As in the years before, the working group on Regulatory Toxicology of the German Society for Toxicology will organise an Advanced Course in the frame of the DGPT’s Annual Meeting  (2nd German Pharm-Tox Summit - 83rd Annual Meeting of the DGPT). This year the course, which will take place on the 6.3.2017, will focus on „Recent developments in exposure assessment“). Klaus Schneider of FoBiG will present results from an ongoing project on behalf of the Federal Institute for Risk Assessment (BfR). In this feasibility study it is investigated how the database on input parameters important for assessing chemical exposure from consumer products (frequency and duration of use, amounts used…) can be improved by consumer surveys.

ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have recently published their final ‘combined’ opinion on Dow’s (Dow Italia S.R.L and Dow France SAS) industrial use of 1,2-dichloroethane (EDC) as a sulphonation swelling agent of polystyrene-divinylbenzene copolymer beads in the production of strong acid cation exchange resins. In their positive opinion the committees recommended a 12 years review period. FoBiG and their authorisation associates, RPA, were responsible for the development of the EDCAC (EDC Authorisation consortium) application dossiers and collaborated with Dow representatives throughout all stages of the process.

Mieke Diebold, EHS Product Steward Manager at Dow Chemical Company, noted that “Dow is very pleased with the outcome of the ECHA opinion” and highlighted that “the cooperation and communication with both FoBiG and RPA was professional, efficient and all time corridors were met”. Further discussing the parties’ collaborative efforts, Ms Diebold noted that “both RPA and FoBiG are committed to get the job well done. They have the required background knowledge and are always ready to assist, both during the dossier creation and the communications with ECHA after the submission. Throughout the process, RPA and FoBiG were reliable and experienced partners. I can highly recommend them!”

If you would like to find out more about FoBiG’s REACH sevices regarding authorisation please contact Klaus Schneider.

In December 2016 the updated Endpoint specific guidance R.7a was published including changes concerning skin and respiratory sensitisation. In terms of mechanistic understanding, skin sensitisation is well understood and key events occurring are mapped within the Adverse Outcome Pathway. Based on that, for several key events in vitro/in chemico testing guidelines (OECD TG 442 C/D/E) are now available. The updated guidance takes into account these in vitro/in chemico tests as well as in silico approaches and presents an Integrated Approach to Testing and Assessment (IATA). This IATA is in accordance with the revised Annexes VII and VIII of the REACH Regulation (Commission Regulation (EU) 2016/1688), in which in vitro/in chemico testing are standard requirements and in vivo testing is only last resort. With the currently validated in vitro/ in chemico testing guidelines only hazard identification is possible, according to CLP potency assessment is required, yet. Potency assessment is currently subject of research.

In case you have any questions please contact our expert Karin Heine.

After FoBiG – together with colleagues from Fraunhofer ITEM – finished a study for the European Food Safety Authority (EFSA) in 2016 (published here), which tested a procedure for the identification of emerging chemical risks in the food chain, the procedure will be applied to all substances registered under REACH in a new study for EFSA. The project will be carried out by FoBiG in collaboration with Fraunhofer ITEM. It starts in January 2017 and has a duration of 2 years.

For further information, please contact Jan Oltmanns

FoBiG together with Fraunhofer ITEM has evaluated the effectiveness of protective gloves, suits and other dermal personal protective equipment under contract of the German Federal Institute for Occupational Safety and Health (BAuA). Relevant dosimetry and biomonitoring studies were selected based on an extensive literature survey. From these studies, datasets with minimum information for identified for a quantitative evaluation of efficiency values. A sufficient number of datasets allowing a statistical evaluation of the efficiency values was only retrieved for protective gloves and suits. Additional analyses, e.g. on the impact of the monitoring method, the study design, the length or the state of protective gloves did not allow drawing definitive conclusions since important information was missing in the studies. Due to these problems, common default values for the efficiency of dermal personal protective equipment could not be reliably confirmed or refuted with the data generated. The final report (in English) was publlished by BauA .

For further information, please contact Jan Oltmanns