Following the entry into force of the Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, all active substances in the European market have to be reviewed to ensure that under normal conditions of use they can be used without unacceptable risk for people, animals or the environment. Thus, in the frame of the review process, the risk assessment of each active substance plays a fundamental role and providing technical guidance to the assessments that must be performed ensures a correct and uniform implementation of the Directive for the different Member States.
According to Annex VI of Directive 98/8/EC the risk assessment shall cover the proposed normal use of the biocidal product together with a ‘realistic worst case scenario’.
The aim of this Emission Scenario Document (ESD) is to set up methods for the estimation of the emission of disinfectants, used in the private and public health area, to the primary receiving environmental compartments.
For Product Type 2 (PT2) an ESD already existed, providing methods for the estimation of the emission of disinfectants used for sanitary purpose and for disinfectant used in the medical sector. The scope of the present ESD is to supplement the existing ESD by providing additional information and emission scenarios for disinfection of industrial areas, of air conditioning systems, of hospital waste and of chemical toilets.
The present ESD is intended to be used by Member States as a basis for assessing applications submitted with a view to include existing active substances used in PT2 in Annex I or IA of Directive 98/8/EC or for assessing applications for product authorisation. It can be a useful tool also for industry, when assessing requirements for a submission.
These Technical Notes for Guidance have been developed in the context of project FKZ 360 04 023 of the German Federal Environmental Agency (UBA), who contracted SCC GmbH for a first draft of the document. The first draft was then revised by the Biocides Sector of the JRC, taking into account the comments of the Member States. The final version, approved by the Technical Meeting, was endorsed by the Competent Authority Meeting in May 2011.
RAFFAEL Barbara;
VAN DE PLASSCHE Erik;
2012-01-16
Publications Office of the European Union
JRC67704
978-92-79-22398-3 (print),
978-92-79-22399-0,
1018-5593 (print),
1831-9424 (online),
EUR 25115 EN,
OP LB-NA-25115-EN-C (print),
OP LB-NA-25115-EN-N (online),
https://publications.jrc.ec.europa.eu/repository/handle/JRC67704,
10.2788/2698 (print),
10.2788/29058 (online),
