Proposal for a 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 (EU) 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

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   EUROPEAN COMMISSION  Brussels, 11.4.2018 COM(2018) 179 final 2018/0088 (COD)  Proposal for a 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 (EU) No 2015/2283 [on novel foods] (Text with EEA relevance) {SWD(2018) 97 final}  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

 

Reasons for and objectives of the proposal 

Regulation (EC) No 178/2002 on general food law (the “GFL” Regulation) provides 
for  a  comprehensive  harmonised  legal  framework.  It  establishes  certain  general 
principles to underpin all future Union and national food law, the most important of 
which  is  the  risk  analysis  principle.  The  risk  analysis  principle  consists  of  three 
separate but interconnected components: risk assessment, risk management and risk 
communication.  Risk  assessment  is  defined  as  the  scientifically  based  process 
consisting  of  four  steps:  hazard  identification,  hazard  characterisation,  exposure 
assessment  and  risk  characterisation.  Risk  management  is  defined  as  the  process, 
distinct  from  risk  assessment,  of  weighing  policy  alternatives  in  consultation  with 
interested  parties,  considering  risk  assessment  and  other  legitimate  factors,  and,  if 
need be, selecting appropriate prevention and control options. Risk communication is 
defined as the interactive exchange of information and opinions throughout the risk 
analysis process as regards hazards and risks, risk-related factors and risk perceptions 
amongst  risk  assessors,  risk  managers,  consumers,  feed  and  food  businesses,  the 
academic community, including the explanation of risk assessment findings and the 
basis of risk management decisions.  

Risk assessment at Union level is carried out by an autonomous agency established 
by  the  GFL  Regulation,  the  European  Food  Safety  Authority  (EFSA),  separately 
from the risk management function of the Union Institutions, and mainly that of the 
Commission. Its primary mission is to provide scientific advice at the request of the 
Commission, Member States and the European Parliament and on its own motion. Its 
mandate is broad and covers all issues impacting directly or indirectly on food and 
feed  safety  (including  the  evaluation  of  dossiers  put  forward  for  the  approval  of 
substances1),  animal  health  and  animal  welfare,  plant  health,  human  nutrition,  and 
GMO issues.  

As confirmed in the recently published Fitness Check of the GFL Regulation (GFL 
Fitness  Check)2,  the  rigorous  implementation  of  the  risk  analysis  principle 
throughout  the  Union  law  has  overall  raised  the  level  of  protection  from  potential 
food  safety  risks  in  a  number  of  ways.  Indeed,  the  science-based  approach  to  food 
legislation,  underpinned  by  the  establishment  and  operation  of  EFSA  at  centralised 
level, has overall improved the scientific basis of measures taken in the area of food 
law and has further contributed to harmonised views between Member States on key 
safety issues as well as to the Union product safety recognition worldwide.  

The impetus for the GFL Regulation came from a succession of food related crises, 
notably  the  Bovine  Spongiform  Encephalopathy  (BSE)  crisis,  foot  and  mouth  disease 
and dioxin in the late 90s-early 2000s. These put public health at great risk and the 
resulting  market  support  measures  and  trade  disruption  cost  a  huge  amount.  They 
also  seriously  undermined  public  confidence  in  the  Union  food  safety  regulatory 
framework.  The  political  response  was  to  adopt  a  White  Paper  on  Food  Safety  in 

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Food  law  authorisations  cover  different  subject  matters:  substances,  products,  health  claims  and 
processes but for the ease of reading, the reference to substances in the text covers all. 
Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation 
(EC) No 178/2002)”, SWD (2018)38 final, dated 15.1.2018. 

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January  2000.  This  paved  the  way  for  a  complete  overhaul  of  the  regulatory 
framework,  with  the  focus  on  the  GFL  Regulation  in  2002.  The  separation  of  risk 
management and risk assessment, with the newly created EFSA responsible for risk 
assessment, was the single biggest innovation in the GFL Regulation.  

In its Communication replying to the European Citizens’ Initiative “Ban glyphosate 
and protect people and the environment from toxic pesticides”3, the Commission also 
announced  the  preparation  of  a  legislative  proposal  “covering  transparency  in 
scientific assessments, quality and independence of the scientific studies that are the 
basis  of  the  Union  risk  assessment  carried  out  by  EFSA  and  the  governance  of 
EFSA”. In parallel, the Commission’s Scientific Advice Mechanism has been asked 
to prepare an opinion on the authorisation process of plant protection products.  

These developments took place against the backdrop of public controversy over the 
approach  towards  the  assessment  and  management  of  sensitive  substances  such  as 
genetically  modified  organisms,  and  plant  protection  products,  especially  those 
containing glyphosate or potentially negative health impacts arising from endocrine 
disruptors. 

The main objectives of this initiative are to update the GFL Regulation so as to: 

 

 

 

 

 

tighten  and  clarify  the  rules  on  transparency,  especially  with  regard  to  the 
scientific studies used as the basis for  risk assessment the EFSA carries out;  

increase  the  guarantees  of  reliability,  objectivity  and  independence  of  studies 
the  EFSA  uses  in  its  risk  assessment,  in  particular  in  the  context    of 
authorisation applications; 

improve  the  governance  of  and  strengthen  the  scientific  cooperation  of 
Member States with and their involvement  in the EFSA;  

strengthen the ability of EFSA to maintain a high level of scientific expertise in 
the  different  areas  of  its  work,  especially  its  capacity  to  attract  excellent 
scientists  to  be  members  of  its  Scientific  Panels;  bearing  the  related  financial 
and budgetary aspects in mind too, and, 

develop a comprehensive and effective risk communication strategy, involving 
the  Commission,  Member  States  and  the  EFSA  throughout  the  risk  analysis 
process, combined with open dialogue amongst all interested parties. 

Problems that the initiative aims to tackle 

The GFL Fitness Check and recent public debates have shown that certain aspects of 
the current legislative framework need to be addressed. In particular: 

 

Citizens demand that the risk assessment process in the area of food law (and 
the  decision-making  based  on  it)  be  more  transparent.  Transparency  and 
confidentiality  rules  currently  vary  depending  on  the  sub-area  of  regulation 
concerned. 

  Many  stakeholders  and  citizens  complain  that  the  EFSA’s  evaluations  of 
authorisation applications are essentially based on studies, data and information 
generated (and paid for) by the applicant for authorisation. Current procedures 
are  based  on the principle that it is for the applicant  to  prove that the subject 

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C(2017) 8414 final. 

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 

matter of an authorisation procedure complies with Union safety requirements 
given the scientific knowledge in its possession. This principle is based on the 
premise  that  public  health  is  better  protected  when  the  burden  is  on  the 
applicant to prove that a particular food or feed is safe prior to its placing on 
the  market,  instead  of  the  public  authorities  having  to  prove  that  it  is  unsafe. 
Moreover,  public  money  should  not  be  used  to  commission  costly  studies 
(several  thousand  to  several  million  Euros)  that  will  eventually  help  the 
industry to place a product on the market. This principle remains valid, but the 
concerns  on  the  transparency  and  independence  of  industry-generated  studies 
and data should be addressed.  

Risk communication was also found not to be effective enough. Evidence has 
pointed  to  occasional  divergences  and,  in  very  few  occasions,  conflicting 
communications amongst Union and national risk assessors and risk managers, 
which  may  have  an  adverse  impact  on  public  perception  as  regards  the 
assessment and management of risk related to the agri-food chain. Divergences 
between  Union  and  national  risk  assessors,  however,  do  not  necessarily 
question the work of the different scientific bodies. These can be explained by 
a  variety  of  factors  including  for  instance:  the  legal  framework  to  which  the 
question refers, the type of question put to scientific bodies by the relevant risk 
managers and how these are framed, whether the assessment relates to a hazard 
or  a  risk,  the  methodologies  followed,  or  the  data,  which  are  utilised.  The 
reasons underlying differences in the assessments and conclusions of scientific 
bodies should be better communicated to the public in order to facilitate their 
understanding.  Furthermore,  scientific  divergences  related  to  food  and  feed 
safety  are  particularly  high  on  the  public  agenda,  whether  these  are  real  or 
perceived,  especially  where  other  societal  choices  are  at  stake,  such  as  the 
protection of the environment or consumers’ right to choose the type of foods 
which  they  eat.  EFSA  is  currently  empowered  to  communicate  on  its  own 
initiative 
the 
Commission’s  competence  to  communicate  its  risk  management  decisions. 
However,  given  the  limits  of  its  competence,  EFSA’s  risk  communication 
activities cannot address questions on issues other than science, notably the risk 
management  decisions  informed  by  its  scientific  advice.  It  is  therefore 
necessary to ensure a more comprehensive and continuous risk communication 
process throughout the risk analysis process, involving Union and national risk 
assessors  and  risk  managers  combined  with  open  dialogue  amongst  all 
interested parties. 

its  mission,  without  prejudice 

the  fields  within 

to 

in 

 

The EFSA’s effectiveness depends on its capacity to attract and pool expertise 
from Member States. The following factors have an impact on this: 

– 

– 

Difficulties  in  attracting  new  experts  due  to  insufficient  recognition  of 
scientists’  career,  inadequate  financial  compensation  in  particular  for 
their employers and excessive demand on their time. 

Dependence on a small number of Member States that provide more than 
two  thirds  of  the  EFSA’s  Scientific  Panels’  experts  and  difficulties  in 
receiving  sufficient  support  from  many  Member  States  for  its  scientific 
work (e.g. by providing  studies, or data).  

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In  addition,  unlike  in  the  case  of  other  Union  Agencies,  EFSA  governance  has  not 
yet  been  brought  in  line  with  the  Common  Approach  on  Union  decentralised 
agencies, including with regard to the composition of its Management Board. 

 

Consistency with existing policy provisions in the policy area 

As  far  as  transparency  and  confidentiality  aspects  are  concerned,  it  is  necessary  to 
amend  not  only  the  General  Food  Law  Regulation  but  also  the  following  eight 
additional sectoral legislative acts covering the food chain, i.e. Directive 2001/18/EC 
of the European Parliament and of the Council4, Regulation (EC) No 1829/2003 of 
the European Parliament and of the Council5, Regulation (EC) No 1831/2003 of the 
European  Parliament  and  of  the  Council6,  Regulation  (EC)  No  2065/2003  of  the 
European  Parliament  and  of  the  Council7,  Regulation  (EC)  No  1935/2004  of  the 
European  Parliament  and  of  the  Council8,  Regulation  (EC)  No  1331/2008  of  the 
European  Parliament  and  of  the  Council9,  Regulation  (EC)  No 1107/2009  of  the 
European  Parliament  and  of  the  Council10  and  Regulation  (EU)  2015/2283  of  the 
European Parliament and of the Council11.  

Regulation  (EC)  No  178/2002,  Directive  2001/18/EC,  Regulation  (EC)  No 
1829/2003, Regulation (EC) No 1831/2003 and Regulation (EC) No 2065/2003 are 
currently  included  in  the  Commission’s  horizontal  alignment  legislative  proposal 
adopted  in  201612.  As  explained  in  the  Explanatory  Memorandum  of  the  latter 
proposal,  the  Commission  did  not  include  in  its  horizontal  alignment  legislative 
proposal,  amongst  others,  Regulation  (EC)  No  1935/2004,  Regulation  (EC)  No 
1331/2008 and Regulation (EC) No 1107/2009, as it is reflecting on whether there is 
a  more  appropriate  way 
individual 
authorisations/setting  of  values/listing  of  specific  substances  based  on  the  specific 
criteria set out in those acts, bearing in mind the improved approach adopted by the 
co-legislators in the context of Regulation (EU) 2015/2283 and the ongoing REFIT 

these  acts  as  concerns 

to  structure 

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Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). 
Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 
on smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, p. 1). 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4). 
Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 
establishing a common authorisation procedure for food additives, food enzymes and food flavourings 
(OJ L 354, 31.12.2008, p. 1). 
Regulation  (EC)  No 1107/2009  of  the  European  Parliament  and  of  the  Council  of  21 October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and  repealing  Regulation  (EC)  No  258/97  of  the  European  Parliament  and  of  the  Council  and 
Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). 
Proposal  for  a  Regulation  of  the  European Parliament  and  of  the  Council adapting  a  number  of  legal 
acts  providing  for  the  use  of  the  regulatory  procedure  with  scrutiny  to  Articles  290  and  291  of  the 
Treaty on the Functioning of the European Union, COM(2016)799 final, dated 14.12.2016. 

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reviews  of  Regulation  (EC)  No  1935/2004  and  Regulation  (EC)  No  1107/2009. 
These reasons are still valid. The present proposal provides one empowerment for a 
delegated act in the context of Regulation (EC) No 178/2002, which is in the process 
of being aligned. 

 

Consistency with other Union policies 

Targeted changes are proposed to align the composition of the Management Board of 
EFSA  and  the  procedure  for  the  external  evaluation  of  EFSA  to  the  Common 
Approach set out in the annex to the 2012 inter-institutional joint statement on Union 
decentralised agencies.  

Since  some  specific  changes  of  EFSA’s  functioning  (pre-submission  advice, 
composition  of  the  Panels)  are  proposed,  care  has  been  taken  to  take  into  account 
procedures followed by other  scientific agencies with  special  attention to European 
Chemicals Agency (ECHA) and European Medicines Agency (EMA).  

2. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

 

Legal basis 

The  proposal  is  based  on  Articles  43,  114,  and  168(4)(b)  of  the  Treaty  on  the 
Functioning of the European Union.  

 

Subsidiarity (for non-exclusive competence)  

The GFL Fitness Check has  clearly shown that a high level of protection of public 
health and consumers’ interests across the Union in the area of food is best achieved 
through  Union  action.  In  particular,  the  systematic  implementation  of  the  risk 
analysis principle at Union level has raised the overall level of protection of human 
health  across  the  Union  and  minimised  differences  in  approach  between  Member 
States  to  key  food  safety  risks.  This  in  turn  ensures  that  there  is  a  common 
understanding  of  and  approach  to  food  safety  that  promotes  both  the  effective 
implementation  and  enforcement  of  legislation  and  facilitates  the  operation  of  the 
internal market in a key sector of the European economy. Member States appreciate 
that the challenges in relation to food safety, in an environment with very high levels 
of trade and a complex food supply chain, require a strong Union regulatory system. 
Business and civil society stakeholders are of the same mind. There are still strong 
memories  of  the  damage  caused  by  successive  food  safety  crises  prior  to  the  GFL 
Regulation which undermined the credibility of the Union to ensure that food is safe. 
Moreover,  as  indicated  in  the  GFL  Fitness  Check,  food  and  feed  safety  measures 
have the greatest effect when taken at Union level.  

 

Proportionality 

Given the problems identified above, the purpose of this Regulation is to introduce 
changes  to  the  existing  legal  framework  which  are  limited  to  what  is  strictly 
necessary to achieve the objectives set up for the initiative in order to improve citizen 
and  stakeholder  confidence  in  the  transparency  and  sustainability  of  the  Union 
approach towards food safety, notably in relation to risk assessment. 

In  particular,  the  increased  level  of  transparency  and  accountability  of  the  studies 
EFSA  uses  to  assess  risks  could  not  be  achieved  without  opening  up  those  studies 
and  the  data  they  use  to  public  scrutiny.  In  addition,  the  current  rules  on 
confidentiality  vary  according  to  the  sub-area  concerned,  thus  not  ensuring  a 
consistent way to manage transparency. It is proportionate to harmonise these rules 

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while  preserving,  where  needed,  the  specific  balance  of  interests  in  sectoral 
legislations. Appropriate provisions are included to protect the rights of commercial 
applicants. 

The assessment of the impacts outlines how the proposal achieves the best balance in 
meeting  the  objectives  laid  out  by  the  initiative,  ensuring  benefits  for  citizens, 
stakeholders  and  Member  States,  while  not  significantly  impacting  on  industry  and 
innovation.  The  consultation  carried  out  demonstrates  an  overall  support  of 
stakeholders to the initiative.  

The regulatory regime on food safety needs to be strong to ensure its credibility and 
effectiveness.  Problems  in  relation  to  safety  have  a  huge  impact  on  consumers’ 
confidence  and  consequently  on  market  stability,  trade  flows  and  the  climate  for 
innovation.  

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

 

Ex-post evaluations/fitness checks of existing legislation 

The  GFL  Fitness  Check,  completed  on  15  January  2018,  concluded  that  the 
systematic  implementation  of  the  risk  analysis  principle  in  Union  food  law  has 
increased overall protection of public health. Setting up the EFSA has given Union 
measures  a  sounder  scientific  basis.  It  has  made  major  progress  on  increasing  its 
scientific  capacity  of  expertise,  boosting  the  quality  of  its  scientific  outputs, 
expanding  its  collection  of  scientific  data  and  developing  and  harmonising  risk 
assessment methodologies. It has also strengthened the cooperation with national and 
international  scientific  bodies  as  well  as  the  exchange  of  information  between 
Member  States,  the  Commission  and  EFSA  itself.  This  has  resulted  in  a  mutual 
understanding  of  risks,  minimised  duplications  of  work  and  limited  the  number  of 
scientific  divergences  between  the  EFSA  and  other  risk  assessment  bodies.  The 
EFSA  also  regularly  fine-tunes  and  strengthens  its  strict  policies  on  independence, 
transparency and openness.  

Nevertheless,  the  following  challenges  have  been  identified:  national  differences  in 
the  implementation  of  the  GFL  Regulation  at  Member  State  level  have  been 
observed, creating in some instances uneven playing field for businesses; a perceived 
lack  of  transparency  of  the  risk  analysis  process;  risk  communication  is,  overall, 
considered not to be effective enough, thus creating a negative impact on consumers’ 
confidence and on the acceptability of risk management decisions; certain limitations 
in EFSA’s capacity to ensure in the long-term sufficient expertise and to fully engage 
all Member States in scientific cooperation; lengthy authorisation procedures in some 
sectors.  

This  proposal  is  addressing  those  challenges  directly  linked  to  the  GFL  Regulation 
and EFSA. 

 

Stakeholder consultations 

Member States were consulted in a meeting of the Expert Group on the General Food 
Law  on  5  March  2018.  The  national  food  safety  authorities  of  the  Member  States 

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(meeting  of  the  EFSA  Advisory  Forum  on  6  February  201813)  and  the  Scientific 
Committee of EFSA (15 February 2018) were also consulted. 

