REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the advisability and feasibility of presenting a legislative proposal enabling EFSA to receive fees
Date: 2010-09-23
Institutions: European Commission
Subjects: EU office or agency, foodstuff, foodstuffs legislation, report

EN 

EN 

   EN 

 
EUROPEAN COMMISSION 

Brussels, 23.9.2010 
COM(2010) 496 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL  

Report on the advisability and feasibility of presenting a legislative proposal enabling 
EFSA to receive fees  

EN 

   EN 

 
 
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Report on the advisability and feasibility of presenting a legislative proposal enabling 
EFSA to receive fees  

According  to  Article  45  of  Regulation  (EC)  N°  178/2002,  the  Commission  shall,  after 
consulting the European Food Safety Authority (EFSA), the Member States and the interested 
parties publish a report stating its position on the advisability and feasibility of presenting a 
proposal establishing fees for EFSA three years after its creation.  

The  Commission  considered  it  necessary  to  base  the  report  on  a  longer  period  of  EFSA's 
existence, in particular because EFSA was still in its development phase as a new EU agency. 
This allowed the Commission to take into account the Authority's experience in managing its 
workload, particularly in the light of new challenges over recent years (increasing workload, 
evolving  number  of  applications  in  various  sectors  such  as  health  claims,  feed  additives, 
flavourings, and the difficulties in assessing poor quality dossiers).  

The processing of applications has significantly increased in EFSA’s overall workload since 
the  end  of  2006.The  share  of  budget  required  for  handling  applications  in  2010  represents 
31% of EFSA's budget, compared to 20% in 2007. These new challenges should be taken into 
account  when  envisaging  the  establishment  of  fees  for  EFSA.  They  provide  useful 
information that needs to be considered in light of the comments gathered from stakeholders1, 
Member States2 and EFSA in 2007. 
The consultation paper issued by the Commission's services 3 identified the tasks rendered by 
EFSA  for  which  fees  could  be  made  payable  (i.e.  scientific  assessment  of  authorisation 
dossiers).  It  also  challenged  stakeholders  on  the  advantages  and  disadvantages  of  charging 
fees for EFSA and on the identification of those liable to pay fees (all applicants – for generic 
as well as individual authorisations- or only authorisation holders - ie. those applicants who 
have a specific economic interest from an individual authorisation).  

The vast majority of the comments received highlighted the complexity of a fee-system in the 
food  safety  sector  and  the  need  to  further  analyse  the  legal,  economic  and  political 
implications of the establishment of fees for EFSA.  

The objective of the report is to examine the feasibility and advisability of a fee-based system. 
It is based on the experience gained by EFSA with application dossiers since its creation and 
takes into account the views expressed by Member States, stakeholders and EFSA.  

1. 

ANALYSIS  OF  THE  CONTRIBUTIONS  FROM  MEMBER  STATES,  STAKEHOLDERS,  AND 
EFSA 

As  required  by  Article  45  of  Regulation  (EC)  N°  178/2002,  the  Commission 
consulted Member States, EFSA and stakeholders on the advisability and feasibility 
of establishing fees for EFSA.  

1 

2 

3 

Stakeholders were consulted in the Advisory Group on the Food Chain, and Animal and Plant Health, see 
http://ec.europa.eu/food/committees/advisory/index_en.htm  
Member States were consulted on 27 June 2007 in the ScoFCAH, see 
http://ec.europa.eu/food/committees/regulatory/scfcah/general_food/sum_25062007_en.pdf  
The consultation paper is available at http://ec.europa.eu/food/consultations/fees_efsa_en.pdf  

EN 

2 

   EN 

                                                 
In 2007, the Commission launched a web consultation and organised meetings with 
Member  States  in  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health4 
and  with  stakeholders  in  the  Advisory  Group  on  the  Food  Chain,  and  Animal  and 
Plant Health5.  

A detailed summary of all the written comments received in 2007 is available on the 
Commission's 
at 
http://ec.europa.eu/food/consultations/sum_cons_efsa_fees_en.pdf 

website 

In May and June 2010, the Commission consulted Member States and stakeholders 
on the Commission's draft report. The minutes of these meetings are available on the 
internet6. 

