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.

Recently ECHA published a clarification regarding the information requirements for cosmetic ingredients under REACH. According to ECHA data for all endpoints relevant to assess human health endpoints for workers are required, despite the test prohibition laid down in the Cosmetics Regulation. In consequence, information requirements for cosmetic ingredients will not deviate substantially from those of other REACH substances of the same tonnage band. For details see here.

This conference provides a state-of-the-art overview on the biocides regulation landscape. New developments and arising problems, such as nanomaterials or impact of CLP, resulting from the entry-into-force of the new Biocidal Products Regulation (BPR; Regulation (EU) No. 528/2012) in September 2013, are presented and discussed. If you have questions regarding biocidal product authorization, contact Klaus Schneider.