COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EC) No 2015/2283 [on novel foods]
Date: 2018-04-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Food Safety Authority, administrative transparency, consumer protection, food industry, food safety, foodstuffs legislation, health control, market approval, marketing standard

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 11.4.2018 SWD(2018) 97 final  COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the transparency and sustainability of the EU risk assessment in the food chain amending Regulation (EC) No 178/2002 [on general food law], Directive 2001/18/EC [on the deliberate release into the environment of GMOs], Regulation (EC) No 1829/2003 [on GM food and feed], Regulation (EC) No 1831/2003 [on feed additives], Regulation (EC) No 2065/2003 [on smoke flavourings], Regulation (EC) No 1935/2004 [on food contact materials], Regulation (EC) No 1331/2008 [on the common authorisation procedure for food additives, food enzymes and food flavourings], Regulation (EC) No 1107/2009 [on plant protection products] and Regulation (EC) No 2015/2283 [on novel foods] {COM(2018) 179 final}  
 
 
1.  INTRODUCTION 

Synopsis report 

This report covers feedback from citizens and national authorities, groups and organisations 
(‘stakeholders’)  as  regards  the  initiative  for  a  Commission  proposal  for  a  Regulation  on  the 
transparency  and  sustainability  of  the  EU  risk  assessment  in  the  food  chain  (‘Commission 
proposal’). The Commission proposal would amend Regulation (EC) No 178/2002 which sets 
out  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food 
Safety Authority (EFSA) and defines procedures in  matters of food safety. For consistency, 
the Commission proposal would also amend other sectoral food legislation. The Commission 
proposal builds on the findings of the Fitness Check of the General  Food Law1 and  follows 
the Commission Communication on the European Citizens’ Initiative to “Ban glyphosate and 
protect people and the environment from toxic pesticides”2.  

Citizens  and  stakeholders  had  the  opportunity  to  provide  feedback  on  a  Commission 
roadmap 3  from  20  December  2017  to  17  January  2018.  20  stakeholders  (15  trade  and 
business associations, four Non-Governmental Organisations (NGOs) and one Member State 
(MS) authority) and one citizen submitted feedback.  

This  was  followed  by  an  open  public  consultation  (OPC) 4 ,  targeting  citizens  and 
stakeholders, open from 23 January 2018 to 20 March 2018. The OPC received replies from 
471 participants: 318 citizens and 153 stakeholders. 18 of the stakeholders had also provided 
feedback on the roadmap. 

The  stakeholders  that  took  part  represented  a  variety  of  sectors:  trade  and  business 
associations  (39.22  %),  companies  and  groups  (14.38  %),  NGOs  (13.07  %),  professional 
associations  (8.5  %),  national/regional  authorities  (8.5  %),  governmental  agencies (5.23  %), 
research  institutes  (3.92  %),  public  bodies  (1.96  %),  professional  consultancies  (1.96  %), 
think-tanks  (1.31  %),  law  firms  (0.65  %),  EU Institutions (0.65  %),  and  other  (0.65  %).  As 
regards the citizens who took part, 318 replies came from 26 MS, 10 came from a European 
Free Trade Association country and five from other non-EU countries.  

Citizens evaluated their level of knowledge of the EU assessment system for food safety and 
its regulatory framework as very good (22.64 %), good (33.65 %), sufficient (26.42 %), little 
(14.78 %) or none (2.52 %). Organisations evaluated their level of knowledge as very good 
(37.25 %), good (47.06 %), sufficient (14.38 %), little (0.65 %) or none (0.65 %).  

Targeted consultations with specific stakeholder groups also took place. EU-level stakeholder 
organisations  representing  farmers,  cooperatives,  the  food  industry,  retailers,  consumers, 
professionals  and  civil  society  were  consulted  in  a  working  group  meeting  of  the  Advisory 

1 https://ec.europa.eu/food/safety/general_food_law/fitness_check_en  
2 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_glyphosate_eci_final.pdf  
3 http://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6265773  
4 https://ec.europa.eu/info/consultations/public-consultation-transparency-and-sustainability-eu-risk-assessment-food-
chain_en  

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Group  on  the  Food  Chain  and  Animal  and  Plant  Health5. Consultations also took place 
via  the  EFSA  Advisory  Forum 6 (national  food  safety  authorities)  and  the  Commission 
Expert Group on General Food Law7 and with the Scientific Committee of EFSA8. 

A  letter  of  the  European  Ombudsman  to  the  President  of  the  European  Commission  on 
ensuring  the  EU  risk  assessment  model  in  the  food  chain  is  independent,  transparent,  and 
allows for meaningful stakeholder engagement, was also considered.  