European  stakeholder  organisations  representing  farmers,  cooperatives,  the  food 
industry, retailers, consumers, professionals and civil society were consulted at an ad 
hoc meeting of the Advisory Group on the Food Chain, Animal and Plant Health on 
5 February 201814. 

A public consultation on the initiative in all Union official languages was launched 
on  23  January  2018  and  ran  until  20  March  2018;  471  replies  were  received  (318 
from individuals and 153 from organisations).  

The contributions received from citizens and stakeholders confirmed the importance 
of the aspects of the Union food safety risk assessment model this proposal addresses 
and  the  need  to  ensure  that  the  proposal  strengthens  all  those  aspects,  while 
safeguarding the principles on which the Union food safety system is based.  

In drafting the proposal, contributions have been taken into account  for measures in 
four  specific  areas:  the  publication  of  studies  supporting  industry  applications  of 
regulated products while protecting confidential  and personal data; guarantees in the 
Union to verify the reliability, and independence of the evidence taken from industry 
studies;  making    risk  communication  more  efficient;  and  strengthening  EFSA’s 
sustainability and governance while ensuring the independence and excellence of the 
expertise made available to the Authority by the Union Member States. 
The results of all consultation activities are summarised in the synopsis report15. 

 

Collection and use of expertise 

Extensive  consultation  and  data  collection  (including  external  studies,  extensive 
surveys,  case  studies  and  workshops  as  well  as  in-depth  interviews  with  relevant 
stakeholders) has taken place on the issues this proposal addresses in the context of 
the GFL Fitness Check16. 

Impact assessment 

 
As  explained  in  the  Roadmap17,  no  impact  assessment  was  carried  out  for  this 
initiative,  as  the  measures  that  are  to  be  introduced  by  the  proposal  will  mainly 
concern the transparency and the way the Commission as risk manager and the EFSA 
as risk assessor will gather and manage the evidence needed to perform their tasks on 
the  basis  of  unchanged  criteria.  Such  measures  are  therefore  not  expected  to  have 
significant socio-economic and environmental impacts that are clearly identifiable ex 
ante. 

A  number  of  impacts  were  however  considered  during  the  preparation  process  as 
follows: 

Transparency:  The  proposal  aims  at  strengthening  the  transparency  of  the  risk 
assessment  process.    This  should  give  EFSA  greater  legitimacy  in  the  eyes  of 
consumers and the general public, increasing their confidence in its work. Since duly 

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https://www.efsa.europa.eu/sites/default/files/event/180206/180206-m.pdf   
https://ec.europa.eu/food/expert-groups/ag-ap/adv-grp_fchaph/wg_2018_en 
Commission Staff Working Document, Synopsis Report, SWD(2018)97, [dated 11.04.2018]. 
https://ec.europa.eu/food/safety/general_food_law/fitness_check_en  
https://ec.europa.eu/info/law/better-regulation/initiative/151777/attachment/090166e5b7579aa2_en  

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justified  confidential  information  is  protected,  incentives  for  innovation  should 
remain unchanged. The proposal will not impinge on any intellectual property right 
which may exist over documents or their content,  nor on any regulatory protection 
set  out  in  Union  sectoral  legislation  covering  the  agri-food  chain  rewarding 
investments (the so-called “data exclusivity rules”). Compliance costs for businesses 
will not increase because existing rules already require applications including studies 
to be submitted to the relevant regulatory authority, e.g. the Commission, EFSA and 
the Member States, followed by confidentiality claims. The main identified costs fall 
on EFSA, since it will have the main responsibility of taking a decision, within tight 
deadlines to avoid making the authorisation procedures longer, on all confidentiality 
claims  made  by  applicants  in  the  context  of  authorisation  procedures,  in  cases  in 
which an opinion of EFSA is to be provided. 

in 

the 

line  with 

Governance and greater Member State involvement in the Management Board: 
The  proposal  will  align  EFSA’s  governance  with  the  model  used  for  other  Union 
agencies 
inter-institutional  Common  Approach  on  Union 
decentralised agencies, thus increasing the global consistency of the Union agencies’ 
Management Board model. This should have a positive impact since experience from 
other  Union  agencies  demonstrates  that  this  model  ensures  efficient  supervision  of 
the  functioning  of  agencies  and  coordinated  views  between  the  Union  and  national 
level. As for other agencies, EFSA independence is appropriately safeguarded by the 
criteria for nomination that privilege members with a profile of risk assessor and the 
strong provisions on independence and on transparency since the rules providing that 
the  members  of  the  Management  Board  have  to  act  independently  in  the  public 
interest  and  make  an  annual  public  declaration  of  interests  remain  unchanged.  In 
addition,  the  role  of  the  Management  Board  is  focussed  on  administration  and 
finances.  

Governance  and  greater  Member  State  involvement  in  nominating  Scientific 
Panel  experts:  the  benefit  of  greater  Member  State  involvement  in  this  aspect  of 
EFSA’s work is expected to be to ensure it has access to a sufficiently large pool of 
independent and excellent experts meeting its needs in the different disciplines areas 
it deals with. This in turn is expected to have a positive impact on the sustainability 
of  the  Union  risk  assessment  system.  The  risk  that  some  Member  States  might  not 
have  enough  experts  to  be  able    to  provide  the  EFSA  with  valuable  candidates    is 
alleviated by the possibility for EFSA to select and appoint additional experts of its 
own  accord  and  the  possibility  for Member  States  to  appoint  experts  who  have  the 
nationality of other Member States. This risk is also addressed by the better financial 
compensation of Member States contributing to EFSA’s work by sending experts or 
providing  preparatory  work.  Provisions  in  relation  to  the  nomination,  selection  and 
appointment  of  experts  include  strict  criteria  on  independence,  thus  providing 
appropriate  safeguards.  The  involvement  of  the  EFSA  Executive  Director  in  the 
selection  process  is  an  additional  guarantee  that  the  independence  criteria  will  be 
met.  In  particular,  the  Executive  Director,  whose  function  is  to  defend  EFSA’s 
independent point of view and interests, selects the experts proposed for appointment 
to  the  Management  Board  from  the  large  pool  of  experts  nominated  by  Member 
States.  The  selection  process  by  the  Executive  Director  involves  checking  that  the 
experts it proposes are in line with EFSA’s policy and rules on independence and it is 
expected that the Executive Director, given its specific role, will be vigilant on this 
key issue for EFSA.     

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With regard to the reliability and robustness of studies submitted by industry in 
the  context  of  authorisation  procedures,  the  following  impacts  were  in 
particular considered:  

The  measures  establishing  a  register  of  commissioned  studies  and  the  measure 
providing for a consultation on submitted studies will bring benefits by ensuring that 
EFSA  has  access  to  as  much  evidence  as  possible  on  a  substance  submitted  for  its 
assessment. The register of commissioned studies will have a positive impact on the 
objectivity  of  the  evidence  submitted  by  industry  since  it  will  provide  additional 
guarantee  that  applicants  submit  all  studies  they  have  performed  on  a  substance  -
whatever their results. In particular EFSA will be able to cross-check the information 
on the studies performed (the laboratories being an external source of information). 
The consultation on submitted studies will identify other available relevant scientific 
data  or  studies  on  a  substance  subject  to  authorisation  thus  strengthening  EFSA’s 
evidence  base  and  diminishing its  reliance  on  only  industry  studies.  The  impact  on 
the timing of authorisation is minimal since the notification of commissioned studies 
takes place at the pre-submission stage and the risk assessment will run in parallel of 
the consultation on submitted studies 

The notification of commissioned studies creates a minimal burden. The consultation 
on submitted studies does not create additional burdens since the obligation to submit 
studies to EFSA, Commission and Member States already exists. There is only a very 
limited risk that notification by laboratories, meaning only Union laboratories, could 
have negative impacts on their competitiveness vis-à-vis non-Union laboratories, or 
that  the  overall  effectiveness  of  the  measure  may  be  undermined  by  applicants 
deciding  to  carry  out  studies  in  laboratories  outside  the  Union  to  circumvent  the 
notification  obligation.  This  is  because  companies  going  to  laboratories  outside  the 
Union would take the risk to be perceived as evading the rules.  

The specific obligations in the case of renewals of authorisations: The obligation 
to  notify  EFSA  of  planned  studies  and  to  systematically  carry  out  consultation  on 
these planned studies with the EFSA issuing systematic advice on the content of the 
intended  application  are  expected  to  have  a  positive  balance  of  effects.  Since  they 
concern the authorisation of a substance already on the market for several years and 
given that they address planned studies, the experience from the similar procedures 
under ECHA shows that there is public knowledge and in some cases new data that 
can be usefully shared concerning the substance at issue. Such obligations avoid the 
unnecessary  repetition  of  studies  on  vertebrates  and  enlarge  the  evidence  base  of 
EFSA, without jeopardising the competitiveness of the relevant applicant. Indeed, the 
notification of planned studies represents a relatively small burden for the applicant. 
It is also proportionate given that the applicant can get useful advice on the content 
of its intended application following the consultation on the planned studies and this 
at  an  early  stage  of  the  process.  The  impact  on  the  duration  of  the  authorisation 
procedures is minimal since this procedure is at the pre-submission stage and it may 
have  a  positive  impact  in  reducing  the  length  of  authorisation  procedures,  as 
concerns may be raised and addressed early on in the process. The impact in terms of 
costs and resources needed is mostly on EFSA. 

The  pre-submission  procedure  ensures  an  additional  involvement  of  EFSA,  to 
ensure  that the  applicant is  aware of and  can  adhere  to  the applicable requirements 
relating  to  the  content  of  authorisation  applications.  It  addresses  industry  demands 
(in  particular  SMEs)  for  further  support  in  the  preparation  of  the  authorisation 
application.  This  should  also  lead  to  more  adequate  and  complete  evidence  being 

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in  particular  small  and  medium  sized  enterprises 

submitted and thus improve the efficiency of the risk assessment process in EFSA. It 
in 
will  help  applicants 
understanding how to prepare authorisation applications. EFSA’s independence will 
not  be  affected  to  any  extent  since  the  scope  of  the  advice  that  EFSA  provides  is 
limited  to  what  the  relevant  provisions  are  and  what  the  required  content  of  the 
application at stake is. Furthermore, the EFSA staff will provide the advice without 
the involvement of the Scientific Panels. EFSA provides the advice in a transparent 
way since it makes it public.  

There  should  be  no  negative  impact  for  innovation  from  the  measures  on  the 
reliability  and  robustness  of  studies.  As  indicated,  the  measures  create  small 
additional  burdens  for  applicants  since  they  are  limited  to  the  notifications  of 
commissioned  studies  in  all  cases  and  of  planned  studies  in  the  case  of  renewals, 
given that the submission of studies in authorisation application is already foreseen 
in  existing  legislation.  The  potential  impact  of  revealing  the  business  strategy  of  a 
company by the notification of commissioned studies on a new substance has been 
neutralised since this information is made public only when the studies included in 
the corresponding authorisation application are made public so at a time where such 
a  publication  cannot  have  the  effect  to  reveal  a  business  strategy.  In  addition,  the 
confidentiality  regime  established  by  the  proposal  provides  that  any  information 
revealing  the  business  strategy  of  the  applicant  is  confidential.  The  impact  for 
innovation  (divulging  business  strategy)  is  not  significant  for  the  notification  of 
planned studies in case of renewals since the substance is already known and the date 
of renewal is set up in legislation The pre-submission procedure will help the SME’s 
access to innovation and is at the request of the applicant except for renewals which 
represent  a  specific  case  and  a  limited  number  of  applications.  It  will  not  divert 
positive investments for innovation to defensive investments, since the measures are 
limited to providing transparent information on studies that in any case the applicant 
has  to  carry  out  in  accordance  with  already  existing  legislation.  Enhanced 
transparency  is  expected  to  contribute  to  strengthening  a  climate  of  consumers’ 
confidence  that  is  beneficial  for  stimulating  innovation  and  for  the  Union  product 
safety recognition worldwide. The impact on the timing of authorisation is minimal 
as detailed for each measure. 

Globally,  all  these  measures  will  also  contribute  to  an  increased  involvement  of 
stakeholders  in  the  risk  assessment  system  and  thus  to  a  more  effective  risk 
communication. 

With  regard  to  additional  controls  on  the  conduct  of  studies,  the  two  measures 
proposed  (audit/controls  by  Union  inspectors  and  possibility  to  commission  ad  hoc 
studies in exceptional circumstances with the aim to verify evidence used by EFSA 
in  its  risk  assessment),  will  provide  additional  assurances  on  the  quality  and 
objectivity of the studies used by EFSA for its risk assessment while not impacting 
on innovation since limited to specific or exceptional cases.  

Auditing  by  the  European  Commission:  This will strengthen  the  guarantees  on  the 
quality  of  the  studies  EFSA  takes  into  consideration  in  its  risk  assessments,  in 
particular  with  regard  to  the  reproducibility  of  results.  The  risk  of  duplicating  with 
activities  Member  States  carry  out  under  OECD  agreements  is  addressed  since  the 
Commission  auditing  programme  will  be  complementary  to  and  coordinated  with 
OECD  Good  Laboratory  Practices  (GLP)  auditing  programmes,  which  currently 
audit each Member State monitoring authority every 10 years. The lack of legal basis 
to audit the monitoring authorities of non-European Union countries is dealt with by 

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coordinating activities with the Member States and OECD GLP programmes and by 
seeking to conclude bilateral international agreements. There are no negative impacts 
in  the  duration  of  authorisation  procedures  since  this  is  a  parallel  activity.  The 
Commission will bear the limited costs. 

The possibility to ask the EFSA to exceptionally commission studies: This is an 
additional  tool  where  scientific  evidence  upon  which  EFSA  relies  needs  to  be 
verified.  It  ensures  that  action  can  be  taken  at  Union  level  where  there  are 
exceptional circumstances of serious controversies or conflicting results. The risk of 
this tool being disproportionally used to unnecessarily commission studies is limited: 
it is to be triggered by the Commission since it will be financed by the Union budget 
and  only  in  exceptional  circumstances.  There  is  no  risk  of  public  authorities 
becoming responsible for providing evidence on the safety of substance for EFSA’s 
assessment, since the principle that it is the responsibility of the industry (applicants) 
to provide such evidence during the risk assessment process remains. There is no risk 
of  duplication  with  the  actual  capacity  of  EFSA  to  commission  scientific  studies 
necessary for the performance of its mission (Article 32 of the GFL Regulation) as 
this is to be considered as a risk management tool.  

Alternatives considered: 

The  option  having  Member  States  requesting  EFSA  to  commission  studies  in 
exceptional  circumstances  as  well  as  the  option  having  EFSA  commissioning  such 
studies on its own motion were not chosen in the end for reasons of proportionality 
(public financing) but also because the EFSA and Member States can already signal 
to the Commission specific reasons to make use of this specific tool.    

 

Regulatory fitness and simplification 

As  announced  in  the  Communication  replying  to  the  European  Citizens’  Initiative 
“Ban glyphosate and protect people and the environment from toxic pesticides”, this 
proposal is a targeted revision of the GFL Regulation (and other measures adopted in 
that  framework)  in  order  to  improve  transparency  in  risk  assessment,  reliability, 
objectivity  and  independence  of  studies  used  by  EFSA  in  its  risk  assessment,  risk 
communication, and governance of EFSA. As this is a revision of an existing piece 
of  legislation  falling  under  the  Commission’s  Regulatory  Fitness  and  Performance 
Programme  REFIT,  the  Commission  has  looked  at  opportunities  to  simplify  and 
reduce burdens. Given the targeted nature of this revision, focussing on transparency, 
the main simplification aspect concerns the introduction of a pre-submission advice 
which should provide support to applicants, in particular SMEs, to better understand 
the specifications on content of applications. 

Other  simplification  aspects  include  the  harmonisation  of  the  confidentiality  rules 
across different sectors providing a similar baseline to all industry applicants in terms 
of predictability.  

On  transparency,  the  measures  envisaged  (i.e.  proactive  disclosure  of  non-
confidential  data,  register  of  commissioned  studies,  voluntary  pre-submission 
procedure,  pre-notification  of,  and  advice  on    planned  studies  in  case  of  renewals, 
consultation of third parties on submitted studies) provide a robust framework which 
is proportional to the objective of enhancing citizens’ confidence in the transparency 
of the system. The Commission does not see scope to simplify or reduce these steps 
as this could have a negative impact not only on the perception of the transparency of 

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the system but also on ensuring that the evidence presented for EFSA’s assessments 
is complete. 

 

Fundamental rights 

To  determine  what  level  of  disclosure  strikes  the  appropriate  balance,  the  public 
interest  in  ensuring  greater  transparency  in  the  risk  assessment  process  is  weighted 
up  against  the  commercial  interests  at  stake.  This  means  taking  into  account  the 
general  objectives  of  the  GFL  Regulation,  namely  a  high  level  of  protection  of 
human health and  consumers’  interests  and the effective functioning of the internal 
market.  To  this  end,  the  proposal  sets  out  a  cross-sectoral  list  of  information  items 
whose disclosure might be considered to significantly harm the commercial interests 
at  stake  and  should  therefore  not  be  disclosed  to  the  public.  The  proposal  also 
stipulates  that  personal  data  be  protected  taking  into  account  the  applicable  Union 
legislative framework on the processing of such data. 

4. 

BUDGETARY IMPLICATIONS 

The main objective of the proposal is to make studies used in risk assessment more 
transparent  and  address  the  demands  of  society  for  a  more  transparent  and 
independent  risk  assessment  process  and  more  effective  risk  communication.  By 
strengthening the EFSA’s governance and making risk assessment more sustainable, 
it will ensure that EFSA will continue to play a fundamental role in the Union food 
safety system and to contribute to the health and wellbeing of Union citizens and to 
an innovative and competitive Union agri-food industry.  

To  address  these  issues,  the  Commission  has  come  up  with  a  wide  ranging  and 
ambitious  proposal  requiring  a  significant  increase  in  the  resources  available to  the 
EFSA to enable it to discharge its existing and proposed new responsibilities. 

Member  States  that  provide  the  EFSA  with  expertise  also  need  to  receive  more 
compensation. 

5. 

