News

On June 13th, 2017, a workshop called "Epoxy resin systems and allergies" takes place in Vienna. The event is organized by the General Accident Insurance Association (AUVA, Austria; the workshop language is German). Current research results and the situation with regard to skin diseases and skin treatment as well as current measures for prevention are presented. Among other things, FoBiG employees present the results of a current project (final report of DGUV FP-0384) supported by German Social Accident Insurance (DGUV). The aim of the project was to evaluate the sensitizing potency of as many ingredients of epoxy resin systems as possible, and to demonstrate the possibilities to incorporate the results into the practical evaluation of the epoxy resin systems. Registration for participation in the workshop is required.

For further Information, please contact Karin Heine.

FoBiG’s staff member Jan Oltmanns will present the results of the first EFSA study on the identification of emerging chemical risks in the food chain at the 13th European Symposium on Food Safety of the International Association for Food Protection (IAFP; Brussels, 29-31 March 2017). The study was performed by FoBiG and Fraunhofer ITEM on behalf of the European Food Safety Authority (EFSA) and the results were published in 2016. The study will also be presented with posters by Fraunhofer ITEM at the 83rd Annual Meeting of the German Society for Experimental and Clinical Pharmacology and Toxicology (Heidelberg, 6-9 March 2017) and the 56th Annual Meeting of the Society of Toxicology (Baltimore, 12-16 March 2017). As already posted here, FoBiG and Fraunhofer ITEM are currently involved in a follow-up project on behalf of EFSA that extend the procedure tested on 100 substances to all substances registered under REACH.

For further information, please contact Jan Oltmanns.

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. 

Many thanks to all our friends, partners and clients working with us in these exciting times. We wish you a well-deserved break, a relaxing Christmas holiday and a perfect start into a Happy New Year 2017!

FoBiG is growing older …
In 2016, it is 30 years from the very beginnings of FoBiG. And next year we will celebrate the 25th anniversary of the foundation of FoBiG as a GmbH (private limited company). On this account, this year’s Christmas card motive is hinting to our company’s history (see explanation below). The experience gained in all these years is our treasure in the demanding and constantly changing world of regulatory toxicology and risk assessment.

… and is getting younger and younger: Welcome to the team, Henrike (H. Berkefeld, biologist) and Anne (A. Bierwisch, toxicologist)!

Our cover picture: Twenty-five symbols for 25 years since the GmbH came to life make a Christmas tree: during these years the company was located at different places in Freiburg, from early beginnings in the Gerberau (3 years there = 3 nuts) to the 14 years we spent in Werderring (oranges) to our (not so new anymore) location in Klarastraße (stars). Neurotransmitters of various kinds and amounts flooded our circulations from time to time.

We are proud to announce that our colleague Markus Schwarz has received the certification of ecotoxicologist (GDCh/SETAC GLB)! Congratulations to you, Markus!

On 22 November 2016 the European Commission hosted a workshop in Brussels on “Acceptable level of risk to workers and consumers exposed to carcinogenic substances”. The workshop’s objective was to discuss how risk-based reference values for carcinogenic substances without threshold can be set for workers and the general public. Fritz Kalberlah (Chairman of the working group on exposure-risk relationships, German Committee for Hazardous Substances, AGS) was moderating a discussion panel on “Acceptable level of risk at the workplace”.
More information can be found here or by contacting Fritz Kalberlah.

FoBiG together with colleagues from the Öko-Institut has developed and maintained Eurostat’s chemical indicator set for many years and is also currently involved in further maintenance of these indicators until 2019. The indicators basically monitor changes in the production and consumption volumes of substances that are hazardous to human health or the environment. Eurostat has now published the statistical working paper 'Compilation of chemical indicators – Development, revision and additional analyses' authored by staff from FoBiG and Öko-Institut. The working paper summarises the basic methodology for these indicators and provides additional background information. It is freely available online.

For further information, please contact Jan Oltmanns. 

FoBiG’s work within two research projects was presented on two poster presentations at this year’s International Societey of Exposure Science Conference from October 9 to 13 in Utrecht. The project ‘Testing a procedure for the indentification of emerging chemical risks in the food chain’ was presented by EFSA staff and has been a joint research project by Fraunhofer ITEM and FoBiG. The project ‘Consumer behavior – compilation and evaluation of primary data’ was presented by the Federal Institute for Risk Assessment Germany (BfR) and has been a research project completed by FoBiG at the end of 2015. The abstracts of both poster presentations are available here.

For further information, please contact Jan Oltmanns.