REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides
Date: 2020-05-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: environmental protection, health risk, market approval, pesticide, pesticide residue, plant health control

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 20.5.2020  COM(2020) 208 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Evaluation of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market and of Regulation (EC) No 396/2005 on maximum residue levels of pesticides {SWD(2020) 87 final}  
 
 
1 

INTRODUCTION 

Plant protection products (PPPs), also often referred to as pesticides, are used to protect crops 
against  pests,  diseases,  or  competing  plants  with  the  aim  of  optimising  food  production  in 
conventional  or  organic  farming.  Pesticides  are  also  used  to  maintain  food  quality  (during 
storage)  or  to  preserve  certain  areas  in  the  condition  needed  for  their  proper  use  (e.g. 
railways). Pesticides  can be of  chemical  or non-chemical  origin  (e.g. micro-organisms) and 
their residues in food and feed can be harmful to consumers.  

Because of their potentially harmful effects on human health or the environment, pesticides 
are  subject  to  strict  rules  in  the  EU,  namely  Regulation  (EC)  No  1107/20091,  hereinafter 
referred to as ‘the PPP Regulation’, and Regulation (EC) No 396/20052, hereinafter referred 
to as ‘the MRL Regulation’. The objectives of the Regulations are to ensure a high level of 
protection for human and animal health and for the environment, to improve the functioning 
of  the  internal  EU  market,  improve  agricultural  production  in  the  EU,  and  facilitate 
international  trade.  Implementation  of  the  Regulations  is  the  joint  responsibility  of  the 
Member  States  and  the  Commission,  as  Member  States  have  key  roles  for  the  scientific 
assessment of active substances and maximum  residue levels,  where they cooperate closely 
with  the  European  Food  Safety  Authority  (EFSA).  Based  on  these  assessments,  the 
Commission proposes decisions on the approval, renewal of approval and maximum residue 
levels of active substances, which are subject to a vote in the Standing Committee on Plants, 
Animals, Food and Feed before formal adoption by the Commission. The responsibility for 
the assessment of PPPs and their authorisation lies entirely with the Member States. 

The  PPP  and  MRL  Regulations  are  embedded  in  a  wider  regulatory  and  policy  context,  in 
particular  as  set  by  the  Sustainable  Use  Directive3  and  the  Common  Agricultural  Policy4, 
which  create  obligations  for  the  use  of  authorised  pesticides  and  provide  incentives  for  a 
more  sustainable  agriculture  and  sustainable  farming  practices.  Environmental  legislation 
governing the quality of surface and ground water includes limits for a number of pesticides 
and the use of pesticides is in general prohibited in areas identified of particular importance 
to preserve biodiversity. 

There  is  a  growing  awareness  in  society  around  the  sustainability  of  food  production,  of 
which the sustainable use of pesticides is an important component, as reflected in the United 
Nations  2030  Agenda  for  Sustainable  Development5  and  the  European  Commission's 
Reflection Paper "Towards a Sustainable Europe by 2030"6.   

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). 

2   Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the  Council  of  23 February  2005  on  maximum 
residue  levels  of  pesticides  in  or  on  food  and  feed  of  plant  and  animal  origin  and  amending  Council 
Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1). 

3   Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework 

for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71). 

4   Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a 
common  organisation  of  the  markets  in  agricultural  products  and  repealing  Council  Regulations  (EEC)  No  922/72, 
(EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). 

5   Available at: https://ec.europa.eu/environment/sustainable-development/SDGs/index_en.htm. 
6   Available at: https://ec.europa.eu/commission/files/reflection-paper-towards-sustainable-europe_en. 

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The Commission is responding to society's concerns regarding sustainability in the European 
Green Deal7, more particularly via the Farm to Fork Strategy8, and the Biodiversity Strategy9. 
These  initiatives  will  promote  healthy  ecosystems  and  biodiversity,  more  sustainable  food 
production systems and healthier diets, while ensuring sustainable livelihood for farmers and 
access  to  high  quality  and  nutritious  food  for  consumers.  The  Green  Deal  Communication 
notably commits to reduce the use and risks of chemical pesticides.  

However, an EU agriculture entirely without pesticides is not a realistic objective, including 
in organic farming where a limited number of pesticides may also be used. Use of pesticides 
is an essential tool to reach the EU’s objectives on plant health, food safety and food security, 
especially in view of the coming increase in global food demand linked to population growth. 
The aim of EU legislation on pesticides is therefore not to eliminate pesticides but rather to 
minimise their impact on human health and the environment through reduced dependency on 
pesticides,  alternative  methods  and  through  increased  use  of  low  risk  and  non-chemical 
pesticides. 

The Commission has carried out an evaluation of the PPP and MRL Regulations covering the 
period of their respective entry into application until end 2018 as part of its regulatory fitness 
and performance programme (REFIT) in order to assess whether the Regulations are fit for 
purpose and achieve their objectives while keeping EU law simple and remove unnecessary 
burdens. This report is submitted pursuant to Articles 82 and 62(5) of the PPP Regulation and 
Article 47  of  the  MRL  Regulation  and  is  accompanied  by  a  Staff  Working  Document 
presenting  all  evidence.  This  report  is  published  at  the  same  time  as  the  Farm  to  Fork 
Strategy  and  the  second  report  on  the  implementation  of  the  Sustainable  Use  Directive.  It 
builds  on  the  evidence  collected  by  an  external  contractor10,  an  opinion  from  the 
Commission’s Scientific Advice Mechanism11, audit reports from the Commission services12, 
and experience gained from the operation of the Regulations.  

In  addition,  the  Commission  has  given  due  consideration  to  two  reports  by  the  European 
Parliament.  The first  report13, adopted in  September 2018,  addressed the implementation of 
the  PPP  Regulation  and  concluded  that  the  PPP  Regulation  is  a  significant  improvement 
compared to the past and that it is appropriate to regulate pesticides at the EU level. However, 
it also concludes that the objectives to protect human and animal health and the environment 
are not fully achieved and that the implementation of the Regulation is not satisfactory. The 
European  Parliament  therefore  calls  for  action  from  all  key  players.  The  second  report14, 
adopted in  January 2019,  of the Special Committee on the Union’s  authorisation  procedure 
for  pesticides  (PEST  Committee),  calls  for  improved  transparency,  strengthened  policies 
tackling conflicts of interest and reinforced independence of science. It also calls for a strict 
application  of  the  precautionary  principle  and  of  the  hazard  based  approach  in  the 
authorisation procedure and argues for more incentives and research for low-risk alternatives, 

9

7   https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en. 
8
   COM(2020) 381. 
   COM(2020) 380. 
10  External support study published in the EU bookshop. 
11  European Commission (June 2018) EU Authorisation processes of plant protection products — from a scientific point 

of view. Group of Scientific Advisors. ISBN 978-92-79-67735-9. 

12   E.g. European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 
the  authorisation  of  plant  protection  products. 
in  place  for 

the  systems 

to  evaluate 

2017 
in  order 
DG(SANTE) 2017-6250.  

13  European Parliament (January 2019) Report on the Union’s authorisation procedure for pesticides (2018/2153(INI)) - 

Special Committee on the Union’s authorisation procedure for pesticides . 

14  European  Parliament  (September  2018)  Report  on  the  implementation  of  the  Plant  Protection  Products  Regulation 

(EC) No 1107/2009 (2017/2128(INI)).  

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as  well  as  the  setting  up  of  a  negative  list  of  prohibited  co-formulants  and  an  approval 
procedure for safeners and synergists. The Commission has already responded directly to the 
two European Parliament reports15,16.  

