Plant protection product dossier

See how ready your plant protection product dossier is, section by section, and what each gap needs.

ProjectsPlant protection product dossier

  • Marta Kowalczyk
  • Henrik Solberg
  • Zainab Rahman
Meridale’s Central zone dossier for MER-2604 SC, by dRR section, with Germany as zRMS.
SectionCompleteOwnerStatus
Identity and composition100%Formulation teamComplete
Efficacy45%Field trials teamAt risk
Analytical methods90%Analytical labIn review
Toxicology82%Tox consultantIn review
Residues76%Residues teamIn progress
Environmental fate64%Fate consultantIn progress
Ecotoxicology58%Ecotox consultantIn progress
Comparative assessment0%Regulatory affairsNot started

Efficacy Potatoes

Status: At risk

May need a second season in 2027

Requires
Trials in at least two growing seasons
Trials
One season, 2026
Unless
The 2026 trials confirm an extrapolation

Your expert signs off each regulation

You get the readiness view, a map of every data point your product needs, agreed before any checking starts, and a record of each decision with its evidence.

Approval

Illustrative project

Marta Kowalczyk

Status: Approved

Head of Regulatory Affairs, after checking each section against the 3 regulations behind the dossier

  • Regulation (EC) No 1107/2009, authorisation

  • Regulation (EU) No 284/2013, data requirements

  • Regulation (EU) 2026/1120, co-formulants

Foresight does the research

Your team brings what only it knows, and your expert makes the call at each checkpoint.

Tasks

Illustrative project

3 of 5 tasks done.

  1. Share your product and studies

    Your team

    Status: Done
  2. Map the requirements

    Foresight

    Status: Done
  3. Agree the requirements

    Checkpoint

    Marta Kowalczyk

    Status: Approved
  4. Check the evidence

    Foresight

    Status: In progress
  5. Approve the review

    Checkpoint

    Marta Kowalczyk

    Status: Not started

Kept current once it’s approved

Monitoring watches the measures behind your dossier. When one moves, Foresight rechecks the sections it affects, and your expert reviews the change.

Monitoring

Illustrative project

Watching 4 measures behind the dossier

  • Azoxystrobin approval

  • Difenoconazole approval

  • Unacceptable co-formulants, Annex III to Regulation (EC) No 1107/2009

    Regulation (EU) 2026/1120 added 12 co-formulants, in force from 16 June 2026. Rechecked, none is in the product above 0.1%.

    Status: To review
  • Draft amendment to Regulation (EU) No 284/2013

What we need from you

Four things, shared at setup before the project starts.

  1. Your product

    The product’s composition and specification, with its active substances and co-formulants.

  2. Your uses

    The crops, diseases and rates you’ll apply for, and the Member States in the zone.

  3. Your studies

    The study reports you hold or can access, who owns each section, and when you plan to submit. A study list with an owner for each section is enough to start.

  4. Your approver

    The person who agrees the requirements map and approves the review.

What teams ask about this project

How do you structure the dossier?

In the draft Registration Report (dRR) format used for zonal applications: Part A for each Member State’s risk management, Part B for the core assessment, section by section, and Part C for confidential information. Each section is broken into the data points Regulation (EU) No 284/2013 sets for products, and each data point is matched to the study or reasoned case that answers it.

Where does the evidence come from?

From your study reports, the EU-agreed endpoints for each active substance, and the regulations and guidance behind each requirement. Every status links to its source, so your team can check it directly.

What changes when an active substance is a candidate for substitution?

Each Member State concerned runs its own comparative assessment under Article 50 of Regulation (EC) No 1107/2009. It must refuse or restrict a use where a significantly safer alternative exists without significant economic or practical drawbacks, and enough chemical diversity remains to manage resistance. Difenoconazole is a candidate for substitution, so the dossier tracks the case for each use in Part A.

Who checks the review before we use it?

The person you name. They agree the requirements map before checking starts, and check each section’s status against its evidence at the end. Nothing is final until they approve it. These checks reduce the risk of error without removing it.

What happens when a rule changes?

Foresight rechecks the sections it affects, such as when an active substance’s approval or the list of unacceptable co-formulants changes. The review your expert approved stays as it is until they accept the change.

What does it cost?

The price follows the dossier’s size: how many uses, Member States and studies it covers. You see it with the scope, before any checking starts.

Bring your study list to a demo

Tell us your product, its uses and the zone you’re applying in. You’ll see the scope and the price before any checking starts.