COMMISSION STAFF WORKING DOCUMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: administrative formalities, animal feedingstuffs, biocide, bovine spongiform encephalopathy, food additive, food inspection, food safety, genetically modified organism, market approval, pesticide residue, plant health product, veterinary inspection

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  EN 

   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  SWD(2025) 1030 final  Simplification Omnibus Package COMMISSION STAFF WORKING DOCUMENT    Accompanying the document Proposal for a  REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements {COM(2025) 1030 final}  
 
 
Table of contents 

1. 
INTRODUCTION ................................................................................................................................ 3 
2.  MAIN ISSUES ...................................................................................................................................... 5 
3.  MEASURES ......................................................................................................................................... 7 

3.1.  Faster access to markets and innovation ........................................................... 7 
3.1.1. 

Biocontrol plant protection products (PPP) ............................................................ 7 

3.1.2. 

Aerial spraying of PPP by drones ......................................................................... 12 

3.2.  Lowering administrative burdens .................................................................... 14 
3.2.1. 

Further PPP simplification ................................................................................... 14 

3.2.2. 

Simplification for biocidal products ..................................................................... 24 

3.2.3.  Maximum Residue Levels .................................................................................... 31 

3.2.4. 

3.2.5. 

3.2.6. 

GMM fermentation ............................................................................................... 35 

Feed additives ....................................................................................................... 37 

Overlap in notification of national hygiene measures .......................................... 44 

3.3.  Reducing unnecessary complexity in risk management .................................. 45 
3.3.1. 

Depopulation reporting ......................................................................................... 45 

3.3.2. 

3.3.3. 

Record-keeping for livestock farmers .................................................................. 45 

Updating BSE rules .............................................................................................. 46 

Flexibility in official controls ............................................................................... 48 

3.3.4. 
4. 
CONCLUSION ................................................................................................................................... 51 
ANNEX I: SUMMARY OF COST-SAVINGS............................................................................................ 53 
ANNEX II: SYNOPSIS OF STAKEHOLDER CONSULTATION ............................................................ 57 
ANNEX III: METHODOLOGY FOR COST SAVINGS ............................................................................ 69 

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Glossary 

Term or acronym 

Meaning or definition 

BSE 

CAP 

COPHS 

ECHA 

EFSA 

EP 

ESFC 

EU  

EURL 

Bovine Spongiform Encephalopathy 

Common Agricultural Policy 

Council  Working  Party  of  Chief  Officers  of Plant 
Health Services 

European Chemicals Agency 

European Food Safety Authority 

European Parliament 

E-Submission Food Chain platform 

European Union 

European Union Reference Laboratory 

EURL-FA 

European Union Reference Laboratory for feed additives 

FA 

FCM 

Feed Additives 

Food Contact Materials 

GMM / GMO 

Genetically Modified Micro-Organism 

JRC 

MEP 

MRL 

MS 

Joint Research Centre of the European Commission  

Member of the European Parliament 

Maximum Residue Level 

Member States 

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OCR 

NRL 

PPP 

RASFF 

RMS 

Official Controls Regulation 

National Reference Laboratory 

Plant Protection Products 

Rapid Alert System for Food and Feed 

Rapporteur Member State 

SCoPAFF 

Standing Committee on Plants, Animals, Food and Feed 

SME 

SRM 

SUD 

TFEU 

TSE 

Small and Medium-sized Enterprise 

Surveillance Risk Material 

Sustainable Use Directive 

Treaty on the Functioning of the European Union 

Transmissible Spongiform Encephalopathy 

WOAH 

World Organisation for Animal Health 

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1. 

INTRODUCTION 

The EU’s food and feed safety legal framework is one of the most robust in the world. It safeguards 
human,  animal  and  plant  health,  enables  smooth  functioning  of  Europe’s  Single  Market,  and 
underpins our global reputation for high standards. To remain effective, this framework must also 
evolve: becoming simpler, faster and more innovation-friendly, while maintaining its high level 
of protection for Europeans. 

For the 2024–2029 mandate, President von der Leyen set out a clear ambition: to make Europe’s 
regulatory environment more supportive of competitiveness, sustainability and resilience, while 
keeping protection high. Europe must ensure that regulation empowers, rather than slows down, 
the twin green and digital transitions. The Commission’s simplification agenda was framed by the 
Communication  on  A  simpler  and  faster  Europe.1  This  set  quantified  targets  to  reduce 
administrative costs by 25% for all companies and 35% for SMEs by the end of this mandate, 
which  will  translate  to  EUR    37.5  billion  in  savings  for  businesses.  To  operationalise  these 
commitments, the Commission launched a series of Omnibus simplification packages. These have 
already demonstrated that policy objectives can be preserved while reducing burdens, as shown in 
areas such as sustainability reporting, customs and climate instruments.2 

This ambition to “make business easier and faster” is particularly relevant for the agri-food sector. 
Europe’s farmers, food producers and consumers expect a framework that guarantees safety and 
trust, while also enabling investment and new market opportunities. The Strategic Dialogue on 
the future of agriculture and food, conducted in 2024, confirmed that the regulatory environment 
must  enable  operators  to  innovate  and  adapt,  while  ensuring  that  the  EU’s  high  safety  and 
sustainability  standards  are  maintained.  Its  conclusions  informed  the  Commission’s  Vision  for 
Agriculture and Food. This roadmap highlights that simplification and access to innovation are 
essential  for  a  competitive,  resilient  and  fair  agri-food  system.  By  contrast,  excessive 
administrative requirements, outdated control mechanisms and rigid and repetitive authorisation 
systems  impose  unnecessary  costs  and  delay,  creating  substantial  barriers  to  competitiveness, 
innovation and efficient risk management. 

Delivering  on  the  Vision  requires  concrete  legislative  action,  as  shown  by  the  Commission’s 
proposals for targeted simplification measures in agriculture since 2024. These respond to direct 
calls  from  farmers  and  Member  States  for  proportionate  rules  and  lighter  administrative 
requirements. In March 2024, a first simplification package of the Common Agricultural Policy 
(CAP) proposed to exempt farms under ten hectares from conditionality controls and penalties, 
streamlined  amendments  to  CAP  Strategic  Plans,  and  revised  several  Good  Agricultural  and 
Environmental Conditions (GAECs) to give Member States and farmers greater flexibility.3 The 
broad  political  consensus  on  the  need  to  reduce  administrative  burden  was  confirmed  by  the 
conclusion of the negotiations between co-legislators within weeks. Since adoption, these changes 
have already reduced compliance costs and eased implementation for both farmers and competent 
authorities while maintaining strict environmental standards.4 

1 COM(2025) 47 final 
2 COM(2025) 81 final, COM(2025)84 final, COM(2025)526 final, COM(2025)531 final 
3 COM(2024) XXX final 
4 SWD(2024)360 final 

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In May 2025, the Commission followed up with another CAP simplification proposal to eliminate 
the annual performance certification mechanism, streamline the procedure of amending Strategic 
Plans, and modify conditionality further. Additionally, the Commission introduced new flexibility 
in  the  provision  of  crisis  payments  and  increased  the  amount  of  lump-sum  support  that  small 
producers  could  receive.  This  proposal  alone  is  projected  to  reduce  administrative  costs  for 
farmers by up to EUR 1.58 billion annually, with particular benefits for small and medium-sized 
farms. Combined, the two packages are anticipated to generate substantial cost savings. 

Alongside  CAP,  simplification  has  been  pursued  in  related  areas  of  the  agri-food  acquis.  A 
proposal to amend the Fertilising Products Regulation, part of the Omnibus on chemicals, aims to 
reduce  duplication  in  conformity  assessment  and  to  enable  digital  labelling,  cutting  costs  for 
operators while  facilitating oversight.5 The ongoing revision of the plant  reproductive material 
(PRM) legislation likewise aims to clarify notification and reporting rules, modernise procedures, 
and remove inconsistencies across Member States.6 A proposal to create a framework for plants 
obtained  by  certain  new  genomic  techniques  (NGTs)7  would  also  streamline  current  rules  and 
benefit farmers, consumers, and the environment. These initiatives confirm a consistent direction 
of travel while maintaining the Union’s high level of protection and policy ambition. 

The next step in implementing the Vision is to extend simplification beyond agriculture into the 
wider  food  and  feed  safety  acquis,  with  the  aim  to  enhance  resilience,  sustainability  and 
investment  in  the  sectors  for  the  benefit  of  farmers  and  citizens.  This  omnibus  proposal 
accompanied  by  this  Staff  Working  Document  responds  to  clear  signals  from  Member  States, 
economic operators and other stakeholders that rules can be streamlined, and procedures made 
more efficient. It introduces a package of targeted measures across the acquis, covering not only 
authorisation/approval procedures but also systematic renewal of authorisations/approvals, mutual 
recognition, surveillance, reporting and other areas where obligations have become unnecessarily 
complex  or  costly.  By  streamlining  these  processes,  aligning  risk  management  with  current 
scientific knowledge and international standards, and creating more agile pathways for safe and 
sustainable  innovations,  the  initiative  reduces  administrative  burden  for  operators  and 
administrations alike, while strengthens the competitiveness and resilience of the EU food chain. 

The  initiative  builds  on  a  substantial  evidence  base.  The  evaluation  of  the  Plant  Protection 
Products (PPP) and Maximum Residue Levels (MRL) legislation identified lengthy and resource-
intensive procedures, insufficient resources in Member States authorities to conduct tasks assigned 
to  them,  limited  incentives  for  low-risk  and  biological  solutions,  and  legal  uncertainty  around 
transition periods when MRLs8. The evaluation of the Feed Additives (FA) 9 modernise labelling 
requirements  for  feed  additives.10  Evidence  from  the  implementation  of  the  Biocidal  Products 
Regulation,  and  the  implementation  of  the  Official  Controls  Regulation  (OCR)  11  highlighted 
obligations  that  could  be  simplified  without  lowering  the  level  of  protection.  Together,  these 
findings provide a robust analytical foundation for the Omnibus, complemented by stakeholders’ 

5 COM(2025) 531 final 
6 COM(2023) 414 final 
7 COM(2023)411 final 
8 SWD(2020) 262 final 
9 SWD(2024) 46 final 
10 In particular COM(2021) 287 final and SWD(2021) 128 final 
11 COM(2021) 350 final 

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and Member States’ input received through Standing Committees, advisory groups and dedicated 
consultations. 

The  Union’s  food  and  feed  safety  acquis  is  anchored  in  a  set  of  horizontal  and  sectoral  acts, 
including the General Food Law Regulation (EC) No 178/2002, the hygiene package, the Official 
Controls Regulation (EU) 2017/625, and legislation on plant health, animal health and welfare, 
feed, biocidal products, maximum residue levels (MRLs), and genetically modified food and feed. 
These acts together ensure a high level of protection while supporting the functioning of the Single 
Market. Evaluations, implementation experience and stakeholder inputs have pointed to specific 
procedural obligations that can be made more efficient without lowering safety standards. 

Against this background, the proposal introduces targeted amendments to a defined set of legal 
acts  in  the  food  and  feed  safety  acquis.  These  include:  Regulation  (EC)  No  1107/2009  (plant 
protection products), Regulation (EC) No 396/2005 (MRLs), Directive 2009/128/EC (sustainable 
use  of  pesticides),  Regulation  (EU)  No  528/2012  (biocidal  products),  Regulation  (EC)  No 
1831/2003  (feed  additives),  Regulation  (EC)  No  852/2004  (food  hygiene),  Regulation  (EU) 
2017/625 (official controls), Regulation (EC) No 1829/2003 (GM food and feed), and Regulation 
(EC)  No  999/2001  (TSEs).  The  package  focuses  on  selected  procedural  and  administrative 
elements  within these acts,  without modifying the underlying risk-assessment  principles or the 
Union’s level of protection. 

This Staff Working Document accompanies the Commission simplification proposal (omnibus) 
amending selected acts in the field of food and feed safety. This omnibus has been structured as a 
package comprising a proposal  for a regulation amending  several  regulations,  a proposal  for a 
directive amending several directives, and a targeted proposal to amend Article 95 of the Biocidal 
Products Regulation on data protection. More specifically, this document includes a presentation 
of  the  main  issues  identified,  an  analysis  of  the  proposed  measures  and  the  specific  problems 
addressed,  the  views  of  stakeholders  and  Member  States,  the  objectives  pursued,  and  an 
assessment of expected impacts, in particular the reduction of administrative burden and costs for 
food business operators and national administrations. 

2.  MAIN ISSUES 

EU  food  and  feed  safety  legislation  has  evolved  over  time  into  a  comprehensive  and  trusted 
framework, protecting public, animal and environmental health and ensuring the functioning of 
the  internal  market.1213  Evaluations  and  implementation  experience,  however,  show  that  the 
incremental build-up of detailed procedures can create frictions and administrative costs that are 
no  longer  proportionate  to  their  added  value.  With  more  mature  administrations,  improved 
scientific  capabilities  and  decades  of  operational  experience,  there  is  scope  to  simplify  and 
modernise specific procedural elements without affecting the level of protection. 14Innovation is 

12  The  Bovine  Spongiform  Encephalopathy  (BSE)  crisis  in  the  1990s  was  a  turning  point  that  prompted  a  rapid 
expansion  and  tightening of EU  food  safety  legislation,  including  the  adoption  of  Regulation  (EC)  No  178/2002. 
Subsequent incidents, such as dioxin contamination in feed and residues of unauthorised substances in imports, further 
embedded precautionary and risk-based approaches. 
13 According to the September 2025 Special Eurobarometer on food safety, there is strong citizen confidence in the 
EU’s food safety framework. 
14 OECD (2025), Regulatory Policy Outlook. 

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increasingly  central  to  productivity  and  sustainability  in  the  agri-food  system.1516  However,  in 
several areas, legislative procedures have not kept pace with technological developments, slowing 
the uptake of safe and beneficial solutions and increasing transaction costs for operators.17 Faster  
decisions, clearer procedural arrangements and the use of digital information tools can help reduce 
unnecessary formalities and enable faster access to safe innovations while preserving high safety 
standards. 

Over  time,  certain  recurring  obligations  in  the  food  and  feed  safety  acquis  have  led  to 
administrative requirements that are no longer proportionate to their added value, particularly for 
SMEs and for authorities with limited capacity. Evaluations point to systematic renewals, mutual-
recognition procedures and the modification of existing authorisations as areas where significant 
resources are spent without corresponding improvements in safety outcomes. 18 

In parallel, several authorisation and renewal systems have become difficult to manage efficiently. 
Procedures often involve sequential steps, duplicated checks and extensive documentation, and 
legal  timelines  are  frequently  missed.19  These  inefficiencies  create  uncertainty  for  operators, 
especially SMEs, and contribute to backlogs for administrations.20 Evidence from cross-cutting 
evaluations and international practice indicates that clearer procedural rules, reduced duplication 
and more risk-based approaches would support timely and predictable regulatory outcomes. 21 

Differences  in  national  implementation  add  to  these  challenges.  Diverging  interpretations  of 
reporting, notification or mutual recognition obligations can lead to inconsistent application across 
Member States, increasing compliance costs for operators active in multiple markets and limiting 
the effectiveness of internal market provisions.22 Addressing this fragmentation would improve 
consistency and reduce unnecessary administrative friction. 

Finally, some parts of the acquis have not kept pace with scientific developments or updates to 
international standards. Outdated analytical terminology, rigid procedures and limited flexibility 
to  integrate  new  evidence  can  increase  compliance  costs  and  make  certain  provisions  more 
stringent  than  necessary.  Targeted  adjustments  to  enable  timely,  evidence-based  updates  and 
alignment with international guidance would preserve the Union’s high level of protection while 
improving regulatory coherence. 

These five challenges, barriers to innovation, disproportionate burdens, procedural inefficiencies, 
fragmentation across Member States, and misalignment with science and international standards, 
illustrate how a framework that remains fundamentally sound can nevertheless create unnecessary 
costs and delays. Simplification, therefore, provides an opportunity to recalibrate the acquis and 
maintain the same high level of protection while reducing complexity, freeing up resources, and 

15 World Bank (2020). Harvesting Prosperity: Technology and Productivity Growth in Agriculture. 
16 OECD (2019), Innovation, Productivity and Sustainability in Food and Agriculture: Main Findings from Country 
Reviews and Policy Lessons. 
17 See the PPP evaluation (SWD(2020) 87 final) 
18 e.g. SWD(2024) 46; SWD(2020) 87; consultation feedback; ongoing evaluation of EFSA performance 2017 - 2024 
19 COM(2021) 350 final 
20 European Court of Auditors (2020), Sustainable use of plant protection products: limited progress in measuring 
and reducing risks (Special Report 05/2020). 
21  OECD  (2021),  Improving  Regulatory  Delivery  in  Food  Safety:  Mitigating  Old  and  New  Risks,  and  Fostering 
Recovery 
22 COM(2020) 93 final 

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enabling innovation. The following section sets out targeted legislative adjustments that address 
these systemic issues. Each measure is designed to tackle one or more of the problems identified 
above,  thereby  facilitating  the  uptake  of  new  solutions,  lowering  administrative  burden,  and 
streamlining procedures. In this way, the initiative delivers directly on the objectives of the Vision 
for Agriculture and Food and the Commission’s broader agenda for sustainable prosperity and 
competitiveness. 

3.  MEASURES 

3.1. 

Faster access to markets and innovation 

3.1.1.  Biocontrol plant protection products (PPP) 

Biocontrol  substances  offer  farmers  lower-concern  plant  protection  “tools”,  such  as  micro-
organisms,  semiochemicals  (e.g.  pheromones)  and  substances  of  biological  origin  or  synthetic 
substances  equivalent  to  naturally  occurring  substances,  that  can  reduce  reliance  on  hazardous 
synthetic chemicals while maintaining crop protection performance. Today, however, biocontrol 
products reach EU markets too slowly and unevenly because procedures to let them access the 
market take too long, the zonal system for authorisation and mutual recognition of authorisations 
between Member States underperforms, and assessment capacity is not adapted to their specific 
needs,  e.g.,  lack  of  life  scientists,  microbiologists,  as  repeatedly  flagged  by  stakeholders  and 
Member States. 

Clarifying what qualifies as “biocontrol” and  accelerating market access is a core strand of the 
simplification  announced  in  the  Commission’s  Vision  for  Agriculture  and  Food  and  in  the 
European  Parliament  resolution  on  Ensuring  the  faster  registration  and  uptake  of  biological 
control agents23. This proposal realises that commitment by defining biocontrol substances and 
prioritising their assessment and authorisation of the products  containing them, including tools 
such as provisional product authorisations while approval procedures are still ongoing, a one-zone 
approach for authorisations and tacit-agreement for mutual recognition if procedural deadlines are 
not respected, and the option to choose EFSA as rapporteur for the initial safety assessment, so 
that  safe,  innovative  products  reach  farmers  faster  without  lowering  the  level  of  protection  or 
undermining  the  internal  market.  This  initiative  would  not  compromise  the  current  levels  of 
protection  as  the  obligation  to  comply  with  safety  standards  and  to  perform  a  sound  risk 
assessment would stay the same. For instance, when acting as Rapporteur Member State (RMS), 
EFSA  would  be  obliged  to  employ  different  experts  between  the  RMS  and  the  peer-review 
assessment, to guarantee an independency between the two processes 

In the absence of a harmonised legal definition of “biocontrol substance”, competent authorities 
apply  different  categorisations  to  comparable  materials  (e.g.  plant  extracts,  micro-organism–
derived metabolites, or synthetic molecules identical to naturally occurring ones). This results in 
divergent implementation of data requirements (e.g., how to apply waivers for biological active 
substances dossiers when they have a chemical nature), additional pre-assessment exchanges to 
determine the applicable track, and increased use of clock-stops to require additional data. For 
instance,  several  biocontrol  substances  (such  as  micro-organism-derived  metabolites)  have  a 
chemical nature, but generally a safer risk profile than other synthetic chemicals. This means that 

23 https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/2086(INI)  

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for these biocontrol substances with a chemical nature some data might not need to be submitted 
in a dossier for their approval, if scientifically justified, due to their nature. This might be true for 
data concerning the persistency of them in nature after application of a PPP containing them, due 
to their natural occurrence and low persistency.  Defining “biocontrol substance” would help in 
harmonising the understanding across Member States on how to implement the data requirements, 
avoiding those frictions which nowadays translate into long timelines. At active-substance level, 
the time taken by Member States to assess dossiers routinely exceeds the legal benchmark: internal 
monitoring from May 2024 shows that rapporteur Member States take an average of 3 years and 
274 days to draft assessment reports for approvals and renewals of approvals of biocontrol actives. 
Further  delays  occur  in  the  product  authorisation  stage,  where  again  deadlines  for  zonal  and 
mutual-recognition procedures are not respected. 

Mutual recognition of authorisations is not delivering timely or predictable outcomes. Divergent 
national practices in dossier handling and categorisation (e.g. product considered as a biocontrol 
agent or not, extra data requirements), frequent clock-stops to clarify scope and implementation 
of  data  requirements  and  missed  legal  timelines  lead  to  heterogeneous  and  delayed  decisions 
across Member States. Smaller markets are particularly affected, as lower sales potential coupled 
with delayed decisions reduce incentives for companies to even apply for authorisation.   

Capacity  constraints  compound  these  issues.  Rapporteur,  co-rapporteur,  zonal  reference  and 
concerned  authorities  operate  with  limited  assessment  capacity.  There  is  no  consistent 
prioritisation of procedures for biocontrol substances and PPP containing them, which reduces the 
predictability  of  work  planning  for  biocontrol  manufacturers,  with  some  MS  even  unable  to 
prioritise due to national laws. Where EFSA participates, its scientific capacity is also finite and 
must be allocated across competing  priorities. Specialist expertise on  how  to  assess  biocontrol 
peculiarities is not uniformly available. Gaps in harmonised scientific consensus and experience 
with  e.g., semiochemicals, microbial  metabolites  and complex plant  extracts  lead to  additional 
pre-assessment  exchanges  between applicants  and Member States  to  determine data needs  and 
applicable templates. These exchanges are frequently followed by clock-stops with requests for 
additional  data,  which  prolong  evaluations  and  create  queues  that  are  difficult  to  clear  once 
formed. 

Procedures  for the renewal  of approvals  consume  the most  substantial share of the  assessment 
capacity  of  Member  State  authorities  and  EFSA.  Applicants’  regulatory  teams  are  drawn  into 
renewal  cycles  as  well,  but  the  binding  constraint  on  throughput  is  the  authorities’  capacity. 
Resources  currently  occupied  with  the  recurrent  workload  from  renewals  and  time  lost  in 
assessment due to insufficient harmonisation reduces strongly capacity for the initial assessments 
of applications for new substances and thus slows the entry of innovative biocontrol solutions into 
the evaluation pipeline. 

Finally,  where  the  Rapporteur  Member  State  has  assessed  the  biocontrol  substance  and  has 
concluded that it may be expected to satisfy the safety requirements, there is no mechanism to 
enable earlier market access for PPPs containing new innovative biocontrol substances while the 
peer  review  of  the  initial  assessment  and  decision-making  on  the  EU  approval  of  the  active 
substance is still pending. As a result, procedures for the authorisation of products cannot start 
even when the initial scientific assessment is already substantially developed at rapporteur level. 

The impacts of these bottlenecks are broad and uneven. Applicants for biocontrol substances, an 
SME-dominated segment with thinner capital buffers, face long and uncertain timelines that raise 

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financing  costs,  heighten  cash-flow  risk,  and  in  some  cases  threaten  business  continuity. 
Stakeholder submissions indicate lost sales of EUR 1 to 3.7 million per product, per year of delay, 
underscoring  the  segment’s  acute  sensitivity  to  time-to-market.  Farmers,  especially  in  smaller 
Member States, experience a narrower and less predictable toolbox for protecting crops: uneven 
or late availability of biocontrol products leads to continued reliance on synthetic chemistry the 
variety of which is decreasing, complicating e.g. resistance management, and can lead to higher 
control costs or yield losses when newer options are not accessible in time for the growing season. 

Member States competent authorities face inefficiencies arising from fragmented practices, e.g. 
different implementation of assessment criteria, need for repeated requests for additional data, and 
workload  related  to  renewal  procedures  that  crowd  out  first  assessments.  Missed  mutual-
recognition  deadlines  increase  case  handling  and  disputes.  At  Member  State  and  EU  level, 
scientific capacity is finite and there is no systematic prioritisation lane for biocontrol substances 
and  products,  which  contributes  to  queues.  For  the  internal  market  and  farmers,  fragmented 
availability delays the uptake of lower-concern biocontrol products, distorts competition, and risks 
eroding confidence in proportionate, science-based regulation making the EU less attractive, as 
there is no true single market for plant protection products, and no strong incentives for bringing 
such products to the market compared to other regions in the world. 

The lack of a clear definition of biocontrol leads to scope ambiguity, divergence in assessment 
practices,  and  slow  throughput.  Commission  monitoring  of  pending  applications  (May  2024) 
highlighted substantial delays at the active-substance stage, and casework shows repeated deadline 
overruns  at  product  and  mutual-recognition  stages.  Operational  feedback  gathered  through 
informal exchanges, inputs from Member State coordinators, and discussions with rapporteur and 
zonal  authorities  consistently  points  to  capacity  bottlenecks,  renewal-driven  crowd-out  of  new 
dossiers,  and  uneven  use  of  existing  procedural  flexibilities,  e.g.  mutual  recognition.  Targeted 
outreach and stakeholder submissions reinforce this picture, indicating disproportionate burdens 
on SMEs and quantifying delay-driven revenue losses. 

Member States support clarifying scope and making timelines predictable and enforceable, and 
they call for practical means of reducing duplication while preserving high  level of protection. 
Manufacturers, especially SMEs, seek a clear definition, prioritised handling of applications for 
biocontrol  substances  and  PPP  with  lower-concern  profiles,  earlier  product-level  access  when 
assessment  is  advanced,  and  mutual-recognition  outcomes  delivered  within  legal  deadlines. 
Farmers’  organisations  support  faster  and  more  even  availability  of  biocontrol  PPP  across  the 
Union  to  strengthen  resistance  management  and  reduce  reliance  on  older  chemistry,  with 
predictability  of  availability  ahead  of  critical  production  windows.  NGOs  and  academia  are 
generally  open  to  streamlining  provided  safety  is  maintained,  and  they  underline  the  need  for 
transparency,  meaningful  monitoring  indicators,  and  safeguards  that  ensure  a  high  level  of 
protection for human, animal and environmental health. If the issues are not addressed, backlogs 
and missed availability for growing seasons will persist, SMEs will defer or abandon innovation, 
smaller markets will remain underserved, and the credibility of streamlining commitments will 
diminish. 

This omnibus proposal removes these procedural frictions for biocontrol tools while preserving 
the  EU’s  high  level  of  protection.  It  clarifies  scope,  accelerates  assessments,  enables  earlier 
product access under safeguards such as provisional authorisation of biocontrol products when a 
RMS  risk  assessment  is  positively  concluded,  and  makes  mutual  recognition  work  more 

9 

 
 
predictably  across  the  internal  market,  while  maintaining  protection  standards.  The  measures 
below are designed to operate together: 

•  Create  an  EU-level  definition  of  “biocontrol  substance”  that  covers  e.g.,  micro-organisms, 
semiochemicals (including pheromones), plant extracts, micro-organism-derived metabolites, 
and synthetically produced substances that are identical to those occurring in nature, which 
will be identified in a Commission-maintained list of approved active substances. 

•  Require Member States to prioritise applications for biocontrol substances and related PPPs in 

their work programmes.  

•  Allow  provisional  authorisations  for  PPPs  containing  new  biocontrol  substances  when  the 
rapporteur Member State has completed a satisfactory assessment, enabling safeguarded, time-
limited  market  access  pending  the  peer-review  and  EU  approval  decision  on  the  active 
substance. 

•  Facilitate the authorisation procedure for biocontrol PPPs by applying a one-zone approach 

for zonal assessment. 

•  Strengthen  zonal  authorisation  system  and  mutual  recognition  for  biocontrol  PPPs  by 
introducing  tacit  agreement  where  legal  deadlines  are  exceeded,  so  that  authorisations  are 
deemed granted if time limits are not respected. 

•  Offer  the  option  to  applicants  to  choose  EFSA  as  rapporteur  for  the  initial  assessment  of 

applications for new biocontrol substances, paired with additional resources for EFSA. 

•  Remove  the  record-keeping  obligation  for  professional  users  where  a  PPP  contains  only 

biocontrol substances. 

The  expected  improvements  can  be  monitored  through  a  series  of  potential  indicators  for 
biocontrol, including for example median substance and product assessment times, the number of 
(provisional)  authorisations,  accelerations  in  mutual-recognition  timelines,  and  availability  of 
biocontrol  PPP  by  Member  State.  The  Commission  will  provide  continued  implementation 
support  through  the  development  or  update  of  relevant  guidance  documents  on  categorisation, 
dossier templates and data requirements for semiochemicals2425 

Apart  from  these  actions  directly  targeted  to  biocontrol  substances  and  products,  horizontal 
changes  to  the  overall  PPP  framework  (see  section  3.2.1  –  PPP),  applicable  to  all  pesticides 
amplify  the  biocontrol  package  by  boosting  throughput  and  predictability  across  the  board. 
Unlimited approvals for most active substances free capacity for the assessment of applications 
for new biocontrol substances, a clearer EU data-protection regime facilitates fair data sharing and 
clarifies the end date for data protection which is crucial for market access for SMEs; streamlined 
mutual-recognition  rules  and  rules  for  extensions  of  authorisations  for  minor  uses  improve 
availability of PPP across Member States and a clarified concept of what constitutes “most recent 
scientific advice” reduce burden for Member States authorities and risk of litigation and expand 
practical  access,  while  high  protection  standards  are  maintained  through  targeted  review 
mechanisms  for  more  problematic  active  substances  and  products,  triggered  by  new  scientific 
evidence or concerns while continuing to periodically review PPPs, whose authorisations remain 
limited in time. . 

25 implementation support is already provided by existing guidance documents such as: PAFF-PPL-October 2023-
Doc.A.07.01, SANTE/2020/12260, SANCO/0253/2008, SANCO/11470/2012, SANTE/12815/2014. 

10 

 
 
 
 
Translating  these  measures  into  outcomes,  the  combined  effect  is  earlier  access,  fewer  repeat 
procedures,  and  materially  lower  costs  for  applicants  and  reduced  burdens  on  authorities. 
Unlimited approvals for biocontrol active substances are expected to save applicants about EUR 
6.5 million per year by removing repeated renewal cycles.26   

Faster  access  to  the  market  then  adds  a  material  commercial  benefit:  using  a  mid-point  of  the 
underlying  estimates,  provisional  authorisations  avert  roughly  EUR  22  million  per  year  in 
delayed-marketing losses, and tacit mutual-recognition outcomes avoid a further EUR 1.2 million 
per year where deadlines are missed. Taken together, these effects cut recurring administrative 
effort, improve planning certainty, and shorten time to market. Because SMEs make up about 90% 
of biocontrol manufacturers, they capture most of the gain: for renewals alone, their savings are 
approximately  EUR  5.9  million  per  year.  In  a  segment  where  some  micro-firms  report  that 
preparing a dossier for a biocontrol active substance can cost 1.5 years of turnover, the scale of 
these savings is significant.  

For  authorities,  unlimited  approvals  reduce  burdens  for  conducting  renewal  assessments  and, 
together  with  clearer  categorisation  of  products,  cut  pre-assessment  exchanges.  This  allows 
Member  State  competent  authorities  and,  where  involved,  EFSA,  to  reallocate  effort  from 
repetitive  renewals  to  initial  assessments  of  new  biocontrol  dossiers,  raising  throughput  while 
maintaining  the  high  level  of  protection,  as  active  substances  and  products  must  comply  with 
safety standards. Delays in authorisations of biocontrol and low-risk PPP are reduced due to a one-
zone assessment across all Member States, which reduces case handling and disputes stemming 
from  divergent  categorisations  or  delayed  decisions.  Combined  with  enforceable  outcomes 
(including tacit agreements for zonal authorisations and mutual recognitions where deadlines are 
missed,  more  consistent  delivery  across  Member  States  and  a  more  predictable  workload  for 
administrations are achieved. 

While  precise  effects  are  not  quantifiable  with  current  data,  earlier  and  more  even  access  to 
biocontrol and low-risk PPP across the Union enlarges the toolbox for farmers,  creates a more 
level  playing  field  among  Member  States,  strengthens  resistance-management  strategies,  and 
lowers  the  risk  of  yield  losses  associated  with  delayed  availability  of  innovative  biocontrol 
products. A targeted derogation from record-keeping where a PPP contains only biocontrol actives 
further facilitates the handling of biocontrol PPPs by farmers and lowers routine compliance tasks 
and can encourage uptake without shifting any risk onto users or consumers. 