The Commission has also been mindful of the discussions held in the AGRIFISH Council in 
November  2018  and  the  Environment  Council  in  December  2018.  In  particular,  Ministers 
exchanged views on the current developments in the approval and authorisation system and 
the impacts on European agriculture and farmers of the increasing numbers of non-renewals 
of approval of active substances. Ministers also discussed the possible launch of a long-term 
reflection  on  the  possible  development  of  EU  measures  to  complement  national  actions  to 
reduce and ultimately phase-out the use of hazardous PPPs and stimulate the development of 
alternatives.  The  Commission  recalled  that  Member  States  are  not  doing  enough  to  reduce 
dependency on  chemical substances  for plant protection and that the potential  of integrated 
pest  management  is  not  fully  exploited.  In  addition,  Member  States  often  do  not  meet 
deadlines  when  they  act  as  rapporteur  Member  States  for  the  EU  approval  system  and  are 
making  increasing  use  of  emergency  authorisations  of  products,  which  undermine  the  EU 
system.  The  Commission  acknowledged  the  need  to  find  ways  to  accelerate  placing  on  the 
market of low-risk active substances and products. 
This  report  outlines  the  main  findings17  of  the  evaluation  of  the  implementation  and 
functioning  of  both  the  PPP  and  MRL  Regulations  in  all  Member  States  since  their 
applicability  in  June  2011  and  September  2008.  It  proposes  actions  to  enhance  the 
implementation  of  the  Regulations  in  order  to  simplify  or  strengthen  the  current  regulatory 
framework.  

While the evaluation has found a number of weaknesses, some of which are divisive among 
different  stakeholders,  stakeholders  from  across  the  spectrum  agree  that  the  current 
legislation  sets  an  adequate  framework  of  pre-market  approval  of  active  substances  and 
authorisation of plant protection products and are not calling for fundamental changes of the 
PPP  Regulation,  while  views  were  more  divergent  as  regards  the  MRL  Regulation.  The 
report identifies in the next section sixteen areas where implementation can be improved in 
the short and medium term. 

2 

 FINDINGS OF THE EVALUATION AND POSSIBLE WAYS FORWARD 

2.1 

STRENGTHENED PROTECTION OF HUMAN HEALTH AND THE ENVIRONMENT 

The evaluation found that the PPP Regulation is largely effective in protecting human health 
and the environment due to the stringency of the approval criteria, although implementation 
can be further improved. Stakeholders from across the spectrum consider that the regulatory 
requirements  in  the  EU  are  among,  if  not  the,  strictest  in  the  world.  The  number  of  active 
substances  decreased  already  by  more  than  50 %  under  Directive  91/414/EEC,  the 
predecessor  to  the  PPP  Regulation,  which  led  to  the  withdrawal  of  the  market  of  many 
substances  that  would  not  have  met  the  requirements  of  the  Directive.  This  means  that  the 
level  of  protection  of  health  and  environment  was  already  high  before  the  PPP  Regulation 
came into force. With the PPP Regulation, a process to regularly review the approval of all 
active substances has been initiated in 2011: active substances approved earlier are reviewed 
against the strengthened approval criteria to further increase the level of protection in the EU. 

15   The Commission’s response to text adopted in plenary SP(2018)829. 
16   The Commission’s response to text adopted in plenary SP(2019)355. 
17   Details of the evaluation can be found in the accompanying Commission Staff Working Document.  

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As  a  consequence,  the  number  of  active  substances  earlier  allowed  in  plant  protection 
products,  is  further  reduced  and  the  overall  number  of  active  substances  approved  is 
substantially lower than in third countries with significant agricultural production. The share 
of  active  substances  with  high  hazard  profiles  is  low  (2%)  and  will  further  decrease  in  the 
future,  while  the  proportion  of  active  substance  with  less  problematic  profiles  is  relatively 
large (37%) and is increasing18. In fact, in recent years, about half of the applications for the 
approval of new active substances (of which there are on average 10 per year) are for micro-
organisms  (non-chemical)  or  substances  that  are  expected  to  meet  the  criteria  for  low-risk 
substances.  From  2011  to  2018,  decisions  to  not  approve,  not  to  renew  the  approval,  or 
withdraw  22  active  substances19  because  of  health-  or  environment-related  concerns,  have 
contributed  to  reducing  serious  risks  for  consumers,  operators,  workers,  bystanders  and 
residents  in  the  EU,  and  for  the  environment.  The  protection  of  human  health  and  the 
environment is expected to further improve in the coming years when the first review of all 
existing approvals will be finalised (expected by 2025). However, not all stakeholders agree 
with  the  conclusion  that  the  PPP  Regulation  is  effectively  protecting  human  health  and  the 
environment - in particular NGOs argue that the implementation of the approval criteria is not 
sufficiently stringent, and that hazardous active substances are still used in the EU.  

While  the  PPP  Regulation  has  the  clear  potential  to  be  effective  in  reaching  its  objectives, 
including increasing the share of low risk substances, these have only been partially attained 
due  to  efficiency  problems.  In  fact,  implementation  of  the  PPP  Regulation  suffers  from 
significant  delays  that  occur  in  the  approval  and  renewal  of  active  substances  and  the  (re-) 
authorisation of PPPs. This leads to the need for the extension of approval periods of active 
substances  for  several  years  in  order  to  conclude  the  decision-making  process,  while  also 
delaying  market  access  for  low-risk  active  substances  and  keeping  on  the  market  active 
substances that ultimately are found to not fulfil the approval criteria anymore.  

The  costs  and  workload  involved  in  approving  and  renewing  the  approval  of  active 
substances and authorising PPPs within the three zones20 established by the PPP Regulation 
are not fairly distributed across Member States. This also contributes to the existing delays as 
certain  Member  States  face  a  high  workload.  In  addition,  the  fees  raised  by  some  Member 
States  seem  to  be  both  insufficient  to  cover  their  costs,  and,  in  addition,  not  all  Member 
States  ring-fence  the  fees  for  the  authorities  actually  carrying  out  the  work,  resulting  in 
insufficient resources being available. 
The European Citizens’ Initiative21 on glyphosate, which collected over 1 million signatures 
in  less  than  9  months  in  2017,  called  for  more  transparency  in  the  process  for  assessing 
pesticides.  In  response,  and  to  increase  trust  in  the  scientific  assessments  conducted  by 
Member  States  and  EFSA,  the  Commission  proposed  an  amendment  of  the  General  Food 
Law22, which has been adopted by the Council and the European Parliament on 13 June 2019 
(Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment 
in  the food chain)23  and  will become  applicable  on 27 March 2021. As of that date the full 
dossier  provided  by  the  applicant    to  support  applications  for  approvals  (or  renewal  of 

18  The  methodology  to  compare  the  toxicological  hazard  profiles  of  active  substances  approved  in  2011  and  2018  is 
summarised in Chapter 5.1.1. of the accompanying Staff Working Document and set out in detail in its Annex 3.  

19   Decisions not-renewing the approval of another 8 active substances were adopted in 2019.  
20   Article 3(17) and Annex I of the PPP Regulation assign Member States to one of three zones with comparable climatic 

and agricultural conditions to facilitate cooperation and mutual recognition of product authorisations. 

21   European Citizens Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’. 
22  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. COM/2018/0179 final — 2018/088 (COD). 

23   Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of 

the EU risk assessment in the food chain, OJ L 231, 6.9.2019, p. 1.   

