Mutual Recognition of Authorisations for Plant Protection Products Containing Low-Risk Active Substances or Substances of Microbial, Plant, or Plant Extract Origin
The Central Control and Testing Institute in Agriculture in Bratislava (hereinafter referred to as the “Institute”) informs applicants for plant protection product (PPP) authorisation of a change in the approach of applications for mutual recognition of authorisations granted in zones other than Zone B – Central, according to Annex I of Regulation (EC) No 1107/2009.
In light of the need to reduce risks arising from the usage of PPPs and in accordance with Objectives 1 and 2 and Measures 2 and 4 of Annex 2 of the National Action Plan for the Sustainable Use of Plant Protection Products rev. 2 (2021–2025), it is necessary to improve the availability of PPPs based on low-risk or potentially low-risk active substances and to replace the use of products containing substances of concern with safer alternatives.
When assessing the predicted environmental concentrations of PPPs in groundwater for authorisation in the Slovak Republic, it is necessary to demonstrate safe use through modelling using the FOCUS scenarios Hamburg, Kremsmünster, Châteaudun and, where applicable scenario Piacenza.
However, in the case of PPPs based on microorganisms, plants, or plant extracts, and those containing low-risk active substances, FOCUS modelling is not required. Such modelling is not feasible due to factors such as rapid degradation of substances, inability to leach into groundwater or persist in the aquatic environment, or because the active substances naturally occur in the environment, making it impossible to distinguish background levels from those originating from product application. For these reasons, alternative assessments of the potential to leach into groundwater are used for such products, which are not restricted to a specific zone.
Additionally, for most low-risk active substances and substances of microbial, plant, or plant extract origin, Maximum Residue Limits (MRLs) are not established, and these substances are included in Annex IV of Regulation (EC) No 396/2005.
For the reasons stated above, the Institute will accept applications for mutual recognition of authorisations for PPPs based on low-risk active substances or those of microbial, plant, or plant extract origin also from Zone A – North and Zone C – South. These applications will be subject to the same requirements and conditions as those for mutual recognition from Zone B – Central and will follow the same evaluation procedure. This means that the applications, together with the submitted documentation, will be forwarded to the Institute’s experts and to the professional bodies authorized according to §7 of Act No. 405/2011 Z. z. for evaluation and preparation of expert assessments. Provided that the expert are favourable, the Institute will issue an authorisation decision for the PPP through mutual recognition.
This procedure will apply to applications submitted from 1 July 2025 onwards.