At single-market level, consistent delivery of authorisations helps to ensure access to biocontrol 
solutions for farmers across all Member States, supporting competitiveness and reducing disparity 
in access to lower-concern tools, relevant particularly in smaller Member States with historically 
low application numbers. Stakeholders broadly support improving access to biocontrol solutions, 
while warning that biological substances cannot yet replace many chemical PPPs one-to-one and 
stressing the need to maintain high protection standards. All accelerated routes, priority handling, 
provisional authorisations and strengthened mutual recognition, remain fully anchored in existing 
EU safety requirements, including interfaces with MRL procedures. These measures uphold the 
EU’s  high  level  of  protection  for  human,  animal  and  environmental  health  and,  within  those 
safeguards, facilitate access to tools that are generally of low concern, advancing sustainability 

26 For more detail on the cost saving calculations, view section 1 of Annex III on methodology 

11 

 
 
 
and  delivering  tangible  benefits  for  consumers  and  citizens  through  lower  residues  in  food,  a 
cleaner environment, and strengthened confidence in the safety of Europe’s food supply. 

3.1.2.  Aerial spraying of PPP by drones 

Drone technology is transforming crop protection globally, with hundreds of thousands of units 
already in use and a rapidly expanding market projected to exceed EUR 3 billion by 2033. Drones 
enable highly targeted application of PPPs, with potential benefits for sustainability, farmer safety 
and  competitiveness.  In  the  EU,  however,  the  Sustainable  Use  of  Pesticides  Directive  (SUD) 
imposes a general prohibition on aerial spraying, including by drones, unless a specific derogation 
is  granted  by  national  authorities.27  This  regime  has  resulted  in  fragmented  practices  across 
Member States, limited uptake of drones for plant protection purposes, and high administrative 
burden for both operators and competent authorities. 

Stakeholders in the Strategic Dialogue on the Future of EU Agriculture, Members of the European 
Parliament, and a majority of Member States are calling for concrete steps to enable the uptake of 
precision  technologies,  particularly  drones.  At  the  December  2024  AGRIFISH  Council,  most 
Member States urged the Commission to present “without delay” clear guidance and a legislative 
proposal  on  drone  use,  including  procedures  for  risk  assessment  and  management.28  This 
momentum has been reinforced by Parliamentary Questions from across the spectrum.   

Member States report that important knowledge gaps remain on how drones perform in practice, 
including  technical  specifications,  drift  behaviour  and  other  parameters  that  are  critical  to 
determine safe conditions of use. This uncertainty directly affects the way derogations are handled 
under  the  SUD  and  adds  considerably  to  the  administrative  burden  for  farmers  and  national 
authorities.  The  2022  evaluation  of  the  Directive  confirmed  that  the  lack  of  clarity  creates 
disproportionate costs and slows down innovation. Stakeholders have also stressed that drones are 
the technology most held back by the current framework, even though drones could contribute to 
more sustainable pesticide use. 

Another major obstacle is the absence of a harmonised EU methodology for assessing risks under 
Regulation  (EC)  No  1107/2009  when  PPPs  are  to  be  applied  by  drones.  Without  a  common 
approach, Member States struggle to evaluate applications consistently, which in turn prevents 
wider use across the Union. There is broad agreement that EU-level guidance is needed to provide 
clarity, ensure a high level of protection and support the safe deployment of drone technology in 
crop protection. 

The  lack  of  a  harmonised  EU  framework  also  weakens  incentives  for  innovation.  Uncertainty 
about the conditions under which drones can be used safely, combined with the need for individual 
derogations in each Member State, means that companies cannot be confident that investments in 
drone technology or in PPP authorisations for aerial use will pay off. This discourages both R&D 

27  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, pp. 71–86, 
ELI: http://data.europa.eu/eli/dir/2009/128/oj). 
28 Council of the European Union (2024), Precision farming – Council conclusions on the use of new technologies 
in agriculture 

12 

 
 
 
and  market  entry,  limiting  the  development  of  a  European  drone  services  sector  for  PPP 
application, and slows down the availability of innovative crop protection solutions for farmers.29 

There  are  certain  initiatives  already  underway  to  generate  the  evidence  that  would  close  the 
knowledge gaps on applications of PPP by drones. The OECD is developing a comprehensive set 
of tools to support risk assessment, including a database of drift data, empirical models, drone 
design  classifications,  guidance  on  mixing  and  cleaning,  and  an  ISO  standard  on  spray 
distribution, as well as recommendations for risk assessors and managers.30 In parallel, the EU’s 
Horizon Europe framework programme  has  funded projects  that demonstrate the  usefulness  of 
drones in agriculture, explore their scalability and provide indications on where further research 
should be directed.31 

To  build  on  this  knowledge  base,  the  Commission  will  request  the  European  Food  Safety 
Authority to develop scientific guidance on how to assess and authorise PPPs for aerial application 
by drones under Regulation (EC) No 1107/2009. In addition, the Commission will consult EFSA 
and Member States  when the Commission prepares a delegated act identifying the types of drones 
that have lower or equal risks compared to the risks arising from land-based pesticide application 
equipment  for  the  same  use.  This  approach  ensures  that  any  future  facilitation  of  drone  use  is 
anchored  in  a  science-based  assessment  and  therefore  does  not  adversely  affect  the  policy 
objective of maintaining a high level of protection of human health and the environment. 

Given the current data gaps, no immediate exemptions for drones from the need for individual 
derogations  are  envisaged.  Instead,  this  package  proposes  to  amend  the  Sustainable  Use  of 
Pesticides  Directive  to  create  an  empowerment  for  the  Commission  to  adopt  a  delegated  act 
identifying the types of drones that have lower or equal risks compared to the risks arising from 
land-based pesticide application equipment for the same use. Subsequently, Member States could 
exempt these types of drones from the prohibition on aerial spraying.  To ensure the framework 
remains  future-proof,  the  identified  types  of  drones  could  be  amended  in  future  in  line  with 
emerging scientific consensus. However, apart from specific conditions concerning pesticide use, 
any proposal would not set new rules and conditions for unmanned aircraft system operations and 
would act within the general aviation safety framework. 

The  amendment  of  the  SUD  is  expected  to  provide  a  strong  impetus  to  the  development  and 
deployment of innovative drone technologies adapted to the Union market. The creation of a clear 
and uniform legal framework, setting strict but predictable conditions, will give stakeholders, and 
in  particular  SMEs,  the  confidence  to  plan  and  invest  in  the  drone  services  sector.  This  legal 
certainty  is  likely  to  stimulate  further  R&I  projects  and  facilitate  the  safe  uptake  of  precision 
spraying and the targeted application of pesticides explicitly authorised for aerial use. While PPP 
users will be better placed to benefit from this fast-evolving technology, stakeholder views vary, 
with  many  citizens  and  NGOs  expressing  concerns  about  drift  and  exposure  risks,  while 

29 Maritan, E. (2025). An agroecological assessment of uncrewed aerial vehicle spraying in Greek viticulture 
30 See Guiding principles, processes, and criteria for the work of the OECD Drone/UASS Subgroup of the Working 
Party on Pesticides; OECD Report on the State of the Knowledge – Literature Review on Unmanned Aerial Spray 
Systems  in  Agriculture;  ISO  23117-2:2025  Agricultural  and  forestry  machinery  —  Unmanned  aerial  spraying 
systems, Part 2: Test methods to assess the horizontal transverse spray distribution. 
31  ICAERUS  focuses  on  drone  monitoring  and  spraying  and  improved  decision-making  for  pesticide  reduction. 
SPADE  develops  a  multi-purpose  drone  model  to  support  precision  farming.  GO  DRONSafe  addresses  safe 
application, aiming to reduce human and environmental exposure. FORTUNA identifies research gaps and promotes 
precision application and digital technologies to monitor pests. 

13 

 
 
 
businesses support enabling drone use under strict, harmonised risk-management and operator-
competence rules. As exemptions would only apply to drone types shown to have risks equal to 
or lower than land-based applications, the measure is not expected to adversely affect, and may 
even support, the objective of reducing the risks associated with pesticide use. 

The precise cost benefits cannot yet be quantified, but evidence indicates considerable potential, 
particularly in challenging agricultural settings such as steep slopes, tall vertical crops and difficult 
terrain. In such contexts, drones can reduce labour intensity, increase operational efficiency and 
deliver measurable savings. In other settings, the balance of benefits will depend on factors such 
as equipment costs, maintenance and lifespan, but may shift further in favour of drones as labour 
and input costs rise. 

Looking ahead, drones are expected to play a central role in the wider digital transformation of 
agriculture. Combined with automated crop surveillance, weather monitoring and precision input 
management, they offer  multiple opportunities to reduce  costs, labour and chemical  use. Low-
altitude drones can improve the targeted delivery of PPPs, reduce drift and use, and thus optimise 
efficient and sustainable crop production.32 

Overall, by creating a predictable and future-proof framework, the measure will make drones a 
practical  and  safe  tool  for  precision  farming  in  the  Union.  This  will  contribute  directly  to  the 
Commission’s policy objectives of reducing the use and risk of pesticides, protecting biodiversity 
and pollinators, and minimising exposure of workers, bystanders and the environment, while at 
the same time fostering innovation, competitiveness and resilience in the agri-food sector. 

3.2.  Lowering administrative burdens 

3.2.1.  Further PPP simplification 

In  a  second  strand  of  measures  beyond  biocontrol  (see  chapter  3.1.1),  this  omnibus  proposes 
targeted simplifications to Regulation (EC) No 1107/2009 that relate to most pesticides, including 
biocontrol  substances  and  products.  The  proposal  responds  directly  to  the  findings  of  the 
evaluation33 of the EU pesticides legislation, which highlighted persistent non-compliance with 
statutory timelines, uneven implementation across Member States, and administrative practices 
that add burden without commensurate gains in safety. These bottlenecks slow down access to 
safe, innovative products and create fragmentation in availability of PPP across the Union. They 
also absorb a large share of the finite assessment capacity of Member States and EFSA, leaving 
less room for first assessments of new, more sustainable solutions. By simplifying procedures and 
clarifying  legal  concepts,  the  package  addresses  the  structural  issues  that  affect  all  PPPs, 
complementing and reinforcing the dedicated biocontrol track presented in 3.1.1. t  

These measures pursue three objectives:  

•  streamline approvals by removing systematic renewal of approval obligations for most  active 

substances  

32  Calderone,  G.,  Ferro,  M.V. and  Catania,  P.  (2025),  A  systematic  literature  review  on  recent  unmanned  aerial 
spraying systems applications in orchards, Smart Agricultural Technology, vol. 10. 
33 COM/2020/208 final 

14 

 
 
 
 
 
•  make the single market work better by reinforcing mutual recognition of authorisations and 

• 

simplifying procedural requirements for applicants 
improve legal clarity and fair competition by reducing uncertainty and ensuring a level playing 
field, especially for SMEs and new entrants. 

More specifically, this omnibus proposes: 

•  unlimited  approvals  for    most  active  substances  with  the  possibility  for  selecting  such 
substances for full renewal procedure and introducing a new provision to allow for targeted 
reassessment (including for substances with limited approval) in addition to maintaining the 
possibility for review of approval under Article 21; 

•  enhanced  mutual  recognition  with  reduced  documentation  requirements  for  applicants; 

simplified requirements for minor-use extensions; 

•  data-protection coherence via clear, EU-wide rules on start/end of protection; 
•  clarification regarding basic substances; 
•  closure of implementation gaps on treated seeds. 

These measures do not alter the fundamental protection standards enshrined in Regulation (EC) 
No  1107/2009;  new  provisions  will  allow  the  Commission  to  identify  active  substances  with 
unlimited approval to undergo either a full renewal process or targeted reassessment (including 
targeted  reassessments  for  active  substances  with  limited  approval).  Substance  selection  will 
involve consultation of the Authority, consider requests of Member States and will be based on 
specific  criteria.  This  will  create  a  more  agile  approach  with  an  accelerated  uptake  of  new 
scientific or technical knowledge and a more rapid response to emerging issues. In practice, this 
means that rather than reassessing all substances at fixed time intervals, authorities can focus effort 
where scientific progress points to a possible change in the risk profile. 

The  current  level  of  protection  for  human  and  animal  health  and  the  environment  will  be 
maintained  and  can  be  expected  to  increase.  Therefore,  the  policy  objectives  underpinning 
Regulation (EC) No 1107/2009 are maintained. All the existing risk assessment requirements and 
procedures  remain  in  force:  while  the  periodic  time-driven  renewal  of  the  approval  of  active 
substances is removed. Safeguards remain to ensure active substances with unlimited approvals 
can still be reviewed at any time where new evidence emerges that this is necessary in view of 
protection of human health or the environment. The package is limited to improving procedural 
efficiency and legal clarity; it does not change the existing strict approval criteria or the possibility 
of review when needed. 

Overall, the measures will deliver significantly lower administrative burden for authorities and 
applicants and increase predictability for the availability of PPPs to farmers. For administrations, 
freeing up capacity from repetitive renewals allows more timely assessments of new applications 
and  a  clearer  focus  on  substances  or  products  that  raise  specific  concerns.  For  businesses,  in 
particular  SMEs,  fewer  routine  procedures  and  clearer  rules  on  mutual  recognition  and  data 
protection  reduce  compliance  costs  and  investment  risk.  These  changes  support  the  Union’s 
broader priorities on competitiveness by making authorisations, and thus farmers’ toolboxes, more 
predictable.  Targeted  reassessments  will  focus  effort  where  risks  are  highest,  therefore 
maintaining the Union’s high level of protection for health and the environment. 

Unlimited approvals with possibility for full renewal or targeted reassessments 

15 

 
 
Today, approvals of all active substances are time-limited and require renewal applications at least 
three years before expiry. This systematic cycle, based on time rather than needs, generates very 
high  volumes  of  work  for  Member  States  and  EFSA  and  obliges  applicants  to  prepare  costly 
dossiers. The evaluation of PPP legislation found persistent delays across the system. These affect 
initial  approvals,  renewals  and  the  timing  of  downstream  decisions  on  authorisation  and 
availability of PPPs. The result of these processes is heavy administrative effort, growing backlogs 
and ever slower processing of applications for new active substances and products. Capacity is 
locked into routine calendar-driven tasks rather than directed to  more relevant reviews that are 
necessary to ensure that high safety requirements are maintained.  This has been confirmed by 
several stakeholders in response to the Call for Evidence. 

For  competent  authorities, recurring  renewal  procedures for active substances  strain  resources, 
make statutory timelines harder to meet and increase demands on EFSA. For companies, renewal 
dossiers  for  active  substances  must  be  assembled  years  in  advance  and  renewal  of  PPP 
authorisations requires additional dossiers to be prepared. Fees and data costs are high, planning 
is complex, and timelines become uncertain as delays and queues lengthen. Smaller firms are hit 
hardest because fixed costs are spread over fewer products and markets. For farmers and other 
professional users, slower decisions at both substance and product levels delay access to new and 
innovative PPPs and keep existing portfolios in frequent reassessment, reducing predictability and 
following non-renewals of approvals of active substances, limiting available tools in the field. 

Overall, the current renewal model absorbs assessment capacity without a commensurate gain in 
protection: effort is spent re-checking substances on a fixed schedule rather than targeting specific 
concerns or new evidence. This reinforces delays and increases administrative burden across the 
system.  It  also  means  that  the  same  intensive  renewal  process  is  applied  to  all  substances, 
irrespective of their risk profile. 

Moreover, it is important to recall that as of 2025, all approved active substances have been fully 
assessed at least once by Member States and EFSA, with many being subject to a full renewal 
assessment  and  in  a  few  cases  a  second  renewal  assessment.  In  December  2025,  210  active 
substances are currently subject to an ongoing renewal procedure, which will continue even once 
the  new  rules  are  in  place.  Hence,  for  most  of  these  substances,  only  at  the  finalisation  of  the 
ongoing renewal procedure –a decision will be taken on whether approval can become unlimited 
or not. The current standard is therefore very high, allowing to move towards a system of unlimited 
approvals for some active substances with possibility for full renewal or targeted reassessment to 
ensure  standards  are  maintained.    It  is  expected  that  targeted  reassessments  will  accelerate  the 
uptake of new scientific or technical knowledge and respond to emerging issue more rapidly. 

Approvals  of  most  active  substances  will  become  unlimited  with  the  exception  of  active 
substances that are candidates for substitution, active substances approved under the derogation 
possibility  set  out  in  Article  4(7)  of  Regulation  (EC)  No  1107/2009  and  active  substances  for 
which a limited time of approval is set in accordance with Article 6 as such active substances have 
properties that are of concern with regards to human or animal health or the environment, and 
cases where the outcome of the assessment or other legitimate factors indicate that a time limit is 
appropriate.  The  Commission  will  set  the  framework  for  work  programmes  that  may  select 
specific active substances for a full renewal procedure or a targeted reassessment (which can also 
be applied to active substances with limited approvals). In addition, the current possibility for ad-
hoc  reviews  under  Article  21  for  specific  substances  is  retained  and  may  be  used  where  new 
evidence or developments arise over time and where an active substance is not being reviewed or 

16 

 
 
reassessed under a specific work programme. It is important to note that the authorisation of plant 
protection  products  will  remain  limited  in  time  and  therefore  products  will  continue  to  be 
periodically reviewed. 

The  new  provisions  therefore  allow  for  various  assessment  possibilities: full  renewal  of  active 
substances with unlimited approval, targeted reassessment of active substances with unlimited or 
limited approval, while review at any time in accordance with Article 21 is maintained. Together 
these provisions ensure sufficient safeguards to maintain the high protection standards already in 
place, as requested by many stakeholders in response to the Call for Evidence. Following renewal 
or targeted reassessment of active substances,  PPPs will also  be re-examined at  Member State 
level. Article 56 obligations for authorisation holders to inform authorities of potentially harmful 
effects from use of PPPs  continue to apply. The possibilities set out in  Article 44 for Member 
States  to  amend  or  withdraw  authorisations  where  Article  29  requirements  are  no  longer  met 
remain  fully  operable,  and  so  do  the  provisions  of  Article  69  and  71  (safeguard  measures  for 
immediate market withdrawal in case of serious risks) ensuring action can be taken promptly if 
new risks emerge. 

Shifting  from  periodic  renewals  to  unlimited  approval  for  most  active  substances,  with  the 
possibility for full renewal or targeted reassessments, will free resources in Member States, so that 
authorities  can  meet  legal  deadlines  and  prioritise  assessments  of  applications  for  new  active 
substances and new PPP. This will help innovative products reach farmers faster. Manufacturers 
will  avoid  routine  renewal  fees  and  dossier  costs  and  can  redirect  spending  to  developing 
alternatives and bringing new or improved products to market. 

At active-substance level, shifting from routine to targeted renewals avoids repeated dossier build-
ups, i.e. study updates, data formatting, expert consultancy, submission management, and related 
regulatory  fees, delivering about  EUR  49.6 million  in  cost  savings  per year  for non-biological 
substances.34  

Beyond costs, farmers’ toolboxes will grow. Faster assessment of new active substances and a 
more stable PPP portfolio will increase availability of innovative and lower-concern PPPs. The 
change from systematic to targeted renewals of approval of active substances will also help reduce 
in  vivo  animal  testing,  supporting  the  objectives  of  Directive  2010/63/EU  on  the  protection  of 
animals used for scientific purposes. 

Essential-use derogation  

The current essential-use derogation in Article 4(7) of the PPP Regulation is too narrow to operate 
in practice. Although this provision allows time-limited approval of an active substance that does 
not meet certain hazard-based approval criteria, no substance has ever been approved under it. 
Instead, Member States have to resort to extensive use of Article 53 of the PPP Regulation to grant 
time-limited emergency authorisations when an active substance is  needed to  control  a serious 
danger to plant health or crop production that cannot be contained by other reasonable means. If 
products would be authorised under such derogation, the obligation to prepare phasing-out plans 
adds administrative burden on Member States. 

34 For more detail on the cost saving calculations, view section 1 of Annex III on methodology 

17 

 
 
 
This proposal clarifies the scope of the essential-use derogation so that, for a limited period, an 
active substance may be approved even if a broader range of approval criteria are not met, where 
it  is  necessary  to  control  a  serious  danger  to  plant  health  or  plant  production  that  cannot  be 
contained  by  other  reasonable  means,  while  excluding  substances  with  certain  hazards  of 
particular concern for health or the environment. It removes the obligation for Member States to 
draw up phasing-out plans when they authorise products containing such substances.  

The changes give competent authorities workable tools to respond to serious plant-health risks 
without the need to resort to emergency authorisations. Farmers and other professional users will 
have more predictability, reducing the risk of production shocks where alternatives are limited. 
Applicants, manufacturers and distributors benefit from greater predictability and a lower risk of 
stock write-offs at market exit. Safeguards remain intact, since the derogation stays exceptional 
and MRLs must be established to ensure consumer safety, as well as mitigation measures being 
put in place to minimise exposure. 

Enhanced mutual recognition  

The authorisation of a PPP granted by one Member State is meant to be accepted by other Member 
States  where  agricultural,  plant-health  and  environmental  conditions  are  comparable.  Such 
‘mutual recognition’ aims to avoid repeating the same assessment, reduce administrative effort, 
and ensure that farmers have more even access to PPPs across the Union. In practice, evidence 
from  the  evaluation,  the  Zonal  Authorisation  Procedure-  Improvements  and  Development 
(ZAPID)  workshop  held  in  December  202335  and  stakeholder  feedback  shows  timelines  for 
completion  of  mutual  recognition  applications  far  beyond  the  four  months  set  out  in  the 
Regulation.36  Typical  durations  are  seven  to  ten  months,  and  newer  stakeholder  data  indicate 
around twelve months. 

Delays are caused by multiple factors, for example applicants who are not the holder of the original 
authorisation face extra steps such as securing the holder’s consent or proving public interest for 
the specific PPP use, which makes submissions by official or scientific bodies and professional 
agricultural organisations harder. This omnibus proposes changes to that mutual recognition works 
as intended. It makes the dossier requirements lighter in certain cases, with particular attention to 
applications from entities that are not the holder of the original authorisation for which mutual 
recognition is sought. Specific enhancements for biocontrol products are addressed separately (see 
section 3.1.1). 

These  measures  will  make  applications  easier  to  prepare  and  process.  Mutual  recognition  is 
cheaper  than  a  full  authorisation,  so  lifting  unnecessary  steps  should  raise  the  number  of 
applications and the number of authorisations, even if the exact savings cannot be calculated in 
advance. In parallel, the proposal will bring about shorter timelines and procedures should move 
closer to the four months set in the Regulation. Faster market entry  for PPPs in more Member 
States would be the result of such improvements. As explained in section 3.1.1, for biocontrol 

35https://food.ec.europa.eu/document/download/21e6b162-ac20-4d3c-aefb-
a9084888f515_en?filename=pesticides_auth-ppp_workshop_20231205_sum.pdf 
36  https://food.ec.europa.eu/plants/pesticides/authorisation-plant-protection-products/assessment-plant-protection-
products-ppps_en 

18 

 
 
 
products,  the  enhanced  mutual  recognition  route  with  tacit  agreement  is  expected  to  speed  up 
access to PPPs even further. 

Applicants for mutual recognition, many of them SMEs, will gain from lower procedural effort 
and earlier market access. Farmers will benefit from wider and more even availability across the 
Union, including in smaller markets, giving them more choice of solutions.  Overall, the level of 
protection will remain unchanged, while the measures will support farmers’ competitiveness. 

Simplification for low-risk active substances 

The identification of low-risk active substances is not straight-forward to apply in practice because 
Article 22 of the PPP Regulation ties the low-risk status of an active substance to specific hazard 
criteria for that active  substance  and  to  Article 47  which concerns low-risk PPPs  and refers to 
requirements in relation to specific risk mitigation measures for which fulfilment is not known at 
the time of approval or renewal of the active substance since the assessment of the product is the 
second step in the procedure. Authorities and applicants cannot confirm at approval stage whether 
the product criteria will be met, which blocks or delays low-risk status of active substances, which 
in turn is a precondition for low-risk status of a PPP containing it. Under the current rules the 
status  of  an  active  substance  cannot  be  changed  after  approval.  Because  the  low-risk  status 
depends on product-level criteria that are not known at approval or renewal, substances that could 
qualify as low-risk often cannot receive that status until the first renewal. This delays access to the 
low-risk route, creates unequal treatment, and adds unnecessary burden for applicants and farmers 
who cannot benefit from simplified procedures for PPP authorisation during the initial approval 
period. 

The omnibus proposes to base low-risk identification only on the intrinsic properties of the active 
substance and to  allow for the submission  of an application to  change the status  of an already 
approved active substance to low-risk. This makes the status more easily confirmable at approval 
and  enables  easier  reclassification  later  if  the  criteria  are  met.  This  is  expected  to  facilitate 
application  procedures  for  low-risk  active  substances  and  to  reduce  administrative  burden  for 
applicants, encouraging development and placing on the market of more products containing such 
substances.  It  supports  the  reduction  target  for  hazardous  pesticides  and  expands  the  farmers’ 
toolbox with more sustainable options. 

Facilitating minor-use extensions 

Extensions  of  PPP  authorisations  for  minor  uses  (i.e.  small  acreage  or  specialty  crops)  are 
hampered by some conditions in Article 51 of the PPP Regulation that stakeholders consider too 
restrictive.  Implementation  also  varies  significantly  across  Member  States.  Procedures  and 
expectations differ, creating uncertainty for applicants and farmers and leading to uneven access 
to  products  for  minor  uses  across  the  Union.  Limited  transparency  and  weak  sharing  of  good 
practices  compound  these  divergences.  Current  rules  constrain  the  mutual  recognition  of 
authorisations across borders for minor uses, especially when the use in the reference Member 
State  is  not  itself  classified  as  minor.  Together,  these  factors  discourage  applications  for 
economically important  but  small-scale uses and leave  farmers with  too  few pest-management 
options. 

This proposal simplifies and aligns the minor-use route across the Union. It removes conditions 
that have made conditions for minor-use extensions overly restrictive, enables mutual recognition 

19 

 
 
of  minor-use  authorisations  even  when  the  reference  use  is  not  classified  as  minor.  It  also 
empowers the Commission for setting out harmonised procedures, so that Member States follow 
the  same  steps  and  documentation  for  minor-use  extensions  and  for  mutual  recognition,  with 
greater transparency and systematic sharing of good practices. 

The  simplified  and  aligned  minor-use  route  makes  applications  easier  to  prepare  and  process. 
Removing  the  condition that  minor  use  extensions  must  be in  the  public  interest  and  allowing 
applicants to rely on mutual recognition even when the reference use is not classified as minor 
reduces procedural complexity and cost. This increases the likelihood that companies, including 
SMEs, will apply for minor-use authorisations and should broaden availability of PPP for minor 
uses across the Union. For farmers, especially those growing high-value crops on limited surfaces 
such as certain fruits and berries, wider availability means more pest-management options. Better 
fit between products and needs can support improved crop protection and yields. The overall effect 
is a more predictable and attractive framework that expands market opportunities for applicants 
while strengthening pest-management choices for users. 

Clarifying provisions related to treated seeds 

Fragmented implementation  of the existing provisions in the PPP Regulation  related to  treated 
seeds  creates  uncertainty  about  which  rules  apply  to  imported  seeds  treated  with  PPP  not 
authorised in any Member State. There are divergent practices between Member States on what 
constitutes lawful sowing of treated seeds, e.g. whether the active substance must be approved in 
the EU; how to handle other propagating material such as tubers or seedlings; and who carries the 
compliance responsibility along the supply chain.  

The proposal clarifies the situation by prohibiting the sowing in the EU of imported seeds treated 
with plant protection products that are not authorised in any Member State of the Union. It also 
clarifies that the rules on treated seeds apply to other plant reproductive material, including tubers, 
bulbs and seed potatoes. To avoid creating additional burden for farmers, machinery used solely 
for  sowing  treated  seeds  is  excluded  from  the  obligations  applicable  to  pesticide  application 
equipment under Directive 2009/128/EC on the sustainable use of pesticides. 

These amendments will facilitate the free movement of treated seeds and improve their availability 
to farmers, irrespective of the Member State of use. They will strengthen controls on imports of 
treated seeds and help to minimise risks to human and animal health and the environment. The 
measure  improves  market  fairness  and  availability  for  compliant  treated  seeds,  with  no  extra 
obligations for farmers or industry. 

Prioritising and simplifying authorisation for PPP to prevent establishment and spread of 
regulated pests 

Failure  to  eradicate  and/or  prevent  spread  of  pests  regulated  under  the  Plant  Health  Law 
(Regulation  (EU)  2016/2031)  carries  very  high  economic  and  social  costs.37  For  some  crops, 
propagating material should be free of regulated pests or meet very low thresholds to safeguard 
production.  If  establishment  or  spread  cannot  be  prevented,  overall  use  of  plant  protection 
products is likely to increase over the medium or long term. National authorities responsible for 

37 The JRC estimates production losses up to €32.5 billion for pine wood nematode, export losses up to €1.9 billion 
for Spodoptera frugiperda, and almost 300 000 jobs lost due to the effects of Xylella fastidiosa. 

20 

 
 
 
plant health need timely access to effective PPP uses to implement contingency plans. Professional 
users,  including  farmers  and  growers,  face  fewer  options  and  slower  access  to  needed  tools. 
Applicants, in particular SMEs, encounter high administrative effort for small markets and limited 
prospects of recouping  costs. Forestry and exporting  plant propagating materials producers are 
exposed to higher risk and potential losses when effective pest control means are not available. 

This proposal introduces a one-zone application for PPP used to control pests regulated under the 
Plant Health Law, replacing the current three-zone approach with a one-zone approach for these 
cases. In parallel, this omnibus will also prioritise such applications in the authorisation workflow. 
Together, these measures will provide for faster access to PPP to control pests regulated under the 
Plant Health Law and let the authorities act quickly and effectively. 

Faster access to the market for PPP needed for the purposes of Regulation (EU) 2016/2031 will 
further  support  effective  control.  In  the  short  term,  Member  State  authorities  and  professional 
users,  including  farmers,  benefit  because  they  often  need  to  act  with  urgency  under  national 
contingency plans. The one-zone approach reduces administrative costs, since applicants prepare 
and submit one interzonal application instead of three zonal applications. 

Over the medium and long term, EU agriculture and forestry benefit because successful prevention 
avoids  the  significant  additional  costs  that  arise  when  regulated  pests  establish  and  spread. 
Applicants,  in  particular  SMEs,  benefit  from  simplified  procedures  that  make  small-scale 
applications more viable and should lead to more submissions for uses against regulated pests. For 
pests that affect forested areas, avoiding establishment and spread also maintains the resilience of 
EU forests and enhances their role as natural carbon sink. 

Ensuring coherent data protection EU-wide 

The current data-protection regime under Regulation (EC) No 1107/2009 is territorial by Member 
State and protection periods lack clear, uniform start and end dates. For the same test or study 
report, protection can begin and expire on different dates across the Union, especially when studies 
are used for renewals or for extensions of authorisations to minor uses. Competent authorities and 
applicants do not have a single, transparent reference point, which creates disputes and adds case-
by-case administrative checks. 

Misaligned timelines distort market entry. When protection still applies in the Member State of 
submission of an application for authorisation, follow-on applicants must assemble data-matching 
dossiers or negotiate letters of access, even if protection has already lapsed elsewhere. This delays 
authorisations, raises costs, and produces uneven availability and prices across the Union. Smaller 
markets  are  hit  hardest,  since  originators  may  deprioritise  submissions  and  SMEs  struggle  to 
recoup high entry costs on limited volumes. Farmers in these Member States face fewer options 
and slower access. 

Systematic  delays  in  renewals  of  PPP  authorisations  can  prolong  protection  in  practice.  If  a 
renewal  runs  late,  studies  remain  protected  for  longer  in  that  Member  State,  creating  artificial 
extensions that block competitors from entering the market without adding safety. Because dates 
are not aligned Union-wide, these extensions occur unevenly and persist unpredictably. 

Divergent  national  interpretations  further  increase  workload  and  litigation  risk.  Determining 
whether a study is protected, for how long, and on what basis requires legal and technical checks 

21 

 
 
that  differ  across  Member  States.  Time  spent  resolving  protection  status  uncertainty  reduces 
capacity  for  risk-relevant  assessment  work.  For  operators,  uncertainty  about  protection  status 
delays investment decisions and creates holding costs, which weigh most on SMEs. 

Taken together, patched territorial protection, opaque timelines, extensions of protection due to 
delays  in  renewal  procedures,  and  divergent  practice  weaken  the  internal  market.  They  slow 
competitive entry for generic products and also for new products based on already approved active 
substances that rely on already approved active substances, fragment availability for farmers, and 
increased costs, while offering no improvement in protection standards. 

This  omnibus  proposes  to  restore  EU-wide  data  protection  for  test  and  study  reports  used  in 
regulatory  procedures  for  approval  of  active  substances  and  authorisation  of  PPP,  with  clear 
starting  and  ending  points  that  apply  across  all  Member  States,  including  for  studies  used  in 
renewals and minor-use extensions. 

EU-wide data protection will make the regime easier to apply, reduce administrative burden for 
competent  authorities,  and  give  applicants  predictable  timelines.  It  will  facilitate  access  to  the 
market for products based on already approved active substances, since protection will start and 
end at the same time in all Member States. Farmers should see more even availability of products 
at comparable costs regardless of where they are established. 

Today,  when  data  protection  still  applies  in  the  Member  State  for  which  an  application  for 
authorisation is submitted, post-patent companies report that a data-matching dossier costs about 
EUR  5.15  million  on  average,  compared  with  EUR  1.45  million  when  protection  has  expired, 
implying an additional EUR 3.7 million for obtaining authorisation for a PPP containing an active 
substance for which data are still protected. Lack of clarity and artificial data protection extensions 
caused  by  renewal  delays  cost  around  EUR  14.8  million  per  year  across  reporting  post-patent 
companies.38 Moving to an EU-wide regime will reduce these extra costs and associated delays, 
and  savings  can  be  reinvested  in  the  development  of  new  products,  broadening  the  toolbox 
available to EU farmers. 

