The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
The ECHA Guidance on biocides legislation describes how to fulfil the information requirements set by the Biocidal Products Regulation, Regulation (EU) 528/2012) (BPR) and how to perform the required assessments. It also explains the guiding principles for the evaluation of the applications to be performed by the authorities.
The IUCLID 5 project was initiated in 2003 when the European Commission decided to completely overhaul IUCLID 4 in order to propose a data submission tool that would support the European REACH Regulation as well as other Chemical Evaluation Programmes, such as the OECD HPVC Programme.
The aim of the Biocides Submission Manual (BSM) series is to provide industry users with detailed and illustrative technical assistance. The BSM series describes how to build IUCLID dossiers for the various Biocidal Product Regulation applications and how to submit and manage those applications in R4BP 3 until a successful outcome is achieved.
A submission for inclusion in the Article 95 list can be made by submitting an LoA to ECHA. The LoA must refer to a ‘complete substance dossier’, i.e. a dossier that has been accepted or validated by a Member State in a procedure provided for by the BPR or the BPD or by ECHA in accordance with Article 95(1), second sub-paragraph, of the BPR.
MAIN GROUP 1: Disinfectants