Risk Assessment of Biocides
The European Union is establishing a regulatory framework for the placing of biocidal products on the market, with a view to ensuring a high level of protection for man and the environment and the proper functioning of the common market. The JRC-IHCP provides scientific and technical support for the approval of active substances in biocidal products as laid down in Directive 98/8/EC concerning the placing of biocidal products on the market.
By the end of 2013 JRC will conclude a period of eleven years of coordination of the scientific and technical tasks for approval of active substances. As from 1st September 2013 the new Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products will enter into operation and the coordination of the scientific and technical tasks will be undertaken by the European Chemicals Agency (ECHA). The new Regulation will remedy a number of weaknesses that were identified during the 11 years of the implementation of the Biocides Products Directive. The Regulation defines biocidal products and sets out the frame for their evaluation.
The biocides work area managed by the JRC-Institute for Health and Consumer Protection provides Technical and Scientific support to Member States' Competent (CAs) Authorities and the European Commission with respect to the implementation of the Directive and will in particular continue to assist DG Environment in some tasks related to the Review Programme up to 31 December 2013.
More information on the legal framework for biocides is available via the web site of European Commission Directorate-General for Environment, including the text of the BPD and of the BPR, the Regulations, scope of the BPD including the Manual of Decisions, withdrawal notices, guidance documents, non-inclusion decisions and the list of participants.
EUSES is a decision-support instrument, which enables the user to calculate the risk for man and environment. The Technical Guidance Documents for Risk Assessment of chemical substances as well as all finalised emission scenario documents for biocides are included in EUSES 2.1.2: European Union System for the Evaluation of Substances (EUSES).
According to the Biocidal Products Regulation (Regulation (EU) No 528/2012) the formats made available by ECHA must be used for submission of the dossiers by applicants. Applicants must submit the data in electronic format using the software package IUCLID for those parts of the dossiers to which IUCLID applies: International Uniform ChemicaL Information Database 5.5 (IUCLID 5.5), IUCLID 5.5 which was released in April 2013 contains new dossier types which should be used for preparing application for approval of an active substance or for authorisation of a biocidal product under the new Regulation.
As 1st September 2013 Mandated National Authorities needs to get access to the ECHA IT system in order to meet their obligations under the Biocides Products Regulation. For assistance please contact the Biocides MSCA IT Support at ECHA e-mail: BiocidesMSCA-ITSupport@echa.europa.eu