The proposal preserves the purpose of data protection, which is to reward investment in generating 
studies for a limited period, while ensuring that protection does not extend beyond the statutory 
duration. By ending territorial fragmentation, it should also help SMEs enter smaller markets once 
protection  expires  across  the  Union  at  the  same  time,  improving  competition  and  choice  for 
farmers. 

Clarifying the provisions related to basic substances 

Basic substances have a primary use outside agriculture but can be valuable for plant protection. 
Article 23 of the PPP regulation, which covers their placing on the market and use, is interpreted 
unevenly across the Union. Several Member States allow only “use” for plant protection purposes 
and do not allow placing on the market for purposes of plant protection, while others permit also 
their  specific  marketing  for  such  purposes.  This  divergence  creates  legal  uncertainty,  unequal 
opportunities for farmers and amateur users, and difficulties in cross-border trade in products that 

38 For more detail on the cost saving calculations, view section 1 of Annex III on methodology. 

22 

 
 
 
are lawful in one Member State but regarded as illegal in another. Authorities face enforcement 
difficulties, and applicants receive inconsistent signals about what is required. 

Key  concepts  are  not  applied  consistently.  The  absence  of  EU-level  clarity  and  a  common 
approach to placing on the market, the presence of stabilisers for ensuring shelf-life, labelling and 
responsibilities along the supply chain leads to disputes and extra administrative work. The current 
exclusion of a “dual approval” (i.e. the same substance cannot be an approved basic substance and 
be marketed as part of an authorised PPP following an approval as regular active substance) creates 
uncertainty  when  an  approved  basic  substance  later  obtains  an  approval  as  a  regular  active 
substance.  Eligibility  criteria  such  as  “primary  use  for  other  purposes”  and  the  handling  of 
substances  of  concern  are  difficult  to  implement  consistently.  This  omnibus  clarifies  what  is 
allowed and streamlines how basic substances are approved and made available, while keeping 
requirements proportionate to their low-concern profile. More specifically, the proposal aims to 

•  clarify that basic substances may be placed on the market for plant protection purposes, in 
addition  to  being  used  for  such  purposes  and  that  products  containing  basic  substances 
may be labelled with clear information on plant protection purposes 

•  streamline  applications  and  approvals  by  clarifying  rules  on  substances  of  concern, 

• 

primary use for other purposes. 
resolve “dual approval” uncertainties, so that a substance approved as basic retains that 
status even if later approved as a regular active substance. 

These amendments streamline approvals and harmonise availability of basic substances across the 
Union. Users gain  a level  playing field  and greater  access  to  products  that are useful for plant 
protection and will be labelled with clear information for correct use, as well as predictability that 
the status of a basic substance will  not change, which improves planning and competitiveness. 
Clarifying eligibility and marketing conditions should increase the number of both applications 
and approvals, making basic substances more readily available to amateur and professional users. 

Resolving  the  dual-approval  issue  protects  the  basic-substance  status  and  its  approved  uses. 
Investments  by  public  bodies,  research  organisations,  farmer  associations  and  SMEs,  who  are 
often the applicants for the approval of basic substances, are safeguarded, since approved basic 
substances  uses  remain  valid  even  if  the  substance  later  receives  a  regular  active  substance 
approval. Co-existence of basic and regular approvals can stimulate innovation, because different 
formulations in PPP may enhance performance while farmers retain the option of using a simpler 
and often more affordable basic substance. 

Public  authorities,  the  Commission  and  applicants  face  less  administrative  burden  as  legal 
uncertainty  and  divergent  national  practices  are  removed.39  For  farmers  and  wider  society, 
increased  access  to  low-concern  tools  helps  diversify  the  plant-protection  toolbox,  supports 
substitution of more hazardous substances, and aligns with integrated pest management.  

Optional EFSA support to Rapporteur Member States 

39 A quantified estimate of cost savings is not possible at this stage, due to limited data on producers, dossier costs 
and market effects, but the expected direction is lower compliance effort and fewer disputes. 

23 

 
 
 
Competent authorities in some Member States lack the complete specific technical and scientific 
expertise  to  complete  their  tasks  as  rapporteur  Member  State  within  the  timelines  of  the  PPP 
regulation. 40 This results in delays in drafting and updating assessment reports for approvals and 
renewals of approvals of active substances and creates avoidable back-and-forth exchanges with 
EFSA during the peer review process. 

This omnibus would allow the RMS, to request optional, targeted technical support from EFSA 
when  preparing  the  initial  assessment  report.  Legal  responsibilities,  protection  standards,  and 
methodologies remain unchanged. 

Faster resolution of technical questions shortens the time needed by the RMS and smoothen the 
peer review  process. Greater methodological  consistency raises the quality  of draft assessment 
reports  and  reduces  the  need  for  rework  during  the  peer  review  process.  For  Member  States, 
targeted  access  to  specialist  expertise,  helps  smaller  or  capacity-constrained  authorities  meet 
deadlines  without  costly  outsourcing,  improves  workload  planning,  and  reduces  the  risk  of 
divergent interpretations that later need correction. For operators, clearer and faster procedures 
mean  more  predictable  timelines,  fewer  iterative  data  requests,  lower  holding  and  compliance 
costs, and earlier clarity on risk-management conditions, which is especially important for SMEs. 

For  farmers  and  the  wider  public,  steadier  regulatory  throughput  supports  a  reliable  supply  of 
approved  tools  while  maintaining  protection  standards,  lowers  administrative  burden  through 
fewer procedural disputes, and improves transparency and trust through earlier convergence on 
methods and risk assessment outcome. The measure is expected to be resource-neutral for EFSA, 
with  capacity  for  technical  support  of  RMS  created  by  efficiencies  from  shifting  to  unlimited 
approvals with targeted reviews (as described above), while any biocontrol-related resource needs 
are addressed separately (see section 3.1.1). 

3.2.2.  Simplification for biocidal products 

The  Commission  Report  on  the  implementation  of  the  Biocidal  Products  Regulation  (EU)  No 
528/2012 (BPR), adopted in June 2021, identified persistent problems in the functioning of the 
system,  notably  substantial  delays  in  the  approval  of  active  substances,  especially  the  review 
programme of existing active substances, and in product authorisations.41 These delays also hinder 
the market entry of innovative active substances. In addition, concerns have recently been raised 
by  Member  States  and  economic  operators  about  the  expiry  of  data  protection  for  all  existing 
active substances at the end of 2025. 

A comprehensive evaluation of the BPR has been launched in 2025 to assess the overall fitness of 
the  regulatory  framework.  However,  given  the  urgency  of  some  of  the  issues  identified,  the 
Commission proposes to introduce a limited set of targeted amendments already now. These aim 
to  alleviate  the  most  pressing  burdens,  improve  efficiency,  and  provide  legal  certainty,  while 
leaving broader structural reforms to be considered as a follow up to the forthcoming evaluation. 

Unlimited approvals with targeted renewals of active substances 

The BPR requires that all active substances used in biocidal products undergo a thorough safety 
and  efficacy  assessment  before  they  can  be  approved  for  use  across  the  EU.  To  manage  the 

40 33rd Pesticide Steering Network meeting | EFSA  
41 COM(2021) 287 final, SWD(2021) 128 final 

24 

 
 
 
transition from previously existing rules, the BPR maintained the review programme introduced 
by its predecessor (Directive 98/8/EC) for a systematic assessment of all existing active substances 
that were already on the market in 2000. This review programme has the objective to ensure that 
only  substances  meeting  EU  safety  requirements  remain  available,  thereby  protecting  human 
health, animal health and the environment, while supporting a well-functioning internal market 
for biocidal products. Pending the conclusion on an existing active substance, biocidal products 
containing it remain regulated under national rules of Member States, where such rules exist. 

Under the BPR, the evaluations are carried out jointly: each application is assigned to a Member 
States authority acting as evaluating competent authority, which prepares an assessment report. 
The European Chemicals Agency (ECHA) then coordinates a peer review among Member States 
experts  and  helps  ensure  consistency  of  the  system.  Final  decisions  on  approval  of  active 
substances are taken by the Commission in consultation with Member States representatives.  

However,  the  review  programme,  launched  in  2000,  has  been  repeatedly  extended  and  is  now 
scheduled to end only by 2030. 42 4344 As of September 2025, just over half of the substance dossiers 
have been assessed. These delays adversely affect the BPR’s core objective of ensuring that only 
substances meeting EU safety requirements remain on the market within predictable timelines. 
Most Member States authorities have not respected the deadlines for submitting their assessment 
reports.  The  2021  implementation  report  identified  several  reasons  for  the  persistent  delay  in 
completing the review programme.45 Many national authorities face capacity constraints, lacking 
sufficient staff and expertise to process complex dossiers within the legal deadlines. Applicants 
themselves also contribute to delays, due to missing information in their initial applications, and 
the  frequent  submission  of  additional  data  requested  during  the  assessment  conducted  by  the 
evaluating Member State later than expected. Some dossiers are technically complex and raise 
scientific  questions  that  must  be  resolved  before  an  assessment  can  be  finalised,  requiring 
sometimes authorities to revisit or update earlier work. Frequent changes in technical guidance 
during  ongoing  evaluations,  and  inconsistencies  in  interpretation  across  Member  States,  have 
further slowed progress.46 Finally, the adoption of new scientific criteria for the identification of 
endocrine-disrupting  properties  introduced  in  2018,  created  further  data  requirements  and 
assessment needs that added to the workload.47 

Since 2015, the Commission has worked with Member States to accelerate the completion of the 
review programme through the expert group of Competent Authorities for Biocidal Products, with 

42 Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending Directive 
98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods 
(OJ L 262, 6.10.2009, p. 40). 
43 Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) No 528/2012 
of the European Parliament and of the Council as regards the duration of the work programme for examination of 
existing biocidal active substances (OJ L 204, 31.7.2013, p. 25). 
44 Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 amending Regulation (EU) No 528/2012 
of the European Parliament and of the Council as regards a further extension of the duration of the work programme 
for  the  systematic  examination  of  all  existing  biocidal  active  substances  (OJ  L,  2024/1398,  22.5.2024,  ELI: 
http://data.europa.eu/eli/reg_del/2024/1398/oj). 
45 These are detailed in COM(2021) 287 final and SWD(2021) 128 final. 
46 Also indicated by stakeholders during the 2025 Implementation Dialogue: Implementation dialogue on Biocides - 
Public  Health  -  European  Commission,  and  referred  in  the  AISE  (2022),  Assessment  of  the  Biocidal  Products 
Regulation (BPR) and its implementation, p. 15–16 
47  Commission  Delegated  Regulation  (EU)  2017/2100  of  4 September  2017  setting  out  scientific  criteria  for  the 
determination  of  endocrine-disrupting  properties  pursuant  to  Regulation  (EU)  No  528/2012  of  the  European 
Parliament and Council (OJ L 301, 17.11.2017, p. 1, ELI: http://data.europa.eu/eli/reg_del/2017/2100/oj).  

25 

 
 
 
stakeholders participating as observers.48 These discussions led to agreements on several actions 
to accelerate the delivery of assessment reports for existing active substances.49 In parallel, ECHA 
organised workshops  and adopted an action plan on active substances. To provide more direct 
support, the Commission launched  in  2023  a call for expressions of interest  allowing Member 
States to apply for financial grants to strengthen their capacity under both the BPR and the PPP 
Regulations. As a result, nine Member States received a total of around EUR 6.8 million related 
to their tasks under the BPR.50 

Despite  these  measures,  by  September  2025,  only  51%  of  the  review  programme  had  been 
completed. This means that the safety of many active substances used in biocidal products on the 
EU market under transitional provisions has still not been established. This situation undermines 
policy  objectives  both  by  delaying  full  safety  verification  and  by  weakening  internal-market 
consistency, since  biocidal  products  remain  in  the meantime  regulated under different  national 
rules.  At  the  same  time,  because  approvals  of  active  substances  are  time-limited,  renewal 
procedures for substances already assessed and approved are ongoing, some even for a second 
cycle.  These  renewals  consume  significant  resources  in  national  authorities,  diverting  capacity 
away  from  the  completion  of  pending  assessments  of  existing  active  substances  and  further 
delaying the execution of the review programme. 

At an Implementation  Dialogue held  on 15 July 2025, suppliers, formulators, and downstream 
users showed broad consensus  on the need to  reduce delays and improve predictability, which 
create  a  fragmented  and  uncertain  regulatory  environment.51  Companies  face  uneven  market 
access  across  Member  States,  long  waiting  times  for  active  substance  approvals  and  product 
authorisations  that  often  exceed  the  legal  timelines,  delaying  market  access  and  distorting 
competition.52 Such unpredictability directly affects the policy objectives of timely access to safe 
products and a level playing field for operators. This not only increases costs but also discourages 
innovation,  as  firms  are  less  willing  to  invest  in  new  solutions  when  regulatory  processes  are 
excessively long.53 

Under the current system, approvals of active substances are granted for a limited period (usually 
5–10 years) and must then be renewed. This creates a continuous cycle of renewal applications, 
even for substances that have already been thoroughly assessed and may not present new concerns. 
With  this  omnibus  proposal,  the  Commission  proposes  to  shift  from  systematic  to  targeted 
renewals. In practice, this means that: 

•  Approvals of most active substances would become unlimited in duration. 
•  Only substances of higher concern, i.e. those meeting the exclusion criteria (Article 
5(1)) or substitution criteria (Article 10), and substances for which it has been decided 

48 Register Code E03125 (Register of Commission expert groups and other similar entities) 
49 Letters sent in 2015 and 2021  to responsible Ministers in all Member States to express her concerns about the 
delays in implementing the Biocidal Products Regulation (active substances assessments, product authorisations), and 
called on Member States to take action, including allocating sufficient resources; CA documents of  CA-March18-
Doc.5.1a  -  Final  -  Actions  for  AS  review  programme.pdf,  CA-Dec23-Doc.5.4  -  Final  -  Extension  of  RP  beyond 
2024.doc  
50 Contributing to more sustainable and circular food production systems by boosting Member States’ capacities to 
evaluate and remove from the market unsafe pesticides and biocides – SMP-FOOD-2022-BIOCIDES-PESTICIDES-
IBA 
51 Implementation dialogue on Biocides - Public Health - European Commission 
52 VCI/FCIO (2021), Joint Position on delays in the authorisation of biocidal products 
53 AISE (2022), Assessment of the Biocidal Products Regulation (BPR) and its implementation, p. 20 - 21 

26 

 
 
 
that  their  approval  should  be  reviewed  as  a  result  of  an  earlier  assessment,  would 
continue to be subject to time-limited approvals. 

To  maintain  a  high  level  of  protection  for  human,  animal  and  environmental  health,  several 
safeguards  will  remain  in  place,  including  that  all  high-concern  substances  remain  subject  to 
periodic reassessment. Time limits could also still be set where justified by a risk assessment. The 
Commission, in cooperation with Member States experts, could periodically select substances for 
a full renewal or re-examination. Early reviews under Article 15 of the BPR would also remain 
possible where new evidence suggests a potential risk. These safeguards ensure that moving away 
from  systematic  renewals  does  not  adversely  affect  the  high  level  of  human,  animal  and 
environmental protection required under the BPR. 

The change would preserve all essential safety safeguards while significantly reducing the number 
of  routine  renewal  procedures.  This  would  free  up  resources  in  Member  States  and  industry, 
allowing faster completion of the review programme and more timely product authorisations. By 
shifting capacity from systematic renewals to targeted assessments of substances more likely to 
present  risks,  the  measure  enhances  the  BPR’s  objectives  of  high  protection,  timely  safety 
evaluations and a well-functioning internal market. Businesses and many Member States strongly 
support  measures  that  prioritise  completion  of  the  review  programme  and  simplify  renewal 
procedures,  while  NGOs  caution  against  modifying  the  BPR  before  the  ongoing  evaluation  is 
finalised. For industry, the proposal is expected to generate substantial cost savings by removing 
the need for systematic renewal applications. The main cost component of a renewal application 
is the generation of data to support the dossier.54 Although a renewal dossier may require fewer 
studies than a first  approval,  the potential savings  are often offset  by new obligations, such as 
updated  testing  requirements  and  decisions  by  evaluating  Member  States  to  conduct  full 
evaluations.  Based  on  the  number  of  active  substances  approved  as  of  1  September  2025  and 
assuming that the changes to the legislation would be applied as from 2027, the estimated savings 
amount  to  around  EUR  71.5  million  per  year.55  These  savings  reflect  avoided  costs  for  data 
generation, fees payable to ECHA, and fees to Member States evaluating authorities.56 

In addition to the direct  costs of data generation, applicants would also avoid  several ancillary 
expenditures. These include consultancy fees for the preparation of dossiers, which can represent 
a  significant  share  of  overall  compliance  costs,  particularly  for  small  and  medium-sized 
enterprises. Applicants would also be relieved of the administrative burden of their involvement 
in renewal procedures that frequently extend over several years; in certain cases, renewals have 
remained under assessment since 2018. Furthermore, the measure would reduce the uncertainty 
borne by companies, such as delays in business planning or the need to adjust to changing approval 
conditions as a result of the outcome of a renewal procedure. 

54 The cost of preparing an active substance dossier under the BPR is estimated at EUR 1,000,000 to EUR 2,500,000 
for  study  data  development,  plus  an  additional  EUR  300,000  to  EUR  500,000  for  dossier  assembly  and  risk 
assessment, and EUR 200,000 to EUR 750,000 in regulatory fees, totalling approximately EUR 1.5 to EUR 4 million 
per dossier.  
55  The  estimates  are  indicative  and  rely  on  existing  data,  primarily  the  2009  Impact  Assessment  for  the  BPR, 
(SEC(2009)774  final)  updated  with  inflation,  current  ECHA  fees,  and  the  number  of  active  substances  approved. 
While renewal dossiers typically require less data than first approvals, this advantage is offset by new obligations 
such as testing for endocrine-disrupting properties. A more detailed quantification will be carried out in the context 
of the full BPR evaluation starting in 2025. 
56 For detailed calculations, view section 2 of Annex III on methodology. 

27 

 
 
 
Competent authorities in the Member States would equally benefit from a reduction in workload. 
Resources currently dedicated to renewal procedures could be reallocated to the completion of the 
review  programme  and  the  assessment  of  product  authorisation  applications.  This  reallocation 
would facilitate more timely decision-making on long-pending dossiers and reduce the indirect 
costs  associated  with  delay  and  unpredictability,  to  the  benefit  of  both  public  authorities  and 
economic operators. 

While these additional benefits are more difficult to quantify than the direct cost savings linked to 
dossier preparation, they are nevertheless significant. The avoided costs of data generation remain 
the  primary  driver  of  savings.  However,  when  combined  with  the  reductions  in  consultancy, 
administrative and business planning costs for applicants, and the efficiency gains for Member 
State  authorities,  the  cumulative  impact  of  the  measure  considerably  strengthens  its  overall 
effectiveness and proportionality. 

Removal of the obligation to publish Union authorisations in the Official Journal of the EU 

The BPR allows companies to  apply  for a  Union authorisation,  which is valid  under the same 
conditions  in  all  Member  States.  At  present,  each  Commission  decision  granting  such  an 
authorisation must be published in full in the Official Journal, including the Summary of Product 
Characteristics in all EU languages. This requirement is cumbersome and causes delays. It adds 
little value, since the complete decision is already available on the ECHA website.57 

With this simplification package, the Commission intends to simplify how Union authorisation 
decisions  are  adopted  and  published.  Today,  each  authorisation  is  issued  via  a  Commission 
Implementing Regulation and published in full in the Official Journal. Under the new approach, 
Union authorisations would instead be granted via Commission Implementing Decisions, notified 
directly to the applicant. For transparency, only a summary of each decision would appear in the 
Official  Journal,  while  the  complete  text  would  remain  available  on  the  ECHA  website.  This 
change  brings  the  procedure  into  line  with  the  way  authorisation  decisions  are  adopted  and 
disseminated  in  other  comparable  regulatory  frameworks,  ensuring  consistency  across  the 
Commission’s decision-making practice.58 

The  proposed  measure  will  simplify  the  publication  procedure  for  Union  authorisations  and 
remove unnecessary administrative burdens. It will not affect the legal certainty of authorisation 
decisions or the objectives of the BPR, as transparency is maintained through summary publication 
in the Official Journal and full access to decisions on the ECHA website. 

For companies, the main benefit is faster adoption and publication of Union authorisations, as well 
as amendments to Union authorisations. This will reduce costs linked to delays in placing products 
on the market in all Member States. The impact is particularly relevant for seasonal products such 
as  insecticides  or  mosquito  repellents,  where  even  short  delays  can  result  in  missed  market 
opportunities. Although the cost savings cannot be precisely quantified, they are expected to be 
significant  for  operators.  By  shortening  procedures,  the  measure  increases  predictability  for 
businesses and improves efficiency for both authorities and applicants. 

57 https://www.echa.europa.eu/information-on-chemicals/biocidal-products 
58 For instance, authorisation decisions of substances adopted under REACH Regulation  (EC) No 1906/2007, or 
authorisation decision of medicines for human or veterinary use adopted under Regulation (EC) No 726/2004 

28 

 
 
 
 
Article 95 data protection 

Article  95(5)  of  Regulation  (EU)  No  528/2012  foresees  that  on  31  December  2025  protection 
expires  for  all  data  submitted  for  existing  active  substance/product-type  combinations  in  the 
review programme but for which a decision on inclusion in Annex I to Directive 98/8/EC was not 
taken before 1 September 2013 and which will still be under examination in the review programme 
after 31 December 2025. The protection period was set to expire 10 years after mandatory listing 
of  active  substance  suppliers  of  existing  active  substances  on  a  specific  list  maintained  by  the 
European Chemicals Agency (ECHA) that took effect on 1 September 2015 (the Article 95 list). 
The  purpose  was  to  guarantee  a  fair  compensation  period  for  review  programme  participants, 
considering also that, for most participants, their data had already been protected since 2004-2008 
(the time of submission of most of the applications for approval in the review programme), while 
foreseeing the possibility for other economic operators to use freely the data as from the beginning 
of  2026  to  access  more  easily  the  market  and  bring  down  costs  for  the  producers  of  biocidal 
products who buy active substances from the suppliers – and hence ultimately for the users of the 
biocidal products. 

However, several active substance suppliers and their representative organisations have repeatedly 
raised  concerns  that,  in  the  light  of  the  delays  in  the  completion  of  the  review  programme,  as 
described above, the expiry of all data protection needs to be reconsidered. Due to the persistent 
delays in the review programme as described above, many active substances will still be under 
examination after that date. At the July 2025 Implementation Dialogue, some review programme 
participants raised concerns that the looming expiry of data protection, combined with ongoing 
delays,  would  weaken  incentives  for  data  generation  and  potentially  lead  to  withdrawal  of 
applications.  59  Similar  concerns  have  been  echoed  by  Member  State  experts60.  The  issue  is 
particularly  acute  for  data  on  endocrine-disrupting  properties  as,  following  the  adoption  of 
Commission Delegated Regulation (EU) 2017/2100, new scientific criteria to identify endocrine 
disrupting properties are applicable since 7 June 2018, and new studies to assess substances against 
these criteria had to be generated — in many cases this is still ongoing — for substances still in 
the  review  programme.  These  studies  would  currently  receive  only  a  very  short  duration  of 
protection or no protection, despite their high cost and scientific importance. In addition, other 
data had also to be generated and submitted due to the lack of quality of initial data submitted in 
the  concerned  applications  and/or  due  the  need  to  submit  new  data  following  the  evolution  of 
technical guidance or requirements. 

Without  adjustment,  this  situation  risks  discouraging  further  investment  in  data  generation, 
leading  to  the  potential  withdrawal  of  applications  altogether  and  eventually  lack  of  active 
substances  to  combat  negative  effects  on  human  health  or  materials.  It  could  also  weaken  the 
functioning of the internal market by undermining fairness between suppliers who have borne the 
costs of generating new data and competitors who would be able to use those data freely. 

With this proposal, the Commission intends to adjust the rules on data protection under Article 
95(5) of the BPR.  The cut-off date for the protection of data related to existing active substances, 
which  were  still  under  review  in  the  review  programme  on  1  September  2013,  should  be 
reconsidered, striking a balance between the interests of review programme participants, on the 
one side, and the interests of alternative suppliers of active substance and applicants for product 

59 Implementation dialogue on Biocides - Public Health - European Commission 
60 CA-June25-Doc.7.10 - Point from NL on data protection.pdf,  

29 

 
 
 
authorisation, on the other side, taking also into account the original intentions of the expiry of 
data protection set out in Article 95(5) of Regulation (EU) No 528/2012. The balance in the various 
interests  should  be  reflected  in  the  scope  of  the  active  substances  and  data  concerned  by  the 
extension of protection, as well as in the duration of protection.  

It is therefore proposed to extend the protection period for all data for active substance/product-
type combinations for which a decision on the approval had not been adopted in accordance with 
Article 89(1), third subparagraph, of Regulation (EU) No 528/2012 by 7 June 2018, date of entry 
into application of the scientific criteria to identify endocrine disrupting properties. To ensure a 
simple application of the new provision by all parties, the extension of protection covers all data 
without  any  distinction.  The  completion  of  the  review  programme  of  existing  biocidal  active 
substances  has  been  extended  until  31  December  2030.  It  is  therefore  proposed  to  extend  the 
protection of the concerned data until the same date. This corresponds to a period of maximum 
11.5 years for data generated since 7 June 2018, which is considered  an  appropriate  period of 
protection during which participants in the review programme can obtain compensation for the 
costs  of  the  generation  of  data  required  by  evaluating  Member  States.  While  the  period  of 
protection  will  be  shorter  for  data  generated  only  in  recent  years,  the  proposed  extension  of 
protection will cover all data in the application, including data submitted since the submission of 
the applications which have already benefitted from a longer period of protection. Furthermore, 
the Commission will conduct a full evaluation of Regulation (EU) No 528/2012 in the course of 
2026/2027, including its rules on data protection, which will provide a basis for the consideration 
of potential changes in the future. 

This  approach  would  safeguard  the  interests  of  review  programme  participants,  while  still 
allowing alternative suppliers and product authorisation applicants to gain access to the market, 
maintaining  a  balance  between  these  different  interests.  The  measure  would  not  affect  the 
objectives of the BPR. It would not lower the level of protection for human health, animal health 
or the environment, but would maintain a fair balance between data owners and other operators. 
The scope of the active substance and data concerned is clearly defined, which limits the measure 
to cases where fairness is at stake.  No direct cost savings are expected for industry, since the data 
in question must in any case be generated and submitted to complete the assessment of the active 
substance, and for the assessment of endocrine-disrupting properties. However, data owners would 
benefit from the possibility of obtaining compensation from other interested companies through 
letters  of  access.  Access  to  protected  data  may  be  granted  to  alternative  suppliers  of  the  same 
active substance, or to companies seeking product authorisations once the substance is approved. 
The terms of access could vary, ranging from financial compensation to free access when data 
owners also act as substance suppliers. 

Most industry stakeholders and Member States favour extending data protection for substances 
still in the review programme, whereas some operators warn that changing rules now could create 
legal uncertainty and hamper competition.  In the Impact Assessment performed in 2009 for the 
proposal  of  Regulation  (EU)  No  528/2012  revising  the  former  Directive  98/8/EC,  the  cost  of 
preparation of an application for approval of an active was estimated between EUR 3 to 5 million 
(based on a study performed in 2007). Although no specific figures are available on the average 
costs  of  generating  data  related  to  endocrine-disrupting  properties,  these  studies  are  generally 
considered highly costly, particularly because they often involve vertebrate testing. The costs for 
the  generation  of  new  studies  related  to  other  elements  of  an  application  are  highly  variable, 
depending on the issue for which evaluating competent authorities have requested a new study. 
By ensuring an appropriate period of protection, the measure helps secure a fair return on these 

30 

 
 
investments  and  maintains  incentives  for  data  generation,  which  is  essential  for  the  scientific 
robustness of the review programme. 

3.2.3.  Maximum Residue Levels 

Regulation  (EC)  No  396/2005  establishes  harmonised  maximum  residue  levels  (MRLs)  for 
pesticides in food and feed, based on EFSA risk assessments, with the dual objective of protecting 
consumer health and ensuring the smooth functioning of the internal market. The 2020 evaluation 
of  the  EU  pesticides  legislation  confirmed  that  the  Regulation  is  overall  fit  for  purpose  and 
continues to deliver a high level of protection, but it also highlighted areas where procedures are 
complex, burdensome or lack legal clarity. In line with these findings, four targeted adjustments 
are proposed to simplify implementation without lowering standards: 

-  Broader possibility for transitional measures when MRLs are lowered 
-  Unlimited validity for monitoring-based MRLs with targeted reviews  
-  Residues of certain hazardous pesticides not approved in the EU in imported products 
-  Terminology alignment (LOD → LOQ) 

Many stakeholders support clearer transitional arrangements for lowered MRLs, whereas NGOs 
and some farmers call for stricter treatment of import tolerances for non-approved substances, and 
several  third-country  partners  warn  about  trade  disruptions.  These  changes  respond  directly  to 
evaluation findings on legal clarity, proportionality and efficiency, while ensuring that consumer 
protection and the internal market remain fully safeguarded. 

Broader possibility for the application of transitional measures 

The MRL Regulation allows the continued marketing of food products placed on the market before 
the entry into force of new and lower MRLs, provided they complied with the applicable limits at 
the time of production or storage.61 This possibility is excluded when the lowering of an MRL is 
the consequence of a potential health concern. In such cases, the newly established lower MRL 
applies immediately to all products on the market, including stocks that were legally compliant 
when produced. This situation often arises when long-standing MRLs are re-evaluated based on 
updated data  requirements  or revised  exposure models. The absence of  the possibility to  grant 
transitional arrangements under these conditions creates disproportionate effects for operators. 

The  impact  is  most  severe  for  products  with  a  long  shelf  life  and  high  unit  value,  such  as  for 
example wine, hops or oils, and certain nuts and dried berries. Producers face the obligation of 
withdrawing or destroying stock, leading to significant financial losses. At the same time, these 
rules drive unnecessary food waste, contrary to the Union’s policy objectives on sustainability and 
food loss prevention. Stakeholders, such as for instance hops, olive oil, wine, tree nuts, berries and 
tea  producers,  have  repeatedly  raised  this  concern  and  requested  amendments  to  ensure  legal 
certainty  in  such  cases.  This  omnibus  amends  the  relevant  provision  in  Regulation  (EC)  No 
396/2005 to permit in principle the continued marketing of products that complied with the MRLs 
applicable  at  the  time  of  production  in  all  cases  when  new,  lower,  MRLs  are  introduced.  To 
maintain  the  existing  high  level  of  consumer  protection,  a  decision  on  whether  or  not  such  a 

61 Article 49(2) 

31 

 
 
 
transitional measure is acceptable in a specific case will then be decided by risk managers on a 
case-by-case basis, taking all the relevant information into account. 

Fresh  products  with  short  shelf  lives,  which  account  for  the  biggest  share  of  dietary  pesticide 
exposure, would remain on the market only for a very limited time (days in most cases) after the 
applicability of the lowered MRLs, while many long shelf-life products that are consumed in less 
amounts  and  are  used  frequently  in  processed  products  blended  with  other  ingredients,  could 
remain on the market until the end of their shelf-life. The adjustment therefore does not alter the 
overall objectives of the legislation in terms of the high level of protection for consumers. The 
amendment would provide farmers and food business operators with legal certainty that stocks 
produced in compliance with the rules in force at the time of production can in principle continue 
to be sold, except where a high level of consumer protection cannot be ensured.  This would reduce 
unnecessary food waste by avoiding the destruction of products that remain safe but become non-
compliant  solely  due  to  technical  re-assessments.  Economically,  the  change  would  prevent 
disproportionate losses for producers of long shelf-life products, being some of them high-value 
products such as wine, hops, oils, tea, coffee and certain nuts and berries. While precise figures 
are difficult to quantify at EU level, for some operators avoided costs can be significant.  

Simplification  on  the  procedure  related  to  setting  MRLs  based  on  monitoring  data  and 
strengthened provisions for review of MRLs 

Regulation (EC) No 396/2005 allows MRLs to be set based on monitoring data instead of residue 
trials.62 This approach is used, for example, for substances that have long been withdrawn from 
use in plant protection products but still persist as environmental contaminants, for minor dietary 
components  such  as  herbal  infusions  and  honey,  or  in  cases  where  residues  remain  detectable 
many years after last use. 

At present, MRLs established based on monitoring data are limited in time and must be reviewed 
within a maximum of ten years. Periodic review is appropriate for substances where residue levels 
can be expected to  decrease. However, for substances that have not  been approved for several 
decades  and  now  persist  only  as  environmental contaminants,  with  residue  levels  shown  to  be 
stable  over  many  years  (e.g.  DDT,  dieldrin,  aldrin,  hexachlorobenzene,  mercury),  mandatory 
reviews at fixed intervals are disproportionate and impose unnecessary costs as no changes are 
expected. 

