News

FoBiG started a new project on behalf of DG ENV. The project is carried out within a framework contract between a consortium led by RPA, Ltd., UK, and the European Commission. This project aims at preparing draft CLH dossiers with proposals for harmonized classification and labelling of selected substances. These CLH dossiers will be submitted to ECHA by Member State Competent Authorities. 

For further information please contact Klaus Schneider.

Perfluorinated chemicals (PFC) are highly persistent and mobile in the environment. Foods are appreciably polluted with PFC, especially fish. Perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are the most prominent and well-studied representatives, which have been already evaluated by several organizations (e.g. European Food Safety Authority). FoBiG has derived guide values for oral exposure for 11 PFC and 4 only partially fluorinated derivatives, under consideration of a) endpoints with species specific mechanisms b) differences in elimination kinetics used for interspecies extrapolation and c) a pragmatic approach to consider combined effects at co-exposure. The assessment, for example, includes perfluorobutanoic-, -pentanoic-, … to decanoid acid; perfluorobutane, -hexane- and -octanesulfonic acid; 1H,1H,2H,2H-perfluorooctanssulfonic acid, 2H,2H-perfluordecanoic acid (report unpublished).

For further information please contact Fritz Kalberlah.

The consequences of the different options for classification of endocrine disruptors presented in the roadmap of the European Commission and by industry were analysed in a case study with natural substances. The results were presented at the Eurotox congress 2016 in Seville (abstract LBA07 and poster).

For further information please contact Ulrike Schuhmacher-Wolz.

We would like to supplement our scientific team.

For details you may have a look at the job posting.

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.

Our colleague Karin Heine will be giving a lecture on the topic of Regulatory Toxicology during the summer semester of 2016. The event is part of the lecture series Toxicology for Chemists and Natural Scientists, organized by the Chair of Experimental and Clinical Pharmacology and Toxicology at Albert Ludwig University of Freiburg. In addition to explaining the fundamental procedures used in the regulation of chemicals according to current standards, Ms. Heine will also present practical examples from the day-to-day work of a toxicologist.

If you have any questions or are interested, please contact Karin Heine directly!

The EU-wide harmonisation of emergency information on hazardous mixtures (e.g. some detergents, paints, adhesives) is laid down in Article 45(4) of the CLP Regulation. The EU commission is currently finalising its proposal. The CLP Implementing Regulation is expected in autumn 2016 and will enter into force later in 2016.

Importers and downstream users placing mixtures on the market that are classified for physical or human health hazards are obliged to submit information to Poison Centres. Poison Centres can then provide immediate support in case of acute poisoning.

In future (the exact date has not been confirmed yet), information must be submitted via an online-based XML reporting format. Details are required on the composition of the mixtures (identity and concentration ranges of ingredients) and information from the safety data sheet such as hazard classification and contact details. By the end of 2016, a new system of product categories will be implemented and a tool to generate a unique formula identifier (UFI). The UFI must be placed on the package label in order to enable a fast identification of the product.

For further information, please contact Marie-Léonie Bohlen.

Epoxy resin systems have excellent technical characteristics and are difficult to replace. Many components of epoxy resin systems can lead to allergies. Currently FoBiG is working on a project called “Ranking of Substances Included in Epoxy Resin Systems According to their Sensitising Potency” which is funded by the German Social Accident Insurance (DGUV; FP-0384). It is a follow-up project from a study performed in 2011/2012 (FP-0324, final report available at GISBAU homepage, only summary available in English). The focus of the ongoing project lies on validation of the chosen evaluation methodology, but mainly on closing of data gaps, which were identified in the previous project and thus contains an extensive test program. In addition, the list of the ingredients assessed has been enlarged and the issue of sensitizing potency of various formulations shall be discussed. The results of the project, especially a list of comprehensive characterization of components with regard to their sensitizing potency but also other properties, will be made publicly available. This is important to the target groups of the project, i.e. manufacturers and users of epoxy resin systems, occupational physicians and control institutions, to allow concrete actions. For example, it may allow manufacturers to develop epoxy resin systems with the least possible sensitizing potency. Users may assist this selection and thus substitution process with their demand patterns. The completion of the project is expected later this year.

For further information please contact Fritz Kalberlah.