News

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.

Due to contradicting statements regarding the number of plant species required for an OECD 208 study („Terrestrial Plant Test: Seedling Emergence and Seedling Growth“) FoBiG sent an inquiry to the German national REACH helpdesk. The answer: at least six plant species are required for a test to be considered a valid chronic study. Find more information here.

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.

FoBiG together with Fraunhofer ITEM tests a procedure for the identification of emerging chemical risks in food and feed under a contract awarded by the European Food Safety Authority (EFSA) in October 2014. This pilot study will select 100 substances registered under REACH and apply the procedure to check whether it is able to identify chemicals that may represent a risk in the food chain. The original procedure developed by EFSA, which will be adapted during the project, is described in detail in a technical report published by EFSA in 2014. The project will run for 18 months until March 2016.