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Consolidation of risk information on mixtures under REACH
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Commissioned by:
German Federal Environment Agency
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Consultants:
Institute for Enviromental Strategies, Germany
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Duration:
2010-2011
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| Background |
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Formulators producing mixtures from substances and/or mixtures are required to consider substance-specific information of the components of the mixture in the development of their (extended) safety data sheet (eSDS = safety data sheet plus exposure scenario (ES). The formulator may forward the ES of the components without modification or consolidate the information into one exposure scenario for the mixture of integrate the information in the safety data sheet. The important aspect is that the relevant and important information are selected and adapted to the specific uses and the knowledge and competences of the downstream users, if necessary.
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| CEFIC has developed a method to consolidate information which should be forwarded with classified mixtures, which is based on the principles of classification and labeling of mixtures (dpd+-method). The method cannot be applied to substances of very high concern (SVHC). Regarding the environmental risks the method uses the R-phrases R50 to R53 to identify the so called lead substances, which are assumed to determine the overall risk of the mixture. |
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| The ECHA guidance for downstream users also describes an approach to consolidating information for mixtures. In contrast to the dpd+-method it is recommended to select the “critical components” based on |
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- PNECs or the quotient of PEC/PNEC of the components without further processing
- Use the classification only in those cases, where PNECs are not available,
- Consider 4 exposure pathways of the environment: water, soil, air and sediments
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| Objectives
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The aim of the project is to evaluate if the operational conditions of use and the risk management measures selected in accordance with the DPD +-method ensure the safe use of a mixture. It will be analyzed if: |
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- The information received in safety data sheets and exposure scenarios or according to article 32 is appropriately considered in forwarding risk information with his mixture
- The used information fulfills the requirements to ensure safe us under REACH and hence ensures that DU has sufficient information to adequately control the risks.
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| The requirements to the risk assessment under REACH will be used as quality standard in the evaluation. However, it will be taken into account and made clear that there is a difference between the legal obligations to formulators and the activities necessary to provide a scientifically sound assessment according to best practice. |
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| Core aspects for the evaluation are the procedure and principles for selecting lead substances (development of the lead substance indicators), the adequacy of operational conditions identified using the DPD +-method and the method as such. |
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| Tasks and approach |
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The analysis of possibilities and limitations of the DPD+-method will comprise a comparison with other methods and approaches for assessments of mixtures, to identify potential underestimations of risk in the selection of lead substances. In addition, the potentially identified weakness will be tested by theoretical case studies, in the frame of which exposure scenarios of substances will be consolidated to an exposure scenario for mixtures using different methods. Based on the example exposure scenarios, consequences of using the CEFIC-method as compared to other approaches will be identified and discussed with regard to their relevance in practice. |
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| Expected results |
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| The main result of the project will be a report describing the analysis and results of evaluating the dpd +-method. It will also contain information on alternative approaches and their usefulness under REACH as well as recommendations for possible improvements or the development of alternative or more detailed methods for consolidating information for mixtures. |
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| Contact |
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| Antonia Reihlen |
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| Olaf Wirth |
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| Dirk Jepsen |
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