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approvals)  of  active  substances  –  except  duly  justified  confidential  information    will  be 
published  early  in  the  risk  assessment  process.  This  will  give  the  general  public  and 
independent scientists direct access to the underlying data. An EU register of commissioned 
studies  will  also  be  created  to  guarantee  that  companies  applying  for  approval  submit  all 
relevant  information  and  do  not  hold  back  unfavourable  studies.  The  Commission  will  be 
empowered to conduct fact finding missions in Member States between 2021-2025 to assess 
whether  testing  facilities  apply  the  relevant  standards  for  carrying  out  tests  and  studies 
submitted  to  EFSA.  To  improve  risk  communication,  the  new  Regulation  (EU)  2019/1381 
sets out certain objectives and general principles of risk communication (e.g. accurate, timely 
and transparent information, attention to risk perceptions, and accessibility for specialists and 
non-specialists),  based  on  which  the  Commission  is  empowered  to  adopt  in  the  future  a 
general plan on risk communication by means of an implementing act.  

1. Better implementation – addressing delays and increasing transparency 
In light of the Green Deal commitment to reduce risks from chemical pesticides and prevent 
and remedy pollution, the Commission calls on the Member States to  significantly increase 
resources to implement all relevant procedures under the PPP and MRL Regulations within 
the legal deadlines. In order to have the required resources available, Member States should 
review the fees they charge, set them at a level fully recovering their costs, and ensure that 
the fees benefit the authorities conducting the work. The Commission will consider opening 
infringements proceedings against those Member States that systematically fail to respect the 
legal deadlines. 

In  line  with  the  views  of  the  European  Parliament  to  avoid  procedural  delays  leading  to 
inefficiencies,  the  Commission  recommends  that  Member  States  only  accept  complete 
dossiers of high quality as admissible - both for applications for first or renewed approval of 
active substance and PPP authorisation applications.  

Furthermore, the Commission calls on EFSA and the Member States to implement the actions 
agreed in the Pesticides Steering Network24 to improve the peer-review process with a view 
to avoiding delays. In addition, the Commission will continue to work with EFSA to improve 
clarity  of  the  EFSA  Conclusions  as  regards  uncertainties  to  facilitate  the  decision-making 
process and readability for non-experts.  

The  Commission  will  adopt  in  the  second  quarter  of  2020,  a  first  list  of  unacceptable  co-
formulants25. The Commission will, thereafter, propose an  Implementing Regulation setting 
out  criteria  and  a  procedure  for  identifying  further  unacceptable  co-formulants.  The 
Commission  will  also  propose  a  work  programme  for  the  assessment  of  safeners  and 
synergists. 
In the course of 2020, the Commission will amend Regulation (EU) 844/201226 governing the 
renewal  process  to  implement  the  necessary  changes  flowing  from  Regulation  (EU) 
2019/1381. The Commission, will also consider to amend Article 13(5) of Regulation (EU) 
No 844/2012  to  introduce  a  short  window  for  applicants  to  submit  comments  and  further 
information  on  the  draft  EFSA  Conclusions  to  address  aspects  that  were  raised  only  late 
during the peer review process and could not be foreseen by applicants in order to increase 

24   The  Pesticide  Steering  Network  is  one  of  EFSA’s  networks  and  consist  of  nationally  appointed  EU  Member  State 

organisations with expertise in the field of pesticides, see https://www.efsa.europa.eu/en/pesticides/networks/. 

25   These will be listed in Annex III to Regulation (EC) No 1107/2009. 
26   Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary 
for  the  implementation  of  the  renewal  procedure  for  active  substances,  as  provided  for  in  Regulation  (EC)  No 
1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the 
market  (OJ L 252, 19.9.2012, p. 26). 

5 

 
 
                                                 
the completeness and robustness of the final EFSA Conclusion. These changes will increase 
transparency  and  efficiency  throughout  the  assessment  and  during  the  ensuing  risk 
management process.  

The human health related cut-off criteria27 introduced in the PPP Regulation have contributed 
to removing the most hazardous active substances from the market, mainly through the fact 
that  for  most  substances  for  which  applicants  expect  that  they  meet  the  criteria  no 
applications  for  renewal  of  approval  have  been  submitted.  This  is  contributing  to  the 
protection  of  human  health  and  the  environment.  Although  a  step-wise  approach  was 
envisaged when evaluating active substances, Member States do not seem to discontinue the 
risk assessment when an active substance meets the cut-off criteria, resulting in equally high 
or higher workload as for a normal active substance for the evaluating authorities. Among the 
reasons to continue the risk assessment are the derogation possibilities for several of the cut-
off criteria, for which new procedures and guidance had to be developed but are still not fully 
complete.  

Another  identified  inefficiency  for  applying  the  cut-off  criteria  has  been  that  not  all  active 
substances have a harmonised classification.  Member States  do not  systematically submit a 
dossier for harmonised classification early in the renewal process. This resulted in delays in 
the overall assessment and in decision-making. It has decreased the immediate effectiveness 
of the cut-off criteria. 

As  a  consequence,  the  expected  reduction  of  the  workload  for  the  evaluation  of  substances 
meeting  (or  expected  to  meet)  the  cut-off  criteria  has  materialised  only  for  those  thirteen 
active  substances  for  which  no  applications  for  renewal  were  submitted  and  where  no 
evaluation needed to be carried out28.  

2. Improved implementation of the cut-off criteria 
The  Commission  adopted  in  the  beginning  of  2020  an  amendment29  to  Regulation  (EU) 
No 844/2012  governing  the  renewal  process  to  ensure  that  Member  States  submit 
systematically – and early in the evaluation process – proposals for harmonised classification 
and labelling under the CLP Regulation30. This will increase certainty in the use of the cut-off 
criteria  and  reduce  difficulties  and  delays  during  the  peer-review  and  the  decision-making 
process for renewal of approval of active substances.  

The  Commission  recommends  that  Member  States  make  full  use  of  Article 11(4)  of 
Regulation (EU) No 844/2012 and only continue the full risk assessment if either the active 
substances do not  meet  the cut-off  criteria or at  least  one of the derogation possibilities for 
their approval is invoked.  
The Commission will in the 1st half of 2020 re-launch discussions with the Member States to 
explore  possibilities  to  finalise  the  guidance  document  on  negligible  exposure  in  order  to 

27   These  are  set  out  in  Annex  II,  points  3.6.2  to  3.6.5,  to  Regulation  (EC)  No  1107/2009:  substances  classified  as 
mutagen, carcinogen or toxic for reproduction category 1A or 1B or having endocrine disrupting properties must not 
be approved as active substances in plant protection products (PPPs) save for certain limited derogation possibilities. 
28   Bromadiolone, carbendazim, carbetamide, difenacoum, glufosinate, molinate, myclobutanil, oxadiargyl, profoxydim, 

spirodiclofen, tepraloxydim, triflumizole and warfarin. 

29

   Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) 

No 844/2012 as regards the harmonised classification of active substances (OJ L 19, 24.1.2020, p. 1). 

30  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, 
labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, 
and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1) 

6 

 
 
 
                                                 
accelerate  the  evaluation  of  whether  this  derogation  possibility  can  apply  when  an  active 
substance meets the cut-off criteria.  

The  rules  for  active  substances  that  are  candidates  for  substitution  are  both  ineffective  and 
inefficient.  Available  evidence  show  that  the  comparative  assessments  for  products 
containing active substances that are candidates for substitution carried out by Member States 
is complex and requires resources but did not lead to any substitution, mainly due to the lack 
of alternatives with proven better risk profiles. Thus, the expected benefits for human health 
or  the  environment  from  substituting  these  more  hazardous  active  substances  have  not 
materialised.  In  addition,  comparative  assessments  have  made  the  authorisation  process 
costlier than for standard authorisations.  

