFIC COMMITTEE 
& 
ADVISORY FORUM
D. Liem

OFFICE OF THE 
EXECUTIVE DIRECTOR &
MANAGEMENT BOARD
G. Gizzi 

MANAGEMENT BOARD

EXECUTIVE DIRECTOR
Catherine Geslain-Lanéelle

STRATEGY & PROSPECTIVE
C. Majewski

INTERNAL AUDIT
D. Caira

QUALITY MANAGEMENT
A. Van Impe

ADMINISTRATION
O. Ramsayer

RISK ASSESSMENT
R. Maijala

SCIENTIFIC COOPERATION & ASSISTANCE
H. Deluyker

COMMUNICATIONS
A.-L. Gassin

ACCOUNTS

P. Pinhal

DATA PROTECTION
C. Reunis

ANIMAL HEALTH & 
WELFARE  
(AHAW)
F. Berthe

FEED ADDITIVES 
(FEEDAP)
C. Roncancio Peña

SCIENTIFIC   
COOPERATION  
(SCO)
B. Berger

ASSESSMENT 
METHODOLOGY  
(AMU)
D. Verloo

PRESS OFFICE

S. Pagani

PUBLIC 
INFORMATION & 
EVENTS (PIE)
C. Buller

FINANCE

F. Monnart

IT & 
OPERATIONS
F. Angelucci

FOOD ADDITIVES & 
NUTRIENT SOURCES 
(ANS)
H. Kenigswald

GENETICALLY 
MODIFIED  
ORGANISMS (GMO)
P. Bergman

EMERGING RISKS 
(EMRISK)
T. Robinson

DATA COLLECTION & 
EXPOSURE  
(DATEX)
S. Fabiansson

WEB

Y. Gamming

HUMAN 
RESOURCES
N. Le Gourierec

LEGAL & 
POLICY AFFAIRS
D. Detken

BIOLOGICAL 
HAZARDS  
(BIOHAZ)
M. Hugas

NUTRITION 
(NDA)
J. Kleiner

PESTICIDES 
(PRAPeR)
H. Fontier

ZOONOSES 
(Data Collection)
P. Makela

FOOD CONTACT
MATERIALS,  
ENZYMES,  
FLAVOURINGS (CEF)
A. Feigenbaum

PLANT HEALTH 
(PLH)
E. Ceglarska

CONTAMINANTS
(CONTAM)
C. Heppner

PLANT PROTECTION 
PRODUCTS  
(PPR)
M. Dunier-Thomann

Directorate
Unit
Section

A N N U A L   R E P O R T   2 0 0 9

37

 
A N N E X   I I   -   G L O S S A R Y

38

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

A N N E X   I I   -   G L O S S A R Y

ADI Acceptable Daily Intake
AFC (Former) Panel/Unit on food additives, flavourings, processing aids and materials in 

contact with foods

AFCWG		 Advisory Forum Communications Working Group

AHAW Panel/Unit on animal health and welfare

AMR Antimicrobial resistance
AMU Assessment Methodology Unit
ANS Panel/Unit on food additives and nutrient sources added to food
ARfD Acute reference dose

BIOHAZ Panel/Unit on biological hazards

BMD Benchmark dose 
BPA Bisphenol A
BSE	 Bovine Spongiform Encephalopathy
CEF Panel/Unit on food contact materials, enzymes, flavourings and processing aids

CIBUS International food fair in Parma

CONTAM Panel/Unit on contaminants in the food chain

DATEX Data Collection and Exposure (Unit)

DG Directorate General (European Commission)

DG	SANCO Health and Consumers DG, Directorate-General for Health and Consumers

DRV(s) Dietary Reference Value(s)
EC European Commission

ECDC European Centre for Disease Prevention and Control
ECHA European Chemicals Agency
EFSA European Food Safety Authority
EMA European Medicines Agency

EMRISK Emerging Risks (Unit)

ENVI

European Parliament Committee on the Environment, Public Health and Food Safety  

EP European Parliament

ESCO EFSA Scientific Cooperation

EU European Union

FAO United Nations Food and Agriculture Organisation

FEEDAP Panel/Unit on additives and products or substances used in animal feed
FSANZ Food Standards Australia New Zealand

GM Genetically modified

GMO(s) Genetically modified organism(s)

HC Health Canada
IAS Internal Audit Services (European Commission)

INEX	 EFSA internal and external review system 
JRC Joint Research Centre
MRL(s) Maximum residue level(s)
MRSA Methicillin-Resistant Staphylococcus aureus
NZFSA New Zealand Food Safety Authority 

NDA Scientific Panel/Unit on dietetic products, nutrition and allergies
OIE World Organisation for Animal Health
PLH Panel/Unit on plant health
PPR Panel/Unit on plant protection products and their residues
PRA Pest Risk Analysis

PRAPeR Pesticide Risk Assessment Peer Review Unit

RA Risk Assessment Directorate

RASFF Rapid Alert System for Food and Feed (European Union)

SC Scientific Committee

SCA Scientific Cooperation and Assistance Directorate

SCENIHR				 Scientific  Committee  on  Emerging  and  Newly  Identified  Health  Risks  (European 

Commission) 

SCO Scientific Cooperation Unit
TDI
Tolerable Daily Intake
TSE Transmissible Spongiform Encephalopathy
UK United Kingdom
US United States

WHO World Health Organisation

A N N U A L   R E P O R T   2 0 0 9

39

ANNEX III -  EFSA’S OPINIONS AND SCIENTIFIC DOCUMENTS 2009

40

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Overview of  EFSA’s scientific outputs 2009:

Panel	/	Unit

Application	
Opinions		
of	the	Scientific		
Committee	/	Panels	

Generic	Opinions		
of	the	Scientific		
Committee	/	Panels

Statements		
of	the	Scientific		
Committee	/	Panels

Guidance	of	the	
Scientific		
Committee	/	Panels

Statements	
of	EFSA

Guidance	
of	EFSA

Conclusions	
on	Pesticides	
Peer	Review

Reasoned	
Opinions

Scientific	or	
Technical	
Reports	
of	EFSA

External	
reports*

Scientific Committee (SC)

Animal health and welfare (AHAW)

Food additives and nutrient sources (ANS)

Biological hazards (BIOHAZ)

Food contact materials, 
enzymes, flavourings (CEF)

Contaminants (CONTAM)

Feed additives (FEEDAP)

Genetically modified organisms (GMO)

Nutrition (NDA)

Plant health (PLH)

Plant protection products (PPR)

Assessment Methodology (AMU)

Data Collection and Exposure (DATEX)

Emerging Risks (EMRISK)

Pesticides (PRAPeR)

Scientific Cooperation (SCO)

Zoonoses – Data Collection (Zoonoses)

-

-

33

-

78

-

36

17

165 

-

4

-

-

-

-

-

-

2

15

2

16

3

12

3

9

9

2

8

-

-

-

-

-

-

-

1

37

2

-

2

-

1

-

1

-

-

-

-

-

-

-

Total

331

81

44

3

1

1

-

2

-

1

-

-

1

-

-

-

-

-

-

-

9

1

-

-

2

1

1

-

1

1

-

-

-

-

-

1

-

-

8

-

-

-

-

-

-

1

-

2

-

1

-

1

-

-

-

5

-

-

-

-

-

-

-

-

-

-

-

-

-

-

28

-

-

28

-

-

-

-

-

-

-

-

-

-

-

-

-

-

76

-

-

76

7

2

-

-

2

-

-

16

-

-

5

1

4

2

1

-

14

54

-

7

-

-

-

2

1

-

-

10

1

2

2

1

-

2

5

33

Total	scientific	outputs	of	EFSA

*Reports produced for EFSA by external parties under specific EFSA procedures

636

A N N U A L   R E P O R T   2 0 0 9

41

Scientific Committee

The	 main	 task	 of	 the	 Scientific	 Committee	 is	 the	 preparation	 of	 scientific	 advice	 in	 the	 area	 of	 new	 and	 harmonised	 approaches	 for	 risk	
assessment	of	food	and	feed.	It	also	provides	strategic	advice	to	EFSA’s	Executive	Director.	

