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Biocidal Products Regulation

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.

Guidance on biocides legislation

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.

IUCLID

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.

Data that can be stored and maintained with IUCLID 5 include information about:

 

R4BP3

R4BP 3 is the central hub through which all biocides applications are made. It provides functions which enable the industry and the authorities to comply with the legislative requirements and exchange information between them. 

Biocides submissions under the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) started on 1 September 2013. 

Biocides Submission Manuals

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.

Letter of access

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.

List of biocidal products types

MAIN GROUP 1: Disinfectants

These product types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.

Product-type 1: Human hygiene

Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.

Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals

Biocidal Products Directive

Guidance and other relevant documents on the implementation of Directive 98/8/EC