3. Simplify the comparative assessment of candidates for substitution 
The Commission will by end 2020 make use of its delegation of power to amend Annex IV 
of the PPP Regulation to improve the effectiveness of comparative assessments of products 
containing candidates for substitution.  

The comprehensive annual monitoring of pesticides residues with more than 80 000 samples 
analysed per year shows high compliance with the established MRLs, indicating that the food 
available  to  consumers  is  well  controlled  and  safe.  By  the  end  of  2018  MRLs  were 
established  for  486 substances  approved  in  the  EU  and  247 non-approved  substances  on  a 
broad range of agricultural commodities. New MRL applications, including import tolerance 
requests,  undergo  a  comprehensive  risk  assessment  process  and  MRLs  can  only  be 
established if they are safe for consumers. In parallel, a thorough review exercise of existing 
MRLs started in 2008, which includes existing import tolerances and maximum residue limits 
established by the Codex Alimentarius Commission31  and ensures that MRLs are kept up to 
date  and  are  not  retained  at  levels  higher  than  necessary  according  to  Good  Agricultural 
Practices.  However,  this  review  of  all  existing  MRLs  was  initially  delayed  because  the 
relevant Article 12 of the MRL Regulation does not set out a clear procedural framework to 
complete  the  review  of  existing  MRLs  for  all  approved  active  substances  within  one  year 
from  the  entry  into  force  of  the  MRL  Regulation.  Procedures,  such  as  assignment  of 
tasks/responsibilities, deadlines, and the possibility to charge fees to be paid by industry, had 
first to be developed and agreed with the Member States which led to delays. The review is 
now progressing well. 

Some stakeholders and Member States requested to set up specific MRLs for feed, fish and 
processed products, an option that is given by the MRL Regulation. The Commission has not 
yet made use of these possibilities, as there is no indication of potential risks that would point 
to  the  need  to  take  priority  action  in  this  area.  Mechanisms  to  take  enforcement  action  are 
already in place in the MRL Regulation and in general food legislation to address situations 
where specific MRLs have not been established. General provisions for processed products, 
including  processing  factors,  are  also  already  in  place,  and  in  line  with  related  food 
legislation  in  other  areas  (e.g.  Regulation  (EC)  No  1881/2006  on  contaminants)  those 
provisions could be clarified and guidance given to Member States (see also box 13).  

Developing a methodology for cumulative risk assessment covering simultaneous exposure to 
multiple chemicals (the ‘cocktail effect’) turned out to be much more complex than initially 
expected  and  is  still  on-going.  So  far,  EFSA  has  established  two  groups  of  chemicals  with 

31

   http://www.fao.org/fao-who-codexalimentarius/en/ 

7 

 
 
 
 
                                                 
impacts on the nervous system and the thyroid, respectively, and has published draft reports32 
with results of cumulative risk assessment for their residues in food for public consultation in 
September  2019  followed  by  a  Technical  stakeholder  event  in  October  201933.  The  final 
reports  are  expected  to  be  published  in  April  2020.  Work  is  currently  ongoing  to  further 
develop  the  methodology  and  perform  cumulative  assessments  for  other  groups  of 
substances,  and  to  eventually  use  it  for  regulatory  decision-making  (e.g.  MRL  setting  and 
approval of active substances). Substantial resources are required in EFSA and the Member 
States to advance the further method development. Therefore it will only be possible at a later 
stage  to  appreciate  the  impact  of  cumulative  risk  assessment  on  the  protection  of  human 
health. 

4. Cumulative risk assessment  
The Commission, EFSA and the Member States will continue to develop a methodology for 
cumulative  risk  assessment  in  order  to  further  strengthen  consumer  protection.  Faster 
progress will require EFSA and Member States to allocate sufficient resources to this task. 

The Commission and EFSA will develop an action plan by the end of 2020 that would set out 
priorities for the ongoing work on method development and the subsequent implementation 
of  the  methodology.  The  plan  will  be  based  on  existing  knowledge,  and  will  be  flexible  to 
respond to changing scientific developments and experiences gained. 

There is a substantial decline in biodiversity in agricultural ecosystems as reflected in a drop 
of farmland birds and losses of insect populations in parts of the EU. Among other factors, 
use  of  pesticides  has  been  identified  as  an  important  driver  for  these  developments.  The 
respective restrictions or non-renewal of approvals of active substances with negative impacts 
on  pollinators  –  such  as  the  neonicotinoids  imidacloprid,  clothianidin,  thiamethoxam  and 
thiacloprid  –  have  contributed  to  a  higher  level  of  environmental  protection.  Pesticides 
contribute to the pollution of ground and surface waters. Monitoring data published in 2018 
regarding the chemical status of European waters shows that pesticides and their metabolites 
(often ‘legacy substances’ that are no longer approved) are the cause of about 6.5% (by area) 
of  groundwater  bodies  not  meeting  the  good  status  objective  set  in  the  Water  Framework 
Directive34. The monitoring data show a reduction in pesticide contamination in surface water 
over recent years (although only a limited number of substances were monitored), indicating 
that  the  PPP  Regulation  seems  to  contribute  positively  to  the  protection  of  the  aquatic 
environment.  Fewer  monitoring  data  are  available  for  other  environmental  compartments 
such  as  soil,  or  from  animals,  plants  and  humans  (biomonitoring).  More  monitoring  data 
would  help  to  verify  whether  the  model  predictions  during  the  risk  assessment  are  correct 
and/or risk mitigation measures are effective. 

5. Environmental- and Bio-monitoring 
As  part  of  the  Green  Deal  deliverables,  the  Commission  will  intensify  the  monitoring  of 
environmental  concentrations  and  effects.  The  Commission  will  notably,  where  found 
relevant,  set  obligations  in  approval  decisions  to  monitor  the  presence  of  active  substances 
(and/or  metabolites  thereof)  in  environmental  compartments.  In  addition,  the  Commission 
will  explore  the  possibility  to  increase  monitoring  of  concentrations  in  soil  by  including 

32    https://www.efsa.europa.eu/en/consultations/call/public-consultation-draft-efsa-scientific-reports. 
33   https://www.efsa.europa.eu/en/events/event/technical-stakeholder-event-cumulative-risk-assessment-pesticides-food. 
34

   https://www.eea.europa.eu/publications/state-of-water  

8 

 
 
 
                                                 
pesticides in the Land Use, and Coverage Area frame Survey (LUCAS)35 carried out in the 
EU.  

The  Commission  is  implementing  the  pilot  project  agreed  by  the  European  Parliament  on 
environmental monitoring of pesticide use through the monitoring of honeybees. A contractor 
was selected and activities started at the end of 201836.  

The  Commission  has  proposed  active  substances  for  prioritisation  in  the  context  of  the  EU 
biomonitoring programme HBM4EU37, and will continue to do so in the future. 

When considering impacts on biodiversity, the effects of pesticides use come in addition to 
effects  of  the  current  agricultural  production  system  with  large  surfaces  of  monocultures, 
requiring increased use of pesticides, and other factors affecting landscapes.  

Some stakeholders criticise that the current scope of non-target species considered in the risk 
assessment is too limited to cover all relevant groups.  

Further  research  is  necessary,  and  assessment  methods  need  to  be  developed  to  take  into 
consideration  cumulative  risks  to  better  understand  the  actual  impact  of  pesticides  on 
populations,  diversity  within  and  between  species,  and  relationships  between  species  and 
ecosystem services.  