Scientific	outputs	2009

Quantity

Generic Opinions of the Scientific Committee

Guidance of the Scientific Committee

Statements of EFSA

Scientific or Technical Reports of EFSA

2

3

1

7

Further advice on the implications of animal cloning 
were sought from the Scientific Committee, in par-
ticular to provide further details on the recommen-
dations  included  in  the  animal  cloning  opinion  
published  in  2008.  An  EFSA  statement  was  pub-
lished  in  June  2009.  The  Scientific  Committee  was 
also requested to prepare a guidance document for 
the safety assessment of applications involving the 
application  of  nanoscience  and  nanotechno logies 
to  food  and  feed.  Work  was  started  on  providing 
practical  recommendations  for  the  risk  assessment 
of food-related applications of nanotechnologies to 
the  extent  possible  with  current  knowledge.  The 
guidance will be finalised by summer 2010. Antimi-

crobial resistance approaches, a cross-cutting activi-
ty  for  EFSA,  were  addressed  by  both  the  GMO  and 
BIOHAZ Panels with the support of the Chair of the 
Scientific  Committee  who  chaired  a  joint  working 
group on this topic. The Scientific Committee adopt-
ed a document focusing on transparency in the sci-
entific  outputs  produced  by  EFSA.  This  document 
deals  with  general  principles  to  be  applied  in  the 
identification of data sources, criteria for inclusion/
exclusion  of  data,  confidentia lity  of  data,  assump-
tions and uncertainties. 

The  Scientific  Committee  and  its  working  groups 
contributed  to  the  development,  promotion  and 
application of new and harmonised approaches and 
methodologies  for  risk  assessment  in  the  area  of 
food  and  feed  safety.  In  particular,  the  guidance 
document  on  transparency  in  risk  assessment  was 
finalised after public consultation. Another guidance 
document on the use of benchmark dose approach 
(BMD) in risk assessment was finalised; a workshop 
will be organised in 2010 to build EFSA’s expertise in 
this  area  and  to  ensure  the  implementation  of  a 

harmonised approach across panels. The opinion on 
the  existing  approaches 
for  the  replacement, 
reduction and refinement of animal testing in food 
and  feed  risk  assessment  was  also  published.  The 
guidance on the safety assessment of botanicals and 
botanical  preparations  was  finalised,  taking  into 
consideration  the  recommendations  made  by  an 
ESCO  (EFSA  Scientific  Cooperation)  working  group 
on  selected  cases.  A  workshop  was  organised  in 
November 2009 to present the work done by EFSA 
to stakeholders and Member States, and to discuss 
the  possible  way  forward  on  this  issue.  Work  is  in 
progress on the wider applicability of the threshold 
of  toxicological  concern  concept  in  EFSA’s  risk 
assessment. The opinion on risk-benefit assessment 
of  foods  will  be  finalised  in  2010  after  public 
consultation. A new working group was established 
to provide a commentary and recommendations on 
genotoxicity testing strategies in the field of EFSA’s 
activities. 

42

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For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Animal health and welfare

The	Panel	on	Animal	health	and	welfare	(AHAW	Panel)	provides	independent	scientific	advice	on	all	aspects	of	animal	diseases	and	animal	welfare.		
Its	work	chiefly	concerns	food	producing	animals,	including	fish.

Scientific	outputs	2009

Quantity

Generic Opinions 

Statements of the AHAW Panel 

Guidance of the AHAW Panel

Scientific or Technical Reports of EFSA

External reports*

15

1

1

2

7

*Reports produced for EFSA by external parties under specific EFSA procedures

The AHAW Panel adopted 13 scientific opinions on 
animal  welfare  issues  covering  the  welfare  of  dairy 
cows,  stunning  and  killing  of  fish  species,  general 
approaches to fish welfare and the concept of sen-
tience  in  fish.  In  addition,  a  statement  on  research 
needs  for  the  welfare  of  farmed  fish  was  adopted. 
Scientific opinions on Brucella suis in swine and epiz-
ootic hemorrhagic disease were adopted. An inter-
nal scientific report on the new pandemic influenza 
(H1N1)  was  completed  as  a  first  preparedness  re-
sponse in collaboration with several other units. Un-
der  Article  36,  external  reports  on  tuberculosis  in 

wildlife in the EU, Crimean Congo haemorrhagic fe-
ver,  epizootic  haemorrhagic  disease,  viral  haemor-
rhagic  septicaemia  virus,  Bonamia  spp.  and  animal 
welfare  risk  assessment  guidelines  in  relation  to 
transport  were  finalised.  Two  Article  36  calls  were 
launched on animal welfare risk assessment guide-
lines (husbandry and management) and the impact 
on animal health and welfare of genetic selection in 
livestock  species,  respectively.  A  technical  meeting 
on  genetic  selection  in  broiler  breeding  was  held 
with  stakeholders  (NGOs,  industry,  farmer  associa-
tions  and  Member  State  experts)  to  discuss  data 
sources  and  availability  and  risk  assessment  ap-
proaches  to  support  the  mandate  on  health  and 
welfare aspects of genetic selection in broilers. In ad-
dition,  a  public  call  for  data  was  launched  for  this 
mandate. 

A guidance document on good practice in conduct-
ing  scientific  assessment  in  animal  health  using 
modelling  was  adopted.  A  special  Advisory  Forum 
meeting  on  animal  health  and  welfare  was  held  in 
May  to  discuss  topics  of  common  interest  and  it  is 

proposed to repeat this exercise to promote closer 
collaboration between Member States and EFSA. A 
technical report presenting the outcome of a survey 
undertaken by the AHAW Unit on the organisation, 
approach  and  procedures  applied  in  risk  assess-
ments  on  animal  health  and  welfare  in  Member 
States was published. Work on the development of 
risk  assessment  methodologies  will  continue,  in-
cluding  an  Article  36  project  on  commodity-based 
import risk assessments.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

43

Food additives and nutrient sources added to food 

The	Panel	on	food	additives	and	nutrient	sources	added	to	food	(ANS	Panel)	deals	with	questions	of	safety	in	the	use	of	food	additives,	nutrient	
sources	and	other	substances	deliberately	added	to	food	(for	flavourings	and	enzymes,	see	p.	46).	

Scientific	outputs	2009

Quantity

Application Opinions of the ANS Panel

Generic Opinions  of the ANS Panel

Statements of the ANS Panel

Guidance of the ANS Panel

33

2

37

1

A total of 72 scientific opinions and statements were 
adopted  by  the  ANS  Panel  corresponding  to  157  
application  dossiers.  To  finalise  the  evaluation  of  
nutrient sources, 23 scientific opinions and 36 scien-
tific  statements  corresponding  to  144  application 
dossiers were adopted. The risk assessment of other 
food additives (e.g. evaluation of new food additives 
and  re-evaluation  of  food  colours)  continued  and 
the Panel adopted 12 scientific opinions (ten appli-
cation opinions and two generic opinions) and one 
statement in this area. Two contracts issued in 2008 
for the preparation of pre-evaluation documents for 
the evaluation of nutrient sources for food supple-
ments  were  finalised  in  May  2009.  Four  new  con-

tracts  were  signed  to  support  ongoing  and  future 
mandates on food additive re-evaluation. A meeting 
was held with the Joint FAO/WHO Expert Committee 
on Food Additives (JECFA) secretariat to discuss co-
operation. 

Three public calls for data were published in order to 
collect data for the re-evaluation of various food ad-
ditives  belonging  to  the  functional  classes  of  pre-
servatives,  antioxidants,  emulsifiers,  stabilisers,  gel-
ling agents and waxes.

The ANS Panel adopted a statement on data require-
ments for food additive applications with the aim of 
providing a basis for the future preparation of guid-

ance on food additive applications. A procurement 
contract to obtain comments on the existing guid-
ance for food additive applications and proposals for 
further  development  of  an  updated  guidance  was 
finalised in May. Stakeholders were also consulted in 
writing on the existing guidance. New guidance for 
food additive applications is planned.

For	further	details	please	refer	to	the	attached	CD-ROM.

