News

Employees of FoBiG have published an article on the safe use of epoxy resin products  in "sicher ist sicher", a technical journal for safety engineering, health protection and humane work design (German only). The article presents the many years of joint activities by experts from various fields (e.g. manufacturers, users, health and safety authorities, accident insurance companies). As a highlight, the newly developed ‘Gemischerechner’ for comparing the sensitizing potency of two technically similar epoxy resin products is presented.

If you have any questions, please contact Karin Heine.

FoBiG and Fraunhofer ITEM have applied the procedure for the identification of emerging chemical risks in the food chain (developed in a pilot study sponsored by the European Food Safety Authority (EFSA)) to chemicals registered under the REACH Regulation in a second EFSA-sponsored study. After the publication of the external scientific report by EFSA, the key results of this study have now been published in the journal Environmental Science: Processes & Impacts. For all substances assessed, relevant input data and results are also available to interested stakeholders for further analyses.
Please contact Jan Oltmanns for further information.

We are at the end of 2019, but in the midst of thrilling projects – here just some highlights: on behalf of the German authority BAuA we are working on methods for deriving occupational exposure limits: what is the empirical basis for quantifying assessment factors? Many applications for authorisation under REACH keep us busy. Together with colleagues of RPA we prepared one of the first review reports, which received (as the first review report ever) a 12 years’ review period recommendation from RAC/SEAC in 2019. And we finalised the toxicological assessment of end-of-life tyre granulate used as infill material for artificial turfs – results will be published soon.

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 the New Year 2020!
 
And, at last, a brainteaser again. Biochemists are at an advantage, but we are sure that all of you will find out the meaning.

The European Commission is planning to define standard information requirements (REACH Annexes VII-X) to evaluate possible endocrine effects of chemicals registered under the REACH Regulation. Furthermore, a change of REACH Annex I is proposed to include an assessment of endocrine disruption as a separate entity (much like the assessment of PBT/vPvB properties that is already required). As a consequence, the Chemical Safety Report will be extended as well and the plans envisage that ECHA develops a corresponding Guidance Document.  While details of the standard information requirements are yet to be drafted, the work required for a chemical safety assessment is likely to increase substantially in the future.

Two webinars will be held in early November (see dates and times below). The webinars will focus on the ADCR, and its activities. In particular, the webinars will give participants the chance to ask any questions they may have and to raise any issues they are encountering in terms of the chromates authorisations. All Aerospace and Defence stakeholders are welcome to register by clicking on a date and time below.
Dates and times:
5 Nov 1600-1700 (CET)
6 Nov 1600-1700 (CET)

Melany Macherey was invited to the annual meeting of the German Association for Waste Oil (Bundesverband Altöl e.V., BVA), which was held on 19 and 20 September in Potsdam. She presented the results of the evaluation report on the classification of waste oils according to the CLP Regulation in the context of the assessment of wastes according to the accident prevention regulation, which FoBiG prepared on behalf of the BVA. The background of the report is the working aid for the classification of waste under Annex I of the 12th BImSchV ("NRW-Leitfaden"), which was published in summer 2018 and according to which waste oils are to be classified as environmentally hazardous substances pursuant to category E2 of Annex I of the 12th BImschV. The evaluation report assesses the relevance of contaminants in representative samples for the classification of oil mixtures.

Please contact Melanie Macherey for further information.

Due to their material properties, epoxy resins are used in many industries. While cured epoxy resins are dermally non-hazardous, ingredients of the starting components may have sensitizing properties that can lead to allergic skin reactions.. In the past, FoBiG was involved in two DGUV funded projects to assess the sensitizing potency of epoxy resin ingredients (FP-0324 and FP-0384, Heine et al. 2012, 2016). In order to supplement the work of the existing two research projects, the working group “Epoxy Resin Ingredients” (AK EIS) was founded in 2017 in addition to the existing working group “Epoxy Resins”. FoBiG scientifically supports the AK EIS. For example, a calculator, the “EIS-Gemischerechner”, was developed. It is a practical tool that compares two technically exchangeable epoxy resin products with regard to their sensitizing potency. The results of the extensive work of both working groups and the research projects is now available online on the updated epoxy resin page of the Federal Institute for Occupational Safety and Health (German only).

