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.
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 Biocidal Products Directive (BPD) 98/8/EC on the placing on the market of biocidal products, which entered into force on 14 May 2000. The Directive defines biocidal products and sets out the frame for their evaluation in a two step procedure where the first step is the entry of the active substances into Annex I (IA or IB) and the second step is the authorisation of the products in which the active substances are used. Active substances are divided into:
- New Active substances that cannot be placed on the market for biocidal purposes unless they are included onto Annex I;
- Existing Active substances evaluated in the Review Programme, according to Article 16 of the BPD. The Review Program was established via several Regulations. The latest Regulation is Regulation (EC) No 1451/2007, which repeals Regulation (EC) No 2032/2003, and entered into force on 31 December 2007.
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, 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 TGD 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 Annex III of Regulation (EC) 1451/2007 the formats made available by the Commission must be used for submission of the dossiers by applicants. In addition, 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 (IUCLID 5).