6. Define Environmental Protection Goals and update Guidance Documents 
The  Commission  and  EFSA  have  made  progress  with  developing  a  methodology  to  define 
specific environmental protection  goals  to  further improve the consideration of biodiversity 
in the risk assessment process. Through the organisation of workshops with risk assessors and 
risk managers from the Member States and all relevant stakeholder  groups, protection goals 
will be agreed in an inclusive process that started in 2019. 

The  Commission  will  continue  efforts  to  update  Guidance  Documents  on  risk  assessment 
methodologies, including the consideration of whether all appropriate non-target species are 
covered, to keep abreast of scientific advancement and calls on the Member States and EFSA 
for their cooperation.  

The  Commission  will  foresee  calls  for  research  projects  on  methodologies  to  assess 
cumulative  risks  and  the  impact  of  pesticides  on  ecosystems  in  the  context  of  Horizon 
Europe.  

2.2  COMPETITIVENESS AND THE INTERNAL MARKET 

The  evidence  remains  inconclusive  on  the  effects  of  the  PPP  Regulation  on  agricultural 
production in the EU as this depends on multiple factors. Growers criticise that there is a lack 
of  PPPs  in  the  EU,  while  the  number  of  approved  active  substances  has  actually  increased 
from  427 in 2011 to  484 in  2018,  and the number of available PPPs has increased in most 
Member States.  

The  number  of  SMEs  producing  PPPs  and  other  agrochemical  products  is  decreasing,  with 
the  high  regulatory  requirements  being  a  contributing  factor.  SMEs  consider  that  the  data 
requirements  and  assessment  procedures  are  disproportionate,  as  such  companies  tend  to 
focus on biopesticides and other potentially low-risk solutions (see also box 11, section 2.5). 

35  https://esdac.jrc.ec.europa.eu/projects/lucas/. 
36  https://www.insignia-bee.eu/. 
37  https://www.hbm4eu.eu/: https://cordis.europa.eu/project/id/733032/. 

9 

 
 
 
                                                 
 
The  zonal  system  for  PPP  authorisation  has  led  to  some  efficiency  gains  and  increased 
numbers  of  PPPs  being  available  in  most  Member  States  but  is  not  working  as  well  as 
expected.  Authorisation  of  PPPs  through  mutual  recognition  of  authorisations  from  other 
Member  States  leads  to  lower  fees  for  applicants  and  reduced  burden  for  Member  States. 
Moreover, Member States using mutual recognition have seen larger increases in the number 
of  PPPs  available  on  their  markets.  However,  the  actual  use  of  mutual  recognition  for 
authorisation of PPPs varies greatly between Member States and zones. The main reasons are 
specific  (or  additional)  national  requirements,  lack  of  harmonisation  in  the  methodologies 
used for conducting evaluations, lack of cooperation and coordination, as well as sub-optimal 
efforts spent on commenting on the work carried out by others during the zonal assessment 
process  –  all  of  which  leads  to  the  duplication  of  work  and  delays.  Increased  use  of  zonal 
authorisations and mutual recognition of authorisations would reduce the duplication of work, 
release resources and speed up access to market for PPPs. 

7. Improve the zonal system for authorisation of PPPs 
The Commission recommends that Member States minimise or remove national requirements 
for PPP authorisations and avoid repetition of assessments already carried out.  

The  Commission  calls  on  the  Member  States  to  increase  efforts  and  resources  dedicated  to 
the  activities  of  the  respective  zonal  steering  committees  to  increase  cooperation  and 
coordination. The Commission recommends that Member States use the Post Approval Issues 
working  group  of  the  Standing  Committee  on  Plants,  Animals,  Food  and  Feed  more 
effectively  to  resolve  divergences,  similar  to  what  is  done  in  the  coordination  group 
established under the Biocidal Product Regulation38.  

There  is  insufficient  availability  of  PPPs  for  minor  uses39  and  Member  States  are  not  fully 
using  the  existing  provisions  to  facilitate  authorisation  for  such  uses.  Cooperation  between 
Member  States,  coordination  of  trials  and  acceptance  of  residue  data  evaluated  by  other 
Member  States  and  acceptance  of  residue  trials  from  outside  the  EU  are  insufficient.  To 
overcome  the  problem,  Member  States  use  emergency  authorisations  instead  of  extending 
existing uses of authorised PPPs.  

8. Solutions for minor uses 
The Commission calls on the Member States to make better use of the existing provisions in 
the  PPP  Regulation  to  extend  uses  of  authorised  PPP  to  minor  uses.  In  addition,  the 
Commission  will  continue  to  regularly  update  the  existing  Extrapolation  Guidelines  for 
MRLs to facilitate MRL setting for minor crops. 

The  Commission  recommends  that  Member  States  review  the  fees  charged  for  minor  use 
extensions and lower them to promote applications from industry or user organisations.  

The Commission calls on the Member States to ensure long-term financing of the Minor Uses 
Coordination  Facility  in  line  with  the  proposal  discussed  by  the  Council  of  Ministers  for 
Agriculture and Fisheries during its meeting of 9 October 201740. 

2.3  EMERGENCY AUTHORISATIONS  

38   Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making 

available on the market and use of biocidal products, OJ L 167, 27.6.2012, p. 1. 

39   A minor use of a PPP is a use on crops that either are not widely grown in a Member State or are widely grown but 
meet an exceptional plant protection need. Minor uses often have a high economic value for farmers, but usually low 
economic  interest  for  the  industry  as  their  acreage  is  limited  or  the  exceptional  plant  protection  need  cannot  be 
predicted. 

40  Agriculture and Fisheries Council, 9/10/2017: https://www.consilium.europa.eu/media/31740/st12959en17.pdf. 

10 

 
 
                                                 
Article 53 of the PPP Regulation gives the possibility to Member States to allow the use of 
PPP  without  regular  authorisation  to  address  dangers  to  plant  health,  which  cannot  be 
contained by any other reasonable means. There has been a 300% increase in the number of 
such  emergency  authorisations  since  2011.  No  data  are  available  on  the  area  on  which 
emergency authorisations are applied. Given that more than 90% of emergency authorisations 
are  granted  for  PPP  containing  approved  active  substances,  Member  States  seem  to  use 
emergency  authorisations  to  overcome  procedural  delays  to  authorise  PPPs  and  mutually 
recognise  authorisations,  in  addition  to  covering  minor  uses  as  described  in  section 2.2. 
Moreover,  some  emergency  authorisations  are  granted  repeatedly,  year  after  year. 
Furthermore,  the  application  procedure  for  setting  MRLs  for  such  emergency  uses  is 
criticised by stakeholders as being too long. 

9. Increase oversight of emergency authorisations 
As  of  3 February 2020,  the  Commission  publishes41  all  notifications  of  emergency 
authorisations  received  from  the  Member  States  on  the  public  interface  of  the  Plant 
Protection  Product  Application  Management  System  (PPPAMS42)  to  increase  transparency 
and allow for increased public scrutiny. The Commission will continue work to achieve full 
implementation of the Plant Protection Product Application Management System (PPPAMS) 
before  the  end  of  2022  for  all  authorisations  and  provide  for  its  mandatory  use  in  an 
Implementing Regulation. 

The  Commission  will  improve  the  Harmonised  Risk  Indicator  2  established  under  the 
Sustainable Use Directive in order to take account of the area on which PPP under emergency 
authorisations are applied. 