The analysis of the contributions shows that while the majority of Member States are 
not, in principle, against a fee-system, they point out its complexity in the food sector 
given that most authorisations delivered in the food sector are generic and benefit the 
whole sector.  

Industry  (both  producers  and  users)  is  generally  opposed  to  a  fee-based  system 
because of the predominance of a generic authorisation system in the food and feed 
sectors.  However,  most  contributions  from  users  of  substances/products  conclude 
that if fees were to be established, they should only be envisaged when the applicant 
(authorisation  holder)  benefits  from  a  legal  protection  (period  of  exclusivity). 
Moreover, they should be linked to a better service to applicants and to a reduction in 
delays in the treatment of applications. 

Farmers are also opposed, as well as some retailers and representatives of small and 
medium-size  enterprises.  Consumer  organisations  are  opposed  to  a  fee-system, 
mainly  because  they  have  concerns  about  EFSA's  independence  and  stress  that  the 
financing of EFSA is a public responsibility. 

1.1. 

Advisability of establishing a fee-system 

1.1.1.  Comments from Member States, stakeholders and EFSA 

1.1.1.1.  Member States 

The  majority  of  the  Member  States  are  not,  in  principle,  against  a  fee-system  to 
remunerate a service to applicants, and most of them consider that it is an element of 
good governance. Some identified the key arguments in favour of fees: 

•  Better security of adequate funding; 

•  A more professional service; 

•  Enhancement  of  cooperation  and  synergy  between  EFSA  and  the  national 

agencies; 

•  Reduction in delays for dealing with authorisation procedures; 

•  Harmonisation of various agency procedures at European level. 

4 
5 
6 

See footnote 2 above  
See footnote 1 above 
http://ec.europa.eu/food/committees/advisory/summary_20052010_efsa_en.pdf 
 http://ec.europa.eu/food/committees/regulatory/scfcah/toxic/index_en.htm 

EN 

3 

   EN 

                                                 
However,  Member  States  recognise  the  complexity  of  establishing  a  fee-system  in 
the  specific  case  of  EFSA.  They  have  therefore  identified  conditions  and  specific 
cases where the principle of fees could apply (see section 2 on feasibility). 

1.1.1.2.  Stakeholders 

Most representatives of the actors of the food chain expressed reservations regarding 
the advisability of establishing fees: 

–  Concerns about EFSA's independence 

This  argument  was  raised  by  almost  all  organisations  (consumer  organisations, 
retailers,  farmers and  the industry). They pointed out that  establishing a fee-system 
for EFSA would create confusion in the public perception of EFSA's independence – 
even if guarantees exist to ensure it in an effective manner. They considered that this 
is a challenging issue as, in an EU centralised authorisation system, it is paramount 
that EFSA's scientific opinions are fully trusted. 

–  The financing of EFSA is a public responsibility 

Representatives  of  the  industry  stressed  that  it  is  not  the  private  sector's  role  to 
compensate for the lack of public funding of an Authority that has been established 
to  protect  public  health.  Fees  should  not  be  established  when  the  current  public 
funding is supposed to be sufficient to cover the increase in EFSA's tasks. Consumer 
organisations also considered that the financing of EFSA is a public responsibility. 

–  Need to be compatible with the better regulation approach 

Representatives  of  the  industry  (including  SMEs)  indicated  that  the  addition  of  a 
further  financial  burden  would  be  contrary  to  the  Lisbon  agenda,  in  particular 
because the cost of compliance with food law is already high. In addition, operators 
would find it more difficult to accede to the markets if fees were established. In their 
view, additional costs could disrupt the cost/benefit ratio, discourage operators from 
submitting  authorisation  files,  and  distort  competition  since  operators  in  third 
countries would not be paying a fee. It would also be detrimental to innovation. 

They  also  stressed  that  the  impact  on  EFSA's  workload  of  some  Regulations 
requiring a pre-market approval in the food area (e.g. on claims and fortified food) 
should have been assessed before being adopted. 

1.1.1.3.  EFSA 

While  not  expressing  a  position  in  favour  of  or  against  the  establishment  of  fees, 
EFSA's  Management  Board  stressed  that  it  is  the  decision-making  bodies 
(Commission,  European  Parliament  and  Council)  which  ultimately  construct  the 
financial system allowing EFSA to function. The source of the funding may not be 
an issue provided that a certain number of conditions, particularly in relation to the 
independence and accountability of EFSA are covered by the legislators.  