OTHER ELEMENTS 

 

Implementation  plans  and  monitoring,  evaluation  and  reporting 
arrangements 

The  GFL  Fitness  Check  has  also  highlighted  the  need  to  establish  a  more 
comprehensive monitoring system of the implementation of Union food law, so as to 
provide  policy  makers  and  the  public  with  more  solid  data  and  evidence  base  to 
regularly assess the relevant impacts. It underlined that this lack should be addressed 
in  future  policy  development,  for  instance  by  making  better  coordinated  use  of 
existing reporting requirements. Although in principle a revision of Regulation (EC) 
No  178/2002  could  be  used  as  an  opportunity  to  set  up  a  more  comprehensive 
monitoring  system  of  the  implementation  of  Union  food  law,  the  targeted  scope  of 
this proposal is too limited to accommodate the establishment of such a system. 

Transitions  measures  are  provided.  The  proposal  at  hand  provides  for  a  periodic 
overall evaluation of the agency, to be commissioned by the Commission, as per the 
Common Approach on Decentralised Agencies.  

 

Detailed explanation of the specific provisions of the proposal 

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1) 
The proposal ensures that scientists and citizens have access to key safety 
related  information  being  assessed  by  EFSA  at  an  early  stage  of  the  risk 
assessment.  In  particular,  the  new  provisions  provide  that  all  supporting  data  and 
information relating to applications for authorisation are to be made public by EFSA 
upon receipt (as applications will be submitted either directly to EFSA or forwarded 
to  EFSA  by  Member  States  or  by  the  Commission),  including  supplementary 
information, except for duly justified confidentiality information. In that respect, the 
proposal  sets  outs  which  type  of  information  is  to  be  considered  confidential.  The 
transparency  provisions  are  without  prejudice  to  any  existing  Intellectual  Property 
Rights and data exclusivity provisions set out in Union sectoral food legislation. The 
process to be followed for the processing of confidentiality claims is also set up.  

It  will  help  to  improve  citizens’  confidence  in  the  credibility  of  scientific 
2) 
studies  and  consequently  confidence  in  the  Union  risk  assessment  system.  The 
proposal will provide for a series of measures to ensure that EFSA has access to the 
broadest  relevant  scientific  evidence  possible  related  to  a  request  for  authorisation 
and to increase the guarantees of reliability, objectivity and independence of studies 
used  by  EFSA  in  its  risk  assessment.  First,  it  will  establish  a  Union  register  of 
commissioned studies on substances subject to a food law authorisation system, to be 
managed  by  EFSA.  The  second  measure  sets  out  a  pre-submission  procedure,  by 
which EFSA can provide advice to an applicant (without entering into the design of 
the  study)  and  this  advice  will  be  made  public.  In  the  case  of  renewals,  the  pre-
submission procedure foresees that studies planned by a potential applicant will have 
to  be  notified  to  EFSA  and,  after  public  consultation  on  these  planned  studies,  the 
Authority  will  systematically  provide  advice  to  the  applicants.  The  third  measure 
provides that at the stage of submission of authorisation application, when all studies 
are made public according to the new provisions on transparency, a consultation of 
third  parties  will  be  launched  with  the  aim  to  identify  whether  other  relevant 
scientific data or studies are available. The fourth measure provides for controls and 
audits  by  Commission  inspectors  in  relation  to  studies.  Finally,  the  proposal 
introduces the possibility for the Commission to request EFSA to commission studies 
in exceptional circumstances (e.g. controversies) for the purpose of verification.  

3) 
Better  Involving  Members  States  in  EFSA’s  governance  structure  and 
Scientific  Panels  and  thus  support  the  sustainability  in the  long-term  of  EFSA 
risk assessment without touching on its independence. It aligns the composition of 
EFSA’s Management Board with the Common Approach on decentralized agencies 
by including representatives of all Member States. It will also address the findings of 
the GFL Fitness Check that identified challenges to EFSA’s capacity to maintain its 
high  level  of  scientific  expertise  by  providing  for  an  increased  involvement  of 
Member States in the nomination process of Panels’ members. The proposal respects 
the needs of EFSA for independence, excellence and multi-disciplinary expertise. In 
particular,  the  existing  strict  criteria  on  independence  are  maintained  and  specific 
provisions  require  Member  States  to  set  up  specific  measures  ensuring  that  the 
experts  have  concrete  means  to  act  independently  as  required  by  the  proposal.  The 
proposal also provides for a better organisation of the Panels’ work.  

4) 
Strengthen risk communication between the Commission/EFSA /Members 
States  and  public  /stakeholders.  It  is  proposed  to  lay  down  in  legislation  the 
objectives and general principles governing risk communication, taking into account 
the  respective  roles  of  risk  assessors  and  managers  pursuant  to  Article  40  of 
Regulation (EC) No 178/2002 and, based on these objectives and general principles, 

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to draw up a general plan on risk communication (“general plan”). The general plan 
should identify the key factors that need to be taken into account when considering 
the  type  and  level  of  communication  activities  needed,  ascertain  the  tools  and 
channels  for  the  relevant  risk  communication  initiatives  taking  into  account  the 
relevant  target  audience  groups;  and,  establish  appropriate  mechanisms  to  ensure 
coherent risk communication.  

It  is  proposed  to  empower  the  Commission  to  draw  up  this  general  plan  for  the 
purposes of Regulation (EC) No 178/2002 by means of delegated acts.  

In parallel to the legislative measures, the Commission will also continue to provide 
support  to  food  safety  via  its  Research  and  Innovation  policies  and  contribute  to 
strengthening  coordination,  cooperation  and  cohesion  of  food  safety  research  and 
innovation activities in the Union and its Member States in particular when building 
the forthcoming ninth European Research and Innovation Framework Programme.  

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2018/0088 (COD) 

Proposal for a 

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 (EU) No 2015/2283 [on novel foods] 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 
43, 114, and 168(4)(b) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee18,  
Having regard to the opinion of the Committee of the Regions19,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

Regulation (EC) No 178/2002 of the European Parliament and of the Council20 lays down 
the  general  principles  and  requirements  of  food  law,  so  as  to  form  a  common  basis  for 
measures governing food law both at Union and Member State level. It provides, amongst 
others, that food law must be based on risk analysis, except where this is not appropriate to 
the circumstances or the nature of the measure.  

Regulation  (EC)  No  178/2002  defines  “risk  analysis”  as  a  process  consisting  of  three 
interconnected components: risk assessment, risk management and risk communication. For 
the  purposes  of  risk  assessment  at  Union  level,  it  establishes  the  European  Food  Safety 
Authority  (“the  Authority”),  as  the  responsible  Union  risk  assessment  body  in  matters 
relating to food and feed safety. Risk communication is an essential part of the risk analysis 
process.  

18 
19 
20 

OJ C , , p. . 
OJ C , , p. . 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down 
the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety  Authority  and 
laying down procedures in matters of food safety, (OJ L 31, 1.2.2002, p. 1). 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

The  evaluation  of  Regulation  (EC)  No  178/200221,  (“Fitness  Check  of  the  General  Food 
Law”),  found  that  risk  communication  is  overall,  not  considered  to  be  effective  enough, 
which has an impact on consumers’ confidence on the outcome of the risk analysis process.  

It  is  therefore  necessary  to  ensure  a  comprehensive  and  continuous  risk  communication 
process  throughout  risk  analysis,  involving  Union  and  national  risk  assessors  and  risk 
managers.  That  process  should  be  combined  with  an  open  dialogue  between  all  interested 
parties to ensure the coherence and consistency within the risk analysis process.  

Particular  emphasis  should  be  placed  on  explaining  in  a  coherent,  appropriate  and  timely 
manner not only risk assessment findings themselves but also how these are utilized to help 
inform risk management decisions along with other legitimate factors, where relevant.  

To  this  effect,  it  is  necessary  to  establish  general  objectives  and  principles  of  risk 
communication, taking into account the respective roles of risk assessors and managers. 

Based  on  these  general  objectives  and  principles,  a  general  plan  on  risk  communication 
should be established  in close  cooperation with the Authority  and the Member States,  and 
following relevant public consultations.  

The  general  plan  should  identify  the  key  factors  to  be  taken  into  account  when  risk 
communications’ activities are considered, such as the different levels of risk, the nature of 
the  risk  and  its  potential  public  health  impact,  who  and  what  are  directly  or  indirectly 
affected by the risk, the levels of risk exposure, the ability to control risk and other factors 
that  influence  risk  perception  including    the  level  of  urgency  as  well  as  the    applicable 
legislative framework and relevant market context. The general plan should also identify the 
tools  and  channels  to  be  used  and  should  establish  appropriate  mechanisms  to  ensure 
coherent risk communication.  

Transparency  of  the risk  assessment  process  contributes to  the  Authority  acquiring greater 
legitimacy in the eyes of the consumers and general public in pursuing its mission, increases 
their confidence in its work and ensures that the Authority is more accountable to the Union 
citizens  in  a  democratic  system.  It  is  therefore  essential  to  maintain  the  confidence  of  the 
general public and other interested parties in the risk analysis process underpinning Union 
food  law  and  in  particular  in  the  risk  assessment,  including  the  organisation  and 
independence of the Authority and transparency. 

(10) 

It is appropriate to align the composition of the Management Board of the Authority to the 
Common Approach on decentralised agencies, in accordance with the Joint Statement of the 
European Parliament, the Council of the European Union and the European Commission on 
decentralised agencies of 201222.  

(11)  Experience  shows  that  the  role  of  the  Management  Board  of  the  Authority  is  focussed  on 
administrative  and  financial  aspects  and  does  not  impact  on  the  independence  of  the 
scientific work performed by the Authority. It is thus appropriate to include representatives 
of all Member States in the Management Board of the Authority, while providing that those 
representatives should have experience in particular on risk assessment. 

(12)  The Management Board should be selected in such a way as to secure the highest standards 
of  competence  and  a  broad  range  of  relevant  experience  available  amongst  the 
representatives of the Member States, the European Parliament and the Commission. 

21 

22 

Commission Staff Working Document, “The REFIT evaluation of the General Food Law (Regulation (EC) No 
178/2002)”, SWD(2018)38 final, dated 15.1.2018. 
https://europa.eu/european-
union/sites/europaeu/files/docs/body/joint_statement_and_common_approach_2012_en.pdf. 

EN 

16 

  EN 

                                                 
 
(13)  The Fitness Check of the General Food Law identified certain shortcomings in the long-term 
capability of the Authority to maintain its high-level expertise. In particular, there has been a 
decrease in the number of candidates applying to be members of the Scientific Panels. The 
system  has  thus  to  be  strengthened  and  Member  States  should  take  a  more  active  role  to 
ensure  that  a  sufficient  pool  of  experts  is  available  to  meet  the  needs  of  the  Union  risk 
assessment  system  in  terms  of  high  level  of  scientific  expertise,  independence  and 
multidisciplinary expertise. 

(14)  To preserve the independence of the risk assessment from risk management and from other 
interests at Union level, it is appropriate that the nomination of the members of the Scientific 
Panels by the Member States, their selection by the Executive Director of the Authority and 
their  appointment  by  the  Management  Board  of  the  Authority  are  based  on  strict  criteria 
ensuring  the  excellence  and  independence  of  the  experts  while  ensuring  the  required 
multidisciplinary expertise for each Panel. It is also essential to this end that the Executive 
Director whose function is to defend EFSA’s interests and in particular the independence of 
its expertise has a role in the selection and appointment of those scientific experts. Further 
measures should also be put in place to ensure that scientific experts have the means to act 
independently.  

(15) 

It  is  essential  to  ensure  the  efficient  operation  of  the  Authority  and  to  improve  the 
sustainability of its expertise. It is therefore necessary to strengthen the support provided by 
the  Authority  and  the  Member  States  to  the  work  of  the  Authority’s  Scientific  Panels.  In 
particular, the Authority should organise the preparatory work supporting the Panels’ tasks, 
including by requesting the Authority’s staff or national scientific organisations networking 
with the Authority to draft preparatory scientific opinions to be peer-reviewed and adopted 
by the Panels. 

(16)  Authorisations procedures are based on the principle that it is for the applicant to prove that 
the  subject  matter  of  an  authorisation  procedure  complies  with  Union  safety  requirements 
given the scientific knowledge in its possession. This principle is based on the premise that 
public health is better protected when the burden of proof is on the applicant since it has to 
prove that a particular subject matter is safe prior to its placing on the market, instead of the 
public authorities having to prove that a subject matter is unsafe in order to be able to ban it 
from the market. Moreover, public money should not be used to commission costly studies 
that  will  in  the  end  help  the  industry  to  place  a  product  on  the  market.  According  to  this 
principle  and  in  accordance  with  applicable  regulatory  requirements,  in  support  of 
applications  for  an  authorisation  under  Union  sectoral  food  law  applicants  are  required  to 
submit  relevant  studies,  including  tests,  to  demonstrate  the  safety  and  in  some  cases  the 
efficacy of a subject matter.  

(17)  Provisions  exist  on  the  content  of  applications  for  authorisations.  It  is  essential  that  the 
application  for  authorisation  submitted  to  the  Authority  for  its  risk  assessment  meets  the 
applicable  specifications  to  ensure  the  best  quality  scientific  assessment  by  the  Authority. 
Applicants and in particular small- and medium-sized enterprises do not always have a clear 
understanding  of  these  specifications.  It  should  be  thus  appropriate  that  the  Authority 
provides  advice  to  a  potential  applicant,  upon  request,  on  the  applicable  rules  and  the 
required  content  of  an  application  for  authorisation,  before  an  application  is  formally 
submitted, while not entering into the design of the studies to be submitted that remain the 
applicant’s  responsibility.  To  ensure  the  transparency  of  this  process,  the  advice  of  the 
Authority should be made public. 

(18)  The Authority should have knowledge of the subject matter of all studies performed by an 
applicant with a view to a future application for an authorisation under Union food law. To 
this end,  it  is  necessary and  appropriate  that  business  operators  commissioning the studies 
and laboratories carrying them out notify those studies to the Authority when commissioned. 
Information  about  the  notified  studies  should  be  made  public  only  once  a  corresponding 

EN 

17 

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application for authorisation has been  made public in accordance with the applicable rules 
on transparency. 

(19) 

In  the  case  of  applications  to  request  the  renewal  of  an  authorisation,  the  authorised 
substance or product has already been on the market for several years. Therefore experience 
and knowledge exist on this substance or product. It is therefore appropriate that the studies 
planned  for  supporting  requests  for  renewals  should  be  notified  by  the  applicant  to  the 
Authority  and  that  following  a  consultation  of  third  parties  on  these  planned  studies,  the 
Authority  systematically  provides  advice  to  the  applicants  on  the  content  of  the  intended 
renewal application, taking into account the received comments. 

(20)  There  are  certain  public  concerns  about  the  Authority’s  assessment  in  the  area  of 
authorisation  being  primarily  based  on  industry  studies.  The  Authority  already  makes 
searches in scientific literature to be able to consider other data and studies existing on the 
subject  matter  submitted  to  its  assessment.  In  order  to  provide  an  additional  level  of 
guarantee  ensuring  that  the  Authority  can  have  access  to  all  relevant  scientific  data  and 
studies  available  on  a  subject  matter  of  an  authorisation  procedure,  it  is  appropriate  to 
provide  for  a  consultation  of  third  parties  in  order  to  identify  whether  other  relevant 
scientific data or studies are available. To increase the effectiveness of the consultation, the 
consultation  should  take  place  when  the  studies  submitted  by  industry  included  in  an 
application  for  authorisation  are  made  public,  under  the  transparency  rules  of  this 
Regulation. 

(21)  Studies,  including  tests,  submitted  by  business  operators  in  support  of  applications  for 
authorisations under Union sectoral food law usually comply with internationally recognised 
principles,  which  provide  a  uniform  basis  for  their  quality  in  particular  in  terms  of 
reproducibility of results. However, issues of compliance with the applicable standards may 
arise in some cases and this is why national systems are in place to verify such compliance. 
It is appropriate to provide an additional level of guarantees to reassure the general public on 
the quality of studies and to lay down an enhanced auditing system whereby Member State 
controls  on  the  implementation  of  those  principles  by  the  laboratories  carrying  out  such 
studies and tests would be verified by the Commission.  

(22)  Food safety is a sensitive matter of prime interest for all Union citizens. While maintaining 
the  principle  that  the  burden  is  on  the  industry  to  prove  compliance  with  Union 
requirements,  it  is  important  to  establish  an  additional  verification  tool  to  address  specific 
cases of high societal importance where there is a controversy on safety issues, namely the 
commissioning  of  additional  studies  with  the  objective  of  verifying  evidence  used  in  the 
context of risk assessment. Considering that it would be financed by the Union budget and 
that  the  use  of  this  exceptional  verification  tool  should  remain  proportionate,  the 
Commission  should  be  responsible  for  triggering  the  commissioning  of  such  verification 
studies.  Account  should  be  taken  of  the  fact  that  in  some  specific  cases  the  studies 
commissioned may need to have a wider scope than the evidence at stake (for example new 
scientific developments becoming available). 

(23)  The Fitness Check of the General Food Law demonstrated that although the Authority has 
made considerable progress in terms of transparency, the risk assessment process, especially 
in  the  context  of  authorisation  procedures  covering  the  agri-food  chain,  is  not  always 
perceived  as  fully  transparent.  This  is  also  partly  due  to  the  different  transparency  and 
confidentiality rules that are laid down not only in Regulation (EC) No 178/2002 but also in 
other Union legislative acts covering the agri-food chain. Their interplay can impact on the 
acceptability of the risk assessment by the general public.  

EN 

18 

  EN 

(24)  The European Citizens’ Initiative “Ban glyphosate and protect people and the environment 
from  toxic  pesticides”  further  confirmed  concerns  regarding  transparency  with  respect  to 
studies commissioned by the industry and submitted in authorisation application23. 

(25) 

It is  therefore  necessary  to  strengthen  the  transparency  of  the  risk  assessment  process  in  a 
proactive manner. Public access to all scientific data and information supporting requests for 
authorisations under Union food law as well as other requests for scientific output should be 
ensured, as early as possible in the risk assessment process. However, this process should be 
without prejudice to existing intellectual property rights or to any provisions of Union food 
law  protecting  the  investment  made  by  innovators  in  gathering  the  information  and  data 
supporting relevant applications for authorisations. 

(26)  Where the opinion of the Authority is requested in relation to authorisation procedures under 
Union food law and having regard to its obligation to ensure public access to all supporting 
information with respect to the provision of its scientific outputs, the Authority should have 
responsibility for assessing confidentiality requests. 

