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FoBiG started a new project on behalf of DG ENV. The project is carried out within a framework contract between a consortium led by RPA, Ltd., UK, and the European Commission. This project aims at preparing draft CLH dossiers with proposals for harmonized classification and labelling of selected substances. These CLH dossiers will be submitted to ECHA by Member State Competent Authorities. 

For further information please contact Klaus Schneider.

Perfluorinated chemicals (PFC) are highly persistent and mobile in the environment. Foods are appreciably polluted with PFC, especially fish. Perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are the most prominent and well-studied representatives, which have been already evaluated by several organizations (e.g. European Food Safety Authority). FoBiG has derived guide values for oral exposure for 11 PFC and 4 only partially fluorinated derivatives, under consideration of a) endpoints with species specific mechanisms b) differences in elimination kinetics used for interspecies extrapolation and c) a pragmatic approach to consider combined effects at co-exposure. The assessment, for example, includes perfluorobutanoic-, -pentanoic-, … to decanoid acid; perfluorobutane, -hexane- and -octanesulfonic acid; 1H,1H,2H,2H-perfluorooctanssulfonic acid, 2H,2H-perfluordecanoic acid (report unpublished).

For further information please contact Fritz Kalberlah.

The consequences of the different options for classification of endocrine disruptors presented in the roadmap of the European Commission and by industry were analysed in a case study with natural substances. The results were presented at the Eurotox congress 2016 in Seville (abstract LBA07 and poster).

For further information please contact Ulrike Schuhmacher-Wolz.

FoBiG and project partner aproxima are currently performing a study on behalf of the Bundesinstitut für Risikobewertung – BfR on chemical exposure from consumer products. This feasibility study aims at developing a methodology, which can be used to perform representative surveys to gather data on amounts, duration and frequency, conditions of uses and location of use. The experimental survey phase starts in August 2016, with the following exemplary consumer products: hand dishwashing liquids, cockpit spray (car interior cleaning products), putty, paints and varnishes (used in the home area), plastic (or rubber) shoes, writing utensils (such as pens and pencils). Various methods (questionnaires, re-call methods, diary documentation, video documentation) will be applied to retrieve information on consumer behaviour from survey participants. Results are expected to become available in early 2017.

For further information, please contact Klaus Schneider.

After an agreement in June 2016 between the European Council and the European Parliament two new EU Regulations for medical devices and in vitro diagnostic medical devices are underway, replacing existing Directives. The Regulation on medical devices, which will probably be adopted next year, will contain a 0.1% concentration limit for category 1A and 1B CMR substances and for endocrine disrupting chemicals. Medical devices with such substances above this concentration intended to come into direct contact with patients have to be labelled accordingly and, if they are used for treatment of children or pregnant or nursing women, a specific justification, based on a scientific assessment and an analysis of alternatives, is required.

More information on the EU rules for medical devices can you get here or by contacting Klaus Schneider.