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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.
 

The legally effective occupational exposure limit values (OELs) for the evaluation of hydrocarbon mixtures in Germany using the RCP methodology are published in the Joint Ministerial Gazette (GMBl, date: 30.11.2017). FoBiG carried out the revision and based on this work commented on the publication by McKee and colleagues "The reciprocal calculation procedure for occupational exposure limits for hydrocarbon solvents: an update" and compared them with the standards in force in Germany. The letter to the Editor is published here.