COMMISSION STAFF WORKING DOCUMENT Accompanying the document 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, pesticides industry, plant health control

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 20.5.2020  SWD(2020) 87 final  COMMISSION STAFF WORKING DOCUMENT    Accompanying the document 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 {COM(2020) 208 final}  
 
 
Table of Contents 

1. INTRODUCTION ...................................................................................................................................... 1 

1.1. Purpose of the evaluation .................................................................................... 2 

1.2. Scope of the evaluation ....................................................................................... 2 

2. BACKGROUND ........................................................................................................................................ 3 

2.1. Intervention logic ................................................................................................ 4 

2.2. Baseline — the situation before the PPP and MRL Regulation .......................... 8 

2.2.1. Plant protection products under Council Directive 91/414/EEC ..................... 8 

2.2.2. A patchwork regulatory system for MRLs of pesticides ................................ 12 

2.3. Baseline — other points of comparison ............................................................ 14 

3. IMPLEMENTATION / STATE OF PLAY .............................................................................................. 16 

3.1. Societal and political developments .................................................................. 16 

3.2. The PPP market ................................................................................................. 17 

3.3. Approval of active substances ........................................................................... 18 

3.4. Authorisation of plant protection products ........................................................ 19 

3.5. Setting and reviewing MRLs ............................................................................. 19 

3.6. Public information, risk communication and transparency ............................... 20 

3.7. Enforcement and monitoring ............................................................................. 20 

3.8. Court cases and complaints ............................................................................... 21 

4. METHODOLOGY ................................................................................................................................... 22 

4.1. Data collection ................................................................................................... 22 

4.2. Limitations and robustness of findings ............................................................. 23 

5. ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ................................................ 24 

5.1. Effectiveness ..................................................................................................... 24 

5.1.1. Protecting human health ................................................................................. 26 

5.1.2. Protecting the environment, including wildlife and water ............................. 37 

5.1.3. Minimising animal testing .............................................................................. 41 

5.1.4. Improving the functioning of the single market ............................................. 43 

5.1.5. Improving agricultural production and competitiveness of EU agriculture ... 47 

5.1.6. Facilitating international trade ........................................................................ 52 

5.1.7. Enforcement ................................................................................................... 55 

5.1.8. Transparency and risk communication ........................................................... 57 

5.2. Efficiency .......................................................................................................... 61 

5.2.1. Costs for industry, farmers and SMEs ............................................................ 62 

 
 
 
 
5.2.2. Costs for the Member States, the Commission and EFSA ............................. 64 

5.2.3. Benefits to human health and to the environment .......................................... 76 

5.2.4. Societal and agricultural benefits and costs related to PPPs in the EU .......... 77 

5.2.5. Benefits from the single market and international trade ................................ 78 

5.3. Coherence .......................................................................................................... 79 

5.3.1. Pesticides policy area ..................................................................................... 80 

5.3.2. Other EU policy areas .................................................................................... 82 

5.3.3. International agreements ................................................................................ 85 

5.4. Relevance .......................................................................................................... 86 

5.4.1. Sustainability .................................................................................................. 87 

5.4.2. Innovation and scientific progress .................................................................. 90 

5.5. EU added value ................................................................................................. 92 

6. CONCLUSIONS ..........................................................................................................   96 

7. REFERENCE LIST ..................................................................................................... 102 

Annex 1. Procedural information 

Annex 2. Synopsis report on the stakeholder consultation 

Annex 3. Methods and analytical models 

Annex 4. Costs and benefits 

Annex 5. Court cases and complaints to the Ombudsman 

 
 
 
 
 
 
 
 
 
 
 
 
GLOSSARY AND LIST OF ABBREVIATIONS 

Acceptable daily intake (ADI) 

ADI is a measure of the amount of a specific substance in food or drinking water that can 
be ingested (orally) on a daily basis over a lifetime without an appreciable health risk. 

Active substances 

An active substance is the active component against pests or plant diseases contained in a 
plant protection product. 

Acute reference dose (ARfD) 

The  acute  reference  dose  is  an  estimate  of  a  daily  oral  exposure  for  an  acute  duration 
(24 hours or less) to humans that is likely not to have deleterious effects during a lifetime. 

Adjuvant 

An adjuvant is a chemical or mixture of chemicals that enhances the efficacy of a plant 
protection product. 

Annex I renewal programme (AIR) 

The Annex I renewal programmes are working programmes for the renewal of approval 
of active substances. They were drawn up to cover all approved active substances and to 
balance the workload for the evaluating authorities. 

ALARA principle 

As  low  as  reasonably  achievable  (ALARA)  is  a  safety  principle  designed  to  minimise 
radiation doses and releases of radioactive materials. This principle is also applied to other 
areas  involving  safety  management  in  particular  for  issues  where  no  quantified  safety 
level can be established.  

Basic substances 

Basic  substances  are  substances  that  are  not  predominantly  used  for  plant  protection 
purposes  but  that  may  be  useful  in  plant  protection.  They  can  be  approved  for  plant 
protection use provided they are of no concern to human health or the environment. Some 
of  these  substances  have  traditionally  been  used  by  farmers,  and  they  may  include 
foodstuffs. 

Biopesticides 

Biopesticides  include  naturally  occurring  substances  derived  from  animals,  plants  or 
bacteria  that  control  pests,  as  well  as  microorganisms  that  control  pests  (microbial 
pesticides) 

Candidates for substitution (CfS) 

Candidates for substitution are active substances approved in the EU that meet any of the 
seven  criteria  listed  in  Annex  II  to  the  Plant  Protection  Products  (PPP)  Regulation.  The 
criteria are based on the active substance’s intrinsic hazardous properties in combination 
with its use. The approval period of a CfS is limited to 7 years.  

Codex Committee on Pesticide Residues (CCPR) 

The CCPR is responsible for establishing Codex MRLs)for pesticide residues in specific 
food items or in groups of food or feed that move in international trade. 

Codex Limits (CXLs) 

These  are  international  standards  of  maximum  residue  levels  of  pesticides  set  by  the 
Codex  Alimentarius  Commission.  CXLs  that  are  considered  safe  for  consumers  by  the 
European  Food  Safety  Authority  (EFSA)  are  taken  over  as  MRLs  in  EU  legislation  to 
facilitate trade. 

 
 
 
 
Commodity 

Food or feed product of plant or animal origin. 

Co-formulant 

Plant  protection  products  may  contain  one  or  more  active  substances  as  well  as  other 
materials  such  as  solvents,  carriers,  inert  material,  wetting  agents,  etc.  These  other 
materials are referred to as co-formulants. 

Cut-off criteria 

Active substances that meet the cut-off criteria cannot be approved in the EU or can only 
be approved under restricted conditions. These are active substances that are mutagenic; 
carcinogenic; toxic for reproduction; have endocrine disrupting properties; are persistent 
organic  pollutants  (POPs);  are  persistent,  bioaccumulative  and  toxic  (PBT);  or  are 
considered to be very persistent and very bioaccumulative (vPvB). 

Dossier 

Dossiers are submitted to the rapporteur Member State to support the approval or renewal 
of  approval  of  an  active  substance.  The  dossier  contains  the  required  data  compiled 
through  experimental  studies  in  line  with  internationally  validated  test  guidelines  or 
through peer-reviewed scientific publications. 

Draft (review/renewal) Assessment Report (dRAR) 

The dRAR contains the scientific assessment by the rapporteur Member State. It is based 
on  the  dossier  submitted  by  the  applicant  in  support  of  the  approval  or  renewal  of 
approval of an active substance. 

Emergency authorisation 

The Plant Protection Product (PPP) Regulation allows Member States to grant emergency 
authorisations  for  plant  protection  products  that  are  not  authorised.  These  emergency 
authorisations  are  limited  to  120  days  to  combat  a  danger  to  plants  that  cannot  be 
controlled by other reasonable means. 

Endocrine disruptor 

Endocrine  disruptors  are  chemicals  that  alter  functions  of  the  endocrine  system  and 
consequently causes adverse health effects in both humans and wildlife. 

European Food Safety Authority (EFSA) 

EFSA is the European agency responsible for risk assessment in the area of food safety. 

Generic manufacturer 

Generic  manufacturers  are  companies  (mostly  smaller  companies)  that  produce  generic 
plant protection products, i.e. non-patent protected products. 

Genotoxicity 

Genotoxicity  describes  the  property  of  chemical  agents  that  damages  the  genetic 
information  within  a  cell.  This  damage  causes  mutations,  which  may  lead  to  cancer. 
Genotoxicity is often confused with mutagenicity  - all mutagens  are genotoxic, whereas 
not all genotoxic substances are mutagenic.  

Good agricultural practices (GAPs) 

Good  agricultural  practice  means  the  nationally  recommended,  authorised  or  registered 
safe use of plant protection products under actual conditions at any stage of production, 
storage,  transport,  distribution  and  processing  of  food  and  feed.  It  also  implies  the 
application of the principles of integrated pest control in a given climate zone, as well as 
using  the  minimum  quantity  of  pesticides  and  setting  MRLs  at  the  lowest  level  which 
allows the desired effect to be obtained. 

Hazard 

The terms  ‘hazard’ and ‘risk’ are often used interchangeably. However, in terms of risk 
assessment, they are two very distinct terms. A hazard is the intrinsic property of an agent 
to cause harm to humans, property or the environment. Risk is defined as the probability 

 
 
that  exposure  to  a  hazard  will  lead  to  a  negative  consequence.  More  simply:  a  hazard 
poses no risk if there is no exposure to that hazard. 

Import tolerance 

Imported commodities must comply with the MRLs established in EU legislation. Import 
tolerances can be set for specific products (e.g. exotic fruit) for which EU uses either do 
not exist (as no applicant applied for such a use in the EU) or do not take into account the 
specific conditions in the country of origin (e.g. different climatic conditions). An import 
tolerance appears as any other MRL in EU legislation and must be safe for consumers.  

Integrated pest management (IPM) 

Integrated  pest  management  is  the  careful  consideration  of  all  available  pest-control 
techniques  and  subsequent  integration  of  appropriate  pest-control  measures.  These 
appropriate pest-control measures should discourage the development of pest populations 
and keep pesticides to levels that are economically justified. They should also reduce or 
minimise risks to human health and the environment. 

Limit of quantification (LOQ) 

The limit of quantification is the smallest amount of an agent that can be measured with 
stated  and  acceptable  imprecision  and  inaccuracy  (e.g.  the  smallest  concentration  of  a 
chemical that can be measured with sufficient precision in a millilitre of water). 

Low-risk active substance 

An active substance can be approved as a low-risk active substance if it meets the regular 
approval criteria and also meets the low-risk criteria as specified in Annex II, point 5 of 
Regulation (EC) 1107/2009. There are specific criteria for low-risk chemical substances 
and for micro-organisms. 

Maximum residue level (MRL) 

The  traces  pesticides  leave  in  treated  commodities  are  called  ‘residues’.  A  maximum 
residue level (MRL) is the highest level of a pesticide residue that is legally tolerated in or 
on  food  or  feed  when  pesticides  are  applied  correctly  according  to  good  agricultural 
practice during the production of the food or feed. 

Minor use 

A  minor  use  of  a  PPP  is  a  use  on  crops  that  are  either  not  widely  grown  in  a  Member 
State, or widely grown but meet an exceptional plant-protection need. 

Mutual recognition 

In principle, mutual recognition allows market access for products that are not subject to 
EU  harmonisation.  Products  lawfully  sold  in  one  EU  Member  State  can  be  sold  in 
another. In the specific context of the PPP Regulation, the authorisation of a PPP in one 
Member  State  is  to  be  recognised  by  other  Member  States  unless  there  are  specific 
environmental or agricultural circumstances not to do so. 

Neonicotinoids 

Neonicotinoids are a class of neuro-active insecticides chemically similar to nicotine. The 
neonicotinoid  family  includes  acetamiprid,  clothianidin,  imidacloprid,  nitenpyram, 
nithiazine, thiacloprid and thiamethoxam. 

Non-governmental organisation (NGO) 

NGOs  are  usually  non-profit  and  independent  of  governments  (though  often  funded  by 
governments)  that  are  active  in  humanitarian,  educational,  health  care,  social,  human 
rights, or environmental causes. 

Organisation for Economic Cooperation and Development (OECD) 

The  OECD  is  an  intergovernmental  economic  organisation  with  36 member  countries, 
founded to stimulate economic progress and world trade. 

 
 
 
Persistent, bioaccumulative and toxic (PBT) substances 

A PBT substance is ‘persistent’ (i.e., the half-life in marine water is higher than 60 days; 
the  half-life  in  fresh  or  estuarine  water  is  higher  than  40  days;  the  half-life  in  marine 
sediment  is  higher  than  180  days;  the  half-life  in  fresh  or  estuarine  water  sediment  is 
higher  than  120  days;  or  the  half-life  in  soil  is  higher  than  120  days),  AND 
‘bioaccumulative’  (i.e.  where  the  bioconcentration  factor  is  higher  than  2  000),  AND 
‘toxic’  (i.e.,  the  long-term  no-observed  effect  concentration  for  marine  or  freshwater 
organisms is less than 0,01 mg/l; the substance is classified as carcinogenic (category 1A 
or 1B), mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2); 
or  there  is  other  evidence  of  chronic  toxicity,  as  identified  by  the  classifications  STOT 
RE 1 or STOT RE 2). 

Persistent organic pollutants (POPs) 

Persistent  organic  pollutants  are  chemicals  of  global  concern  due  to  their:  potential  for 
long-range transport; persistence in the environment; ability to bio-magnify; and ability to 
bio-accumulate in ecosystems. 

Plant protection product (PPP) 

Plant protection products are formulations containing one or more active substances and 
intended to protect plants and plant products. 

Plant Protection Products Application Management System (PPPAMS) 

The PPPAMS is being developed by the European Commission to enable industry users 
to  create  applications  for  PPPs  and  submit  these  to  EU  Member  States  for  evaluation, 
concluding with authorisation of the PPP or refusal of the application. 

Precautionary principle 

The precautionary principle is detailed in Article 191 of the Treaty on the Functioning of 
the  European  Union.  It  may  be  invoked  when  a  phenomenon,  product  or  process  may 
have  a  dangerous  effect,  identified  by  a  scientific  and  objective  evaluation,  if  this 
evaluation does not allow the risk to be determined with sufficient certainty 1. 

Rapporteur Member State 

The rapporteur Member State carries out the risk assessment for the approval of an active 
substance, which is then peer-reviewed by the other Member States and EFSA. A zonal 
rapporteur Member State is carrying out the risk assessment for the authorisation of a PPP 
on  behalf  of  the  other  Member  States  in  the  same  zone,  e.g.  in  the  northern,  central  or 
southern zone.  

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 

Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  of 
18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction 
of Chemicals (REACH). 

Registration report (for authorisations) 

The registration report is part of the procedure to authorise a PPP. The zonal rapporteur 
Member  State  makes  the  draft  registration  report  available  to  the  concerned  Member 
States for commenting, and subsequently finalises the registration report after considering 
the comments received. 

European Commission’s regulatory fitness and performance programme (REFIT) 

REFIT is part of the Commission’s better regulation agenda. It makes sure that EU laws 
deliver their intended benefits for citizens, businesses and society while removing red tape 
and lowering costs. It also aims to make EU laws simpler and easier to understand. 

Risk 

1   European Commission (2000) Communication from the Commission on the precautionary principle, COM/2000/0001 final. 

 
 
                                                 
Risk is the probability that exposure to a hazard will lead to a negative consequence. 

Safener 

A safener is a chemical contained in a PPP that protects crop plants from damage from the 
PPP. 

Small, medium and micro-sized enterprise (SME) 

The main factors determining whether an enterprise is an SME are (1) staff headcount, (2) 
either turnover or balance sheet total: 
Company category 
Medium-sized 
Small 
Micro 

Staff headcount  Turnover  Balance sheet total 
< 250 
< 50 
< 10 

≤ € 43 m 
≤ € 10 m 
≤ € 2 m 

< 250 
< 50 
< 10 

Stop-the-clock procedure 

During  the  risk  assessment  stage,  the  rapporteur  Member  State  or  EFSA  may  request 
more data directly from the applicant, in which case the clock is stopped for the regulatory 
timetable  until  this  is  supplied.  This  period  is  a  maximum  of  6  months  (where  the 
rapporteur Member State triggers it) or 3 months (where EFSA triggers it). 

Synergist 

Synergists are chemicals that make the active substance in a PPP more effective. 

Very persistent and very bioaccumulative (vPvB) 

A vPvB substance is both ‘very persistent’ (i.e. the half-life in marine, fresh- or estuarine 
water is higher than 60 days; the half-life in marine, fresh- or estuarine water sediment is 
higher  than  180  days;  OR  its  half-life  in  soil  is  higher  than  180  days),  AND  ‘very 
bioaccumulative’ (i.e. its bioconcentration factor is greater than 5 000). 

World Trade Organisation (WTO) 

The World Trade Organisation (WTO) is a global international organisation dealing with 
the rules of trade between countries. 

World  Trade  Organisation  —  Sanitary  and  Phytosanitary  Measures  Agreement 
(WTO-SPS) 

The WTO-SPS is an agreement on how governments can apply food-safety and animal-
and-plant-health measures. 

World Trade Organisation — Technical Barriers to Trade Agreement (WTO-TBT) 

The TBT Agreement aims to ensure that technical regulations, standards, and conformity-
assessment procedures are non-discriminatory and do not create unnecessary obstacles to 
trade. 

 
 
 
 
1. INTRODUCTION 

Plant protection products (PPPs), also called pesticides, are used to protect crops against 
pests,  diseases,  or  competing  plants  with  the  aim  of  optimising  food  production  in 
conventional or organic farming2. Pesticides are also used to maintain food quality (e.g. 
during  storage)  or  to  maintain  certain  areas  in  the  condition  needed  for  their  proper 
functioning (e.g. railways, golf courses). 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,  PPPs  are  strictly  regulated  in  the  EU  to 
provide a high level of protection to the environment and to the health of everyone in the 
EU.  Harmonised  regulation  of  PPPs  also  improves  the  functioning  of  the  internal  EU 
market  as  it  enables  manufacturers  of  PPPs  to  apply  for  authorisation  according  to  the 
same rules and producers of food and feed can sell their products without barriers. It also 
gives  people  in  the  EU  increased  access  to  safe  food  produced  outside  their  national 
territory. 
Pesticides  and  their  residues  are  regulated  under  Regulation  (EC)  No  1107/20093, 
hereinafter  referred  to  as  ‘the  PPP  Regulation’,  and  Regulation  (EC)  No  396/20054, 
hereinafter  referred  to  as  ‘the  MRL  Regulation’  –  in  essence  a  risk  management 
framework.  The  European  Commission,  the  European  Food  Safety  Authority  (EFSA) 
and the Member States all play a role in the implementation of these Regulations. Based 
on scientific advice received from Member States and EFSA, the Commission approves 
active  substances  for  use  in  PPPs  and  sets  MRLs  at  safe  levels  for  food  and  feed 
(including  for  imported  products).  Once  an  active  substance  is  approved  and  its  MRLs 
are set, Member States can authorise the use of PPPs containing the active substance in 
question.  The  Sustainable  Use  Directive5  and  Regulation  1185/2009  on  statistics  of 
pesticides  are  additional  parts  of  the  ‘pesticide  package’,  which  was  adopted  in  2009. 
Both  these  instruments  help  ensure  a  high  level  of  protection  of  human  health  and  the 
environment from pesticides. 

The  European  Parliament  and  the  Council  are  involved  in  setting  MRLs  under  the 
regulatory procedure with scrutiny. Both the Council and the European Parliament have 
addressed the issue of pesticides on several occasions in recent years. In 2016 and 2017, 
the  European  Parliament  adopted  resolutions  on  endocrine  disruptors  and  on  the  active 
substances glyphosate and bentazone6. The AGRIFISH Council of June 20167 endorsed 
recommendations on the acceleration of sustainable plant protection. 

2   Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of 

organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). 

3   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). 

4   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). 

5   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). 

6   European Parliament resolution of 23 November 2016 on the draft Commission implementing regulation renewing the approval 

of the active substance bentazone in accordance with Regulation (EC) No 1107/2009 (D047341/00 – 2016/2978(RSP)). 
European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation renewing the approval of the 
active substance glyphosate in accordance with Regulation (EC) No 1107/2009 (D044281/01 — 2016/2624(RSP)). 

1 

 
 
                                                 
  
 
1.1. Purpose of the evaluation 

The  objective  of  the  evaluation  is  to  perform  an  evidence-based  assessment  of  the 
implementation  and  application  of  the  PPP  and  MRL  Regulations,  taking  stock  of  the 
experience  gained.  This  staff  working  document  accompanies  a  report  to  the  European 
Parliament and to the Council on the functioning of both Regulations8. 

The evaluation assesses the accomplishment of the  Regulations’ objectives in  line with 
the  better  regulation  guidelines9.  It  covers  the  following  five  criteria:  effectiveness, 
efficiency, relevance, coherence, and EU added value (including the potential for burden 
reduction, simplification and improving the delivery of the objectives). 

1.2. Scope of the evaluation 

The  evaluation  assesses the  implementation  and functioning of  both  the PPP  and  MRL 
Regulations in  all  28 Member States10 between their  dates of application (in June 2011 
and September 2008, respectively) and October 2018. 

The evaluation covers the essential elements of: (i) the PPP and MRL regulatory systems, 
(ii)  the  links  between  the  two  Regulations,  and  their  implementing  regulations.  The 
evaluation  also  discusses  the  following  topics  for  which  the  Commission  has  legal 
reporting obligations: 

  mutual recognition of PPP authorisations and the functioning of the zonal system; 
 

the  functioning  of  comparative  assessment  when  authorising  PPPs  containing 
candidates for substitution (CfS); 
the application of the approval criteria, including the cut-off criteria; 
the  effects  of  the  provisions  on  data  protection  for  studies  involving  vertebrate 
animals. 

 
 

The evaluation includes evidence-based conclusions and an assessment of whether, and 
to  what  extent,  the  Regulations  have  achieved  their  objectives.  The  results  will  be 
available to inform decisions on future policy actions, including potential amendments of 
the Regulations to improve their performance. 

As  stated  above,  there  are  several  other  pieces  of  legislation  that  are  relevant  to  this 
subject, but are not covered by this evaluation, namely the Sustainable Use Directive and 
Regulation  1185/2009  on  statistics  of  pesticides.  The  implementation  period  for  the 
Sustainable  Use  Directive  for  Member  States  ended  in  November 2016  and  in 
October 2017  the  Commission  presented  a  first  implementation  report11,  which 
concluded  that  the  Sustainable  Use  Directive  offers  the  potential  to  greatly  reduce  the 
risks derived from pesticide use. However, until it is more rigorously implemented by the 
Member  States,  the  improvements  are  limited,  and  certainly  insufficient  to  achieve  the 

European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of 
the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 (D053565-01 — 2017/2904(RSP). 
European Parliament resolution of 4 October 2017 on the  draft Commission regulation amending Annex II to Regulation (EC) 
No 1107/2009  by  setting  out  scientific  criteria  for  the  determination  of  endocrine  disrupting  properties  (D048947/06  – 
2017/2801(RPS)). 

7   Outcome of the Council meeting available online: https://www.consilium.europa.eu/en/meetings/agrifish/2016/06/27-28/. 
8   As required in Article 82 and 62(5) of Regulation 1107/2009 and Article 47 of Regulation 396/2005. The report was intended to 
be presented in December 2014. However, to allow for a meaningful assessment, a sufficient level of implementation had to be 
achieved before carrying out the evaluation. 

9   European Commission Better Regulation Guidelines. 
10   The assessment of the implementation in Croatia will start as of the date of its accession to the European Union on 1 July 2013. 
11   European  Commission  (2017),  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  Member  State 
National  Action  Plans  and  on  progress  in  the  implementation  of  Directive  2009/128/EC  on  the  sustainable  use  of  pesticides, 
COM/2017/0587. 

2 

 
                                                                                                                                                 
environmental  and  health  improvements  it  was  designed  to  achieve.  New  assessments 
will  soon  begin  of  both  the  Sustainable  Use  Directive  and  Regulation  (EC) 
No 1185/2009 on statistics of pesticides. 

In addition, the link of the PPP Regulation with Regulation (EC) No 1272/2008 on the 
classification,  labelling  and  packaging  of  substances  and  mixtures  is  assessed  in  a 
separate  ‘fitness  check’  by  the  Commission12.  Finally,  the  criteria  for  endocrine 
disrupting  properties13  are  not  addressed  in  this  evaluation,  as  the  application  of  the 
criteria started on 10 November 2018 and will be subject to a dedicated assessment14 in 
the future. 

2. BACKGROUND 

Pesticides and their residues are regulated at EU level to respond to certain needs and to 
achieve  several  objectives.  The  PPP  Regulation  establishes  a  two-step  system  that 
reflects  the  principle  of  subsidiarity.  In  the  first  step,  the  active  substance  of  a  PPP  is 
approved at EU level provided it is demonstrated that at least one use with a formulated 
product is safe. In the second step, Member States authorise PPPs containing the active 
substance for specific uses, according to harmonised EU standards (the so-called uniform 
principles15) and good agricultural practices (GAPs). The Member States consider local 
agricultural and geographical/climatic differences when authorising PPPs. 

The  Sustainable  Use  Directive  provides  the  general rule  on  the  use  of  PPPs.  It  aims  to 
reduce  the  risks  and  impacts  of  pesticide  use  on  human  health  and  the  environment.  It 
also  aims  to  promote  the  use  of  integrated  pest  management  (IPM)  and  alternative 
approaches  or  techniques,  such  as  non-chemical  alternatives  to  pesticides.  Finally,  the 
MRL  Regulation  regulates  the  residues  that  are  left  on  crops.  It  does  this  by  setting 
MRLs  at  EU  level  to  protect  all  consumers,  including  vulnerable  groups  (see  Figure  1 
below). 

Figure 1. How pesticides and their residues are regulated in the EU 

12   European  Commission  (2019)  Commission  Staff  Working  Document  Fitness  Check  of  the  most  relevant  chemicals  legislation 

(excluding REACH), as well as related aspects of legislation applied to downstream industries. SWD/2019/199 final 

13   Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out 

scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33). 

14   See Article 3 of Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 

by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33). 

15   Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the 

Council as regards uniform principles of evaluation. 

3 

 
 
                                                 
2.1. Intervention logic 

The  PPP  Regulation  was  proposed  after  13  years  of  experience  gained  from  the 
application  of  Directive  91/414/EEC16.  The  proposal  for  the  MRL  Regulation  built  on 
both  national  requirements  and  EU  Directives  that  co-existed  for  many  years.  The 
sections  below  outline  the  needs  identified  and  objectives  of  the  PPP  and  MRL 
Regulations and the actions that were expected to lead to positive long-term impacts. 

indirect  exposure 

PPPs  can  affect  human  health  via  direct  exposure,  i.e.  through  residues  in  food  and 
occupational  exposure,  as  well  as 
through  environmental 
contamination.  Therefore,  to  address  the  need  of  protecting  the  health  of  operators, 
bystanders,  workers and residents  from the adverse  effects of pesticides,  the hazards 
and risks of active substances are rigorously assessed against strict approval criteria set in 
the  PPP  Regulation.  Following  the  submission  of  a  comprehensive  data  package  by  an 
applicant  according  to  the  provided  requirements,  a  Member  State  assumes  the  role  of 
rapporteur  for  the  active  substance.  The  rapporteur  Member  State  conducts  a  scientific 
evaluation  that  is  peer  reviewed  by  EFSA  and  the  other  Member  States.  Based  on  the 
scientific evaluation by the Member States and EFSA, the Commission prepares a legal 
act to approve (or not) the active substance, which is discussed with and voted on by the 
Member States. Active substances that do not meet the approval criteria cannot be used 
in the EU.  

To promote the sustainable use of pesticides and reduce risks from the use of PPPs to 
human  health  and  the  environment,  active  substances  with  less  problematic  hazard 
profiles are promoted in the PPP Regulation. These substances include basic substances, 
which  benefit  from  unlimited  approval  periods,  and  low-risk  active  substances,  which 
enjoy longer approval and data protection periods. At the opposite end of the spectrum, 
particularly  hazardous  active  substances  are  approved  as  ‘candidates  for  substitution’ 
(CfS)  with  shorter  approval  periods.  When  they  authorise  PPPs  containing  these  more 
hazardous  active  substances,  Member  States  must  conduct  comparative  assessments 
aimed  at  replacing  them  with  less  hazardous  active  substances.  In  addition,  the  PPP 
Regulation  introduced  cut-off  criteria  for  active  substances  that  are:  mutagenic; 
carcinogenic; toxic for reproduction; have endocrine disrupting properties; are persistent 
organic  pollutants  (POPs);  are  persistent,  bioaccumulative  and  toxic  (PBT);  or  are 
considered to be very persistent and very bioaccumulative (vPvB). Active substances that 
meet  the  cut-off  criteria cannot  be  approved  in  the  EU,  or  can  only  be  approved  under 
severely  restricted  conditions.  This  regulatory  system  should  result  in  less  hazardous 
PPPs being placed on the market, thereby ensuring a high level of protection of human 
and animal health and the environment. 

To  keep  abreast  of  scientific  developments  and  the  expectations  of  society,  the 
Commission  may  review  the  approval  of  an  active  substance  at  any  time.  Active 
substances also have time-limited approvals and are periodically re-evaluated. The goal 
of  this  periodic  review  process  is  to  create  an  up-to-date  comprehensive  set  of  data, 
ensure a clear division of tasks between the Member States, EFSA and the Commission, 
and  reduce  the  hazardousness  of  PPPs  on  the  market.  In  meeting  these  goals,  the 
Regulation  aims  to  create  a  transparent  and  predictable  system  with  less  administrative 
burden  than  the  previous  regulatory  situation.  The  expected  impacts  on  society  of  this 

16   Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the  market (OJ  L 230, 

19.8.1991, p. 1) 

4 

 
                                                 
review  process  are  continued  high  levels  of  safety  for  operators,  bystanders  and 
consumers, as well as a high level of protection of the environment. 

Once an active substance is approved at EU level, applicants can submit applications for 
the  authorisation  of  one  or  several  PPPs  containing  that  active  substance  to  a  Member 
State.  To  improve  access  to  PPPs  for  farmers  in  different  Member  States  and  the 
functioning  of  the  internal  market,  the  EU  is  divided  into  three  geographical  zones: 
north, central and south. Applicants can choose one Member State in each zone to act as 
the  zonal  rapporteur.  This  zonal  rapporteur  Member  State  assesses  the  application  on 
behalf of all Member States in the same geographical zone for which the application is 
intended, i.e. the concerned Member States. The zonal rapporteur Member State makes 
the  draft  registration  report  available  to  the  concerned  Member  States  for  commenting, 
and  subsequently  finalises  the  registration  report  after  considering  the  comments 
received.  The  finalised  registration  report  then  forms  the  basis  for  national  product 
authorisations  within  the  particular  zone.  Within  each  zone,  Member  States  must,  in 
principle,  mutually  recognise  each  other’s  authorisations.  This  should  enable  Member 
States to benefit from the evaluations made by other Member States, while manufacturers 
of  PPPs  benefit  by  not  having  to  submit  product  authorisations  in  each  individual 
Member  State  of  a  zone.  This  is  expected  to  reduce  administrative  burden,  thus 
improving  the  functioning  of  the  single  market.  Nevertheless,  national  product 
authorisations  allow  to  address  specific  climatic,  geographical  or  agricultural  concerns. 
This two-step authorisation system is meant to harmonise the availability of PPPs within 
zones,  resulting  in  a  better  functioning  of  the  single  market.  The  consideration  of 
national environmental and climatic conditions should ensure a high level of protection 
of the environment. 

To  address  the  problem  of  lengthy  procedures  under  Directive  91/414/EEC,  the  PPP 
Regulation  introduced  strict  deadlines  for  approval  and  authorisation  procedures  and 
encouraged  cooperation  between  Member  States  with  the  aim  of  making  PPPs  timely 
available on the market. This would in turn help improve EU agricultural production 
and  safeguard  its  competitiveness.  Promoting  low-risk  active  substances  with  faster 
market access is a way to improve the availability of such PPPs for EU farmers. The PPP 
Regulation includes further measures to ensure that farmers have access to PPPs in cases 
where  they  need  to  control  a  serious  danger  to  plant  health.  At  EU  level,  limited 
derogations  are  possible  for  the  approval  of  active  substances  that  meet  the  cut-off 
criteria,  if  the  applicant  has  demonstrated  that  the  active  substance  concerned  is 
necessary to control a serious danger to plant health which cannot be contained by other 
available  means  including  non-chemical  methods.  At  Member  State  level,  emergency 
authorisations  for  non-authorised  PPP  can  be  issued  for  120  days  for  limited  use  to 
address  a  danger  to  plant  health  which  cannot  be  contained  by  any  other  reasonable 
means. The need to have safe food for consumers in the EU implies that PPPs should be 
used  safely  and  assessed  according  to  a  predictable,  trustworthy  and  transparent 
regulatory system, as described above. In addition, MRLs are set to ensure that pesticide 
residues  on  foods  are  safe  in  order  to  protect  consumer  health.  When  an  application  to 
authorise  a  PPP  for  a  new  use  is  submitted,  the  consumer  risk  assessment  to  establish 
MRLs  is  carried  out  in  a  two-step  procedure:  first  by  evaluating  Member  State  and 
second by EFSA. Based on the scientific evaluation, the Commission prepares a legal act 
to set or amend MRLs. This legal act is then discussed with and voted on by the Member 
States. The result is meant to be an efficient procedure that ensures a high level of safety 
for consumers, including vulnerable groups. 

5 

 
Implementation and enforcement must be efficient and consistent in all Member States. 
To  meet  these  needs,  and  to  improve  the  functioning  of  the  single  market,  MRLs  are 
harmonised  at  EU  level.  Food-business  operators  that  sell  their  products  in  several 
Member  States  must  comply  with  a  single  MRL,  which  is  valid  across  the  EU  and 
publicly  available.  This  reduces  administrative  burden,  and  makes  relevant  information 
readily available to users and consumers. Ultimately, these rules are expected to improve 
the functioning of the single market and ensure the consistent protection of consumers. 

Another  aim  of  the  MRL  Regulation  is  to  promote  the  smooth  functioning  of 
international  trade  and  ensure  that  non-EU  countries  can  export  their  produce  to  the 
EU.  This  aim  is  met  by  setting  MRLs  for  all  relevant  pesticide  residue-commodity 
combinations,  including  import  tolerances  resulting  from  the  use  of  PPPs  in  non-EU 
countries.  The  EU  benefits  from  facilitating  trade:  consumers  can  buy  imported  crops 
that  are  not  grown  in  the  EU,  and  there  is  a  greater  range  of  food  products  available 
throughout the year at a competitive price. 

The  implementation  of  many  actions,  both  procedurally  and  technically,  is  detailed  in 
guidance  documents. Guidance  documents  are  produced  by  EFSA  or  the  Commission 
together with the Member States. Because  guidance is  feeding  into all areas the results 
and impacts are dependent on the availability of clear, commonly agreed and up-to-date 
guidance documents. 

Finally,  the  identified  need  to  minimise  animal  testing  was  addressed  in  the  PPP 
Regulation  by  obliging  industry  to  share  data  on  studies  involving  vertebrate  animals. 
This is expected to reduce the need to duplicate existing studies, and therefore reduce the 
number of animals involved. 

Figure 2 summarises the paragraphs above with boxes visualising: the needs identified, 
the  objectives  to  be  pursued,  the  actions  taken;  the  outcomes  produced;  the  general 
results achieved, and the impacts seen. 

6 

 
 
 
RELEVANCE 
Are the objectives of 
the policy consistent 
with the identified 
needs? 

OTHER EU POLICIES 
Agriculture, 
Environment, 
Food Safety, 
Chemicals, 
etc. 

EFFICIENCY 
What is the relationship 
between the resources 
spent and the outcomes 
achieved? 

EU ADDED VALUE 
How do the results 
compare with those 
expected if needs were 
addressed in other ways, 
e.g. nationally or 
internationally? 

Figure 2: Intervention logic of the policy area of pesticides 

NEEDS 

Availability of safe and effective PPPs and their sustainable use. 
Safe food for consumers. 
Clear, predictable, efficient and transparent procedures. 
Consistent enforcement of legislation in all Member States. 
Minimising animal testing. 

OBJECTIVES 

High levels of protection of human health, including consumer health. 
Protection of animal health and the environment when PPPs are used. 
Improving the functioning of the single market. 
Safeguarding the competitiveness of European agriculture and improving agricultural 
production. 
Facilitating the smooth functioning of international trade. 

 
 
 
 
 

 
 
 
 

 

ACTIONS 

Approval of active substances   
 
 
 
 

Strict deadlines for approval and renewal of approval of active substances. 
Data submission by applicants according to strict data requirements. 
Requirement for industry to share vertebrate studies. 
Member States acting as rapporteur Member State and co-rapporteur Member State for the 
risk assessment of active substances. 
EFSA  coordinates  peer  review  and  performs  risk  assessment  of  active  substances  based  on 
assessment by the rapporteur Member State and co-rapporteur Member State. 
‘Cut-off’ criteria implemented. 
Rules established for candidates for substitution (CfS). 

 

 
 
Authorisation of plant protection products 
 
 

Strict deadlines for authorisations and re-authorisations of PPPs. 
Member  State  evaluates  applications  for  mutual  recognition  within  the  same  geographical 
zone. 
Rules on packaging, labelling and advertising. 
Checks and inspections carried out on marketing and use of PPPs. 

Centralised MRLs set by Commission after risk assessment by Member State and EFSA. 
Checks and inspections carried out in relation to MRLs. 
Commission proposing monitoring regulations. 
Member State taking samples and monitor MRLs.  

 
 
Setting of MRLs 
 
 
 
 

OUTCOMES 

Fewer studies involving animals. 
Comprehensive set of scientific data and risk assessment made available to the public. 
Publicly available database of approved active substances and harmonised MRLs. 
Fewer hazardous plant protection products on the market. 
List of substances drawn up, including active, low-risk, basic substances and CfS. 
Harmonised list of safe MRLs drawn up, including default MRLs for non-approved 
substances. 
PPP authorisations granted in the zonal authorisation system, including by mutual 
recognition. 
Reports published on controls on marketing and use of PPPs 
Annual monitoring report on residues. 
Clear administrative division of tasks. 

RESULTS 

Transparent and efficient risk assessment and risk management processes. 
Increased predictability and more timely access to market for PPPs. 
Relevant information available to applicants, importers, users, public authorities and 
consumers. 
Reduced administrative burden. 
Intra-EU trade of food and feed facilitated due to harmonisation of MRLs. 

IMPACTS 

High level of safety for people, including vulnerable groups. 
High level of protection of animal health and the environment. 
Better functioning of the single market. 
Improved agricultural production and competitiveness of EU agriculture. 
7 
Smooth functioning of international trade. 

 
 
 
 
 
 

 

 
 
 

 
 
 

 
 

 
 
 
 
 

COHERENCE 
Do the Regulations 
complement or conflict 
with one another, with 
other EU legislation or 
with international 
policies? 

I

G
U
D
A
N
C
E
D
O
C
U
M
E
N
T
S

EXTERNAL FACTORS 
Public concern, 
Member State resources 
& capacity, 
International agreements, 
Political drivers, 
Technological 
developments. 

EFFECTIVENESS 
Have the policies 
achieved the desired 
results and met their 
objectives? 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.2. Baseline — the situation before the PPP and MRL Regulation  

The baseline for the evaluation is the situation before the Regulations became applicable. 
This  baseline  is  different  for  PPPs  and  MRLs.  However,  other  different  points  of 
comparison are used as described below and in section 2.3. 

2.2.1. Plant protection products under Council Directive 91/414/EEC 

The situation in June 2011, when the PPP Regulation became applicable, is considered as 
the  baseline  for  the  evaluation  of  the  PPP  Regulation.  The  predecessor  to  the  PPP 
Regulation was Directive 91/414/EEC17, which laid down uniform rules on the approval 
of active substances and authorisations of PPPs in  the EU. The system  under Directive 
91/414/EEC  was  similar  to  that  created  by  the  PPP  Regulation:  only  PPPs  containing 
approved  active  substances  that  did  not  pose  a  risk  to  human  or  animal  health  or  the 
environment could be authorised. Authorisation was granted by Member States on their 
territory under uniform principles, and optional mutual recognition applied for the use of 
the same product under identical  conditions. The PPP Regulation  subsequently took on 
board these main principles and existing rules while reinforcing the approval criteria. 

Approval of active substances 
With  Directive  91/414/EEC,  there  was  a  shift  in  the  EU’s  PPP  regulatory  system  from 
maintaining a negative list of 17 banned active substances18 to maintaining a positive list 
of  approved  active  substances  deemed  to  be  safe19.  The  implementation  of  Directive 
91/414/EEC  began  with  an  inventory  of  all  active  substances  on  the  market  in  the 
Member  States.  This  was  followed  by  the  establishment  of  four  work  programmes20  to 
evaluate these substances and which included calls for application. For most of the active 
substances  in  the  inventory,  no  application  or  data  were  submitted  by  the  industry  and 
they thus disappeared from the market. As seen in Figure 3, this resulted in a reduction 
from around 1 000 active substances available in 1993 to less than 400 in 201021. 

s
e
c
n
a
t
s
b
u
s
e
v
i
t
c
a
f
o
r
e
b
m
u
N

1000

800

600

400

200

0

1994

1996

1998

2000

2002

2004

2006

2008

2010

Active substances to be evaluated

Approved active substances

Approved new active substances

Figure 3. Number of available active substances in the EU between 1993 and 2010. 

17   Council  Directive  91/414/EEC  of  15 July  1991  concerning  the  placing  of  plant  protection  products  on  the  market  (OJ  L  230, 

19.8.1991, p. 1). 

18   See  Council  Directive  79/117/EEC  of  21 December  1978  prohibiting  the  placing  on  the  market  and  use  of  plant  protection 

products containing certain active substances. 

19   See the initial list  of approved active substances  in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 
implementing  Regulation  (EC)  No  1107/2009  of  the  European  Parliament  and  of  the  Council  as  regards  the  list  of  approved 
active substances. 

20   See,  for  instance,  Commission  Regulation  (EC)  No  2266/2000  of  12 October  2000  amending  Regulation  (EEC)  No  3600/92 
laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of 
Council Directive 91/414/EEC concerning the placing of plant protection products on the market. 

21   EU Pesticides Database. 

8 

 
 
                                                 
 
 
 
 
Decisions on the approval of active substances under Directive 91/414/EEC were based 
on  the  outcome  of  risk  assessments.  Hazards  were  determined  for  classification  and 
labelling  purposes,  but  were  not  decisive  by  themselves  for  the  approval  assessment. 
Even  very  hazardous  active  substances  could  be  approved.  Approvals  were  valid  for 
10 years if acceptable risks were demonstrated for at least one use. 

To have an active substance approved under Directive 91/414/EEC, an applicant had to 
submit  a  dossier  to  a  rapporteur  Member  State,  which  is  similar  to  the  current 
requirement  in  the  PPP  Regulation.  The  dossier  had  to  contain  the  required  data22 
compiled through internationally validated test guidelines (e.g. OECD) or peer-reviewed 
scientific publications. The rapporteur Member State carried out the first risk assessment, 
compiling a draft assessment report (dRAR), which was sent to EFSA (or before 2002 to 
the Commission23)  which performed  a peer review of the assessment.  Within 1 year  of 
receiving the dRAR, EFSA had to prepare a conclusion summarising the discussions that 
took place in the peer review. Based on the EFSA conclusion, the Commission prepared 
a draft review report and draft Directive that were discussed with the Member States in 
the Standing Committee on the Food Chain and Animal Health. Following a vote in the 
Committee,  the  Commission  adopted  the  Directive.  The  first  approval  of  an  active 
substance under Directive 91/414/EEC was adopted in 199724. 

The approval procedure was inefficient as in 2001 (10 years after adoption of Directive 
91/414/EEC),  only  30  of  the  979  existing  active  substances  had  completed  the  full 
evaluation procedure25. In 2008, the number of evaluated and approved active substances 
had increased to 96, with another 186 active substances still under review. The average 
time from dossier submission until approval was 6 years. The preparation of the dRAR 
by the Member State took 27 months, and the peer-review process took between 5 and 87 
months26. The identified reasons for these delays were lack of resources, complexity of 
procedures but also the lack of incentives for industry to provide quickly additional data 
after submission of the dossier as PPPs could in the meantime be placed on the market 
through provisional national authorisations27.  

Authorisation of PPPs 
Under  Directive  91/414/EEC,  several  types  of  authorisations  could  be  granted  by  the 
Member States. These are outlined below. 

  National  authorisations  were  granted  for  a  maximum  of  10  years  after  the 
assessment of a product dossier. The assessment was made by the concerned Member 
State only, without the involvement of the Commission or other Member States. 
  Provisional national authorisations (granted for 3 years) could be used to fast-track 
the  introduction  of  PPPs  containing  new  active  substances  before  a  decision  was 
made  on  the  approval  of  the  active  substance  at  EU  level.  These  could  be  granted 
2 years after submission of the application for approval of the active substance. 

  Emergency  authorisations  could  be  issued  temporarily  by  the  Member  States  in 
special  circumstances  for  a  maximum  period  of  120  days.  The  use  of  emergency 

22   Listed in Annex II and III of Directive 91/414/EEC. 
23   Before the establishment of EFSA in 2002, a peer-review of the dRAR was organised by the Commission, with administrative 

support provided by the competent authorities of the UK and Germany. 

24   Concerning the active substance Imazalil. 
25   EU pesticide database, see: https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database. 
26   European  Commission  (2006).  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5. 

27   European  Commission  (2006).  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5, pp. 67-68. 

9 

 
                                                 
authorisations  was  limited  to  situations  of  an  unforeseeable  danger  to  plant  health 
which could not be contained by other means. In 2007, there were 59 such emergency 
authorisations in the EU; in 2008 there were 63; in 2009 there were 107; and in 2010 
there were 32128. 

  Mutual recognition of authorisations was optional for products already authorised in 
another Member State if applied for under identical conditions, but this provision did 
not  work.  Only  three  Member  States  applied  mutual  recognition  to  a  significant 
extent.  Member  States  often  requested  additional  data  or  required  the  repetition  of 
efficacy trials. This resulted in many Member States investing almost as much time in 
mutual recognition evaluations as in national authorisation evaluations29. 

Under Directive 91/414/EEC, the market for PPPs in the EU remained fragmented. The 
number of authorised PPPs in the Member States varied from a few hundred to more than 
4 000.  Unauthorised  cross-border  sourcing  of  PPPs  was  also  a  major  problem:  17  of 
22 Member  States  that  answered  to  a  survey  reported  problems  with  unauthorised 
imports or use; 3 Member States had minor problems; and only 1 Member State had no 
problems before 200630. 

As  Directive  91/414/EEC  was  transposed  into  national  legislation,  the  processes, 
timelines  and  authorisation  fees  varied  between  Member  States.  According  to  the 
timelines in the Directive, getting a product authorised should have taken between 1 and 
2 years. But in practice, depending on the Member State, the actual time for evaluating 
applications  for  authorisations  was  between  1  and  4  years31.  Fees  for  the  evaluation  of 
applications  for  new  active  substances  ranged  between  EUR 23 100  and  EUR 450 000, 
with most Member States charging more than EUR 100 000. Fees for the authorisation of 
new  PPPs  ranged  between  EUR 10 000  and  EUR 240 000,  with  most  Member  States 
charging more than EUR 50 00032. 

An  impact  assessment  calculated  the  annual  administrative  burden  of  Directive 
91/414/EEC for the EU-25 in 2005 at EUR 23 million33. 

Data protection, data sharing and animal testing 
Provisions  in  Directive  91/414/EEC  on  data  protection  and  data  sharing  for  active 
substances caused several problems, both for Member States and applicants. The level of 
data  protection  granted  depended  on  the  status  of  the  active  substance  and  on  when 
decisions were taken in the Member States. 

The data protection rules presented a particularly serious obstacle for generic competition 
(i.e.  products  no  longer  protected  by  patents).  The  market  share  of  generic  companies 
was  low  in  most  EU  Member  States,  and  in  several  Member  States  the  approval  of  an 

28   European Commission. No data on emergency authorisations pre-2007. 
29   Ecorys (2018), Study supporting the REFIT Evaluation of the EU legislation on plant protection products and pesticide residues 

(Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005). 

30   Mattaar, H. (2010). Competent Authority Survey, A comparison of Member State Authorisation Processes, Pappas & Associates, 

Brussels, Belgium. 

31   An overview table with the timelines, fees and staff for authorisations and applications under Directive 91/414/EEC is available 

in the support study carried out in the framework of this evaluation. 

32   Phillips  McDougall  (2016),  The  Cost  of  New  Agrochemical  Product  Discovery,  Development  and  Registration  in  1995,  2000, 

2005-8 and 2010 to 2014. R&D expenditure in 2014 and expectations for 2019. 

33   European  Commission  (2006),  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5. 

10 

 
                                                 
active  substance  led  to  a  reduction  in  generic  competition  because  of  data  protection 
rules34. 

Directive 91/414/EEC established rules on data sharing to avoid duplication of testing on 
vertebrate animals. Applicants were required to inquire with the Member States whether 
relevant  experiments  involving  vertebrate  animals  had  been  already  submitted  and 
evaluated in earlier product authorisation applications. The applicant then had to reach an 
agreement  with  the  existing  authorisation  holder  so  that  the  Member  State  concerned 
could use the data. If no such agreement could be reached, the Member State could, at its 
own  discretion,  introduce  national  measures  to  oblige  sharing  of  the  data  within  their 
territory.  However,  Directive  91/414/EEC  did  not  oblige  Member  States  to  introduce 
these measures. 

Court cases 
Under  the  period  of  application  of  Directive  91/414/EEC,  from  1991  to  2011,  21  court 
cases  were  initiated,  mostly  by  industry.  Almost  all  the  cases  related  to  the  process  of 
approval  of  active  substances,  and  in  particular  contested  the  Commission’s  decision 
based  on  the  outcome  of  the  risk  assessment.  Except  for  2  cases35,  the  outcomes  were 
favourable for the Commission. See Annex 5 for an overview of all court cases. 

The PPP market 
In  2004, the global PPP  market was valued at EUR 24.7 billion of which the European 
market  share  amounted  to  EUR 6.8  billion  (27.4 %  of  the  total)36.  At  this  time,  the 
producers of agrochemicals could be separated into three main groups, as detailed below. 

  Multinational companies: Following a consolidation wave between 1984 and 2003, 
the ‘big six’ multinational companies37 held 75 % of the global agrochemical market 
and 81% of the EU market. 

  Smaller  research-based  companies:  A  number  of  medium-sized  companies38  held 

7% of the EU market in 200439. 

  Generic  manufacturers40:  Generics  are  non-patent-protected  products,  and 
represented  two  thirds  of  sales  globally.  However,  a  large  share  of  non-patent-
covered products were sold by multinational companies. 

Innovation  was  an  important  driver  of  growth  in  the  global  agrochemical  market. 
However,  only  the  multinational  companies  had  a  significant  capacity  to  develop  new 
active  substances.  Between  2005  and  2008,  the  average  cost  of  discovery  and 
development  of  a  new  plant  protection  product  was  estimated  at  EUR 189 million, 
including  EUR 15.5 million  fees  for  the  approval  and  authorisation  processes.  In  2004, 
industry  observers  noted  a  decline  in  research  and  development  activity  in  PPPs.  This 
was  illustrated  by  the  declining  rate  of  submissions  of  applications  for  the  approval  of 

34   European  Commission  (2006),  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5. 

35   Case  T-158/03:  Industria  Químicas  del  Vallés,  SA  v  Commission  of  the  European  Communities  on  the  active  substances  — 
Metalaxil;  and  case  T-229/04:  Kingdom  of  Sweden  v  Commission  of  the  European  Communities  on  the  active  substance 
paraquat. 

36   ECPA, Annual Report 2004-2005, p. 10. Estimates of different sources may differ considerably due to definitions applied etc. 
37   Monsanto, Du Pont, Bayer, BASF, Dow, Syngenta. 
38   Isagro, Crompton, Gowan, ISK, Taminco, Luxan, IQV, Janssen, Stahler, Japan Agro S. 
39   Phillips  McDougall  (2005)  Market  Position  in  EU  25  for  Small  and  Medium  sized  Agrochemical  companies  involved  with 

Research and Development. 

40   e.g. Maktheshim-Agan Industries, Nufarm, Cheminova, United Phosphorus, Sipcam Oxon, Cerexagri. This group included many 

smaller companies, most of them not operating in the EU market. 

11 

 
                                                 
new  active substances  in  the  EU,  which  between  1994  and 2004  decreased  to  5-10 per 
year from an earlier average of 15-20 per year41.  

By  2004,  biotechnology  was  the  fastest  growing  segment  of  the  global  crop-protection 
market.  In  response,  some  of  the  multinational  companies  began  to  dedicate  an 
increasing  share  of  their  research  and  development  effort  into  this  area,  and  decreased 
their investment in traditional PPP portfolio development42. 

Pesticide  sales  fluctuated  between  1994  and  2006,  with  an  average  of  around  350  000 
tonnes  of  active  substances  sold  per  year  (the  data  covers  20  countries  that  are  EU 
Member  States  in  2018)43.  For  example,  in  1995,  330  000  tonnes  of  active  substances 
were sold, and in 1999, 377 000 tonnes were sold demonstrating that the volumes could 
fluctuate between the years. 

From Directive 91/414/EEC to the PPP Regulation 
The  PPP  Regulation  was  proposed  after  13  years  of  experience  gained  from  the 
application  of  Directive  91/414/EEC.  Considering 
technical 
developments,  it  appeared  that  the  basic  approach  of  Directive  91/414/EEC  was  still 
acceptable but that the system was overloaded and inefficient44. To increase efficiency, 
corrective measures and new policy actions were proposed in the PPP Regulation. These 
are listed in the bullet points below. 

the  scientific  and 

  National  provisional  authorisations  of  not  yet  approved  new  active  substances 
duplicated efforts in Member States, increased differences in the availability of PPPs 
between  Member  States  and  decreased  incentives  for  industry  to  provide  timely 
additional  data  requested  to  finalise  the  approval  procedure.  They  were  therefore 
removed in the PPP Regulation. 

  The  optional  mutual  recognition  of  authorisation  of  PPPs  was  only  applied  in  rare 
cases.  This led  to  a  duplication  of  work  and  fragmentation  of  the  single  market  for 
PPPs.  The  PPP  Regulation  introduced  a  zonal  system  and,  in  principle,  mandatory 
mutual  recognition  within  zones,  thus  encouraging  cooperation  and  work  sharing 
between Member States. The Regulation sets out three zones on the basis of similar 
climatic and agricultural conditions. For climate-independent uses (e.g. indoor uses, 
seed treatment) the zonal partition does not apply. 

  To further protect human health and the environment the cut-off criteria in the PPP 
Regulation  were  introduced  to  increase  the  stringency  of  the  approval  criteria  for 
active substances. 

  To further minimise the risks to health and environment, the PPP Regulation sets out 
a list of active substances that are ‘candidates for substitution’ with shorter approval 
periods. When evaluating a PPP containing an active substance that is a candidate for 
substitution, Member States must conduct a comparative assessment to see if the PPP 
can be replaced with a safer alternative. 

  The PPP Regulation harmonised the rules on data protection to facilitate competition 

by companies selling generic PPPs. 

41   Uttley, N., The EU Market for Generic Agrochemicals, Enigma Marketing Research, 2004, p. 28. 
42   European  Commission  (2006),  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5. 

43   For  Austria,  Belgium,  Czech  Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Italy, 
Luxembourg, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom. Data from OECD statistics database. 
44   European  Commission  (2006),  Report  on  the  impact  assessment  for  a  Regulation  replacing  Directive  91/414/EEC  on  plant 

protection products, SANCO/10273/2006 Rev. 5. 

12 

 
                                                 
2.2.2. A patchwork regulatory system for MRLs of pesticides  

The situation in September 2008 when the Regulation came into force is the baseline for 
the evaluation of the MRL Regulation. Before 2008, there was a dual system in place for 
MRLs in the EU: Member States could set national MRLs, but some MRLs were set at 
EU level through a number of Directives45. These Directives established EU MRLs for 
fruit  and  vegetables,  cereals,  foodstuffs  of  animal  origin,  and  other  plant  products. 
Between 1976 and 2008, more than 45 000 EU MRLs were set for 245 pesticide residues 
in 190 commodities. However, these EU-level MRLs represented only a small subset of 
the MRLs that were set at national level (around 500 000) - there were more than 1 000 
active  substances  on  the  market  and  national  MRLs  covered  a  larger  range  of 
commodities.  