(27)  To determine what level of disclosure strikes the appropriate balance, the relevant rights of 
the public to transparency in the risk assessment process, should be weighted up against the 
rights  of  commercial  applicants,  taking  into  account  the  objectives  of  Regulation  (EC)  No 
178/2002. 

(28)  Accordingly  and  with  respect  to  the  procedures  governing  requests  for  authorisation 
procedures  provided  in  Union  food  law,  experience  gained  so  far  has  shown  that  certain 
information items are generally considered sensitive and should remain confidential across 
the  different  sectoral  authorisation  procedures.  It  is  appropriate  to  lay  down  in  Regulation 
(EC)  No  178/2002  a  horizontal  list  of  information  items  whose  disclosure  may  be 
considered  to  significantly  harm  the  commercial  interests  concerned  and  should  not 
therefore be disclosed to the public, (“general horizontal list of confidential items”). Only in 
very limited and exceptional circumstances relating to foreseeable health effects and urgent 
needs to protect human health, animal health or the environment, such information should be 
disclosed. 

(29)  For  the  purposes  of  clarity  and  to  increase  legal  certainty,  it  is  necessary  to  set  out  the 
specific  procedural  requirements  to  be  followed  in  respect  of  a  request  for  information 
submitted for the purposes of authorisation procedures under Union food law to be treated in 
a confidential manner. 

(30) 

It is also necessary to set out specific requirements with respect to the protection of personal 
data for the purposes of the transparency of the risk assessment process taking into account 
Regulation  (EC)  No  45/2001  of  the  European  Parliament  and  of  the  Council24  and 
Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council25.  Accordingly, 
no  personal  data  should  be  made  publicly  available  under  this  Regulation,  unless  it  is 
necessary  and  proportionate  for  the  purposes  of  ensuring  the  transparency,  independence 
and the reliability of the risk assessment process, while preventing conflicts of interests.  

(31)  For the purposes of increased transparency and in order to ensure that requests for scientific 
outputs  received  by  the  Authority  are  processed  in  an  effective  manner,  standard  data 

23 

24 

25 

Communication  from  the  Commission  on  the  ECI  “Ban  glyphosate  and  protect  people  and  the  environment 
from toxic pesticides”, C(2017) 8414 final. 
Regulation  (EC)  No  45/2001  of  the  European  Parliament  and  of  the  Council  of  18  December  2000  on  the 
protection  of  individuals  with  regard  to  the  processing  of  personal  data  by  the  Community  institutions  and 
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection 
of natural persons with regard to the processing of personal data and on the free movement of such data, and 
repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 

EN 

19 

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formats and software packages should be developed. In order to ensure uniform conditions 
for  the  implementation  of  Regulation  (EC)  No  178/2002  with  regard  to  the  adoption  of 
standard data formats and software packages, implementing powers should be conferred on 
the Commission. Those powers should be exercised in accordance with Regulation (EU) No 
182/2011 of the European Parliament and of the Council26. 

(32)  Having  regard  to  the  fact  that  the  Authority  would  be  required  to  store  scientific  data, 
including confidential and personal data, it is necessary to ensure that such storage is carried 
out in accordance with a high level of security. 

(33)  Furthermore,  in  order  to  assess  the  effectiveness  and  efficiency  of  the  different  provisions 
applying to the Authority, it is also appropriate to provide for a Commission evaluation of 
the  Authority,  in  accordance  with  the  Common  Approach  on  Decentralised  Agencies.  The 
evaluation  should,  in  particular,  review  the  procedures  for  selecting  the  members  of 
Scientific  Committee  and  Panels,  for  their  degree  of  transparency,  cost-effectiveness,  and 
suitability to ensure independence and competence, and to prevent conflicts of interests.  

(34) 

In  order  to  ensure  consistency  with  the  proposed  adaptations  in  Regulation  (EC)  No 
178/2002, provisions relating to public access and the protection of confidential information 
in Directive 2001/18/EC of the European Parliament and of the Council27, Regulation (EC) 
No  1829/2003  of  the  European  Parliament  and  of  the  Council28,  in  Regulation  (EC)  No 
1831/2003  of  the  European  Parliament  and  of  the  Council29,  in  Regulation  (EC)  No 
2065/2003  of  the  European  Parliament  and  of  the  Council30,  in  Regulation  (EC)  No 
1935/2004  of  the  European  Parliament  and  of  the  Council31,  in  Regulation  (EC)  No 
1331/2008  of  the  European  Parliament  and  of  the  Council32,  in  Regulation  (EC)  No 
1107/2009  of  the  European  Parliament  and  of  the  Council33  and  in  Regulation  (EU) 
2015/2283 of the European Parliament and of the Council34 should be amended.  

(35)  For the purposes of ensuring transparency of the risk assessment process, it is also necessary 
to extend the scope of Regulation (EC) No 178/2002, currently limited to food law, to also 
cover  applications  for  authorisations  in  the  context  of  Regulation  (EC)  No 1831/2003  as 

26 

27 

28 

29 

30 

31 

32 

33 

34 

Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011  laying 
down  the  rules  and  general  principles  concerning  mechanisms  for  control  by  Member  States  of  the 
Commission’s exercise of implementing powers, (OJ L 55, 28.2.2011, p. 13). 
Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the  deliberate 
release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC 
(OJ L 106, 17.4.2001, p. 1). 
Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the  Council  of  22  September  2003  on 
genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 
Regulation  (EC)  No  1831/2003  of  the  European  Parliament  and  of  the  Council  of  22  September  2003  on 
additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). 
Regulation  (EC)  No  2065/2003  of  the  European  Parliament  and  of  the  Council  of  10  November  2003  on 
smoke flavourings used or intended for use in or on foods (OJ L 309, 26.11.2003, p. 1). 
Regulation  (EC)  No 1935/2004  of  the  European  Parliament  and  of  the  Council  of  27 October  2004  on 
materials  and  articles  intended  to  come  into  contact  with  food  and  repealing  Directives  80/590/EEC  and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4). 
Regulation  (EC)  No  1331/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008 
establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 
354, 31.12.2008, p. 1). 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning 
the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives  79/117/EEC  and 
91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
Regulation  (EU)  2015/2283  of  the  European  Parliament  and  of  the  Council  of  25  November  2015  on  novel 
foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (OJ L 327, 11.12.2015, p. 1). 

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regards feed additives, Regulation (EC) No 1935/2004 as regards food contact materials and 
Regulation (EC) No 1107/2009 as regards plant protection products.  

(36)  To  ensure  that  sectoral  specificities  with  respect  to  confidential  information  are  taken  into 
account, it is necessary to weigh up the relevant rights of the public to transparency in  the 
risk assessment process, including those flowing from the Aarhus Convention35, against the 
rights of commercial applicants, taking into account the specific objectives of sectoral Union 
legislation  as  well  as  experienced  gained.  Accordingly,  it  is  necessary  to  amend  Directive 
2001/18/EC,  Regulation  (EC)  No  1829/2003,  Regulation  (EC)  No  1831/2003,  Regulation 
(EC)  No  1935/2004  and  Regulation  (EC)  No  1107/2009  to  provide  for  additional 
confidential items to those set out in Regulation (EC) No 178/2002. 

(37) 

In order to further strengthen the link between risk assessors and risk managers at Union and 
national levels as well as the coherence and consistency of risk communication, the power to 
adopt  acts  in  accordance  with  Article  290  of  the  Treaty  should  be  delegated  to  the 
Commission  to  adopt  a  general  plan  on  risk  communication  on  matters  covering  the  agri-
food  chain.  It  is  of  particular  importance  that  the  Commission  carries  out  appropriate 
consultations  during  its  preparatory  work,  including  at  expert  level,  and  that  those 
the 
consultations  be  conducted 
Interinstitutional  Agreement  on  Better  Law-Making  of  13  April  2016.  In  particular,  to 
ensure equal participation in the preparation of delegated acts, the European Parliament and 
the  Council  receive  all  documents  at  the  same  time  as  Member  States’  experts,  and  their 
experts  systematically  have  access  to  meetings  of  Commission  expert  groups  dealing  with 
the preparation of delegated acts. 

in  accordance  with 

the  principles 

laid  down 

in 

(38) 

In order to enable the Authority and the business operators to adapt to the new requirements 
while ensuring that the Authority continues its smooth operation, it is necessary to provide 
for transitional measures for the application of this Regulation.  

(39)  The  appointment  of  the  Scientific  Committee  and  Scientific  Panels’  members  being 
dependent of the entry in function of the new Management Board, it is necessary to provide 
for specific transitional  provisions allowing a prolongation of the current term of office of 
the members of the Scientific Committee and Scientific Panels members. 

(40)  The European Data Protection Supervisor was consulted in accordance with Article 28(2) of 
Regulation (EC) No 45/2001 of the European Parliament and of the Council36 and delivered 
an opinion on […], 

HAVE ADOPTED THIS REGULATION: 

Article 1 
Amendments to Regulation (EC) No 178/2002 

Regulation (EC) No 178/2002 is amended as follows:  

(1) 

in Chapter II the following SECTION 1a is inserted:  

"SECTION 1a 

RISK COMMUNICATION 

35 

36 

Regulation  (EC)  No 1367/2006  of  the  European  Parliament and of  the  Council  of  6 September  2006  on  the 
application  of  the  provisions  of  the  Aarhus  Convention  on  Access  to  Information,  Public  Participation  in 
Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 
264,  25.9.2006, p.13). 
Regulation  (EC)  No  45/2001  of  the  European  Parliament  and  of  the  Council  of  18  December  2000  on  the 
protection  of  individuals  with  regard  to  the  processing  of  personal  data  by  the  Community  institutions  and 
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 

EN 

21 

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Article 8a 

Objectives of risk communication 

Risk  communication  shall  pursue  the  following  objectives,  while  taking  into  account  the 
respective roles of risk assessors and risk managers:  

(a) 

promote  awareness  and  understanding  of  the  specific  issues  under  consideration 
during the entire risk analysis process; 

(b)  promote  consistency  and 

transparency 

in 

formulating 

risk  management 

recommendations; 

(c) 

(d) 

(e) 

(f) 

provide a sound basis for understanding risk management decisions; 

foster public understanding of the risk analysis process so as to enhance confidence 
in its outcome; 

promote appropriate involvement of all interested parties; and,  

ensure appropriate exchange of information with interested parties in relation to risks 
associated with the agri-food chain. 

Article 8b 

General principles of risk communication 

Taking  into  account  the  respective  roles  of  risk  assessors  and  risk  managers,  risk 
communication shall: 

(a) 

ensure that accurate, appropriate and timely information is interactively exchanged, 
based on the principles of transparency, openness, and responsiveness; 

(b)  provide  transparent  information  at  each  stage  of  the  risk  analysis  process  from  the 
framing of requests for scientific advice to the provision of risk assessment and the 
adoption of risk management decisions;  

(c) 

take into account risk perceptions;  

(d) 

facilitate understanding and dialogue amongst all interested parties; and, 

(e) 

be  accessible,  including  to  those  not  directly  involved  in  the  process,  while  taking 
into account confidentiality and protection of personal data.  

Article 8c 

General plan for risk communication 

1. 

2. 

The  Commission,  in  close  cooperation  with  the  Authority,  the  Member  States  and 
following  appropriate  public  consultations  shall  be  empowered  to  adopt  delegated 
acts  in  accordance  with  Article  57a  establishing  a  general  plan  for  risk 
communication  on  matters  relating  to  the  agri-food  chain,  taking  into  account  the 
relevant objectives and general principles set out in Articles 8a and 8b. 

The  general  plan  for  risk  communication  shall  promote  an  integrated  risk 
communication  framework  to  be  followed  both  by  the  risk  assessors  and  the  risk 
managers  in  a  coherent and  systematic  manner  both  at  Union  and  national  level.  It 
shall:  

(a) 

(b) 

identify the key factors that need to be taken into account when considering the 
type and level of risk communications’ activities needed;  

identify  the  appropriate  main  tools  and  channels  to  be  used  for  risk 
communication  purposes,  taking  into  account  the  needs  of  relevant  target 
audience groups; and,  

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22 

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(c) 

establish  appropriate  mechanisms  in  order  to  strengthen  coherence  of  risk 
communication amongst risk assessors and risk managers and ensure an open 
dialogue amongst all interested parties. 

3. 

The  Commission  shall  adopt  the  general  plan  for  risk  communication  within  [two 
years  from  the  date  of  application  of  this  Regulation]  and  shall  keep  it  updated, 
taking into account technical and scientific progress and experience gained."; 

(2) 

Article 25 is amended as follows: 

(a) paragraph 1 is replaced by the following:  

“1.  Each  Member  State  shall  nominate  a  member  and  an  alternate  member  to  the 
Management  Board.  The  members  and  alternate  members  thus  nominated  shall  be 
appointed by the Council and have voting rights. ”, 

(b)  

the following paragraphs 1a and 1b are inserted: 

“1a.  In addition to members and alternate members referred to in paragraph 1, the 

Management Board shall include:  

(a) 

two  members  and  the  alternate  members  appointed  by  the  Commission 
and representing the Commission, with the right to vote. 

(b)  one  member  appointed  by  the  European  Parliament,  with  the  right  to 

vote. 

(c) 

four  members  with  the  right  to  vote  representing  civil  society  and  food 
chain  interests  namely,  one  from  consumers  organisations,  one  from 
environmental  non-governmental  organisations,  one  from  farmers 
organisations and one from industry organisations. Those members shall 
be  appointed  by  the  Council  in  consultation  with  the  European 
Parliament  on  the  basis  of  a  list  drawn  up  by  the  Commission  which 
includes more names than there are posts to be filled.  The list drawn up 
by  the  Commission  shall  be  forwarded  to  the  European  Parliament, 
together with the relevant background documents. As quickly as possible 
and  within  three  months  of  notification,  the  European  Parliament  may 
submit  its  views  for  consideration  to  the  Council,  which  shall  then 
appoint those members. 

1b.  The  members  of  the  Management  Board  and  where  relevant,  the  alternate 
members shall be appointed taking into account high competence in the area of 
food  safety  risk  assessment  as  well  as  competences  in  the  food  chain  safety 
legislation  and  policy,  and 
relevant  managerial,  administrative  and 
budgetary/financial skills.”, 

(c)   paragraph 2 is replaced by the following: 

“2.  The  term  of  office  of  members  and  alternate  members  shall  be  four  years. 
However, the term of office of the members referred to in paragraph 1a(a) and 
(b) shall not be limited in duration. The term of office of the members referred 
to in paragraph 1a(c) may be renewable only once.”,  

(d)  

the second subparagraph of paragraph 5 is replaced by the following: 

         “Unless  otherwise  provided,  the  Management  Board  shall  act  by  a  majority  of  its 
members. Alternate members shall represent the member in his absence and vote on 
his behalf.”; 

(3) 

Article 28 is amended as follows: 

(a)   Paragraph 5 is replaced by the following: 

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“5.  The members of the Scientific Committee who are not members of Scientific 
Panels  and  the  additional  members  referred  to  in  paragraph  5b  shall  be 
appointed  by  the  Management  Board,  acting  upon  a  proposal  from  the 
Executive  Director,  for  a  five  year  term  of  office,  which  may  be  renewable, 
following  publication  in  the  Official  Journal  of  the  European  Union,  in 
relevant leading scientific publications and on the Authority’s website of a call 
for expressions of interest.”, 

(b)    The following paragraphs 5a to 5g are inserted: 

“5a.  The  members  of  the  Scientific  Panels  shall  be  appointed  by  the  Management 
Board  for  a  renewable  five  year  term  of  office    in  accordance  with  the 
following procedure: 

(a)  The  Executive  Director,  after  consulting  the  Management  Board,  shall 
send  to the Member States the request for the specific multidisciplinary 
expertise needed in each Scientific Panel and shall indicate the number of 
experts  to  be  nominated  by  the  Member  States.  The  Executive  Director 
shall  notify  the  Member  States  of  the  Authority’s  independence  policy 
and  implementing  rules  applicable  to  Scientific  Panels’  members. 
Member  States  shall  launch  a  call  for  interest  as  a  basis  for  their 
nominations.  The  Executive  Director  shall  inform  the  Management 
Board of the requests sent to the Member States. 

(b)  Member States  shall nominate experts  with  a  view to  collectively  reach 
the number indicated by the Executive Director. Each Member State shall 
nominate  at  least  12  scientific  experts.  Member  States  may  nominate 
nationals of other Member States.  

(c)  On the basis of the nominations made by Member States, the Executive 
Director shall draw for each Scientific Panel a list of experts larger than 
the number of members to be appointed. The Executive Director may not 
draw up such a list where he/she can justify that the nominations received 
do not allow him, given the criteria for selection set up in point d) of this 
paragraph, to draw up a larger list. The Executive Director shall submit 
the list to the Management Board for appointment. 

(d)  The  nominations  by  the  Member  States,  the  selection  by  the  Executive 
Director and the appointments by the Management Board shall be made 
on the basis of the following criteria: 

(i)  A high level of scientific expertise; 

(ii) 

Independence  and  absence  of  conflict  of  interests  in  accordance 
with  Article  37(2)  and  the  Authority’s  independence  policy  and 
implementing  rules  on  the  independence  of  the  Scientific  Panels’ 
members; 

(iii)  Meeting  the  needs  for  the  specific  multi-disciplinary  expertise  of 
the  Panel  to  which  they  will  be  appointed  and  the  applicable 
language regime. 

(e)  The  Management  Board  shall  ensure  that  the  broadest  possible 

geographical distribution is achieved in the final appointments. 

5b.  When  the  Authority  identifies  that  specific  expertise  is  missing  in  a  Panel  or 
several Panels, the Executive Director shall propose additional members of the 
Panel(s)  for  appointment  to  the  Management  Board  in  accordance  with  the 
procedure laid down in paragraph 5. 

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5c.  The Management Board shall adopt, on the basis of a proposal of the Executive 
Director, rules on the detailed organisation and timing of the procedures set up 
in paragraphs 5a and 5b of the present Article. 

5d.  The Member States shall put in place measures ensuring that the members of 
the  Scientific  Panels  act  independently  and  remain  free  from  conflict  of 
interests as provided for in Article 37(2) and the Authority’s internal measures. 
Member States shall ensure that the members of the Scientific Panels have the 
means to dedicate the necessary time and effort to contribute to the work of the 
Authority.  Member  States  shall  ensure  that  the  members  of  the  Scientific 
Panels  do  not  receive  any  instruction  at  any  national  level  and  that  their 
independent scientific contribution to the risk assessment system at Union level 
is recognised as a priority task for the protection of the safety of the food chain.  

