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
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Introduction
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MAIN ISSUES
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MEASURES 3.1. Faster access to markets and innovation 3.1.1. Biocontrol plant protection products (PPP) 3.1.2. Aerial spraying of PPP by drones 3.2. Lowering administrative burdens 3.2.1. Further PPP simplification 3.2.2. Simplification for biocidal products 3.2.3. Maximum Residue Levels 3.2.4. GMM fermentation 3.2.5. Feed additives 3.2.6. Overlap in notification of national hygiene measures 3.3. Reducing unnecessary complexity in risk management 3.3.1. Depopulation reporting 3.3.2. Record‑keeping for livestock farmers 3.3.3. Updating BSE rules 3.3.4. Flexibility in official controls
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CONCLUSION ANNEX I: SUMMARY OF COST‑SAVINGS ANNEX II: SYNOPSIS OF STAKEHOLDER CONSULTATION ANNEX III: METHODOLOGY FOR COST SAVINGS Glossary Term or acronym Meaning or definition BSE Bovine Spongiform Encephalopathy CAP Common Agricultural Policy COPHS Council Working Party of Chief Officers of Plant Health Services ECHA European Chemicals Agency EFSA European Food Safety Authority EP European Parliament ESFC E‑Submission Food Chain platform EU European Union EURL European Union Reference Laboratory EURL‑FA European Union Reference Laboratory for feed additives FA Feed Additives FCM Food Contact Materials GMM / GMO Genetically Modified Micro‑Organism JRC Joint Research Centre of the European Commission MEP Member of the European Parliament MRL Maximum Residue Level MS Member States OCR Official Controls Regulation NRL National Reference Laboratory PPP Plant Protection Products RASFF Rapid Alert System for Food and Feed RMS Rapporteur Member State SCoPAFF Standing Committee on Plants, Animals, Food and Feed SME Small and Medium‑sized Enterprise SRM Surveillance Risk Material SUD Sustainable Use Directive TFEU Treaty on the Functioning of the European Union TSE Transmissible Spongiform Encephalopathy WOAH World Organisation for Animal Health -
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. 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 € 37.5 billion in savings for businesses.
This ambition to “make business easier and faster” is particularly relevant for the agri‑food sector. 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. The Commission’s proposals for targeted simplification measures in agriculture since 2024 respond to direct calls from farmers and Member States for proportionate rules and lighter administrative requirements.
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. This proposal alone is projected to reduce administrative costs for farmers by up to € 1.58 billion annually, with particular benefits for small and medium‑sized farms.
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. 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. A proposal to create a framework for plants obtained by certain new genomic techniques (NGTs) would also streamline current rules and benefit farmers, consumers, and the environment.
The next step 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.
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 MRLs. The evaluation of the Feed Additives (FA) modernise labelling requirements for feed additives. Evidence from the implementation of the Biocidal Products Regulation, and the implementation of the Official Controls Regulation (OCR) highlighted obligations that could be simplified without lowering the level of protection.
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.
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)
- 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.
- 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. 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.
Key challenges identified:
- Disproportionate administrative burdens – systematic renewals, duplicated checks and extensive documentation.
- Procedural inefficiencies – sequential steps, missed timelines and backlogs.
- Fragmentation across Member States – divergent interpretations of reporting, notification or mutual‑recognition obligations.
- Misalignment with science and international standards – outdated terminology, rigid procedures and limited flexibility for evidence‑based updates.
These challenges provide an opportunity to recalibrate the acquis, maintaining high protection while reducing complexity, freeing up resources and enabling innovation.
- MEASURES
2.0 Faster access to markets and innovation
2.0.0 Biocontrol plant protection products (PPP)
Biocontrol substances (micro‑organisms, semi‑ochemicals, plant extracts, etc.) offer lower‑concern tools for growers. Current procedures are too slow, the zonal authorisation system underperforms and assessment capacity is insufficient. The proposal:
- Creates an EU‑level definition of “biocontrol substance”.
- Requires Member States to prioritise biocontrol applications.
- Allows provisional authorisations for PPPs containing new biocontrol substances once the RMS assessment is satisfactory.
- Introduces a one‑zone approach for authorisations and a tacit‑agreement rule for missed deadlines.
- Enables applicants to choose EFSA as rapporteur for initial assessment.
- Removes record‑keeping obligations for professional users where a PPP contains only biocontrol substances.
2.0.1 Aerial spraying of PPP by drones
The Sustainable Use of Pesticides Directive (SUD) currently prohibits aerial spraying except by national derogation. The proposal amends SUD to empower the Commission to adopt a delegated act identifying drone types with equal or lower risk than ground‑based equipment, allowing Member States to exempt those types from the prohibition. This creates a clear, science‑based framework for drone use while preserving high protection standards.
2.1 Lowering administrative burdens
2.1.0 Further PPP simplification
- Unlimited approvals for most active substances, with targeted reassessments where needed.
- Enhanced mutual recognition with reduced documentation.
- EU‑wide data‑protection coherence.
- Clarification of basic substances and treated seeds.
2.1.1 Simplification for biocidal products
- Unlimited approvals for most biocidal active substances, retaining systematic renewals only for high‑concern substances.