This  omnibus  proposes  that  MRLs  based  on  monitoring  data  should  by  default  be  permanent, 
while retaining the possibility of review at any time where new information warrants it. To this 
end, this proposal aims to clarify Article 43 of Regulation (EC) No 396/2005 to specify that the 
Commission may initiate a review at any moment, based on an EFSA risk assessment. 

This approach preserves the high level of consumer protection, as no reduction in safety standards 
or changes to the functioning of the internal market are foreseen. It increases procedural efficiency 
by removing unnecessary reviews, while ensuring that MRLs can still be reassessed at any time if 
new evidence emerges. At the same time, it alleviates administrative burdens for food business 
operators and Member States without creating significant additional costs. The amendment also 
strengthens legal clarity by explicitly confirming that reviews remain possible whenever required.  

62 Article 16 

32 

 
 
 
Residues of certain hazardous pesticides not approved in the EU in imported products 

Regulation (EC) No 1107/2009 governs the approval of active substances used in plant protection 
products, implementing criteria that prevent approval for the use in the EU of the most hazardous 
pesticides for health and environmental reasons. Regulation (EC) No 396/2005 allows the setting 
of import tolerances and alignment with Codex standards for residues of pesticides not approved 
in  the  EU  if  they  pose  no  risk  to  consumers.  This  means  that  substances  not  approved  under 
Regulation (EC) No 1107/2009 due to their intrinsic properties may still be present in imported 
products, provided they comply with the MRL. 

The Parliament63, Council64 and stakeholder groups65 have highlighted the perceived difference in 
the  level  of  protection  between  the  PPP  and  MRL  regulations  and  called  for  an  alignment  of 
production standards between imported and domestic products. 

In the Vision for Agriculture and Food, the Commission announced to pursue a stronger alignment 
of production standards applied to imported products, notably on pesticides. To advance on this, 
the Commission has launched in November 2025 a study to prepare an impact assessment that 
will consider the impacts on the EU’s competitive position and the international implications and, 
if appropriate, the Commission will propose amendments to the applicable legal framework. In 
the meantime Regulation (EC) No 396/2005 is amended to provide that, for substances that are 
not approved in the Union and that have certain particularly hazardous properties, MRLs that have 
been set based on good agricultural practices in third countries nor Codex maximum limits may 
be set at the limit of quantification (technical zero) if considered appropriate in the light of the 
outcome of an impact assessment.  

Based on the scientific criteria listed in Regulation (EC) No 1107/200966, this concerns substances 
with mutagenic, carcinogenic, or reprotoxic properties as well as endocrine disruptors that may 
cause adverse effects in humans. In addition, this concerns substances that are persistent organic 
pollutants (POP), persistent, bioaccumulative and toxic (PBT) substances, and very persistent and 
very  bioaccumulative  (vPvB)  substances,  as  well  as  substances  with  endocrine  disrupting 
properties that may cause adverse effect in non-target organisms. Persistent substances, by their 
very  nature,  resist  degradation,  resulting  in  prolonged  presence  in  the  environment.  Their 

63 See for instance European Parliament resolution of 18 September 2024 as regards maximum residue levels for 
benomyl,  carbendazim  and  thiophanate‐methyl  in  or  on  certain  products;  European  Parliament  resolution  of  17 
January  2024  as  regards  maximum  residue  levels  for  thiacloprid  in  or  on  certain  products;  European  Parliament 
resolution of 14 December 2023 as regards maximum residue levels for tricyclazole in or on certain products. 
64 AGRIFISH Council 24 June 2025 on the alignment of production standards applied to imported products in terms 
of pesticide MRLs. 
65 The Eurobarometer surveys, conducted by the European Commission, consistently reveal strong public support for 
pesticide reduction and environmental protection: 2019 Eurobarometer: Food Safety in the EU(link is external), 2020 
Eurobarometer: Making our food fit for the future(link is external) – new trends and challenges, 2022 Eurobarometer: 
Food Safety in the EU(link is external), 2024 Eurobarometer: Attitudes of Europeans towards the environment(link 
is external)A 2023 Ipsos survey confirmed the strong concerns EU citizens hold about the impacts of pesticides on 
their health and the environment: IPSOS Citizens Poll on Pesticides(link is external) The final report of the Conference 
for  the  Future  of  Europe(link  is  external)  included  the  need  for  high  environmental  ambition  in  food  production 
systems, and to drastically reduce pesticide use (2022). 

67 Organisation for Economic Co-operation and Development (OECD).  Guidance document for single laboratory 
validation  of  quantitative  analytical  methods  -  guidance  used  in  support  of  pre-  and  post-  registration  data 
requirements for plant protection products and biocidal products. ENV/JM/MONO(2014)20.  

33 

 
 
 
accumulation  poses  a  significant  threat  to  ecosystems,  endangering  biodiversity,  agricultural 
production and food security. Endocrine disruptors, similarly, interfere with the hormonal systems 
of living organisms, causing detrimental effects not only to individual species, including migratory 
species,  but  also  to  entire  ecosystems  across  national  boundaries.  Therefore,  these  substances 
create environmental concerns of a global nature that have a connection with the territory of the 
Union. Where an appropriate evaluation by the European Food Safety Authority (EFSA) of the 
hazardous properties of the substance under Regulation (EC) No 1107/2009 is not available, the 
Commission may ask EFSA for an evaluation under Article 43 of Regulation (EC) No 396/2005. 

In addition, the proposal replaces the term “import tolerance”, which is often misunderstood, with 
"MRL based on a Good Agricultural Practice implemented in a third country”. 

The changes proposed will increase clarity for stakeholders and authorities in the MRL setting 
process.  They  will  also  slightly  reduce  human  resource  needs  in  EFSA  and  Member  States’ 
authorities as lengthy unnecessary assessments will be avoided. 

Alignment of “limit of determination” with “limit of quantification” 

There is a terminological inconsistency between Regulation (EC) No 396/2005 and international 
laboratory  standards.67  The  Regulation  refers  to  the  “limit  of  determination  (LOD)”  as  the 
threshold for quantifying residues. In analytical practice, however, the correct term is the “limit of 
quantification (LOQ)”, meaning the lowest residue concentration that can be reliably measured 
and  reported  using  validated  control  methods.  The  confusion  arises  because  “LOD”  is  widely 
understood in laboratory science as “limit of detection”, which is a different and lower threshold. 
Using “LOD” in the Regulation therefore creates ambiguity and has led to misinterpretation by 
laboratories  and  food  business  operators,  undermining  legal  clarity  and  consistency  with 
international standards. 

This omnibus amends the relevant provisions in Regulation (EC) No 396/2005 to harmonise the 
terminology to conform to the internationally recognised term "limit of quantification (LOQ)". 

By aligning  the Regulation  with  international  terminology,  the amendment  removes  ambiguity 
and ensures clarity for laboratories and food business operators. This improves legal certainty and 
facilitates compliance, without altering consumer protection standards or the functioning of the 
internal market. The change is purely terminological and therefore does not generate any costs for 
operators  or  authorities  while  generating  savings  from  avoided  problems  due  to  different 
interpretations of the current terminology. 

3.2.4.  GMM fermentation 

The use of fermentation processes to manufacture products is of growing importance in the food 
and feed sector and in the wider bioeconomy. Genetically modified micro-organisms (GMMs), 
such as genetically modified bacteria and yeasts, are commonly used in fermentation processes to 

67 Organisation for Economic Co-operation and Development (OECD).  Guidance document for single laboratory 
validation  of  quantitative  analytical  methods  -  guidance  used  in  support  of  pre-  and  post-  registration  data 
requirements for plant protection products and biocidal products. ENV/JM/MONO(2014)20.  
Codex Alimentarius. Guidelines on performance criteria for methods of analysis for the determination of pesticide 
residues in food and feed. CAC/GL 90-2017. 

34 

 
 
 
 
produce enzymes, amino acids, vitamins and other compounds used in food and feed production. 
Around 80 companies globally are active in this field, of which 32 based in Europe. Over 400 such 
fermentation products have been authorised in the last thirty years under sectoral EU legislation 
on  food  additives68,  feed  additives69  or  novel  foods70,  all  of  which  require  a  pre-market  safety 
assessment and authorisation.   

Where viable GMMs are present in the final product, the product constitutes genetically modified 
food or feed under Regulation (EC) No 1829/2003 and is subject to that Regulation.71 However, 
for many fermentation products, the GMM is only used as a production strain and removed before 
the  product  is  placed  on  the  market.  Such  products  may  contain  residues  of  the  production 
organism, as it is not always technically feasible to eliminate all traces. The GM food and feed 
regulation  does  not  apply  to  food  and  feed  produced  ‘with’  a  GMO,  such  as  food  and  feed 
manufactured  with  the  help  of  a  genetically  modified  processing  aid.  However,  uncertainties 
remain as to whether the presence of residues of the genetically modified production strain render 
the food or feed ‘produced from a GMO’ and subject to the Regulation. This creates significant 
legal uncertainty for food and feed business operators and enforcement authorities in the Member 
States.  

This lack of clarity has in some cases led to the withdrawal of fermentation products from the 
market  on  grounds  of  alleged  non-compliance  with  Regulation  (EC)  No  1829/2003.  Such 
withdrawals generate economic losses for producers and downstream food and feed operators, and 
unnecessary expenditure for competent authorities. Over the last five years, 18 alerts have been 
issued through the Rapid Alert System for Food & Feed (RASFF) portal. The total value of a recall 
depends on the quantities on the market of the affected product and of food and feed in which this 
product  was  used  that  need  to  be  recalled.  For  instance,  the  cost  of  internal  testing  and 
investigation during a recent recall was calculated by the operator concerned at 20k EUR, and 
legal and regulatory fees increased the cost by a further 50 k EUR . 

In addition, indirect costs range from reputational damage, disruption of business relationships, 
and loss of client trust, all impossible to quantify. For start-ups and SMEs, a single recall can be 
business-ending.  Finally,  recalls  entail  administrative  burden  through  delays  in  shipment 
clearance,  back-and-forth  enquiries  between  business  operators  and  competent  authorities,  and 
temporary  blocking  of  consignments,  all  of  which  add  further  costs  to  operators.   Competent 
authorities also face costs when recalls are triggered, such as inspection, administrative follow-
up, and legal procedures. 

In such situation, operators may pursue GMO authorisations under Regulation (EC) No 1829/2003 
to shield themselves from enforcement risks. The cost of a full GMO authorisation is documented 
for plants, with an average cost of EUR 13 million.72 Industry considers that a GMO authorisation 
would deter innovation, especially considering the cost for authorisation under another framework 
(e.g. for feed additives product  approval  estimated at  basic costs without  target  animal studies 
approx. 100.000 EUR ). In addition, it considers a GMO authorisation, with an associated timeline 

68 Regulation (EC) No 1333/2008 on food additives 
69 Regulation (EC) No 1831/2003 on additives for use in animal nutrition 
70 Regulation (EU) 2015/2283 on novel foods 
71 Regulation (EC) No 1829/2003 on genetically modified food and feed 
72  Study  to  support  the  impact  assessment  of  legislation  for  plants  produced  by  certain  new  genomic  techniques, 
https://op.europa.eu/en/publication-detail/-/publication/f00cd313-1ae1-11ee-806b-01aa75ed71a1/language-en 

35 

 
 
 
of over 5 years, too long in a highly competitive commodity business and rapidly adapting market 
compared to approximately 2 years for a feed additive authorisation. 

Both the European fermentation industry and various Member States have repeatedly called for 
legal clarification, particularly in view of recent advances in analytical testing that allow to detect 
now even minimal DNA residues. Without it, legal uncertainty and inconsistent enforcement are 
likely to persist and intensify as the sector expands and detection methods become more sensitive. 
Consequently, the EU in most cases is no longer the first-choice market for innovations in this 
field by start-ups and global companies, and investments are directed outside of the EU. 

To address the situation, this omnibus would clarify Regulation (EC) No 1829/2003 by specifying 
that fermentation products obtained using GMMs only as production strain are not food and feed 
“produced from GMOs”73, provided there is no presence in those products of those GMMs and 
that  any  residues  thereof  are  limited  to  non-viable  cells,  are  minimized  through  reasonable 
attempts  to  remove  them  in  accordance  with  good  manufacturing  practice  and  have  no 
technological effect on the food or the feed. 

This clarification does not affect the need for a pre-market safety assessment and authorisation of 
the products concerned and only concerns the determination of the legal framework under which 
the safety assessment and authorisation must be obtained. Products such as feed additives, food 
additives, food enzymes and novel foods would continue to be assessed under their respective EU 
rules  before  they  can  be  placed  on  the  market.  Likewise,  genetically  modified  food  and  feed 
products  that  do  contain  viable  GMMs  would  remain  fully  covered  by  Regulation  (EC)  No 
1829/2003 and would continue to require pre-market authorisation and safety assessment under 
the GMO legislation.   

The amendment will maintain the high level of protection for human, animal and environmental 
health established in EU food and feed law. Its purpose is not to weaken safety requirements but 
to provide clarity where the current rules are applied in different ways. Several Member States 
and  industry  stakeholders  support  clarifying  that  fermentation  products  containing  no  viable 
GMMs  are  not  covered  by  Regulation  (EC)  No  1829/2003,  while  NGOs  argue  that  all  such 
products should undergo full GMO risk assessment and labelling. 

Overall, this amendment is expected to accelerate the entry of valuable fermentation products onto 
the EU market. This will particularly benefit SMEs and innovative biotech companies developing 
new  enzymes,  vitamins,  amino  acids  and  other  fermentation  products,  helping  them  to  bring 
innovations  to  market  with  greater  certainty.  In  turn,  the  clarification  will  strengthen  the 
competitiveness of the EU bioeconomy in a rapidly expanding global market. 

3.2.5.  Feed additives 

The  2024  evaluation  of  the  Feed  Additives  (FA)  Regulation  (Regulation  (EC)  No  1831/2003) 
confirmed  that  the  legislation  continues  to  meet  its  core  objectives:  ensuring  a  high  level  of 
protection of human and animal health and the environment, safeguarding users’ interests, and 

73 Building on recital (16) of Regulation (EC) No 1829/2003 and the Commission Report on the implementation of 
Regulation (EC) No 1829/2003 of 25 October 2006 (COM(2006) 626 final), a clarification would be included in 
Regulation (EC) No 1829/2003 excluding from the definition of ‘produced from GMOs’ food and feed fermentation 
products obtained with GMMs under certain conditions. 

36 

 
 
 
supporting the functioning of the internal market.74 At the same time, the evaluation identified 
several  provisions  whose  implementation  creates  some  complexity  or  administrative  burden, 
without  corresponding  safety  benefits.  These  issues  primarily  affect  feed  business  operators, 
especially SMEs, but also the Member States, EFSA and the Commission, who are required to 
process  and  handle  applications  for  authorisation  of  feed  additives.  Three  main  areas  for 
simplification or clarification emerged from the evaluation and subsequent stakeholder feedback: 

•  Renewal of authorisations: the systematic 10-year renewal obligation is seen as too resource-

intensive for both operators and authorities. 

•  Modification of existing authorisations: some of the current procedures are too burdensome, 
for example when changing an authorisation-holder, or could be improved in terms of clarity 
and coherence. 

•  Labelling requirements: the current obligation for physical labels on additives and premixtures 
does not reflect the potential of digital tools for non-safety information and is not fully coherent 
with the labelling rules for feed materials and compound feed. 

The amendments proposed in this omnibus target these specific provisions to simplify procedures, 
reduce administrative or regulatory burden and costs, and improve legal clarity. As they do not 
alter the fundamental objectives of the Regulation, businesses and many public authorities support 
removing renewals and streamlining authorisation processes to reduce administrative burden and 
improve  competitiveness,  while  emphasising  that  high  safety  standards  must  be  maintained. 
Safeguards such as the possibility to modify, suspend or revoke authorisations at any time remain 
in place, and are even strengthened, to ensure  that these standards are not compromised. 

Renewal of authorisations 

Under the FA Regulation, feed additives are authorised for a period of ten years, and a renewal 
dossier must be submitted  to  request  a  subsequent ten-year authorisation. The 2024 evaluation 
concluded that this requirement generates high administrative and financial costs for businesses, 
EFSA and national authorities.75 Renewal procedures absorb resources that could otherwise be 
directed towards the development and assessment of novel additives or towards focusing on the 
assessment  of  higher-risk  categories,  e.g.  coccidiostats  and  histomonostats.  While  renewals  of 
authorisation are granted after confirmation of safety, they are rarely based on substantive changes 
in  the  assessment,  meaning  the  considerable  costs  involved  are  not  justified  by  corresponding 
health benefits. A screening made of the about 120 feed additives, other than coccidiostats and 
histomonostats,  whose  authorisation  has  been  renewed  until  October  2025,  showed  that  safety 
issues were identified in that context only once, leading to a restriction of use of the authorised 
additive. Based on that finding, imposing  a requirement of systematic 10-year renewal process 
appears to be disproportionately burdensome, taking account of the significant administrative and 
financial costs incurred by that requirement. 

For  feed  business  operators,  the  requirement  creates  significant  recurring  costs  and  lengthy 
procedures,  which  weigh  heavily  on  SMEs  and  may  discourage  market  participation.  Smaller 
firms may forgo maintaining authorisations or delay bringing new products to market, leading to 

74 SWD(2024) 46 final. 
75 SWD(2024) 46 final, pp. 30-31, 35-39, 43-44, 50, 58 and 60-61.  

37 

 
 
 
 
greater concentration of approvals among larger operators. For EFSA, Member State authorities 
and the Commission, the constant flow of renewal dossiers ties up scientific and administrative 
capacity, even where no new evidence is available, reducing their ability to focus on genuinely 
novel  products  or  emerging  risks.  At  a  systemic  level,  the  EU  feed  sector  considers  that  this 
framework  undermines  its  competitiveness  compared  with  countries  such  as  Japan,  Argentina, 
China or, more recently, the United Kingdom, where authorisations are not time-limited or subject 
to lighter, risk-based renewal requirements76. Unless addressed, the current regime will continue 
to drain resources, create unnecessary delays, and reduce the availability of innovative additives 
in the EU market. 

Stakeholder  input  consistently  reinforces  these  findings.  The  public  consultation  and  targeted 
survey conducted in support of the evaluation, and the feedback received in the context of the Call 
for Evidence, revealed that businesses perceive the 10-year renewal as overly burdensome. In their 
view, this process undermines competitiveness by eroding return on investment and delaying the 
market  entry  of  innovative,  otherwise  safe  additives.  Several  national  authorities  also 
acknowledged  the  need  to  improve  efficiency  of  the  authorisation  system  by  reducing 
administrative costs, to encourage innovation by reviewing the 10-year authorisation period, and 
admitted the potential for simplification. Several public authorities who provided feedback in the 
context  of  the  Call  for  Evidence  showed  support  for  a  removal  of  the  burdensome  renewal 
obligation, favouring a more flexible risk-based approach. 

The joint letter of 28 March 202477, co-signed by six major feed chain associations (FEFANA, 
FEFAC,  FEDIAF,  COPA-COGECA,  FEAP  and  AnimalhealthEurope),  warned  that  resource-
intensive renewals risk depriving EU farmers and feed producers, particularly SMEs, of innovative 
solutions. It called for a shift towards a risk-based approach, allowing reassessment only when 
justified by new safety data. Subsequent exchanges, including a FEFANA event in June 202478￼ 
with broad participation from industry, academia, Member States and the Commission, confirmed 
consensus on the need to modernise the Regulation. Follow-up letters and bilateral meetings in 
2024–2025 reiterated that systematic renewals are considered as disproportionate, may result in 
discontinuation  of  market  availability  and  should  be  replaced  by  continuous  monitoring  with 
targeted  reassessments,  when  necessary,  in  line  with  the  regime  in  force  under  other  sectorial 
legislation, such as food additives. 

This view has also been echoed at political level. Certain Members of the European Parliament79 
have raised the issue in questions and bilateral contacts, requesting the Commission to propose a 
revision of the FA Regulation as soon as possible in order to remove regulatory burden, allowing 
to foster technical and scientific innovation and to ensure a more balanced and fairer competitive 
environment between operators acting in the EU and in third countries.   

76 SWD(2024) 46 final, pp. 33 and 266-267 and subsequent stakeholder feedback referred to in this section of the 
Staff Working Document. 
77 Letter of 28 March 2024 addressed to Executive Vice-President Maroš Šefčovič (Ares(2024)2404843). 
78 FEFANA Event ‘The role of specialty feed ingredients for sustainable feed and food production and the need for 
modernisation of Regulation (EC) No 1831/2003 on additives for use in animal nutrition’, Copenhagen, 20 June 2024. 
79 Letter of 6 March 2023 from the Chair of the Committee on Agriculture and Rural Development of the European 
Parliament, MEP Norbert Lins, addressed to Commissioner Stella Kyriakides (ref. Ares(2023)1608370). Letter of 11 
March 2025 from MEP Markus Ferber, addressed to Commissioner Olivér Várhelyi (ref. Ares(2025)2168177). 

38 

 
 
 
This proposal would remove the requirement for the systematic 10-year renewal of authorisations 
for all feed additives, except for coccidiostats and histomonostats. This category of additives is 
maintained under time-limited authorisations given the antimicrobial nature and higher risk profile 
of  those  products.  For  all  other  additives,  authorisations  would  remain  valid  without  renewal, 
unless evidence emerges that calls their safety or efficacy into question, which would trigger a 
review of the authorisation concerned in accordance with the provisions of Article 13 of the FA 
Regulation which allows to modify, suspend or revoke authorisations at any time, based on a new 
EFSA  evaluation  performed  either  on  its  initiative  or  on  request  from  the  Commission  or  a 
Member State. 

The policy objective pursued by the FA Regulation to ensure a high safety level of protection will 
be preserved, considering in particular: 

- 

- 

including 

implementation  of  post-market  monitoring 

the  general  supervision  obligation  and  monitoring  requirements  on  authorisation-
holders, 
in 
authorisations granted before the proposed new rules,  
the EFSA’s possible scientific reassessment of authorisations on its own initiative or 
on Member States’ or Commission’s request or upon submission of applications for 
modification of authorisations or for the authorisation of new uses of authorised feed 
additives, under Article 13 of the FA Regulation.  

required 

In view of a scientific reassessment of existing authorisations, the EFSA’s powers should include 
the possibility of requesting information and data to applicants and authorisation-holders and the 
accomplishment of any relevant tasks provided by Regulation (EC) No 178/2002 of the European 
Parliament and of the Council80, such as data collection, commissioning of scientific studies and 
use of information identified from monitoring of emerging risks. 

Alternative measures to the option of authorisations unlimited in time, such as longer authorisation 
periods for some or all feed additives or different authorisation periods according to the type of 
additives,  were  not  considered  as  satisfactory.  There  would  be  a  lack  of  objective  criteria  to 
differentiate between additive categories or functional groups in terms of safety or efficacy. There 
could also be a risk of absence of applicants for the renewal of non-holder specific authorisations, 
where, after a very long authorisation period, the initial applicant might no longer exist, and other 
interested  parties  would  not  be  aware  of  a  lack  of  timely  preparation  of  an  application  for 
authorisation renewal. That situation could possibly create a discontinuation of market availability 
in the EU as regards certain feed additives with non-holder specific authorisation, but considered 
as essential for animal health, such as vitamins, trace elements or amino acids.  

The measure would directly benefit feed business operators, especially SMEs, by removing the 
need to prepare costly renewal dossiers. It would also relieve EFSA, the Commission, the EURL 
for Feed Additives (EURL-FA) and national authorities of the resource-intensive tasks associated 
with renewals. Indirectly, farmers and the feed sector will benefit from more predictable access to 
innovative  additives,  while  the  EU  economy  gains  in  competitiveness  and  investment 
attractiveness. 

80 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and requirements of food law, establishing the European Food Safety Authority and laying down 
procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj. 

39 

 
 
 
Currently, preparing a renewal application entails substantial costs for feed additive businesses. 
These  costs  mainly  relate  to  generating  the  required  data  (mostly  safety  studies  for  renewal 
dossiers),  staff  time  for  dossier  preparation,  and,  since  2021,  compliance  with  additional 
transparency  obligations  under  Regulation  (EU)  2019/1381  (Transparency  Regulation).  On 
average,  the  direct  cost  per  renewal  application  was  estimated  at  EUR  216,000  in  2019  and 
increased to EUR 294,433 in 2024, including an additional 14% in costs and ~33.5 extra staff days 
due to more stringent transparency requirements81. These costs apply broadly across the industry, 
with  little  difference  between  SMEs  and  larger  companies.  For  smaller  firms,  however,  the 
financial  weight  of  renewal  dossiers  represents  a  proportionally  greater  barrier  to  market 
participation. 

Based on projected renewal volumes between 2025 and 2034, assuming 751 applications in total, 
applicants would face cumulative costs exceeding EUR 220 million in renewal-related expenses. 
Removing the periodic renewal  obligation would  thus  produce an average cost  saving  of  EUR 
22.1 million annually.82 The amendment would also reduce uncertainty linked to pending renewal 
decisions, freeing resources that companies could reallocate to research, product development and 
market expansion, and strengthen the competitiveness of operators who carry out their activities 
in the EU compared with those established and active in third countries who often benefit from 
lighter or non-time limited authorisation regimes in force in those countries. Overall, abolishing 
these systematic renewals is expected to provide strong benefits for SMEs especially, as they are 
disproportionately affected by the recurring financial and administrative burden. 

The removal of the renewal obligation would also deliver significant savings for public authorities 
involved  in  the  authorisation  process.  Based  on  projected  renewal  volumes  between  2025  and 
2034, the cumulative cost of renewals for EU institutions and Member States would reach more 
than  EUR  5  million  annually,  which  could  be  redirected  to  higher-value  activities  such  as  the 
assessment  of  new  feed  additives  or  emerging  risks  83.  Beyond  direct  budgetary  savings,  the 
measure  would  enhance  efficiency  and  prioritisation  within  EFSA  and  national  competent 
authorities, allowing scarce scientific expertise to be focused where it adds most value. It would 
also reduce the administrative burden associated with processing applications, and issues handled 
within the SCoPAFF meetings. 

Modification of existing authorisations 

The FA Regulation sets out procedures for modifying existing authorisations after the adoption of 
an  EFSA  opinion,  either  on  the  initiative  of  EFSA,  on  request  of  a  Member  State  or  of  the 
Commission, or through the submission of an application by an authorisation-holder. In practice, 
some of these procedures are disproportionately heavy or could be improved in terms of clarity 
and coherence. In particular: 

81 Survey carried out in March 2024 by FEFANA among its members on the impact of the Transparency Regulation 
on the costs and processes faced when submitting applications for authorisation. 
82 For detailed calculations, view section 3 of Annex III on methodology. 
83 Average costs per renewal dossier, when adjusted to 2024 values, are estimated at €16,022 for the Commission, 
€4,424 for the EURL-FA, €36,079 for EFSA, and €16,958 for Member States. These figures reflect staff time, expert 
costs,  and  administrative  resources  devoted  to  processing  renewals,  including  the  additional  transparency  tasks 
introduced since 2021. 

40 

 
 
 
-  Any change of the holder of an authorisation requires the adoption of a specific regulation. 
This creates unnecessary administrative burden and inefficient allocation of resources for 
all entities involved in the handling of these requests.  

-  There  is  no  specific  procedure  for  requesting  a  modification  of  non-holder  specific 
authorisations. Operators wishing to introduce changes are therefore, in principle, required 
to submit a new comprehensive application dossier, which generates unnecessary costs. In 
practice, this gap has led companies to submit requests to the Commission, which has in 
some cases consulted EFSA on whether the existing authorisation continued to meet the 
safety and efficacy conditions after modification. This ad hoc approach has created some 
inconsistency and legal uncertainty. 

The  2024  evaluation  highlighted  the  burdensome  or  complex  nature  of  the  above-mentioned 
modification  procedures.  The  processes  of  changing  authorisation-holder  and  modifying  non-
holder  specific  authorisations  were  identified  as  particular  areas  for  potential  clarification  and 
simplification84. These findings were echoed by stakeholders: in the consultations underpinning 
the  evaluation,  a  majority  of  business  respondents  viewed  these  procedures  as  excessive  and 
creating uncertainty. Industry associations such as FEFANA and FEFAC have since reiterated the 
need  to  remove  legal  uncertainties  and  non-safety  related  burdens  which  prevent  business 
operators, in particular SMEs, to keep-up with regulatory and administrative demands85. Likewise, 
several national competent authorities noted that the administrative burden linked to modification 
requests can be reduced and called for simplification. 

The proposal introduces a clear and simplified procedure for modifying existing authorisations for 
these recurrent cases: 

•  Change  of  authorisation-holder:  this  change  would  require  a  mere  administrative 
notification, with an update to the Register of feed additives, without the need to adopt a 
dedicated regulation. 

•  Modification  of  non-holder  specific  authorisations:  operators  seeking  to  modify  some 
terms  of  such  authorisations,  by  expanding  use  conditions,  would  no  longer  need  to 
resubmit  full  applications  for  a  new  authorisation  or  use  an  ‘indirect’  procedure  via  a 
request  to  the  Commission,  who  might  in  turn  possibly  consult  EFSA  on  a  proposed 
modification. Instead, they will be able to submit a targeted modification request limited 
to the relevant data supporting the change.  

These reforms deliver both administrative and financial savings. Removing the obligation to adopt 
a regulation for holder changes is estimated to avoid around EUR 320,440 in Commission staff 
costs  over  2025–2034,  with  modest  additional  savings  for  Member  States  86.  While  limited 
financial impact on the costs incurred by industry, it will lighten administrative burden. 

84 SWD(2024) 46 final, pp. 30, 58-59, 235. 
85 Concerns expressed in particular in an e-mail of 4 December 2024 from FEFANA  addressed to the  Cabinet of 
Commissioner  Olivér  Várhelyi,  referring  to  the  joint  letter  of  28  March  2024  co-signed  by  six  major  feed  chain 
associations (ref. Ares(2024)8662776). 
86 Based on the 13 such regulations adopted between 2015 and 2024, with average processing costs of €16,022 per 
application (2024 prices) for the Commission, there is an assumption for 20 holder changes in 2025 - 2034. 

41 

 
 
 
The proposed simplification and clarification of the modification procedures will be all the more 
necessary since, in the absence of a renewal obligation, these procedures will be more likely to be 
used.  In  particular,  the  proposed  clarification  on  the  modification  of  non-holder  specific 
authorisations would enable smaller companies to adapt products and respond more flexibly to 
market opportunities, while preserving the high level of safety oversight for the modifications. 

Beyond  these  gains,  the  simplifications  bring  greater  legal  certainty,  speed  and  predictability, 
particularly during mergers, acquisitions or product portfolio adjustments. For public authorities, 
the  reform  reduces  the  time  and  resources  spent  on  low-value  administrative  work,  allowing 
expertise to be redirected to the assessment of genuinely novel products and emerging risks. These 
simplifications do not compromise policy objectives and do not weaken existing safeguards: any 
modification with potential safety implications will continue to undergo a full scientific evaluation 
by EFSA, thereby maintaining the high level of protection for human health, animal health, and 
the environment. 

Digital labelling of non-safety related information 

The  2024  evaluation  of  the  FA  Regulation  found  that  the  labelling  provisions  are  generally 
effective in ensuring that safety information is available along the feed chain. However, it also 
concluded that greater coherence with the labelling rules for feed materials and compound feed 
under Regulation (EC) No 767/2009 would improve the system by allowing more flexibility, in 
particular through digital labelling87. The current obligation to display extensive information on 
the physical label, even when not safety-related, places a disproportionate burden on operators. 
SMEs are especially affected, as smaller batch sizes and less flexible stock management make 
them more vulnerable to packaging and labelling costs. 

Stakeholders  strongly  echoed  these  findings:  in  the  public  consultation  and  targeted  surveys 
underpinning  the  evaluation,  most  industry  representatives  stressed  that  current  provisions  are 
outdated and should be modernised to make them more practical, facilitating the information flow 
along the feed chain. In their joint letter of 28 March 2024, FEFANA, FEFAC, FEDIAF, COPA-
COGECA, FEAP and AnimalhealthEurope also called for an urgent revision, describing the rules 
as excessively costly and not aligned with digital tools already used elsewhere. They highlighted 
three  priorities:  permitting  digital 
information,  simplifying 
communication through  internationally recognised pictograms,  and developing a voluntary EU 
Code of Good Labelling Practice to harmonise implementation and set rules for claims. Industry 
also urged that scientifically substantiated claims on secondary benefits of feed additives should 
be allowed, as in several non-EU jurisdictions. Member State authorities were more divided: many 
consider  current  costs  justified  to  ensure  safety,  while  others  acknowledged  that  non-safety 
information could be handled more efficiently. 

for  non-safety 

labelling 

The  proposal  introduces  greater  flexibility  in  the  labelling  provisions  of  Regulation  (EC)  No 
1831/2003, aligning them more closely with the framework for feed materials and compound feed 
under Regulation (EC) No 767/2009, in the sense that labelling by other means than a physical 
label will be allowed under certain conditions. In particular, the amendments would: 

•  allow the use of digital labelling for certain non-safety related information, under clear 

conditions ensuring accessibility and reliability; 

87 SWD(2024)46 final, pp. 44-45, 59. 

42 

 
 
 
•  maintain  the  obligation  to  display  all  essential  safety  and  use  information  on  the 

physical label, so that users have immediate access; 

•  empower  the  Commission  to  adopt  further  rules  to  enhance  and  facilitate  digital 

labelling. 

