New ECHA risk assessment for bees: what biocide manufacturers need to know by February 2026

In February 2024, the European Chemicals Agency (ECHA) published guidance that fundamentally changes the approach to assessing the risk of biocides to bees. For the first time in the history of biocidal product regulation in the EU, manufacturers and importers will have to use a quantitative methodology to assess the impact of their products on bee populations.

Date of application: 1 February 2026. From that date it applies to all new applications for the approval of active substances and the renewal of biocidal product authorisations.

For Serbian companies that export biocidal products to the EU, or plan to, the key question is: What situation are you in and what does it mean for you?

Are you planning a new application in early 2026? Is your renewal coming up soon? Or do you have more time to prepare? Your action plan depends on the answers to these questions.

What situation are you in? Segmentation by compliance deadlines

The new ECHA guidance does not affect everyone in the same way. Your situation depends on when you plan to submit an application or when your existing authorisation in the EU expires.

Category 1: New applications for the EU in early 2026 (NOW – February 2026)

If you plan to submit a new application for:

approval of new active substances
authorisation of a biocidal product

And you submit it AFTER 1 February 2026:

✓ The application MUST meet the new requirements

✓ You should already have all tests completed

✓ PEQ calculations and risk assessments ready

If you are not ready:

Consider postponing the submission of the application
Use the time to prepare the documentation
Better to postpone than to submit an incomplete dossier

Category 2: Renewal of authorisation in 2026 (URGENT – planning needed immediately)

If your authorisation expires for:

Active substances
biocidal products

During 2026:

⚠️ The renewal documentation will probably need to comply with additional requirements

⚠️ Gap analysis needed IMMEDIATELY

Action steps:

Contact the regulatory authorities to clarify the requirements
Urgent gap analysis of the existing documentation
Identification of the critical missing data
Fast-track testing for critical analyses

Category 3: Renewal of authorisation 2027-2028 (Ideal timing for preparation)

If your authorisation expires:

During 2027
In early 2028

✓ You have enough time for systematic preparation

✓ You can plan the tests properly

✓ Budget approval through the standard procedure

Proposed timelines:

Q1-Q2 2026: Gap analysis and planning
Q2-Q4 2026: Laboratory testing
Q1-Q2 2027: Data analysis and report writing
Q3 2027: Documentation ready for submission

Category 4: Renewal 2028+ (Proactive planning)

If your authorisation expires:

After 2028 or later

✓ A good position for strategic planning

✓ Time to optimise costs

✓ Possibility of a phased approach

Strategic considerations:

Portfolio review: which products are worth the investment?
Multi-year budget planning
A proactive instead of a reactive approach
Possibility of reformulation or the use of alternative active substances

What is new in the methodology? (For all categories)

From qualitative assessment to quantitative methodology

Until now: Risk assessment for bees in the context of biocidal products was based on qualitative assessment or, at best, on methods adapted from pesticide regulation. There was no specified quantitative methodology for biocides.

From February 2026: A complete “tiered approach” methodology is introduced, developed specifically for biocidal products, based on the EFSA guidance for plant protection products (May 2023) but adapted to the specific use scenarios of biocides.

This change is not cosmetic. It requires:

New laboratory tests
PEQ (Predicted Exposure Quantity) calculations
A detailed assessment of four risk cases
An assessment of Time Reinforced Toxicity (TRT)
An analysis of sublethal effects on bees

Who is covered by the new ECHA guidance?

Directly affected: PT18 products

Product Type 18 (insecticides, acaricides and products to control other arthropods) is the primary target of the new rules. This includes:

Insecticides used in livestock production (treatment of stables and manure)
Treatments of building walls and foundations
Preparations for disinfecting water used for irrigation
Large-scale treatments of trees, shrubs and natural water surfaces

Indirectly affected: Other types of biocidal products

A risk assessment for bees may also be required for biocidal products that are NOT PT18, if:

The active substance has an insecticidal mode of action
There is significant potential exposure of bees
The way the product is used may lead to bees coming into contact with it

What is new in the methodology?