The Directives setting EU-level MRLs were substantially amended several times. These 
amendments  were  transposed  differently  into  national  legislation  by  Member  States. 
Moreover,  minor  crops  were  not  always  listed  in  the  Directives,  which  led  to  legal 
uncertainty about the applicable MRLs for those crops. In view of the number of active 
substances which had been withdrawn under Directive 91/414/EEC in the early 2000s, a 
practical  solution  to  this  uncertainty  had  to  be  found  to  permit  realistic  enforcement 
action on MRLs. 

Reports  from  annual  monitoring  carried  out  in  the  EU  showed  that  the  number  of 
analysed  samples  increased  from  around  41 000  samples  in  1996  to  65 000  samples  in 
2006. The compliance rate was high, with 54 % of samples free of quantifiable residues, 
an  additional  42 %  of  samples  within  legal  limits,  and  4 %  of  samples  with  residues 
exceeding  the  legal  limits  in  2006.  The  reports  covered  the  national  situations  for 
pesticide-residue  monitoring  in  EU  Member  States  and  three  European  Free  Trade 
Association (EFTA) states46. 

From a patchy regulatory system to the MRL Regulation 
The Commission carried out a series of audits in the Member States between 1998 and 
200347  and  between  2003  and  200648  to  evaluate  the  control  systems  in  place  for 
pesticide residues. The main findings are set out in the bullet points below. 

 

In  general,  the  control  system  for  pesticide  residues  was  better  developed  than  the 
control system for placing on the market and use of PPPs. 

  The  fact  that  MRLs  were  not  harmonised  for  all  the  pesticide  residue-commodity 

combinations caused some problems with compliance in Member States. 

  There  was  great  variance  in  the  planning,  priorities  and  scope  of  monitoring 
programmes. Sampling deficiencies were also found. One of the weakest points in the 
residue  area  was  in  follow-up  and  enforcement  where  non-compliance  with  MRLs 
had been found. In some Member States, no or only limited enforcement action was 

45   Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on 
fruit  and  vegetables  (OJ  L  340,  9.12.1976,  p.  26).  Council  Directive  86/362/EEC  of  24 July  1986  on  the  fixing  of  maximum 
levels for pesticide residues in and on cereals (OJ L 221, 7.8.1986, p. 37). Council Directive 86/363/EEC of 24 July 1986 on the 
fixing  of  maximum  levels  for  pesticide  residues  in  and  on  foodstuffs  of  animal  origin  (OJ  L  221,  7.8.1986,  p.  43).  Council 
Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of 
plant origin, including fruit and vegetables (OJ L 350, 14.12.1990, p. 71). 

46   Norway, Iceland and Liechtenstein are members of the European Economic Area. 
47   European Commission (2003), General report on the outcome of a series of missions carried out in all Member States from 1998 
to 2003 in the field of control systems on placing on the market of plant protection products and residues in foodstuffs of plant 
origin, DG (SANCO)/9507/2003. 

48   European Commission (2007), General report  of a series of missions carried out between 2003 and 2006 in 25 Member States 

concerning controls of pesticides in food of plant origin. DG(SANCO)/7599/2007. 

13 

 
                                                 
taken, and there was a long delay between sampling for analysis and reporting of the 
analytical results. 

In the proposal for the MRL Regulation presented in 200349, the Commission identified 
several reasons that justified the introduction of the Regulation. These reasons are set out 
in the bullet points below. 

  For  simplification  and  clarity,  and 

to 

improve  consistency  with  Directive 

91/414/EEC, a single Regulation would replace the earlier Directives. 

  The Regulation was needed to define the role of EFSA and separate responsibilities 

in the areas of risk assessment and risk management. 

  A  practical  solution  was  needed  for  the  enforcement  of  MRLs  for  the  active 

substances that were withdrawn under Directive 91/414/EEC. 

  All existing MRLs needed to be harmonised at EU level and set on the basis of: (i) 
data on national diets, (ii) the authorisations granted by the Member States, and (iii) 
their agricultural practices. In exceptional cases, MRLs could be set on the basis of 
monitoring data. 

  There was a need to recognise that different agricultural practices outside the EU led 
to different residue levels on imported products. This meant there was a need to set 
import tolerances for imported products provided they were safe for consumers.  
  The  workload  for  pesticide  residues  was  expected  to  increase,  and  the  existing 
legislation  did  not  provide  a  basis  to  recover  costs.  A  framework  within  which 
Member States could set fees for the evaluation of dossiers was desirable. 

2.3. Baseline — other points of comparison 

To complement the historical comparison, this evaluation will in a few places compare 
the MRL Regulation and PPP Regulation with other regulatory systems. 

The regulatory system for review of pesticide registration in the United States 
The  United States  has  unlimited  registration  periods  for active  substances  but  has  a  re-
registration process to review active substances to ensure that they meet current scientific 
and  regulatory  standards50.  The  United  States  Environmental  Protection  Agency  (EPA) 
assesses both the active substances and the products containing it in one step51. The EPA 
is both the risk assessor and risk manager, which is different from the EU where there is 
a clear division between the risk assessors and risk managers52.  

To initiate a review of an active substance, the EPA establishes a ‘public docket’, which 
is open for public comment for at least 60 days. The docket contains a preliminary work 
plan with: (i) facts about the pesticide and its use, (ii) the anticipated risk assessment, (iii) 
the anticipated data needs, and (iv) an estimated timeline for the review.53 Anyone may 
submit data or information to the public docket, and based on the information received, a 
final  work  plan  is  developed.  The  EPA  then  holds  focus  meetings,  which  typically 
involve  registrants  and  other  players  such  as  NGOs.  Focus  meetings  are  intended  to 
address any areas of uncertainty, such as unclear labels or missing studies. By obtaining 

49   European  Commission  (2003),  Proposal  for a  Regulation  of  the  European  Parliament  and  of the  Council  on  maximum  residue 

levels of pesticides in products of plant and animal origin, COM(2003), 117 final. 

50  EPA website on reregistration of pesticides. 
51   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. 

52   The EU is world-leading in its separation of the roles of risk assessor and risk manager, which is internationally-recognised best 

practice. 

53   EPA website on the registration review process 

14 

 
                                                 
better  information  early  in  the  process,  the  EPA  claims  that  it  can  narrow  the  scope  of 
pesticide  re-evaluations  to  areas  that  pose  real  concerns.  The  EPA  then  assesses  any 
changes that have occurred since the last registration decision to determine whether the 
pesticide  still satisfies the standard for registration or  if a new risk assessment  must be 
conducted.  If  a  new  assessment  of  the  pesticide  is  needed,  the  EPA  determines  if  they 
need new data or information. If additional data or information are needed, the EPA will 
issue  a  ‘data-call  in’  notice  to  the  registrants.  The  EPA  then  makes  the  draft  risk 
assessment  available  for  public  review.  If  risks  are  identified,  the  public  is  invited  to 
submit suggestions for mitigating the risks. Finally, the EPA decides whether a pesticide 
meets  the  standard  for  registration.  In  2007,  the  median  time  for  the  re-registration 
process  was  30  months  and  the  average  54,  i.e.  some  assessments  were  relatively 
straightforward while others required considerable resources54. In 2019, the review of an 
active substance was reported to take on average 6 years55. 

The regulatory system for review of pesticide registration in Canada 
In Canada, re-evaluations of PPPs must be initiated no later than 16 years from the last 
major regulatory decision. This is to ensure that all pesticides continue to meet the health 
and  environmental  safety  standards56.  Each  re-evaluation  process  takes  about  2-4  years 
depending on the complexity and the implementation of the decision (e.g. amendments to 
product  label)  may  take  another  2-3  years.  The  number  of  re-evaluations  that  the 
Canadian  authorities  is  required  to  initiate  is  increasing:  there  are  currently  125  re-
evaluations  ongoing  and  145  re-evaluations  are  anticipated  in  the  next  5  years.  This  is 
double the number of initiations compared to the previous 5-year period. 

The  Canadian  authorities  have  noted  that  the  scale  and  complexity  of  re-evaluation 
reviews continue to increase. The main issues  identified  are (1) a continuous stream of 
new data being generated which needs to be considered; (2) multiple data providers with 
varying  quality  of  information;  (3)  increased  expectation  for  stakeholder  engagement; 
and (4) users, registrants, public, health/environmental groups have opposing positions. 

The EU Biocidal Products Regulation 
The  Biocidal  Products  Regulation57  regulates  pesticides  used  for  non-agricultural 
purposes in the EU58. The Biocidal Products Regulation and the PPP Regulation are both 
built  on  a  two-step  approach,  where  active  substances  are  first  approved  at  EU  level. 
However,  the  second  step  differs  in  the  two  Regulations.  For  the  PPP  Regulation, 
products containing the approved active substances are authorised by Member States. For 
the Biocidal Products Regulation, biocidal products containing the active substances are 
in most cases also authorised by Member States but can also be authorised at EU level by 
the  Commission  for  certain  products  which  have  similar  uses  across  the  EU,  e.g.  hand 
disinfectants, and can then be placed on the market in all Member States.  

The  Biocidal  Products  Regulation  provides  for  the  risk  assessment  to  result  in  a  single 
opinion  by  the  Biocidal  Products  Committee  in  the  European  Chemicals  Agency 
(ECHA).  In  general,  the  opinion  is  adopted  ‘by  consensus’,  which  means  unanimous 

54   Environmental Protection Agency (2007) Evaluation of the U.S. EPA Pesticide product Reregistration Process: Opportunities for 

Efficiency and Innovation. 

55   Estimate provided by the US EPA at a meeting with the Commission services on 2-3 April 2019.  
56   Government of Canada (Health Canada's Pest Management Regulatory Agency) website on the Re-evaluation Program. 
57   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. 

58   Biocidal  products  have  diverse  uses  with  22  different  product-types,  including  disinfectants,  pest  control,  preservatives, 

antifouling, or embalming fluids. 

15 

 
                                                 
the  Member  States  experts 

support  by 
the  Biocidal  Products  Committee. 
Consequently, most of the decisions on the approval of active substance proposed by the 
Commission  were  unanimously  supported  by  the  Member  States  in  the  Standing 
Committee on Biocidal Products. For new biocidal active substances, the procedure for 
approval takes on average 44 months. 

in 

The  Biocidal  Products  Regulation  provides  for  a  coordination  group  to  facilitate 
authorisations through mutual recognition by resolving disagreements between Member 
States. In the Biocidal Products Regulation, it is also possible to request the authorisation 
of a group of similar products via one application. 

3. IMPLEMENTATION / STATE OF PLAY 

This  section  describes  the  current  situation  in  the  EU.  The  MRL  Regulation  and  PPP 
Regulation have been applicable since September 2008 and June 2011, respectively. The 
vast majority of the measures and activities provided for in the Regulations are in place, 
such  as:  the  data  requirements  for  active  substances59  and  products60;  the  uniform 
principles  for  authorisations61;  the  labelling  requirements62;  the  renewal  Regulation63; 
criteria  to  define  endocrine  disruptors64;  a  list  of  potential  low-risk  active  substances65; 
and  five  work  programmes  for  renewals66.  In  addition,  to  detail  and  clarify  the 
implementation, there are 39 procedural guidance documents and 49 technical guidance 
documents67. Additional guidance documents are also under development.  

Some  provisions  in  the  PPP  Regulation  have  not  been  fully  implemented.  Work  is 
ongoing to identify unacceptable co-formulants. A work programme should be created to 
review safeners, synergists and adjuvants. However, this work has not yet started. 

Parts  of  the  MRL  Regulation  are  not  yet  implemented.  Work  has  not  yet  started  on 
drawing up a list  of harmonised concentration or  dilution factors for certain processing 
and/or  mixing  operations.  Nor  has  work  begun  on  drawing  up  specific  MRLs  for 
processed products, feed and fish. The development and application of a methodology to 
take into account cumulative and synergistic effects of pesticides is still ongoing.  

The evaluation focusses on the effectiveness of the implemented aspects of the PPP and 
MRL  Regulations.  Discussed  is  also  the  progress  made  to  date  and,  to  the  extent 
possible, how the missing elements impact the overall effectiveness of the system.  

59   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. 

60   Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, 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. 

61   Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the 

Council as regards uniform principles of evaluation. 

62   Commission Regulation (EU) No 547/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the 

Council as regards labelling requirements for plant protection products. 

63   See Commission Implementing Regulation (EU) No 844/2012 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). 

64   Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out 

scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33). 

65   Commission notice concerning a list of potentially low-risk active substances approved for use in plant protection, C/2018/4828 

(OJ C 265, 27.7.2018, p. 8). 
66   Europa webpage on renewals. 
67   Europa webpages on guidance documents for PPPs and for MRLs. 

16 

 
                                                 
3.1. Societal and political developments 

In  recent  years,  there  has  been  growing  public  and  media  attention  on  the  way  food  is 
produced. Europeans are paying greater attention to the topic of pesticides for both health 
and  environmental  reasons.  The  European  Citizens’  Initiative  on  glyphosate,  which 
collected  over  1  million  signatures  across  Europe  in  less  than  9  months  in  2017,  is  an 
example of this increasing societal interest. The European Citizens’ Initiative called for a 
ban on glyphosate, and for more transparency in the process for assessing pesticides. It 
also called for a reduction in the use of PPPs, with the ultimate goal of a pesticide-free 
future. 

In  the  run-up  to  the  renewal  of  the  approval  of  glyphosate,  the  European  Parliament 
adopted  two  Resolutions  in  April  201668  and  October  201769.  After  the  renewal,  the 
European  Parliament  created  a  special  committee  on  the  EU  pesticides  authorisation 
procedure  (PEST).  This  special  committee  had  a  mandate  to  analyse  and  assess  the 
procedure  for  placing  PPPs  on  the  EU  market  and  identify  potential  failures  in  the 
process. The Parliament adopted the final report of the Committee in January 201970. In 
addition,  the  European  Parliament  adopted  in  September  2018  a  report  from  the 
Environment Committee on the implementation of the PPP Regulation71. 

Citizens and their political representatives have repeatedly called for more transparency 
in  the  procedures  leading  to  the  placing  on  the  market  of  PPPs  —  be  it  at  the  risk 
assessment stage or at the risk management stage. This led the Commission to adopt in 
April 2018 a proposal on the transparency and sustainability of EU risk assessment in the 
food chain72. The content of the proposal is described in a text box in section 5.1.8. This 
amendment of the General Food Law has been adopted by the Council and the European 
Parliament on 13 June 201973 and will become applicable in March 2021.  

At international level, the EU strict approach to pesticides is often criticised by a number 
third countries who argue that certain aspects of the EU legal framework and practice are 
not  in  line  with  the  WTO  SPS  Agreement  and  are  too  restrictive.  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. At the same time, there is criticism from 
within  the  EU  that  MRLs  are  set  for  non-approved  active  substances,  which  allow 
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.  

68   European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation renewing the approval of the 
active substance glyphosate 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, and amending the Annex to Implementing Regulation (EU) 
No 540/2011 (D044281/01 — 2016/2624(RSP)). 

69   European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of 
the  active  substance  glyphosate  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, and amending the Annex to Implementing Regulation 
(EU) No 540/2011 (D053565-01 — 2017/2904(RSP). 

70   European  Parliament  (January  2018)  Report  on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

71   European  Parliament  (September  2018),  Report  on  the  implementation  of  the  Plant  Protection  Products  Regulation  (EC) 

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

72   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). 

73   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.  

17 

 
                                                 
3.2. The PPP market 
In  2016,  the  six  largest  agrochemical  firms74  reported  global  agrochemical  sales  of 
EUR 32 billion75.  In  Europe, 
the  crop-protection  market  generated  revenues  of 
EUR 12 billion  in  201676.  Since  2016,  the  ‘big  six’  firms  have  consolidated  further, 
following  three  global  mergers  of  Syngenta  and  ChemChina;  Dow  and  Dupont;  and 
Bayer  and  Monsanto. Together with  BASF, these multinational  companies are now the 
‘big  four’77.  There  are  also  a  number  of  smaller  research-based  PPP  companies  (see 
page 11), and generic manufacturers, i.e. for non-patent-protected products.  

In 2014, the discovery and development of a new plant protection product was estimated 
to cost EUR 250 million and to take about 10 years78. Globally, biotechnology continues 
to  play  an  important  role,  as  demonstrated  by  the  Bayer/Monsanto  merger  in  which 
Monsanto’s  biotechnology  portfolio  was  combined  with  Bayer’s  more  traditional  PPP 
portfolio.  

Sales  of  pesticides  were  reported  to  be  relatively  unchanged  between  2011  and  2016, 
with around 350 000 tonnes of active substances sold per year79.  

Based on the limited data provided by Member States, most active substances contained 
within  PPPs  marketed  in  the  EU  are  manufactured  abroad.  Increasingly,  formulation 
which is the mixing of PPPs, is also moving to non-EU countries. There is also a lot of 
trade within the EU, so most PPPs are not used in the Member State in which they are 
actually imported or manufactured80. 

3.3. Approval of active substances 
As of December 2018, 484 active substances were approved in the EU81. This is a 15 % 
increase  compared  to  2011.  In  some  cases,  one  approval  decision  covers  several 
individual  substances,  so  the  number  of  approval  decisions  for  these  substances  was 
around 43082.  

Active  substances  currently  approved  under  the  PPP  Regulation  have  been  subject  to 
different  approval  criteria  depending  on  when  they  were  approved  or  when  the 
application  for  approval  was  submitted.  These  differences  are  discussed  in  the  bullet 
points below. 

  Active substances approved under Directive 91/414/EEC were deemed to have been 
approved  under  the  PPP  Regulation.  These  active  substances  have  then  been 
reviewed  under  one  of  the  renewal  programmes.  Some  active  substances  in  this 
category fall under the cut-off criteria. However, the cut-off criteria will only impact 
the approval status of the active substances at the time of renewal of approval. 

74   Syngenta, Bayer, BASF, Dow, Monsanto and Dupont. 
75   According to Agribusiness intelligence, Top 20 2017. 
76   According to InkWood Research, https://www.inkwoodresearch.com/reports/europe-crop-protection-market/. 
77   Syngenta/ChemChina, Corteva, Bayer and BASF. 
78   According  to  CropLife  and  McDougal  P.  (2016),  The  Cost  of  New  Agrochemical  Product  Discovery,  Development  and 

Registration in 1995, 2000, 2005-2008 and 2010-2014. 

79   Eurostat, Pesticide sales dataset [aei_fm_salpest09]. 
80   European  Commission  (2016)  Overview  report  on  a  series  of  audits  carried  out  in  EU  Member  States  in  2015  and  2016  to 
evaluate the control systems in place for the marketing and use of plant protection products, DG(SANTE) 2016-6004 – MR. 

81   EU Pesticides Database 
82   For instance ‘copper compounds’ covers 7 individual copper salts. ‘Straight Chain Lepidoptera Pheromones’ covers 27 individual 
strains  of  Straight  Chain  Lepidoptera  Pheromones.  See  Regulation  (EU)  No  540/2011  as  regards  the  list  of  approved  active 
substances. 

18 

 
                                                 
  New  active  substances  for  which  applications  had  been  submitted  under  Directive 
91/414/EEC  (i.e.  before  June  2011),  but  approved  under  the  PPP  Regulation  were 
subject to the approval criteria in Directive 91/414/EEC. 

  Active  substances  are  reviewed  and  assessed  according  to  the  updated  data 
requirements  that  came  into  force  in  2013.  If  approval  is  renewed,  the  active 
substances are in most  cases  approved for another 15 years. As of December  2018, 
68 renewal  procedures  have  been  completed.  For  53  active  substances  the  approval 
has been renewed, and for 15 active substances the approval has not been renewed. In 
addition,  72  active  substances  approved  earlier  are  no  longer  supported  by  any 
company at EU level under the AIR 3 and AIR 4 work programmes.  

  New active substances for which approval has been sought under the PPP Regulation 
must  meet  the  strict  approval  criteria  set  out  in  the  Regulation.  Dossiers  for  these 
substances must be submitted according to the updated data requirements. Since June 
2011, applications for 69 new active substances have been submitted. The rapporteur 
Member States for these applications have mostly been France, the Netherlands and 
the UK (France was rapporteur Member State for 16 applications, the Netherlands for 
14  and  the UK  for  12).  Table  1  provides  an  overview  of  the  number  of  new  active 
substance  applications  received  per  year:  of  the  69  applications  between  2011  and 
2018,  26  have  been  approved.  New  active  substances  can  be  new  innovative  active 
substances never before placed on the market in the EU. New active substances can 
also be  active  substances that  were previously not  approved in  the EU or  that  were 
withdrawn from the market under Directive 91/414/EEC and for which the applicant 
is making a new application under the PPP Regulation. 

Table 1. Applications for new active substances received from June 2011 to December 201883 
Year 
New active substance applications 

2011 
4 

2014 
6 

2012 
8 

2013 
12 

2015 
15 

2016 
10 

2017 
4 

2018 
10 

3.4. Authorisation of plant protection products 

The  number  of  PPPs  authorised  varies  between  Member  States.  For  instance,  in  2016 
there were 134 in Malta, 322 in Sweden, 753 in Germany, 1 825 in France, 3 300 in the 
UK, and 4 200 in Italy84. The number of products available in a particular Member State 
somewhat  correlates  with  the  size  of  the  Member  States,  the  size  of  their  agricultural 
sector, and their climatic conditions. 

3.5. Setting and reviewing MRLs 
When the MRL Regulation came into force in 2008, temporary MRLs85 were set for all 
pesticide residue-commodity combinations previously covered by national MRLs. EFSA 
carried out a  preliminary  risk  assessment of those temporary  MRLs on the basis of the 
information provided by Member States86. The MRL Regulation requires a review of all 
existing MRLs for active substances 1 year after their initial approval or non-approval. 
MRLs for substances that were already approved at the time of the implementation of the 
Regulation must also be reviewed. This includes a review of existing import tolerances 
and  Codex  Limits  (CXLs).  The  timeframe  for  this  review  (i.e.  1  year)  was  overly 

83   Information from the summary reports from the Standing Committee on Plants, Animals, Food and Feed. 
84   Member State survey. 
85   100 000 MRLs were set in the MRL Regulation on a temporary basis to cover the most critical good agricultural practices that 

were authorised in single Member States. 

86   Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. EFSA 

Journal, 2007; doi: 10.2903/j.efsa.2007.32r. 

19 

 
                                                 
ambitious,  in  particular  because  the Regulation  did  not  set  out  a  procedure  on  how  the 
review  should  work  in  practice  (resources,  responsibilities,  etc.).  Therefore,  Member 
States, the Commission and EFSA agreed on an ad-hoc procedure under which Member 
States provide support to EFSA to share the workload. In spite of this effort, the MRLs of 
only about half of the substances have now been reviewed. Part of the initial delay can be 
attributed to the need for the development of a new procedure. 

After a Member State revokes an authorisation for a PPP, the Commission may prepare a 
draft  measure  to  delete  the  relevant  existing  MRLs.  In  practice,  the  Commission  only 
makes  use  of  this  procedure  when  all  existing  authorisations  for  PPPs  containing  a 
specific  active  substance  have  been  revoked  (e.g.  following  non-approval  or  non-
renewal).  Provided  they  are  judged  safe  for  EU  consumers,  MRLs  corresponding  to 
CXLs  based  on  uses  in  non-EU  countries  are  not  deleted, nor  are  MRLs  that  had been 
specifically set as import tolerances. 

As a result, MRLs are either set to a default value of 0.01 mg/kg, or, where specific data 
on analytical feasibility are available, they are set to the relevant limit of quantification 
(LOQ) of the active substance. The EU reference laboratories for pesticide residues are 
consulted  on  the  appropriate  LOQ  and  residue  definitions  to  be  used  for  enforcement 
purposes.  In  exceptional  circumstances,  a  lower  level  than  the  default  can  be  set  for 
substances  with  high  toxicity.  As  the  lowering  of  MRLs  affects  trade,  WTO  members 
must be consulted under the SPS agreement87. 

Since  2008,  more  than  1 000  applications  were  submitted  to  Member  States  to  set  or 
review  MRLs,  either  for  uses  in  the  EU  or  to  set  import  tolerances88  (see  Table  2). 
Currently,  486  approved  and  247  non-approved  substances  are  covered  by  the  MRL 
Regulation, which sets 190 000 MRLs89. Note that for 130 active substances, no MRLs 
are  required,  because  of  their  low-risk  profile  or  because  they  naturally  occur  in  the 
environment and are considered safe. 

Table 2. Number of applications received to set and review MRLs since 2008 

Procedure 
Setting of MRLs 
Setting of import tolerances 
Review of MRLs 

Applications 
518 
94 
487 

3.6. Public information, risk communication and transparency 

Access  to  information  has  been  built  into  the  risk  assessment  and  risk  management 
processes.  Efforts  have  been  made  to  ensure  that  relevant  information  can  be  accessed 
easily and in a timely manner. The EU Pesticides Database90 provides data on the status 
of  all  active  substances  and  on  all  MRLs.  The  plant  protection  products  application 
management system (PPPAMS)91 currently being developed by the Commission aims at 
increasing  transparency on authorisations granted in  the Member  States. It also aims at 
facilitating  the  implementation  of  mutual  recognition  and  parallel  trade  permits.  Since 
July 2016, Member States have accepted to notify emergency authorisations only within 
the PPPAMS. To populate the PPPAMS and create a public website, the Commission is 
currently working with Member States to collect data on all existing authorisations held 
in national databases. 

87   The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). 
88   EFSA Register of Questions. 
89   For further explanation and calculation, see Annex 3. 
90   EU Pesticides Database. 
91   https://ec.europa.eu/food/plant/pesticides/authorisation_of_ppp/pppams_en.  

20 

 
                                                 
3.7. Enforcement and monitoring 

Member States are required to perform official checks to verify compliance with the PPP 
and the MRL Regulations. In addition to the general obligation laid down to this effect in 
Regulation  (EC)  No  882/2004,  which  requires  Member  States  to  plan  and  perform 
official controls at all stages of the agri-food chain, special rules are also laid down in the 
PPP and MRL Regulations92.  
For the MRL Regulation, checks consist mostly of: (i) an EU-coordinated programme93 
of sampling and analysis, the results of which are reported to EFSA on an annual basis, 
and (ii) risk-based official controls planned at national level, the results of which are also 
reported to EFSA along with the enforcement actions taken. 

Under  the  EU-coordinated  programme,  the  Commission  and  the  Member  States  agree 
every  year  on  the  number  of  samples  (approximately  80 000)  to  be  taken  that  are 
representative  of  ‘the  residue  situation  of  food  products  available  to  consumers’.  They 
also  agree  on  the  active  substances  to  be  analysed.  These  two  measures  ensure  the 
adaptability of  the  programme  to  cover  those  pesticides  of  high  interest.  Together  with 
other relevant information, the results of the EU-coordinated programme are also used to 
determine whether increased levels of import controls are required on certain products94.  

For the PPP Regulation, Member States monitor and control the manufacturing, import, 
distribution and use of PPPs. They also send annual reports to the Commission to inform 
about the activities they have carried out. 
Since 2011, the Commission has conducted several series of audits in Member States95. 
These  audits  have  focused  on  how  Member  States  organise  their  official  controls  and 
other  official  activities  in  this  area  (e.g.  the  controls  of  PPPs,  official  laboratories  and 
sampling  methods,  the  authorisation  of  PPPs).  Further  enforcement  action  to  detect 
counterfeit  and  illicit  PPPs  is  taking  place  through  coordinated  measures  supported  by 
Europol and the European Anti-Fraud Office through the Silver Axe joint operation. 
Some significant changes have recently been introduced96 to strengthen enforcement of 
the PPP Regulation by the Member States. These changes include: 

  a new obligation for national enforcers to perform dedicated official checks aimed at 
identifying  possible  fraudulent  and  deceptive  practices,  including  in  imported 
products; 

  explicit  powers  for  national  enforcers  to  inspect  the  production  chain  ‘upstream’ 
(including manufacturing, transport distribution of substances and products) and take 
remedial action in the event of established violations; 

  strengthened rules for cross-border cooperation if fraudulent products move from one 

Member State to the other; 

  strengthened penalties for fraud; and 

92   These special rules will be replaced (by December 2022 at the latest) by the provisions of the recently adopted Regulation (EU) 

No 2017/625 (see Article 115 and Article 161 of Regulation (EU) n. 2017/625). 

93   Commission Implementing Regulation (EU) 2018/555 of 9 April 2018 concerning a coordinated multiannual control programme 
of  the  Union  for  2019,  2020  and  2021  to  ensure  compliance  with  maximum  residue  levels  of  pesticides  and  to  assess  the 
consumer exposure to pesticide residues in and on food of plant and animal origin. 

94   As described in Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the 
European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of 
non-animal origin and amending Decision 2006/504/EC. 

95   Europa webpage with all overview reports. 
96   By Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other 
official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and 
plant protection products. 

21 

 
                                                 
 

the possibility for the Commission to adopt specific rules to govern official controls 
and other enforcement activities in this area. 

3.8. Court cases and complaints 

Since 2011, 25 court cases related to PPPs and MRLs have been initiated by industry and 
NGOs against the Commission. The cases are not only about approval or non-approval 
decisions  of  active  substances.  They  also  deal  with:  restrictions  of  approvals,  internal 
reviews  under  the  Regulation  implementing  the  Aarhus  Convention,  the  inclusion  of 
active  substances  in  the  list  of  candidates  for  substitution,  and  requests  for  interim 
measures  to  suspend  the  action  that  is  subject  to  the  court  case.  Industry  most  often 
challenges the Commission’s decisions on active substances based on arguments related 
to the risk assessment and procedural rights97. A comprehensive analysis of the outcomes 
cannot be performed at present as more than 50 % of the cases are still pending98. 

In  addition,  4  complaints  to  the  Ombudsman  have  been  made  both  by  industry  and 
NGO’s. These complaints relate to: (i) the Commission’s practice of approving an active 
substance  while  simultaneously  requesting  data  confirming  its  safety99;  (ii)  the 
Commission’s  practice  of  extending  the  approval  periods  of  active  substances;  (iii)  the 
Commission’s  compliance  with  rules  on  the  approval  of  active  substances,  including 
whether MRLs for new active substances should be set after approval of a substance or 
before100;  and  (iv)  the  Commission’s  response  to  18  applications  for  access  to 
documents101. 

A complete list of court cases and complaints to the Ombudsman is provided in Annex 5. 

4. METHODOLOGY 

The  roadmap102  for  the  REFIT  evaluation  was  published  in  November  2016  and  this 
Staff Working Document answers the questions posed in the roadmap. Feedback on the 
roadmap  was  received  from  21  stakeholders103  and  taken  into  consideration  when 
drafting the terms of reference for the external support study. The final report of a study 
commissioned  to  an  external  contractor  was  published  on  18 October 2018104  (and  is 
referred  to  elsewhere  in  this  report  as  ‘the  support  study’).  The  REFIT  evaluation  was 
supported  by  an  inter-service  steering  group  with  representatives  from  relevant 
Commission  DGs  (see  Annex  1  on  procedural  information).  More  information  on  the 
support study and methodology can be found in Annex 3.  

In  addition  to  the  support  study,  several  other  reports  and  studies  have  been  published 
recently  on  the  implementation  of  the  PPP  Regulation  and  the  functioning  of  the 
regulatory system for pesticides in the EU. These publications are listed in Annex 1 and 
have been carefully considered in the analysis. 

97   This includes the right to be heard, the right of defence and the right regarding the protection of legitimate expectations. 
98   In the cases where the Court has ruled, the Court upheld the Commission’s restrictions for three neonicotinoids, as well as the 
inclusion of copper compounds and metalaxyl in the list of candidates for substitution. However, the Commission lost the case 
concerning the restriction of the active substance fipronil. 

99   Complaint 12/2013/JN, see https://www.ombudsman.europa.eu/cases/correspondence.faces/en/93729/html.bookmark. 
100  Complaint 2000/2015/ANA). 
101  Complaint 1869/2013/AN. 
102  Roadmap 
103  Feedback can be accessed online. 
104  External support study published in the EU bookshop. 

22 

 
                                                 
4.1. Data collection 

The Commission drew up a consultation strategy together with the terms of reference for 
the support study in order to collect  stakeholder perceptions and quantifiable data. This 
quantifiable data included the costs for preparing a dossier for approval and renewal, and 
the number of full-time staff equivalents working with the PPP and MRL Regulations. A 
literature  review  was  carried  out  to  gather  key  information  from:  impact  assessments; 
position papers; academic and scientific research; papers and reports prepared by relevant 
scientific bodies; and regulatory submissions. Stakeholders contributed to one or several 
consultations,  as  planned  in  the  consultation  strategy  (see  Table  3).  These  stakeholders 
included: public authorities in the Member States; EFSA; the Commission; the pesticides 
industry;  the  food  industry;  NGOs  for  environment,  health,  protection  of  animals  and 
transparency;  consumers,  citizens  and  farmers;  and  authorities  and  other  stakeholders 
from non-EU countries. Despite efforts to get their contribution, only three respondents 
from the research community participated in the stakeholder survey. 

A summary of the views collected in the consultations is provided in the synopsis report 
on the stakeholder consultation in Annex 2. The Commission set-up a webpage to inform 
the  public  about  the  REFIT  evaluation  in  general  and  the  consultation  activities  in 
particular105. 

Table 3. Consultation activities carried out 
Target/participants 

Consultation 
Open public 
consultation 

SME consultation 
panel 

Stakeholder survey 

Member State 
survey 

Focus groups 

First Workshop 

Second Workshop 

In-depth interviews 

Consumers, citizens and farmers. 

Distributed via the Europe Enterprise Network 
to target small, medium and micro-sized 
companies. 
Trade and industry associations covering the 
chemical industry; retailers and wholesalers; 
the food and feed industry; environmental, 
health and consumer NGOs; farmers’ 
associations. 
Member States and European Economic Area 
(EEA) countries. 

Member State authorities, EFSA, the 
Commission, stakeholders working with risk 
assessment. 

Member State authorities; the Commission; 
trade and industry associations; NGOs at EU 
level. 
Member State authorities; the Commission, 
trade and industry associations; NGOs at EU 
level. 
Trade and industry associations, NGOs at EU 
level, Member States, non-EU countries, EFSA, 
the Commission. 

When? 
13 Nov 2017 - 
12 Feb 2018 

14 Nov 2017 - 
15 Jan 2018 

14 Nov 2017 - 
12 Jan 2018 

16 Nov 2017 - 
19 Feb 2018 
24 Jan 2018 
28 Feb 2018 
5 Mar 2018 
9 Mar 2018 

12 Sep 2017 

16 May 2018 

10 Jan 2018 - 
25 Apr 2018 

Contributions 

9 847 

294 

240 

30 

8 
9 
7 
8 

40 

50 

60 

4.2. Limitations and robustness of findings 

The following shortcomings and challenges limit the analysis. 

105  REFIT pesticide webpage 

23 

 
                                                 
 

  The  Regulations  are  still  at  a  relatively  early  stage  of  implementation,  with  some 
provisions still to be implemented. This is especially the case for the PPP Regulation 
as  it  takes  a  long  time  to  evaluate  each  active  substance.  All  active  substances  or 
MRLs have not yet been reviewed, so the evaluation will not capture all the impacts 
or expected benefits from the Regulations. 
It  is  difficult  to  quantify  the  benefits  of  the  Regulations.  This  is  due  to  attribution 
problems  and  a  lack  of  studies  establishing  a  causal  link  between  the  use  of  single 
pesticides or specific MRLs and health or environmental outcomes. Data on the use 
of pesticides also do not exist in a harmonised way in the EU, and quantities alone do 
not necessarily reflect risk, given that each substance has a particular hazard profile 
and some more recently introduced active substances have a more ‘specific activity’ 
affecting  less  non-target  organisms.  This  limits  the  assessment  of  how  effective  the 
MRL and PPP Regulations are in protecting human health and the environment. An 
additional limitation is that most scientific publications rely on old data and consider 
effects from already non-approved active substances. They are therefore of little use 
in this evaluation, which focuses on impacts after 2008 and 2011, respectively. Better 
health  and  environmental  information  could  be  obtained  through  more  and  better 
targeted  monitoring  and  controls.  Health  and  environmental  impacts  could  be 
investigated through research projects and epidemiological studies. Further inclusion 
of  pesticides  in  human  biomonitoring  (such  as  HBM4EU106)  could  be  considered. 
Possible  solutions  to  collect  use  data  are:  new  technologies  such  as  intelligent 
application equipment  that  directly  transmits  the  data  or  remote  sensing  by  satellite 
(e.g. via Copernicus).  

  Despite  efforts  to  collect  data  on  costs  through  surveys  and  specific  queries  (in 
addition to Eurostat data and other publicly available data), it was not always possible 
to  fill  data  gaps.  Therefore,  cost  estimates  should  be  considered  only  as  an 
approximation  of  the  costs  incurred  by  the  different  stakeholders.  Better  cost  data 
could  be  collected  by  systematically  requiring  applicants  to  submit  cost  figures  as 
part of their application dossiers. Member States could keep better records of the time 
and resource costs. 

  Farmers were consulted as part of the public consultation, and efforts have been made 
to  analyse  the  answers given  by  farmers  in  the part  of  the  survey  that  contained  an 
open question in which they were free to write at length. 

  Data from Regulation 1185/2009 on statistics of pesticides107 could only be used on 
an  aggregated  level  due  to  confidentiality  restrictions  set  in  the  Regulation  by  the 
European Parliament and the Council. This restricted the possibility of assessing the 
impacts  of  approval  decisions  on  use  patterns  in  the  EU,  and  such  analysis  is 
therefore omitted. 
It  has  not  been  possible  to  distinguish  the  effect  on  human  health  and  the 
environment of the approval of an active substance from the authorisation of the PPP 
containing that active substance. This is because of the difficulty in disentangling the 
impact  from  the  two  processes,  as  an  active  substance  is  only  released  into  the 
environment in the form of a PPP. 

 

Despite  these  limitations,  the  evaluation  relied  on,  as  described  above,  an  extensive 
literature  review  and  data  collection  through  desk  research.  The  wide  stakeholder 

106 Human biomonitoring for EU HBM4EU is a joint effort by 28 countries, the European Environment Agency and the European 

Commission, co-funded under Horizon 2020. 

107  Regulation  (EC)  No  1185/2009  of  the  European  Parliament  and  of  the  Council  of  25 November  2009  concerning  statistics  on 

pesticides (OJ L 324, 10.12.2009, p. 1). 

24 

 
                                                 
consultation made it possible to collect the opinions of many stakeholders. To ensure the 
reliability  of  the  data  collected,  different  sources  of  data  were  compared,  and  opinions 
from stakeholders were examined against other evidence (i.e. triangulation) as much as 
possible. 

5. ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS 

5.1. Effectiveness 

  To  what  extent  have  the  objectives  been  achieved  as  a  result  of  the 
implementation  of  the  PPP  and  MRL  Regulations  at  both  EU  and  at  Member 
State level? 

  Where  expectations  have  not  been  met,  what  factors  have  hindered  their 

achievement? 

  Which unintended effects were observed? 
  Did other factors influence the results observed? 

MAIN FINDINGS 

The Regulations are to a large extent effective in protecting human health. The number of 
highly hazardous active substances is low in the EU and will decrease in the future, while 
the proportion of low hazard  active substances is  increasing albeit slowly.  The level of 
compliance  with  MRLs  is  high  showing  that  the  food  available  to  consumers  is  safe. 
Although  the  Commission  has  not  yet  made  use  of  the  possibilities  given  by  the  MRL 
Regulation  to  establish  specific  MRLs  for  certain  product  groups  (fish,  feed,  processed 
foods)  as  well  as  a  harmonised  processing  factors,  this  has  not  decreased  consumer 
protection. Developing a method for cumulative risk assessment for residues is still on-
going as it turned out to be much more complex and require more resources than initially 
envisaged.  The  protection  of  human  health  is  expected to  improve  in  the  coming  years 
when  the  review  programmes  for  active  substances  and  MRLs  will  be  finalised.  Less 
progress  has  been  made  in  the  development  of  methodology  for  the  cumulative  risk 
assessment of active substances under the PPP Regulation. 

The approval criteria in the PPP Regulation are effective in protecting the environment. 
Monitoring shows a reduction in the contamination of surface water by certain individual 
pesticides, although the monitoring data available do not cover all pesticides used.  The 
restrictions on  active  substances  with  negative  impacts  on  pollinators  should  contribute 
to their protection. However, increased monitoring would make it possible to assess the 
effectiveness of the PPP authorisation in more detail, and to identify illegal uses that may 
pose a threat to the environment.  

Enforcement  of  the  Regulations  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  by  the  PPP 
Regulation.  The  MRL  Regulation  ensures  that  effective  and  timely  enforcement  action 
can  be  taken,  however  some  problems  have  been  experienced  in  practice,  in  particular 
with substances coming from multiple sources. 

The Regulations have overall improved the functioning of the single market, in particular 
the  harmonisation  of  MRLs.  The  zonal  system  created  with  the  PPP  Regulation  is  not 
working as well as expected. The lack of cooperation between Member States and lack of 
harmonisation between national requirements decreases effectiveness. In some cases the 

25 

 
MRL  Regulation  was  found  to  lack  flexibility  to  provide  quick  responses  to  newly 
emerging issues, such as unexpected findings of pesticides residues in food and residues 
as a result of emergency uses to address plant health risks.  

More information on the relationship between the use of different PPPs and agricultural 
productivity  is  needed  in  order  to  fully  assess  the  PPP  Regulation’s  impact  on  the 
competitiveness  of  EU  agriculture.  Farmers  and  food-business  operators  expressed 
concern  about  more  active  substances  being  taken  off  the  market  in  the  future  and  not 
being  replaced  by  sufficient  low-risk  active  substances.  This  would  limit  farmers’ 
choices related to resistance management and the handling of pest outbreaks. 

The  setting  of  MRLs  has  contributed  to  the  smooth  functioning  of  international  trade. 
However,  when  MRLs  are  decreased,  the  length  of  the  procedure  for  setting  import 
tolerances may create barriers to trade.  

26 

 
 
 
5.1.1. Protecting human health 

Approval criteria for active substances 
The approval criteria in the PPP Regulation, which are underpinned by the precautionary 
principle, are frequently referred to as the most stringent in the world. As seen in Figure 
3 in section 2.1, the number of active substances placed on the market in PPPs decreased 
by more than 50 % under Directive 91/414/EEC. This means that the level of protection 
of human health was already increasing before the PPP Regulation came into force. With 
the  PPP  Regulation,  active  substances  have  been  reviewed  against  the  strengthened 
approval criteria to further increase the protection of human health in the EU. 

When the PPP Regulation became applicable in 2011, there were 427 active substances 
available  (see  Table  4).  On  31  December  2018,  there  were  484  approved  active 
substances in the EU, a slight reduction compared to 2017 because of a number of recent 
non-renewals of approvals. The increase in available active substances between 2011 and 
2018 is due to new active substances, for which applications for approval were submitted 
mostly still under Directive 91/414/EEC. 
Table 4. Approved active substances per year108  
Year 
Total approved active substances 
of which basic substances 
of which low-risk active substances 
of which candidates for substitution* 

2011  2012  2013  2014  2015  2016  2017  2018 
427 

483 
9 
3 
1 

490 
12 
7 
5 

484 
20 
13 
10 

494 
18 
11 
8 

467 
3 

432 

443 

*This refers only to the active substances approved as candidates for substitution and listed in Annex E to Regulation 540/2011 

Since 2011, the renewal process has been initiated for all approved active substances and 
finalised  in  68  cases.  A  first  full  cycle  should  be  finalised  by  2025109.  Only  when  all 
approved  active  substances  have  been  re-assessed  against  the  current  criteria  will  it  be 
possible  to  fully  assess  the  impact  of  the  PPP  Regulation  on  the  number  of  active 
substances  and  their  toxicological  profile  —  and  by  extension  the  positive  effect  on 
human  health.  The  decisions  to  not  approve,  not  renew  the  approval,  or  withdraw  22 
active  substances110  because  of  health-related  concerns  has  contributed  to  avoiding 
serious health risks in the EU. Potential hazards such as genotoxicity, long-term toxicity, 
carcinogenicity  and  reproductive  toxicity  have  been  reduced  for  consumers,  operators, 
workers, bystanders and residents111. 

Even if some benefits are evident, it remains challenging to assess the impact of the PPP 
Regulation  on  human  health  because  of  the  difficulties  of  linking  exposure  to  a  single 
active  substance  with  a  certain  health  effect.  Only  one  relevant  scientific  study  was 
found: it used data from 2003 to assess the health impact and damage cost of pesticides 
in the EU112. This study found that 13 active substances113 contributed to 90 % of overall 
health impacts. Only 3 of these 13 active substances114 are still on the market in the EU 
and  they  are  currently  being  re-evaluated.  The  study  concluded  that,  although  it  was 

108  EU Pesticides Database. 
109  This statement will hold true if all active substances are assessed on time. However, with the delays in the system it is possible 

that the full cycle of renewals will only be finalised after 2025. 

110  2-naphthyloxyacetic  acid,  3‑ decen-2-one,  amitrole,  chloropicrin,  diphenylamine,  diquat,  etoxazole,  fenamidone,  flufenoxuron, 
flupyrsulfuron-methyl,  flurtamone,  iprodione,  linuron,  orthosulfamuron,  oxasulfuron,  picoxystrobin,  propanil,  propargite, 
propiconazole, propineb, Pseudozyma flocculosa ATTC 64874, thiram and tricyclazole. 

111  Support study p. 57. 
112 Fantke, P., Friedrich, R., and Jolliet, O., (2012) Health impact and damage cost assessment of pesticides in Europe. Environment 

International Vol 49, p 9-17. https://doi.org/10.1016/j.envint.2012.08.001. 

113 1.3-D, amitrole, dazomet, diazinon, glufosinate, linuron, mancozeb, methomyl, parathion, propineb, simazine, terbuthylazine and 

trifluralin. 

114 Dazomet, mancozeb and terbuthylazine. 

27 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
possible  to  partially  assess  health  impacts,  more  detailed  statistics  on  PPP  use  are 
required to make a full assessment and to evaluate pesticide policy measures.  

The  study  discussed  above  demonstrates  that  it  is  possible  to  link  health  impacts  with 
individual  active  substances,  even  if  results  are  uncertain  as  they  rely  on  a  series  of 
assumptions.  Regardless,  the  study’s  findings  imply  that  the  PPP  Regulation  has 
contributed to reducing adverse health effects in the EU. No other study was found that 
used more recent data and linked active substances used in the EU with health effects.  

To  further  assess  the  effectiveness  of  the  PPP  Regulation  as  regards  protecting  human 
health, the following discussion in this section provides an overall picture of the hazard 
profile of active substances on the market in the EU.  

To  visualise  the  trend  towards  using  less  hazardous  active  substances,  all  active 
substances approved in the EU since 2011 have been mapped according to their hazard 
classification115 and divided into three groups: low hazard, intermediate hazard and high 
hazard.  Figure  4  compares  the  toxicological  profiles  of  approved  active  substances  for 
2011, 2018 and a projection for 2022 (made by removing all active substances that are no 
longer  supported  at  EU  level116).  The  proportion  of  less  hazardous  substances  used  is 
increasing, and there is a small decrease in the proportion of more hazardous substances. 
Note that this comparison of the hazard profiles of active substances only considers the 
number  of  active  substances  and  does  not  take  into  consideration  the  actual  volume  of 
PPPs used, nor their specific activity, as such data are not readily available and would be 
difficult to collect in the EU. As a second best option, data on pesticide sales could have 
informed  the  analysis.  However,  due  to  confidentiality  restrictions,  data  on  sales  of 
individual active substances collected under Regulation 1185/2009 were not available117.  

By the end of 2022, the number of active substances will have decreased as the approval 
of  60  active  substances  that  are  no  longer  supported  at  EU  level  will  have  expired. 
Several  of  those  are  active  substances  with  hazard  classifications  meeting  the  cut-off 
criteria or ones that are listed as candidates for substitution, which means that they will 
not  adversely  affect  health  much  longer.  Moreover,  40 %  of  all  applications  for  the 
approval  of  new  active  substances  are  for  micro-organisms  or  for  presumed  low-risk 
active  substances.  There  was  an  increase  in  these  in  2018  and  a  further  increase  is 
predicted in 2022. 

70%

60%

50%

40%

30%

20%

10%

0%

S
E
C
N
A
T
S
B
U
S
E
V
I
T
C
A
F
O
%

66% 

62% 

61% 

37% 

38% 

31% 

Low hazard active substances

Intermediate hazard active
substances

High hazard, cut-off active
substances

HAZARD 

2011

2018

projection 2022

3% 

2% 

1% 

Figure 4. Distribution of toxicological profile of approved active substances in 2011, 2018 and 2022 

115 See Annex 3 for a description on the methodology. 
116 Where no application has been made 3 years before expiry of approval or where the applicant has communicated that they have 

withdrawn their support for the active substance in the EU. 

117  The  Commission  has  recently  established  harmonised  risk  indicators  to  estimate  trends  in  the  risk  from  pesticide  use  under 

Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides.  

28 

 
 
                                                 
 
 
 
 
Furthermore,  the  proportion  of  high  hazard  active  substances  is  very  small  (14  active 
substances) and it is expected that this will be reduced further by at least two thirds (five 
active substances) in 2022. 

Although  a  full  assessment  of  the  impacts  of  the  PPP  Regulation’s  approval  criteria 
cannot be carried out at this time, there is a clear positive trend towards less hazardous 
substances. The decisions on the non-renewal of approvals taken in recent years show the 
stringency  of  the  PPP  Regulation  and  confirm  that  active  substances  posing  a  risk  to 
human health can no longer be placed on the EU market. 

Cut-off criteria 
The  cut-off  criteria  introduced  under  the  PPP  Regulation  are  mainly  based  on  the 
intrinsic properties of active substances, i.e. the properties that are considered so severe 
that any exposure to the substance poses an unacceptable level of risk. The criteria were 
introduced  to  improve  the  protection  of  human  health  and  the  environment.  Their 
introduction also intended to reduce the workload for the evaluating authorities because 
if  an  active  substance  meets  any  of  the  cut-off  criteria,  the  risk  assessment  can  be 
discontinued and the active substance not approved. Very limited derogation possibilities 
exist for substances for which the applicant demonstrates that exposure is negligible118, 
or which are needed in order to control a serious danger to plant health and this cannot be 
contained by other available means. Application of these derogations has caused delays 
in the re-assessment of several active substances (see the discussion of the inefficiency of 
cut-off criteria in section 5.2.2). 

The cut-off criteria are both criticised (by industry and non-EU countries) and welcomed 
(by  NGOs).  Member  States  are  divided  in  their  opinions  of  the  usefulness  of  these 
criteria.  The  main  critique  is  that  a  substance’s  intrinsic  properties  do  not  accurately 
signal potential risk because exposure is not taken into consideration. Active substances 
might  therefore  not  be  approved  even  though  they  could  pass  the  risk  assessment  if 
exposure to them is low. The main argument in favour of the cut-off criteria is that high 
hazard substances should never be used and that exposure assessments are hampered by 
uncertainty; in line with the precautionary principle, it is therefore appropriate to ensure 
that the risks related to exposure to these substances are completely avoided. 

The main effect of the cut-off criteria observed so far is the low application rate for the 
renewal  of  approval  of  active  substances  that  are  expected  to  meet  them.  In  the  AIR  3 
programme,  six  of  nine  active  substances  expected  to  meet  the  cut-off  criteria  were  no 
longer  supported119.  In  the  AIR  4  programme,  12  active  substances  that  may  meet  the 
cut-off  criteria  were  identified.  Of  these,  seven  are  no  longer  supported  and  their 
approval will expire by the end of 2021120. 

So  far,  the  approvals  of  three  active  substances  have  not  been  renewed  because  of  the 
cut-off criteria121. However, there were several other problematic issues with these active 
substances and they also failed the overall risk assessment122.  

118 One example of negligible exposure could be where the PPP is applied  inside a trap and so there is no exposure outside of the 

trap. 

119 These substances have a harmonised, proposed or notified classification in the Classification and Labelling inventory as toxic for 
reproduction 1B, mutagenic 1B, or a combination of toxic for reproduction and carcinogenic 2. The active substances that are no 
longer supported are carbendazim, glufosinate molinate, oxardiargyl, quinoclamine, tepraloxydim and warfarin. 

120  The  active  substances  that  are  no  longer  supported  are  difenacoum,  triflumizol,  spirodiclofen,  bromadiolone,  carbetamide, 

myclobutanil and profoxydim. 

121 Linuron, iprodione and propiconazole. 
122  The  operator  exposure was  too high,  there was  a  high  risk  to  birds  and  wild  mammals,  the  consumer risk  assessment  was  not 

finalised and the risk assessment for groundwater could not be finalised. 

29 

 
                                                 
In conclusion, the cut-off criteria have been effective in contributing to the protection of 
human health as  they discourage  applicants  from re-applying for approval. However, it 
appears that for the cases in which the criteria were applied during decision-making, the 
outcome  of  the  risk  assessment  would  also  have  led  to  non-approval  of  the  active 
substance. In addition, delays in assessing some active substances due to the application 
of derogations have possibly failed to protect human health as the substances remained 
on the EU market under the previous approval conditions for a longer time. 

the  authorisations. 

In  2017,  Member  States 

Authorisation of PPPs 
Member  States  must  authorise  PPPs  according  to  uniform  principles,  taking  into 
consideration all product ingredients, i.e. active substance(s) and all co-formulants listed 
by  the  applicant.  The  risk  assessment  conducted  for  approved  active  substances  feeds 
into  the  PPP  assessments  as  Member  States  take  into  consideration  all  relevant 
information (endpoints). Member States must ensure that every use of an authorised PPP 
does not pose any unacceptable risk to human or animal health or to the environment. If 
an  authorisation  does  no  longer  fulfil  the  criteria,  the  Member  States  concerned  must 
reported 
withdraw  or  amend 
378 authorisation  amendments  or  withdrawals123.  Withdrawals  or  amendments  show 
Member  States’  continuous  work  to  ensure  that  PPPs  placed  on  the  market  are  safe  to 
use. However, the available evidence does not make it possible to measure the extent to 
which  the  authorisation  procedure  contributes  to  protecting  human  health.  This  is 
because  of  the  difficulty  in  distinguishing  between  the  impact  of  approving  active 
substances and the impact of authorising PPPs.  
NGOs  and  the  European  Parliament124  have  expressed  concerns  about  the  two-step 
approval and authorisation system and consider that the process is not rigorous enough to 
protect human health. They claim that the data requirements for PPPs are not sufficient 
and that the performance of Member States leaves room for improvement. This is despite 
the fact that: (i) the PPP Regulation requires the application dossiers for authorisations to 
be  much  more  ‘data  rich’  than  registration  dossiers  under  REACH;  and  (ii)  Member 
States  are  required  to  assess  the  safety  of  the  PPP  with  all  its  ingredients  during  the 
authorisation.  
NGOs  and  the  European  Parliament125  have  further  criticised  the  Commission  for  the 
delay  in  compiling  a  list  of  unacceptable  co-formulants126.  Many  co-formulants  are 
considered  of  no  or  low  concern  (e.g.  water  and  dyes),  but  some  of  them  have  the 
potential to cause harm to human health or the environment. This was the case for the co-
formulant  POE-tallowamine,  which  was  used  in  some  PPPs  containing  glyphosate  and 
according to EFSA had a significant toxicity level. To ensure a high level of protection of 
human health, the Commission proposed in 2016 to ban the use of this co-formulant in 
PPPs containing glyphosate127. This has led to Member States withdrawing hundreds of 
authorisations for PPPs containing glyphosate and POE-tallowamine, which is expected 
to  have  contributed  to  the  protection  of  human  health.  For  co-formulants  in  general, 
Member  States  agree  that  a  harmonised  list  of  unacceptable  co-formulants  at  EU  level 

123 As reported under Article 44(4) in the Standing Committee of Plants, Animals, Food and Feed. 
124  European  Parliament  (December  2018)  Report on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

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

No 1107/2009. 

126 This is required under Article 27 of Regulation 1107/2009, albeit without a precise deadline. 
127  Commission  Implementing  Regulation  (EU)  2016/1313  of  1 August  2016  amending  Implementation  Regulation  (EU) 

No 540/2011 as regards the conditions of approval of the active substance glyphosate. (OJ L 208, 2.8.2016, p. 1). 

30 

 
                                                 
would  be  beneficial  and  could  improve  protection128.  However,  as  co-formulants  are 
already  part  of  the  scientific  assessment  of  PPPs  prior  to  authorisation,  the  additional 
protection of an EU list is likely to be relatively low. Nevertheless, the Commission has 
given priority to compiling such a list129: a first draft was discussed with Member States 
in the Standing Committee for Plants, Animals, Food and Feed in December 2018 and a 
draft  Regulation  was  published  for  commenting  under  the  Better  Regulation  Feedback 
Mechanism from 16 January until 13 February 2020. Adoption is foreseen in the course 
of 2020. 