1.1.2.  Commission's analysis 

•  Concerns about EFSA' independence 

The  Commission  has  always  set  excellence,  independence  and  transparency  as 
essential  requirements  of  EFSA's  Scientific  Committee  and  Panels'  work.  As 
required  by  Article  37  of  Regulation  (EC)  N°  178/2002,  EFSA's  independence  is 
ensured  by  a  series  of  mechanisms.  Its  Scientific  Committee  and  Panels  are 

EN 

4 

   EN 

composed  of  independent  experts  who  are  required  to  complete  declarations  of 
independence and interests, which are made public.  

The  Commission  considers  that  the  establishment  of  fees  would  not  diminish  the 
independence of EFSA. Neither would it affect the perception of independence, even 
if specific attention should be given to how fees may be perceived in sensitive areas 
such  as  genetically  modified  (GM)  organisms  and  GM  feed  and  food.  As  effective 
and  transparent  mechanisms  are  in  place,  a  fee-system  can  be  established  without 
compromising 
for  other 
European/national  agencies  that  have  a  cost-recovery  system  for  the  assessment  of 
applications/authorisation dossiers (e.g. the European Medicines Agency (EMA), the 
European  Chemicals  Agency  (ECHA)7.  Experience  shows  that  they  do  not 
undermine the perception of the agencies’ independence.  

independence.  This 

the  Authority's 

the  case 

is 

•  The financing of EFSA is a public responsibility 
Most of EFSA's tasks8 are of general interest and financed by the public budget (69% 
of  EFSA's  budget  is  used  for  such  tasks).  According  to  the  current  operating 
principles,  only  EFSA's  tasks  related  to  the  assessment  of  authorisation  dossiers 
could  be  subject  to  fees  because  in  this  case  public  money  might  partly  be  used  to 
serve private interests and the services rendered appear as being supplied separately 
to clearly differentiated users. 

It is useful to mention that the distinction between general and private interest is not 
always  straight-forward.  For  example,  the  clarification  of  specific  scientific  issues 
raised  by  an  individual  application  (e.g.  antibiotic  resistance  marker  genes)  led  to 
additional EFSA scientific opinions which were of general interest. 

Suitable mechanisms should be put in place to prevent distortions of priority and to 
ensure  appropriate  balance  between  the  interests  of  a  more  efficient  service  for  fee 
paying services and other work of general-interest objectives. 

.  

•  Need to be compatible with the better regulation approach 

The  Commission  is  committed  to  the  better  regulation  approach,  which  implies,  in 
particular, performing impact assessments on new policy initiatives. This implies that 
fees  would  not  be  established without a meaningful  cost/benefit ratio. To meet this 
objective, a global analysis will be carried out in order to assess the impact that a fee-
system would have on EFSA's functioning and its independent public health mission, 
as well as its impact on competitiveness and SMEs. 

7 

8 

Regulation  (EC)  N°  1107/2009  of  the  European  Parliament  and  the  Council  of  21  October  2009  concerning  the 
placing  of  plant  protection  products  on  the  market.  In  the  pesticides  sector,  the  authorisation  procedure  is  partly 
decentralised. 
The tasks performed by EFSA are essentially as follows: scientific opinions issued for the Commission, Member 
States and the European Parliament; technical and scientific assistance to the Commission; collection and analysis 
of  data  on the  safety  of the  food  chain;  identification of  emerging  risks;  scientific  support  to  the  Commission  in 
cases of emergency/crisis; communication to the public on risks.  

EN 

5 

   EN 

                                                 
1.2. 

Feasibility of establishing a fee-system 

1.2.1.  Main difficulties identified by Member States and stakeholders on the establishment 

of a fee-system 

The analysis of the contributions shows that the vast majority of the Member States 
and stakeholders consider that a system for the collection of fees would be complex 
and difficult to institute. Interestingly, there is a common line amongst those whose 
opinions  diverge  on  the  advisability  of  establishing  fees  for  the  assessment  of 
authorisation dossiers by EFSA (see section 1.1).  