44
44

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A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Biological hazards including TSEs

EFSA’s	 Panel	 on	 biological	 hazards	 (BIOHAZ	 Panel)	 deals	 with	 biological	 hazards	 related	 to	 food	 safety,	 foodborne	 diseases,	 transmissible	
spongiform	encephalopathies	(TSEs),	food	microbiology,	food	hygiene	and	associated	waste	management	issues.	

Scientific	outputs	2009

Quantity

Application Opinions of the BIOHAZ Panel

Generic Opinions  of the BIOHAZ Panel

Statements of the BIOHAZ Panel

Statements of EFSA

2

16

2

2

The BIOHAZ Panel adopted a total of 24 scientific 
opinions  and  reports  in  2009.  A  joint  opinion  on 
AMR  was  issued  in  collaboration  with  EMA,  ECDC 
and  SCENIHR  and  a  joint  scientific  report  on 
meticillin-resistant  Staphylococcus  aureus  (MRSA) 
in  collaboration  with  ECDC  and  EMA.  In  addition, 
BIOHAZ  adopted  an  opinion  on  MRSA  in  animals 
and  food  and  with  the  GMO  Panel  issued  a  joint 
opinion on the use of AMR genes as markers in GM 
plants. Other opinions covered: the use of bacteri-
ophages in food production; food safety aspects of 
dairy  cow  welfare;  Campylobacter;  BSE  resistance 
in  goats;  BSE  in  bovine  intestinal  casings;  risk  to 
human and animal health related to the revision of 

the  BSE  monitoring  regime  in  some  Member 
States; and three opinions on animal by-products 
(ABP).  The  first  EU-wide 
full  quantitative 
microbiological  risk  assessment  (QMRA)  model  of 
Salmonella  in  pigs,  funded  by  Article  36,  was 
concluded in 2009. 

A workshop was held with experts and stakeholders 
and the BIOHAZ Panel will deliver its opinion based 
on  the  report  in  2010.  Stakeholder  meetings  were 
also  held  with  the  European  Livestock  and  Meat 
Trading  Union  (UECBV)  and  the  European  Fat 
Processors  and  Renderers  Association  (EFPRA). The 
outsourced project on the fate of Salmonella spp. on 
broiler carcasses was completed. 

Meetings  of  the  Microbiological  Risk  Assessment 
and  the  BSE-TSE  networks  were  held  in  June  and 
October  2009,  respectively.  The  opinion  on  the 
maintenance of the list of Qualified Presumption of 
Safety (QPS) microorganisms was adopted.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

45

 Food contact materials, enzymes, flavourings and processing aids

The	Panel	on	food	contact	materials,	enzymes,	flavourings	and	processing	aids	(CEF	Panel)	deals	with	questions	on	the	safety	of	use	of	materials	
in	contact	with	food,	enzymes,	flavourings	and	processing	aids,	and	also	with	questions	related	to	the	safety	of	processes.	

Scientific	outputs	2009

Quantity

Application Opinions of the CEF Panel

Generic Opinions  of the CEF Panel

Guidance of the CEF Panel

Statements of EFSA

Scientific or Technical Reports of EFSA

78

3

2

1

2

A total of 78 opinions were adopted by the CEF Pan-
el  of  which  38  covered  300  flavouring  substances 
and  29  covered  substances  used  to  manufacture 
materials  in  contact  with  foodstuffs.  A  total  of  11 
opinions  on  smoke  flavourings  were  adopted.  Ur-
gent advice was given in the form of an EFSA state-
ment on possible risks associated with 4-benzophe-
none  and  hydroxybenzophenone  originating  from 
food  contact  materials.  A  total  of  eight  meetings 
with stakeholders (industry, consumer organisations 
and the Commission) were organised. The ongoing 
evaluation  of  2600  flavouring  substances  on  the 

market  was  supported  by  two  contracts  and  two 
new contracts were assigned for preparatory work in 
the area of food contact materials.

The CEF Panel adopted guidelines for the evaluation 
of active and intelligent packaging and the evalua-
tion of food enzymes. Public consultations were held 
for  three  guidance  documents  on  enzymes,  active 
and  intelligent  packaging,  and  flavourings.  Eight 
meetings  with  industry  were  organised  to  discuss 
and clarify the requirements laid down in the guid-
ance document for the evaluation of enzymes. In ad-

dition, opinions on the clarification of the margin of 
safety applied for smoke flavouring evaluations and 
dietary  exposure  assessment  of  smoke  flavourings 
were adopted. A safety assessment of the extraction 
solvent dimethylether was completed.

For	further	details	please	refer	to	the	attached	CD-ROM.

46

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A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Contaminants in the food chain

The	Panel	on	contaminants	in	the	food	chain	(CONTAM	Panel)	is	responsible	for	questions	on	contaminants	in	the	food	and	feed	chain,	and	
undesirable	substances	such	as	natural	toxicants,	mycotoxins	and	residues	of	unauthorised	substances	not	covered	by	other	panels.	

Scientific	outputs	2009

Quantity

Generic Opinions of the CONTAM Panel

Statements of the CONTAM Panel

Statements of EFSA

External reports*

12

2

1

2

*Reports produced for EFSA by external parties under specific EFSA procedures

The  CONTAM  Panel  adopted  14  scientific  outputs 
(12  opinions  and  two  statements). Three  opinions 
covered  the  impact  of  metals  such  as  cadmium,  
arsenic and uranium. In addition, five opinions on 
regulated shellfish toxins were finalised. The Panel 
issued  a  statement  addressing  the  influence  of 
processing  on  shellfish  toxins  and  a  statement  on 
the  public  health  effects  of  aflatoxins  in  tree  nuts 
other than almonds, hazelnuts and pistachios. The 
evaluation of risks to animal health of natural plant 
toxicants present in animal feed was finalised (two 
opinions).  Following  a  request  from  the  Commis-

sion, the CONTAM Panel evaluated the criteria and 
safety  of  substances  that  are  transported  as  car-
goes in ship containers that are then used to ship 
edible fats and oils into the EU (two opinions). 

In  addition,  the  CONTAM  Panel  in  collaboration  
with  the  DATEX  and  PRAPeR  Units  provided  fast 
track  advice  on  nicotine  in  wild  mushrooms  which 
implement  timely 
enabled  the  Commission  to 
measures  to  safeguard  public  health.  A  database  
on  veterinary  medicinal  products  used  in  third 
countries  was  successfully  developed  within  the 

framework  of  an  Article  36  project;  the  database 
facilitates  a  proactive  approach  to  preparation  for 
future requests on residue limits of pharmacologi-
cally active substances in foodstuffs of animal origin. 
A background document summarising information 
related to the analysis, occurrence, and toxicology of 
eight  mycotoxins  and  natural  plant  products  was 
prepared via an Article 36 project to facilitate future 
risk assessments.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

47

 Additives and products or substances used in animal feed

EFSA’s	Panel	on	additives	and	products	or	substances	used	in	animal	feed	(FEEDAP	Panel)	provides	independent	scientific	advice	on	the	safety	
and/or	efficacy	of	additives	and	products	or	substances	used	in	animal	feed.	