5e.  Member  States  shall  ensure  that  the  public  bodies  employing  those  scientific 
experts  and  those  having  responsibility  for  the  setting  of  priorities  of  the 
scientific bodies employing those experts implement the measures provided for 
in paragraph 5d.  

5f.  The Authority shall support the tasks of the Panels by organising their work, in 
particular the preparatory work to be undertaken by the Authority’s staff or by 
designated  national  scientific  organisations  referred  to  in  the  Article  36 
including  by  organising  the  possibility  for  preparing  scientific  opinions  to  be 
peer-reviewed by the Panels before they adopt them. 

5g.  Each Panel shall include a maximum of 21 members.”, 

(c) 

paragraph 9(b) is replaced by the following: 

“The number of members in each Scientific Panel within the maximum provided for 
in paragraph 5g.”; 

(4) 

the following Articles 32a, 32b,  32c, 32d and 32e are inserted: 

“Article 32a 

General advice 

At  the  request  of  a  potential  applicant  for  a  food  law  authorisation,  the  staff  of  the 
Authority  shall  advise  on  the  relevant  provisions  and  the  required  content  of  the 
application  for  authorisation.  The  advice  provided  by  the  staff  of  the  Authority  shall  be 
without  prejudice  and  non-committal  as  to  the  subsequent  assessment  of  applications  for 
authorisation by the Scientific Panels. 

Article 32b 

Union Register of Studies 

1.  A  Union  register  of  studies  commissioned  by  business  operators  to  obtain  an 
authorisation  under  Union  food  law  is  hereby  established.  Business  operators  shall 
notify, without delay, to the Authority the subject matter of any study commissioned 
to  support  a  future  application  for  an  authorisation  under  Union  food  law.  The 
register shall be managed by the Authority. 

2. 

3. 

The  notification  obligation  under  paragraph  1,  also  applies  to  Union  laboratories 
carrying out those studies. 

The  notified  information  shall  be  made  public  only  in  case  a  corresponding 
application  for  authorisation  has  been  received  and  after  the  Authority  has  decided 
on  the  disclosure  of  the  accompanying  studies  in  accordance  with  Article  38  and 
Articles 39 to 39f.  

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4. 

The  Authority  shall  lay  down  in  its  internal  rules  the  practical  arrangements  for 
implementing the notification obligations laid down in paragraphs 1 and 2, including 
the  notification  obligation.  Those 
consequences  of  non-compliance  with 
arrangements shall however be in accordance with the present Regulation and other 
Union sectoral food law. 

Article 32c 

Consultation of third parties 

1.  Where Union food law provides that an authorisation may be renewed, the potential 
applicant  for  the  renewal  shall  notify  the  Authority  of  the  studies  it  intends  to 
perform  for  that  purpose.  Following  this  notification,  the  Authority  shall  launch  a 
consultation of stakeholders and the public on the intended studies for renewal and 
shall  provide  advice  on  the  content  of  the  intended  renewal  application  taking  into 
account  the  received  comments.  The  advice  provided  by  the  Authority  shall  be 
without  prejudice  and  non-committal  as  to  the  subsequent  assessment  of  the 
applications for renewal of authorisation by the Scientific Panels. 

2. 

The  Authority  shall  consult  stakeholders  and  the  public  regarding  the  studies 
supporting applications for authorisation once they are made public by the Authority 
in  accordance  with  Article  38  and  Articles  39  to  39f  in  order  to  identify  whether 
other relevant scientific data or studies are available on the subject matter concerned 
by the application for authorisation. This provision does not apply to the submission 
of  any  supplementary  information  by  the  applicants  during  the  risk  assessment 
process. 

3. 

The  Authority  shall  lay  down  in  its  internal  rules  the  practical  arrangement  for 
implementing the procedures referred to in Articles 32a and this Article. 

Article 32d 

Controls 

The Commission experts shall perform controls, including audits, to obtain assurance that 
testing facilities comply with relevant standards for carrying out tests and studies submitted 
to the Authority as part of an application for an authorisation under Union food law. These 
controls  shall  be  organised  in  cooperation  with  the  competent  authorities  of  the  Member 
States. 

Article 32e 

Verification studies 

Without  prejudice  to  the  obligation  of  applicants  for  authorisations  under  food  law  to 
demonstrate  the  safety  of  a  subject  matter  submitted  to  a  system  of  authorisation,  the 
Commission,  in  exceptional  circumstances,  may  request  the  Authority  to  commission 
scientific  studies  with  the  objective  of  verifying  evidence  used  in  its  risk  assessment 
process. The  studies  commissioned may have  a wider scope than the evidence  subject to 
verification.”; 

(5) 

Article 38 is amended as follows: 

(a)   Paragraph 1 is replaced by the following:  

“1.  The Authority shall carry out its activities with a high level of transparency. It 

shall in particular make public without delay:  

(a) 

agendas  and  minutes  of  the  Scientific  Committee  and  the  Scientific 
Panels and their Working Groups;  

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26 

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(b) 

(c) 

(d) 

 (e) 

(f) 

(g) 

(h) 

all  its  scientific  outputs,  including  the  opinions  of  the  Scientific 
Committee  and  the  Scientific  Panels  after  adoption,  minority  opinions 
and results of consultations performed during the risk assessment process 
always being included; 

law, 

food 

scientific data, studies and other information supporting applications for 
supplementary 
authorisation  under  Union 
information  supplied  by  applicants,  as  well  as  other  scientific  data  and 
information  supporting  requests  from  the  European  Parliament,  the 
Commission  and  the  Member  States  for  a  scientific  output,  including  a 
into  account  protection  of  confidential 
scientific  opinion, 
information  and  protection  of  personal  data in  accordance  with  Articles 
39 to 39f.   

including 

taking 

the  information  on  which  its  scientific  outputs,  including  scientific 
opinions  are  based,  taking  into  account  protection  of  confidential  data 
and protection of personal data in accordance with Articles 39 to 39f;  

the annual declarations of interest made by members of the Management 
Board,  the  Executive  Director,  members  of  the  Advisory  Forum  and 
members  of  the  Scientific  Committee,  Scientific  Panels  and  of  their 
Working Groups, as well as the declarations of interest made in relation 
to items on the agendas of meetings;  

its scientific studies in accordance with Articles 32 and 32e; 

the annual report of its activities;  

requests  from  the  European  Parliament,  the  Commission  or  a  Member 
State for scientific opinions which have been refused or modified and the 
justifications for the refusal or modification.  

(i) 

advice  provided  by  the  Authority  to  potential  applicants  at  pre-
submission phase pursuant to Article 32a and 32c. 

Those items referred to in the first subparagraph shall be made public on a dedicated 
section of the Authority’s website. That section shall be publicly available and easily 
accessible.  The  relevant  items  shall  be  available  to  download,  print  and  search 
through in an electronic format.”, 

(b) 

the following paragraph 1a is inserted:  

“1a.  The disclosure of the information mentioned in paragraph (1)(c) to the public 
shall be without prejudice: 

(a) 

(b) 

to any intellectual property right which may exist over documents or their 
content; and, 

any provisions set out in Union food law protecting the investment made 
by  innovators  in  gathering  the  information  and  data  supporting  relevant 
applications for authorisations (‘data exclusivity rules’). 

The disclosure to  the public of the information  mentioned in  paragraph (1)(c) shall 
not be considered as an explicit or implicit permission or license for the relevant data 
and information and their content to be used, reproduced, or otherwise exploited and 
its use by third parties shall not engage the responsibility of the European Union.” 

(c) 

paragraph 3 is replaced by the following:  

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27 

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“3.  The  Authority  shall  lay  down  in  its  internal  rules  the  practical  arrangements  for 
implementing  the  transparency  rules  referred  to  in  paragraphs  1,  1a  and  2  of  this 
Article, taking into account Articles 39 to 39g and Article 41.”; 

(6) 

Article 39 is replaced by the following:  

“Article 39 

Confidentiality 

1. 

2. 

By  way  of  derogation  from  Article  38,  the  Authority  shall  not  make  public 
information for which confidential treatment has been requested under the conditions 
laid down in this Article. 

The  Authority  may  only  accept  to  provide  confidential  treatment  in  relation  to  the 
following  information,  the  disclosure  of  which  may  be  deemed,  upon  verifiable 
justification, to significantly harm the interests concerned: 

(1) 

(2) 

(3) 

the  method  and  other  technical  and  industrial  specifications  relating  to  that 
method, used to manufacture or produce the subject matter of the request for a 
scientific output, including a scientific opinion; 

commercial  links  between  a  producer  or  importer  and  the  applicant  or  the 
authorisation holder, where applicable;  

commercial information revealing sourcing, market shares or business strategy 
of the applicant; and, 

(4)  quantitative  composition  of  the  subject  matter  of  the  request  for  a  scientific 

output, including a scientific opinion. 

3. 

The list  of information referred to in paragraph 2 shall  be without prejudice to  any 
specific Union food law.  

4.  Notwithstanding paragraphs 2 and 3, the following information shall nevertheless be 

made public:  

(a)  Where urgent action is essential to protect  public health, animal health or  the 
environment, such as in emergency situations, the Authority may disclose the 
information referred to paragraphs 2 and 3; and, 

(b) 

information  which  forms  part  of  conclusions  of  scientific  outputs,  including 
scientific opinions, delivered by the Authority and which relate to foreseeable 
health effects.”; 

(7) 

the following Articles 39a to 39g are inserted: 

“Article 39a 

Request for confidentiality 

1.  When  submitting  an  application  for  an  authorisation,  supporting  scientific  data  and 
other  supplementary  information  in  accordance  with  Union  food  law,  the  applicant 
may  request  certain  parts  of  the  information  submitted  to  be  kept  confidential  in 
accordance with paragraphs 2 and 3 of Article 39. This request shall be accompanied 
by  verifiable  justification  demonstrating  how  making  public  the  information 
concerned significantly harms the interests concerned in accordance with paragraphs 
2 and 3 of Article 39.  

2.  Where  an  applicant  submits  a  request  for  confidentiality,  it  shall  provide  a  non-
confidential  version  and  a  confidential  version  of  the  information  submitted  in 
accordance with standard data formats, where they exist, pursuant to Article 39f. The 
non-confidential  version  shall  be  without  the  information  the  applicant  deems 

EN 

28 

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confidential  in  accordance  with  paragraphs  2  and  3  of  Article  39.  The  confidential 
version  shall  contain  all  information  submitted, including  information  the  applicant 
deems  confidential.  Information  requested  to  be  treated  as  confidential  in  the 
confidential version shall be clearly marked. The applicant shall clearly indicate the 
grounds on the basis of which confidentiality is requested for the different pieces of 
information.  

Article 39b 

Decision on confidentiality 

1. 

The Authority shall:  

(a)  make  public, without delay, the non-confidential version,  as submitted by the 

applicant; 

(b)  proceed,  without  delay,  to  a  concrete  and  individual  examination  of  the 

confidentiality request in accordance with this Article; 

(c) 

(d) 

inform the applicant in writing of its intention to disclose information and the 
reasons  for  it,  before  the  Authority  formally  takes  a  decision  on  the 
confidentiality  request.  If  the  applicant  disagrees  with  the  assessment  of  the 
Authority it may state its views or withdraw its application within two weeks 
from the date on which it was notified of the Authority’s position.  

adopt a reasoned decision on the confidentiality request taking into account the 
observations of the applicant within ten weeks from the date of receipt of the 
confidentiality  request  with  respect  to  applications  for  authorisation  and 
without  undue  delay  in  the  case  of  supplementary  data  and  information  and 
notify  the  applicant  and  inform  the  Commission  and  the  Member  States,  as 
appropriate, of its decision; and,  

(e)  make public any additional data and information for which the confidentiality 
request has not been accepted as justified not earlier than two weeks after the 
notification  of  its  decision  to  the  applicant  has  taken  place,  pursuant  to  point 
(d). 

Decisions taken by the Authority pursuant to this Article may be subject to an action 
before the Court of Justice of the European Union, under the conditions laid down in 
Articles 263 and 278 of the Treaty respectively. 

Article 39c 

Review of confidentiality 

Before  the  Authority  issues  its  scientific  outputs,  including  scientific  opinions,  it  shall 
review  whether  information  that  has  been  previously  accepted  as  confidential  may 
nevertheless be made public in accordance with paragraph 4(b) of Article 39. Should that 
be the case, the Authority shall follow the procedure laid down in Article 39b, which shall 
apply mutatis mutandis.  

Article 39d 

Obligations with regard to confidentiality 

1. 

The  Authority  shall  make  available,  upon  request,  to  the  Commission  and  the 
Member  States  all  information  in  its  possession  relating  to  an  application  for  an 
authorisation  or  to  a  request  by  the  European  Parliament,  the  Commission  or  the 
Member States for a scientific output, including a scientific opinion, unless otherwise 
indicated in specific Union food law. 

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2. 

3. 

The  Commission  and  the  Member  States  shall  take  the  necessary  measures  so  that 
information received by them under Union food law for which confidential treatment 
has been requested is not made public until a decision on the confidentiality request 
has been taken by the Authority and has become definitive. The Commission and the 
Member States shall also take the necessary measures so that information for which 
confidential treatment has been accepted by the Authority is not made public. 

If  an  applicant  in  the  context  of  an  authorisation  procedure  withdraws  or  has 
withdrawn  an  application,  the  Authority,  the  Commission  and  the  Member  States 
shall respect the confidentiality of commercial and industrial information as accepted 
by  the  Authority  in  accordance  with  Articles  39to  39f.  The  application  shall  be 
considered  withdrawn  as  of  the  moment  the  written  request  is  received  by  the 
competent body that had received the original application. Where the withdrawal of 
the  application  takes  place  before  the  Authority  has  decided  on  the  relevant 
confidentiality request, the Authority, the Commission and the Member States shall 
not make public the information for which confidentiality has been requested. 

4.  Members  of  the  Management  Board,  the  Executive  Director,  members  of  the 
Scientific Committee and Scientific Panels as well as external experts participating in 
their working groups, members of the Advisory Forum and members of the staff of 
the Authority, even after their duties have ceased, shall be subject to the requirements 
of confidentiality pursuant to Article 339 of the Treaty.  

5. 

The  Authority  shall  lay  down  in  its  internal  rules  the  practical  arrangements  for 
implementing  the  confidentiality  rules  laid  down  in  Articles  39,  39a,  39b,  39e  and 
this  Article,  including  arrangements  concerning  the  submission  and  treatment  of 
confidentiality requests with respect to information to be made public under Article 
38, and taking into account Articles 39f and 39g.”;  

Article 39e  

Protection of personal data 

1.  With  respect  to  requests  for  scientific  outputs,  including  scientific  opinions  under 

Union food law, the Authority shall always make public: 

(a) 

(b) 

(c) 

the name and address of the applicant;  

the  names  of  authors  of  published,  or  publicly  available,  studies  supporting 
such requests; and 

the  names  of  all  participants  in  meetings  of  the Scientific  Committee  and  the 
Scientific Panels and their Working Groups. 

2.  Notwithstanding paragraph 1, disclosure of names and addresses of natural persons 
involved  in  testing  on  vertebrate  animals  or  in  obtaining  toxicological  information 
shall be deemed to significantly harm the privacy and the integrity of those natural 
persons and shall not be made publicly available, unless there is an overriding public 
interest.  
Regulation  (EU)  2016/679  of  the  European  Parliament  and  of  the  Council37  and 
Regulation (EC) No 45/2001 of the European Parliament and of the Council38 shall 

3. 

37 

38 

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection 
of natural persons with regard to the processing of personal data and on the free movement of such data and 
repealing Directive 95/46/EC (General Data Protection Regulation), (OJ L 119, 4.5.2016, p. 1). 
Regulation  (EC)  No  45/2001  of  the  European  Parliament  and  of  the  Council  of  18  December  2000  on  the 
protection  of  individuals  with  regard  to  the  processing  of  personal  data  by  the  Community  institutions  and 
bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1). 

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apply to the processing of personal data carried out pursuant to this Regulation. Any 
personal data made public pursuant to Article 38 and this article shall only be used to 
ensure the transparency of risk assessment process under this Regulation and not be 
further  processed  in  a  manner  that  is  incompatible  with  these  purposes,  in  the 
meaning  of  Article  5(1)(b)  of  Regulation  (EU)  2016/679  and  Article  4(1)(b)  of 
Regulation (EC) No 45/2001, as the case may be. 

Article 39f 

Standard data formats 

1. 

For the purposes of Article 38(1)(c) and in order to ensure the efficient processing of 
requests to the Authority for a scientific output, standard data formats and software 
packages shall be adopted to allow documents to be submitted, searched, copied and 
printed,  while  ensuring  compliance  with  regulatory  requirements  set  out  in  Union 
food law. These draft standard data formats and software packages shall not be based 
on  proprietary  standards  and  shall  ensure  interoperability  with  existing  data 
submission approaches to the extent possible. 

2.  For  the  adoption  of  standard  data  formats  and  software  packages  the  following 

procedure shall be followed:  

(a)  The Authority shall draw up draft standard data formats and software packages 
for  the  purposes  of  the  different  authorisation  procedures  in  Union  food  law 
and  relevant  requests  for  a  scientific  output  by  the  European  Parliament,  the 
Commission and the Member States.  

(b)  Taking  into  account  the applicable  requirements  in  the  different authorisation 
procedures  and  other  legislative  frameworks  and  following  any  necessary 
adaptations, the Commission shall adopt standard data formats and software by 
means  of  implementing  acts.  Those  implementing  acts  shall  be  adopted  in 
accordance with Article 58(2).  

(c)  The Authority shall make the standard data formats and software packages, as 

adopted, available on its website.  

(d)  Where  standard  data  formats  and  software  packages  have  been  adopted 
pursuant to this article, applications as well as requests for a scientific output, 
including a scientific opinion by the European Parliament, the Commission and 
the  Member  States  under  Union  food  law,  shall  only  be  submitted  in 
accordance with the standard data formats and software packages laid down in 
those acts. 

