Challenges with the Guidance on the Biocidal Products Regulation (Volume II: Efficacy) for PT18 (Insecticides) and PT19 (Repellents and Attractants) – a Laboratory Perspective
Kerona Scientific held their third Biocide Symposium on the 28th and 29th of March 2023. The Symposium centered on several key aspects related to the registration of products and active substances under the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). Dr. Catherine Linn, Head of Department, Biology, at BioGenius GmbH Germany, spoke about the challenges surrounding the guidance on the Biocidal Products Regulation (EU) No. 528/2012 in terms of the efficacy tests for PT18 and PT19 from a laboratory perspective.
To comply with the guidelines set out in the latest version of the BPR Efficacy Guidance, appropriate test designs must be selected. Catherine’s presentation focused on laboratory and simulated use tests. Laboratory tests are required mostly for insecticides, where the mortality of insects exposed to the substance in petri dishes is evaluated. Simulated use tests are more complex; bigger systems like hand in cage tests or entire room tests are used to recreate the most realistic use conditions.
The guidance provides well-written explanations on the test design for certain tests, such as the mosquito repellent test and the tick-repellent test. However, for other tests such as the PT18 test against mites and against fleas, poor descriptions are provided. This leaves much room for interpretation and can lead to errors as a result.
Catherine ended the presentation by emphasizing that the guidance is constantly under revision, and this should be considered when registering a biocide product. The requirements of the guidance should also be checked, a study plan should be prepared and discussed in a pre-submission meeting before adjusting the test set-up to meet the requirements of the authorities.
If you missed the Biocide Symposium, a copy of all the presentations is available on the publications section here: https://kerona.ie/product/dublin-biocides-symposium-2021-speakers-presentations/
If you need assistance with registration of biocides of PT18 or PT19, please contact the experts of the biocides team at Kerona Scientific at email@example.com and for Southern Europe firstname.lastname@example.org