The  Commission  will  continue  to  work  together  with  the  Member  States  to  improve  the 
relevant  guidance  on  emergency  authorisations  by  mid-2020  to  clarify  the  criteria  when 
emergency authorisations can be granted. If found necessary, the Commission will consider 
adopting an Implementing Regulation setting out such criteria in a legally binding way.  

The Commission has further increased oversight of the emergency authorisations granted by 
Member  States  by  using  the  provisions  of  Article 53(2)  of  the  PPP  Regulation  to  request 
opinions from EFSA on the justification of emergency authorisations. Where appropriate, the 
Commission will continue to propose Decisions in accordance with Article 53(3) preventing 
Member States from granting unjustified emergency authorisations43. 

2.4  TESTING ON VERTEBRATE ANIMALS 

The sharing of tests and study reports is an important element to reduce animal testing. While 
the  number  of  shared  studies  on  vertebrate  animals  has  increased,  as  intended,  preliminary 
data  show  that  overall  vertebrate  testing  has  not  decreased.  This  is  due  to  the  increased 
scientific  evidence  required  to  approve  active  substances.  The  situation  is  not  expected  to 
improve  because  increased  evidence  will  be  required  in  the  future  to  assess  substances’ 
effects,  e.g.  on  the  endocrine  system  and  metabolites.  In  addition,  the  requirement  for 

41   https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/ppp. 
42

   An  IT  system  developed 

to  enable  applicant 

to  create  applications  for  PPPs  and  submit 

them  for  evaluation. 

https://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/pppams_en 

43   The  Commission  proposed  in  May  2019  two  draft  Decisions  preventing  two  Member  States  from  granting  again 
emergency  authorisations  issued  repeatedly  for  products  containing  neonicotinoids  that  were  found  unjustified  by 
EFSA.  The  draft  Decisions  were  presented  for  vote  in  the  Standing  Committee  Plants,  Animals,  Food  and  Feed  in 
October 2019, which led to no opinion in both cases. Subsequent votes in the Appeal Committee also resulted in no 
opinion.  The  Commission  nevertheless  adopted  the  Decisions  on  3  February  2020:  Commission  Implementing 
Decision (EU) 2020/152 and Commission Implementing Decision (EU) 2020/153 (OJ L 33, 5.2.2020, p. 16 and p. 19).  

11 

 
 
                                                 
periodic re-assessment of all active substances may increase or maintain the need for in-vivo 
testing. 

10. Further reduce the need for vertebrate animal testing 
The Commission  will  continue efforts  to  reduce vertebrate animal  testing  by promoting the 
development and validation of testing strategies using alternatives to animal testing through 
the  funding  of  research  projects  under  Horizon  202044  and  the  European  Partnership  for 
Alternatives  to  Animal  Testing  (EPAA45).  The  European  Union  Reference  Laboratory  for 
Alternatives to Animal Testing (EURL ECVAM) actively supports the protection of animals 
used  for  scientific  purposes.  The  Commission 
the 
Communications  accompanying  the  data  requirements  validated  alternative  test  methods 
when available to phase out the need for animal testing under the PPP Regulation46. 

is  committed 

include 

into 

to 

2.5 

SUSTAINABILITY OF PLANT PROTECTION AND LOW-RISK PRODUCTS 

The PPP and MRL Regulations contribute to achieving some of the Sustainable Development 
Goals47, in particular goal 2 ‘No Hunger’ and goal 3 ‘Good health’, goal 6 ‘Clean water and 
sanitation’,  goal  12  ‘Responsible  consumption  and  production’,  goal  14  ‘Life  below  water’ 
and  goal  15  ‘Life  on  land’,  according  to  which  major  threats  to  the  primary  production  of 
food must be mitigated and at the same time food and feed must be kept safe and free from 
biological and chemical threats. 

The provisions of the PPP Regulation promoting low-risk active substances and products are 
particularly  relevant.  The  availability  of  basic  substances,  low-risk  PPPs,  including  micro-
organisms,  has 
and 
approval/authorisation procedures as too lengthy. While the Commission and some Member 
States have taken action to  accelerate the procedures to place low-risk PPPs on the market, 
their effects are expected to materialise only in the future48.  

increased  but 

stakeholders 

insufficient 

consider 

as 

it 

Furthermore, new application techniques (e.g. robotics and digitisation) have the potential to 
strongly reduce risks from the use of pesticides. 

11. Promote sustainable plant protection, low-risk solutions and efficient risk mitigation  
The European Green Deal and the Farm to Fork Strategy make the reduction of dependency 
on pesticides and the move towards low-risk substances a priority. The first will be addressed 
in the context of the Sustainable Use Directive. As to the second, the Commission will speed 
up the work already started with Member States and EFSA to update, by the end of 2020, the 
data  requirements  and  assessment  methodologies  for  micro-organisms.  Consideration  will 

45

44  Examples include the following recently selected projects aimed at developing new methods and testing strategies  to 
identify  endocrine disruptors: ATHENA and SCREENED on thyroid hormone disruption, EDCMET and OBERON 
on metabolic disorders, ENDPOINTS on developmental neurotoxicity, FREIA on female reproductive toxicity. 

   The  EPAA  is  a  private-public  partnership  between  five  Directorates-General  of  the  European  Commission  and  8 

industry federations.  

46   Commission Communication in the framework of the implementation of Commission Regulation (EU) No 283/2013 
of  1  March  2013  setting  out  the  data  requirements  for  active  substances,  in  accordance  with  Regulation  (EC) 
No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on 
the market (OJ C 95, 3.4.2013, p. 1). 

47  UN Resolution A/RES/70/1. 
48  A  workplan  of  40  actions  was  endorsed  by  the  Council  of  Ministers  for  Agriculture  and  Fisheries  of  June 2016 
(http://data.consilium.europa.eu/doc/document/ST-10041-2016-REV-1/en/pdf). A progress report was presented to the 
Council of Ministers for Agriculture and Fisheries in July 2019, which found that actions for Member States had been 
implemented 
States 
(http://data.consilium.europa.eu/doc/document/ST-10238-2019-INIT/en/pdf).  

divergence 

Member 

between 

partially 

great 

with 

only 

and 

12 

 
 
                                                 
also  be  given  to  the  specific  properties  of  micro-organisms  and  other  low-risk  PPPs  when 
considering more specific rules for pesticides residues (see also box 14). 

The  Commission  will  initiate  and  fund  a  cycle  of  Better  Training  for  Safer  Food  (BTSF) 
starting  in  2020  to  strengthen  the  expertise  in  Member  States  for  the  assessment  of 
applications for micro-organisms and other biopesticides.  

The Commission has already followed-up on the implementation of the work plan noted by 
the  Council  of  Ministers  for  Agriculture  and  Fisheries  to  accelerate  the  availability  of  low-
risk  substances  and  products,  and  enhance  information  sharing  on  Integrated  Pest 
Management  between  Member  States.  The  Commission  calls  on  Member  States  for 
reinforced commitment to implement the actions assigned to them in the light of the progress 
report presented to the Council in July 2019. 

The  Commission  will  boost  the  availability  of  basic  substances,  e.g.  through  clarifying 
procedures  and  deadlines  for  their  approval  and  examining  possibilities  to  provide  more 
directly information about their usefulness in plant protection.  

The  Commission  will  continue  to  allocate  funding  under  the  research  framework 
programmes49  to  develop  more  sustainable  plant  protection  methods  and  technologies  to 
reduce  use  and  risks,  such  as  pest  monitoring,  prediction  models,  digitalised  farming 
practices,  and  new  precision  application  equipment.  The  Commission  strongly  encourages 
Member  States  to  support  in  their  CAP  Strategic  Plans  management  commitments  and 
investments  aimed  at  implementing  the  methods  and  practices  targeting  the  reduction  of 
pesticides use and the use of alternative methods. 