The  review  of  safeners,  synergists  and  adjuvants  is  delayed  due  to  a  lack  of  resources 
(see also section 5.2.2). However, it is expected that the added value from the EU-level 
assessment of safeners and synergists is lower than that arising from the identification of 
unacceptable co-formulants130. This is due to the relatively low number of safeners and 
synergists  and  their  perceived  low  health  risk.  As  regards  adjuvants,  a  majority  of 
Member States agree that a harmonised approach is required as adjuvants are effectively 
co-formulants131. 

After PPPs are authorised, users are obliged to use them correctly and according to their 
labels,  in  accordance  with  good  agricultural  practices132  and  the  Sustainable  Use 
Directive.  A  guidance  document  covering  both  human  health  and  environmental 
monitoring is available for Member States enforcement activities133. In addition, human 
biomonitoring  programmes  have  recently  been  agreed  in  the  context  of  the  HBM4EU 
project134.  The  project  aims  to  support  policy  making  by  providing  better  evidence  of 
citizens’  actual  exposure to chemicals and  the possible health effects of such  exposure. 
Several  active  substances  used  in  PPPs  have  been  included  in  the  priority  lists  for 
monitoring.  To  further  improve  the  protection  of  human  health  and  the  environment, 
there  are  calls  to  introduce  similar  chemical  and  biological  monitoring  in  the  post-
authorisation phase in order to compare modelling results and estimations with empirical 
findings under realistic practical conditions135,136,137. There are also calls to give greater 
consideration to the effects of combined exposure to multiple substances (including other 
chemicals). 

Emergency authorisations of PPPs 
The PPP Regulation allows Member States to  grant  emergency  authorisations  for PPPs 
that  are  not  authorised  for  use  on  a  specific  crop.  These  emergency  authorisations  are 
limited to 120 days and should only be used to combat a danger to plants that cannot be 
controlled by other reasonable means. Member States are required to inform immediately 
the Commission and other Member States about all emergency authorisations. 

128 The support study p. 216. 
129 Information has been collected and lists from five Member States have been used in the preparatory work to compile a first list of 
unacceptable  co-formulants.  The  draft  list  has  been  shared  with  Member  States  and  EFSA  and  was  discussed  in  the  Standing 
Committee for Plants, Animals, Food and Feed in December 2018. 

130 The support study, p. 215. 
131 The support study, p. 215. 
132 Good agricultural practices are specific methods which, when applied to agriculture, create food for consumers or lead to further 

processing that is safe and wholesome. 

133 https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_sup_monitoring-guidance_en.pdf. 
134 Human biomonitoring for EU HBM4EU is a joint effort by 28 countries, the European Environment Agency and the European 

Commission, co-funded under Horizon 2020. 

135 Milner, A. M. & Boyd, I. L. (2017) Toward pesticidovigilance. Science 357, 1232–1234 
136 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. 

137 Schäffer A, Filser J, Frische T, Gessner M, Köck W, Kratz W, Liess M, Nuppenau, E-A, Roß-Nickoll M, Schäfer R, Scheringer 

M. The Silent Spring - On the need for sustainable plant protection. Leopoldina Discussions No. 16; 61. 

31 

 
                                                 
The  number  of  emergency  authorisations  in  the  EU  has  increased  since  the  PPP 
Regulation  entered  into  force  and  is  considerably  higher  than  during  the  2007-2009 
period (see Figure 5). This may indicate that not enough PPPs are available or that there 
are  new  emerging  pests,  problems  with  resistance,  etc.  There  is  growing  criticism  of 
Member States from the Commission, European Parliament and NGOs for misusing this 
possibility as a derogation from regular authorisations, in particular as it is being used for 
PPPs  containing  active  substances  that  might  not  be  approved,  might  be  restricted  or 
which might have never been approved in the EU. The main concern is that the use of 
emergency  authorisations  decreases  the  level  of  protection  of  human  health  and  the 
environment. 

550 

510 

425 

427 

387 

y
c
n
e
g
r
e
m
e
f
o
r
e
b
m
u
N

s
n
o
i
t
a
s
i
r
o
h
t
u
a

500

400

300

200

100

59 

63 

0

321 

235 

107 

127 

90 

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

Figure 5. Emergency authorisations in the EU between 2007 and 2018. Source: European Commission 

The  rise  in  emergency  authorisations  has  been  attributed  by  some  stakeholders  to  the 
decreasing  availability  of  effective  active  substances  and  the  lack  of  PPPs  for  specific 
uses138.  However,  given  that  91 %139  of  emergency  authorisations  concern  PPPs 
containing approved active substances, these are often misused to overcome procedural 
delays in the regular national authorisation process and to ensure increased availability of 
PPPs  in  Member  States140.  The  main  issues  that  contributed  to  the  increase  have  been 
identified as follows141: 

  emerging  new  pests  for  which  the  submission  and  evaluation  of  applications  for 

 

 

regular authorisations takes some time; 
the loss of a number of pesticides with widespread use which have to be replaced by 
several PPPs containing different active substances; 
lack of applications for authorisations of PPPs for minor uses or small markets, such 
as the northern zone; 

  procedural  delays  in  granting  zonal  or  national  authorisations  or  in  the  mutual 

recognition of authorisations. 

The  need  to  use  emergency  authorisations  as  an  answer  to  insufficient  availability  of 
PPPs  is  strongly  criticised  by  NGOs,  who  claim  that  non-chemical  methods  are  not 

138 The support study, p. 74. 
139 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

140 European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

141 PPP authorisation focus group. 

32 

 
 
 
                                                 
 
 
 
 
sufficiently  taken  into  consideration142.  NGOs  have  also  criticised  the  fact  that 
emergency authorisations are granted for restricted or non-approved active substances. In 
fact, seven Member States have repeatedly granted emergency authorisations for use of 
neonicotinoids  the  approvals  of  which  were  restricted  in  2013143.  Such  repeated 
emergency  measures  seem  difficult  to  reconcile  with  the  strict  conditions  envisaged 
under the PPP Regulation. In response, the Commission mandated EFSA to examine the 
emergency  authorisations  for  neonicotinoids  granted  repeatedly  by  Member  States  for 
2017 in light of these Member States’ specific situations concerning pests and available 
alternatives.  Based  on  this  examination,  EFSA  concluded  that  around  25 %  of  the 
evaluated authorisations were not scientifically justified144. 

The  frequent  use  of  emergency  authorisations  is  thus  a  signal  of  a  dysfunctional  PPP 
authorisation procedure. There are, however, examples of best practices. Some Member 
States are working with, for instance, farmers’ organisations, to identify upcoming issues 
for specific crops. This aims to speed up the evaluation of suitable products and to grant 
regular authorisation before there is a need for emergency authorisation. 

Although  the  vast majority (91 %) of emergency  authorisations are for approved active 
substances and should not negatively impact human health or the environment, the use of 
emergency  authorisations  for  PPPs  containing  non-approved  active  substances 
potentially diminishes the positive benefits for human health and the environment. 

Comparative assessment of PPPs containing candidates for substitution  
Candidates for substitution (CfS) are active substances approved in the EU that meet any 
of the seven criteria listed in point 4 of Annex II to the PPP Regulation. The criteria are 
based on the active substances’ intrinsic hazard properties, for some in combination with 
its use pattern. If approved as a CfS, the approval period of the active substance is limited 
to  7  years  (instead  of  10  or  15  years).  In  December  2018,  there  were  ten  active 
substances approved as CfS. 
A study carried out in 2013145 screened the 422 active substances then approved in the 
EU against the seven criteria. Based on this study, a list of 77 approved active substances 
identified as CfS was published in January 2015. As of October 2018, the approvals of 
six of these have been renewed under the PPP Regulation. For 14 CfS146, the approvals 
were not renewed, leaving 63 CfS on the list. Another seven active substances147 on the 
list are no longer supported by any company and their approval will expire by the end of 
2021 at the latest. 

The PPP Regulation introduced the concept of CfS to reduce the use of active substances 
with  problematic  toxicological  profiles.  Member  States  have  to  carry  out  comparative 
assessments  before  authorising  the  use  of  PPPs  containing  active  substances  listed  or 
approved as CfS, i.e. the PPP should only be authorised if there is no alternative with a 
significantly  lower  risk  to  human  or  animal  health  or  the  environment.  This  makes  it 
possible to phase out CfS from the EU market because Member States should substitute 
them at the authorisation stage. 

142 The support study, p. 47. 
143 Bulgaria, Estonia, Finland, Hungary, Latvia, Lithuania and Romania. 
144 Neonicotinoids: EFSA evaluates emergency uses. 
145  European  Commission  (2013)  Ad-hoc  study  to  support  the  initial  establishment  of  the  list  of  candidates  for  substitution  as 

required in Article 80(7) of Regulation (EC) No 1107/2009. 

146 Amitrole, carbendazim, diquat, fenbutatin oxide, fipronil, glufosinate, imazosulfuron, isoproturon, linuron, mecoprop, molinate, 

oxadiargyl, tepraloxydim and triasulfuron. 

147 Bifenthrin, bromadiolone, difenacoum, lufenuron, methomyl, myclobutanil and profoxydim. 

33 

 
                                                 
As  of  January  2018,  only  24  Member  States  and  European  Economic  Area  countries 
reported  that  they  perform  comparative  assessments.  Member  States  conducted  278 
comparative assessments of PPPs containing one or several CfS in 2015 and 2016, but no 
substitution was made148. The main reason for this was a lack of viable alternatives. The 
general perception of both stakeholders and Member States is that substituting CfS will 
remain rare in the future. Thus,  contrary to what was expected, the introduction of CfS 
and  comparative  assessments  has  not  led  to  any  further  improvements  in  the  level  of 
protection of human health beyond what is already achieved by the standard approval and 
authorisation process for active substances and PPP, respectively. 

The relationship between the publication of the list and the actual use of CfS could not be 
further examined as data collected under Regulation (EC) No 1185/2009 on statistics of 
pesticide use are confidential and were not made available due to  restrictions set out in 
the Regulation. 

Setting MRLs to protect consumers 
As the MRL Regulation has a strong focus on consumer protection, MRLs set for plant 
and  animal  products  must  be  safe  for  consumers.  To  ensure  that  pesticide  residues  on 
food  do  not  constitute  a  health  risk  to  consumers,  both  acute  and  chronic  risks  are 
assessed  by  considering  a  wide  range  of  diets  across  the  EU149,  including  those  of 
vulnerable  groups  such  as  infants  and  pregnant  women.  MRLs  must  also  take  into 
account possible carry-over into animal products from commodities used equally as food 
and feed. The specific impact of MRLs on animal health is not considered when setting 
MRLs  and  specific  data  on  this  are  not  required  as  animal  health  considerations  are 
generally part of the approval procedure for active substances. 
According  to  the  ALARA150  principle,  MRLs  are  set  at  the  lowest  achievable  levels 
when  using  good  agricultural  practices  (GAP).  Comprehensive  field  trials  are therefore 
required  to  determine  the  amount  and  application  frequency  needed  for  an  active 
substance to achieve the intended plant protection effect. MRLs are only set when it is 
guaranteed that the concentration of pesticide residues does not have any harmful effects 
on  human  health.  In  particular,  a  safety  factor  of  at  least  100  is  applied  when  deriving 
toxicological  reference  values  for  chronic  and  acute  exposure  below  which  consumers 
are  protected  (i.e.  the  acceptable  daily  intake  (ADI)  and  the  acute  reference  dose 
(ARfD)).  

The  setting  of  a  default  value  or  a  specific  limit  of  quantification  (LOQ)  for  pesticide 
residue-commodity combinations for which there are no authorised uses enables Member 
States to take enforcement action. Default values generally apply, including for pesticides 
not listed in the MRL Regulation, e.g. pesticides authorised in non-EU countries which 
were never assessed in the EU. Table 5 below shows examples of substances for which 
LOQs were set at lower levels than the default value as for substances with a low ADI, 
the presence of residues below the default value might still have an impact on consumer 
safety. In such cases, Member States have to improve the analytical techniques used by 
their  enforcement  laboratories  to  detect  the  presence  of  residues  at  very  low  levels  to 
further protect consumers. 

148 The support study, p. 23. 
149 Pesticide Residue Intake Model (PRIMo). 
150 ‘As low as reasonably achievable’. 

34 

 
                                                 
Table 5. Substances for which lower limit of quantification values than the default apply151 

Substances 

Carbofuran 
Chlordane 
Endrin 
Fipronil 

Products 

Several fruits and vegetables 
Milk and eggs 
Milk and eggs 
All products 

Limit of quantification 
(LOQ) (mg/kg) 
0.001-0.005 
0.002-0.005 
0.0008-0.005 
0.005* 

Acceptable daily intake 
(ADI) (mg/kg bw/day) 
0.00015 
0.0005 
0.0002 
0.0002 

All parties that show, through adequate evidence, a legitimate interest in health, including 
civil  society  organisations,  are  entitled  to  submit  an  application  to  set  or  review  an 
existing MRL to protect consumers. In 2018, the Commission asked EFSA to deliver a 
scientific opinion on the safety of the existing MRLs for acetamiprid152 and iprodione153 
after lower toxicological reference values were set as part of the renewal process for the 
active substances. Consequently, the MRLs were lowered for several commodities. 

Based  on  the  MRL  Regulation,  the  EU  multi-annual  coordinated  programme  for 
pesticide  residues  in  food  is  annually  re-evaluated  to  identify  the  pesticide  residue-
commodity combinations to be analysed in order to assess human exposure to pesticides 
and the compliance of food throughout the EEA area. In addition, the MRL Regulation 
requires  Member  States  to  run  national  control  programmes  based  on  their  own 
assessment  of  risk,  thus  leading  to  risk-based  sampling  schemes.  This  dual  system  of 
monitoring, based on both random and risk-based sampling, is effective in reinforcing the 
pesticide-residue monitoring framework in the EU.  

Based on the data provided by the Member States, EFSA prepares an annual report that 
assesses consumer exposure to pesticides across the EU. The findings of EFSA’s annual 
reports are reassuring as the level of consumer protection in the EU is high. Overall, the 
results of 96.2% of the 84 657 samples analysed in 2016154 as part of the EU-coordinated 
and national control programmes fell within the legal limits. In total, 50.7% of the tested 
samples were free of quantifiable residues, while a further 45.5% of the samples analysed 
contained quantified residues not exceeding the MRLs. 

Monitoring results show consistency over the years, since the programme is based on a 
random sampling plan that takes into account the pesticides and food commodities that 
are most relevant in terms of the risk that their exposure potentially poses to the public 
(see Figure 6). 

151 EU Pesticides Database. 
152 Focused assessment of certain existing MRLs of concern for acetamiprid and modification of the existing MRLs for table olives, 

olives for oil production, barley and oats, EFSA Journal 2018;16(5):5262. 

153 Follow-up assessment of MRLs for the active substance iprodione, EFSA Journal 2018; doi: 10.2903/sp.efsa.2018.EN-1404. 
154 The 2016 EU report on pesticide residues in food, EFSA Journal 2018;16(7):5348. 

35 

 
 
                                                 
100%

75%

50%

25%

0%

l

»
n
o
i
t
a
u
g
e
R
L
R
M
«

Samples with residues
exceeding legal limits

Samples with residues
within legal limits

Samples free of
quantifiable residues

Figure 6. Pesticide residues in the EU, based on monitoring carried out by Member States in the time 
period 1996-2016155156, 
The  rapid  alert  system  for  food  and  feed  (RASFF)157  makes  it  possible  for  control 
authorities  to  exchange  information  on  measures  taken  to  respond  to  serious  risks 
identified  in  relation  to  food  or  feed  that  are  placed  on  the  market  in  the  European 
Economic  Area.  In  2017158,  a  total  number  of  3 832  notifications  were  reported  in  the 
system. 186 notifications were submitted for pesticide residues mostly found in fruits and 
vegetables.  132  notifications  concerned  products  that  were  rejected  at  the  European 
Economic  Area  border  and  therefore  never  entered  the  EU.  Note  that  notifications  are 
made for pesticide residues only when there is a possible health risk. 

As  mentioned  earlier,  not  all  the  temporary  MRLs  were  reviewed  within  the  12-month 
deadline  after  the  MRL  Regulation  came  into  force.  To  date,  EFSA  has  only  reviewed 
about half of the temporary MRLs. To minimise the impact that this delay may have had 
on  consumer  safety,  the  Commission  and  Member  States  have  worked  together  to 
identify  the  substances  that  may  have  posed  a  risk  to  consumers;  all  temporary  MRLs 
have been reviewed for these. 

The Commission has not yet made use of the possibilities given by the MRL Regulation 
to  establish  more  specific  MRLs  for  feed,  processed  food  and  fish  as  well  as  a  list  of 
specific  harmonised  processing  factors.  According  to  the  support  study,  some  Member 
States indicated that the lack of harmonisation for these products may negatively impact 
the  protection  of  human  health.  Conversely,  stakeholders  considered  that  the  lack  of 
harmonisation  has  no  impact.  However,  it  can  be  concluded  that  the  lack  of  specific 
MRLs  for  fish,  feed  and  processed  products  has  not  had  a  negative  impact,  for  the 
following reasons: 

  Despite  the  absence  of  MRLs  specific  for  feed,  feed  is  already  covered  in  all  risk 
assessments.  In  practice  this  means  that  the  risk  assessors  use  a  dietary  intake 
calculator to predict the expected residues in animal products resulting from feeding 
studies. 

  For processed food, general provisions are already available in the MRL Regulation 
allowing  Member  States'  enforcement  authorities 
in 
concentration of residues during processing. While a harmonised and legally binding 
list  of  processing  factors  has  not  been  established,  national  and  EU-level  databases 

to  consider  changes 

155 1996 to 2006 Annual EU-wide pesticide residue monitoring reports. 
156 2010 to 2016, all reports are available on the EFSA webpage. 
157  https://ec.europa.eu/food/safety/rasff_en. 
158 The Rapid Alert System for Food and Feed, Annual Report (2017). 

36 

 
 
                                                 
 
 
 
 
are  available  and  can  be  used  by  Member  States'  enforcement  authorities  to  inform 
their  decisions.  EFSA,  by  default,  makes  a  very  conservative  risk  assessment  using 
assumptions that rather over-estimate the risk, e.g. by using the processing factor that 
would lead to the highest possible exposure to ensure maximum consumer protection. 
Member States requested some more guidance on how processing factors provided by 
food business operators could be considered when taking enforcement action. Clear 
provisions  exist  for  example 
legislation  (Regulation  (EC) 
in  similar  food 
No 1881/2006 on contaminants) which could serve as reference. 

  For  fish,  a  working  document  with  data  requirements  is  still  under  development. 
National  monitoring  results  show  only  very  few  instances  of  findings  of  pesticides 
residues in fish.  

Studies  have  been  carried  out  to  assess  how  the  consumption  of  organic  food,  which 
contain different pesticide residues as only a limited range of approved active substances 
may be used in organic production, affects human health compared to conventional food. 
A comprehensive review of such studies was published in 2017159. Overall, the evidence 
is  not  conclusive  as  consumers  of  organic  food  tend  to  also  lead  healthier  lifestyles. 
Moreover, the assessments carried out by EFSA in its annual reports take into account a 
wide range of consumption data based on different diets. 

In view of the above, it can be concluded that the MRL Regulation is to a large extent 
effective in protecting consumers and that the lack of MRLs for fish, feed and processed 
products  has  not  negatively  impacted  consumer  protection.  The  risk  assessment 
conducted  to  set  MRLs  is  based  on  strict  requirements  and  is  carried  out  both  by  the 
Member States and EFSA. National and EU monitoring programmes show that the rate 
of MRL non-compliance is overall very low. Moreover, control authorities have a system 
that detects food which might pose a risk to consumers and that makes it possible to take 
appropriate  enforcement  action.  However,  there  are  delays  in  reviewing  the  existing 
MRLs,  which  could  make  it  difficult  to  take  timely  action  to  protect  consumers  from 
certain substances. 

Cumulative risk assessment of pesticide residues 
The assessment of the level of risk for consumer health is currently based on a substance-
by-substance  assessment  of  acute  and  chronic  exposure  to  pesticide  residues.  Both  the 
PPP and MRL Regulations include provisions for the assessment of the cumulative and 
synergistic  effects  (also  known  as  ‘the  cocktail  effect’)  of  multiple  pesticide  residues 
during the approval of an active substance and during MRL setting respectively, when a 
suitable  method  for  doing  so  is  available.  Although  EFSA  and  the  Commission  have 
been working on an appropriate methodology to conduct cumulative risk assessment for 
human  health,  as  described  below,  to  date  the  development  and  application  of  a 
methodology  is  still  ongoing.  This  task  turned  out  to  be  much  more  complex  and  to 
require much more resources than expected.  

In 2012, EFSA published a guidance document on the use of probabilistic methodology 
for modelling dietary exposure to pesticide residues160. In 2013, it published a scientific 
opinion161 that: (i) identified pesticides to be included in cumulative assessment groups 

159 Mie, A., Raun Andersen, H., Gunnarsson, S., Kahl, J., Kesse-Guyot, E., Rembiałkowska, E., Quaglio, G., Grandjean, P. (2017) 
Human health implications of organic food and organic agriculture: a comprehensive review. Environmental Health, 16:111. 
160  Guidance  on  the  use  of  probabilistic  methodology  for  modelling  dietary  exposure  to  pesticide  residues’,  EFSA  journal  2012; 

10(10):2839. 

161  Scientific  Opinion  on  the  identification  of  pesticides  to  be  included  in  cumulative  assessment  groups  on  the  basis  of  their 

toxicological profile, EFSA Journal 2013;11(7):3293 [131 pp.]. 

37 

 
                                                 
based on their toxicological profile; (ii) developed criteria for grouping chemicals with a 
similar  mode  of  action;  and  (iii)  made  further  recommendations  for  developing  such  a 
methodology. 

The  probabilistic  approach  was  a  breakthrough  change  from  the  deterministic 
calculations currently used to assess exposure. It can now be used thanks to a specific IT 
tool  developed  under  the  ACROPOLIS162  research  project.  EFSA,  Member  States  and 
the  Commission  are  continuing  work  on  the  specific  details  of  the  model  as  regards 
exposure  assessment  using  monitoring  data  from  the  annual  EFSA  reports  mentioned 
above (retrospective scenario). Work on this retrospective scenario is well advanced and 
the  outcome  is  expected  to  be  gradually  applied  for  those  groups  of  chemicals  with 
effects  on  the  same  target  organ  (cumulative  assessment  groups)  already  established 
during the annual evaluation of the monitoring data for pesticide residues. For the MRL-
setting (prospective) scenarios, work will begin in 2020, building on the experience and 
the  outcomes  gained  from  the  retrospective  scenario.  However,  detailed  discussions  on 
the  parameters  to  be  used  for  regulatory  purposes  (approval  of  substances  and  MRL 
setting) have not yet started. 
EFSA has published draft reports163 for two cumulative assessment groups for the thyroid 
and  the  nervous  system  for  public  consultation  in  September  2019  followed  by  a 
Technical  stakeholder  event  in  October  2019.164  The  final  reports  including  risk 
characterisation are expected to be published in spring 2020. Further scientific reports of 
the cumulative assessment groups for more organs will be published in the future.  

In  June  2018,  EFSA’s  Scientific  Committee  launched  an  open  consultation  on  a  draft 
guidance  document  on  harmonised  methodologies  for  risk  assessment  of  combined 
exposure  to  multiple  chemicals  for  all  relevant  areas  within  EFSA’s  remit,  i.e.  human 
health, animal health and ecological areas. In February 2019, the guidance was adopted 
and is now available in the EFSA Journal165.  

The  presence  of  multiple  pesticide  residues  occurred  in  30%  of  the  total  food  samples 
analysed by EFSA in 2016166. However, EFSA’s latest reports on the effects of dietary 
exposure to pesticide residues on the nervous system and the thyroid, showed that effects 
of  multiple  residues  on  human  exposure  were  mainly  driven  by  high  exposures  to 
specific single substances and that the outcome of single residues and multiple residues 
assessments  were  very  similar.  This  was  supported  by  reports  of  Member  States  that 
carried  out  preliminary  cumulative  risk  assessments167.  Given  that  so  far  cumulative 
assessment groups have been finalised only for two organs (thyroid and nervous system) 
and that future cumulative assessment groups will focus on effects on other organs, it is 
currently  not  possible  to  draw  clear  conclusions  on  the  impact  of  the  absence  of 
cumulative risk assessment on human health.  

5.1.2. Protecting the environment, including wildlife and water 

The  use  of  pesticides  has,  to  some  extent,  unavoidable  impacts  on  biodiversity,  which 
need  to  be  balanced  against  the  crop  protection  needs.  The  PPP  Regulation  aims  to 

162 ACROPOLIS — Aggregate and cumulative risk of pesticides: an online integrated strategy. 
163 https://www.efsa.europa.eu/en/consultations/call/public-consultation-draft-efsa-scientific-reports. 
164 https://www.efsa.europa.eu/en/events/event/technical-stakeholder-event-cumulative-risk-assessment-pesticides-food/. 
165 EFSA Scientific Committee (2019) Guidance on harmonised methodologies for human health, animal health and ecological risk 

assessment of combined exposure to multiple chemicals. EFSA Journal 2019;17(3):5634. 

166 The 2016 European Union Report on Pesticide Residues in Food. EFSA Journal 2018; 16(7):5348, doi: 10.2903/j.efsa.2018.5348 
167  Summary  record  of  the  meeting  of  the  Standing  Committee  on  Animals,  Food  and  Feed  (PAFF)  of  21  November  2017: 

https://ec.europa.eu/food/sites/food/files/plant/docs/sc_phyto_20171121_ppr_sum.pdf. 

38 

 
                                                 
protect  the  environment  with  its  strict  approval  criteria  and  the  introduction  of  cut-off 
criteria  for  active  substances.  Guidance  documents  complement  these  actions  by 
specifying  how  environmental  concerns  should  be  evaluated  by  Member  States  during 
the  risk  assessment  process.  Since  the  PPP  Regulation  became  applicable,  21  active 
substances168  have  not  been  approved  or  approval  has  not  been  renewed  due  to 
environmental  concern.  The  reasons  include  risks  to  groundwater,  surface  water,  soil, 
aquatic organisms, soil-dwelling organisms, wild mammals, non-target terrestrial plants, 
and  honeybees.  This  shows  that  the  approval  criteria  were  effectively  applied  to  better 
address environmental risks. 

The  Commission  has  also  restricted  certain  uses  of  active  substances  to  protect  the 
environment.  Since  June  2011,  10  active  substances  have  been  approved  with  uses 
restricted  to  greenhouses169,  application  rate  restrictions170  to  protect  groundwater,  and 
application  frequency  restrictions171  such  as  ‘one  application  every  three  years  on  the 
same  field’.  Member  States  take  further  protective  measures  for  the  environment  when 
authorising  PPPs.  To  facilitate  this,  the  Commission  specifies  where  Member  States 
should  be  vigilant  and  what  they  should  pay  particular  attention  to  in  the  approval 
process  for  active  substances.  This  may  include  potential  risks  to  groundwater,  aquatic 
organisms, non-target terrestrial and aquatic plants, earthworms, birds and mammals, etc. 
Member  States  also  take  regional  climatic  and  environmental  differences  into 
consideration  when  authorising  PPPs.  Even  though  it  is  not  possible  to  link  non-
approvals  or  restrictions  with  specific  positive  environmental  outcomes,  it  can  be 
assumed  that  the  above-mentioned  actions  have  a  positive  impact  on  protecting  the 
environment in the EU. Based on the available evidence, it is, however, not possible to 
conclude whether this will be sufficient in relation to the significant challenges posed by 
loss of biodiversity and other environmental impacts.  

Stakeholders  and  Member  States  alike  consider  that  the  PPP  Regulation  positively 
contributes to protecting animal health and the environment172. However, no studies were 
identified  that  show  a  causal  link  between  the  non-approval  of  active  substances  and 
environmental  effects173.  It  can  also  be  expected  that  full  implementation  of  the 
Sustainable  Use  Directive  would  support  the  objectives  of  protecting  health  and  the 
environment by reducing the risks linked to PPPs, through the adoption of non-chemical 
control  methods  and  a  reduction  in  dependency  on  PPPs.  Sustainability  is  covered  in-
depth in section 5.4.1. 

Biodiversity and wildlife 
The PPP Regulation aims to protect biodiversity and ecosystems by taking into account 
the impact on populations of organisms, as well as water, soil and air quality during the 
risk assessment. It does this by assessing the expected environmental exposure, covering 
a  wide  range  of  environmental  scenarios  which  include  the  application  of  the  PPP  for 
several consecutive years. Based on this exposure assessment and experimental data on 
expected effects on a variety of different species, the potential risks are calculated. These 
species  serve  as  indicators  for  the  whole  ecosystem  and  the  approach  therefore  should 

168 2-naphthyloxyacetic acid, amitrole, chloropicrin, etoxazole, fenamidone, flufenoxuron, flupyrsulfuron-methyl, iprodione, linuron, 
orthosulfamuron, oxasulfuron, picoxystrobin, propanil, propargite, propiconazole, Pseudozyma flocculosa ATTC 64874, thiram, 
tricyclazole, beta-cypermethrin, isoproturon, pymetrozine and quinoxyfen. 

169 For the active substances 8-hydroxyquinoline, bifenthrin, pyridalyl and sodium silver thiosulfate. 
170 For the active substances acrinathrin, metam, oxyfluorfen, prochloraz and prosulfuron. 
171 For the active substances metam, oxyfluorfen, penflufen and prosulfuron. 
172 As shown in Figure A.13 of Annex 2: Synopsis report on the stakeholder consultation  
173 The support study, p. 60. 

39 

 
                                                 
ensure the protection of biodiversity in general. Nonetheless, there are still concerns that 
biodiversity  in  a  wider  sense  is  not  fully  protected  from  the  use  of  PPPs,  and  that 
pesticides  are  a  threat  to  terrestrial  ecosystems174,175.  There  are  also  concerns  regarding 
declining trends in insect populations176 and pesticides use has been mentioned as one of 
several  important  factors  contributing  to  this  decline177,  178.  However,  it  is  difficult  to 
distinguish  between  the  effects  of  PPPs  on  biodiversity,  and  the  effects  of  the  current 
agricultural production system and increased surfaces of monocultures, and other factors 
affecting  the  landscape.  Further  research  is  necessary,  and  testing,  modelling  and 
assessment  methods  to  take  into  consideration  cumulative  risks179,180,181,  need  to  be 
further  developed  to  better  understand  the  actual  impact  of  pesticides  on  populations, 
diversity  within  and  between  species,  relationships  between  species  and  ecosystem 
services. More specific protection goals can also contribute to effective protection of the 
environment182.  EFSA  and 
improve 
environmental  protection  in  the  EU  of  which  the  first  step  is  to  set  out  the  specific 
protection  goals  for  environmental  risk  assessment183,184.  The  positive  effects  of  this 
work are expected to materialise in the future.  

the  Commission  are  working 

together 

to 

Protecting bees and other pollinators 
Pollinators  provide  important  ecosystem  services,  pollinating  more  than  80 %  of  crops 
and  wild  plants  in  the  EU185.  Pollinators,  including  honey  bees,  bumblebees  and  wild 
bees, contribute around EUR 15 billion to EU agriculture each year186. To recognise the 
value of pollinators and protect them, the approval criteria for active substances include 
specific considerations of honey bees.  

A decline in bee populations has been observed in the EU and globally. The decline of 
bees  is  multifactorial,  with  land-use  change,  intensive  agricultural  management  and 
pesticide  use,  environmental  pollution,  invasive  alien  species,  pathogens  and  climate 
change  identified  as  the  main  threats187.  Due  to  the  multifactorial  reasons  behind  the 
decreasing number of bees, and lack of data, it is not possible to directly link decisions 
taken to protect bees under the PPP Regulation with an increase in bee populations.  

174 European Commission (2015) The State of Nature in the EU. Reporting under the EU Habitats and Birds Directives 2007-2012. 
175 Sánchez-Bayo, F., Henk A Tennekes, H. A. (2017) Assessment of ecological risks of agrochemicals requires a new framework. 

ISSN: 2529-8046. 

176 Hallmann CA, Sorg M, Jongejans E, Siepel H, Hofland N, Schwan H, et al. (2017) More than 75 percent decline over 27 years in 

total flying insect biomass in protected areas. PLoSONE 12 (10): e0185809. 

177  Ewald  JA,  Wheatley  CJ,  Aebischer  NJ,  Moreby  SJ,  Duffield  SJ,  Crick  HQ,  et  al.  Influences  of  extreme  weather,  climate  and 
in  cereal  fields  over  42  years.  Global  Change  Biology.  2015;  21(11):3931–3950. 

invertebrates 
pesticide  use  on 
https://doi.org/10.1111/gcb.13026 PMID: 26149473 

178 Cardosoa, P. et al. (2020) Scientists' warning to humanity on insect extinctions, Biological Conservation, Volume 242, February 

2020, doi.org/10.1016/j.biocon.2020.108426 

179  Gustavsson,  M.,  Kreuger,  J.,  Bundschuh,  M.,  Backhaus,  T.  (2017)  Pesticide  mixtures  in  the  Swedish  streams:  Environmental 
risks, contributions of individual compounds and consequences of single-substance oriented risk mitigation. Science of The Total 
Environment. Volume 598. 

180  Scientific  methodologies  for  the  assessment  of  combined  effects  of  chemicals  –  a  survey  and  literature  review,  European 

Commission, Joint Research Centre, EUR 27471 EN, 2015 

181  Bopp  et  al.  (2018)  Current  EU  research  activities  on  combined  exposure  to  multiple  chemicals,  Environment  International, 

Volume 120 

182 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. 

183 EFSA Panel on Plant Protection Products and their Residues (PPR); Scientific Opinion on the development of specific protection 
goal options for environmental risk assessment of pesticides, in particular in relation to the revision of the Guidance Documents 
on Aquatic and Terrestrial Ecotoxicology (SANCO/3268/2001 and SANCO/10329/2002). EFSA Journal 2010;8(10):1821.  
184  Nienstedt,  K.,  Brock,  T.C.M.,  van  Wensem,  J.,  Montsfort,  M.,  Hart,  A.  (2012)  Development  of  a  framework  based  on  an 
ecosystem  services  approach  for  deriving  specific  protection  goals  for  environmental  risk  assessment  of  pesticides.  Science  of 
The Total Environment, Volume 415 

185 Europa webpage on honey bees 
186 European Commission (2018c). EU Pollinators Initiative. Communication from the Commission to the European Parliament, the 

Council, the European Economic and Social Committee and the Committee of the Regions. COM(2018) 395. 

187 See EFSA’s bee health webpage 

40 

 
                                                 
Since 2010, stakeholders such as beekeepers’ associations and the European Parliament 
have criticised the appropriateness of the guidance document that sets out the principles 
of  the  risk  assessment  for  bees188,189.  EFSA  concluded  in  2012  that  the  guidance 
document was not sufficient to protect bees and should be expanded to include exposure 
routes other than spray applications, a chronic risk assessment and an assessment of the 
risk to wild species (bumblebees and solitary bees)190. In 2013, EFSA developed a new 
guidance document, but this has not yet received the Member State support necessary for 
it  to  be  used  in  the  renewal  process  for  active  substances.  Opponents  argue  that  many 
substances  that  do  not  pose  an  unacceptable  risk  to  bees  would  (unnecessarily)  fail  the 
risk assessment as the proposed principles and trigger values are too conservative and the 
proposed  options  to  refine  the  risk  assessment  are  too  difficult  to  carry  out.  The 
Commission  is  committed  to  continuing  its  efforts  to  get  the  improved  guidance 
document endorsed in order to reinforce the protection of pollinators in the EU. 

In 2013, in response to the availability of new scientific information on toxicity to bees, 
the  Commission  reviewed  the  approval191  of  four  active  substances192.  The  review 
resulted in restrictions on the use of the four active substances in 2013193,194 and further 
restrictions for three of them in 2018195. The approval of the fourth substance, fipronil, 
expired on 30 September 2017. The applicants concerned challenged the first restrictions 
in court, but the General Court ruled in favour of the Commission in May 2018. In the 
light of the last restrictions, the applicants for two of the three active substances196 have 
discontinued their support for renewal. As stated above, it is not possible to directly link 
the restrictions of these substances to potential increases in bee populations because bee 
decline is multifactorial. Moreover, the repeated granting of emergency authorisations by 
Member  States  for  many  of  the  restricted  uses  may  reduce  the  effectiveness  of  the 
restrictions  for  environmental  protection.  However,  as  a  precautionary  approach,  the 
restrictions are expected to improve the environmental situation for pollinators.  

Protecting groundwater and surface water 
Groundwater provides a major source of drinking water for many EU citizens as well as a 
steady  base  flow  of  rivers  and  wetlands.  Pressures  on  the  chemical  quality  of 
groundwater mainly arise from diffuse pollution, which is caused by nitrates in fertiliser 
or  manure  and  by  pesticides,  and  presents  a  significant  and  widespread  challenge.  The 
European  Environment  Agency’s  reports  on  the  assessment  of  EU  waters  and  a 
comparison  of  the  status  of  groundwater  between  the  report  published  in  2012197  (with 

188  In  particular  the  EPPO  ‘Environmental  risk  assessment  scheme  for  Plant  Protection  Products  —  chapter  10:  honey  bees’ 

(EPPO/OEPP, 2010) revised in September 2010 with ICPBR recommendations. 

189 Communication from the Commission to the European Parliament and the Council on Honeybee Health, COM(2010) 714 final 
190  EFSA  (2012)  Panel  on  Plant  Protection  Products  and  their  Residues  (PPR);  Scientific  Opinion  on  the  science  behind  the 
development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees).  EFSA 
Journal 2012; 10(5) 2668.  

191 Article 21 of Regulation 1107/2009 allows the Commission to review the approval of an active substance at any time in light of 

new scientific and technical knowledge and monitoring data. 

192 Clothianidin, imdacloprid, thiametoxam and fipronil. 
193  Commission  Implementing  Regulation  (EU)  No  485/2013  of  24 May  2013  amending  Implementing  Regulation  (EU)  No 
540/2011,  as  regards  the  conditions  of  approval  of  the  active  substances  clothianidin,  thiamethoxam  and  imidacloprid,  and 
prohibiting the use and sale of seeds treated with plant protection products containing those active substances. 

194  Commission  Implementing  Regulation  (EU)  No  781/2013  of  14 August  2013  amending  Implementing  Regulation  (EU)  No 
540/2011, as regards the conditions of approval of the active substance fipronil, and prohibiting the use and sale of seeds treated 
with plant protection products containing this active substance. 

195  The  Commission  Implementing  Regulations  amending  the  conditions  of  approval  of  the  active  substances  imidacloprid, 
clothianidin  and  thiamethoxam  were  published  in  the  Official  Journal  on  30 May  2018.  These  regulations  completely  ban  the 
outdoor uses of the three substances, and only the use in permanent greenhouses remains. 

196 Thiametoxam and clothianidin. 
197 The European Environment Agency (2012) European waters — Assessment of status and pressures No 8/2012.  

41 

 
                                                 
data  from  2009)  and  the  report  published  in  2018198  (with  data  from  2015)  show  little 
change in the chemical status of groundwater as regards pesticides. In 2009, an estimated 
5 % of all groundwater bodies had poor chemical status due to pesticides. In 2015, 6 % of 
groundwater  bodies  by  area  had  poor  status  due  to  pesticides199.  The  European 
Environment Agency notes a decline in the occurrence of some pesticides (e.g. atrazine 
and diuron200) as a result of the non-approval of, or restrictions on, their use.  

For surface waters, the European Environment Agency’s report in 2018 does not specify 
the  extent  to  which  the  poor  quality  of  bodies  of  water  is  caused  by  pesticides201. 
However, analysis from a separate 2018 report202 shows that most individual pesticides 
causing  failure  to  reach  good  status  do  so  in  fewer  than  200  water  bodies  across  the 
EU203. One substance that is reported to be among the top 15 substances causing failure 
to achieve good chemical status is isoproturon, which caused failure of good status in 199 
surface water bodies in eight Member States, i.e. 0.2 % of all surface water bodies in the 
EU.  Future  improvements  are  expected  since  the  approval  of  isoproturon  was  not 
renewed in 2016 because of a high risk to groundwater204,205. Another substance reported 
among the top 15 chemicals is hexachlorocyclohexane, which caused the poor quality of 
120 bodies of water in 11 Member States. This active substance has not been approved in 
the EU since 2004 but is persistent in the environment, which may explain why it is still 
found during monitoring. The European Environment Agency report concluded that the 
status  of  571  bodies  of  water  improved  from  ‘failing’  to  ‘good’  as  regards  pesticides 
between the first and second monitoring cycle. If this rate of improvement continues, the 
number of bodies of water that fail to achieve good status because of the use of priority 
pesticides, i.e. those listed as  priority substances under the Water Framework Directive 
because of the risk they pose to or via the aquatic environment, may be very small during 
the  next  monitoring  cycle.  AMPA  (a  breakdown  product  of  glyphosate)  is  the  most 
frequently  occurring  pesticide-related  substance,  causing  185  bodies  of  water  to  fail  to 
achieve  good  status.  As  AMPA  was  not  specified  in  earlier  reports,  it  is  impossible  to 
assess whether the situation has improved or deteriorated.  

Although  the  monitoring  approach  envisaged  under  the  Drinking  Water  Directive  does 
not  make  it  possible  to  carry  out  a  comprehensive  EU  assessment  of  pesticide 
contamination in drinking water206, the reported compliance rates are consistently high (a 
total of more than 99.9 % in 2011-2013 and about 99.6 % for individual pesticides207). 

Comparisons  between  the  two  reporting  cycles  of  the  Water  Framework  Directive,  on 
which  the  European  Environment  Agency  reports  are  based,  need  to  be  made  with 
caution  because  of  improvements  in  status-assessment  methods  and  changed  threshold 
values.  The  expected  achievement  of  good  status  reported  in  the  second  river  basin 
management  plans  for  most  of  the  groundwater  bodies  by  2027  or  beyond  2027 
demonstrates  the  long  time  lag  between  the  implementation  of  measures  and  their 

198 The European Environment Agency (2018) European waters — Assessment of status and pressures No 7/2018.  
199  See Annex 3 describing the calculation based on figures from the European Environmental Agency reports. 
200 The European Environment Agency (2018) European waters — Assessment of status and pressures No 7/2018.  
201  In  the  European  Environmental  Agency  report  from  2012,  1 %  of  surface  water  bodies  had  poor  chemical  quality  due  to 

pesticides. However, there was a large number of surface water bodies whose status was unknown. 

202 The European Environment Agency (2018) Chemicals in European Waters 
203 Of 111 105 surface water bodies and 13 411 groundwater bodies. 
204  Commission  Implementing  Regulation  (EU)  2016/872  of  1 June  2016  concerning  the  non-renewal  of  approval  of  the  active 

substance isoproturon (OJ L 145, 2.6.2016, p. 7). 

205 Isoproturon is currently being reviewed also under the Biocidal Product Regulation.  
206  A  comprehensive  EU  assessment  is  not  possible  given  that:  (a)  Member  States  choose  which  pesticides  and  metabolites  to 

monitor in drinking water; (b) only pesticides that are likely to be present in a given water supply need to be monitored. 

207  European Commission (2016) Synthesis Report on the Quality of Drinking Water in the Union examining Member States’ reports 

for the 2011-2013 period, envisaged under Article 13(5) of Directive 98/83/EC. COM(2016) 666 final. 

42 

 
                                                 
effectiveness.  Furthermore,  a  key  issue  as  regards  the  reporting  of  pesticides  under  the 
Water  Framework  Directive  is  that  the  monitoring  is  limited  both  in  frequency  and 
number of substances covered and may, therefore, miss pesticides currently approved but 
not assessed in the environment at EU level. 

In  conclusion,  the  PPP  Regulation  seems  to  be  contributing  to  the  achievement  of  the 
objective of protecting EU’s bodies of water, but further progress still needs to be made. 

5.1.3. Minimising animal testing 

The PPP Regulation has a specific objective to minimise the use of animals in testing to 
approve active substances and authorise PPPs208. Data owners and prospective applicants 
must  make  every  effort  to  share  tests  and  studies  involving  animals.  This  obligation 
applies both to vertebrate and non-vertebrate animals. In the case of studies on vertebrate 
animals, if the parties fail to reach an agreement, the Member State concerned is entitled 
to refer to the studies for the benefit of the prospective applicant. At the same time, the 
data owner is entitled to lodge a claim in national courts regarding the costs. 

It is not possible to compare data on the number of vertebrate animals used in toxicology 
experiments involving products or substances intended for agricultural use from the pre-
2011 baseline period with more recent data. This is because new reporting obligations for 
2015 onwards were adopted in 2010209 and further aligned in 2019210. Data presented in 
Table 6 do not show a clear trend  towards reducing the number of animals used. More 
recent  data  count  only  the  number  of  animal  uses  for  tests  under  the  PPP  Regulation, 
while earlier data included animals used for tests of substances ‘intended for agricultural 
use’, which is different. Official data for several years is needed to make a more robust 
analysis possible.  

Table 6. Number of animals used in experiments involving products intended for agricultural use in 
2008 and 2011. Number of animal uses in testing under the PPP Regulation 2014 to 2017211  
2011 
Year 
Number of animals used / 
Number of animal uses 

81 979 

74 147 

97 879 

61 502 

75 205 

72 084 

2008 

2016 

2014 

2015 

2017 

Furthermore, the numbers in Table 6 only include animals used in experiments in the EU 
and  do  not  take  into  consideration  the  fact  that  extensive  testing  of  products  to  be 
registered  in  the  EU  can  take  place  in  the  context  of  other  regulatory  systems  like  the 
United States. Such studies can then also be used for regulatory purposes in the EU. 

Stakeholders  and  Member  States  alike  consider  that  the  data-sharing  mechanism  for 
studies  on  vertebrate  animals212  introduced  in  the  PPP  Regulation  is  effective  as  it 
increased the number of shared studies in application dossiers213. However, this provision 
is not the only influencing factor and is not sufficient to significantly reduce the number 
of  animals  used  in  testing.  In  fact,  the  new  data  requirements  agreed  in  2013  require 
increased testing on vertebrate animals to be carried out for certain toxicological effects, 
e.g.  genotoxicity.  Alternative  methods  are  still  not  considered  sufficiently  developed  to 
replace  animal  (in  vivo)  testing  for  all  toxicological  effects214.  Another  contributing 

208  Which  is  in  addition  to  Directive  2010/63/EU  of  the  European  Parliament  and  of  the  Council  of  22 September  2010  on  the 

protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). 
209 Directive 2010/63/EU on the protection of animals used for scientific purposes. 
210 Regulation (EU) 2019/1010 on the alignment of reporting obligations in the field of legislation related to the environment. 
211 For 2008 and 2011, see the support study, p. 15. For 2014, see the support study, p. 42, for the years 2015 to 2017, see official 

reports available at: https://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm. 
212 Article 62 of Regulation 1107/2009 ‘Sharing of tests and studies involving vertebrate animals’. 
213 The support study, p. 43. 
214 Joint Research Centre (2014) Alternative methods for regulatory toxicology – a state-of-the-art review. ISBN 978-92-79-39651-9 

43 

 
                                                 
factor  working  against  the  reduction  of  animal  testing  is  the  increasing  amount  of 
information required to conclude the risk assessment for an active substance, in particular 
for metabolites215. Further in vivo testing is sometimes suggested during the peer-review 
process  in  order  to  rule  out  genotoxic  potential  of  metabolites,  e.g.  in  the  cases  of 
metsulfuron-methyl216 and terbuthylazine217. Increasing information will also be required 
to assess the effect of active substances on the endocrine system218, which will be part of 
the  forthcoming  implementation  of  the  new  scientific  criteria  to  identify  endocrine 
disruptors.  In  addition,  the  requirement  for  periodical  re-assessment  of  all  active 
substances may mean that in vivo testing remains necessary. 

There are no specific rules on sharing of studies involving vertebrate animals for cases in 
which the same studies are performed on the same active substance under different EU 
legislation  (e.g.  PPP  Regulation  and  Biocidal  Product  Regulation).  This  situation  gives 
leeway for interpretation and in particular for the possibility to accept (or not) studies on 
vertebrate  animals  undertaken  outside  the  PPP  Regulation.  The  PPP  Regulation  also 
leaves  room  for  interpretation  as  regards  studies  on  vertebrate  animals  that  have  been 
carried out in other jurisdictions. Member States have noted that increased clarity on how 
to  implement  the  sharing  of  data  from  studies  on  vertebrate  animals  and  more  specific 
rules  related  to  data  protection  could  help  reduce  the  number  of  tests  on  vertebrate 
animals. 

In  the  light  of  increasing  requirements  related  to  ensuring  a  high  level  of  protection  of 
human health, the use of animals in tests is not expected to decrease in the future unless: 
(i)  the  weight  of  evidence  of  available  information  is  better  taken  into consideration  in 
the  risk  assessment  and  related  guidance  documents;  (ii)  the  data  requirements  are 
modified to include more alternative validated testing methods and approaches; and (iii) 
more  clarity  is  achieved  as  regards  data  protection.  As  regards  the  second  point,  more 
research  is  needed  to  make  it  possible  to  replace  the  remaining  animal  studies  with 
alternative  approaches219.  New  Horizon  2020  projects  on  methods  for  endocrine 
disruptors focus on using alternative methods and will ultimately help to gain acceptance 
of non-animal data in a weight of evidence approach220. Beyond the Cosmetics Products 
Regulation,  which  already  bans  animal  testing  in  cosmetics,  the  Commission  and  the 
European  Chemical  Agency  are  making  significant  efforts  to  minimise  animal  testing 
within other regulatory frameworks  such  as  REACH  with  annual funding of  more than 
EUR 40  million221.  In  addition,  the  Commission  promotes  actively  the  reduction  and 
replacement  of  animal  testing  through  the  European  Partnership  for  Alternatives  to 

215  Worth,  A.,  Fuart-Gatnik,  M.,  Lapenna,  S.,  and  Serafimova,  R.  (2011)  Applicability  of  QSAR  analysis  in  the  evaluation  of 
developmental  and  neurotoxicity  effects  for  the  assessment  of  the  toxicological  relevance  of  metabolites  and  degradates  of 
pesticide active substances for dietary risk assessment. EFSA Supporting Publications Vol 8, Issue 6.  

216  As  identified  by  the  comment  ‘Overall,  no  firm  conclusion  can  be  drawn  concerning  the  gene  mutation  induction  potential  of 
triazine amine and an appropriate in vivo study should be performed.’ EFSA (European Food Safety Authority), 2017. Technical 
report  on  the  outcome  of  the  consultation  with  Member  States,  the  applicant  and  EFSA  on  the  pesticide  risk  assessment  for 
metsulfuron-methyl 
pp. 
data.  EFSA 
doi:10.2903/sp.efsa.2017.EN-1257. 

2017:EN-1257. 

confirmatory 

publication 

supporting 

light 

44 

of 

in 

217  As  identified  by  the  data  gap  ‘More information  on  the  repeat-dose  toxicity  for the  groundwater  metabolites  […] is needed  in 
order to conclude on the relevant reference values to be used for the consumer risk assessment.’ EFSA (European Food Safety 
Authority), 2017. Conclusion on the peer review of the pesticide risk assessment for the active substance terbuthylazine in light of 
confirmatory data submitted. EFSA Journal 2017;15(6):4868, 20 pp. https://doi.org/10.2903/j.efsa.2017.4868. 

218  ECHA  (European  Chemicals  Agency)  and  EFSA  (European  Food  Safety  Authority)  with  the  technical  support  of  the  Joint 
Research Centre (JRC) (2018) Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn 
S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A and Van der Linden S, 2018. Guidance for the identification of endocrine 
disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311, 135 pp. 

219 Focus group on risk assessment 
220  European  Commission  (2018)  Funding  and  tender  opportunities:  New  testing  and  screening  methods  to  identify  endocrine 

disrupting chemicals. 

221  European  Commission  (2018)  Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain  elements 

Conclusions and Actions. SWD/2018/058. 

44 

 
                                                 
Animal  Testing  (EPAA222).  The  EU  Reference  Laboratory  for  alternatives  to  animal 
testing  is  working  to  advance  the  replacement,  reduction  and  refinement  of  animal 
procedures223,224. These will ultimately also help to reduce the need for animal testing for 
regulatory purposes under the PPP Regulation. 

In  conclusion,  the  PPP  Regulation  has  led  to  an  increasing  number  of  shared  studies 
being included in application dossiers. However, this has not proven sufficient to achieve 
the objective of minimising animal testing as tests on vertebrate animals are still required 
to guarantee the protection of human and animal health and the environment. 

5.1.4. Improving the functioning of the single market 

Setting MRLs 

The  MRL  Regulation  replaced  four  earlier  Directives,  thus  creating  a  single  legislative 
framework in the area of pesticide residues. It is directly applicable in all Member States 
and  does  not  need  to  be  transposed  into  national  legislation.  The  same  provisions  and 
data  requirements  apply  across  the  EU,  as  do  common  principles  for  conducting  risk 
assessments. Consequently, national competent authorities can rely on a harmonised risk 
assessment  and  do  not  need  to  re-evaluate  the  safety  of  products  originating  from 
neighbouring  countries.  Furthermore,  the  MRL  Regulation  extended  the  list  of 
harmonised  food  commodities  to  also  cover  minor  and  very  minor  crops.  This  reduced 
trade  barriers  between  Member  States  and  guarantees  legal  certainty  for  food-business 
operators who only have to comply with one set of MRLs. 

Under the MRL Regulation, there are provisions that address specific circumstances such 
as  environmental  or  other  contamination,  occurrences  of  pesticide  residues  in  honey, 
herbal  infusions  and  other  products  that  constitute  a  minor  component  of  the  diet  of 
consumers. In such cases, temporary MRLs may be set based on monitoring data from all 
Member  States,  as  long  as  that  there  are  no  unacceptable  risks  to  consumers.  The 
maximum duration of such temporary MRLs is 10 years, after which the MRLs need to 
be reviewed.  

Serious risks related to food safety can easily and quickly be addressed by the provisions 
of the MRL Regulation and the provisions of the General Food Law. However, there is 
no fast track procedure foreseen in the MRL Regulation to quickly address other issues 
that  are  not  of  consumer  health  concern,  but  that  arise  unexpectedly  and  require  quick 
action  to  avoid  disturbances  of  the  internal  market.  Examples  in  recent  years  were 
unexpected residues occurring in food for which harmonised MRLs were either not yet 
available or set at unrealistically low levels. This was the case for residues in processed 
foods  stemming  from  use  of  biocidal  products  such  as  DDAC  and  BAC,  residues  of 
chlormequat in mushrooms as cross-contamination from cereal straw, where chlormequat 
is  used.  Other  examples  include  residues  stemming  from  emergency  authorisations 
granted by Member States to address plant health risks. 

The  Commission  has  used  the  possibility  to  set  temporary  MRLs  on  the  basis  of 
monitoring  data  in  such  circumstances.  While  this  speeds  up  the  process  somewhat  as 
residue  trial  data  do  not  always  need  to  be  generated  to  the  full  extent,  the  evaluation 

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

federations.  

223 EU Reference Laboratory for alternatives to animal testing webpage. 
224 Zuang et al., (2018) EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative 

Methods and Approaches, EUR 29455, Publications Office of the European Union, Luxembourg. 

45 

 
                                                 
procedure as such is not shorter than usual and risk management measures in response to 
such situations remain slow.  

Criticism  was  raised  in  particular  by  Member  States  on  the  length  of  the  procedure 
following  emergency  authorisations,  when  a  Member  State  may,  in  exceptional 
circumstances,  authorise  food  not  complying  with  MRLs  to  be  placed  on  its  domestic 
market, as long as such food does not constitute an unacceptable risk to consumers. This 
is,  however,  difficult  to  control  and  enforce,  and  disturbs  the  principles  of  the  single 
market. The MRL Regulation envisages the possibility to submit an MRL application to 
address  emergency  use  by  setting  a  temporary  MRL.  Since  there  is  no  fast-track 
procedure, the Commission requests EFSA to prioritise assessment of these applications 
to speed up the process. However, this is not sufficient to provide a fast solution. 

