Prallethrin, an insecticidal pyrethroid with eight isomers (predominantly the 1R-trans, S isomer), has been officially approved for product type 18 (PT18), effective March 1, 2026. This approval places specific compliance obligations on market players, including the need to submit a market authorization (MA) dossier for each product containing this active substance. Here’s an overview of the implications and requirements to anticipate.
What is Prallethrin and Why is it Regulated under PT18?
Prallethrin is a potent insecticide from the pyrethroid family, commonly used for its rapid knockdown and lethal effect on various nuisance insects, particularly mosquitoes, cockroaches, fleas, and bed bugs. Due to its high efficacy and frequent use in domestic spaces, it is strictly regulated under the biocidal regulations for PT18, which covers insecticides.
Implications of this Approval for Market Players
The approval of prallethrin for PT18 introduces new regulatory requirements for manufacturers and distributors. To continue marketing products containing this active substance after March 1, 2026, these stakeholders must submit an authorization dossier demonstrating the safety and efficacy of their products. Without a complete and validated dossier, products containing prallethrin will have to be withdrawn from the market. Companies aiming for compliance should begin preparing now to meet the deadlines.
Prallethrin Dossier Specifics
The prallethrin authorization dossier has important specifications. This substance is subject to a substitution criterion due to its classification as very persistent (vP) and toxic (T). Consequently, prallethrin will only be approved for a duration of five years, after which a renewal will be necessary.
Currently, two suppliers, Sumitomo Chemical and Endura, have submitted separate dossiers targeting different applications. Sumitomo Chemical’s dossier requires a minimum purity of 92%, while Endura’s requires 93%. Details on the classification of representative products can be found in the substance’s Competent Authority Report (CAR).
What to Include in a Prallethrin Authorization Dossier
A complete MA dossier for a product containing this active substance must demonstrate its safety and efficacy while meeting specific biocidal regulation requirements. Key elements of the dossier include:
- Product Characteristics: Description of the formulation, prallethrin concentration, and other ingredients.
- Safety Data: Information on toxicity, persistence, and environmental impacts of the product. Given its classification as a very persistent and toxic substance, detailed studies on these points are essential.
- Efficacy Assessment: Evidence of the product's effectiveness against target insects.
- Substitution Information: If the product is subject to a less hazardous alternative, an analysis of substitution options must be included, as prallethrin is subject to a substitution criterion.
These requirements aim to ensure that the product is not only effective but also safe for end users and environmentally responsible. By entrusting the preparation of their authorization dossier to EcoMundo, market players benefit from support at every stage, from data collection to dossier submission to the competent authorities.
Conclusion: Preparing Your Authorization Dossier
This new prallethrin approval for PT18 urges market players to prepare well-documented authorization dossiers to ensure the continuity of their product sales. EcoMundo is ready to assist companies in this process, helping them achieve regulatory compliance and optimize their chances of obtaining an authorization.
Need Help Ensuring Product Compliance?
EcoMundo is here to help you build a strong market authorization dossier that complies with the new regulatory requirements. With our expertise in biocide regulations and personalized support, we make every step easier to ensure your product’s continuity in the market. Contact us today to optimize your chances of obtaining your authorization and staying competitive!
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Prallethrin, an insecticidal pyrethroid with eight isomers (predominantly the 1R-trans, S isomer), has been officially approved for product type 18 (PT18), effective March 1, 2026. This approval places specific compliance obligations on market players, including the need to submit a market authorization (MA) dossier for each product containing this active substance. Here’s an overview of the implications and requirements to anticipate.
What is Prallethrin and Why is it Regulated under PT18?
Prallethrin is a potent insecticide from the pyrethroid family, commonly used for its rapid knockdown and lethal effect on various nuisance insects, particularly mosquitoes, cockroaches, fleas, and bed bugs. Due to its high efficacy and frequent use in domestic spaces, it is strictly regulated under the biocidal regulations for PT18, which covers insecticides.
Implications of this Approval for Market Players
The approval of prallethrin for PT18 introduces new regulatory requirements for manufacturers and distributors. To continue marketing products containing this active substance after March 1, 2026, these stakeholders must submit an authorization dossier demonstrating the safety and efficacy of their products. Without a complete and validated dossier, products containing prallethrin will have to be withdrawn from the market. Companies aiming for compliance should begin preparing now to meet the deadlines.
Prallethrin Dossier Specifics
The prallethrin authorization dossier has important specifications. This substance is subject to a substitution criterion due to its classification as very persistent (vP) and toxic (T). Consequently, prallethrin will only be approved for a duration of five years, after which a renewal will be necessary.
Currently, two suppliers, Sumitomo Chemical and Endura, have submitted separate dossiers targeting different applications. Sumitomo Chemical’s dossier requires a minimum purity of 92%, while Endura’s requires 93%. Details on the classification of representative products can be found in the substance’s Competent Authority Report (CAR).
What to Include in a Prallethrin Authorization Dossier
A complete MA dossier for a product containing this active substance must demonstrate its safety and efficacy while meeting specific biocidal regulation requirements. Key elements of the dossier include:
- Product Characteristics: Description of the formulation, prallethrin concentration, and other ingredients.
- Safety Data: Information on toxicity, persistence, and environmental impacts of the product. Given its classification as a very persistent and toxic substance, detailed studies on these points are essential.
- Efficacy Assessment: Evidence of the product's effectiveness against target insects.
- Substitution Information: If the product is subject to a less hazardous alternative, an analysis of substitution options must be included, as prallethrin is subject to a substitution criterion.
These requirements aim to ensure that the product is not only effective but also safe for end users and environmentally responsible. By entrusting the preparation of their authorization dossier to EcoMundo, market players benefit from support at every stage, from data collection to dossier submission to the competent authorities.
Conclusion: Preparing Your Authorization Dossier
This new prallethrin approval for PT18 urges market players to prepare well-documented authorization dossiers to ensure the continuity of their product sales. EcoMundo is ready to assist companies in this process, helping them achieve regulatory compliance and optimize their chances of obtaining an authorization.
Need Help Ensuring Product Compliance?
EcoMundo is here to help you build a strong market authorization dossier that complies with the new regulatory requirements. With our expertise in biocide regulations and personalized support, we make every step easier to ensure your product’s continuity in the market. Contact us today to optimize your chances of obtaining your authorization and staying competitive!