The  Commission  will  continue  the  work  started  in  2019,  together  with  Member  States  and 
EFSA,  to  assess  the  potential  of  risk  mitigation  measures  including  for  new  application 
techniques in order to harmonise the assessment of their potential for risk reduction.  

2.6  ENFORCEMENT  

Enforcement of the PPP Regulation varies between Member States and this negatively affects 
overall effectiveness. It is estimated that illegal and counterfeit PPPs represent around 10 % 
of the EU market, which is a concern as this may decrease the level of protection of human 
health and the environment otherwise achieved.  

12. Better enforcement of the PPP Regulation 
The Commission calls on the Member States to raise awareness about the risks of illegal and 
counterfeit products and to increase and broaden enforcement efforts in the sector, including 
as regards proper use of pesticides, and consider reviewing the level of the penalties for non-
compliance. The Commission has started consultations with Member States whether there is 
a  need  to  set  more  specific  requirements  as  regards  PPPs  through  the  empowerment  in  the 
context of Regulation (EU) 2017/625 on official controls.  

The MRL Regulation ensures that enforcement action can be taken by Member States for all 
possible  pesticides  -  commodity  combinations.  If  no  specific  MRL  is  set,  the  so-called 
‘default  MRL’  of  0.01 mg/kg  automatically  applies.  This  ensures  maximum  consumer 
protection,  as  every  pesticide  -  commodity  combination  is  covered  by  a  MRL.  The  MRL 

49   Ongoing  projects  under  Horizon  2020  include  OPTIMA,  VIRO-PLANT,  SUPER-PEST,  INNOSETA,  which  are 
focusing  on  finding  new  plant  protection  solutions,  including  biological  (e.g.  microorganisms,  baculovirus,  plant 
extracts) and non-chemical alternatives (e.g. prevention, monitoring, mechanical) to complement the portfolio of low-
risk products available to farmers. 

13 

 
 
 
                                                 
Regulation also covers dual/multiple use substances, i.e. substances that are used for different 
purposes (e.g. both as pesticides and as veterinary medicines or biocides) and substances that 
had  been  used  as  pesticides  in  the  past,  but  are  no  longer  used  as  such.  In  such  cases,  the 
default  MRL  of  0.01  mg/kg  may  be  applicable  and  samples  may  be  found  to  be  non-
compliant with that level even though the residues in food do not stem from the use of a PPP. 
This  has led to  enforcement problems in  practice,  e.g. in  case of  biocidal  uses  for drinking 
water  disinfection,  processing,  or  environmental  contamination.  The  MRL  Regulation  also 
established  some  MRLs  that  differ  from  those  in  other  sectoral  legislation  for  the  same 
substance  -  commodity  combination  (e.g.  veterinary  medicinal  products  legislation).  Those 
issues can be addressed to a certain extent within the existing legal framework, e.g. by setting 
temporary MRLs based on monitoring data to account for other uses. However, in practice, 
inefficiencies  arose  from  the  fact  that  the  MRL  Regulation  allows  the  setting  of  temporary 
MRLs  in  certain  exceptional  circumstances  only,  which  are  however  not  well  defined, 
leading  to  lengthy  discussions  among  risk  managers  before  action  could  be  taken.  Other 
solutions  are  the  alignment  of  MRLs  that  are  safe  for  consumers  in  different  sectoral 
legislation and work on harmonised methodologies for e.g. exposure assessments at EU and 
international level.  

General  provisions for processed products, including processing  factors,  are also  already  in 
place, but those provisions would benefit from clarification. More guidance could be given to 
Member States on how to make use of more specific information provided by food business 
operators. This would be in line with related food legislation in other areas (e.g. Regulation 
(EC) No 1881/2006 on contaminants). 

13. Better enforcement of the MRL Regulation 
The  Commission  will,  before  the  end  of  2021,  clarify  the  scope  of  what  is  considered 
‘exceptional circumstances’ for setting temporary MRLs to avoid misinterpretations. 

The Commission will examine possibilities to allow acceptance of specific MRLs set under a 
different legal framework (e.g. for substances also used as veterinary medicinal products) and 
found  to  be  safe  for  consumers  and  will  support  ongoing  discussions  at  EU  and  at 
international  level  to  develop  a  harmonised  and  coordinated  procedure  for  exposure 
assessment.  

The Commission will clarify before the end of 2021 the provisions of the MRL Regulation 
and  give  guidance  to  Member  States  how  processing  factors  provided  by  food  business 
operators could be taken into account for enforcement decisions. 

2.7  FASTER RESPONSES IN THE CONTEXT OF THE MRL REGULATION TO EMERGING 

ISSUES AND TECHNICAL PROGRESS 

The  current  provisions  of  the  MRL  Regulation  are  not  sufficiently  flexible  as  regards 
necessary adaptations to technical progress, for example in case of active substances that are 
not  chemicals  such  as  micro-organisms.  It  is  anticipated  that  with  new  scientific  and 
technological  progress  other emerging issues  could  arise, e.g. nano-pesticides, MRL setting 
for large groups of substances following cumulative risk assessment, etc. 

14. Faster response to emerging MRL issues and to technical progress 
The  Commission  will  in  2020  start  to  explore  practical  solutions  to  integrate  new  active 
substances with different properties into the Annexes of the existing MRL Regulation, which 
was mainly designed for individual chemical substances.  

2.8 

INTERNATIONAL TRADE 

14 

 
 
At  international  level,  the  strict  approach  of  the  EU  to  pesticides  is  often  criticised  by  a 
number  of  third  countries  who  argue  that  certain  aspects  of  the  EU  legal  framework  and 
practice are not in line with the World Trade Organisation Sanitary and Phytosanitary (WTO-
SPS) Agreement and are too restrictive. At present, our main trading partners rely heavily on 
the  use  of  pesticides  for  food  production,  including  for  export  to  the  EU,  and  do  not 
necessarily apply the same standards of protection of the environment as the EU (for example 
when it comes to the impact on bees).  

There  is  a  growing  tension  between  the  expectations  of  European  consumers  that  imported 
food  should  not  contain  pesticides  that  are  not  approved  in  the  EU  and  the  international 
commitments  of  the  EU,  in  particular  in  the  context  of  the  WTO.  The  EU  regularly 
incorporates  limits  agreed  in  Codex  Alimentarius  that  are  safe  for  consumers  into  its  MRL 
Regulation,  which  facilitates  international  trade.  At  the  same  time,  there  is  criticism  from 
within  the  EU  that  MRLs  which  are  safe  for  consumers  are  set  for  non-approved  active 
substances (so-called “import tolerances”), e.g. in cases where the EU non-approval decision 
was  not  due  to  public  health  reasons,  but  for  instance  based  on  environmental  risks.  This 
allows  imports  of  products  treated  with  active  substances  that  are  not  available  to  EU 
farmers,  thus  negatively  affecting  the  competitiveness  of  EU  agriculture,  as  well  as  the 
environment in third countries. Lastly, as part of these tensions, the cut-off criteria in the PPP 
Regulation are also often challenged at international level, both bilaterally and in the context 
of  the  WTO,  as  non-EU  countries  consider  that  they  potentially  cause  significant  trade 
implications.  