The  MRL  Regulation  envisages  the  compiling  of  a  list  of  active  substances  for  which 
MRLs are not required to facilitate the free movement of commodities that were treated 
with  substances  with  a  low-risk  profile  or  substances  that  naturally  occur  in  the 
environment  and  are  considered  safe.  Some  general  principles  are  set  out  in  the 
legislation, but there are no clear criteria for selecting these substances which prompted 
the Commission to draft a guidance document to address this225. Overall, since the MRL 
Regulation  came  into  force,  such  exemptions  have  been  granted  for  130  substances  or 
micro-organisms.  However,  there  are  cases  where  micro-organisms  can  be  human 
pathogens (e.g. Bacillus thuringiensis), meaning that specific MRLs might need to be set. 
The  MRL  Regulation  covers  all  active  substances  by  the  default  level  of  0.01  mg/kg 
where no more specific MRLs are set. However, the default level is not suitable for non-
chemicals such as micro-organisms that may require a different type of default level (see 
also  section  5.4.2).  The  existing  data  requirements  are  not  fully  adapted  to  the 
specificities of non-pathogenic micro-organisms, leading EFSA to regularly identify data 
gaps  when  evaluating  applications,  which,  in  consequence,  delays  risk  management 
decisions.  

Some industry stakeholders claim that the lack of MRLs for feed, processed food and fish 
may have an impact on the single market, as food-business operators have difficulties in 
understanding the legal requirements, and believe that national competent authorities do 
not  take  a  consistent  approach.  However,  there  is  not  sufficient  evidence  to  confirm 
this226. The lack of specific MRLs for feed, fish and processed products is discussed in 
detail in section 5.1.1. It should be noted that MRLs are already set for feed commodities 
when they are also consumed by humans. For processed food, there are national and EU-
level  databases  that  list  the  various  processing  factors  that  can  be  used  by  Member 
States’ enforcement authorities (see also section 5.1.1.)  

The zonal system and mutual recognition of authorisations 
The PPP Regulation divides Member States into three zones based on comparable agri-
environmental  conditions  to  facilitate  the  granting  of  authorisations  for  PPPs,  increase 
access to  PPPs for farmers and avoid duplication of work. This  feature did  not exist in 
Directive 91/414/EEC (see section 2.1.1).  

Dividing the EU into three zones has led to an increase in authorisations granted through 
the mutual recognition procedure, from 409 in 2011 to 1 109 in 2016227. However, there 

225 European Commission (2015), Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation 

(EC) No 396/2005 (SANCO/11188/2013 Rev. 2). 

226 The support study, p.119. 
227 The support study, p. 46. 

46 

 
                                                 
are  large  differences,  with  some  Member  States  mutually  recognising  more  than  100 
PPPs  per  year  (Malta  and  Poland)  while  some  hardly  use  mutual  recognition  at  all 
(Germany and Denmark). Each zone has set up a zonal steering committee to distribute 
work and facilitate cooperation. Depending on how well the steering committee works, 
those  in  charge  of  zonal  authorisation  have  reported  that  it  is  working  more  or  less 
smoothly. The northern zone is reported to work well, the southern zone moderately well, 
while  the  central  zone  is  reporting  difficulties228.  However,  the  number  of  mutual 
recognitions  per  zone  does  not  corroborate  this,  as  the  Member  States  in  the  northern 
zone report very few authorisations through mutual recognition229. This could possibly be 
explained by the low number of PPPs used there overall.  

Compared with the Biocidal Products Regulation that provides for a coordination group 
to  facilitate  authorisations  through  mutual  recognition,  no  such  formalised  body  exist 
under  the  PPP  Regulation.  In  case  of  disagreements  between  Member  States,  there  are 
only  the  respective  zonal  steering  committees  as  well  as  a  working  group  on  post-
approval issues under the umbrella of the Standing Committee that can provide informal 
advice.  In  addition,  Member  States  have  identified  the  need  to  have  secretariat(s)  to 
handle administrative issues and facilitate coordination230 between zones. 

In submission XI.22a. to the REFIT platform, an NGO in Poland criticises the need for 
national  authorisations  within  zones  as  ‘red  tape’.  To  remedy  the  situation,  the 
submission  suggests  that  a  PPP  authorised  in  one  Member  State  in  a  specific  zone  is 
automatically  authorised  in  all  Member  States  within  the  same  zone.  However,  in  the 
platform opinion231, it is clarified that  the differences in agricultural  and environmental 
(including  climatic)  conditions  even  for  the  Member  States  within  a  zone,  justify  no 
automatic mutual recognition. Member States paid particular attention to this during the 
adoption of the PPP Regulation and the possibility to refuse an authorisation is the result. 
In the REFIT opinion, it is further recognised that better implementation of the existing 
system would already address many of the problems encountered and more PPPs would 
be available in the Member States, preventing illegal trade of non-authorised PPPs. 

Introducing  a  zonal  system  for  authorisation  was  meant  to  trigger  cooperation,  work 
sharing  and  reliance  on  the  evaluation  work  conducted  by  other  Member  States  of  the 
same  zone.  However,  this  has  not  materialised.  The  main  reasons  why  Member  States 
fail  to  use  the  opportunities  for  work  sharing  is  their  insistence  on  specific  national 
requirements,  the  re-evaluation  of  applications  for  authorisation,  and  the  lack  of 
harmonisation  in  the  methodologies  used  for  conducting  evaluations232.  This  results  in 
structural delays for all authorisation procedures in most Member States (see also section 
5.2.2  for  further  details).  When  Member  States  apply  additional  national  requirements, 
they  miss  out  on  the  opportunity  to  accept  evaluations  carried  out  by  other  Member 
States which would decrease the workload for themselves and speed up PPPs’ access to 
the market. Moreover, the Member States that use mutual recognition benefit from more 
PPPs available on their national markets (see data and analysis in the next section 5.1.5).  

228 The support study, Annex 3. 
229 Collected through the Member State survey carried out in the context of the support study. 
230 European Commission (2015) Final report, EU Workshop on Zonal Evaluation, Mutual Recognition and Re-authorisation. 
231 REFIT Platform Recommendations – Health and Food Safety: XI.22a ‘Registration of plant protection’ 
232 Focus group on PPP authorisation. 

47 

 
                                                 
There  are  several  underlying  reasons  leading  to  a  sub-optimal  functioning  of  the  zonal 
system. Member States report233 some issues that are directly reflecting a lack of trust in 
one another:  

  The quality of the risk assessment performed by other Member States;  
  Some Member States do not comment on the risk assessment during the commenting 
period due to resource constraints (i.e. priorities). This may lead to a situation where 
their concerns are not known or taken into consideration and ultimately the Member 
States then refuse the authorisation or re-evaluate the application; 

  The zonal rapporteur Member State does not take into consideration comments from 
the concerned Member States during the peer review, leading to the same situation as 
described in the previous bullet; 

However, there are also other issues that are not related to a lack of trust: 

  Different interpretation of the available guidance; 
  Different opinions when new endpoints should be applied; 
  Different working practices between Member States as regards accepting new data to 

address concerns that arise during the commenting period; 

  Coordination and communication between and within zones, such as the difficulty to 
reach the co-ordinators in other zones which costs time and turns out to be ultimately 
less efficient than doing the assessment separately; 

  Dossiers are not available in workable electronic format, which effectively diverts the 
time of the risk assessor from spending time on core tasks which leads to delays; 
  Data  protection  is  a  national  competence  which  can  lead  to  some  studies  being 

available in one Member State and protected and unavailable in another.  

Stakeholders

Member States

0%

25%

50%

75%

100%

Not at all

To a small extent only

Moderately

To a large extent

Excellent

Figure 7. How well is mutual recognition working across zones? 

According  to  stakeholders  and  Member  States,  mutual  recognition  across  zones  is 
working  even  less  effectively  than  mutual  recognition  within  the  same  zone  (see 
Figure 7). The inter-zonal work is reported to be particularly challenging as there is not 
much harmonisation or communication between the zones234. 
In conclusion, the zonal system is not working sufficiently well235,236 and some problems 
are  caused  by  the  absence  of  basic  structures  that  could  facilitate  work  sharing, 
communication and arbitration. Nevertheless, compared to the situation under  Directive 
91/414/EEC, recourse to mutual recognition has improved. 

233 European Commission (2015) Final report, EU Workshop on Zonal Evaluation, Mutual Recognition and Re-authorisation. 
234 Position paper submitted by the Northern zone – ”Input from the Northern Zone on the Review of Regulation 1107/2009” 
235 According to the support study, the vast majority of stakeholders (˃70 %) consider that the zonal authorisation system is working 

to a small extent only or not working at all. 

236  European  Parliament  (December  2018)  Report on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

48 

 
                                                 
5.1.5. Improving agricultural production and competitiveness of EU agriculture 

PPPs are an important factor in agricultural production. All other things being equal, the 
improved availability and reduced cost of PPPs have a positive impact on productivity237. 
The  magnitude  of  this  impact  is  subject  to  debate  and  varies  across  crops,  but  some 
estimates  report  losses  between  5 %  and  15 %  in  the  absence  of  PPPs238,239..  Sufficient 
access  to  PPPs  is  relevant  when  comparing  the  competitiveness  of  EU  farmers  versus 
farmers  from  non-EU  countries..  When  productivity  of  EU  agriculture  is  high,  farmers 
are  able  to  compete  with  non-EU  countries.  Conversely,  reduced  availability  or  higher 
cost of PPPs might have a negative impact on yields and productivity if no or only more 
expensive  alternatives  are  available.  This  might  also  negatively  affect  competitiveness. 
Nevertheless, the profitability of organic farms, where most chemical pesticides are not 
permitted is, on EU average, higher than of conventional farms, which is a result of lower 
input costs and higher CAP support for organic products240. 
There  is  criticism  from  stakeholders,  farmers  and  the  public241  that  farmers  in  the  EU 
face unfair competition compared to non-EU countries, because import tolerances can be 
set for active substances that are not approved in the EU. Farmers in non-EU countries 
can then use PPPs that are not available to EU farmers while still exporting to the EU, 
decreasing the competitiveness of EU agriculture and exporting the risks associated with 
the use of those PPPs to other countries.  

The  evidence,  including  a  study  by  the  Joint  Research  Centre  on  the  impact  of 
restrictions on neonicotinoids in the EU242, remains inconclusive on the potential effects 
of the PPP Regulation on agricultural competitiveness243. Comparing baseline data from 
2008-2009 with data from 2015-2016, the input costs for farmers stemming  from PPPs 
increased in some Member States, while they remained stable or decreased in others244. 
Less spending on PPPs may make funds available to spend on something else that may 
increase  productivity.  A  comparison  of  the  costs  of  PPPs  between  the  EU  and  the  US 
does not clearly indicate any competitive advantage or disadvantage as these costs differ 
depending on the crop that is grown245. Any impact of the Regulation on competitiveness 
is  expected  to  occur  only  in  the  short  term.246  In  the  long  run,  it  can  be  expected  that 
producers of PPPs and farmers will adapt. 

During  this  evaluation  it  became  apparent  that  there  is  a  lack  of  research  on  the 
relationship  between  competitiveness  and  the  PPP  Regulation.  As  mentioned  above, 
there is evidence that the use of PPPs increases yield and productivity, which implies that 
the availability and use of PPPs is a factor that affects competitiveness. However, there is 
no clear evidence to link between decisions at EU level and competitiveness. 

Availability of PPPs in the EU 

237  See  for  example  Popp  J.,  Pető  K.,  Nagy  J.  (2013).  Pesticide  Productivity  and  Food  Security.  A  Review.  Agronomy  for 

Sustainable Development 33(1). 

238 Hossard L., Philibert A., Bertrand M., Colnenne-David C., Debaeke P., Munier-Jolain N., Jeuffroy M.H., Richard G., Makowski 

D. (2014). Effects of Halving Pesticide Use on Wheat Production. Science Report 4, 4405. doi: 10.1038/srep04405. 

239 Damalas C.A. (2009). Review-Understanding Benefits and Risks of Pesticide Use. Scientific Research and Essay Vol. 4 (10). 
240 FADN data reviewed in the Evaluation Study of the impact of the CAP on biodiversity 
241 Open public consultation, see responses to the open field questions in Annex 2.  
242 Kathage J., Castañera P., Alonso‑ Prados J.L., Gómez‑ Barbero M., Rodríguez‑ Cerezo E. (2017). The impact of restrictions on 
neonicotinoid  and  fipronil  insecticides  on  pest  management  in  maize,  oilseed  rape  and  sunflower  in  eight  European  Union 
regions. Pest Management Science, Vol. 74, Issue 1, pp. 88-99. https://doi.org/10.1002/ps.4715. 

243 The support study, p. 69. 
244 The support study, p. 73. 
245 The support study, p. 74. 
246 The support study, p. 69. 

49 

 
                                                 
In  general,  Member  States  and  stakeholders  consider  the  availability  of  PPPs  on  the 
market sufficient or somewhat sufficient, whereas the availability of PPPs for minor uses, 
organic  farming,  and  low-risk  PPPs  are  considered  insufficient.  Insecticides  have  been 
identified as the group with the lowest availability of products247.  

In  most  Member  States,  the  number  of  available  PPPs  has  increased  compared  to  the 
situation  before  the  PPP  Regulation  came  into  force.  However,  the  opposite  is  true  for 
some of the larger Member States like France and Spain, where the availability of PPPs 
has decreased. Figure 8 depicts the percentage change in the number of PPPs available in 
a given Member State between the baseline period 2008-2010 and 2014-2016. The figure 
shows  for  example,  that  Estonia  has  seen  a  62 %  increase  in  the  number  of  available 
PPPs, while France has seen a 40 % decrease. 

160%

140%

120%

100%

80%

60%

40%

20%

0%

-20%

-40%

T
M

T
A

L
P

E
E

*
K
S

U
H

V
L

E
B

T
L

L
N

E
D

*
Y
C

I

U F
L

G I
E
B

T
P

E
S

Z
C

K
U

K
D

L
E

I
S

R
H

S
E

T
I

R
F

*
O
R

Figure 8. Percentage change in PPP availability in 2014-2016 compared to 2008-2010, based on Member 
State survey. Triangles represent the northern zone, diamonds represents the central zone and circles 
represent the southern zone. *Data incomplete for Romania, Slovakia and Cyprus.  

The Member States with the largest increase in the number of available PPPs are also the 
ones who make use of the mutual recognition possibilities provided for in the Regulation. 
Malta  relies  entirely  on  mutual  recognition  —  it  is  the  Member  State  who  mutually 
recognises authorisations the most. However, Malta started from a very low baseline in 
2008  (24  PPPs).  Poland  was  second  to  Malta  in  the  number  of  mutual  recognitions  in 
2016, while Austria has granted a high number of authorisations via mutual recognitions 
since  2012.  Note  that  an  increase  in  the  number  of  PPPs  may  also  reflect  an  increased 
number of generic PPPs on the market and not an increase in the uses covered. 

A number of smaller Member States reported that one of the main underlying problems 
for  the  low  availability  of  PPPs  on  their  market  is  that  industry  is  not  interested  in 
applying for authorisations due to that market’s small size.  

Stakeholders,  especially  from  the  agricultural  sector,  reported  negative  effects  on 
competitiveness,  citing reduced  availability  of PPPs  due  to  stricter approval  criteria  for 
active  substances248.  However,  as  the  number  of  approved  active  substances  has 
increased  since  2011  and  the  number  of  available  PPPs  has  also  increased  in  most 
Member  States,  this  statement  is  not  supported  by  the  available  data.  Indeed,  in 
interviews conducted in the context of the support study, stakeholders acknowledged that 
the concern is mostly about negative effects expected to materialise in the future because 
of  the  expected  non-renewal  of  approval  for  several  substances,  which  will  limit  the 
availability of PPPs for many uses. It is true that the number of non-renewals increased in 

247 The support study, p. 55. 
248 The support study, p. 69. 

50 

 
 
                                                 
2018 and this trend is expected to continue over the next few years. A number of active 
substances  will  also  be  removed  from  the  market  as  they  are  no  longer  supported  (see 
section 5.1.1). As such, farmers’ concerns remain249: the current approval criteria do not 
include resistance management and it is therefore possible that in the future resistance to 
certain modes of action may increase and farmers will be left without efficacious PPPs 
for certain pests or diseases. At the same time, the full implementation of the Sustainable 
Use  Directive  could  help  address  farmers’  need  for  pest  management  as  it  promotes 
integrated  pest  management  and  the  more  widespread  adoption  of  non-chemical  pest 
control techniques and thus, has the potential to reduce dependence on chemical PPPs. 

Availability of PPPs for minor uses 
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. This leads to a lack of authorised PPPs for such crops, which in turn can lead 
to illegal uses or to loss of crop production. These crops include most vegetables, fruits, 
nurseries,  flowers  and  forest  trees.  It  is  estimated  that  overall  their  value  is  more  than 
EUR 70 billion per year, which equates to 22 % of the total EU plant production value250.  

To address industry’s low interest in applying for authorisations for minor uses, the PPP 
Regulation includes the possibility to extend an existing authorisation of a PPP for minor 
uses  via  a  simplified  procedure,  even  without  the  consent  of  the  authorisation  holder. 
Despite  this  possibility,  Member  States  and  stakeholders  consider  that  there  is  still 
insufficient availability of PPPs for minor uses251 (see Figure 9). 

Member States

Stakeholders

0%

20%

40%

60%

80%

100%

Highly insufficient

Insufficient

Somewhat sufficient

Sufficient

Highly sufficient

Figure 9. How would you characterise the availability of plant protection products for minor uses on the 
market? 

It  is  expected  that  the  situation  may  deteriorate  in  the  future  as  the  availability  of 
traditional  broad-spectrum  active  substances  is  expected  to  decrease  due  to  them  no 
longer meeting the approval criteria. It also takes longer to approve an active substance 
and  authorise  a  product  than  to  withdraw  approval  and  authorisation  where  a  risk  is 
identified. The focus group on PPP authorisation identified the following reasons for the 
lack of PPPs authorised for minor uses: 

  A minor use in one Member State can be a major use in another Member State. As 
zonal  evaluation  and  mutual  recognition  do  not  function  perfectly,  a  minor  use  is 
seldom  covered  by  an  authorisation.  This  negatively  affects  harmonisation  as 
authorisations and extensions need to be granted nationally.  

249 The support study, p. 163. 
250 Minor Uses Coordination facility webpage. 
251 The support study, p. 82. 

51 

 
 
                                                 
 

It is only possible to grant an extension for a minor use to an existing authorisation. If 
there is no industry interest in applying for a regular authorisation, it is consequently 
not possible to extend uses. 

  To authorise a PPP under mutual recognition, Member States still need to receive an 
application,  although  this  can  be  from  official  or  scientific  bodies  as  well  as 
professional agricultural organisations and professional users. 

  There  may  be  liability  concerns  when  it  is  not  the  initial  authorisation  holder  who 
applies for the extension, i.e. it is the authorisation holder who is liable if the PPP is 
used  on  another  crop  (the  minor  crop)  and  the  crop  is  destroyed.  As  each  label 
includes  a  reference  to  the  liability  of  the  person  using  the  PPP  as  regards  failures 
concerning the efficacy or phytotoxicity of the product for which the minor use was 
granted,  research  institutes,  farmers’  organisations  and  national  agencies  may  be 
reluctant to apply for extensions due to legal concerns. 

Member States have established their own national procedures for minor uses and do not 
cooperate,  even  within  the  zones.  In  addition,  the  definition  of  minor  uses  is  not 
sufficiently clear and is not harmonised. Thus, applicants are not incentivised to apply for 
uses that could be relevant for minor crops in other Member States252. To solve the issue 
of  a  lack  of  PPPs  for  minor  uses,  Member  States  often  use  emergency  authorisations. 
Over  4  months  in  2018,  54 %  of  all  emergency  authorisations  issued  were  for  minor 
uses253. This is an unintended effect of the PPP Regulation and would not be necessary if 
Member States extended uses more frequently. 

To address the problem of minor uses in a more coherent way, in 2015 the Commission 
proposed to provide significant financial support and partly funded the EU Minor Uses 
Coordination  Facility  for  3  years254.  Member  States  have  welcomed  this  initiative  as  it 
will  create  a  more  level  playing  field  for  EU  farmers.  The  Minor  Uses  Coordination 
Facility  lists  Member  States’  minor  use  needs  online  in  the  European  Minor  Uses 
database255. The knowledge generated by the Minor Uses Coordination Facility will help 
to  develop  a  harmonised  approach  to  minor  uses  in  the  EU.  It  must  be  emphasised, 
however, that the whole process from identifying a minor use need to the generation of 
data and the application process generally takes 4-5 years. Therefore, it is expected that 
the positive effects of the work of the Minor Uses Coordination Facility will only begin 
to materialise in the coming years, but future funding remains uncertain.  

As  mentioned  before,  the  Commission  is  developing  the  plant  protection  products 
application  management  system  (PPPAMS256)  as  a  database  that  in  the  future  will 
contain  information  on  all  PPP  authorisations  in  the  Member  States.  Once  fully 
operational,  the  PPPAMS  will  improve  the  transparency  of  authorisations  and  make  it 
easier to identify existing uses in Member States that would also cover minor uses. 

Good practices have  been identified in  France and Ireland, who have  taken a proactive 
approach  to  addressing  critical  good  agricultural  practices  (GAP)  in  PPPs  for  minor 
crops. In France, there is an annual programme of residue and efficacy trials, designed to 
address crop/pest specific problems by generating data to facilitate full authorisation of 

252 As reported by the focus group on PPP authorisation. 
253 103 of 165 emergency authorisations between April and May 2018 were issued for minor uses. See Annex 3 for methodology. 
254 Report from the Commission to the European Parliament and the Council on the establishment of a European fund for minor uses 

in the field of plant protection products (COM/2014/082). 

255 The EMUDA database 
256 Information about the PPPAMS is available online on the EUROPA website. 

52 

 
                                                 
relevant  PPPs  on  these  crops.  This  is  a  more  sustainable  alternative  to  emergency 
authorisations257. 

Availability of PPPs in the outermost regions 
Tropical  crops  such  as  bananas,  passion  fruit,  coffee  and  pineapples  are  grown  in  the 
EU’s  outermost  regions258.  These  minor  crops  suffer  from  particularly  low  access  to 
relevant  authorised  PPPs.  For  example,  in  the  French  outermost  regions,  only  30 %  of 
uses are covered by the available authorised PPPs259. 

The main reason for this is the low level of applications for authorising PPPs for tropical 
uses and for pests that only exist in the tropics. The low involvement of PPP producers is 
due to: (i) the high costs of data generation with uncertain return on investments; (ii) the 
small  size  of  the  market;  and  (iii)  the  lack  of  tropical  crop  expertise260.  This  is  very 
similar to the situation for minor crops in the main EU regions but taken to another level 
as there is no major use from which authorisation can be extended. 

The situation of the outermost regions as regards minor uses is a national issue relevant 
for a few Member States, as the main problems relate to the lack of authorised PPPs. One 
way for Member States to solve the problem has been to grant emergency authorisations. 
This  has  been  done  by  Spain  for  use  on  mangoes  and  pineapple,  and  repeatedly  by 
France for use on sugar cane.  

Socioeconomic considerations in decision-making 
Although one of the objectives of the PPP Regulation is improving the competitiveness 
of  EU  agriculture,  socioeconomic  considerations  are  not  listed  as  part  of  the  approval 
criteria. Other EU legislations such as REACH and the Biocidal Products Regulation can 
take  socioeconomic  factors  into  consideration  when  deciding  to  allow  the  use  of 
chemicals  that  should  in  general  be  substituted.  In  the  PPP  Regulation,  such 
considerations only  play a role in  the possibility to  derogate from the cut-off criteria261 
and when Member States grant emergency authorisations.  

This was a political choice as PPPs are seen as a specific category of chemicals - they are 
designed  to  have  effects  on  living  organisms  and  are  deliberately  released  into  the 
environment. This is not the case for industrial chemicals and, therefore, safety and the 
protection  of  human  health  and  the  environment  are  particularly  important  in  the  PPP 
Regulation.  

Stakeholders

Member States

0%

25%

50%

75%

100%

Highly insufficiently

Insufficiently

Somewhat sufficiently

Sufficiently

Highly sufficiently

Don't know

257 European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

258 The EU has nine ‘outermost regions’: Guadeloupe, French Guiana, Martinique, Mayotte, Réunion and Saint Martin (France), the 
Canary Islands (Spain) and the Azores and Madeira (Portugal). They are an integral part of the EU and must apply its laws and 
obligations. 

259 The support study, p. 81. 
260 The support study, p. 81. 
261 Under Article 4(7) of Regulation 1107/2009. 

53 

 
 
                                                 
Figure  10.  Are  economic  factors  sufficiently  taken  into  consideration  in  the  decision-making  of  the 
approval of active substances? 

Nevertheless,  more  than  50 %  of  Member  States  and  almost  75 %  of  stakeholders, 
representing  all  sectors  except  NGO’s,  consider  that  social  and  economic  factors  are 
insufficiently  taken  into  consideration  in  decision-making  related  to  the  approval  of 
active  substances  (see  Figure  10).  Stakeholders  consider  that  having  the  ability  to  take 
economic or social considerations into account as part of the approval criteria means that 
some active substances of high  importance may remain on the market for limited uses, 
which  would  positively  impact  the  competitiveness  of  EU  agriculture262.  However,  the 
inclusion of socio-economic consideration could be seen as a weakening of the approval 
criteria in particular as regards the protection of human health or the environment. 

5.1.6. Facilitating international trade 

Academic literature shows that harmonisation of standards, such as MRLs for pesticides, 
facilitates  trade  between  countries263.  This  implies  that  different  MRLs  in  the  EU  and 
non-EU countries would have a negative impact on international trade. However, a recent 
empirical  study  shows  that  stricter  MRLs  can  have  a  positive  impact  on  international 
trade264. According to the study, stricter standards positively affect international trade as 
the demand-enhancing effect of importing food considered safe outweighs the trade-cost 
effect.  Moreover,  it  can  be  argued  that  harmonising  EU  MRLs  has  made  it  easier  for 
food-business operators worldwide to comply with standards. One MRL used throughout 
the  EU  makes  it  possible  for  trade  partners  to  export  products  to  the  Member  State  of 
their  choice,  based  on  trade  interests  and  partnership,  rather  than  selecting  a  Member 
State  only  because  a  different  MRL  applies  there.  Nevertheless,  most  stakeholders 
consulted  perceive  the  MRL  Regulation  as  having  had  a  negative  impact  on  imports, 
while Member States reported a positive impact both for imports and exports265. 

As  shown  in  Figure  11  below,  overall  imports  of  agricultural  commodities  in  the  EU 
steadily increased between 2005 and 2017, with the exception of the 2008-2010 period, 
which  can  be  explained by  the  global  economic  crisis.  Given  that  international  trade  is 
affected by many factors such as the existence of trade agreements and economic growth, 
the  trade  data  do  not  allow  for  a  clear  assessment  of  any  potential  effects  of  the  MRL 
Regulation on trade with non-EU countries. 

n
o

i
l
l
i

b
R
U
E

150

100

50

0

Agricultural Products

Vegetables

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

262 Focus group on risk management and decision-making 
263 Support study, p. 109. 
264 Anirudh Shingal, Malte Ehrich and Liliana Foletti (2017) ‘Re-estimating the effects of stricter standards on trade: endogeneity 

matters’, EUI Working Paper RSCAS 2017/20, European University Institute, Badia Fiesolana. ISSN 1028-3625. 

265 Support study, Annex III, consultation activities — surveys and interviews. 

54 

 
 
                                                 
 
 
Figure 11. EU-28 imports of agricultural products and vegetables from non-EU countries266 

Setting of import tolerances 
For substances for which no MRL exists because there is no use in the EU, operators in 
non-EU countries can request import tolerances. Since 2008, 94 applications for import 
tolerances  were  submitted,  among  which  80  were  assessed  positively  and  9  received  a 
negative opinion. The remaining 5 applications are still under assessment. 

Although import tolerances are clearly mentioned in the MRL Regulation, little guidance 
is  provided  on  how  they  should  be  addressed.  The  same  procedure  for  setting  MRLs 
applies to EU uses as well as to import tolerance requests, which ensures the same level 
of  protection  for  consumers  regardless  of  the  origin  of  a  foodstuff.  However,  the 
procedures are not detailed enough for applicants and the competent authorities of non-
EU  countries,  so  a  guidance  document267  was  developed  to  provide  the  necessary 
information and to set out practicable and workable solutions. 

One  factor  that  non-EU  countries  often  mention  as  hindering  international  trade  is  the 
review of MRLs. For many pesticide commodity combinations, non-EU countries rely on 
the  MRLs  that  are  currently  set  in  the  EU.  Key  examples  are  haloxyfop-P  and 
thiabendazole268,  for  which  the  MRLs  were  lowered  for  linseeds  and  mangoes 
respectively  due  to  the  lack  of  data  supporting  uses  on  those  crops.  Although  WTO 
members are informed in advance of the lowering of MRLs via the SPS procedure, the 
time in which they can react is considered by them to be insufficient to prepare an import 
tolerance  application  to  prevent  the  lowering  of  the  MRL.  To  assist  trade  partners,  the 
Commission prepared a Communication269 outlining the overall MRL review process and 
listing the active substances for which an MRL review is planned.  

Implementation of international standards (Codex limits) 
The MRL Regulation makes reference to international standards, but does not provide for 
a  clear  legal  basis  for  their  implementation.  A  legal  basis  is,  however,  included  in  the 
General Food Law Regulation270. At regular intervals, the Commission drafts a measure 
to  implement  CXLs,  which  are  the  limits  adopted  by  the  Codex  Alimentarius 
Commission.  The  EU  presents  reservations  to  the  Codex  Committee  on  Pesticide 
Residues  (CCPR)  in  cases  where  EFSA  considers  that  CXLs  may  pose  a  risk  to 
consumers in the EU or where a different methodology, different toxicological reference 
values  or  different  residue  definitions  are  used  to  derive  MRLs.  A  reservation  is  also 
made  where  a  parallel  assessment  is  being  carried  out  in  the  EU,  such  as  during  the 
approval of an active substance. However, depending on the outcomes of the assessment, 
the reservation may turn into the adoption of the CXLs at a later stage. 

CXLs for which the EU does not make a reservation during CCPR meetings are included 
in  the  MRL  Regulation,  except  if  they  relate  to  commodities  for  which  MRLs  are  not 
(yet)  set  in  that  Regulation,  such  as  feed  items.  Currently,  CXLs  are  set  for  208 
substances on 20-25 commodities on average271. The total number of CXLs implemented 
is  thus  much  lower  than  the  total  number  of  EU  MRLs.  Moreover,  several  CXLs  are 

266 Eurostat [DS-018995]. 
267 MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005and Article 8 of Regulation (EC) 
No 1107/2009 (SANTE/2015/10595), Chapter 3.1. 
268 See case study in the support study. 
269 Committee on Sanitary and Phytosanitary Measures, Communication from the European Union,  On-going review of maximum 

residue levels of pesticides in the European Union (G/SPS/GEN/1494/Rev.1). 

270 Articles 5(3) and 13(e) of Regulation (EC) No 178/2002 of the European Parliament and of the Council. 
271 Codex Pesticides Residues in Food Online Database 

55 

 
                                                 
actually based on EU uses, which in the long term may constitute an alternative to import 
tolerance requests where the uses are withdrawn in the EU. The percentage of EU MRLs 
harmonised with CXLs in the past years is shown in Table 7. 

Table 7. The percentage of EU MRLs harmonised with CXLs 

Year 

2012 
2013 
2014 
2015 
2016 
2017 
2018 

Total number of CXLs for 
food adopted CAC272 
242 
352 
301 
326 
349 
417 
305 

 EU MRLs set at lower 
values than CXLs 
22 % 
21 % 
28 % 
25 % 
37 % 
47 % 
21 % 

EU MRLs set at the same or 
higher values273 than CXLs 
78 % 
79 % 
72 % 
75 % 
63 % 
53 % 
79 % 

The  EU  is  criticised  by  trade  partners  in  relation  to  the  reservations  made  at  CCPR 
meetings. Trade partners claim that the EU does not comply with international standards 
(see  section  5.3.3).  However,  only  a  minor  portion  of  recent  CXLs  have  not  been 
transposed in the MRL Regulation, accounting for 29 % of the total CXLs adopted by the 
Codex Alimentarius Commission for food between 2012 and 2018. When comparing the 
percentage  of  harmonised  CXLs  accepted  by  major  WTO  members,  the  EU  has  the 
highest rate of harmonisation which is facilitating trade (see Figure 12). 

65% 

73% 

67% 

40% 

45% 

80%

70%

60%

50%

40%

30%

20%

10%

0%

Australia

Canada

EU

Japan

United States

Figure 12. Comparison of harmonised Codex limits adopted between 2012 and 2016 by WTO members 

Export of treated seeds 
When Directive 91/414/EC was in force, there was a lack of legal provision for treated 
seeds.  The  PPP  Regulation  contains  provisions  that  allow  for  the  free  circulation  of 
treated  seeds274  in  the  EU  if  there  is  at  least  one  authorisation  in  at  least  one  Member 
State. This clear provision in the PPP Regulation has had a positive harmonising effect 
within the EU275. In the PPP Regulation, it is the treatment of the seeds that constitutes 
the use of a PPP and requires an authorisation, whereas the sowing of the seeds does not. 
This has led to two complications. First, Member States are experiencing difficulties in 
tracing and controlling treated seeds276. Second, there is no common view yet on whether 

272 Codex Alimentarius Commission. 
273 MRLs may be set at a higher level in the EU based on different GAPs than the ones used to establish CXLs. Such MRLs facilitate 

trade as they cover both international and EU uses.  

274 ‘Seed treatment’ is a preventive measure to enhance growth and reduce loss of plant material to pests in early stages of the plant 

life cycle. 

275 The support study, p. 114. 
276 The support study, p. 117. 

56 

 
 
                                                 
it is possible to treat seeds for exports with an active substance that is not approved in the 
EU. 

5.1.7. Enforcement 

Enforcement of the PPP Regulation 
All  Member  States  carry  out  monitoring  and  official  control  activities  to  ensure 
compliance  with  the  PPP  Regulation.  A  series  of  audits  conducted  by  the  Commission 
found that controls  on users  of PPPs are satisfactory. The effectiveness of enforcement 
activities at national level varies, however, particularly in relation to certain provisions of 
the  PPP  Regulation277.  PPP  users  have  an  incentive  to  comply  because  of  the  cross-
compliance mechanism under the Common Agricultural Policy278, where non-compliant 
PPP users may lose their entitlements to financial benefits. 

The  Commission’s  audits  reported  difficulties  with  official  controls  on  imports  and 
exports of PPPs and with official controls to verify compliance of PPPs placed on the EU 
market  with  the  conditions  of  their  authorisation  or  with  parallel  trade  permits279.  Not 
surprisingly,  therefore,  one  of  the  main  issues  is  the  presence  of  illegal and  counterfeit 
PPPs  on  EU  territory.  It  is  estimated  that  illegal  and  counterfeit  PPPs  represent  around 
10 % of the EU PPP market280, while in some Member States this might be up to 25 % of 
PPPs sold281. Member States bordering non-EU countries generally have the highest level 
of  illegal  PPPs.  The  last  three  operations  by  Europol,  the  European  Anti-Fraud  Office 
and  the  Member  States  targeting  illegal  and  counterfeit  PPPs  at  major  seaports  and 
airports  and  at  the  land  borders  seized  more  than  670  tonnes  of  illegal  or  counterfeit 
PPPs282. 

Sanctions  related  to  marketing  illegal  PPPs  are  not  always  effective  at  ensuring 
enforcement  as  the  level  of  sanctions  is  too  low  or  infrequent  to  incentivise 
compliance283. 
The  European  Parliament284  has  criticised  the  poor  enforcement  of  the  PPP  Regulation 
and  called  on  the  Member  States  to  ensure  effective  implementation.  Stakeholders 
consistently  hold  a  very  negative  opinion  —  more  than  80 %  consider  that  the  PPP 
Regulation is not adequately enforced285.  

The  Commission’s  overview  audit  report  recognises that  official  controls  on  the  use  of 
PPPs and increased focus on enforcing the requirements applicable to the sustainable use 
of PPPs provide some assurance as to the responsible use of PPPs. However, the report 
also states that the lack of adequate official controls in the stages prior to use on farms 

277 European Commission (2016) Overview report on a series of audits carried out in EU Member States in 2015 and 2016 in order 
to evaluate the control systems in place for the marketing and use of plant protection products. DG(SANTE) 2016-6004 – MR. 

278 Cross-compliance is ensured under Article 55 of Regulation 1107/2009. 
279  European Commission (2016) Overview report on a series of audits carried out in EU Member States in 2015 and 2016 in order 
to evaluate the control systems in place for the marketing and use of plant protection products. DG(SANTE) 2016-6004 – MR. 
280 European Commission (2015) Ad-hoc study on the trade of illegal and counterfeit pesticides in the EU — DG Health and Food 

Safety. 

281 Report from the Awareness conference on Fake and Illicit Pesticides held in Alicante in 2012. 
282  In  2015,  during  Silver  Axe,  350  inspections  of  containers  were  carried  out  and  190  tonnes  of  illegal  PPPs  were  discovered 
entering the EU through seven Member States. In 2018, during Silver Axe II, over 940 shipments of PPPs were inspected in 16 
Member  States  resulting  in  the  discovery  of  almost  122  tonnes  of  illegal  or  counterfeit  pesticides.  During  Silver  Axe  III,  181 
suspicious shipments were inspected and 360 tonnes of illegal or counterfeit pesticides seized. 

283 European Commission (2015) Ad-hoc study on the trade of illegal and counterfeit pesticides in the EU — DG Health and Food 

Safety. 

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

No 1107/2009. 

285 The support study, p. 107. 

57 

 
                                                 
(e.g.  during  manufacturing,  distribution  and  marketing  stages)  compromise  the 
effectiveness of a system intended to guarantee the safety of PPPs. 

Changes introduced by Regulation (EU) 2017/625, which will be applicable at the end of 
2019 (see section 3.7), are likely to improve the enforcement of the PPP Regulation, but 
the final outcome will depend on Member States’ action in this area. 

Enforcement of the MRL Regulation 
Food-business operators placing products on the EU market need to make sure they are 
safe  for  human  consumption286,  so  they  must  ensure  compliance  with  the  MRL 
Regulation. The results of the EU multi-annual coordinated programme287 which requires 
random sampling and analysis of a range of specific substances in certain commodities 
indicate a high level of protection for the EU citizen (see Figure 6 in section 5.1.1). 

Another  step  forward  towards  harmonisation  concerns  the  analytical  methods  used  by 
enforcement  laboratories.  These  methods  are  validated  and  the  laboratory’s  overall 
performance  assessed  via  proficiency  tests  organised  by  the  EU  reference  laboratories. 
Audit results indicate a high degree of harmonisation despite some shortcomings found 
in a few Member States concerning the range of pesticides analysed, mainly due to lack 
of resources. 

The MRL Regulation covers in its scope also pesticides no longer used as such, residues 
of biocidal products and of veterinary medicinal products etc. Either a specific MRL or 
the  default  value  applies  to  a  pesticide-commodity  combination  under  the  MRL 
Regulation, regardless of the source of the residue found. For substances no longer used 
as pesticides, the default value applies, although the substance may well be lawfully used 
in veterinary medicine or as a biocide.  

Covering all possible sources with one MRL ensures a maximum of consumer protection 
as Member States can take enforcement action for each and every pesticide – commodity 
combination.  However,  in  practice  this  has  led  to  enforcement  problems  as  sometimes 
the MRLs are not reflecting other uses and are then too low or are different from limits 
set in other legislation, e.g. on veterinary medicinal products. Different recommendations 
for MRLs are sometimes given by different agencies for the same substance, e.g. EMA 
for  MRLs  of  veterinary  medicinal  products  and  EFSA  for  pesticides  residues,  as  the 
methodology for exposure assessment is different. This has led to confusion for Member 
States'  enforcement  authorities  and  has  hampered  enforcement  action.  For  example,  if 
low  amounts  of  biocidal  active  substances  (such  as  those  used  in  cleaning  agents  that 
were  formerly  used  as  pesticides)  are  found  in  foods  but  do  not  pose  a  risk  to 
consumers288, the default MRLs for the substances continues to apply to the agricultural 
commodities as the substances are no longer authorised or used as pesticides. Moreover, 
the substances do not occur in the raw products to which the MRLs apply, but only enter 
the food chain at a later stage, during processing.  

286  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. 

287 Commission Implementing Regulation (EU) 2018/555 of 9 April 2018 concerning a coordinated multiannual control programme 
of  the  Union  for  2019,  2020  and  2021  to  ensure  compliance  with  maximum  residue  levels  of  pesticides  and  to  assess  the 
consumer exposure to pesticide residues in and on food of plant and animal origin. 

288  Reasoned  opinion  on 

the  dietary  risk  assessment  for  proposed 

temporary  maximum  residue 

levels  (MRLs)  of 

didecyldimethylammonium chloride (DDAC) and benzalkonium chloride (BAC). EFSA Journal 2014;12(4):3675. 

58 

 
                                                 
This  concern  was  in  particular  raised  for  chlorate,  and  discussed  by  stakeholders  and 
governments  in  the  context  of  the  REFIT  platform.  In  its  opinion289  on  ‘multiple 
use/multiple  source  substances-chlorate’,  the  REFIT  Platform  Stakeholder  group 
recommended  changing  the  definition  of  ‘pesticides  residues’  and  setting  limits  for 
multiple  use  substances  under  the  most  suitable  legislative  framework,  including  under 
another legal framework than the MRL Regulation if appropriate. In the REFIT Platform 
Government  group,  different  opinions  were  expressed  as  regards  the  definition  of 
‘pesticides  residues’  and  the  Government  group  considered  that  the  issues  deserved 
thorough assessments and therefore welcomed the evaluation of the PPP legal framework 
(see  also  section  5.3.2).  For  chlorate,  eventually  a  multi-disciplinary  action  plan  was 
agreed in May 2017 at a meeting of the Heads of Food Safety Agencies which includes 
actions  on  drinking  water,  food  hygiene,  foods  for  infants  and  young  children  and  the 
setting of temporary MRLs for chlorate under the MRL Regulation. While the action on 
food hygiene has been completed, the actions on drinking water and MRL setting in food 
are currently ongoing.  

In  the past, the Commission  has  addressed such situations case by case in  the past and 
always  as  a  reaction  to  requests  of  Member  States  and  stakeholders  who  already 
experienced  problems.  The  Commission’s  action  consisted  often  of  setting  temporary 
MRLs on the basis of monitoring data to reflect other legitimate uses, or by aligning the 
MRLs  for  pesticides  with  limits  set  under  other  legislation.  Since  the  MRL  Regulation 
regards EFSA as the only agency in matters of food safety, direct action on basis of a risk 
assessment carried out by another agency (e.g. the European Medicines Agency) has not 
been  possible  (see  also  section  5.2.1).  Furthermore,  in  some  cases  the  different 
methodologies  used  for  consumer  exposure  assessments  of  the  same  substance  by 
different European agencies, which directly mirrors the different methodologies used at 
international level by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), and 
the  Joint  FAO/WHO  Expert  Committee  on  Food  Additives  (JECFA)  for  veterinary 
medicines  lead  to  different  risk  assessment  outcomes  making  alignments  of  legislation 
difficult. 

Setting  of  temporary  MRLs  on  the  basis  of  monitoring  data  is  limited  to  "exceptional 
circumstances" which are not well defined. This regularly leads to delays due to the need 
to clarify the scope of this provision.  

5.1.8. Transparency and risk communication 

The  PPP  Regulation  aims  to  improve  the  transparency  of  procedures  and  access  to 
documents, while trying to balance the need for confidentiality in view of industry’s right 
to  keep  certain  information  protected.  Compared  to  Directive  91/414/EEC,  it  is  better 
defined when and which documents should be made public and what information can be 
kept  confidential290.  Most  of  the  consulted  stakeholder  groups  (except  NGOs)  are 
satisfied with the balance between transparency and confidentiality, noting that this has 
improved  substantially  since  the  previous  legislation  was  in  force291.  Citizens, 
organisations and businesses can also request access to documents292. 

289 REFIT Platform Opinion on the submission by a member of the REFIT Platform Stakeholder Group on “Multiple use/Multiple 

source substances – Chlorate”, 7 June 2017 
290 According to Article 63 of Regulation 1107/2009. 
291 The support study, p. 165. 
292 According to 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 (OJ L 145, 31.5.2001, p. 43). 

59 

 
                                                 
There  is  increased  public  interest  in  pesticides  in  general  and  in  the  approval  of  active 
substances  at  EU  level.  To  inform  the  public  about  decisions  taken  in  the  EU,  risk 
communication  has  to  work  effectively.  The  fitness  check  of  the  General  Food  Law 
recognised the fact that risk communication has not always been effective and has had a 
negative  impact  on  consumer  trust293.  One  particular  example  is  the  Commission’s and 
EFSA’s  unsuccessful  risk  communication  on  glyphosate.  The  public  consultation 
conducted for this evaluation294, although not statistically significant, confirmed that the 
public feels insufficiently informed about decisions about pesticides in the EU. 

100%

75%

50%

25%

0%

18% 

31% 

38% 

12% 

14% 

30% 

39% 

15% 

Don't know
Very well
Somewhat sufficiently
Insufficiently
Not at all

Pesticides

Pesticide residues

Figure 13. Do you feel well informed about the decisions made in the EU with regard to pesticides and 
their residue levels? 

The following initiatives have been developed to increase transparency: 
  The  EU  Pesticides  Database295  contains  information  about  active  substances 
(approved  and  not  approved)  in  the  EU.  The  review  reports  underpinning  decision-
making are available, as are classifications, information about historical and current 
MRLs, etc. 

  EFSA regularly launches public consultations as part of the risk assessment and peer 
review  of  active  substances  and  makes  them  available  on  its  website296.  Based  on 
each  peer  review,  EFSA  publishes  its  conclusions  and  technical  reports297,  which 
later form the basis of decision-making by the Commission and Member States. The 
public consultation is the right moment to intervene in the risk assessment, but NGOs 
report  that  due  to  lack  of  resources  and  the  short  deadlines  to  provide  input  they 
rarely make use of the opportunity298. 

  Member States are consulted on draft reasoned opinions on MRL reviews, but these 

are not full public consultations. 

  EFSA  publishes the upcoming  schedule299 for reviewing MRLs to  inform operators 
and non-EU countries of what is in the pipeline and facilitate early generation of data 
and applications for import tolerances. However, non-EU countries still criticise the 
EU for lack of information as regards revisions of MRLs, which they claim lead to 
negative consequences for international trade. 

293  European  Commission  (2018)  Commission  Staff  Working  Document  the  REFIT  Evaluation  of  the  General  Food  Law 

(Regulation (EC) No 178/2002). SWD(2018) 38. 

294 Open public consultation held as part of the support study. 
295 EU Pesticides Database. 
296 EFSA’s consultations webpage. 
297 All EFSA conclusions and reports are published in the EFSA Journal. 
298 The support study, p. 165. 
299 MRL review progress report. 

60 

 
 
 
                                                 
  EFSA’s  Register  of  Questions300  contains  all  mandates  sent  to  EFSA,  all  ongoing 
procedures,  deadlines  for  EFSA’s  work,  summary  dossiers,  the  rapporteur  Member 
State’s review assessment reports, and commenting tables for every active substance. 
The  site  contains  numerous  relevant  documents  but  even  experienced  users  find  it 
difficult to navigate. Furthermore, there is criticism, in particular from NGOs, that the 
documents are too complex for non-scientists to understand. 

  The agendas and summary reports from the Standing Committees on Plants, Animals, 
Food  and  Feed  are  published  on  the  Commission’s  website301.  There  are  also 
dedicated  webpages  with  detailed  information  for  high  profile  topics  such  as 
endocrine disruptors, glyphosate and neonicotinoids. However, there is criticism from 
stakeholders  that  the  minutes  are  too  basic  and  uninformative302,  and  that  Member 
State positions are not disclosed - the latter is in fact prevented by the rules governing 
the  comitology  process.  The  Commission  has  proposed  to  disclose  the  votes  of 
Member States at the Appeal Committee level taken in comitology303, but neither the 
European  Parliament  nor  the  Council  have  moved  the  adoption  of  this  proposal 
forward yet. 

  The  plant  protection  products  application  management  system  (PPPAMS304)  will 
eventually contain information on all PPP authorisations in the Member States. The 
database is currently used only for emergency authorisations under Article 53 of the 
PPP Regulation but will be used for all authorisations in the future. However, the full 
implementation  of  the  system  is  delayed  due  to  resource  constraints  both  in  the 
Commission and in the Member States. Currently, information on PPP authorisations 
varies  between  Member  States  as  some  have  databases  while  others  provide 
information  through  downloadable  individual  documents.  There  is  currently  no  EU 
overview and it is difficult to know which PPPs are available across the EU. 

  To  access  information,  anyone  can  request  access  to  Commission  and  EFSA 
documents. Between 2013 and 2018, the Pesticides and Biocides Unit in DG Health 
and  Food  Safety  released  more  than  4 000  documents  to  NGOs,  industry 
representatives,  journalists  and  citizens  in  response  to  requests  for  public  access  to 
documents. To increase transparency, in April 2018 the Pesticides and Biocides Unit 
in  DG  Health  and  Food  Safety  launched  a  pilot  project  that  involves  the  online 
publishing  of  documents  which  have  been  partially  or  fully  released  following  an 
‘access to documents’ request305.  

The platforms and websites listed above are available, but knowledge about them is low: 
37 % of respondents to the public consultation were not aware that any of them existed, 
while 22 % of respondents were aware that the tools exist but say that they cannot easily 
find  the  information  they  need.  Simply  having  information  publicly  available  does  not 
necessarily translate into a better informed public if the information is difficult to find or 
understand. 

NGOs criticise the regulatory system for PPPs and MRLs, saying that it is opaque, that 
documents are published too late, that there are conflicts of interest and that industry is 

300 EFSA Register of Questions. 
301 Standing Committee for Plants, Animals, Food and Feed - section phytopharamceuticals. 
302 The support study, p. 168. 
303 Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down 
the  rules  and  general  principles  concerning  mechanisms  for  control  by  Member  States  of  the  Commission’s  exercise  of 
implementing powers. COM(2017) 85. 

304 Information about the PPPAMS is available online on the EUROPA website. 
305 Transparency pilot projects webpage. 

61 

 
                                                 
too  involved  in  the  risk  assessment306.  The  risk  management  process  is  seen  as 
particularly  secretive  and  it  is  not  clear  to  stakeholders,  NGOs  in  particular,  how 
negotiations  with  Member  States  are  carried  out  in  the  Standing  Committee307.  All 
stakeholder groups reported that it is necessary to increase the transparency of the MRL-
setting process308.  

Increased transparency and sustainability of the risk assessment in the food chain 

In  April  2018  the  Commission  proposed  a  targeted  revision  of  the  General  Food  Law 
Regulation309 in response to the concerns expressed in the European Citizens’ Initiative, 
in order to improve the transparency and sustainability of the risk assessment process in 
the EU in the food safety area. The proposal was coupled with a revision of eight pieces 
of  sectoral  legislation,  one  being  the  PPP  Regulation.  This  amendment  of  the  General 
Food Law has been adopted310 by the Council and the European Parliament on 13 June 
2019 and the majority of the provisions will become applicable on 21 March 2021. The 
Regulation gives citizens greater access to information submitted to EFSA on approvals. 
The key elements of the proposal are: 

  Ensure more transparency, by allowing citizens to have immediate access to all safety 

related information submitted by industry in the risk assessment process; 

  Create  a  common  EU  Register  of  commissioned  studies.  This  will  provide  a 
mechanism  by  which  EFSA  will  be  able  to  double-check  whether  all  studies 
commissioned  by  an  applicant  in  the  context  of  its  application  for  an  authorisation, 
have  been  submitted  and  it  will  guarantee  that  companies  submit  all  relevant 
information, and do not hold back unfavourable studies;  

  Allow  additional  studies  to  be  requested,  in  exceptional  circumstances,  by  EFSA, 
upon request of the Commission  and  financed by the EU budget  to  verify evidence 
used in its risk assessment process; 

  Require consultation of stakeholders and the public on studies submitted by industry 

 

to support product authorisation requests; 
Increase  the  Member  States  involvement  in  EFSAs  governance  structure  and 
scientific panels; 

  Strengthening  risk  communication  to  citizens,  with  common  actions  to  enhance 
consumer  confidence  by  promoting  public  awareness  and  understanding  and  better 
explaining  scientific  opinions  expressed  by  EFSA,  as  well  as  the  basis  of  risk 
management decisions. 

306 Citizens for Science in Pesticide Regulation. 
307  Bozzini  E.  (2017)  Pesticide  Policy  and  Politics  in  the  European  Union;  Regulatory  Assessment,  Implementation  and 

Enforcement. Palgrave Macmillan. ISBN 978-3-319-52735-2. 

308 The support study p. 168. 
309 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). 

310 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. 

62 

 
 
 
                                                 
5.2. Efficiency 

  To  what  extent  the  costs  for  the  Commission  including  EFSA,  Member  States, 
operators  involved  in  the  approval  of  substances  and  authorisation  of  plant 
protection  products,  in  the  setting  of  MRLs  have  been  justified  and  evenly 
distributed given the effects achieved? 

  Are there issues which pose particular problems for SMEs and micro-enterprises? 
  What benefits have been achieved from implementing the legislation? 
  Is the legal framework generating unnecessary regulatory burden? Are there any 
actions  that  could  reduce  regulatory  burden,  or  potential  alternative  policy 
mechanisms that could improve cost-effectiveness? 

MAIN FINDINGS 

The  PPP  and  MRL  Regulations  are only  partly efficient:  there are  significant  delays  in 
approving  and  renewing  the  approval  of  active  substances,  in  authorising  PPPs,  and  in 
the  review  of  all  existing  MRLs.  The  deadlines  most  frequently  missed  in  the  renewal 
process are those for: (i) the admissibility check by the rapporteur Member States; (ii) the 
assessment  of  the  supplementary  dossier  by  the  rapporteur  Member  State;  (iii)  the 
additional  assessment  needed  by  the  rapporteur  Member  State  during  the  peer-review 
process; and (iv) the Commission’s decision-making. This leads to repeated extensions of 
approval periods of active substances in order to finalise decision-making.  

There  are  also  delays  in  the  implementation  of  certain  parts  of  the  Regulations  due  to 
limited  resources  available,  e.g.  a  list  of  unacceptable  co-formulants  is  still  not 
established.  When  the  Regulations  were  adopted,  the  estimated  amount  of  work  to  be 
carried out and the resources required appear to have been severely underestimated. 

The  setting  of  MRLs  is  considered  efficient.  However,  the  MRL  Regulation  is  not 
flexible  enough  to  address  unforeseen  circumstances,  and  this  decreases  overall 
efficiency.  The  MRL  review  programme  is  heavily  delayed  as  the  workload  was  much 
greater than initially expected. As of 2018, only a little over half of the substances have 
been reviewed. 

Due to a lack of data, not all the benefits of the two Regulations could be quantified. The 
available  quantified  evidence  suggests  that  benefits  linked  to  the  non-renewal  of  five 
active substances under the PPP Regulation, even if uncertain and incomplete, amount to 
about EUR 38.5 million annually. 

The costs for industry, Member States, EFSA and the Commission is well accounted for 
and  shows  that  industry  incurs  considerable  costs  to  prepare  the  dossiers  and  apply  for 
the approval and renewal of approval of active substances, for authorisations of PPPs and 
for  setting  MRLs.  This  particularly  affects  SMEs  as  the  high  upfront  costs  especially 
related to the costs of preparing a high quality dossier are a barrier to entering the market.  

The fees raised by some Member States are not sufficient to cover their costs, and some 
Member  States  do  not  directly  link  the  fees  with  the  work  carried  out.  For  MRLs,  the 
Member  States’  work  on  the  MRL  review  is  not  covered  by  fees.  This  results  in  an 
insufficient  number  of  staff  being  available  to  carry  out  the  necessary  work,  which 
contributes to the delays. 

In the Member States, the regulatory system for PPPs and MRLs is mostly financed by 
fees paid by industry to Member States, who use the fees to recover their expenses. The 
costs of protecting human health and the environment from PPPs are also partly covered 
by public funds through the work carried out by EFSA and the Commission as this work 

63 

 
is not covered by fees. All costs and benefits are reported in the overview table in Annex 
4. In  addition, Annex 2 to  the support study explains  how the costs for Member States 
and stakeholders have been calculated. 

5.2.1. Costs for industry, farmers and SMEs 

Industry 

Businesses wanting to place a PPP on the market in the EU face considerable costs. The 
main cost is incurred in discovering and developing new active  substances and proving 
their safety through laboratory and field studies. According to industry, this requires an 
investment  of  between  EUR 200-250  million311.  These  costs  have  increased  in  recent 
years due to higher demands in the PPP Regulation to prove safety for human health and 
the environment312. 