Scientific	outputs	2009

Quantity

Application Opinions of the FEEDAP Panel

Generic Opinions of the FEEDAP Panel

Guidance of the FEEDAP Panel

Guidance of EFSA

External reports*

36

3

1

1

1

*Reports produced for EFSA by external parties under specific EFSA procedures

A  total  of  36  opinions  in  the  framework  of  Regu-
lation  (EC)  No  1831/2003  were  adopted  by  the 
FEEDAP  Panel, 
including  22  opinions  for  new  
products or extension of use of authorised products, 
one  for  a  re-evaluation,  three  combining  a  new  use 
and  re-evaluation,  two  for  a  modification  of  the  
terms  of  authorisation  of  an  authorised  product,  
one  for  an  urgent  authorisation  and  seven  requests 
for  the  evaluation  of  supplementary  information 
submitted  by  the  applicants  after 
inconclusive 
opinions.  Other  adoptions  included:  part  III  of  the 
opinion on carotenoids relating to yellow carotenoids; 

an  opinion  on  ractopamine;  and  an  opinion  on  the 
use  of  cobalt  compounds  as  additives  in  animal 
nutrition.  Nine  technical  hearings  were  held  with 
industry  associations/applicants  to  discuss  issues 
related to applications. In order to prepare the work 
for the re-evaluation of all existing feed additives in 
accordance  with  Article  10  of  Regula tion  (EC)  No 
1831/2003,  five  meetings  were  organised  with 
Member States, the Commission and the Community 
Reference  Laboratory.  In  addition,  administrative 
guidance  for  applicants  for  the  presentation  of 
applications  for  authorisation  of  feed  additives  was 
updated  in  2009.  With  the  aim  of  improving  the 
management, distribution, archiving and assessment 
of  data  included  in  applications,  a  procurement 
procedure  was  initiated  in  collaboration  with  EFSA’s 
“IT & Operations” (ITOP) Unit for the review of systems 
for the electronic submission of dossiers. An Article 36 
grant was awarded for the preparation of a series of 
monographs  on  the  biological  role,  content  in  feed 
and requirements in animal nutrition of 27 trace and 
ultra-trace elements.

The  FEEDAP  Panel  finalised  the  technical  guidance 
document  for  sensory  additives,  which  completes  a 
set  of  guidance  documents  for  applicants  in  the 
preparation  and  presentation  of  applications.  The 
external report of an Article 36 project on mycotoxin-
detoxifying  agents  used  as  feed  additives  was 
received and will be used by the FEEDAP Panel in the 
preparation of the guidance document. An Article 36 
grant was awarded for the preparation of a report to 
collect and synthesise scientific data and information 
on  the  potential  of  microorganisms  and  enzymes 
used 
induce  respiratory 
sensitisation.  The  final  report  on  a  procurement 
project for the pre-assessment of the environmental 
impact of zinc and copper used in animal nutrition is 
expected in January 2010.

in  food  and  feed  to 

48

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Genetically modified organisms

The	Panel	on	genetically	modified	organisms	(GMO	Panel)	conducts	risk	assessments	of	GM	food	and	feed	applications,	provides	scientific	
advice	in	response	to	ad-hoc	requests	from	risk	managers,	and	identifies	scientific	issues	which	require	further	attention.

Scientific	outputs	2009

Quantity

Application Opinions of the GMO Panel

Generic Opinions of the GMO Panel

Statements of the GMO Panel

Statements of EFSA

Scientific or Technical Reports of EFSA

17

9

1

1

16

The  GMO  Panel  adopted  17  scientific  opinions 
covering 21 application dossiers. EFSA published 12 
technical reports connected to application dossiers 
(“overall opinions”), which in addition to the scientific 
opinion also contain Member State comments and 
other  documents  stipulated  in  the  regulation.  A 
total of 14 of the scientific opinions adopted covered 
applications  for  placing  GM  plants  on  the  market 
under  Regulation  (EC)  No  1829/2003,  while  three 
were  co-adoptions  with  the  FEEDAP  Panel  (under 
Regulation  (EC)  No  1831/2003).  A  total  of  eight 
generic opinions were adopted, three in relation to 
the evaluation of information submitted in support 

of  Safeguard  Clauses  invoked  by  Member  States 
(Article 23 of Directive 2001/18/EC), two in relation 
to a request from the European Commission on the 
safety  assessment  of  antibiotic  resistance  marker 
genes,  and  three  on  requests  for  scientific  advice 
related to previously adopted application opinions. 

In 2009, EFSA organised four meetings with Member 
State  experts,  three  with  applicants  and  one  with 
NGOs to discuss applications.

The GMO Panel adopted draft scientific opinions on 
guidance for the statistical analysis of data generat-
ed for comparative food safety evaluation and guid-
ance  on  the  risk  assessment  of  GM  plants  for  non-
food  or  non-feed  purposes.  Both  were  subject  to 
public consultation, comments from which were in-
corporated in the adopted versions. The GMO Panel 
adopted  one  draft  guidance  document  for  appli-
cants concerning the allergenicity of GM plants and 
GM  microorganisms;  a  public  consultation  was 
launched in December 2009 and adoption of the fi-
nal document is scheduled for 2010. In the process 

of  developing  guidance,  meetings  were  held  with 
Member  State  experts  (2),  applicants  (1)  and  third 
parties (2). In addition, a conference on the risk as-
sessment of GMOs for human and animal health and 
the  environment  was  held  in  September  2009  in 
Brussels bringing together 150 key actors from Eu-
rope and beyond. In order to support the work of the 
GMO  Panel  in  developing  guidance  for  the  risk  as-
sessment of GM animals, three outsourcing projects 
were signed.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

49

Dietetic products, nutrition and allergies 

The	NDA	Panel	deals	with	questions	related	to	human	nutrition,	dietetic	products	and	food	allergies.	It	also	advises	on	associated	subjects	such	
as	novel	foods,	dietary	recommendations	for	nutrients	and	energy,	and	the	EU’s	regulation	on	Nutrition	and	Health	Claims.	

Scientific	outputs	2009

Quantity

Application Opinions of the NDA Panel

Generic Opinions of the NDA Panel

Statements of EFSA

Guidance of EFSA

165

9

1

2

In 2009, the NDA Panel adopted 174 opinions, most 
(125  opinions)  relating  to  Article  13(1)  functional 
claims  covering  937  claims.  On  children  and  risk 
reduction claims, 24 opinions were adopted and ten 
opinions  were  adopted  on  claims  based  on  newly 
developed  science  and/or  proprietary  data.  In  the 
context  of  the  procedure  for  the  authorisation  of 
health  claims,  the  NDA  Panel  also  adopted  two 
opinions  on  the  conditions  for  the  use  of  health 
claims  on  essential  fatty  acids  and  on  plant  sterols 
and stanols. In the area of the safety assessment of 
novel  foods,  the  NDA  Panel  adopted  five  opinions 
corresponding  to  five  applications.  In  addition,  the 
Panel adopted opinions on the appropriate age for 

in 
introduction  of  complementary  feeding 
the 
infants  and  the  possible  exemption  from  labelling 
for beta-amylase from barley. In relation to Dietary 
Reference  Values,  the  NDA  Panel  launched  public 
consultations  on  its  draft  opinions  on  fats  and 
carbohydrates  and  organised  an  expert  meeting 
with Member States to discuss these opinions along 
with  draft  opinions  on  food-based  dietary  guide-
lines,  general  principles  of  deriving  and  applying 
Dietary  Reference  Values  and  Dietary  Reference 
Values 
these 
for  water.  Revised  versions  of 
documents  incorporating  the  feedback  received 
were adopted. Advice on labelling reference intake 
values  for  selected  nutritional  elements  was  also 
adopted.  In  light  of  the  experience  gained  from  
the  health  claim  applications,  EFSA  provided 
additional  advice  to  applicants  in  the  form  of  a 
frequently  asked  questions  document  (FAQ).  The 
draft  FAQ  was  subject  to  public  consultation  and 
discussed  at  a  meeting  with  applicants  before 
finalisation as a technical report of EFSA. Comments 
received  from  both  the  public  consultation  and 

meeting  were  published  along  with  a  summary  of 
how comments had been taken into consideration. 
EFSA also held a meeting with Member States and 
the Commission to update them on the evaluation 
of Article 13(1) health claims and, to this end, a draft 
briefing  document  was  prepared  which  was  up-
dated  and  published  after  the  meeting  as  a  
technical report of EFSA. A project on the characteri-
sation  of  probiotics  in  the  framework  of  health 
claims evaluation was outsourced. 

In  the  light  of  the  upcoming  revision  of  the  novel 
foods  regulation,  a  Scientific  Colloquium  was 
organised  to  receive  early  input  from  stakeholders 
for  the  preparation  of  revised  scientific  and  
technical  guidance  for  applicants  for  the  prepara-
tion of novel food applications.

50

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Plant health

The	 EFSA	 Panel	 on	 plant	 health	 (PLH	 Panel)	 provides	 scientific	 advice	 on	 risks	 posed	 by	 pests	 which	 can	 harm	 plants,	 plant	 products	 or	
biodiversity	in	the	EU.		