Their main concerns are the following: 

•  Generic authorisations and difficulties in identifying beneficiaries 

One of the principal arguments is based on the fundamentals of EU food legislation, 
i.e. that the legal framework imposing authorisation procedures for certain foods or 
substances used in the food chain is mainly aimed at giving general approvals for the 
benefit  of  all  operators.  It  contains  little  protection  of  proprietary  data  and  seldom 
offers exclusivity to the applicant.  

For  these  reasons,  some  stakeholders  and  Member  States  stressed  that  it  is  not 
possible  to  compare  food  or  substance  authorisations  to  medical  products.  The 
medical product legislation indeed offers pay-back for investments to the applicants 
by protecting clinical pharmaceutical data and granting exclusivity.  

The predominant system of generic authorisations in the food area makes it complex 
to identify beneficiaries, and therefore the potential fee-payer. Most stakeholders and 
some  Member  States  made  it  clear  that  if  fees  were  to  be  established,  it  would  be 
unfair  to  make  the  applicant  pay  a  fee  for  a  generic  authorisation  since  the  whole 
sector  benefits  from  the  authorisation.  However,  in  the  case  of  individual 
authorisations where an authorisation holder benefits from some specific protection 
(e.g. GMOs, Plant Protection Products etc), the payment of fees by the applicant is 
seen as more justified. 

Some Member States expressed a different view and suggested that a general, simple 
fee system could be put in place: all applicants for authorisation dossiers would pay a 
fee, but this fee should be modest. 

•  EFSA's budget instability and the potential inefficiency of a fee-system 

The introduction of fees may not always guarantee a stable annual EFSA budget as 
the number of dossiers for assessment may vary unpredictably from year to year. In 
addition, a fee system may provide grounds for reducing public funding, even though 
such contributions are necessary for stable and efficient management of all EFSA's 
activities of general interest. Fees could lead to a decrease in EFSA's budget. 

If  a  system  were  to  be  put in  place,  it  could  generate  a  disproportionate  amount  of 
administrative burden and all the benefit could go to "self-financing the system and 
no more". 

1.2.2.  Commission's analysis 

•  Generic authorisations 

The  Commission  shares  the  view  that  the  predominance  of  a  generic  authorisation 
system  in  the  food  and  feed  sectors  makes  it  difficult  to  identify  beneficiaries,  and 
therefore the potential fee-payers. In this respect, the EU food legislation is different 

EN 

6 

   EN 

from  the  legislative  framework  setting  up  EMA9  and  ECHA10,  which  provide  for 
specific benefits to individual applicants.  
Under the medicinal products legislation11, Article 14 (11) states: "Without prejudice 
to  the  law  on  the  protection  of  industrial  and  commercial  property,  medicinal 
products  for  human  use  which  have  been  authorised  in  accordance  with  the 
provisions  of  this  Regulation  shall  benefit  from  an  eight-year  period  of  data 
protection and a ten-year period of marketing protection…."  
The  chemicals  legislation12  (REACH)  provides  for  a  registration  system  that  also 
includes  an  authorisation  system.  Only  the  manufacturers/importers  who  have 
registered  specific  chemical  substances  may  manufacture  or  import  them.  A 
transition system based on pre-registration is established to phase in substances and 
allow importers/manufacturers who currently manufacture/import these substances to 
continue  to  do  so.  The  payment  of  a  fee  to  ECHA  is  one  of  the  conditions  of 
registration. 

Contrary to EMA and ECHA, EFSA has to process applications under approximately 
15  different  pieces  of  vertical  legislation  requiring  scientific  assessment  and  re-
assessment  through  mechanisms  of  "applications"  that  have  not  been  designed  to 
integrate  the  requirements  of  a  cost-recovery  system  (i.e.  applicants  paying  for 
services of private interest). It is therefore not always straightforward to associate an 
application with one unique "owner" of the request who can enjoy proprietary rights 
or an exclusive use of the approved substance for a certain period. 

For these reasons, the Commission considers that it is not possible to apply reasoning 
by  analogy  with  EMA  and  ECHA  cost-recovery  systems  when  discussing  the 
establishment  of  fees  in  the  food  and  feed  area.  In  the  case  of  EFSA,  a  sector-by-
sector  approach  would  be  more  rational  as  only  some  sectorial  legislation  provides 
for  individual  authorisations  granting  some  specific  rights.  The  legal  procedures 
provide for an authorisation holder in the case of genetically modified food and feed, 
GMOs, pesticides, some smoke flavourings, some categories of feed additives, some 
categories of nutritional and health claims and, potentially some novel food13, even if 
in some sectors (for example smoke flavourings) there is both an authorisation holder 
and a positive list.  

