…on temporary procedures for inquiries…

Every potential registrant of a non phase-in substance (or a phase-in substance that has not been pre-registered) must inquire of the European Chemicals Agency (ECHA) whether a registration has already been submitted for the same substance. However, as the inquiry functionality is not yet available on the REACH-IT portal, ECHA has issued instructions (via its website at http://echa.europa.eu/reachit/inquiry_en.asp) on the temporary procedure to be used.

Potential registrants are required to submit certain information that must be created in IUCLID 5, but since it is not possible using this software to identify some new studies that need to be carried out, an “information requirements form” (http://echa.europa.eu/reachit/list_prod_en.asp) should also be attached to section 13 of the IUCLID 5 substance datasheet. Procedures for doing this and for submitting the dossier are described in a new ECHA publication. [European Chemicals Agency. Data Submission Manual 2. How to prepare and submit an inquiry dossier (Release 1.2). Dated 10 July 2008 (http://echa.europa.eu/doc/reachit/how_to_prep_sub_inquiry_doss_en_20080529.pdf).] {178836}

For further help on inquiry dossiers, potential registrants may find it useful to consult a list of questions/answers prepared by ECHA. [European Chemicals Agency. Questions and answers on inquiry (Release 1). Dated 21 August 2008 (http://echa.europa.eu/doc/reachit/echa-08-qa-03-en_inquiry_qa_20080821.pdf).] {178835}

Those requiring only a broad overview of these submission procedures may find a recently issued two-page leaflet instructive. [European Chemicals Agency. How to submit data to ECHA (Release 2.2) (http://echa.europa.eu/doc/reachit/data_submission_leaflet_20080724.pdf).] {178834}

…and guidance documents

A new document with the self-explanatory title “Guidance on information requirements and chemical safety assessment Appendix R.7.13-2: Environmental risk assessment for metals and metal compounds” (dated July 2008) is now accessible from the internet (by visiting . {177085}

Other parts of the document on “Guidance on information requirements and chemical safety assessment” (reported in Toxicology and Regulatory News 2008, 47(7), 110) that appear to have been updated (without any such indication on the ECHA website) are chapters R2, R13 and R18 (July 2008) and parts D and G and chapters R7b, R12, R13 and R15 (versions 1.1; May 2008). The latest versions of these documents can be downloaded by appropriate finger clicks (via . {177085}

The above items were taken from the October 2008 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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