Article 39g 

Information systems 

The information systems operated by the Authority to store its data, including confidential 
and personal data shall be designed to a high level of security  appropriate to the security 
risks  at  stake,  taking  into  account  Articles  39  to  39f  of  this  Regulation.  Access  shall  be 
based  at  the  minimum  on  a  system  requiring  two  factor  authentication  or  providing  an 
equivalent  level  of  security.  The  system  shall  ensure  that  any  access  to  it  is  fully 
auditable.”; 

(8) 

in Article 40, the second subparagraph of paragraph 3 is replaced by the following:  

“The Authority shall publish all scientific outputs including the scientific opinions issued 
by it and supporting scientific data and other information in accordance with Article 38 and 
Articles 39 a to 39f.”; 

(9) 

in Article 41, the following sentence is added at the end of paragraph 1:  

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“Where  environmental  information  is  concerned,  Articles  6  and  Article  7  of  Regulation 
(EC) No 1367/2006 of the European Parliament and of the Council39 shall also apply.”; 

(10) 

the following Article 57a is inserted after the title of Section 1 in Chapter V:  

“Article 57a 

Exercise of the delegation 

1. 

2. 

3. 

4. 

The power to adopt delegated acts is conferred upon the Commission subject to the 
conditions laid down in this Article.  

The powers to adopt delegated acts referred to in Article 8(c) shall be conferred upon 
the Commission for an indeterminate period of time from [date of entry into force of 
this Regulation].  

The delegation of power referred to in Article 8(c) may be revoked at any time by the 
European Parliament or by the Council. A decision to revoke shall put an end to the 
delegation of power specified in that decision. It shall take effect the day following 
the publication of the decision in the Official Journal of the European Union or at a 
later  date  specified  therein.  It  shall  not  affect  the  validity  of  any  delegated  acts 
already in force.  

Before adopting a delegated act, the Commission shall consult experts designated by 
each  Member  State  in  accordance  with  the  principles  laid  down  in  the  Inter-
institutional Agreement on Better Law-Making of 13 April 201640.  

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 

the European Parliament and to the Council.  

6.  A  delegated  act  adopted  pursuant  to  Article  8(c)  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  European  Parliament  or  by  the  Council 
within a period of two months of notification of that act to the European Parliament 
and the Council or if, before the expiry of that period, the European Parliament and 
the  Council  have  both  informed  the  Commission  that  they  will  not  object.  That 
period shall be extended by two months at the initiative of the European Parliament 
or of the Council.”; 

(11) 

Article 61 is replaced by the following: 

“Article 61 

Review clause 

1. 

The  Commission  shall  ensure  the  regular  review  of  the  application  of  this 
Regulation. 

2.  Not later than five years after the date referred to in Article [entry into force of the 
Regulation  amending  the  GFL],  and  every  five  years  thereafter,  the  Commission 
shall assess the Authority’s performance in relation to its objectives, mandate, tasks, 
procedures and location, in accordance with Commission guidelines. The evaluation 
shall  address  the  possible  need  to  modify  the  mandate  of  the  Authority,  and  the 
financial implications of any such modification.  

39 

40 

Regulation  (EC)  No  1367/2006  of  the  European  Parliament  and  of  the Council  of  6 September 2006  on  the 
application  of  the  provisions  of  the  Aarhus  Convention  on  Access  to Information,  Public  Participation  in 
Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 
264, 25.9.2006, p. 13). 
OJ L 123, 12.5.2016, p. 1. 

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3.  Where the Commission considers that the continuation of the Authority is no longer 
justified  with  regard  to  its  assigned  objectives,  mandate  and  tasks,  it  may  propose 
that the relevant provisions of this Regulation be amended accordingly or repealed. 

4. 

The  Commission  shall  report  to  the  European  Parliament,  the  Council  and  the 
Management Board on the evaluation findings. The findings of the evaluation shall 
be made public.” 

Article 2 

Amendments to Directive (EC) 2001/18/EC on the deliberate release into the environment of 
genetically modified organisms 

Directive (EC) No 2001/18/EC is amended as follows:  

(1)  

In Article 6, the following paragraph 2a is inserted:  

“2a.  The  notification  referred  to  in  paragraph  1  shall  be  submitted  in  accordance  with 
standard data   formats, where they exist, pursuant to Article 39f of Regulation (EC) 
No 178/2002.”; 

(2)  

In Article 13, the following paragraph 2a is inserted:  

“2a.  The  notification  referred  to  in  paragraph  1  shall  be  submitted  in  accordance  with 
standard data formats, where they exist, pursuant to Article  39f of Regulation (EC) 
No 178/2002.”; 

(3)  

Article 25 is replaced by the following:  

“Article 25 

Confidentiality 

1. 

In accordance with the conditions and the procedures laid down in Article 39 to 39f 
of  Regulation  (EC)  No  178/2002,  which  shall  apply  mutatis  mutandis,  and  this 
article,  

(a) 

(b) 

the  notifier/applicant  may  request  certain  information  submitted  under  this 
Directive to be kept confidential, accompanied by verifiable justification; and,  

the  competent  authority  shall  assess  the  confidentiality  request  submitted  by 
the notifier/applicant. 

2. 

In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 
39(3)  thereof,  which  shall  apply  mutatis  mutandis,  confidential  treatment  may  be 
accepted with respect to the following information, the disclosure of which may be 
deemed, upon verifiable justification, to significantly harm the interests concerned: 

(a)  DNA sequence information, except for sequences used for the purpose of detection, 

identification and quantification of the transformation event; and,  

(b)  breeding patterns and strategies.”; 

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(4)  

In Article 28, the following paragraph 4 is added:  

“4. Where the relevant Scientific Committee is consulted under paragraph 1, it shall make 
public the notification/application, relevant supporting information and any supplementary 
information  supplied  by  the  notifier/applicant,  as  well  as  its  scientific  opinions,  in 
accordance with Article 38 and Articles 39 to 39f of Regulation (EC) No 178/2002, which 
shall apply mutatis mutandis, and Article 25 of this Directive.”. 

Article 3 
Amendments to Regulation (EC) No 1829/2003 on genetically modified food and feed 

Regulation (EC) No 1829/2003 is amended as follows:  

(1) 

Article 5 is amended as follows:  

(a) 

in paragraph 3 the introductory sentence is replaced by the following:  

“The application shall be submitted in accordance with standard data formats, where 
they  exist  pursuant  to  Article  39f  of  Regulation  (EC)  No  178/2002,  and  shall  be 
accompanied by the following:”; 

(b) 

in paragraph 3 point (l) is replaced by the following:  

“(l)  an  identification  of  the  parts  of  the  application  and  any  other  supplementary 
information that the applicant requests to be kept confidential, accompanied by 
verifiable justification, pursuant to Articles 30 of this Regulation and Article 39 
of Regulation (EC) No 178/2002; ”; 

(c) 

in paragraph 3 the following point (m) is added : 

“(m)  a summary of the dossier in a standardised form.”; 

(2) 

in Article 6, paragraph 7 is replaced by the following:  

“7.  The  Authority,  in  conformity  with  Article  38(1)  of  Regulation  (EC)  No 178/2002, 
shall  make  its  opinion  public,  after  deletion  of  any  information  identified  as 
confidential  in  accordance  with  Articles  39  of  Regulation  (EC)  No 178/2002  and 
Article  30  of  this  Regulation.  The  public  may  make  comments  to  the  Commission 
within 30 days from such publication.”; 

(3) 

in Article 10, paragraph 1 is replaced by the following:  

“1.  On  its  own  initiative  or  following  a  request  from  a  Member  State  or  from  the 
Commission, the Authority shall issue an opinion on whether an authorisation for a 
product referred to in Article 3(1) still meets the conditions set by this Regulation. It 
shall forthwith transmit this opinion to the Commission, the authorisation-holder and 
the  Member  States.  The  Authority,  in  conformity  with  Article  38(1)  of  Regulation 
(EC) No 178/2002,  shall  make  its opinion public, after deletion of any information 
identified  as  confidential  in  accordance  with  Article  39  of  Regulation  (EC)  No 
178/2002 and Article 30 of this Regulation. The public may make comments to the 
Commission within 30 days from such publication.”; 

(4) 

in Article 11(2), the introductory sentence is replaced by the following: 

“2.  The application shall be submitted in accordance with standard data formats, where 
they exist pursuant to Article 39f of Regulation (EC) No 178/2002 and accompanied 
by the following:”; 

(5) 

Article 17 is amended as follows: 

(a)  

in paragraph 3 the introductory sentence is replaced by the following:  

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“The application shall be submitted in accordance with standard data formats, where 
they exist pursuant to Article 39f of Regulation (EC) No 178/2002, and accompanied 
by the following:”, 

(b) 

in paragraph 3 point (l) is replaced by the following:   

“(l)  an  identification  of  the  parts  of  the  application  and  any  other  supplementary 
information that the applicant requests to be kept confidential, accompanied by 
verifiable justification, pursuant to Articles 30 of this Regulation and Articles 
39 to 39f of Regulation (EC) No 178/2002; ”, 

(c)  

 in paragraph 3 the following point (m) is added: 

“(m)  a summary of the dossier in a standardised form.”; 

(6) 

in Article 18, paragraph 7 is replaced by the following:  

“7.  The  Authority,  in  conformity  with  Article  38(1)  of  Regulation  (EC)  No 178/2002, 
shall  make  its  opinion  public,  after  deletion  of  any  information  identified  as 
confidential in accordance with Articles 39 to 39f of Regulation (EC) No 178/2002 
and  Article  30  of  this  Regulation.  The  public  may  make  comments  to  the 
Commission within 30 days from such publication.”; 

(7) 

in Article 22, paragraph 1 is replaced by the following:  

“1.  On  its  own  initiative  or  following  a  request  from  a  Member  State  or  from  the 
Commission, the Authority shall issue an opinion on whether an authorisation for a 
product referred to in Article 15(1) still meets the conditions set by this Regulation. It 
shall forthwith transmit this opinion to the Commission, the authorisation-holder and 
the  Member  States.  The  Authority,  in  conformity  with  Article  38(1)  of  Regulation 
(EC) No 178/2002,  shall  make  its opinion public, after deletion of any information 
identified as confidential in accordance with Article 39 to 39f of Regulation (EC) No 
178/2002 and Article 30 of this Regulation. The public may make comments to the 
Commission within 30 days from such publication.”; 

(8) 

in Article 23, the introductory sentence of paragraph 2 is replaced by the following: 

“2.  The application shall be submitted in accordance with standard data formats, where 
they exist pursuant to Article 39f of Regulation (EC) No 178/2002 and accompanied 
by the following:”; 

(9) 

in Article 29, paragraphs 1 and 2 are replaced by the following:  

“1.  The  Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting  information  and  any  supplementary  information  supplied  by  the 
applicant,  as  well  as  its  scientific  opinions  and  opinions  from  the  competent 
authorities  referred  to  in  Article  4  of  Directive  2001/18/EC,  in  accordance  with 
Article  38,  Articles  39  to  39f  and  Article  40  of  Regulation  (EC)  No  178/2002  and 
taking into account Article 30 of this Regulation.  

2. 

The  Authority  shall  apply  Regulation  (EC)  No  1049/2001  of  the  European 
Parliament and of the Council of 30 May 2001 regarding public access to European 
Parliament,  Council  and  Commission  documents  when  handling  applications  for 
access to documents held by the Authority.”; 

(10) 

Article 30 is replaced by the following:  

“Article 30 

Confidentiality 

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1. 

In accordance with the conditions and the procedures laid down in Article 39 to 39f 
of Regulation (EC) No 178/2002 and this article,  

(a) 

(b) 

the applicant may request certain information submitted under this Regulation 
to be kept confidential, accompanied by verifiable justification; and,  

the  Authority  shall  assess  the  confidentiality  request  submitted  by  the 
applicant. 

In  addition  to  Article  39(2)  and  pursuant  to  Article  39(3)  of  Regulation  (EC)  No 
178/2002,  the  Authority  may  also  accept  to  provide  confidential  treatment  to  the 
following  information,  the  disclosure  of  which  may  be  deemed,  upon  verifiable 
justification, to significantly harm the interests concerned: 

(a)  DNA  sequence  information,  except  for  sequences  used  for  the  purpose  of 

detection, identification and quantification of the transformation event; and,  

(b)  breeding patterns and strategies. 

The  use  of  the  detection  methods  and  the  reproduction  of  the  reference  materials, 
provided under Article 5(3) and 17(3) for the purpose of applying this Regulation to 
the GMOs, food or feed to which an application refers, shall not be restricted by the 
exercise of intellectual property rights or otherwise.” 

2. 

3. 

Article 4 
Amendments to Regulation (EC) 1831/2003 on feed additives 

Regulation (EC) No 1831/2003 is amended as follows:  

(1) 

Article 7 is amended as follows: 

(a)    paragraph 1 is replaced by the following: 

“1.   An application for an authorisation as provided for in Article 4 shall be sent to 
the  Commission,  in  accordance  with  standard  data  formats,  where  they  exist 
pursuant  to  Article  39f  of  Regulation  (EC)  No  178/2002,  which  shall  apply 
mutatis  mutandis.  The  Commission  shall  without  delay  inform  the  Member 
States  and  forward  the  application  to  the  European  Food  Safety  Authority 
(hereinafter referred to as the Authority).”; 

(b) 

in paragraph 2 point (c) is replaced by the following:  

“(c)  ensure  public  access  to  the  application  and  any  information  supplied  by  the 

applicant, in accordance with Article 18.”; 

(2) 

Article 18 is replaced by the following:  

“Article 18 

Transparency and confidentiality 

1. 

2. 

The  Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting  information  and  any  supplementary  information  supplied  by  the 
applicant, as well as its scientific opinions, in accordance with Article 38, Articles 39 
to  39f  and  Article  40  of  Regulation  (EC)  No  178/2002,  which  shall  apply  mutatis 
mutandis. 

In accordance with the conditions and the procedures laid down in Articles 39 to 39f 
of Regulation (EC) No 178/2002 and this Article, the applicant may request certain 
information submitted under this Regulation to be kept confidential, accompanied by 
verifiable  justification;  and,  the  Authority  shall  assess  the  confidentiality  request 
submitted by the applicant. 

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3. 

In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 
39(3)  of  that  Regulation,  the  Authority  may  also  accept  to  provide  confidential 
treatment to the following information, the disclosure of which may be deemed, upon 
verifiable justification, to significantly harm the interests concerned: 

(a) 

(b) 

the study plan for studies demonstrating the efficacy of a feed additive in terms 
of  the  aims  of  its  intended  use  as  defined  in  Article  6(1)  and  Annex  I  to  this 
Regulation; and,  

specifications  of  the  impurities  of  the  active  substance  and  the  relevant 
methods of analysis developed internally by the applicant, except for impurities 
that    may  have  adverse  effects  on  animal  health,  human  health,  or  the 
environment.”. 

Article 5 
Amendments to Regulation (EC) No 2065/2003 on smoke flavourings 

Regulation (EC) No 2065/2003 is amended as follows:  

(1) 

Article 7 is amended as follows: 

(a)  

in paragraph 2, point (c) is replaced by the following:  

“(c)  The Authority shall: 

(i) 

(ii) 

inform without delay the other Member States and the Commission of the 
application  and  shall  make  the  application  and  any  supplementary 
information supplied by the applicant available to them; and,  

ensure  public  access  to  the  application,  relevant  supporting  information 
and  any  supplementary  information  supplied  by  the  applicant,  in 
accordance with Articles 14 and 15.”; 

(b) 

 paragraph 4 is replaced by the following:  

“The  Authority  shall  publish  detailed  guidance,  following  the  agreement  with  the 
Commission,  concerning  the  preparation  and  the  submission  of  the  application, 
referred  to  in  paragraph  (1),  taking  into  account  standard  data  formats,  where  they 
exist in accordance with Article 39f of Regulation (EC) No 178/2002.”; 

(2) 

in Article 14, paragraph 1 is replaced by the following:  

“1.  The  Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting information and any supplementary information supplied by the applicant 
as well as its scientific opinions, in accordance with Article 38, Articles 39 to 39f and 
Article 40 of Regulation (EC) No 178/2002.”; 

(3) 

Article 15 is replaced by the following:  

“Article 15 

Confidentiality 

In  accordance  with  the  conditions  and  the  procedures  laid  down  in  Articles  39  to  39f  of 
Regulation (EC) No 178/2002,  

(a) 

the applicant may request certain information submitted under this Regulation to be 
kept confidential, accompanied by verifiable justification; and,  

(b) 

the Authority shall assess the confidentiality request submitted by the applicant.”. 

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Article 6 
Amendments to Regulation (EC) No 1935/2004 on Food Contact Materials 

Regulation (EC) No 1935/2004 is amended as follows:  

(1) 

Article 9 is amended as follows: 

(a)  in paragraph 1 point (c) is replaced by the following:  

“(c)  the Authority shall without delay:  

(i) 

(ii) 

inform  the  other  Member  States  and  the  Commission  of  the  application 
and  shall  make  the  application  and  any  supplementary  information 
supplied by the applicant available to them; and, 

ensure  public  access  to  the  application,  relevant  supporting  information 
and  any  supplementary  information  supplied  by  the  applicant,  in 
accordance with Articles 19 and 20.”; 

(b) 

paragraph 2 is replaced by the following:  

“2.  The Authority shall issue and publish detailed guidelines, following agreement 
with  the  Commission,  concerning  the  preparation  and  the  submission  of  the 
application,  taking  into  account  standard  data  formats,  where  they  exist  in 
accordance  with  Article  39f  of  Regulation  (EC)  No 178/2002,  which  shall 
apply mutatis mutandis.”; 

(2) 

in Article 19, paragraph 1 is replaced by the following:  

“1.  The  Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting  information  and  any  supplementary  information  supplied  by  the 
applicant, as well as its scientific opinions, in accordance with Article 38, Articles 39 
to  39f  and  Article  40  of  Regulation  (EC)  No  178/2002,  which  shall  apply  mutatis 
mutandis and Article 20 of this Regulation.”;  

(3) 

Article 20 is replaced by the following:  

“Article 20 

Confidentiality 

1. 

In accordance with the conditions and the procedures laid down in Articles 39 to 39f 
of Regulation (EC) No 178/2002 and this article:  

(a) 

(b) 

the applicant may request certain information submitted under this Regulation 
to be kept confidential, accompanied by verifiable justification; and,  

the  Authority  shall  assess  the  confidentiality  request  submitted  by  the 
applicant. 