“Tiered Approach” - Risk assessment in tiers

The new ECHA guidance introduces a structured approach with three tiers for both exposure and effects assessment:

Tier 1 – Lower tier (conservative approach):

Worst-case scenarios
Standard laboratory tests
Defined exposure models

Tier 2 – Refined assessment:

More realistic use scenarios
Additional data on metabolites
More precise calculations

Tier 3 – Higher tier:

Field study or semi-field study
Real exposure conditions
Assessment at colony level

Four risk cases that must be covered

For every biocidal product subject to assessment, the following must be analysed:

Acute-contact exposure – Acute exposure through contact
Acute-dietary exposure – Acute exposure through diet (pollen, nectar)
Chronic-dietary exposure – Chronic exposure through diet
Larvae-dietary exposure – Exposure of larvae through diet

For each risk case:

PEQ (Predicted Exposure Quantity) calculation
Derivation of dose-response curves (DRC)
Quantitative risk characterisation

New tests and data requirements

Standard laboratory tests:

Acute oral toxicity test (honey bees)
Acute contact toxicity test (honey bees)
Chronic oral toxicity test (honey bees, 10 days)
Larval toxicity test

Additional requirements:

Time Reinforced Toxicity (TRT) assessment: does the substance show increased toxicity with long-term exposure to small doses?
Analysis of sublethal effects: effects on behaviour, learning, orientation
Risk assessment for metabolites
Assessment of the mixture (for final products)

Specific emission scenarios for biocides

The ECHA guidance defines four main use scenarios for PT18 products with potential exposure of bees:

1. Application of manure/slurry from stables

Scenario: Biocides used in livestock production end up in manure that is applied to agricultural land.

Exposure route:

Direct contamination of flowers on the treated area
Contamination of weeds growing on the treated area
Translocation through the soil into next season’s plants

2. Spraying of building walls and foundations

Scenario: Treatment of building walls and foundations against insects.

Exposure route:

Vegetation growing next to the building (0.5 m zone)
Drift during application
Run-off from the treated surface

3. Irrigation of private gardens with treated water

Scenario: Water treated with biocides is used for irrigation.

Exposure route:

Contamination of flowers through irrigation water
Contact with wet surfaces
Residues in pollen and nectar

4. Large-scale treatment of trees, shrubs or water surfaces

Scenario: Large-scale applications to control disease vectors or pests.

Exposure route:

Direct contact during application
Residues on vegetation
Contamination of water sources

Financial and operational impact

The new ECHA guidance significantly increases the complexity and volume of documentation needed for compliance.

Additional requirements:

Laboratory tests:

Acute oral toxicity test (honey bees)
Acute contact toxicity test (honey bees)
Chronic oral toxicity test (honey bees, 10 days)
Larval toxicity test
Additional studies as needed (TRT assessment, sublethal effects, metabolites)

Additional documentation:

Extended exposure calculations (PEQ for all scenarios)
More complex risk characterisation

Operational impact:

PEQ calculations for all relevant emission scenarios
Derivation of dose-response curves (DRC)
Risk characterisation for 4 types of cases
A detailed exposure assessment
Risk mitigation measures and instructions for use

Operational impact:

Preparation timeframe:

Depends on the existing state of the documentation (gap analysis!)
A minimum of 12-18 months for complete preparation
Laboratory tests = the longest part (6-12 months)

Resources needed:

GLP-certified laboratories with experience in bee toxicity testing
Consultants with experience in BPR submissions
Internal technical staff for data analysis
A QA/RA team for documentation review

Financial aspect:

The exact scale of costs depends on:

The existing state of the documentation (gap analysis!)
The number of products in the portfolio
The complexity of the formulations and emission scenarios
The need for higher-tier studies

Recommendation: Start with a gap analysis to get a realistic estimate of the specific costs and timeframe for your portfolio.

What does this mean for Serbian manufacturers and exporters?

Immediate impact on exporters to the EU

Companies that currently export PT18 products to the EU, or plan to, must be prepared for the new requirements.

Link with the domestic Law on Biocidal Products

With the Law on Biocidal Products (Official Gazette of RS, No. 109/21), Serbia has harmonised with the EU BPR. This means:

Companies planning to export to the EU must already be preparing for the upcoming application
Domestic legislation follows changes in EU legislation with a delayed implementation date
Best practice is to prepare documentation according to EU standards where and when this is possible and relevant.

Practical implication:

Although the ECHA guidance is not directly applicable in Serbia from 1 February 2026, companies that prepare early will have:

A competitive advantage on the EU market
“Future-proof” documentation
An easier transition when Serbia implements similar requirements
Credibility with international partners

A practical action plan for your situation

What you need to do depends on your specific situation. Here are detailed action plans for each category:

Action Plan 1: New applications for approval in early 2026 (February)

Your situation: You planned to submit an application in January-February 2026.