Based on stakeholder and Member State data, the support study calculated that industry 
spends  annually  around  EUR 300  million  on  preparing  dossiers  for  approvals  and 
renewal  of  approvals  in  the  EU313.  Around  half  of  the  cost  (EUR  122-189  million314) 
relates  to  new  active  substance  procedures,  excluding  research  and  development  costs. 
There are on average  9 new active substance applications per year. The remaining  half 
(up  to  EUR  196  million315)  are  for  the  renewal  procedures  which  are  more  numerous, 
around 48 per year, but the individual investment is lower than for new active substances. 
Fees to Member States are a small part (up to 10 %) of the cost of preparing the dossiers 
at  the  required  standard.  Indeed,  the  main  drivers  behind  the  costs  for  industry,  both 
under  Directive  91/414/EEC  and  the  PPP  Regulation,  are  the  high  study  and  testing 
demands  to  fulfil  the  data  requirements.  To  put  these  figures  in  perspective,  the  crop-
protection market in Europe generated revenue of EUR 12 billion in 2016316. 

The  costs  estimated  for  an  applicant  to  obtain  authorisation  of  a  PPP  in  one  Member 
State range  between  EUR 0.5  million  and  EUR 1  million.  However,  as  it  is  possible  to 
apply  using  the  same  dossier  in  several  Member  States,  a  simple  multiplication  would 
inflate the total cost. The information available is too uncertain to calculate total costs for 
PPP authorisation in the EU. What has been possible to estimate is the increased costs of 
EUR 26.7  million  in  2016  to  obtain  authorisation  of  PPPs  containing  candidates  for 
substitution  compared  to  regular  authorisations.  The  increase  is  due  to  Member  States 
charging  higher  fees  for  such  authorisations.  These  higher  costs  further  reduce  the 
efficiency  of  the  authorisation  procedure  for  candidates  for  substitution  as  none  of  the 
comparative assessments has led to any substitution317. 

For  MRLs,  the  combined  annual  costs  for  industry  to  prepare  dossiers  are  estimated  at 
EUR 55 million. The costs for reviewing MRLs are lower per procedure than the setting 
of  MRLs  and  import  tolerance  procedures  (see  Table  8).  No  significant  administrative 
costs for companies were identified in the support study318. 

311 McDougal P. (2016). The Cost of New Agrochemical Product Discovery, Development and Registration in 1995, 2000, 2005-8 

and 2010-2014. 

312 Ibid. 
313 The support study, p. 144. 
314 The support study, p. 146. 
315 The support study, p. 146. 
316 According to InkWood Research. 
317 The support study, p. 227. 
318 The support study, p. 135. 

64 

 
                                                 
Table 8. Costs for MRL dossier preparation per type of procedure 

Average costs for dossier 
preparation per procedure 
Average number of applications at 
the EU level (2008-2016) 

MRL setting 

MRL review 

Import tolerances 

EUR 500 000 

EUR 300 000 

EUR 500 000 

76 

39 

11 

Total costs per year for industry 

EUR 38 million 

EUR 11.7 million  

EUR 5.5 million  

While  industry  stakeholders  report  that  the  impact  of  the  PPP  Regulation  on  their 
businesses has been negative, data from Eurostat319 do not support this claim as the value 
of  PPPs  and  other  agrochemical  products  increased  on  average  by  22 %  between  2014 
and  2016  compared  to  2008-2010.  Also,  PPP  sales  were  stable  from  2011  and  2016  at 
EU level and within the three zones. The number of people employed  in  the pesticides 
and  other  agrochemical  products  manufacturing  sector  increased  by  15 %  (+ 6 000 
people) between 2008 and 2016320. 

Farmers 
For  farmers,  data  from  the  European  Commission  Farm  Accountancy  Data  Network 
indicate that the share of  spending on crop protection  has  not  increased since the entry 
into force of the PPP Regulation321. From 2004 to 2010, the share of spending on crop 
protection out of total specific costs fluctuated between 9.5 % and 10.5 %, and between 
9.3 % and 10.3 % from 2011 to 2016. Although there is evidence, based on different data 
from Eurostat, that the input costs stemming from PPPs have increased since 2010 in the 
EU322,  farmers  in  the  EU  are  not  at  a  disadvantage  compared  with  those  in  the  United 
States. Whether EU farmers or US farmers have the  competitive advantage depends on 
the crop grown323.  

The PPP Regulation has increased uncertainty for farmers as the non-approvals of some 
active  substances  have  removed  solutions  and  options  for  pesticide  resistance 
management.  Alternatives  are  sometimes  more  expensive  or  harder  to  find,  while  non-
chemical  alternatives  and  low-risk  active  substances  are  often  not  yet  available.  When 
alternatives  are  available,  they  may  require  specific  new  knowledge  and  attention  to 
monitor pest cycles in order to efficiently apply solutions more linked to prevention than 
cure.  This  implies  that  farmers  need  the  support  of  proper  integrated  pest  management 
advisory  services,  which  is  the  responsibility  of  Member  States.  Overall,  no  firm 
conclusions  can  be  made  on  the  PPP  Regulation’s  impact  on  the  costs  incurred  by 
farmers, except that the share spent by farmers on PPPs is comparable to what they spent 
before the PPP Regulation came into application and to what they spend on fertilisers and 
that these costs are not negligible. 

Specific issues related to SMEs 
The number of SMEs producing PPPs and other agrochemical products is decreasing. In 
2012,  there  were  413  pesticide  manufacturers  classified  as  SMEs,  while  in  2015  there 
were 349324. The reasons are likely multiple, but the high regulatory requirements are a 

319 Eurostat [sbs_sc_ind_r2] and [sts_inpr_a] for volume index of production. 
320 23 600 people employed in 2008 and 29 591 people in 2016, see the support study p. 153. 
321 The Farm Accountancy Data Network is an instrument for evaluating the income of agricultural holdings and the impacts of the 

Common Agricultural Policy. 

322 The support study p. 74. 
323 The support study p. 74. 
324 Eurostat, Annual enterprise statistics by size class for special aggregates of activities [sbs_sc_sca_r2]. 

65 

 
 
 
                                                 
contributing factor. Smaller firms experience particular difficulties with the high upfront 
investments necessary to develop and commercialise active substances and the long time 
to  market  (on  average  around  5  years  for  new  active  substances325)  as  they  have  less 
capital  than  larger  firms.  This  is  further  exacerbated  by  the  unpredictable  delays  in  the 
system  (see  section  5.2.2).  Stakeholders  working  with  biopesticides  and  in  organic 
farming do not consider the data requirements and procedures in the PPP Regulation to 
be  appropriate  or  proportionate  for  potentially  low-risk  solutions  such  as  micro-
organisms. This particularly affects SMEs as they are more often involved in developing 
such  substances  than  in  developing  chemical  active  substances.  The  Commission  is 
working  to  improve  the  situation  by  drafting  guidance  documents  supporting  the 
assessments  of  biopesticides,  e.g.  microbial  pesticides  and  pheromones  (see  section 
5.1.5).  In  addition,  the  data  requirements  on  micro-organisms  can  be  updated  and 
modernised (see section 5.4.2).  

The PPP and MRL Regulations seem to incur some costs to SMEs in order for the firms 
to  comply.  For  instance,  24%  of  the  SMEs  consulted in  the  SME  panel  confirmed  that 
they need to hire an external consultant occasionally or frequently to comply with either 
the MRL Regulation and/or the PPP Regulation. In the consultation, SMEs stated that 1-
5% of all their administrative costs stem from the PPP Regulation.  

Some  SMEs  claim  that  the  data  protection  granted  for  studies  other  than  on  vertebrate 
animals is used by the data owners as an anti-competitive tool, limiting SMEs’ access to 
the market. While the PPP Regulation provides for mandatory sharing of tests and studies 
involving vertebrate animals, this is not the case for non-vertebrate studies. As a result, 
authorisation  holders  can  refuse  access  to  such  studies  for  generic  firms  to  discourage 
competition. Generic companies may spend significant time negotiating access to studies. 
If an agreement is not reached, the company needs to commission its own study, which 
prolongs  the  time  taken  to  complete  the  dossier  and  submit  an  application  for 
authorisation, ultimately leading to a delay in accessing the market.  

5.2.2. Costs for the Member States, the Commission and EFSA 

The overall annual costs for Member States on approval and authorisation procedures for 
PPPs  are  estimated  at  EUR 44  million,  with  around  930  full-time  staff  equivalents 
working  as  risk  assessors and risk managers326.  Approvals and renewals of approval of 
active  substances  are  estimated  to  account  for  23 %  of  these  resources,  at  a  cost  of 
EUR 10  million  (210  full-time  staff  equivalents).  For  MRL  procedures,  the  estimated 
costs for Member States are EUR 5 million. The costs should be covered by fees paid by 
industry, the exception being the MRL review programme where fees cannot be raised as 
an ad-hoc procedure has been established between Member States and EFSA to manage 
the unexpectedly high workload. 

Although fees can be recovered for most procedures, it is not clear if the fees are set at a 
level  that  actually  covers  the  costs.  There  are  large  discrepancies  between  the  fees 
charged  by  Member  States:  for  example,  Romania  charges  EUR 51 000  to  be  the 
rapporteur  Member  State  for  the  approval  of  a  new  active  substance  while  Austria 
charges EUR 350 000; Italy charges EUR 45 000 to be the rapporteur Member State for 
the  renewal  of  approval  of  an  active  substance  while  Sweden  charges  EUR 440 000327. 
While the cost of labour is different in the Member States, it seems that not all Member 

325 Using data from the support study p, 123 (44 months for the approval of a new active substance) and adding 12 months for the 

authorisation procedure in the Member States. 

326 The support study, p. 144. 
327 Annex 2 to the Support Study. 

66 

 
                                                 
States really charge high enough fees to cover their expenses. Many Member States have 
also decoupled the work to be carried out from the fees, i.e. the fees paid by industry are 
channelled  to  the  general  state  budget  rather  than  earmarked  for  the  authority(ies) 
carrying  out  the  work.  This  has  several  implications,  but  the  main  one  is  the  issue  of 
hiring enough staff to handle the workload. This finding is further supported by a recent 
report of the European Court of Auditors who found that the EU food safety system as 
regards  chemicals  (i.e.  not  only  pesticides  and  pesticide  residues)  is  over-stretched  and 
the Commission and Member States do not have the capacity to implement it fully328. 

The costs for the Member State authorities are not fairly distributed either. This is clearly 
illustrated  by  the  number  of  active  substances  evaluated  per  Member  State.  Smaller 
Member  States  in  terms  of  population  and  number  of  authorised  PPPs on  their  market, 
such as the Netherlands and Sweden, contribute over-proportionately to the functioning 
of the system. 

E
C
N
A
T
S
B
U
S
E
V
I
T
C
A

S
N
O
I
T
A
U
L
A
V
E

50 

40 

30 

20 

10 

0 

NL  FR  AT  IT  DE  ES  UK  SE  BE  CZ  EL  PL  FI  HU  IE  DK  EE  SI  LT  HR  BG  PT  NO  SK  LV  MT RO 

Figure  14.  Rapporteur  Member  State  distribution  for  approvals  and  renewals  of  approvals  of  active 
substances329  

There  are  clear  discrepancies  in  the  authorisation  of  PPPs,  with  some  Member  States 
serving  as  zonal  rapporteur  Member  State  disproportionately  often.  The  United 
Kingdom,  for  example,  received  a  high  number  of  applications  and  was  the  Member 
State with by far the highest number of decisions taken when acting as zonal rapporteur 
Member State. Comparing two Member States from the southern zone clearly illustrates 
that applicants choose France as zonal rapporteur Member State for evaluation 15 times 
more often than Spain330 (see Figure 15). This imbalance in the pattern of applications, 
and  the  difficulties  which  Member  States  have  in  cooperating  and  sharing  the  work, 
undermine the PPP Regulation’s aim to ensure a fair division of the workload. 

328 European Court of Auditors (2019) Special Report No 2: Chemical hazards in our food: EU food safety policy protects us but 

faces challenges (pursuant to Article 287(4), second subparagraph, TFEU). 

329 The Official Journal and summary reports from the Standing Committees on Plants, Animals, Food and Feed. 
330 European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

67 

 
 
                                                 
 
 
 
248 

35 

250

200

150

100

50

0

140 

199 

136 

3 

9 

9 

14 

5 

15 

9 

France

Germany

Lithuania

Portugal

Spain

United Kingdom

Applications received

Number of Decisions

Figure  15.  Number  of  applications  received  for  evaluation  (2013-2014)  and  number  of  authorisation 
decisions taken331 

For  approval  and  renewals  of  active  substances,  the  cost  for  EFSA  is  EUR 3.4  million 
and for the Commission EUR 2.2 million per year. The combined costs for EFSA and the 
Commission  for  MRL  procedures  are  estimated  at  approximately  EUR 3  million  per 
year332.  None  of  these  costs  are  covered  by  fees  from  applicants.  In  the  financial 
statement for the PPP Regulation333 it was expected that 13 full-time staff equivalents (9 
administrators  and  4  assistants)  could  carry  out  the  work,  but  in  2018  there  were  18.9 
full-time  staff  equivalents  working  with  the  implementation  of  the  Regulation  in  the 
Commission.  In  the  financial  statement  for  the  MRL  Regulation334,  5  full-time  staff 
equivalents  were  expected  to  carry  out  the  work,  but  in  2018  there  were  7.5  full-time 
staff equivalents working in the Commission with the implementation of the Regulation.  

In  addition to the work to implement  the Regulations, other legally required tasks bind 
significant  resources  in  the  Commission.  Such  tasks  include  responding  to  court  cases 
(25  since  2011)  and  complaints  to  the  Ombudsman  with  subsequent  investigations  (4 
since 2011), and access to document requests. In addition, Commission services reply to 
Parliamentary  questions  (699  between  2011  and  2017),  to  objections  by  Members  of 
Parliament  regarding  draft  Commission  Regulations  concerning  the  approval  of  active 
substances or  amendments  of MRLs (11  since  2015335),  and questions  from the special 
PEST  Committee  (65  questions  between  April  and  June  2018).  Finally,  Commission 
departments  reply  directly  to  individual  letters  from  citizens  and  to  petitions  from 
citizens,  the  replies  to  petitions  being  published  on  the  Commission’s  transparency 
portal336.  

Taken  together,  all  these  duties  divert  Commission  resources  away  from  implementing 
the regulations. This has contributed to delaying the Commission’s work on several tasks 
that were expected to have been implemented by now, such as the adoption of a list of 
unacceptable co-formulants, a work programme to establish a positive list of safeners and 
synergists, and MRLs for feed, fish and processed food.  

331 European Commission (2016) Overview report on a series of audits carried out in EU Member States in 2015 and 2016 in order 
to evaluate the control systems in place for the marketing and use of plant protection products. DG(SANTE) 2016-6004 — MR. 

332 The support study p. 137. 
333 Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on 

the market. COM/2006/0388. 

334 Proposal for a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in products of 

plant and animal origin. COM/2003/0117. 

335 This does not include the objection of the European Parliament to the criteria to identify endocrine disruptors in 2017. 
336 Transparency portal. 

68 

 
 
                                                 
Delays in the procedures for approval and renewal of approval 
Decisions on the approval of a new active substance under Directive 91/414/EEC could 
take more than 8 years337. This was because repeated submissions of data were invariably 
necessary  to  close  data  gaps  before  approval  decisions  could  be  issued.  To  increase 
efficiency  and  incentivise  speedy  evaluations,  the  possibility  to  grant  provisional 
authorisations  for  PPP  containing  new  active  substances  was  removed  from  the  PPP 
Regulation.  To  increase  efficiency  in  the  procedure  for  renewal  of  approvals  it  was 
decided to allow submission of new data only during very specific time windows during 
the  evaluation  process  and  only  at  the  request  of  a  Member  State  or  EFSA.  The 
Commission specifically laid down in Implementing Regulation 844/2012 governing the 
renewal process that any data submitted after the end of the second submission window 
cannot be taken into consideration338.  

Compared  to  Directive  91/414/EEC,  it  takes  less  time  to  evaluate  and  decide  on  the 
approval of new active substances under the PPP Regulation: procedures for decisions on 
the  approval  of  new  active  substances  take  on  average  3  years  and  7  months,  with  the 
longest  cases  taking  6  years339.  However,  the  time  taken  is  still  slower  than  required 
under the PPP Regulation, according to which it is supposed to take 3 years to reach the 
overall  approval  decision.  Furthermore,  an  unintended  effect  of  the  removal  of 
provisional  authorisations  has  been  the  use  of  emergency  authorisations  for  new  active 
substances that are ‘in the pipeline’. 

The  same  time  frame  of  three  years  applies  for  the  procedure  for  renewal  of  approval, 
which breaks down as follows: 

  6 months between the application for renewal of approval and the submission of the 

supplementary dossier 

  1 year for scientific evaluation by the  rapporteur Member State when assessing the 

supplementary dossier for renewal of approvals; 

  11 months for the peer review and the drafting of a conclusion by EFSA; 
  a  proposal  for  a  Commission  decision  through  the  comitology  procedure  within  6 

months of receipt of the EFSA conclusion. 

In reality, delays occur at almost every step of the process, from the risk assessment by 
the  Member  States,  during  peer  review  and  adopting  conclusions  by  EFSA,  to  the  risk 
management by the Commission and Member States. Consequently, repeated extensions 
of  the  approval  periods  are  necessary  to  finalise  the  scientific  evaluation  and  decision-
making process for renewals. Extensions of approval were also granted in the transition 
period  between  Directive  91/414/EEC  and  the  PPP  Regulation  to  enable  applicants  to 
prepare  their  applications  according  to  the  new  format  and  data  requirements.  These 
extensions  are  heavily  criticised  by  NGOs  and  the  European  Parliament340,  and  the 
Ombudsman has opened an inquiry following a complaint by an NGO. As a result of the 
delays,  as  of  October  2018,  not  a  single  active  substance  has  been  renewed  within  the 
initial 10-year approval period. 

337 The support study p. 7. 
338 Article 13(5) of Regulation (EU) No 844/2012. 
339 The support study p. 123. 
340  European  Parliament  (September  2018)  Report  on  the  implementation  of  the  Plant  Protection  Products  Regulation  (EC) 

No 1107/2009. 

69 

 
 
                                                 
The four most difficult deadlines to meet for renewals are: 

(i) The 30-day deadline  for the rapporteur Member State to check the admissibility of 
application(s) and supplementary dossier(s). The result is an administrative check where 
Member States accept poor quality and sometimes data-deficient dossiers and later accept 
additional studies to make up for the data gaps encountered during evaluation. 

(ii) The 12-month period for the rapporteur Member State to assess the supplementary 
dossier and draft the renewal assessment report. During this period, Member States may 
ask  for  additional  information  but  the  period  cannot  be  extended.  About  10 %  of  the 
active  substances  are  evaluated  on  time  (see  Figure  16),  while  the  rest  have  varying 
degrees  of  delays,  with  some  being  severe.  Figure  16  below  presents  the  delays  by the 
rapporteur Member States for completing the risk assessment for the renewal of approval 
of active substances. It shows for example that 10 active substances have been evaluated 
with a nine-month delay, i.e. the time for those Member States to finalise the scientific 
assessment  took  in  total  21  months.  For  6  active  substances  Member  States  are  30 
months or more late in delivering the draft renewal assessment report. 

Since 2016, the Commission has repeatedly reminded Member States of their obligations 
to keep to the legal deadlines for assessing active substances. Despite these reminders, no 
improvement has occurred; on the contrary, the delays continue to increase. 

20

15

10

5

0

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-3

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3

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12

15

18

21

24

27

30

33

MONTHS DELAY 

Figure 16. Number of months delay as of October 2018 for Member States to deliver the draft renewal 
assessment report. Data on 205 active substances for which the supplementary dossier was submitted 
between 2012 and 2017. The size of the bubbles is proportionate to the number of active substances 
concerned;  the  darker  the  colour,  the  longer  the  delay.  Calculations  made  by  the  European 
Commission. 

In  February  2017  the  Commission  sent  a  letter  to  all  Member  States  that  were  behind 
schedule, asking for explanation as to why the draft renewal assessment reports were not 
delivered  on  time.  In  response,  Member  States  reported  the  following  reasons 
contributing  to  the  delays.  These  show  that  there  is  no  one  single  factor  behind  the 
delays, but rather a systemic failure: 

  The  12-month  assessment  period  to  prepare  a  draft  renewal  assessment  report  of  a 
high  standard  is  insufficient  without  a  ‘stop-the-clock’341  possibility.  The  data 
requirements have  been updated and the expected  level  of details  in the assessment 
reports  is  considerably  higher  than  in  the  past.  Recent  additional  requirements, 

341  The  stop-the-clock  procedure refers  to  the  possibility for the  Member State  to  ’pause’  the  legal  time  and  ask  the  applicant for 

more data. 

70 

 
 
                                                 
 
 
 
 
updated  through  guidance  documents,  include  the  following  areas:  metabolites, 
residue  definition,  impurities,  technical  specification,  endocrine  effects,  water 
treatment  processes,  bees,  genotoxicity,  assessment  of  open 
literature  and 
increasingly  complex  higher  tier  environmental  studies.  Furthermore,  there  are 
several  cross-cutting  areas  where  EFSA  has  produced  scientific  opinions,  such  as 
those on weight of evidence and biological relevance that may also have an impact on 
the  complexity  of  assessments.  As  a  result,  the  workload  per  assessment  report  has 
increased but the timelines for the assessments have not been adapted to reflect this. 
Some  very  large  dossiers,  such  as  for  glyphosate,  demand  extraordinary  resource 
requirements. 

  Dossiers are sometimes of low quality and studies are missing or not reported to the 
required  standard.  Applicants  then  submit  additional  studies  during  the  assessment, 
which  delays  the  process.  In  some  cases  the  applicant  does  not  have  access  to  the 
original  dossier  for  the  first  approval  and  therefore  cannot  provide  a  fully  updated 
assessment for the active substance in question. 

  The  necessity  to  re-assess  old  studies  was  not  laid  down  in  the  Renewal 
Regulation342.  EFSA  requests  in-depth  re-evaluation  of  almost  all  old  data  in  line 
with new data requirements and international protocols, plus an updated presentation 
of the results. Re-opening previously submitted studies is sometimes indispensable in 
order to conclude on the risk assessment, but should not always be required. 

  Supplementary  dossiers  submitted  for  renewal  of  approvals  were  expected  to  be 
‘lighter’  as  they  were  only  an  update  on  top  of  the  original  dossier.  In  reality  they 
have  proven  to  be  of  similar  size,  or  sometimes  larger  and  more  complex,  than 
dossiers  for  new  active  substance  approvals.  The  assessment  of  relevant  open 
literature and datasets greatly increases the time the Member State needs to complete 
the process. 

  Multiple applicants who submit separate dossiers significantly increase the workload, 
while  the  timeline  laid  down  for  preparing  the  draft  renewal  assessment  report 
anticipates only a single application. 

  The  risk  assessment  requires  expertise,  which  is  not  easy  to  find.  This  is  a 
considerable challenge, especially for small Member States. Training experts is costly 
and time consuming, while outsourcing is not a viable short-term solution due to the 
very  specific  expertise  required.  Moreover,  new  developments  make  continuous 
training  necessary  to  ensure  that  experts  can  perform  assessments  that  reflect  the 
latest scientific and technical knowledge. Also, since the number of active substances 
allocated  to  some  Member  States  tends  to  fluctuate,  those  Member  States  find  it 
difficult to manage the human resources working on the assessments. 

  Aligning  the  risk  assessment  process  with  the  Classification,  Labelling  and 
Packaging Regulation is a significant additional burden and is affecting an increasing 
number of substances. 

(iii)  The  two-month  period  for  the  rapporteur  Member  State  to  evaluate  additional 
information during the peer-review process. During the peer-review process, EFSA may, 
following consultation with the rapporteur Member State and the co-rapporteur Member 
State, request additional information from the applicant, setting a deadline of 1 month for 
the  applicant  to  provide  such  information.  The  rapporteur  Member  State  then  has  2 
months to evaluate the additional information and update the renewal assessment report. 

342  Commission  Implementing  Regulation  (EU)  No  844/2012  setting  out  the  provisions  necessary  for  the  implementation  of  the 

renewal procedure for active substances 

71 

 
                                                 
In  many  cases,  the  number  of  additional  requests  is  significant.  For  example,  for  the 
active substance chlorpyrifos there were 162, 98 and 90 points of additional information 
requested from 3 applicants. The additional information submitted to the Member States 
is  extensive  and  requires  far  more  time  than  the  two-month  period  allowed  for  by  the 
legislation. In some cases, entire sections need to be re-written and the risk assessments 
completely re-performed. This leads to severe delays. 

(iv) The six-month deadline for the Commission covers preparation of the draft renewal 
report and a draft Regulation deciding on the renewal (or not) of the approval of an active 
substance. While the Commission presents a review report within the 6 months in 75 % 
of cases343, adoption of the implementing Regulations to renew (or not) the approval of 
active substances takes between 7.5 months and 3 years, with an average of 15 months344. 
This leads inevitably to the extension of the approval periods. To avoid this it would be 
necessary  to  conclude  the  entire  process  including  the  adoption  of  the  decision  within 
6 months.  This  has  proven  to  be  unrealistic  given  that  the  internal  Commission 
procedures for  preparing a formal draft Regulation and adopting it after the vote in the 
Standing  Committee  take  already  about  3  months.  For  many  substances,  extensive 
discussions are necessary in the Standing Committee to secure the necessary support for 
the  draft  Regulation.  In  a  growing  number  of  problematic  cases,  Member  States’ 
positions (or absence of positions) have led to the votes resulting in ‘no opinion’, which 
makes it necessary for the Appeal Committee to meet, causing further delays. 

As  described  at  the  beginning  of  this  section,  the  decision  to  only  allow  submission  of 
new data during very specific time windows in the renewal process was well intended for 
historical  reasons,  but  the  unintended  negative  consequences  have  proven  to  outweigh 
the  benefit  of  having  a  streamlined  process.  There  have  been  several  cases,  such  as 
flurtamone  and  fosetyl,  where  the  rapporteur  Member  State  has  accepted  a  complete 
dossier and performed a scientific assessment recommending renewal of approval, only 
for EFSA to identify data gaps following the peer review. At that moment in time, such 
data gaps cannot be addressed by the applicant — even though the relevant studies may 
exist. If the uncertainties are significant, the approval of the active substance may not be 
renewed, the only option for the applicant being to re-apply to have the active substance 
approved as a new active substance. This would create considerable (unnecessary) work 
for  the  Member  States,  EFSA  and  the  Commission  and  come  at  significant  cost  to  the 
applicant. Analysis of the workflow shows that the problems relate to: 

 

 

the late involvement by EFSA and sometimes by other Member States, who identify 
more data gaps than the rapporteur Member State;  
the rigidity of the system, which does not allow information to be accepted at a late 
stage  to  close  data  gaps  identified  late  in  the  process  or  outside  the  permitted 
submission  period  during  the  peer-review  process.  The  fact  that  new  information 
cannot be taken into consideration even when it could solve a critical area of concern 
for  an  active  substance  is  then  a  source  of  delays  in  the  decision-making  process 
described before. 

The  problem  with  regulating  PPPs  efficiently  is  not  unique  to  the  EU.  Canada 
experiences  similar  problems  due  to  limited  resources  coupled  with  the  requirement  to 
periodically review the registration of active substances and products. This has become 
increasingly  demanding  and  unsustainable  in  the  long  term  in  view  of  the  resources 

343 Calculated for 60 active substances where data were available. 
344 Calculated for 52 active substances where data were available. 

72 

 
                                                 
required.  The  workload  pressures  are  impacting  the  performance  of  the  evaluating 
authority, as well as the ability of the authority to respond to stakeholders’ expectations 
and  react  to  emerging  issues.  To  manage  the  situation,  the  Canadian  authorities  are 
prioritising  the  evaluation  of  the  most  hazardous  active  substances  and  have  started  a 
process to review the activities relating to the pesticide re-evaluation programme with a 
view to increasing both the efficiency and the effectiveness.  

Another point of comparison is the United States (see section 2.3 on the baseline — other 
points  of  comparison),  as  the  US  system  is  considered  by  industry  in  the  EU  as  more 
efficient and predictable. The US system seems to allow for a more narrow and focused 
renewal assessment in which it is determined if new data are needed and what data are 
needed  upfront,  in  US  parlance  this  is  called  ‘data-call  in’.  As  identified  above,  one  of 
the reasons for the delays in the EU is that the rapporteur Member States often needs to 
re-assess  at  least  parts  of  old  dossiers  during  the  risk  assessment;  in  the  US  the 
Environmental Protection Agency decides earlier whether this is necessary. In addition, 
while  in  the  EU  system  the  need  for  further  data  often  only  emerges  during  the  peer-
review process and the time available at that stage often does not allow the applicant to 
submit  all  the  required  additional  information  to  alleviate  possible  concerns,  in  the 
United States it is decided upfront what new data are needed from the applicant. Indeed, 
one of industry’s main criticisms of the EU system is that it is unpredictable. 

Considering available data for re-registration process, the US system is not necessarily a 
more efficient way of evaluating active substances. According to a report in 2007, in the 
US,  the  median  time  for  the  re-registration  process  was  30  months  and  the  average 
54 months  indicating  that  the  distribution  is  skewed  with  some  assessments  being 
relatively straightforward while others require considerable resources345. More recently, 
the US EPA estimated346 that the average review period is 6 years. In the EU, the renewal 
of  approval  of  the  active  substance  has  taken  on  average  43  months  and  in  addition  it 
takes 12 months for re-authorisation of the PPP, i.e. a minimum of 55 months. Also in 
the  EU,  there  is  high  variability  between  active  substances  due  to  their  complexity. 
Similar to the EU, the US struggles with considerable backlog and severe delays during 
the re-registration process. One of the sources of delay are the responses to the data call-
in, which require a lot of time for the registrants to prepare and submit, as well as for the 
Agency  to  receive,  track,  review,  and  respond  to  (if  required).  These  are  the  same 
problems  as  identified  in  the  EU.  Another  issue  is  also  the  quality  of  data  from 
registrants, and in order to fill data gaps additional time is required for the registrant to 
prepare  and  submit  studies  and  for  the  Agency  to  review  them.  Thus,  considering  the 
problems identified and looking at available data, it is difficult to give a definitive answer 
as  to  how  much  more  efficient  the  US  system  is,  if  at  all.  Moreover,  several  of  the 
inefficiencies  identified  in  the  EU  system  can  be  solved  by  better  cooperation  between 
the  Member  States  and  EFSA.  Earlier  involvement  by  EFSA  (in  e.g.  pre-submission 
meetings)  could  also  solve  certain  issues  —  some  which  are  already  addressed  by  the 
proposal to amend the General Food Law Regulation. 

When  comparing  to  the  Biocidal  Products  Regulation  in  the  EU,  it  emerges  that  the 
evaluating  authorities  are  facing  similar  or  even  more  severe  delays  in  the  work  to 
implement the Biocidal Product Regulation. In fact, originally, the review programme of 
all  existing  active  substance  on  the  market  was  intended  to  be  completed  in  10  years 

345 Environmental Protection Agency (2007) Evaluation of the U.S. EPA Pesticide product Reregistration Process: Opportunities for 

Efficiency and Innovation. 

346 Estimate provided by the US EPA during a meeting with the Commission services on 2-3 April 2019. 

73 

 
                                                 
(from  2004  to  2014),  but  had  to  be  extended  by  10  years  when  the  Biocidal  Products 
Regulation was adopted. So far, it is not assured that the new deadline will be met as the 
delays for evaluating Member States to submit the assessment reports keep growing. For 
new  active  substances,  the  procedure  for  approval  takes  on  average  44  months,  again 
longer than foreseen in the Regulation. This is far better than under the previous Biocidal 
Products  Directive  were  dossiers  for  new  active  substances  were  assessed  on  average 
within 62 months with a minimum of 35 months and maximum up to 122 months. 

However, the Biocidal Products Regulation is more efficient during the risk management 
phase. One reason is that the risk assessment results in a single opinion by the Biocidal 
Products Committee of the European Chemicals Agency (ECHA) composed of Member 
States experts, rather than dual outputs of a rapporteur Member State Assessment Report 
and  EFSA  Conclusions  under  the  PPP  Regulation.  While  there  are  often  lengthy 
discussions in the Standing Committee for Plants, Animals, Food and Feed on approvals 
of  active  substances,  in  general  under  the  Biocidal  Products  Regulation,  most  of  the 
decisions on the approval of active substance proposed by the Commission were swiftly 
and  unanimously  supported  by  the  Member  States  in  the  Standing  Committee  on 
Biocidal Products. 

In conclusion, this comparison is intended to demonstrate that complex and demanding 
legislation  such  as  the PPP  Regulation  is  challenging  to  manage  in  view  of  the  limited 
resources  available  –  but  similar  problems  exist  for  other  comparable  legislation  in  the 
EU and also in other jurisdictions. 

Efficiency of the cut-off criteria 
The cut-off criteria were introduced with the PPP Regulation to increase the protection of 
human health and the environment (see section 5.1.1 for an in-depth discussion of these). 
The  cut-off  criteria  were  also  expected  to  reduce  the  workload  for  the  evaluating 
authorities  by  reducing  the  need  for  full  assessments  since  such  substances  would  be 
identified early and the assessment would be limited. However, this efficiency gain has 
materialised only for the 13 active substances for which no applications for renewal were 
submitted  and  where  no  evaluation  needed  to  be  carried  out.  For  the  other  eight  active 
substances meeting the cut-off criteria, the workload for Member States was the same as 
when  Member  States  conduct  full  risk  assessments,  or  higher,  although  a  step-wise 
approach was envisaged347. 
Derogations348 can be applied for several of the cut-off criteria. In combination with the 
absence of initial harmonised classification, this has led to increased workload and delays 
in the assessment of active substances. To illustrate this, in the case of bromoxynil there 
was  no  harmonised  classification  for  any  of  the  cut-off  criteria  in  place  when  the 
applicant submitted the dossier, and the rapporteur Member State did not propose a new 
harmonised  classification.  However,  after  the  peer  review,  EFSA  considered  a 
classification  according  to  which  the  substance  would  fall  under  the  cut-off  criteria  (as 
toxic for reproduction category 1B) to be more appropriate. Consequently, the applicant 
had to be given the possibility to demonstrate whether the derogation possibilities could 
apply,  and  the  evidence  submitted  had  to  be  assessed.  This  made  an  additional  peer 
review  necessary  before  EFSA  could  publish  a  conclusion  on  the  outcome  of  the  peer 

347 According to the second subparagraph of Article 4(1) of Regulation (EC) No 1107/2009. 
348  Very  limited  derogation  possibilities  exist  for  active  substances  where  the  applicant  demonstrates  that  exposure  is  negligible 
(Annex  II  to  the  PPP  Regulation),  or  where the  active  substance  is  needed  in  order  to  control  a  serious  danger to  plant  health 
which cannot be contained by other available  means (Article 4(7) of the PPP Regulation). No derogation possibilities exist for 
active substances that are classified as mutagenic 1A or 1B, or for active substances that are POP, PBT or vPvB. 

74 

 
                                                 
review.  Naturally,  this  process  took  longer  than  initially  envisaged  and  more  resources 
were  required  than  first  expected.  Similar  delays  were  incurred  for  pymetrozine  and 
flupyrsulfuron-methyl. 

In  addition,  the  decision-making  on  the  renewal  of  approval  of  the  active  substance 
flumioxazin  was  affected  by  delays  owing  at  least  in  part  to  the  absence  of  agreed 
guidance  to  assess  negligible  exposure  and  the  delayed  finalisation  of  the  protocols  to 
assess a serious danger to plant health349. 

Rather  than  simplifying  the  scientific  evaluation  by  the  Member  States,  the  cut-off 
criteria have thus led to an increase in the workload and delays in the system, which have 
increased the costs of the procedure. 

Delays in authorising PPPs 
The authorisation process for PPPs in Member States is also affected by severe delays, 
with  legal  deadlines  in  the  PPP  Regulation  for  granting  authorisations  for  PPPs  being 
exceeded for all types of authorisations. Mutual recognition is particularly affected, with 
the compliance rate with legal deadlines in some Member States being below 5 %. This 
results  in  delayed  or  reduced  access  to  pest-control  tools  for  growers,  while  the 
availability of PPPs varies among Member States, even for those in the same zone. Such 
delays clearly reduce efficiency and might also affect the effectiveness of the Regulation 
in reaching its objectives as PPPs may remain on the market under earlier authorisations 
although  the  conditions  of  authorisations  would  need  to  be  tightened.  The  legal 
requirement for systematic re-authorisation of all PPPs following a renewal of approval 
of an active substance increases the pressure on an already overloaded system350. 

The most problematic delays are those in mutual recognitions and when authorising PPPs 
as concerned Member State within a zone. There is consensus among Member States that 
more time  is  needed. The envisaged deadline  is 4 months but  in reality Member States 
take  on  average  10  months.  In  some  Member  States  there  are  cases  where  it  has  taken 
more  than  2  years  to  authorise  a  PPP  through  mutual  recognition  or  as  a  concerned 
Member State. Another particularly problematic procedure is the re-authorisation of PPPs 
after  the  renewal  of  approval  of  their  active  substance.  This  is  because  the  re-
authorisation  should  be  granted  9  months  following  the  application  for  authorisation 
which needs to be submitted at the latest 3 months following the renewal of approval of 
the active substance. It is difficult for the Member States to plan their work because it is 
unpredictable  when  the  re-approval  decision  will  be  made  at  EU  level.  As  with  the 
renewal of active substances, re-authorisation is more burdensome than expected because 
of  the  need  to  consider  requirements  on  additional  new  information  or  higher  tier  tests 
that are not available at the time of the first authorisation. On top of the problems with 
the  procedure  per  se,  Member  States  also  fear  that  with  the  increasing  number  of 
renewals in the pipeline they will be overloaded with work and unable to deal with other 
procedures. 

Delays  also  occur  in  situations  where,  following  an  initial  negative  conclusion  on  an 
evaluation,  applicants  are  allowed  multiple  opportunities  to  submit  further  studies  to 
satisfy  the  requirements351.  Member  States  explained  that  they  request  additional 

349  The  guidance  document  on  the  derogations  for  ‘negligible  exposure’  has  not  been  finalised  (as  of  October  2018).  The  EFSA 
protocols  for  the  evaluation  of  active  substances  to  control  a  serious  danger  to  plant  health  were  finalised  in  July  2016  for 
herbicides, in April 2017 for insecticides and in December 2017 for fungicides. 

350  European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

351 Ibid. 

75 

 
                                                 
information  during  mutual  recognition  because  the  quality  of  the  dossier  is  poor  or 
because  it  is  outdated  when  the  application  is  submitted.  This  is  despite  mutual 
recognition  applying  to  all  existing  authorisations,  including  those  based  on  approvals 
under Directive 91/414/EEC, as confirmed by a national court in Germany352.  

This  failure  to  fully  use  the  possibilities  offered  by  the  zonal  system  and  mutual 
recognition is all the more deplorable given that: (i) in 56 % of cases, the authorisation 
granted by the concerned Member State or through mutual recognition remained identical 
to that granted in the Member State of origin; and (ii) in 27 % of cases, the PPPs were 
authorised  with  different  risk  mitigation  measures.  As  a  result,  in  most  cases 
authorisation  is  delayed  beyond  the  deadlines,  even  though  the  outcome  of  the  extra 
evaluation conducted by the concerned Member States is either the same or very similar 
to the original authorisation353. 

As  described  in  section  5.1.4,  there  are  particular  difficulties  with  mutual  recognition 
reported  in  the  central  zone.  This  has  been  somewhat  counterbalanced  by  the  United 
Kingdom, which is the Member State with by far the highest number of decisions taken 
when acting as zonal rapporteur Member State. This offsets to some extent the problems 
in  the  central  zone  by  allowing  applicants  to  apply  for  mutual  recognition  of  the 
authorisations  in  other  Member  States  of  the  central  zone354.  In  fact,  benefits  do 
materialise  for  those  Member  States,  as  seen  in  section  5.1.5:  Member  States  who  use 
mutual recognitions to a large extent have also increased the number of available PPPs 
on their national market the most. 

Efficiency of the MRL procedures 
Overall, stakeholders and Member States consider that the procedure to establish MRLs 
is  efficient  and  that  the  benefits  outweigh  the  costs.  On  average,  an  application  to 
establish MRLs is addressed (i.e. the MRLs become applicable) within 24 months from 
its submission. However, the length of the process varies greatly depending on how fast 
the  evaluating  Member  State  assesses  the  application.  While  the  MRL  Regulation 
specifies clear deadlines for EFSA and the Commission, it does not set out a timeline for 
the  evaluating  Member  State.  This  makes  the  overall  process  unpredictable.  Moreover, 
applications are often submitted incomplete and the assessment is put on hold either by 
the evaluating Member State or by EFSA pending the submission of the missing data. In 
this  case  also,  no  deadline  for  submission  is  specified.  To  address  these  issues,  the 
Commission has recommended that the evaluating Member State complete the evaluation 
of  an  application  within  12  months  (plus  6  months  if  the  applicant  has  to  submit 
additional  data).  Where  it  is  clear  that  the  applicant  cannot  fulfil  the  data  requirements 
within  a  reasonable  period,  the  evaluating  Member  State  should  contact  the  applicant, 
requesting that it withdraws the application. 

As the MRL Regulation does not provide means to promote minor uses, the Commission 
and  Member  States  have  developed  a  guideline  on  the  extrapolation  of  MRLs355.  An 
example  of  how  the  extrapolation  of  MRLs  works  is  presented  in  Table  9.  For  minor 
crops,  the  applicant  must  perform  four  residue  trials  only,  whereas  for  major  crops  a 
minimum of eight trials is required. 

352 Summary of the two judgments in German. (Aktenzeichen: 9 A 27/16; 9 A 28/16). 
353 European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

354 Ibid. 
355  European  Commission  (2017),  Guidelines  on  comparability,  extrapolation,  group  tolerances  and  data  requirements  for  setting 

MRLs (SANCO 7525/VI/95 Rev. 10.3). 

76 

 
                                                 
Table 9. Example of extrapolation alternatives from major to minor crops 

Bulb vegetables 

onions 

leeks 

onions 

→ 

→ 

→ 

garlic 

shallots 

spring onions/green onions and Welsh onions 

Whole group of bulb vegetables 

The Regulation does not offer any guidance or flexibility in cases where an application is 
made to set an MRL for a minor crop on the basis of extrapolation from a major crop; to 
remedy  this,  a  fast-track  procedure  was  agreed  with  the  Member  States  ad  hoc.  In  this 
simplified procedure, neither a thorough evaluation report nor an EFSA reasoned opinion 
is needed. Overall, the above described measures were introduced to ensure that MRLs 
could be set faster for minor uses. 

In exceptional cases, MRLs can be set on the basis of monitoring data. However, there 
are  no  provisions  outlining  how  this  should  be  carried  out,  so  decisions  are  taken  on  a 
case-by-case  basis.  Furthermore,  such  situations  are  addressed  by  setting  temporary 
MRLs,  which  have  a  maximum  validity  of  10  years.  This  may  be  inappropriate  for 
addressing certain cases of environmental contamination for persistent substances where 
only  a  permanent  MRL  would  provide  for  a  solution  in  the  long  term  and  where  no 
reductions  are  expected  in  a  time  span  of  10  years.  The  automatic  lowering  of  the 
temporary  MRLs  may  cause  difficulties  where  new  monitoring  data  are  submitted  at  a 
late  stage  to  extend  the  validity  of  the  MRL.  This  is  because  the  overall  MRL-setting 
process  takes  time  and  the  lowering  of  the  temporary  MRL  needs  to  be  prevented  by 
applying retroactive application dates in an MRL measure356. The Commission recently 
started  setting  deadlines  for  the  submission  of  new  data  by  the  applicants  concerned 
rather than applying an expiry date to the temporary MRL. 

The current provisions are somewhat inflexible since the MRL-setting process is always 
triggered by the submission of an application. This prevents the Commission from taking 
the initiative, even in cases where new information is available that points to the need for 
a  review  of  an  existing  MRL  related  to  a  public  health  concern  and  an  EFSA  opinion 
confirms such a concern. Legal clarifications became necessary, delaying the procedures 
and thus decreasing overall efficiency. 

Moreover,  even  when  immediate  action  is  needed,  EFSA  still  has  to  issue  a  thorough 
scientific  opinion.  In  fact,  the  MRL  Regulation  considers  EFSA  as  the  only  competent 
authority  in  matters  of  food  safety.  It  does  not  provide  for  the  possibility  to  consider 
assessments  carried  out  by  other  European  agencies  such  as  the  European  Medicines 
Agency . This causes duplication of work when setting MRLs for substances used both in 
plant protection products in and veterinary medicinal products (see also section 5.1.7. on 
enforcement) 357. 

The procedure to review MRLs is considered by stakeholders and Member States to be 
less  efficient  than  the  procedure  to  establish  MRLs  and  the  main  reasons  of  this  lower 

356 See Article 2 of Commission Regulation (EU) No 241/2013 of 14 March 2013 amending Annexes II and III to Regulation (EC) 
No 396/2005  of  the  European  Parliament  and  of  the  Council  as  regards  maximum  residue  levels  for  chlorantraniliprole, 
fludioxonil and prohexadione in or on certain products (OJ L 75, 19.3.2013, p. 1). 

357 Commission Regulation (EU) 2017/623 of 30 March 2017 amending Annexes II and III to Regulation (EC) No 396/2005 of the 
European Parliament and of the Council as regards maximum residue levels for acequinocyl, amitraz, coumaphos, diflufenican, 
flumequine, metribuzin, permethrin, pyraclostrobin and streptomycin in or on certain products (OJ L 93, 6.4.2017, p. 1). 

77 

 
 
                                                 
efficiency  are  the  delays  in  the  procedure  and  the  insufficient  alignment  with  the  PPP 
Regulation358. 

The MRL review is a tool to: 
 

take stock of the authorised uses in plant protection of a given active substance per 
crop across the EU; 

  ensure  that  all  critical  uses  are  supported  by  data  according  to  the  pertinent  data 

requirements; 

  align the legislation with international standards, where appropriate; and 
  ensure that all MRLs are sufficiently protective for European consumers. 

The implementation of the MRL review was initially hampered by a number of factors: 
(i) the formal lack of involvement of Member States in the review process; (ii) the need 
to establish a working procedure to collect and assess the relevant information; (iii) the 
absence of empowerment of the Commission to put in place implementing Regulations in 
this regard; and (iv) the unrealistic timeline to complete the review of all MRLs existing 
at the time when the Regulation became applicable. The first two issues have since been 
addressed  through  voluntary  involvement  of  the  Member  States  and  pragmatic 
arrangements  between  Member  States,  EFSA  and  the  Commission.  However,  the 
Member States cannot request fees to cover their resource needs and the lack of such an 
incentive further delays the overall process. Also the resources attributed to EFSA are not 
sufficient  to  meet  the  tight  deadlines.  Currently,  MRL  reviews  for  about  24  substances 
are completed per year and overall about half of all MRLs have been reviewed so far. 

A  major  cause  of  inefficiency  of  the  MRL  review  procedure  is  the  lack  of  integration 
with the periodic renewal of the approval of active substances under the PPP Regulation. 
The toxicological reference values agreed in the peer review of the approval/renewal of 
approval  assessment  are  an  important  input  for  the  MRL  review,  and  revisions  to  the 
approval  conditions  may  affect  the  authorisations  of  PPP  for  use  on  certain  crops. 
Therefore,  the  timing  of  the  MRL  review  relative  to  the  various  procedures  under  the 
PPP Regulation is crucial to maximise the benefit from the MRL review and to prevent 
MRL review results becoming obsolete. Here also, the absence of empowerment of the 
Commission to put in place implementing Regulations addressing the interplay between 
the PPP Regulation and the MRL Regulation hampers more efficient implementation. A 
pragmatic approach was agreed between the Commission, EFSA and the Member States 
to minimise inconsistencies: MRL reviews are now scheduled after the renewal process 
so  as  to  take  into  account  the  possible  new  toxicological  reference  values  and  new 
residue  definition  recommended  by  EFSA  after  the  peer  review  of  the  renewal 
assessment. This, however, obviously further delays the MRL review process. 

5.2.3. Benefits to human health and to the environment 

A  full,  comprehensive  quantification  of  the  health  and  environmental  benefits  of 
applying the approval criteria in the PPP Regulation was not possible due to problems in 
assessing  causality  (see  sections  5.1.1  and  5.1.2359).  Nevertheless,  the  non-approval  of 
substances  on  health-based  criteria  has  contributed  to  avoiding  risks,  e.g.  from 
genotoxicity, toxicity to reproduction, carcinogenicity or acute poisoning. Similarly, the 

358 The support study, p. 138. 
359  A  cost-benefit  analysis  of  the  kind  carried  out  for  the  REACH  Regulation  could  not  be  carried  out  for  the  PPP  and  MRL 
Regulations as data on actual use are not accessible. For REACH, the health benefits were estimated at EUR 700 million per year 
due to a reduction of exposure to e.g. mercury and lead. However, that report also acknowledged that a number of benefits could 
be  qualitatively  assessed  only.  Ref:  ECHA  (2016)  Cost  and  benefit  assessments  in  the  REACH  restriction  dossiers.  doi: 
10.2823/57600. 

78 

 
                                                 
non-approval  of  substances  due  to  environmental  concerns  has  led  to  the  avoidance  of 
risks to groundwater, soil and wildlife. 

Several economic studies have tried to quantify the costs of using PPPs on healthcare and 
on  the  environment,  e.g.  due  to  loss  of  biodiversity.  The  problem  in  relying  on  these 
studies for this evaluation is that they are either old or use old data which actually capture 
the  effect  of  Directive  91/414/EEC.  Compared  to  the time  when  Directive  91/414/EEC 
was  in  force,  i.e.  the  baseline,  more  than  50 %  of  all  active  substances  have  been 
removed  from  the  market.  Thus,  the  expected  economic  benefits  such  as  reduced 
healthcare costs and reduced costs for remedying environmental damage started already 
under  Directive  91/414/EEC.  The  PPP  Regulation  is  sustaining  and  fostering  those 
benefits through the implementation of strict approval criteria. A (rough) estimate of the 
health  benefits  has  been  made  based  on  one  study360  assessing  the  health  impact  and 
damage costs of pesticides in the EU (see section 5.1.1 for further details). According to 
our  calculations  (see  Annex  3),  the  non-approval  and  withdrawal  of  five  active 
substances361 under the PPP Regulation has contributed to annual cost savings of about 
EUR 38.5 million for human health. These are the benefits that could be quantified and 
covers  only  a  few  active  substances  non-approved  in  the  EU  since  2011.  The  overall 
benefits  are  expected  to  be  considerably  larger.  To  give  a  flavour  of  the  magnitude  of 
costs versus benefits, the quantified benefits of EUR 38.5 million can be compared with 
the  costs  spent  on  the  renewal  of  approval  of  the  five  active  substances  which  is 
calculated at EUR 6.6 million362. This comparison shows that the benefits in these cases 
outweigh the costs incurred by the PPP Regulation for non-renewals of approvals.  

The setting of MRLs at safe levels is also expected to have generated positive monetary 
benefits  for  human  health,  but  these  could  not  be  quantified.  Quantification  of  these 
benefits  was  not  possible  as  there  is  a  very  high  number  of  different  possible 
combinations between substances, crops, and MRLs. An aggregation of the effects of the 
different MRLs on human health cannot be performed, and exploring the health effects of 
single substance residues on specific crops would not provide a complete picture.363 

As  described  in  section  5.1.2,  the  use  of  PPPs  has  been  identified  as  one  of  the 
contributing factors to the decline in bee populations, although the magnitude of its role 
is  unknown  and  most  likely  varies  between  regions.  The  multiple  reasons  behind  the 
decline  in  bees  make  it  impossible  to  estimate  the  benefit  of  restricting  the  use  of 
pesticides  harmful  to  bees,  such  as  the  three  neonicotinoids  imidacloprid,  clothianidin 
and  thiamethoxam.  However,  the  restrictions  can  be  expected  to  contribute  to  an 
improvement  in  pollination  services,  which  overall  are  estimated  to  generate  economic 
benefits of around EUR 15 billion per year in the EU364. 

The  impact  assessment  accompanying  the  proposal  for  the  PPP  Regulation  estimated 
costs  of  treating  drinking  water  at  EUR 30  million  in  the  Netherlands365  and  EUR 184 
million  in  the  United  Kingdom366.  Recent  estimations  of  the  costs  of  treating  drinking 
water  in  the  EU  are  scarce  and  this  evaluation  did  not  identify  any  relevant  studies 

360 Fantke, P., Friedrich, R., and Jolliet, O., (2012) Health impact and damage cost assessment of pesticides in Europe. Environment 

International Vol 49, p 9-17. https://doi.org/10.1016/j.envint.2012.08.001. 

361 amitrole, glufosinate, linuron, methomyl and propineb. 
362 See Annex 3 for calculation and further explanation.  
363 The support study, p. 136. 
364 European Commission (2018c). EU Pollinators Initiative. Communication from the Commission to the European Parliament, the 

Council, the European Economic and Social Committee and the Committee of the Regions. COM(2018) 395. 

365  Kiwa  N.V  Water  Research  2004:  Door  drinkwaterbedrijven  gemaakte  kosten  als  gevolg  van  bestrijdingsmiddelgebruik, 

Nieuwegein, p 3. 

366  DEFRA  2003,  Partial  Regulatory  Impact  Assessment:  Groundwater  Proposals  under  Article 17  of  the  Water  Framework 

Directive, p12. 

79 

 
                                                 
published after 2011. However, as reported in section 5.1.2, monitoring the occurrence of 
pesticides  in  surface  water  suggests  that  implementation  of  the  PPP  Regulation  has 
brought some improvements, and this trend is expected to continue. As a result, the cost 
of removing pesticides from drinking water is likely to have decreased in the EU since 
the baseline period, i.e. before 2011. 

5.2.4. Societal and agricultural benefits and costs related to PPPs in the EU 
The agricultural sector provides benefits in the EU, some of which accrue from the use of 
PPPs. The quantity and quality of food produced in the EU may be dependent on the use 
of  effective  PPPs.  There  is  a  high  demand  for  fresh  produce  free  of  marks,  spots  and 
dents and with a long shelf-life. PPPs contribute to higher yields and are used to prevent 
rot and moulds of harvested produce. 

The EU agricultural sector also provides employment opportunities in rural areas. PPPs 
affect  the  competitiveness  of  EU  agriculture  as  the  availability  or  not  of  PPPs  may 
influence  decisions  to  move  to  cultivating  less  human-resource-intensive  crops. 
Furthermore, there are certain crops that are of cultural importance, e.g. rice in Portugal 
and Italy, where it is important to have access to certain PPPs to protect this crop. 

As the PPP Regulation has been effective in ensuring sufficient availability of PPPs, at 
least for major crops (see section 5.1.5), it has generated benefits for the EU agricultural 
sector.  However,  it  is  difficult  to  quantify  these  short-term  benefits  and  to  estimate  the 
PPP  Regulation’s  contribution  to  making  PPPs  available  for  use  in  the  EU  agricultural 
sector. Agricultural productivity and profitability are indeed affected by multiple factors, 
including significant subsidies through the Common Agricultural Policy. 

In  the  long  term,  a  high  level  of  environmental  protection  through  the  PPP  Regulation 
can ensure sustainability of farming (e.g. through preserved biodiversity and soil fertility) 
and therefore lead to food security. 

The  availability  of  PPPs  generate  other  benefits  that  are  not  related  to  the  agricultural 
sector:  for  instance,  weed  control  on  railways.  In  these  situations,  weeds  are  often 
controlled using broad-spectrum herbicides and the availability of such PPPs is important 
for public safety needs. In the United Kingdom, manual weeding and other maintenance 
of the railway network could increase costs by as much as EUR 99 million367 a year if it 
were not possible to use glyphosate.  

Another  benefit  not  related  to  agriculture  is  landscape  management,  in  particular  in 
controlling invasive species. The control of bracken (a type of fern) on hills in the United 
Kingdom  is  one  example  where  the  active  substance  asulam  is  the  only  efficacious 
alternative368.  Since  the  active  substance  was  not  approved  in  2011,  the  only  viable 
method has been for the United Kingdom to issue emergency authorisations for asulam, 
which  is  not  a  long-term  sustainable  solution.  This  shows  the  benefit  of  having 
emergency  authorisations  in  the  PPP  Regulation,  while  highlighting  deficiencies  in  the 
system, as the active substance asulam actually does not meet the strict approval criteria. 

5.2.5. Benefits from the single market and international trade 

Cost savings from the zonal system 

367 Oxford Economics (2017) Economic impact of a glyphosate ban — Impact on the rail network. 
368 Article in the Guardian, Uplands protest over ban on bracken spray. 