Scientific	outputs	2009

Quantity

Generic Opinions of the PLH Panel

Statements of the PLH Panel

Guidance of the PLH Panel

External reports*

2

1

1

10

*Reports produced for EFSA by external parties under specific EFSA procedures

The PLH Panel adopted four outputs in 2009, includ-
ing opinions on the reliability and the effectiveness 
of  a  proposed  method  to  treat  wood  shavings  in-
fested by the pinewood nematode Bursaphelenchus 
xylophilus  and  an  evaluation  of  a  pest  risk  analysis 
(PRA) made by the United Kingdom on the oak pro-
cessionary  moth,  Thaumetopoea  processionea.  The 
Panel also produced a statement as an urgent reply 
on a proposal for cold treatment of strawberry plants 
to eliminate Bemisia tabaci from consignments to be 
shipped  to  the  EU  from  the  USA.  Guidance  on  the 
evaluation of pest risk assessments for phytosanitary 
measures made by third parties was also issued.

The  PLH  Panel  adopted  a  guidance  document  for 
evaluating PRAs made by third parties to justify phy-
tosanitary  measures  under  Council  Directive 
2000/29/EC. The second Special Advisory Forum on 
Plant Health meeting took place in October and the 
agenda included data requirements, emerging risks 
and pest surveillance. Collaboration with the JRC on 
modelling  used  for  predicting  establishment  and 
spread of harmful organisms resulted in the launch 
of ClimPest, a framework for modelling pest climatic 
suitability. An Article 36 project on an inventory of 
data sources for PRAs (PRASSIS) was completed and 
an Article 36 call for a comparative approach to case 

studies  for  PRAs  was  signed.  A  renewed  collabora-
tive project with Agricast and JRC (Ispra) was agreed 
and signed at the end of 2009. The guidance docu-
ment  on  a  harmonised  framework  for  the  assess-
ment  of  risks  of  organisms  harmful  to  plants  and 
plant products was endorsed by the panel and the 
comments received from public consultation incor-
porated into the document for adoption and publi-
cation in 2010.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

51

Plant protection products and their residues 

The	PPR	Panel	provides	independent	scientific	advice	on	the	risk	assessment	of	plant	protection	products	(commonly	known	as	pesticides)	
and	their	residues,	looking	at	risks	for	the	user/worker,	the	consumer	and	the	environment.	

Scientific	outputs	2009

Quantity

Generic Opinions of the PPR Panel

Guidance of EFSA

Scientific or Technical Reports of EFSA

External reports*

8

1

5

1

*Reports produced for EFSA by external parties under specific EFSA procedures

The PPR Panel adopted one opinion on cumulative 
exposure  assessment  of  triazole  fungicides  and  six 
opinions on the update of the Annexes II and III of 
Directive  91/414  EEC.  Opinions  on  protection  goal 
options and on the development of eco-regions are 
scheduled to be published in first half of 2010.

The  PPR  Panel  adopted  an  opinion  on  the  assess-
ment  of  exposure  in  soil  –  this  is  related  to  the 
guidance document on persistence of pesticides in 
is  under  development.  The  guidance 
soil  that 
document  on  risk  assessment 
for  birds  and  
mammals  was  published  in  December  by  a  joint 

working  group, 
State 
representatives,  the  European  Commission  and 
EFSA. 

comprising  Member 

Reports  produced  via  Article  36  grants  were  used  
in  the  preparatory  work  for  the  production  of 
guidance  documents  on  emissions  from  protected 
crop  systems  (e.g.  greenhouses)  scheduled  for 
adoption  in  2010,  exposure  of  workers,  operators, 
bystanders and residents and for an opinion on the 
establishment  of  common  assessment  groups  of 
active  substances  for  cumulative  risk  assessment 
and the evaluation of the toxicological relevance of 
pesticide metabolites.

An outsourcing contract was signed for preparatory 
work for guidance on dermal absorption. Guidance 
documents  for  the  evaluation  principles  of  the 
toxicological  burden  of  metabolites,  degradation 
food 
and  reaction  products  of  pesticides 
commodities  and  on  persistence  in  soil  (to  be 
published in the first half of 2010) were completed 
via contracts with JRC. Two stakeholder workshops 

in 

on  the “fate”  of  pesticides  were  orga nized  by  the 
PPR  unit  in  May  in  JRC  (Ispra)  and  in  November  in 
Parma, with 70 and 60 participants, respectively. In 
2010, work on updating the two existing guidance 
(terrestrial  and 
documents  on  ecotoxicology 
aquatic) will continue.

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E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Assessment methodology 

The	Assessment	Methodology	Unit	(AMU)	provides	technical	support	in	the	field	of	statistics,	modelling,	data	management	and	risk	assessment.	
It	contributes	in	particular	to	the	development	and	application	of	new	or	refined	risk	assessment	approaches	in	the	field	of	food	and	feed	
safety.

Scientific	outputs	2009

Quantity

Scientific or Technical Reports of EFSA

External reports*

1

2

*Reports produced for EFSA by external parties under specific EFSA procedures

The AMU Unit provided scientific support for opin-
ions of the CONTAM, PLH, AHAW, BIOHAZ and GMO 
Panels and the Scientific Committee. This included: 
data  management  support  for  BIOHAZ  opinions; 
epidemiological and statistical analysis for BIOHAZ, 
CONTAM and PLH; and systematic literature reviews 
with meta-analyses. An example of the latter was the 
technical  report  “Meta-analysis  of  Dose-Effect  Rela-
tionship of Cadmium for Benchmark Dose Evaluation” 
which was integrated into the CONTAM opinion on 
cadmium. 

In  December,  AMU  Unit,  supported  by  a  working 
group of external experts, issued a guidance docu-
ment on the application of systematic review meth-
odology to food and feed safety assessments. It will 

be  tested  during  a  workshop  for  EFSA  experts  and 
staff in February 2010. Since 2003, there have been 
reports in Europe and the USA of serious mortality of 
bees in beehives. In 2006 the term Colony Collapse 
Disorder  (CCD)  was  first  used  to  describe  this  phe-
nomenon  which  is  characterised  by  the  rapid  loss 
from a colony of its adult bee population. While the 
cause of CCD has not been determined, several aeti-
ologies have been proposed. To investigate further 
possible  risk  factors,  AMU  launched  a  call  for  a 
project open to competent organisations under Ar-
ticle  36  of  Regulation  (EC)  No  178/2002.  The  out-
come  of  this  project  was  published  in  December 
2009.

the 

spread, 

establishment 

AMU also published a report on quantitative models 
describing 
or 
development  of  plant  pests  on  crops  in  Europe 
including  geographical  and  climatic  data  and/ 
or  plant  phenology  as  input  factors. The  output  of 
this  project,  which  was  supported  by  an  Article  36 
grant,  also  includes  a  structured,  electronic  inven-

tory  of  selected  and  analysed  models  which  will  
be  valuable 
future  plant  pest  predictive 
modelling work. 

for 

While foods rich in isoflavones are considered to be 
part of a healthy diet, questions remain with regard 
to their impact on health, reduction of disease risk 
and  improvement  of  quality  of  life.  Following  con-
sultation with the Advisory Forum, it was determined 
that this topic is of interest to several Member States. 
Consequently,  AMU  was  requested  to  establish  an 
ESCO  working  group  that  will  deliver  a  report  in 
2010 providing a literature overview of the potential 
hazards  and  health  benefits  associated  with  isofla-
vone  consumption.  AMU  also  provided  epidemio-
logical  and  modelling  support  to  the  DATEX  Unit 
(β-casomorphin-7) and to the Zoonoses Unit base-
line studies as well as data management support for 
the Annual Report on Pesticide Residues.

For	further	details	please	refer	to	the	attached	CD-ROM.

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53

Data collection and exposure

The	Data	Collection	and	Exposure	(DATEX)	Unit	deals	with	the	collection,	collation	and	analysis	of	data	on	food	consumption	and	chemical	
occurrence	in	food	and	feed	for	exposure	assessments	at	European	level.	

