News

FoBiG together with partner aproxima are performing a study on behalf of the Bundesinstitut für Risikobewertung – BfR on consumer exposure. 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. These data are targeted to improve REACH exposure assessments for consumer products; the methodology should be applicable to any kind of consumer product.

For further information, please contact Klaus Schneider.

Metalworking fluids (MWFs) used in metal processing are often mixtures of numerous individual substances (e.g., for lubrication, as extreme-pressure additives, biocides, etc.). As a result, questions frequently arise as to whether certain substances are still to be expected in MWFs according to the current state of the art, or whether an identified ingredient poses a health concern. For this reason, a working group consisting of metalworking fluid users (VKIS), metalworking fluid manufacturers (VSI), and employees involved in their application (represented by the Industrial Union of Metalworkers, IG Metall) publishes an annual list (“VKIS-VSI-IGM Substance List for Metalworking Fluids”), documenting, for example, occupational exposure limits, restrictions on use, or maximum concentrations in MWFs (see link below).

As a supplement and in greater depth, FoBiG, with support from the German Social Accident Insurance Institution for the woodworking and metalworking industries (BGHM), developed a “Metalworking Fluid Components Online Information System,” which classifies additional potential ingredients of MWFs and provides further information on many substances. For example, references are made to registration dossiers under European chemicals legislation (REACH), and the relevance of substances in MWFs is reported.

This Metalworking Fluid Components Online Information System now appears in a completely new format: the structure and design of the website have been entirely revised. The technical platform has also been changed. Links to the REACH registration dossiers have been updated. In terms of content, the occupational exposure limits (OELs) and classifications under the CLP Regulation in the fact sheets have been updated (as of October 2015). In addition to the updated fact sheets, all substance entries in the database have now been aligned with the new VKIS-VSI-IGM List of December 18, 2015.

Visit the new Metalworking Fluid Components Online Information System here! 

If you have any questions, please feel free to contact Jan Oltmanns.

The next deadline for submitting REACH registration dossiers (1 June 2018) holds several new features. In a contribution to CHEManager, FoBiG describes peculiarities for phase-in substances in the tonnage band 1 to 10 tons/year (regarding possibilities to waive studies for toxicity and ecotoxicity endpoints, and regarding exposure data). More information can be obtained in the publication (in German) Characteristics of REACh 2018 – in: CHEManager 05/2016 or as pdf document or contact Klaus Schneider.

A busy period lies behind us! FoBiG together with partners and experts for socio-economic analysis, RPA Ltd., worked on many applications for authorisation in parallel. In total, AfAs for 13 companies were successfully submitted in the last months. The AfAs were for uses of several chromates and ethylene dichloride.

Do you have any questions concerning the authorisation of chemicals under REACH? Please, contact Klaus Schneider.

We are seeking an employee for a permanent part-time position as a

Scientific Assistant / Project Assistant

with a variety of cross-functional responsibilities in the areas of project acquisition and project implementation (including research, analysis, and preparation of scientific data), as well as office administration. The following qualifications (based on a completed bachelor's degree or an equivalent qualification) are required:

• IT/Computer Systems, Website: assistance with minor technical issues, software updates, procurement of electronic equipment, liaison with external IT service providers, technical maintenance of our website, etc.
• Good knowledge of MS Office applications, particularly EXCEL^®, WORD^®, and PowerPoint^®
• Strong organizational skills
• Scientific and technical understanding

We expect candidates to have strong teamwork skills, social competence, the ability to learn quickly when faced with changing tasks, and a good command of English.

FoBiG is a private scientific consulting company specializing in toxicological risk assessment (not a laboratory) and has been based in Freiburg for more than 25 years.

We offer a positive working environment, challenging work with room for initiative, a high degree of flexibility (e.g., to balance private life and working hours), and appropriate compensation in a permanent position.

We look forward to receiving your application (exclusively in writing) by email at gabriele.haeffner@fobig.de or
by post to FoBiG, Klarastraße 63, 79106 Freiburg. Thank you!