80 

 
                                                 
The  cooperation  of  Member  States  during  the  zonal  evaluation  of  an  application  to 
authorise  a  PPP  creates  somewhat  higher  upfront  costs.  This  is  because  the  reference 
Member State has to consult the concerned Member States on the draft assessment report 
and  the  concerned  Member  States  should  review  and  comment  the  draft  assessment 
report.  However,  these  should  be  more  than  compensated  by  gains  later  on  thanks  to 
lighter  procedures  when  authorising  PPPs  through  mutual  recognition  as  the  concerned 
Member State. Mutual recognition across zones should also lead to cost savings both for 
industry and Member States. 

times 

less  resource-intensive 

It has been estimated that authorisations for a concerned Member State are 2.6 times less 
resource-intensive  than  for  reference  Member  State  authorisations,  while  mutual 
recognitions  are  4 
than  reference  Member  State 
authorisations369.  Monetising  these  benefits  gives  a  figure  of  EUR 15 000  for  each 
concerned Member State per PPP authorised. For mutual recognition procedures across 
zones, the authorisation cost is almost EUR 20 000 lower for Member States. Moreover, 
the  fees  for  industry  mirror  the  costs:  for  zonal  authorisation  the  fees  are,  on  average, 
EUR 30 000  in  the  reference  Member  State,  EUR 10 000  for  mutual  recognition  and 
EUR 6 000 for authorisation in a concerned Member State370. In other words, concerned 
Member State authorisations and mutual recognitions offer efficiency gains in lower fees 
for  applicants  and  reduced  burden  for  Member  States.  Overall,  during  the  five-year 
period  between  2012  and  2016,  Member  States  (and  also  applicants  as  they  pay  fees) 
saved  EUR 13-17  million  compared  to  what  they  would  have  spent  if  they  had  issued 
standard  authorisations  only371.  There  was  no  estimation  of  the  number  of  expected 
mutual  recognitions  in  the  impact  assessment  accompanying  the  proposal  for  the  PPP 
Regulation,  meaning  that  comparison  with  an  ‘ideal’  situation  is  unfortunately  not 
possible. 

Benefits of international trade 
In  2017,  the  EU  maintained  its  position  as  the  largest  global  exporter  and  importer  of 
agri-food products, reaching a total value of EUR 255 billion372. Of this figure, EUR 117 
billion can be attributed to imports. This shows how important it is to set clear provisions 
in the MRL legislation for the setting of import tolerances and for the adoption of Codex 
limits.  The  EU  is  compliant  with  international  standards,  and  the  MRLs  based  on  EU 
uses can also accommodate import tolerances for the crops concerned if these are grown 
inside and outside of the EU. The EU also benefits from trade facilitation through import 
tolerances as this allows for the import of crops not grown in the EU, while increasing 
the availability of the entire range of food products throughout the year. 

The export of agri-food products accounts for EUR 138 billion. The global demand for 
food is likely to increase with population growth and changes in consumer preferences. 
The EU’s agri-food sector stands to gain from this demand growth. Non-EU countries are 
attracted  by  food  produced  in  the  EU  because  of  its  reputation  as  offering  safe, 
sustainably  produced,  nutritious  and  quality  products.  In  particular,  non-EU  countries 
rely  on  the  stringent  assessment  provided  for  by  the  MRL  Regulation  in  relation  to 
consumer protection. 

The MRL Regulation is therefore contributing positively to promoting international trade 
both by allowing imports as well as by attracting markets in non-EU countries. However, 

369 The support study p. 132. 
370 The support study, table 5.2, p. 131. 
371 The support study, p. 132. 
372 European Commission (2018), Monitoring Agri-trade Policy 2018-1, Agri-food trade in 2017. 

81 

 
                                                 
an  aspect  which  might  harm  trade  is  the  timeline  for  the  setting  of  import  tolerances, 
which is considered by trade partners as being too long to prevent the lowering of MRLs 
following the withdrawal of an EU use. 

5.3. Coherence 

  To what extent have the MRL Regulation and PPP Regulation put in place a coherent 

policy on pesticides? 

  To  what  extent  is  the  legal  framework  consistent  with  agricultural  policies,  food 

policies, environmental policies and policies on chemicals and biocides? 

  To  what  extent  is  the  legal  framework  consistent  with  international  rules  and 

agreements related to trade, food, environment and chemicals? 

  Where  coherence  is  not  achieved,  what  factors  or  elements  have  hindered  its 
achievement? Which are the main differences, overlaps and inconsistencies? How do 
these shortcomings impact the compliance level? 

MAIN FINDINGS 

For the most part, the Regulations show internal coherence and are consistent with one 
another.  The  exceptions  are  the  interplay  of  the  review  of  MRLs  with  the  renewal  of 
approval of active substances leading to unnecessary administrative burden. The fact that 
the  cut-off  criteria  in  the  PPP  Regulation  are  not  reflected  in  the  MRL  Regulation  is 
another  inconsistency  leading  to  potentially  significant  trade  implications  with  non-EU 
countries. 

Consistency with other EU policy areas is moderate as the interactions with policies on 
foods for infants and young children, hygiene policy, and chemicals legislation regarding 
persistency may all require attention. 

The  cut-off  criteria in  the  PPP  Regulation  are controversial  at  international level  in  the 
framework of the WTO. On the other hand, the EU regularly incorporates Codex limits 
that are safe for consumers into its MRL legislation (see Figure 12). 

The definitions of ‘plant protection product’ and ‘pesticide residue’ could be updated to 
increase clarity in relation to substances used also for other purposes.  

5.3.1. Pesticides policy area  

The  PPP  and  MRL  Regulations  are  considered  to  be  overall  internally  coherent. 
However, the following areas have been identified as not fully coherent by the Member 
States and the Commission during their work as risk managers and lead to problems in 
implementing the Regulations. 

Internal coherence of the PPP Regulation 
  Article 4(1) provides for a step-wise approach in the scientific evaluation for cut-off 
criteria,  i.e.  if  an  active  substance  meets  at  least  one  of  the  cut-off  criteria,  the 
Member State can stop the assessment.  This simplification of the safety assessment 
of an active substance has not yet happened, as described in section 5.2.2 above. This 
is already an inconsistency in itself: the provision was meant to simplify the process 
with a step-wise approach, but in fact the Regulation requires a full risk assessment to 
allow for the evaluation of the derogation possibilities based on negligible exposure 
and/or essential use under Article 4.7. Furthermore, the cut-off criteria mentioned in 
Article 4(1)  are  not  consistent  with  Annex  II,  which  contains  more  cut-off  criteria 

82 

 
(e.g.  endocrine  disrupting  properties).  This  results  in  difficulties  at  implementation 
stage. 

  Grace periods for sale and use of stocks of PPPs following non-renewals of approvals 
of active substances are covered by both Article 20(2) and Article 46; the wordings in 
the  two  articles  differ,  leading  to  questions  about  their  respective  scope  of 
application. 

  PPPs  containing  exclusively  basic  substances  are  not  subject  to  the  EU  rules  on 
authorisations  (Article 28(2)(a)).  Consequently  they  may  not  be  marketed  as  PPPs 
nor labelled as such. In light of the growing importance of alternatives to PPPs, this 
creates  questions  regarding  the  availability  and  the transmission  of  appropriate  user 
information 
to  consumers  and  workers  using  basic  substances.  Moreover, 
uncertainties arise where a producer applies for approval of an active substance that is 
already approved as a basic substance – or vice versa. 

  The  provisions  related  to  authorisations  (Article  31)  and  labelling  of  PPPs  (Article 
65) are currently not fully aligned as regards the use of Integrated Pest Management. 

Internal coherence of the MRL Regulation 
  Article 49  provides  for  the  possibility  to  grant  transitional  measures  in  several 
circumstances  to  allow  for  the  normal  marketing,  processing  and  consumption  of 
products. However, the procedure for modifications of MRLs following revocation of 
authorisations of PPPs (Article 17 of the MRL Regulation) is not explicitly covered 
by  this  Article,  despite  the  fact  that  this  is  currently  the  most  frequent  case  where 
transitional measures would be needed to give trade partners the possibility to adapt 
to the lowering of EU MRLs. 

Definitions 
Some  definitions  in  the  PPP  and  MRL  Regulations  are  identified  as  problematic  and 
lacking clarity. A majority of the Member States and stakeholders (in particular from the 
agricultural, food and feed, and PPP/chemical industry)373 have identified that there is a 
need  for  changes  to  the  definitions  of  plant  protection  product374  and  pesticide 
residues375. For PPPs, Member States and stakeholders consider that there is a need for 
clarification  on  dual  and  multiple-use  substances  as  well  as  for  naturally  occurring 
substances376,  e.g.  active  substances  used  in  plant  protection  products  and  in  growth 
stimulants and biocides. The definition should also include the possibility to use ‘product 
in  bulk’  and  a  definition  of  ‘in  situ  production’,  in  order  to  cover  innovative  modes  of 
action  of  formulations.  For  pesticide  residues,  Member  States  argue  that  the  definition 
should  be  clarified  to  ensure  that  appropriate  enforcement  action  can  be  taken  for 
multiple source substances. As regards the scope covered by the MRL Regulation, some 
Member  States  proposed  that  the  definition  of  pesticide  residues  should  also  cover 
unacceptable co-formulants, adjuvants, safeners and synergists, and that some flexibility 
would be needed to exceptionally remove from the scope very specific active substances 
(e.g.  substances  such  as  chlorate  that  have  not  been  used  in  PPP  for  a  long  time,  but 
occur  due  to  other  legitimate  uses)  in  order  to  regulate  them  under  another  more 
appropriate legal framework.  

373 The support study, pp. 175 and 176. 
374 The scope of what is a plant protection product is provided in Article 3(1) of Regulation 1107/2009. 
375 Article 3(2)c of Regulation 396/2005. 
376 REFIT Platform Opinion on the submission by a member of the REFIT Platform Stakeholder Group on “Multiple use/Multiple 

source substances – Chlorate”, 7 June 2017 

83 

 
                                                 
Consistency between the PPP and the MRL Regulations 
Consistency  between  the  MRL  Regulation  and  the  PPP  Regulation  is  ensured  by  a 
logical  sequence  starting  with  the  active  substance  approval.  The  application377  for 
approval  of  an  active  substance  has  to  include,  where  relevant,  an  application  for  a 
MRL378. This pre-requisite for MRL application avoids approving active substances for 
which no safe MRL can be set and therefore ensures good resource management. 
Authorisations of PPPs cannot be granted until the relevant MRLs are in place379, so the 
process  is  sequential.  To  minimise  delays,  the  Commission  prepares  a  draft  measure 
setting MRLs as soon as the approval decision under the PPP Regulation is made. This 
approach is also supported by the Ombudsman380. 
Consistency  issues  have  arisen  between  the  review  of  MRLs381  and  the  renewal  of 
approval of active substances. The procedures are currently not sufficiently aligned and 
have resulted in duplication of work and unnecessary updates of EFSA opinions on MRL 
reviews that became obsolete after the renewal process. As mentioned in section 5.2.2, in 
the  absence  of  any  provisions  in  the  Regulations,  a  pragmatic  approach  was  agreed 
between the Commission, EFSA and the Member States to minimise inconsistencies by 
scheduling MRL reviews after the renewal process so as to take into account the possible 
new  toxicological  reference  values  and  new  residue  definition  recommended  by  EFSA 
after the peer review of the renewal assessment. 

The support study identified that the PPP Regulation and MRL Regulation have different 
definitions  of  vulnerable  groups  (see  page  179  of  that  study).  The  MRL  Regulation 
defines vulnerable groups as ‘children and the unborn’ while the PPP Regulation extends 
this  definition  to  also  include  ‘nursing  women,  the  elderly  and  workers  and  residents 
subject to high pesticide exposure over the long term’. No issues have been reported to 
date  as  a  result  of  this,  although  the  existence  of  different  definitions  potentially  could 
have an effect on the risk assessment when setting MRLs. 

The  MRL  Regulation  divides  the  EU  into  two  zones  for  the  evaluation  of  residue 
behaviour and the setting of MRLs, a northern European and a southern European zone. 
This is inconsistent with the PPP Regulation, which has established three zones  for the 
purpose  of  granting  authorisations  for  PPPs.  The  number  of  zones  is  an  obvious 
difference, but there is no evidence that this difference has created any problems as the 
zones have no correlated purpose. While the two zones for MRL setting were established 
based on climatic considerations and different residue behaviour under different climatic 
conditions, the three zones for authorisation purposes were established based on climatic, 
agricultural  (practices)  and  biological  (pests)  considerations.  The  establishment  of  the 
three zones also included other elements, such as already existing collaboration between 
Member States. 

Differences  in  required  scientific  assessments  are  also  a  source  of  difficulties, 
particularly in managing import tolerances. While the PPP Regulation introduced human 
health  and  environmental  cut-off  criteria,  the  MRL  Regulation,  which  was  adopted 
before  the  PPP  Regulation,  is  based  solely  on  risk  assessment.  Non-compliance  of  a 
substance with the cut-off criteria leads in principle to its non-approval, meaning that no 

377 Under Article 8(1)(g) of Regulation (EC) No 1107/2009. 
378 Referred to in Article 7 of Regulation (EC) No 396/2005. 
379 Following Article 29(1)(i) of Regulation (EC) No 1107/2009. 
380 Decision of the European Ombudsman in case 2000/2015/ANA on the European Commission’s compliance with the rules on the 

approval of plant protection products. 

381 Under Article 12 of Regulation (EC) No 396/2005. 

84 

 
                                                 
PPPs  containing  that  active  substance  are  authorised  in  the  EU.  Following  the  MRL 
Regulation, import tolerances can, however, still be requested for such substances and the 
subsequent  risk  assessment  may  conclude  that  no  risk  for  human  health  is  identified, 
which  could  lead  to  the  granting  of  the  import  tolerances.  While  the  same  level  of 
consumer protection is always ensured (i.e. the same set of safe MRLs apply equally to 
imported  and  EU  produced  food),  this  discrepancy  may  have  a  negative  impact  on  the 
competitiveness of EU agriculture. 

5.3.2. Other EU policy areas 

The PPP Regulation and MRL Regulation interact with other EU policies on agriculture, 
food, environment and chemicals. While the overall consistency is considered adequate, 
some inconsistencies have been identified, as described below. 

Consistency with other chemicals legislation 
The  PPP  Regulation  and  other  chemicals  legislation  in  the  EU  create  categories  of 
substances,  e.g.  endocrine  disruptors  or  substances  that  are  persistent,  and  these 
categories are subject to different regulatory consequences. The consistency of the PPP 
Regulation with other EU chemicals legislation is covered in depth in the fitness check 
on  the  chemicals  legislation  (except  REACH)382.  On  endocrine  disruptors,  the  fitness 
check concluded that ‘horizontal’ criteria for endocrine disruptors i.e. criteria applicable 
across all EU legislation, have not been set. The same criteria to identify substances with 
endocrine  disrupting  properties  have  been  adopted  under  the  PPP  Regulation  and  the 
Biocidal  Products  Regulations.  Other  pieces  of  legislation  referring  to  endocrine 
disruptors  have  different  wordings,  creating  uncertainty  as  to  which  chemicals  are 
considered by the respective legislative provisions and what level of evidence is required 
to  identify  such  chemicals.  To  increase  consistency  across  EU  policy  as  regards 
endocrine  disruptors,  the  Commission  presented  in  November  2018  a  strategy  entitled 
‘Towards a comprehensive European Union framework on endocrine disruptors’, which 
includes  the  commitment  to  carry  out  a  cross-cutting  fitness-check.  The  fitness-check 
will  analyse  how  the  different  provisions/approaches  on  endocrine  disruptors  interact, 
identify any possible gaps, inconsistencies or synergies, and assess their collective impact 
in terms of costs and benefits for human health and the environment, the competitiveness 
of EU farmers and industry, and international trade383. 

The  PPP  Regulation  includes  criteria  to  identify  substances  that  are  persistent  organic 
pollutants (POP), active substances that are persistent, bioaccumulative and toxic (PBT), 
and active substances that are considered to be very persistent and very bioaccumulative 
(vPvB). These criteria are substantially the same as those in REACH and in the Biocidal 
Products Regulation. However, the guidance on how to assess such criteria is different. 
For  instance,  there  are  substantial  difference  in  the  consideration  of  the  POP,  PBT  and 
vPvB properties of metabolites and the temperature to which key degradation studies are 
normalised. This can lead in some cases384 to a substance being identified as a PBT under 
REACH  and  the  Biocidal  Products  Regulation  and  as  ‘not  PBT’  under  the  PPP 
Regulation.  Scientifically  it  makes  no  sense  that  the  properties  of  a  substance  differ 
depending  on  the  regulatory  sector.  The  reasons  are  historical,  as  agricultural  activities 

382  European  Commission  (2019) Commission  Staff  Working  Document  Fitness  Check  of  the  most  relevant  chemicals  legislation 

(excluding REACH), as well as related aspects of legislation applied to downstream industries. SWD/2019/199 final 

383 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee 
and the Committee of the Regions. Towards a comprehensive European Union framework on endocrine disruptors. COM(2018) 
734. 

384 Such as in the case of acetamiprid. 

85 

 
                                                 
take  place  when  it  is  warm,  and  because  a  higher  normalisation  temperature  was  also 
used  until  recently  for  industrial  chemicals.  In  addition,  the  PPP  Regulation  has  very 
strict  regulatory  consequences  for  POP,  PBT  and  vPvB  substances,  i.e.  non-approval 
with no possibility of derogation while under REACH the regulatory consequence is not 
necessarily  as  severe  (i.e.  the  use  of  such  substances  can  be  authorised  if  the  relevant 
conditions  set  out  in  REACH  are  met).  The  fitness  check  on  chemicals  concluded  that 
additional benefits of introducing PBT and vPvB substances as new hazard classes need 
to  be  further  assessed.  Such  assessment  is  one  of  the  priority  areas  for  future 
improvement of the current EU legislative framework for chemicals. 

Consistency  between  the  MRL  Regulation  and  the  legislation  on  foods  for  infants  and 
young children 
Directive 2006/125/EC385 and Directive 2006/141/EC386 require that the food they cover 
must  not  contain  residues  of  individual  pesticides  at  levels  exceeding  0.01 mg/kg  and 
establish  levels  lower  than  0.01 mg/kg  for  several  very  toxic  pesticides.  These  specific 
rules  on pesticides  in  food for infants  and young children are not  fully in  line with the 
MRL Regulation, as the definition of ‘pesticide residues’ is outdated and comprises only 
residues of plant protection products, whereas the MRL Regulation also includes residues 
of  biocides.387.  This  has  led  to  legal  uncertainty  about  the  coverage  of  residues  of 
biocidal products by the legislation on foods for infants and young children, making legal 
interpretations  necessary.  Furthermore,  the  lack  of  a  cross  reference  with  the  MRL 
Regulation  prevents  the  automatic  update  of  the  specific  residue  definitions  of  active 
substances.  For  example,  when  EFSA  identifies  a  metabolite  the  toxicity  of  which 
requires  its  inclusion  in  the  residue  definition,  the  residue  definition  of  the  active 
substance at stake has to be updated both in the MRL Regulation and in the legislation on 
foods for infants and young children. 

Consistency between the MRL Regulation and hygiene policy 
At EU level, food hygiene is regulated by Regulations (EC) No 852/2004, 853/2004 and 
854/2004, which set rules and criteria covering all stages of the production, processing, 
distribution  and  placing  on  the  market  of  food  intended  for  human  consumption. 
However,  rules  ensuring  compliance  with  food  hygiene  criteria  on  the  use  of  chemical 
decontaminants in food processing are laid down only in national legislation, with the EU 
issuing  only  guidelines  on  this  issue.  Certain  chemical  decontaminants  can  lead  to 
residues in foods. The MRL Regulation comes into play when these chemicals are also 
residues of active substances currently or previously used in PPPs. For example, the use 
of chlorinated solutions in food processing (e.g. as processing aids authorised by Member 
States'  national  legislation)  can  lead  to  chlorate  residues  in  foods,  while  the  use  of 
chlorate as an active substance in PPP is no longer approved and chlorate MRLs are set 
at the default value. Levels higher than the default levels that can be found in foods are 
then due to the legal use of disinfectant solutions and not to the illegal use of a pesticide. 
However, this leads to systematic non-compliances with the chlorate MRLs currently in 
place. This concern over multiple source substances is not limited to chlorate, as similar 
concerns were identified for other substances (see also section 5.1.7).  

385 Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young 

children (OJ L 339, 6.12.2006, p. 16). 

386 Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 
1999/21/EC (OJ L 401, 30.12.2006, p. 1). Directive 2006/141/EC will be replaced by Commission Delegated Regulation (EU) 
2016/127. 

387 According to Article 3(2)b) of Regulation 396/2005. 

86 

 
                                                 
Consistency between the PPP Regulation and environmental policy 
There  are  concerns  that  the  PPP  Regulation  is  not  fully  consistent  with  the  EU’s 
biodiversity strategy to 2020388, in particular as regards the scope of the risk assessment. 
While  the  biodiversity  strategy  covers  the  full  variety  of  life  (diversity  within  species, 
diversity between species/communities and diversity of ecosystems), the risk assessment 
conducted  under  the  PPP  Regulation  evaluates  effects  on  the  populations  of  individual 
species (see also section 5.1.2).  In addition, the range of non-target indicator species is 
limited and some stakeholders consider that these do not cover all animal taxa that could 
be affected by PPP use. Pesticides policy is not sufficiently consistent with EU climate 
policy.  While  the  EU’s  climate  policy  aims  to  minimise  greenhouse  gas  emissions,  no 
such  considerations  are made  when  approving  or  not approving  active substances. This 
relates most prominently to herbicides as their use may reduce the need for mechanical 
tillage.  Tillage  releases  carbon  emissions  both  through  the  use  of  machinery  and  by 
releasing carbon stored in the soil389.  

The  PPP  Regulation  relates  to  the  Water  Framework  Directive  and  its  daughter 
directives, as the objective of good status (surface and groundwater) should be taken into 
account  when  approving  and  renewing  active  substances.  A  more  coordinated  link 
between  the  risk  assessments  and  monitoring  carried  out  under  the  Directive  and 
Regulation could improve the decision-making. 

Consistency between the PPP Regulation and Fertilising Products Regulation 
Some economic operators have tried to  register substances that are approved for use in 
PPPs as fertilisers. Such attempts have been unsuccessful and all active substances that 
fall  under  the  PPP  Regulation  have  been  evaluated  as  such.  To  increase  clarity  in  the 
future, the Commission proposed amending the relevant definition in the PPP Regulation 
as  part  of  its  proposal  for  a  new  Regulation  on  fertilising  products390.  The  new 
Regulation was published in the Official Journal in June 2019391. 

The  new  legislation  defines  a  new  product  category  called  plant  biostimulant,  which 
concerns  substances,  mixtures  or  microorganisms  that,  in  principle,  fall  in  the  scope  of 
the  PPP  Regulation,  although  their  function  relates  to  plant  nutrition  and  not  to  plant 
protection.  By  amending  the  PPP  Regulation,  to  exclude  plant  biostimulants  from  the 
scope,  the  new  legislation  creates  a  clear  demarcation  line  between  the  two  pieces  of 
legislation  and  keeps  products  influencing  plant  nutrition  outside  the  scope  of  PPP 
Regulation. The new legislation is maintaining, however, the authorisation obligation for 
products with dual claims, relating to both plant protection and plant nutrition features. 

5.3.3. International agreements 

Consistency of the Regulations and WTO, OECD and Codex Alimentarius 

The EU regulatory system for pesticides is to a large extent consistent with international 
rules  and  agreements.  OECD  guidance  documents  are  applied  when  evaluating  studies 
under the PPP Regulation and the MRL Regulation.  

388 EU Biodiversity strategy to 2020. 
389 Fitness check on chemicals legislation (excluding REACH), http://ec.europa.eu/growth/sectors/chemicals/ec-support. 
390  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down  rules  on  the  making  available  on  the 
market  of  CE  marked  fertilising  products  and  amending  Regulations  (EC)  No  1069/2009  and  (EC)  No  1107/2009. 
COM/2016/0157 final — 2016/084 (COD). 

391  Regulation  (EU)  2019/1009  of  the  European  Parliament  and  of  the  Council  of  5  June  2019  laying  down  rules  on  the  making 
available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and 
repealing Regulation (EC) No 2003/2003, OJ L 170, 25.6.2019, p. 1–114. 

87 

 
                                                 
The EU is a Party to the Sanitary and Phytosanitary Measures (SPS) Agreement and the 
Technical Barriers to Trade (TBT) Agreement. The MRL Regulation is considered to be 
coherent  with  the  requirements  of  the  SPS  Agreement.  The  EU’s  trading  partners  are 
systematically informed within the WTO about proposed amendments to MRLs and all 
non-renewals  or  restrictions  are  notified  to  the  WTO  allowing  for  comments  during  a 
period  of  60  days.  Observations  by  trading  partners  are  taken  into  account  before  risk 
management decisions are adopted. 

A problematic issue identified is the potentially significant trade implications of the cut-
off criteria, which is the subject of continuous concerns raised by trading partners in the 
WTO. Non-EU countries often remind the Commission that non-approval decisions need 
to respect WTO principles and be risk-based392. The cut-off criteria, including the criteria 
to  identify  endocrine  disruptors,  have  been  the  subject  of  discussion  in  the  WTO-TBT 
and  WTO-SPS  Committees  since  2013393.  Between  2015  and  2017,  in  the  WTO 
Committees,  non-EU  countries  raised  specific  trade  concerns  on  pesticides  208  times 
against the EU. During the same time, the EU raised only two specific trade concerns on 
pesticides against other countries394. Although decisions under the MRL Regulation are 
based on assessments of risk only, the effects of the cut-off criteria, i.e. the non-approval 
of  active  substances  with  subsequent  lowering  of  MRLs,  is  claimed  to  result  in 
inconsistency between the EU approach and WTO obligations. However, so far no active 
substance has not been approved based solely on the cut-off criteria, as there have always 
been other issues identified as well during the risk assessment, and it remains possible to 
request import tolerances  for such  substances. See also section 5.1.6 for the impacts of 
MRLs on international trade. 
The EU is a member of the Codex Alimentarius. Under the MRL Regulation395, Codex 
limits  (CXLs)  are taken  into  account  when  MRLs  are  set, which  means  that  MRLs  are 
progressively  aligned  with  international  standards.  Where  the  EU  deviates  from  CXLs 
due  to  concerns  for  consumer  protection,  different  data  requirements  or  extrapolation 
rules, it explains these in a transparent manner to Codex members and observers, trading 
partners,  stakeholders  and the general public. For  more details  see section 5.1.6. While 
data  requirements  and  the  risk  assessment  methodology  are  overall  consistent  between 
the  Codex  and  the  EU,  a  few  differences  persist.  The  EU  is  actively  working  with  the 
relevant bodies396 to address such divergences. 

5.4. Relevance 

  Are the objectives of the Regulations pertinent to the evolving needs, problems and 

issues in the fields of pesticide residues and the placing on the market of PPPs? 

MAIN FINDINGS 

The  Regulations  make  a  relevant  contribution  towards  meeting  the  Sustainable 
Development Goals. 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 PPP Regulation and MRL Regulation contribute to achieving those 
goals. 

392 In particular Article 5 of the SPS Agreement. 
393  European  Commission  (2016)  Impact  assessment  defining  criteria  for  identifying  endocrine  disruptors  in  the  context  of  the 

implementation of the plant protection products regulation and biocidal products regulation. 

394 Data from the WTO-SPS Committees’ summary reports, compiled by the Commission. 
395 In line with Article 14(2)(e) of Regulation 396/2005. 
396 Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and Codex Committee on Pesticide Residues (CCPR). 

88 

 
                                                 
There is increased demand for more sustainable agriculture in the EU. In this regard, the 
objective of protecting the environment is still relevant and the PPP Regulation provides 
for  the  proper  use  of  PPPs,  which  includes  the  application  of  good  plant  protection 
practice  and  compliance  with  the  principles  of  integrated  pest  management.  The  PPP 
Regulation is also complemented by the Sustainable Use Directive and by the Common 
Agricultural Policy, which create additional incentives for a sustainable agriculture. 

The availability of low-risk active substances, including micro-organisms, has increased 
but  is  still  considered  by  stakeholders  as  insufficient  and  procedures  are  considered 
lengthy.  While the Commission  and the Member  States  have taken action to  accelerate 
the  procedures  to  place  low-risk  PPPs  on  the  market,  the  effects  of  these  efforts  are 
expected to materialise only in the future. Furthermore, the MRL Regulation only offers 
limited  flexibility  to  address  the  specificities  of  non-chemical  active  substances,  e.g. 
micro-organisms or other biopesticides. 

The  PPP  and  MRL  Regulations  are  relevant  to  the  Sustainable  Development  Goal  on 
innovation. The PPP Regulation has the potential for continuous adaptation to scientific 
progress  as  the  data  requirements  and  risk  assessment  methods  laid  down  in 
implementing  Regulations  or  guidance  documents  can  be  adapted  to  take  into 
consideration  new  concepts  such  as  nanopesticides,  micro-organisms  and  new 
application  techniques  (e.g.  robotics).  However,  the  MRL  Regulation  offers  less 
flexibility  to  adapt  to  evolving  technology  and  future  needs  (e.g.  nanopesticides, 
integration of large cumulative assessment groups) 

89 

 
 
 
5.4.1. Sustainability 

Sustainable Development Goals (SDGs) and sustainable agriculture in the EU 
The PPP and MRL Regulations contribute to achieving the 2030 Agenda for Sustainable 
Development397. Sustainable agriculture has been and is a priority for the EU which has 
made  a  commitment  to  fully  implement  the  SDGs  in  its  policies  and  set  out  the  way 
ahead in  a Commission  Communication  in  November 2016398. The approach  set out in 
the  Communication  upholds  the  principle  of  subsidiarity  as  many  actions  can  only  be 
successfully  implemented  through  national  legal  frameworks  and  non-legislative  action 
at  Member  State  level.  The  objective  of  the  PPP  and  MRL  Regulations  are  mainly 
relevant for the following SDGs: 

Figure 17. Sustainable Development Goals related to the PPP Regulation and MRL Regulation 

Food  security  is  one  of  the  most  fundamental  among  basic  needs.  Major  threats  to 
primary production of food must be mitigated. Food and feed must also be kept safe and 
free from biological and chemical threats. While the use of PPPs reduces losses to pests 
during food production, it is essential that it does  not result in residues of pesticides in 
food that  are  harmful  for consumers.  The MRL Regulation ensures  that consumers can 
eat safe food and that food exceeding the MRLs for pesticides cannot be placed on the 
market.  

The  PPP  Regulation  makes  sure  that  professionals  using  PPPs  in  their  daily  work  and 
bystanders  and  residents  are  not  exposed  to  unacceptable  levels.  With  its  extensive 
environmental  protection  provisions,  the  PPP  Regulation  ensures  that  groundwater, 
surface  water,  and  drinking  water  quality  are  not  jeopardised  by  the  use  of  PPPs  in 
agriculture,  as  substances  not  complying  with  the  relevant  criteria  cannot  be  approved. 
The  PPP  Regulation  contributes  to  preserving  the  quality  of  natural  resources  due  to 
strict  requirements  on  the  protection  of  water,  wildlife,  pollinators,  soil  and  air,  which 
must  be  met  before  an  active  substance  can  be  approved  and  a  PPP  authorised  by  a 
Member State. 

There  is  demand  in  the  EU  for  more  sustainable  agriculture  with  less  impact  on  the 
environment,  including  increased  demand  for  organic  food.  In  a  European  Parliament 
survey,  stakeholders  across  all  categories  found  the  objectives  of  the  PPP  Regulation 
relevant,  while  noting  that  the  PPP  Regulation  should  better  promote  the  use  of 
integrated pest management399.  

While  it  is  clear  that  the  PPP  and  MRL  Regulations  contribute  to  a  more  sustainable 
agriculture  in  the  EU,  they  cannot  achieve  this  alone.  The  Sustainable  Use  Directive 
introduced for the first time clear principles at EU level for integrated pest management 
and a range of measures to achieve sustainable use of pesticides to reduce the impacts of 

397 UN Resolution A/RES/70/1. 
398 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committees 
and the Committee of the Regions: Next steps for a sustainable European future,- European action for sustainability (COM(2016) 
739 final of 22.11.2016. 

399 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

90 

 
 
                                                 
the use of PPPs on human health and the environment. These measures cover: (i) national 
action  plans  to  reduce  the  dependency  on  the  use  of  pesticides  and  promote  integrated 
pest management; (ii) actions to improve information, training, control and the upgrade 
of application techniques and the handling and storage of pesticides; and (iii) monitoring 
of outcomes. The link between the Sustainable Use Directive and the PPP Regulation is 
through the proper use of PPPs, including compliance with integrated pest management 
principles  laid  down  in  the  Sustainable  Use  Directive400.  The  Commission’s  report  in 
2017  on  the  implementation  of  the  Sustainable  Use  Directive  concluded  that  the 
Directive offers the potential to greatly reduce the risks of pesticide use. However, more 
rigorous  and  ambitious  implementation  by  Member  States  would  be  needed  to  achieve 
the environmental and health improvements sought401.  

Another  complementary  policy  instrument  is  the  Common  Agricultural  Policy.  In  a 
recent  Communication402,  the  Commission  reflected  on  the  future  of  food  and  farming 
and on the need of the Common Agricultural Policy403 to address citizens’ concerns on 
sustainable agriculture, including the sustainable use of pesticides. The current Common 
Agricultural  Policy  (since  2013)  already  includes  measures  which  promote  proper 
sustainable  use  of  PPPs  as  an  environmental  cross-compliance  obligation,  under  which 
farmers may face a reduction in direct payments if they do not comply with the rules set 
for  use  of  PPPs.  In  the  proposal  for  a  new  Common  Agricultural  Policy  (2018)404,  the 
Commission has further prioritised the sustainable use of PPPs via the objectives detailed 
in the proposal and via the proposed indicators.  

Availability of low-risk active substances and basic substances 
To  support  the  implementation  of  integrated  pest  management,  the  PPP  Regulation 
introduced the categories of basic and low-risk substances to promote the development of 
less  harmful  PPPs;  these  are  acknowledged  as  an  integral  part  of  integrated  pest 
management  and  the  implementation  of  the  Sustainable  Use  Directive.  The  number  of 
basic  and  low-risk  substances  approved  in  the  EU  is  steadily  increasing  (see  Table  4, 
section  5.1.1).  As  of  December  2018,  there  were  13  low-risk  active  substances  and  20 
basic substances approved. 
Despite  the  intended  promotion  of  low-risk  active  substances,  most  Member  States405 
consider  that  the  provisions  of  the  PPP  Regulation  do  not  facilitate  placing  low-risk 
active  substances  on  the  market.  There  is  consensus  among  stakeholders  and  Member 
States that the availability of low-risk PPPs is insufficient. Many stakeholders, including 
the European Parliament406,407, are critical  of the fact that  progress  is  slow and that  not 
enough is being done to promote low-risk active substances. Stakeholders working with 
biopesticides  and  organic  farming  also  complain  that  there  is  no  ‘lighter’  fast-track 
procedure  to  approve  low-risk  active  substances  and  to  place  low-risk  PPPs  on  the 

400 According to Article 55 of Regulation 1107/2009. 
401  European  Commission  (2017)  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  Member  State 
National  Action  Plans  and  on  progress  in  the  implementation  of  Directive  2009/128/EC  on  the  sustainable  use  of  pesticides. 
COM/2017/0587 final. 

402 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee 

and the Committee of the Regions. The Future of Food and Farming COM(2017) 713 final. Brussels, 29.11.2017. 

403 https://ec.europa.eu/info/food-farming-fisheries/key-policies/common-agricultural-policy/cap-glance_en. 
404 Proposal for a Regulation of the European Parliament and of the Council establishing rules on support for strategic plans to  be 

drawn up by Member States under the Common agricultural policy […] SEC(2018)305 

405 20 out of 27 Member States consider that the provisions are working ‘not at all’ or ‘to a small extent only’. 
406  European  Parliament  (September  2018)  Report  on  the  implementation  of  the  Plant  Protection  Products  Regulation  (EC)  No 

1107/2009. 

407  European  Parliament  (December  2018)  Report on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

91 

 
                                                 
market. In  fact, confirming whether an active substance can  be  approved as low-risk is 
only possible at the end of the risk assessment and risk management process, as for all 
substances  subject  to  the  PPP  Regulation.  Only  then  can  it  be  demonstrated  that  the 
substance  meets  the  very  demanding  low-risk  criteria.  The  approvals  of  several  active 
substances  that  are  presumably  low-risk  are  in  the  process  of  being  renewed  and  the 
benefits will only materialise once the renewal assessment is finalised. The delays in the 
renewal  process  negatively  affect  also  the  renewal  of  low-risk  substances  (see  section 
5.2.2). 

In  view  of  the  above,  while  the  PPP  Regulation  and  the  Sustainable  Use  Directive  are 
seen  as  mostly  consistent  with  one  another,  a  slight  inconsistency  relates  to  the  delays 
and the long time it takes to bring low-risk PPPs and non-chemical control techniques to 
the  market.  This  complicates  the  effective  implementation  of  the  Sustainable  Use 
Directive  as  in  order  for  such  methods  to  contribute  to  a  more  sustainable  agriculture 
they need be made available to farmers. 

To  promote  low-risk  active  substances  and  PPP,  the  Commission  has  worked  together 
with the Member States408 to identify short- and long-term actions that could accelerate 
the procedures involved in bringing low-risk products to the market. A plan of 40 actions 
was endorsed by the AGRIFISH Council of June 2016409. All actions identified for the 
Commission  are  either  in  progress,  close  to  finalisation,  or  finalised.  This  includes  the 
compilation  of  a  list  of  57  potentially  low-risk  active  substances410  approved  in 
accordance  with  the  former  Directive  91/414/EEC,  which  allows  Member  States  to 
inform users about products whose use should be encouraged. Such awareness-raising is 
expected  to  translate  into  more  interest  from  manufacturers  in  applying  for  national 
authorisations  pushed  by  the  sector’s  demand  for  such  products.  Furthermore,  Member 
States  are  expected  to  become  more  familiar  with  the  concept  of  low-risk  and  the 
potential  portfolio  of  low-risk  PPPs.  In  turn,  it  is  expected  that  Member  States  will 
process  the  re-authorisations  faster  for  the  low-risk  PPPs  following  their  renewal  of 
approvals in the coming years. Unfortunately, these assumptions cannot be verified yet as 
the  active  substances  in  question  will  only  be  reviewed  in  the  coming  years  under  the 
AIR 4 programme. 

Many presumed low-risk active substances are microbial pesticides and pheromones and 
the Member States, EFSA and applicants are still acquiring experience in assessing them. 
The Commission has developed a guidance document on low-risk criteria and has started 
drafting guidance documents supporting the assessments of biopesticides, e.g. microbial 
pesticides  and  pheromones.  The  guidance  documents  will  address  key  concerns  and 
increase clarity on how to conduct the assessments. This should result in faster and more 
accurate scientific evaluations. 

Some  stakeholders  and  Member  States  consider  that  the  current  data  requirements  are 
neither appropriate (as they derive from requirements imposed on chemicals in the case 
of  micro-organisms)  nor  proportionate  to  low-risk  substances  for  which  the  risk 
assessment  should  in  principle  be  less  data  consuming.  The  findings  of  the  European 

408 Within the Expert Group on Sustainable Plant Protection. 
409 Outcome of the Council meeting available online: https://www.consilium.europa.eu/en/meetings/agrifish/2016/06/27-28/. 
410 Commission notice concerning a list of potentially low-risk active substances approved for use in plant protection. C/2018/4828, 

(OJ C 265, 27.7.2018, p. 8). 

92 

 
                                                 
Parliamentary Research Service study highlight the limited use of low-risk PPPs because 
they generate low profits due to often being marketed as niche products411. 

As to basic substances, there are procedural problems that lead to delays. In the absence 
of  clear  provisions  in  the  PPP  Regulation,  the  Commission  and  Member  States  have 
agreed on a Guidance Document412 setting out an ad-hoc procedure for the approval of 
basic  substances,  which  is  lighter  and  sets  out  fewer  requirements  compared  to  the 
approval of active substances. The Commission is responsible for the first step, which is 
the  admissibility  check  of  the  application.  Due to  resource constraints, there  have  been 
delays  in  completing  the  admissibility  verifications.  As  of  December  2018,  the 
Commission performed an admissibility check for 40 out of 58 applications (not counting 
extension  of  uses).  On  average  it  takes  about  4  months  for  the  Commission  to  take  an 
admissibility  decision  on  a  basic  substance  application.  Following  the  completion  of  a 
Technical Report by EFSA, it takes on average 7 months until a draft Regulation on the 
approval (or not) is submitted to the Member States for vote in the Standing Committee 
for Plants, Animals, Food and Feed. These delays are heavily criticised by the applicants 
of basic substances. In addition, it is fair to recognise that it can be difficult for users to 
identify  the  usefulness  of  products  containing  basic  substances  for  purposes  of  plant 
protection as these may not be labelled as PPPs. Several Member States have indicated 
this as a limit on the full exploitation of the marketing potential of such products, because 
their labels cannot include information on the crop-protection uses allowed. 

5.4.2. Innovation and scientific progress 

Scientific  knowledge  on  substances  and  testing  methods  is  continuously  evolving.  In 
parallel, new substances are developed, possibly raising new concerns and risks to human 
health  and  the  environment.  Since  the  PPP  and  MRL  Regulations  have  to  work  in  this 
evolving context it is important that they can adapt to this changing environment quickly 
and efficiently.  

The REACH review identified combination effects and endocrine disruptors as emerging 
issues;  both  of  these  are  already  conceptually  addressed  in  the  PPP  and  MRL 
Regulations,  although  their  implementation  is  still  under  development.  The  work  to 
include  cumulative  risk  assessment  (the  ‘cocktail  effect’  of  simultaneous  exposure  to 
multiple substances) is under development and described in depth in section 5.1.1. In a 
European  Parliament  survey,  stakeholders  across  all  categories  found  that  the  PPP 
Regulation should better reflect the need for innovation413.  

Although innovation is not explicitly among the objectives of the Regulations, both the 
PPP  and  MRL  Regulations  can,  in  general,  be  adapted  to  new  scientific  concepts  by 
adapting  data  requirements  and  risk  assessment  methods  laid  down  in  implementing 
Regulations  or  guidance  documents.  To  update  guidance  documents,  the  Commission 
and EFSA work together with the Member States and stakeholders. There are currently 
49  technical  guidance  documents414  available  and  additional  guidance  documents  are 
under  development.  While  guidance  is  essential  to  adapt  to  new  scientific  concepts 
relatively  easily,  they  make  the  assessments  more  complex.  Outdated  guidance  on  the 
other hand, may not provide the protection of human health and the environment that is 

411 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

412 Guidance Document available online on the Europa webpage. 
413 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

414  Europa webpages on guidance documents for PPPs and for MRLs. 

93 

 
                                                 
endeavoured.  In  general,  there  is  a  good  level  of  harmonisation  and  coherence  among 
guidance  for  active  substance  approval,  while  some  cases  of  incoherence  exist415  and 
some existing guidance documents have not been updated for a considerable time due to 
resource constraints.  

Micro-organisms and biopesticides 
Micro-organisms  and  substances  of  biological  origin  are  often  identified  as  more 
sustainable  alternatives  to  chemical  active  substances.  However,  these  also  need  to  be 
proven  safe  by  an  appropriate  risk  assessment  relying  on  a  suitable  set  of  data.  The 
current  data  requirements  and  assessment  principles  are  often  criticised  as  being  too 
costly  and  unsuitable  for  developers  of  innovative  micro-organisms  or  substances  of 
biological origin that often find only niche markets. 

Pertinence of the current data requirements is questioned as regards micro-organisms as 
well  as  innovative  modes  of  action,  such  as  RNA-dependent  gene  silencing  where  the 
mode of action against pests is not through any of the currently common routes, e.g. with 
a  chemical,  a  toxin/metabolite  or  an  infection  of  the  targeted  pests.  To  overcome  these 
barriers for micro-organisms, the European Parliament adopted a Resolution in February 
2017416 calling for a  new and separate legal framework  for such  products.  At the same 
time, the report from the PEST Committee calls for an assessment of such products that 
is equally stringent as that for chemical active substance417. 

The  support  study  concluded  that  the  PPP  Regulation  does  not  provide  a  sufficient 
possibility  to  adapt  to  scientific  and  technical  progress  as  regards  the  scope  of  the 
legislation418.  However,  the  framework  created  by  the  PPP  Regulation  actually  offers 
flexibility  to  accommodate  specific  needs.  This  includes  accommodating  innovative 
technologies  through  the  adaption  of  data  requirements  and  the  relevant  assessment 
methodologies. There is already a specific set of data requirements for micro-organisms, 
which  can  be  adapted  to  technological  progress.  The  OECD  guidance  for  the  risk 
assessment of micro-organisms has been expanded by a working group of Member States 
experts on bio-pesticides as regards metabolites of concern and anti-microbial resistance. 

The MRL Regulation, on the other hand, lacks some flexibility to address MRLs for non-
chemical active substances, e.g. micro-organisms, due to the default MRL of 0.01 mg/kg 
which  applies  to  all  actives  substances.  Although  specific  MRLs  for  micro-organisms 
could in principle be set under the MRL Regulation already now (e.g. by using specific 
footnotes in the Annexes to change the expression of measurement units from “mg/kg” to 
another  more  appropriate  expression,  e.g.  “colony  forming  units”)  in  Annex  V,  an 
exemption of micro-organisms from the general default level of 0.01 mg/kg or the setting 
of another more appropriate default level for micro-organisms is not possible within the 
current legal framework. 

Furthermore,  as  discussed  in  section  5.1.4.  the  existing  data  requirements  are  not  fully 
adapted  to  the  specificities  of  non-pathogenic  micro-organisms,  leading  EFSA  to 
regularly identify data gaps when evaluating applications, which, in consequence, delays 

415 Nganga, J., Bisonni, M., and Christodoulou, M. (2018) Guidelines for submission and evaluation of applications for the approval 
of active substances in pesticides. Study requested by the European Parliament's Special Committee on the Union’s authorisation 
procedure for pesticides (PEST Committee). 

416  European  Parliament  (2017)  Biological  low-risk  pesticides  European  Parliament  resolution  of  15 February  2017  on  low-risk 

pesticides of biological origin (2016/2903(RSP)). 

417  European  Parliament  (December  2018)  Report on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

418 The support study, p. 172. 

94 

 
                                                 
risk management decisions. It is also doubtful whether potential new needs that may arise 
in  future  from  new  technologies  (e.g.  nanopesticides,  MRLs  for  whole  cumulative 
assessment groups instead of single substances) can be sufficiently addressed within the 
current MRL framework.  

Application techniques — robotics, GPS and digital agriculture 
Diffuse  and  point-source  pollution  in  the  environment  have  been  significantly  reduced 
thanks to constant innovation improving the accuracy of spraying equipment. Low-drift 
nozzles, deflectors and shields are reducing spray drift and incidental spillages, and result 
in  improved  handling  and  pre-  and  post-application  procedures  (such  as  loading  and 
rinsing).  Similar  progress  has  been  observed  for  personal  protective  equipment. 
Innovative  tools  are  made  available  on  the  market  but  practical  implementation  highly 
depends on whether these techniques are perceived as effective and efficient by users.  

Precision  farming  techniques  have  also  advanced,  enabling  PPPs  to  be  applied  only  to 
plants  that  are  actually  attacked  by  pests.  Combined  with  GPS  technologies,  this  also 
improves  record-keeping  on  crop  spraying,  which  facilitates  enforcement.  Once 
digitalisation is made affordable for the ‘average farmer’, this will continue to improve 
the performance and accuracy of PPP application, thus significantly reducing the applied 
quantities  of  PPP.  Such  advances  could  potentially  allow  for  more  hazardous  active 
substances to be approved considering that where the exposure is minimal, the risk would 
become acceptable. 

These  innovative  techniques’  potential  to  mitigate  risk  for  operators  has  not  been  fully 
exploited  to  date  and  they  are  not  being  considered  in  the  risk  assessment  procedures. 
However, future revisions of the ‘uniform principles’ to assess PPPs and develop agreed 
guidance on the efficacy  of the various  methodologies  could enable refined application 
techniques to be considered as risk reduction tools. 

Nanopesticides 
Nanotechnology is offering new methods for formulating and delivering pesticide active 
to  as 
ingredients,  as  well  as  novel  active 
‘nanopesticides’419.  While  some  concerns  have  been  expressed  about  the  altered  risk 
profile  of  these  new  products,  many  see them  as  offering  great  potential  to  support the 
necessary increase in global food production in a sustainable way420. As the application 
of nanotechnology in agriculture is still in the early stages, there is limited information on 
the  impact  on  humans,  animals  and  the  environment.  This  makes  it  challenging  for 
scientists and government officials to improve knowledge in this field421.  

ingredients  collectively 

referred 

The  PPP  Regulation  currently  contains  no  specific  provisions  or  even  a  definition  for 
nanomaterials. However, data requirements and risk assessment methods can be adapted 
to  take  on  board  such  new  technologies,  and  in  the  near  future  this  may  even  become 
necessary. 

419  Hayles,  J.,  Johnson,  L.,  Worthle,  C.,  Losic,  D.  (2017)  Nanopesticides:  a  review  of  current  research  and  perspectives.  New 

Pesticides and Soil Sensors, p 193-225. https://doi.org/10.1016/B978-0-12-804299-1.00006-0. 

420 Kah, M., Kookana, R.S., Gogos, A., and Bucheli, T. D. (2018) A critical evaluation of nanopesticides and nanofertilisers against 

their conventional analogues. Nature Nanotechnology. Volume 13, pages 677-684. 

421  Villaverde,  J.J.,  Sevilla-Morán,  B.,  López-Goti,  C.,  Sandín-España,  P.,  Alonso-Prados,  J.L.  (2017)  6  —  An  overview  of 
legislation.  New  Pesticides  and  Soil  Sensors.  p  227-271. 

framework  of  European 

in 

nanopesticides 
https://doi.org/10.1016/B978-0-12-804299-1.00007-2. 

the 

95 

 
                                                 
5.5. EU added value 

  What  is  the  added  value  of  regulating  plant  protection  products  and  pesticide 

residues at EU level? 

  To  what  extent  have  the  MRL  Regulation  and  the  PPP  Regulation  resulted  in 
added  value  with  regard  to  the  objectives  pursued  that  could  not  be  achieved  at 
national/international level? 

MAIN FINDINGS 

All  stakeholders  and  Member  States  acknowledge  the  added  value  of  the  Regulations. 
Their added value are: (i) the EU-wide protection of human health; (ii) the generation of 
data  and  scientific  knowledge,  and  the  public  availability  of  such  data;  (iii)  increased 
cooperation among Member States; and (iv) a harmonised system for trading partners. 

The costs of achieving the objectives to protect human health and the environment were 
lower  than  in  a  system  where  each  Member  State  conducts  the  risk  assessments  on  its 
own.  There  have  been  attempts  to  conduct  the  risk  assessment  for  active  substances  at 
international  level,  but  they  proved  to  require  more  time  and  more  resources  for 
coordination with the same results. 

Increased added value could possibly be achieved by introducing EU-wide authorisations 
for low-risk PPPs which do not require risk mitigation, and for PPPs which have similar 
conditions of use throughout the EU, e.g. in greenhouses. 

There is wide consensus among all Member States and stakeholder groups that regulating 
PPPs and  MRLs at EU level adds  value422. The European  Parliament Research Service 
also concluded from stakeholders’ views that regulating pesticides at EU level has added 
value423. Some stakeholders call for even greater harmonisation and for the authorisation 
of PPPs at EU level or further international harmonisation. This evaluation has identified 
EU added value stemming from: (i) the data and scientific knowledge generated; (ii) the 
increased  capacity  to  perform  assessment  work  in  many  Member  States;  (iii)  EU-wide 
protection  of  human  health;  and  (iv)  a  harmonised  system  for  trading partners.  Despite 
the inefficiencies and delays described in section 5.2.2, EU added value also stems from 
the  cost-effectiveness  of  the  system  compared  to  a  situation  where  each  Member  State 
were to regulate PPPs on its own. 

Although  the  EU  system  for  approving  active  substances  is  very  comprehensive  and 
costly,  it  benefits  from  economies  of  scale  as  it  achieves  higher  total  output  while 
keeping  the  individual  input  relatively  lower.  In  a  system  where  each  Member  State 
creates  a  similar  system  on  its  own,  the  combined  total  costs  would  be  higher  and 
duplication  of  work  inevitable.  Approving  active  substances  at  EU  level  is  thus  more 
cost-effective  and  allows  for  work  sharing  where  each  Member  State  performs 
assessments on behalf of the others. This is all the more important as there is a limited 
number  of  scientific  experts  in  the  EU  in  general  and  in  some  Member  States  in 
particular.  Cooperation  via  the  peer-review  system  has  also  boosted  capacity  in  many 
Member States due to knowledge exchange between them. 

The data generated to support approvals of active substances and authorisations of PPPs 
are considerable and could not have been collected on the same scale by a Member State 

422 The support study, p. 213. 
423 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

96 

 
                                                 
operating  individually.  This  is  in  particular  true  for  areas  such  as  endocrine  disruptors 
and cumulative risk assessment, in which the science is still not mature. Where there is a 
demand  for  increased  knowledge  for  regulatory  purposes  in  specific  areas  such  as 
genotoxicity,  investments  are  made  collectively.  Since  the  outcome  of  the  risk 
assessment  is  published,  the  system  also  contributes  to  the  general  availability  of 
information about agrochemicals. 

The  system  provides  for  equal  EU-wide  protection  of  human  health.  First,  through 
harmonised  MRLs,  which  provide  for  the  same  protection  of  everyone  from  pesticide 
residues in  food.  Second,  the  risk  assessment  for  active  substances  and approval  at EU 
level ensure the same level of protection of operators, bystanders and residents. This may 
not have been achieved were there no legislation at all in the EU. It may also not have 
been achieved if there were legislation at Member State level only as the protection goals 
could have had varying stringency in the Member States, resulting in varying protection 
levels. Of course, the final protection of human health also depends on the conditions of 
authorisation laid down by the Member States and on the respect of these by users and 
the  level  of  enforcement  in  the  Member  States,  which  has  been  shown  to  vary  (see 
section 5.1.7 on enforcement). 

In view of the frequent amendments to the MRL Regulation, the Commission has set up 
the  EU  Pesticides  Database  to  facilitate  the  work  of  food-business  operators,  national 
competent  authorities  and  laboratories.  The  database  can  be  consulted  in  23  official 
languages  of  the  EU.  Having  a  single  MRL  throughout  the  EU  enhances  the  free 
movement of food and enables trade partners to export products to the Member State of 
choice, based on trade interests and partnership. 

To assess the full added value of the PPP and MRL Regulations it is necessary to look 
beyond  the  EU.  The  capacity  of  the  EU  and  the  ability  to  set  up  a  comprehensive 
scientific system to evaluate active substances has positive effects in non-EU countries. 
For example, EFSA conclusions are used to support regulatory decisions in the countries 
participating  in  the  Permanent  Interstate  Committee  for  Drought  Control  in  the  Sahel 
(CILSS),  i.e.  Burkina  Faso,  Cape  Verde,  Chad,  The  Gambia,  Guinea-Bissau,  Mali, 
Mauritania,  Niger,  Senegal  and  Togo.  The  publicly  available  information  in  the  EU 
provided  by  EFSA  and  the  Commission  is  known  to  assist  risk  managers  in  those 
countries in their decision-making.  Consequently, the PPP  Regulation  is supporting the 
protection of human and animal health and the environment also in Western Africa. 

While  most  developed  countries  have  their  own  regulatory  system,  it  seems  that  some 
countries, also make use of scientific assessments and regulatory decisions in the EU. For 
instance,  the  outcome  of  the  risk  assessment  or  decisions  to  not  approve  or  to  restrict 
active  substance  in  the  EU  may  trigger  early  reviews  of  active  substances  in  other 
countries,  such  as  Australia.  This  saves  resources  in  non-EU  countries  and  facilitates 
focused assessments on specific issues. 

As regards MRLs, the limits set for crops in the EU apply also to imported products. For 
active substances that are not approved, the MRLs are set at the ‘limit of quantification’ 
(LOQ), which means no residues are allowed. This encourages substitution of the active 
substance also in non-EU countries to avoid the need for requesting an import tolerance. 
Thus, the PPP and MRL Regulation contribute to the protection of human health and the 
environment for more people than just those living in the EU. 

Should authorisations of PPPs be made at EU level? 