In cases where the authorisation is not generic but granted to specific authorisation 
holders,  specific  economic  advantages  derive  from  the  authorisation  system. 
Therefore,  as  public  money  is  partly  being  used  for  private  interests,  a  legislative 
system for charging fees should be explored in more detail. 

9 

10 

11 

12 

13 

Commission  Regulation  (EC)  N°  297/95  of  10  February  1995  on  fees  payable  to  the  European  Agency  for  the 
Evaluation of Medicinal Products. 
Commission  Regulation  (EC)  N°  340/2008  of  16  April  2008  on  the  fees  and  charges  payable  to  the  European 
Chemicals Agency pursuant to Regulation (EC) N° 1907/2006 of the European Parliament and of the Council on 
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 
Regulation  (EC)  N°  726/2004  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  laying  down 
procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human  and  veterinary  uses  and 
establishing a European Medicines Agency. 
Regulation  (EC)  N° 1907/2006 of  the  European  Parliament and  of  the  Council of  18 December  2006  concerning 
the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH),  establishing  a  European 
Chemicals Agency. 
Proposal  for  a  Regulation  of  the  European  Parliament  and  the  Council  on  novel  foods  COM  (2007)  872  final, 
which proposes applicant specific authorisations for five years linked to approved data protection. See also footnote 
19.  

EN 

7 

   EN 

                                                 
•  EFSA's budget instability and the potential inefficiency of a fee-system 

Since the Union subsidy for EFSA’s budget has a balancing effect, the risk of budget 
instability  is  limited.  In  particular,  a  number  of  fixed  costs  should  be  able  to  be 
guaranteed  by  public  funding  in  order  to  stabilise  EFSA's  budget.  In  addition,  the 
establishment  of  fees  can  only  be  based  on  the  stable  workload,  as  is  the  case,  for 
example,  for  ECHA  under  the  REACH  Regulation. This difficult issue needs to be 
further  explored  in  order  to  identify  the  sectors  where  a  predictable  workload  is 
foreseen.  

The  Commission  agrees  that  the  introduction  of  any  fee  system  comes  at  a  cost. 
However, experience shows that these costs did not change the final cost benefit/ratio 
for the establishment of fees in EMA, REACH and Joint Research Centre. 

2. 

2.1. 

EFSA’S EXPERIENCE IN MANAGING APPLICATIONS 

Part of the applications in EFSA’s overall workload  

A  certain  number  of  new  elements  have  to  be  taken  into  account  since  EFSA's 
creation  when  envisaging  the  establishment  of  a  cost-recovery  system.  EFSA  has 
become a mature Authority that has recently entered a phase of stabilisation, both in 
terms  of  staff  and  budget.  In  parallel,  EFSA  has  been  faced  with  an  increasing 
number of applications in various sectors, as shown in graph 1 below.  

Graph 1 – Estimated Number of Applications 2007-2013 (source: EFSA) 

Graph  2  below  shows  that  since  2003,  the  number  of  applications  has  significantly 
increased, especially in 2009 and 2010. 

Graph 2- Scientific output evolution (source: EFSA) 

EN 

8 

   EN 

 
It  should  be  noted  that  the  estimates  provided  by  EFSA  include  generic  as  well  as 
individual applications. They also comprise the reviews EFSA had to carry out over 
the  last  few  years  (on  nationally  authorised  substances/claims  or  on  "old 
authorisations"), which form an important part of the increased workload (e.g. health 
claims, "old" pesticides, flavourings, “old” additives). 

These  preliminary  data  lead  to  the  following  observations  that  would  need  to  be 
further analysed:  

The “peaks” of applications received in a certain number of areas destabilise EFSA’s 
workload.  Experience  shows  that  they  require  significant  human  and  financial 
resources, and that EFSA has to reorganise its work in order to manage these peaks. 

