…Updated guidance on information requirements and chemical safety assessment (IR&CSA)

One of the key features of the latest version (4.0) of Chapter R.7a of the IR&CSA guidance is an updated section on the assessment of local toxicity (to the skin, eye and respiratory tract), comprising new information relevant to the testing and assessment of this endpoint, such as on quantitative structure-activity relationships (QSARs) and recently approved in vitro assays.

The section on reproductive and developmental toxicity testing has also been revised to include recommendations on the use of the new extended one-generation reproductive toxicity study (EOGRTS) and updated guidance on prenatal developmental toxicity testing.

A further update regarding skin and respiratory sensitisation is still in the draft stages (version 5.0).

European Chemicals Agency (2015). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance.

Version 4.0. July 2015. http://echa.europa.eu/documents/10162/13632/information_requirements_r7a_en.pdf

Draft version 5.0. July 2015. http://echa.europa.eu/documents/10162/13643/ir_csa_r7a_r7-3_guidance_sensitisation_draft_to_peg_en.pdf


…Guidance on substance identification for complex natural substances

The European Federation of Essential Oils (EFEO) and International Fragrance Association (IFRA) have, in consultation with ECHA, drafted guidelines on the substance identification of complex natural substances (e.g. UVCBs) such as essential oils under REACH and for classification and labelling purposes.

European Chemicals Agency (2015) news alert (ECHA/NI/15/28).


EFEO/IFRA (2015). Guidelines on substance identification and sameness of natural complex substances (NCS) under REACH and CLP. 5 August 2015. http://efeo-org.org/wp-content/uploads/2015/08/EFEO-IFRA-Guidelines-NCS-SID-REACH-CLP-Version-5-August-2015.pdf


…Applications for authorisation

ECHA welcomes comments by 7 October on various applications for the authorisation of uses of 1,2‑dichloroethane, sodium chromate, sodium dichromate and chromium trioxide.

European Chemicals Agency (2015). Applications for authorisation – current consultations. http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation


…Other items of interest

Draft updated Part E (risk characterisation for physicochemical properties) and Chapter R.15 (consumer exposure estimation) of the IR&CSA guidance sent for consultation to ECHA’s Partner Expert Group.




Video tutorials released for ECHA’s Chemical Safety Assessment and Reporting tool (Chesar).



New version of fee calculation plug-in available for IUCLID.



Testing proposals involving vertebrate animals: request for information from third parties on three substances (deadline 14 or 22 September).




The above items were taken from the September 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

News Home Guest Write For Us? Contact Us