EU authorisation of pyrethrum-based repellents: follow the newly updated efficacy guidance
ECHA’s Biocidal Product Committee adopted a positive opinion for the approval of two Chrysanthemum cinerariaefolium extracts under the Biocidal Products Regulation (EU) No 528/2012 for Product Type (PT) 19 (repellents) in December last year. Companies intending to submit an application for EU product authorisation should start working on their dossier now.
Adopting an opinion on use of the actives (listed opposite) in both PT 18 and 19 was scheduled for the December 2021 ECHA Biocidal Product Committee (BPC) meeting. However, only the PT 19 opinion was finalised. The next step will be the publication of the Commission Implementing Regulation approving the actives for use in biocidal products in PT 19. December 2023 is the expected approval date and also determines the deadline for submitting EU product authorisation applications to keep existing repellents on the market.
As of writing, it is unknown when the opinion for PT 18 will be scheduled for discussion but it is expected to be in March during the next BPC meeting. For insecticides based on a combination of pyrethrum and permethrin, it is important to bear in mind that post-approval data required as part of the PT 18 approval of permethrin has resulted in the substance now meeting the candidate for substitution criteria. A comparative assessment will be performed by the authority as part of the evaluation and the biocidal product authorised if there are no better alternatives.
Pyrethrum extracts under EU review:
- Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbondioxide
- Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents
Elements to consider
Biocidal products based on pyrethrum often have historical efficacy test data. However, with the updated guidance on efficacy assessment and evaluation, in which numerous target organisms are considered (such as ants, bed bugs, biting midges, flies and mosquitoes), historical test data may not meet the requirements. New testing to support the product’s claims will be needed. Conducting the initial laboratory testing now, to be ready for semi-field or field trials when the insects are in season, is recommended.
In addition, Chrysanthemum cinerariaefolium extracts are classified as very toxic to the aquatic environment and the conservative emission scenarios can be challenging to pass. Airspace and surface treatment will likely need inventive refinements and risk mitigation measures to reduce the risk to acceptable levels for both indoor and outdoor uses.
Having an in-depth scientific understanding of such products – by performing a preliminary risk assessment and developing a robust efficacy strategy – will enable companies to balance efficacy and acceptable risk.
Finding an evaluating competent authority to assess dossiers may be challenging with similar approval dates anticipated for two widely used quaternary ammonium compounds (ADBAC/BKC and DDAC). Companies should therefore begin discussions with their chosen evaluating competent authority as soon as possible to lock in agreement to take the dossier. Leave it too late and the chosen authority may be full, meaning an alternative authority needs to be found.
Capacity at efficacy test sites for trials including field trials and seasonal availability of some insects are also important aspects to consider at an early stage.
How can TSG help?
Determining a biocidal product’s claims and the efficacy testing needed to support them while demonstrating safe risk is a challenge that TSG Consulting routinely helps companies overcome. Efficacy data is the cornerstone of a dossier and our scientific and regulatory consultants help companies find the balance between application rate and safe risk. We also support companies in adapting their products to comply with changing requirements.
TSG’s team of consultants and scientists have many years’ experience working in the field of repellents both at active substance and biocidal product level. We are familiar with the requirements for biocidal products containing pyrethroid and plant-derived active substances, facilitating a smoother authorisation process.
We can help with:
- Exposure modelling, human health and environmental risk assessments, toxicology and ecotoxicology, environmental fate modelling expertise
- Building biocidal product families
- Monitoring efficacy studies to support label claims
Get in touch at [email protected] to schedule an informal chat with our regulatory consultants about your pyrethrum-based repellents.