News
ECHA recently released its “Progress Report 2014”. It provides valuable information for registrants for preparing their REACH registration dossiers.
Key recommendations concern
- correct information on identity and composition of substances (e.g. with regard to isomeric forms)
- the content of IUCLID study records to consider them “robust” study summaries
- the adequate presentation of testing proposals in IUCLID
- the correct and complete documentation of QSAR results
- justification for read-across and grouping
- use mapping and exposure assessment (including proper justification for use of certain environmental release factors or spERCs)
Here you can find the “Progress Report 2014” next to further information.
The regulatory ordinance ‘TA Luft’ limits emissions of carcinogenic substances into ambient air in section 5.2.7.1.1. Carcinogenic potency is addressed by a “unit risk” term (estimated excess risk for cancer morbidity per µg/m³). Three potency categories are discriminated. This project was finalized in February 2015 covering the update of 24 existing classifications and an analogue extension for further 11 carcinogenic chemicals. The respective proposals were developed by FoBiG within a contract from the German environmental protection Agency (Umweltbundesamt; Projekt UBA Z6-55682/1) and were discussed with an expert committee for the purpose of an upcoming update of the regulatory ordinance. For further information you may contact Fritz Kalberlah at FoBiG.
The reciprocal calculation procedure (RCP), which is designed to establish occupational exposure limits for refined hydrocarbon solvent vapour mixtures, was updated by FoBiG in a project funded by the German Social Accident Insurance (DGUV). The proposal includes restructuring of hydrocarbon groups, lower hydrocarbon group guidance values (GGV) based on available data and exclusion of various substances from GGV. First results will be presented in a poster at the Occupational health research conference in April 2015 in Nancy. Have a look at the programme.
Currently, protection of drinking water is not explicitly addressed of European chemicals regulation under REACH. In cooperation and by financial support of the German Environmental Protection Agency (Umweltbundesamt, Dessau, Germany) FoBiG developed a concept to characterise substances as being ‘persistent’ (P), ‘mobile’ (M) and ‘toxic’ (T) in raw water. Identification of PMT substances enables avoidance and/or restriction of such chemicals. For this purpose, it was necessary to provide transparent and conclusive definitions for PMT properties. The internal project report (UBA-FKZ 371265416) was finalised in November 2014 and will be publicly available later in 2015. The project will be presented at the SETAC 2015, meeting in Barcelona, Spain. For further information please contact Fritz Kalberlah.
In collaboration with Prof. Birgit Grahl (Integrahl – Industrial ecology, Heidkamp, Germany) and Dr. Eva Schmincke (PE International, Tuebingen, Germany) FoBiG is developing an indicator to characterise potential health impact from construction products within the environmental product declaration (supplemental information according to ISO 14025). This indicator TOXSCALE applies and combines REACH derived information according to principles derived from life cycle assessment (LCA). First area of application are construction products with the option, to extend the indicator to the building level and to also integrate potential ecotoxicological impacts. The development of this first stage of TOXSCALE is sponsored by BASF, Ludwigshafen, Germany. The project will be presented at the SETAC 2015, meeting in Barcelona, Spain. For further information you may contact Fritz Kalberlah.
As every year the AK Regulatorische Toxikologie of the German Society of Toxicology organises an Advanced Course as part of the annual meeting of the society, this year on the topic REACH. Based on real case studies industry and authority representatives will discuss with attendees requirements on toxicological studies and assessments. Please have a look at the programme.
On behalf of the German Social Accident Insurance for the woodworking and metalworking industries, FoBiG updated the online information system for metalworking fluid components in January 2015. Following this update, the online system contains information on more than 370 metalworking fluid (MWF) components, and for nearly 60 of these substances, additional information is available in the form of data sheets. The new version includes the information from the VKIS-VSI-IGM substance list for metalworking fluids according to DIN 51385 for metal processing, adopted in December 2014, updated occupational exposure limits, and classification information in accordance with the ECHA Classification and Labelling Inventory in the data sheets, as well as updated links to REACH registration dossiers, including an assessment of the relevance of the substances for metalworking fluids (as of 19 December 2014). You can find the metalworking fluid components online information system at http://www.kss-komponenten.de/index.html.
Dear friends, clients and colleagues
a methodology to screen for hazardous substances in raw and drinking water, substances in indoor air, cosmetic ingredients, and much more: 2014 again yielded exiting projects, with topics reaching from method development to substance-specific evaluations. And Authorisation under REACH came to full speed. Together with our partners we successfully submitted several dossiers. And there is more good news. Marie-Léonie Bohlen (MSc, University Amsterdam) joined our team In October and will support our ecotoxicology section.
We thank you very much for the pleasant and successful cooperation and wish you a Merry Christmas and a Happy New Year!
For all of you who are familiar with the Periodic Table of Elements this year’s brainteaser should not pose a problem. The solution is a German seasonal greeting. Have fun!
Annex VIII to X of the REACH regulation require in vivo testing for skin irritation except the specific rules for adaptation mentioned in column 2 apply. But, as outlined in a recent ChemicalWatch Webinar even if column 2 does not apply in vivo testing is not automatically necessary. According to Annex XI it can be waived if adequately and reliably documented results of validated in vitro assays which are sufficient for classification are available. For the endpoint skin irritation this refers to a validated in vitro assay on skin corrosion (e.g. OECD 430, 431 or 435) and – in case of a negative result – followed by a validated in vitro skin irritation assays (e.g. OECD 439). Please contact us for further information.
On 24.11.2014 EMA published the ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’, which describes the derivation of ‘permitted daily exposures’ (PDE). PDEs are health-based values for evaluating cross-over of pharmaceuticals produced in shared facilities and for the quality assurance in the context of cleaning validation. Important: the revised version of Annex 15 of the Good Manufacturing Guidelines (GMP) ‘Qualification and Validation’, which will become effective in June 2015, obliges manufacturers to perform a risk assessment for cleaning validation using PDEs. If you have furter questions, you may contact Klaus Schneider.
We would like to supplement our scientific team.