Scientific	outputs	2009

Quantity

Guidance of EFSA

Scientific or Technical Reports of EFSA

External reports*

1

4

2

*Reports produced for EFSA by external parties under specific EFSA procedures

A  major  undertaking  for  the  DATEX  Unit  was  the 
formation  of  a  working  group  to  review  available 
scientific  evidence  of  possible  health  effects  of 
β-casomorphins  and  related  peptides,  and 
in 
particular  β-casomorphin-7 
(BCM7),  a  peptide 
sequence present in the milk protein β-casein. A few 
studies had suggested that BCM7 might contribute 
to  increased  risk  of  certain  non-communicable 
diseases,  such  as  autism,  cardiovascular  diseases 
and  type  I  diabetes.  EFSA  undertook  this  work  as 
part  of  its  regular  monitoring  and  assessment  of 
possible  emerging  risks  associated  with  the  food 
chain.  The  working  group  concluded  that  a  cause 
and  effect  relationship  could  not  be  established 
intake  of  BCM7,  related 
between  the  dietary 

peptides  or  their  possible  protein  precursors  and 
non-communicable diseases.

level  available 

A  comprehensive  food  consumption  database  is 
being  populated  with  information  at  the  most 
detailed 
in  each  collaborating 
Member State for children and adults. It is expected 
that  the  database  will  be  operational  from  2010  
to  enable  more  precise  exposure  calculations  in 
relation  to  beneficial  or  harmful  substances  or 
agents  in  food.  Guidelines  to  further  harmonise  
issued 
food  consumption  data  collection  were 
during  the  year. 
In  a  cooperative  effort  with  
Mem ber  States,  EFSA  took  a  major  step  to  further 
improve  the  quality  of  European  food  safety 

exposure assessments. A draft guidance document 
on  how  to  best  handle  left-censored  data  (data 
below  the  detection  limit)  was  developed  by  a 
working group coordinated by the DATEX Unit. The 
unit  investigated  default  assumptions  used  across 
EFSA for estimating risk with the aim of harmonising 
such  use  across  disciplines.  The  document  will  be 
published during 2010.

On request of the European Commission, the DATEX 
Unit  analysed  data  collected  by  Member  States  for 
acrylamide  and  furan,  and  issued  two  reports. The 
acrylamide report reviewed the impact of voluntary 
measures  taken  by  industry  to  reduce  acrylamide 
levels. Although there seemed to be a trend towards 

>>>

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A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

lower  exposure,  it  is  not  yet  clear  if  the  measures 
have had the desired effect. The furan report was an 
interim step in better understanding levels of furan 
in  food  and  was  complemented  by  two  projects 
granted  under  Article  36  covering  the  influence  of 
food  preparation  methods  on  furan  formation  and 
exposure to furan by inhalation during cooking. The 
resulting  data  sets  will  enable  EFSA  to  produce  a 
more robust assessment of exposure through differ-
ent routes including inhalation. A report on the pres-
ence  of  dioxins  in  food  and  feed  was  drafted.  The 
unit also assisted the Commission for the first time in 
preparing  the  statistics  for  the  annual  veterinary 
medicine residue report.

The  DATEX  Unit  contributed  to  several  opinions  by 
assessing dietary exposure to a range of substances, 
in  particular  contaminants.  Information  on  levels  
of  marine  biotoxins  in  seafood  was  collected  and 
exposure 
levels  compared  with  health-based 
guidance  values  by  the  CONTAM  Panel.  The 
collection of data on arsenic proved difficult in that 
little information was available for inorganic arsenic, 
the major toxic component. Algorithms were produ-
ced based on literature information to relate levels of 
total arsenic to estimates of inorganic arsenic in the 
respective food groups. Exposure was calculated for 
adults and for the first time it was possible to provide 
detailed  exposure  calculations  for  different  age 

groups  of  children  covering  several  Member  
States.  Support  was  provided  to  the  CEF  Panel  in 
selecting a method suitable for assessing exposure 
to smoke flavourings.

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

55

Emerging risks

The	Emerging	Risks	(EMRISK)	Unit	is	responsible	for	establishing	procedures	to	monitor,	collect	and	analyse	information	and	data	in	order	to	
identify	emerging	risks	in	the	field	of	food	and	feed	safety	with	a	view	to	their	prevention.	

Scientific	outputs	2009

Quantity

Scientific or Technical Reports of EFSA

External reports*

2

1

*Reports produced for EFSA by external parties under specific EFSA procedures

The  ESCO  Working  Group  on  Emerging  Risks  pub-
lished  a  technical  report  on  emerging  risks  which, 
along with previous reports from the Scientific Com-
mittee, forms the basis of EFSA’s first Annual Report 
on  Emerging  Risks  due  in  2010.  A  technical  report 
describing the evaluation of different web monitor-
ing systems for the identification of emerging risks 
was published. This report describes the evaluation 
of a media monitoring tool, MedISys, developed by 
the Joint Research Centre, and its comparison with 
ProMED-mail for its usefulness in identifying emerg-
ing risks. A database on bioactive compounds from 

plants was delivered through an outsourced project 
and a call was launched and awarded on modelling, 
predicting  and  mapping  the  emergence  of  myco-
toxins in cereals in the EU due to climate change. 

EMRISK  is  also  responsible  for  coordinating  EFSA’s 
preparedness  for  responding  to  urgent  issues.  To 
this  end,  the  procedures  put  in  place  by  EFSA  for 
dealing  with  such  urgent  requests  (the  Emergency 
Manual) have been updated, building on the experi-
ence gained in handling urgent issues and internal 
training  exercises.  An  exercise  held  with  Member 

States  and  DG  SANCO  was  coordinated  by  EMRISK 
with the specific aim of simulating communication 
in “crisis” situations. The exercises were planned and 
executed in collaboration with an external consult-
ant  (funded  through  procurement)  and  an  expert 
working group. 

56

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Pesticide risk assessment peer review 

The	 Pesticide	 Risk	 Assessment	 Peer	 Review	 (PRAPeR)	 Unit	 is	 responsible	 for	 the	 peer	 review	 of	 active	 substances	 used	 in	 plant	 protection	
products.	The	 assessments,	 including	 the	 peer	 review,	 are	 sent	 to	 the	 European	 Commission	 to	 decide	 whether	 the	 substance	 should	 be	
included	on	the	EU’s	positive	list	of	permitted	substances	that	may	be	used	in	products	across	Europe.	The	Unit	is	also	involved	in	the	risk	
assessment	of	consumers	exposed	to	pesticide	residues	in	food,	which	forms	the	basis	for	the	setting	of	maximum	residue	levels	(MRLs)	under	
EU	law.	The	unit	is	also	responsible	for	preparing	the	annual	report	on	pesticide	residues.	

Scientific	outputs	2009

Quantity

Statements of EFSA

Conclusions on Pesticides Peer Review

Reasoned Opinions

Scientific or Technical Reports of EFSA

1

28

76

1

On 1 September 2008, Regulation (EC) No 396/2005 
came  into  effect.  As  a  result,  the  PRAPeR  Unit  was 
involved  in  procedures  for  setting  and  amending 
maximum  residue  levels  (MRLs)  for  which  Member 
States  intend  to  authorise  new  uses  of  pesticides 
and 
import 
tolerances  (Article  10  of  Regulation  396/2005).  In 
2009, 101 MRL applications were submitted by the 
European  Commission  pertaining  to  the  amend-
ment  of  approximately  400  MRLs.  In  response  to 
these  requests,  EFSA  issued  70  reasoned  opinions 

in  the  framework  of  establishing 

(addressing 76 requests). In addition, EFSA provided 
specific 
reasoned  opinions  concerning 
three 
requests  of  the  European  Commission  for  active 
substances  for  which  consumer  health  risks  were 
presumed. In the MRL review programme (Article 12 
of Regulation 396/2005), EFSA received background 
information  from  Member  States  for  137  active 
substances  which  are  now  assessed  by  EFSA.  In 
collaboration with Member States and the European 
Commission,  a  work  plan  for  prioritisation  and 
finalisation of the reasoned opinions was established. 
It was not possible to finalise the expected numbers 
of Article 12(1) and Article 12(2) reasoned opinions 
as  outlined  in  Management  Plan  2009  for  the 
following reasons:

•  delayed  submission  of  documents  by  Member 

States; 

•  higher priority given to routine MRL applications 

(Article  10  of  Regulation  396/2005)  and  priori-
tised  allocation  of  available  resources  in  the 
PRAPeR Unit to this task; 

• 

the number of routine MRL applications and the 
reasoned opinions issued by EFSA in response to 
these  applications  (Article  10  of  Regulation 
396/2005)  was  higher  than  expected,  further  
limiting  the  capacity  available  for  Article  12  ap-
plications.