Feedback received during the consultations was not taken into account if it went  beyond the 
scope of the Commission proposal. 

2.  TRANSPARENCY OF INDUSTRY STUDIES 

Citizens  and  stakeholders  acknowledged  the  importance  of  public  access  to  the  industry 
studies used by EFSA in its risk assessments, with the exception of the business secrets and 
other  confidential  information,  as  a  significant  element  of  ensuring  trust  in  the  EU’s  food 
safety risk assessment. The OPC showed such access as important or very important in 86.8 
%  of  citizen  replies  and  88.2  %  of  stakeholder  replies.  The  information  that  EFSA  makes 
public on its activities and contributions was also judged as very important. 

Citizens and stakeholders found that  publishing industry studies, including raw/aggregated 
data  but  excluding  business  secrets or  other  confidential  information,  has  a  positive  or  very 
positive impact on:  

  enhancing the transparency of the EU risk assessment system: 87.4 % of replies from 

citizens, 91.5 % from stakeholders, 

  strengthening consumer trust in the EU risk assessment system: 84.9 % of replies from 

citizens, 73.9 % from stakeholders, 

  allowing scrutiny by other scientific and third parties: 81.8 % of replies from citizens, 

80.4 % from stakeholders,  

  enhancing  the  exchange  of  information  on  risk  among  interested  parties:  81.5  %  of 

replies from citizens, 76.5 % from stakeholders. 

As  consumers  may  in  general  lack  the  scientific  knowledge  to  use  these  studies,  consumer 
organisations suggested that trust would depend on other factors, e.g. third-party scrutiny of 
the studies.  

As regards the impact of publishing industry studies, 42.1 % of citizen replies and 21.6 % 
of stakeholder replies state that it is important or very important for competitiveness; 56.3 % 
of citizen replies and 31.4 % of stakeholder replies state that it is positive or very positive for 
innovation.  Furthermore,  about  35  %  of  replies  from  stakeholders,  in  this  case  mainly 
industry organisations, state that publishing industry studies will be negative or very negative 

5 https://ec.europa.eu/food/expert-groups/ag-ap/adv-grp_fchaph/wg_2018_en  
6 https://www.efsa.europa.eu/en/events/event/180206  
7 https://ec.europa.eu/food/safety/general_food_law/expert_group_en  
8 https://www.efsa.europa.eu/sites/default/files/event/180214-m.pdf  

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for  both  competitiveness  and  promoting  innovation.  Industry  organisations  commented  that 
there is a risk of the published data being misuse.  

There were different views on the timing  of  publishing  non-confidential  parts of industry 
studies  throughout  the  risk  assessment  process  and  the  impact  on  transparency.  Among 
citizens, 58.8 % considered that immediate publication without confidentiality checks would 
have a positive or very positive impact, 6.9 % consider it would have no impact and 28.9 % 
considered that the impact would be negative or very negative. Replies on the other scenarios 
related  to  the  timing  of  publication  do  not  showed  strong  polarisation  of  opinions,  with  the 
exception of the option to not publish industry studies at all: 77.1 % of citizens state that this 
would  have  a  negative  or  very  negative  impact,  with  only  4.1  %  considering  that  it  would 
have  a  positive  or  very  positive  impact.  For  stakeholders,  71.9  %  believe  that  the  non-
publication of industry studies would have a negative or very negative impact and only 1.3 % 
considered that it would have a positive impact.  

In general, industry stakeholders state that the timing of publication could have a negative or 
very  negative  impact  on  competitiveness,  in  particular  if  publication  happens  early  in  the 
assessment  process.  Industry  stakeholders  also  highlighted  the  need  to  avoid  unfair  use  of 
commercial  data.  Some  comments  from  MS  authorities  reflect  on  the  need  to  specify  what 
should be considered confidential in legislation. NGOs commented on the need to review the 
validity of the confidentiality claims made in relation to industry studies. 

Both citizen and stakeholder replies to the OPC showed that an open registry of studies, the 
use  of  machine  readable  formats  and  having  different  levels  of  access  to  studies  would  be 
useful  or  very  useful  tools.  Regarding  the  establishment  of  a  register  of  industry  studies, 
mainly  MS  authorities  highlighted  the  challenges  as  regards  applicability  outside  the  EU. 
Some  MS  authorities  and  industry  stakeholders  considered  that  it  may  have  a  detrimental 
impact on EU innovation. 

3.  EVIDENCE FROM INDUSTRY STUDIES 

Most citizens and stakeholders found important or very important the elements currently in 
place to ensure that the studies provided by industry are sufficiently robust to serve EFSA’s 
risk assessment needs.  