The amendments  preserve the core  policy  objective of ensuring safe use  of feed additives. All 
safety-critical and essential-use information remains mandatory on the physical label. At the same 
time, operators will gain new flexibility to provide non-safety related information digitally. This 
change  will  reduce  the  cost  of  frequent  label  updates  and  enable  clearer,  more  user-friendly 
communication along the feed chain. 

In  addition,  the  proposal  clarifies  the  identification  of  the  feed  business  operators  who  are 
responsible  for  the  labelling  of  feed  additives  and  premixtures  of  feed  additives,  to  bring 
consistency with the general provisions of Regulation (EC) No 767/2009 regarding the labelling 
of feed. 

The amendments are expected to deliver efficiency gains across the sector, with the greatest impact 
for producers of premixtures and SMEs active in  several  Member States. The 2024 evaluation 
estimated that annual labelling costs for premixture producers range from  EUR 80,000 to EUR 
223,000 per plant, covering translation, design, printing and label management.88 While physical 
labels will still be required for safety information and a QR code, digital labelling will reduce the 
amount of text that must be printed and translated. Stakeholders highlight that the main benefits 
will stem from stock management, particularly for production aimed at the EU market  (unified 
stock system) and shorter multilingual labels, thereby simplifying logistics.  

Beyond direct cost reductions, the reform will generate operational efficiencies. Real-time updates 
will lower compliance risks and increase supply chain flexibility, and shorter labels will improve 
readability.  Digital  channels  will  also  make  it  possible  to  provide  more  detailed  product 
information  than  can  be  displayed  on  a  physical  label,  under  the  conditions  defined  in  the 
Regulation. 

Because  production  models,  labelling  practices  and  stock  management  strategies  differ  widely 
across operators, a single EU-wide estimate of savings is not feasible. Nevertheless, the measure 
will enhance coherence with the rules for feed materials and compound feed, as well as with other 
EU legislation such as fertilising products, where digital labelling is already foreseen. It will also 
contribute 
to  broader  EU  policy  objectives  on  digitalisation,  burden  reduction  and 
competitiveness.   

3.2.6.  Overlap in notification of national hygiene measures 

Member States must notify draft national hygiene measures under two different legal frameworks 
depending on the type of measures: the Hygiene Regulations (Regulations (EC) Nos 852/2004 
and  853/2004)  and  Directive  (EU)  2015/1535  (TRIS  database).  This  creates  overlapping 
notifications and uncertainty about which procedure applies in each case. Competent authorities 
in Member States, as well as the Commission, end up applying the wrong procedure or providing 
duplicative notifications. Around 50 draft national hygiene measures are notified per year under 

88 SWD(2024)46 final, p. 36. 

43 

 
 
 
the Hygiene Regulations, with each notification inducing staff costs equivalent to roughly three 
weeks of a full-time post in both the notifying Member State and the Commission. Feedback from 
Member States  indicates that distinguishing which parts of national  measures fall under which 
procedure is not always straightforward. In addition, Regulation (EU) 2017/625 has replaced the 
specific notification procedure laid down in Regulation (EC) No 854/2004 on official controls of 
products  of  animal  origin  by  the  procedure  provided  for  in  Directive  (EU)  2015/1535.  The 
proposed amendment will therefore lead to more coherent rules. 

The proposal amends the Hygiene Regulations to require that national measures be notified only 
under  Directive  (EU)  2015/1535.  This  aligns  hygiene  notifications  with  the  existing  general 
notification procedure. As a result, Member States will only use a single, harmonised procedure; 
the  Commission  will  receive  notifications  through  one  channel;  and  all  stakeholders  will  have 
access to them via the TRIS database. The general notification procedure ensures transparency, 
provides translation  into all EU languages, and allows for peer scrutiny by all Member States. 
Streamlining  the  system  reduces  administrative  burden  without  reducing  the  substantive 
safeguards in place. 

Member State authorities and the Commission will benefit most directly from reduced duplication 
or misuse. Based on ~50 notifications per year, simplification could reduce notifications by 25–
50%, leading to savings of several FTE for both MS and the Commission. Overall, Member States 
generally  welcome  simplifying  these  notification  procedures,  seeing  it  as  a  proportionate 
improvement that supports transparency and subsidiarity. 

3.3.  Reducing unnecessary complexity in risk management 

3.3.1.  Depopulation reporting 

The objective of Regulation (EC) No 1099/2009 is to protect animals at the time of killing. The 
Regulation  also  requires  Member  States  to  submit  a  specific  annual  report  on  depopulation 
operations.89  In  addition,  Member  States  provide  annual  compliance  reports  under  the  Official 
Controls  Regulation  (OCR),  which  also  cover  animal  welfare  during  killing,  including  during 
depopulation  activities.  These  compliance  reports  are  sufficient  to  ensure  that  the  objective  of 
Regulation (EC) No 1099/2009 is met. 

In practice, the added reporting has proven of limited value. Several Member States do not submit 
depopulation reports at all, and where they are submitted the information is often incomplete, lacks 
analysis  and  is  difficult  to  compare  across  countries.90  In  their  replies  to  a  Commission 
questionnaire  in  April  2025,  nine  Member  States  shared  their  views  and  experiences;  three 
explicitly  highlighted  problems  with  the  current  system,  including  inconsistent  definitions, 
incoherent reporting practices, and duplication with the OCR. Maintaining a separate reporting 
form  on the DG SANTE Data Collection Platform also  requires time and resources from both 

89 Article 18(4) 
90  For  2024,  only  six  Member  States  provided  the  Commission  with  the  required  information  regarding  their 
depopulation activities through the intended DG SANTE data collected platform (compared to nine Member States 
in 2022 and 2023). An additional six Member States included similar information about depopulation activities in 
their 2024 annual reports under the Official Controls Regulation. 

44 

 
 
 
Member States and the Commission, without delivering meaningful additional benefits for risk 
management. 

To address this duplication, this proposal removes the obligation in Article 18(4) of Regulation 
(EC)  No  1099/2009  for  Member  States  to  submit  a  separate  annual  report  on  depopulation 
operations.  Information  on  compliance  with  animal  welfare  requirements  during  depopulation 
activities  will  instead  continue  to  be  reported  through  the  existing  OCR  annual  reports.  This 
streamlining ensures that relevant data remain available while consolidating reporting into a single 
framework that is more consistent and better suited to comparative analysis. 

Removing the depopulation reporting obligation will reduce unnecessary administrative work for 
Member State authorities and free up resources for more targeted enforcement activities. It will 
also  eliminate  the  need  for  the  Commission  to  maintain  and  support  a  separate  reporting  tool, 
bringing efficiency gains on both sides. By consolidating reporting within the OCR framework, 
the information available will be more coherent and comparable, while safeguards for monitoring 
animal welfare at the time of killing remain fully in place. Overall, Member States appear to favour 
simplifying and integrating depopulation reporting into existing official-controls reporting, citing 
double reporting and inconsistent definitions as current problems. 

3.3.2.  Record-keeping for livestock farmers 

Directive  98/58/EC  requires  farmers  to  keep  records  of  medicinal  treatments  and  animal 
mortalities.91 Yet these obligations are covered in greater detail under Regulation (EU) 2019/6 on 
veterinary  medicinal  products92  and  Regulation  (EU)  2016/429  on  animal  health93.  The 
coexistence of parallel requirements leads to duplication for farmers and complicates compliance 
checks for national authorities. 

While  the  potential  for  further  simplification  for  farmers  in  general  will  be  considered  in  the 
process of modernising EU animal welfare legislation under the Vision for Agriculture and Food, 
this  proposal  already  deletes  the  overlapping  provisions  from  Directive  98/58/EC.94  This  will 
consolidate record-keeping obligations under sectoral legislation, simplify compliance for farmers 
and ensure a clearer legal basis for enforcement. National authorities and the Commission will 
benefit from a more streamlined and coherent framework, while safeguards for animal health and 
welfare remain in place. 

3.3.3.  Updating BSE rules 

Regulation (EC) No 999/2001 on transmissible spongiform encephalopathies (TSEs) is outdated 
and disproportionate to the current level of risk. It is no longer aligned with the latest scientific 
advice or with the international standards of the World Organisation for Animal Health (WOAH). 
Adopted  at  the  height  of  the  bovine  spongiform  encephalopathy  (BSE)  epidemic,  when  strict 
precautionary  measures  were  justified,  the  framework  has  not  adapted  to  the  evolving 
epidemiological situation. Surveillance obligations, the list of specified risk materials (SRM) and 

91 points 5 and 6 of the Annex to Directive 98/58/EC 
92 Article 108 of Regulation (EU) 2019/6 
93 Articles 102(1)(d) and 186(1)(d) of Regulation (EU) 2016/429 
94 https://agriculture.ec.europa.eu/overview-vision-agriculture-food/vision-agriculture-and-food_en 

45 

 
 
 
 
trade restrictions on certain commodities remain in place, even though they are now excessive and 
scientifically unjustified. 
The problem has become more acute since the adoption of the revised WOAH Chapter on BSE95 
in 2023 and EFSA’s opinion confirming negligible risks from gelatine and collagen derived from 
bovine bones96. These inconsistencies have been repeatedly flagged by stakeholders and Member 
States in formal fora such as the PAFF Committee, the Chief Veterinary Officers’ meeting, the 
Animal Health Advisory Committee and the EU TSE Working Group. The ongoing evaluation of 
the  Animal  Health  Law  (AHL)  also  finds  that  excluding  TSEs  from  its  categorisation  process 
creates confusion, hinders prioritisation and leads to inefficient allocation of resources. Industry- 
and  most  authorities  support  alignment  with  updated  WOAH  standards  and  clearer,  risk-
proportionate  rules,  while  a  minority  warn  that  simplification  must  not  dilute  strict  BSE/TSE 
protections. 

This  situation  imposes  heavy  and  disproportionate  burdens  on  both  operators  and  competent 
authorities. For operators, the mandatory removal and destruction of materials that no longer pose 
a  risk  generates  substantial  regulatory  and  financial  costs.  Safe  material  is  treated  as  waste, 
preventing  its  reuse  in  higher-value  applications  and  running  counter  to  the  objectives  of  the 
circular economy. For competent authorities, large amounts of financial and human resources are 
tied up in monitoring and enforcement tasks that no longer reflect the actual level of risk. This 
diverts  attention  away  from  higher-priority  animal  health  challenges  where  surveillance  and 
enforcement would be more effective. 

At EU level, partial misalignment with WOAH standards creates challenges for the EU operators 
in  global markets.  Unless  the framework is  revised, outdated provisions  will continue to  drive 
disproportionate  measures,  misallocate  resources  and  generate  inconsistencies,  with  millions 
being  spent  each year on controls  that no longer add value. Against this  background, Member 
States and industry both call for a science-based revision. They strongly  support a modernised 
framework  that  simplifies  surveillance,  rationalises  SRM  disposal  and  removes  outdated  and 
unjustified trade restrictions, while safeguarding human and animal health.  

The revision of Regulation (EC) No 999/2001 will modernise the provisions on BSE surveillance, 
the list of SRM, and trade restrictions on gelatine and collagen from ruminant bones.97 Instead of 
prescribing  rigid  technical  requirements  in  the  basic  act,  the  framework  will  be  streamlined  to 
allow these provisions to be updated more flexibly in line with new EFSA assessments and WOAH 
standards,  using  the  regulatory  procedures  provided  under  Article  24.  This  will  keep  the  TSE 
framework scientifically robust and internationally consistent, while maintaining a high level of 
protection  of  human  and  animal  health,  reducing  disproportionate  burdens,  strengthening  EU 
credibility,  and  allowing  resources  to  be  redirected  towards  higher-risk  priorities  in  line  with 
proportionality and the circular economy. 

95  World  Organisation  for  Animal  Health  (WOAH),  Terrestrial  Animal  Health  Code,  Chapter  11.4  Codes  and 
Manuals - WOAH - World Organisation for Animal Health 
96 EEFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2020. Scientific opinion on the potential BSE risk 
posed by the use of ruminant collagen and gelatine in feed for non-ruminant farmed animals. EFSA Journal, 18(10), 
e06267 
97  Specifically,  amendments  will  concern  Article  6,  Article  8  and  Article  16,  together  with  consequential 
adjustments to other provisions to ensure coherence and consistency across the Regulation, as well as timely updates 
within the annexes. 

46 

 
 
 
The proposed amendments will deliver significant benefits across the food chain and for public 
authorities. Food business operators, including around 10,000 slaughterhouses and cutting plants 
across the EU, as well as many SMEs in the food and by-product processing sector, will benefit 
from  lower  disposal  costs  through  a  revised  SRM  list,  fewer  regulatory  obligations  and  wider 
opportunities  for  trade.  Each  year,  around  490,000  tonnes  of  bovine  material  are  treated  as 
Category  1,  including  SRM  from  slaughtered  cattle  and  from  fallen  stock.  With  the  proposed 
revision, a substantial share could be reclassified and channelled into renewable fuels, biogas and 
other higher value uses instead of being destroyed at high cost. More than 3.7 million livestock 
farmers  and  EU  exporters  will  gain  from  clearer,  risk-based  rules  for  BSE  control,  which 
strengthen the EU’s credibility on international markets and support smoother market access. For 
competent  authorities, streamlined surveillance requirements and simplified SRM controls  will 
reduce workload and free up resources for higher-risk animal health priorities. At EU level, the 
Commission  will  benefit  from  a  clearer  and  more  proportionate  legal  framework  for  disease 
control, ensuring consistency across Member States. 

Alignment  of  BSE  surveillance  requirements  with  WOAH  standards  is  expected  to  save   
approximately EUR 8.5 million annually for national authorities, with an additional EUR 3 million 
in indirect savings from reduced sampling, transport and laboratory workload.9899 Operators will 
also benefit from lower on-farm sampling and logistics requirements, faster slaughter line speed, 
and reduced costs linked to  cold  storage  carcasses until  test  results are available, though  these 
savings vary between Member States and are more difficult to quantify. At EU level, EUR 1.55 
million will be saved under the co-financed TSE activities of the Single Market Programme or 
future equivalents. 

Updating the SRM list to reflect negligible BSE risk status could reduce about 445,000 tonnes per 
year of material that would no longer require to be treated as Category 1 and could be reclassified. 
This would generate EUR 132 million per year in disposal cost savings, with. around EUR 92 
million  benefiting  operators  and  EUR  40  million  benefiting  administrations  through  reduced 
supervision and enforcement.100   

Beyond cost savings, the revision will modernise the legal framework, making it more responsive 
to new scientific advice and international standards. It will reduce waste by enabling safe materials 
to be reclassified and processed under more economical rules, promote the recovery of materials 
for higher value uses that support the circular economy, and strengthen the EU’s credibility in 
international  fora.  Crucially,  these  benefits  will  be  achieved  while  maintaining  a  high  level  of 
protection for human and animal health. 

98 For detailed calculations, view section 4 of the Annex III on methodology. 
99  Calculations  are  based  on  EFSA’s  TSE  Surveillance  Report  (2023)  and  Commission  unit  cost  rates.  For 
surveillance, the assumption of a 65% reduction corresponds to alignment with WOAH risk-based testing standards, 
applied to 922,841 annual tests at €12.83/test. Indirect savings include reduced sampling, transport and laboratory 
workload, and operational efficiencies for operators such as shorter carcass holding times and faster slaughterline, 
depending on national arrangements.  
100  The  assumption  of  a  40%  reduction  reflects  partial  alignment  with  WOAH  Chapter  11.4.  This  involves 
reclassifying 196,000 tonnes per year of material consisting of SRM from healthy bovines slaughtered in Member 
States with negligible BSE risk and ~80% of fallen stock to be reclassified from Category 1 to another Category. This 
would  result  in  disposal  savings  and  avoid  the  incineration  costs  of  ~€275/tonne,  through  increased  recovery  of 
renewable  materials. The 40% alignment scenario reflects a  plausible level of regulatory adjustment based on the 
expected outcome of ongoing scientific assessments, while maintaining certain precautionary elements of the current 
framework. 

47 

 
 
 
3.3.4.  Flexibility in official controls 

Targeted amendments to Regulation (EU) 2017/625 are proposed in two areas. First, to create a 
legal basis for partial  clearance of consignments of plants and plant products at border control 
posts  (BCPs).  Second,  to  introduce  limited  derogations  from  accreditation  requirements  for 
reference laboratories. 

Both changes are intended to reduce procedural burden for operators and competent authorities. 
In the case of BCPs, the current rules do not permit release of compliant parts of consignments 
when other parts are still under examination, creating delays and costs for perishable goods. In the 
case of laboratories, the current requirements to accredit all methods, for all possible contaminants, 
pests and matrices impose very high costs on those laboratories, as noted repeatedly by Member 
States and the Joint Research Centre of the European Commission (JRC). The amendments will 
not  alter  the  objectives  of  the  OCR.101  They  will  provide  flexibility  in  implementation  while 
maintaining high standards of official controls. 

Partial clearance of consignments of plants and plant products 

Compliant parts of a consignment may not be released when other parts still require checks. In the 
particular case of phytosanitary certificates which cover very diverse lots, all products are held 
until all controls are completed. This affects importers of perishable goods, who face delays and 
potential spoilage on the one hand;  and competent  authorities  who need  legal  provisions  more 
tailored to the complexity of official controls. In certain instances, the data registered in TRACES 
system show that the delay in obtaining laboratory results may exceed one month, a timeframe 
that is more than sufficient to render perishable goods unsalvageable. 

The issue results  from  Art. 50(3) of the OCR, which means that  a single decision  is taken  per 
consignment.  Importers  and  MS  authorities  have  repeatedly  raised  the  lack  of  flexibility, 
particularly  during  meetings  of  the  Plant  Health  section  of  the  Standing  Committee  on  Plants, 
Animals, Food and Feed, and of the Working Party of Chief Plant Health Officers (COPHs) at the 
Council. 

A  targeted  amendment  would  allow  for  partial  clearance  of  consignments  of  plants  and  plant 
products at BCPs. This would enable competent authorities to issue clearance decisions for the 
compliant lots of a consignment, while retaining the non-compliant or pending-decision lots for 
further  checks.  The  change  would  not  affect  the  level  of  phytosanitary  protection,  as  non-
compliant lots would continue to be retained or rejected. Rather, it would make the implementation 
of OCR more proportionate and efficient for competent authorities, where BCP would gain from 
simplified procedures.  

The  proposed  amendment  would  also  bring  significant  benefits  for  operators.  Importers  of 
perishable products would avoid losses linked to the unnecessary detention of compliant goods. 
For  example,  in  2023,  the  competent  authorities  of  the  Netherlands  reported  that  2  965 
consignments  of  perishable  goods  were  subject  to  laboratory  sampling,  of  which  1  198  were 

101 Amendments are limited to Articles 50(3), 93 and 100 of Regulation (EU) 2017/625. 

48 

 
 
 
 
sampled only for parts of consignments. In 1 073 of these cases the consignments were ultimately 
compliant but were nevertheless detained until all checks were finalised. Extrapolating the Dutch 
data102 to the EU as a whole suggests that around 4 160 consignments are unnecessarily delayed 
each year. With imports of fruit and vegetables valued at EUR 27.8 billion in 2023103, the average 
value per consignment is approximately EUR 35 070. This implies potential avoidable losses of 
around EUR 146 million  annually for fruit and vegetables  alone. Considering other perishable 
products such as cut flowers, the total value of avoided losses may exceed EUR 150 million per 
year. Updated data from 2024 confirm that import values in these categories continue to increase, 
suggesting even higher potential savings.104 

In addition to the quantified savings, the amendment would ease administrative pressure on border 
authorities  and  make  procedures  more  predictable  for  operators.  By  reducing  unnecessary 
detentions, it would also limit food waste and strengthen confidence in the functioning of border 
controls.  Operators  and  Member  States  strongly  support  allowing  partial  clearance  of 
consignments to reduce spoilage and delays, provided implementation is harmonised and control 
procedures  remain  robust. Overall, the measure  would align implementation  of the OCR more 
closely  with  its  objectives:  ensuring  a  high  level  of  phytosanitary  protection  while  keeping 
procedures efficient. 

Accreditation of laboratories 

The  requirement  for  laboratories  to  obtain  accreditation  for  the  methods  they  use  has  created 
significant  challenges,  particularly  in  plant  health,  food  contact  materials  (FCM)  and  feed 
additives  (FA).105  Laboratories  are  expected  to  seek  accreditation  for  a  very  large  number  of 
contaminants, pests, matrices  and methods, including those for which reference material is not 
available  or  which  are  only  rarely  applied.106  This  obligation  affects  in  particular  all  relevant 
European  Union  reference  laboratories  (EURLs)  and  the  196  national  reference  laboratories 
(NRLs), including technical units within those laboratories, operating across Member States.  

Compliance  requires  extensive  preparation,  repeated  audits,  and  ongoing  administrative  work, 
drawing heavily on limited human resources. Laboratory experts are diverted from diagnostic and 
surveillance tasks to manage accreditation procedures. As a result, il is very difficult for reference 
laboratories to meet the requirements. This problem has been repeatedly flagged by Member States 
and by EURLs, such as the those for food contact materials and feed additives hosted by the JRC, 
who  underline  that  the  current  framework  does  not  sufficiently  take  into  account    operational 
realities.107 

102 Collected from European Commission: Directorate-General for Health and Food Safety, TRACES – 2023 annual 
report, Publications Office of the European Union, 2024, https://data.europa.eu/doi/10.2875/231566 
103 DG AGRI, chapter 6,7,8 in table ‘Evolution of Agri-food imports from Extra EU27, 2020 – 2024, page 8 
104 For detailed calculations, view section 5,1 of Annex III on methodology. 
105 Articles 93 and 100 of Regulation (EU) 2017/625 
106 The total accreditation burden depends on several parameters: the number of pests covered (more than 500 Union 
quarantine pests, of which 20 are designated as priority pests), the number of sample types (“matrices”) for which 
tests must be validated (e.g. leaves, roots, soil), and the number of recognised diagnostic methods per pest. 
107 For example, during several meetings of the Plant Health section of the Standing Committee on Plants, Animals, 
Food and Feed, and COPHs meetings, and EURL Directors meeting in October 2022 

49 

 
 
 
This  proposal  amends  Regulation  (EU)  2017/625  to  allow  targeted  derogations  from  the 
requirement of mandatory accreditation for all the methods reference laboratories use. It is also 
proposed to allow derogations from the requirements to operate and be accredited in accordance 
with standard  EN ISO/IEC 17025. While accreditation will remain in place for priority pests, feed 
additives,  food  contact  materials  and  routinely  used  methods,  where  it  is  both  feasible  and 
proportionate, this change avoids laboratories devoting substantial resources to procedures that 
cannot realistically be fulfilled and resolves the current structural non-compliance. 

This  amendment  will  generate  substantial  cost  savings.  COFRAC  (Comité  Français 
d’accréditation) data shows that accreditation of a single technical unit of an NRL for two methods 
costs around EUR 68 000 over five years.108 Applied to the 142 technical units covered by the 27 
plant  health  NRLs,  while  assuming  accreditation  of  an  initial  batch  of  50  quarantine  pests 
prioritised per unit, among more than 500 quarantine pests, and considering a minimum of three 
different plant matrices, this results in a potential burden of around EUR 290 million annually.109 

In  the  plant  health  area,  the  amendment  would  avoid  that  all  142  technical  units  should  be 
accredited for numerous pests, but only for one pest per main group of pests (bacteria, insects, 
fungi, nematodes or viruses) and per method. If a technical unit is accredited for one method for 
one  bacterium,  the  amendment  grants  accreditation  with  the  same  method  for  all  bacteria. 
Considering the cost for one of pest, 2 methods and three matrices, the estimated cost for the 142 
technical units would amount to EUR 5.8 million annually. This corresponds to a cost saving of 
EUR 478million annually. 

For feed additives and food contact materials, data of the Belgian Accreditation Body (BELAC) 
indicate that accrediting a laboratory for two methods over five years costs around EUR 35,500, 
equivalent to EUR 3,550 per method per year. Applied to 54 NRLs and two EURLs, and assuming 
600 methods per laboratory, this translates into an annual fee burden of about EUR 119 million. 
Accreditation also entails staff costs. Preparing documentation and undergoing audits requires 2 
to 4 person-months per method, equivalent to EUR 12,000–56,000 over five years. Using a mid-
point of EUR 6,800 per method per year, the EU-wide staff burden amounts to roughly EUR 19 
million  annually.  The  combined  baseline  cost  of compliance  for  FA  and  FCM  accreditation  is 
therefore close to EUR 138 million per year. 

Applying  the  same  family-based  logic  as  in  plant  health,  laboratories  would  need  to  maintain 
accreditation for about five representative method families, rather than 600 individual methods. 
This reduces the accredited scope to around 10% of the baseline, leaving a residual cost of about 
EUR 13.8 million per year and generating savings of approximately EUR 124 million annually. 

In addition to the quantified savings, the amendment delivers legal certainty for laboratories and 
competent  authorities  through  clearer,  more  proportionate  requirements.  Many  stakeholders, 
including  Member  State  laboratories,  support  more  flexibility  on  accreditation  for  certain 
methods, seeing current requirements as disproportionate, while stressing that the general quality-
assurance  framework  should  remain  intact.  Staff  resources  can  be  redirected  from  lengthy 

108 Comité Français d’accréditation represents the French Committee for accreditation and is the reference body in 
France for accreditation, unit cost based on data for a medium-size laboratory with one technical section. Costs include 
instruction fees, evaluation fees, audit logistics, extension fees and annual licence fees over a 5-year accreditation 
cycle. 
109 For detailed calculations, view section 5,2 of Annex III on methodology. 

50 

 
 
 
accreditation  exercises  to  core  diagnostic  and  surveillance  work,  strengthening  the  Union’s 
preparedness for plant health and food safety challenges. 

4.  CONCLUSION 

This Staff Working Document consolidates the analysis underpinning the food and feed safety 
simplification  omnibus.  The  omnibus  provides  for  a  focused  set  of  adjustments  to  streamline 
procedures and clarify rules, while maintaining a high level of protection for human, animal and 
environmental  health.  Intervention  is  limited  to  areas  where  recurrent  administrative  costs  and 
avoidable delays are most pronounced, notably systematic renewals, without altering core safety 
standards. In other words, these “quick fixes” do not affect the underlying safety objectives: all 
review, withdrawal and risk-management powers remain fully available to act on new scientific 
evidence and implementation experience. 

The  expected  effects  are  reduced  administrative  workload  for  economic  operators,  faster  and 
simpler decision making by competent authorities, official controls with fewer bottlenecks, and 
greater  legal  certainty  through  the  removal  of  grey  zones  and  duplications.  Administrative 
capacity  can  be  reallocated  to  higher-risk  files  and  to  the  assessment  of  new  science  and 
innovations. Overall, safeguards remain intact across the sectoral legislation and key definitions 
are  clarified  to  support  consistent  implementation.  Science-based  risk  assessment  continues  to 
anchor decision-making. 

The  implementation  of  the  proposed  measures  will  take  place  in  two  phases  reflecting  their 
technical  complexity  and  the  adaptation  time  needed  by  administrations  and  operators.  Most 
measures,  covering  biocontrol  PPP,  biocides,  feed  additives,  etc.  will  start  producing  tangible 
benefits already from 2027 onwards. By contrast, the simplification of the wider PPP framework, 
which entails  structural  changes to  renewal  and  authorisation  procedures, will require a longer 
transition period. 

For businesses, these measures are estimated to deliver overall annual cost savings of EUR 335 
million from 2027, rising to EUR 428 million annually from 2029 once the PPP simplification 
becomes operational. In this mandate, these twelve simplification measures will therefore amount 
to at least EUR 1 billion between 2027 and 2029, and a further EUR 2.1 billion of cost savings for 
business are expected in the following mandate. 

For national and EU administrations, the gains are equally significant. The simplification measures 
are expected to reduce administrative costs by about EUR 661 million per year, reflecting freed 
capacity  in  national  competent  authorities,  EFSA  and  the  Commission.  This  corresponds  to  a 
cumulative reduction of around EUR 3.3 billion in administrative costs between 2027 and 2034. 

Following adoption, practical implementation support will be provided where useful, for example 
through  harmonised  guidance.  Stakeholder  input  on  future  simplification  opportunities  will 
continue notably via the European Board on Agriculture on Food, the usual feedback channels 
and structured exchanges with the European Commission and competent authorities. Insights from 
implementation and monitoring will be part of the regular stress-testing exercise and inform any 
subsequent proposals. 

51 

 
 
 
52 

 
 
 
ANNEX I: SUMMARY OF COST-SAVINGS 

Measure 

Businesses (EUR/year) 

SMEs (EUR/year) 

National & EU 
administrations (EUR/year) 

Type of cost 
saving 

Aerial spraying 
of PPP 

PPP 
simplification, 
including 
biocontrol 

Moderate savings from more 
efficient PPP application, i.e. 
reduced labour needs, easier 
access in difficult terrain, 
lower fuel & logistics costs, 
and potential lower PPP use 
through more precise 
application. Scale depends on 
MS uptake. 

22 million due to provisional 
authorisations of biocontrol 
PPP: reduced dossier 
preparation and consultancy 
needs 

6.5 million for unlimited 
approval of biocontrol active 
substances: avoided renewals, 
avoided data-generation cycles 

49.6 million for unlimited 
approval of most active 
substances: removal of 
systematic renewal costs, 

Small–moderate gains where 
labour / access constraints bind 

Small efficiency gains in 
permitting and regulatory 
oversight. 

Recurrent 
adjustment cost 
savings. 

Substantial benefit, especially 
in regard to biocontrol PPP, 
but no robust EU-wide split 
feasible. 

Small–moderate admin time 
saving 

Recurrent 
administrative 
cost savings. 

 
 
including studies, fees and 
expert support 

14.8 million for amended 
provisions on data protection: 
reduced preparation of 
supporting studies and lower 
cost of navigating data-sharing 
obligations 

71.5 million in recurrent 
administrative savings from 
the elimination of routine 
renewal dossiers, reduced need 
for new studies, lower 
consultancy expenditure and 
lower fees. 

Small to moderate savings 
from fewer MRL adjustment 
requests and avoided write-
offs respectively. 

Avoids costly misclassification 
and recalls, but event-driven, 
so large cost savings when 
incidents avoided. 

Biocides 

MRLs 

GMM 
fermentation 

High relative gain for SME 
formulators. 

Small–moderate admin saving. 

Small–moderate savings for 
SME traders. 

Minor case-handling 
efficiency. 

Event-driven protection for 
SME innovators. 

Minor enforcement/admin 
saving. 

Recurrent 
administrative 
cost savings. 

Recurrent 
administrative + 
adjustment cost 
savings. 

One-off 
adjustment cost 
savings. 

54 

 
 
Feed additives 

22.1 million through removal 
of renewal obligations, 
streamlined modification 
procedures and reduced 
dossier and consultancy costs. 

Moderate recurring saving for 
SME producers/formulators; 

5.5 million 

National hygiene 
measures 

Minor recurring saving from 
reduced duplications. 

Minor saving, esp. micro-
FBOs. 

Minor reduction in duplicate 
processing 

Depopulation 
reporting 

Neutral–small positive (fewer 
ad-hoc data calls) 

Neutral–small positive. 

Small admin saving 
(streamlined reporting) 

Record-keeping 
for farmers 

Small–moderate time saving 
per holding 

Small–moderate relative gain 
for small farms 

Small admin saving 
(streamlined reporting) 

BSE realignment 

92 million due with fewer 
steps and documentation in 
addition to lower frequency of 
checks. 

Small–moderate share for 
SME slaughterhouses / 
renderers, proportional to 
throughput. 

53.1 million 

Recurrent 
administrative 
cost savings. 

Recurrent 
administrative 
cost savings. 

Recurrent 
administrative 
cost savings. 

Recurrent 
administrative 
cost savings. 

Recurrent 
administrative 
cost savings 

55 

 
 
Flexibility in 
official controls 

150 million for clearance of 
partial consignments due to 
savings from reduced spoilage 
and demurrage costs, faster 
turnover of perishable goods, 
and fewer re-routing or 
disposal costs at border control 
posts. 

Moderate–high positive for 
partial consignments due to 
spoilage reduction. 

602.2 million for accreditation 
of NRL with fewer methods to 
accredit and less time and 
external cost for being widely 
accredited. 

Recurrent 
adjustment cost 
savings.  

Total annual 
savings 

At least 428 million in cost 
savings per year. Large, 
recurring savings from 
scrapping routine renewals. 
Additional streamlining is not 
monetised, so the true total is 
substantially higher than the 
quantified subtotal. 

Highly positive impact, 
especially in biocontrol and for 
smaller formulators/importers, 
via fewer renewal rounds, 
faster time-to-market, and 
better cash-flow from reduced 
border delays. 

At least  661 million per 
year. Major structural 
efficiencies from risk-based 
renewals, proportionate 
accreditation and risk-aligned 
surveillance, plus smaller 
gains from simplified 
notifications and reporting. 
The underlying savings are 
clearly higher than the 
quantified estimate. 

