EBRC Consulting GmbH services

Risk assessments according to current EU guidelines and specific national requirements covering all groups of ecological relevant species:

A critical evaluation of environmental fate of parent compounds, relevant metabolites and co-formulants is conducted for all compartments including surveys of metabolic pathways and model calculations for distribution patterns and biodegradation rates.

Dossiers in support of inclusion in Annex I of Directive 98/8/EC:For inclusion into Annex I of Directive 98/8/EC of both new and existing active substances, a comprehensive dossier has to be submitted to EU competent authorities. EBRC’s services comprise all activities necessary for a successful application:

Forming a task forces or consortia for the purpose of Annex I inclusion of an active substance can save costs and facilitate the entire regulatory process. Our service includes scientific, administrative and legal support of founding members as well as acquisition of potentially new members. Confidentiality with respect to sensitive information is ensured as a matter of course.

In the registration dossier, all relevant and reliable data on a specific substance shall be considered. This includes, e.g.Physico-chemical data and analytical methodsEcotoxicity, environmental fate dataToxicity data obtained from animal testingHuman clinical and epidemiological dataExposure data, such as workplace air monitoring and emissions to ambient air or waterTherefore, initially the proprietary data held by the client (e.g. in-house study reports) is collected and archived. In addition, publicly and commercially available sources are searched for physico-chemical, toxicological and ecotoxicological properties. These sources include bibliographic databases and factual handbooks, as well as data published by national and international authorities and chemical review programmes, such as OECD, WHO, ATSDR, IARC, etc.Based on these sources, all relevant data are identified and then subjected to a quality and reliability assessment, in accordance with REACH guidance documents.

The basis for any data-gap analysis are the specific dossier requirements, which depend on the tonnage band of the substance and it’s possible status as an intermediate. Based on the formal requirements and the available data, the so-called data-gap analysis is conducted by assessing whether sufficient data are available for a complete dossier, or whether data-gaps exist which need to be closed.

Based on the available or new newly generated data, the CSA will be performed under consideration of the following aspects:

Substances that are considered PBT (persistent, bioaccumulative and toxic) and/or vPvB (very persistent and very bioaccumulative) require special attention under REACH. The major concern with these substances is that after release to the environment they may accumulate, persist for a long time and/or may be transported over long distances. Toxic effects may potentially be exerted only after an extended period of time and possibly in areas far away from the point of release. A conventional establishment of a DNEL (derived no effect level) is not possible for such substances. PBT and vPvB substances will be included in REACH Annex XIV, meaning that authorisation is required.

The outcome of the chemical safety assessment and of the exposure assessment and risk characterisation (if required) will be documented in the chemical safety report (CSR).Some parts of this report can be generated automatically from the technical dossier (IUCLID 5), whereas others need to be added manually. The CSR also includes some formal declarations by the registrant, as well as data on tonnages and uses.