EBRC Consulting GmbH Services

Industrial Chemicals – REACH
Data Gathering, Literature Searches and Evaluation

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...
Data-Gap Analysis, Closing of Data-Gaps and Study Monitoring

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.
Chemical Safety Assessment (CSA) Services

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

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...
Risk Characterisation Services

The REACH registrant needs to demonstrate safe production and use of his substance. To assess whether the substance is “safe”, the risk characterisation needs to be conducted, in which exposure estimates will be compared to DNEL (human exposure patterns) and PNECs (environmental exposure). If the quotient between exposure estimate and the DNEL/PNEC (the so called risk characterisation ratio, RCR) is below 1, a safe situation is demonstrated.
Chemical Safety Report (CSR) Services

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.
Classification and Labelling (GHS / CLP) Services

CLP or CLP Regulation stands for Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. It came into force on 20 January 2009 and applies across the European Union.

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EBRC Consulting GmbH Services

Industrial Chemicals – REACH

Data Gathering, Literature Searches and Evaluation

Data-Gap Analysis, Closing of Data-Gaps and Study Monitoring

Chemical Safety Assessment (CSA) Services

PBT and vPvB Assessment Services

Risk Characterisation Services

Chemical Safety Report (CSR) Services

Classification and Labelling (GHS / CLP) Services