56 

 
 
 
 
ANNEX II: SYNOPSIS OF STAKEHOLDER CONSULTATION 

1.  Consultation approach 

The Commission conducted a proportionate and targeted stakeholder consultation to inform 
the calibration of the proposed measures. Evidence was drawn from regular discussions with 
Member States authorities and stakeholders, recent evaluations and implementation reviews, 
in  particular  the  pesticides  legislation  evaluation  and  the  evaluation  of  the  Feed  Additives 
Regulation.110  This  was  complemented  by  a  targeted  Implementation  Dialogue  on  biocides 
with  stakeholders  representing  businesses  (active  substance  manufacturers,  product 
formulators  and  downstream  users)  and  civil  society.  No  open  public  consultation  was 
conducted  because  the  initiative  does  not  aim  to  alter  the  objectives  of  the  legislation  and 
addresses  technical  adjustments  aimed  at  efficiency  gains  within  the  existing  framework. 
Instead, evidence was gathered primarily via a Call for Evidence targeted at directly affected 
stakeholders,  open  from  16  September  to  14  October  2025,  and  complemented  by  ad  hoc 
consultations with competent authorities and stakeholder organisations. 

The Commission received a total of 6,440 responses to the Call for Evidence on the Food and 
Feed Safety Simplification Omnibus. These submissions reflected a broad spectrum of views 
from citizens, businesses, NGOs, public authorities, and academic institutions. Nearly 6,000 
submissions came from citizens, largely as part of organised campaigns. Among institutional 
stakeholders, 318 replies were submitted by business  associations, 52 by  public authorities, 
107  by  NGOs,  and  16  by  academic  organisations.  In  addition,  319  detailed  position  papers 
were  shared,  providing  in-depth  feedback  on  specific  legislative  areas  and  simplification 
measures. 

The sections below present stakeholder views from the Call for Evidence primarily, by topic, 
indicating where positions converge or differ and noting any concrete operational suggestions. 
Overall, input has been used to refine the problem definition, prioritise certain options, and 
shape safeguards. 

2.  Stakeholder views by topic 

2.1. Plant Protection Products 

Biocontrol 

Making new active substances and PPP alternatives available is fundamental to fill gaps left 
by products no longer authorised, and to provide a larger variety of substances with different 
modes  of  action  to  mitigate  the  occurrence  of  resistances.  Farmers  want  to  use  safe  and 
effective products and therefore ensuring the availability of biocontrol active substances and 
PPPs plays an important role.  

Member States have also called for the urgent need to safeguard the tools needed for farmers, 
including  access  to  chemical  PPPs,  as  evidenced  in  the  Agriculture  and  Fisheries  Council 
meetings in June and July of 2025. Member States have also repeatedly indicated, either via 

110 SWD(2020) 87 final and SWD(2024) 46 final 

57 

 
 
 
the Call for Evidence, in bilateral meetings, or through working groups of Chief Plant Health 
Officers,  the  need  to  ensure  availability  of  plant  protection  products  for  the  purposes  of 
implementing Regulation 2016/2031.   

Industry stakeholders, including farmers, highlighted the importance of facilitating access to 
market  of  biocontrol  active  substances  and  products  but  underlined  that  it  would  be  too 
simplistic to consider biological active substances as “1 to 1 replacement” for banned chemical 
active substances. A more holistic approach would need to be taken into consideration in this 
transition to ensure farmers have affordable and effective tools to fight pests. Citizens often 
referred to the European Citizens Initiatives ‘Stop Glyphosate’ and ‘Save Bees and Farmers’ 
to ensure that the Omnibus Initiative does not lead to any regression in the protection of health, 
biodiversity,  and  the  environment  but  promotes  biopesticides  and  other  low-risk  plant 
protection products. 

According to stakeholders, some plant pests affecting certain crops would need a more urgent 
biological solution available as the synthetic chemical active substances used to combat such 
pest are either no longer approved (with no current alternative), or at risk to be withdrawn from 
the  market,  or  approved  under  too  stringent  conditions  (e.g.,  low  MRL  making  their 
effectiveness critical), or not offering a substantial differentiation of modes of actions. This is 
particularly  true  for  (but  not  limited  to)  herbicides/weed  control  substances  as  the  group  of 
biocontrol  active  for  this  function  has  not  been  developed  by  applicants;  this  is  more  valid 
across  several  types  of  crops  (cereals,  cotton,  fruits  and  vegetables,  oilseeds,  rice)  for  
insecticides (cereals, fruits and vegetables, hops, olive groves, potatoes, seeds, sugar beet), and 
fungicides  (fruits  and  vegetables,  hops,  olive  groves,  ornamentals,  potatoes,  rice,  seeds, 
tobacco). While no crop has been entirely abandoned solely due to a lack of active ingredients, 
the  steady  withdrawal  of  active  substances  and  PPPs  has  led  many  growers  to  gradually 
discontinue  certain  crops,  posing  them  at  abandonment  risks  in  certain  areas.  Stakeholders 
highlighted  that  in  view  of  those  data,  there  would  be  an  urgent  need  for  new  biocontrol 
solutions. However, according to stakeholders, exerting control of some diseases, e.g. against 
fungi and weeds, by employing solely biological substances remains unfeasible with the current 
available  technology.  Industry  stakeholders  recognise  the  value  of  biological  PPPs  when 
combined with conventional PPPs, especially for finishing treatments when pest pressure is 
low and to help reducing residues at harvest. This suggests that the need for having more rapid 
biocontrol  PPPs  available  on  the  market  must  be  combined  with  increased  research  and 
innovation to allow new technologies gaining more efficacy and trust from farmers.  

Basic substances 

In the Call of Evidence, many competent authorities suggested to clarify and harmonise rules 
on basic substances. Already during previous ad hoc consultations of Member States and via 
specific reactions of industry stakeholders on basic substances several aspects were identified 
as  in  need  of  clarifications.  The  previous  feedback  revealed  that  there  are  insufficient 
provisions  for  the  labelling  of  products  containing  basic  substances  and  inconsistencies 
between  the  conditions  of  approvals  set  at  the  EU-level  with  the  market  reality.  Several 
Member States also reported problems related to the cross-border trade of basic substances-
containing products and the limited use of products containing basic substances in agriculture 
because the formulation and packaging is not suitable for professional uses. In addition, the co-
existence on the EU market of products containing the same substance as active substance and 

58 

 
 
as  basic  substance  is  perceived  as  generating  distorted  pricing  for  the  same  compound  and 
limitations of use for certain sectors. 

Furthermore, in the Call of Evidence, growers call on the European Commission to ensure that 
substances once approved as basic substances are available to farmers in all Member States 
and that the basic substance status cannot be superseded by an approval  as “regular” active 
substance. Industry is also concerned with this issue and asks for clarification of existing rules 
so that market distortion and legal uncertainty is avoided. 

Finally, growers also indicate a need to streamline the approval procedures for well-known low 
concern substances, such as basic substances. 

Active substances 

Growers,  farmers  and  Member  States  are  very  concerned  about  the  reduced  number  of 
approved active substances and the lack of viable alternatives to pest control. Some highlight 
the importance of ensuring a range of solutions  and not relying on biocontrol only. Delays, 
complexity in and costs emanating from the existing regulatory system, alongside the overall 
difficulty  in  placing  plant  protection  products  on  the  market  are  a  significant  concern  of 
companies  affected.  As  highlighted  in  the  evaluation  of  Regulation  (EC)  No  1107/2009, 
feedback  to  this  Call  for  Evidence  reiterated  that  delays  occur  across  all  work  streams, 
including active substances and PPPs. The periodic renewal of all active substances and PPPs 
appears to be a substantial contributor, as it requires vast amounts of resources. Such delays 
slow down the access to market access for innovative PPPs and lead to a lack of predictability 
for industry and farmers. Businesses ask for transparent criteria to select substances into a full 
renewal  procedure,  for  published  timelines/service  standards  for  initiating  and  concluding 
targeted reviews, and for clear escalation pathways if new risks emerge. A minority cautions 
against  any  weakening  of  scrutiny  and  seeks  explicit  commitments  on  post-authorisation 
vigilance  and  communication  that  protection  levels  are  unchanged.  Many  respondents  also 
point to the increasing number of active substances no longer approved while very few new 
alternative  active  substances  are  being  approved.  This  might  increase  the  risk  of  resistance 
development and has led to more requests for emergency authorisations under Article 53 of 
Regulation (EC) No 1107/2009. Several respondents would like to see the principle of no non-
approval without the availability of an alternative enshrined in the legislation. Growers, but 
also industry, ask further for strengthening of the use of Article 4(7), the possibility to approve 
under  conditions  of  negligible  exposure,  the  use  of  precise  application  techniques,  stronger 
support for minor uses and for risk-based decision making. 

NGOs  call  on  the  European  Commission  to  ensure  that  the  simplification  of  food  and  feed 
safety legislation does not weaken environmental or health protection and that the high level 
of  protection  enshrined  in  primary  EU  law  is  maintained,  as  well  as  ensuring  existing 
safeguards  in  the  regulation  on  pesticides  are  not  weakened.  This  is  also  echoed  by  water 
suppliers pointing towards pesticides as a major pressure on the status of water bodies in the 
EU. NGOs further consider that derogations should remain strictly justified, time-limited, and 
backed by independent scientific evidence. Specific concerns about impacts of use of pesticides 
on biodiversity were raised by several NGOs and citizens with some respondents calling for a 
strengthening  of  the  pesticide  regulation  instead  of  a  simplification  and  for  a  reduction  in 

59 

 
 
pesticide  use.  One  NGO  considers  there  is  a  need  to  include  measures  to  phase  out  animal 
testing.  

Researchers  and  academics  expressed  mixed  views,  some  criticising  the  existing  system  as 
being outdated and obstructive and hindering innovation whereas others expressed the need to 
ensure existing protection and safeguards are maintained.  

Feedback from citizens mostly points towards concerns about use of pesticides for health and 
the environment and call for no weakening of regulations and even for a phase out of pesticides.  

One Member State expressed concerns about ensuring up-to-date risk assessment if approvals 
are  no  longer  systematically  renewed  and  fears  slower  authorisation  processes  and  de-
harmonisation if Member States would have to reinterpret the available data on the basis of 
newer assessment guidelines without a previous EU level assessment. Overall, contributions 
from  Member  States  and  industry  stakeholders  show  support  for  reducing  unnecessary 
renewal-driven burden, but stress that any change to the current system, including a move away 
from  systematic,  time-based  renewals,  must  be  accompanied  by  clear  criteria  for  targeted 
reviews and safeguards to maintain the existing high level of protection. 

Authorisations 

Industry  stakeholders  and  farmers  expressed  concern  about  the  lack  of  harmonisation  of 
authorisation  procedures  in  Member  States.  As  a  result,  they  called  for  harmonisation  and 
simplification of authorisation processes, which should in turn speed up the issuance of new 
and renewal of existing PPP authorisations. However, as indicated by consumer associations, 
environmental NGOs, and public health NGOs, simplification must not come at the expense of 
human and environmental safety. 

Comments on mutual recognition and the minor uses extensions were essentially in the same 
direction. All relevant stakeholders considered that the potential of a simplified pathway for 
these two specific types of authorisations has not been realised at Member State level, leading 
to delays, higher costs and lower availability of plant protection products. This, in turn, has a 
negative impact on the response time to threats emerging ever faster due to climate change. 
They also pointed to the role of independent scientific evaluation of plant protection products 
and the role of agroecological practices in reducing pesticide dependency. 

Mutual recognition 

Industry  and  farming  stakeholders  provided  information  on  the  numbers  of  applications 
submitted per year, delays of Member States  in  assessing  requests, and estimated monetary 
losses of companies due to these delays. According to their association, relevant agrochemical 
producers submit 3.6 requests for mutual recognition to 4.6 Member States yearly. Average 
delays of Member States in assessing these requests are 163 and 356 days for Zonal Mutual 
recognition  and  Interzonal  Mutual  recognition  applications,  respectively.111  In  the  Call  for 
Evidence,  industry  stakeholders  primarily  expressed  a  view  that  the  mutual  recognition  of 

111 beyond the 120 days provided for by the Regulation (EC) No 1107/2009 

60 

 
 
 
product authorisations and extensions for minor uses is not functioning as intended, leading to 
unequal availability of plant protection products to farmers in different Member States. The 
availability of solutions for minor crops is also a concern for some farmers, who currently do 
not have access to the necessary PPPs to fight pests and diseases in their cultivars. 

Data protection 

Several  small  Member  States  have  already  expressed  their  concerns  linked  to  the  lack  of 
availability  of  plant  protection  products  in  their  country  due  to  small  market  size  and  the 
complex data protection rules that prevents SMEs and generic companies to enter the market. 
During  the  Call  of  evidence,  applicants  who  develop  and  market  post-patent  PPPs  also 
signalled  that  incumbent  data  protection  rules  are  too  complex,  and  the  fragmented  data 
protection scope hinders the placing on the market of PPPs. 

2.2. Aerial spraying of PPP 

Stakeholder  views  are  relatively  divergent,  with  many  responses  to  the  Call  for  Evidence 
reflecting widespread concern about environmental and health risks, particularly pesticide drift 
and  exposure.  Certain  stakeholders  still  call  for  the  retention  of  the  derogation  application 
system  while  many  businesses  support  enabling  drone  application  under  harmonised  risk-
management conditions, citing precision, drift reduction and operator safety. 

Among  most  stakeholder  categories,  there  is  cautious  support  for  drone  use  in  precision 
agriculture,  contingent  on  strict  regulatory  frameworks,  rigorous  risk  assessments,  and 
maintaining  stringent  controls.  While  innovation  and  updated  regulations  are  encouraged, 
stakeholders emphasise the need to uphold high standards for environmental and public health 
protection. There is also advocacy for reduced pesticide reliance and a transition to sustainable 
farming  practices.  Effective  enforcement,  monitoring,  and  operator  certification  are 
highlighted as essential for safe drone operations. Overall, while drones offer potential benefits, 
stakeholders call for balanced regulatory approaches that prioritize safety over administrative 
ease.  If  pursued,  stakeholders  seek  EU-wide  rules  on  pilot  competence,  buffer  zones, 
nozzle/droplet specifications, digital flight logs, and integration with farm records; critics seek 
strict area limits and sensitive-site safeguards. 

2.3. Maximum Residue Levels 

A significant number of respondents expressed their support for the proposed amendments and 
clarifications  in  terminology  related  to  pesticide  Maximum  Residue  Levels  (MRLs).  They 
emphasized  the  importance  of  implementing  clear  and  equitable  transitional  measures  to 
prevent food waste and mitigate economic losses for farmers and food business operators. As 
part of previous exchanges, stakeholders representing farmers, producers and trade association 
had for many years requested amendments to the legislative framework on MRLs to allow for 
transitional measures (examples include: International Hop Growers’ Convention, the German 
Hop Industry Association, the Hop Growers of America, The Brewers of Europe and the Hop 
Growers Union of the Czech Republic on MRLs for bifenazate in hops,112 the World Wine 

112 Ares(2024)645834 

61 

 
 
 
Trade  Group  on  MRLs  for  iprodione  in  grapes,113  several  fruits  and  vegetable  industry 
associations from Poland on MRLs for acetamiprid in currants.114 

Regarding third countries, the feedback was rather limited but revealed significant concerns 
related to the divergence between EU MRLs and international standards, abrupt changes of EU 
MRLs leading to trade disruptions, the inclusion of environmental factors in MRL setting, and 
the EU's hazard-based approach. A few third countries respondents supported establishing fair 
transitional measures. 

2.4. Biocidal Products Regulation 

When  discussing  actions  to  progress  on  the  implementation  of  the  Biocidal  Products 
Regulation  (BPR)  and  reduce  delays  in  the  review  programme  on  the  review  programme, 
Member  States  and  stakeholders  mentioned  overtime  the  need  to  give  more  priority  to 
completion  of  the  review  programme.  In  this  respect,  some  Member  States  also  asked  to 
postpone the renewal process of active substances until the review programme for first approval 
of  existing  active  substances  is  completed115.  During  the  Implementation  Dialogue  in  July 
2025, most participants acknowledged the importance of the ambitious goals set by the BPR to 
ensure a high level of safety for humans, animals and the environment, which will only be fully 
achieved with the completion of the review programme of existing active substances, and the 
fact that that the current rules have allowed to achieve a certain degree of harmonisation.   

In response to the Call for Evidence, businesses and business associations broadly welcomed 
efforts to bring some simplification to the regulatory process for access to market, actions to 
progress on the completion of the review programme of active substances and simplify renewal 
procedures.  Beyond  the  measures  proposed,  they  considered  that  new  technical  guidance 
should  not  be  applied  to  on-going  evaluations,  called  for  simplification  of  the  product 
authorisation  scheme,  asked  for  simplification  for  natural  or  food  grade  active  substances, 
ensure fair cost-sharing, and avoid any perception of reduced scrutiny for high-risk uses. A few 
operators  asked  to  focus  on  a  risk-based  approach  and  no  longer  include  a  hazard-based 
approach in the management of active substances and biocidal products and emphasised the 
need for continuity of supply for essential disinfectants and rodenticides in certain applications. 
Many businesses also asked to avoid restricting flexibility on certain procedures linked to the 
authorisation of biocidal products families or same biocidal products, asked a reduction of fees 
and/or  specific  fees  for  SMEs.  A  few  public  authorities  supported  some  simplification 
measures, asking to only have a risk-based approach and no longer a hazard-based approach, 
thus asking to maintain biocidal products that are not economically interesting and have the 
possibility  to  extend  existing  authorisations  to  minor  uses,  and  synchronise  the  evaluation 
processes of the same active substance under different regulatory frameworks to go towards a 
“One Substance One Assessment” approach. A public authority asked a modification of the 
provisions of Article 19(5) of the BPR derogations on the use by the general public of certain 
products. 

113 Ares(2019)1447179 
114 Ares (2025)3271768  
115 100th CA meeting of June 2023, agenda item 5.2, 100th meeting - Expert group for the implementation of the 
Biocidal Products Regulation - Public Health 

62 

 
 
 
In  the  other  direction,  NGOs  and  citizens  expressed  strong  concerns  about  a  potential 
deregulation  of  the  legislation  on  biocides  and  called  on  the  Commission  to  maintain  high 
standards  for  the  protection  of  human  health  and  the  environment.  In  particular,  NGOs 
considered that any modification of the BPR should be guided by the results of the evaluation 
started in 2025, and that the BPR should not be modified by these proposals in the meantime. 

On the provisions relating related to the limitation of data protection to 31 December 2025 for 
existing active substances in the review programme, as set out in Article 95(5) of the BPR, 
some industry stakeholders as well as certain Member States requested action to provide more 
protection to the concerned data. A few bilateral meetings took place at the request of different 
industry stakeholders on this topic. Directly affected operators requested an extension of data 
protection  for  all  data  generated  in  dossier  since  7  June  2018,  i.e.  the  date  of  entry  into 
application of the scientific endocrine disruptor criteria. Member States requested to extend 
data protection for substances in the Review Programme, at least those related to ED properties, 
until December 31, 2031. On the other hand, Commission services have been also contacted 
by companies who report difficulties in obtaining letters of access to protected data or in getting 
agreement from established participants to join them in the support of the substance and would 
thus benefit from a free access to data, e.g. SME associations indicating the importance to strive 
for  a  balance  between  the  interest  of  review  data  owners  and  other  actors.116  Finally,  some 
Member States referred also to potential difficulties of changing the rules on data protection at 
this  stage,  creating  legal  uncertainty  for  the  management  of  applications  of  product 
authorisation submitted as from 1st January 2026 containing data that would be again protected, 
creating  potential  conflicts  between  the  interests  of  companies  owning  concerned  data  and 
those companies who hoped to benefit from this data. 

In  response  to  the  Call  for  Evidence,  most  contributions  on  biocides  from  businesses  and 
businesses associations relate to this issue on data protection. A large number of companies 
and associations criticised the current hard stop to data protection for substances in the review 
programme, arguing it is misaligned with the extended review programme and creates free-
rider risks, distorts competition, and disincentives investment in data packages, notably costly 
ED studies.  Many explicitly supported extending or resetting protection for all data generated 
after 2018 and not solely those data submitted to determine endocrine disrupting properties as 
they argued that other updated data had to be generated due to the evolution of other technical 
documents or requirements,  but  had diverse views on what  should be the extension period: 
until the end of the review programme; a 10-year extension from 2025 (i.e. until 2035); normal 
application of Article 60 of Regulation (EU) No 528/2012 which provides for data protection 
after the approval of a substance for a period of 10 years; up to 15 years after the decision on 
the approval of the active substance; until the end of the review programme or 10 years after 
the approval of the substance, whichever is the earliest. Manufacturers warned that companies 
that invested early in compliance would lose protection before competitors have to share costs, 
undermining innovation and supply security. 

On  the  other  hand,  a  few  industry  stakeholders  would  prefer  not  to  extend  data  protection 
beyond  2025,  as  rules  have  been  clear  since  2013.  In  their  view,  extending  exclusivity  and 
complicating data-sharing may potentially slow authorisations if access negotiations stall, thus 

116 CA-Sept25-Doc.7.11 - SMEunited feedback.pptx 

63 

 
 
 
discourage innovation by prolonged market protection of a few companies. Steady delays in 
the  review  programme  already  resulted  in  considerably  longer  amortisation  of  costs,  and  a 
further  extension  of  data  protection  would  decrease  competition  and  keep  products  at  high 
level, maintaining oligopolistic-like situations. In parallel, NGOs and citizens did not appear 
to provide substantive comments on this data protection issue. 

2.5. Definition of GMM fermentation  

Several  Member  States  have  raised  the  need  to  clarify  Regulation  (EC)  No  1829/2003  as 
regards the legal status of fermentation products produced using genetically modified micro-
organisms (GMM) when they contain traces from the production GMM to ensure harmonised 
enforcement.  The  matter  has  been  discussed  in  a  dedicated  working  group  of  the  Standing 
Committee on Plants, Animals, Food and Feed since 2021. The same issue was raised by eight 
public authorities from five Member States and one EFTA country in their responses to the call 
for evidence. These respondents considered it should be clarified that  fermentation products 
are not subject to Regulation (EC) No 1829/2003 if the fermentation product itself contains no 
GMMs or no viable cells  or no high concentrations of their recombinant DNA.  

The biotech and fermentation industries were of the view that GMM fermentation products that 
do not contain viable cells should not be regulated under Regulation (EC) No 1829/2003, and 
that providing legal clarity on the status of such products would align the EU with practices in 
other jurisdictions whilst upholding EFSA oversight. They stressed the importance of a clear 
framework and consistent  implementation  to  allow them to  continue using safe, sustainable 
GMM fermentation  products  in  a secure and reliable legal  environment.  They consider that 
additional  regulatory  clarity  and  harmonised  enforcement  are  key  factors  to  increase  the 
fermentation industry’s confidence in the path to market and supporting EU competitiveness 
in a challenging global landscape for these products.  

One respondent in the call for evidence, representing organic producers, calls for a coherent 
and clear clarification between “produced with” and “produced by” in the Organic Regulation 
(EU) 2018/848. Respondents from academia considered that the presence of trace quantities of 
recombinant  DNA  is  of  no  regulatory  concern.  In  the  call  for  evidence,  most  NGOs  that 
responded considered that GMO legislation should cover all products, regardless of whether 
these are ‘produced from’ or ‘produced with’ GMOs. In their view, such products need a proper 
and mandatory risk assessment. These emphasize the importance of transparent labelling and 
traceability of such products as GM to guarantee freedom of choice to consumers. One NGO 
highlighted the importance of adequate purification techniques and documented evidence that 
fermentation products are free of viable GMMs. Citizen responses to call for evidence included 
both calls to ban GMOs and to clarify that products produced with GMMs are not GMOs. 

2.6. Feed additives 

The  proposed  amendments  to  Regulation  (EC)  No  1831/2003  builds  on  the  findings  of  the 
evaluation of Regulation (EC) No 1831/2003, which included extensive consultations on the 
effectiveness and efficiency of EU feed additives Regulation.117 The details on the consultation 

117 SWD(2024) 46 final 

64 

 
 
 
strategy,  the  methodology  and  analysis  and  the  results  of  the  consultation  activities  are 
provided in Annex V to the Commission Staff Working Document on the evaluation. 

Stakeholders of the feed additives supply chain,  including manufacturers, traders and users, 
both large companies and SMEs, actively engaged in the consultation process and, after the 
publication of the evaluation, continued to submit to the Commission further position papers 
and suggestions regarding possible amendments to Regulation (EC) No 1831/2003, involving 
other associations of the feed chain sector. 

According to representatives of the EU feed chain sector, while Regulation (EC) No 1831/2003 
has served as a cornerstone of feed safety in the EU, its implementation over time has revealed 
some inefficiencies that disproportionately impact innovation and market access, particularly 
for SMEs in the animal nutrition sector. To reduce regulatory costs and administrative burden 
as well as to improve implementation and to ensure proportionality of EU law, the Regulation 
should be modernised and simplified, in particular by streamlining procedures and timelines 
provided for therein, which would significantly benefit the competitiveness and resilience of 
the EU feed additives industry, without compromising safety or environmental standards. 

Such modernisation of the Regulation should especially include a revision of the authorisation 
system in order to better protect innovative ‘non-holder specific’ feed additives, the removal 
of the renewal  requirement  concerning authorisations, i.e. all authorisations should be valid 
without  a  time-limit,  align  with  other  legislation  such  as  food  additives,  novel  food  or 
veterinary medicinal products, and introduce the widespread use of digital labelling for ‘non-
essential information’ concerning feed additives and premixtures, including the possibility of 
voluntary labelling (claims) and the development of a EU Code of Good Labelling Practice.  

According to the evaluation, national competent authorities tend to have a more positive view 
on the implementation of the Regulation, including coherence and relevance of the objectives, 
in comparison with business stakeholders’ views. However, several of them acknowledged the 
need to improve the efficiency of the authorisation system. 

In  response  to  the  Call  for  Evidence,  almost  100  contributions  were  specifically  submitted 
regarding the proposed amendments to the feed additives Regulation. More than half originated 
from the feed business sector and their associations, who confirmed the views provided during 
the evaluation and were largely supportive of the proposed measures. However, they shared 
requests for additional measures, such as allowing the intra-EU circulation of non-authorised 
feed additives intended exclusively for export to third countries, to retain industrial production 
capacities in the EU and maintain global competitiveness of the EU feed sector. 

Ten public authorities from EEA countries also provided feedback in the context of the Call 
for Evidence, expressing support to the objectives and scope of the envisaged measures. Some 
requested  further  measures,  such  as  the  above-mentioned  status  of  non-authorised  feed 
additives  intended  for  export,  a  clarification  of  the  rules  on  claims  and  in  particular  the 
sustainability effects of additives and the controllability of labelling particulars. The United 
Kingdom  also  submitted  feedback  to  the  Call  for  Evidence,  providing  notably  elements  in 
favour of a removal of the renewal obligation for feed additives, as recently implemented in 
the country. 

65 

 
 
In general, both businesses and public authorities request a more substantial revision of the 
Regulation as a follow-up to the evaluation, while maintaining the current policy objectives of 
a high safety level, protection of users and effective functioning of the internal market in place. 
However, they call for a stronger focus on incentivising product innovation and sustainability. 

2.7. Hygiene 

Member  States  mentioned  that  the  simplification  of  procedures  for  notifying  draft  national 
measures in accordance with Regulations (EC) Nos 852/2004 and 853/2004 will be beneficial 
to  subsidiarity  and  the  adoption  of  rules  adapted  to  local  needs,  where  necessary.  This 
simplification will also contribute to more transparent and efficient procedures. 

2.8. Animal welfare 

In April 2025, Member States were asked by the Commission to provide information on their 
views, challenges and experiences related to the reporting on depopulation operations required 
by Article 18 of Regulation  (EC) No 1099/2009.  Replies were received from nine Member 
States. 

Some of these Member States described problems with the current reporting system, including 
a lack of common definitions and incoherent reporting of challenges faced when performing 
depopulation  activities,  which hampers the  comparability and usefulness of the information 
provided. In addition, several Member States complained about double reporting requirements 
and suggested that such information should rather be included in the Member States’ annual 
reports under the Official Controls Regulation, as is currently the practice in many Member 
States already. 

2.9. BSE surveillance 

Misalignment of the EU legislation with WOAH international standards, adopted in 2023, and 
the  recent  EFSA  scientific  opinion  on  BSE  risk  posed  by  ruminant  collagen  and  gelatine 
derived  from  bones,  published  in  2024,  have  been  flagged  repeatedly  by  stakeholders  and 
Member States in PAFF Committee meetings, Chief Veterinary Officers meetings, the Animal 
Health  Advisory  Committee,  and  the  EU  TSE  Working  Group.  Consultations  performed  in 
support of the ongoing evaluation of the Animal Health Law (AHL) also indicate that excluding 
TSEs  from  its  categorisation  process  creates  confusion,  hinders  prioritisation,  and  leads  to 
inefficient allocation of resources. 

Industry, operators, farmers, NGOs, and competent authorities all welcomed alignment with 
WOAH  standards,  simplification  of  procedures,  greater  legal  certainty,  and  reduced 
administrative burden while maintaining strong safeguards for animal and public health. Some 
academics, EU citizens, and a few manufacturers, shared concerns in regard to the complexity 
of existing rules and warned against diluting BSE/TSE protections, stressing the importance of 
maintaining strict surveillance, testing, and feed prohibitions. 

Beyond the scope of this omnibus, research institutions pointed to burdensome import permit 
procedures  under  the  ABP  Regulation,  while  some  stakeholders  opposed  the  intraspecies 
feeding ban for fish in Regulation 999/2001, arguing it lacks scientific justification and limits 

66 

 
 
sustainable resource use. A few respondents went further, calling for repealing the current BSE 
Regulation and integrating its essential provisions into broader animal health or food safety 
legislation. 

Overall, the consultation reflects broad support for a science-based, risk-proportionate update, 
tempered by calls to ensure that the EU framework will keep the high level of animal and public 
protection. 

2.10. 

Official Controls Regulation 

Partial clearance of consignments 

The possibility to accept the partial clearance of consignments of plant and plant products at 
border control posts (BCPs) has been requested repeatedly by food business operators and their 
associations,  who  are  concerned  about  the  lack  of  flexibility  and  the  spoilage  of  perishable 
goods.  Similarly,  Member  State  authorities  have  requested  flexibility  several  times  already 
during meetings of the Plant Health section of the PAFF committee, and of the Working Party 
of Chief Plant Health Officers.  

In the Call for Evidence, directly affected operators and their associations broadly support the 
measure. They expect a reduction of storage costs at Union entry points and fewer delays in 
perishable food supply chains, without weakening the reliability of phytosanitary controls. This 
support  is  conditional  on  uniform  implementation  and  clear,  harmonised  procedures  by  the 
competent  authorities  in  Member  States.  They  also  expect  implementing  rules  describing 
control procedures, splitting process, and the adaptation of IT platforms made available by the 
authorities (TRACES and national customs systems). In short, this measure is perceived as an 
effective measure that provides targeted efficiency while preserving the rigor of controls. 

Laboratory accreditation 

The exemption from laboratory accreditation, in certain conditions, has been repeatedly flagged 
by  Member  States  and  by  EURLs,  e.g.  those  for  food  contact  materials  and  feed  additives 
hosted  by  the  JRC,  who  underlined  that  the  current  framework  is  not  proportionate  to 
operational realities. The issue was raised, during several meetings of the Plant Health section 
of the PAFF committee, in several COPHs meetings at the Council, and also in a meeting of 
EURL Directors in October 2022.  

The  Call  for  Evidence  shows  that  a  majority  of  stakeholders  endorse  the  Commission’s 
proposal to reduce administrative burden and provide more flexibility in relation to obligatory 
accreditation requirements  for all laboratory methods in  certain  sectors. According to  many 
directly  affected  stakeholders,  it  has  proven  unrealistic  and  excessively  costly  for  reference 
laboratories to accredit all methods in certain sectors, e.g. to accredit all methods for each plant 
pest. Stakeholders indicate that the general requirement for accreditation should be maintained, 
and such flexibility should be limited in scope. Since there are already derogations for official 
laboratories  stipulated  in  Commission  Delegated  Regulation  (EU)  2021/1353,  the  same 
approach should be applied for the reference laboratories. Overall, the laboratories in question 
expect  this  modification  of  Regulation  (EU)  2017/625  to  facilitate  a  more  effective  use  of 
capacities and resources. 

67 

 
 
68 

 
 
 
ANNEX III: METHODOLOGY FOR COST SAVINGS 

This annex sets out the approach used to quantify reductions in administrative burden. The Standard 
Cost Model (SCM) was applied where feasible and proportionate, focusing on measures supported 
by  sufficiently  reliable  volume  and  time  data.  Quantitative  estimates  are  provided  for  biocontrol 
(renewals), PPP (renewals), biocides (renewals), BSE surveillance adjustments, and selected OCR 
measures (plant-health laboratory accreditation and partial consignments). Where evidence did not 
support robust quantification, order-of-magnitude indications or qualitative impacts are reported on 
the basis of conservative assumptions. Unless otherwise indicated, figures are indicative and reflect 
steady-state annual effects; they are intended to inform the expected scale and distribution of savings 
rather than replace a full impact assessment. 