Situation check:

❌ It is very likely too late to prepare complete documentation if you do not have the tests done
✓ You can postpone submitting the application until you are ready
✓ Better to postpone than to submit an incomplete dossier

Steps NOW:

Urgent gap analysis (immediately)
- A list of all the tests required under the ECHA guidance
- A check of what already exists in the documentation
- Identification of the critical missing data
Honest assessment (next week)
- Is it realistic to finish during January?
- How much does fast-track testing cost?
- Is it worth investing, or is it better to wait?
Making a decision:
- Option A: Postpone submitting the application by 6-12 months and do it properly
- Option B: Submit the application with the data you have and make a plan for obtaining the missing data (if the regulatory authority accepts this)
- Option C: Consult the regulatory authorities for further guidance
Contact:
- Contact the regulatory authority in the EU Member State for additional clarification
- Specialised consultants for support of this kind
- GLP laboratories about options for priority testing (if plan B is the option you choose)

Action Plan 2: Authorisation expiring during 2026

Your situation: Your existing authorisation expires during 2026.

Situation check:

⚠️ The timeframe is tight, but it is doable
✓ It depends on the deadline for submitting the application to renew the authorisation
✓ Consult the responsible regulatory authorities – KEY

Steps by priority:

1. Clarifications from the responsible regulatory authorities (IMMEDIATELY)

When exactly does your authorisation expire?
When is the deadline for submitting a new application?
Will the new requirements be mandatory for your renewal?
Is there a transition period?

2. Gap analysis (December 2025)

Existing documentation vs. the requirements of the ECHA guidance
Identification of missing studies
Prioritisation: what is critical, what is “nice to have”

3. Contact with laboratories (January 2026 START)

Contact GLP-certified laboratories IMMEDIATELY
Priority scheduling for key tests
A realistic timeframe from them
Cost estimate

4. Parallel activities (February-June 2026)

Tests in progress
Preparing the PEQ calculations in the meantime
Developing the risk characterisation framework
Draft version of the report

5. Preparation for submitting the application (July-September 2026)

Data analysis
Finalising the report
Data quality report
Assembling the documentation into a dossier

6. Additional time in case it is needed (October 2026+)

Contingency plan
Responses to questions from the regulatory authorities
Final corrections/revisions

Action Plan 3: Authorisation expiring during 2027/2028

Your situation: Your authorisation expires in mid/late 2027 or in 2028.

Situation check:

✓ You have enough time for a quality application
✓ You can plan within regular budget cycles
✓ An opportunity to optimise costs

Recommended timeline:

Q1 2026: Planning phase

Comprehensive gap analysis
Portfolio review: all products that need their authorisation renewed
Budgeting for testing and consultancy services
Obtaining approvals for activities within normal company procedures

Q2 2026: Preparation for starting activities

Selection of laboratories
Development of study protocols and approvals
Initial meetings with all relevant stakeholders
Setting up a structure for delivering this project

Q2-Q4 2026: Testing phase

Laboratory testing
Monitoring results
Adjustments in line with initial results
Backup plan in case of unforeseen problems

Q4 2026-Q1 2027: Analysis phase

Completing the experimental data
Statistical evaluation
PEQ calculations – finalisation
Development of the risk characterisation

Q1-Q2 2027: Report generation phase

Draft report
Preparation of the technical dossier
Internal quality review
Expert assessment (in case you have engaged external consultants)

Q2-Q3 2027: Ready for submission

Final checks
If possible, carry out a check with the regulatory authority before submitting the application
Submission of the application

Action Plan 3: Authorisation expiring during 2027/2028

Your situation: Your authorisation expires in mid/late 2027 or in 2028.