Applications are an important part of EFSA’s current workload, as reflected in the two 
graphs above. It would be necessary to distinguish between the number of applications 
for  authorisation  of  new  substances/products/claims  from  the  number  of  applications 
originating from reviews in order to identify the yearly income that a fee-system could 
generate. An initial, rough estimate that would need to be further refined, shows that 
the  number  of  applications 
that  would  be  predictable/foreseeable  for  new 
products/substances/claims  would  amount  to  around  210  applications  per  year14. 

(1) 

(2) 

EFSA  can  undertake  three  types  of  "reviews"  which  have  different  objectives,  as 
follows: 

(a)  Mandatory  renewal  of  an  authorisation  after  10  years,  required  by 
sectorial legislation (pesticides, GMOs and feed additives) (similar to 
renewals  under  the  medicinal  products  legislation).  This  type  of 

14 

Estimates  are  the  following:  Food  additives:  20;  Feed  additives:  34;  GMOs:  15;  Food  contact  materials:  30; 
Food  flavourings:  25,  Food  enzymes:  20;  Smoke  flavourings:  3;  Novel  foods:  10;  Food  supplements:  3;  Health 
claims: 50 minimum. 

EN 

9 

   EN 

 
 
                                                 
(b) 

(c) 

review brings direct profits to individual natural or legal persons (i.e. 
firms applying for the renewal of the authorisation).  

Some  "old"  substances  have  to  be  reviewed  by  EFSA  in  the  light  of 
new  information  and  the  Commission  sends  a  mandate  to  EFSA  to 
undertake this review. These reviews are not based on legal provisions 
and concern generic substances. Contrary to category (1) above, this is 
a  task  of  general  interest.  In  addition,  it  might  be  difficult  to  predict 
the  workload  involved  with  this  type  of  review  as  it  is  not  legally 
required.  

Assessment of substances (or claims) already on national market(s) in 
order to be authorised at EU level (submitted by the Member States). 
The  reviews  belonging  to  this  category  will  come  to  an  end  or  will 
have started by the time a fee system could be established in 2012/13. 
It  must  also  be  taken  into  account  that  recent  experience  has 
demonstrated that in some cases EFSA received "empty dossiers" that 
resulted  in  a  waste  of  resources  in  terms  of  time  and  money.  Fees 
would be an incentive for applicants to submit better quality dossiers. 
At  the  same  time,  it  would  help  EFSA  to  optimise  the  resources  it 
allocates to assessing dossiers. 

2.2. 

Estimates of costs of applications 

One of the arguments put forward by some stakeholders was that a decision on the 
establishment of fees should be based on their potential level. Evaluating the cost of 
applications  by  sector  is  a  complex  and  difficult  task,  as  the  types  of  applications 
(and  therefore  the  resources  needed  to  assess  them)  differ  according  to  +/-  15 
different pieces of vertical legislation required for an EFSA scientific assessment. 

EFSA has provided estimates of the costs related to the applications processed. Table 
1  below  shows  that  the  percentage  of  EFSA's  budget  required  for  processing  the 
applications has increased in the last three years. 

Table  1  –  Percentage  of  EFSA's  budget  allocated  to  the  processing  of  applications 
(source: EFSA)  

%  of  EFSA's  budget  required  for 
processing of applications  

Number  of  applications  processed 
(number 
on 
and 
previous year)  

evolution 

Number  of  applications  received 
(number 
on 
previous year) 

evolution 

and 

2007 

2008 

2009 

201015 

20%  

29% 

31% 

31% 

132 

542 

195 

1258 

2209 

(+48%) 

(+545%) 

(+76%) 

4741 

596 

970 

(+774%)

(-87%) 

(+63%) 

Table  1  above  demonstrates  that  there  is  little  correlation  between  the  number  of 
applications  and  the  resources  allocated  to  their  processing,  as  EFSA's  budget  is 
subject to constraints specific to public spending patterns. In order to respond to this 

15 

Estimates. 

EN 

10 

   EN 

 
                                                 
problem, EFSA has had to prioritize, to limit the service to applicants and to spread 
the workload over rather long periods of time. 

Graph  3  below  shows  the  amount  of  EFSA’s  budget  devoted  to  applications  and 
projections over the period 2007-2013. 