The estimates should be read as ranges rather than precise point values. They draw on partial and 
heterogeneous  data  across  Member  States  and  sectors,  and  rest  on  simplifying  assumptions  on 
volumes,  time  spent  and  wage  rates  that  may  not  fully  reflect  local  practice  or  learning  effects. 
Baselines and prices are fixed to a reference year, while inflation, fee schedules and salary scales will 
evolve. For renewal-related measures, forward-looking volumes of applications are uncertain, and 
steady-state assumptions may understate short-term transition costs or overstate near-term savings. 
Some effects are distributional and may shift effort between authorities and businesses, rather than 
provide  a  net  reduction.  To  limit  double  counting,  savings  were  allocated  conservatively  where 
measures interact, though a residual overlap risk remains. Where evidence gaps persisted, parameters 
were proxied or triangulated from evaluations and implementation reports; otherwise, impacts are 
described qualitatively. Overall, the figures should be interpreted as order-of-magnitude indications 
of scale and direction. 

 
 
1.  Methodology  for  the  calculation  of  cost  savings  from  the  proposed  amendments  to 

Regulation (EC) No 1107/2009 (PPP Regulation) 

Despite  efforts  to  collect  data  on  costs  through  specific  queries  addressed  to  relevant  stakeholder 
groups (in addition to Eurostat data and other publicly available data), it was not possible to find cost 
figures  for  all  intended  measures.  Therefore,  cost  estimates  should  be  considered  only  as  an 
approximation of the cost savings for the different stakeholders. The following costs savings were 
considered and were quantified as far as possible with the data available. Where quantification was 
not possible or only partially possible this was highlighted as uncertainties.  

1.1 

Calculation of cost savings due to unlimited approval periods for most active substances  

Expected cost savings due to unlimited approval periods for most active substances were calculated 
for substances with an expiry date in the reference years 2033-2035, as applications for renewal of 
approval of substances expiring in those years must be submitted not later than 3 years before the 
expiry of approval of the active substance concerned. The listed active substances are thus the first 
substances  expected  to  be  impacted  by  the  proposal.  It  is  to  be  noted,  that  the  listed  substances 
exclude candidates for substitution as for those unlimited approval periods are not proposed and basic 
substances for which a renewal process is not required. 

Average cost saving per year for applicants were calculated taking into accounts both dossier costs 
and fees required by Member States (see table 1 below).  

Dossier costs 

Data were provided by stakeholders on dossier costs for chemical substances (shown in regular font 
in table 1) and for biocontrol substances (shown in bold and italics in table 1). Knowing the number 
of biocontrol  substances and the number of chemical  substances that will expire in  the time span 
2033-2035, the sum dossier costs were calculated per year as weighted sum and then averaged over 
the time span 2033-2035. Following this method, the average dossier costs for chemical substances 
amounted to 8,555,585 Euro per active substance, while the average dossier costs were about 7 times 
lower for biocontrol substances (1,211,250 Euro per active substance).  

Fees 

Data on fees per Member State per year were communicated to the Commission in 2025 following a 
survey with Member States or were taken from publicly available sources on the internet, except for 
those indicated with an asterisk for which values from the evaluation were taken. 

Several  Member  States  charge  an  extra  fee  if  there  is  more  than  one  applicant,  more  than  one 
representative use, to process comments received or if the file requires more work than originally 
foreseen. Per renewal file there is also a co-Rapporteur Member State for which some Member States 
also charge a fee. The total cost saving will, therefore, be higher than the estimate provided below. 

There  was  no  indication  that  fees  for  chemical  substances  and  biocontrol  substances  would  be 
different, therefore the same average values for fees provided by Member States were taken for all 
substances. 

Table  1:  Dossier  costs  and  fees  for  active  substances  with  expiry  date  in  2033-2035. 
Substances in bold and italics are biocontrol active substances, substances in normal font are 
chemical active substances  

 
 
2033 

2034 

2035 

Acetamiprid, RMS: DE 

Tribenuron, RMS: FR 

Metalaxyl-M, RMS: DE 

Fee: 176.100 EUR  

Fee: 260.000 EUR  

Fee: 176.100 EUR  

Silthiofam, RMS: NL 

Isoxaflutole, RMS: SE 

Foramsulfuron, RMS: FR 

Fee: >380.000 EUR  

Fee: 605.500 EUR  

Fee: 260.000 EUR  

Forchlorfenuron,  RMS: 
ES 

Fee: >190.840 EUR  

Zoxamide, RMS: BE 

Fee: >200.000EUR  

Carvone, RMS: IT 

Pyriproxyfen, RMS: ES 

Fee: >137.000EUR  

Fee: >190.840 EUR  

1-methylcyclopropene, 
RMS: DE 

Pythium 
strain B301 

oligandrum 

Fee: 176.100 EUR  

RMS: not set yet, original 
RMS BE 

Fee: >200.000EUR  

Trifloxystrobin, 
HR 

RMS: 

Dimethenamid-P,  RMS: 
BE 

Lavandulyl  senecioate; 
RMS: SE 

Fee: 
by 
case 
negotiated  with 
applicant 

case 
the 

Fee: >200.000EUR  

Fee: 605.500 EUR  

Carfentrazone-ethyl, 
RMS: FR 

Tolclofos-methyl,  RMS: 
FI 

Ferric  pyrophosphate, 
RMS: CZ: 

Fee: 260.000 EUR  

Fee: >200.000EUR  

Fee: >10,395EUR  

Pethoxamid, RMS: AT 

Fee: >~400.000EUR  

Clonostachys 
strain J1446, RMS: HU 

rosea 

Fee: 30.612 EUR  

Laminarin, RMS: EL 

ABE-IT 56, RMS: FR 

Fee: >~40.000EUR  

Fee: 46.000 EUR  

Phlebiopsis 
gigantea 
strain  VRA  1835,  RMS: 
EE 

Fee*: 23100 EUR  

Phlebiopsis 
gigantea 
strain  VRA  1984,  RMS: 
EE 

Fee*: 23100 EUR  

71 

 
 
 
2033 

2034 

2035 

gigantea 
Phlebiopsis 
strain  FOC  PG  410.3, 
RMS: EE 

Fee*: 23100 EUR  

Sodium 
carbonate, RMS: AT 

hydrogen 

Fee: 130000 EUR  

Pasteuria 
Pn1, RMS: NL 

nishizawae 

Bacillus  subtilis  strain 
IAB/BS03, RMS: ES 

Fee: >170.000 EUR  

Fee: 40.456 EUR  

Verticillium  albo-atrum 
strain  WCS850,  RMS: 
NL 

Fee: >170.000 EUR  

Ampelomyces  quisqualis 
strain AQ10 RMS: SE 

Fee: >275.230 EUR  

Glyphosate,  RMS:  not 
appointed  yet,  previously 
the Assessment Group on 
Glyphosate  (‘AGG’:  FR, 
HU, NL and SE)  

Fee > 605.500 EUR 118 

2033 

Total 
(excluding 
trifloxystrobin): 
2.697.670EUR  

Average  2033  fee  per 
substance: 
active 
245.242EUR  

average 
Estimated 
dossier  cost 
(without 
fees)  chemical  active 
substance (X): 8 517 537 
EUR  119 

fees 

Total 
2034 
1.865.668EUR  

fees:  

Total 
fees:1.642.135EUR  

2035 

Average  2034  fee  per 
active 
substance: 
186.567EUR  

Average  2035  fee  per 
active substance:164.214 
EUR  

average 
Estimated 
dossier  cost 
(without 
fees)  chemical  active 

average 
Estimated 
dossier  cost 
(without 
fees)  chemical  active 

118 The fee requested by the AGG is not known. This figure is estimated based on the fee requested by SE and is expected 
to be higher given the volume of the file and the necessary coordination. 
119 Data provided by stakeholders on average costs for renewal dossiers of chemical active substances (8 750 000 €) 
where only available with MS fees included. To have the average dossier cost without fees, the average fee was then 
deducted (i.e., 8 750 000 € - 232 463 € = 8 517 537 €),   

72 

 
 
 
 
 
 
 
 
 
2033 

2034 

2035 

average 
Estimated 
dossier  cost 
(without 
fees)  biocontrol  active 
substances  (Y):  1  211 
250 EUR  120 

Estimated  total  dossier 
cost  (without  fees)  as 
weighted  sum:  8X+3Y= 
(8*  8.517.537  EUR)  + 
(3*  1.211.250  EUR)  = 
71.774.046 EUR  

Estimated 
total  2033 
dossier  costs  with  fees: 
+ 
EUR 
2.697.670 
71.774.046  EUR 
= 
74.471.716 EUR   

substance (X): 8 563 433 
EUR  121 

substance (X): 8 585 786 
EUR  123 

average 
Estimated 
dossier  cost 
(without 
fees)  biocontrol  active 
substances  (Y):  1  211 
250EUR  122 

Estimated  total  dossier 
cost  (without  fees)  as 
weighted  sum:  6X+4Y= 
(6*  8.563.433  EUR)  + 
(4*1.211.250  EUR)  = 
56.225.598 EUR  

Estimated 
total  2034 
dossier  costs  with  fees: 
+ 
1.865.668 
56.225.598 
= 
58.091.266EUR  

EUR 
EUR 

average 
Estimated 
dossier  cost 
(without 
fees)  biocontrol  active 
substances  (Y):  1  211 
250EUR  124 

Estimated  total  dossier 
cost  (without  fees)  as 
weighted  sum:  3X+7Y= 
(3*  8.585.786  EUR)  + 
(7*1.211.250  EUR)  = 
34.236.108EUR  

Estimated 
total  2035 
dossier  costs  with  fees: 
+ 
1.642.135 
34.236.108 
= 
35.878.243EUR  

EUR 
EUR 

Table 2:  Biocontrol active substances: dossier costs and fees 

2033 

2034 

2035 

4 

7 

Number of biocontrol active 
substances  expected  to  be 
submitted  for  renewal  of 
approval 

3 

120  This  is  the  absolute  mean  calculated  with  the  "average  min”  (982  500  €)  and  the  ”average  max”  (1  440  000 €) 
provided by stakeholders. 
121 Data provided by stakeholders on average costs for renewal dossiers of chemical active substances (8 750 000 €) 
where only available with MS fees included. To have the average dossier cost without fees, the average fee was then 
deducted (i.e., 8 750 000 € - 186 567 € = 8 563 433 €),   
122  This  is  the  absolute  mean  calculated  with  the  "average  min”  (982  500  €)  and  the  ”average  max”  (1  440  000 €) 
provided by stakeholders. 
123 Data provided by stakeholders on average costs for renewal dossiers of chemical active substances (8 750 000 €) 
where only available with MS fees included. To have the average dossier cost without fees, the average fee was then 
deducted (i.e., 8 750 000 € - 164 214 € = 8 585 786 €).   
124  This  is  the  absolute  mean  calculated  with  the  "average  min”  (982  500  €)  and  the  ”average  max”  (1  440  000 €) 
provided by stakeholders. 

73 

 
 
 
 
 
 
2033 

2034 

2035 

EUR  245.242 

EUR  186.567 

EUR 1.211.250 

EUR 1.211.250 

EUR  
164.214 

EUR 
1.211.250 

Average  fee  per  biocontrol 
active substance 

(without 

Estimated  average  dossiers 
fees)  on 
cost 
renewal  of 
those  active 
substances 

Cost  savings  for  renewal 
dossiers (per year) 

EUR 4.369.476 

EUR 5.591.268  EUR 

9.628.248 

n.b., calculated as:  

EUR 6,529,664 on average per year 

(average 
fee  +  average 
dossier  cost)  *  dossier 
number 

(EUR 19,588,992 for the years 2033-2035) 

Conclusions for biocontrol substances and other active substances 

Conclusion on dossier costs: 

 In total the cost savings resulting from unlimited approvals on dossier costs for all the substances 
with an expected expiry in 3033-3035 amounted to 54,078,584 Euro on average per year. 

Conclusion on fees:  

Using  this  methodology  average  fees  for  active  substances  were  calculated  as  198,674  Euro  per 
year. 

Conclusion on the sum of dossier costs and fees:  

Estimated cost savings as sum of dossier costs and fees would therefore amount to 56,147,075 Euro 
per year.  

Total costs for biocontrol active substances:   

amounted to an average of EUR 6,529,664 per year (about 11,5% of the total amount of 54,078,584 
Euro  (Table  3),  while  for  other  active  substances  (excl.  candidates  for  substitution)  the  costs 
amounted to EUR 49,617,411 on average per year (about 85,5% of the total) (Table 4). 

74 

 
 
 
 
 
 
 
 
 
 
 
Table 3:  Other active substances than biocontrol active substances (excluding candidates for 
substitution) 

2033 

2034 

2035 

8 

6 

3 

of 

active 
Number 
(excluding 
substances 
biocontrol 
CfS) 
expected to be submitted for 
renewal of approval 

and 

Average 
substance 

fee  per  active 

EUR 245,242 

EUR 186,567  EUR 164,214 

(without 

Estimated  average  dossiers 
fees)  on 
cost 
renewal  of 
those  active 
substances 

EUR 8,517,537 

EUR 
8,563,433 

EUR 
8,585,786 

Cost  savings  for  renewal 
dossiers (per year) 

EUR 70,102,232  EUR 

52,500,000 

EUR 
26,250,000 

n.b., calculated as:  

EUR 49,617,411 on average per year 

(average 
fee  +  average 
dossier  cost)  *  dossier 
number 

(EUR 148,852,232 for the years 2033-2035) 

1.2 

Cost savings from other proposed provisions for simplification 

1.2.1 

 Provisional authorisations for biocontrol PPP 

As regards renewals of authorisation of biocontrol PPP, according to the information provided by 
stakeholders, the average delays are 483.5 days beyond the legal deadlines (i.e., the legal deadlines 
are 120 days for low-risk PPP – including biocontrol PPP – and 1 year for non-low-risk PPP) with 
an estimation by stakeholders of average losses in terms of missing sales ranging between EUR  1 
million and EUR  3.7 million per year of delay. Expressed on a per day basis this could result in 
average losses per day of delay between EUR 2,740 and EUR 10,136. 

75 

 
 
 
 
 
 
 
 
 
 
With the possible introduction of provisional authorisations, a biocontrol PPP could be on the market 
at “day zero” after a DAR (i.e., Draft Assessment Report ) would be issued by a RMS, hence on 
average  848.5  days  before  what  currently  happens  (i.e.,  483.5  days  of  delay  beyond  the  legal 
obligations plus the current legal deadline of 365 days). 

The potential cost savings due to the possible introduction of provisional authorisations, in terms of 
avoided  losses,  would  then  be  between  EUR  2.32  and  EUR  8.6  million  for  each  biocontrol  PPP 
(ranging from EUR 2,74 per day x 848.5 days and EUR 10.136 per day x 848.5 days).  

In the years 2016 – 2025 the European Commission approved 32 new biocontrol active substances, 
hence  3.2  /  year.  Assuming  that,  combined  with  the  measures  incentivising  biocontrol  PPP 
development, around four new biocontrol PPPs will reach authorisation per year, these per-product 
savings imply avoided delayed-marketing losses of EUR 22 million  per year, with actual savings 
likely to be even higher as the number of biocontrol dossiers increases over time. 

Further estimations for future cost savings for biocontrol products due to provisional authorisations 
are not possible as the number of dossiers that will be submitted can currently be predicted. 

1.2.2. 

Cost savings from the amended provisions on data protection 

The cost savings from the simplification of the data protection provisions are calculated based on the 
data provided by the industry (ECCA which is representing the post-patent companies which do not 
develop new active substances but only products based on already approved active substances). 

According to data provided by ECCA, the average dossier cost for an application for authorisation 
of an innovative PPP under Article 33 where the active substance data protection expired is  EUR 
1,500,000 while the cost of a dossier where data matching is needed (duplication of active substance 
studies) as the active substance data protection has not expired is respectively  EUR 5,500,000 for 
innovative product containing one active substance and EUR 8,800,000 for a product containing 2 
active substances.  

For generic products (same or similar to already authorised plant protection product e.g. the reference 
product) where the data protection of the active substance expired, the average dossier cost is EUR 
80,000 for Article 34 dossier (34 dossier depends solely on the data and the evaluation of the reference 
PPP, there are no new studies to be generated, the label is similar to the one of the reference product) 
and  EUR  1,050,000  for  Article  33  dossier  (the  dossier  includes  also  unprotected  data  from  the 
reference  product,  newly  generated  data  for  the  generic  PPP,  and  a  complete  risk  assessment 
evaluation; .thee label for the approved generic is also different from that of the reference product, 
incorporating new crops or varying application conditions). 

If the active substance data protection has not expired, the average cost of a dossier is increased due 
to the data matching and amounts to EUR 5,150,000 for Article 33 dossier (new product) and EUR 
4,500,000 for Article 43 dossier (renewal of already existing product).125  

125 The cost is significantly higher than the average cost of a renewal PPP dossier as indicated in Table 2 as in this case 
they include also the fee for data matching of the active substance data for which the data protection has not expired. 

76 

 
 
 
Therefore, the average costs vary significantly depending on the data protection status of the active 
substance data: 

•  For innovative PPP –increase from EUR  1.45 M to EUR  5.15 or EUR  8.85 M (depending 

on one or two active substance data matching dossiers being generated for a PPP) 

•  For  article  33/34  dossier  or  article  43  –increase  from  EUR  1,050,000  to  EUR    4.75  M 

(assuming one data matching dossier) 

•  Article 34 dossier or renewal dossier of a generic product–increase from EUR 80,000 to EUR  

3.78 M (assuming one data matching dossier) 

Based on the above, the difference between a plant  protection dossier where the active substance 
expired (without data matching) and a plant protection dossier where the active substance data is still 
protected (with data matching) is on average EUR 3,700,000. This sum includes the price of a letter 
of  access  (license  to  use  the  data  for  which  protection  has  not  expired)  or  the  costs  to  conduct 
duplicate studies in order to “compensate” for the active substance studies that are still protected.  

ECCA estimates that the half of the data matching dossiers generated by its members are actually not 
necessary as the data protection of the active substance studies was artificially extended due to the 
fragmentated territorial scope combined with the delays in the risk assessment at Member State level. 
Therefore from 8 data matching dossiers per year, 4 could be spared thus generating a cost savings 
of  EUR  14,800,000  annually  only  for  the  ECCA  member  companies  (EUR  3,700,000  being  the 
difference between a dossier with data matching and dossier without data matching multiplied by 4). 

1.3 Impact on SMEs 

If high dossiers costs and delays of assessments are concrete issues which biocontrol manufacturers 
in the EU struggle to face, this is particularly true for SMEs, which are typically characterised by a 
lower turnover compared to bigger companies.  

To provide a practical example on how these costs have a dramatic impact on SMEs, a micro-sized 
enterprise manufacturing biocontrol claimed in a recent meeting with DG SANTE that only the cost 
of the renewal dossier of one of its active substances amounted up to 1.5 years of its turnover. This 
underlined the high investments these companies must commit to, without any guarantee of a quick 
profit.  

These  difficulties  are  widespread  across  biocontrol  manufacturers  in  the  EU  since,  according  to 
stakeholders’ representatives: 

the 90% of EU biocontrol manufacturers are SME, 

the number of SME (i.e., <50M turnover) operating in the EU is 149, of which almost a half (i.e., 71 
companies) are “micro-sized” (i.e., <2M Euro turnover). 

This data highlights how the structure of the market of biocontrol is dominated by SMEs, therefore 
particular attention on facilitating access to market of biocontrol should be contextualised into the 
SMEs remit.  

77 

 
 
In this regard, for analogy with the calculation made above in the sections above “Cost savings due 
to  possible  introduction  of  permanent  approval/authorisation  of  biocontrol”,    the  savings  due  to 
possible introduction of permanent approval of biocontrol active substances for the years 2033, 2034 
and 2035 would be EUR 17,630,093 for SMEs (i.e.,  90% of the sum of the cost savings for the years 
2033, 2034, and 2035 calculated in Table 3, Annex 3 (EUR 19,588,992). This would mean savings 
of EUR 5,876,698 annually. N.b., due to unavailability of data on biocontrol PPP renewal dossiers 
which  will  be  submitted,  this  estimation  was  limited  to  data  on  renewal  of  approval  of  active 
substances.  

78 

 
 
 
 
1.4  Overall cost savings under Regulation (EC) No 1107/2009 

Measures 
Simplification proposal* 

included 

in 

the  SANTE 

Estimated costs savings in EUR per year  

Biocontrol active 
approvals 

substances 

-  unlimited 

6,529,664 (dossier costs and fees) 

Provisional  authorisations 
products 

for  biocontrol 

 22,000,000 

Other active substances*  - unlimited approvals   49,617,411 (dossier costs and fees) 

Basic substances  

Data protection  

TOTAL  

Mutual recognition  

Minor uses  

Treated seeds  

N/A 

N/A 

N/A 

N/A 

14,800,000  

92,947,075 

*  This  includes  all  other  active  substances  except  candidates  for  substitution,  basic  substances  and 
biocontrol active substances.  

79 

 
 
 
 
 
 
 
2.  Methodology for the calculation of costs saving from the proposals on the Biocidal Products 

Regulation (EU) No 528/2012 (the BPR) 

The  cost  assessment  is  based  on  the  situation  of  active  substances  approved  under  the  Biocidal 
Products  Regulation  (EU)  No  528/2012  (BPR)  as  of  1  September  2025,  assuming  the  Omnibus 
proposal is adopted and applied from 2027 onwards. Given that a full evaluation of the BPR is starting 
in 2025, the figures presented are illustrative. They draw mainly on the 2009 Impact Assessment for 
the BPR, updated to 2025 prices, and complemented by current information on ECHA fees, Member 
State fees and the renewal pipeline. More precise data will be generated in the context of the BPR 
evaluation and used for subsequent initiatives. 

The exercise is deliberately narrow in scope: it quantifies only the cost savings for industry from 
removing the obligation to submit systematic renewal applications for active substances not subject 
to  exclusion  or  substitution  criteria.  Other  elements  of  the  omnibus  proposal,  such  as  changes  to 
Union authorisations, data protection under Article 95(5), or procedural streamlining for authorities, 
are  expected  to  bring  further  benefits,  but  these  could  not  be  robustly  quantified  at  this  stage. 
Accordingly,  the  results  presented  here  should  be  seen  as  partial  estimates  of  overall  savings, 
focusing on avoided active substance renewal applications, which represent the most significant and 
measurable cost driver for the proposals presented under the BPR. 

The proposal foresees unlimited approvals for active substances, except those meeting exclusion or 
substitution criteria. Cost savings for industry are estimated as the avoided costs of systematic active 
substances  renewal  applications.  Case-by-case  renewals  or  re-examination  requested  by  the 
Commission or Member States are excluded from this estimate.  

The costs have been assessed based on the situation of active substances approved on 1st September 
2025 under the Biocidal Products Regulation (EU) No 528/2012 (the BPR), and assuming that the 
Omnibus proposal would be adopted and applied as from 2027. 

Considering that a full evaluation of the BPR is starting in 2025, rough estimations are being made 
for  the  present  assessment.  More  quantitative  data  will  be  gathered  in  the  context  of  the  BPR 
evaluation and will rather be used in that context, and for the actions that would follow as an outcome.  

In the context of the current proposal, estimations are therefore made based mostly on data gathered 
in  the  Impact  Assessment  performed  in  2009  for  the  proposal  of  the  BPR  revising  the  former 
Directive 98/8/EC, as well as some updated information (ECHA fees, number of currently approved 
substances). 

2.1  On the unlimited duration of approval of active substances, except for active substances 

meetings the exclusion and the substitution criteria 

2.1.1 

Costs savings for industry 

The costs savings for industry are estimated considering the number of applications for the renewal 
of the approval of active substances that will not have to be systematically submitted by the biocides 
industry if the proposal is adopted. 

However, these estimations and cost savings: 

80 

 
 
• 

• 

do  not  include  the  number  of  applications  for  renewal  that  would  still  have  to  be 
submitted  by  companies  on  a  case-by-case  for  specific  substances  or  groups  of 
substances   at the request of the Commission following discussions with Member States 
Competent authorities, due to the impossibility to make estimations at this stage. 

do not take into account the substances still under evaluation in the review programme 
set  out  under  Article  89  of  Regulation  (EU)  No  528/2012  that  will  eventually  be 
approved in the coming years, and that would be/would have been normally subject to 
requirement of the systematic renewal of approval due to limited duration of approval as 
currently applied in the BPR. 

To quantify the costs savings for industry, the following method is followed: 

• 

• 

• 

• 

the number of applications for renewal that will not have to be submitted is estimated 
(A) 

the average cost for application for renewal an application for renewal is estimated (B); 
it covers cost related to the gathering of required data in application dossiers 

the fees paid to the European Chemicals Agency is estimated (C) 

the average fee paid for an application to the evaluating Competent Authority (D) 

The costs savings for industry = A* (B+C+D).  

Number of applications for renewal of approval that will not have to be submitted 

The following is considered for the estimations: 

•  an application for renewal corresponds to an application submitted to renew the approval 
of one active substance for one product-type (PT) as defined in Annex V to the BPR. 
When an active substance is approved for several PTs, an application for renewal needs 
to be submitted for each PT. 

Table  5  provides  an  overview  of  the  deadlines  for  the  submission  of  applications  for  renewal  of 
approval for active substances, for which the application for renewal is currently under evaluation or 
will have to  be submitted in  coming  years and indicating whether the active substance is  already 
known to meet the exclusion or substitution criteria126. 

Table 5 

Year 
of 
submission 

Normal 
substance 

Exclusion 

Substitutio
n 

2018 

3 

1 

1 

Total 

5 

126 As stated in their current approval regulation, or due to the hazard classification of the active substance, in the light of 
the criteria set out in Article 5(1) and 10(1) of the BPR. 

81 

 
 
 
 
Year 
of 
submission 

Normal 
substance 

Exclusion 

Substitutio
n 

Total 

2019 

2020 

2021 

2022 

2023 

2024 

2025 

2026 

2027 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

2035 

Grand 
Total 

1 

3 

4 

6 

16 

21 

23 

38 

27 

1 

2 

12 

5 

11 

15 

4 

5 

0 

3 

1 

8 

2 

4 

0 

0 

0 

1 

1 

1 

0 

0 

0 

0 

0 

0 

0 

2 

1 

1 

3 

9 

0 

0 

1 

0 

2 

0 

0 

0 

2 

0 

1 

6 

7 

15 

19 

28 

32 

38 

27 

3 

3 

15 

5 

11 

15 

6 

5 

197 

22 

22 

241 

If the proposal is  adopted and applicable as from 1st January 2027, excluding substances meeting 
exclusion  or  substitution  criteria  for  which  a  systematic  renewal  application  would  always  be 
requested,  at  least  82  applications127  for  approval  would  no  longer  have  to  be  submitted 
(corresponding  to  35  active  substances  for  one  or  more  product-types)  for  the  period  2027-
2035. 

Such figure is a low estimation on the long-term costs savings, as it can be assumed the majority of 
the  active  substances  currently  under  evaluation  for  their  renewal  of  approval  would  obtain  their 
renewal and would eventually still not be meeting exclusion or substitution criteria (i.e. applicants 

127 27+1+2+12+5+11+15+4+5= 82 applications 

82 

 
 
  
 
submit all required data for the assessment, conditions for approval still met)128 Furthermore, more 
substances still under assessment in the review programme set out in Article 89(1) of the BPR will 
eventually be (firstly) approved in the coming years and will not meet the exclusion or substitution 
criteria.129  

Average cost for an application for renewal of approval 

No specific study would be carried out on the matter for the preparation of the current proposal. In 
the Impact Assessment performed in 2009 for the proposal of the BPR revising the former Directive 
98/8/EC, the cost of preparation of an application for approval of an active was estimated between 
EUR 3 to 5 million, based on a study performed in 2007.130 

On one hand, the cost of constitution of an application for (first) approval is supposed to be higher 
than  the  cost  of  a  renewal  application,  considering  most  of  the  data  and  previous  testing  on  the 
properties of the substances would still be valid. In addition, most of the data required to assess the 
substance  for  one  product-type  will  be  valid  to  assess  other  products-types  for  the  same  active 
substance, making the cost of constitution of subsequent applications for additional PTs for the same 
active substance less important. 

On the other hand, some testing methods have evolved overtime, and updated data may be needed in 
certain area in the light of scientific progress. Additionally, companies must usually provide in their 
application  since  2018  additional  testing  to  assess  the  scientific  criteria  for  the  determination  of 
endocrine-disrupting properties131, as in many cases the data package available before that date would 
not  be sufficient  to  assess those criteria. Testing of ED properties may involve vertebrate testing, 
which  are  usually  known  to  be  costly  compared  to  other  testing  (ex:  testing  of  physico-chemical 
properties).  

Taking into account the above considerations, and that cost savings on the renewal data package for 
dossiers compared to the first approval dossier may be compensated by other costs (some updated 
tests, ED testing, other), and in absence of a revised study to assess the real costs in 2025 for the 
constitution for a renewal dossier, the same figures as in the Impact Assessment performed in 2009 
for the proposal of the BPR will be used as an estimation. 

The cost of preparation of an application for renewal of approval for an active substance is therefore 
estimated between EUR  3 to 5 million in 2007. Corrected with inflation132, and take into account 
other  costs  for  applicant,  i.e.  costs  linked  to  contracting  consultancies  to  help  them  build  an 

128 In the best-case scenario that all current approvals are renewed, it could be up to 197 applications that would no longer 
have to be submitted on the long term, corresponding to 101 active substances for one or more product-types) 
129 Around 305 dossiers are still under assessment in the review programme, for 109 active substances for one or more 
product-types 
130 See pages 13, 14, 85 and 86 of Commission Staff Working document Accompanying document to the Proposal for a 
Regulation  of  the  European  Parliament  and of  the  Council concerning  the  placing on  the  market  and  use  of  biocidal 
products, 
https://eur-lex.europa.eu/legal-
assessment, 
content/EN/TXT/PDF/?uri=CELEX:52009SC0773  
131  Commission  Delegated  Regulation  (EU)  2017/2100  of  4  September  2017  setting  out  scientific  criteria  for  the 
determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament 
and Council 
132 Considering a cumulated inflation of 54% in the EU over the period 2007-2025, annual inflation as measured by the 
HICP 
at: 
https://ec.europa.eu/eurostat/databrowser/view/prc_hicp_aind__custom_17877141/default/table   

SEC(2009)774, 

(Harmonised 

Consumer 

available 

Impact 

Prices) 

Index 

of 

83 

 
 
 
application, costs of following the renewal process on the active substances for several years, and 
uncertainty costs linked to the outcome of the renewal procedure, the cost of preparing a  renewal 
application  in  2025  is  estimated  between  EUR  4.6  to  7.7  million.  For  the  sake  of  the  present 
calculations, the costs are estimated at EUR 7.7 million.  

Fees paid to the European Chemicals Agency 

The fees to be paid by an applicant to ECHA to the examination of an application to renew an active 
substance are established by Commission Implementing Regulation (EU) No 564/2013133. 

These  fees  depends  on  the  nature  of  the  application,  whether  the  same  application  submit  the 
application for renewal of an active for one product, or whether it submit it for subsequent product-
type as well (as the fee to be paid to ECHA is lower such case), whether a full or limited evaluation, 
and whether the applicant is entitle to benefit from SME fee reduction from 20% to 60%.  

For the purpose of the present estimation: 

•  all companies will be assumed as not benefitting from the SME fee reduction.  

•  all  evaluation  will  be  considered  “full  evaluation”,  as  based  on  experience  Member 
States authorities consider that a full evaluation is needed in the overall majority of cases 

The  following  fees  from  Commission  Implementing  Regulation  (EU)  No  564/2013  are  therefore 
considered:  

Table 6 

Renewal  of  an 
approval;  Article 
13(3) 

Fee  for  the  first  product-type  for 
that  active 
which 
substance is sought 

renewal  of 

      17.925 
EUR   

Additional fee for the first product-
type for which renewal of that active 
substance  is  sought  in  case  a  full 
evaluation  is  found  necessary  in 
accordance  with  Article  14(1)  of 
Regulation (EU) No 528/2012 

Fee per additional product-type 

      29.875 
EUR   

        1.793 
EUR   

133 Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable to the 
European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council 
concerning  the  making  available  on  the  market  and  use  of  biocidal  products  Text  with  EEA  relevance,  modified  by 
Commission Implementing Regulation (EU) 2025/1490 of 24 July 2025 amending Implementing Regulation (EU) No 
564/2013 as regards the adaptation of fees to inflation. 

84 

 
 
 
 
fee 

per 

Additional 
additional 
product-type in case a full evaluation 
is  found  necessary  in  accordance 
with  Article  14(1)  of  Regulation 
(EU) No 528/2012 

        2.988 
EUR   

Considering  that  all  renewal  applications  are  estimated  to  necessitate  a  “full  evaluation”  by 
experience, the following total fees per application are therefore considered: 

Table 7 

Renewal  of  an 
approval;  Article 
13(3) 

Total  fee  for  the  first  product-type 
for  which  renewal  of  that  active 
substance is sought (full evaluation) 

47.800EUR 
134  

Total fee per additional product-type 
(full evaluation) 

4.781EUR 135  

Assuming that 35 active substance renewal dossiers for “first PT” and 47 dossiers the “additional 
PTs” (for a total of 82 dossiers) will not have to be submitted for the period 2027-2035, the total costs 
savings for industry from ECHA fees are estimated to: 1.897.707 EUR 136 . 

