News

The European Chemicals Agency (ECHA) hosts another seminar on applications for authorisation under REACH in Helsinki on 29-30 June 2015 (in cooperation with Cefic and Eurometaux). At the seminar, FoBiG’s Jan Oltmanns will present the exposure assessment performed for an application for authorisation of Grupa Azoty S.A. (Tarnów, Poland) for a specific use of trichloroethene. The presentation will cover inhalation and dermal exposure assessment for workers as well as human exposure via the environment. Further information on the seminar is available on the ECHA website.

An article on a research project performed by FoBiG on behalf of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung (BfR)) was recently published in Regulatory Toxicology and Pharmacology. Default values used in tier 1 tools used for consumer exposure estimation (ECETOC TRA, EGRET (ESIG Consumer GES Risk and Exposure Tool) and REACT (Reach Exposure Assessment Consumer Tool)) were compared and consequences of differences in default values were discussed. The results of the study show that the defaults are generally conservative, but may potentially lead to underestimated exposures if modified defaults are not well founded.

Reports from two projects carried out by FoBiG on behalf of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung (BfR)) were published recently. The first report describes a feasibility study and systemically analyses consumer uses with potential chemical exposures and differentiates several ‘core exposure scenarios’ (CES; see the report ‘Validierung von Expositionsmodellen zur Abschätzung der Verbraucherexposition – Machbarkeitsstudie’).  The second report analyses tier 1 tools used under REACH for consumer exposure estimation (ECETOC TRA, EGRET und REACT). The focus is on the plausibility of the algorithms and the quality of the underlying parameter values (see report ‘Prüfung von Standardmodellen zur Schätzung der Verbraucherexposition’. Both reports are available in German only.

Please contact Jan Oltmanns if you like to know more about the publications.

Permitted daily exposures (PDE) are a central concept for the toxicological evaluation of impurities or residues in pharmaceutical products. PDEs are health-based values for assessing:

-   cross-over residues in pharmaceuticals produced in shared facilities in the context of cleaning validation (see EMA ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’)
-   residues in excipients used for producing pharmaceutical products (see e.g. EMA ‘Guideline on the specification limits for residues of metal catalysts or metal reagents’)
-   impurities in pharmaceutical substances such as solvents and threshold-genotoxins (see ICH Guidelines)

If you have further questions on deriving PDEs for substances in pharmaceutical products, contact Klaus Schneider.

Together with our RegisGate partners FoBiG offers a complete and comprehensive service for preparing authorisation dossiers for biocidal products under the BPR (Biocidal Product Regulation). We are pleased to announce a new release of the RegisGate website, offering a fast overview on partners and services. Have a look: www.regisgate.eu