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EBRC
Consulting GmbH

Kirchhorster Str. 27
D-30659 Hannover
Germany

Phone:
+49 (0) 511 - 89 83 89 - 0
Fax:
+49 (0) 511 - 89 83 89 - 10

mail@ebrc.de

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Active substances

Approval of new active substances and renewal of substances under the Biocidal Products Regulation (EU) 528/2012. EBRC’s services comprise all activities necessary for a successful application:

• Product-type specific initial completeness check of data sets
• Identification of data gaps
• Evaluation of the validity of existing studies
• Strategy for closing data gaps, e.g. through comprehensive literature searches or conduct of new experimental studies
• Planning, coordination and monitoring of experimental studies
• Development of concepts for data waiving
• Modelling of physicochemical, toxicological and environmental substance properties [(Q)SAR]
• Evaluation of physicochemical hazards of active substances
• Assessment of the basic effectiveness of active substances
• Evaluation of the toxicological profile of active substances
• Derivation of safe exposure levels for humans: e.g. A(O)EL, ADI, etc.
• Evaluation of the environmental fate of active substances
• Evaluation of the ecotoxicological profile of active substances
• Derivation of PNECs (predicted no-effect concentrations of active substances)
• Proposals for classification & labelling
• Preparation of complete dossiers in support of EU listing of both new and existing active substances, according to product-type specific data requirements, including all relevant risk assessments, and preparation of a comprehensive IUCLID 6 file
• Submission of dossiers and defence in the review process
• Performance of non-standard risk assessments (biostatistics, data management, etc.)