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.



FoBiG and partner Fraunhofer ITEM developed and tested a procedure to identify emerging risks in the food chain. The project was carried out under contract for the European Food Safety Authority (EFSA). EFSA now published the external scientific report, which is freely available online.

The principle approach to identify emerging chemical risks in the food chain is to combine exposure potential and toxic properties in a scoring and ranking procedure. The scope of evaluation is limited to chemicals registered under REACH (≥ 1 000 t/a), covering human exposure via the environment.

The procedure evaluates six blocks of individual endpoints, i.e. environmental exposure, biodegradation, bioaccumulation in food, repeated dose toxicity, reproductive and developmental toxicity as well as genotoxicity (carcinogenicity). A novel model (ACC-HUMANsteady) was used to predict bioaccumulation of chemicals in eleven different food and feed items to gain in-depth information on potential sources of emerging chemical risks in the food chain. During the development of the procedure, (Q)SAR predictions were also evaluated for the applicability and are integrated as part of the procedure.

A follow-up project is planned and will apply the new methodology to all chemicals registered under REACH in order to identify potential emerging risks in the food chain.

Do you have further interest or questions? Please, do not hesitate to contact Jan Oltmanns.

In a dispute over the interpretation of Art. 14 of REACH ECHA’s Board of Appeal (BoA) now (28 June 2016) filed a decision. The question was: is a registrant obliged to perform an environmental exposure assessment and risk characterization for a substance classified according to the CLP Regulation for human health endpoints, but not for environmental hazards? BASG AG contested ECHA’s interpretation, who answered this question with yes. BoA in its decision now confirmed ECHA’s position; the company has to submit the missing parts of the Chemical Safety Report.

ECHA now published the announced inventory of substances likely to meet the criteria of Annex III to the REACH Regulation. Together with instruction and examples how to gather relevant information and to check for the Annex III criteria the inventory is meant to help registrants of substances in the tonnage band 1 to 10 tonnes/year to decide whether they can register their substances in 2018 with a reduced information package (consisting of physicochemical data only).

For further information, please contact Karin Heine.