2. 

In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 
39(3)  of  that  Regulation,  the  Authority  may  also  accept  to  provide  confidential 
treatment to the following information, the disclosure of which may be deemed, upon 
verifiable justification, to significantly harm the interests concerned: 

(a) 

any  information  provided  in  detailed  descriptions  of  starting  substances  and 
preparations used to manufacture the substance subject to the authorisation, the 
composition of preparations, materials or articles in which the applicant intends 
to  use  this  substance,  the  manufacturing  methods  of  these  preparations, 
materials or articles, impurities, and migration testing results;  

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(b) 

the  trademark  under  which  the  substance,  shall  be  marketed  as  well  as  the 
tradename  of  the  preparations,  material  or  articles  in  which  it  shall  be  used, 
where applicable; and, 

(c) 

any other information deemed confidential within the specific procedural rules 
referred to in Article 5(1)(n) of this Regulation.”. 

Article 7 
Amendments to Regulation (EC) No 1331/2008 on the common authorisation procedure for 
food additives, food enzymes and food flavourings 

Regulation (EC) No 1331/2008 is amended as follows:  

 (1) 

in Article 6, the following paragraph 5 is added:  

“5.  The  Authority  shall  ensure  public  access  to  the  additional  information  supplied  by 

the applicant in accordance with Articles 11 and 12.”; 

(2) 

Article 11 is replaced by the following:  

“Where  the  Commission  requests  its  opinion  in  accordance  with  Article  3(2)  of  this 
Regulation,  the  Authority  shall  make  public  the  application  for  authorisation,  relevant 
supporting  information  and  any  supplementary  information  supplied  by  the  applicant,  as 
well as its scientific opinions, in accordance with Article 38, Articles 39to 39f and Article 
40 of Regulation (EC) No 178/2002. It shall also make public any request for its opinion as 
well as any extension of period pursuant to Article 6(1) of this Regulation.”; 

(3) 

Article 12 is replaced by the following:  

“Article 12 

Confidentiality 

1. 

The applicant may request certain information submitted under this Regulation to be 
kept  confidential,  accompanied  by  verifiable  justification,  upon  submission  of  the 
application.  

2.  Where an opinion by the Authority is required in accordance with Article 3(2) of this 
Regulation,  the  Authority  shall  assess  the  confidentiality  request  submitted  by  the 
applicant, in accordance with Articles 39 to 39f of Regulation (EC) No 178/2002.  

3.  Where an opinion by the Authority is not required in accordance with Article 3(2) of 
this Regulation, the Commission shall assess the confidentiality request submitted by 
the applicant. Articles 39 to 39f of Regulation (EC) No 178/2002 shall apply mutatis 
mutandis.”; 

Article 8 
Amendments to Regulation (EC) No 1107/2009 on plant protection products 

Regulation (EC) No 1107/2009 is amended as follows:  

(1) 

Article 7 is amended as follows: 

(a)   paragraph 1 is replaced by the following:  

“1.  An application for the approval of an active substance or for an amendment to 
the conditions of an approval shall be submitted by the producer of the active 
substance  to  a  Member  State,  (the  rapporteur  Member  State),  together  with  a 
summary and a complete dossier as provided for in Article 8(1) and (2) of this 
Regulation  or  a  scientifically  reasoned  justification  for  not  providing  certain 
parts  of  those  dossiers,  demonstrating  that  the  active  substance  fulfils  the 

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approval criteria  provided for in  Article 4 of this  Regulation. The application 
shall be submitted in accordance with standard data formats, where they exist 
pursuant  to  Article  39f  of  Regulation  (EC)  No  178/2002,  which  shall  apply 
mutatis mutandis.”, 

(b)  paragraph 3 is replaced by the following:  

“3.  When  submitting  the  application,  the  applicant  may  pursuant  to  Article  63 
request  certain  information,  including  certain  parts  of  the  dossier,  to  be  kept 
confidential and shall physically separate that information.  

Member  States  shall  assess  the  confidentiality  requests.  Upon  a  request  for 
access to information and after consultation with the Authority, the rapporteur 
Member  States  shall  decide  what  information  is  to  be  kept  confidential,  in 
accordance with Article 63.”; 

(2) 

Article 10 is replaced by the following:  

“Article 10 

Public access to the dossiers 

The  Authority  shall  without  delay  make  the  dossiers  referred  to  in  Article  8  of  this 
Regulation  including  any  supplementary  information  supplied  by  the  applicant,  available 
to  the  public,  excluding  any  information  in  respect  of  which  confidential  treatment  has 
been requested and accepted by the Authority pursuant to Article 38, Articles 39 to 39f and 
Article  40  of  Regulation  (EC)  No  178/2002,  which  shall  apply  mutatis  mutandis  and 
pursuant to Article 63 of this Regulation.”; 

(3) 

In Article 15, paragraph 1 is replaced by the following:  

“1.  The application provided for in Article 14 of this Regulation shall be submitted by a 
producer of the active substance to a Member State, with a copy to the other Member 
States, the Commission and the Authority, no later than three years before the expiry 
of the approval. The application shall be submitted in accordance with standard data 
formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002, 
which shall apply mutatis mutandis.”; 

(4) 

Article 16 is replaced by the following:  

“Article 16 

Access to the information for renewal 

The  Authority  shall  assess,  without  delay,  any  request  for  confidentiality  and  make 
available to the public the information provided by the applicant under Article 15 as well 
as any other supplementary information submitted by the applicant, except for information 
in  respect  of  which  confidential  treatment  has  been  requested  and  accepted  by  the 
Authority pursuant to Article 38, Articles 39 to 39f and Article 40 of Regulation (EC) No 
178/2002,  which  shall  apply  mutatis  mutandis  and  pursuant  to  Article  63  of  this 
Regulation.”;  

(5) 

in Article 63, paragraphs 1 and 2 are replaced by the following:  

“1. 

In  accordance  with  the  conditions  and  the  procedures  laid  down  in  Article  39  of 
Regulation  (EC)  No  178/2002  and  this  article,  the  applicant  may  request  certain 
information submitted under this Regulation to be kept confidential, accompanied by 
verifiable justification. 

2. 

In addition to Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 
39(3),  confidential  treatment  may  be  accepted  with  respect  to  the  following 

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information, the disclosure of which may be deemed, upon verifiable justification, to 
significantly harm the interests concerned: 

(a) 

the specification of impurity of the active substance and the related methods of 
analysis for impurities in the active substance as manufactured, except for the 
impurities  that  are  considered  to  be  toxicologically,  ecotoxicologically  or 
environmentally  relevant  and  the  related  methods  of  analysis  for  these 
impurities;  

(b) 

results of production batches of the active substance including impurities; and, 

(c) 

information on the complete composition of a plant protection product.”; 

Article 9 
Amendments to Regulation (EU) No 2015/2283 on novel foods 

Regulation (EU) No 2015/2283 is amended as follows:  

(1) 

Article 10 is amended as follows: 

(a)   paragraph 1 is replaced by the following:  

“1.  The procedure for authorising the placing on the market within the Union of a 
novel  food  and  updating  of  the  Union  list  provided  for  in  Article  9  of  this 
Regulation  shall  start  either  on  the  Commission’s  initiative  or  following  an 
application  to  the  Commission  by  an  applicant,  in  accordance  with  standard 
data formats, where they exist pursuant to Article 39f of Regulation (EC) No 
178/2002. The Commission shall make the application available to the Member 
States without delay.”; 

(b)  paragraph 3 is replaced by the following:  

“3.  Where  the  Commission  requests  an  opinion  from,  the  European  Food  Safety 
Authority  (‘the  Authority’),  the  Authority  shall  ensure  public  access  to  the 
application  in  accordance  with  Article  23  and  shall  give  its  opinion  as  to 
whether the update is liable to have an effect on human health.”; 

(2) 

in Article 15, at the end of paragraph 1 the following sentence is added:  

“The Authority shall ensure public access to the notification pursuant to Article 23.”; 

(3) 

Article 16 is amended as follows: 

(a)  

the following sentence is added at the end of the first paragraph:  

“The application shall be submitted in accordance with standard data formats, where 
they exist pursuant to Article 39f of Regulation (EC) No 178/2002.”, 

(b) 

the following sentence is added at the end of the second paragraph:  

“The  Authority  shall  ensure  public  access  to  the  application,  relevant  supporting 
information  and  any  supplementary  information  supplied  by  the  applicant  in 
accordance with Article 23.”; 

(4) 

Article 23 is replaced by the following:  

“Article 23 

Transparency and confidentiality 

1.  Where the Commission requests its opinion in accordance with Articles 10(3) and 16 
of this Regulation, the Authority shall make public the application for authorisation, 
relevant supporting information and any supplementary information supplied by the 

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applicant, as well as its scientific opinions, in accordance with Article 38, Articles 39 
to 39f and Article 40 of Regulation (EC) No 178/2002 and with this Article.  

2. 

The applicant may request certain information submitted under this Regulation to be 
kept  confidential,  accompanied  by  verifiable  justification,  upon  submission  of  the 
application.  

3.  Where the Commission requests its opinion in accordance with Articles 10(3) and 16 
of this Regulation, the Authority shall assess the confidentiality request submitted by 
the applicant, in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002.  

4.  Where the Commission does not request the Authority’s opinion pursuant to Articles 
10 and 16, the Commission shall assess the confidentiality request submitted by the 
applicant.  Article  39  and  39a  of  Regulation  (EC)  No 178/2002  shall  apply  mutatis 
mutandis.”. 

Article 10 
Transitional measures 

The  provisions  of  this  Regulation  shall  not  apply  to  applications  for  authorisations  under  Union 
food law as well as requests for scientific outputs submitted to the Authority prior to [general date 
of entry of application:18 months after its entry into force].  

Article 11 
Entry into force 

This Regulation shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Union. 

It shall apply from [18 months after its entry into force], except for the following provisions:  

(a) 

(b) 

Article 1(2) shall apply from 1st July 2022.  

Article  1(3)  shall  apply  as  from  the  date  of  appointment  of  the  members  of  the 
Scientific   Panels,  which  shall  be  announced  in  a  notice  in  the  ‘C’  series  of  the  Official 
Journal of the European Union. The current term of office of the Scientific Committee and 
Panel members shall be prolonged until that date. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management mode(s) planned  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on [body]’s appropriations  

3.2.3. Estimated impact on [body]’s human resources 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party contributions  

3.3.  Estimated impact on revenue 

EN 

43 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT  

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal for a 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 (EU) No 2015/2283 [on novel foods. 

1.2. 

Policy area(s) concerned 

Policy area: [Food Safety] 

Activity: [General Food Law] 

1.3. 

Nature of the proposal/initiative  

 The proposal/initiative relates to a new action  

  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action41  

 The proposal/initiative relates to the extension of an existing action  

XThe proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objective(s) 

1.4.1.  The Commission’s multiannual strategic objective(s) targeted by the proposal/initiative  

The  Commission  acknowledged  in  its  Communication  in  reply  to  the  European  Citizen’s 
Initiative  (ECI)  “Ban  glyphosate  and  protect  people  and  environment  from  toxic  pesticides” 
that  “transparency  in  scientific  assessments  and  decision-making  is  vital  to  ensuring 
consumers’ confidence in the regulatory system. It also attaches continuous importance to the 
quality  and  independence  of  scientific  studies  that  are  the  basis  of  the  EU  risk  assessment 
carried  out  by  EFSA”.  The  Commission  therefore  committed  to  come  forward  with  a 
legislative proposal by May 2018 covering these and other aspects such as the governance of 
EFSA drawing up on the results of the Fitness Check of the GFL Regulation and after a public 
consultation. 

The Commission open public consultation is published on: 
https://ec.europa.eu/food/safety/general_food_law/transparency-and-sustainability-eu-risk-
assessment-food-chain_en  

1.4.2. 

Specific objective(s)  

Specific objective No  

41 

As referred to in Article 54(2)(a) or (b) of the Financial Regulation. 

EN 

44 

  EN 

 
                                                 
[1)  improve  and  clarify  the  rules  on  transparency,  especially  with  regard  to  the  scientific 
studies supporting the risk assessment;  

2) increase the guarantees of reliability, objectivity and independence of studies used by EFSA 
in its risk assessment, in particular in the framework of authorisation applications;  

3)  improve  the  governance,  strengthen  the  involvement  of  Member  States  and  address  the 
limitations  affecting  the  long  term  scientific  capacity  of  EFSA  taking  also  account  of  the 
related financial and budgetary aspects,  

4)  develop  a  more  effective  and  transparent  risk  communication  with  the  public  in 
collaboration with Member States] 

Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

1) 
The proposal ensures that scientists and citizens have access to key safety related 
information being assessed by EFSA at an early stage of the risk assessment. In particular, 
the new provisions provide that all supporting data and information relating to applications for 
authorisation are to be made public by EFSA upon receipt (as applications will be submitted 
either  directly  to  EFSA  or  forwarded  to  EFSA  by  Member  States  or  by  the  Commission), 
including supplementary information, except for duly justified confidentiality information. In 
that respect, the proposal sets outs which type of information is to be considered confidential. 
The transparency provisions are without prejudice to any existing Intellectual Property Rights 
and  data  exclusivity  provisions  set  out  in  Union  sectoral  food  legislation.  The  process  to  be 
followed for the processing of confidentiality claims is also set up.  

It will help to improve citizens’ confidence in the credibility of scientific studies and 
2) 
consequently  confidence  in  the  Union  risk  assessment  system.  The  proposal  will  provide 
for  a  series  of  measures  to  ensure  that  EFSA  has  access  to  the  broadest  relevant  scientific 
evidence  possible  related  to  a  request  for  authorisation  and  to  increase  the  guarantees  of 
reliability, objectivity and independence of studies used by EFSA in its risk assessment. First, 
it will establish a Union register of commissioned studies on substances subject to a food law 
authorisation system, to be managed by EFSA. The second measure sets out a pre-submission 
procedure,  by  which  EFSA  can  provide  advice  to  an  applicant  (without  entering  into  the 
design  of  the  study)  and  this  advice  will  be  made  public.  In  the  case  of  renewals,  the  pre-
submission  procedure  foresees  that  studies  planned  by  a  potential  applicant  will  have  to  be 
notified to EFSA and, after consultation of third parties on these planned studies, the Authority 
will  systematically  provide  advice  to  the  applicants.  The  third  measure  provides  that  at  the 
stage of submission of authorisation application, when all studies are made public according to 
the new provisions on transparency, a consultation of third parties will be launched with the 
aim  to  identify  whether  other  relevant  scientific  data  or  studies  are  available.  The  fourth 
measure  provides  for  controls  and  audits  by  Commission  inspectors  in  relation  to  studies. 
Finally,  the  proposal  introduces  the  possibility  for  the  Commission  to  request  EFSA  to 
commission  studies  in  exceptional  circumstances  (e.g.  controversies)  for  the  purpose  of 
verification.  

3) 
Better  Involving  Members  States  in  EFSA’s  governance  structure  and  Scientific 
Panels  and  thus  support  the  sustainability  in  the  long-term  of  EFSA  risk  assessment 
without  touching  on  its  independence.  It  aligns  the  composition  of  EFSA’s  Management 
Board  with  the  Common  Approach  on  Union  decentralised  agencies  by  including 
representatives  of  all  Member  States.  It  will  also  address  the  findings  of  the  GFL  Fitness 

EN 

45 

  EN 

Check  that  identified  challenges  to  EFSA’s  capacity  to  maintain  its  high  level  of  scientific 
expertise  by  providing  for  an  increased  involvement  of  Member  States  in  the  nomination 
process  of  Panels’  members.  The  proposal  respects  the  needs  of  EFSA  for  independence, 
excellence  and  multi-disciplinary  expertise.  In  particular,  the  existing  strict  criteria  on 
independence are maintained and specific provisions require Member States to set up specific 
measures  ensuring  that  the  experts  have  concrete  means  to  act  independently  as  required  by 
the proposal. The proposal also provides for a better organisation of the Panels’ work.  

4) 
Strengthen  risk  communication  between  the  Commission/EFSA  /Members  States 
and public /stakeholders. It is proposed to lay down in legislation the objectives and general 
principles  governing  risk  communication,  taking  into  account  the  respective  roles  of  risk 
assessors and managers pursuant to Article 40 of Regulation (EC) No 178/2002 and, based on 
these  objectives  and  general  principles,  to  draw  up  a  general  plan  on  risk  communication 
(“general  plan”).  The  general  plan should  identify  the  key factors  that need  to  be  taken  into 
account when considering the type and level of communication activities needed, ascertain the 
tools  and  channels  for  the  relevant  risk  communication  initiatives  taking  into  account  the 
relevant target audience groups; and, establish appropriate mechanisms to ensure coherent risk 
communication.  

1.4.3. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

N° of documents (or parts of) subject to claims of confidentiality; 

N° of requests for access to documents addressed to EFSA and the Commission. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The  challenges  to  be  addressed  related  to  transparency,  sustainability  of  the  EU  risk 
assessment  system  (which  for  authorisations  of  products/substances  is  an  EU  centralised 
system, with the exception of pesticides dual system) and the demand for risk communication 
to be more effective. 

Citizens  /  civil  society  perceive  the  risk  assessment  process  as  opaque  and  demand  more 
transparency, due to several different transparency and confidentiality rules applicable to risk 
assessment and decision-making process, making the system complex and non-uniform.  

Recent  debates  raised  concerns  on  transparency  and  independence  of  industry-generated 
studies  and  data.  EFSA’s  evaluations  of  authorisation  applications  are  essentially  based  on 
industry studies (burden of proof of safety of products on the applicant) also perceived as non-
transparent by civil society. 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g.  coordination 
gains,  legal  certainty,  greater  effectiveness  or  complementarities).  For  the  purposes  of  this 
point ‘added value of Union involvement’ is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone. 

Reasons for action at European level (ex-ante)  

EN 

46 

  EN 

 
 
To address the emerging challenges in the area of food law in light of the experience gained to 
date  (Fitness  Check  of  the  GFL  Regulation  published  on  15  January  2018)  and  the 
Commission’s reply to the ECI. Any actions in these areas need to take place at Union level 
and  primarily  within  the  existing  Union  legislative  framework  established  by  the  GFL 
Regulation and in seven other relevant sectoral legislative acts.  