To inform  business  operators and third countries, the Commission  and EFSA provide early 
information  about  developments  related  to  the  approval  of  active  substances  that  might 
eventually  lead  to  lowering  of  MRLs.  Despite  this  early  warning,  trading  partners  often 
submit applications for import tolerances too  late to  avoid  trade disruption and criticise  the 
EU  because  they  consider  that  the  time  available  for  the  setting  of  import  tolerances  is  too 
short following the lowering of MRLs. 

The PPP Regulation contains provisions that allow for the free circulation of treated seeds in 
the EU if there is at least one authorisation in at least one Member State. However, there is no 
common view yet on whether it is possible to treat seeds for exports with an active substance 
that  is  not  approved  in  the  EU  -  some  Member  States  consider  this  possible,  while  the 
Commission and others do not. 

15. Using green diplomacy to promote our green agenda for pesticides 
In line with the Green Deal Communication, the EU will use all its diplomacy, trade policy 
and  development  support  instruments  to  promote  the  phasing  out,  as  far  as  possible,  of  the 
use  of  pesticides  no  longer  approved  in  the  EU  and  to  promote  low-risk  substances  and 
alternatives to pesticides globally. It is important that efforts made in the EU are also made 
outside the EU to maximise environmental benefits and  ensure a level-playing field for EU 
operators. In addition, the Commission will reflect on ways to consider environmental aspects 
when assessing requests  for import tolerances for substances no longer approved in  the EU 
while  respecting  WTO  standards  and  obligations.  If  found  necessary,  the  Commission  will 
consider  a  revision  of  the  MRL  Regulation  in  order  to  strengthen  its  environmental 
dimension and make relevant alignments with the pesticides approval process. 

The EU will use discussions in international fora, including in the WTO SPS Committee and 
Codex Alimentarius, to explain the approach followed in the EU for pesticides and encourage 
third countries to adopt a similar approach. 

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The EU will look to build green alliances with other regions in the world. This will include a 
special  focus  on  neighbouring  countries.  In  addition,  the  Commission  will  look  at  the 
possibility  to  promote  the  use  of  certain  development  funds  to  support  e.g.  Andean  and 
Central  American  countries that have requested  EU support to  help  them  reduce the use of 
pesticides  in  fruit  production.  The  EU  will  use  discussions  in  the  context  of  Free  Trade 
Agreements  to  promote  convergence  of  approaches  in  the  pesticides  area,  and  include 
provisions in future Free Trade Agreements with a view to reach equal standards in this area.  

The Commission will enhance communication efforts on the impacts of the PPP Regulation 
on  MRLs  as  well  as  the  timing  of  the  various  procedures  to  make  the  EU  system  more 
predictable for non-EU countries, including for the cut-off criteria. 

The Commission will continue contributing to the development at international level of risk 
assessment  and  risk  management  methodologies  to  facilitate  the  alignment  of  MRLs  with 
limits agreed in the Codex Alimentarius and the setting of MRLs following import tolerance 
requests.  

The  Commission  will  continue  efforts  to  find  a  common  understanding  among  Member 
States  on  the  possibility  to  treat  seeds  for  exports  with  an  active  substance  that  is  not 
approved in the EU (see also section 3.1). 

The  Commission  will  continue  funding  Better  Training  for  Safer  Food  (BTSF)  in  non-EU 
countries  to  inform  about  the  EU  Regulations  on  pesticides,  decrease  the  divergence  in 
farming practices and to promote more selective and less toxic substances as alternatives to 
older and more toxic substances. 

2.9 

INTERNAL COHERENCE AND CONSISTENCY WITH OTHER EU LEGISLATION 

For the most part, the PPP and MRL Regulations show internal coherence and are consistent 
with one another. One notable exception are the cut-off criteria which are not reflected in the 
MRL Regulation. This created uncertainties as regards the consequences for MRLs when the 
approval of an active substance is not renewed under the PPP Regulation because of the cut-
off criteria. This can be addressed by improving clarity on the impacts of the cut-off criteria 
on  MRLs  for  the  substances  concerned  and  the  timing  of  various  processes  to  enhance 
predictability for non-EU countries (see box 15). 

Another  exception  is  the  interplay  of  the  review  of  MRLs  with  the  renewal  of  approval  of 
active substances, which - due to different timelines - has led to unnecessary administrative 
burden, duplication of work in the Member States, EFSA and the Commission. 

Consistency with other EU policy areas is not always ensured and issues have been identified 
with  the  policy  on  foods  for  infants  and  young  children  (e.g.  the  definition  of  ‘pesticide 
residues’),  hygiene  policy,  and  chemicals  legislation  regarding  the  criteria  to  identify 
substances as persistent.  

16. Increase internal coherence and consistency with EU legislation 
The  Commission  will  continue  to  work  with  the  Member  States  and  EFSA  to  improve 
coordination between the procedure for the renewal of approval of active substances and the 
MRL review process  to  gain  efficiency and  avoid overlaps or  contradicting outcomes. This 
applies to deadlines as well as responsibilities of Member States. 

The Commission will align the relevant provisions in the legislation on foods for infants and 
young children with the MRL Regulation in order to make them consistent and up to date to 
the latest technical standards. 

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3  CONCLUSION  

Stakeholders  from  across  the  spectrum  consider  that  the  regulatory  requirements  for 
pesticides in the EU are among the strictest in the world. The evaluation, as detailed in the 
accompanying  Staff  Working  Document,  shows  that  the  PPP  and  MRL  Regulation  provide 
for the protection of human health and the environment and are generally effective, although 
implementation can be further improved. Following on from the reduction of the number of 
active  substances  under  Directive  91/414/EEC,  the  PPP  Regulation  has  in  particular  been 
effective in further phasing out of high-risk substances and the provisions promoting low-risk 
substances have started to bear fruit. The Regulations have a recognised added value at EU 
level and are relevant for the evolving needs of society. Apart from the noted inconsistencies 
as regards the cut-off criteria coherence is mostly ensured, both internally within and between 
the Regulations, and externally with other EU legislation and international rules.  

Efficiency stands out  as the critical  area requiring attention. Due to a lack of resources and 
capacity in the Member States, most of the procedures set out in the Regulations are suffering 
from severe delays, which in turn negatively affects their effectiveness.  

The  immediate  focus  for  follow-up  of  this  evaluation  will  be  on  improving  the 
implementation  of  the  existing  legislative  framework.  Sixteen  areas  have  been  identified 
where  implementation  in  the  short  and  medium  term  could  be  improved.  These  actions  are 
expected  to  deliver  substantial  improvements  in  the  effective  implementation  of  the  two 
Regulations  in  a  short  timeframe,  which  will  bring  substantial  contribution  to  the 
achievement of the objectives of the European Green Deal, the Farm to Fork Strategy and the 
Biodiversity Strategy. A swift phasing out of active substances that do not fulfil the approval 
criteria will promote healthy ecosystems and biodiversity, while promoting low-risk and non-
chemical  pesticides  combined  with  enhanced  implementation  of  the  provisions  of  the 
Sustainable Use Directive – in particular as regards Integrated Pest Management, will reduce 
the  dependency  on  chemical  pesticides  and  contribute  to  more  sustainable  food  production 
systems.  

In  addition,  the  Commission  will  reflect  on  ways  to  consider  environmental  aspects  when 
assessing requests for import tolerances for substances no longer approved in the EU while 
respecting WTO standards and obligations. If found necessary, the Commission will consider 
a  revision  of  the  MRL  Regulation  in  order  to  strengthen  its  environmental  dimension  and 
make relevant alignments with the pesticides approval process. 

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