Graph 3: Estimated cost of applications 2007-2013 (source: EFSA) 

Preliminary  estimates  provided  by  EFSA  show  that  the  costs  per  application  vary 
considerably according to the different sectors: € 23,000 for a health claim, € 29,000 
for  a  food  contact  material,  €  68,000  for  a  novel  food  application,  €  337,000  for  a 
GMO application, between € 43,000 and € 91,000 for feed additives, € 66,000 for a 
food additive, € 34 000 for a food flavour ing, € 58 000 for a smoke flavouring, € 32 
000  for  a  food  enzyme,  €  88,000  for  nutrient  sources  (food  supplements,  food  for 
particular  nutritional  uses,  fortified  food),  between  €  4,900  (MRLs)  and  €  375,000 
(active substances) for pesticides and €  131,000 for an infant formulae application.  

The  cost  allocated  to  dossiers  is  influenced  by  their  complexity  and  the  number  of 
dossiers involved. 

These preliminary estimates include operational and administrative costs (staff costs, 
operational  support,  development  of  guidance  documents,  infrastructure  costs, 
overheads), and also a percentage of supplementary services that would be developed 
for the applicants.  

They give a general overview of the repartition of the costs according to the various 
sectors, but need to be further analysed and completed. In particular, there is a need 
to break down, by sector, all the activities required to assess the applications, identify 
the time required for each activity, and to quantify the costs according to the labour 
costs.  It  will  also  be  important  to  identify  how  costs  that  are  linked  to  general 
services,  such  as  the  development  of  guidance  documents,  should  be  attributed  or 
shared. 

EN 

11 

   EN 

 
The Commission considers that, besides a further analysis of the costs of application 
per sector, the following elements should be taken into account: 

- The cost of the application should not be the level of fees itself. The latter should be 
based on the cost of the service rendered and take into account other elements such 
as  an  average  cost,  the  eventual  differences  of  complexity  of  the  different 
applications (extension of authorisation, renewal etc), the possibility of joint dossiers 
and the possibility of reduced fees for SMEs.  

-  The  level  of  the  fees  should  take  into  account  not  only  the  cost  of  the  work 
currently carried out by EFSA, but also the cost of the additional services that would 
be  delivered.  For  example,  the  Authority  would  be  able  to  introduce  service 
standards,  which  would  ensure  that  the  Authority  commits  itself  to  the  respect  of 
precise standards, intermediate deadlines and tangible indicators. 

3. 

OPTIONS STEMMING FROM THE STAKEHOLDER CONSULTATION 

Most  of  the  comments  provided  by  Member  States  and  stakeholders  (see  section  1 
above) acknowledged that, in principle, fees are a useful tool for good governance. 
They  stressed,  in  particular,  that  a  fee-system  can  contribute  to  ensuring  that  the 
spending of public money is focussed on financing activities of public interest while 
promoting  a  more  professional  service  to  applicants  (section  1.1.1  on  advisability). 
Their main concerns relate to the feasibility of the establishment of a fee system in 
the food sector, given that the legal framework imposing authorisation procedures for 
certain foods or substances used in the food chain is mainly aimed at giving general 
approvals for the benefit of all operators (section 1.2.1 on feasibility). 

Four options emerge from these contributions: 

(1) 

(2) 

(3) 

Flat-rate fee16 for all applicants for authorisation;  
Graduated17 fees for all applicants for authorisation; 
Graduated18 fees for applicants who are authorisation holders; 

(4)  Maintain the existing system without fees. 

Under options (1), (2), and (3), the issues related to the reviews as mentioned under 
2.1 will also be examined. 

This  is  not  an  exhaustive  list  of  possible  options,  but  those  that  resulted  from  the 
stakeholder  consultation.  They  are  a  good  basis  for  further  work,  but  are  not 
exclusive of other alternatives. 

The  Commission's  analysis  on  feasibility  (see  1.2.2)  concludes  that  a  number  of 
issues need to be further examined. In addition, a decision on the establishment and 
level of fees needs to be taken in the light of the costs of the services that could be 
subject to fees and the current estimation of these costs has to be further refined (see 
2.2).  

