Securing EU authorisation for pyrethrum-based insecticides: balancing efficacy and risk in a challenging landscape
Successful authorisation of a biocidal product relies on conducting comprehensive risk assessments that establish its safe use for both the environment and human health. Insecticides present a substantial challenge, particularly when they contain more than one active substance or substances of concern. With the EU dates of approval for two Chrysanthemum cinerariaefolium extracts rapidly approaching, now is the opportune moment to start assessing the risks and plan efficacy studies.
Preliminary risk assessments
While pyrethrum is a highly efficient insecticide extracted from flowers, it is classified as very toxic to aquatic life with long-lasting effects. Additionally, it shows an intrinsic hazard to bees. Often, pyrethrum is used in combination with synergists or other active substances like piperonyl butoxide, cypermethrin, permethrin, s-methoprene, or margosa extract.
Passing the very conservative emission scenarios can prove incredibly challenging. It is strongly recommended to perform preliminary risk assessments as even with innovative refinements, reducing the risk to acceptable levels across all scenarios, be it indoor or outdoor use, can be difficult. Furthermore, Chrysanthemum cinerariaefolium extracts are classified as skin sensitisers so finding the appropriate concentration of active substances in biocidal products intended for public use becomes crucial, as personal protective equipment is typically not an accepted risk mitigation measure for such users.
Insecticides usually have historical efficacy data which at the existing use rate may not meet the current efficacy requirements against target organisms and may fail to demonstrate acceptable risk.
Therefore, it becomes imperative to develop a robust efficacy strategy that effectively balances efficacy and acceptable risk. Starting initial laboratory testing now, in 2023, will allow sufficient time to organize the semi-field or field trials required to substantiate certain efficacy claims. Factors such as capacity at efficacy test sites for trials and seasonal availability of certain insects should be carefully considered during the planning process.
By navigating the complex landscape of biocidal product authorisation, manufacturers of pyrethrum-based insecticides can ensure compliance with regulations while mitigating unacceptable risks. Stay proactive, conduct thorough efficacy testing, and strike the right balance between efficacy and safety to pave the way for successful authorisation in the EU market.
Pyrethrum extracts under EU review
The two Chrysanthemum cinerariaefolium extracts (CAS No 89997-63-7) under Biocidal Products Regulation (EU) No 528/2012 review are:
- Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide
- Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents
EU dates of approval
- 1 February 2024: PT 19 (repellents) - Commission Regulation No 2022/1003
- 1 February 2025: PT 18 (insecticides) – draft regulation, date not yet confirmed
How TSG can help
At TSG, we are well-positioned to support applicants in devising effective strategies for higher-tier environmental risk assessments, as well as developing studies to improve the data package for both environmental and human health. We can work with you to develop a sound strategy for the efficacy package needed to support your products.
Our team of experienced consultants have a deep understanding of the specific requirements involved in insecticide and repellent applications for both active substances and biocidal products.
We can help you with:
- Finding the right balance between efficient application rate and safe use
- Commissioning and monitoring of studies
- Finding inventive solutions for acceptable risk for products, for example applied via large-scale spraying outdoors
- Guidance on label claims and efficacy data package
Do get in touch at [email protected] if you’d like to schedule an initial chat with our biocides specialists.
Follow the link to learn more about our EU Biocidal Products Regulation (BPR) services.