On October 2, 2024, the European Commission published the Implementing Regulation (EU) 2024/2575, which indicates the approval date of Prallethrin as an insecticide biocidal active substance (PT18).
The effective date of its approval will be March 1st, 2026, which will give sufficient time to submit both national registrations for those companies that do not yet have national registrations of insecticidal products based on this active substance, and to start preparing the European dossier that must be submitted before the indicated date.
In the event that by March 2026, companies already have national registration of their product/s in the EU countries, they will be subjected to submit their corresponding European dossier in order to continue marketing the product/s under the national registrations. These national authorisations which will remain valid until the product is authorized at European level a few years later.
Elements that will be taken into account when authorising products:
- The active substance prallethrin is considered as a candidate for substitution in accordance with Article 10(1)(d) BPR, and consequently the competent authority shall perform a comparative assessment as part of the evaluation.
- The authorisations of prallethrin-based biocidal products are subject to the following conditions:
- The product assessment should pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation.
- In view of the risks identified for the uses assessed during the EU revision, the product assessment should pay particular attention to:
- Children (toddlers)
- Surface water, sediment, soil and groundwater for products applied indoors by non-professional users by residual spraying (barrier treatment) in private households.
- For products containing prallethrin that may lead to residues in food or feed, Member States should verify the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005 and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.
- The placing on the market of treated articles is subject to the following condition:
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- The person responsible for the placing on the market of a treated article treated with or incorporating prallethrin shall ensure that the label of that treated article provides the information listed in the BPR.
- Member state competent authorities or, in the case of a union authorisations the Commission shall specify in the SPC of a product containing prallethrin the relevant instructions for use and precautions to be indicated on the label of the treated articles under BPR.
- The active substance does not fulfil the criteria according to Article 28(2) BPR to enable inclusion in Annex I to BPR as it has a harmonized classification as Acute Tox. 3 (inhalation), H331 and Aquatic Acute 1, H400. In addition, it is proposed to be classified as Acute Tox. 3 (oral), H301 and STOT SE 1 (nervous system), H370. Furthermore, it fulfils the criteria for being very persistent and toxic.
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