16 

17 

18 

In the case of flat rate fees, all applicants pay the same fee. One of the sub-option could be to consider 
the payment of administrative fees (only covering administrative costs) for all applications  
In the case of graduated fees, the level of fees will differ according to the type of product/substance and 
the corresponding sectorial authorisation procedure. The fee could therefore be a flat rate that will differ 
according to the sector concerned or it could be an hourly fee. . 
See foot note 17  

EN 

12 

   EN 

                                                 
The following elements will also have to be taken into account:  

–  In the plant protection products sector, EU legislation provides for the possibility 
of national fees. Additional fees could largely duplicate national fees since a part 
of  these  national  fees  may  already  contribute  to  the  financing  of  the  Member 
States' participation in the EFSA peer review.  

–  It  is  important  to  maintain  the  capacity  of  SMEs  to  accede  to  the  market. 

Therefore specific conditions for SMEs will have to be examined.  

–  The establishment of fees for ESFA should not become an incentive to give rights 
of  exclusivity  to  the  applicants,  considering  that  one  of  the  aims  of  generic 
authorisations is to ensure that substances that are not really innovative can be put 
on the market at the best price by any producer. 

3.1. 

General conclusion 

In  view  of  the  all  the  issues  outlined  in  this  report,  in  particular  the  complexity  of 
establishing  a  fee-system  in  the  area  of  EU  food  legislation,  the  Commission 
considers that more reflection is needed on the range of options to be considered and 
that  it  is  not  possible  to  draw  any  definitive  conclusions  at  this  stage.  This  will  be 
done  in  the  course  of  an  impact  assessment.  Without  pre-empting  the  outcome  of 
such an assessment, the option of graduated fees for applicants who are authorisation 
holders (option 3) should in any cases be given further consideration. In this context, 
the issue of enhanced services for applicants will also have to be explored. 

The introduction of fees for EFSA could, in particular, be considered in the following 
sectors where the authorisation in all cases, or in some specific cases, is issued to a 
specific holder and is not generic:  
•  authorisation of genetically modified organisms (cultivation);  
•  authorisation of genetically modified food and feed; 
•  authorisation of feed additives issued to a specific holder; 
•  authorisation of claims issued to a specific holder;  
•  authorisation of novel foods issued to a specific holder19; 
•  positive  listing  of  active  substances  eligible  for  authorisation  as  plant  protection 

products; 

•  authorisation of smoke flavourings20.  

In  order  to  develop  the  optimum  approach,  the  Commission  intends  to  launch  an 
impact  assessment  which  will  take  into  account  the  results  of  the  Member  States', 
stakeholders' and EFSA's comments and the observations and remarks highlighted in 
this  report.  The  assessment  will  also  look  at  other  EU  policy  areas  as  well  as 
practices of other EU regulatory agencies. 

Each potential candidate sector will have to be assessed in detail in order to identify 
the  economic  and  budgetary  impact  of  the  various  scenarios  of  fees  on  enterprises 
(including SMEs). This will allow an identification of the distributional impact of the 
different types of fees on the different sectors, the amount of fees that could be set 

19 

20 

According to Articles 7 and 12 of the Commission proposal on novel food (COM (2007) 872), in cases where the 
novel  food  would  be  included  in  the  Community  positive  list  on  the  basis  of  newly  scientific  evidence  and  /or 
proprietary data, the novel food may not be used for the benefit of another application during a period of five years 
from  the  date  of  the  inclusion  of  the  novel  food  in  the  Community  list  without  the  agreement  of  the  applicant 
(which name and address appear on the list). 
For plastic recycling processes, an authorisation holder is foreseen.  

EN 

13 

   EN 

                                                 
up,  the  conditions  to  determine  affordable  fees  for  SMEs  and  their  impact  on 
innovation. 

It  is  also  essential  to  assess  the  impact  that  a  fee-system  would  have  on  EFSA's 
overall functioning and efficiency, in particular: the various options for providing a 
more  professional  service  to  applicants,  the  impact  on  the  sharing  of  work  with 
national agencies/bodies, the balance between the interests of a more efficient service 
and  the  preservation  of  general  interest  objectives,  the  perception  of  EFSA's 
independence, and the impact on the overall sustainability of EFSA's functioning. 

The Commission requests the Parliament and the Council to take a position on this 
report and the conclusions made by the Commission. 

EN 

14 

   EN 

EN 

15 

   EN