97 

 
Authorisation  of  PPPs  are  made  at  Member  State  level  because  of  subsidiarity  — 
national agencies have historically been in the best position to evaluate PPPs and decide 
on  appropriate  risk  mitigation  measures  due  the  very  specific  agricultural  and  climatic 
conditions  in  their  home  country.  However,  in  June  2018,  the  Commissions’  Scientific 
Advice  Mechanism  questioned  the  added  value  and  efficiency  of  the  current  two-step 
process consisting of approving active substances at EU level then authorising the PPP at 
national level. The Scientific Advice Mechanism, as well as EFSA424, argues that PPPs 
should be authorised at EU level425. The European Parliament on the other hand would 
like to see an assessment whether it would be appropriate to make EFSA responsible for 
the  risk  assessment  of  PPPs,  while  leaving  the  actual  decision  on  the  authorisation  of 
plant  protection  products  at  national  level,  in  order  to  take  account  of  country-specific 
situations426. 

However,  the  added  value  of  introducing  a  single-step  risk  management  decision  on 
PPPs  including  all  ingredients  at  EU  level  is  not  clear.  Aside  from  the  significant 
differences in agricultural and environmental conditions in the Member States, there are 
several  thousand  PPPs  compared  to  less  than  500  active  substances,  meaning  that  the 
number of assessments and decisions taken at EU level would have to increase strongly, 
requiring a significant increase in resources for EFSA and the Commission, but also in 
the  Member  States  as  they  would  have  to  participate  in  significantly  more  peer-review 
processes.  

22 to 28 
Member 
States 
22% 

1 to 7 
Member 
States 
39% 

15 to 21 
Member 
States 
20% 

8 to 14 
Member 
States 
19% 

Figure 18. Share of active substances that are authorised in a PPP in Member States 

Moreover, as shown in Figure 18, only for 22 % of the active substances approved in the 
EU  PPPs  containing  them  are  authorised  in  more  than  22  Member  States,  while  for 
almost  60 %  of  active  substances  PPPs  containing  them  are  authorised  in  14  or  fewer 
Member States. EU authorisations of PPPs would therefore seem to be useful only for a 
limited number of PPPs. Another argument in favour of the current two-step process is 
that it keeps technical and scientific capacity in Member States. 

Although  it  is  true  that  by  leaving  authorisation  of  PPPs  at  the  national  level  Member 
States  duplicate  work  and  spend  a  lot  of  resources  on  product  evaluations,  much  can 
already  be  done  within  the  current  system  to  reduce  duplication.  If  fully  exploited,  the 
zonal system and mutual recognition allow for cooperation and work sharing, as well as 

424  EFSA  (European  Food  Safety  Authority)  (2018)  Scientific  risk  assessment  of  pesticides  in  the  European  Union  (EU):  EFSA 

contribution to on-going reflections by the EC. EFSA supporting publication 2018:EN-1367. 17 pp. 

425 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. 

426  European  Parliament  (December  2018)  Report on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

98 

 
 
                                                 
avoidance of duplicative work. As to improved knowledge about all PPPs authorised in 
the Member States, the full implementation of the plant protection products application 
management system (PPPAMS) will remedy the lack of a complete overview of all the 
products available in the Member States. 

Increased added value could possibly be achieved with a system similar to the Biocidal 
Product  Regulation  where  authorisations  of  products  can  be  made  at  both  national  and 
EU level. EU authorisations can be granted for products which have similar conditions of 
use in the entire EU, e.g. hand disinfectants. For PPPs, this approach could be taken for 
uses in greenhouses. This approach could also be taken for low-risk PPPs which do not 
require  risk  mitigation  measures.  A  clear  advantage  of  an  EU  authorisation  is  that  it  is 
directly applicable in all Member States and therefore reduces the administrative burden 
for applicants. The challenge for the Commission and EFSA, however, would be, in view 
of the limited resources available, to manage not only the approval of active substances, 
but also the authorisation of such products. 

Should pesticides be regulated internationally? 
International cooperation could potentially add even more value as more countries would 
share the risk assessment work. However, international reviews have been tried under the 
auspices of the OECD in the global joint reviews, where the EU, US and Australia have 
worked  together  to  jointly  review  some  new  active  substances427.  The  outcome  was 
mixed,  with  a  good  risk  assessment  coming  at  the  cost  of  an  inefficient  process  where 
increased  coordination  efforts  and  the  inflexibilities  of  each  regulatory  system  worked 
against  effective work sharing.  It therefore seems that  the EU system  has  higher added 
value  than  conducting  the  risk  assessment  in  a  global  context.  However,  this  could 
change  in  the  future  if  the  right  institutions  and  work  sharing  mechanisms  were  to  be 
created. 

6. CONCLUSIONS 

This  evaluation  assessed  the  effectiveness,  efficiency,  relevance,  coherence  and  EU 
added value of the PPP Regulation and the MRL Regulation. The assessment compared 
the current situation against conditions before the Regulations applied, i.e. pre-2008 for 
the  MRL  Regulation  and  pre-2011  for  the  PPP  Regulation.  Additional  points  of 
comparison were used in the evaluation, as appropriate, including a comparison with the 
US  and  Canadian  regulatory  systems  for  PPPs  and  the  EU’s  Biocidal  Products 
Regulation.  

The  Sustainable  Use  Directive  is  a  complementing  piece  of  legislation  that  was  not  in 
scope  of  the  evaluation.  As  the  Directive  does  not  cover  the  risk  assessment  and 
management  framework,  it  is  unlikely  that  the  conclusions  in  the  current  evaluation 
would  be  different  as  regards  the  robustness  of  the  risk  assessment  at  EU  level  if  the 
Directive  had  been  included  in  the  evaluation.  However,  it  could  be  expected  that  full 
implementation  of  the  Sustainable  Use  Directive  would  support  the  objective  of 
protecting  health  and  the  environment  by  reducing  the  risks  linked  to  plant  protection 
products,  through  the  adoption  of  non-chemical  control  methods  and  a  reduction  in 
dependency on plant protection products. 

427 See case study for cyantraniliprole in the support study. 

99 

 
                                                 
The  analysis  was  constrained  by  some  limitations.  First,  the  difficulty  in  establishing  a 
clear causal link between the two Regulations and health and environmental impacts, due 
to the fact that such impacts are determined by a multitude of factors. Second, the process 
for  reviewing  the  approval  of  all  active  substances  and  their  MRLs  has  not  yet  been 
completed  and  the  full  effects  of  the  Regulations  can  therefore  not  yet  be  captured. 
Finally, data at national level in particular as regards the actual use of pesticides in spatial 
and temporal  dimensions  are  not  available, which does  not allow for the assessment of 
the scale of the impacts. The evaluation, nevertheless, is based on an extensive literature 
review and data collection through desk research, as well as a wide consultation, which 
allowed incorporating the opinions of a broad range of stakeholders. To ensure reliability 
of  the  data  collected,  different  sources  of  data  were  compared  and  opinions  from 
stakeholders  were  examined  against  other  evidence  (i.e.  triangulation)  to  the  extent 
possible. This approach mitigates the effect of the limitations described above.  

The  objectives  of  the  Regulations  were  found  to  be  relevant  for  the  evolving  needs 
and  problems  identified  in  the  field  of  pesticides,  although  the  demand  for  more 
sustainable agriculture should be better taken into account.  

The  Regulations  are  mostly  coherent  and  consistent,  both  internally  and  with  one 
another.  The  exceptions  are  the  interplay  of  the  review  of  MRLs  with  the  renewal  of 
approval of active substances and the fact that the cut-off criteria in the PPP Regulation 
are  not  reflected  in  the  MRL  Regulation.  Consistency  with  other  EU  policy  areas  is 
moderate, with the policy on foods for infants and young children, hygiene policy, and 
chemicals  regarding  persistency  possibly  requiring  attention.  The  cut-off  criteria  in  the 
PPP Regulation are often challenged at international level in the context of WTO. On the 
other hand, the EU regularly incorporates Codex limits that are safe for consumers into 
its MRL Regulation, which facilitates international trade. 

The PPP Regulation was found to be  effective to a large extent in protecting human 
health and the environment due to the stringency of the approval criteria, which led to 
non-approval or non-renewal of approval of active substances that are harmful for human 
health and/or the environment. Currently, there are very few (2 %) active substances with 
high  hazard  profiles  compared  to  a  large  share  (37  %)  of  active  substances  with  low 
hazard profiles. Further benefits are expected in the future once the full review cycle of 
all  approved  active  substances  is  finalised  (expected  by  2025).  However,  not  all 
stakeholders agree with this conclusion, in particular NGO’s. It has to be recognised also, 
that  while  the  Regulations  have  the  clear  potential  to  be  effective  in  reaching  their 
objectives,  these  have  only  been  partially  attained  due  to  the  delays  and  efficiency 
problems, and implementation can be improved.  

The cut-off criteria remove the most hazardous active substances from the market and 
therefore contribute to protecting human health and the environment. In particular, 
for less than 40% of the few active substances that meet the criteria and are still on the 
market  companies  apply  for  the  renewal  of  approval.  However,  the  absence  of 
harmonised  classification  for  many  active  substances  and  the  need  to  evaluate  whether 
the  foreseen  derogation  possibilities  can  apply  resulted  in  delays  in  the  overall 
assessment  and  in  the  decision-making.  New  procedures  and  guidance  had  to  be 
developed which are still not fully complete. Thus, some active substances that meet the 
cut-off criteria are still approved under the conditions from Directive 91/414/EEC instead 
of  having  been  restricted  or  not  having  their  approval  renewed.  This  has  decreased  the 
immediate effectiveness of the cut-off criteria.  

100 

 
The  rules  on  active  substances  that  are  candidates  for  substitution  are  ineffective 
and inefficient and did not deliver the expected results. The comparative assessments for 
products containing active substances that are candidates for substitution carried out by 
Member States in 2015 and 2016 did not lead to any substitution, mainly due to the lack 
of  alternatives  with  proven  better  risk  profiles.  Thus,  the  expected  benefit  for  human 
health  or  the  environment  from  substituting  these  hazardous  substances  has  not  been 
achieved. In addition, comparative assessments were found to be costlier (in total EUR 
26.7 million) than standard authorisation procedures.  

Emergency  authorisations  allow  Member  States  to  address  unexpected  dangers  to plant 
health where other viable alternatives do not exist, although these derogations are often 
used  to  address  other  issues.  In  fact,  the  number  of  emergency  authorisations  has 
increased by 300 % since 2011. Member States seem to use emergency authorisations to 
mitigate  the  consequences  of  the  delayed  processes  to  authorise  PPPs,  the  failure  to 
mutually recognise authorisations, and to cover minor uses.  The application procedures 
for setting MRLs for such emergency uses were also considered by stakeholders to be too 
long. Moreover, there is concern that emergency authorisations issued for non-approved 
or restricted active substances can negatively affect the protection of human health and 
the environment. 

The  MRL  Regulation  has  contributed  to  protecting  human  health  by  setting  safe 
MRLs, including MRLs based on import tolerances and CXLs. The EU’s comprehensive 
annual  monitoring  showed  high  compliance  with  the  established  MRLs,  indicating  that 
the food available to consumers is safe. Although the Commission has not yet made use 
of the possibilities given by the MRL Regulation to establish specific MRLs for certain 
product groups (fish, feed, processed foods) as well as a harmonised processing factors, 
this  has  not  decreased  consumer  protection.  Developing  a  method  for  cumulative  risk 
assessment  turned  out  to  be  much  more  complex  and  required  more  resources  than 
initially expected and therefore is still ongoing.  

The results from monitoring the status of European waters show a reduction of pesticide 
contamination  in  surface  waters,  at  least  in  relation  to  priority  pesticides  under  the 
Water  Framework  Directive,  which  indicates  that  the  PPP  Regulation  contributes 
positively to the protection of the aquatic environment. 

The  number  of  shared  studies  on  vertebrate  animals  has  increased,  as  intended, 
although preliminary data show that overall animal 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  increasing  evidence  will  be  required  in  the  future  to 
assess  substances’  effects  on  the  endocrine  system.  In  addition,  the  requirement  for 
periodic re-assessment of all active substances may increase or at least maintain the need 
for in-vivo testing. 

Having  harmonised  MRLs  across  the  EU  has  meant  that  the  functioning  of  the  single 
market  for  food  and  feed  has  improved  considerably.  The  overall  MRL  setting 
procedure  is  working  well,  although  it  lacks  sufficient  flexibility  to  provide  quick 
responses  to  newly  emerging  issues,  such  as  unexpected  findings  of  pesticides  in  food 
(e.g. through environmental contamination) or residues arising from emergency uses or 
from substances coming from multiple sources. 

The zonal system for product authorisation is not working as well as expected. The 
use  of  mutual  recognition  for  authorisation  of  PPPs  varies  greatly  between  Member 
States and zones. The main reasons for this are additional national requirements, the re-
evaluation of applications, and the lack of harmonisation in the methodologies used for 

101 

 
conducting  evaluations,  leading  to  duplication  of  work.  Authorisation  of  PPPs  by 
concerned Member States and mutual recognition of authorisations from other Member 
States  were found  to  lead  to  lower  fees  for  applicants  and  reduced  burden  for  Member 
States.  It  was  estimated  that  between  2012  and  2016  Member  States  using  mutual 
recognition saved EUR 13-17 million compared to what they would have spent had they 
issued regular authorisations. Furthermore, Member States using mutual recognition have 
seen larger increases in the number of PPPs available on their markets. The lack of trust 
will  probably  be  gradually  overcome  by  growing  experience  in  collaboration  between 
Member  States.  In  a  more  substantial  change  -  as  also  called  for  by  the  European 
Parliament  -  moving  the  scientific  assessment  of  PPP  authorisations  to  the  EU  level 
could further enhance mutual trust, but would have significant resource implications both 
for Member States and EFSA. 

International trade is facilitated by harmonised MRLs at EU level that allow imports 
into  the  entire  EU  at  the  same  standards.  Nevertheless,  trading  partners  continue  to 
express their dissatisfaction that MRLs in the EU are often set at lower levels than those 
applying  in  non-EU  countries  or  set  internationally,  thus  creating  trade  barriers.  At  the 
same  time  there  is  criticism  from  within  the  EU  that  MRLs  are  set  for  non-approved 
active  substances  which  allow  imports  of  products  treated  with  those  active  substances 
that are not available to EU farmers, decreasing the competitiveness of EU agriculture. 

The overall process for setting import tolerances takes on average about 2 years instead 
of 1 year due to poor quality dossiers and lack of resources in Member States and EFSA. 
Moreover, the time available for the setting of import tolerances is criticised for being too 
short to avoid the lowering of MRLs in the EU following the non-renewal of approval of 
an  active  substance.  However,  applications  are  often  submitted  too  late  in  the  process, 
although  information  about  a  forthcoming  lowering  of  MRLs  is  announced  to  trading 
partners significantly in advance.  

The evidence remains inconclusive on the effects of the PPP Regulation in improving 
the  competitiveness  of  EU  agriculture  as  this  depends  on  multiple  factors.  There  is 
criticism on the lack of PPPs in the EU, while the number of approved active substances 
has  actually  increased  since  2011  (from  427  to  484)  and  also  the  number  of  products 
available has  increased in  most  Member  States. Evidence  shows that  EU sales  of PPPs 
were  stable  during  the  2011-2016  period  and  that  the  value  of  PPPs  and  number  of 
persons employed in the sector has increased. The number of SMEs producing PPPs and 
other  agrochemical  products  is  decreasing,  with  high  regulatory  requirements  being  a 
contributing  factor.  Data  requirements  and  assessment  procedures  are  considered 
disproportionate for SMEs, who tend to focus on biopesticides and other potentially low-
risk solutions. As regards farmers, the information available does not offer a clear picture 
as data on spending on crop protection suggest that their share in farm expenditure has 
been stable, while costs for PPPs show an increasing trend since 2010, i.e. from before 
the  applicability  of  the  PPP  Regulation.  At  the  same  time,  farmers  expressed  concerns 
regarding the future availability of PPPs, following the expected non-renewal of approval 
of several  active substances. Although such  concerns are legitimate,  farmers’  needs for 
pest  management  can  be  addressed  also  by  the  full  implementation  of  the  Sustainable 
Use Directive and the promotion of non-chemical alternatives. To assess or monitor the 
relationship between competitiveness, the use of PPPs and regulatory changes, it would 
be necessary to establish relevant indicators and collect data over time on a sufficiently 
granular level.  

There  is  insufficient  availability  of  PPPs  for  minor  uses  and  Member  States  are  not 
fully  using  the  existing provisions  to  facilitate authorisation  for  such  uses.  Cooperation 

102 

 
between  Member  States,  acceptance  of  residue  data  evaluated  by  other  Member  States 
and  acceptance  of  residue  trials  outside  the  EU  are  insufficient.  To  overcome  the 
problem,  Member  States  are  using  emergency  authorisations  instead  of  extending 
existing uses of authorised products. Minor crops in outermost regions face similar issues 
in  terms  of  availability  and  emergency  authorisations  have  been  used  also  there  to 
overcome this problem. 

The  availability  of  low-risk  active  substances,  including  micro-organisms,  has 
increased  but  is  still  considered  by  stakeholders  as  insufficient  and  procedures  are 
considered lengthy. While the Commission and the Member States have taken action to 
accelerate  the  procedures  to  place  low-risk  PPPs  on  the  market,  the  effects  of  these 
efforts are expected to materialise only in the future. Furthermore, the MRL Regulation 
only  offers  limited flexibility to  address non-chemical  active substances, e.g. micro-
organisms or other biopesticides. Similar issues may arise with evolving technology and 
future needs (e.g. nanopesticides, integration of large cumulative assessment groups). 

The quantifiable benefits of the two Regulations are only a share of the overall health 
and environmental benefits, while the costs are well accounted for. The costs incurred by 
industry  for  PPP  authorisation  were  found  to  have  increased  compared  to  the  baseline 
(i.e. Directive 91/414/EEC) due to more stringent criteria and stricter data requirements. 
The available quantified evidence suggests that benefits linked to the non-renewal of five 
active substances under the PPP Regulation, even if uncertain and incomplete, amount to 
about EUR 38.5 million annually and are higher than the costs related to the evaluation 
procedures. 

There is wide agreement among Member States and stakeholders that both Regulations 
have  an  EU  added-value  in  achieving  their  objectives.  The  added-value  includes 
achieving EU-wide protection of human health, offering economies of scale in generation 
of data and scientific knowledge, increasing cooperation among the Member States, and 
simplifying the system for trading partners. 

The PPP and MRL Regulations are only partly efficient due to the significant delays 
that occur in the approval and renewal of approval of active substances, the authorisation 
of  PPPs,  and  the  review  of  all  existing  MRLs.  The  deadlines  missed  most  often  in  the 
renewal  process  are  those  for:  (i)  the  admissibility  check  by  the  rapporteur  Member 
States: (ii) the assessment of the supplementary dossier by the rapporteur Member State; 
(iii) the  additional  assessment  needed  by  the  rapporteur  Member  State during  the  peer-
review process; and (iv) the decision-making by the Commission. The re-authorisation of 
PPPs after the renewal of approval of the products’ active substance is also identified as 
problematic. This is because the delays at the approval stage have reduced predictability 
of the timing of the approval decisions, which in turn does not allow for good resource 
management in the Member States. The MRL review process started with several years 
of  delay  since  the  MRL  Regulation  does  not  establish  the  necessary  procedural 
framework.  Working  procedures  and  arrangements  had  first  to  be  agreed  between  the 
Commission, EFSA and Member States and rely on voluntary support from the Member 
States. As of 2018, the MRLs of a little over half of the substances have been reviewed 
and completion of the review for the remaining ones cannot be accurately predicted. 

The free circulation of treated seeds has had a positive harmonising effect within the EU, 
although  there  have  been  some  enforcement  difficulties  in  the  Member  States  for 
tracing  and  controlling  treated  seeds.  Weaknesses  were  also  found  as  regards  official 
controls on imports and exports of PPPs, as well as on compliance of PPPs placed on the 
EU market with the conditions of their authorisation, or with parallel trade permits. This 

103 

 
has  resulted  in  the  presence  of  illegal  and  counterfeit  PPPs  on  the  EU  market  which 
may  harm  human  health  and  the  environment.  The  MRL  Regulation  ensures  that 
effective  and  timely  enforcement  action  can  be  taken,  however,  some  problems  have 
been  experienced  in  practice  by  enforcement  authorities,  in  particular  with  multiple 
source substances. The new Regulation on official controls and enforcement in the agri-
food  chain,  which  will  become  applicable  in  2019  will  give  Member  States  a 
strengthened  toolkit  to  detect  fraudulent  and  deceptive  practices,  including  in  the  areas 
covered by the PPP and MRL Regulations.428 

The main cause of delays is the lack of sufficient staff in Member States to carry out 
the necessary work within the deadlines set in the Regulations. Member States argue that 
finding the expertise for the risk assessment is a challenge, especially for small Member 
States. When the Regulations were adopted, the estimated amount of work to be carried 
out and the resources required appear to have been severely underestimated, resulting in 
too short and unrealistic deadlines. Such constraints are not expected to be solved in the 
near future and might worsen as additional requirements during the renewal procedures 
for active substances and re-authorisation of PPPs are expected. The costs and workload 
involved  in  approving  and  renewing  the  approval  of  active  substances  and  authorising 
PPPs within zones are not fairly distributed across Member States. This also contributes 
to  the  existing  delays  as  certain  Member  States  face  a  large  workload.  In  addition,  the 
fees raised by some Member States seem to be insufficient to cover their costs, and not 
all  Member  States  link  the  fees  to  the  actual  work  carried  out,  resulting  in  fewer 
resources being available. Furthermore, the work carried out by the Member States on the 
MRL review is not covered by fees. 

In  summary,  the  Regulations  are  generally  effective,  in  particular  with  regard  to  the 
protection  of  human  health  and  the  environment,  but  are  not  entirely  efficient  and  in 
several  areas  burdens  can  be  reduced.  Coherence  is  mostly  ensured,  both  internally 
(within  and  between  the  Regulations)  and  externally  with  other  EU  legislation  and 
international rules. The objectives of the Regulations are relevant for the evolving needs, 
although the demand for a more sustainable agriculture may need to be better addressed. 
The  Regulations  are  complemented  by  the  Sustainable  Use  Directive  and  the  Common 
Agricultural Policy that create additional strong incentives for a sustainable agriculture. 
The Regulations have a recognised added-value at EU level but also beyond the borders 
of the EU. This conclusion is further supported by the European Court of Auditors who 
found that the EU food safety model related to chemicals, including PPPs and MRLs, is 
soundly  based  and  respected  worldwide.  However,  it  is  currently  over-stretched,  as  the 
Commission and Member States do not have the capacity to implement it fully429. 

To reduce the above-mentioned inefficiencies, margins for improvement exist. This Staff 
Working  Document  is  accompanying  a  Commission  report  to  the  European  Parliament 
and  the  Council,  which  contains  a  number  of  proposals  for  action  to  enhance 
implementation in order to simplify or strengthen the current regulatory framework.  

428 Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed 

law, rules on animal health and welfare, plant health and plant protection products 

429 European Court of Auditors (2019) Special Report No 2: Chemical hazards in our food: EU food safety policy protects us but 

faces challenges (pursuant to Article 287(4), second subparagraph, TFEU) 

104 

 
 
 
 
                                                 
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110 

 
 
Annex 1: Procedural information 

Lead DG, Decide Planning/CWP references 
DG  Health  and  Food  Safety  led  the  REFIT  evaluation  of  EU  legislation  on  plant 
protection  products  and  pesticide  residues.  It  was  item  24  of  the  Commission  REFIT 
initiative in the Commission’s work programme for 2016430 and item 6 in 2019431. This 
initiative  is  linked  to  REFIT  action  43  on  the  Commission’s  work  programme  for 
2015432, ‘Fitness check on the General Food Law’, which was carried out in 2017. 

Organisation and timing 
The  inter-service  group  was  set  up  in  June 2015  to  steer  and  provide  input  into  the 
evaluation  of  the  legal  framework  in  the  field  of  pesticides.  It  included  representatives 
from  five  directorates-general  —  Agriculture;  Environment;  Health  and  Food  Safety; 
Internal Market, Industry, Entrepreneurship and SMEs; and Trade — and from the Legal 
Service  and  the  Secretariat-General.  In  addition,  a  representative  of  the  Directorate-
General for Regional Development contributed to the meetings from January 2018. The 
group met nine times during the evaluation process; see Table A.1. 

Table A.1. Inter-Service Steering Group meetings and discussion topics  

Dates 

20 November 2015 

18 October 2016 

3 July 2017 

3 October 2017 

14 February 2018 

23 May 2018 

12 September 2018 
16 November 2018 
11 December 2018 

Topics for discussion 
Agreement in principle on the mandate, scope and strategy of the 
evaluation. Discussion on the Roadmap. 
Discussion on the draft terms of reference of the support study — final 
endorsement through email consultation on 2 March 2017. 
Kick-off meeting for the support study with the contractor. 
Discussion on the inception report and consultation strategy of the support 
study — final endorsement through email consultation on 
8 November 2017. 
Discussion on the interim report on the support study — final endorsement 
through email consultation on 23 March 2018. 
Discussion on the draft final report on the support study — final 
endorsement through email consultation on 28 September 2018. 
Discussion on the structure and content of the staff working document. 
Discussion on the draft final staff working document. 
Discussion on the draft final staff working document. 

External expertise 
The analysis of the evaluation is based on an external support study conducted by Ecorys 
Brussels  from  June  2017  to  October  2018.  This  support  study  answered  28  evaluation 
questions linked to the five evaluation criteria433. 

Several other reports and studies have been published recently on the implementation of 
the  PPP  Regulation  and  the  way  in  which  the  system  for  regulating  pesticides  and 
chemicals  in  the  EU  operates.  The  findings  of  the  reports  listed  below  have  been 
carefully considered for the analysis in this staff working document: 

430 Commission Work Programme for 2016. No time for business as usual. COM(2015) 610. 
431 Commission Work Programme for 2019. Delivering what we promised and preparing for the future. REFIT initiatives. 
432 Commission Work Programme for 2015. A New Start. COM(2014) 910. 
433 Support study published in the EU bookshop. 

111 

 
 
                                                 
  The  European  Commission  reports  on  audits  and  overview  reports  of  a  series  of 
audits in Member States. These include overview reports on the authorisation of plant 
protection products434, and on checks on pesticides in food of plant origin435. 

  Following  a  request  from  the  College  of  Commissioners,  led  by  Commissioner 
Andriukaitis, the Group of Chief Scientific Advisors published a scientific opinion on 
EU processes for the authorisation of plant protection products in June 2018436. 

 

In  April 2018 
the  European  Parliament’s  Research  Service  published  an 
implementation  report  on  the  PPP  Regulation  on  the  placing  of  plant  protection 
products  on  the  market437.  The  report  was  requested  in  May  2017  by  the  European 
Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI).  

  The European Parliament adopted in September 2018 an own-initiative report on the 
implementation  of  the  PPP  Regulation  which  had  been  prepared  by  the  ENVI 
committee, with MEP Pavel Poc as rapporteur438. The report is based on the external 
study by the European Parliament’s Research Service. 

  On  6 February 2018  the  European  Parliament  adopted  a  decision  on  setting  up  a 
special  committee  on  the  EU’s  procedure  for  the  authorisation  of  pesticides  (the 
PEST Committee), its responsibilities, its numerical strength and its term of office. In 
January 2019, the Parliament adopted the report of the PEST Committee which had 
been prepared by MEPs Norbert Lins and Bert Staes as rapporteurs439. 

  The REFIT evaluation of the General Food Law440, the REACH review441, the fitness 
check  on  chemicals  legislation  other  than  REACH442  and  the  report  on  the 
implementation of the Sustainable Use Directive443. 

Consultation of the Regulatory Scrutiny Board 
The Commission’s Regulatory Scrutiny Board assessed a draft version of this evaluation 
and issued a positive opinion on 4 February 2019444. The Board made recommendations 
to improve the report further. These were addressed as follows in the revised report. 

To better take into account the interactions with related pieces of legislation, section 5.4 
on  relevance  brings  together  all  issues  related  to  sustainability  and  low-risk  active 
substances in a more comprehensive discussion. In addition, section 1.2 on the scope of 
the  evaluation  has  been  expanded  to  clarify  why  an  evaluation  encompassing  also  the 
Sustainable  Use  Directive  was  not  possible  to  carry  out  at  this  point  in  time.  The 

434 European Commission (2017). Overview report on a series of audits carried out in EU Member States in 2016 and 2017 in order 

to evaluate the systems in place for the authorisation of plant protection products. DG(SANTE) 2017-6250. 

435 European Commission (2012). Overview Report of a Series of Audits in Member States in Order to Assess the Official Control 

Systems in Place for Pesticide Residues in Food of Plant Origin, DG(SANCO)/2012-6631. 

436 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. 

437 European Parliament Research Service (April 2018) European Implementation Assessment. Regulation (EC) 1107/2009 on the 

Placing of Plant Protection Products on the Market. ISBN: 978-92-846-2734-9. 

438  European  Parliament  (September  2018)  Report  on  the  implementation  of  the  Plant  Protection  Products  Regulation  (EC)  No 

1107/2009. 

439  European  Parliament  (January  2018)  Report  on  the  Union’s  authorisation  procedure  for  pesticides  (2018/2153(INI))  Special 

Committee on the Union’s authorisation procedure for pesticides. 

440 European Commission (2018) The REFIT Evaluation of the General Food Law (Regulation (EC) No 178/2002) SWD(2018) 38. 
441  European  Commission  (2018)  Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain  elements 

Conclusions and Actions. SWD/2018/058. 

442 Fitness check on chemical legislation (excluding REACH) 
443  European  Commission  (2017)  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  Member  State 
National  Action  Plans  and  on  progress  in  the  implementation  of  Directive  2009/128/EC  on  the  sustainable  use  of  pesticides. 
COM/2017/0587. 

444 Regulatory Scrutiny Board opinions on evaluations and fitness checks. 

112 

 
                                                 
Sustainable  Use  Directive  will  be  evaluated  in  the  near  future  and  the  findings  are 
expected to complement this evaluation.  

In section 5.1.4, the part on the zonal system has been deepened to provide for a more 
thorough  analysis  of  the  underlying  reasons  for  the  reported  lack  of  trust  in  the  zonal 
system  that  hampers  mutual  recognition.  In  section  5.1.8  on  transparency  and  risk 
communication, a text box has been inserted describing more details of the Commission's 
proposal  on  transparency  and  sustainability  of  EU  risk  assessment  in  the  food  chain  to 
clarify how the proposal already addresses some of the concerns raised by stakeholders. 
The  difficulties  related  to  residues  of  chlorate  are  brought  together  and  discussed  in 
section 5.1.7 on enforcement, further expanding on the opinion delivered by the REFIT 
platform.  

The  description  of  the  findings  has  been  nuanced  on  some  occasions  to  reflect  better 
divergent views among stakeholders (e.g. in section 5.1.1 on effectiveness). 

All recommendations for simplification and burden reductions are contained in the report 
to  the  European  Parliament  and  the  Council  which  this  Staff  Working  Document 
accompanies.  The  report  contains  an  expanded  discussion  about  future  actions  for  the 
Commission, Member States and EFSA that are expected to improve implementation of 
the Regulations. 

113 

 
Annex 2: Synopsis report on the stakeholder consultation  

This  synopsis  summarises  the  consultation  activities  carried  out,  the  stakeholders  who 
contributed,  and  their  opinions.  The  roadmap  for  the  evaluation  was  published  in 
November  2016.  21  stakeholders  sent  in  feedback  on  the  roadmap  via a  dedicated 
webpage. Responses received in the first four weeks after the roadmap was published fed 
into  the  design  of  the  evaluation,  influencing  the  terms  of  reference  of  the  support 
study445.  The  support  study  then  collected  data  from  stakeholders  through  consultation 
activities. 

Consultation strategy 
The  consultation  strategy  was  drawn  up  in  January  2017  together  with  the  terms  of 
reference  of  the  support  study,  and  data  were  collected  on  all  five  evaluation  criteria. 
Stakeholders  that  have  contributed  to  one  or  more  consultations  are:  national  public 
authorities;  EFSA;  the  Commission  services;  the  pesticide  industry,  the  food  industry, 
NGOs working on the environment, health, animal protection and transparency; members 
of the public, consumers and farmers, and authorities and other stakeholders from non-
EU countries. 

Table A.2. Consultation activities carried out 

Consultation 
Open public 
consultation 

SME consultation 
panel 

Stakeholder survey 

Member State 
survey 

Focus groups 

First workshop 

Second workshop 

In-depth interviews 

Target/participants 

Consumers, citizens and farmers. 

Distributed via the Europe Enterprise Network 
to target: small, medium and micro-sized 
companies. 
Trade and industry associations covering the 
chemical industry; retail and wholesalers; food 
and feed industry; environmental, health and 
consumer NGOs; and farmer associations. 

Member States and EEA countries. 

Member State authorities, EFSA, the 
Commission, stakeholders working with risk 
assessment. 

Member State authorities, the Commission, 
trade and industry associations, and NGOs at 
EU level. 
Member State authorities, the Commission, 
trade and industry associations, and NGOs at 
EU level. 
Trade and industry associations, NGOs at EU 
level, Member States, non-EU countries, EFSA 
and the Commission. 

When? 
13 Nov 2017 - 
12 Feb 2018 

14 Nov 2017 - 
15 Jan 2018 

14 Nov 2017 - 
12 Jan 2018 

16 Nov 2017 - 
19 Feb 2018 
24 Jan 2018 
28 Feb 2018 
5 Mar 2018 
9 Mar 2018 

12 Sep 2017 

16 May 2018 

10 Jan 2018 - 
25 Apr 2018 

Contributions 

9 847 

294 

240 

30 

8 
9 
7 
8 

40 

50 

60 

445 The feedback can be accessed via the Europa webpage. 

114 

 
 
 
                                                 
Analysis of the data 
The data collected from the surveys was downloaded in spreadsheets. The contractor of 
the  support  study  was  responsible  for  the  first  analysis  of  the  data  and  to  take  into 
consideration  the  opinions  of  the  public,  stakeholders  and  Member  States.  17  position 
papers  were  sent  by  non-EU  countries446,  stakeholder  organisations447  and  Member 
States448.  These  were  all  read  and  taken  into  account  in  the  analysis.  Once  the  support 
study had been finalised, all data were sent to the Commission who conducted a second 
analysis for the preparation of the staff working document. The open field questions in 
the surveys and the position papers were reanalysed. 

The answers to the questions to all four surveys are available in tabular form in Annex 3 
of the support study. 

Online public consultation 
The public consultation opened on 13 November 2017 and closed on 12 February 2018. 
A  total  of  9 879  responses  were  submitted  (including  32  duplicates,  which  were 
removed). The remaining 9 847 responses were analysed. 

The  public  consultation  was  designed  to  collect  the  views  of  the  public  on  plant 
protection  products  and  pesticide  residues  in  the  EU.  In  particular,  it  sought  to  gather 
information on how well informed the public feel about pesticides, pesticide residues and 
EU  decision-making.  The  survey  focused  on  public  perceptions  of  how  pesticides  and 
pesticide residues are regulated. It comprised 24 questions and was available online (via 
‘EU  survey’)  in  the  EU’s  23  official  languages.  It  could  be  accessed  via  the  European 
Commissions’  public  consultation  website449.  Contributions  received  by  post  were  also 
considered as input into the EU survey.  

65 % of respondents lived in Germany or France 
4 % were from non-EU countries 
77 % were aged 30-64 
76 % were employed or self-employed 
55 % lived in a rural area 
20 % worked in farming 
56 % said the PPP or MRL Regulations were relevant to their professional work 

446 Argentina, Australia, Brazil, Canada, India, Kenya, Malaysia, New Zealand, Peru, Thailand and the USA. 
447 ECPA, Syngenta and Wine Institute. 
448 From Sweden, Belgium and the Netherlands and from the northern zone steering group. 
449 Online Public Consultation 

115 

 
 
                                                 
5000

4000

3000

2000

1000

0

4491 

1894 

0  0  1  1  3  7  7  12  13  15  19  20  22  24  30  32  37  56  68  69 134 164 221 233 267 406 489 530 582 

Y
C

T
M

E
E

T
L

K
S

K
D

I

G S
B

I

U F
L

E
I

V
L

L
P

O
R

O
N

R
H

L
E

Z
C

T
P

U
H

T
A

H
C

S
E

E
S

T
I

L
N

E
B

K
U

R
F

E
D

r
e
h
t
O

Figure A.1. Distribution of replies by country in absolute numbers 

The  vast  majority  (99 %)  of  respondents  knew  that  the  EU  regulates  pesticides  and 
pesticide residues. However, the public does not think that the PPP Regulation provides 
sufficient protection for human health, animal welfare and the environment. 

Protect human health

Protect the environment

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Not at all

Insufficiently

Somewhat

Sufficiently

Fully protected

Don't know

Figure  A.2.  In  your  opinion,  are  human  health  and  the  environment  protected  from  the  use  of 
pesticides in the EU? 

One of the main concerns identified is that consumers do not feel safe eating food that 
has been treated with pesticides, even though MRLs are set at safe levels and, according 
to  the  annual  residue  monitoring  reports,  are  complied  with  to  a  large  extent450.  The 
proportion of consumers who feel unsafe increases when they are asked if they feel safe 
eating imported food treated with pesticides. 

100%

75%

50%

25%

0%

38% 

10% 

21% 

31% 

11% 

16% 

24% 

48% 

Don't know
Safe
Somewhat safe
Quite unsafe
Not safe at all

Food grown or treated in the
EU (Question 3)

Food grown or treated
outside the EU (Question 4)

450 See all reports on EFSA’s webpage. 

116 

 
 
 
 
                                                 
Figure A.3. Do you feel safe consuming food that has been grown or treated with pesticides in the EU 
and outside the EU? 

Responses are influenced by whether or not the respondents’ work has any link with the 
Regulations.  People  whose  work  has  some  connection  with  the  Regulations  feel  safer 
about  eating  food  treated  with  pesticides  than  those  whose  work  does  not.  The  same 
pattern recurs in other questions, such as:  

  whether  it  is  necessary  to  use  PPPs  to  meet  existing  demand  for  food  (see  Figure 

A.4); 

  whether human health is protected from pesticides in the EU; 
  whether the environment is protected from pesticides; 
  whether MRLs in the EU are sufficiently stringent. 

In all these questions, those who stated that the Regulations were relevant to their work 
had a more positive view of their effects. Better knowledge of the regulatory system thus 
goes hand in hand with a more positive view of benefits and safety. 

Overall
(n=9820)

Regulations are relevant
(n=5503)

Regulations are not relevant
(n=4317)

Rather unnecessary
Figure A.4. Do you believe pesticides are necessary to meet the current demand for food? 

Rather necessary

0%

25%

50%

75%

100%

Respondents are clearly divided on whether pesticides are necessary to meet the existing 
demand for food (see Figure A.4). About 70 % of respondents for whom the Regulations 
are relevant to their work say pesticides are necessary or crucial to meet demand. Among 
them, 75 % of farmers consider plant protection products and pesticides (PPPs) necessary 
or crucial for this purpose. Farmers who use PPPs themselves were also asked about the 
availability of pesticides. The majority (64 %) said the PPPs they need were ‘mostly’ or 
‘very’  available,  while  a  minority  (4 %)  said  they  were  not  available  at  all.  69 %  of 
farmers also said they were at a competitive disadvantage compared with farmers outside 
the EU.  

The public were asked for their opinion about the level of MRLs in the EU. While 28 % 
thought the MRLs were about right, 50 % thought them too high (see Figure A.5). Of the 
respondents for whom the Regulations were not relevant to their work, 82% were of the 
opinion that  MRLs  are  too  high  in  the  EU.  Most  respondents  working  in  the  food/feed 
industry said the harmonisation of MRLs had had a positive effect on the single market. 

117 

 
 
100%

75%

50%

25%

0%

9% 

50% 

28% 

13% 

Don't know

Too high (i.e. the EU is not strict enough)

Just about right

Too low (i.e. the EU is too strict)

Figure A.5. What do you think about MRLs in the European Union? 

Half of respondents feel they are not well enough informed — or completely uninformed 
–  about  decisions  taken  in  the  EU  on  PPPs  and  pesticide  residues.  There  are  several 
platforms and webpages with information about pesticides and pesticide residues in the 
EU. However, awareness of these is low; 37 % of respondents were not aware that any 
such  sources  existed.  One  issue  is  that  22 %  of  respondents  know  the  tools  exist,  but 
cannot easily find the information. Just having information publicly available thus does 
not necessarily mean the public is better informed, if that information is hard to find. 

The public was asked about the level at which pesticides and pesticide residues should be 
regulated. 35 % thought they should be regulated at national level to some extent, 55 % 
thought  they  should  be  regulated  at  EU  level  to  some  extent,  and  61 %  thought  they 
should be regulated at international level to some extent. 

DG Health and Food Safety has analysed the position papers submitted in the course of 
the consultation. Of the 186 documents sent in that were in a readable format (e.g. .pdf, 
.doc,  .txt),  18  files  were  corrupted  and  could  not  be  opened.  A  total  of  168  documents 
were  therefore  analysed.  Most  of  them  were  critical  of  the  PPP  Regulation  and  MRL 
Regulation, with only 2 % taking a positive view of the current regulatory system. 

The  main  concerns  expressed  had  to  do  with  adverse  effects  on  the  environment  — 
particularly  the  declining  insect  and  bee  populations  —  and  human  health.  Many 
concerns about  human  health  had  to  do  with  cumulative exposure  to multiple  pesticide 
residues and the long-term exposure of workers and bystanders to pesticides. 24 % made 
a  link  between  the  active  substance  glyphosate  and  inadequate  protection  of  human 
health  and  the  environment.  Several  submissions  about  glyphosate  referred  to  growing 
concern about its impact on biodiversity, but most expressed concern that it might cause 
cancer.  11 %  of  submissions  contained  references  to  scientific  literature  or  scientific 
articles. 4 % included references to the UN special report on the right to food451. Some 
submissions  contained  suggestions  for  improving  the  current  system  to  take  more 
account  of  innovation  in  application  techniques  or  for  reforming  the  VAT  system  to 
support more sustainable farming. Many referred to the environmental and human health 
benefits  of  organic  farming.  5 %  of  submissions  criticised  the  survey  itself  and  the 
wording of the questions. 

The Commission read all the 4108 submissions to the open field question. The responses 
were  submitted  in  German  (2145),  French  (797),  English  (713),  Dutch  (177),  Swedish 
(107),  Italian  (89),  Spanish  (42),  Polish  (16),  Czech  (7),  Latvian  (6),  Greek  (3), 

451 United Nations (2017) Report of the Special Rapporteur on the right to food. A/HRC/34/48. 

118 

 
 
                                                 
Hungarian (3), Croatian (2), Danish (1), Estonian (1), Lithuanian (1), and Romanian (1). 
Comments fall into one of two contradictory groups: (i) those in favour of pesticides and 
(ii)  those  opposing  them.  However,  both  sides  agree  that  EU  agriculture  faces  unfair 
competition,  as  imports  are  not  subject  to  the  same  strict  rules  as  farm  produce  from 
within the  EU.  Farmers  would  therefore  like  to see  more  harmonisation  of  PPPs  in  the 
EU. The issues most frequently raised are as follows: 

(i) Arguments for pesticides 
  Pesticides are necessary to produce enough food at affordable prices. 
  Media reporting and public opinion are biased, alarmist and one-sidedly negative. 
  Decision-making is no longer based on science and facts, but is politicised. 
  Decision-making is  biased towards protecting  health and the  environment, and fails 
to take account of the needs of agriculture. The result is fewer types of PPPs. Farmers 
lack  the  tools  they  need,  especially  for  minor  uses,  while  resistance  problems  are 
growing. 
Innovation is declining. 

 
  MRLs provide full protection for consumers. 
  PPPs  have  not  been  harmonised  enough  across  the  EU,  nor  are  they  sufficiently 
available.  National  authorities  insist  on  applying  extra  rules  and  deadlines  to  the 
various processes. 

(ii) Arguments against pesticides 
  Pesticides are unnecessary or can be used far less without jeopardising adequate food 

production, as organic farming shows. 

  All  farming  should  go  organic.  Existing  ‘industrial’  farming  is  unsustainable.  EU 
subsidy policy must be altered so as to stop supporting industrial farming and instead 
support organic production instead. 

  Decision-making is biased towards the economic interests of industry and agriculture; 

the precautionary principle is not applied as it should be. 

  Assessments  cannot  be  trusted,  as  studies  provided  by  industry  cannot  be  trusted, 
there  is  not  enough  transparency,  and  the  evaluating  authorities  are  not  genuinely 
independent. 

  Pesticides  are  poisonous  and  adversely  affect  soils  and  water,  leading  to  decreased 

fertility. 

  Pesticides are responsible for insect and bird population decline. 
  Overall assessments of active substances are not stringent enough and MRLs do not 
provide  sufficient  protection  for  consumers,  as  they  fail  to  take  account  of  the 
cocktail effect. 

  More research is needed into alternatives to pesticides. 

SME consultation panel 
The SME survey was launched on 14 November and closed on 15 January 2018. A total 
of  296  responses  were  submitted,  of  which  two  were  duplicates.  294  responses  were 
therefore available for analysis. 

The  survey  was  designed  to  collect  the  views  of  micro,  small  and  medium-sized 
enterprises  (SMEs).  Its  main  purpose  was  to  gat  her  information  on  how  the  existing 
rules governing the approval of active substances, authorisation of PPPs and the  setting 
of MRLs of pesticides are working. The focus was on administrative burden and costs. 
Responses were collected via the Europe Enterprise Network. 

119 

 
The  survey,  which  comprised  19  questions,  was  available  in  all  official  EU  languages. 
The  Europe  Enterprise  Network’s  regional  partners  translated  responses  to  the  survey 
into English where necessary.  

50 % were from either Poland or Portugal. 
46 % were involved in farming or businesses to do with farming. 
73 % were micro-enterprises with a turnover of less than EUR 2 million. 
15 % had a turnover of less than EUR 10 million. 

100

80

60

40

20

0

99 

46 

49 

40 

1 

FR

1 

UK

2 

CZ

2 

EE

3 

3 

CY

DE

3 

LT

4 

8 

8 

9 

16 

LV

DK

ES

BE

SI

IT

RO

PT

PL

Figure A.6. SME respondents by Member State 

The largest single group of SMEs responding (136) are involved in agricultural business. 
The others work in the following areas: processing food and feed (50), retail and logistics 
(38), manufacturing PPPs (11), and manufacturing agricultural inputs (9). The 49 SMEs 
in the category ‘other’ classified themselves as working in fields including consultancy, 
importing seeds, scientific work and research, and breeding. 

The main issue the survey addressed was the administrative burden and costs which the 
two Regulations impose on SMEs. This is covered by several questions, such as whether 
businesses have difficulties complying with the Regulations, or whether they need to hire 
external  consultants  to  advise  them  or  help  them  comply  with  the  Regulations. 
Respondents were also asked to estimate the share of administrative costs stemming from 
the Regulations on pesticides as a percentage of all the administrative costs incurred by 
their business. 

86 

99 

100

80

60

40

20

0

14 

14 

16 

0%

1% to 5%

5% to 10%

10% to 15%

 more than 15%

Figure A.7. What is the share of administrative costs stemming from the Regulations on pesticides as a 
percentage of all the administrative costs incurred by your business? 

Overall, businesses report that the administrative costs arising from the Regulations are 
fairly  low.  Most  businesses  that  responded  to  the  question  about  impacts  on  their 
business  reported  that  the  MRL  Regulation  had  had  no  impact  on  their  production 
(76 %), competitiveness (61 %), or  sales  (64 %). Similarly,  the majority responded  that 
the  PPP  Regulation  had  not  affected  their  investments  (74 %),  production  (69 %)  or 
competitiveness (59 %). 

Most  SMEs  (86 %)  reported  that  they  had  had  no  serious  difficulty  in  complying  with 
MRLs  set  in  the  EU.  Only  5  respondents  (2 %)  reported  frequent  difficulties  in 
complying  with  MRLs.  To  comply  with  the  MRL  Regulation  or  the  PPP  Regulation, 

120 

 
 
 
24 %  of  respondents  hire  an  external  consultant,  either  frequently  or  occasionally,  to 
advise them or help them comply. 

SMEs were asked their views on the level of MRLs in the EU. While 36 % thought they 
were about right, 26 % thought them too high. 

100%

75%

50%

25%

0%

25% 

26% 

36% 

12% 

Don’t know / Not applicable 

Too high (i.e. the EU is not strict enough)

Just about right

Too low (i.e. the EU is too strict)

Figure A.8. What do you think about MRLs in the European Union? 

Respondents are concerned mainly by the complexity of the rules and the administrative 
burden,  especially  as  they  are  relatively  small.  When  asked  if  their  needs  were 
sufficiently  taken  into  consideration,  half  the  respondents  were  satisfied  and  half 
dissatisfied with the Regulations. In the open field questions, SMEs expressed concerns 
about the difficulties of developing and commercialising new active substances. Meeting 
the requirements  for research and development and bearing the high  costs involved are 
particularly difficult for smaller firms. SMEs say the data requirements and procedures in 
the  PPP  Regulation  are  not  considered  appropriate  or  proportionate  for  low-risk 
solutions. 

Stakeholder survey 
The  stakeholder  survey  ran  from  14 November  2017  to  12 January 2018.  It  comprised 
136  open  and  closed  questions,  and  was  made  available  to  all  stakeholders  affected 
directly or indirectly by the Regulations. The aim was to collect data and views on how 
the system was working. 

Stakeholders from all key groups responded to the questionnaire. Of the 240 respondents, 
185  were  listed  in  the  EU  Transparency  Register.  Responses  from  organisations  not 
registered were grouped in the ‘Other’ category. Stakeholders listed in the transparency 
register were grouped into six categories (see Figure A.9). 

41 

39 

37 

28 

24 

16 

55 

Agriculture

Food/ Feed
industry

PPP & Chemical
industry

Retail &
Wholesale

NGO/ Think tank

Public/ IO &
Research

Other

121 

 
 
 
 
 
Figure A.9. Overview of types of stakeholders who submitted responses to the stakeholder survey 

A majority of stakeholders think the PPP Regulation achieves the aim of protecting users, 
bystanders and residents, at least to a large extent, as well as the environment (see Figure 
A.10).  A  majority  do  not  think  it  achieves  the  aim  of  ensuring  that  EU  agriculture  is 
competitive.  Almost  50 %  think  the  MRL  Regulation  improves  international  trade  to  a 
small extent only, or not at all. 

0%

20%

40%

60%

80%

100%

N
O
I
T
C
E
T
O
R
P

I

G
N
V
O
R
P
M

I

Human health

The environment

Internal market

Agricultural competitiveness

International trade

Not at all

To a small extent

Moderately

To a large extent

Fully

Don't know

Figure A.10. To what extent have the PPP and MRL Regulations reached the following objectives? 

NGOs and think tanks are more critical of the Regulation’s benefits. 75 % of them say it 
does not achieve the objective of protecting human health, or only to a small extent. 25 % 
say it totally fails to protect the environment.  

There is agreement across stakeholder groups that the provisions of the PPP Regulation 
are  not  working  very  well.  As  regards  the  approval  of  new  active  substances,  most 
respondents from the food and the crop-protection industries say the provisions work to a 
small extent only. NGOs are even more critical: 77 % say the provisions work to a small 
extent  only.  Respondents  are  similarly  critical  of  how  the  provisions  on the  renewal  of 
approval of active substances work in practice. 

As  regards  the  implementation  and  enforcement  of  the  approval  procedure,  there  are 
differences of opinion among different stakeholder groups. Most NGOs and think tanks 
say the provisions are implemented to a small extent only. Representatives of the crop-
protection industry and associated industries, on the other hand, say the provisions have 
been implemented, at least to a large extent. Over three quarters of NGOs say the cut-off 
criteria have not been implemented correctly. The crop-protection industry, on the other 
hand, criticises them as too restrictive. 

With  similar  response  patterns  across  all  stakeholder  groups,  respondents  say  that  the 
authorisation of new PPPs and the zonal system work better than the procedures to renew 
an authorisation and inter-zonal mutual recognitions.  

Organisations  with  a  vested  economic  interest  mostly  rate  the  risk  assessment  and  risk 
management  of  the  approval  process  as  moderately  or  sufficiently  transparent.  Again, 
NGOs  take  a  different  view.  In  their  opinion,  the  processes  involved  are  not  at  all 
transparent. All stakeholder groups agree that the MRL-setting process needs to be made 
more transparent. 86 % of respondents say this could be done by defining clearly which 
documents should be made publicly available. 

As regards the MRL Regulation, many respondents from the industry say the MRLs for 
food and feed set at EU level are too strict. NGOs, on the other hand, say the levels at 

122 

 
 
which they are set are too high. About a third of respondents think existing MRL levels 
are just about right. Consequently, respondents from the food industry say the Regulation 
has  had  an  overall  negative  impact  on  imports  of  products  from  non-EU  countries  into 
the EU. 

100%

75%

50%

25%

0%

71% 

66% 

81% 

77% 

50% 

41% 

47% 

41% 

23% 

31% 

3% 

0% 

0% 

0% 

0% 

13% 

15% 

8% 

Agriculture

Food/ Feed
industry

PPP & Chemical
industry

Retail &
Wholesale

NGO/ Think tank

Public/ IO &
Research

Too low

Just right

Too high

Figure A.11. What do you think about MRLs in the European Union? 

Respondents across stakeholder groups say the MRL Regulation is achieving the benefits 
it  is  supposed  to  provide;  most  think  it  achieves  the  aim  of  protecting  consumers  to  a 
large  extent,  or  even  fully.  Respondents  have  similar  opinions  on  the  objective  of 
improving the workings of the single market. 

Member State survey 
All 28 Member States and two European Economic Area countries (Iceland and Norway) 
gave  input  through  a  targeted  survey,  which  was  online  from  16 November 2017  to 
19 January 2018.  Respondents  had  the  option  of  completing  the  survey  online  or  of 
emailing  their  responses.  The  questionnaire  had  126  questions  of  two  kinds  (open  and 
closed). The northern-zone steering committee and 3 EU countries submitted additional 
position papers. 

The  Member  States  take  a  positive  view  overall  of  the  effects  the  PPP  Regulation  has 
had.  They  rate  its  impact  on  the  objectives  of  protecting  human  health  and  the 
environment  and  improving  the  workings  of  the  single  market  as  ‘very  positive’  or 
‘positive’. As regards agricultural production, however, 40 % of Member States think the 
Regulation has had a ‘negative’ or ‘very negative’ impact (see Figure A.12).  

Protection of human health

Protection of the environment

Internal market

Agricultural production

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Very negative

Negative

No impact

Positive

Very positive

Don't know

Figure A.12. What impact has the PPP Regulation had on the following objectives? 

The Member States say the MRL Regulation has had either a positive or a very positive 
impact on all objectives (see Figure A.13).  

123 

 
 
 
Consumer protection

Internal market

International trade

0%

20%

40%

60%

80%

100%

Very negative

Negative

No impact

Positive

Very positive

Don't know

Figure A.13. What impact has the MRL Regulation had on the following objectives? 

The  Member  States  seem  satisfied  with  the  procedure  for  approving  active  substances. 
However, they voice greater concern about the procedure for renewing approvals. Only 
five of them say the provisions on the renewals work, at least to a large extent. Four say 
they work to a small extent only. The majority of Member States also think the approval 
criteria appropriate. The cut-off criteria, however, appear to be controversial. Fewer than 
half  of  the  Member  States  think  they  are  appropriate.  Three  prefer  stricter  cut-off  and 
risk-based criteria (see Figure A.14). 

Hazard-based criteria

Other criteria

0%

25%

Less strict

50%

75%

100%

Appropriate

More strict

Figure  A.14.  Are  the  criteria  for  approving  an  active  substance  appropriate?  If  not,  should  they  be 
stricter or less strict? 

A majority of Member States say the benefits of the PPP Regulation outweigh its costs. 
In general, they say the procedures are more efficient today than before the Regulation 
was implemented (Figure A.15). They say the partial harmonisation of the authorisation 
procedures was successful. 

100%

75%

50%

25%

0%

46% 

31% 

23% 

68% 

7% 

25% 

More efficient
Equally efficient
Less efficient

Approval of active substances

Authorisation of PPPs

Figure A.15. Do you think procedures today are more efficient or less efficient  than before the entry 
into force of the PPP Regulation? 

Member States say they approve of the default limit of 0.01 mg/kg set out in the MRL 
Regulation.  Only  one  says  the  limit  is  not  strict  enough.  Member  States  say  the 
provisions on setting and reviewing MRLs work well in practice. Greater problems are 

124 

 
 
 
 
reported on the review of existing MRLs; four Member States say the provisions work to 
a small extent only. 