The ‘REACH Baseline Study’, originally initiated by the European Commission (Directorate General EUROSTAT) investigates the impact of REACH on the risks caused by chemicals as well as the impact on the quality of the underlying data. The study has a strong time trend focus by repeating the assessments every 5 years. From the beginning, FoBiG was involved in the conceptualisation and the original study as well as in the 5 years update. As in the past, FoBiG together with colleagues from INERIS, DHI and under the lead of the Öko-Institut Freiburg is now engaged in the 10 years update of the study. The work is sponsored by the European Commission (Directorate General Internal Market, Industry, Enterprise and SME)

In case of questions, please contact our colleague Jan Oltmanns.

On January 5th 2016, a new implementing regulation (Regulation (EU) No. 2016/9) of the European Commission entered into force. This regulation provides provisions for data sharing for REACH registration purposes. Duties and rights of data owners and companies requiring the data for their registration dossiers, cooperation in SIEFs (“substance information exchange fora“) as well as cost sharing mechanisms are regulated. The principle “one substance, one registration” is emphasised. These rules are especially relevant for unexperienced companies with registration obligations in 2018 (last REACH registration deadline for phase-in substances).

For further information, please contact Klaus Schneider.

We thank you very much for the pleasant and fruitful cooperation during the past year and wish you great perspectives (not only on Ilulissat Icefjord), a Happy Holiday Season and a prosperous New Year!

Fritz Kalberlah and Karin Heine published an article in the loose leaf collection "Gefahrstoffe" (Welzbacher, Ulrich, Ed., 138. Update, October 2015; article only in German; ISBN: 978-3-8111-7730-7). Differences between German and international Occupational Exposure Levels (AGWs/OELs) as well as Derived No Effect Levels (DNELs) from European chemicals legislation (REACH) are discussed. Inter alia, the authors concluded that approximately 10 % of the DNELs may not be sufficient to insure occupational safety. However, despite this insecurity DNELs may be used as a rule in the absence of German AGWs or OELs. Differences between the assessment methods are described. It was found that some key studies used for the assessment of OELs are outdated in the meanwhile and that the use of a transparent assessment method is an important starting point for harmonization.

In case of any questions, please contact our colleagues Karin Heine and Fritz Kalberlah!

The Endpoint specific guidance R.7a was updated concerning endpoints skin corrosion/irritation and serious eye damage/eye irritation. In July 2015, the OECD updated several testing guidelines and published new ones regarding these endpoints (i.e. update: in vivo: TG 404 (skin); in vitro: TG 430, 431, 435 and 439; new - in vitro: TG 491 (STE) und TG 492 (EpiOcular)). These renewed and new testing guidelines are considered within the updated guidance. In general, in vivo testing is the standard information requirement of REACH Annex VIII (Column 1) for skin corrosion/irritation and serious eye damage/eye irritation. The reader of the guidance is reminded that due to the sequential nature of the REACH standard information requirements, at quantities of ≥10 tpa, the information requirements of Annex VII also apply. This means that in vivo testing has to be the last resort in case no adequate information can be gathered or obtained via in vitro tests. Currently, in vitro tests are able to assess skin corrosion and irritation as well as no classification can be justified, when combining several tests. There are adequate in vitro tests to determine serious eye damages and substantiate no classification. However, no validated prediction model exists to classify a chemical into eye irritation category 2 according to Regulation (EC) No. 1272/2008 (CLP). In case you have any questions regarding a current state of the art testing strategy for your chemicals, please contact our expert Ulrike Schuhmacher-Wolz.

Watch out for more news on testing skin sensitisation soon!

We are proud to announce that our colleague Karin Heine has received the certification of toxicologist DGPT! Congratulations to you, Karin!

In an article for 'Nachrichten aus der Chemie', the journal of the Society of the German Chemists (GdCh), Klaus Schneider together with RPA colleagues Tom Persich and Panos Zarogiannis report about their experiences with applications for authorisation under REACH. In recent years, the FoBiG/RPA team performed application dossiers for numerous Annex XIV-listed substances for chemical companies and consortia. The paper (in German) can be found here.