>>>

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57

Pesticide risk assessment peer review 

>>>

The  PRAPeR  Unit  updated  the  database  on 
toxicological  reference  values  of  pesticides,  taking 
into  account  new  or  amended  values  established  
in  the  EU  or  by  international  bodies. The  database 
comprises  more  than  1100  acceptable  daily  intake 
(ADI)  values  and  900  acute  reference  dose  (ARfD) 
values.  A  call  for  tender  was  launched  aimed  at 
enhancing 
the  scientific  database  on  MRLs 
recommended  by  Codex  Alimentarius.  This  infor-
mation is necessary for performing a compre hensive 
risk  assessment  as  required  in  the  MRL  review 
programme  under  Article  12,  and  to  provide  risk 
managers  the 
information  whether  the  MRLs 
established  by  Codex  Alimentarius  are  safe  for 
European  consumers.  In  collaboration  with  the 
CONTAM,  DATEX  and  EMRISK  Units,  the  PRAPeR 
Unit  prepared  a  statement  in  response  to  the  
request  for  an  urgent  scientific  opinion  on  the  risk 
for public health due to the presence of nicotine in 
wild mushrooms.

In  2009,  EFSA  published  the  first  Annual  Report  on 
Pesticide Residues for 2007. The report summarises 
the results of approximately 74 000 samples analysed 
in 2007 by Member States to ensure compliance with 
the  legal  provisions.  In  brief,  the  report  found  that 
96 %  of  the  samples  analysed  were  compliant  with 
the  legal  maximum  residue  levels  (MRLs)  and  4 % 
exceeded them, compared to 5 % in 2006. These data 
were used to estimate the actual consumer exposure 
to  pesticide  residues  via  food;  the  results  of  this 
assessment  are  also  included  in  the  report.  Due  to 
deficiencies 
in  the  current  reporting 
format, EFSA developed a new data model to submit 
the  results  of  monitoring  activities.  This  new  data 
format was tested in a pilot project with six Member 
States that submitted the results of the monitoring 
results  derived  in  2008  for  approximately  6  million 
determinations of pesticides in 27 000 samples. The 
Unit  launched  a  call  for  tender  regarding  scientific 
and technical assistance for the drafting of the next 
annual report on pesticide residues.

identified 

58

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A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

in  both  the  Annex 

not  been  asked  by  the  Commission  to  draft 
conclusions  on  confirmatory  data;  unforeseen 
delays 
I  renewal  and  the 
resubmission programmes; and, by agreement with 
the  Commission,  extension  of  the  deadline  for  the 
majority  of “green  track”  substances  to  2012.  As  a 
result, the number of public consultations launched 
in 2009 was also lower than expected. 

consultation period extends into 2010. EFSA has also 
received a request from the European Commission 
to organise a peer review with Member State experts 
and  provide  conclusions  on  20 
resubmitted 
substances and six substances for Annex I renewal. 
In response to the challenging timelines associated 
with  the  resubmission  and  renewal  programmes, 
the  PRAPeR  Unit 
increased  the  use  of  tele-
conferences,  organising  23  tele-conferences  with 
Member  State  experts,  for  example.  EFSA  was  also 
invited  to  provide  comments  to  the  European 
Commission on the assessment of confirmatory data 
submitted by the rapporteur Member States for nine 
substances. 

In  total,  the  PRAPeR  Unit  delivered  conclusions  on 
28  substances  in  2009,  including  nine  new  active 
substances, nine resubmitted substances and seven 
existing  active  substances  included  in  Annex  I  but 
for which the peer review had been postponed. This 
number  is  lower  than  expected  because:  EFSA  has 

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

59

an 

in  Annex 

in  Annex 

Activities in pesticide peer review in 2009 included: 
new  active  substances;  substances  resubmitted  for 
inclusion 
I  of  Directive  91/414/EEC 
following 
initial  non-inclusion  decision; 
I  with 
included 
substances  already 
inclusion  periods  expiring;  substances  included  in 
Annex  I  for  which  EFSA  conclusions  are  due  to  be 
delivered by 31 December 2010 (the so-called “green 
track”, i.e. substances complying with the criteria of 
clear 
indications  of  no  harmful  effects);  and 
substances  for  which  confirmatory  data  have  been 
submitted  after  inclusion.  A  series  of  scientific 
meetings  was  held  with  Member  State  experts  in 
relation to new and existing active substances and 
microorganisms  used  as  active  substances.  EFSA 
received  assessment  reports  for  50  resubmitted 
substances and six substances for Annex I renewal, 
and  opened  consultation  with  Member  States, 
applicants  and  the  general  public  to  provide 
feedback  to  the  European  Commission.  For  a  large 
proportion  of  the  resubmitted  substances  the 

Scientific cooperation 

The	objective	of	the		Scientific	Cooperation	(SCO)	Unit	is	to	foster	scientific	cooperation,	projects	and	exchange	of	scientific	information	between	
EFSA	and	national	food	safety	agencies	in	EU	Member	States.

Scientific	outputs	2009

External reports*

Quantity

2

*Reports produced for EFSA by external parties under specific EFSA procedures

The Focal Point network, which started in 2007, con-
tinued  its  work  in  supporting  the  Advisory  Forum 
Members.  To  this  end,  multi-annual  Focal  Point 
agreements were signed with all 27 Member States 
to  consolidate  the  existing  network.  In  September 
2009,  the  three  EU-candidate  countries  joined  the 
Focal Point network. Many Focal Points, in particular 
in  Central  European  countries,  organised  events  to 
raise awareness of the work of Member States and 
EFSA. The SCO Unit prepared a report on Focal Point 
activities  in  2009.  The  priorities  of  the  Focal  Point 
network  included  the  exchange  of  information  on 
training activities and on projects such as data col-
lection and research funding. 

The  extended  list  of  Article  36  organisations  that 
support EFSA now comprises 370 organisations and 
the  2010  work  programme  was  adopted  by  the  

EFSA’s Management Board in 2009 to ensure an early 
start to its implementation. Training was provided to 
Focal  Points  in  2009  to  enable  them  to  enhance 
support  for  the  Article  36  organisations  in  their 
countries  and  IT  tools  are  under  development  to 
improve  networking.  An  assessment  report,  based 
on a survey of activities covered by EFSA’s grant and 
procurement schemes, was prepared. EFSA’s expert 
database has continued to grow and now includes 
around  2000  experts  from  over  60  countries.  This 
growth  results  from  cooperation  activities  initiated 
this  year  with  Member  States  and  international 
organisations  to  enhance  the  use  of  this  database. 
Five regular activity reports on the expert database 
project were issued during 2009. 

The  ESCO Working  Group  on  the “Analysis  of  Risks 
and Benefits of Fortification of Food with Folic Acid” 
completed  its  work.  Its  report,  incorporating  the 
outcomes  of  a  scientific  event  in  Uppsala,  was  
issued  and  submitted  by  the  Executive  Director  to 
the  Scientific  Committee  for  consideration  by  the 

NDA Panel. The Information Exchange Platform (IEP) 
provides a tool for Member States and EFSA to ex-
change  information  on  risk  assessment  activities 
undertaken  by  Member  State  organisations  with  a 
mandate  similar  to  EFSA’s.  To  date,  the  IEP  has 
published  over  400  scientific  documents.  In  addi-
tion,  it  provides  work  plans  and  other  country 
specific information. Starting in April, nine monthly 
reports have been provided to users. 