In  general,  citizens  found  that  all  the  additional  measures  regarding  industry  studies 
proposed  in  the  OPC  contribute  to  some  or  a  large  extent  to  strengthening  EFSA’s  risk 
assessments;  over  75  %  of  replies  regarding  the  single  measures  acknowledged  this. 
Although,  in  general,  stakeholders  showed  similar  views,  some  saw  certain  measures  as 
having different levels of importance. In particular, industry stakeholders considered valuable 
to some or to a large extent the possibility for providing pre-submission advice to individual 
applicants, while consumer organisations and some other NGOs considered that it would not 
contribute  very  much.  The  latter  also  highlighted  the  need  to  ensure  the  independence  of 
EFSA’s  scientific  processes.  Some  MS  saw  the  potentially  for  a  small  value  of  pre-
submission advice in relation to its cost vs benefit analysis.  

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83.7 % of replies from citizens and by 63.4 % from stakeholders stated that complementing 
industry studies with verification studies would strengthen EFSA’s risk assessment to some 
or to a large extent. As regards the financing of these verification studies, a small percentage 
of both citizens and stakeholders considered that the costs should be covered by the individual 
applicant  concerned.  The  other  financing  options  proposed,  i.e.  the  EU  budget,  common 
funding provided by all industry applicants or a combination of public and industry funding, 
were  considered  relevant  by  32.1  %,  27  %  and  25.2  %  of  citizens,  respectively.  For 
respondents from the stakeholder group, these percentages were 47.7 %, 21.6 % and 9.2 %, 
respectively.  

As regards the potential to re-enforce  the  audit system  used  for  laboratories carrying out 
industry studies, the majority of both citizens (78.3 % of respondents) and stakeholders (72.6 
%  of  respondents)  considered  that  this  would  contribute  to  some  or  to  a  large  extent  to 
strengthening  EFSA’s  risk  assessments.  Some  MS  expressed  reservations  on  the  potential 
added value of this measure.   

Both  citizens  and  stakeholders  considered  that  allocating  more  public  resources  to 
financing food safety studies is important for strengthening EFSA’s risk assessment: around 
80 % of citizen replies state that EU or national funding could contribute to some or to a large 
extent;  the  figure  for  stakeholders  is  slightly  lower.  Some  NGOs  and  EFSA’s  Scientific 
Committee  supported  the  added  value  of  more  public  resources  dedicated  to  food  safety 
studies. 

Discussions  with  stakeholders  highlighted  the  potential  for establishing  procedures for  open 
consultations  on  data  related  to  the  studies  submitted  by  industry  as  part  of  authorisation 
dossiers.  Although  this  was  in  general  welcomed,  some  MS  authorities  and  industry 
stakeholders mentioned the potential negative impact on the length of EFSA’s risk assessment 
processes.  The  latter  also  highlighted  the  potential  negative  impact  on  competitiveness  and 
innovation,  in  particular  on  new  substances  due  to  risks  relating  to  potential  unfair  use  of 
disclosed data and concerns over intellectual property rights.  

4.  RISK COMMUNICATION  

Overall,  all  consulted  parties  acknowledged  the  value  of  the  actions  aiming  to  improve  risk 
communication.  

In  the  OPC,  over  a  third  of  citizens  consider  that  existing  risk  communication  does  not 
contribute  very  much  or  at  all  to  building  trust  in  the  EU’s  decision-making  process  in  the 
food chain. All the new  measures  proposed as potentially strengthening the consistency of 
risk communication were considered by most respondents from both groups to be effective or 
very  effective  (between  61.4  %  and  92.2  %  of  replies).  There  is  an  exception  to  this  in  the 
stakeholder group of respondents: some NGOs (23.5 % of replies from stakeholders) do not 
consider that including general principles of risk communication in legislation would be very 
effective. 

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Some  citizens  highlighted  the  need  to  avoid  complexity  and/or  confusion  in  risk 
communication,  and  recommended  making  it  clearer  and  simpler.  Consumer  organisations 
commented  on  the  need  to  clearly  explain  the  political  choices  made  and  improve  the  MS 
involvement  in  risk  communication.  MS  acknowledged  the  need  for  more  coordination 
among all actors.  

5.  SUSTAINABILITY OF THE RISK ASSESSMENT SYSTEM AND INVOLVEMENT OF MS  

It  was  found  that  the  tools  currently  available  to  support  scientific  cooperation  between 
EFSA and MS to a significant extent already engage MS in the EU risk assessment system: 
over  70  %  of  respondents  (both  citizen  and  stakeholder  groups)  found  that  all  the  tools 
described contribute to some or a large extent.  