The weighted average ECHA fee savings for the period for period 2027-2035 would be 23.143 EUR 
137  for a renewal application. Compared to the costs of constitution of a renewal application estimated 
in section 1.2, these costs are minimal (less than 0,5% of the cost of a dossier). 

Average fee paid for an application to the evaluating Competent Authority 

The fees paid by applicants to the evaluating competent authorities are set by each Member States 
and  varies  a  lot  across  the  EU.  Some  data  were  gathered  by  the  Commission  services  and  were 
presented to the expert group of the Biocidal CA meeting138, and are available online on the websites 
of Member States’s Biocidal Competent Authorities139. Fees can be fixed at flat rate or can depend 
on the among of work spent by the evaluating authority. 

Based on data collected on the fees in 20 Member States, Norway and Switzerland, the following 
fees can be estimated:  

134 17.925,00 € + 29.875,00 € = 47.800,00 € 
135 1.793,00 € + 2.988,00 € = 4.781,00 € 
136 47.800,00 € * 35 + 4.781,00 € * 47 = 1.897.707,00 € 
137 1.897.707,00 € / (35+47) = 23.142,77 € 
138 CA-July19-Doc.7.5 - Fees overview June 2019.docx 
139 https://echa.europa.eu/contacts-of-the-member-state-competent-authorities  

85 

 
 
  
      
        
  
 
• 

• 

The fee for the first product-type for which renewal of that active substance is sought, for a 
full evaluation: it can vary from EUR 61.000 (Portugal) to EUR 625.000 (Norway), with a 
median around EUR 180.000 

The fee per additional product-type for which renewal of that active substance is sought, for 
a full evaluation: it can vary from EUR 33.000 (Finland) to EUR 312.000 (Norway), with a 
median around EUR 75.000 

For the purpose of the present estimation, the following fees will be used: 

Table 8 

Fee  for  the  first  product-type 
for which renewal of the active 
substance 
(full 
evaluation) 

sought 

is 

   180.000 EUR   

Fee  per  additional  product-
type (full evaluation) 

     75.000 EUR   

Assuming that 35 active substance renewal dossiers for “first PT” and 47 dossiers the “additional 
PTs” (for a total of 82 dossiers) will not have to be submitted for the period 2027-2035, the total costs 
savings for industry from Member States fees are estimated to:  9.825.000 EUR 140. 

The  weighted  average  Member  States  fee  savings  for  the  period  for  period  2027-2035  would  be 
119.817  EUR  141  for  a  renewal  application.  Compared  to  the  costs  of  constitution  of  a  renewal 
application estimated in section 1.2, these costs represent a small portion of the renewal costs (less 
than 3% of the cost of a dossier). 

Result calculation of cost savings for industry 

Considering: 

• 

• 

• 

• 

The number of renewals not to be submitted: 82 

The costs of a dossier preparation: 7.7 million EUR  

The weighted average ECHA fee for a renewal application: 23.143 EUR  

The weighted average Member State fee for a renewal application: 119.817 EUR , 

140 180.000 €*35 + 75.000 €*46 = 9.825.000 € 
141 9.825.000 € / (35+47) = 119.817 € 

86 

 
 
  
 
the costs savings are for industry coming from the unlimited approval period of active substances not 
meeting  the  exclusion  or  substitution  criteria,  which  avoid  the  systematic  submission  of  renewal 
applications, are estimated at 643.122.707 EUR  for the period 2027-2035.  

These savings are rounded and estimated at 643,122,707 EUR  for the 9-year period 2027-2035. 
This would mean 71,458,079 EUR  per year.  

In addition, evaluating Member States could re-orientate part of their resources that would have been 
dedicated for the renewal of approval process of these active substances to completion of the review 
programme and the evaluation of product  authorisation  applications, which would contribute to  a 
quicker decision-making on the delayed active substances still in the review programme set up under 
Article 89 of the BPR and product authorisations, reducing potential costs linked to the management 
of those applications in the waiting of the approval/authorisations decisions. The review programme 
has started 2004 and the assessment of active substances has been substantially delayed, being on-
going for most substances since 2004-2008. 

These costs savings are difficulty to estimate and could not be quantified. However, these costs for 
an applicant are considered minimal compared to costs savings linked to the constitution of a dossier. 

87 

 
 
 
3.  Methodology for the calculation of cost savings stemming from the proposed amendments 

to Regulation (EC) No 1831/2003 on additives for use in animal nutrition 

This  analysis  estimates  the  costs  avoided  by  abolishing  the  systematic  ten-year  renewal  of 
authorisations for feed additives under Regulation (EC) No 1831/2003. It covers direct compliance 
and administrative costs borne by applicants (data generation, dossier preparation and internal staff 
time,  including  obligations  introduced  by  the  Transparency  Regulation  (EU)  2019/1381)  and  by 
public authorities (Commission/DG SANTE, EFSA, EURL-FA and Member States). Coccidiostats 
and histomonostats, which retain time-limited authorisations, are excluded from the saving. 

Baseline parameters were taken from the Commission’s 2024 evaluation (SWD(2024) 46 final) and 
from operational inputs provided by EFSA and the EURL-FA on the relative effort of renewals versus 
new authorisations. Costs reported for 2019 were first updated using the euro-area HICP accumulated 
between  2019  and  2024  (+19.57%).  On  this  inflation-adjusted  base,  a  further  14%  was  added  to 
reflect Transparency Regulation obligations and, where relevant, approximately 33.5 additional staff-
days per renewal dossier on the applicant side. This yields an average applicant cost of EUR 294,433 
per renewal (from EUR 216,000 in 2019, inflated to EUR 258,275 and uplifted by 14%). 

Average costs incurred by applicants per application for renewal of authorisation is as follows 

Estimated  amount  in  2019  (EUR  ) 
(before 
Transparency 
Regulation) 

the 

Adjusted to 2024 (EUR ) 

(including estimated additional costs 
resulting  from  the  Transparency 
Regulation) 

Average 
applicants 

costs 

for 

216,000 

294,433 

(258,275 + (14% =36,158) 

To provide a homogeneous overview of costs across actors in a given year, costs are presented against 
the expiry year of the authorisation, even though Article 14(1) of Regulation (EC) No 1831/2003 
allows  submission  of  renewal  applications  up  to  one  year  before  expiry.  The  expected  renewal 
volumes for 2025–2034 were estimated by applying the Evaluation’s established method: renewals 
are proxied by the number of initial authorisation applications submitted 10 years earlier, irrespective 
of  the  number  of  additives  covered  per  application.  On  this  basis,  and  assuming  that  each  initial 
application led to an authorisation granted in the year of submission, 751 renewal applications are 
expected over 2025–2034, with the year-by-year distribution and totals reported in the table below. 

Applications for initial authorisation per year and expiry date of corresponding authorisation 

YEAR  OF  APPLICATION  FOR 
INITIAL AUTHORISATION 

NUMBER  OF  APPLICATIONS 
FOR AUTHORISATION UP FOR 
RENEWAL AT EXPIRY DATE 

EXPIRY DATE OF THE INITIAL 
AUTHORISATION 

2015 

2016 

2017 

41 

57 

55 

2025 

2026 

2027 

 
 
 
 
  
 
 
2018 

2019 

2020 

2021 

2022 

2023 

2024 

GRAND TOTAL 

82 

83 

96 

112 

82 

83 

60 

751 

2028 

2029 

2030 

2031 

2032 

2033 

2034 

For applicants, data requirements for a renewal are less demanding than for a new authorisation, and 
this is reflected in lower unit costs on the industry side. By contrast, for the Commission and Member 
States,  the  procedure  for  processing  and  adopting  a  renewal  measure  mirrors  that  of  a  new 
authorisation, so their processing costs are considered similar across the two cases. The EURL-FA 
confirmed that renewal handling typically represents about 20% of the cost of a new authorisation 
because  new  reference  samples  and  a  new  evaluation  report  are  generally  not  required;  in  these 
renewal cases, fees are usually not charged to applicants. For EFSA, renewal work includes internal 
staff time and costs for external experts (Panel and working groups). Historically, EFSA’s renewal 
costs are around 60% of a new authorisation; since 27 March 2021, the Transparency Regulation has 
added specific tasks across the pre-submission (e.g. advice, public consultation on intended studies, 
reception/management  of  study  notifications),  submission/completeness  (verification  of  pre-
submission  obligations),  and  risk-assessment  phases  (public  consultation  on  applications, 
confidentiality  handling).  These  extra  tasks  are  estimated  at  EUR  16,350  per  renewal  on  top  of 
EFSA’s renewal baseline. 

All  public-authority  costs  (Commission,  EURL-FA,  EFSA  and  Member  States)  were  derived  by 
multiplying the number of days spent on renewal-related tasks by the average daily rate including 
overheads, in line with the Evaluation. For EU administrations, the daily rate is based on the 2018 
annual  update  of  remuneration  and  pensions  for  EU  officials  and  other  servants  (OJ  C  451,  14 
December 2018). While applicant costs are detailed above, public-authority unit costs per renewal 
are DG SANTE EUR 16,022; EURL-FA EUR 4,424; EFSA EUR 36,079 (comprising a EUR 19,729 
renewal  baseline  plus  EUR  16,350  for  Transparency  tasks);  and  Member  States  EUR  16,958 
(aggregate). 

Average  costs  incurred  by  the  Commission,  the  EURL-FA  and  EFSA  per  application  for 
renewal of authorisation, based on the number of days spent on their respective related tasks 

Average 
Commission (DG SANTE) 

costs 

for 

Estimated amount in 2019 (EUR )  Adjusted to 2024 (EUR ) 

13,400 

16,022 

89 

 
 
  
  
Average costs for the EURL-
FA 

Average costs for EFSA 

3,700 

16,500 

4,424 

19,729 + 16,350 = 36,079 

The time to decision for renewals averages 24 months from submission to adoption. Article 14(4) 
automatically extends the authorisation where, for reasons beyond the applicant’s control, no decision 
is  taken  before  expiry;  however,  until  the  renewal  regulation  is  adopted,  outcome  uncertainty 
remains,  including  on  potential  amendments  to  terms  of  the  existing  authorisation.  Removing 
periodic  renewals  therefore  eliminates  both  the  recurring  dossier  costs  and  this  procedural 
uncertainty. 

Applying the above unit costs to the annual renewal counts produces the global baseline for 2025–
2034. The table below shows the number of expected applications for renewal of authorisation and 
the  corresponding  costs  for  DG  SANTE,  EURL-FA,  EFSA,  Member  States  and  applicants, 
culminating  in  the  following  decadal  totals:  Applicants  EUR  221,119,183;  DG  SANTE  EUR 
12,032,522; EURL-FA EUR 3,322,424; EFSA EUR 27,095,329; Member States EUR 12,735,458; 
Grand total  EUR  276,304,916. Annual  averages  over the decade are then used as  average  annual 
savings  under  the  proposed  measure  to  abolish  periodic  renewals.  This  yields  around  EUR  22.1 
million per year for operators and just over EUR 5 million per year for public authorities. 

Based on the expected number of applications for renewal of authorisation to be submitted per year 
for  the  period  2025-2034,  the  table  below  provides  an  estimate  of  the  average  global  costs,  with 
amounts adjusted to 2024, for the entities involved in the authorisation process: 

Year  Number of 

expected 
applicatio
ns 
renewal 

for 

DG 
SANTE 
(EUR ) 

EURL-FA 
(EUR ) 

EFSA 
(EUR ) 

MS  (EUR 
) 

Applicants 
(EUR )    

2025 

41 

656,902 

181,384 

1,479,239 

695,278 

12,071,753 

2026 

57 

913,254 

252,168 

2,056,503 

966,606 

16,782,681 

2027 

55 

881,210 

243,320 

1,984,345 

932,690 

16,193,815 

2028 

82 

1,313,804 

362,768 

2,958,478 

1,390,556 

24,143,506 

2029 

83 

1,329,826 

367,192 

2,994,557 

1,407,514 

24,437,939 

2030 

96 

1,538,112 

424,704 

3,463,584 

1,627,968 

28,265,568 

2031 

112 

1,794,464 

495,488 

4,040,848 

1,899,296 

32,976,496 

2032 

82 

1,313,804 

362,768 

2,958,478 

1,390,556 

24,143,506 

90 

 
 
2033 

83 

1,329,826 

367,192 

2,994,557 

1,407,514 

24,437,939 

2034 

60 

961,320 

265,440 

2,164,740 

1,017,480 

17,665,980 

TOT
AL 

751 

12,032,522  3,322,424 

27,095,329  12,735,458  221,119,183 

GRAND TOTAL     276,304,916 EUR   

For  completeness,  costs  for  the  Commission  comprise  staff  time  across  all  activities  required  to 
process renewal applications. EURL-FA costs correspond to sample storage and maintenance and 
reporting  limited  to  renewal  needs,  i.e.  verification  of  applicability  of  previous  evaluation  report 
(≈20% of a new case). EFSA costs comprise internal time and external expert remuneration, with 
Transparency-related tasks accounted for as an explicit add-on per renewal. Member-State costs 
cover participation in SCoPAFF and associated implementation duties.

91 

 
 
 
4.  Cost  savings  calculations  from  the  alignment  of  the  EU  BSE  framework  with  WOAH 

Chapter 11.4. 

4.1 Cost savings from BSE surveillance update  

Methodology  

The  calculation  estimates  the  annual  savings  resulting  from  the  alignment  of  BSE  surveillance 
requirements with WOAH Chapter 11.4. 

Under this alignment, BSE testing would be focused exclusively on at-risk populations, leading to an 
estimated 85% reduction in the total number of surveillance tests performed annually. 

Baseline data were sourced from the EFSA Report on TSE Surveillance (2023)142, The unit cost per 
test (EUR 12.83) corresponds to the average rate reimbursed by the European Commission under the 
Single Market Programme143. 

Assumptions: 

•  Baseline: 922,841 tests/year. 
•  Average unit cost: EUR 12.83/test. 
•  EU co-financing rate: 12–18%. 
•  Reduction in testing volume: 85%. 

Calculations  

•  Tests reduced: 922,841 tests/year x 85% = 784.415 tests/year 
•  Total direct savings: 784.415 x EUR 12.83 = EUR 10.05 million/year 
•  Distribution of savings: 

 - National authorities: EUR 8.5 million/year 
 - EU budget (Single Market Programme reimbursements): EUR 1.55 million/year 

Indirect operational savings from sampling, logistic, administration, and laboratory workload are not 
included in the above figures, but represent an additional EUR 3 million.  

4.2 Cost savings from SRM list update  

Methodology  

The calculation estimates the annual cost savings expected from updating the list of Specified Risk 
Materials (SRMs) in line with the 85% alignment scenario under WOAH Chapter 11.4.  

This alignment would remove the requirement to designate SRMs for healthy slaughtered bovines 
and would allow most fallen stock to be processed as Category 2 instead of Category 1 material under 

142 The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies 
(TSE) in 2023 
143  WORKING  DOCUMENT  SANTE/2021/10502  Guidelines  for  the  Union  co-funded  programmes  of  eradication, 
control  and  surveillance  of  animal  diseases  and  zoonoses  for  the  years  2021-2022  -20ac5c39-dc3b-453e-a424-
3f8f2656eb7e_en 

 
 
 
 
Regulation  (EC)  No  1069/2009.  The  calculation  is  based  on  the  current  volumes  of  Category  1 
materials  and  average  EU  disposal  costs  weighted  by  disposal  routes  (65%  incineration  and  35% 
recovery).  

Assumptions: 

Source 

Method of estimation 

Volume (tonnes/year) 

SRM from slaughtered bovines  Based  on  appr.  17  million 
bovines  aged  over  12  months 
slaughtered annually in the EU 
(2023 data144) and an average 
of  10  kg  SRM  per  animal 
(skull,  spinal  cord,  vertebral 
column, etc.) 

170,000 tonnes 

Fallen stock (on-farm deaths) 

354,090 tonnes  

kg 

80 

Estimated  from  average  cattle 
mortality  rates  (2%  for  >24 
months  and  5% 
for  <24 
months)  and  carcass  weights 
kg, 
and 
(350 
respectively), 
in 
approximately  407,000  tonnes 
of  fallen  stock  annually.  Of 
this,  around  87%  is  currently 
classified 
as  Category  1 
material 
under  Regulation 
(EC) No 1069/2009. 

resulting 

Total Category 1 material 

524,090 tonnes/year 

Under the 85% alignment scenario, approximately 445,000 t/year of Category 1 material would be 
reclassified in a different category, leaving around 79,000 t/year still subject to Category 1 treatment. 

•  Disposal cost ranges  

- Incineration EUR  357.5/t (65%) 
 - Recovery (biodiesel) EUR 182 /t (35%) 

Calculation 

•  Weighted average disposal cost: EUR  357.5 x 65% + EUR 182 x 35% - 232.37 + 63.7 =EUR 

296.1/t  

•  Baseline total disposal cost: 524,090 x 296.1/t = 155.1 million/year 

144 Database - Eurostat 

93 

 
 
 
 
 
•  85% alignment scenario: remaining Category 1 material = 78.614 t (15% of baseline)  

After applying the 85% reduction, the cost for the remaining 78.614 t of Category 1 material is: 

78.614 t x EUR 269 million = 23.3 million/year  

This result in total annual savings of EUR 155.1 million - EUR 23.3 million = EUR 131.8 million 
/year 

Total savings: the savings are distributed as follows: 

 - operators (70%) = 92.3 million/year 

 - authorities (30%) 39.5 million/year 

94 

 
 
 
5. Official Controls Regulation 

5.1 Cost savings for the partial clearance of consignments of plants 

This data estimates the financial impact of amending the current rules implemented in BCPs. The 
calculations are based on data from the year 2023. 

TRACES 2023 Annual report 

TRACES - Publications Office of the EU 

Financial impact on the operators 

The financial impact of the current rules on operators can be assessed based on the figures collected 
from the Netherlands, which is the biggest importer in the EU. 

 Out  of  300  690  Dutch  consignments,  2965  consignments  of  perishable  goods  were  subject  to 
laboratory samples. Out of these 2965 consignments, 1198 consignments were subject to samples on 
only parts of consignments (On a ‘lot’, following Article 2(7) of Regulation (EU) 2016/2031). This 
means that some lots are cleared by inspectors, and others are awaiting laboratory results, meaning 
that a ‘partial decision’ was applicable in these numerous cases. 

Therefore, perishable commodities being shipped within one of these 1198 consignments could be 
potentially lost while awaiting laboratory results.  

Only 125 of these 1198 consignments were rejected for the presence of plant pests, the other 1073 
were  compliant  and  unnecessarily  detained,  their  commodities  potentially  destroyed.  In  certain 

 
 
 
instances, the delay in obtaining laboratory results may exceed one month, a timeframe that is more 
than sufficient to render perishable goods unsalvageable. 

If we extrapolate this number at EU level, if 1198 consignments represent 28.8% of all consignments 
being partially sampled for laboratory results, we estimate the number of total EU consignments to 
reach 4160. 

Figure 3: Number of Dutch consignments subject to laboratory samples  

Estimated Economic Impact 
The  estimated  total  value  of  EU  imports  of  fruits  and  vegetables  in  2023  was  almost  EUR  30 
million.   

Chapter  Product category 

Value 2023 (Mio EUR 
) 

Share  in  all  Agri 
2023 

07 

08 

Total 

Edible vegetables, roots, and tubers  EUR  6.622 

Edible fruits & nuts 

EUR  21.205 

EUR  27.827 

4.2 % 

13.3 % 

17.5% 

Figure 4: Agri-food trade statistical factsheet - Extra EU27, chapter 6,7,8 in table ‘Evolution of 
Agri-food imports from Extra EU27, 2020 – 2023, page 8 

Imports of fruits and vegetables accounted for EUR 27 827 million in 2023 and made for 17.5% of 
all Agri imports. It is to be noted that edible fruits and nuts are the most valuable assets in the report’s 

96 

 
 
 
 
 
  
 
table and show the highest import share. Now, as explained above in the TRACES report, 76% of 
consignments were for fruits and vegetables in 2023, which accounted for 793 465 consignments, 
representing EUR 27 827 million. 

Therefore, on average, one consignment of this type has an estimated economic value of EUR 35 
070. It was estimated above that at EU level 4160 of such partially sampled consignments could carry 
perishable commodities that may potentially be destroyed. 

This represents a potential loss of EUR 145 892 156, or EUR 146 million per year. Only the costs for 
fruits and vegetables were estimated. Other living plants like cut flowers could also be considered as 
perishable goods. This market is valued at several billion euro, and as such, the potential annual losses 
could exceed EUR 150 million annually. 

Moreover, the data and reports referenced are based on figures from 2023. The 2024 DG AGRI report 
(98c0d1eb-4fb9-4b8c-87c7-8034c17b1e82_en)  indicates  an  increase  in  import  costs  for  these 
categories of commodities, especially edible fruits and nuts, which rose from EUR 21,037 million in 
2023 to EUR 23,694 million in 2024. This category accounted for 13.8% of all agricultural imports 
in 2024. Based on this data, the potential loss for 2024 may exceed previous estimates. 

It should also be noted that this analysis does not account for commodities contained within mixed 
consignments, a common occurrence in the plant health sector, which may not individually require a 
CHED-PP  but  are  included  as  part  of  larger  consignments  and  may  consequently  be  subject  to 
destruction during the process. These commodities are listed in Regulation (EU) 2019/2072, Annex 
XI, Part B. 

5.2 Cost savings for accreditation of reference laboratories 

COFRAC (Comité Français d’accréditation) represents the French Committee for accreditation and 
is  the  reference  body  in  France  for  accreditation.  This  estimation  is  based  on  COFRAC  Data  for 
medium  size  laboratories  (more  than  5  laboratory  experts)  with  one  technical  section,  that  files  a 
dossier for accreditation for one method first within a fixed scope, then a second one later with an 
extension of the scope, for a period of 5 years. 

To obtain and maintain accreditation, a laboratory must incur and pay various associated costs: 

• 
Instruction fees  
•  Evaluation fees  
•  Extension fees (Optional) 
•  Annual fee. 

4.1.1.1.Instruction fees 

The  application  fees  are  intended  to  cover  the  resources  used  for  registering  the  application, 
compiling and examining the file. 

The instruction fees are divided into two components. Part A and Part B. 

Part A corresponds to the flat-rate administrative fees, which cover file management and the logistical 
organization of the evaluation. This amount is set at EUR 442 x 2, where “2” is the coefficient applied 

97 

 
 
 
for one subdomain, within the fixed scope. Consequently, the cost for Part A is estimated at  EUR 
884 for one subdomain within the fixed scope. 

Part B corresponds to the technical expertise fees, which cover the technical analysis of the file prior 
to the audit. The rate is set at EUR 1332 per day per assessor. The analysis is estimated to require 
two days, resulting in an estimated cost of EUR 2664 for Part B. 

4.1.1.2. Evaluation fees 

The  fees  associated  with  the  assessment  cover  the  preparation  of  assessments  by  Cofrac,  the 
remuneration  of  the  assessment  team,  logistical  costs  incurred,  any  translation  costs,  and  the 
resources used to process the assessment report and notify the accreditation decision. 

The assessment fees are calculated on the basis of: 

•  EUR 1474 per day, per person, for quality assessors and technical assessors responsible for 

conducting the assessment (lead). 

•  EUR 1352 per day, per person, for assessors and technical experts. 

This results in a total of EUR 2826 per day for an audit team composed of one lead assessor and one 
technical assessor, in addition to logistical costs (transport, accommodation and catering) estimated 
at EUR 800 per team, per day. 

In addition, the preparation costs represent 2% of the evaluation costs. 

3 types of audits occur: 

Initial audit, estimated at 4 days. 

• 
•  Surveillance audit, estimated at 2 days, every 15 months, so 4 times for 5 years. 
•  Renewal audit, estimated at 2 days, to renew the accreditation once every 5 years. 
•  Extension audit, estimated at 2 days, to extend the scope. 

4.1.1.3. Extension fees 

Extension fees are applicable when a laboratory applies for accreditation for an additional recognized 
laboratory  method.  For  such  an  extension,  the  costs  are  generally  similar  to  those  of  the  initial 
accreditation but differ slightly, notably due to the shorter audit duration. For Part A of the instruction 
fees, the coefficient is set at 1.5 and the initial audit is estimated to last only one day. 

4.1.1.4. Annual fee 

The  licence  fees  are  intended  to  cover  the  various  operations  necessary  to  maintain  a  level  of 
accreditation service that satisfies all the economic players concerned, from which derives the right 
to use the Cofrac mark. 

This represents EUR 1471 per year, therefore EUR 7355 for 5 years. 

TOTAL  COST  FOR  ONE  TECHNICAL  UNIT  WITHIN  ONE  LABORATORY,  ONE 
ACCREDITATION, FOR TWO METHODS (Fixed scope + Extension) 

Initial fees: 

• 

Initial Part A instruction fees = 442 x 2 = 884 EUR  

98 

 
 
 
• 
• 
• 
• 

Initial Part B instruction fees = 2 x 1332 = EUR 2664 
Initial evaluation fees = 4 days x 2826 = EUR 11304 
Initial preparation costs = 2% x 11,304 = EUR 226.08 
Initial audit logistics costs= 4 x 800 = EUR 3200 

Surveillances (4 audits x 2 days, over 5 years): 

•  Surveillance evaluation fees = 4 x (2 x 2826) = 4 x 5652 = EUR 22608 
•  Surveillance preparation fees = 4 x (2% x 5652) = EUR 452.16 
•  Surveillance logistics costs = 4 x (2 x 800) = EUR 6400 

Renewal (1 audit x 2 days, once after 5 years): 
•  Renewal evaluation fees = EUR 5652 
•  Renewal preparation fees = EUR 113.04 
•  Renewal logistics costs = (2 x 800) = EUR 1600 

Extensions (1 audit x 1 day): 

•  Extension Part A instruction fees = EUR 663 (442 x (1.5) 
•  Extension Part B instruction fees = EUR 1332 
•  Extension evaluation fees = EUR 2826 
•  Extension preparation costs = EUR 56.52 
•  Extension logistics costs = EUR 800 

Annual fees: 5 x 1471 = EUR 7355 

Total = EUR 68135.80 for ONE TECHNICAL UNIT. 

Note:  A  flexible  scope  is  also  available,  as  defined  by  COFRAC,  and  is  categorized  as  FLEX1, 
FLEX2, and FLEX3. The average cost of accreditation under these flexible scopes is EUR 64043.41, 
which is close the fixed scope’s estimated cost. 

TOTAL COST FOR ALL LABORATORIES, for TWO  METHODS for ONE PEST (Fixed 
scope + Extension) 

In  the  European  Union,  National  Reference  Laboratories  (NRLs)  and  European  Union  Reference 
Laboratories  (EURLs)  are  responsible  for  identifying  plant  pests  using  accredited  laboratory 
methods. These laboratories are distributed across Member States, with some comprising multiple 
technical  sections.  Each  section  must  be  accredited  for  the  tests  it  performs  on  plant  pests,  using 
specific recognized laboratory methods.  

The total number of technical units across the EU is 142. 

Commission  Implementing  Regulation  (EU) 2019/2072  Annex II lists the Union quarantine pests 
into 180 entries, categorized as bacteria, fungi and oomycetes, insects and mites, nematodes, parasitic 
plants, and viruses, viroids and phytoplasmas. Each entry may consist of a pest species, a group of 
species, a family or a genus. Each group, family or genus of pests may encompass multiple individual 
pests, in some cases several dozens. Consequently, it is estimated that this Regulation covers more 
than 500 Union quarantine pests. Laboratories may be assigned the task of identifying any of these 
listed pests. 

99 

 
 
Since  a  technical  unit  is  typically  specialized  in  a  specific  category  of  plant  pests  (bacteria, 
nematodes,  etc)  it  only  needs  to  be  accredited  for  the  tests  performed  on  the  pests  within  that 
particular category of specialization.  

An agreement was reached at COPHs level to adopt a stepwise approach to laboratory accreditation, 
beginning with priority areas. These priorities include the 20 priority pests listed in Regulation (EU) 
2019/1702, potato pests, pests associated with outbreaks, and pests linked to imports and imported 
commodities.  It  may  be  estimated  that,  in  accordance  with  these  guidelines,  the  conservative 
minimum  number  of  pests  requiring  priority  accreditation  is  at  least  50  on  average  per  technical 
section of laboratories.  

Therefore, on the conservative assumption that accreditation is required for a minimum of 50 plant 
pests per technical section, as an average number per technical section, then the total cost is: 

•  50 x 68135.80 = EUR 3 406 790 for one technical unit. 
•  50 x 68135.80 x 142 = EUR 483 764 180 total cost for all reference laboratories. 

Note:  These  estimates  are  based  for  only  two  methods.  In  practice,  technical  units  often  require 
accreditation for multiple methods, with the total number of recognized methods used by reference 
laboratories, as listed by EPPO, exceeding 20. Furthermore, plant pest detection can be performed 
on  various  matrices  (plant  leaves,  fruits,  roots,  soil,  etc).  Detection  on  a  specific  matrix  may 
necessitate  a  separate  accreditation  file,  and  another  method  could  also  require  an  additional  file, 
thereby further multiplying the costs. 

These  factors  significantly  increase  the  costs  of  accreditation  for  laboratories.  For  three  matrices, 
(fixed or flexible scope) the total costs for reference laboratories across the EU would approach EUR 
1.5  billion,  even  assuming  only  two  accredited  methods  per  technical  unit  and  for  only  50  pests, 
which are very low numbers as compared to the total number of EU regulated quarantine pests. It is 
therefore reasonable to assume that the total cost of accreditation would be increased by orders of 
magnitude when additional pests, and multiple methods and matrices are considered. 

The amendment avoids the need for technical units to be accredited for all regulated pests to be tested, 
but only for one main group of pests (Bacteria, viruses, nematodes, etc), meaning that if a technical 
unit is accredited for one method for one  bacterium, the amendment grants accreditation with the 
same method for all bacteria. 

EUR 68 000 is the cost for one technical  unit over 5 years to  be accredited for one pest,  for two 
methods. 

There is one pest per group for which accreditation is needed for the two methods. We consider the 
estimation for 3 matrices. And the final number is multiplied by 142 as the estimation is drawn for 
the 142 technical units. 

- 68 000 x 3 x 142 = 28 968 000 over 5 years at EU level, for accreditation with 2 methods. 

Annually, these equals to EUR 5 793 600 annually. Compared to the estimation of the current regime 
of EUR 483 764 180 annually, this is a difference of EUR 477 970 580, or a difference of 98%.  

100 

 
 
 
TOTAL  COST  FOR  ONE  LABORATORY,  ONE  ACCREDITATION,  FOR  TWO 
METHODS (Fixed scope + Extension) 

In  the  European  Union,  National  Reference  Laboratories  (NRLs)  and  European  Union  Reference 
Laboratories (EURLs) are responsible for detecting and quantifying feed additives and food contact 
materials using accredited laboratory methods. In the EU there are 2 EURLs and 54 NRLs that must 
be  accredited  for  the  tests  they  perform  on  FA  and  FCM,  using  specific  recognized  analytical 
methods.  

For  an  accreditation  issued  by  the  Belgian  Accreditation  Body  (BELAC)  with  one  method  under 
fixed scope and one extension: 

RENEWAL assessment: 

General assessment: 1 day assessment  = 3500 EUR 

Technical assessment one method – fixed scope: ½ day assessment = 1500 EUR 

Extension assessment for one method: 1 day assessment = 3500 EUR 

TOTAL = 8500 EUR 

3 SURVEILLANCE assessments: 

General assessment: 1 day assessment  = 3500 EUR 

Technical assessment of two methods under accreditation: 1 day assessment: 3500 EUR 

TOTAL = 7000 EUR x 3 = 21.000 EUR 

Dossier costs: 1200 EURO (one accreditation standard) x 5 = 6000 EUR 

TOTAL: 35.500 EUR for 2 methods under accreditation for 5 years 

AVERAGE: 3550 EUR / method / year 

5.3 CONCLUSION 

Given the clearly unattainable legal objectives for National Reference Laboratories and European 
Union Reference Laboratories to be accredited for all tests and methods for all pests, feed additives 
and food  contact  materials  across different  matrices due to  the unreasonable associated costs, the 
resulting total cost at EU level is disproportionate. 

In this context, a legal amendment to Regulation (EU) 2017/625 of the European Parliament and of 
the Council is necessary to ensure that reference laboratories in plant health, feed additives and food 
contact materials can operate effectively and in full compliance with EU law. 

Therefore,  a  derogation  to  the  requirement  of  mandatory  accreditation  for  all  methods  used  by 
national and European Union Reference Laboratories is needed and indispensable.  

101 

 
 
Notes: 

•  At present, some laboratories have already started accreditation for certain pests, while others 
have  not  yet  begun.  Consequently,  there  is  currently  heterogeneity  in  the  progress  of 
accreditation among laboratories across Member States. 

•  Regular mandatory proficiency tests are mandatory to maintain accreditation, while reference 

• 

material and methods are lacking for numerous pests. 
In addition to cost, time represents another critical factor. Indeed, the accreditation process is 
lengthy and resource-intensive, encompassing compliance preparation, audit planning, and 
the conduct of the numerous audits themselves. 

•  Finally,  human  resources  constitute  a  critical  factor  for  laboratories.  The  time,  which 
laboratory experts devote to preparing for accreditation, represents an increased allocation of 
staff to quality-related activities, to the detriment of laboratory work. 

102