A new web  area for the EFSA  Journal was launched  
in December to facilitate the inclusion of the Journal 
in bibliographic databases. The enhancement of the 
Journal  is  aimed  at  providing  an  outlet  of  EFSA’s  
scientific  work  that  is  visible  and  influential  in  the  
scientific community and at the same time complies 
with  best  practice  in  academic  publishing.  The  
Summary  Report  on  Colloquium  No  12  (Campylo-
bacter) was published in March. On 19–20 November, 
approximately  100  scientists  and  stakeholders  from 
25  countries  attended  EFSA’s  13th  Scientific  Collo-
quium: “What’s new on Novel Foods” in Amsterdam. 

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For	further	details	please	refer	to	the	attached	CD-ROM.

A N N E X   I I I   - E F S A ’ S   O P I N I O N S   A N D   S C I E N T I F I C   D O C U M E N T S   2 0 0 9

Zoonoses data collection

The	Zoonoses	Unit	analyses	and	reports	data	of	zoonoses,	antimicrobial	resistance,	microbiological	contaminants	and	food-borne	outbreaks.	
The	data	is	submitted	by	Member	States	and	other	reporting	countries	in	accordance	with	Directive	2003/99/EC.		

Scientific	outputs	2009

Quantity

Scientific or Technical Reports of EFSA

External reports*

14

5

*Reports produced for EFSA by external parties under specific EFSA procedures

The  harmonisation  of  monitoring  and  reporting  of 
zoonoses in EU was continued in 2009 with the aim 
of  improving  the  quality  of  the  data  received  and 
analysed at the Community level. In particular, four 
reports on specifications for harmonised monitoring 
and reporting of zoonotic parasites (Trichinella, Eci-
nococcus,  Cysticercus  and  Sarcocystis)  in  animals  by 
EU  Member  States  were  published  as  outcomes  of 
an Article 36 grant project. In addition, the unit coor-
dinated two other Article 36 grant projects aiming to 
harmonise  the  monitoring  and  reporting  of  rabies 
and Q fever in animals as well as the survey methods 
for  zoonotic  agents  in  food  among  the  Member 
States. Furthermore, the unit itself, supported by the 
Task Force of Zoonoses Data Collection and external 

working  groups,  issued  specifications  for  harmo-
nised surveys on two zoonotic pathogens, verotoxi-
genic E.coli and Yersinia enterocolitica, in animals and 
food.  These  specifications  are  intended  to  guide 
Member  States  in  their  national  monitoring  activi-
ties highlighting the importance of good survey de-
sign.  On  the  request  of  the  Commission,  technical 
specifications  for  an  EU-wide  survey  on  Listeria 
monocytogenes, an important foodborne pathogen, 
in ready-to eat foods were also prepared for a survey 
that will take place in 2010. 

Data  from  the  annual  zoonoses  reporting  by  the 
Member States and from the three EU-wide baseline 
surveys  carried  out  in  2008  were  successfully  vali-
dated  using  a  new  SAS-based  data  management 
system with automatic validation criteria. Special ef-
forts were made to improve the analyses of the an-
nual zoonoses and baseline survey data from both 
the IT and methodological aspects. To this end, web-
based data warehouse and GIS (geographic informa-
tion)  systems  were  developed  to  facilitate  easier 

data  handling  and  access.  Furthermore,  the  devel-
opment  of  statistical  and  spatial  analyses  of  zoon-
oses data as well as analyses of temporal trends were 
further  addressed  by  two  expert  working  groups 
that provided recommendations for the most appro-
priate methods to be applied in future development. 
The  improved  analytical  methodology  was  previ-
ously  used  in  the  Community  Summary  Report  on 
Zoonoses  in  2008  and  in  the  Summary  Report  on 
Foodborne Outbreaks in 2007 which were prepared 
in  collaboration  with  the  European  Centre  for  Dis-
ease Prevention and Control (ECDC). Once again Sal-
monella  and  Campylobacter  were  found  to  be  the 
most frequently reported zoonotic pathogens in the 
EU. Two reports on the EU-wide baseline surveys on 
methicillin-resistant  Staphylococcus  aureus  (MRSA) 
and Salmonella in breeding pigs were published. In 
all  reports,  special  emphasis  was  placed  on  clear 
communication of findings and analyses. 

For	further	details	please	refer	to	the	attached	CD-ROM.

A N N U A L   R E P O R T   2 0 0 9

61

ANNEX IV - F I N A N C I A L   R E P O R T

62

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

A N N E X   I V   -   F I N A N C I A L   R E P O R T

Budget	Execution	2009

•  EUR  68.92  million  or  97.1	%  of  the 
EUR  70.96  million  budget  including 
the  Pre-accession  programme  was 
committed.  The  commitment  level 
was  1 %  below  the  target  set  for  the 
year, i.e. 98 %. 

•  EUR  53.47  million  or  75.4	%  of  the 
total  appropriations  were  paid.  This 
payment  level  stands  3 %  below  the 
target of EUR 55.6 million.

•  EUR 9.5 million of payment appropri-
ations  were  carried  forward  to  2010  
or  13	%  of  the  executed  budget 
(24.4 % in 2008).

million EUR       35

30

25

20

15

10

5

0

Personnel

Infrastructure

Operations

Appropriations

Commitments

Payments

Title

Personnel

Infrastructure

Operations

of which Pre-accession

TOTAL

Appropriations	
(million	EUR)

Commitments	
(million	EUR)

Percentage	
committed

Payments	
(million	EUR)

Percentage	
paid

RAL	
(million	EUR)

34.77

 10.75

25.44

0.51

70.96

33.81

10.69

24.42

0.35

68.92

97 %

99 %

96 %

69 %

97 %

33.12

6.30

14.05

0.23

95 %

59 %

55 %

46 %

0.69

4.40

10.37

0.11

53.47

75 %

15.45

A N N U A L   R E P O R T   2 0 0 9

63

Activity	Based	Budgeting	(ABB)	Execution	2009

million EUR      30

25

20

15

10

5

0

Activity

Activity 1

Activity 2

Activity 3

Activity 4

TOTAL

Activity	1	

Activity	2	

Activity	3	

Activity	4	

Appropriations

Commitments

Payments

Appropriations	
(million	EUR)

Commitments	
(million	EUR)

Percentage	
committed

Payments	
(million	EUR)

Percentage	
paid

RAL	
(million	EUR)

30.72

19.52

10.42

10.30

70.96

29.84

19.04

9.96

10.09

68.92

97 %

98 %

96 %

98 %

97 %

24.05

13.58

7.18

8.67

78 %

70 %

69 %

84 %

5.79

5.46

2.78

1.42

53.47

75 %

15.45

Activity	1:   Scientific advice and opinions
Activity	2:   Risk assessment methodologies
Activity	3:			Communication and dialogue
Activity	4:   Management and administration 

64

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

A N N E X   I V   -   F I N A N C I A L   R E P O R T

ABB	Appropriations	2009

	Activity	1	

43	%

Activity	2

27	%

15	%

15	%

Activity	3

Activity	4

Activity	1:   Scientific advice and opinions
Activity	2:   Risk assessment methodologies
Activity	3:			Communication and dialogue
Activity	4:   Management and administration 

ABB	Execution	2009

	Activity	1	

43.3	%

Activity	2

27.6	%

14.4	%

14.6	%

Activity	3

Activity	4

A N N U A L   R E P O R T   2 0 0 9

65

66

E U R O P E A N   F O O D   S A F E T Y   A U T H O R I T Y

© European Food  Safety  Authority, 2010

ISBN: 978-92-9199-211-9

doi: 10.2805/3682

Reproduction is authorised, provided the source  
is acknowledged, save where otherwise stated.
The views or positions expressed in this Annual Report do not 
necessarily represent in legal terms the official position of the 
European Food Safety Authority.  
The European Food Safety Authority assumes no responsibility or 
liability for any errors or inaccuracies that may appear.

A N N U A L   R E P O R T   2 0 0 9

67

T
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A
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1
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E
N

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C

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43121 Parma 
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Tel.   + 39 0521 036 111
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