Reform of Regulation (EC) No 1107/2009

On 16 December 2025 the European Commission published proposals to amendment legislations related to plant protection products.

Introduction of a clear legal definition of biocontrol active substances covering in particular micro-organisms, semiochemicals (pheromones), plant extracts.
Accelerated approval and authorisation procedures for biocontrol substances (e.g. priority of proceedings, application to EFSA).
Provisional product authorisations prior to approval.
Only “one zone” for product authorisations.
“Tacit agreement” if cMS or recognizing MS do not make a decision within the 120-day period (authorisation is deemed to have been granted).
Removal of record-keeping obligation for products containing only biocontrol substances.

Shift to approvals unlimited in time for most active substances.
- Exceptions for candidates for substitution and substances of higher concern (Article 4(7) Regulation (EC) No 1107/2009).
- EU may set time limits for approvals in consequence of the outcome of the risk assessment.
- Commission may identify active substances with unlimited approval for which a full renewal procedure shall be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment of certain criteria or specific aspects.
- Possibility of ad-hoc reviews acc. to Article 21 Regulation (EC) No 1107/2009 remains unchanged.
- Transitional provision: Pending renewal procedures will be finished; upon renewal the approval is unlimited in time (subject to the exceptions above).
Clarifications and simplification for approvals based on Article 4(7) Regulation (EC) No 1107/2009
MS may request EFSA to support in approval or renewal proceedings.
Duration of product authorisations which contain active substances approved unlimited in time is set to 15 years.

Low-risk status for active substances based solely on intrinsic properties of the substance.
Introduction of a procedure to reclassify already approved substances as low-risk.
Only “one zone” for product authorisations.
Tacit agreements if cMS or recognizing MS do not take a decision within the 120-day period (authorisation is deemed to have been granted).

Current Articles 20(2) and 46 Regulation (EC) No 1107/2009 are replaced by new provisions.
When terminating an active substance approval, Commission shall set grace periods up to 6 months for sale and distribution and additional 12 months for disposal, storage and use.
If necessary to allow transition to alternatives, maximum grace periods are extended to up to one year for sale and two years for use.
Member States shall set grace periods within the limits of the period set by the Commission.

Clarification of the term “current scientific and technical knowledge”: When assessing an application for product authorisation zRMS shall rely on the last assessment conducted at EU level.
In case of new findings, zRMS shall send a request to the Commission for initiating a review acc. to Art. 21, a renewal or a targeted reassessment of the specific issue.

Mutual recognition allowed only if the product is actually marketed in the reference Member State.
Less formal requirements for applications from official or scientific bodies or agricultural organisations for Mutual Recognition in cases where the authorisation holder does not file an application for authorisation in that specific Member State.
Simplifications and accelerations for products containing biocontrol or low-risk substances (see above).

Removal of the requirement of “public interest”.
Enabling applications for mutual recognition of authorisations from other MS for uses which are authorized as major uses in the reference MS, but which are minor uses in the recognizing MS.
Establishment of a legal basis for the Commission to adopt implementing acts harmonising the procedures for granting extensions for minor uses.

Only one zone for uses needed to fight pests listed in accordance with Plant Health Regulation.
Priority for applications for authorisation of such uses.

New definition of “basic substances” and new provisions clarifying approval criteria and status of basic substances.
Easier market access for basic substances without national authorisations.
Harmonised rules on treated seeds, including clarification that sowing machinery is not pesticide application equipment acc. to Directive (EC) No 2009/128.

Introduction of uniform EU-wide data protection periods for studies and test reports to improve transparency and competition.
Transitional provision: Old provisions on data protection will apply to studies for which the data protection period has already started in a specific Member State.

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