- Removal of the obligation to publish Union authorisations in the Official Journal; only a summary will be published.
- Revision of Article 95 data‑protection expiry dates to align with the review programme timeline.
2.1.2 Maximum Residue Levels
- Allows transitional measures for lower MRLs to avoid waste.
- Makes monitoring‑based MRLs permanent, with review possible when new information arises.
- Sets a “technical zero” limit for certain hazardous substances in imports.
- Aligns terminology from “limit of determination” to “limit of quantification”.
2.1.3 GMM fermentation
Clarifies that fermentation products produced with genetically modified micro‑organisms are not food or feed “produced from GMOs” provided no viable GMMs are present and residues are limited to non‑viable cells, removing uncertainty for innovators while keeping safety assessments under the appropriate sectoral regulations.
2.1.4 Feed additives
- Removes systematic 10‑year renewal obligation for all feed additives except coccidiostats and histomonostats.
- Simplifies modification of existing authorisations (administrative notification instead of dedicated regulation).
- Allows digital labelling for non‑safety information, maintaining physical labels for safety data.
2.1.5 Overlap in notification of national hygiene measures
National hygiene measures will be notified only under Directive (EU) 2015/1535 (TRIS database), eliminating duplicate notifications under Regulations (EC) Nos 852/2004 and 853/2004.
2.2 Reducing unnecessary complexity in risk management
2.2.0 Depopulation reporting
The separate annual depopulation report required by Regulation (EC) No 1099/2009 is removed; relevant information will continue to be reported through the existing OCR annual reports.
2.2.1 Record‑keeping for livestock farmers
Duplication between Directive 98/58/EC and sectoral regulations is eliminated; record‑keeping obligations are consolidated under the more detailed sectoral rules.
2.2.2 Updating BSE rules
Regulation (EC) No 999/2001 will be modernised to align surveillance, SRM lists and trade restrictions with the latest WOAH standards and EFSA scientific advice, preserving high protection while removing obsolete provisions.
2.2.3 Flexibility in official controls
- Allows partial clearance of consignments at border control posts, preventing unnecessary detention of compliant goods.
- Introduces targeted derogations from mandatory accreditation for reference laboratory methods, keeping accreditation where essential while reducing burdens for low‑risk methods.
- CONCLUSION
The omnibus proposal delivers concrete legislative adjustments that streamline procedures, reduce administrative burdens and improve legal clarity, while maintaining the EU’s high level of protection for human, animal and environmental health. Expected outcomes include:
- Annual cost savings of at least € 428 million for businesses and € 661 million for administrations from 2027 onward.
- Faster market access for innovative biocontrol and low‑risk PPPs.
- Greater legal certainty for feed additives, biocidal products and GMM‑derived fermentation products.
- Improved efficiency of official controls and reduced waste in the food chain.
Implementation will be phased, with most measures becoming operational from 2027 and the wider PPP simplification rollout completing by 2029.
| ANNEX I: SUMMARY OF COST‑SAVINGS | Measure | Businesses (EUR/year) | SMEs (EUR/year) | National & EU administrations (EUR/year) | Type of cost saving |
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| Aerial spraying of PPP | 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. | Small–moderate gains where labour / access constraints bind | Small efficiency gains in permitting and regulatory oversight. | Recurrent adjustment cost savings. | |
| PPP simplification, including biocontrol | 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, 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 | Substantial benefit, especially in regard to biocontrol PPP, but no robust EU‑wide split feasible. | Small–moderate admin time saving | Recurrent administrative cost savings. | |
| Biocides | 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. | High relative gain for SME formulators. | Small–moderate admin saving. | Recurrent administrative cost savings. | |
| MRLs | Small to moderate savings from fewer MRL adjustment requests and avoided write‑offs respectively. | Small–moderate savings for SME traders. | Minor case‑handling efficiency. | Recurrent administrative + adjustment cost savings. | |
| GMM fermentation | Avoids costly misclassification and recalls, but event‑driven, so large cost savings when incidents avoided. | Event‑driven protection for SME innovators. | Minor enforcement/admin saving. | One‑off adjustment cost savings. | |
| 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 | Recurrent administrative cost savings. | |
| National hygiene measures | Minor recurring saving from reduced duplications. | Minor saving, esp. micro‑FBOs. | Minor reduction of duplicate processing | Recurrent administrative cost savings. | |
| Depopulation reporting | Neutral–small positive (fewer ad‑hoc data calls) | Neutral–small positive. | Small admin saving (streamlined reporting) | Recurrent administrative cost savings. | |
| Record‑keeping for farmers | Small–moderate time saving per holding | Small–moderate relative gain for small farms | Small admin saving (streamlined reporting) | Recurrent administrative cost savings. | |
| 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 | |
| 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. | 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, via fewer renewal rounds, faster time‑to‑market, and lower cash‑flow risk. | 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. |
ANNEX II: SYNOPSIS OF STAKEHOLDER CONSULTATION
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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. 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.
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Stakeholder views by topic (Full stakeholder summaries are provided in the original document; the key conclusions are reflected in the measures above.)
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 of savings rather than replace a full impact assessment.
(Additional methodological details are omitted for brevity.)
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