For further information, please contact Karin Heine.

Melanie Macherey and Markus Schwarz attended this year's conference of the Society of Environmental Toxicology and Chemistry (SETAC) Europe in Helsinki (26-30 May). Again this year, endocrine disruption was an important issue, also on account of the new "ECHA/EFSA Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009", published in June 2018. In order to meet the requirements of the Guidance, concepts were discussed and new scientific methods were presented, e.g. for modelling population-relevant adverse effects in non-target organisms or for identifying endocrine disruption of thyroid hormone signaling. There was also a lively discussion as to whether - in view of a hazard-based assessment in the EU - biological plausibility alone is sufficient, or whether the causality of the link is decisive if an adverse effect is to be assigned to a specific endocrine mechanism of action; and what role the mechanistic potency of a substance plays for this mechanism of action.
 

If an applicant is unable to implement substitution of a substance subject to authorisation within the review period of a granted authorisation, the applicant may submit a review report to request another authorisation. In the present case, FoBiG and our long-term partners from RPA Ltd have supported the Czech company Spolana s.r.o. in the submission of such a review report. In this context, more than 500 occupational measurements (air and biomonitoring) as well as several thousand measurements related to releases to the environment were evaluated in detail, extensively discussed and exposure values for risk characterisation derived. The resulting Chemical Safety Report (CSR) was submitted as part of the review Report. The recently published ‚RAC/SEAC Opinion‘ (available here) proposed a review period of 12 years as requested by the applicant and it is now to the European Commission to decide on the review period granted.

For further questions please contact Klaus Schneider.
 

Substances classified for reproductive toxicity are regulated in the European Union under the Chemical Agents Directive (CAD, Dirctive 98/24/EC).
A study on behalf of the Directorate General Employment, Social Affairs & Inclusion investigated, how effective protection with regard to reprotoxins at the workplace could be achieved and whether including them in the Carcinogens and Mutagens Directive (CMD, Directive2004/37/EC) would be beneficial. This study performed by a consortium under the lead of Risk and Policy Analysis, Ltd. und in cooperation with FoBiG, was recently published here.

For further informations please contact Klaus Schneider.
 

FoBiG and Fraunhofer ITEM have applied the procedure for the identification of emerging chemical risks in the food chain (developed in a pilot study sponsored by the European Food Safety Authority (EFSA)) to chemicals registered under the REACH Regulation. Starting from about 15 000 registered chemical, this EFSA-sponsored study identified 2 336 substances that met specific eligibility criteria. These substances were evaluated in relation to possible releases to the environment, biodegradation and potential accumulation in the food chain. Chronic human health hazards were assessed on the basis of classifications under the CLP Regulation. A total of 212 substances were identified as potential emerging chemicals risks in the food chain using the established methodology. This methodology and the detailed results were now published by EFSA as an external scientific report. Relevant input data and the key results for all 2 336 substances as well as a batch version of the ACC-HUMANsteady software, which was used to predict potential accumulation in the food chain, are made available and allow interested stakeholders to perform additional analyses.

Please contact Jan Oltmanns for further information.

Dose-response modelling (or benchmark dose modelling) is a key method for deriving health-based guidance values in a scientifically rigorous manner. Recently, an expert meeting took place in Geneva at WHO headquarters in order to facilitate the update of Chapter 5 (Dose-Response Assessment and Derivation of Health-Based Guidance Values) of the Environmental Health Criteria document 240: “Principles and methods for the risk assessment of chemicals in food”. Klaus Schneider took part as an invited expert. The updated chapter 5 is expected to be published in 2019.