Situation check:

✓ You have enough time for a quality application
✓ You can plan within regular budget cycles
✓ An opportunity to optimise costs

Recommended timeline:

Q1 2026: Planning phase

Comprehensive gap analysis
Portfolio review: all products that need their authorisation renewed
Budgeting for testing and consultancy services
Obtaining approvals for activities within normal company procedures

Q2 2026: Preparation for starting activities

Selection of laboratories
Development of study protocols and approvals
Initial meetings with all relevant stakeholders
Setting up a structure for delivering this project

Q2-Q4 2026: Testing phase

Laboratory testing
Monitoring results
Adjustments in line with initial results
Backup plan in case of unforeseen problems

Q4 2026-Q1 2027: Analysis phase

Completing the experimental data
Statistical evaluation
PEQ calculations – finalisation
Development of the risk characterisation

Q1-Q2 2027: Report generation phase

Draft report
Preparation of the technical dossier
Internal quality review
Expert assessment (in case you have engaged external consultants)

Q2-Q3 2027: Ready for submission

Final checks
If possible, carry out a check with the regulatory authority before submitting the application
Submission of the application

Action Plan 4: Authorisation expiring during 2028+

Your situation: Your authorisation expires at the end of 2028. You have enough time

What the situation is:

✓ Time for strategic planning
✓ You can consider reformulation or alternative active substances
✓ Cost optimisation through a phased approach

Strategic decisions:

1. Portfolio review (During 2026)

Which products are worth investing in?
Analysis of market share and profitability
Strategic importance per product
Options for gradually phasing marginal products out of the portfolio

2. Cost-benefit analysis (2026-2027)

Carry out a cost analysis per product
Estimated profit over the product’s lifetime
ROI calculation
Invest by priority

3. Assessment of alternative solutions (2026-2027)

Can reformulation reduce testing costs?
Are there alternative active substances?

4. Phased implementation (2027-2028)

Priority products first
Learn from the first few applications
Optimise for subsequent applications
Seek preferential treatment from external partners for a large number of products (consultants, laboratories)

5. Proactive positioning (2027-2028)

Fast compliance = market positioning
An advantage in communicating with clients
Reduction of unforeseen costs
A strategic advantage over the competition

Universal steps - Relevant for ALL categories

Regardless of your specific situation, these steps are useful:

1. Monitoring regulations

Subscribe to ECHA notifications
Follow notices from the competent authorities
Industry association news
Newsletters for consultants (like this one!)

Why: Getting relevant information, additional documentation.

2. Networking

Contact with other companies in the same situation
Industry associations
Share experiences
Cooperation where and when possible

Why: Learn from other people’s experience, avoid repeating mistakes, the possibility of joining forces to reduce costs.

3. Internal alignment

Management awareness and buy-in
Plans for budget allocation
A cross-functional team (R&D, RA, QA, Procurement and Sales)
Clear ownership of processes and responsibilities, division of roles

Why: It is essential that all relevant stakeholders in the company are on the same page

4. Systematic documentation management

A central repository for all documents
Versioning of documentation
Documenting internal controls
Easy access in case of an inspection or when submitting an application

Why: Long-term benefit beyond a purely short-term advantage.

5. Assessing expert support

When you need help:

Complex technical assessments (PEQ calculations, risk characterisation)
Strategy for submitting applications and preparing dossiers
Expert interaction with government authorities
Project management for multiple products

How to choose:

Experience with the BPR is key (not just general regulation)
Knowledge of the ECHA guidance for bees
References in the biocides industry
Realistic about what they can and cannot help with

Universal steps - Relevant for ALL categories

The new ECHA guidance on assessing the risk of biocides to bees represents a significant change in biocides regulation. But its impact on YOU depends on your specific situation.

Key messages:

For urgent cases (application submission in early 2026):

Be realistic about what is feasible
Consider postponing if you are not ready
Consult the competent authorities about your options

For authorisation renewal in 2026:

Urgent action, but still feasible
Gap analysis and contact with the authorities IMMEDIATELY
Accelerated approaches where possible

For authorisation renewal in 2027-2028:

Ideal timing for quality preparation
A systematic approach through normal cycles
An opportunity to optimise costs

For authorisation renewal with a longer deadline (2028+):

The advantage of strategic planning
Opportunities to optimise the portfolio
The benefits of proactive positioning

Universally:

Knowledge is power: Understanding the guidance = better decisions
Planning beats panic: Earlier = cheaper and better quality
Expert support pays off: In complex cases you can benefit from someone with experience
Every situation is unique: Generic advice is only a starting point

The new methodology is more complex, but it is not insurmountable. With the right approach, the right team and realistic deadlines, compliance is achievable.

SOURCES:

This blog post is for informational purposes only and does not constitute legal advice. For specific situations, consult a licensed chemical adviser or a lawyer specialising in chemical regulation.