News

In mid-July 2015, the second supplement to “Drinking Water Update” was published, the standard reference work newly released in 2014 containing legal, technical, and health-related information on all aspects of drinking water. The current supplement includes a contribution by FoBiG employee Ulrike Schuhmacher-Wolz on “Arsenic in Drinking Water.” In addition, the supplement contains publications on nickel and phosphate in drinking water, as well as articles on by-products of drinking water disinfection and residues of human pharmaceuticals and their transformation in the environment and during water treatment. “Drinking Water Update” is published by Erich Schmidt Verlag. Further information can be found here. Or send an email to Ulrike Schuhmacher-Wolz.

In June the 80. Joint FAO/WHO Expert Committee on Food Additives (a joint expert group of the World Health Organisation and the Food and Agriculture Organisation of the UN for the evaluation of food additives and contaminants) convened in Rome. Our general manager Klaus Schneider was invited to participate and contribute as an expert to the toxicological evaluation of pyrrolizidine alkaloids and non-dioxin-like polychlorinated biphenyls (ndl-PCB). Results will be published in the JECFA series.

For further information please contact Klaus Schneider.

In Germany, the use of wood preservatives containing creosote requires an authorisation since 1st of May 2013. In 2013, FoBiG analysed the current uses of these preservatives and possible alternatives in a research project on behalf of the German Federal Environmental Agency. The project report is available now (in German and English abstract).

If any questions arise, please contact Martin Hassauer or Ulrike Schuhmacher-Wolz.

ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) have recently published their final ‘combined’ opinion on the industrial use of trichloroethylene as a process chemical in caprolactam purification.  The use was applied for in an application for authorisation submitted in August 2014 by Grupa Azoty S.A., one of Poland’s largest chemical companies.

FoBiG and their authorisation associates, RPA, were responsible for the development of the application dossier and collaborated with Grupa Azoty S.A. throughout all stages of the process.

In the opinion, the RAC concluded that the risk managements measures and operating conditions described in the application were “appropriate and effective in limiting the risk to workers and the general population” and according to the SEAC “benefits of continued use that by far outweigh the risks” were demonstrated.

The RAC did not provide advice on the proposed length of the review period to SEAC, which concluded that 12 years was appropriate based on the information submitted by the applicant and the committees’ pre-established criteria.

Marek Pabis, Grupa Azoty S.A. REACH Representative, hailed the recommendation as a “tremendous success for both the consultants and the company”, adding that Grupa Azoty S.A is “very satisfied with the opinion, which will allow sufficient time for the company’s transition to a feasible alternative, as essential for our future business survival”.

Discussing the parties’ collaborative efforts, Mr Pabis noted that cooperation and communication with RPA and FoBiG was “smooth, fast and effective”.  “They are committed to the job, responsible, punctual, reliable and always ready to assist and help. Both companies possess considerable expertise and the experience required to elaborate an authorisation application. Grupa Azoty had already cooperated with them and they had always been successful in previous projects. Their contribution was enormous”.

The combined opinion will now be send to the European Commission who will take the final decision on the application.  A summary of the decision will be published in the Official Journal of the EU.

Coal-fired power plants make a significant contribution to mercury emissions into the environment. Against this background, FoBiG prepared an expert report on behalf of Greenpeace that further characterizes the significance of mercury for humans and the environment:
(1) We examine trends in exposure (primarily through the consumption of contaminated fish by people in Europe) over recent years and attempt to look ahead to future developments. (2) We compare mercury exposure with existing assessment values. (3) We evaluate the level of protection provided by these assessment values. (4) Using evidence of links between Alzheimer's disease and mercury exposure, we discuss the uncertainty associated with these assessment values and explain the existing concerns. (5) We point out that mercury is often considered only in terms of its effects on human health, although this heavy metal also has serious impacts on living organisms in the environment, and we attempt to assess these findings in a concluding evaluation (more). The study was completed in April 2015.

If you have any questions, please feel free to contact Fritz Kalberlah.

A new research project on behalf of the German Federal Environmental Agency – led by FoBiG and with partners Hydrotox and ECT – will investigate and further develop methods for assessing persistence in substances, such as screening tests for ready biodegradability. In 2016, project results will be presented at an international workshop in Dessau.

For further questions please contact Klaus Schneider.

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.

The German translation of Regulation (EC) No. 1272/2008 (CLP) has been revised, including partial updates to the wording of the precautionary statements (P-statements). The correction was published on April 10, 2015, in the Official Journal of the EU (L94, Vol. 58, page 9). The old wording may only be used for another 18 months. A tabular overview of the current versions of the P-statements can be downloaded from the website of the Federal Institute for Occupational Safety and Health at Safety advice for hazardous substances .

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