Most Member States consider the benefits of the MRL Regulation to outweigh the costs. 
About  half  of  them  say  the  benefits  outweigh  the  costs,  at  least  to  a  large  extent. 
However,  perceptions  of  the  efficiency  of  the  MRL-setting  and  reviewing  procedures 
vary somewhat. Overall, the Member States  see the setting  procedure as more efficient 
than the review procedure. 

The  Member  States  were  asked  what  level  pesticides  and  their  residues  should  be 
regulated at. They still favour the current system, with approval of active substances and 
MRLs at EU level and authorisation of PPPs at  national level. Several would welcome 
more international cooperation. 

30

25

20

15

10

5

0

26 

26 

12 

7 

2 

1 

24 

13 

0 

Approval of active substances

Authorisation of PPPs

MRL Setting

International level

EU level

National level

Figure A.16. What level of governance is most appropriate for regulating pesticides and their residues? 
(Multiple responses possible) 

Focus groups 
Four focus groups were convened between January and March 2018 to collect additional 
information from experts from Member States, EFSA, the Commission, the Minor Uses 
Coordination Facility, and from consultants advising on the submission of dossiers. The 
Member  States  represented  at  each  of  the  focus  groups  were  selected  to  reflect 
geographical  coverage  and  the  size  of  the  countries.  The  topics  examined  by  the  focus 
groups  were:  1)  risk  assessment;  2)  risk  management  and  decision  making;  3)  MRL 
setting; and 4) PPP authorisation. 

1.  Risk assessment 

Participants:  NL,  UK,  FR,  DE,  BE,  EFSA,  JSC  International,  Exponent  International 
Limited. 

Participants in the focus group identified reasons for the delays in the course of the risk 
assessment procedure. One particular issue is the amount of information to be processed 
by  the  relatively  tight  deadlines  for  responding  to  applications.  Participants  were  very 
satisfied with the cooperation between Member States and EFSA. It was also generally 
agreed that there should be a formalised forum to discuss general risk assessment issues 
where Member States could have a say.  

Although the cut-off criteria were supposed to speed up the process, participants reported 
that  in  practice,  there  is  too  little  time  to  first  conduct  an  evaluation  on  the  cut-off 
criteria,  then  a  full  evaluation.  There  is  a  general  consensus  among  the  Member  States 
that the cut-off criteria do not speed up the process.  

125 

 
 
As  alternative  methods  to  animal  testing  are  becoming  increasingly  prominent,  it  was 
agreed that the risk assessment should be improved to allow taking those new methods 
also into consideration. It was reported that the reduction of animal testing is difficult to 
enforce  at  European  level,  and  that  a  register  of  earlier  studies  conducted  would  be 
needed to avoid the duplication of studies involving animals. Participants also discussed 
the transparency of the process and civil society participation in it. They appreciated the 
fact  that  EFSA  has  published  a  good  deal  of  information  on  the  assessment  of  active 
substances  and  acknowledged  that  the  process  has  become  more  transparent  over  the 
years.  At  the  same  time,  although  some  stakeholders  are  actively  involved,  it  is  often 
difficult to engage the scientific community. 

2.  Risk management and decision-making 

Participants: EL, SE, LU, SK, PL, EFSA, and the Commission. 

Participants noted that one of the key objectives of the PPP Regulation was to harmonise 
and  streamline  procedures  across the  EU,  and  that  further  streamlining  processes  could 
help  boost  cooperation,  particularly  in  terms  of  enabling  risk  managers  to  take  more 
decisions.  It  was  suggested  that  EFSA  conclusions  should  allow  for  some  flexibility, 
underpinned  by  sufficient  information  on  how  risks  can  be  managed.  It  was  further 
suggested  that  involving  risk  managers  in  the  drafting  of  guidance  documents  for  risk 
assessment could improve understanding of the procedures while also strengthening the 
link between the two stages of the process. All of this could help reduce delays, as risk 
managers  sometimes  think  the  risk  assessment  lacks  sufficient  depth  and  completeness 
for sound decision-making, and file additional data requests. 

The timeframe for risk management was generally reported to be appropriate. However, 
one  key  problem  was  the  lack  of  a  stop-the-clock  option  (during  the  risk  management 
process) which could provide more predictability as regards timelines and reduce the use 
of  confirmatory  information  procedures.  Application  of  the  precautionary  principle  is 
thought to be one of the least well understood concepts in the PPP Regulation. This leads 
to  differences  in  understanding  among  stakeholders  as  to  how  the  principle  should  be 
applied, and there are calls for it to be better defined. 

It is generally agreed that scientific progress is taken into account in the risk management 
process.  However,  other  factors  (socioeconomic  and  agronomic)  are  not  taken  into 
account sufficiently and should be more clearly included in the Regulation for this to be 
improved.  There  is  a  parallel  with  the  participants’  opinion  on  risk  assessment;  while 
they  think  the  PPP  Regulation  has  improved  transparency,  they  highlight  a  need  to  do 
more  to  include  the  scientific  community  —  widely  perceived  as  disengaged  –  in  the 
process, to improve scientific scrutiny. 

3.  PPP authorisation 

Participants:  BE,  ES,  DK,  PT,  HU,  the  Minor  Uses  Coordination  Facility  and  the 
Commission. 

This group focused on aspects related to the authorisation of PPPs at Member State level. 
Participants described the renewal procedures as burdensome, as the legal deadlines are 
too tight and resources are in short supply. One specific example is the need to provide 
all  the  information  required  in  both  the  national  language  and  English,  which  binds 
resources  and  time.  Coordination  within  the  zonal  system  was  reported  to  vary  across 
zones. For example, participants stressed the role of meetings and knowledge exchange 
in the Northern zone in enabling proceedings to run smoothly. In the central zone, on the 
other  hand,  harmonisation  and  zonal  cooperation  were  thought  to  pose  particular 

126 

 
challenges. The reasons for this are the size of the zone and the diversity of the Member 
States belonging to it. 

Participants  said  the  number  of  national  requirements  was  rising  rather  than  falling,  as 
Member  States  generally  believe  national  requirements  provide  additional  protection. 
This creates obstacles for mutual recognitions. Emergency authorisations are considered 
by  Member  States  to  be  helpful  in  solving  some  of  the  problems  thought  to  have  been 
created  under  the  current  legislative  framework.  Participants  pointed  to  a  lack  of  PPPs 
available  in  their  country,  partly  due  to  delays  in  re-authorisations,  with  smaller 
countries,  in  particular,  seeing  emergency  authorisations  as  an  important  mechanism  to 
provide agriculture with the tools needed. The focus group also discussed low incentives 
for  industry  to  apply  for  authorisations  as  one  of  the  reasons  why  few  alternatives  are 
available. As there is no common definition of minor uses, Member States apply the rules 
differently,  which  is  a  further  obstacle  to  placing  these  products  on  the  market  and 
hinders zonal authorisations. An EU-wide minor uses database would be welcomed. 

4.  MRL setting 

Participants: EL, UK, DE, FR, EFSA, EFSA and the Commission 

As  regards  procedures  and  timelines,  the  participants  identified  several  problematic 
elements. The main concern relates to the review of existing MRLs under Article 12. In 
practice, EFSA is dependent upon Member States' support for this procedure, yet Article 
12 does  not have  the  same priority for Member States as,  for  instance, Article 6 of the 
MRL  Regulation.  It  was  suggested that  a  guidance  document  for  Article  12  could help 
support  the  work.  Participants  also  agreed  that  legal  deadlines  are  too  short  for  more 
complex  applications.  Different  Member  States  handle  incomplete  dossiers  in  different 
ways; some make use of the stop-the-clock procedure and request additional data, while 
others do not allow additional submissions.  

Participants  highlighted  inconsistency  between  the  OECD  and  EFSA  guidance 
documents  as  one  of  the  problems,  as  it  was  not  always  clear  which  guidance  applied. 
Another element that was highlighted was the fact that cumulative risk assessment is not 
adequately  accounted  for  when  MRLs  are  set  or  reviewed.  Inconsistency  between  the 
PPP Regulation and legislation on genetically modified organisms was also highlighted; 
this  could  be  solved  by  updating  the  definition  for  residues.  According  to  the 
participants, there is also a need to improve the transparency of the MRL-setting process. 
One Member State said that although stakeholders had the option of reacting, the process 
was difficult. Overall, participants agreed that the MRL Regulation had helped achieve a 
harmonised  approach,  and  that  overall  the  Regulation  had  also  been  effective  in 
achieving closer cooperation between Member States and EU-level authorities. 

Workshops 
Two  workshops  were  held  on  12 September 2017  and  16 May 2018,  respectively,  to 
engage  with  stakeholders  and  Member  States.  The  minutes  are  available  on  the 
Commission's REFIT webpage452. 

Interviews 
The  contractor  of  the  support  study  conducted  around  60  interviews.  The  information 
was used in the answers to the evaluation questions in the support study. 

452 Pesticide REFIT webpage 

127 

 
                                                 
The  stakeholders  and  Member  States  interviewed  were:  European  Seed  Association, 
European  Crop  Protection  Association,  European  Crop  Care  Association,  IBMA, 
Pesticide  Action  Network,  FDE,  Greenpeace,  PROFEL,  COPA-COGECA,  UK 
Pesticides  Campaign,  Bee  Life,  Coceral,  IFOAM,  Freshfel,  SNE,  Health  and 
Environment Alliance, Clientearth, FEFAC, COE, Austria, Belgium, Croatia, Denmark, 
Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Luxembourg, 
Malta,  Netherlands,  Norway,  Poland,  Portugal,  Slovakia,  Slovenia,  Spain,  Sweden  and 
United  Kingdom.  Representatives  of  the  European  Commission  and  EFSA  were  also 
interviewed. 

128 

 
 
Annex 3: Methods and analytical models 

External support study 

The  support  study  was  carried  out  by  Ecorys  Brussels  for  the  Commission.  The  study 
answered  28  evaluation  questions.  The  evaluation  questions  were  derived  from  the 
questions in the roadmap but with higher level of detail combining the questions with the 
scope of the evaluation.  

In the structuring phase, the contractor set out the strategy for the study and sequence of 
tasks. The structuring ended with the delivery of the inception report, which included the 
methodology  and  analytical  methods  to  be  used  together  with  the  questionnaires  to  be 
used in the data collection. Based on the consultation strategy, the contractor carried out 
the  data  collection,  which  included  surveys,  interviews,  focus  groups,  case  studies  and 
workshops. An interim report was delivered following the data collection to take stock of 
the progress made. The final report was published on 18 October 2018453.  

Toxicological profile of approved active substances 

To compare the toxicological hazard profile of active substances approved in  the EU in 
2011  and  2018,  a  dataset  was  created  based  on  an  extract  from  the  EU  Pesticides 
Database.  The  substances  approved  in  2011  were  mapped  with  the  help  of  Regulation 
540/2011  and  implementing  Regulations  on  approvals,  renewal  of  approvals,  non-
approvals,  non-renewal  of  approvals  and  withdrawals.  Following  the  mapping  of 
approved  active  substances,  the  hazard  classification  as  reported  on  the  European 
Chemical Agency’s website454 was added. This was done using a step-wise approach: 

1.  harmonised classification; 
2.  proposed classifications yet to be reviewed; 
3.  notified (self-reported) classifications; 
4.  EFSA  views  on  appropriate  classifications  from  the  most  recent  EFSA 

conclusion. 

Based on the hazard classifications for human health, the substances were divided into 10 
categories  (see  Table  A.3).  Based  on  the  10  groups,  3  larger  groups  were  created.  The 
high hazard group represents the active substances meeting the cut-off criteria. The active 
substances which had no classification were placed in the low-hazard group. One caveat 
with this approach is that active substances that should have a harmonised classification 
but  have  no  proposed  or  notified  classification  are  placed  in  the  low  hazard  category. 
However, it is not expected that this concerns a significant number of active substances, 
distorting  the  analysis.  Micro-organisms  are  considered  low-hazard,  although  it  is 
acknowledged  that  they  can  still  exhibit  skin-sensitising  properties,  despite  not  being 
classified. 

Figure  A.17  shows  the  comparison.  In  the  graph  there  is  also  the  projection  for  2022 
which is based on the application for renewal of approval of active substances. For more 
than 56 active substances, there is no longer support at EU level. The projection for 2022 

453 The support study published in the EU Bookshop  
454 https://echa.europa.eu/ 

129 

 
 
                                                 
does  not  include  applications  for  new  active  substances,  as  it  is  not  possible  to  predict 
what  new  active  substances  will  be  approved  in  the  future  and  how  they  will  be 
classified.  

To  account  for  the  larger  number  of  active  substances  available  in  the  EU  in  2018 
compared  to  2011, the share of active  substances falling within  a group was calculated 
and compared over the years instead of comparing just the numbers or active substance. 

Table A.3. Hazard classifications related to human health. 

Classification, proposed classification or notified classifications: C&L inventory 

S
S
E
N
S
U
O
D
R
A
Z
A
H

Mutagenic Cat. 1 
Carcinogenic Cat. 1 
Carcinogenic Cat. 2 
Acute toxic Cat. 1 
Acute toxic Cat. 2 
Acute toxic Cat. 3 
Acute toxic Cat. 4 
STOT Cat. 3 
Skin Irrit Cat. 2 
Micro-organisms 
No classification 

Reprotoxic Cat. 1 
Reprotoxic Cat. 2 

Resp sensitiser Cat. 1 
Skin sensitiser Cat. 1 
Eye damage/irrit. Cat. 1 
Eye damage/irrit. Cat. 2 

 Mutagenic Cat. 2 

STOT Cat. 1 
STOT Cat. 2 

Skin corrosive Cat. 1 

Cut-off 

Intermediate 

Low 

66% 

62% 

61% 

37% 

38% 

31% 

70%

60%

50%

40%

30%

20%

10%

0%

S
E
C
N
A
T
S
B
U
S
E
V
I
T
C
A
F
O
%

3% 

2% 

1% 

HAZARD 

Low hazard active substances

Intermediate hazard active
substances

High hazard, cut-off active
substances

2011

2018

projection 2022

Figure A.17. Distribution of toxicological profile of active substances from 2011, 2018 and 2022. 

Emergency authorisations for minor uses 

The  share  of  emergency  authorisations  that  are  issued  for  minor  uses  was  estimated  at 
54%. The calculation is based on all emergency authorisations registered in the PPPAMS 
for  four  months  in  2018:  January,  February,  April  and  May.  The  four  months  were 
selected  to  contain  a  peak  in  submissions  (April-May)  and  a  trough  in  submissions 
(January-February). 

Table A.4. Emergency authorisations issued by Member States for minor uses 
Emergency authorisations 
36 
56 
91 
74 
257 

Month 
January 2018 
February 2018 
April 2018 
May 2018 
Total / Average 

for minor uses 
12 
24 
50 
53 
139 

% 
33 % 
43 % 
55 % 
72 % 
54 % 

130 

 
 
  
  
 
  
  
  
  
  
  
  
  
  
 
 
 
 
 
 
The  information  is  retrieved  from  the  PPPAMS,  from  the  information  in  the  good 
agricultural practice table where Member States state whether the use is major or minor. 
In  the  four  months  analysed,  257  emergency  authorisations  were  issued,  of  which  139 
were for minor uses, i.e. 54 %. The share of minor uses increases in the months with the 
highest number of granted authorisations (Table A.4). 

Calculation of health benefits — cost savings 

The calculations of health benefits are based on data from a scientific study and rely on 
several  assumptions,  therefore  allowing  only  for  a  very  rough  estimate.  The  study 
concluded  that  in  the  EU,  13  active  substances455  account  for  90 %  of  health  damage 
costs  (EUR 78  million  annually,  based  on  2003  data).  Using  Eurostat  data  on  the 
harmonised index of consumer prices (HICP456), these costs were inflated to 2017 values, 
amounting to about EUR 100 million per year. 

Annual costs at 2003 price level: EUR 78 million 

HICP in 2003: 79.49 

HICP in 2017 (latest year available): 101.97 

Annual costs at 2017 price level: (78 000 000*101.97)/79.49 = EUR 100 058 624 

Of those 13 active substances, 10 are no longer on the market in the EU. 5 of those active 
substances  were  already  non-approved  under  Directive  91/414/EEC.  The  cost  savings 
attributed to the PPP Regulation could therefore only refer to 5 of the active substances 
that  were  still  approved  in  2011  when  the  PPP  Regulation  became  applicable.  To 
simplify  calculations,  it  is  assumed  that  each  of  the  13  active  substances  contributed 
proportionately  to  health  damage.  The  non-approvals  and  withdrawals  of  the  10  active 
substances have contributed to cost savings of: 

(10/13=0.769)*100 058 624=76 968 172 (about EUR 77 million). 

As  only  half  of  the  costs  are  directly  related  to  the  PPP  Regulation,  it  follows  that 
EUR 76 968 172/2  =  38 484 086.  Thus,  annual  health  benefits  amount  to  about 
EUR 38.5 million. 

Calculation of the costs of the (non) renewal of approval of five active substances 

To allow for a comparison of the benefits reported, the cost for the review of the approval 
of  the  five  active  substances  have  been  estimated.  These  are  reported  in  section  5.2.3. 
The calculation concerns the active substances amitrole, glufosinate, linuron, methomyl 
and propineb that were approved in 2011 when the PPP Regulation became applicable.  

The applicants supported the renewal of approval of amitrole, linuron and propineb and 
prepared the dossiers and paid fees to the rapporteur Member States. The cost for dossier 
preparation  for  the  renewal  of  approval  of  a  conventional  active  substance  is 
approximated  at  around  EUR  2  million457.  Glufosinate  was  initially  supported  by  the 
applicant but the support was withdrawn in December 2017. It is therefore assumed that 
the  cost  of  the  dossier,  as  well  as  the  fee  to  the  Member  State  was  paid  in  full.  For 

455 The 13 active substances are: 1.3-D, amitrole, dazomet, diazinon, glufosinate, linuron, mancozeb, methomyl, parathion, propineb, 

simazine, terbuthylazine and trifluralin. 

456 Eurostat, Harmonised index of consumer prices (HICP) [prc_hicp_aind], accessed on 9 November 2018. 
457 The support study, page 146. 

131 

 
 
                                                 
methomyl, the applicant did not apply for renewal of approval and the active substance 
expired without a renewal assessment. The cost is therefore assumed to be zero. 

Information  on  the  fees  were  retrieved  from  Annex  3  in  the  support  study  as  the  fees 
varies between Member States. France was the rapporteur Member State for amitrole and 
charges  according  to  the  support  study  EUR  200  000.  Germany  was  the  rapporteur 
Member  State  for  glufosinate  and  charges  EUR  189  000.  Italy  was  the  rapporteur 
Member  State  for  propineb  and  linuron  and  charges  EUR  45  000  for  a  renewal  of 
approval.  

As EFSA and the Commission do not charge fees it is difficult to estimate the exact costs 
for the work on one individual active substance. However, combining the costs for EFSA 
and the Commission for approvals and renewals (EUR 3.4 million + EUR 2.2 million = 
EUR 5.6  million)  and  dividing with the approximate number  of procedures per  year (9 
new active substances and 48 renewals = 57 procedures) the cost is around EUR 100 000 
per active substance. As the support for glufosinate was discontinued during the Member 
State assessment, the costs for EFSA and the Commission is not taken into  account for 
that active substance. 

In total the costs to review the approvals of the active substances are (2 000 000*4) + 189 
000 + 200 000 + (45 000*2) + (100 000*3) = 8 779 000  EUR 8.8 million 

Calculation of the number of the MRLs currently set under the MRL Regulation 

As  of  October  2018,  486  approved  and  247  non-approved  substances  were  reported  in 
the Annexes to the MRL Regulation. These substances were notified or an application for 
approval  was  submitted  under  either  the  PPP  Regulation  or  its  predecessor  Directive 
91/414/EEC. All other substances that are used worldwide, but were never notified at EU 
level,  are  not  considered  in  the  calculation,  although  the  default  value  of  0.01  mg/kg 
applies  to  them.  Among  the  MRLs  included  in  the  MRL  Regulation,  no  MRLs  are 
required for 130 substances. These substances need to be subtracted from the calculation. 
For each substance considered in the calculation, MRLs are set for the 315 commodities 
of  plant  and  animal  origin,  which  are  listed  under  the  MRL  Regulation.  This  also 
includes MRLs that are set at the limits of quantification. 

MRLs set under the MRL Regulation: (486 + 247 -130) * 315 = 189 945  190 000 

Comparison of harmonised CXLs 

The  calculation  of  the  CXLs  that  were  transposed  in  the  EU  and  other  major  countries 
was  carried  out  for  the  purpose  of  estimating  the  level  of  harmonisation  with 
international standards. Australia, Canada, Japan and the United States were selected for 
comparison  because  of  the  availability  of  data  in  English  and  because  they  are  OECD 
members with developed regulatory systems in place. The timeframe 2012-2016 ensures 
that these countries had sufficient time to transpose CXLs in their national legislation and 
update the relevant databases. As the MRL Regulation does not report specific MRLs for 
feed items, only food was considered in the comparison.  

Between  2012  and  2016,  a  total  of  1570  pesticide  CXLs  for  food  commodities  were 
adopted  by Codex,  for  103  different  pesticides.  This  information  can  be  retrieved  from 
the Codex Alimentarius Commission reports. When assessing the level of harmonisation, 
the following was considered: i) national MRLs that are set at the same level of the CXLs 
ii) national MRLs that are set at higher levels than the CXLs for the same food products. 
This  is  because  products  that  are  compliant  with  the  CXLs  can  also  be  marketed  in 

132 

 
countries where higher MRLs apply. The various national databases were consulted and 
compared to the CXLs listed in the Codex Alimentarius Commission reports to assess the 
percentages of harmonisation. 

Table A.5. CXLs transposed in the MRL Regulation.  

Year 

2012 
2013 
2014 
2015 
2016 
TOTAL 

Total number of CXLs for 
food adopted  

242 
352 
301 
326 
349 
1570 

Share of EU MRLs set at the 
same or higher values than 
CXLs 
78 % 
79 % 
72 % 
75 % 
63 % 
73 % 

Number of EU MRLs set at 
the same or higher 
values458 than CXLs 
189 
278 
217 
245 
220 
1149 

1 149 MRLs / 1 570 CXLs = 0,7318 = 73% 

A  similar  comparison  per  year  for  the  number  of  transposed  CXLs  was  made  for 
Australia,  Canada,  Japan  and  the  United  States  to  allow  for  a  comparison  between 
jurisdictions. The result of the comparison is visualised in Figure A.18 and shows that the 
EU  transposed  the  highest  share  of  CXLs,  while  Australia  and  the  US  transposed  less 
than 50% of CXLs. 

Sources, with hyperlinks: 
  Codex Alimentarius Commission meeting reports 
  Australian Government Federal Register of Legislation 
  Health Canada MRL Database 
  EU Pesticides Database 
  The Japan Food Chemical Research Foundation Search Engine for MRLs 
  US Government Publishing Office - Electronic Code of Federal Regulations 

65% 

73% 

67% 

40% 

45% 

80%

70%

60%

50%

40%

30%

20%

10%

0%

Australia

Canada

EU

Japan

United States

Figure  A.18.  Comparison  of  harmonised  Codex  limits  adopted  between  2012  and  2016  by  WTO 
members 

Currency converter 

To facilitate comparisons, all currencies in publications have been converted into EUR. 
The online currency converter fxtop.com was used for this purpose. The exchange rate on 
1 January was used for any given year. 

458  MRLs  may  be  set  at  higher level  in  the  EU to  address  more critical GAPs  than  the ones  used  to  establish CXLs.  Such  MRLs 

facilitate trade as they cover both international and EU uses. 

133 

 
 
                                                 
Environmental impacts — groundwater 

In  section  5.1.2  on  the  environmental  impacts  of  the  PPP  Regulation,  two  figures  are 
reported to compare the chemical status of groundwater. They are calculated as shown in 
Table A.6 on the basis of data reported in the following European Environment Agency 
reports: 

  European waters — Assessment of status and pressures, 2012 
  European waters — Assessment of status and pressures, 2018 

Table A.6. Comparison of chemical status of groundwater in the EU – 2012 and 2018 reports 

European Environment Agency report, 2012 

European Environment Agency report, 2018 

r
e
t
a
w
d
n
u
o
r
G

Chemical status by area  Pesticides 
72 % good status 
25 % poor status 

In 20 % of groundwater 
bodies with poor status, 
pesticides are responsible 
for the poor status 

3 % unknown 

Pesticides in groundwater by area 

In 6 % of groundwater bodies (by area), 
pesticides are responsible for the poor status 

25 % * 20 % =  

5 % of groundwater bodies have poor chemical 
status as a result of pesticides 

6 % of groundwater bodies (by area) have poor 
chemical status as a result of pesticides 

134 

 
 
  
 
Annex 4: Costs and benefits 

This  annex  provides  a  table  giving  an  overview  of  all  costs  and  benefits.  Annex  3 
explains how the health benefits were calculated. Annex 2 to the support study explains 
in detail the methodology for quantifying costs. 

135 

 
 
 
 
 
 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Cost: Approval 
of active 
substances 

Economic cost for 
businesses 
(regulatory charges 
and compliance 
costs) in preparing 
a dossier, 
application fee etc. 
Cost for 
administrations in 
carrying out the 
risk assessment and 
risk management. 

Indirect costs for 
citizens and consumers 
as they are not directly 
involved in the 
approval process but as 
taxpayers they are 
covering the remaining 
costs that are not 
covered by fees for the 
Commission, EFSA 
and the Member 
States. 

Expected. 

Approx. per year: 

New active 
substances 
EUR 122-189 
million. 

Renewal of active 
substances 
EUR 196 million. 

Member States: cost for 
approval and re-
approvals of active 
substances approx. 
EUR 10 million (210 
Full-Time Equivalents). 
This cost can be 
recovered by the fees 
paid by industry to the 
Member State 

EFSA: cost for approval 
and re-approvals of 
active substances 
approx. EUR 3.4 
million. 

Commission: costs 
approx. EUR 2.2 
million.  

Cost: Delays in 
the renewal of 
approval of 

Unexpected costs 

Benefits for 
businesses from 
retained profits of 

The cost for 
administrations 
investing more 

459  All costs for industry and the Member States are from the support study. The costs were reported by the Member States and stakeholders through the online consultations. Other sources are reported separately in the table. 

136 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

active 
substances 

Benefit: Delays 
in non-renewal 
decisions 

Cost: 
Authorisation of 
PPPs 

Unexpected 
benefits  

Economic cost for 
businesses 
(regulatory charges 
and compliance 
costs) in preparing 
a dossier, 
application fee etc. 
Cost for 
administrations in 
carrying out the 
risk assessment and 
risk management. 

Expected. 

resources than 
expected. 

existing PPPs on 
the market are 
estimated between 
EUR 10 million 
and 100 million per 
active substance 
per year.  

The cost for dossier 
preparation for 
authorisation of 
new PPPs range 
between EUR 1-2 
million. For 
renewal of 
authorisation 
between EUR 0.2-
0.4 million. As the 
same dossier can 
be used in several 
Member States it 
was not possible to 
calculate the total 
cost as an additive 
approach would 
inflate the cost.  

For other 
procedures, the 
approx. cost per 

Member States: cost for 
authorisations approx. 
EUR 34 million per year 
for all Member States. 
The Full-Time 
Equivalents associated 
with PPP authorisations 
ranges from 1 to more 
than 100 depending on 
the Member State. These 
costs should be covered 
by fees paid by industry. 

137 

 
 
 
 
 
 
 
 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Cost: 
Comparative 
assessment of 
CfS 

Economic cost for 
businesses 
(regulatory 
charges) due to 
higher fees. Cost 
for administrations 
in carrying out the 
comparative 
assessment. 

Unexpected. 

Benefit: Cost 
savings by using 
mutual 
recognition 

Reduced 
economic cost for 
administrations 
when re-assessing 
dossiers against 
national 

year: 

Minor uses 
extension EUR 43-
80 million. 

Parallel trade 
permit EUR 3 
million. 

Approx. per year: 

Renewal of 
authorisation with 
CfS EUR 120 
million. 

Increased costs for 
applicants for 
comparative 
assessment 
procedures amount 
to EUR 26.7 
million in 2016. 

The cost savings 
from using 
mutual 
recognition also 
benefit industry 
(applicants) as 

138 

Member States: the Full-
Time Equivalents 
associated with 
comparative assessments 
ranges from less than 1 
to 3. 

Between 2012 and 2016, 
Member States have 
saved EUR 13-17 
million compared to a 
situation where they 
would have issued only 

 
 
 
 
 
 
 
  
 
 
 
 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Cost: Setting 
and reviewing 
MRLs 

requirements. 

Unexpected. 

Economic cost for 
businesses 
(regulatory charges 
and compliance 
costs) in preparing 
a dossier, 
application fee etc. 

Cost for 
administrations to 
carry out risk 
assessment and risk 
management. 

Expected. 

Cost: 
Enforcement 
and monitoring 

Economic costs 
for administrations 
(enforcement costs 
and administrative 
costs) monitoring, 
reporting and 

standard authorisations. 

The Commission and 
EFSA: costs for MRL 
procedures are estimated 
to EUR 3 million per 
year. 

Member States: cost for 
MRL procedures are 
approximately EUR 5 
million per year. 

they are the ones 
paying the fees. 

139 

The combined 
annual costs for the 
industry for MRL 
procedures are 
estimated at 
approximately 
EUR 55 million of 
which the costs 
stem from: 

MRL setting: EUR 
38 million  

MRL Review: 
EUR 11.7 million  

Import tolerances: 
EUR 5.5 million 

The costs for the 
Member States of 
reviewing MRLs 
were unexpected as 
the related activities 
were not foreseen in 
the MRL Regulation. 
The ad hoc 
procedure created to 
manage the work 
implied less work for 
EFSA but more work 
for the Member 
States without the 
possibilities to raise 
fees.  

For SMEs, 1-5 % 
of all 
administrative 
costs stem from the 
MRL Regulation.  

There are costs for 
the Member States to 
enforce the 
Regulations and 
monitor. They were 
not quantified 

 
 
 
 
 
 
 
 
 
 
 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

enforcing. 

Expected. 

Cost: Impact 
from PPP 
Regulation on 
the price of 
PPPs.  

Economic costs 
for farmers due to 
supply of PPPs. 

Unexpected. 

separately in the 
framework of the 
support study but are 
expected to be 
moderately high. 

From 2011 to 
2016, the share of 
spending on crop 
protection over 
total specific costs 
fluctuated between 
9.3% and 10.3%.460 

No firm 
conclusions can 
be made on the 
impact of the PPP 
Regulation on the 
costs incurred by 
farmers. The 
share spent by 
farmers on PPPs 
are comparable to 
what they spend 
on fertilisers and 
these costs are 
not negligible. 

Benefit: Health 
benefits from 

Health benefits 
due to reduced 

EUR 38.5 million, see 
calculation in Annex 3.  

460 The Farm Accountancy Data Network is an instrument for evaluating the income of agricultural holdings and the impacts of the Common Agricultural Policy. 

140 

 
 
 
 
 
 
 
 
 
 
 
                                                 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

reduced 
exposure461 

exposure of 
pesticide residues. 

Expected 

Environmental 
costs to reduce 
pollutions levels. 

Expected 

Costs: 
Removing 
pesticides from 
drinking water 

Benefit: 
Avoidance of 
cost of removing 
pesticides from 
drinking water 

There is a cost of 
removing pesticides 
from drinking water 
as pesticides may be 
present in surface 
waters used for 
drinking water. 

Benefits for national 
water utilities in 
terms of cost savings 
to remove pesticides 
from drinking water 
are expected to 
decrease due to the 
improved chemical 
status of surface 
waters with respect 
to pesticides.  

Cost: Hiring an 
external 

Economic cost for 
businesses 

24 % of SMEs 
consulted need to 

461 Fantke, P., Friedrich, R., and Jolliet, O., (2012) Health impact and damage cost assessment of pesticides in Europe. Environment International Vol 49, p 9-17. https://doi.org/10.1016/j.envint.2012.08.001. 

141 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

consultant to 
comply with the 
Regulations. 

(compliance costs). 

Benefit: 
Avoidance of 
acute poisoning 
of operators or 
neighbours 

Direct health 
benefits for 
operators due to 
increased safety 
from labelling, 
equipment and less 
hazardous PPPs. 

Benefit: reduced 
threats to 
pollinators 

Direct economic 
benefits from 
pollinators on 
orchards and crops 
dependent on 
pollination. 

There are 
multifactorial reasons 
behind the decline in 
bees, therefore, the 
annual benefit from 
restricting the use of 
some neonicotinoids is 

hire an external 
consultant 
occasionally or 
frequently to 
comply with either 
the MRL 
Regulation and/or 
the PPP 
Regulation. 

Active substances 
that are 
scientifically 
demonstrated to 
be dangerous for 
human health are 
not approved or 
not renewed, 
ensuring the 
safety of 
operators. 

142 

 
 
 
 
 
 
 
 
 
 
 
 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Benefit: Food 
security in the 
EU 

Expected 

Indirect societal 
benefits from 
ensuring a 
sustainable food 
supply in the EU.  

Benefit: A 
thriving 
agricultural 
sector 

Indirect social 
benefits from 
providing 
opportunities in 
rural areas. 

a share of EUR 15 
billion462. 

Restricting the 
approval and renewal 
of active substances 
that are dangerous for 
the environment 
allows to better 
preserve soil and 
insects that are 
essential for long-term 
productivity. 

PPPs remain available 
to ensure pest 
management and 
support agriculture in 
the EU. Agricultural 
activities translate into 
employment 
opportunities in rural 
areas. 

462 European Commission (2018c). EU Pollinators Initiative. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. 

COM(2018) 395. 

143 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
OVERVIEW OF COSTS AND BENEFITS IDENTIFIED IN THE EVALUATION459 

Citizens/Consumers/Environment 

Businesses 

Administrations 

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Qualitative 

Quantitative  

Benefit: Access 
to high quality 
of fresh produce 
year round 

Indirect social 
and individual 
benefits from 
eating a variety of 
food. 

Consumers value food 
variety and fresh food 
products that are 
ensured by the use of 
PPPs. 

144 

 
 
 
 
 
 
 
 
 
 
Annex 5: Court cases and complaints to the Ombudsman (Status as of December 2018) 

OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

CASE463 

C-499/18 P 

C-445/18 

T-574/18 
T-574/18 R 

T-393/18 

Parties 

Active Substance 

Subject  

Bayer Cropscience and 
Bayer AG v Commission 

clothianidin and 
imidacloprid 

n/a 
Reference for preliminary 
ruling 
Vaselife International and 
Chrysal International 
Agrochem-Maks vs 
Commission 

n/a  

oxasulfuron 

Mellifera eV vs. 
Commission 

Internal Review Aarhus 
Regulation: Glyphosate 

C-115/18  (suspended  until  a 
judgment  is  rendered  in  case 
C-616/17  which  concerns 
nearly identical issues) 

n/a 
Reference for preliminary 
ruling 

n/a (indirect: Glyphosate 
— national criminal 
proceedings against 
individuals destroying 
glyphosate containing 
products in stores) 

463 T: General Court, C: Court of Justice, R: interim measures, P: appeal. 

Appeal, by Bayer Cropscience and Bayer AG against the 
judgment in case T-429/13 of 17 May 2018 by which the general 
court dismissed the appellants’ action for annulment of 
Regulation 485/2013 as regards the conditions of approval of the 
appellants’ active substances. 
Parallel trade 

Suspend the application (interim) and Annul (main case) the 
Commission Implementing Regulation (EU) 2018/1019 of 
18 July 2018 concerning the non-renewal of approval of the 
active substance oxasulfuron 
Annul Commission decision to not carry out an internal review 
of Commission Implementing Regulation (EU) No 2017/2324 
on the renewal of approval of the active substance glyphosate 
Validity of Regulation (EC) No 1107/2009 in the light of the 
precautionary principle 

145 

Pending/outcome 

Pending 

Pending 

Pending 

Pending 

Pending 

 
 
 
 
 
                                                 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

CASE463 

T-25/18 

T-178/18 

T-125/18 

T-67/18 

Parties 

Active Substance 

Subject  

Pesticide Action Network 
Europe (PAN Europe) 
vs Commission 

n/a 

Région de Bruxelles-
Capitale v Commission 
Associazione — 
GranoSalus vs 
Commission 
PROBELTE SA. vs 
Commission 

glyphosate 

glyphosate 

8-hydroxyquinoline 

C-616/17 

n/a: Reference for 
preliminary ruling 

T-719/17 
T-719/17 R 

DuPont & FMC vs 
Commission 

n/a (indirect: Glyphosate 
— national criminal 
proceedings against 
individuals destroying 
glyphosate containing 
products in stores) 
flupyrsulfuron-methyl 

Annul Commission decision C(2017) 7604 final of 
9 November 2017, partially refusing to grant the applicant 
access to documents relating to the drafting of Delegated 
Regulations on scientific criteria for the assessment of endocrine 
disrupting substances 
Annul Commission Implementing Regulation (EU) 2017/2324 
renewing the approval of the active substance glyphosate 
Annul Commission Implementing Regulation (EU) 2017/2324 
renewing the approval of the active substance glyphosate 

Annul Commission Implementing Regulation 2017/2065 
confirming the conditions of approval of the active substance 8-
hydroxyquinoline, as set out in Implementing Regulation 
540/2011 and modifying Implementing Regulation 2015/408 as 
regards the inclusion of the active substance 8-hydroxyquinoline 
in the list of candidates for substitution 
(The applicant had applied for an amendment of the approval — 
to lift the restrictions to greenhouse applications) 
Validity of Regulation (EC) No 1107/2009 in the light of the 
precautionary principle 

Pending/outcome 

Pending 

Pending 

Pending 

Pending 

Pending 

Annul Commission Implementing Regulation 2017/1496 of 
concerning the non-renewal of approval of the active substance 
DPX KE 459 (flupyrsulfuron-methyl) 

The main application is 
still pending. 
The application for 
interim measures was 
rejected by Order of 
President of the General 

146 

 
 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

CASE463 

T-476/17 
T-746/17 R 

Parties 

Active Substance 

Subject  

Arysta vs Commission 

diflubenzuron  

Annul Commission Implementing Regulation 2017/855 as 
regards the conditions of approval of the active substance 
diflubenzuron (restriction to greenhouse uses) — based on the 
assessment of confirmatory information required in the earlier 
approval 

Annul Commission Decision Ares (2016) 6306335 of 
8 November 2016. 
Order the Commission to adopt a new decision on the merits of 
the applicant’s request for internal review of Implementing 
Regulation (EU) 2016/1056 on the extension of authorisation for 
glyphosate 
Annul Commission Implementing Regulation 2016/872 
concerning the non-renewal of approval of the active substance 
isoproturon 
Annul Commission Implementing Regulation (EU) 2015/2069 
approving the basic substance sodium hydrogen carbonate. 
The annulment was not about Article 4 approval criteria but 
regarding the use of data for approving sodium hydrogen 
carbonate as a basic substance  
Action for annulment of Implementing Regulation No 
2015/1295, approving the active substance sulfoxaflor 

Pending/outcome 

Court on 22 June 2018. 
The main application is 
still pending. 
The application for 
interim measures was 
rejected by Order of 
President of the General 
Court on 22 June 2018. 
Pending 

No decision — Action 
withdrawn by the 
applicant 
Action dismissed as 
inadmissible (Order of the 
General Court of 
9 November 2016) 

Action was dismissed as 
inadmissible — Order of 
the General Court of 
28 September 2016 

copper compounds 

Partial annulment of Commission Implementing Regulation 
(EU) 2015/408 establishing a list of candidates for substitution 

The Appeal brought by 
the Taskforce was 

147 

T-12/17 

Mellifera eV vs 
Commission 

Internal review (Aarhus 
Convention) — 
glyphosate 

T-476/16  

Adama vs Commission 

isoproturon 

T-746/15 

BIOFA vs Commission 

sodium hydrogen 
carbonate 

T-600/15 

T-310/15 

Pesticide Action Network 
Europe (PAN Europe) and 
Others 
vs 
Commission 
European Union Copper 
Task Force vs Commission 

sulfoxaflor 

 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

CASE463 

Appeal C-384/16 P 

Parties 

Active Substance 

Subject  

— for copper compounds 

T-296/15 and appeal 
C-244/16 P 

Industrias Químicas del 
Vallés vs Commission 

metalaxyl 

 Partial annulment of Commission Implementing Regulation 
(EU) 2015/408 establishing a list of candidates for substitution 
— for metalaxyl 

C-442/14 

n/a: reference for 
preliminary ruling 

Several plant protection 
and biocidal products 

T-671/13 

Pesticide Action Network 
Europe (PAN Europe) (and 
Syndicat agricole 

clothianidin, 
thiamethoxam and 

National Court case (NL) — Bayer CropScience SA-NV 
Stichting De Bijenstichtig vs College voor de toelating van 
gewasbeschermingsmiddelen en biociden: 
Interpretation of Directive 2003/4/EC of the European 
Parliament and of the Council of 28 January 2003 on public 
access to environmental information — concept of emissions 
into the environment; overriding public interest: 
Underlying national case — request to the Netherlands authority 
responsible for authorising the marketing of plant protection 
products and biocidal products (the College voor de toelating 
van gewasbeschermingsmiddelen en biociden, CTB) for 
disclosure of 84 documents concerning marketing authorisations 
issued by that authority for certain plant protection products and 
biocides. 
Annul the Commission decision of 9 October 2013 in which the 
Commission declared inadmissible the request for internal 
review of Implementing Regulation (EU) No 485/2013 of 

148 

Pending/outcome 

dismissed. 
(Judgment of the Court of 
13 March 2018) 
The application was 
judged inadmissible 
(Article 263 (4) TFEU)  
The Appeal was 
dismissed. 
(Judgment of the Court of 
13 March 2018) 
The application was 
inadmissible (Article 263 
(4) TFEU)  
Judgment of the Court 
23 November 2016 
Wide interpretation of the 
expression ‘information 
on emissions into the 
environment’ by the 
Court 

Action withdrawn in 2015 
by the applicant 

 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

Parties 

Active Substance 

Subject  

Pending/outcome 

CASE463 

T-578/13 

T-584/13 

Confédération paysanne vs 
Commission) 

imidacloprid 

Luxembourg Pamol 
(Cyprus) and Luxembourg 
Industries vs Commission 

potassium phosphonates 
(case still governed by 
Directive 91/414/EC) 

BASF AGRO vs 
Commission 

fipronil 

24 May 2013 amending Implementing Regulation (EU) No 
540/2011, as regards the conditions of approval of the active 
substances clothianidin, thiamethoxam and imidacloprid 
Annulment of EFSA Decision of 8 October 2013 concerning the 
publication of certain parts of the Peer Review Report and Final 
Addendum on Potassium Phosphonates in respect of which the 
Applicants claimed confidentiality pursuant to Council Directive 
91/414/EEC and Commission Regulation (EU) No 188/2011 
Annul Commission Implementing Regulation 781/2013 
amending the conditions of approval for fipronil and the sale and 
use of treated seeds 

Joined casesT-429/13 and T-
451/13 
(C-499/18 P) 

Bayer CropScience and 
Syngenta Crop protection 
vs Commission 

neonicotinoids 

Annul Commission Implementing Regulation 485/2013 
amending the conditions of approval for imidacloprid, 
chlothianidin and thiametoxam (neonicotinoids) and the sale and 
use of treated seeds 

T-545/11 
Appeal 
C-673/13 P 
T-545/11 RENV 

Stichting Greenpeace 
Nederland and PAN 
Europe vs Commission 

Access to documents — 
glyphosate 

Declare that the Commission’s decision of 10 August 2011 is in 
violation of the Aarhus Convention on Access to Information, 
Public Participation in Decision-making and Access to Justice in 
Environmental Matters, Regulation (EC) No 1049/20012 and 
Regulation (EC) No 1367/2006 

149 

Judgment of the General 
Court of 3 June 2015: 
Action dismissed as 
inadmissible 

Judgment of the General 
Court of 17 May 2018: 
- Commission decision 
partially annulled 
(amendment of conditions 
of approval of the active 
substance) 
- Action on sale and use 
of treated seeds dismissed 
(inadmissible) 
Judgment of the General 
Court of 17 May 2018: 
The action was dismissed. 
The Appeal was 
submitted by Bayer see 
entrance with Reference 
C-499/18 P. 
Judgment of 
23 November 2016 on the 
Commission’s appeal: 
Judgment of the General 
Court of 8 June 2013 was 

 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF REGULATION 1107/2009 

CASE463 

Parties 

Active Substance 

Subject  

(see also C-442/14 on substance) 

Pending/outcome 

set aside and case referred 
back to the General Court 
where the case is still 
pending (hearing took 
place in March 2018). 
The criteria developed in 
the appeal judgment have 
now to be applied to the 
specific situation 
underlying the case. 

150 

 
 
 
 
 
 
 
OVERVIEW OF COMPLAINTS TO THE EUROPEAN OMBUDSMAN CONCERNING THE APPLICATION OF 
REGULATION 1107/2009 AND REGULATION 396/2005 

Case 

678/2018/TE 

2000/2015/ANA 

Complaint 

Subject 

PAN 

ECPA 

Extension of the approval period for active substances in 
plant protection product 
MRLs and compliance with the rules on the approval of 
PPPs. 

1869/2013/AN 

Bayer CropScience AG 

Access to documents  

Pending/Outcome 

Pending 

The Ombudsman concluded in the sense that the practice is 
acceptable and there was no maladministration from the 
Commission side. The Commission must act diligently 
when the approval is done 
The Ombudsman concluded that there had not been any 
maladministration on the part of the Commission. 

12/2013/JN 

ECPA 

Confirmatory data Procedure  

Ongoing. Commission submitted to Ombudsman a detailed 
report in February 2018. 

151 

 
 
 
 
CASE 

T-232/11 

T-362/11 

T-232/11 

T-446/10 

T-71/10 
T-71/10R (I) 
T-71/10 R (II) 
C-149/12 P 

T-95/09 

OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

Parties  

Active Substance 

Subject 

glyphosate 

Internal review and access to documents 

Stichting Greenpeace 
Nederland, Pesticide Action 
Network Europe (PAN 
Europe) vs Commission 
Stichting Greenpeace 
Nederland, Pesticide Action 
Network Europe (PAN 
Europe) vs Commission 

Greenpeace NL & PAN 
Europe vs European 
Commission 

n/a 

glyphosate (still under 
Directive 91/414/EEC 
regime) 

Action for annulment of the Commission’s decision of 
6 May 2011, refusing to grant the applicants full access to 
certain documents concerning the first authorisation to place the 
active substance glyphosate on the market under Council 
Directive 91/414/EEC of 15 July 1991 concerning the placing 
of plant protection products on the market 
Aarhus. 31substances (including glyphosate) (refusal by the 
Commission of internal review) 

Dow AgroSciences Ltd and 
Dintec Agroquímica — 
Produtos Químicos, Lda v 
European Commission 

Xeda International SA and 
Pace International LLC v 
European Commission 

Diphenylamine (I) 

United Phosphorus Ltd v 
Commission of the European 

napropamide 

trifluralin 

Non-inclusion in Annex I to Directive 91/414/EEC — 
Regulation (EC) No 33/2008 — Accelerated assessment 
procedure — Manifest error of assessment — Principle of non-
discrimination — Proportionality 

Non-inclusion in Annex I to Directive 91/414/EEC — 
Withdrawal of authorisations of plant protection products 
containing that substance — Action for annulment — Locus 
standi — Admissibility — Proportionality — Article 6(1) of 
Directive 91/414/EEC — Rights of the defence — Article 3(2) 
of Regulation (EC) No 1095/2007. 
Decision concerning the non-inclusion of napropamide in 

152 

Pending/outcome 

Case withdrawn in 2015 
by the applicant. 

Case withdrawn in 2012 
by the applicant 

The applicant informed 
the General Court that 
they wished to 
discontinue the 
proceeding. Therefore, 
the case was removed 
from the register of the 
General Court. 
Judgment of the General 
Court (Sixth Chamber) of 
10 September 2015. 
Favourable for the 
Commission 
Judgment of the General 
Court (Fifth Chamber) of 
19 January 2012. 
Favourable for the 
Commission. 

Interim Measures were 

 
 
 
 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

CASE 

T-95/09 R 

T-338/08 
C-405/12 

T-475/07 
T-475/07 R 
C-391/08 PR 
C-584/11 P 

T-467/07 
T-467/07 R 
C-228/08 PR 

Parties  

Communities 

Active Substance 

Subject 

Annex I o Directive 91/414/EEC. 
Request for interim measures and main case. 

Stichting Natuur en Milieu 
and Pesticide Action Network 
Europe v European 
Commission 

Internal review of temporary MRLs 

Dow AgroSciences Ltd and 
Others v European 
Commission 

trifluralin 

Active substance trifluralin: Non-inclusion in Annex I to 
Directive 91/414/EEC Action for annulment; Evaluation 
procedure; Concepts of ‘risk’ and ‘hazard’; Manifest error of 
assessment; Draft review report; Legitimate expectations; 
Principle of proportionality. 

Du Pont de Nemours (France) 
and Others v Commission 

methomy 

Annulment of Commission Decision 2007/628/EC of 
19 September 2007 concerning the non-inclusion of methomyl 
in Annex I to Council Directive 91/414/EEC and the withdrawal 
of authorisations for plant protection products containing that 
substance 

Pending/outcome 

grated. 
Judgment on the main 
Case favourable for the 
Commission. 

Judgment of the General 
Court (Seventh 
Chamber), 14 June 2012. 
Not favourable for 
Commission. This 
Judgment was appealed, 
Judgment of the Court 
(Grand Chamber) of 
13 January 2015.  
Judgment of the General 
Court (Third Chamber) of 
9 September 2011. 
Order of the Court (Fifth 
Chamber) of 7 May 2013. 
Outcome favourable for 
the Commission. 
The applicant informed 
the General Court that 
they wished to 
discontinue the 
proceeding. Therefore, 
the case was removed 
from the register of the 
General Court. Order — 
01/07/2009 
The interim were not 

153 

 
 
 
 
 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

CASE 

Parties  

Active Substance 

Subject 

T-470/07 

Dow Agrosciences and Others 
v Commission 

1.3-dichloropropene 

Action for annulment of Commission Decision 2007/619/EC of 
20 September 2007 concerning the non-inclusion of 1.3-
dichloropropene in Annex I to Council Directive 91/414/EEC 
and the withdrawal of authorisations for plant protection 
products containing that substance 

T- 403/07 

Union nationale de 
l’apiculture française and 
Others v Commission of the 
European Communities 

fipronil 

Action for annulment — Directive 91/414/EEC — Plant 
protection products — Directive 2007/52/EC 

T-367/07 
T-367/07 R 
C-99/08 P (R) 

Cheminova A/S and Others v 
Commission of the European 
Communities 

malathion 

Active substance ‘malathion’ — Non-inclusion in Annex I to 
Directive 91/414/EEC — Action for annulment — Locus standi 
— Admissibility — Evaluation procedure — Assessment by 
EFSA — Plea of illegality — Article 20 of Regulation (EC) No 
1490/2002 — Submission of new studies — Article 8(2) and (5) 
of Regulation (EC) No 451/2000  

T-31/07 

Du Pont de Nemours (France) 
SAS and Others v European 

flusilazole 

Active substance flusilazole — Inclusion of flusilazole in 
Annex I to Directive 91/414/EEC — Actions for annulment — 

154 

Pending/outcome 

granted. 
The applicant informed 
the General Court that 
they wished to 
discontinue the 
proceeding. Therefore, 
the case was removed 
from the register of the 
General Court. Order — 
30/09/2008 
The Order of the Court of 
First Instance (Fourth 
Chamber) of 
3 November 2008 
dismissed the action as 
inadmissible. 
Judgment of the Court of 
First Instance (Eighth 
Chamber) of 
3 September 2009, 
favourable for the 
Commission. 
The interim Measures 
were not grated (Order of 
the President of the Court 
of First Instance of 
4 December 2007). 
The Appeal on the interim 
measures was dismissed.  
Judgment of the General 
Court (First Chamber) of 

 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

CASE 

T-31/07 R 

Parties  

Commission 

Active Substance 

Subject 

Partial annulment — Non-severability — Inadmissibility — 
Non-contractual liability — Limiting the inclusion for a period 
of 18 months and for four crops — Precautionary principle — 
Principle of proportionality — Right to be heard — Equal 
treatment — Statement of reasons. 

T-30/07 

Denka International BV v 
Commission 

dichlorvos (MRLs) 

Action for annulment — Directive 2006/92/EC — Maximum 
levels for dichlorvos residues. 

T-416/06 
T-416/06 R 
C-236/07 PR 

Sumitomo Chemical Agro 
Europe v Commission 

procymidone 

Annulment in part of Commission Directive 2006/132/EC of 
11 December 2006 amending Council Directive 91/414/EEC of 
15 July 1991 concerning the placing of plant protection 
products on the market, with a view to include procymidone as 
an active substance 

T-393/06 
T-393/06 R(I) 

Makhteshim-Agan Holding 
BV, Makhteshim-Agan Italia 
Srl and Magan Italia Srl v 

azinphos-methyl 

Action for annulment — Action for failure to act — Directive 
91/414/EEC — Plant protection products — Active substance 
azinphos-methyl — Inclusion in Annex I to Directive 

155 

Pending/outcome 

12 April 2013. 
Favourable for the 
Commission. 
The interim measures 
were granted and the act 
was suspended (Order of 
the President of the Court 
of First Instance of 
19 July 2007). 
Lack of individual 
concern, the application 
was dismissed as 
considered inadmissible 
(Order of the Court of 
First Instance (Seventh 
Chamber) of 
27 June 2008). 
The applicant informed 
the General Court that 
they wished to 
discontinue the 
proceeding. Therefore, 
the case was removed 
from the register of the 
General Court (Order — 
21/01/201). 
The interim measures 
were not grated. 
Favourable outcome for 
the Commission. 

 
 
 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

Parties  

Active Substance 

Subject 

Pending/outcome 

CASE 

T-393/06 R(II) 
T-393/06 R(III) 
C-277/07 P(R) 
C-69/09 
T-454/05 
T-454/05 R 

T-420/05 
T-420/05 R(I) 
T-420/05 R(II) 
T-380/06 
C-459/06 P (R) 
T-34/05 R 
C-258/05 P(R) 
T-75/06 (integrating T-34/05) 
C-517/08P 

Commission of the European 
Communities 

91/414/EEC — Absence of a new Commission proposal after 
opposition by the Council — Article 5(6) of Decision 
1999/468/EEC — Non-actionable measure — Absence of a 
request to act — Inadmissibility. 

Sumitomo & Philagro France 
v Commission 

procymidone 

Active substance procymidone — Directive 91/414/EEC — 
Action for annulment — Action for failure to act — No need to 
adjudicate — Action for damages 

Vischim Srl v Commission of 
the European Communities 

chlorothalonil 

Inclusion in Annex I to Directive 91/414/EEC — Assessment 
procedure — Directive 2005/53/EC — Application for 
annulment — Application for a declaration of failure to act — 
Application for damages. 

Bayer CropScience and 
Others v Commission 
Commission officially 
supported by Rapporteur 
Member State (ES) 

endosulfan 

Endosulfan as an active substance — Withdrawal of marketing 
authorisations — Evaluation procedure — Time-limits — 
Rights of the defence — Principle of proportionality 

T-229/04 

Sweden v Commission 

paraquat 

Directive 91/414/EEC — Plant protection products — Paraquat 
as an active substance — Marketing authorisation — 
Authorisation procedure — Protection of human and animal 
health. 

156 

Order of the Court of 
First Instance (Third 
Chamber) of 
17 October 2007, The 
case was dismissed as 
considered manifestly 
unfounded. 
Judgment of the Court of 
First Instance (Sixth 
Chamber) of 
7 October 2009, 
favourable for the 
Commission. 

Interim measures were 
dismissed. 
Order of the Court 
(Second Chamber) of 
15 April 2010 favourable 
for the Commission. 
Judgment of the Court of 
First Instance (Second 
Chamber, extended 
composition) of 
11 July 2007. The 
Commission act was 
annulled.  

 
OVERVIEW OF COURT CASES BROUGHT TO COURT CONCERNING THE APPLICATION OF DIRECTIVE 91/414/EEC 

CASE 

T-158/03 

Parties  

Active Substance 

Subject 

Industrias Químicas del 
Vallés, SA v Commission of 
the European Communities. 

metalaxyl 

Directive 91/414/EEC — Plant protection products — Active 
substances — Metalaxyl — Authorisation procedure — 
Summary dossier and complete dossier — Time-limits — 
Principle of proportionality — Misuse of powers 

Pending/outcome 

Judgment of the Court of 
First Instance (Second 
Chamber) of 
28 June 2005. The 
Commission act was 
annulled.  

157 

 
 
 
 
 
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