Expected generated Union added value (ex-post)  

The proposal is expected to contribute to the Union risk assessment system acquiring greater 
legitimacy in the eyes of the Union consumers and general public, increasing their confidence 
in its outcome and ensure that it is more accountable to the Union citizens. At the same time, 
the proposal is expected to ensure the long-term sustainability of EFSA’s capacity of scientific 
expertise. 

1.5.3.  Lessons learned from similar experiences in the past 

This urgent proposal draws up from the findings of the Fitness Check of the GFL Regulation 
and  is  based  on  the  commitments  made  by  the  Commission’s  reply  to  the  ECI 
Communication. 

1.5.4.  Compatibility and possible synergy with other appropriate instruments 

To improve transparency of studies and address the societal concerns for a more transparent 
and independent risk assessment process and a more effective risk communication. 

To align EFSA Management Board with the Inter-Institutional agreement to include Member 
States  in  the  Management  Board,  similarly  to  other  Union  agencies  and  provide  for  an 
increased  involvement  of  Member  States  in  the appointment  of  scientific  experts  as  it is  the 
case in other similar scientific Union agencies. 

To  guarantee  maintenance  of  a  high  level  of  scientific  expertise  in  EFSA  and  its  risk 
assessment capacity to ensure the sustainability of the Union risk assessment system that is the 
basis of all measures taken on food safety. 

Laboratory  related  audit  can  be  performed  by  existing  service  SANTE.F  “Health  and  Food 
audits and analysis”. 

1.6. 

Duration and financial impact  

 Proposal/initiative of limited duration  

–    Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial impact from YYYY to YYYY 

X Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from 2020 to 2022  

–  followed by full-scale operation. 

EN 

47 

  EN 

 
1.7.  Management mode(s) planned42  

 Direct management by the Commission through 

–    executive agencies  

 Shared management with the Member States  

X Indirect management by entrusting budget implementation tasks to: 

 international organisations and their agencies (to be specified); 

the EIB and the European Investment Fund; 

X bodies referred to in Articles 208 and 209; 

 public law bodies; 

 bodies governed by private law with a public service mission to the extent that they provide 
adequate financial guarantees; 

  bodies  governed  by  the  private  law  of  a  Member  State  that  are  entrusted  with  the 
implementation of a public-private partnership and that provide adequate financial guarantees; 

  persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP  pursuant  to 
Title V of the TEU, and identified in the relevant basic act. 

Comments  

Impact on the European Food Safety Authority (EFSA) 

42 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx. 

EN 

48 

  EN 

                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

EFSA Single Programming Document (SPD), EFSA Management Board meeting (responsible 
for Authority’s governance), EFSA Annual report activities. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

As  risks  due  to  an  important  exposure  to  potential  conflicts  of  interest  in  EU  decentralised 
agencies and Scientific Committees are assessed as significant (see DG SANTE’s 2017 MP), 
DG  SANTE’s  planned  actions  focus  on  improving  the  handling  of  conflict  of  interest 
situations. 

2.2.2.  EFSA  has  in  place  and  strictly  monitors  its  rules  on  “independence”  and  “conflict  of 

interest”; Control method(s) envisaged  

DG  SANTE  actively  monitors  the  compliance  of  agencies’  independence  policies  with  the 
Commission’s  guidelines  on  independence  through  a  DG  SANTE’s  task  force  including  all 
SANTE’s agencies and through bilateral contacts. In addition to monitoring compliance, DG 
SANTE identifies and disseminates good practices in collaboration with the agencies. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

In  addition  to  the  application  of  all  regulatory  control  mechanisms,  the  responsible  services 
will  devise  an  anti-fraud  strategy  in  line  with  the  Commission’s  anti-fraud  strategy  (CAFS) 
adopted on 24 June 2011 in order to ensure inter alia that its internal anti-fraud related controls 
are  fully  aligned  with  the  CAFS  and  that  its  fraud  risk  management  approach  is  geared  to 
identify  fraud  risk  areas  and  adequate  responses.  Where  necessary,  networking  groups  and 
adequate  IT  tools  dedicated  to  analysing  fraud  cases  related  to  the  financing  implementing 
activities of this Regulation will be set up. 

In particular a series of measures will be put in place such as: 

- decisions, agreements and contracts resulting from the financing implementing activities of 
the Regulation will expressly entitle the Commission/EFSA, including OLAF, and the Court 
of Auditors to conduct audits, on-the-spot checks and inspections; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  proposers  and  tenderers  are 
checked against the published exclusion criteria based on declarations and the Early Detection 
and Exclusion System (EDES);  

-  the  rules  governing  the  eligibility  of  costs  will  be  simplified  in  accordance  with  the 
provisions of the Financial Regulation; 

- regular training on issues related to fraud and irregularities is given to all staff involved in 
contract  management  as  well  as  to  auditors  and  controllers  who  verify  the  beneficiaries’ 
declarations on the spot. 

Moreover, a strict application of the rules on conflict of interests provided in the proposal will 
be ensured. 

EN 

49 

  EN 

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 

3 

Budget line 

Type of  
expenditure 

Contribution  

Number  
[Heading……………………...…………] 

Diff./Non-
diff.43 

from 
EFTA 
countries
44 

from 
candidate 
countries
45 

from third 
countries 

within the 
meaning of 
Article 21(2)(b) 
of the Financial 
Regulation  

17.03 11 

European Food Safety Authority 

Diff. 

YES 

NO 

NO  

NO 

The  estimated  impact  on  expenditure  and  staffing  for  the  years  2021  and  beyond  in  this 
legislative financial statement is added for illustrative purpose and does not pre-judge the next 
multiannual financial framework. 

Please note that inflation adjustments to the figures mentioned in the tables below, need to be 
considered as from the year 2023 onwards. 

  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 

Budget line 

Type of 
expenditure 

Contribution  

Number  
[Heading………………………………] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

[…] 

[XX.YY.YY.YY] 

[…] 

[…] 

YES/ 
NO 

YES 
/NO 

YES 
NO 

within the 
meaning of 
Article 21(2)(b) 
of the Financial 
Regulation  

YES/NO 

43 
44 
45 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

50 

  EN 

                                                 
3.2. 

Estimated impact on EFSA expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial  
framework  

3 

Security and Citizenship 

[Body]: <EFSA.> 

Title 1: Staff expenditure 

2: 

Title 
expenditure 

Infrastructure 

and 

operating 

Title 3: Operational expenditure 

TOTAL appropriations 
for [body] <EFSA.> 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

Commitments 
Payments 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

(3a) 

(3b) 

=1+1a 
+3a 

=2+2a 

+3b 

5.490 
5.490 

9.608 
9.608 

13.726 
13.726 

13.726 
13.726 

13.726 
13.726 

19.512 

34.145 

48.779 

48.779 

48.779 

19.512 

34.145 

48.779 

48.779 

48.779 

25.002 

43.753 

62.505 

62.505 

62.505 

25.002 

43.753 

62.505 

62.505 

62.505 

56.276 
56.276 

199.994 

199.994 

256.270 

256.270 

EN 

51 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

5 

‘Administrative expenditure’ 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

DG: <…….> 

 Human Resources  
 Other administrative expenditure  

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework  

Commitments 

25.002 

43.753 

62.505 

62.505 

62.505 

Payments 

25.002 

43.753 

62.505 

62.505 

62.505 

256.270 

256.270 

EN 

52 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on [body]’s appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–  X  The proposal/initiative requires the use of operational appropriations, as explained below: 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

2024 esq. (see point 1.6) 

TOTAL 

o
N

Cost  N

o

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost  N

o

Cost  N

o

Cost 

Total 
No 

Total 
cost 

0.160 

0.280 

0.400 

0.400 

0.400 

1.640 

Indicate 
objectives and 
outputs  

 

Type46 

Avera
ge 
cost 

SPECIFIC OBJECTIVE No 147 
improve and clarify the 
rules on transparency, 
especially with regard to 
the scientific studies 
supporting the risk 
assessment 

Register of 
commissioned 
studies 

Develo
pment 
& run 

46 
47 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)…’ 

EN 

53 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
IT support for 
data disclosure 

Licenc
es/mai
ntenan
ce/stor
age/sec
urity 

0.960 

1.680 

2.400 

2.400 

2.400 

9.840 

Subtotal for specific objective No 1 

1.120 

1.960 

2.800 

2.800 

2.800 

11.480 

SPECIFIC OBJECTIVE No 2 . 
increase the guarantees of 
reliability, objectivity and 
independence of studies 
used by EFSA in its risk 
assessment for 
authorisation purposes 

Additional ad 
hoc studies 

16 ad 
hoc 
studies 

Subtotal for specific objective No 2 

SPECIFIC OBJECTIVE No 3  

improve the governance, 
strengthen the involvement 
of Member States and 
address the limitations 
affecting the long term 
scientific capacity of 
EFSA 

6.000 

10.500 

15.000 

15.000 

15.000 

6.000 

10.500 

15.000 

15.000 

15.000 

61.500 

61.500 

EN 

54 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MB with MSs & 
observers 

21 Panel 
members 

New indemnity 
regime panels 
experts 

New indemnity 
regime working 
groups 

Capacity 
building 

Preparatory 
work sharing 
with MSs 

27 
MSs + 
4/6 
observ
ers 

10 
panels 
x6meet
ings/y 

2520 
panel 
membe
rs days 
year 

Tot. 
No 
experts 
w.days
= 4600 
10 
panels/
21 
membe
rs 

Tot. 
day 
cost= 

1152 

Tot. 
day 
cost= 
1.152  

Tot. 
day 
cost= 
2549 

Tot. 
day 
cost= 
2549 

7 
days/tr
aining 
/y 

grants/
procur
ements 

0.048 

0.084 

0.120 

0.120 

0.120 

0.221 

0.387 

0.553 

0.553 

0.553 

1.408 

2.464 

3.520 

3.520 

3.520 

2.571 

6.426 

6.426 

6.426 

4.492 

0.224 

0.392 

0.560 

0.560 

0.560 

5.120 

8.960 

12.800 

12.800 

12.800 

Subtotal for specific objective No 3 

9.592 

16.785 

23.979 

23.979 

23.979 

SPECIFIC OBJECTIVE No 4 
develop a more effective 
and transparent risk 
communication with the 
public in collaboration 
with Member States 

0.492 

2.267 

14.432 

26.347 

2.296 

52.480 

98.314 

EN 

55 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
0.600 

1.050 

1.500 

1.500 

1.500 

0.500 

0.875 

1.250 

1.250 

1.250 

1.700 

2.975 

4.250 

4.250 

4.250 

Stakeholders 
engagement in 
RA process  

50 
events/
year 

10 
panels
5event 
panel/
y 

Strengthened 
analysis of 
social science 
survey analysis 

Strengthen 
advocacy: 
targeted 
messages, 
narrative, 
translations, etc 

Increas
e 
targete
d 
comm
unicati
on key 
topics 

Sc.liter
acy 
actions 

Subtotal for specific objective No 4 

2.800 

4.900 

7.000 

7.000 

7.000 

TOTAL COST 

19.512 

34.145 

48.779 

48.779 

48.779 

3.2.3.  Estimated impact on [body]’s human resources  

3.2.3.1.  Summary  

6.150 

5.125 

17.425 

28.700 

 199.994 

–    The proposal/initiative does not require the use of appropriations of an administrative nature  

–  X The proposal/initiative requires the use of appropriations of an administrative nature, as explained below: 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

TOTAL 

EUR million (to three decimal places) 

EN 

56 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Officials (AD Grades) 

Officials 
grades) 

(AST 

Contract staff 

Temporary staff  

Seconded National 
Experts 

0.629 

1.101 

1.572 

1.572 

1.572 

4.861 

8.507 

12.154 

12.154 

12.154 

6.446 

49.830 

TOTAL 

5.490 

9.608 

13.726 

13.726 

13.726 

56.276 

Estimated impact on the staff (additional FTE) – establishment plan 

Function group and grade 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

AD16 
AD15 
AD14 
AD13 
AD12 
AD11 
AD10 
AD9 

EN 

57 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AD8 
AD7 
AD6 
AD5 

AD Total 

AST11 
AST10 
AST9 
AST8 
AST7 
AST6 
AST5 
AST4 
AST3 
AST2 
AST1 

AST Total 

AST/SC 6 
AST/SC 5 
AST/SC 4 
AST/SC 3 
AST/SC 2 
AST/SC 1 

EN 

58 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AST/SCTotal 

GRAND TOTAL 

 34 

 60 

 85 

 85 

 85 

Estimated impact on the staff (additional) – external personnel 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

Contract agents 

Function group IV 

Function group III 

Function group II 

Function group I 

Total 

 8.5 

 14.9 

 21.2 

 21.2 

 21.2 

Seconded National Experts 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

Total 

EN 

59 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment occurs in July, only 50 % of the average cost is taken 
into account) and provide further explanations in an annex.  

1) improve and clarify the rules on transparency 

Actions and total 
No FTEs 

Details  Details 

2020 
Millio
n 

2021 
Millio
n 

2022 
Millio
n 

Confidentiality 
checks 

12.600
studies 

25.2 FTEs 

450 
dossier
s 

Appeals 

8.4 FTEs 

450/ 
dossier
10% 
=45 
appeal
s 

80%co
nfid.st
udies 
0.4day 
scrutin
y 

Avera
ge No 
studies 
/dossie
r= 35 

10% 
confid. 
claims
/dossie
r 

1.302 

2.279 

3.256 

0.432 

0.757 

1.081 

EN 

60 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2) increase reliability, objectivity and independence of studies 

Actions and total 
No FTEs 

Details  Details 

176 
dossier
s & 
meetin
gs 

74appl
ication
s 

376dos
siers 
for PC 

7 
days/d
ossier 

7 man-
days+ 

4 PC 

0.5 
effort/
day+4 
outco
me 

Register of 
commissioned 
studies 

2 FTEs 

Pre-submission 
meetings 
without PC 

6.2 FTEs 

Pre-submission 
meetings for all 
renewals with 
PC 4.3 FTEs 

PC on all 
dossiers 

8.5 FTEs 

Laboratory 
related audit 
2FTEs 

Additional ad 
hoc studies 

4FTEs 

Toxicological 
studies (H2020-
FP9) 

2FTEs 

2020 
Millio
n 

0.103 

2021 
Millio
n 

0.181 

2022 
Millio
n 

0.258 

0.318 

0.557 

0.796 

0.220 

0.385 

0.550 

0.437 

0.765 

1.093 

0.103 

0.181 

0.258 

0.207 

0.362 

0.517 

0.103 

0.181 

0.258 

EN 

61 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3)  improve  the  governance,  strengthen  the  involvement  of  Member  States  and  address  the  limitations  affecting  the  long  term  scientific  capacity  of 
EFSA 

Actions and total 
No FTEs 

Detai
ls 

Details 

MB with MSs & 
observers 0.2 
FTEs 

Capacity 
building 2.4 
FTEs 

Preparatory 
work sharing 
with MSs 6.9 
FTEs 

Insourcing 
routine  work  15 
FTEs 

2020 
Millio
n 
0.010 

2021 
Millio
n 
0.018 

2022 
Millio
n 
0.025 

0.124 

0.217 

0.310 

0.356 

0.624 

0.891 

0.775 

1.357 

1.938 

EN 

62 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4) develop a more effective and transparent risk communication with the public in collaboration with Member States 

2020 
Millio
n 

0.646 

2021 
Millio
n 

1.131 

2022 
Millio
n 

1.615 

0.103 

0.181 

0.258 

0.248 

0.434 

0.620 

Actions and total 
No FTEs 

Details  Details 

Stakeholders 
engagement in 
RA process 12.5 
FTES 

Strengthened 
analysis of 
social science 
survey analysis 
2 FTEs 

Strengthen 
advocacy: 
targeted 
messages, 
narrative, 
translations etc 
4.8 FTEs 

EN 

63 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.2.  Estimated requirements of human resources for the parent DG 

–    The proposal/initiative does not require the use of human resources.  

–    The proposal/initiative requires the use of human resources, as explained below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 
Year 
2022 

2024 esq. (see point 1.6) 

Year 
2023 

 Establishment plan posts (officials and temporary staff) 

XX 01 01 01 (Headquarters and Commission’s Representation 
Offices) 

Year 
2020 

Year 
2021 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

 External staff (in Full Time Equivalent unit: FTE)48 

XX 01 02 01 (AC, END, INT from the ‘global envelope’) 

XX 01 02 02 (AC, AL, END, INT and JED in the Delegations) 

XX 01 04 yy49 

- at Headquarters50 

- in Delegations  

XX 01 05 02 (AC, END, INT – Indirect research) 

10 01 05 02 (AC, END, INT – Direct research) 

48 
49 
50 

AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JED = Junior Experts in Delegations.  
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 
Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and the European Fisheries Fund (EFF). 

EN 

64 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Other budget lines (specify) 

TOTAL 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within 
the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the 
light of budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

External staff 

Description of the calculation of cost for FTE units should be included in the Annex V, section 3.  

3.2.4.  Compatibility with the current multiannual financial framework  

–  X  The proposal is compatible with the current multiannual financial framework and may entail the use of special instruments as defined in 

Council Regulation (EU, Euratom) No 1311/2013. 

–    The proposal/initiative will entail reprogramming of the relevant heading in the multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding amounts. 

[…] 
–    The proposal/initiative requires application of the flexibility instrument or revision of the multiannual financial framework51. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding amounts. 

[…] 

51 

See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial framework for the years 2014-2020. 

EN 

65 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.5.  Third-party contributions  

–  X The proposal/initiative does not provide for co-financing by third parties.  

–  The proposal/initiative provides for the co-financing estimated below: 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

Total 

EUR million (to three decimal places) 

Specify  the  co-financing 
body  

TOTAL 
co-financed  

appropriations 

3.3. 

Estimated impact on EFSA revenue  

–  X  The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

– 

– 

 

 

on own resources  

on miscellaneous revenue  

Budget revenue line: 

Appropriation
s available for 
the current 
financial year 

Impact of the proposal/initiative52 

Year 
2020 

Year 
2021 

Year 
2022 

Year 
2023 

2024 esq. (see point 1.6) 

EUR million (to three decimal places) 

52 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 25 % for collection 
costs. 

EN 

66 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Article …………. 

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected. 

[…] 

Specify the method for calculating the impact on revenue. 

[…] 

EN 

67 

EN