The Biocides Regulation (UE) No. 528/2012 (BPR) entered into force on 1 of September 2013 replacing the old Biocidal Products Directive 98/8 EC (BPD) and implementing new and harmonized procedures under the supervision of the European CHemicals Agency (ECHA). Since then, many new active substances have been approved under the BPR framework and some others which approval was granted under the BPD have been renewed. Data requirements under BPR have become more and more complex and the revision of active substances more and more exhaustive.
Applications for active substance renewal must be submitted 550 days in advance before the expiry date set out in the relevant inclusion directive (or approval regulation) of the active substance and PT combinations. However, the planification of the submission must start well in advance in order to consider the latest advances in the Regulation and generate the data to assure a good regulatory compliance.
Among the most relevant deadlines for active substance renewal, we can highlight:
|Active substance||PT||CAS No||Application deadline|
|Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52||18||–||29/03/2022|
|Basic Copper carbonate||8||12069-69-1||30/07/2022|
|Margosa, ext. (from the kernels of Azadirachta indica extracted with water and further processed with organic solvents)||18||84696-25-3||28/10/2022|
|PHMB (1600; 1.8) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8)||2, 3, 11||27083-27-8||28/10/2022|
|hydrogen cyanide||8, 14, 18||74-90-8||30/03/2023|
|Alkyl (C12-16) dimethylbenzyl ammonium chloride; C 12-16-ADBAC||8||68424-85-1||31/07/2023|
|Didecyldimethylammonium chloride; DDAC||8||7173-51-5||31/07/2023|
If you are interested in supporting the renewal application for any of the active substances above or any other not listed here, Staphyt’s Regulatory team can help you to plan the submission strategy by preparing data gap analysis, conducting proper risk assessments, monitoring new studies, building your dossier and co-ordinating the project with the relevant evaluator Member State to successfully achieve your goal.
Do not hesitate to contact us for further information. Our highly skilled regulatory team will guide you through the regulation and will help you to overcome the hurdles to successfully achieve your goals!
Aurély Beghin firstname.lastname@example.org