Over  40  %  of  citizen  replies  disagreed  or  strongly  disagreed  with  the  statement  suggesting 
that MS are sufficiently involved in EFSA’s  work. There was a similar response from the 
stakeholder  group.  In  addition,  both  citizens  (75.2  %)  and  stakeholders  (79.7  %)  agree  or 
strongly agree that the costs of national bodies’ scientific contribution to EFSA’s tasks should 
be adequately compensated. Most respondents (over 75 % in both the citizen and stakeholder 
groups) agreed or strongly agreed that an increased involvement of MS is important to ensure 
that EFSA has a large pool of experts from MS. MS authorities highlighted the importance of 
incentives  when  promoting  cooperation.  Some  MS,  industry  stakeholders,  NGOs  including 
consumer associations, and EFSA’s Scientific Committee stressed that cooperation with MS 
needs  to  respect  the  independence  of  the  experts  in  their  contribution  to  EFSA  and  the 
separation between risk assessment and risk management.  

As regards MS being represented in EFSA’s Management Board, 57.5 % of citizens and 
53.6 % of stakeholders agreed or strongly agreed. However, 27.7 % of citizen replies and 26.1 
% of stakeholder replies disagree or strongly disagree with this statement. Some citizens and 
stakeholders  (including  MS  authorities)  highlighted  the  need  to  clearly  separate  risk 
assessment and risk management and suggested having representation from other stakeholder 
groups as well. MS authorities also considered the importance of defining clear roles for the 
Management Board to avoid duplication with EFSA’s Advisory Forum.  

Elements  including  EFSA  being  able  to  choose  excellent  and  independent  experts  from  a 
large  pool  of  candidates,  as  well  as  its  independence  from  risk  managers  (Commission  and 
MS)  and  from  industry,  were  found  by  over  80  %  of  respondents  in  both  the  citizen  and 
stakeholder  groups  to  be  useful  or  very  useful.  The  possibility  of  choosing  excellent  and 
independent  experts  from  a  large  pool  of  candidates  scored  higher,  with  96.2  %  of  citizen 
replies  and  98.7  %  of  stakeholder  replies  considering  it  useful  or  very  useful.  Avoiding 
scientific divergences between the EU and national levels was considered to be useful or very 
useful by 72.3 % of respondents from the citizen group; this equals 79.1 % for the stakeholder 
group.  Over  75  %  of  respondents  from  both  groups  considered  it  useful  or  very  useful  to 
avoid  duplication  of  risk  assessments  between  EU  and  national  levels,  and  to  ensure  an 
appropriate level of resources for EFSA.  

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Some  MS  authorities  highlighted  the  need  to  ensure  a  proper  balance  between  EFSA’s 
independence  policies  and  its  links  with  scientific  excellence,  and  the  need  to  consider 
incentives  to  stimulate  the  contribution  of  MS  experts  to  EFSA’s  work,  including  financial 
and non-financial elements.  

6.  CONCLUSIONS 

Overall,  in  their  replies  citizens  and  stakeholders  expressed  the  importance  of  the  elements 
addressed by the Commission initiative to improve the EU risk assessment in the food chain. 
They  also  highlighted  the  need  to  ensure  that  the  Commission  proposal  strengthens  these 
elements while safeguarding the principles on which the EU food safety system is based. 

The  contributions  to  the  different  consultations  showed  a  need  to  consider  the  following 
when preparing the Commission proposal: 

  The earlier the access to industry studies in the risk assessment process, the greater its 

impact on transparency. 

  Safeguarding confidentiality and intellectual property rights is fundamental in order to 

avoid hampering innovation and competitiveness. 

  Details on what information from industry studies can be claimed as confidential need 

to be clear, and the related claims must be thoroughly assessed. 

  Need  for  proportionate  verification  processes  on  the  quality  of  industry  studies  as 

regards compliance with relevant standards. 

  Potential  value  of  EFSA’s  pre-submission  advice  to  industry  applicants  while  fully 

respecting the independence of scientific processes. 

  Capacity for more public resources to finance studies on food safety. 
  Need to tackle potential negative impacts of consultations on studies submitted on the 
length of the assessment processes. Need to ensure the protection of confidential data 
and personal data.  

  Risk  communication  on  food  safety  can  be  further  strengthened  by  improving 

coordination and involving relevant stakeholders.   

  Further  involvement  of  MS  authorities  in  EFSA’s  activities  must  continue  to  ensure 

the separation between risk assessment and risk management. 

  Scientific  independence  and  excellence  of  experts  are  cornerstones  of  the  EU  risk 

assessment system. 

  Adequate incentives are needed in order to ensure that EFSA obtains the expertise it 

needs from MS.  

6